The Journal of Healthcare, Science and the Humanities (Spring 2011)

Journal of Healthcare, Science and the Humanities

Volume I, Number 1

Spring 2011

Journal of Healthcare, Science and the Humanities

Published by the Navy Medicine Institute for the Medical Humanities and Research Leadership, USN Bureau of Medicine and Surgery in partnership with the Smithsonian Institution Scholarly Press

Journal of Healthcare, Science and the Humanities

Volume I, Number 1, 2011

Smithsonian Institution Scholarly Press Published in cooperation with the Smithsonian Institution Scholarly Press. http://www.scholarlypress.si.edu/

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Prepared by Graphic Arts and Publishing Services at The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

Volume I, Number 1, 2011

Journal of Healthcare, Science and the Humanities

2011 Journal Editorial Board Editor: Edward Gabriele, DMin Senior Associate Editor: Bruce Boynton, MD Assistant Senior Associate Editor: Mary Adams, MTS

Administrative Officer/Manager: André B. Sobocinski

Senior Advisors: Jan Herman, MA Elizabeth Holmes, PhD, ABPP

Associate Editors: José A. Acosta, MD, MBA, FACS Shaun Baker, PhD Charmagne Beckett, MD Brett Cook, JD Michael Cowan, MD Eric Elster, MD Lisa Gleason, MD Christine Kasper, PhD, RN Patricia Kelley, PhD, RN John Sanders, MD Lorenzo York, DMin

Office of Counsel: Salvatore Maida, JD, LLM, MBA Office of Public Affairs: Joseph Surette, MA, APR Development Officer: L. Edward Antosek, DO, MPH Academic Review Committee Chair: Eric Elster, MD Members: Ibrahim Adib, MD, MPH Angelica Almonte, PhD, RN Lyndsay Baines, PhD Coleman Bryan, MD, MSPH Vaughan Caines, MSc Bruce Cohen, MD, MPH, FAAFP Mary Pat Couig, MPH, RN, FAAN Marlene DeMaio, MD Mill Etienne, MD Joseph Ford, MSW James Giordano, PhD Brent Glass, PhD Exnevia Gomo, PhD Eric Hall, PhD Anne Harding David Harlan, MD Jason Higginson, MD John Howe, MD Michele C. Huddleston, MS, RN Rahul Jindal, MD, PhD, FACS, FRCS Linda Kimsey, PhD David Langley, PhD Scott Miller, PhD Paul Ndebele, MSc, PhD (cand) Michael Owen, PhD Scott Pyne, MD James Rapley, MD James Ragain, DDS, PhD, FICD, FACD Ann-Marie Regan, MSOD Jason Robert, PhD Thomas Roberts, PhD Shelia Robertson, MDiv Shawn Safford, MD Journal of Healthcare, Science and the Humanities

Fabian Sandoval, MD Elizabeth K Satter, MD Catherine Schempp, PhD, RN J. Michael Slocum, JD Dale Smith, PhD Bruce Steinert, PhD, CCRA Pam Vargas, MBA Michael Whitecar, MIS Richard Wilkerson, PhD Julie Zadinsky, PhD, RN Manuscript Editing Committee Interim Chair: Carol Parsons, PhD Members: Timothy Atkinson, EdD Linnea Axman, DrPH Ben J. Balough, MD Jere M. Boyer, PhD Bruce A. Cohen, MD Philip A. Cola, MA Mark Flores, MBA Darlene Gilson Mary I. Greenwood Anita Hartmann, PhD Richard T. Higdon, PhD (cand) Linda Kimsey, PhD Deirdre A. Krause, PhD, RN Michael J. Krentz, MD, MPH Jeb Kucik, MD Kendall Lane, MD Eric C. Nastasi, Esq Michael Payne, PhD Debra Schaller-Demers, MSOM Ashley A. Schroeder, MD Jessie R. Tate, DMin

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The Journal of Healthcare, Science and the Humanities In cooperation with the Smithsonian Institution Scholarly Press, The Journal of Healthcare, Science and the Humanities is published by the Navy Medicine Institute for the Medical Humanities and Research Leadership, USN Bureau of Medicine and Surgery, Washington, DC, USA. As an agency of Navy Medicine, the Institute supports the mission of the Navy Surgeon General and Navy Medicine itself for force health protection and readiness. The Institute is dedicated to the academic enrichment and professional development of Navy Medicine leaders and their collaborators in other federal agencies, in institutions of higher learning, and in private agencies around the world. Representing all of the arts and sciences related to healthcare, the Institute serves as an international academy serving Navy Medicine by enriching its mission of scholarship and innovation in systems healthcare and professional excellence on behalf of the public trust. ISSN (print): 2159-8800.

ISSN (online): 2159-8819.

Correspondence Manuscripts are to be submitted to the Editor. Submission of a manuscript is considered to be a representation that it is not copyrighted, previously published, or concurrently under consideration for publishing in print or electronic form. Contact the JHSH Editor for specific information for authors, templates, and new material. The preferred communication route is through email at Journal@med.navy.mil. To obtain copies, individuals may email the Journal Executive Leadership at Journal@med.navy.mil or call (202) 762-3817. Journal issues are available for download from the Navy Medicine Veterans and Alumni Association.

Copyright Information As a federally funded publication, the Journal is in the public domain. All material in the Journal that is subject to copyright may be reproduced only for limited non-commercial educational purposes with the written permission of the author and with appropriate credit. Opinions expressed in the Journal represent the opinions of the authors and do not reflect official policy of the Department of the Navy, the Smithsonian Institution, or the US Government. Papers prepared by employees of the US Government as part of their official duties are not copyrighted.

Photos: Courtesy of U.S. Navy 2

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Table of Contents Contributing Authors……………………………………….………...…..……...…5 Prelude

From the Editor’s Desk…………………………………………………..……...…11 Edward F. Gabriele

Articles

On Becoming a Healthcare Professional………………………….………..……15 Tonse N. K. Raju Pain Medicine from “Bench to Bedside”: Bridging the Disconnect(s) between Research and Clinical Care …………………………………….………22 James Giordano, Michael E. Schatman Health Policy for Renal Replacement Therapy in Developing Countries ….…41 Rahul M. Jindal, Edward M. Falta, Lyndsay S. Baines, Eric A. Elster Ethical Decision Making: A Process Influenced by Moral Intensity …….….…55 Sarah Hope Lincoln, Elizabeth K. Holmes Organizational Behavior and Learning in Healthcare Services: A Socio-Technical Systems Framework.……………………………………...…70 Thomas G. Mihara Prescribing Architecture: A Critical Evaluation of How Design Impacts Health and Wellness..…………………………………………........……89 James Shraiky

Special International Conference Reports

Military Forces, Global Health, and the International Health Regulations (2005) ………………………………..………………………………117 David P. Fidler Global Militaries Unite. Discussion of Responsibilities under the International Health Regulations (2005): St. Petersburg 2010………….……131 Kevin L. Russell, Matthew Johns, Robert Lipnick, Cecili Sessions

Young Scholars’ Corner

Reflections on the Current Status of Bioethics Education……………………143 Alexandra Mogyoros, Maxwell Smith, Diego S. Silva, Serena Purdy

Reviews

Book Review: Reforming Medicare: Options, Tradeoffs, and Opportunities (2008) ........…………….………………………….…………....…153 Carol A. Parsons Review and Commentary: Claims of Innocence (2010)....…...…….…………157 Vaughan Caines

Postlude

A Voyage of Discovery………………………….…………………………………163 Bruce R. Boynton, Jan K. Herman

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In This Edition Contributing Authors Lyndsay S. Baines, PhD is a Case Manager at Walter Reed Army Medical Center. Dr. Baines has worked in the United Kingdom and United States as a Medical Sociologist and Psychotherapist specializing in trauma and quality of life issues. She is the co-author of an important volume: The Struggle for Life: A Psychological Perspective of Kidney Disease And Organ Transplantation and a contributing author of Wounded Warriors: Diversity And Inclusion In A Culture of Uniformity.

Bruce R. Boynton, MD, MPH, FAAP is Senior Associate Editor of the Journal of Healthcare, Science and the Humanities. Dr. Boynton has had a distinguished career as a Naval Officer, pediatrician, researcher, educator, and hospital administrator. He was formerly the Executive Officer of Naval Hospital Sigonella, Italy; Commanding Officer, Naval Medical Research Unit - 3 in Cairo, Egypt; and Commanding Officer of the Medical Treatment Facility aboard USNS Comfort, a 1,000 bed hospital ship.

Vaughan Caines, MSc, is a forensic toxicologist enrolled in the graduate law program at the University of Bristol, UK; and active in The Innocence Project. Holding the master’s in forensic science from the University of Strathclyde, he has completed scientific internships with the Laboratory of the UK Government Chemist, and the Office of the Miami Medical Examiner. He has published book reviews, and also scholarly research concerning DNA identification and its importance in research ethics.

Eric Elster, MD, FACS is Deputy Director of Regenerative Medicine at the Naval Medical Research Center. He co-directs a translational research program focused on the development of improved diagnostics and therapies for serious traumatic injuries, transplantation and advanced operative imaging. CDR Elster is also an attending general and transplant surgeon at the National Naval Medical Center and Walter Reed Army Medical Center as well an Associate Professor at the Uniformed Services University.

Edward Falta, MD, FACS is the Integrated Chief of the Army Navy Organ Transplant Services at Walter Reed Army Medical Center. He serves on the teaching faculty at the Uniformed Services University of the Health Sciences. He also serves as a consultant to the Surgeon General of the United States Army.

David P. Fidler, JD, MPhil, BCL is the James Louis Calamaras Professor of Law at the Indiana University Maurer School of Law. He is one of the world’s leading experts on international law and global health. He has published widely in law, international relations, and public health journals, and he has served as an international legal consultant to government agencies, international institutions, and non-governmental organizations.

James Giordano, PhD is Director of the Center for Neurotechnology Studies of the Potomac Institute for Policy Studies, Arlington, VA, USA, and a Senior Research Associate of the Oxford Centre for Neuroethics, University of Oxford, UK. Dr. Giordano is also University Affiliate Professor of Neuroscience at the Krasnow Institute for Advanced Studies, George Mason University, Fairfax, VA, USA. His work focuses upon the neuroscience of pain, and neuroethical issues in research, therapeutics and national defense.

Jan Herman, MA holds a graduate degree in history from the University of New Hampshire where he also held a Ford Foundation Teaching Fellowship. He is Special Assistant to the Navy Surgeon General for Medical History and Archivist. As such he is the Navy Medicine executive

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In This Edition director for healthcare history and archives policy, programs, compliance, and development. He has produced historical Navy Medicine documentaries including “The Lucky Few” premiered at the Smithsonian Institution in 2010.

Elizabeth Holmes, PhD is Director of Assessment at the VADM Stockdale Center for Ethical Leadership, at the United States Naval Academy (USNA) in Annapolis, Maryland. At USNA, she has also been Professor of Psychology, Leadership and Ethics. Dr. Holmes has led a distinguished career of teaching and research in psychology, health promotion, and ethical leadership. She serves the ethics center as its liaison to USNA’s Academy Effectiveness Board.

Rahul Jindal, MD, PhD, MBA is a Transplant Surgeon at Walter Reed Army Medical Center, and Clinical Professor, The George Washington University. Dr Jindal has received an NIH award for improving quality of life for colo-rectal cancer patients. He is the author of two important volumes: The Struggle for Life: A Psychological Perspective of Kidney Disease And Organ Transplantation and The Story of the First Kidney Transplant in Guyana, South America: And Lessons for Developing Countries.

Matthew C. Johns, MPH is the Head of the Department of Global Outbreak Alert and Response/IHR Implementation within the Global Emerging Infections and Response System at the Armed Forces Health Surveillance Center. He completed his MPH training in global health and infectious diseases at Emory University in Atlanta, while he also worked as an epidemiologist at the US CDC. He was commissioned into the US Public Health Service as an officer in 2009.

Sarah Hope Lincoln, PhD (cand) was a psychology intern at the VADM Stockdale Center for Ethical Leadership, at the United States Naval Academy in Annapolis, Maryland. She is currently a clinical psychology doctoral student at Harvard University, Cambridge, Massachusetts, where she is teaching psychology undergraduates and pursuing research on brain functioning in schizophrenia.

Robert Jay Lipnick, ScD is Chief of the Communications, Standards & Training Division, Armed Forces Health Surveillance Center. Since graduating from Harvard University School of Public Health in 1983, Lipnick has served as an epidemiologist in numerous US and overseas assignments to include the Joint Staff, Office of the Army Surgeon General and the Uniformed Services University. He has numerous awards and decorations and has more than 20 peer-reviewed publications.

Thomas Mihara, PhD completed his doctorate in Health Services Management and is Associate Professorial Lecturer, Health Services Management and Leadership, The George Washington University. He holds dual graduate degrees in operations analysis and systems management.

He is a Credentialed Health Care Administrator & Fellow, American Academy of Medical Administrators & American College of Contingency Planner. Mihara holds additional designation in Certified Professional Healthcare Information & Management Systems; and is a Project Management Professional.

Alexandra Mogyoros, BAS is a JD candidate at the University of Ottawa. Her research interests mainly lie at the intersection of law and technology and health law. Her previous experiences include research on the Genome Prairie/Genome Canada funded project VALGEN, a clinical ethics internship, and a summer fellowship with the Ontario Genomics Institute. Ms. Mogyoros anticipates being engaged in bioethics education at Yale University’s Interdisciplinary Center for Bioethics in the summer of 2011.

Carol A. Parsons, PhD is an economist and urban planner. Holding two doctorates from the University of California Berkeley, she is formerly on the University of Iowa faculty; and continues to contribute diverse scholarly publications including present efforts with the Journal of Research 6

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In This Edition Administration. She is currently the project director for the Clinical Knowledge Development study being conducted at the Graduate School of Nursing, Uniformed Services University of the Health Sciences, Bethesda, Maryland.

Serena Purdy, BA(Hons), MS (cand) is a graduate student in the Bioethics Program at Union Graduate College/Mt. Sinai School of Medicine. Ms. Purdy has primarily published on the subject of the regulation of biosimilars in the United States.

Tonse N. K. Raju, MD, DCH is a neonatologist by training, working as Medical Officer at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Maryland. Before joining the National Institutes of Health, he co-directed the neonatology program, taught, and conducted research at the University of Illinois in Chicago. Dr. Raju has authored 187 professional papers, and has published two books and a number of articles on history of medicine.

Kevin L Russell, MD, MTM&H is the Director, Department of Defense Global Emerging Infections Surveillance and Response System, and Deputy Director, Armed Forces Health Surveillance Center. His priorities are standardization, greater affiliations with world militaries, continuing to introduce scientific rigor into the network, and synchronization with other US government global surveillance programs. Previous work has included surveillance throughout South America, among military recruits, and clinical trials. He has over 80 peer-reviewed publications.

Michael Schatman, PhD, CPE is Executive Director of the Foundation for Ethics in Pain Care, Bellevue, WA; and a partner in Schatman-Robinson Pain Psychology Associates also in Bellevue.

He has spent the past 25 years working in the field of chronic pain management as a clinician, educator and author. His current work focuses on improving pain care in the United States through the mitigation of the influence of special interest groups that threaten the endeavor.

Cecili Sessions, MD, MPH currently serves as the Air Force liaison at the Armed Forces Health Surveillance Center in Silver Spring, MD. She is board certified in Pediatrics (Georgetown University) and General Preventive Medicine (Uniformed Services University). Previous assignments were as a pediatrician in Turkey and Japan. She received her medical degree from the University of Southern California in 2000, and majored in International Relations at Stanford University while in the AFROTC. James Shraiky, MARCH is the Director of Healthcare Initiatives and a Professor in the Herberger Institute for Design and the Arts, School of Architecture and Landscape Architecture at Arizona State University, USA. Before coming to ASU, he worked as a healthcare architect and a medical planner in North America, Asia, and the Middle East. His research focuses on disease pathology interpretation into design decisions-making in addition to interdisciplinary healthcare design education.

Diego S. Silva, MA is a PhD candidate at the Dalla Lana School of Public Health, University of Toronto and a student in the Collaborative Program in Bioethics at the Joint Centre for Bioethics, University of Toronto. He holds a Frederick Banting and Charles Best Canada Graduate Scholarship from the Canadian Institutes of Health Research. His primary research focuses on public health ethics and mental health ethics.

Maxwell J. Smith, BA, MSc is a doctoral student in public health and bioethics at the University of Toronto. He is also a research assistant with the Canadian Program of Research on Ethics in a Pandemic at the University of Toronto Joint Centre for Bioethics. Additionally, he has worked clinically in the department of bioethics at Toronto’s Mount Sinai Hospital and contributed to the development of ethics infrastructures within several community-based healthcare agencies in Toronto.

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FROM THE EDITOR’S DESK

Prelude From the Editor’s Desk Dr. Edward F. Gabriele Editor, Journal of Healthcare, Science and the Humanities Deputy Vice Chancellor, Navy Medicine Institute for the Medical Humanities & Research Leadership USN Bureau of Medicine and Surgery Washington, DC 20352 Tel: (202) 762-3600 Email: Edward.Gabriele@med.navy.mil On behalf of the Navy Medicine Community and our colleagues at the Smithsonian Institution, as Editor I am pleased and honored to present to you the inaugural edition of the Journal of Healthcare, Science and the Humanities. This is a moment of celebration for the birth of a new international, academic, peer-reviewed publication that brings into high relief the very best scholarship from so many disciplines and perspectives.

But in the midst of the celebration, in the midst of the congratulations, a series of questions must be asked: “What is the meaning of all this? What does this new publication pose? How does one understand its potential and its richness?”

In the Fall of 2008, I was asked to be the keynote speaker at a special symposium at Georgetown University where I hold a professorship in clinician education. I was asked to address the challenge of scholarship and academic leadership in the contemporary environment. As I was considering what I would present, the university’s motto kept coming to mind: “Utraque unum.” This Latin phrase has its origins in Greco-Roman culture, particularly in some specific humanistic literature and ancient music. It translates into something akin to: “From the many disparate, bringing into one.” From a certain perspective, one might consider this phrase more accurately as a type of metaphor. It is not just a phrase. Rather it is a doorway through which one is caught up in things much larger and more meaningful. Then and now, I find that this phrase draws upon the experience of synergy with which many of us are very familiar in contemporary organizational theory.

Synergy is when the whole is greater than the sum of its parts. When synergy is experienced, the present historical moment catapults by a quantum leap into something inconceivably and unforeseeably new.

I found this phrase to be an extremely powerful metaphor for my keynote back then. I find it an even more powerful metaphor today as we publish the first edition of the new Journal. In a special and intriguing way, this Journal strives to bring together the many disparate and richly diverse academic and professional disciplines that are part of the experience of healthcare and medicine.

We are immensely aware today that the realities we have called “medicine” or “healthcare” are systems experiences. They are not about one particular science or one particular art. They are not about just one profession. They are not about one particular perspective or approach or technology. Indeed, the healthcare provider does not treat one

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Prelude cell or one symptom. One treats whole persons, their entire selves including their loved ones and their world, their fears and hopes, their share in the created order. When one enters the room of the patient, one enters into a type of circle in which the tumult and maelstrom of the patient’s illness and sense of alienation collides with one’s own experience. This circle is a place of disparate realities; or, as Carl Jung might call it, the “conjunctio oppositorum,” the “conjunction of opposites.” In this experience the healer seeks to make “the disparate many into one.” Such is the phenomenology of palliation or “covering” that is extended to all patients, not just those who are chronically ill or at the crossroads from this life into something beyond. The healer brings together and covers with care all the disparate elements of the patient’s experience. The healer gathers them up and seeks to make them something supremely different, supremely better, supremely one.

Health and medicine require, then, the bringing together of every art and science that becomes caught up in the intricate immensity that is foundational to patient-centered care. Nothing is left out. The best patient-centered care brings together the wealth of knowledge, skill, and wisdom found in all the healing arts and sciences, socio-behavioral studies, technological development, spirituality, human relationships, law, culture, religious faith, organizational systems, human common sense, and most of all the mysteries of compassion and love. Healthcare and medicine, therefore, demand forums in which all that we know, desire, and hope for can come together and be catapulted by some energy or quantum leap into something never before dreamed or imagined. This is the ultimate mission of the Journal of Healthcare, Science and the Humanities --- to allow the richness of human hope in the face of illness to become a dangerous desire experienced within the ferment of academic and professional international discourse from every discipline and perspective. This Journal, perhaps unlike others, is not just a publication. It is an experience.

One does not just read the articles therein. One does not just seek to publish a manuscript here. Authors and readers come together as disparate seekers and are invited to enter into the mystery and experience of human inquiry to know and become something far greater than we were before. We seek together, as our Navy Medicine Institute’s motto professes, to “Promote the Global Good.”

Therefore, on the occasion of this inaugural edition, Navy Medicine and the Smithsonian Institution invite you to let us be the portal through which our service of the public trust becomes your entryway into a new understanding of healing and servant leadership. Just as ancient authors and musicians coined the phrase “Utraque unum” envisioning a capstone holding together the disparate stones of a portal, this Journal seeks to create a gateway through which one can enter the powerful and immense mystery of authentic human inquiry.

I have no doubt that you will enjoy the articles in this first edition. I have no doubt at all that the challenge of what you will enter within will beckon you to let your own “disparate things” become something new, something one, something ever more hopeful for all those who come to you for care and life.

April 2011

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ARTICLES

Articles On Becoming a Healthcare Professional Tonse N. K. Raju, MD, DCH Medical Officer, Pregnancy and Perinatology Branch Center for Developmental Biology and Perinatal Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda, MD Tel: (301) 402-1872 Fax: (301) 496-3790 Email: rajut@mail.nih.gov

Author Note This essay article is an edited version of the commencement address entitled “On the Path to Becoming a Doctor and a Scientist” given in March 2010 by the author at Sri Devaraj Urs Academy of Higher Education and Research and Deemed-to-be Medical University, Kolar, Karnataka, India, as part of the Academy’s Medical College Graduation Ceremony.

The author wishes to thank the Vice Chancellor and senior leadership of Sir Devaraj Urs Academy for their kind invitation, as well as the National Institutes of Health for permitting him to represent it in an official capacity. The words “doctor” and “physician” are used as inclusive terms to represent the entire field of healthcare professionals in the widest sense.

The opinions expressed are those of the author alone and not necessarily those of the National Institutes of Health, the Department of Health and Human Services, or of the United States Government.

Keywords: Medical Education; Medical Ethics; History of Medicine; Professional Development

Introduction To my fellow students: Congratulations for having reached a pivotal juncture in your professional careers. In achieving this milestone, you have made your family proud, your teachers happy, and your society grateful. Along with my personal congratulations, I bring greetings from the United States National Institutes of Health, arguably, one of the finest organizations in the world and one which I am proud to represent in an official capacity.

An ideal healthcare professional is an individual whose craft is firmly rooted in science and whose practice is constantly guided by humanistic principles. In this article, I will discuss what it means to “become” a healthcare professional and what it takes to achieve this goal. Let us see how we strive to get there.

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Articles Our Professional Calling The Global Family of Healthcare Professionals I want to first stress that with this graduation you have joined a larger family - the family of healthcare professionals worldwide. Your new family soars beyond all mountains and spans across the entire globe. This family has no national boundaries - it has no intellectual barriers.

Given that diseases do not stop at borders, the healthcare profession is regarded as universal. Diabetes is diabetes, whether you live in Delhi, Damascus, or Dresden. If Anopheles mosquitoes bite, the victim develops malaria, whether s/he lives in Mali, Madagascar, or Madhya Pradesh. As long as diseases do not honor national borders and regard continental divides, our collective weapons against them must also be universally effective. As a consequence, you must wield those weapons wisely, fearlessly, and collectively. Once again, welcome to your new family.

You might wonder: “What is there to ‘becoming’ a doctor or a healthcare professional? I am already a doctor!” Yes, now you can put those magical letters “D” and “r” before your name - or “MBBS” or “MD” after it. But, “becoming” a healthcare professional is more than adding academic degrees to our names.

I use the term “becoming” with the sense that you have chosen a path in pursuit of a goal -- a way of life aimed at achieving the noble aspirations of our professional ancestors and fulfilling the fond hopes of our society. As healthcare professionals, we care for our patients and their families. We listen and hear them. We diagnose and treat them. We also try to understand the human aspects of their sufferings and pain, without becoming callous or patronizing. We provide care with passion and compassion. This is the pursuit of becoming a doctor, a complete healthcare professional, and a healer; it is a lifelong quest, far more difficult than prescribing drugs, performing operations, dispensing remedies, or dressing wounds.

I also stress that our professional path is firmly rooted in science; therefore, just as we try to become complete healthcare professionals, we must continue to be good scientists - these are inseparable pursuits, and one complements the other. A good scientist should be “humane,” and a good doctor needs to be a good scientist. Becoming a scientist is a lifelong pursuit.

It involves perfecting one’s imperfections and acquiring new knowledge. It is an attempt to improve our understanding of both scientific knowledge and lessons from life, maintaining a sense of wonder, and developing wisdom. The famous philosopher-physician, Sir William Osler, taught that every doctor’s life must be one of a “Student’s Life” (Osler, 1951; Verney, 1960). He also said: “With half an hour’s reading in bed every night as a steady practice, the busiest man can get a fair education before the plasma sets in the peri-ganglionic spaces of his gray cortex” (Silverman, Murray, & Bryan, 2003). To this, I would add that students should include in their reading routines, books on literature, poetry, history, and philosophy.

As students, we are never fully satisfied about what we know, especially since what we know or believe today may turn out to be wrong. A teacher (identity unknown) once confessed to his graduating class that one-half of what he taught was correct, but he was not sure which the correct half was! In spite of the incredible progress we have made, medical science remains “a work in progress.” It is an imperfect science. Thus, as lifelong students, 16

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Articles we must strive to contribute towards the profession’s betterment, while at the same time, we derive benefits from it. Let us look at some elements of our professional calling.

I think the desire to help fellow human beings is uniquely human - perhaps an instinct ingrained in our genomes. Consider the remarkable phenomenon of childbirth. In all of the animal kingdom, humans are the only mammals that require at least one other person’s help for safe childbirth. Tigers and elephants do not call an obstetrician when they go into labor; rather, they seek an isolated place and deliver their pups and babies alone, safely. On the other hand, a pregnant woman in labor seeks help; she calls her husband, a doctor, an ambulance to reach the nearest maternity facility.

The phenomenon of childbirth says much about our evolutionary history. It is worth noting that the biological evolution of Homo sapiens resulted in our bipedal locomotion, which, in turn, led to a dangerously narrow pelvic outlet. Along with this, the evolutionary forces that brought about a relatively huge fetal body and head must have occurred side-by-side with a sociological evolution, assuring that help was available for safe childbirth. Only with such help at hand was it possible for both the mother and her progeny to withstand the perils of childbirth and for us to survive as a species (Wittman & Wall, 2007).

Most scientists consider the art and science of helping women during childbirth, “midwifery,” as a profession as old as mankind itself. Similarly, I suggest that the instinct to help others in times of their physical suffering has evolved as an ingrained trait in our collective genomic pool.

Our Intellectual Heritage We are the inheritors of a fantastic intellectual heritage. Charaka, Sushrutua, Vagbhatta, Hippocrates, Soranus, Sydenham, and Pasteur, enriched by the contributions of hundreds of others from the Far East to the Middle East, from Greece to Rome, form the backbone of current medical corpus. Nonetheless, progress in medical science has not come easily. It has never been a straight path - never a linear progression of breakthroughs. It has taken generations to reach where we are today in the field of medicine.

Not long ago, doctors routinely purged, bled, or gave emetics to cure heart failure, headaches, and fevers. In 1799, when President George Washington developed a sore throat and high fever, doctors gave him molasses, vinegar, and poultices and bled him six times.

After two days, the president died, probably from acute epiglottitis; he had not been helped by the therapy he received (Eyewitness to History, 2010). But, we cannot blame his doctors today. They did the best they could in delivering the standard of care for that time.

We have made great progress in medical science over the past two centuries. As recently as the 1920s, diabetes was considered a death sentence, yet today, most diabetic patients live a near-normal lifespan. In the mid 1950s, people debated about the exact number of chromosomes in the human body - today we have sequenced the entire human genome. In the 20th century alone, more than 300 million people died from smallpox - three times more than the number of people killed in World War I, World War II, and all of the battles and wars of the 20th century combined! Because of global efforts, the last reported

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Articles case of naturally occurring smallpox occurred in Somalia in 1977 (WHO, 2010). Smallpox died in Somalia, and today it is a merely a memory.

In spite of the positive developments in medicine, many tragic paradoxes are, nevertheless, evident. A majority of the world’s population still cannot receive even the most basic forms of medical care. While in most countries of the world, people are living longer than ever before, tens of thousands of women die each year from postpartum hemorrhage.

Malaria continues to kill, malnutrition continues to prevail, and the “new malnutrition” of the new millennium is the burden of obesity.

Further, medical care has become more and more expensive; in some cases, it is prohibitive. But this is not new. An ancient Sanskrit poem describes what a patient told her doctor: Oh dear Doctor, brother of Yama, the Lord of Death, I salute you For Yama snatches only the life, you Sir, snatch both life and money!

It is important to recognize the actuality that our patients, for the most part, do not forget us! In fact, they are likely to remember just about everything we say and do or don’t say and don’t do. This is because, as doctors, we encounter fellow citizens at the most vulnerable periods in their lives; what we do or say will make an indelible impression on their recollections and on their lives. Doctors may forget some of their patients, but believe me, patients remember their doctors - the good, the bad, and the ugly! Make sure you are remembered for good reasons - the reasons about which you can be proud and which you can fondly reminisce and relay to your children and grandchildren.

Our Rewards As doctors, we also reap great many rewards. Imagine how many people in the world are able to say: “I treated a man who can now see the world - and his granddaughter better”; “A child I treated who had joint pains now has no pain at all”; or “A bread-earner in a family is alive and well, supporting her three children because I cured her.”

These are benefits we cannot measure using mathematical terms - not by looking at our bank balances, measuring the size of our bungalows, or counting the number of cars we own! The gifts and rewards of doctors are made of treasures that will linger happily in our memories.

Before I close, let me tell you two stories. One highlights the gifts to humanity by a great scientist, and the other, the rewards given by a little girl to her healthcare professional team.

A relentless scientist In 1538, a young man, Andreas Vesalius, became Professor of Anatomy and Surgery at the prestigious University of Padua in Italy. Vesalius was of Flemish origin in today’s Belgium (Nuland, 1988). He was only 24 years old. How was it possible for him to obtain the post of Professor? One explanation is that his diligent research wiped clean all of the “rubbish” that had been taught as anatomy for 1300 years.

18

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Articles Until the mid 1500s, Claudius Galen, a Roman doctor, was the ONLY authority on all medical subjects (Nuland, 1988). Sadly, Galen had made spectacular mistakes. He had dissected and studied apes and monkeys, pigs and horses, and dogs and cows, but in his writings, he made little or no distinction between the human anatomy and the anatomy of other animals. Year after year, century after century, professors of anatomy taught Galen’s anatomy as foundation of all of medical sciences to medical students, as if it was the final truth.

Imagine the classroom of the mid 16th century, where a professor would sit at the uppermost row in a classroom, or “theater.” He would read from Galen’s books. And, far below at the ground level, a “demonstrator” would stand next to the dissected animal or a cadaver and show the body parts to students. That was it!

But even as a student, Vesalius would have none of this. He wanted to understand human anatomy by studying human anatomy. What a great idea! He obtained cadavers of executed criminals, and he robbed graves (at night, of course). He carried home those bodies and meticulously prepared, dissected, and studied them. He worked from sunrise to midnight studying each internal organ, measuring every muscle and nerve, and examining and counting every joint and bone.

Then, in just four years, he was ready. He had made notes of everything he had discovered. With the help of a local artist, he had his anatomical discoveries illustrated with spectacular, full-page drawings. From these he wrote a sizeable, four-volume book, which was published in 1543 under the title De Humani Corporis Fabrica, or The Fabric of the Human Body (Saunders & Malley, 1950). The volumes described how human beings were “put together” and what we are made of - in other words, the very fabric of man. This was the first text to utilize life-like illustrations providing precise and accurate descriptions of human anatomy. It was also the first substantial scientific research project conducted by a single man, completed to near perfection, and most notably, supported by no grants or contracts.

Today, it may be impossible for us to imagine the impact of Vesalius’ work when it first came out. While some traditionalists were skeptical, the medical community, as well as the general public, embraced the Fabirca as a great revelation. It became an instant international bestseller and remains a monumental piece of scientific work, even by today’s standards. For all those reasons, we honor Vesalius as the “father” of modern medicine - not just of anatomy.

Christie’s Story My second story is a contemporary one. Christie was born in 1975 and transferred to the University Hospital where I worked as a junior fellow in neonatology. She was three months premature and weighed some 900 grams, lighter than a convocation robe. She was so tiny you could hold her on the palm of your hand.

Christie needed respiratory support. She had severe hyaline membrane disease—or RDS. In the 1970s, her chance of survival was less than 10%, but she was “stable,” and we were cautiously optimistic that she would make it.

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Articles On approximately the 5th day of her life, as we made our routine morning rounds, Christie looked good; we examined her, renewed her medication orders, and moved on.

Within about 60 seconds, her nurse shouted that Christie was going into cardiac arrest. We turned back. Christie’s heart rate had dropped from the baseline normal of 140 to 100 in five seconds. As we looked on, the heart rate monitor showed the rate to be dropping to 80, to 70, to 60.

We dragged over the “crash cart.” Someone checked her endotracheal tube, which was fine. Someone shouted “Epinephrine.” By the time we acquired the drug, her EKG was a straight line. This beautiful little baby, who looked just fine a few minutes ago, was now deathly pale, with no heart beat. She was as white as a sheet of writing paper—as if, all her blood had been drained from her body - but she was not bleeding.

A nurse handed me a syringe with diluted epinephrine; I attached it to a standard three-way adapter, and then inserted the needle into her chest to inject the medication into her heart. I pulled back the piston of the syringe to draw some blood, to make sure that the needle was indeed in her heart, before I gave the drug - a standard procedure.

But, instead of blood, I drew air - pure, clear, colorless air coming from her heart. It was immediately apparent that Christie had experienced a spontaneous tension penumopericardium (a condition in which air gets trapped between the heart and its outer layer, the pericardium).

Obviously, the treatment for this was to remove air from her pericardium before it strangulated her heart completely, and I had begun to do this, accidentally.

Consider this: a one-kilogram baby’s heart is the size of a walnut - a bit larger than my thumb. A small amount of air, say 10-15 ml, locked-up in the pericardial sac with nowhere to go, can smother the heart within seconds. But, almost accidentally, we had done the right thing. I withdrew some more air - in all, about a syringe-full (10 ml), from the pericardium and pulled the needle out of her chest.

Before the needle was removed, while we were all watching, Christie’s color changed. From a deathly-white pallor, she turned pink---pink as a perfect blooming rose. In no time, her heart was beating; within a minute it was back to 140.

Now, for a follow-up: Christie went home after a few months’ stay at the neonatal intensive care unit. She came to our clinic. Her parents sent us Christmas cards with pictures and stories just about every year. She continued to bloom as a beautiful child. In 5th grade, she was first in her class in all subjects and played piano like a champ. She became a doctor, was married, and now lives in California.

What is the moral of the Christie story? There is nothing really so special about it. For instance, it is not an “interesting” or “unusual” or rare case report - it could not be published in a medical journal. I am sure many professors can relate similar stories from their own experiences.

Nevertheless, this is a great story for those who were there on that day. It is a story that taught us that sometimes, the most mundane aspects of our daily life can turn into incredible and unforgettable experiences. For Christie and her family, this episode was 20

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Articles the difference between her dying as a newborn, or growing up to become a doctor. For the doctors, nurses, and students involved, the experience left us with an enduring memory. That was our greatest reward. Such rewards cannot be measured in material terms. In fact, these are the basic elements of our collective professional calling; they make our work and life all the more meaningful and worthwhile.

Conclusions Your Honorable Vice Chancellor of this institution gave me an enticing assignment.

He asked me to “inspire” you. I am not sure if I have succeeded, but I have tried!

What I said can be summarized in a few sentences. Becoming a complete healthcare professional and remaining a full-time student of science are inseparable pursuits, with one path enriching the other. We are the fortunate few with an incredible opportunity to touch, heal, and help fellow members of our species. Most importantly, the returns and rewards of our works will be immeasurable in value and everlasting in our memories. Treasure them, savor them, and go after them!

Once again, congratulations, best wishes and thank you.

References Eyewitness to History (2010). The Death of George Washington, 1799. Retrieved 23 July 2010 from http://www.eyewitnesstohistory.com/washington.htm Nuland, S.B. (1988) Doctors: The Biography of Medicine. New York. Alfred Knopf Inc. Osler, W. (1951) A Way of Life and other Selected Writings of Sir William Osler. New York.

Dover Publication Inc. Saunders, J.B.de.C.M., & Malley, C.D.O. (1950). The Illustrations from the Works of Andreas Vesalius of Brussels. New York. Dover Publication Inc. Silverman, M.E., Murray, T.J., & Bryan, C.S. (2003). The Quotable Osler (page 204) Philadelphia, American College of Physicians.

Verney, R.E. (1960). The Student Life: The Philosophy of Sir William Osler. Edinburg, Livingston Ltd. Wittman, A., & Wall, L. (2007). The evolutionary origins of obstructed labor: bipedalism, encephalization, and the human obstetric dilemma. Obstet Gynecol Surv, 62:739–48 World Health Organization (WHO) (2010). Smallpox: Historical Significance WHO. Retrieved 23 July 2010 from http://www.who.int/mediacentre/factsheets/smallpox/en/

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Articles Pain Medicine from “Bench to Bedside�: Bridging the Disconnect(s) between Research and Clinical Care James Giordano, PhD Director, Center for Neurotechnology Studies Potomac Institute for Policy Studies Arlington, VA, USA University Affiliate Professor of Neurosciences Krasnow Institute for Advanced Study George Mason University, Fairfax, VA and Senior Research Associate Oxford Centre for Neuroethics Uehiro Centre for Practical Philosophy University of Oxford, Oxford, UK 703-525-0770 Email:jgiordano@potomacinstitute.org Michael E. Schatman, PhD Executive Director Foundation for Ethics in Pain Care Bellevue, WA

Author Note This manuscript reflects the ongoing work of the co-authors and was supported in part by grants from the Nour Foundation (JG), N3P3 Project (JG), and Office of Naval Research (JG). The authors acknowledge the graphic artistry and technical assistance of Sherry Loveless in this manuscript.

Abstract Pain medicine is plagued by an ever-present gap between objectifiable and wholly subjective aspects of pain. This has established pain as something of an enigma. Given the problem of pain, both research and clinical care are vital to its treatment, and these enterprises are reciprocally dependent. In this essay we 1) describe a schism that has developed between pain research and clinical practice, 2) address the ways that this has disrupted the relationship between knowledge, decision and action that is critical to the ethically sound conduct of both the science and clinical implementation of pain medicine, and 3) posit that systematic, profession-wide, socio-economic and policy changes are needed to bridge the schism and re-constitute the enterprise of research and clinical practice as inter-digitating entities within the estate of pain medicine. Toward these ends we propose that the research and clinical communities must engage the coordinated efforts of individuals, professional organizations, medical research and treatment institutions, and government(s) to restore the efficacy and integrity of pain care.

Keywords: Pain medicine, research, therapeutics, schism, ethics, policy 22

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Articles Introduction The relationship of science to medicine has long been the topic of considerable discourse and debate. (Conrad, Neve, Nutton, Porter, & Wear, 2000; Magner, 2005) Differing types and levels of knowledge are contributory to the practical wisdom (what Aristotle called phronesis) used in medical decision-making, and such decisions are essential to the execution of medicine as an intellectual and moral endeavor (Aristotle, 1999; Pellegrino, 2002; Davis, 1997). Although a complete discussion of whether medicine is a truly phronetic exercise, and/or how various forms of knowledge are utilized in different medical disciplines is beyond the scope of this essay (for overview, see Davis, 1997; Giordano, 2009a), at the very least it can be claimed with confidence that differing categories of knowledge are important to all fields of medicine to “…deal with the particularities of the maladies upon which they focus.” (Giordano, 2009a). In light of this, the connection between research and clinical practice becomes evident and fundamental: science affords a methodology for the acquisition of knowledge that is useful to and in medicine, and research provides the task(s) and tool(s) through which such knowledge is obtained. Moreover, this establishes medicine as an estate – a conceptual and practical entity composed of multiple enterprises that contribute to its wealth of knowledge and power, and the execution of such knowledge (and power) in society.

While this schema describes the relationship between knowledge, science, research and medicine in general, it may be more acutely important to those domains and fields of medicine that confront peculiar problems of the objectivity-subjectivity gap (between what is observable in the third-person lens of clinical knowledge and examination and explanation, and what is understood via the first-person experience of the patient; Svenaeus, 2001; Gadamer, 1993; Giordano, 2009a,b). Knowledge allows successive approximation of this gap by affording information about the substrates, mechanisms and processes of physiology, psychology and pathology, that enable the clinician to gain deepened insight into how and why these variables are manifested in and by the phenomenological and experiential dimensions of the patient who is ill. In this way, such knowledge sustains both Sydenham’s nosological method (to determine what is wrong with a given patient; King, 1970) and the acts of medicine (to discern what can and should be done to treat both the disorder and its unique expression and effects in the person who is ill; Pellegrino, 1979).

This is most certainly the case for pain medicine, a field that is plagued by an everpresent gap between objectifiable aspects of pain and the pain patient that can be quantified and qualified via current techniques of assessment and diagnosis, and the subjectivity of pain qua pain that remains inaccessible to these means (Giordano, Engebretson, & Benedikter, 2008; Giordano, 2009a,b, Giordano 2010a-c; Giordano, Abramson, & Boswell, 2010).

This has established pain as something of an enigma, and in many ways has prompted the ongoing philosophical and scientific inquiry to unravel its nature and depict its effects.

Given the problem of pain, research and clinical care are inarguably vital to its treatment, and inextricably entwined on ethical and technical grounds (Giordano, 2004, 2006a,b; 2009a,b; 2010 b).

While this may be true in concept, we posit that 1) a schism has developed that has breached the bi-directional continuity of pain research and clinical practice, 2) this disconnect has negatively impacted the conduct and ethical integrity of both the science and clinical implementation of pain medicine, and 3) systematic, profession-wide, socioJournal of Healthcare, Science and the Humanities

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Articles economic and policy changes are required to bridge the schism and re-constitute the enterprise of research and clinical practice as inter-digitating entities within the estate of pain medicine.

The Historical Basis of the Disconnect between Research and Practice Historically, medicine has engaged the most contemporary advances in science and technology to effect its goals of curing, healing and care (Starr, 1982; Illich, 1976; Fabregá, 1997). Clearly, medicine is a broadly humanitarian endeavor, and thus, while aspects may be deeply derived from and laden with scientific and technological applications, medicine cannot – nor should not – be considered merely applied biotechnology (Pellegrino 1990, 2002; Reiser, 1986). Yet, an expanding scientific knowledge-base, and the progressively sophisticated outcomes and technological products of scientific innovation have incontrovertibly advanced the scope and capability of the medical profession, and have affected the tenor of its practice. (Kass, 2003; Reiser, 2009; Harris, 2007; Eaton & Kennedy, 2007) This has been particularly evident following the second Industrial Revolution and Flexnerian revision of the early 1900s, which contributed to (and/or evoked) conflation of scientific, techno-industrial, and socio-economic agendas within medical education, professional administration and practical conduct.

This evolution enabled extension of the human lifespan through preventive and curative approaches to disease. Yet, in such success we evidence a paradox: a medicallyextended lifespan does not totally obviate disease and illness, but rather may only impart 1) chronicity and perhaps other disorders (that are fostered by medically-altered genetic frequencies), and 2) an ever-increasing need to manage such conditions through the development and implementation of medical techniques and technologies. Simply put, with progress come new problems.

Still, a constant underlying focus of medicine has been – and continues to be – the alleviation of pain. Efforts to understand and control pain have been inherent to philosophy and medicine since antiquity, although the study of pain as a specific field of investigation was not formalized until the rise of the experimental trend in science in the early-to-mid 19th century (Rey, 1993; Valadas, 2010). However, American medical training during this time was inchoate, and the increasing exposure to European advances in science and medicine led many American physicians and medical students to pursue training in Germany. Upon their return to the United States, they espoused and evidenced virtues of the German system of medical scholarship, in which basic science and research were fundamental to clinical training and practice (Evans & Fargason, 1996). The apparent superiority of the German model was not lost on Abraham Flexner, who was charged by the American Medical Association with analyzing and proposing revision(s) to the general curriculum used in American medical schools.1 Thus, the “scientist-practitioner” model was adopted in American medical training and practice, and remained prominent for at least the first half of the 20th century.2

Pain Medicine Many advances in medical technique and technologies (inclusive of pharmaceutics) were developed as a consequence of industrialization and its progressively influential

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Articles effects in, and upon the conduct of science, society and (perhaps most notably) warfare.

Of particular interest is that the discipline of pain medicine was fostered in direct response to the needs of soldiers who were wounded during the Second World War, and thereafter manifested chronic pain (Bonica & Loeser, 2001; Valadas, 2010). However, the war also generated exigencies for rapid training of physicians that led to a relative de-emphasis of the scientist-clinician model of education, and as a consequence the research component became divested from medical education and direct clinical engagement (Wagner, Kee, & Gray, 1995; Casberg, 1959).

This need-driven transformation fostered an educational, occupational, practical and economic schism between the enterprises of academic research and clinical practice.

This schism 1) has been fostered and perpetuated by several historical and socio-economic forces (both within and beyond the biomedical estate); 2) adversely affects the capability of science to provide the knowledge required to inform the safe and effective practice of medicine, and 3) is therefore contrary to the principal ethical obligation for (and of ) research to elucidate, verify and achieve the technical rectitude and provide services and resources that afford relative good(s) that can be employed in patients’ best interests. In light of this, we argue that given the advances of both science and medicine to date, there is an ethical and practical imperative to bridge research and clinical endeavors, to 1) ensure the moral character of science and medicine; 2) more directly focus upon persistent aspects of the human predicament that warrant the translation of scientific outcomes and technological advancements into safe clinical care, and in these ways, 3) uphold the fiduciaries of science to medicine, and both science and medicine to society.

We contend that in many ways, pain care reflects the essential “nature” of medicine (at least as classically defined) in that 1) pain is both a physiological event and a psychological/phenomenological experience of the patient; 2) its assessment, diagnosis and treatment must entail subjective and objective domains; 3) the combinatory use of technical knowledge, skill and tools together with intuition are mandatory, and thus 4) it represents a working complementarity of Asclepian and Hygieiean aspects of the profession and practice (Giordano 2009a, 2010b; Giordano & Jonas, 2007). Obviously, knowledge (of pain, its effects in particular patients, approaches to assessment and treatment) is necessary to articulate this practice, and such knowledge is gained from both (basic and clinical) research and empirical findings evidenced in clinical care. The reciprocity of research and practice are foundational to medicine, and the intricacies of this relationship – and its importance – to pain care have been explored in significant detail elsewhere (Querido, van Es, & Mandema, 1994; Giordano, 2004, 2006a, b; 2009a,b; 2010a-c).

Yet, the disconnect between research and clinical practice in pain medicine appears to be firmly established and in some cases widening as a result of both cultural forces intrinsic to the biomedical estate (of research and clinical enterprises), and socioeconomic forces that are extrinsic to, but imposed upon this estate. This has impeded the communication of needs and values of the clinical community that are important to direct the scope and direction of academic research, and compel the efficient translation of research findings and technological developments to clinical therapeutics. Taken together, these factors can limit the likelihood of meaningful progress in the field, and compromise the quality of care that is provided to pain patients.

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Articles Insights into the Schism between Bench and Bedside Discrepant Professional Requirements and Values To better understand this schism, it is necessary to first examine the discrepancy between the professional requirements (and resulting values and goals) of the clinical enterprise that provides services to pain patients, and the academic research enterprise that is engaged in scholarship and teaching. Several authors (Clark, 2009; Cousins, 1999; Edwards, 1984; Giordano 2006b, 2007, 2009a,b, 2010a,b; Loewy, 1991; Pellegrino, 2009; Peppin, 2009; Pullman, 2002; Randall, 1999) have discussed the moral obligation – and motivation - of pain clinicians to ameliorate pain. Such motivations are likely to be important to pain researchers as well; however, the responsibilities of the scholar are not necessarily focused upon patient care, per se, but rather upon the conduct of research and the obligations of academe (Mandema, 1994). To be sure, research is not in any way divorced from underlying imperatives for beneficence, non-harm, and the ultimate ends of engaging new knowledge and technological innovations toward the achievement of some humanitarian good (Giordano 2010c; Giordano, Akhouri, & McBride, 2009; Giordano, Benedikter, & Boswell, 2010).

But it is important to recognize that the most proximate goals of research involve the acquisition of information through methods of observation, experimentation and analyses. This process is incremental, and at the most basic level, studies are oriented toward elucidating substrates and mechanisms that may not be directly or easily translated into clinical care. These qualities do not obviate the importance of such work to the field, nor do they negate the value of time and effort engaged.

Funding Research incurs costs, and generation of external support is a necessity – if not responsibility – of most scholars (within both the sciences and, increasingly, the medical humanities) within academia. Often, the sustainability of research programs – and security of jobs – remains contingent upon such funding. As a result, value systems in medical academia are highly oriented toward the level of extramural subsidy, as such fiscal support is directly related to viability of an academic research program, consistent scholarly publications and presentations, performance evaluation, and promotion and tenure (Lubitz, 1997; Atasoylu et al., 2003).

Funding priorities do not always reflect the most relevant clinical issues, and thus, the goals and directions of academic pain research may be inconsistent and/or misaligned with those of practice. For example, Henschke, Maher, Refschauge, Das & McAuley (2007) note that the priorities for low back pain research are generally developed by funding bodies, rather than through a consensus of physicians who are actually engaged in the diagnosis and treatment of pain patients. As well, market factors may influence, or in some cases dictate, research funding: pharmaceutical and biotechnology industries characteristically subsidize studies of products and techniques that have high market value, and market demands for particular types of medical resources and services affect both private and (to some extent) federal support. Thus, the allocation of research funding – and the focus, scope and direction of the research conducted – is determined by decision-makers who may not necessarily be sensitive to the needs of the clinical endeavor (Koes, van Tudder, Ostelo, Kim-Burton & Waddell, 2001).

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Articles Values and Ethics Even within academic medical centers, there is an apparent division between researchers and clinicians that is fostered, in part, by universities’ divergent requirements – and thus goals’ and values’ priorities – between these professional groups. (Mukmal, Smetana, & Delbanco, 2002) Frequently, the criteria for tenure and promotion differ for researchers and clinicians, due to institutions’ differential reliance upon large-scale extramural funding generated by research, subsidies from patient care, and concerns about the provision of long-term financial commitments to faculty with primarily clinical and teaching responsibilities (Levinson & Rubenstein, 1999; Buckley, Sanders, Shih, & Hampton, 2000). Although it is theoretically possible to maintain a dual (research and clinical) career in academic pain medicine, it is nonetheless difficult to balance the time commitment(s) necessary for effectively discharging the duties of patient care and research; institutional inflexibility regarding allocation of time and effort may add to this difficulty.

As well, there are numerous ethical issues that arise from the dual responsibilities borne by clinicians who engage in research involving patients in their care. While maxims of beneficence and non-maleficence are certainly overarching in the conduct of both research and clinical endeavors, the more proximate goals of research (viz. - non-biased acquisition of data) and clinical practice (viz.- primacy of patients’ best interest) can come into conflict (King & Churchill, 2008; Viens, 2010).

Implications As a result of concerted efforts by the Pain Care Coalition, in conjunction with the American Academy of Pain Medicine, American Pain Society, American Headache Association, and the direct support of Sen. Orrin Hatch (R-Utah), US President Clinton signed HR 3244 on October 31, 2000, to approve the congressionally-declared Decade of Pain Control and Research (DCPR, January 2001-2010). The goals of this agenda were to raise public awareness and generate opportunities and resources for research funding to address the clinical and social problems of chronic pain. It may be premature to accurately assess if and how the DCPR has affected the schism between pain research and the clinical practices of pain care. Any such process of change is likely to be measured, arduous and therefore slow. Yet, we argue that it is important to evaluate what changes have been proposed and made, to gauge what steps toward progress remain to be achieved.

Research One of the notably positive effects of the DPCR has been an axiomatic enthusing of basic and clinical research efforts relevant to pain. This has been fueled by, and may be an extension of neuroscientific research agendas generated during the prior Decade of the Brain (1990-2000), and the availability of funds that were then re-allocated under the programs of the DCPR. The multi-disciplinarity of neuroscience (i.e., conjoining anatomical, behavioral, cognitive, genetic, pharmacological, and physiological approaches and foci) has been instrumental to instantiating a somewhat broader, more comprehensive study of pain and its treatment. As well, other disciplines - inclusive of the social sciences and humanities (e.g., anthropology, ethics, philosophy, sociology, e.g.) - have steadily become more involved with addressing questions, issues and problems of pain.(Giordano, 2009a; Giordano & Boswell, 2009) Still, despite the eponymy of the DCPR, there is little to suggest that the scope and pace of research has been effectively translated into (improved or novel methods, tools and/ Journal of Healthcare, Science and the Humanities

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Articles or paradigms for) controlling pain in clinical settings, and accordingly, the overall quality of pain care in the United States has not been appreciably elevated (Mularski et al., 2006; Scholz & Woolf, 2002).

The disconnect between clinical and research communities is such that a general ambience of pro status quo tends to prevail regarding the types and foci of research that are necessary to facilitate translational efforts. Without doubt, basic and clinical studies are important, as each afford meaningful contributions to the overall knowledge base that can – and should – direct medical practice. However, there is also a need to address how such research is actually conducted, the viability of extant and/or modified and novel methods (e.g., randomized controlled trials versus other types of protocols), and the relevance of such approaches to pain and pain care in light of emerging data to indicate unique genoand phenotypic aspects of individual physiology and pathology, and recent calls for (and trends in) personalized medicine (Giordano, 2009a,b; 2010a,b). Ambiguities in research methodology call into question the nature, validity and value of evidence-based practice, and prompt address of whether criteria, forms and levels of evidence used to determine guidelines and standards for pain care require re-examination and revision to better align research with clinical practice. Here too, extrinsic forces (e.g., market agendas, commercial incentives and patterns of use) may influence how evidence is accrued, weighed and employed, and this can give rise to yet additional ethical issues. (Boswell &Giordano, 2009)

Clinical Care We argue that 1) the schism between the research and clinical enterprises is strongly related to a decremented quality of pain care, and 2) socio-economic factors play a strong – if not deterministic – role in establishing the climate that affects and sustains this relationship. For example, we have noted that despite research to support the effectiveness of the integrative multi-disciplinary approach to chronic pain, the number of interdisciplinary pain clinics (IPCs) in the United States has decreased from approximately 1000 to less than 200 over this past decade (Schatman, 2006; 2007). To a large extent, market forces and their (direct and indirect) effects have driven this decline (Giordano, Schatman, & Höver, 2009). In the absence of the IPCs, much of chronic pain care has become (re-)relegated to the independent practitioner and/or hospital setting. Yet, independent pain specialists are not abundant, and as a result, chronic pain care is often provided by non-specialists (e.g., general practice, internal medicine, or emergency department, or in some cases, practice providers such as nurse practitioners and physicians’ assistants; McGrew & Giordano, 2009). Typically, pain research is not directed at, or explicitly disseminated to practitioners of these disciplines (Saint, et al. 2000), and as a result, the research-clinical schism is furthered, and the quality of pain care may be impacted.

In both the private practice and the hospital settings, chronic pain is often treated pharmacologically and/or through the use of interventional techniques and (increasingly other, more advanced) technologies. Prima facie these approaches are not problematic, yet in reality they are plagued with difficulties arising from ambiguities in clinical guidelines, and economic and legal influences upon the direction of research, its translation, and the patterns of use and/or provision of various techniques and technologies in clinical care. So for example, pharmaceutical companies are developing medications with lower abuse potential (Sinatra, 2006); while such agents are certainly important to mitigate inappropriate and/

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Articles or non-compliant consumption by patients, and may ultimately reduce defensive practice by pain physicians who are reluctant to prescribe opioids (even if medically indicated) due to fear of patient misuse, abuse, and resultant medical sanction or legal prosecution, it is equally (if not perhaps more) important to devote time and funding to develop more effective medications, and pharmacological strategies and tactics for the management of chronic pain.

Research has shown that both opioids and interventional approaches to pain can certainly be effective, but are not a panacea, and should not be used to the extent once deemed appropriate (Ballantyne, 2006; Deshpande Furlan, Mailis-Gagnon, Atlas, & Turk. 2007; Mailis-Gagnon, Furlan, Sandoval, & Taylor, 2004; Nelemans, deBie, deVet, & Sturmans. 2000; Turner, Sears, & Loeser, 2007). As well, studies support the use of novel biotechnologies to improve both pharmacological and interventional pain therapeutics (Deer, 2009; Giordano, 2010a, Giordano, Benedikter, & Boswell, 2010; Giordano & McBride, 2009; Giordano, Akhouri, & McBride, 2009; Jeannotte, Schiller, & McBride, 2009), yet the translation of such research to practice remains tentative, at best, and economic systems to support and sustain demand-side distribution of such high-tech resources remains lacking (Giordano, Benedikter, & Boswell, 2010).

This calls into question the nature, validity, and value of evidence-based practice in pain medicine (Boswell & Giordano, 2009; Giordano & Boswell 2009). The disconnect between the research and clinical estates has led to a troublesome trend in which third-party payer reimbursement has, in itself, come to constitute something of an “evidence-basis” to justify the use or non-use of particular techniques and technologies.. Chapman (2000) and Lebovits (2001) have elucidated ethical concerns associated with pain management becoming “lost in a sea” of medications and procedures, and navigating this proverbial sea is difficult, if not impossible without clear (clinical) destinations and a reliable (research-based) “map.” To carry this metaphor further, we argue that the lack of cohesion between research and clinical practice negatively impacts the ethical compasses needed to guide the profession and practice of pain medicine (Giordano, 2004; 2006a,b; 2007; 2008, 2009; 2010a,b; Giordano & Benedikter, in press).

Possible Resolutions We maintain that such broad revision of the estate of pain medicine should entail and obtain re-alignment of its component enterprises – both with each other and to the overall ends of the profession and its practices. Such a teleological approach to pain medicine establishes the duties of the profession, specific ethical responsibilities and tasks of its constituent enterprises, and the execution of these duties, responsibilities and tasks by professional agents in practice as consistent with, and directed toward the ultimate ends of rendering technically right and morally sound pain care as appropriate to uphold and sustain the best interests of the patient (Giordano, 2007; Giordano, 2006b; Giordano, 2009; Maricich & Giordano, 2009; Giordano & Schatman, 2008b; see Figure 1).

We have stated elsewhere, and re-claim here, that any meaningful attempt to revise the scope and conduct of pain medicine will require a re-orientation to, and re-affirmation of these ethical precepts, and articulation of both large scale administrative (i.e., “top-down”) changes and coordinated, participatory efforts on the part of researchers, clinicians and

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Articles

Figure 1. Structure and functional relations of research and clinical enterprises of pain medicine. institutional administrators (i.e. – “bottom-up” actions) (Giordano & Boswell, 2009; 2010).

As depicted in Figure 2, such top-down engagement includes the activities of government, the commercial sector, healthcare and academic institutions, and professional organizations.

This latter group can be seen as nexus between top-down and bottom-up efforts in that professional and patient organizations can often provide practical conduits through which to conjoin various audiences, generate and/or coalesce ideas, values, goals and ideals, and advocate and develop guidelines. Bottom-up efforts also include the activities of localized departments within academic and healthcare institutions, and individual researchers, clinicians, and administrators toward affecting change.

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Figure 2. Systematic (top-down and bottom-up) efforts affecting the scope and conduct of pain medicine.

Top-down activities must include programs, policies and laws that establish and support funding and focus priorities in research, clinical practices and translational exchange, and modify existing administrative and market forces that affect these enterprises, and the estate of pain medicine, writ large. Such efforts will institute changes that affect the posture and conduct of the commercial sector, to foster biotechnologic research, development, testing and evaluation (RDTE) geared toward high translational capability3, and systems of insurance coverage that could adequately subsidize the provision and use of both highand low-tech approaches to pain care, as necessary, and in this way, create market dynamics capable of sustaining research translation, and more comprehensive pain therapeutics.

(Giordano, Benedikter, & Schatman, 2009) Over time, this would establish research priorities that are both reflective of, and directed toward various basic and applied aspects of clinically–relevant problems in pain care, and could facilitate bi-directional communication between the research and clinical sectors.

Such an approach would enable (or perhaps, more accurately, necessitate) a reformation of academic infrastructure to allow, recognize, and reward collaboration, between both research and clinical endeavors, and between various individuals and groups in these fields, to engender true inter-disciplinarity. This last point is noteworthy in that de-siloing research and clinical activities is much called for, yet remains difficult to actualize, as systems are not uniformly in place to foster and sustain trans-disciplinary collaboration between scholars and clinicians in medical academia. If the schism between research and clinical practice is to be bridged through cooperative planning and execution of relevant academic projects and programs, then the merits of this approach must be encouraged, maintained and acknowledged in ways that are consistent with the professional values of these groups.

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Articles As a viable bridge between top-down and bottom-up efforts, professional organizations, and to some extent patient-advocacy groups, in pain medicine play a key role in communicating and affecting bi-directionality of purpose and process of change. In the ideal, such organizations enable members of a professional community to caucus, express and exchange ideas, and formulate plans and guidelines with which to self-regulate professional conduct. Obviously, such organizations assume a variety of scales, from the large national constituency of the American Medical Association to smaller, more “grass-roots” groups such as local medical organizations and their special-interest sub-chapters.

Specific to pain medicine are organizations such as the International Association for the Study of Pain, American Pain Society, American Academy of Pain Medicine, American Society of Interventional Pain Physicians, World Institute of Pain, American Academy of Pain Management, and the American Society of Pain Educators (although other organizations, with more specific orientation to certain pain disorders/conditions, e.g., headache and fibromyalgia, also exist).4 While all of these groups maintain an overarching interest in and focus upon pain and its treatment, they each obtain a slightly different orientation and perspective, and although there is impetus and movement to become more directly cooperative, this has not always been the case, and some extent of competitive rivalry (albeit implicit) has existed between these societies and their constituencies. Some are more research oriented, while others are focused upon practice; as well, there continues to be an element of parochialism in practice disciplines, perspectives and ideals, with certain groups having a more neurological, anesthesiological, allied health, or alternative/complementary “flavor.” Fortunately, such distinctions and rivalries appear to be dissipating, and each of these groups is actively encouraging broader, more inclusive membership.

But while such parochialism may be on the wane, there is still the very real issue of economics: membership in these organizations is not free, and researchers and clinicians must often choose one (or two) versus others. Such choices may reflect personal and professional affirmations and identification with a particular group, but membership in a particular organization should still afford the opportunity to conjoin its community interests to the dual enterprises of research and clinical practice. Moreover, active sharing of these organizations’ journals and meetings allows for a richer discourse regarding developments in research and care (as finely or coarsely grained as necessary or desired). There have been proactive moves toward such goals, and this is certainly encouraging not only to the character and conduct of professional organizations in the field, but toward these efforts making headway in bottomup/top-down changes in pain medicine as a profession, practice and social good.

Other bottom-up approaches include the efforts of local academic and clinical departments, and individual researchers and clinicians toward change. Ultimately, the responsibility to execute research, patient care, and/or the administrative charges intrinsic to (and affecting changes in) pain medicine rests upon individual agents. We have argued that these responsibilities are both intellectual and moral (Giordano, 2006b, 2007; 2009; Giordano & Boswell, 2009; Maricich & Giordano, 2009), and have addressed how various ethical approaches and systems define and could be used to accomplish such moral and practical obligations (Giordano, 2007; 2009; Maricich & Giordano 2009; see also: Clark, 2009; Pellegrino, 2010; Peppin, 2009; Rich, 2000). We believe that recognizing the need for change, and acting to accomplish it is certainly part of this set of intellectual and moral responsibilities (Giordano & Schatman, 2008a,b; 2009).

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Articles Conclusions Writing on the importance of scientific studies to the practice of medicine, Altman (1994) has stated that, “we need … better research and research done for the right reasons” (p.283). Furthermore, it has been suggested that researchers should be seen as providers of value-added services and products that affect the beliefs and conduct of practitioners (Stevens & Glatstein, 1996). This establishes a model in which knowledge changes attitudes, and attitudes change behaviors (St. Leger, 2000). The schism between pain research and clinical practice has precluded the effective operation of this model, and the negative effects of this disconnect can be – and have been – imposed upon patient care.

To re-iterate, resolution to this problem involves, but is not limited to the efforts of individual researchers and clinicians, professional organizations, medical institutions, and local, state, and federal government. The schism between the research and clinical enterprises of pain medicine has resulted in two distinct and disconnected communities; both must participate in bridging the gap to restore the clinical efficacy and integrity of pain care.

One solution is a return to the scientist-practitioner model, whereby research and practice are more closely integrated to address and treat the problem of chronic pain.

This may require a more pluralistic approach, involving a closer cooperation of researchers and clinicians, as well as an expanded cadre of clinician-researchers. But as we have noted, such pluralism must be collaborative, aligned with and adherent to the telic claims of pain medicine (Giordano, 2006; 2007; 2009; Giordano & Schatman, 2008a,b; 2009). In contemplating the characteristics of medical knowledge and those who seek and employ it, Pellegrino (1990) relates, “…knowledge…is not to be acquired primarily for its own sake… as stewards we are obliged to preserve, validate, teach, and extend medical knowledge and to see that it is available and accessible to those for whom it is acquired in the first place” (page 228). We concur, and opine that a more encompassing commitment to both the science and practice of pain medicine is required to reassess professional roles and responsibilities in light of the realities of pain, the predicament of the person in pain, the exigencies of pain care.

Notes 1. Although the Flexnerian revision instituted a scientifically-based and uniform curriculum in medical education throughout the United States, a notable “side-effect” was the refutation of many “folk” remedies that were practiced by peoples who immigrated to the US during the 1800s. In the main, this did much to improve the overall quality of medical training and practice, however, in some ways it also “threw out the baby with the bath water” in that a number of potentially valuable, but as yet unexplained or un-studied types of care were banished from both the curriculum and consideration (for further scientific study and/or clinical use). A number of these practices and interventions have been re-appraised – under the rubric of complementary and alternative medicine (CAM) - and have become newly appreciated for both mechanism of action and possible clinical benefit(s). This illustrates the limitations of temporally-bound epistemic capital, and the need for ongoing research to allow revision of knowledge about why and how various treatments work (or do not work), and how they can and should be employed in practice. For further detail, see: Giordano J, Engebretson J, & Garcia MK (2005). Challenges to CAM research: Focal issues influencing integration into a cancer care model. J Integ Cancer Ther, 4(3), 210-218; Giordano J, Stapleton S,

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Articles Boatwright D, & Huff G (2002). Blending the boundaries: Steps toward the integration of complementary and alternative practice to mainstream medicine. J Alt Complement Med 2002, 8(6), 897-906.

2. Yet, it is noteworthy that the scientist-clinician/clinician-scientist model of practice can, and historically has incurred ethical dilemmas, and in some cases abject abrogation of moral probity. Notorious examples include the experimental work of certain German physicians during the Third Reich (e.g. - Drs. Viktor Brack, Karl Brandt, Rudolf Brandt, Karl Gebhardt, Waldemar Hoven, Joachim Mrugowsky, et al.) and Dr. J. Cutler (i.e. - the Tuskegee, and subsequent Guatemala syphilis experiments; see: Riverby S. (2009) Tuskegee Examined. Chapel Hill: University of North Carolina Press). Of interest is that the so-called “Doctor’s Trial” of 1946-47 which tried 20 German physicians for war crimes and crimes against humanity (International Military Tribunal 1: The United States of America versus Karl Brandt, et al.) gave rise to the Nuremberg Code, which explicitly addressed the moral responsibilities of research and its role to patient care, and established a foundation upon which subsequent codes of research and clinical ethics (e.g.- the Belmont Report, and Tom Beauchamp and James Childress’ seminal Principles of Biomedical Ethics) were based. See also: Baumslag N. (2005) Murderous Medicine: Nazi Doctors, Human Experimentation, and Typhus. Westport, CT: Praeger; Kater M. (1989) Doctors Under Hitler. Chapel Hill; University of North Carolina Press; Lifton RJ. (1986) The Nazi Doctors. NY: Basic Books; Spitz V. (2005) Doctors from Hell.

Boulder, CO: Sentient Publications.

3. Including non-monopolized small scale venture capital companies that concentrate their efforts (and subsidies) upon research and the development of techniques and technologies to treat less prevalent forms of pain pathology. These approaches might be of great benefit to fewer absolute numbers of patients, yet maximize benefit to those patients for whom said agents/technologies are ideally suited to treat their pain disorder, and could (in at least partial accordance with the maximin principle) afford a more balanced equilibrium of commutative and distributive provision of resources, and thereby more broadly sustain the total social good of pain medicine. See: Rawls J. (1971) A Theory of Justice. NY: Belknap; May W. Contending images of the healer in an era of turnstile medicine. In JK Walter & EP Klein (Eds.) (2003) The Story of Bioethics: From Seminal works to Contemporary Explorations. Washington, DC; Georgetown University Press, (pp. 149-162); Giordano J, Hutchison P, Benedikter R. (2010) Re-grounding medicine amidst a technological imperative and post-modern mindset. Int J Polit Cult Sociol, 10(10).

4. For additional information about these organizations, their scope, mission, and activities, see the following websites: International Association for the Study of Pain: www.iasp-pain.org; American Pain Society: www.ampainsoc.org; American Academy of Pain Medicine: www. painmed.org; American Society of Interventional Pain Physicians: www.asip.org; World Institute of Pain: www.worldinstituteofpain.org; American Academy of Pain Management: www.aapainmanage.org; American Society of Pain Educators: www.paineducators.org

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Articles Health Policy for Renal Replacement Therapy in Developing Countries Rahul M. Jindal, MD, PhD, MBA Division of Organ Transplant Surgery Department of Surgery, Walter Reed Army Medical Center 6630 Georgia Avenue Washington, DC 20307 Clinical Professor, Division of Nephrology and Hypertension The George Washington University Washington, DC Tel: 202-782-6462 Fax: 202-782-3186 Email: jindalr@msn.com Edward M. Falta, MD, FACS Department of Surgery, Walter Reed Army Medical Center Washington, DC Lyndsay S. Baines, PhD Department of Surgery, Walter Reed Army Medical Center Washington, DC Eric A. Elster, MD, FACS Department of Surgery National Naval Medical Center Wisconsin Avenue Bethesda, MD

Author Note

The views and opinions expressed in this article are solely those of the authors and do not reflect the official position or policy of the Department of the Army, the Department of the Navy, the Department of Defense, or the U.S. Government. We are grateful to Dr Moro O. Salifu, Chief of Nephrology, SUNY-Downstate Medical Center, Brooklyn, New York and Dr Panduranga S Rao, Department of Medicine, Division of Nephrology, University of Michigan, for critical reading of the manuscript.

Abstract In developing countries, treatment of end stage renal failure is largely guided by economic considerations; only about 5% of patients undergo transplant surgery. Studies have clearly shown that, compared to dialysis, a successful kidney transplant improves patient survival.

Even taking into account the cost of immunosuppressants, kidney transplantation is cost Journal of Healthcare, Science and the Humanities

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Articles effective. We found that in the context of a developing country, pre-emptive transplant offered patient and graft survival comparable to conventional kidney transplant and eliminated complications, inconvenience and cost of dialysis. We submit that there is a need for the development of specific national strategies for treatment of end stage renal failure, with consideration toward the unique economic conditions of the countries involved. Creation of a national registry for renal replacement therapy for each country will help in assessing the need.

Equal importance should be given to preventive measures and public education.

Keywords: Renal failure in developing countries; kidney transplant in developing countries; economics of dialysis; economics of kidney transplantation; pre-emptive kidney transplant in developing countries; national registry for renal replacement therapy in developing countries

Introduction As developing countries rapidly become connected to the rest of the world by way of travel and the World Wide Web, expectation is rising for a range of medical and surgical therapies, from primary care to specialized areas such as complex heart surgery and renal transplantation, to be made available to all. It is not clear whether a national taxpayerfunded universal health service, similar to that in the United Kingdom and Canada, or an insurance-based system resembling that in the United States, would be the best type of health care system for developing countries. Identifying an ideal structure for making health care available is a matter of debate and controversy (Lameire, Joffe, & Wiedemann, 1999).

India’s mixed form of health care, in which the government provides only basic care and a few tertiary centers offer highly specialized care (Bhowmik, Pandav, & Tiwari, 2008), may be another alternative.

In developing countries, the possibility of long-term dialysis does not exist; it is too expensive, and patients simply die unless they can afford to obtain a kidney transplant. Even in a middle-income country such as India, only 5–10% of all patients with end stage renal failure (ESRD) gain access to some form of registry for renal replacement therapy (RRT) (Bhowmik, Pandav, & Tiwari, 2008).

The introduction of kidney transplantation in relatively poor countries, including Guyana, Ghana and Kenya, has recently been reported (Delmonico, 2009). Physicians from both the private sector and local governments performed the first few living-kidney transplants in these countries. A French agency, Etablissement français des greffes, in collaboration with a number of developing and East European countries, has undertaken an innovative plan to develop transplant programs; long-term success of this effort will be closely watched.

Pre-emptive living kidney transplantation with free or reduced-cost immunosuppressive medications from generic pharmaceuticals has been shown to be more cost effective than long-term dialysis (Milton, Russ, & McDonald, 2008). In developing countries such as India, treatment of ESRD is largely guided by economic considerations; only about 5% of patients undergo transplant surgery (Singh & Bhandari, 2004). Although the removal of organs from brain-dead patients has been legalized, the concept of donation of organs from the deceased has not received adequate social sanction. Only 2% of all transplants are performed with organs from deceased donors. The socioeconomic implication of a young population afflicted with a potentially terminal illness is devastating, and in the 42

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Articles face of growing epidemics of diabetes and hypertension, the burden of chronic kidney disease (CKD) is not likely to ease. In the final analysis, a national strategy taking into account the unique economic conditions of the specific country is needed for treatment of ESRD. A combination of private-governmental partnership with assistance from developed countries may be a solution for providing RRT.

Economics of Kidney Transplantation in Developing Countries Incidence of Kidney Failure The number of patients in both developing and developed countries requiring RRT either by dialysis or kidney transplantation is estimated to be 1.4 million; this number is growing at the rate of 8% annually (Schieppati & Remuzzi, 2005). Several factors may account for this increase, with diabetes, an aging population and hypertension seen as major causes. Due to a lack of national registries, it is difficult to estimate the burden of ESRD in developing countries. The incidence of diabetes, hypertension and genetic causes of renal failure in these countries is not apparent, as no hard data are available. However, it is anticipated that the incidence of kidney failure is likely to increase due to a dramatic rise in the incidence of diabetic nephropathy in developing countries (Cutter, 1998; Agarwal & Srivastava, 2009). Developing countries also have a high incidence of infectious causes of kidney disease. The role of environmental pollution and the widespread use of herbal medicines in causing ESRD are being explored (White, Chadban, Chapman, & Cass, 2008) in both developing and developed countries.

The incidence of ESRD varies from country to country. Some of the differences could be due to lack of national registries and under-reporting; large numbers of people may die from ESRD without ever receiving RRT. The incidence of new patients with ESRD treated with dialysis in Singapore rose from 96 per million population (pmp) in 1992 to 167 pmp in 2000. This near-doubling is not unique to Singapore. Many other Asian countries have seen a similar increase in the incidence of ESRD, in large part due to an increasing incidence of the risk factors for renal disease (Tan et al., 2005; Narasimhan et al.,2006; Teo, Ma, Xu, Li, & Lee, 2010).

Consequent to the high incidence of ESRD, toward the end of 2002, an estimated 301,649 patients in Asia were reported to be on dialysis; this, however, is a gross underestimate, since the acceptance rate for RRT in Asian countries is very low (Chugh, Jha, & Chugh, 1999).

Cost Effectiveness of Dialysis versus Kidney Transplantation A vast body of literature has shown that kidney transplantation is more cost effective than dialysis and that it confers improved quality of life. Globally, utility values for dialysis were 0.65 for the first six months and 0.68 after the first six months (Hornberger, Best & Garrison, 1997). Utility values range from 1.0 (perfect health) to 0.0 (death). The higher the utility value, the better the quality of life associated with a health state; the lower the value, the poorer the quality of life. Utility values can be obtained from patients or from surrogate respondents, such as physicians, administrators and the general public, although those obtained from patients who actually have a given health state are most relevant (Redelmeier & Detsky, 1995). The utility value for kidney transplantation was 0.84 six months post-transplant. In developing countries, this is particularly important, as Journal of Healthcare, Science and the Humanities

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Articles dialysis facilities may be non-existent or prohibitively expensive. Even allowing for the cost of immunosuppressants, kidney transplant is more cost effective.

Survival Advantage of Kidney Transplantation Studies have shown that a successful kidney transplant will markedly improve patient survival compared to dialysis (Port, Wolfe, Mauger, Berling, & Jiang, 1993). In Scotland, investigators assessed the magnitude of the survival benefit of renal transplantation as compared with that of dialysis (Oniscu, Brown, & Forsythe, 2005). In a longitudinal study of survival and mortality risk in 1,732 adult patients, relative risk (RR) of death during the first 30 days after transplantation was 1.35 compared with patients on dialysis; the longterm RR (at 18 months) for the transplant recipients was 0.18 when compared with patients on dialysis. The projected life expectancy with a successful kidney transplant was 17.19 years, compared to 5.84 years on dialysis. Wolfe, et al. (1999) conducted a longitudinal study of mortality in 228,552 patients in the US who were receiving long-term dialysis for ESRD. Among these patients, 46,164 were placed on a waiting list for transplantation, and 23,275 of these received a first deceased-donor kidney transplant between 1991 and 1997. Among the various subgroups, the standardized mortality ratio for the patients on dialysis who were awaiting transplantation (annual death rate, 6.3 per 100 patient-years) was 38–58% lower than that for all patients on dialysis (annual death rate, 16.1 per 100 patient-years). Patients on the waiting list tended to be fitter and followed more rigorously with routine preventive work-up and careful cardio-pulmonary assessment at regular intervals. The long-term mortality rate was 48–82% lower among transplant recipients than patients on the waiting list, with relatively larger benefits among patients who were Caucasian and between 20 and 39 years old.

Rabbat, Thorpe, Russell, & Churchill (2000) investigated the potential of kidney transplantation in offering a survival advantage in regions where dialysis survival is superior to that in the US. A cohort of 1,156 patients who started RRT and were wait-listed for deceased-kidney transplant in Ontario, Canada between January 1, 1990 and December 31, 1994 was studied. Patients were followed from wait-listing (n = 1156), to first deceased kidney transplant (n = 722), to death, or to study end. The average RR of death was 2.91 in the first 30 days after transplantation, but was significantly lower one year after transplantation, indicating a beneficial long-term effect.

Survival benefit was observed even with Expanded Criteria Donor (ECD) kidney transplants. In a retrospective cohort study using data from a US national registry of mortality and graft outcomes among kidney transplant candidates and recipients, ECD recipients had a 27% lower risk of death (Merion, et al., 2005). However, in areas with shorter waiting times, only recipients with diabetes demonstrated survival benefit with ECD kidney transplants. This would mean that ECD should be offered to patients in regions of the country that have a long waiting list. Patients who have a living-kidney donor should not be offered ECD kidney, as the half-life of living kidneys is twice as long as that of a deceasedkidney donor.

Need for Kidney Transplants In India, where some reliable data are available, 5â&#x20AC;&#x201C;10% of all patients receive some kind of RRT. Most patients are initiated on hemodialysis, and a small proportion (<0.5%) 44

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Articles are started on continuous ambulatory peritoneal dialysis. About 60% of patients are lost to follow up within three months due to economic reasons, lack of education, or living a long distance from a dialysis center. Despite the fact that kidney transplantation is a less expensive option owing to reduced maintenance costs over time, only about 5â&#x20AC;&#x201C;10% of patients with ESRD receive a transplant (Sakhuja & Kohli, 2006).

Burden of Chronic Kidney Disease In the absence of nation-wide reporting systems or registries, the true incidence and prevalence of CKD in developing countries is difficult to determine. Observational and anecdotal data suggest that the normal ranges of glomerular filtration rate (GFR) may be lower in vegetarian, less muscular, Indian patients with different creatinine generation rates compared to their Western counterparts. In the last decade, we have seen a major evolution in the definition and classification of CKD based upon estimated GFR (eGFR). Application of these definitions would impact identification of disease, and, as a result, issues of global implementation will need to be resolved. Modi and Jha (2006) reported from an urban population in the city of Bhopal, India, that the crude and age-adjusted incidence rates of ESRD were 151 and 232 ppm, respectively. ESRD incidence rates lend themselves more easily to international comparisons, as the diagnosis is less susceptible to inaccuracies. These estimates are roughly similar to those of the US.

Pre-Emptive Kidney Transplant in Developing Countries In many countries, it has been shown that pre-emptive kidney transplantation yields better patient outcomes than dialysis (Milton, et al., 2008; Shrestha, 2008; Liem & Weimar, 2009; Witczak, et al., 2009). This is especially true in developing countries, where practice involves avoidance of expensive and prolonged dialysis. Providing treatment for ESRD, however, is particularly difficult in developing countries where national incomes are not sufficient to cover even the basic requirements of their citizens (Jha, 2004). Although some developing countries are making active efforts to establish deceased-donor transplant programs, currently, for the majority, such programs are virtually non-existent (Evans & Kitzmann, 1998; Chugh, Jha, & Chugh, 1999).

John, Rao, and Jacob (1998) compared the results of 43 patients from India who underwent living-related, pre-emptive kidney transplants to 86 matched controls who underwent transplantation after hemodialysis. Controls received more transfusions, had higher hepatitis B surface antigen and more commonly had hepatic dysfunction in the pre-transplant period compared with the pre-emptive group. Similarly, at six months after transplant, the incidence of hepatitis B surface antigen positivity (13 versus two patients) and hepatic dysfunction (18 versus three patients) were higher in the control group compared with the pre-emptive group. This suggested that dialysis-associated complications were more common in their program in India and that pre-emptive transplant could avoid these complications. The one- and two-year graft and patient survival rates were comparable.

Similar experiences were demonstrated in Egypt (el-Agroudy, Donia, Bakr, Foda, & Ghoneim, 2004). Between 1976 and 2001, 1,279 first living-donor kidney transplants were performed at a single center. The 82 patients (6.4%) who underwent transplant without prior dialysis were compared with 1,197 patients who had been dialyzed before transplant.

Actuarial graft and patient survival at five years was comparable in both groups; however, Journal of Healthcare, Science and the Humanities

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Articles there was an obvious economic advantage in eliminating the cost associated with dialysis after taking the cost of immunosuppressive medications into consideration. In Iran, pre-emptive kidney transplantation was compared with 300 kidney recipients receiving pre-transplant dialysis for at least six months. No significant differences were noted in the gender of the recipients or the age and gender of the donors, donor source or immunosuppressive therapy.

The authors found that pre-emptive kidney transplant eliminated costs and complications associated with dialysis (Pour-Reza-Ghol, et al., 2007).

The timing of pre-emptive kidney transplantation should be carefully considered.

In developed countries, the concept of pre-emptive kidney transplantation may be applied liberally; generally, a creatinine clearance of less than 20 mL/min is a sufficient legal and accepted indicator. Nevertheless, in developing countries, to reduce the cost of immunosuppressive medications, kidney transplant may be delayed as long as possible, while also avoiding the need for expensive dialysis and associated complications.

Experience of Renal Replacement Therapy in Developing Countries Pakistan Pakistan, with a population of 140 million people, two-thirds of whom live in rural areas, is fairly representative of a developing country. The per capita income is less than US $500, and health expenditure by the government is 0.9% of the GNP. Overall, 33% of the people live below the poverty line, with only US $1 per day for sustenance. Life expectancy is 61 years for males and 63 years for females. Rizvi, et al. (2003), from the Sindh Institute of Urology and Transplantation (SIUT), Dow Medical College, Karachi, have developed a unique community-government partnership, which has been successful for patients over age 15 years. This partnership carries out 110 transplants annually, with follow-up of free after-care and immunosuppressive drugs. According to their estimates, the prevalence of ESRD in Pakistan is 100 pmp. For a population of 140 million, the country has 150 dialysis centers, mostly in the private sector. The per-session cost for dialysis is US $25. The country also has 15 transplant centers, 10 of which are in the private sector, where a transplant costs US $6,000-10,000, an exorbitant amount for the vast majority of the population. The ÂŤfreeÂť kidney transplant costs to the SIUT are US $1,640 for the surgery and US $300 per month for immunosuppressive drugs. SIUT spends US $1.6 million each year on transplantation alone, and excellent results have been consistently reported. More than 1,000 transplants have been performed in the last 20 years, with one- and five-year graft survival of 92% and 75%, and one- and five-year patient survival of 94% and 81%, respectively. In spite of this, the problem of post-transplant infections continues to be a major issue, with 15% of patients developing tuberculosis, 30% cytomegalovirus and nearly 50% bacterial infections.

Jamaica Trisolini, Ashley, Harik, and Bicknell (1999), from Boston, collaborated with physicians, governmental officials and health care payers in Jamaica to develop a health policy for patients with ESRD. They concluded that rationing the available treatment capacity may be the best option; however, this action was regarded as politically challenging. In addition, it was believed that cost-saving strategies, such as peritoneal dialysis, pre-emptive kidney transplantation, preventive measures and public education, should be undertaken rigorously. They calculated that if all ESRD patients in Jamaica were to be treated with dialysis, the recurrent costs could reach 68% of the total Ministry of Health budget, a situation that would be unacceptable.

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Articles India In India, Jha (2004) summarized the state of treatment options for ESRD. The high cost of dialysis puts it beyond the reach of all but the very wealthy, and maintenance dialysis is the exclusive preserve of private hospitals. India does not have state-funded or private health insurance schemes, and patients must finance health care on their own. Physicians in India have empirically tried to reduce costs by cutting down the frequency of dialysis, using cheaper cellulosic dialyzers, reusing dialyzers and reducing the use of erythropoietin. There is no organized deceased-donation program, and an overwhelming majority of transplants are performed using living donors. Jha concluded that the financial burden of RRT in developing nations impacts the lifestyle and future of entire families and extracts a cost far higher than the actual amount of money spent on treatment.

Guatemala It is has been estimated that only 35% of Guatemalan patients with ESRD would be diagnosed and treated at any time, and, unlike many developed countries, the age of presentation in 60% of the patients is before the fourth decade (Lou-Meda, 2006). The cost of death and disability due to ESRD in this young population is thus particularly severe, and results in reduced productivity, eventually affecting the economic growth of the country. It is also estimated that 400 pediatric cases develop progressive kidney disorder (e.g., neurogenic bladder, reflux nephropathy, chronic glomerulonephritis) annually, which, if left untreated, could result in ESRD in adulthood.

Thailand Prakongsai, Tangcharoensathien, and Kasemsup (2006) explored the policy options of RRT for ESRD patients under universal coverage in Thailand. They investigated the efficiency in utilization of government heath resources and equity in access to health care.

They found that although neither hemodialysis nor peritoneal dialysis was cost-effective due to the expensive costs per life-year saved, a wider societal concern of protecting households against financial catastrophe justified public-funding treatment of ESRD. For this to be feasible, rationing would be unavoidable. They proposed that prevention of ESRD and provision of RRT to every patient up to a predetermined age, or to every patient with a defined number of renal replacement years, would be accomplished by providing more years to younger patients. These two options were financially viable and would achieve ethical principles of providing an equal chance to all patients, while two other alternatives â&#x20AC;&#x201C; provision of life-time medical services to all or a selection of some â&#x20AC;&#x201C; would become relatively less possible. Nonetheless, they recommended significant improvement in health services for preventive strategies, a centralized system of purchasing key medications, and, finally, a mandatory report on the Thailand Registry of RRT, with special emphasis on peritoneal dialysis and kidney transplantation.

Bangladesh Rashid (2004) described the experience of managing patients with ESRD and kidney transplants in this country of 128 million people, 75% of whom lived in rural areas where the annual per capita gross national product was US $380. As expected, treatment of ESRD had low priority: fewer than 10% of ESRD patients were able to maintain dialysis.

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Articles The majority of patients presented late in the course of their disease. Eighty percent of patients presenting with ESRD were unaware of their disease, and, as a result, most either dialyzed by temporary access, like jugular or femoral catheterization. Survival rates for patients on a three-times-per-week dialysis schedule were 77% and 57% at three and five years, respectively, whereas those on twice-weekly dialysis had survival rates of 55% and 40% at three and five years, respectively. All patients usually received cyclosporine, azathioprine and prednisolone for three to six months; cyclosporine was generally withdrawn within six months to one year due to financial reasons. The graft survival in Rashid’s report was 90% and 80% at one and five years, respectively. The annual cost of hemodialysis varied from US $4,000–5,500, an excessive amount in a developing country. The cost of renal transplant in Bangladesh is approximately US $3,000, including surgical fees, medications and other hospital charges, for one month.

Establishing the First Kidney Transplantation Program in Guyana, South America Burden of Renal Disease in Guyana Renal diseases contribute to a major public health problem in Guyana, mainly because of a high incidence of diabetes and hypertension. Guyana has approximately 10,000 new hypertension and 8,000 new diabetes patients each year (Guyana Minister of Health, personal communication January, 5, 2008). These two conditions typically result in kidney failure, and account for a considerable portion of the more than 200 Guyanese in need of dialysis at this time.

Social Networks in Establishing the First Kidney Transplant Surgery in Guyana The Guyanese-American community in the US has been actively participating in numerous medical charity programs in Guyana for the past 20 years. Because long-term dialysis is an expensive option (in 2006, the per-capita annual income in Guyana was US $1,219 compared to $43,562 in the US) (United Nations, 2006), a few influential members of the community decided to work towards establishing a kidney transplant program in that country.

The first kidney transplant was performed on a 17-year-old Guyanese boy in 2008. It required a collaborative effort among four communities: Guyanese-Americans, the Guyanese Ministry of Health, US transplant professionals and a team of Guyanese physicians.

Teams were evenly balanced in terms of power, skill base and support. Representatives of the American-Guyanese business community, who had taken many goodwill health initiatives to their native Guyana in the past, were familiar with the socio-economic and political infrastructure of the country. The US Army’s medical team (part of the US transplant professionals group) had the medical and surgical skills, as well as the training necessary to adapt to different and less sophisticated medical environments, including the operating facilities that would encounter in Guyana. The medical team based in Guyana was critical for the smooth functioning of the surgery, as members were familiar with the patient’s social networks and medical history. The Minister of Health and his team were ready to facilitate and organize the teams and commit to providing free medications for at least three years (the cost of anti-rejection medications for one year was approximately US $8,000).

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Articles In 2008, Dr Rahul M. Jindal, from Walter Reed Army Medical Center, and the US Army-Navy medical team began to cultivate a working relationship via email and telephone with local Guyanese doctors as they conducted patient work-up. The flow of information supplied vital information to formulate both a budget and the manpower requirements for the proposed kidney transplant. The Guyanese team created a “dense social network” based upon a shared opportunity to fulfill a medical need within their country (Jindal, 2009).

Based on previous experience (Baines & Jindal, 2003), the network had to be highly flexible to effect a number of timely transitions in its role in the operation. In the early work-up stages, the members assumed a heightened responsibility that required them to be at the forefront of the operation. However, once the US-based team arrived in Guyana, their role became both supportive (hosting the visiting team and helping them negotiate the logistics of hospital life) and educational (accumulating knowledge from the visiting medical team). The psychosocial history of the donor and recipient presenting for transplant was intertwined with post-transplant medical and financial support from the Ministry of Health. Kidney disease and transplantation played out within the context of family attitudes, values, beliefs and cultures, along with the relational history of the families. Social network interactive relational history helped to determine what aspects might predispose or compromise medical non-adherence after a kidney transplant.

Jindal (2009) acted as the focal point to pull together all four social networks for this operation. His centralized positioning meant that all information flowed through him and that he was consequently in a strategic position to ensure cohesiveness of the group, solidify inter-dependencies, minimize differences and prevent isolation among the four networks. He accomplished this by ensuring that inter-connecting paths of communication among all four networks were in place. This eliminated the potential for rigid social boundaries and enabled maintenance of a balanced and harmonized collective network.

The transplant team (from the Walter Reed Army Medical Center [WRAMC] and National Naval Medical Center [NNMC]) had made an exploratory visit to Guyana to meet with native physicians, the Minister of Health, the patient, and donor (the patient’s mother), then returned later to set about the task of coordinating the transplant work-up. It was necessary to prepare the medical team, secure medical licenses to work in Guyana and arrange for travel, and the local team had to be advised in terms of OR, anesthesia, ICU and nursing staff. Also critical to the mission was the establishment of laboratory facilities for preand post-operative care.

Some tests, such as tissue typing and cross-match, were not done in Guyana. Jindal obtained blood samples to perform tests in the Immunology Laboratory of WRAMC and NNMC, Washington, DC. The staffs in both institutions were gracious in donating their time and expertise. Over three hundred emails and 100 telephonic calls to Guyana were made by the medical team based in the US in the course of coordinating this effort.

Recommendations International cooperation to draw the peoples of the world together takes various forms, and the first kidney transplant done in Guyana is an example of one such attempt.

Jindal’s team has subsequently performed three additional living-kidney transplants and placed peritoneal dialysis catheters in seven patients with ESRD, representing the first

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Articles peritoneal dialysis in Guyana. Approximately 33 patients are in various stages of transplant work-up. Other agencies are also working to help bring RRT to people of the developing world. An innovative program has been undertaken by Etablissement français des greffes, a French organization that has been collaborating with a number of developing countries to support the procurement of transplantation programs within a proper ethical and regulatory framework. The main programs involve Morocco, Tunisia, Romania and Bulgaria, and, to a smaller extent, Mexico and Vietnam. The focus of these exchanges is to foster transfer of “know-how” between institutions, improve cooperation among professionals within their hospitals, and develop policies in the field of kidney failure and transplantation. The major drawback, according to the Etablissement français des greffes, has been reliance on a few highly motivated individuals, resulting in less satisfactory results in the projects aimed at developing procurement from deceased donors. Most of the organ transplantation programs in these countries rely on living donors. While this option is clearly relevant in terms of feasibility, it cannot alone provide access for all patients in need of an organ.

In an effort to increase awareness, detection, prevention and treatment of kidney and related diseases, a “World Kidney Day” was established in 2006 (www.worldkidneyday. org). The aim of this event was to raise awareness about the heavy burden CKD has on human lives and on health care budgets, and to put CKD on the agenda of governments and other institutions worldwide. The initiative has assumed increasing importance, as recently published studies have confirmed that CKD is a more common disorder than previously thought. Clinical trials have recommended use of three simple and inexpensive tests to detect CKD: urine for protein, serum creatinine and eGFR. It seems that despite the availability and validity of this approach, the task of developing widespread detection and management programs for CKD that produce improved outcomes at a reasonable cost is formidable. It is unlikely that even developed countries have adequate financial and human resources for whole-population screening programs for CKD, and there is no substantial evidence that these measures are cost-effective.

Based on current information, Shah and Feehally (2008), on behalf of the World Kidney Day Steering Committee, have recommended that all countries endorse targeted screening programs.

Steps for Health Care Professionals to Take to Establish an Effective Screening Program for CKD 1. Report estimated GFR in all laboratories measuring serum creatinine.

2. Measure eGFR and proteinuria in people at highest risk of CKD, including all those with diabetes, hypertension, coronary heart disease and cerebro-vascular disease, who constitute the majority of patients with CKD and with ESRD. 3. Regularly measure blood pressure, eGFR and proteinuria in people identified with CKD. 4. Establish targets for blood pressure control in people with CKD and appropriate use of drugs blocking the renin-angiotensin system.

5. Agree on guidelines for identifying the minority of people with CKD who would benefit from the advice of a nephrologist, as well as from the routine care of a family physician.

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Articles Conclusion Many developing countries are grappling with the issue of health care funding for renal failure. In a 2002 review, Barsoum collaborated with leading nephrologists in 10 developing countries in filling out a 103-item questionnaire that addressed epidemiology, etiology and management of ESRD in their respective countries. Through this joint effort, it was possible to identify a number of important trends, including the expected high prevalence of renal failure and limited access to RRT. Glomerulonephritis, rather than diabetes, was the main cause of CKD, while the implementation of different modalities of RRT was inhibited by the lack of funding. Hemodialysis was the preferred modality in most countries, with the exception of Mexico, where chronic ambulatory peritoneal dialysis took the lead. In several other countries, dialysis was available only for those on the transplant waiting list. Dialysis was associated with a high frequency of complications, particularly HBV and HCV infections; data on HIV were lacking, and aluminum intoxication remained a major problem. Treatment withdrawal was common for socioeconomic reasons, while transplantation was offered to an average of only 4 pmp.

The opinion that kidney transplantation is far cheaper than prolonged dialysis is near unanimity, and the benefit to the recipient is significant in terms of the years of life saved and the improved quality of life. It is interesting to note that physicians in most developing countries rely on less expensive medications (e.g., use of azathioprine instead of mycophenolate mofetil) as part of their immunosuppressive regimen [http://www. kidneybangla.org/]. Withdrawal of calcineurine inhibitor medications (e.g., tacrolimus and cyclosporine) is done routinely to reduce cost.

The authors believe that pre-emptive living-kidney transplantation with reduced cost immunosuppressive medications from generic pharmaceuticals may be more effective than long-term dialysis. Clearly evident is the need to develop a national strategy for treatment of ESRD, taking into account the unique economic conditions of individual nations. A combination of private-governmental partnership with assistance from developed countries may be a solution. The creation of a national registry for RRT within each country will surely help in assessing needs. Finally, equal importance should be given to preventive measures and public education on the subject.

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Articles Chugh, K.S., Jha, V., & Chugh, S. (1999). Economics of dialysis and renal transplantation in the developing world. Transplantation Proceedings, 31(8), 3275–3277.

Cutter, J.L. (1998). Diabetes mortality in Singapore, 1991- A preliminary study. Singapore Medical Journal, 39, 311–318.

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Articles Merion, R.M., Ashby, V.B., Wolfe, R.A., Distant, D.A., Hulbert-Shearon, T.E., Metzger, R.A., Ojo, A.O., & Port, F.K. (2005) Deceased-donor characteristics and the survival benefit of kidney transplantation. Journal of the American Medical Association 294, 2726–2733.

Milton, C.A., Russ, G.R., & McDonald, S.P. (2008). Pre-emptive renal transplantation from living donors in Australia: Effect on allograft and patient survival. Nephrology, 13, 535–540.

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Narasimhan, B., Chacko, B., John, G.T., Korula, A., Kirubakaran, M.G., & Jacob, C.K. (2006). Characterization of kidney lesions in Indian adults: Towards a renal biopsy registry. Journal of Nephrology, 19, 205–210.

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Articles Sakhuja, V., & Kohli, H.S. (2006). End-stage renal disease in India and Pakistan: incidence, causes, and management. Ethnic Diseases, 16 (Supplement 2), 20–23.

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Articles Ethical Decision Making: A Process Influenced by Moral Intensity Sarah Hope Lincoln, PhD (cand) Psychology Intern VADM Stockdale Center for Ethical Leadership United States Naval Academy, 112 Cooper Road Annapolis, Maryland, 21402 Tel: (410) 293-6088 Fax: (410) 293-6081 Email: ekholmes@usna.edu Elizabeth K. Holmes, PhD Director of Assessment VADM Stockdale Center for Ethical Leadership United States Naval Academy, 112 Cooper Road Annapolis, Maryland, 21402 Tel: (410) 293-6088 Fax: (410) 293-6081

Author Note The authors acknowledge the Canadian Forces and Department of National Defence for sharing their Defence Ethics Survey. We thank Dr. Albert C. Pierce, Dr. Linda Mallory, and Mr. Stephen Newberry, without whom this research would not have been conducted. The authors are solely responsible for the contents of this article. The contents do not necessarily reflect the policy of the U.S. Department of Navy, the U.S. Department of Defense, or the U.S. Government. All correspondence should be directed to Dr. Elizabeth Holmes.

Abstract Understanding the process in which individuals engage in ethical decision making and the factors influencing this process may be important for developing more effective ethics education and leader development programs. This study investigated three components of ethical decision making: moral awareness, moral judgment, and moral intention, and their relationship with five components of moral intensity: Social Consensus, Magnitude of Consequences, Temporal Immediacy, Proximity and Probability of Effect. The results suggest that as individuals face morally charged situations, their awareness of the moral dilemma, judgments about potential consequences, and intention to act are significantly affected by characteristics of the moral situation.

Keywords: Ethical decision making; moral intensity; moral reasoning; moral development; leader development programs Journal of Healthcare, Science and the Humanities

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Articles Introduction Societies and institutions become more interested in analyzing what makes an ethical, effective leader as they suffer the effects of poor leadership and the resulting polarization and cynicism. How does one develop ethical, effective leaders? In the United States, the long tradition of professional military education and officer development can serve as an exemplar.

The military’s emphasis on continuous development and focus on ethical decision making may offer an approach that can be adapted to other professions, including health care. Health care providers and researchers have to make ethical decisions all the time.

This paper, about the results of a study conducted in a professional military education environment with students, aims to foster an intellectual and cultural exchange about how people in any setting make ethical decisions. Once the steps involved in the process of making ethical decisions are recognized and understood—along with the pressures and biases that can influence decision making—then institutions of higher education can explore how to best develop ethical, effective leaders.

In their constant discovery of the world and themselves, students often face morally charged situations. Moral education attempts to prepare individuals to recognize and respond effectively to moral dilemmas. Examining different philosophical approaches to ethics, evaluating the decisions and consequences of historical moral problems, and discussing hypothetical case studies are some of the ways individuals can acquire skills for making ethical decisions. However, these approaches fail to explain the decision-making process and the factors influencing it, and as a result may be limited in their ability to provide students with the tools they need to think through ethical dilemmas.

Current literature on moral development has sought to provide a comprehensive understanding of what determines moral behavior; specifically, research in this area has focused on understanding the process of ethical decision making and factors that influence this process. Knowing how individuals engage in ethical decision making and learning about the factors that influence these decisions may be important in moral education and character development programs. Understanding the process of ethical decision making will allow an individual to be aware of and deliberate about the steps he or she takes when forming a decision and choosing to act. In addition, if external factors influence an individual’s decision-making ability, those individuals who can acknowledge these potential influences and take them into consideration will be better prepared to make moral decisions.

Ethical Decision Making: The Four Component Model James Rest’s (1994) theoretical model to explain the process of ethical decision making developed out of a desire to piece together theories and research on moral development and behavior from a variety of perspectives. Not only were researchers looking at moral development from a cognitive-development perspective, arguably the most predominant approach in moral development, but from social, behavioral, and psychoanalytic approaches as well (Rest). According to Rest, a new model was necessary to account for the different findings from each approach. Until this point, significant attention had been given

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Articles to the concept of moral judgment, the evaluation of a decision or action as good or bad, as the basis for ethical decision making. In contrast, Rest argued that moral judgment, while important, is not the only, nor the most significant, influence on ethical decision making.

Rest proposed that ethical decision making involves four distinct psychological processes: moral sensitivity, moral judgment, moral motivation/intention, and moral character/action.

Moral sensitivity (moral awareness), as described by Rest (1994), refers to an individual’s ability to recognize that a situation contains a moral issue. Recognizing a moral issue requires the individual’s awareness that his/her actions have the potential to harm and/or benefit other people. Later research broadens this definition, suggesting that moral sensitivity is the decision maker’s recognition that a situation has moral content and, as a result, a moral perspective is valid (Reynolds, 2006).

Moral judgment refers to formulating and evaluating which possible solutions to the moral issue have moral justification. This step in the process requires reasoning through the possible choices and potential consequences to determine which are ethically sound.

Moral motivation (moral intention) refers to the intention to choose the moral decision over another solution representing a different value. This component of the ethical decision- making process involves committing to choose the moral value. For example, an individual may recognize two solutions to a dilemma, one that results in an increase of personal power and one that is morally right. In this instance, moral motivation is the individual’s intention to choose the value of morality over the value of power.

Moral courage (moral action) refers to an individual’s behavior. This component is the individual’s action in the situation. This step involves courage, determination, and the ability to follow through with the moral decision.

Though these steps are arranged logically, they are not in a fixed order. Rest (1994) suggested that each component is distinct and can influence the others. Furthermore, failure at any step can result in a failure to make an ethical decision. An individual may have strong moral judgment skills but will not begin to use them if she or he lacks moral sensitivity and fails to recognize a moral issue.

Moral Intensity The lack of research on the characteristics of a moral issue initiated Thomas Jones’s (1991) development of the moral intensity model. Jones argued that the characteristics of the moral issue, what he collectively termed moral intensity, influence ethical decision making. Jones conceptualized his model such that moral intensity might influence each of the components of Rest’s Four Component model. The six dimensions of moral intensity are Magnitude of Consequences, Temporal Immediacy, Social Consensus, Proximity, Probability of Effect, and Concentration of Effect. Magnitude of Consequences refers to the degree to which an individual may be harmed by or benefit from the decision maker’s action. A greater degree of harm or benefit results in an increase in moral intensity. Temporal Immediacy refers to the length of time between the action and its consequences. An action that results in immediate negative consequences will cause a greater increase in moral intensity than an action for which the consequences are delayed. Social Consensus refers to the degree

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Articles of agreement among a social group that an action is good or bad. This social group could be society as a whole (e.g., an illegal act is not morally acceptable by society because a law prohibits it) or a smaller social group, such as an individual’s academic peers. A strong Social Consensus that an act is morally wrong increases moral intensity. Proximity refers to the nearness of the decision maker to the individuals potentially affected by the consequences.

Proximity can be a feeling of physical, cultural, social, or psychological nearness. An increase in Proximity results in an increase of moral intensity. Probability of Effect refers to the likelihood that the predicted consequences and the expected level of harm/benefit will occur.

If the probability that the action will occur and cause the predicted harm is high, moral intensity increases. The final dimension, Concentration of Effect, refers to the relationship between the number of people affected and the magnitude of harm. If the Concentration of the Effect is great, moral intensity increases (Jones, 1991).

The four-step model shown here combines both Rest’s and Jones’s ideas and is one approach to making practical, pragmatic decisions quickly, with conscious and deliberate awareness of these factors (Figure 1).

Figure 1. Ethical decision-making model.

Moral Intensity & Ethical Decision Making Empirical work on the relationships among moral intensity dimensions and ethical decision making is limited. Research in this area tends to be narrowly focused, rarely evaluating multiple dimensions of moral intensity and/or the numerous steps involved in ethical decision making (May & Pauli, 2002).

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Articles To date, the research on moral awareness creates at best a vague picture of the relationship between moral awareness and moral intensity. The majority of research on moral awareness suggests the importance of Social Consensus (Chia & Mee, 2000; Barnett, 2001; Butterfield, Trevino, & Weaver, 2000; Frey, 2000; Harrington, 1997; Singhapakdi, Vitell, & Kraft, 1996) and Magnitude of Consequences (Chia & Mee, 2000; Butterfield, Trevino, & Weaver, 2000; Frey, 2000; Singhapakdi et al., 1996) as significant predictors of moral awareness, and the lack of importance of Concentration of Effect as a predictor of moral awareness (Chia & Mee, 2000; Frey, 2000). However, the findings are equivocal for the impact of Proximity, Temporal Immediacy, and Probability of Effect on an individual’s sensitivity to a moral issue (Chia & Mee; Frey).

A more consistent relationship exists between moral judgment and the concept of moral intensity as defined by Jones’s moral intensity factors than that between moral awareness and the moral intensity factors. Research frequently finds that Social Consensus and Magnitude of Consequences are strong predictors of moral judgment (Morris & McDonald, 1995; Singer, 1998; Barnett, 2001; Harrington, 1997). Studies on the influence of Probability of Effect are inconclusive, and further investigation is needed to provide a clearer understanding. For example, Frey (2000) found Probability of Effect to be a significant predictor of moral judgment, but this dimension was found to have only relatively little influence in another study by Singer (1998). Research on Proximity, Temporal Immediacy, and Concentration of Effect, though not definitive, suggests that these dimensions do not significantly influence an individual’s moral judgment (Frey, 2000; Singer, 1998; Barnett, 2001).

Similar to moral judgment, the majority of research on moral intention and moral intensity suggests that Social Consensus, Magnitude of Consequences (Barnett, 2001; Frey, 2000; Singhapakdi et al., 1996), and Probability of Effect (Frey, 2000) are strong predictors of moral intention. Research also indicates that Proximity, Temporal Immediacy, and Concentration of Effect have little to no influence on an individual’s moral intention (Barnett, 2001; Frey, 2000).

At this time, research on the relationship between moral action and moral intensity is sparse due to the difficulty in studying moral actions. Nonetheless, Jones (1991) cites a number of previous studies of moral behavior that suggest dimensions of moral intensity will influence moral action. For example, in his research, Stanley Milgram conducted a series of famous studies to learn whether individuals would obey commands from a stranger (wearing a lab coat) who prompted them to inflict increasingly powerful electric volts on another person. The results showed that people who were physically closer to the individual they were asked to shock were less likely to continue to administer the shock (Milgram, 1974 as cited in Jones, 1991). This particular finding potentially provides some basis for the hypothesis that Proximity might influence an individual’s moral action (Jones). Though more research is needed to investigate the relationship between moral intensity and moral action, the present study does not include moral action in its investigation because of the inherent challenges of examining individuals’ behaviors in moral dilemmas.

Research investigating ethical decision making, moral intensity, and the relationship between the two constructs is continually expanding, but these theories need more empirical support. A comprehensive study exploring multiple dimensions of moral intensity and Journal of Healthcare, Science and the Humanities

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Articles multiple steps in the ethical decision-making process would greatly contribute to theory and practice in this field. The present study, exploring moral awareness, judgment, and intention, as well as five of the six components of moral intensity (Social Consensus, Magnitude of Consequences, Temporal Immediacy, Proximity, and Probability of Effect) across five scenarios, provides an opportunity to add to the understanding of the relationships among moral intensity components and steps in ethical decision making. In addition to contributing to the more general field of research on moral development, understanding how individuals respond to moral dilemmas could offer an important addition to ethics education and character development programs.

Method Participants and Procedure Data were collected from 812 students (644 male, 168 female) attending a service academy. Students were recruited to voluntarily participate in an anonymous computer survey. The sample included students from all class years, 18.8% seniors, 27% juniors, 29.1% sophomores, and 25.1% first-year students. The race and ethnicity of the sample was 80.7% Caucasian, 7.6% Hispanic, 5.2% Asian American, 3.3% African American, 2.1% Native American, 0.9% Multiracial, and 0.1% Other (Figure 2)

Figure 2. Study demographics.

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Articles Measure The Canadian Department of Defence gave permission to adapt their Ethics Survey, which is not copyrighted (Dursum, Morrow, & Beauchamp, 2003), into a questionnaire in two parts for the purposes of this study. Part I measured individual moral approaches to ethical decision making. Part II was developed to assess three components of Rest’s (1994) process of ethical decision making, moral awareness, moral judgment, and moral intention, and the influence of moral intensity on ethical decision making. The results from Part II are the focus of this study.

Part II of the questionnaire consisted of five scenarios, varying in ethical intensity, each describing a moral dilemma and a subsequent action/decision. All five scenarios were adopted from the compilation of Canadian focus group findings in which the military and civilian employees identified the ethical issues to which they were exposed. An initial selection of ten scenarios was pilot tested to insure the relevance of the stimulus for both civilian and military audiences. The scenarios were written in the third person, with the gender unspecified. The final five scenarios chosen for the Canadian survey were then modified for use in this study based on focus group findings from U.S. military officers and midshipmen to confirm the ethical dilemma exposure and relevance for the college student.

The five scenarios are described in Figure 3.

1.

2.

3.

4.

5.

Failure to report someone who damaged equipment by accident A career person who does not select the best person for the job, but rather an outspoken one who complained about unfairness Unfair business practices in grading A leader overlooks a fake claim that was submitted by a subordinate An operational military member gets goods and services from a dealer on the black market

Figure 3. Canadian and American scenarios.

Based on the decision made in each scenario, participants were asked a series of 15 questions, assessing their moral awareness, judgment, intention, and perception of five of the six moral intensity dimensions.

Moral awareness was determined by the student’s responses to the question “Do you believe that there is a moral or ethical issue involved in the above action/decision?” following each scenario. The questions used a seven-point Likert scale, ranging from 1 (completely agree) to 7 (completely disagree). The responses were recoded so that a higher score reflected a higher level of moral awareness. The moral judgment component was composed of seven different judgment factors: just/unjust, fair/unfair, morally right/wrong, acceptable/ unacceptable to family, acceptable/unacceptable in our culture, acceptable/unacceptable in our traditions, does not violate/violates an unspoken promise, and does not violate/violates an unwritten contract. Each item used a seven-point Likert scale, with statements reflecting a decision as morally appropriate (1) to morally inappropriate (7). An overall judgment score was computed by summing and averaging the ratings given to each factor. This moral judgment scale was originally developed by Reidenbach and Robin (1988, 1990), and its use in several empirical studies has shown reliability coefficients between .70 and .90 (Barnett, Journal of Healthcare, Science and the Humanities

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Articles 2001). Moral intention was determined by the student’s responses to the statement “Please indicate the likelihood that you would make the same decision described in the scenario” following each scenario. The questions used a seven-point Likert scale ranging from 1 (definitely would) to 7 (definitely would not).

Basing their responses on the decision or action in each scenario, participants evaluated the five dimensions of moral intensity; these questions measured each dimension on a seven-point Likert scale. Singhapakdi et al. (1996) developed the perceived moral intensity scale that was adapted for use in this study. The first statement measured Magnitude of Consequences (“The possible harm resulting from the decision within the context of that situation would be:” from minor to severe). The second statement measured Temporal Immediacy (“Any negative consequences of that decision are likely to occur:” from after a long time to immediately). The third statement measured Social Consensus (“Most students would consider that decision to be:” from appropriate to inappropriate). The fourth statement measured Proximity (“The specific decision would negatively affect:” from my group to people outside of my group). The fifth statement measured Probability of Effect (“The chances of any negative consequences occurring as a result of that decision are:” from not likely to very likely). Concentration of Effect, the sixth dimension of moral intensity, was not included because other research has failed to find empirical support for its inclusion in the moral intensity construct.

Results Table 1 presents the means and standard deviations for participants’ responses to questions regarding moral awareness, judgment, and intention. The mean scores for each scenario were averaged to create overall means for moral awareness, judgment, and intention. The results from the study suggest that in general, the participants are morally aware, judge immoral actions negatively, and are inclined towards the intention to act morally. A t-test revealed no significant gender differences for moral awareness, judgment, or intention.

Table 1. Means and Standard Deviations: Moral Awareness, Judgment, and Intention; Collapsed Scenarios (N=812) Means

Standard Deviations

Moral Awareness (Recoded)

5.23

1.06

Moral Judgment

5.00

.77

Moral Intention

4.78

.85

Regression analyses were conducted to investigate how, if at all, moral intensity dimensions predict moral awareness, judgment, and/or intention.

Table 2 shows the results from a multiple regression analysis of moral awareness and the five dimensions of moral intensity used in this study. The overall regression was significant for four of the five scenarios (F=8.83, p<.01, F=16.04, p<.01, F=19.64, p<.01, F=12.47, p<.01, F=19.06, p>.05). However, while significant, only a small portion of the variation in each scenario, 5%, 9%, 11%, 8%, and 11% for Scenarios 1 through 5

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Articles respectively, was accounted for by the moral intensity dimensions. T-tests show that both Social Consensus and Proximity were strong predictors of moral awareness, significantly affecting all five scenarios and four of the five scenarios respectively. There was moderate support for Probability of Effect and Temporal Immediacy, each significantly associated with three of the five scenarios; Magnitude of Consequences was a weak predictor of moral awareness, as significant effects were found with only two of the scenarios. These results suggest that Social Consensus and Proximity are significantly associated with an individual’s moral awareness, but Probability of Effect and Temporal Immediacy, while showing some association, have a weaker relationship with moral awareness. The results of this study also indicate that Magnitude of Consequences does not contribute to an individual’s recognition that a situation presents a moral dilemma.

Table 2. Multiple Regression Analyses: Moral Awareness and Moral Intensity (N=812) Variables

Scenario 1 Bt

Scenario 2 Bt

Scenario 3 Bt

Scenario 4 Bt

Scenario 5 Bt

Model 1 Magnitude of Consequences

.08 1.99*

.05 1.23

.02

.02

.15 3.23*

Temporal Immediacy

−.01 −.36

−.02 −.51

.37

−.11 2.93**

−.15 −4.06**

−.09 −2.25*

.22 5.50**

.16 4.28**

−.08 −2.19*

−.18 −5.27**

−.05 1.32

Social Consensus

.10 2.52*

Proximity

−.10 −2.63**

−.80 −2.34*

−.13 −3.53**

Probability of Effect

.12 2.97**

.05 1.25

.10 2.38*

.23 5.98**

.35

−.02 −.58

.26 5.55**

F

8.83**

16.04**

19.64**

12.47**

19.06

R

.05

.09

.11

.08

.11

2

Note. B is standardized beta coefficient. *p<.05, **p<.01

Table 3 shows the results of a hierarchical regression analysis conducted to test the relationship of moral judgment to moral awareness and moral intensity. In the analysis, moral awareness was entered first and found to be a significant predictor of moral judgment in all five scenarios (p<.01), though only a small amount of variance was accounted for in each scenario, 12%, 12%, 14%, 9%, and 4% for Scenarios 1 through 5 respectively. A significant change for the R2 value occurred in all five scenarios when the moral intensity dimensions were entered into the regression. Overall, moral awareness and moral intensity account for 28%, 48%, 57%, 43%, and 47% of the variation in Scenarios 1 through 5. The addition of moral intensity, with the exception of Scenario 1, explained at least three times the amount of variation in moral judgment as moral awareness. These results suggest that the moral intensity dimensions have more predictive value for an individual’s moral judgment than moral awareness. Results from the t-tests for moral intensity’s influence on moral judgment indicate that Social Consensus, Magnitude of Consequences, and Probability of Effect, each significantly associated with all five scenarios, were strong predictors of participants’ moral judgment. Proximity and Temporal Immediacy were found to be weak Journal of Healthcare, Science and the Humanities

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Articles predictors of moral judgment, significantly affecting only two of the five and one of the five scenarios respectively. These findings suggest that an individual’s consideration of Social Consensus, Magnitude of Consequences, and Probability of Effect significantly contributes to his/her judgments about a moral situation; Proximity and Temporal Immediacy are less important factors.

A hierarchical regression was conducted to examine moral intention’s relationship with moral judgment and moral intensity.

Table 3. Hierarchical Regression Analyses: Moral Judgment, Moral Intensity & Moral Awareness (N=812) Variables

Scenario 1 B R2

Scenario 2 B R2

Scenario 3 B R2

Scenario 4 B R2

Scenario 5 B R2

Model 1 Moral Awareness

.35** .12**

.34** .12**

.38** .14**

.30** .09**

.19** .04**

Model 2 Moral Awareness

.28**

.16**

.17**

.21**

.05

Magnitude of Consequences

.09**

.14**

.10**

.10**

.16**

Temporal Immediacy

−.04

Social Consensus

.35**

Proximity

.00

Probability of Effect

.05

R2∆

.16**

−.08* .51** −.03 .28**

−.01 −.60* −.06*

−.02 .49** −.07*

.03 .42** −.03

.12** .48**

.07* .57**

.10** .43**

.24** .47**

.37**

.42**

.34**

.44**

Note. B is standardized beta coefficient. *p<.05, **p<.01

As shown in Table 4, moral judgment was entered first and found to be a significant predictor of moral intention for all five scenarios (p<.01). Moral judgment explained 43%, 43%, 53%, 38%, and 52% of the variation for moral intention. Adding moral intensity dimensions in the second step of the regression significantly increased the R2 value (p<.01), though the percentages are R2∆ for each scenario are small. This finding suggests that moral judgment is a better predictor of moral intention than moral intensity, but when combined, moral judgment and moral intensity are significantly stronger predictors of moral intention than either alone. T-tests show that Social Consensus, significantly affecting all five scenarios, Magnitude of Consequences, and Probability of Effect, each significantly associated with four of the five scenarios, were strong predictors of moral intention. Results also show Proximity was a moderate predictor of moral intention, significantly associated with three of the five scenarios. Temporal Immediacy was a weak predictor of moral intention, having a significant relationship with only one of the five scenarios. These findings are similar to the 64

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Articles results of moral intensity’s relationship to moral judgment. These results indicate that Social Consensus, Magnitude of Consequences, and Probability of Effect significantly contribute to an individual’s intention to act in morally charged situations; Proximity is also related to an individual’s intention to act, but to a lesser degree. Furthermore, when deciding his/her intention, Temporal Immediacy does not play a significant role in the individual’s decision.

Table 4. Hierarchical Regression Analyses: Moral Intention, Moral Intensity & Moral Judgment (N=812) Variables

Scenario 1 B R2

Scenario 2 B R2

Scenario 3 B R2

Scenario 4 B R2

Scenario 5 B R2

Model 1 Moral Judgment

.65** .43**

.65** .43**

.73** .53**

.62** .38**

.72** .52**

Model 2 Moral Judgment

.55**

.47**

. 50**

.42**

.57**

Magnitude of Consequences

.07*

.06

.00

.17**

.05

−.11**

.03

.05*

.04

.29**

.19**

.19**

.03

.00

.09** .48**

.01

.10**

.03**

Temporal Immediacy

−.01

Social Consensus

.17**

Proximity

−.07**

Probability of Effect R2∆

.22** −.06*

−.04

.06* .47**

.04

.47**

.05**

.05**

.02 .05**

.58**

.56**

Note. B is standardized beta coefficient. *p<.05, **p<.01

Discussion Other studies have not researched the service academy population. This study is the first, and it is not a developmental theory-based study. The population of 18- to 24-year-olds in this study is similar to previous studies at all adult ages.

The findings provide evidence supporting the importance of the relationship between moral intensity and ethical decision making. As individuals face morally charged situations, their awareness of the moral dilemma, their judgments about choices and consequences, and their intention to act are significantly affected by specific characteristics of the moral situation.

The results of this study strongly suggest that the moral intensity component, Social Consensus, is significantly associated with moral awareness, judgment, and intention. As students recognize a moral issue, form a judgment, and decide their intention to act, they

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Articles are strongly affected by what they believe others within their social group consider morally right or wrong. These findings support previous studies regarding the importance of Social Consensus in ethical decision making (Chia & Mee, 2000; Barnett, 2001; Butterfield et al., 2000; Frey, 2000; Harrington, 1997; Singhapakdi et al., 1996). Conformity studies in social psychology have consistently indicated the significant power of a group over the individual (e.g. Asch’s conformity experiments, 1956); as a result, the strong impact of Social Consensus is not surprising. Increasing an individual’s awareness of his/her susceptibility to the influence of the social group will provide him/her with the opportunity to consciously consider the extent to which the group may be positively and negatively affecting his/her decision.

The results also indicate that other dimensions of moral intensity are likely to affect specific parts of the ethical decision-making process. Proximity’s significant effect on moral awareness suggests that the closer an individual feels to the individual(s) affected by his/ her actions, the greater the likelihood that s/he will be aware of the moral issue. However, because of Proximity’s weak relationship to moral judgment and moderate relationship to moral intention, its overall association with ethical decision making remains unclear.

Previous studies have not reached a consensus on Proximity’s role in ethical decision making (Barnett, 2001; Chia & Mee, 2000; Frey, 2000). Perhaps Proximity is an important predictor for moral awareness because individuals may be more sensitive to the potential of their actions to harm or benefit another, if the “other” is closer (physically, culturally, socially, or psychologically) to them.

Participants’ moral judgment and their intention to act were strongly associated with Magnitude of Consequences and Probability of Effect. This finding suggests that, as individuals make judgments and form intentions, they consider the consequences of their actions, both the extent of the harm or benefit their actions might cause and the likelihood that those consequences will occur. These results are only partially consistent with previous research. Other research supports this study’s assertion that Magnitude of Consequences and Probability of Effect are important predictors for moral judgment and intention (Barnett, 2001; Morris & McDonald, 1995). However, while a number of studies have also found moral awareness to be significantly affected by Magnitude of Consequences (Chia & Mee, 2000; Butterfield et al.; Frey, 2000), this study did not.

The strong association Magnitude of Consequences and Probability of Effect have with moral judgment makes sense. Moral judgment requires the individual to focus on possible choices and consequences, evaluating their value. The extent of harm or benefit of those consequences and the likelihood that they will occur would be reasonable measures by which to form judgments. Similarly, the relationship of Magnitude of Consequences and Probability of Effect to moral intention is also reasonable. Choosing to intend to behave morally rather than follow another choice may force the individual to weigh the costs and benefits of his/her choices; thinking about the extent of those consequences and the likelihood that they will occur may be appropriate ways to determine which course of action to pursue. While moral awareness requires that an individual be sensitive to the possibility that his/her actions may affect other people, in this step of the ethical decision making process, the decision maker may not have formulated potential consequences to evaluate in terms of their magnitude or probability. He or she may simply recognize that any future choices involve the well-being of at least one other person; consequently, moral awareness would not necessarily be as strongly affected by Magnitude of Consequences and Probability of Effect.

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Articles As an individual engages in the awareness, judgment, and intention components of the ethical decision-making process, Temporal Immediacy has little influence. This factor of moral intensity, only negligibly affecting moral awareness, judgment, and intention, is the weakest of all the factors. Other studies (Barnett, 2001; Frey, 2000) report similar results, suggesting that Temporal Immediacy should not be included as a dimension of moral intensity.

In addition to exploring the significance of the relationships among the steps in the ethical decision-making process and the dimensions of moral intensity, the analyses used in this study provide insight into the strength of these relationships. An interesting result, worth future exploration, shows that the dimensions of moral intensity do not affect each step in the decision- making process to the same degree. Moral intensity accounts for approximately 5-10% of the variance in moral awareness and moral intention for the five scenarios. In contrast, with the exception of Scenario 1, moral intensity accounts for approximately 3040% of the variance in moral judgment. This finding suggests that while moral intensity is significantly related to moral awareness, judgment, and intention, its predictive value may be strongest with moral judgment. Future research should further explore the strength of the relationships among moral intensity and the steps in the ethical decision-making process.

Similarly, the results also suggest that the steps in the process of ethical decision making are significantly related to one another, but the strengths of these relationships differ. Moral awareness is significantly associated with moral judgment, but explains a smaller proportion of the variance in moral judgment than that explained by moral intensity. In contrast, moral judgment is significantly associated with moral intention and explains a greater proportion of variance in moral intention than that explained by moral intensity. These results indicate that the steps of the ethical decision-making process may not relate to one another to the same degree. More research is needed to explore the relationships between the steps in Restâ&#x20AC;&#x2122;s process of ethical decision making to provide empirical support for this model.

Conclusion Future research should take into consideration how much the implicit interpersonal relationships in the dimensions of moral intensity affect ethical decision making. If Temporal Immediacy and Concentration of Effect were excluded, the remaining four dimensions have important interpersonal components. As the decision maker evaluates Proximity, Probability of Effect, Magnitude of Consequences, and Social Consensus, he or she necessarily considers the impact his/her actions will have on other people. The decision maker must ask: How close is this person to me? To what extent will this person be affected by my decision? How likely is it that this person will be affected? What will my peers think? Neither Temporal Immediacy nor Concentration of Effect is as focused on interpersonal relationships; more research is needed to determine if the interpersonal aspect of the other four dimensions contributes to their significant effects.

The findings of this study have important implications for moral education and leader development programs. Recognizing and understanding the steps involved in ethical decision making allows institutions of higher education to educate their students about the process of making ethical decisions and their own strengths and weaknesses. In addition, knowing that specific characteristics of a moral issue significantly influence the process of ethical decision making can help individuals focus on and ask questions about important aspects of the moral issue, allowing them to gather critical information that will help them more thoroughly assess a moral dilemma.

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Articles References Asch, S. (1956). Studies of independence and conformity: I. A minority of one against a unanimous majority. Psychological Monographs, 70(9).

Barnett, T. (2001). Dimensions of moral intensity and ethical decision making: An empiricalstudy. Journal of Applied Social Psychology, 31, 1038–1057.

Butterfield, K., Trevino, L., & Weaver, G. (2000). Moral awareness in business organizations: Influences of issue-related and social context factors. Human Relations, 53, 981–1018.

Chia, A., & Mee, L. (2000). The effects of issue characteristics on the recognition of moral Issues. Journal of Business Ethics, 27, 255–269.

Dursum, S., Morrow, R. O., & Beauchamp, D. L .J. (2003). 2003 Defence ethics survey report. In Sponsor research report (pp. 204–218). Ottawa, Canada, Frey, B. (2000). The impact of moral intensity on decision making in a business context.

Journal of Business Ethics, 26, 181–195.

Harrington, S. (1997). A test of a person issue contingent model of ethical decision making in Organizations. Journal of Business Ethics, 16, 363–375.

Jones, T. (1991). Ethical decision making by individuals in organizations: An issue-contingent Model. Academy of Management Review, 16, 366–395.

May, D., & Pauli, K. (2002).The role of moral intensity in ethical decision making.

Business & Society, 41, 84–117.

Morris, S., & McDonald, R. (1995). The role of moral intensity in moral judgments: An empirical Investigation. Journal of Business Ethics, 14, 715–726.

Reidenbach, D., & Robin, R. (1988). Social responsibility, ethics, and marketing strategy: Closing the gap between concept and application. Journal of Marketing, 51(1), 44–58.

Reidenbach, D., & Robin, R. (1990). Toward the development of a multidimensional scale for improving evaluations of business ethics. Journal of Business Ethics, 9, 639–653.

Rest, J. (1994). Background: Theory and research. In J. Rest & D. Narvaez (Eds.), Moral development in the professions: Psychology and applied ethics (pp. 1–26). New Jersey: Lawrence Erlbaum Associates, Inc. Reynolds, S. (2006). Moral awareness and ethical predispositions: Investigating the role of individual differences in the recognition of moral issues. Journal of Applied Psychology, 91, 233–243.

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Articles Singer, M. (1998). The role of subjective concerns and characteristics of the moral issue in moral considerations. British Journal of Psychiatry, 89, 663–679.

Singhapakdi, A., Vitell, S., & Franke, G. (1999). Antecedents, consequences, and mediating effects of perceived moral intensity and personal moral philosophies. Journal of the Academy of Marketing Science, 27, 19–36.

Singhapakdi, A., Vitell, S., & Kraft, K. (1996). Moral intensity and ethical decision-making of marketing professionals. Journal of Business Research, 36. 245–255.

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Articles Organizational Behavior and Learning in Healthcare Services: A Socio-Technical Systems Framework Thomas G. Mihara, PhD, CFAAMA, FACCP, MT, CPHIMS, PMP Associate Professorial Lecturer in Health Services Management and Leadership, George Washington University School of Public Health & Health Services; Navy Medicine Information Systems Support Activity 300 Convent Street, Suite 1100 San Antonio, TX 78205 Tel: (210) 808-0502 Fax: (210) 808-0677 Email: Thomas.Mihara@med.navy.mil

Author Note The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the U.S. Department of the Navy, U.S. Department of Defense, nor the U. S. Government.

Abstract A socio-technical systems framework is developed and offers a basis for further research regarding organizational learning and change in healthcare services management. The perspective includes a thorough historical literature review starting with a philosophical basis in pragmatism and then operationalized in terms of systems thinking. Given a leadership viewpoint based on both internal and external forces, this approach supersedes research based on either reductionism or deconstruction. The knowledge base for systems thinking makes assumptions about the unit of analysis, environment, relationships, group paradigms, personal observation, and self-organization. The environment for research is constrained only in the context of analysis, which by definition assumes boundaries. Cause and effect are interpreted as a circular association, as opposed to a linear causality. Events are considered indeterminate because the direction of change can occur through unexplored or unanticipated feedback. Reflexivity is expected since an organization is composed of knowing subjects. Medical facilities are seen in this context as learning systems. Observations are dependent on the characteristics of the observer as manifested by social interaction and evolving technology. The elements of the system are complex, and organizational structure emerges from interactions among the system, leadership, and individuals. Finally, management activities are not limited to the executives of the organization and require participation by employees at all levels.

Keywords: systems, management, pragmatism, health services philosophy, socio-technical

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Articles Introduction In practice, leaders of health services organizations are encouraged to use a systems model to manage the interrelationship of social and technical functions (Longest & Darr, 2008). However, nearly absent from the health services literature is a philosophical or epistemological basis for this approach. While the medical body of literature does discuss the philosophical basis for ethical behavior in health services management (Darr, 2005), health services literature lacks a cohesive philosophical and theoretical basis to offer a dialogue about systems models. During discussion about health care systems, the dialog jumps quickly to healthcare systems - its suprasystems and subsystems. Rather than ask why there should be a systems approach, leaders of health services organizations define their role in suprasystems like parent corporations or multihospital systems or subsystems like departments or even formal committees. The intent for this effort is to provide a philosophical basis for organization learning and change in health services that is theoretically grounded in sociotechnical theory. Readers may be interested that much of socio-technical theory was derived from empirical and action research conducted by medical providers.

The management of health care services requires continual reorganization of physical and social systems to accommodate changes in medical practice and external requirements. Physical systems include equipment, offices, clinics, and institutions, plus other process subsystems to coordinate resources, like personnel, finances, logistics, and information. Social systems encompass both external and internal relationships. External social systems include community relationships and networks of health care affiliates.

Internal social systems support operations among providers like doctors, paid staff, and volunteers. The acceleration of medical technology, genetic engineering, and challenges of bioethics blurs the boundaries of physical and social systems. To maintain or improve the organization, internal systems require sufficient controls to manage the variety of the internal system and emergent challenges from external systems.

Systems Approach The systems approach offers a broad theoretical basis to understand organizational behavior in terms of change and learning. The systems approach accommodates a viewpoint that an organization is to be understood in terms of its entirety as it evolves with the environment or is encouraged to transform by members of the organization, higher authority, or regulation. By definition, a system demonstrates qualities that may be more than the sum of its parts, and complex effects are not necessarily predetermined in time or space. Systems thinking looks at relationships based on principles common to general systems theory, cybernetics, complexity theory, and system dynamics (Richardson, 1991). A multi-method systems approach offers comprehensive theory and a language that explains purposeful change in an organization (Midgley, 1997). In times of change, systems theories propose that the relationships among the components of the organization and the environment are neither necessarily linear nor deterministic.

The purposes of the system are attainment of goals, self-maintenance, environmental adaptation, and integration of subsystems (Reeves & Coile, 1989). Systems associated with the delivery of healthcare are evaluated in terms of quality as a function of structure, process, and outcome (Donabedian, 1966). Indeed, insurance payers now link providersâ&#x20AC;&#x2122; bonus payments directly to patient satisfaction (Gellene, 2000).

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Articles The structure of a health care delivery system includes the organization of people and technology (Garrett, 1973). Patients, staff, and other stakeholders interact within the capabilities and capacity of the system. The characteristics of the patient population encompass health habits, medical conditions, demographics, expectations, and health-related measures (Tarlov et al., 1989). While staff characteristics vary across types of health care organizations, medical services require a mixture of specialization that is consistent with standards of care, the needs of community stakeholders, and others such as agencies, insurers, employers, and independent medical practitioners (Aday, Begley, Lairson, & Slater, 1998). The interaction of patients and providers as embedded social systems influences the selection of technology to achieve desired outcomes such as the prevention of disease and restorative care.

As the rate of change in the environment continues to accelerate into the twentyfirst century among most industries, management tools meant to stabilize organizations are almost useless when unanticipated events invalidate premises for prediction. Forwardlooking options such as strategic plans are also less valuable when environmental change makes it difficult to make assumptions about the future (Peters & Tseng, 1983). Consistent with systems theory, the trend is for the boundaries of the healthcare organization to become less defined and to diffuse into the community vortex comprised of diverse interests (Lombardi, 1997). Management tools such as metrics or value stream analyses have value when they provide the requisite feedback to encourage process change or maintain improvements. These measurements have meaning when they are integrated into the social system.

A first-order systems approach accommodates the relationship of controls among subsystems and the environment (Reeves & Coile, 1989). In a first-order systems approach, management exercises social and technical controls by means of feedback loops that communicate the status of the system â&#x20AC;&#x201C; usually to maintain organizational homeostasis.

A second-order systems approach facilitates the development of socially constructed goals among diverse stakeholders. The reflection necessary in that approach questions roles for management, as well as missions and values for an organization or the current understanding of the world for an individual. In generic terms, feedback represents information about the results of a process which is used to alter a component of the process. Technically, negative feedback reduces the error or deviation from a goal state and positive feedback increases the deviation from an initial state (Umpleby, 2001).

The systems approach further explains why it is difficult to change or transform an organization. To maintain dynamic processes (such as patient care), systems theory proposes that a steady-state system responds through feedback to maintain a constant ratio of inputs and outputs. Using techniques such as statistical process control, management seeks to limit variation in the social and technical systems to be productive and encourage high quality services. Since a disruption of a stable state causes problems, the system comprised of people and processes seeks to prevent disruptions. Otherwise, resources are dynamically reallocated so that the organization can meet intended objectives. Whereas incremental change in organizations maintains stability, discontinuous change results in disequilibrium (Nadler & Nadler, 1998).

Rather than seeking to control events, some hospital leaders see their organizations as complex adaptive systems where constructive change occurs at the edge of chaos when the system is intentionally destabilized by management (Zimmerman, Lindberg, & Plsek, 1998).

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Articles To change, an organization needs a stimulus or disruption from the environment to initiate conditions that trigger reflection or learning (Argyris & Schรถn, 1974). For the Triple Aim System proposed by the Institute for Healthcare Improvement (Beasley, 2008), the first two components of a learning system are system level measures and an explicit theory for system changes. Once change is initiated, positive feedback is needed to continue implementation.

The mechanism to maintain new structures occurs by means of control, which is generally performed through negative feedback which reinforces stability in the system.

Socio-Technical Systems Theory General Systems Theory developed quickly after World War II. As a biologist known for publishing the individual growth model in 1934, von Bertalanffy is also widely recognized for his contributions as a general systems theorist (von Bertalanffy, 1950). The addition of concepts of feedback and compensation systems (Wierner, 1948), known as cybernetics, offered a method to control larger systems. The most robust principle of the systems approach -- the Law of Requisite Variety -- indicated that variety in the environment must be matched by variety in the control mechanism (Ashby, 1956). As a psychiatrist, Ashby applied the principle by mapping diverse mental syndromes into variety-driven therapeutic regimens (Geyer & van der Zouwen, 1986). The role of attenuation and amplification showed that large systems -- including social systems -- could be managed by accommodating variety in the environment with an appropriate response through the control mechanism. Nine levels of systems were postulated according to complexity in the following manner: frameworks, clockworks, cybernetic systems, open systems, blueprinted growth systems, internal-image systems, symbol-processing systems, social systems, and transcendental systems (Boulding, 1956). Level one -- a framework -- represented static structure, while level eight -- a social system -- accommodated a socio-cultural system comprised of roles, values, and science. Reductionist science, including experiments framed by contingency theory, was unable to explain dynamic feedback in complex systems since many factors change simultaneously (Forrester, 1968). More complex systems are comprised of assemblies of interacting feedback loops. Stated in another way, social systems are complex because they cannot be described as hierarchies of components (Ulrich, 1983).

The theoretical basis for socio-technical systems theory emerged from the convergence of field theory (Lewin, 1948), general systems theory, and the Tavistock tradition (Emery & Trist, 1960) as shown in Figure 1. The concept of unfreezing, changing (by introducing new values and behavior), and refreezing remains a model for organizational transformation (Lewin). For individuals to unfreeze, they need evidence that their actions lead to inappropriate consequences. They then seek new actions and values. In turn, the use of new actions influences behavioral change (Argyris & Schรถn, 1996).

In field theory, a force is determined by the state of the person, the environment, and the position of the person in the environment -- the totality is a gestalt. A force arises from tensions such as involvement in an activity and the gestalt works towards a state of equilibrium. Even if a system is characterized by considerable tension, it can be in equilibrium with surrounding states that are also in tension (de Rivera, 1976). An implementation of the theory occurred during World War II when the War Office wanted to alleviate meat shortages by using certain underutilized beef parts. Lewin set up an experiment where an audience was given a lecture by a dietitian that illustrated the nutritional value Journal of Healthcare, Science and the Humanities

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Articles General Systems Theory von Bertalanffy (1950) Cybernetics Wierner (1948)

Law of Requisite Variety Ashby (1956)

Action Research / Field Theory Lewin (1948)

Classification of Systems Boulding (1956)

Experiences in Groups Bion (1961)

Tavistock Trist (1960)

Socio-Technical Systems Theory

Figure 1. Consolidation of socio-technical systems theory. of these parts. Half of the audience was dismissed and the other half formed small groups and discussed what they heard. Six months later, individuals who participated in discussion were more likely to use these parts than those who did not. When he was unable to treat the numbers of returning veterans from World War II, Bion (1961) began experimenting with psychotherapy in groups as an alternative to individual treatment. He discovered that groups could facilitate or inhibit overall performance.

Group interaction was also found to be the most important consideration when researchers at the Tavistock Institute were given the task to determine why new technology and better pay resulted in lower productivity and increased absenteeism among coal workers (Trist & Bamforth, 1951; Trist, 1980). The Tavistock approach started with insights gained from treating post traumatic stress for World War I veterans (Patten, 1989). Using the combination of field theory, general systems theory, and Bionâ&#x20AC;&#x2122;s work, the Tavistock researchers tested how the fit of social and technical systems could best meet the needs of an organization. The result became known as socio-technical systems theory (Emery & Trist, 1960), which can be categorized as a structural, open system, natural model. To accelerate the two years required for a typical socio-technical systems intervention, recent applications of the theory include large group intervention activities such as future search (Weisbord, 1987), search conference (Emery, 1993), fast cycle full participation work design (Pasmore, 1994), organizational performance (Ackoff, 1999), software engineering (Mate & Silva, 2005), and process improvement methods such as Lean Six Sigma (Quarterman & Snyder, 2007).

Within this construct, effective adaptation to changes in the environment requires modification of the technological system or alterations in the social system. Empirical 74

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Articles studies in Europe and the United States demonstrate that sustained system change requires a combined modification of the social and technical systems. Based on the principles of systems theory, socio-technical systems theory predicts that an organization is shaped by the joint relationship of its social system and technical system. The socio-technical systems theory explains organizational change in terms of a single large system and subsystems comprised of individuals (Emery & Trist, 1960). Subsystems in turn are examined as processes that require people and technology (Seidel, Gorsky, & Lewis, 1995).

While negative and positive feedback can reinforce or impede change, satisfactory performance in terms of socio-technical systems theory requires four other major components: information, regularization, adaptivity, and robustness. Prior information provides an understanding of the process. Regularization embeds prior information into the design of controls to stabilize an operation. Adaptivity accounts for the predictability or the stochastic structure of the environment and tracks nonstationary trends in behavior. Robustness implies that the operation is insensitive to small deviations that are unavoidable disturbances due to initial conditions and other causes, such as errors in perception. Feedback improves convergence of subsystems and reduces disturbances from variation in parameters (Haykin, 2001). In real-world situations, predictable and chaotic processes are bundled together.

To reiterate, social systems are classified as open systems since they can change with the environment. When an unstable open system disintegrates, it demonstrates that it is viable when it spontaneously develops a new set of structures (Yolles, 1999). Otherwise, if it is a business -- for example -- it goes bankrupt; for a multi-billion dollar entity such as Enron, this process took months, or days for Bear Stearns Companies, Incorporated.

According to the principle of autopoiesis, a system creates its own structure which is optimal for the task (Maturana & Varela, 1980). If that structure is eliminated, another structure starts over again and becomes a self-organized entity. In addition, a specific structure is not transferable to another organization (Baets, 1998). The systems approach as a framework suggests that successful transformation requires the management of complex interactions rather than the organization of sequential events. The approach also explains why applications, such as total quality management or lean six sigma, require absorption into existing system relationships in order to endure.

Building on general systems theory, system dynamics theory examines organizational transformation through structural change that reduces or alters compensating mechanisms (Kiefer & Senge, 1984). Compensating mechanisms either impede or encourage change. The effects of these mechanisms arise because groups and individuals with their own goals respond to changes to offset transformation. Thus, knowledge of system dynamics provides insight into change in ways that may not be obvious -- an important consideration, since management intervention is often focused on the symptoms of a crisis rather than its root causes. Further, system dynamics models do not require clear-cut beginning and ending dates for an intervention or a study (Senge, Roberts, Ross, & Smith, 1994).

One strategy to alter system dynamics without putting the system into chaos is to create an informal parallel organization alongside the formal organization. The parallel organization comprised of staff provides the variation to test alternative methods of achieving desired outcomes. Complexity theory proposes that stability comes from patterns

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Articles of similarities or self regulation (Kauffman, 1993). The characteristics of self-regulation are differentiation in response to tension, communication among differentiated parts, integration of parts, emergence of a common identity, dynamic stabilization as a whole, and recursion to other levels of organizational dynamics (Schwarz, 1996). Information becomes a dynamic element that introduces order and prompts growth (Wheatley, 1992). Specifically, leaders can influence people to view reality at three distinct levels: events (reactive), patterns of behavior (responsive), and systemic structure (generative) (Senge, 1990b). Thus, prescriptive transformation requires an understanding of mechanisms that resist or encourage change.

Although the medical facility is usually identified as a hospital, the organization is a web of relationships often with multiple core missions -- in addition to medical care and the training of professionals. Change in a medical facility needs to account for thousands of interconnected and compensating interactions among imbedded interdependent subsystems or clusters of groups of individuals (Warner & Holloway, 1978).

Socio-Technical Systems Theory in Practice The intent of socio-technical systems theory is to accommodate socially constructed values and the characteristics of a technical system. Similarly, the research objectives examine how structural change in a medical facility affects satisfaction with patients and staff. Given external environmental demands, the medical facility must compete effectively or lose support of its governing body. As an institution, the medical facility is caught in the paradox of seeking more sophisticated technology while at the same time refocusing on care that emphasizes social values and providing services that are associated with the general health needs of a community.

The three conditions for a socio-technical design require that work be based on an open system within a complex environment, that the organization exhibits systematic complexity, and that the system can generate a level of flexibility that is required for its tasks (Pava, 1983). In its current formulation socio-technical systems theory encompasses seven related concepts (Jackson, 2000). The following concepts are derived from experiences during more than 20 years of field use: 1. Work groups or organizations are interdependent systems with interacting technological aspects and social behaviors.

2. Social, technological, and economic subsystems need to be jointly optimized.

3. Joint optimization occurs because there is organizational choice.

4. The subsystems are jointly optimized to realize the task that the organization needs to achieve in order to survive.

5. The open systems model explains production systems.

6. Workers are more satisfied if they work in autonomous groups.

7. Administration focuses on relating the organization as a whole to its environment (instead of enforcing autocratic regulations).

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Articles The operalization of socio-technical systems principles evolved during interventions primarily in manufacturing (Rice, 1963). Socio-technical systems theorists realized that the focus on product rather than task made it distinct from the Scientific Management theory of Taylor (1911). The break from task and predetermined job classifications was needed to broaden employee roles. Second, the addition of key variance analysis also emphasized the complexity in the conversion process. Thus, the variances were seen as covariates in the interconnections among the operations needed to create the product. Autonomy was enhanced through task differentiation, boundary control, and task control (Cummings, 1978). The theory and practical applications led to 10 critical principles as follows: 1. The process of design must be compatible with the objectives of the organization.

2. A minimal critical specification of work describes processes and associated individuals.

3. Variances from socio-technical specifications are controlled near the point where they arise.

4. To provide for flexibility and equity, an individual should be able to perform more than one function.

5. Control of activities in a department becomes the responsibility of its members and the supervisor concentrates on boundary conditions.

6. Information first goes to work teams for task performance.

7. Systems of social support reinforce the organizational structure.

8. Human values are associated with the minimal critical specification, the socio-technical criterion, the multifunction principle, boundary location, information flow, and support congruence.

9. Design is an iterative process.

10. Those who need resources for tasks have the authority to command them, while accepting responsibility for their use.

The most frequent design feature is the formation of autonomous groups (Friedlander & Brown, 1974; Taylor, 1977; Walton, 1974; Pasmore & Friedlander, 1982).

Team building exercises are distinct from autonomous groups and are not seen as having an impact on task effectiveness (Guzzo & Shea, 1992). Further research using sociotechnical systems for health care is encouraged since results have not been uniformly positive (Chisholm & Ziegenfuss, 1986; Pasmore, Petee, & Bastian, 1987).

The introduction of soft-systems methodology (Checkland, 1981; Checkland, 1999; Checkland & Scholes, 1990) augments the mental construction of an ideal organization.

Similar visualization of unconstrained organizational options is proposed by Ackoff (1999). The components of social-technical systems theory include four stages comprised of discovery, open systems scan with analysis, design, and implementation (Taylor & Felten, 1993).

Recent research using socio-technical systems theory encourages a preliminary system scan to assess values underlying the organizational mission and to articulate the

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Articles relationship of the organization to other stakeholders, along with concerns about job satisfaction (Fox, 1995). Other considerations include the creation of coalitions and network steering committees to assess progress and coordinate development between social and technical systems (Chisholm, 1998). Additional emphasis is now placed on identifying crucial power relationships to determine which groups have the most to gain or lose from the change (Oden, 1999). Support comes through the participation of people and groups who are expected to become major stakeholders.

The guidance for managing medical facilities is not consistent, and various stakeholders propose different levels of involvement in management by clinicians and other providers. The institutional management literature does not validate whether more specialization requires more sophisticated methods of coordination and integration, or less (Robinson & Casalino, 1996; Robinson, 1999). The increase in technology leads to more specialization among health care providers such as doctors, nurses, technologists, and support staff. Additional complexity (such as financing, data processing, and logistics) results in more specialization of department staff who are not licensed providers. The challenge of managing this level of complexity is addressed by using socio-technical systems theory within the context of organizational learning.

Philosophical Foundation The foundation for socio-technical systems theory is based on a pragmatism that does not propose a best or normative method to organize social systems and technical systems. Interpretations are tested to evaluate whether they attain instrumental values that lead to changes in organizational behavior. In addition to satisfaction of customers and staff, examples of instrumental values are improved effectiveness and prevention of disease.

Techniques or methods are then validated or invalidated in terms of achieving a purpose or resolving a problem. Knowledge accumulates as the result of dealing with problems that arise within a specific context (Dewey, 1929). Dewey viewed the world as a dynamic process where problem resolution leads to more problems (Evans, 2000). With reflection, the solutions lead to knowledge.

Pragmatism, as a process of inquiry, can be modeled in terms of a system (Rescher, 1977). A specific example of such a model of inquiry is the Plan-Do-Study-Act or Shewhart cycle, which is used as a method to implement continuous quality improvement for a process (Deming, 1986). Following a philosophy of pragmatism (Lewis, 1929), Deming states that transformation requires profound knowledge based on appreciation for a system, knowledge about variation, theory of knowledge, and psychology (Deming, 1993). He asserts that a system must have an aim and that managementâ&#x20AC;&#x2122;s job is to optimize the entire system over time through innovation. Further, everyone must understand that aim and focus on customers. In stable systems, statistics show patterns to help manage variation. For medical services organizations, Deming (1986) concurs that statistical evidence will cause us to ask more penetrating questions about interactions with patients and colleagues. Theory is critical since it precedes prediction; thus, information is only relative to working and operational definitions. The purpose of psychology is to coordinate intrinsic motivation (self-esteem, dignity, and desire to learn) and recognize differences in people in order to improve processes and bring joy in work. In addition, problem solving based on pragmatism uses invention, science, and democratic means (Towns, 1997).

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Articles An exploration of Deming’s foundation for transformation or organizational change requires a review of systems approaches and the epistemology of pragmatism. The first component -- appreciation of a system -- encompasses a number of traditions including general systems theory, cybernetics, operations research, system dynamics, organizational learning, and chaos theory. Several underlying assumptions define differences among the various traditions, such as unit of analysis, environment, causality, reflexivity, determinism, observation, and self-organization (Dent, 1997). The systems traditions subscribe to a view that an organization must be understood in its entirety and that the organization may have a characteristic that does not belong to one of its subunits (Clemson, 1984).

General systems theory was proposed as an alternative to the science of reductionism. Reductionism implies that an entity can be divided into its component parts and that a cumulative explanation of the parts and their relationships fully explains the entity. Claiming that analysis is necessary but not sufficient for knowledge, von Bertalanffy (1974) cautioned how “mechanistic attitudes had seeped into virtually every area of social behavior, encouraging doctors to view patients as cases, employers to regard workers as units, advertisers to regard consumers as stimulus-response robots, and television programmers to reduce the public to a set of demographic numbers.” From a systems perspective, every individual is a part of interconnected social systems. The interrelationship of problems forces systems designers not to content themselves with partial solutions that consider only a limited number of whole systems implications (Churchman, 1981). With social systems intervention, subjectivity and group norms are included in any design. The democratic processes espoused in pragmatism are seen in the systems approach as a form of pluralism that is a source of variety and change (Mingers & Gill, 1997).

Pragmatism as a basis for a theory of knowledge requires operational definitions, instrumental action, and a scientific method to validate a course of action. Pragmatic knowledge in turn emphasizes the interaction of practice and community, including discourse as a fundamental component of communication (Mingers, 1992). Meaning occurs in the context of how a concept modifies purposeful action (Peirce, 1934). Truth is then tested in a community of others who critically evaluate the concept. Thus, instrumentalism links truth and meaning in terms of the consequences of action that can be verified in practical situations (Dewey, 1938). Since understanding occurs among individuals to the benefit of all, pragmatism leads to a focus on social conditions (West, 1989) and the reconstruction of institutional practices that impede communication (Habermas, 1979).

Since pragmatism does not require an assessment of values or norms, the efficacy of techniques and practical decisions is demonstrated by action (Ulrich, 1983). In seeking a consensus theory of truth, social organization is interpreted in terms of work, language, and power within a historical context (Denzin, 1992). In pragmatism, instrumentalism implies that meaning is scientifically valid if problems are solved in the process of inquiry (Kaplan, 1964).

For post-modern organizational theory, pragmatism offers a philosophy to deal with contradictions (Wersig, 1997). Systems theorists are often labeled as modernists when the analyst’s approach is based on expertise only rather than a postmodern approach, which allows for an exploration of reflexivity with emphasis on actual practice and lived experiences (Montuori & Purser, 1996). However, system theorists encourage participative approaches that support interaction through discourse and personal worldviews (Checkland, 1981).

Knowledge is derived from the context of the observing system (von Foerster, 1984), where Journal of Healthcare, Science and the Humanities

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Articles paths of inquiry are constructed by inquirers. Observed behavior occurs at the surface level of the system and the deep level is defined by the paradigm (Mingers, 1995). The paradigm for this framework is processual, rather than rationalistic or evolutionary (van der Heijden, 1996).

Paradigms are largely hidden and thus the validity of the underlying assumptions is not tested. If individuals do challenge paradigms, then they might seek a new way of sensing the world in order to form more accurate interpretations (Kuhn, 1970). Individual inquiry then needs to enable collective dialog (Senge, 1993). To add to knowledge, researchers can help restructure viewpoints to go beyond the superficial conditions and events into the underlying causes of problems - and therefore to see new possibilities for shaping the future (Senge, 1990a).

In summary, the knowledge base for the systems approach makes assumptions about the unit of analysis, environment, relationships, group paradigms, personal observation, and self-organization. The unit of analysis is relationships or interaction with individuals (Bateson, 1979). The environment is essential and is constrained only in the context of analysis, which by definition assumes boundaries. Cause and effect are interpreted as a circular association, as opposed to a linear causality. Events are considered indeterminate because the direction of change can occur through unexplored feedback.

Reflexivity is expected since an organization is composed of knowing subjects. Observations are dependent on the characteristics of the observer as manifested by social interaction (Dewey, 1929). The elements of the system are complex and organizational structure emerges from interactions among the system and individuals. Finally, management activities are not limited to the executives of the organization and require participation by employees at all levels (Senge, 1990b).

Mismatches between the technical and social structure result in discordance in the system. In organizational learning, this correction is called single-loop learning. However, a detection of incongruous beliefs between the organization and an individual often requires a different form of inquiry, called double-loop learning, to learn new norms and interaction strategies (Halal, 1998; Argyris, 1999). By examining compensating mechanisms, the application of system dynamics offers another method to detect inappropriate assumptions about organizational relationships and structures.

The interaction of people and groups is imbedded in a historical and evolving environment (Wan, 1995). To survive within a larger suprasystem, the organization fulfils a purpose through the social system and the technical system. Contemporary socio-technical systems theorists concede that the social system manages the technical system. (Bunker & Alban, 1997). The distinction is critical since the aim is overall organizational effectiveness rather than a mechanistic efficiency that might result from optimizing the use of technology.

While the characterization of organization as a system is well documented (Parsons, 1951), systems theory also acknowledges the important relationship between organizational structure and the environment (Katz & Kahn, 1966). Systems theory ties patterns of collective behavior among levels of an organization (Likert, 1961). Five basic subsystems are based on production, supportive, maintenance, adaptation, and management. The approach accommodates the hospital as a service organization which demonstrates unique arrangements among highly technical work and professionals in the production subsystem 80

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Articles (rather than as staff in the managerial subsystem), along with concurrent beliefs between staff and patients that the interaction can improve medical conditions through mutual cooperation (Katz & Kahn, 1978).

Given a moderately uncertain environment for the medical industry and the moderate level of disagreement about organizational values among staff, the medical facility is modeled as an open system which is between taxonomy of closed systems and chaotic systems.

Closed or mechanistic systems approaches are not described since the theoretical bases require predefined outcomes and they do not accommodate the complexity of medical facilities.

Conclusion The perspective of emerging systems offers health services management a viewpoint that organizational survival in a changing environment requires a non-equilibrium state at all times (Nonaka, 1994). Based on systems theory, no prefabricated management template can automatically transform an organization. Thus, the transferability of experiences occurs through imagination, as a parallel organization to explore applications in another organizational setting. While the origin of the quest for knowledge comes from a need to understand Demingâ&#x20AC;&#x2122;s concept of profound knowledge, the organizational learning needed for transformation comes from the synthesis of knowledge from the systems approach and changes in paradigms in terms of values and norms.

With fiscal incentives and improvement in medical technology, more efficient operations are available through alternatives such as stand-alone surgery centers and less comprehensive intermediate facilities. To reduce costs, third-party payers (such as insurers and employers) seek substitutes for specialists and the expensive diagnostic regimens associated with their practices. Funding for graduate medical education is being challenged, while the number of American citizens interested in the medical professions declines even as the population ages. The well-developed bureaucracies created to support the hospital as an institution, now interfere with the ability of medical facilities to change.

Problems of every type afflict the medical professions, as well. During the last decade, the role of the physician has become more uncertain. Under managed care, the physicianâ&#x20AC;&#x2122;s orders can be challenged on the basis of published evidence and efforts to save dollars. In addition, the failure to document the need for services can result in loss of payment. Secondly, the federal government established payment schedules for professional services that encouraged primary care and discouraged reimbursement for specialty procedures. Third, the literature supported the use of interdisciplinary approaches such as continuous quality improvement which focuses on system outputs rather than technical peer review. Further, customer satisfaction involves tradeoffs for consumers who seek both primary care closer to their homes and highly specialized care that is different or newer than that available in many physician practices.

To reduce medical errors, for example, the Institute of Medicine encourages the creation of safety systems through a systems approach (Kohn, Corrigan,& Donaldson, 2000). However, few guidelines are given in regard to actual use of a systems approach. The use of systems tools as described by the socio-technical framework offers an approach to help medical facilities respond to changing market conditions and innovation in practice patterns.

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Articles The framework addresses the complex organizational structures and systems of internal controls reduce the flexibility to meet new needs. Medical facilities are also particularly vulnerable since they are personnel and capital-intensive and unable to respond rapidly to the changing demands of the market and technology. In an environment that demands broader choices and more convenience for customer, systems tools attempt to explain how medical facilities can best initiate and continue organizational transformation and learning. Finally, the underlying philosophy of the socio-technical framework provides a basis for further research in health services management.

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Articles Prescribing Architecture: A Critical Evaluation of How Design Impacts Health and Wellness Professor James Shraiky, MARCH Director of Healthcare Design Initiatives School of Architecture and Landscape Architecture The Herberger Institute for Design and the Arts Arizona State University Tel: (602) 740-7887 Fax: (480) 965-9656 Box 872105 Tempe, AZ 85287-2105 Email: jshraiky@asu.edu

Abstract In a world where thousands of medications are prescribed to remedy disease, pain, anxiety, depression and other physiological and psychological ailments, healthcare researchers are continually exploring multiple, innovative means to aid the healing process. In recent years, a growing body of research has focused on how the built environment impacts health, healing, and well-being. The built environment has a profound effect on the brain and its overwhelming influence over the body’s perception of pain as well as its ability to function and heal itself. Within this realm, then, would it be conceivable for a doctor to prescribe healthy doses of architecture to support a patient’s healing process? This article explores how design of the built environment is essential to improving quality of life, supporting recovery, and maintaining well-being. Secondly, through a literary review of three specific healthcare settings -- cancer, autism, and dementia -- the article identifies contemporary design responses that are found to have a positive impact on health and well-being. It is important to note that this article looks at design and architecture from multiple perspectives: materiality, aesthetics, structure, spatial adjacencies, volume, and user interaction.

Keywords: Healthcare Design, Healing Environments, Cancer Design, Autism Design, Alzheimer’s Disease Design

Introduction In a world where thousands of medications are prescribed to remedy disease, pain, anxiety, depression, and other physiological and psychological ailments, healthcare researchers are continually exploring multiple innovative and non-traditional treatments to aid the healing process. One example is the surgical use of maggots to disinfect wounds.

Healthcare professionals perform maggot debridement therapy to treat open wounds because maggots have the capacity to distinguish necrotic from healthy tissues (Lin, 2010). Another example is the administration of human breast milk to combat cancer. The University of Gothenburg researchers suggest that breast milk, which contains human alpha-lactalbumin, found to be lethal to tumor cells, can potentially terminate cancer cells (Lin). Finally,

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Articles methamphetamine, found to reduce the risk of brain damage, may one day be prescribed to treat stroke victims. Researchers at the University of Montana discovered that low dosages of methamphetamine may help reduce the risk of brain damage for 50% of post-stroke patients (Poulsen, 2010). Within this realm, would it be conceivable for a doctor to prescribe healthy doses of architecture to support a patient’s healing process? This may seem far-fetched, but not if one considers how environmental conditions have profound effects on the brain and its overwhelming influence over the body’s perception of pain as well as its ability to function and heal itself.

Centuries ago, before the birth of modern medicine, built environments were used to facilitate healing (Sternberg, 2009). In ancient Greece, temples to Asclepius (Figure 1), the Greek god of medicine and healing, were architecturally designed to promote healing (Schweitzer, Gilpin, & Frampton, 2004; Sternberg, 2009).

Figure 1. Model of the Asklepeion at Epidauras, Greece.

Temples provided a space to relax, meditate or pray, sleep, and recharge. People travelled great distances to envelop themselves in peaceful, calming environments because these magical and spiritual places were perceived to provide positive outcomes. Exemplifying how the fundamentals of healing are shared globally, eastern cultures, like their western counterparts, also sought out peaceful, spiritual and healing destinations. Some, like the Ganges River in India, considered to be sacred to Hindus, were found in nature (Hayes, 2010). Others were of human design, like the Shaolin Buddhist temples sited on the sacred mountain of Songshan in China’s Henan Province (Hayes, 2009). Empowered by belief and aided by the practice of meditation and prayer, these civilizations created environments that were found to have had a profound influence over the body’s ability to heal itself.

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Articles So, if people from various civilizations, over time and across geographic, cultural, and religious backgrounds, looked to nature and architecture to create healing environments, would it be possible for design responses in modern-day design and architecture to have the same effect on the human brain and thus, the body? In addition to medication and physical therapy, could a doctor prescribe a trip to a well-known museum or botanical garden to improve patients’ level of comfort, enhance their well-being, and support their overall healing process?

Before getting to that point, this article will first explore how the built environment impacts wellness and healing. Secondly, through a literary review of three specific healthcare settings -- cancer, autism and dementia -- it will identify contemporary design responses that have a positive impact on health and well-being. It is important to note that this article looks at design and architecture within healthcare environments from multiple perspectives: materiality, aesthetics, structure, lighting, spatial adjacencies, volume, functionality, and user interaction.

How Built Environment Affects One’s Well-Being A growing body of research suggests that the built environment does, indeed, impact health and well-being (Dube, Barth, Cutshall, Olson, & Sulia, 2008; Hendrich & Chow, 2008; Ulrich, 1991). Many of these reports examine the impact of architecture, landscape, and interior environments, through sensory-based experiences on user’s emotions, behaviors, and overall quality of living (Ulrich, 1991). Virtually every human experience, including spatial, engages our sensory and motor systems (Thelen & Smith, 2000). A wide variety of sensory parameters, through the built environment, have been shown to negatively and positively affect human behavior and user outcomes (Barrera, Rykov & Doyle, 2002; Dube et al., 2008; Evans, 2001; Redwine, Hauger, Gillin & Irwin, 2000; Shabha, 2006; Wysocki, 1996).

Healthcare Settings as Primary Driver The majority of the research that examines how the built environment affects well-being is conducted in hospitals and healthcare settings. In fact, out of 328 healthcare design articles reviewed by several research databases, 168 were relevant to the betterment of the patient recovery process (U.S Department of Health and Human Services, 2009).

Within these institutions, the quality and outcome of the user experience are caused by either illness or physical environments and the symptoms can be psychological, physiological, and behavioral (Ulrich, 1991). Anxiety and depression are the two primary psychological effects while physiological symptoms include increased blood pressure, muscle tension, and the release of high levels of stress hormones. Patient stress is also linked to behavioral problems like physical and verbal outbursts, reclusiveness, sleeplessness, and compliance with prescribed regimes (Shabha, 2006; Ulrich, 1991).

Traditional institutional architecture and design emphasized function over form, resulting in clinical settings that were functionally effective, yet psychologically stressful (Ulrich, 1991). According to Schweitzer, et al. (2004), . . . [w]hile it is well-documented that stress, depression and anxiety have a deleterious effect on health, modern hospitals, with their emphasis on diagnosing, curing, and treating, have become noisy, cluttered, institutional-environments with Journal of Healthcare, Science and the Humanities

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Articles little regard for the potentially detrimental effects theses environments have on the patients’ physical or psychological well-being. (p. 71) Since the early 20th century, environmental psychologists have studied the effects of the physical environment on mood (Sternberg, 2009). New trends in healthcare design incorporate the findings of noted environmental psychologists like Robert S. Ulrich, who in 1984 performed a study that uncovered the effects of a window view on a patient’s recovery (Figure 2). Ulrich is considered a pioneer for his Theory of Supportive Design, a scientifically-based design tool to help create successful healthcare facilities (Ulrich, 1991).

Two fundamental aspects of the Theory of Supportive Design are: 1) Health-based facilities should not raise obstacles to coping with stress; contain features that are themselves stressors; and therefore add to the total burden of illness; and 2) These environments should be designed to facilitate access or exposure to physical features and social situations that have stress-reducing influences (Dube et al., 2008; Ulrich, 1991).

Figure 2. The Atrium at Henry Ford Hospital in West Bloomfield, MI, featuring stress-reducing elements, like personal and community spaces, live music, connection to nature, and soft lighting.

Just as stress can be physical or psychological, so too are the design responses found to alleviate it. Physical design issues deal with noise, lighting, scenery, material selection, and other environmental factors (Dube et al., 2008; Hendrich & Chow, 2008; Ulrich, 1991).

Psychological design solutions take a more comprehensive analysis of the physical stressors to address a patient’s sense of control, comfort level, connection to nature and social support (Ulrich, 1991).

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Articles A patient’s greater perception of control has a positive influence on stress and wellness and has been linked to shorter hospital stays (Dube et al., 2008; Ulrich, 1991; Schweitzer et al., 2004). Control is associated with orientation, noise, sense of privacy and personal control over room settings and layout. An environment that is easy to navigate also allows one to feel less reliant on others. Unfortunately, easily navigable healthcare facilities are not the norm. Hospitals are known for being intimidating and disorienting (Schweitzer et al.). Successful building orientation is the first step to resolving challenging navigation issues.

“Orientation is the property of space that communicates to the user its physical relationship to other spaces. It includes access, the ability to find and gain entrance to a building, and the ability to locate a destination within a building” (Horsburgh, 1995, p.735). Successful orientation starts with an easily recognizable main entrance (Figure 3), use of landmarks or artwork as points of reference to guide the way along a path, signage and wayfinding guides, and differentiating similar spaces through the use of color and ceiling height (Horsburgh; Schweitzer et al.).

Figure 3. The Queen Elizabeth Hospital Entrance in London, UK, featuring clearly-marked main entrance, utilizing an artistic shade structure, and well-defined pedestrian and vehicular access.

Noise is one of the most common complaints in hospital environments (Schweitzer et al., 2004): “It is a highly negative environmental characteristic that heightens patients’ perception of pain, increases the use of pain medications, contributes to sleep deprivation and causes confusion and disorientation” (p.74). Solutions to the negative influence of noise, although not 100% effective, include private patient rooms, patient controls over television and radios, and installation of sound-reducing acoustic ceiling tiles and soft flooring (Ulrich, 1991). Using natural sounds to ease patients, though not supported by significant scientific research, is also suggested to have a positive effect on patient well-being (Schweitzer et al.).

The following case studies present a compelling connection between architecture and the user’s well-being. The subjects were chosen based on the abundance of research

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Articles available and the mountain of evidence that demonstrates how patients, care-givers and others affected by the diseases are significantly impacted by design.

Oncology Environments According to the American Cancer Society (2010), there are millions of people who are living with or are survivors of cancer. It is predicted that more than half of all men and one-third of all women will develop some form of cancer in their lifetime (American Cancer Society). In 2010, an estimated 1.5 million new cancer cases were diagnosed in the United States alone (American Cancer Society). The term â&#x20AC;&#x153;cancerâ&#x20AC;? is attributed to over 100 diseases where abnormal cells in a particular part of the body grow uncontrollably and begin to invade cells from other tissue. Where normal cells die after a full life cycle, cancer cells continue to grow and produce more abnormal cells (American Cancer Society). Among dozens of available treatment options, the most common are chemotherapy and radiation therapy (National Cancer Institute, 2010).

Chemotherapy drugs are used to kill or slow the growth of cancer cells. However, the treatment can also destroy healthy cells (National Cancer Institute, 2010). Side effects often include fatigue, nausea, vomiting, hair loss, loss of appetite, and pain. Additionally, patients often express feelings of anxiety, depression, fear, anger, frustration, helplessness, and loneliness while undergoing treatment (National Cancer Institute).

Radiation therapy is prescribed to shrink tumors and kill cancer cells in the hopes of not only curing the disease but also preventing recurrence (National Cancer Institute).

It administers high-energy radiation externally through external-beam radiation therapy or internally by placing radioactive material near the cancer cells in the body (National Cancer Institute). External-beam radiation therapy is delivered daily for up to five days a week for several weeks. Internal radiation therapy can be delivered surgically through tubes, orally, or through injection. Like chemotherapy, radiation therapy can also kill or damage healthy cells, causing similarly painful and discomforting side effects like anxiety and depression (National Cancer Institute).

Regardless of what treatment protocol oncology patients undergo, evidence suggests that the majority of users experience numerous negative side effects and, overall, a deteriorating quality of life (Payne, 1992). As a result of the mentally and physically discomforting treatment process experienced by cancer patients, Block, Block, and Gyllenhaal (2004) have recommended a departure from the design of stark, sterile oncology spaces found in traditional healthcare.

Sterile and stark hospital environments can induce more anxiety and fear in patients and contribute to an overall negative patient outcome (Block et al., 2004). This is counterproductive to the already stressful experience undergone by chemotherapy and radiation therapy patients. For the design of oncology care environments, several design researchers propose key recommendations for creating optimal healing environments to improve the quality of the clinical experience of patients undergoing rigorous treatment protocols (Figure 4).

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Figure 4. The DCH Cancer Center Infusion Space in Tuscaloosa, AL, which incorporates natural finishes, views to nature, and daylighting.

Visual Transparency One of the most important recommendations is creating, through architecture, transparency with the exterior. Visual transparency can be achieved through the implementation of see-through building materials like glass and acrylic, creation of larger of openings like windows and doors, and the incorporation of natural materials within the layout and adjacencies of the building (Fouts & Gabay, 2008; Sherman, Varni, Ulrich, & Malcarne, 2005; Webb, 2006). In oncology environments, multiple studies show that viewing natural settings can significantly reduce stress within five minutes of the healthcare intervention (Sherman et al., 2005). Other research suggests that viewing nature over time can foster improvement in clinical outcomes, such as reducing the intake of pain medication and shortening hospital stays (Sherman et al.). Additionally, transparency with the outdoors provides well-lit and naturally-lit spaces for treatment rooms (Figure 5). Research suggests that “artificial light can lead to fatigue, depression, and elevated systolic blood pressure” (Fouts & Gabay, 2008, p. 30). Natural light affects the body’s circadian cycles, which in return, impacts the body’s sensitivity to drugs, stress and anxiety levels, reproductive systems and immune responses (Chong et al., 2007).

It is important to note that the design of intimate spaces used for physical therapy and counseling should offer low lighting conditions through either the size of openings or artificial light. Soft lighting in such personal spaces generates a sense of intimacy, relaxation, and safety (Block, et al., 2004; Chong et al., 2007).

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Figure 5. MCGHealth Cancer Center Chemotherapy balcony in Augusta, GA, providing access to natural lighting and transparency with outdoors.

Color Application In combination with light, research also stresses the importance of color within treatment and inpatient spaces (Edge, 2003; Schweitzer et al., 2004). Appropriate color application positively influences patient recovery rates, reaction to the environment, stress and anxiety levels, motivation, and perceived quality of the overall healthcare experience (Dalke et al., 2006; Edge, 2003; Lehman, 2006; Schweitzer et al., 2004). Perception of color influences both the pituitary and thyroid glands. The pituitary gland controls the sense of appetite and sleep pattern while the thyroid gland controls the rate of oxygen consumption in the body, which is tied to the perception of mental and physical stimulation (Dalke et al.; Lehman, 2006). In both treatment and waiting areas, a warm color pallet is highly recommended (Dalke, 2006). Researchers warn against colors known to induce negative side-effects, i.e. red for anxiety, gray for depression and yellow/green for nausea (Block, et al., 2004; Dalke et al.). On the contrary, shades of blue and green upheld relaxation and promoted balance (Figure 6) (Edge, 2003; Lehman, 2006).

Flexible Design Another key recommendation is the design for flexible spaces, private settings, and interactive social and physical environments for patients undergoing chemotherapy and some internal radiation treatments. Malkin (2008) suggests providing the option of private chemotherapy stations as well as group-based treatment rooms so patients can choose their environment depending on how they feel on the day of treatment. Providing the two options empowers patients, caters to their personalized social needs, and reduces stress 96

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Figure 6. Herbert Irving Comprehensive Cancer Center waiting area in New York City, NY, featuring a recommended color palate to support relaxation and promote balance. and anxiety (Malkin). For interactive and social spaces, researchers suggest cozy, home-like environments to accommodate family support, community interaction, and general physical activities (Block et al., 2004; Malkin). Community and social involvement among patients, family, friends, volunteers, and staff in the oncology treatment process, provides a range of emotional, psychological, and physical support (Speice et al., 2000).

Connection to Nature The design of the exterior setting is also essential. Healing gardens, natural settings where people engage in calming and peaceful activities, are more commonly incorporated in healthcare environments as a tool to support patient recovery. A wealth of research demonstrates how healing gardens enhance mood by reducing perceptions of pain and stress and how the connection to nature creates a restorative effect on the mind and body (Figure 7).

Studies involving patient and non-patient groups show that natural scenery is significantly more effective in promoting recovery or restoration from stress than built scenery (Marcus, 2010; Marcus, 2007; Sherman et al., 2005). Well-designed healing gardens should provide an escape from stressful healthcare environments as well as a place for social and family support (McCaffrey, 2007; Sherman, et al.). Sherman et al. (2005) conducted a study to examine, among other queries, the levels of stress and pain for pediatric patients inside the Journal of Healthcare, Science and the Humanities

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Figure 7. The Healing Garden at the Yale Cancer Center in New Haven, CT, proving community spaces for social support. hospital building versus the garden setting . The study surveyed 11 individuals in the hospital and 11 in the garden on their perception of anxiety, sadness, anger, worry, fatigue, and pain, caused by chemo- and radiation therapies. All symptoms were lower for individuals in the healing garden. The widest gaps were found in perceptions of pain, worry, and sadness. This was the first test of its kind in a pediatric cancer center and though the authors of the study agree that research with a larger patient sample needs to be performed to be more conclusive, the outcomes suggest that healing gardens can support the recovery process for pediatric cancer patients by reducing pain and stress while they undergo treatment (McCaffrey, 2007; Sherman et al.).

In their book The Architecture of Hope, Jencks and Heathcote (2010) cultivate the above theories into a series of franchised cancer centers based on the prototype developed by Maggie and Charles Jencks. While battling and ultimately losing her life to cancer, Maggie and her husband, Charles, collaborated with and provided inspiration for a team of architects and healthcare providers to design and develop a non-traditional cancer support center for patients undergoing cancer treatment. After several miserable and distressful visits to cold, confusing, and stressful typical healthcare environments, Maggie and her team developed the foundation for a Caring Cancer Center (Jencks & Heathcote).

The centers are designed to be small, informal, and comforting, like oneâ&#x20AC;&#x2122;s own home. However, their atypical format creates â&#x20AC;&#x153;a house thatâ&#x20AC;&#x2122;s not a home, a collective hospital which is not an institution, a church which is not religious, and an art gallery which is not 98

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Articles a museum” (Jencks & Heathcote, 2010, p.14).There are intimate private spaces, interactive and supportive group spaces, and calming and spiritual gardens filled with art. The centers’ programmatic elements are housed in quirky, high-design buildings that are sited in scenic locations (Figure 8). The philosophy behind the centers is that architecture should support people’s emotions just as much as it supports function. Patients state that the architecture of Maggie’s Centers makes them feel important and uplifted (Jencks & Heathcote).

Figure 8. Maggie’s Cancer Center in Dundee, Scotland.

Autism Environments It is estimated that one in 110 children in the United States struggles with autism. Autism is the most common of the five subsets of disorders that make up Pervasive Development Disorders (PPD). PPDs are neurological disorders categorized by “severe and pervasive impairment in several areas of development” (Autism Society, 2009). Autism spectrum disorders (ASD) are a group of developmental disabilities stemming from a neurological disorder that affects the brain function that influences social behavior and communication skills (The Centers for Disease Control [CDC], 2010). Typical symptoms include challenges with verbal and non-verbal communication, social interactions, and leisure and play activities (Autism Society). An estimated 1.5 million Americans have some form of autism (CDC).

There is no known cause of autism but studies show that genetics and environmental factors can increase the risk of developing the disease (Autism Society, 2008).

Autism affects each individual differently, but common characteristics include trouble communicating and participating in conversation, resistance to change, emotional outbursts, solitary behavior, avoiding physical contact, over and under-sensitivity to pain, lack of fear Journal of Healthcare, Science and the Humanities

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Articles and uneven gross or fine motor skills (Autism Society, 2008). Additionally, research suggests that caregivers for people with autism experience significant stress. Individuals supporting family members who struggle with autism are likely to experience more stress than those dealing with other disorders (Schieve, Blumberg, Rice, Visser, & Boyle, 2007). These caregivers, especially parents, experience relationship dysfunction, high relational stress, depression, fear, anxiety, and burnout, and often report difficulties in daily management of basic functions (Morgan, 1988).

Design responses for treating, educating, and supporting people with autism need to take in account patientsâ&#x20AC;&#x2122; extreme sensitively to their surroundings and the physical environment. Facilities that ease sensory overload, ensure safety and offer vestibular, linear and proprioceptive stimulation provide optimal support (Farmer, 2010). Sensory-based spaces must be designed to promote and enhance basic means of communication by creating a sense of well-being through the manipulation of lighting, sound, smell, and touch (Figure 9). Individual expression is developed and nurtured in response to the sensual stimulation (Beaver, 2010)

Figure 9. The Minster School for Autistic Children in Nottingham, UK, featuring wide circulation and entry points that offer vestibular, linear, and proprioceptive stimulation.

Design Interventions Although official architectural design guidelines for autism treatment and education centers are still in development, design researchers have been analyzing the relationship between the built environment and autistic usersâ&#x20AC;&#x2122; behavior, learning process, and social development, in an effort to develop a preliminary and specific framework of architectural guidelines for autism facilities. Recommendations include specifying flexible furnishings

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Articles and lighting; eliminating audio distractions through sound-absorbing acoustical design; decreasing visual distractions with window screens and shades and minimal signage; defining space with color; creating private and public spaces; using non-toxic, odor-free and lowemitting finishes and furnishings; and incorporating warm colors and lighting (Vogel, 2008).

These design interventions need to respond to safety and security for the individual living with autism while they create a sense of familiarity and clarity, support health and wellness, provide means for social interaction and privacy, facilitate choice and independence, and maintain durability (Ahrentzen & Steele, 2009).

Spatial Perception To analyze how autistic users view and interact within the built environment, researchers primarily focus on the following design considerations: volume of the space; spatial layout; finishes, patterns and colors; and lighting (Ahrentzen & Steele, 2009; Beaver, 2010; Luigia, 2006; Vogel, 2008). Proxemics, how much space is required for the end user to feel comfortable is one of the most significant design considerations (Luigia). Multiple case studies suggest that too little space can cause discomfort and agitation due to claustrophobia while too much space can also negatively impact users by creating a sense of isolation and loss (Ahrentzen & Steele; Luigia). To provide a sense of adequate space, color-based blocking, visual cues, and distinct lighting conditions are used to define a well-balanced setting for individuals living with autism (Ahrentzen & Steele, 2009; Luigia, 2006). Color zoning with flooring, wall covering, and upholstery applications along with well-defined cognitive signs such as furniture, artwork, and wayfinding features, can help identify the character of various functional zones (Ahrentzen & Steele). Projected colored lighting can also be used to create boundaries within the built environment.

Because individuals living with autism perceive colors more intensely, color palettes should be soft and Figure 10. The Development Learning Center lobby neutral. Visually strong hues can in Monroe Township, NJ, featuring colored zoning, cause agitation, confusion and well-defined cognitive signs, and wayfinding to overstimulation in some users (Figure help identify functional zones.

10) (Ahrentzen & Steele).

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Articles Lighting Individuals living with autism may experience visual perceptual problems that are influenced by direct lighting variations (Ahrentzen & Steele, 2009). Since lighting impacts color, soft, glowing lights with dimmers are frequently incorporated into facilities that cater to autistic users (Luigia, 2006). To prevent distraction, lighting is designed to minimize glare and reflections and natural lighting is controlled by window coverings (Ahrentzen & Steele; Beaver, 2010). Hidden and indirect lighting provide the least amount of overstimulation; research warns against the use of visually and audibly distracting florescent and halogen lighting as people with autism are extremely sensitive to soft noises (Ahrentzen & Steele; Luigia, 2006).

Spatial Layout According to Mostafa (2008), â&#x20AC;&#x153;autistic behavior can be influenced favorably by altering the sensory environment, i.e. the stimulatory input, resulting from the physical architectural surrounding before rather than after the sensory malfunction occursâ&#x20AC;? (p. 191).

How a space is organized is essential to achieving adequate spatial layout. In institutional environments, for example, researchers recommend organizing the space in such a manner to promote routine with defined stations, furniture, zones, and escape space (Mostafa).

Supporting spatial routine can also be achieved though visual transparency among multiple spatial zones in addition to functional clarity in environmental sequencing (Ahrentzen & Steele, 2009; Beaver, 2010; Luigia, 2006). Visual routine generates a sense of comfort and familiarity, which in return allows for softer, inter-spatial transition and helps keep arousal levels low to minimize anxiety and stress (Ahrentzen & Steele). The use of transitional spaces and structures like half-walls, vestibules, and cutouts, will allow users the opportunity to familiarize themselves with the space before entering it. People with autism will most likely use a space if they can assess the volume and potential social interactions before entering the environment (Ahrentzen & Steele; Luigia).

Noise Control As previously mentioned, individuals living with autism are hyper-sensitive to sound and noise generated by elements in the environment, including heating, ventilating, and air conditioning (HVAC) systems, domestic appliances, ventilation fans, and artificial lighting. Minimal noise-producing equipment and design interventions are utilized when possible. Conventional equipment is located as far as possible, or properly insulated, from the usersâ&#x20AC;&#x2122; daily functions (Ahrentzen & Steele, 2009; Beaver, 2010). Controlling the acoustics in an environment was found to have a profound influence on attention span, response time, and behavioral temperament for individuals with autism disorder. In her study, Mostafa (2008) tested the impact of acoustics on a control group and study group of autistic children ages 6-10. To test how acoustics influence the children, Mostafa soundproofed a speech and therapy room and compared the results to a similar speech and therapy class in a nonsoundproofed room. Students in the soundproofed room had increased attention spans, decreased response times, and fewer self-stimulatory occurrences, whereas the control group in the non-soundproofed room did not show the same progress.

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Articles Alzheimer’s Disease/Dementia Environments Alzheimer’s disease, a neurological disorder that worsens over time, occurs when an increasing number of nerve cells in the brain deteriorate and die, causing a disruption in the flow of information that helps the brain process memory, thoughts, and skills (Alzheimer’s Association, 2010). Typical symptoms in the early stages include difficulty remembering names and recent events and feelings of apathy and depression. As the disease progresses, individuals develop impaired judgment, disorientation, agitation, confusion, behavioral changes, and difficulty speaking, swallowing, and walking (Alzheimer’s Association).There is no cure, but new treatments are slowing the degenerative process (Alzheimer’s Association).

Alzheimer’s disease is the most common form of dementia, accounting for 50 to 70 percent of all dementia cases, and is the seventh leading cause of death in the United States.

Currently, there are 5.3 million people in the United States living with Alzheimer’s disease (Alzheimer’s Association). It is estimated that by 2050, one in 85 persons will be living with the disease (Brookmeyer, Ziegler-Graham, Arrighi & Johnson, 2007). As the rates of Alzheimer’s disease increase due to population growth and longer life expectancies, so too will the need for patient care -- from adult day care in the early stages to high-level nursing home care in the later stages (Brookmeyer et al., 2007).

For people living with Alzheimer’s, the environment must function to support the delay of the progression of the disease. In caring for individuals, design researchers found that there is overwhelming evidence that attests to how the built environment has an impact on their physical and emotional health (Brawley, 2001; Devlin & Arneill, 2003; Van Hoof & Kort, 2009). In fact, “many of the problems experienced by people with dementia and their caregivers are linked directly to the planning and design of the environment” (Cohen & Weisman, 1991, p. 20). The design of care facilities that cater to Alzheimer’s and dementia patients is important because, as the Environmental Docility Hypothesis suggests, “people who are subjected to restriction on their health or cognitive ability cannot always adapt the environment to their specific needs and therefore are more dependent on their external environment” (Marquardt & Schmieg, 2009, p. 333).

Prioritizing Quality of Life Too many case studies that focus on the effects of design on dementia care facilities emphasize problem behavior over all other outcomes (Day, Carreon, & Stump, 2000). That is most likely because of the high impact problem behavior has on healthcare providers, staff, visitors, and other patients. In recent years, however, multiple design researchers have argued that turning the focus to increasing quality of life can not only improve the end users’ well-being, but can also reduce stressors that cause bad behavior (Day et al., 2000; National Center for Assisted Living, 2009). Based on improving overall quality of life, design considerations recommended by multiple researchers who have adapted Day’s recommendations include units with fewer residents to control noise and overstimulation; home-like setting to promote intellectual and emotional well-being; community space to enhance social interaction and reduce the need to stray; simple, calming patterns that reduce confusion and agitation; access to the outdoors for physical activity, a sense of home and access to the positive health effects of natural sunlight; and spatial designs that balance privacy with autonomy (Calkins, 2009; Day et al., 2000; Torrington & Tregenza,

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Articles 2006). Designers who focused on the overall quality of life and positive user outcomes have proposed guidelines that accommodate colors, patterns, volume, light, orientation, and structure (Alzheimer’s Australia, 2004; Brawley, 2001; Calkins, 2009; Day et al., 2000; National Center for Assisted Living; Torrington & Tregenza).

Traditional institutional layouts with multi-bed rooms, long corridors and multipurpose dining and activity rooms do not support positive outcomes, as they may induce confusion, precipitate agitation, and increase stress levels (Brawley, 2001; Calkins, 2009).

Current design trends include reducing the size of interior spaces to accommodate fewer residents; providing private bedrooms that are adjacent to shared, community-oriented spaces; and creating a calming, home-like environment (Calkins, 2009). Like autism, sensory stimulation in Alzheimer’s patients can cause increased distraction and disorientation.

Therefore, care facilities should incorporate a neutral design and color pallet and minimal audio and visual distractions (Brawley, 2001; Calkins, 2009; Day et al., 2000).

Safety and Comfort Whether at home or in a healthcare institution, the visual experience of the environment needs to convey safety and familiarity for individuals struggling with Alzheimer’s (Brawley, 2001; Calkins, 2009; Torrington & Tregenza, 2006; Van Hoof & Kort, 2009). A sense of safety can be achieved by using pastel colors for the flooring, wall covering, and upholstery, and eliminating busy and repetitive patterns. Pastel colors can also help decrease confusion and anxiety. Eliminating the use of patterns helps diminish depth misperceptions; individuals may perceive certain prints as differences in surface levels, which can cause unease and restlessness (Figure 11) (Van Hoof & Kort, 2009).

Figure 11. The USF Health Byrd Alzheimer’s Institute lobby in Tampa, FL, featuring neutral design and color palette.

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Articles As with autism patients, defined space is crucial to avoid disorientation and the discomfort that stems from an introduction to an environment. Using color blocking to distinguish a space can help individuals determine location and function, and potential social interaction (Burke, 2006; Confino-Rehder, 2010; Devlin & Arneill, 2003). Familiarity can be implemented by using open, non-clattery zones while implementing transparent materials and structural elements (Marquardt & Schmieg, 2009; Van Hoof & Kort, 2009).

It is advised to minimally rely on corridors and vestibules for spatial transition; smaller spaces, like internal circulation zones, are known to cause restlessness, visual confusion, disorientation, and claustrophobia. Interior spaces with low partitions allow overall spatial review and simple, fixed pieces of furniture accommodate visual familiarity (Calkins, 2009).

Lighting Applications Natural and artificial lighting can do more than just support the cognitively impaired by enhancing the eyesight of elderly adults; it improves their quality of the spatial perception and overall experience (Torrington & Tregenza, 2006). Several environmental researchers concluded that the mental and physical well-being of people suffering from dementia is greatly impacted by exposure to a day/night lighting cycle, sunlight, natural views, and perception of place (Brawley, 2001; Calkins, 2009; Torrington & Tregenza, 2006). Facilities that provide care for patients with dementia are recommended to provide daylit public spaces, such as activity rooms, circulation spaces, and community spaces, and dark sleeping areas to promote proper sleeping cycles and reduce the risk of agitation and depression (Figure 12).

Figure 12. The Alzheimerâ&#x20AC;&#x2122;s Respite Center activity room in Dublin, Ireland, featuring daylit activity space.

Windows that provide natural views were found to have a universally positive effect on all users, including patients with dementia, by reducing discomfort and depression and promoting a sense of control over oneâ&#x20AC;&#x2122;s environment (Brawley, 2001; Torrington & Tregenza, 2006; Ulrich, 1984).

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Articles Supporting Independence Adequate space experience like circulation, way-finding, and independent living has been strongly linked to the high satisfaction rate with individuals struggling with Alzheimer’s/dementia (Calkins, 2009; Marquardt & Schmieg, 2009). Multiple design researchers studied architectural and structural features that support residential living and nursing home residual spatial abilities that promote mobility, way finding, and independence to formulate design recommendations. They include providing memorable reference points like live-in kitchens, furniture, structural elements like columns and beams, fixtures, or fittings; designing unique, non-repeated spaces; providing easily-identified, simple signage, landmarks and guiding elements; and assigning fewer resident to a living area (Marquardt & Schmieg, 2009 ). Color and textures are used to enhance mobility and movement and attract attention to space designated for different functions, such as community or private areas. It is advised to paint the users’ area with bright colors and apply pale colors for restricted spaces (Devlin & Arneill, 2003).

Conclusion Based on the well-demonstrated impact of the built environment on health and well-being, innovation in healing designs continues to accelerate. Within this realm, then, how far are we from a day where physicians prescribe a design intervention or architectural experience as an essential component of the healing and/or treatment process?

Why not? Research of oncology environments shows that materials diminish perceptions of pain; natural light improves recovery rates; color influences both emotions and physiological functions; varied environmental layouts contribute to the reduction of stress and anxiety; and access to physical nature mollifies side effects of chemotherapy and radiation therapy. For autism environments, spatial layout decreases agitation and claustrophobia; color moderates confusion and overstimulation; patterns and textures support perceptual deficiencies; and noise control lowers distraction and improves attention span. Finally, for Alzheimer’s disease and dementia, color soothes disorientation and agitation; open and clear spatial layouts reduce confusion and restlessness; and exposure to daylight regulates sleeping cycles and reduces the risk of depression.

At a closer look, even for those not struggling with cancer, autism, or Alzheimer’s, many of the aforementioned symptoms can be experienced through daily living. In the United States, the number of individuals seeking palliative, psychological, and physiological care has increased over recent decades (Murray & Fortinberry, 2005; Nelson, 2010; Wiess, 2005). It is estimated that 50 million Americans suffer from persistent pain, beyond chronic pain, each year (Beyond Chronic Pain). According to the CDC (2009), 15.7% of individuals living in the US have struggled with depression, and 11.3% of people reported being told by a healthcare provider that they had anxiety at some point during their lifetime. Additionally, 40% of Americans are moderately to severely sleep-deprived, 36.7% struggle with fatigue and 2.7% with chronic fatigue (Furberg et al., 2005).

With these statistics, is it fair to hypothesize that specific architectural interventions, like those examined in these case studies, can assist in treating illness and promote wellness if implemented in daily built environments, such as homes, places of employment and 106

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Articles public/community facilities? Why not prescribe an architectural experience at a cultural institution similar to the Getty Center in Los Angeles as part of treatment? The Getty Center is designed to provide transparency with nature and access to natural settings, which can help reduce the perception of pain. Walls are finished with Italian travertine stone. The pastel colors and organic, rough textures may have calming affects for individuals struggling with anxiety. Naturally and well-lit interior spaces may project an uplifting feeling for individuals struggling with depression (Figure 13).

Figure 13. The Getty Center in Los Angeles, CA. On a more personal scale, a physician can advise a patient to make modifications to his or her household and workplace as part of the treatment or wellness prescription.

Wall coverings, furniture and fixtures can be refinished with calming colors and patterns; spatial layout can be reorganized to clearly defined and easily navigable zones; window design and treatments can allow for natural lighting; and landscape can be enhanced to create a connection.

This hypothesis might not be too far from reality. Over the past decades, numerous design research organizations have been created with a focus on generating design guidelines that enhance health outcomes. For example, the Center for Health Design (2010), whose primary mission is to improve usersâ&#x20AC;&#x2122; outcome in built environments, published multiple reports that directly link health with architecture (The Center for Health Design). Its research encompasses the impact of design on wellness and recovery in various healthcare settings. The Academy of Neuroscience for Architecture (2009) was developed to â&#x20AC;&#x153;promote and advance knowledge that links neuroscience research to a growing understanding of human responses to the built environmentâ&#x20AC;? (Academy of Neuroscience for Architecture). This organization, comprised of architects, professors, physicians, scientists, and researchers, directs multiple Journal of Healthcare, Science and the Humanities

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Articles workshops and educational sessions to enlighten the design community on the relationship between the built environment and the brain’s governance over body function.

Of course, design alone cannot cure a disease. However, as demonstrated though the analysis of oncology, autism and Alzheimer’s treatment environments, good design is essential to improving quality of life, supporting recovery and maintaining well-being. Research suggests that poorly designed spaces can harm and negatively impact health and wellness (Ulrich, 2000). On the other hand, good design responses can have a positive influence over an individual experience by responding to the human need for comfort and serenity and aid providing overall positive outcomes (Caretsky, 2010).

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Articles Dube, A., Barth, M., Cutshall, S., Olson, S., & Sulia, S. (2008). Environmental noise sources and interventions to minimize them: A tale of 2 hospitals. Journal of Nursing Care Quality, 23(3), 216–224.

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Articles Malkin, J. (2008). A visual reference for evidence-based design. San Francisco, CA: The Center for Healthcare Design.

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Articles Redwine, L., Hauger, R.L., Gillin, J., Irwin, M. (2000). Effects of sleep and sleep deprivation on interleukin-6, growth hormone, cortisol, and melatonin levels in humans.

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Shabha, G. (2006). An assessment of the impact of the sensory environment on individuals’ behavior in special needs schools. Facilities, 24(1/2), 31–42.

Sherman, S. A., Varni, J. W., Ulrich, R. S., & Malcarne, V. L. (2005). Post-occupancy evaluation of healing gardens in a pediatric cancer center. Landscape and Urban Planning, 73(2-3), 167-183. doi: 10.1016/j.landurbplan.2004.11.013.

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Involving family members in cancer care: Focus group considerations for patients and oncological providers. Psycho-oncology, 9(2), 101–112. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/10767748.

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Torrington, J., & Tregenza, P. (2006). Lighting for people with dementia. Lighting Research & Technology, 39(1), 81–97.

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Articles Ulrich, R. (1984). View through a window may influence recovery from surgery. American Association for the Advancement of Science, 224. 4647 ISSN: 0036–8075 Date: 04/1984, 420 – 421.

Ulrich, R. (1991). Effects of interior design on wellness: Theory and recent scientific research. The Journal of Healthcare Interior Design, 3, 97–109.

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Van Hoof, J., & Kort, H. S. M. (2009). Supportive living environments, A first concept of a dwelling designed for older adults with dementia. Dementia, 8(2), 293-316. doi: 10.1177/1471301209103276.

Vogel, C. (2008). Classroom design for living and learning with autism. Autism Aspergerâs Digest. Retrieved from http://www.autismdigest.com/Portals/0/docs/Classroom(2)-AADMay08.pdf.

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Photo Credits Figure 1. Model of the Asklepeion at Epidauras, Greece, 1936 [Photograph]. (2004).

Retrieved January, 03, 2011 from: http://www.sciencemuseum.org.uk/images/I023/10284986.aspx Figure 2. The Atrium at Henry Ford Hospital in West Bloomfield, Michigan [Photograph].

(2005). Retrieved January, 03, 2011 from: http://www.planterra.com/media/henryford/index.php Figure 3. The Entrance of Queen Elizabeth Hospital Entrance in London, UK [Photograph]. (2002). Retrieved January, 03, 2011 from: http://www.architen.com/projects/queen-elizabeth-hospital

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Articles Figure 4. Cancer Center lobby in Tuscaloosa, Alabama [Photograph]. (2010). Retrieved January, 03, 2011 from: http://www.architen.com/projects/queen-elizabeth-hospital Figure 5. MCGHealth Cancer Center Chemotherapy balcony in Augusta, Georgia [Photograph]. (2010). Retrieved January, 03, 2011 from: http://www.mcghealth.org/cancer/ mcgcontentpage. aspx?nd=2082#/media/ PhotoGalleries/10/roof-top-garden.jpg Figure 6. Herbert Irving Comprehensive Cancer Center waiting area in New York City, New York [Photograph]. (2009). Retrieved January, 03, 2011 from: http://www.architecturesdesign.com/search/colorful+buildings/ Figure 7. The Healing Garden at Yale Cancer Center [Photograph]. (2010).

Retrieved January, 03, 2011 from: http://yalecancercenter.org/news/newsltr_html/summer10_garden.html Figure 8. Maggie’s Cancer Center in Dundee, Scotland [Photograph]. (2003). Retrieved January, 03, 2011 from: http://www.galinsky.com/buildings/maggiescentre/index.htm Figure 9. The Minster School for Autistic Children in Nottingham, UK [Photograph].

(2008). Retrieved January, 03, 2011 from: http://www.bdonline.co.uk/events/ education-penoyre-and-prasad/3126353.article Figure 10. The Development Learning Center lobby in Monroe Township, New Jersey [Photograph]. (2010). Retrieved January, 03, 2011 from: http://usaarchitects. wordpress.com/2010/04/26/design-sensitivity-strengthens-learning-experiencefor-autistic-students/ Figure 11. The Health Byrd Alzheimer’s Institute lobby in Tampa, Florida [Photograph].

(2010). Retrieved January, 03, 2011 from: http://farm5.static.flickr.com/4140/4902360935_f96fd0dd5b.jpg Figure 12. The Alzheimer’s Respite Center activity room in Tampa, Florida [Photograph].

(2010). Retrieved January, 03, 2011 from: http://www.lcl.ie/projects/healthcare/alzheimer-day-care-respite-centre/ Figure 13. The Getty Center in Los Angeles, California [Photograph]. (2009).

Retrieved January, 03, 2011 from: http://www.mariotticarlo.com/

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SPECIAL INTERNATIONAL CONFERENCE REPORTS

Special Reports Military Forces, Global Health, and the International Health Regulations (2005) David P. Fidler, MPhil, JD, BCL James Louis Calamaras Professor of Law Maurer School of Law Indiana University 211 S. Indiana Avenue Bloomington, IN, 47405 Tel: 812-855-6403, E-mail: dfidler@indiana.edu

Author Note This article was originally prepared as a background paper for the International Military Forum on Emerging Infectious Diseases: The Military’s Role Under the International Health Regulations (2005), held in September 2010 in St. Petersburg, Russia, and sponsored by the U.S. Armed Forces Health Surveillance Center, the Russian Academy of Medical Sciences, and the International Committee of Military Medicine.

Abstract Security, economic, development, and humanitarian threats created by infectious diseases have heightened the importance of military forces to national and global public health responses. This article explores the increasing need for military involvement in public and global health surveillance and response to infectious disease threats, and focuses on how military forces can more effectively support implementation of the World Health Organization’s International Health Regulations (2005) (IHR (2005)). The article explains the major changes made in negotiations that produced the IHR (2005) and the importance of these changes to military-to-military activities and civilian-military cooperation. It identifies five areas in which military forces can advance implementation of the IHR (2005) —compliance, coherence, coordination, cooperation, and capacity — and includes examples from various countries illustrating how militaries can contribute to progress on IHR (2005) implementation. It recommends additional actions from military forces, including a proposal for a Global Military Working Group on the Implementation of the IHR (2005) led by the International Committee on Military Medicine.

Keywords: bioterrorism, capacity building, civilian-military cooperation, Department of Defense, emerging infectious diseases, global health, global health security, implementation, International Health Regulations (2005), military forces, military-to-military cooperation, public health, surveillance, World Health Organization

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Special Reports Introduction The history of humanity’s struggle with infectious diseases records the impact of military forces on the emergence, spread, and control of such diseases. This military involvement has included spreading pathogens through war, mitigating the damage infections have inflicted on fighting forces, and contributing to the protection of general population health. The complexity of the military’s role in public health nationally and globally has increased in the past 10 to 15 years because of changes in the threats posed by infectious diseases. With such diseases increasingly manifesting as security, economic, development, and humanitarian concerns, military forces have faced new demands on their capabilities to support public health within and beyond the territories they protect.

One important development in this new relationship between the military and global health is the International Health Regulations (2005) (IHR (2005)), adopted by the World Health Organization (WHO) (WHO, 2008). Developed to advance global health security (WHO, 2010a), the IHR (2005) radically changed the international law applicable to the international spread of disease (Fidler, 2005). Although most attention generated by the IHR (2005) has focused on civilian public health, the IHR (2005) are important to militaries. Understanding the challenges and opportunities defense establishments face from the IHR (2005) is important to support the regulations and manage the increasing health demands on militaries. This article examines the IHR (2005)’s implications for military forces and explores strategies for militaries to advance the IHR (2005) as an instrument of global health security.

Military Forces and Global Health: New Context, New Rules New Context: The Military and Global Health Military forces have long been concerned about population health in two contexts.

First, militaries require healthy personnel to undertake their missions. Historically, armies endured severe morbidity and mortality from infectious diseases during armed conflict. This attrition led to improvements in military hygiene, sanitation, and treatment of wounds.

Starting in the twentieth century, the task of protecting troops also addressed the potential use of biological weapons in warfare. The laws of war also placed increasing demands on military forces concerning the health of enemy combatants, prisoners of war, and civilians in war zones or under military occupation. These rules included, among others, the prohibition on weapons that cause superfluous injury or unnecessary suffering (Henckaerts & DoswaldBeck, 2005), and the duty of an occupying military to maintain health services in occupied territory (Geneva Convention (IV), 1949, Article 56).

These contexts are limited to the primary security functions of military forces.

However, efforts to mitigate health threats to troops and reduce adverse health consequences of military operations have produced some “spill over” benefits for general population health. Knowledge gained and research undertaken by military personnel have informed interventions for protecting civilians, such as contributions the U.S. military made to malaria control and treatment (Ockenhouse, Magill, Smith, & Milhous, 2005).

The relationship between military forces and public and global health changed in the 1990s, producing an expanded role for military organizations, especially with respect 118

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Special Reports to supporting the civilian sector. This context emerged in the wake of two crises. The first involved the vulnerability of countries to the emergence and re-emergence of naturally occurring infectious diseases. For military forces, emerging infectious diseases (EIDs) presented new threats to the old concern about the health of military personnel, as evidenced by concerns about the impact HIV and AIDS could have on armed forces in Africa (Feldbaum, Lee, & Patel, 2006).

However, political responses that characterized EIDs as threats to national security, foreign policy, and development interests affected the military’s involvement in national and global public health. In the United States, President Bill Clinton expanded the Department of Defense’s mission “to include supporting global surveillance, training, research, and response to emerging infectious disease threats” (White House, 1996). This new task made the Department of Defense important to the larger U.S. effort to “[e]stablish a global infectious disease surveillance and response system” that would protect U.S. citizens from naturally occurring infectious diseases (White House, 1996). Later, national strategies to address infectious disease threats, such as pandemic influenza, assigned roles to the military (U.S Homeland Security Council, 2006; U.S. Department of Defense, 2006). The message behind these developments was that it was necessary to utilize defense assets in integrated “whole of government” efforts to strengthen surveillance and response, given the nature and danger of the threat.

The second crisis involved bioweapons and bioterrorism. Revelations in the early 1990s about the former Soviet Union’s and Iraq’s bioweapons programs stimulated efforts to address bioweapons proliferation by states. This concern connected with long-standing military needs to protect troops from bioweapons in armed conflict. However, fears about bioterrorism added a new element. Military capabilities in disease surveillance and biodefense research and development were brought to bear on bioterrorism through surveillance of suspicious events and development of detection systems and countermeasures. These efforts supported actions being taken in the civilian sector to prevent, protect against, and respond to bioterrorist attacks.

What unified developments across these crises was the need for civilian and military capabilities to work together against EIDs and bioterrorism for the protection of the health of military personnel and the general public. This objective required conceptual and policy shifts. Civilian public health, long starved of resources in many countries, had to accept the need to draw on military capabilities in addressing EIDs. National security communities had to understand that responding to a bioterrorist attack required robust civilian health systems. The lines demarcating military and civilian realms began to blur, creating the need to integrate civilian and military efforts against pathogenic threats.

Similar conclusions emerged from other health activities undertaken by military forces. The use of military capabilities for medical treatment and public health in responding to humanitarian disasters (WHO, 2005, ¶¶ 46-49), winning “hearts and minds” in counterinsurgency operations (Feldbaum & Michaud, 2010), and delivering health assistance to developing countries through hospital ships (O’Brien, 2009) raised the profile of military forces in global health. These activities generated controversy because they highlighted inadequate civilian capacities and created concerns about the militarization of development and humanitarian assistance. Nevertheless, these activities deepened the importance of Journal of Healthcare, Science and the Humanities

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Special Reports military capabilities and their integration into civilian efforts to strengthen public health nationally and globally.

New Rules: Towards the IHR (2005) At the same time the relationship between the military and global health was transforming, WHO embarked on revising the International Health Regulations (1969) (IHR (1969)) (WHO, 1983). This process had to address the threats from EIDs and bioterrorism that were altering the military-global health interface. Thus, crafting new rules for international disease at a time when the military’s role in this realm was expanding constituted an important development for armed forces.

The IHR (1969) and predecessor treaties did not affect military forces significantly.

The regime that developed from the nineteenth century through the IHR (1969) focused on infectious diseases, the spread of which countries associated with international trade and travel. The rules applied to only a few diseases, with only cholera, plague, and yellow fever remaining constant from the first international sanitary conference in 1851 through the IHR (1969). The rules were geared more toward protecting trade than strengthening public health. The regime’s basic bargain involved two obligations: countries suffering outbreaks of specified diseases agreed to report such outbreaks, and other countries agreed to apply only scientifically justified responses to the trade and travel coming from the outbreak country.

Governments did not view this regime as important to foreign policy, national security, or development interests. The rules left the matter of bioweapons to the security community to handle through arms control.

The regime’s narrow scope had limited impact on civilian and military health efforts. Civilian officials and military forces had more diseases to worry about than cholera, plague, and yellow fever. During the 1960s and 1970s, experts questioned the traditional regime’s approach in light of changes in transportation technologies and the need to address diseases not covered by the rules (Dorolle, 1969; Velimirovic, 1976). Violations by countries (e.g., failure to report outbreaks and application of unjustified trade restrictions) undermined the regime’s credibility (Fidler, 1999).

EIDs and bioterrorism again exposed the inadequacy of the traditional rules and highlighted the need for a strategy that required a broader scope of application, imposed more demanding obligations, and produced more surveillance and response capacities. With the military’s role in global health increasing, new rules with wider application, tougher duties, and requirements for more capacity promised to implicate defense organizations more than the traditional regime. From the military’s perspective, the IHR (2005)’s adoption reflected the transformed global health context in which the military operated, and underscored the new responsibilities of military forces in this context.

International Health Regulations (2005): Key Changes The IHR (2005) contain rules never before seen in efforts to control the international spread of disease. The differences between the IHR (2005) and the IHR (1969) are too many to analyze here, so this paper focuses on key revisions, which make

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Special Reports the IHR (2005) “one of the most radical and far-reaching changes to international law on public health since the beginning of international health cooperation in the mid-nineteenth century” (Fidler, 2005, p. 326). The IHR (2005) contain other provisions that have undergone less radical, but still important, changes. Understanding these transformations and changes is a necessary prelude to examining their implications for militaries.

Expanded Scope of the IHR (2005) The IHR (2005) expand the scope of the rules in terms of their purpose, application, obligations, participation, and WHO’s authority. The IHR (2005)’s purpose resembles that of the IHR (1969) in aiming to control the international spread of disease while avoiding unnecessary interference with trade and travel (Article 2). However, the new regulations focus more on protecting population health than trade interests. The change is clear in the new scope of disease coverage, which abandons the disease-specific approach and adopts a strategy to identify existing and unknown disease threats. The IHR (2005) require States Parties to notify WHO of all disease events that might constitute a public health emergency of international concern (PHEIC) (Article 6 and Annex 2) — an expansion of the obligations of States Parties in notifying disease outbreaks.

The IHR (2005) also expand the scope of application by including accidental and intentional releases of biological, chemical, and radiological agents (Articles 1, 6, and 7).

This change reflects the understanding that health harms are not limited to EIDs but can include biological, chemical, and radiological terrorism and accidental releases of healthharming substances. Including these dangers is consistent with an “all hazards” approach, which also expands the scope of the obligations.

The IHR (2005) also expand WHO’s scope of participation and authority. As examined further below, the IHR (2005) allow WHO to use information from nongovernmental sources (Articles 9 and 10) — powers neither the IHR (1969) nor any prior version of these rules permitted. This rule makes non-governmental actors participants in global surveillance and empowers WHO to assess information received from outside governmental channels. In another unprecedented move, the IHR (2005) increase WHO’s authority by empowering the WHO Director-General to declare a PHEIC and issue temporary recommendations on actions States Parties should take in response to a declared PHEIC (Articles 12 and 15).

Core Capacities for Surveillance and Response The IHR (2005) require States Parties to develop and maintain core capacities for surveillance and response (Articles 5, 13, and Annex 1). The old rules only imposed requirements for public health capabilities at designated points of entry and exit (e.g., adequate sanitation at sea ports). The new rules include such requirements (Annex 1), but transcend them in imposing obligations on developing core surveillance and response capacities throughout their territories. These obligations seek to ensure that countries have baseline capabilities to identify and respond to disease events and comply with the IHR (2005). States Parties have to develop these core capacities by 2012, with options for extensions until 2016 (Articles 5 and 13).

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Special Reports Use of Non-Governmental Sources of Information The IHR (2005) empower WHO to collect, analyze, and verify information received from non-governmental sources (Articles 9 and 10). This authority reflects the conclusion that any regime on the international spread of disease limited to government-provided information would fail, as the IHR (1969) had. New information technologies created opportunities for national and international health agencies to obtain information from more sources about disease events. Permitting WHO to use such information and requiring States Parties to respond to WHO verification requests transform the notification dynamic by (1) reducing incentives governments have to cover up disease events for fear of economic or political repercussions; and (2) increasing incentives for countries to cooperate with WHO to address identified problems. WHO statistics demonstrate that non-governmental actors constitute a significant source of information (Institute of Medicine, 2009).

WHO Director-General’s Power to Declare a PHEIC and Issue Temporary Recommendations The IHR (2005) authorize the WHO Director-General to declare that a disease event constitutes a PHEIC (Article 12), and to issue temporary recommendations on how States Parties should respond (Article 15). Nothing like these authorities existed in previous regimes. The WHO Director-General first exercised these powers in declaring pandemic influenza A (H1N1) a PHEIC in April 2009, and issuing temporary recommendations on responding to the threat. The authority to declare a PHEIC and issue temporary recommendations represents the potential for the WHO Director-General to exercise political and economic power vis-à-vis governments. Combined with the ability to collect, use, and verify information from non-governmental sources, the declaration and temporary recommendation powers create constraints on sovereignty in the name of global health.

Respect for Human Rights The IHR (2005) state that their implementation “shall be with full respect for the dignity, human rights and fundamental freedoms of persons” (Article 3.1). The IHR (2005) contain other provisions (Articles 23.2-23.5, 31.1, 31.2, 32, 42, 43.2, and 45.145.3) relevant to protecting the human rights of persons subject to health measures within the scope of the regulations (Plotkin, 2007). The inclusion of human rights principles underscores how the IHR (2005) have departed from the past primary concern about balancing trade and public health. It also reflects increased attention on human rights created by policy responses to EIDs and bioterrorism. Actions taken by some governments during the H1N1 pandemic, such as isolation and quarantine of travelers, came under human rights scrutiny through the IHR (2005)’s application.

National IHR Focal Points The IHR (2005) seek to improve communications by requiring each government to establish a National IHR Focal Point with the responsibility of implementing the regulations (Article 4). This approach aims to streamline and make more effective communication channels within and among national governments and WHO, which also must establish IHR Contact Points. Experience to date, including with H1N1, indicates that the National IHR Focal Points have improved information flows and contributed to the success achieved so far (Katz, 2009).

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Special Reports Other Changes The IHR (2005) contain other important, if less radical, changes that deserve mention. With abandonment of the disease-specific approach, the new regulations could not contain maximum measures limiting States Parties’ responses to disease events. Instead, the IHR (2005) require that measures applied to trade and travelers have public health and scientific justifications. For measures that seek greater protection than WHO recommends, the State Party has to consider scientific principles, evidence, and advice from WHO (Article 43.2). For more protective measures that significantly interfere with trade and travel, the State Party must provide WHO with the public health rationale and scientific information supporting the measures (Article 43.3). During the H1N1 pandemic, some countries applied measures, such as import bans on pork, which had no public health or scientific justification. WHO also modified technical aspects of the regulations, such as replacing the old de-ratting certificate for ships with the ship sanitation control certificate (Annex 3) and the old international certificate of vaccination or revaccination against yellow fever with the model international certificate of vaccination or prophylaxis (Annex 6).

International Health Regulations (2005) and Military Forces In keeping with the expanded role of military forces in global health, the IHR (2005)’s implications for defense establishments are significant (Johns et al., 2010). Given diversity among militaries, no single blueprint for handling the IHR (2005) is possible.

However, each military should review the IHR (2005) against its missions and resources.

Such reviews could keep in mind five useful categories: compliance, coherence, coordination, cooperation, and capacity. Table 1 provides examples of military strategies under each category and of national efforts to implement such strategies.

Compliance The IHR (2005) contain binding international legal obligations. The IHR (2005) do not exempt military forces, dilute rules for such forces, or provide national security exceptions. The only IHR (2005) provision that specifically mentions “Armed Forces” permits, under certain conditions, active members of such forces to have a document different from but equivalent to the International Certificate of Vaccination and Prophylaxis (Annex 6). The IHR (2005)’s principle of achieving “universal application for protection of all people of the world” underscores this point (Article 3). The extent of military compliance needed will depend on how governments use militaries for functions affected by the IHR (2005). For example, some militaries might control points of entry and exit, and, depending on the functions of the military’s border control responsibilities, the IHR (2005) could apply to military personnel actions. Other militaries might have no role in border control but be involved in disease monitoring among troops at home and overseas that the IHR (2005) affect through provisions on surveillance and notification of disease events.

Controversy in this context arose concerning an understanding the United States issued upon accepting the new regulations. The IHR (2005) require States Parties, as far as practicable, to inform WHO of public health risks identified outside their territories that might cause international disease spread (Article 9.2). The United States accepted this obligation with the understanding that it is impractical to notify these risks when a notification “would undermine the ability of the U.S. Armed Forces to operate effectively in pursuit of Journal of Healthcare, Science and the Humanities

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Special Reports U.S. national security interests” (Appendix 1). The concern is that notifying such risks in a country hosting U.S. military forces could harm the forces’ ability to fulfill their mission by creating problems with the host government, especially if that government has failed to notify WHO of the risk, as required under the IHR (2005). Iran criticized the U.S. understanding, arguing that it dilutes U.S. obligations by placing its interests above the IHR (2005)’s universal application and exempting U.S. armed forces from the regulations (Appendix 1).

The merits of the U.S. and Iranian positions could be debated, but, as a practical matter, the key to mitigating the potential tension created by Article 9.2 is effective cooperation about the IHR (2005) between the government providing military forces and the government hosting them (Johns et al., 2010). Such cooperation can increase the incentives a host government has to communicate with WHO about public health risks in its territory that might cause international disease spread, reducing the need for Article 9.2 to cause friction.

This article returns to the importance of cooperation on the IHR (2005) below.

Coherence For a State Party to comply with the IHR (2005), all governmental elements must be consistent in their implementation of the regulations. The military plays an important part in achieving coherence among national agencies with responsibilities for activities affected by the IHR (2005) (WHO, 2007). For most countries, control over military forces is not decentralized, removing coherence challenges created by federal systems that locate civilian public health powers at the state or provincial level. Achieving coherence requires vetting relevant legislation, regulations, instructions, and operating practices in civilian and military sectors and making changes to ensure both sectors apply the same or equivalent rules and strategies. Coherence issues could arise in a number of IHR (2005) contexts, including use of defined terms, application of the decision instrument that guides notification of disease events, recognition of technical requirements (e.g., the new ship sanitation certificate), and respect for human rights principles.

Coordination Coherence is necessary but not sufficient to advance “whole of government” implementation of the IHR (2005). Also important is coordination among governmental agencies tasked with responsibilities relevant to the IHR (2005) (WHO, 2010b). Branches of the military must work together and communicate in managing the surveillance, response, and other obligations in the IHR (2005), as must military and civilian agencies. Effective intra-military and civilian-military coordination have been problematic in other contexts, including intelligence sharing, counterinsurgency, counterterrorism, development efforts, and disaster relief. Thus, the coordination challenge facing the military in implementation of the IHR (2005) should not be underestimated.

The obligation to establish an IHR National Focal Point has helped facilitate better communication and coordination, but intra-military and civilian-military coordination and communication involve complex political, chain-of-command, information sharing, and technical issues that should be addressed proactively and not primarily as part of post-crisis “lessons learned.” Including “stress tests” for intra-military and civilian-military coordination capabilities in simulations and “table top” exercises involving EID or bioterrorism threats could facilitate identifying and managing coordination problems.

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Special Reports Cooperation Military forces also have a role in IHR (2005) implementation by including the IHR (2005) in military-to-military and civilian-military cooperation. Many countries participate in military-to-military programs that involve technical assistance, training, and joint military exercises. Such programs can incorporate more health-related issues, including the military’s role in IHR (2005) implementation. For example, the Global Health and Security Working Group of the Center for Strategic and International Affairs has proposed that the U.S. government “create a specific health theme for DOD’s military-to-military activities,” (Center for Strategic and International Studies, 2010) and cooperation on the IHR (2005) could form part of such a health focus. Similarly, potential exists to address the IHR (2005) in ventures between military forces and civilian agencies in other countries (International Military Forum on Emerging Infectious Diseases, 2010). Such military-tomilitary and civilian-military cooperation would help countries fulfill their obligation under the IHR (2005) to collaborate on implementation of the regulations (Article 44.1).

Capacity Militaries in developed and developing countries have a role to play in the capacity building needed to implement the IHR (2005) (International Military Forum on Emerging Infectious Diseases, 2010). As noted earlier, the IHR (2005) require States Parties to develop and maintain core capacities for surveillance and response, and, as a nearly universally accepted instrument, all countries have responsibilities for capacity building. One of the biggest concerns about the IHR (2005)’s future remains the inadequacy of these capacities in many countries and the insufficient efforts being mounted to address this problem (Wilson, Brownstein, & Fidler, 2010). Military forces alone will not solve this challenge, but they can contribute by: a. Strengthening the military’s own capacities in disease surveillance and response; b. Supporting civilian efforts at home and abroad to build detection and intervention capacities; c. Supplementing civilian capacity in contexts where such capacity is inadequate or ineffective because of insecure conditions; d. Helping foreign militaries build their IHR (2005)-relevant capacities; and e. Assisting development agencies build capabilities in developing and least-developed countries.

Although important, military involvement with capacity building faces challenges.

Not all militaries have the resources and personnel to scale up capacity-building activities, and resources for such activities are increasingly difficult to access because of fiscal problems in many nations. Increasing military contributions should not come at the expense of building civilian capacity and increasing civilian-led capacity-building endeavors. Further, military efforts need to avoid building capacity that is mainly relevant to the health and security interests of the country providing assistance, meaning that the capacity must reflect not only the IHR (2005)’s demands but also the recipient country’s public health challenges.

Military participation in capacity building with foreign civilian counterparts also has to

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Special Reports be sensitive to concerns in the civilian and non-governmental communities about greater military involvement in public health (Table 1).

Table 1. Summary Table of IHR (2005) Implementation Objectives and Potential Military Strategies Strategy for Military Forces

National Examples

IHR (2005) Implementation Objective: Compliance Comprehensively review military missions and existing law, regulations, instructions, and operating procedures against requirements of the IHR (2005)

• Czech Republic Ministry of Defense legal review on IHR (2005) compliance (International Military Forum on Emerging Infectious Diseases, 2010) • U.S. Department of Defense strategy for compliance with the IHR (2005), which, among other things, amended the U.S. Cooperative Biological Threat Reduction program to promote IHR (2005) compliance (Weber, 2010)

IHR (2005) Implementation Objective: Coherence Ensure military understanding, interpretation, and application of IHR (2005) is identical or equivalent within all military branches and with those civilian agencies

• Thai military efforts to work with and support the Thai Ministry of Public Health on IHR (2005) implementation and compliance (International Military Forum on Emerging Infectious Diseases, 2010) • Disease reporting within branches of military forces and between the military and civilian health agencies in Peru through development of military-based electronic disease surveillance system based on IHR (2005) requirements (Chretien et al., 2007) • Integration of the decision instrument in Annex 2 of the IHR (2005) into U.S. Department of Defense management of public health emergencies (U.S. Department of Defense, 2010)

IHR (2005) Implementation Objective: Coordination Establish effective coordination mechanisms within defense establishments and with civilian partners to facilitate IHR (2005) implementation

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• Expanding an inter-ministerial group on preparing Brazil’s responses to emerging infectious diseases to include the Brazilian military (International Military Forum on Emerging Infectious Diseases, 2010) • Inclusion of the military in South Africa’s Provincial Outbreak and Response Teams to coordinate disease surveillance and responses consistent with the IHR (2005) (International Military Forum on Emerging Infectious Diseases, 2010) • Military reporting of disease information in remote areas on the Thai/Myanmar and Thai/Cambodian borders to the Thai Ministry of Public Health (International Military Forum on Emerging Infectious Diseases, 2010)

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Special Reports Strategy for Military Forces

National Examples

IHR (2005) Implementation Objective: Compliance Include IHR (2005) implementation issues in health aspects of overseas military-to-military activities and in military assistance to foreign civilian agencies

• Czech Republic bilateral (e.g., with Poland) and multilateral (e.g., with NATO) military-to-military cooperation on disease surveillance (International Military Forum on Emerging Infectious Diseases, 2010) • Peruvian military-to-military cooperation with Ecuador and military-to-civilian cooperation with Panama concerning electronic disease surveillance (International Military Forum on Emerging Infectious Diseases, 2010) • Enhancement of civilian-military cooperation on pandemic influenza at U.S. Africa Command meeting for Asian and African countries (Skinner, 2009)

IHR (2005) Implementation Objective: Capacity Support surveillance and response capacity building in foreign countries in both the military and civilian sectors

• Thai military efforts to support malaria control capacities in Myanmar and Cambodia (International Military Forum on Emerging Infectious Diseases, 2010) • Capacity-building assistance on malaria control provided by the Institute of Tropical Medicine of the French Army Health Corps to the Vietnamese Army Health Corps (Chretien et al., 2007)

Global Military Working Group on Implementation of the IHR (2005) Given the complexity of issues that arise for military forces under the IHR (2005), a working group of representatives of different military forces around the world that identifies difficulties militaries have with IHR (2005) compliance, disseminates best practices for implementation, generates opportunities for military-to-military cooperation, and collaborates with WHO could be valuable. The International Committee on Military Medicine, which is in official relations with WHO, could sponsor such a working group.

Formation of this working group could be an outcome of the International Military Forum on Emerging Infectious Diseases on the military’s role under the IHR (2005) held in St. Petersburg in September 2010.

Conclusion Elevating the IHR (2005) within the transformed responsibilities militaries have in global health requires understanding these regulations and the need for military forces to leverage their capabilities for IHR (2005) implementation. Moving in this direction does not mean the militarization of the IHR (2005) but acceptance that EIDs and bioterrorism warrant effective “whole of government” responses. In the global health realm, the main military mission is to support and supplement civilian-led actions. To the extent that militaries have not identified how they can shoulder their burden of implementing the IHR (2005), this mission will not be accomplished.

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Discussion of Responsibilities under the International Health Regulations (2005): St Petersburg 2010 Kevin L. Russell, MD, MTM&H, FIDSA Director, Global Emerging Infection Surveillance and Response System Deputy Director, Armed Forces Health Surveillance Center (AFHSC) 503 Robert Grant Avenue Silver Spring, MD 20910 Tel: (301) 319-3246 Fax: (301-319-9213 Email: Kevin.russell4@us.army.mil Matthew Johns, MPH Armed Forces Health Surveillance Center (AFHSC) Silver Spring, MD 20910 Email: Matthew.c.johns@us.army.mil Robert Lipnick, ScD Armed Forces Health Surveillance Center (AFHSC) Silver Spring, MD 20910 Email: Robert.lipnick@us.army.mil Cecili Sessions, MD, MPH Armed Forces Health Surveillance Center (AFHSC) Silver Spring, MD 20910 Email: Cecili.sessions@us.army.mil

Author Note This paper is prepared as a companion article to Military Forces, Global Health, and the International Health Regulations (2005) by David P. Fidler, also found in this issue of JHSH. The professionals listed in the acknowledgments section provided expert oral presentations at the International Military Forum on Emerging Infectious Diseases: The Militaryâ&#x20AC;&#x2122;s Role under the International Health Regulations (2005), held in September 2010 in St. Petersburg, Russia; each gave permission for public availability of their presentations which were referenced for development of this Forum synopsis. One participant declined to provide this permission, and is not listed. The Forum was sponsored by the U.S. Armed Forces Health Surveillance Center, the Russian Academy of Medical Sciences, and the International Committee of Military Medicine (ICMM), with the active participation and cooperation of the World Health Organization. The opinions, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the US Department of Defense.

Additionally, the Forum presentation interpretations are also those of the authors and may not reflect the original intent of the presenters.

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Special Reports Abstract Global Militaries with global presence and global capabilities: in a world increasingly concerned about the potential ramifications of infectious disease spread, a moral obligation to humanity exists within the health sectors of these organizations. In September 2010, the International Committee of Military Medicine (ICMM), United States Armed Forces Health Surveillance Center Global Emerging Infections Surveillance and Response System (AFHSCGEIS), and the Russian Academy of Medical Sciences co-sponsored the “International Military Forum on Emerging Infectious Diseases: the Military’s Role under International Health Regulations (IHR 2006)” in St. Petersburg, Russia. The objective of the forum was information sharing on the International Health Regulations (2005), and recognition of the responsibilities of global militaries, in cooperation with their civilian sector, to be knowledgeable and vigilant to health events of international concern. Health professionals from 41 militaries throughout the world attended. The meeting discussed the significant cooperation already occurring, identified gaps, and recognized that the IHR (2005) could be used as a powerful framework for empowerment, coordination, timely and transparent sharing of information, and ultimately improved global security Keywords: International Health Regulations; IHR (2005); military; surveillance; emerging infections; public health surveillance; civil-military cooperation; security.

Introduction In our world of increasing global population density, trade, and travel, the opportunities for spread of infectious diseases are truly unlimited. Crops, wild and domestic animals, and humans can all suffer the impact of such spread, resulting in catastrophic economic loss. Such economic instability could contribute to societal breakdown, political unrest and a threat of global insecurity. Either natural or deliberate (“intentional use”) events could result in instability; therefore, surveillance programs are necessary to identify early and produce actionable information that can be used to prevent spread and mitigate the consequences. With global presence and capability, the world’s militaries have not only a moral obligation, but also a direct interest in minimizing the instability that results from the spread of infectious diseases.

The International Health Regulations (IHR) have been the framework for reporting diseases and outbreaks to the World Health Organization for many years. Since the penultimate 1969 revision of the IHR, the field of play for infectious diseases has changed dramatically. There was the recognition that we had not conquered infectious diseases with our armamentarium of pharmaceutical interventions, despite earlier predictions (Fauci, 2005). The impact of emerging infectious diseases as well as intentionally or accidentally released agents was also becoming increasingly apparent. The result was the negotiation of the new International Health Regulations in 2005 which entered into force 15 June 2007 (WHO, 2008).

The companion article by Fidler in this journal more thoroughly describes the changes contained in this 2005 revision, but it was considered “one of the most radical and farreaching changes to international law on public health since the beginning of the international health cooperation in the mid-nineteenth century” (Fidler & Gostin, 2006). Briefly, the focus changed from six specific diseases to all public health threats, and from control at borders to 132

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Special Reports identification and containment at the source. These changes resulted from the recognition that in the “global world” we live in, borders are porous, and to make the regulations pertinent and meaningful, they needed relevance beyond a few infectious diseases. Each country has a “focal point” that is responsible for national implementation of the IHR (2005), including the capacity building necessary for meeting the expectations of identification and reporting. This “focal point” is located in the civilian sector, as would be expected. However, militaries of the world have an interest in detection and identification of infectious threats, not only to keep their own forces healthy, but as a method of detecting intentional release of bio-agents for nefarious reasons (biowarfare). Additionally, global military forces’ public health assets often complement or even exceed that of the local civilian population.

This three-day Forum in Russia was organized with the intent of educating health sectors of militaries throughout the world to the IHR (2005) and was attended by health professionals from 41 countries (Figure 1). It was recognized that militaries are at times best equipped to identify emerging public health threats (Chretien, Blazes et al., 2007), but the responsibility of their civilian counterparts to report any public health emergency of international concern (PHEIC) under the IHR (2005) is not well recognized. Militarycivilian coordination is necessary, and efforts to facilitate and strengthen these relationships are needed. The remainder of this paper will share in broad strokes the information shared during the Forum, concluding with overall impressions and way forward.

Figure 1: Health professionals from 41 countries attended the Forum, to learn about and discuss their engagement with the International Health Regulations (2005).

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Special Reports Emerging Infections and the Public Health/Security Interface Emerging infectious diseases (EID) as defined by the Institutes of Medicine are “New, reemerging or drug-resistant infections whose incidence in humans has increased…. or whose incidence threatens to increase in the near future” (IOM, 1992).

Factors contributing to the emergence of infectious diseases are many, including but not limited to human demographics and behavior, economic development and urbanization, international travel and commerce, microbial adaptation and change, breakdown of public health measures, climate and weather, poverty and social inequity, war and famine, lack of political will, and intent to harm. The wisdom of the expanded IHR (2005) framework becomes abundantly clear when considering the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak, thought by many to be the primary motivating factor behind the updated regulations. As quoted by James Hughes during the Forum, “The SARS experience…. made one lesson clear early in its course: inadequate surveillance and response capacity in a single country can endanger national populations and the public health security of the entire world” (Heymann & Rodier, 2004).

Robust biosurveillance must be present, but the vigilance of medical communities, from the clinician to the laboratorian, veterinarian, research scientist, or public health official, cannot be understated. The astute communicative individual is often crucial.

Involvement and inclusion of many disciplines is the intent of the “One Health” initiative (http://www.onehealthinitiative.com), which seeks to strengthen collaboration in preparation for diseases affecting both animal and human populations. Ideally, surveillance systems must include the agricultural and veterinary communities, to identify risks before human illness occurs (Pike et al., 2010).

Much discussion also centered around the mobility of militaries during times of natural disaster. Local or national public health assets are unlikely to have mobile medical or laboratory capabilities. Many militaries do have these capabilities, in addition to their logistical and transportation support. From the Russian perspective, several examples of military-civilian cooperation were described, from the Armenia 1988 earthquake to the Chernobyl nuclear accident. “A robust public health system—in its science, capacity, practice, and through its collaborations with clinical and veterinary medicine, academia, industry and other public and private partners—is the best defense against any microbial threat” (IOM, 2003). The value of partnerships was emphasized, not just from the “One Health” perspective, but multi-sectoral cooperation among different governmental, industry, and private partnerships and collaborations. Transparency, political will, advance planning, addressing training and education, and making communication a priority are all needed for improving preparedness and response.

The concept of the IHR (2005) encouraging discussions between the “security” and “public health” communities was discussed at length. Militaries, according to the strictest and most conservative way of thinking, are responsible for the security of the nation they represent. From the perspective of aggressive actions of others, and within the context of infectious diseases, this means the intentional release of a biological agent with the intent to do harm or disrupt. But militaries are also responsible for the general public health of their forces. Through the centuries, measures to prevent and treat infectious diseases within militaries have often yielded dividends for civilian public health. A few examples among

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Special Reports many include the influenza vaccine, yellow fever vaccine, and most anti-malarial agents.

Until recent years, “public health” from the civilian perspective has been essentially devoid of concern with “intent to do harm” introduction of infectious agents. Now, more than ever, both communities must work together. An emerging infectious disease is a public health threat, and a public health threat is a security threat. The lines of responsibility to manage, respond and mitigate such occurrences are blurred.

The IHR (2005) recognize the global world we now live in. It is crafted with the knowledge that borders are not barriers to infectious disease transmission. There was wisdom inserted that a list of 6 infectious diseases is not where the responsibility ends, but rather with the ability to identify, communicate, and contain any public health emergency of international concern. Through the legal framework of the IHR (2005), the two worlds of “security” and “public health”, that traditionally had different objectives, perspectives, and accountability, must now find ways to accomplish their work in synergy. They must take the disadvantage of these different perspectives, and turn it into the opportunity to utilize more resources, more vision, and more empowerment for the good of each, and subsequently for the good of all.

Global State of EID Detection With the recognition that robust surveillance systems are needed, and communication and collaboration with the civilian sector are essential under the framework of IHR (2005), several surveillance systems were presented: The World Health Organization Global Outbreak Alert and Response Network (GOARN), US CDC Global Disease Detection program, US DoD Global Emerging Infections Surveillance and Response, European CDC, NATO Deployment Health Surveillance Capability, and the ICMM Regional programs as represented by South Africa, Tunisia, Saudi Arabia, Brazil, Switzerland, and Asia-Pacific.

Current lines of communication with the respective civilian sectors were emphasized, but varied with each country depending on legislation and role of the military in their countries.

The presentations highlighted that robust global, national, and military surveillance systems exist. Many have collaborations and cooperation with each other. However, the need still far exceeds the collective breadth. Several presentations distinguished between “indicator-based surveillance” and “event-based surveillance”. The former represents classic surveillance that involves commitment to ongoing and routine collection of data, and the latter is organized around events or recognized clusters of concern. Both are considered essential components of efficient surveillance systems.

Recurring themes of successes included: Open lines of communication and sharing of information between the military and civilian sectors exist in many countries; the role of the CDC and WHO in providing guidelines and expertise is valued; there is extensive willingness of different organizations, either military-military or military-civilian, to cooperate; mass gatherings (The Hajj, global sporting events) present unique challenges where the defense sector can be a valuable partner; Ministries of Defense need to contribute to the strength of National surveillance systems.

Recurring themes of challenges included: the current speed of communications and media correspondence brings new challenges; despite living in a “global world”, language barriers still persist; although numerous sources of information exist, near-real Journal of Healthcare, Science and the Humanities

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Special Reports time web-based systems do not, and information sharing between the systems is extremely problematic; filtering of unnecessary and redundant information needs to be improved; although diagnostic capability and utilization was mentioned by all regions, there was consensus that much progress could be made in this field; and training initiatives need to be institutionalized and routine rather than sporadic or after events occur.

There are several specific examples of the above mentioned success related to willingness of military to work with the civilian sector that are very powerful. For example, the mission statement of the Ministry of Health of Brazil embraces the need for interagency cooperation. It reads: “To promote population health by integrating and building partnerships with federal agencies, units of the Federation, municipalities, the private sector and society, contributing to improve the quality of life and the exercise of citizenship”. The Unites States military reporting of pandemic H1N1 in members throughout the world through the national civilian focal point presented unique challenges, and solutions were found collectively (Johns M.C., 2011). The Swiss Armed Forces medical service has already established an IHR (2005) focal point through whom all potential issues of declaration by the Armed Services are routed. This individual then has a sole line of communication directly to the National IHR Focal Point. An “Asia Pacific Strategy for Emerging Diseases” was described which outlines a “5-year strategy to provide a common framework to strengthen capacity to manage and respond to disease outbreaks”. As highlighted, the common framework is the strength in this paradigm. Not just a Defense framework; not just a Singaporean framework; rather, a common framework for the region: a whole of government, a whole of region approach. Although these networks can be critical, they cannot be at the expense of local capacity building.

Response to the Challenge of Global EID New paradigms must also be considered. As components of preparedness, much has been learned about traditional laboratory-based and public information-based surveillance systems for early awareness of outbreaks of infectious disease. But our information-rich and technologically-advanced world is providing new, unique, and exciting methods for exploration of risks. Recognition of technology-appropriate tools is critical. Although the computer age is upon us, in resource limited settings computer and internet accessibility may be sparse. Conversely, mobile phones are abundant in the most remote settings. Surveillance systems that incorporate mobile phones as a modality for collection of information are being explored, and have proven successful in many settings (Chretien et al., 2008).

Another unique and promising methodology discussed involves utilization of remote sensing capabilities. Optimal conditions for transmission exist for any given infectious disease. Global climate variability is known to affect these conditions. Remote sensing capabilities are sufficiently advanced to be able to give abundant information on ocean temperatures, vegetation indices, cloud cover and rainfall, to name a few. Correlating these images with information on the ground—”ground truthing”—is critical, and must strongly leverage the many other surveillance systems. The ability of synergy between this remote sensing and ground truthing to predict outbreaks before they occur has been demonstrated. Successes with predicting Rift Valley Fever in the Horn of Africa with this methodology are most apparent (Anyamba et al., 2009; Linthicum, Bailey, Davies, & Tucker, 1987). Promise also exists with a variety of other infectious diseases, such as dengue, malaria, 136

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Special Reports chikungunya, or other arthoropod-borne agents (Anyamba, Chretien, Small, Tucker, & Linthicum, 2006; Chretien, Anyamba et al., 2007).

Several excellent presentations highlighted response priorities and challenges. As touched on earlier, the flow of information today is immediate and accessible to all, but the credibility of the source is often difficult to ascertain. “Mechanisms for effective risk communications during a public health emergency” are a core capacity component of the IHR (2005) (WHO, 2008). The dominance of negative news, as “bad news travels fast”; lack of trust in authority figures; difficulty of clearly considering information provided when under stress; and contributions of sociocultural and health beliefs make effective communication difficult. Particularly during an EID event, crisis communication is critical.

Ways to improve effective communication include establishing the competence of the organization and speaker by using a familiar and consistent spokesperson, honesty, clarity, simplicity, consistency, the admission of uncertainty, and description of current plans. The intent is to restore or maintain confidence to promote useful action. For this to be optimally effective, a certain degree of interaction and communication to the populace is required before the crisis occurs. During the actual crisis, expedient and frequent communication should occur to minimize the voice of less credible sources. Figure 2, adapted from the presentation by Fischer, addresses many of these issues.

From the WHO perspective, an “All-hazards System” was elaborated upon as the most effective approach to event management. This system recognizes that there are common elements to all emergencies; by recognizing these commonalities and standardizing around them, greater coordinated impact can be leveraged during any given event. Historically,

Figure 2: A Communications Model: From the ongoing baseline surveillance, to the detection of a public health event of concern, through resolution of the event: optimal communications should be a priority.

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Special Reports lack of leadership, coordination, integration, resources, prior planning, and media support were all listed as challenges that led to less effective management. Emphasis was put on the fact that organizations and countries must consider and develop plans in advance. An All-Hazards System that is scalable, provides recognition and support for engagement of joint organizations and regions, and has clear lines of accountability and responsibility that are supported by normal roles and training—all optimize the chance of success.

When implemented, this success can be measured by the ability to clearly communicate focused objectives with sustained collaborations at high levels. The system must also have accountability with a feed-back mechanism. This requires the wisdom and open-mindedness that improvement is always possible.

The vested interest of both the civilian sector and military communities in identification of health events, whether natural or intentional, and subsequent reporting as required under the IHR (2005) has been discussed. However, the challenges of multi-agency coordination are known to be extensive. A continuum exists between simple co-existence and true productive cooperation. In these relationships, the concept of “do no harm” must be remembered and exercised. The involvement of the military must be carefully considered without endangering the humanitarian sector. Military personnel must be true to their priorities, and never represent themselves as humanitarian workers. Although military personnel can also be assisting with truly altruistic motives, many complex emergencies can be culture dependent, with the critical component of trust lacking. Without the trust of the populations being served, more harm might be caused than good, despite the best intentions. Do no harm.

Conclusions This Forum provided the opportunity for constructive discussions on the role of militaries in the realm of biosurveillance and public health security. A critical component of this role under the IHR (2005) is the responsibility for cooperation and communication directly with respective civilian counterparts. The International Committee of Military Medicine (ICMM) is an impartial, neutral organization that could be leveraged to increase the capacity of global militaries through both a physical and virtual network of tools and subject matter experts.

Key points made include the need for well-considered and socialized all hazard event management plans that can be implemented when needed. Surveillance systems must be in place and highly functional to minimize effects of bio-events; it is too late to implement after an event is recognized. Weakness in one country can endanger the whole world. A “culture” of technologically-appropriate surveillance and preparedness is required, rather than a reactionary posture. Regional plans are highly encouraged, but not at the expense of local capacity building. Those countries with resources must facilitate those with few resources, but trust must be cultivated first. There must be training, communication, testing and evaluation, application of lessons learned, and training again. Human capacity is a key.

In all of the above, “political will” is absolutely essential. Fostering this political will, both within our military communities and civilian counterparts, is our primary challenge.

There was overwhelming recognition and appreciation for the fact that the IHR (2005) can be strongly leveraged to motivate this political will. This legal framework must be empowered for the health and stability of our world.

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Special Reports Fidler concludes his paper on “Military Forces, Global Health, and the International Health Regulations (2005)” in this edition with “In the global health realm, the main military mission is to support and supplement civilian-led actions. To the extent that militaries have not identified how they can shoulder their burden of implementing the IHR (2005), this mission will not be accomplished.” The conduct of this Forum, with the participation of representatives from 41 countries, and the willingness to discuss openly and without hidden agendas, demonstrates that this mission can be accomplished. The security and public health sectors have a common goal with their objectives and needs strongly overlapping. Transparency of military endeavors is a powerful start. We must find ways to grow and mature as a global community, learning from the very pathogens we monitor: borders are not barriers.

Acknowledgments Expert oral presentations, and permission for public sharing, were provided by: James M. Hughes, Emory University, USA; Ivan Kholikov, Russia; Maurizio Barbeschi, World Health Organization, Switzerland; Scott F. Dowell, Center for Disease Control and Prevention, USA; Kevin L. Russell, Armed Forces Health Surveillance Center, USA; Anna Sominia, Research Institute of Influenza, Russia; Massimo Ciotti, European Center for Disease Control and Prevention, Sweden; Oleg Kiselev, Research Institute of Influenza, Russia; Maria D Van Kerkhove, Imperial College London, England; Cloete van Vuuren, Military Health Services, South Africa; Ridha Bellaaj, Military Teaching Hospital, Tunisia; Ali Al-Barrak; Riyadh Armed Forces Hospital, Saudi Arabia; Jose Luiz de Medeiros Amarante Jr, Ministry of Defense, Brazil; Sergei Bankoul, Swiss Armed Forces, Switzerland; Vernon Lee, Singapore Armed Forces Biodefence Centre, Singapore; Julie E. Fischer, Stimson Center, USA; Jean-Louis Koeck, French Armed Forces, France; Hans-Ulrich Holtherm, Deployment Health Surveillance Centre, Germany; Kenneth J. Linthicum, Department of Agriculture, USA; Hilary Martins Aba Agada, Armed Forces, Nigeria; Chen Reis, World Health Organization, Switzerland; Joan M. Neyra, United States Naval Medical Center Detachment, Peru. Thanks to the professionals of the International Committee of Military Medicine and the Russian Institute of Influenza for their assistance with the organization of this Forum, as well as the expert staff of the Armed Forces Health Surveillance Center and Henry M. Jackson Foundation for their dedication and professionalism in the coordination of this event. It could not have been done without their tireless work. Lastly, our sincere thanks to Dr. Matthew Lim who was visionary in first expressing the need for such a Forum, and then working diligently on the Scientific Advisory Board to see it to reality.

References Anyamba, A., Chretien, J. P., Small, J., Tucker, C. J., Formenty, P. B., Richardson, J. H., et al. (2009). Prediction of a Rift Valley fever outbreak. Proc Natl Acad Sci U S A, 106(3), 955–959.

Anyamba, A., Chretien, J. P., Small, J., Tucker, C. J., & Linthicum, K. J. (2006). Developing global climate anomalies suggest potential disease risks for 2006-2007. Int J Health Geogr, 5, 60.

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(2007). Drought-associated chikungunya emergence along coastal East Africa.

Am J Trop Med Hyg, 76(3), 405–407.

Chretien, J. P., Blazes, D. L., Coldren, R. L., Lewis, M. D., Gaywee, J., Kana, K., et al.

(2007). The importance of militaries from developing countries in global infectious disease surveillance. World Hosp Health Serv, 43(4), 32–37.

Chretien, J. P., Burkom, H. S., Sedyaningsih, E. R., Larasati, R. P., Lescano, A. G., Mundaca, C. C., et al. (2008). Syndromic surveillance: adapting innovations to developing settings. PLoS Med, 5(3), e72.

Fauci, A. S. (2005). Emerging and reemerging infectious diseases: the perpetual challenge.

Acad Med, 80(12), 1079–1085.

Fidler, D. P., & Gostin, L. O. (2006). The new International Health Regulations: An historic development for international law and public health. J Law Med Ethics, 34(1), 85-94, 84.

Heymann, D. L., & Rodier, G. (2004). Global surveillance, national surveillance, and SARS. Emerg Infect Dis, 10(2), 173–175.

Institute of Medicine (IOM). (1992). Emerging infections: Microbial threats to health in the United States. Washington, DC: National Academy Press.

Institute of Medicine (IOM). (2003). Microbial threats to health: Emergence, detection and response. Washington, DC: National Academies Press.

Johns M.C., B. D. L., Fernandez J., Russell K., Chen D.W., & Loftis R. (2011). The US military and the international health regulations. (2005): Perceptions, pitfalls, and progress toward implementation. Bulletin of the World Health Organization.

Linthicum, K. J., Bailey, C. L., Davies, F. G., & Tucker, C. J. (1987). Detection of Rift Valley fever viral activity in Kenya by satellite remote sensing imagery.

Science, 235(4796), 1656–1659.

Pike, B. L., Saylors, K. E., Fair, J. N., Lebreton, M., Tamoufe, U., Djoko, C. F., et al. (2010).

The origin and prevention of pandemics. Clin Infect Dis, 50(12), 1636–1640.

World Health Organization (WHO). (2008). International Health Regulations (2005) (2ND ed.). Geneva: World Health Organization Press.

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YOUNG SCHOLARS’ CORNER

Young Scholarsâ&#x20AC;&#x2122; Corner Reflections on the Current Status of Bioethics Education Alexandra Mogyoros, BAS University of Ottawa 57 Louis Pasteur Street Ottawa, ON Email: alexandra.mogyoros@uottawa.ca Maxwell Smith, BA, MSc University of Toronto 155 College Street Toronto, ON Email: max.smith@utoronto.ca Diego S. Silva, MA University of Toronto 155 College Street Toronto, ON Email: diego.silva@utoronto.ca Serena Purdy, BA Graduate Union College 80 Nott Terrace Schenectady, NY Email: serena.purdy@gmail.com

Author Note This paper is a critical analysis of the current models of bioethics education based on the experiences and reflections of the authors. The authors would like to thank Dr. Paula Chidwick for her encouragement and thoughtful insight, and Dr. Bruce Boynton for his endless patience and support.

Abstract As bioethics is a field in transition, it is of the utmost importance that we discuss the implications that this flux is having on students and the future generation of bioethicists.

While conversations about the regulation of the profession have been in the forefront, dialogue about the impact that the educational system has on aspiring bioethicists has been overlooked. The implications of bioethics education are not only essential to the next generation of bioethicists, but will play an integral role in shaping the profession itself. After completing bachelorâ&#x20AC;&#x2122;s degrees, many students interested in bioethics question whether to seek interdisciplinary degrees in bioethics departments or study in traditional streams, such as philosophy, law, or health policy, with a bioethics focus. Two models of graduate bioethics education have emerged: the departmental model, and the bioethics-centered model. This Journal of Healthcare, Science and the Humanities

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Young Scholars’ Corner paper explores the merits and challenges of each model in light of a student’s individual ambitions and the bioethics landscape as a whole.

Keywords: Bioethics, Education, Graduate Studies, Interdisciplinary Education

Introduction The educational path that a student pursues in hopes of attaining his or her career goals is informed by personal interests and values, and supported by a variety of organized courses, degrees, and credentialing programs. However, some careers are easier to plan for than others. For example, while aspiring physicians must make choices regarding their educational path, ultimately they do so within clear educational guidelines for medical students. For students who wish to pursue a career in bioethics, this is not the case (Faden, 2004; Zoubul, 2002).

How to define the field of bioethics is heavily debated, and to delineate the boundaries of this area of practice and study lies beyond the scope of this paper (Jecker, 2007).

However, for the purposes of this paper, bioethics denotes the ethical questions and challenges that arise at the intersection of research and practice in health and healthcare, including (but not restricted to) clinical medicine, community medicine, public health, and governance.

Questions of how one can best navigate the waters of formal academia towards the goal of working in the field of bioethics are often met with a myriad of responses. One can almost be assured that a different answer will be given depending on who is asked. The reply that aspiring bioethicists are bound to hear repeated is, “There is no one way to become a bioethicist.”

While there is no one way to become a bioethicist, there is also is no one way to be a bioethicist. Bioethicists, now more than ever, fulfill a wide range of functions. They serve as clinical consultants within healthcare institutions, sit on research ethics boards, write and research on a wide range of topics, consult on policy issues for government agencies and corporations, and teach as university professors. While further exploring what it means to be a bioethics practitioner or scholar is outside the scope of this paper, it is essential to note that the path one embarks on in light of one’s future goals, depends very much on how a given individual, and the field as a whole, conceptualises this idea in the years to come (Faden, 2004; McGee, Magnus, & Carroll, 2002; Magnus, 2001).

The field of bioethics is in transition (Faden, 2004), caught between an interdisciplinary study conducted by academics and practitioners from a wide variety of disciplines and professions, and a stand-alone discipline (Butkus & McCarthy, 2002). Given this transition, the education of the next generation of bioethicists and bioethics academics seems under-discussed and underdeveloped. For this reason, as graduate students with a vested interest in the field and education in bioethics, we have reflected on our experiences to provide a frontline perspective on this topic.

Although defining education can be difficult and contentious, it seems that, at the very least, education is multifaceted and multi-purposeful. Education is a means of engaging in relationships and partaking in social interactions of exchanging knowledge,

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Young Scholars’ Corner whether face-to-face or through distance/on-line opportunities. Formal and institutionalized education (e.g., graduate education) functions as a means of transmitting knowledge of discriminate pieces of information, including perhaps most importantly, skill sets that can be applied in future situations without the necessary assistance of a teacher. Skills are meant to empower the skill-holder both personally and pragmatically, by enriching one’s personal life, by allowing him or her to contribute to the field of bioethics, and by providing tools for employment. Learning, though part of formal education, is most likely an amorphous, lifelong endeavour that transcends mere mastery of facts or skill-sets; however, the authors set this issue aside since this paper is about formal bioethics education rather than learning writ large.

The options for those interested in pursuing bioethics education may be best categorized in two ways. One option is the home department model, where students study in one of the traditional feeder disciplines (e.g. philosophy, law, or medicine), and then focus their individual research projects on bioethics topics (Tiplic, 2008). Alternatively, the bioethics-centered model treats bioethics solely as a field of study and practice focused on bioethical inquiry rather than on the lines of inquiry drawn predominantly from other disciplines (Callahan, 1973).

This paper will explore the advantages and disadvantages of pursuing a career in bioethics via both educational paths, in light of one’s individual goals and ambitions as well as the current bioethics landscape. The authors hope that this discussion will provide insight into the merits of each educational model for our peers and the bioethics community at large.

Ultimately though, given the lack of clear guidance as to the goals and benefits of either model with respect to future careers in bioethics (Faden, 2004), the authors conclude that it is best that students be as informed as possible about which model will best suit their ambitions.

Bioethics as a Multi-Disciplinary Pursuit: The Home Department Model The home department model is the traditional approach for bioethics education (Faden, 2004; Callahan, 1973). Students pursue graduate studies in a particular discipline (e.g., philosophy, public health, law) and focus their research within the field of bioethics.

This approach often requires a student to be accepted into a home discipline before applying to a collaborative program in bioethics. A student’s research on bioethics topics is primarily informed by the perspective of the home discipline; collaboration with members of other disciplines occurs often.

One of the most fundamental characteristics of learning bioethics in this model is that one learns the specific skill set of an established discipline. For example, a law student or a public health doctoral student will be trained to examine issues using the viewpoints of their respective disciplines. For instance, the issue of informed consent through a legal lens may primarily be framed within relevant legislation and case law. The same holds for other traditional disciplines such as medicine, theology, and philosophy. It should be noted that legal, medical, or philosophical viewpoints may not be the exclusive domain of those in faculties or departments of law, medicine, or philosophy; however, the preparation necessary to master and participate in robust discussions regarding these topics is often left to those with graduate education in these disciplines.

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Young Scholars’ Corner A potential drawback of this model is that by studying bioethics from the perspective of a single discipline, one runs the risk of becoming myopic and having difficulty appreciating other perspectives and viewpoints when discussing bioethics issues with fellow academics and practitioners (Voss, 2002; Chaitin, 2002). For example, a philosopher’s bioethical considerations may overlook legal factors or fail to appreciate the legal nuances relevant to a given situation, while an individual with a scientific background may not fully appreciate the thought experiment approach often employed by moral philosophers.

Ultimately, it is the acquisition of a skill set and the viewpoint of a conventional discipline that attracts students to pursue a bioethics education under this approach.

Students who aspire to work in academia may decide that it is more valuable for them to pursue graduate education in a specific discipline, and apply their skills and perspectives to bioethical issues. This justification is two-fold. First, while there are several bioethics research centers, an informal review by the authors suggests that there are only a limited number of bioethics departments in North America. Thus, there would be fewer opportunities in formal academia for a graduate degree only in bioethics. Second, as new issues and topics emerge in bioethics (as they always do), students will have a foundational skill set and disciplinary perspective from which to interpret and examine these complex issues. While these students’ knowledge of bioethics will be specific to the modes of inquiry utilized in their respective disciplines, they will have the tools and experience needed to contribute to the discussions of new bioethics issues as they materialize.

Bioethics as a Focused Pursuit: The Bioethics-Centered Model Historically, in the absence of focused bioethics education, those trained in the disciplines noted in the previous section have served as bioethicists. However, as the prevalence of bioethics within the hospital, policy, and education sectors has increased, there has been a surge in the development of educational programs focused strictly in bioethics (Faden, 2004; Voss, 2002; McGee, Magnus, & Carroll, 2002). Accordingly, the bioethicscentered model intends to equip students with the necessary tools and skill sets to be, first and foremost, effective bioethics practitioners (Butkus & McCarthy, 2002). For our purposes, a bioethics practitioner is someone who engages in applying bioethics knowledge in concrete clinical, organizational, or research settings, e.g., a hospital ethics committee or an institutional review board or research ethics board (Voss, 2002; Zilberberg, 2002).

The bioethics-centered educational model has many benefits for aspiring students. The very existence of such programs validates bioethics as a complex field that requires instruction and specific focus. Further, it provides concentrated schooling to those particularly interested in the issues specific to bioethics, without requiring the educational dependence on another complimentary discipline that may be of secondary interest. For those who have pursued a career in a field other than bioethics and who have come to appreciate the ethical nature of their work, bioethics-centered degrees may also offer the relevant education to address these on-the-job needs (Chaitin, 2002). Finally, unique skills in bioethics, such as those gained through clinical, policy, or research ethics practice, may be more readily offered in a degree program focused in bioethics (Voss, 2002).

This approach however, is still nascent (Faden, 2004; Callahan, 1973), and there is no guarantee that a master’s degree in bioethics will provide the requisite education for 146

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Young Scholars’ Corner any position - academic, clinical, or otherwise. Further, completing a bioethics-centered degree may not provide students with the necessary prerequisites for further education in other disciplines. While there are some interdisciplinary doctoral programs in Canada (at University of British Columbia and Concordia University, for instance), even these programs often require that a student establish a home department. Thus, pursuing a bioethicscentered degree may be best suited to those who have established careers in a complimentary discipline (McGuire, 2002; Chaitin, 2002; Callahan, 1973; Zilderberg, 2002; Zoubul, 2002).

Some graduate programs do support junior academics pursuing advanced bioethics education without specialization in another discipline (e.g. the Bioethics Program at Union Graduate College, in Schenectady, New York). Nevertheless, what steps should be taken to further one’s education to a doctoral level in bioethics remain unclear. There is uncertainty as to which prerequisites beyond a master’s in bioethics will be sufficient to practice and teach bioethics (Faden, 2004). One has to question if pursuing such a degree at this point would even be beneficial. Indeed, having three degrees in one discipline may make one an expert in some fields, but in bioethics this may indicate that an individual lacks the necessary perspective that is gained from an established discipline.

Conclusion It seems that at this time, a bioethics-centered graduate degree would be more beneficial for someone interested in a career practicing bioethics (i.e. as a clinical ethicist, research ethicist, or institutional review board coordinator), as these programs provide a more applied education (Voss, 2002). However, it is not clear that such a degree on its own would serve as a sufficient prerequisite for these careers (McGuire, 2002). As bioethics is currently not its own discipline (Jecker, 2007), it seems that to become an academic in bioethics one requires a degree from an established discipline via the home department model. We suggest that aspiring bioethicists be explicitly aware of this distinction.

While efforts have been made to evaluate bioethics graduate education (American Society for Bioethics and Humanities, 2001), the crux of the problem with the current status of bioethics education is the lack of consistent guidance regarding the various goals and purposes of the different bioethics education models (Faden, 2004; McGuire, 2002).

Understanding the different educational paths will provide essential knowledge for students to make an informed decision about their future. Otherwise, students may find that they have elected an undergraduate degree specialized in bioethics, with the belief that it will be beneficial in obtaining a career in bioethics, only to find that their qualifications do not coincide with the admissions requirements of the graduate degree of their choice.

The difficulty for students choosing an educational path in bioethics may be ameliorated by consistency in the goals of bioethics education, and a clearer articulation of the formal academic and experiential requirements for employment in bioethics. It is the responsibility of the bioethics community to discuss the purposes of these different educational pathways and to communicate what it means to pursue a graduate degree in bioethics via either of the two models discussed here. In addition, McGuire (2002) suggests that those involved in developing bioethics programs could improve guidance to students by “bolstering mentor/mentee relationships, emphasizing opportunities for publication, and integrating theoretical study with clinical experience and research” (p.1). Finally, those who Journal of Healthcare, Science and the Humanities

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Young Scholars’ Corner hire bioethicists as scholars or practitioners need to be a part of this discussion to ensure that the transition from study to career is advantageous to all involved (McGee, Magnus, & Carroll, 2002).

In light of the ongoing debate regarding the professionalization of the field (Faden, 2004; Magnus, 2001), and more conceptually, what it means to be a bioethicist (Callahan, 1973), what is involved in bioethics education is more important than ever. While this does not imply that homogeneity is required in bioethics education, it does mean that to assist the next generation of bioethicists, and the field as a whole, we must ensure that the goals of our bioethics education are clearly defined and communicated. Accordingly, the authors believe it is time for the bioethics community to engage in a discussion about the education of the next generation of bioethics practitioners and scholars.

References Butkus, M. A., & McCarthy, C. S. (2002). Principle and praxis: Harmonizing theoretical and clinical ethics. The American Journal of Bioethics, 2(4). Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html Callahan, D. (1973). Bioethics as a Discipline. The Hastings Centre Studies, 1(1), 66–73.

Chaitin, E. (2002). Earl Weaver was right: It’s what you learn after you think you know it all that counts. The American Journal of Bioethics, 2(4). Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html Faden, R. R. (2004). Bioethics: A field in transition. Journal of Law, Medicine & Ethics, 32, 276.

Jecker, N., Jonsen, A., & Pearlman, R. (2007). Bioethics: An introduction to the history, methods, and practice. Sudbury, MA: Jones & Bartlett.

Magnus, D. (2001). Bioethics programs evolve as they grow. Nature Biotechnology, 19, 991–992.

McGee, G., Magnus, D., & Carroll, K. (2002). Evaluating graduate programs in bioethics: What measures should we use? The American Journal of Bioethics, 2(4), 1–2.

Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html McGuire, A. (2002). Clearing the mist. The American Journal of Bioethics, 2(4). Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html North American Graduate bioethics and medical humanities training program survey. (2001).

American Society for Bioethics and Humanities Studies of the Field Committee.

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Young Scholars’ Corner Tiplic, D. (2008). Managing organizational change during institutional upheaval: BosniaHerzegovina’s higher education in transition. BI Norwegian School of Management, Department of Leadership and Organizational Management. Nordberg: BI Norwegian School of Management.

Voss, K. E. (2002). One field, many disciplines, one goal. The American Journal of Bioethics, 2(4). Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html Zilberberg, J. M. (2002). Self-directed bioethics education. The American Journal of Bioethics, 2(4). Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html Zoubul, C. S. (2002). Why study bioethics? Because it’s interesting. The American Journal of Bioethics, 2(4). Retrieved from http://muse.jhu.edu/journals/american_journal_of_bioethics/toc/ajb2.4.html

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REVIEWS

Reviews Book Review: Reforming Medicare: Options, Tradeoffs, and Opportunities (2008) The Century Foundation Henry J. Aaron and Jeanne M. Landrew, 202 pp.

Carol A. Parsons, PhD Project Director, Clinical Knowledge Development Study Graduate School of Nursing Uniformed Services University of the Health Sciences Bethesda, MD Email: carol.parsons.ctr@usuhs.mil Changes in demography and cost have spurred a serious discussion about the future structure of Medicare. The imminent retirement of the baby boom population will strain the program by driving up the demand for health care services while the cost of those services is likewise rising. These facts form the basis of Aaron and Landrew’s book, Reforming Medicare: Options, Tradeoffs, and Opportunities. This carefully researched and detailed account of the history of the program and the options available for reforming it is an important resource for those who want to understand the program and the ongoing debate about its future. This review discusses the options presented in the book and presents a brief overview of the effect of the new health care law on the future of Medicare.

Medicare was signed into law by President Lyndon Johnson on July 31, 1965.

Now in its fifth decade, the program covers virtually all the nation’s elderly and a large group of individuals with disabilities -- almost 44 million. It has also become one of the country’s most popular social programs. It is the single largest payer in the U.S. health care system, with a history of program innovation, particularly in the case of prospective payment approaches, many of which have been adopted by private payers.

The last major piece of Medicare legislation, prior to the 2010 Patient Protection and Affordable Care Act (PPACA), was the Medicare Modernization Act of 2003 (MMA), which moved the program decisively in the direction of reliance on private health insurance to organize and deliver Medicare services. For example, the prescription provision in Medicare Part D requires beneficiaries to choose among a broad array of private insurers to provide the benefit, rather than rely on traditional Medicare itself. MMA prohibits Medicare from using its power to bargain with pharmaceutical companies for volume discounts, a system already in place in the Veterans Administration and the Department of Defense health care systems. MMA also made “extra” payments to private Medicare Advantage (MA) Part C plans, giving incentives to beneficiaries to opt out of traditional Medicare. The law increased enrollment of Medicare beneficiaries in private MA plans 13 to 25 percent, with these enrollment trends continuing. By expanding plan choices for beneficiaries and partly privatizing Medicare, however, the program spends 12 percent more, on average, for a beneficiary selecting care in a private plan than one staying in the traditional program.

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Reviews Aaron and Landrew lay out three options for reform: social insurance, premium support for individuals, and a consumer-driven system. The three options differ fundamentally.

Under social insurance, cost, access, and quality of care are determined collectively. Under premium support, private plans determine cost, access, and quality based on consumer preferences. Under the consumer-directed option, enrollees themselves select the combination of cost, access and quality coverage they can afford. The authors devote one chapter to each option.

Under a social insurance model, a single payer program retains Medicare’s core principle that all beneficiaries are entitled to the same defined benefits. Medicare’s multiple parts (physician payments - Part A, hospital payments - Part B, Medicare Advantage - Part C, and prescription coverage - Part D) would be consolidated into a single system with one premium. Medicare would be given wide authority to modify the system to keep the program up to date. Improvements in quality could result from using Medicare’s leverage to improve performance. Overall, the assumption is that a single payer could do a better job than private insurers to ensure access, raise quality, and contain costs.

Second, the program could be altered by providing individuals with premium support. This option would replace traditional Medicare with a subsidy that recipients could use to buy private insurance in a regulated market. Benefit standards would be used to limit risk selection. Beneficiaries could spend their own money to buy more coverage than the basic subsidy would afford. Insurers would compete for enrollees by providing high-quality services, packaging appealing mixes of benefit, and controlling the growth of premiums. The goal of this competition would be to offer cost-effective care at an affordable price.

Lastly, Medicare could become a consumer-directed and market-driven program that would be supported by improved information and motivated by economic incentives.

Beneficiaries would shop for medical services at a price and quality they desire. Medicare’s financial responsibility for paying for health care would be limited to subsidizing highdeductible plans and making deposits into beneficiaries’ tax-favored personal savings accounts that would be available to pay for health care. Unspent balances would roll over from year to year. No backup funding from Medicare would be available for those who exhaust their accounts. High-deductible plans would compete for beneficiaries as they do under premium support, although with little oversight from Medicare. The task of monitoring quality would fall to beneficiaries.

Beneficiaries’ choice of providers would remain a key feature of social insurance, although administrators might exercise their authority to either discourage or exclude lowquality providers. Under premium support, the choice of providers would depend on the breadth of the provider network and particular plan the enrollee joins. Consumer-driven Medicare would provide beneficiaries with information on quality of providers and cost of care, but beneficiaries could receive care from any provider who would see them and whose services they could afford.

Under both premium-support and consumer-driven Medicare, quality improvements would depend largely on whether insurers see quality promotion as a good marketing device; a reformed social insurance program would have quality promotion built in. The government could support research to identify cost-effective treatments under all three reform options.

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Reviews The authors’ overall evaluation is based on health services research, predictions about how the plans would behave, and their own values. They acknowledge that no single option is best to meet all three goals of ensuring access, promoting quality and controlling costs. In the authors’ estimation, the social insurance model would do the best job of preserving and improving access and satisfaction. It has done well historically, and a reformed version might do somewhat better. It may improve performance in controlling costs, but to a lesser degree than alternatives. If Medicare’s administrators were empowered to use its market leverage aggressively, the program could spearhead a revolution in quality. It could, for example, use its market power to negotiate prices for prescription drugs.

Premium support would likely do the best job of controlling the growth of total health care spending for the Medicare population. Aggressive management of care by insurers could advance quality. But such cost-control tools as limited networks of providers and use of management would lower satisfaction, physical access to care, and the possibility of financial access to care if risk selection persists.

Consumer-directed Medicare is most likely to control federal spending but otherwise offers the least promise of advancing Medicare’s other goals. It would reduce access to care, especially among those with high need. Despite its name, it is likely to lower enrollee satisfaction. And it is not clear that patients are well positioned to demand high-quality care.

The authors conclude with a list of needed changes to Medicare no matter what option is chosen. First, the evidence-base must be strengthened to better define optimal care.

Paying for research to build this knowledge-base must be a public responsibility because knowledge, once developed, would be freely available to all. Second, with spending projected to outpace revenue in the near future, cost control is key.

It would be possible to hold down federal outlays simply by shifting costs to enrollees, but balancing the public budget in this way would undermine Medicare’s fundamental purpose. Therefore, cost control must apply not just to what taxpayers spend but also to the total cost of health care used by the Medicare population. This distinction leads to two important facts. One, no amount of cost control under any reform option will obviate the need for higher taxes if Medicare is to continue making high-quality health care available to the elderly and people with disabilities. Two, the three reforms will not be equally effective in controlling health care spending. Higher outlays may mean greater access and potential for superior quality, but they require larger tax increases than the other options.

Lower spending may be achieved by premium support and consumer-driven Medicare, but such cost control may result in diminished access and less improvement in quality than under the social insurance model. American voters cannot escape these tradeoffs and must consider them if they are to fully understand how the Medicare reform strategies differ.

Medicare reform faces daunting political challenges. The financial stakes are huge.

In 2007, Medicare spending exceeded $400 billion, more than nearly all other nations spent in total health care, and far more than every other public program in the U.S. except Social Security and national defense. The Medicare program supports whole industries; the income security of seniors and people with disabilities depends on it. Medicare is so central a cog in the entire health care system that seemingly small changes could produce widespread reverberations. For these reasons, Medicare reform has historically occurred gradually.

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Reviews Although passed into law after this book was written, it is worthwhile to briefly examine a few of the Medicare reforms included in the PPACA. Half the $938 billion price tag will be paid by decreased Medicare spending. There will be increases in premiums for high-income people, cutbacks in the advantages some seniors gain from MA plans, and reductions in cost-sharing in the prescription drug benefit and for preventive services.

Roughly half of the costs of the PPACA over the next decade will be offset by reductions in Medicare payments to MA plans, hospitals, and skilled nursing facilities, though having them in place for several years could lead to differences between private and Medicare plans.

These changes will extend the solvency of Part A to 2029.

PPACA will begin a Center for Medicare and Medicaid Innovation within the Centers for Medicare and Medicaid Services (CMS). The purpose of this center is to develop, test and implement new payment approaches in the organization of healthcare delivery. But most of the cost savings will come from reducing substantial overpayments to private MA plans. This will produce an estimated $132 billion in savings over 10 years.

What Aaron and Landrewâ&#x20AC;&#x2122;s excellent book makes clear is the enormous complexity of reforming Medicare while maintaining its original goals of access, quality and affordability.

While not including the latest reforms to Medicare in the PPACA, it remains one of the best and most clearheaded policy analyses of Medicare reform options available.

Author Note The views and opinions expressed in this article are solely those of the author and do not reflect the official position or policy of the Department of the Navy, the Uniformed Services University of the Health Sciences, the Department of Defense, or the U.S. Government.

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Reviews Review and Commentary: Claims of Innocence (2010) Michael Naughton, with Gabe Tan University of Bristol UK, 80 pp.

Vaughan Caines, MSc Forensic Scientist Master of Arts in Law Program, School of Law University of Bristol, UK Email: vcaines@mac.com

Author Note The views expressed here are those of the author and do not reflect the official policy of the University of Bristol, the Innocence Project, or other institutions with whom the author may be associated.

Introduction On Tuesday, January 4, 2011, Texas citizen Cornelius Dupree was declared innocent after having spent thirty years in prison for alleged crimes dating back to 1979.

According to various news reports, only two other individuals in similar situations had had longer prison terms before exoneration. Originally, Mr. Dupree had been sentenced to seventy-five years in prison beginning in 1980. His exoneration was achieved after DNA testing proved his innocence. Represented by the Innocence Project in the United States, Mr. Dupreeâ&#x20AC;&#x2122;s exoneration is one of any number that now are occurring world-wide due to important advancements of science and technology and their applicability in criminal proceedings and the pursuit of human and social justice.

Like Cornelius Dupree, Paul Blackburn spent twenty five years of his life behind bars after being falsely accused of attempted murder and sexual assault. He was only fourteen years old when he was convicted. Though on different continents and separated by an ocean, there is the common thread of miscarriage of justice which binds them and which is present in the collective systems of justice. These cases detail the crucial need for publication of the subject matter contained in this monograph, Claims of Innocence. The cause of obtaining justice for those that are wrongfully accused of any crime is universal, regardless of race, nationality, or any other human category. An injustice to one is an injustice to us all.

It is the aim of this review of and commentary upon Claims of Innocence to give readers a cursory yet definite introduction to the interdisciplinary and valued partnership of science and law in approaching possible miscarriages of justice in any judicial system.

This review summarizes this recent manual that was written by authors associated with the United Kingdomâ&#x20AC;&#x2122;s branch of the Innocence Project. The monograph was written to provide basic knowledge and resulting advisement on legal applicability including the use of scientific endeavours for those in the United Kingdom who feel they, like Mr. Dupree and Mr. Blackburn, have been wrongfully accused. While individuals reading this review may Journal of Healthcare, Science and the Humanities

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Reviews have widely divergent views regarding various such cases, the central aim of this commentary is to illustrate how forensic technologies and scientific advancements can influence social processes. In this vein, this review of Claims of Innocence, by Dr. Michael Naughton of the United Kingdom Innocence Project, is designed to celebrate the mission of academic and professional interdisciplinarity that is at the heart of this inaugural edition of the Journal of Healthcare, Science and the Humanities.

Synopsis Claims of Innocence, published in 2010, is a very short monograph of 80 pages written and published at the University of Bristol in the United Kingdom. It is a short procedural manual designed for individuals who are seeking advice for the potential overturning of wrongful convictions. In its introduction (pp. 1-2) the book illustrates that instructional information is not readily available to individuals who maintain innocence after conviction. The text has been written as a response to this informational gap. It provides critically needed information in three distinct parts. Part 1 is a general overview of the key causes of wrongful convictions. Part 2 details how claims of innocence are dealt with in England and Wales specifically. Part 3 provides enlightenment on the practical routes that innocent victims of wrongful convictions may use in attempting to prove their innocence.

Though Part 2 is compelling in and of itself, it admittedly is focused on the utilization of methods localized to the United Kingdom. Therefore, to meet the academic and professional perspectives of various international readers of this review who may have a more general scientific interest, this summary will focus on Parts 1 and 3 alone. These two sections detail key causes of wrongful convictions and the practical remedies in which science can play a vital role to assist the wrongfully convicted to prove their innocence.

From its onset the book sets a very sobering tone by describing the lives of individual persons wrongfully convicted. The text describes well the effects that wrongful convictions make on individuals, their families, and society at large. The authors approach this well and vividly through eight different case studies presented as autonomous vignettes (pp. 7-10). By placing a name and face to each of the eight key causes of wrongful conviction, the authors invite the reader to approach these key causes not as an abstract intellectual exercise but something more. The reader is provided with a human face to human injustice.

In all of the listed causes of wrongful confessions, by way of commentary within this review it is interesting to note that science can play a direct role in combating or confirming the existence of each. The powerful role of science in criminal law is a fascinating field of inquiry. While it is not its intention per se, this monograph calls important attention to this reality. However there is a cautionary tale to be heeded and it is found in the text in one of the categories, namely that of flawed expert evidence.

In this one area, the book uses the case studies of two individuals to describe how science initially â&#x20AC;&#x153;got it wrongâ&#x20AC;? (p. 10). These two case studies illustrate a definite need to demystify a contemporary and very unscientific fascination that is often attached to forensic science. Due to the development of this cultural adulation of forensic science, some members of the public believe that the involvement of forensics in a conviction absolutely substantiates 158

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Reviews the correctness of the conviction itself. This is not necessarily so. It is sometimes easy in the popular imagination to forget that scientific data must be validly interpreted. Science is fundamentally an interpretative act. Scientific data can be interpreted in multiple ways.

Therefore, it can be misapplied or misused depending on context.

With advances in science, it is possible to piece together information to provide a more complete timeline concerning proximity and location, with the aim of exonerating or proving the conviction of an individual (pp. 50-54). As all would readily realize, this applicability of scientific knowledge has great value. Yet, especially in the sensitive areas of exoneration, scientific knowledge and scientific evidence require rigorous testing and validation. Claims of Innocence illustrates the importance of such validation and calls for extremely careful, step-by-step re-examination of retained evidence when looking to the exoneration of a person wrongfully convicted of a crime. As the monograph illustrates, a large portion of any case is evidentiary in nature. To reverse the presumption of guilt in wrongfully accused cases, as the text states, one must “…actively find evidence… or produce new evidence” that could positively establish innocence in a particular case (p. 45).

As the text discusses the interaction of law with scientific expertise, false witness testimony, faulty witness identification, and forced/coerced confessions can be refuted. Yet the text warns: “much of forensic science and expert testimonies are far from foolproof ”... and the overturning of cases (involving forensic science) “demonstrate(s) the limitations of such forms of evidence” (pp. 45; 50) Valid conclusions must be based upon valid and accurate interpretation. The process is not simply “black and white.” Depending on the expert and the use of the data, different conclusions can arise from the same data. Therefore, the power of science in the social processes of law and legal justification is not automatic.

The text rightly calls attention to the need for scientific rigor and analysis.

Proceeding from this attention to scientific rigor and analysis, the monograph gives a concise but informative framework regarding general principles of forensic science as well as their limitations and the context of these principles themselves (p. 50). The text expertly explains how law utilizes science as an aid. It discusses the critically powerful academic and professional impact of the National Academy of Sciences in the field of forensic science (p.

51). The text skilfully details forensic scientific vocabulary when used by professionals in oral or written conclusions, and the different ways such vocabulary can be construed. The text also provides pertinent prudent advice for avoiding conflictual analyses (p. 51). Much of this material is an excellent summary especially for individuals who are laypersons regarding forensic science or even the physical sciences in general.

As a specific instance regarding the above, when a layperson thinks of law utilizing forensic science, an assumption can many times be made that forensic science is equated with the discriminating power and finality of DNA analysis for outcomes. Yet, this assumption is not completely valid. Indeed, the power of DNA in legal proceedings is indisputable.

The text chronicles the number of DNA exonerations in the United States and the United Kingdom since 1989 therefore illustrating the scope and power of DNA science (p. 52).

However Claims of Innocence strongly invites the reader to consider carefully the critical context of information obtained in DNA analysis, specifically as it pertains to the particulars of each case (p. 54). This clearly underscores the need for correct contextual evaluation and scientific interpretation. This point cannot be stressed enough.

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Reviews DNA forensic practitioners are acutely aware that, though the science indicates the presence or absence of a specific genetic profile, it is not up to the scientist to infer or imply guilt or innocence. That is the purview of the fact-finder in a court of law. The domain of the forensic scientist is to analyse the material, collate the data, present the facts of that material in report or oral form, and then explain the possibilities of the data in the social context highlighted by each individual case. Illustrated in sections beginning with page 50, the text aptly addresses the harnessing of science by law and the power of science to provide law itself with a greater illumination of events and their circumstances in a methodical, systematic, logical and precise context. Law uses the practical exacting authority of science to bolster social policy. Within this social context, science also has the ability to exonerate as it previously had been used to convict.

The remainder of Claims of Innocence explains to its intended readership and expounds on the details needed to choose legal representatives wisely and the utilization of alternative methods such as Innocence Projects and the media to help in working on any case.

The structure is concise and clear, yet contains practical applicable information, enabling the reader to digest and understand such an overwhelming topic in palatable portions.

Conclusion The aim of Claims of Innocence is to illustrate the key causes of wrongful convictions, and the problems faced by those seeking to regain their innocence in the face of a system that considers them to be guilty with limited opportunities to prove their innocence. The text also looks at practical pathways by which alleged innocent victims of wrongful convictions might prove their innocence. For the purposes of this review itself, the text illustrates well how science is an invaluable tool for social processes.

Science can be used to level the cultural playing field as its ethos is based on verifiable physical principles. The pure scientific equation is an invaluable objective resource for social policy, especially for law. Due to its inherent rigor and basis upon proofs and repeatability, the impartiality of scienceâ&#x20AC;&#x2122;s examination of facts is a perfect complementary partner for law. As this review points out, this is not to say that scientific analysis in and of itself has no possibility of error. Such is not the case. Claims of Innocence demonstrates that quite well. The possibility of error is indisputable. Yet what is equally indisputable is the essential and profound value that scientific analysis gives to the pursuit of law. In the cases found in Claims of Innocence, the specific value of forensic science is unquestionable.

While a text written as a manual of procedures for a special readership, namely those seeking to prove their exoneration, Claims of Innocence indeed has a value for the general reader. The text gives an individual a clear and cogent way by which to view â&#x20AC;&#x153;science in action.â&#x20AC;?

It shows the cultural value of science generally and forensic science in particular. It does so with a cultural corrective to popular misconceptions of forensics as an absolute imprimatur of truth. Presented within the sensitive context of human rights, Claims of Innocence gives readers the rare opportunity of becoming caught up in forensic science as a culturally powerful tool whether for ill or for betterment. Readers therefore should enter the text with as much care and prudence as the text reminds them is necessary for the pursuit of justice.

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POSTLUDE

Postlude Reviews A Voyage of Discovery Bruce R. Boynton, MD, MPH Senior Associate Editor Journal of Healthcare Science and the Humanities Bureau of Medicine and Surgery Washington, DC Email: Bruce.Boynton@gmail.com Jan K. Herman, MA Special Assistant for Medical History and Archivist Navy Medicine Institute for the Medical Humanities and Research Leadership Bureau of Medicine and Surgery Washington, DC Email: Jan.Herman@med.navy.mil During the 15th and 16th centuries, the European nations embarked on a series of exploratory voyages that changed the world. This movement, known as the Age of Discovery, paralleled the Renaissance in art and was equally influential, being a bridge between the Middle Ages and the modern period. This was the age of the great explorers, including Bartholomeu Dias, Christopher Columbus, Vasco da Gama and Ferdinand Magellan. These explorers, driven by a genuine curiosity in other peoples and cultures as well as the hope for economic gain, rounded the southern tip of Africa (Dias, 1488), discovered the New World (Columbus, 1492), found a sea route to India (da Gama, 1498) and circumnavigated the globe (Magellan,1522) in little more than 30 years. The invention of movable type by Gutenberg in 1439 and the increased availabilty of printed materials spread the word of these discoveries across Europe. It must have been a heady time to be alive.

The Age of Discovery lives on, albeit in a different form. Fast forward to another voyage. The year was 1975 and America’s exit from the Vietnam War was unfolding. The North Vietnamese Army had surrounded Saigon and cratered the airport runway. Operation Frequent Wind, the last act of the war, had begun, to evacuate American staff and many South Vietnamese military personnel and their families whose lives were endangered by their long association with the Americans. It seemed an “aerial Dunkirk as Marine and Navy helicopters flew a shuttle service between Saigon and the carriers and amphibious assault ships lying offshore. Waves of Vietnamese military helicopters packed with refugees followed in their wake. These helicopters sought out any vessel that might offer the sanctuary of a flight deck. Empty of fuel, some helicopters ditched and their passengers drowned. Others landed on the decks of aircraft carriers and amphibious ships, or found a clear flight deck on a smaller support vessel.

Enter the USS Kirk, a tiny destroyer escort assigned to radar picket duties in the South China Sea. The commanding officer, Commander Paul Jacobs, signaled that he could accept helicopters on the Kirk’s tiny flight deck. Helicopters began to land aboard the vessel, and as they discharged their human cargo, crewmen pushed the abandoned helicopters over Journal of Healthcare, Science and the Humanities

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Reviews Postlude the side to make way for more. A South Vietnamese Chinook helicopter, far too large to land aboard the Kirk’s flight deck, approached the ship. Although the sailors desperately tried to wave him off, the pilot was determined. He signaled that he would hover as low as he could and his passengers, including women and children would jump onto the flight deck. Sailors rushed out to catch the refugees, who were literally falling from the sky. His cargo discharged safely, the pilot then ditched his aircraft alongside the ship and the Kirk’s motor whaleboat quickly plucked him from the water. The ship filled quickly with refugees, who were fed and cared for and then transferred to larger vessels.

Commander Jacobs then took up a new challenge; the Kirk would rendezvous with the escaping remnants of the South Vietnamese Navy and lead that flotilla across the South China Sea to the safety of the Philippines. When the Kirk reached the South Vietnamese ships she found them barely seaworthy and packed with 30,000 refugees, including infants and pregnant women. This was a task that called for more resources than the Kirk had aboard.

Using airdrops of medical supplies, the vessel’s independent duty corpsman provided medical care for all 30,000 refugees, making house calls on a gig motoring from one vessel to the next.

The improvised flotilla finally arrived in the Philippines safely and only after very sensitive diplomatic negotiations, disembarked the refugees to start a new life in the free world. The events of this dramatic rescue have been captured in “The Lucky Few,” a documentary written by Jan Herman and produced by Navy Medicine. The film made its debut on 11 November 2010 in the Smithsonian Institution’s National Museum of Natural History. In the audience were members of the Kirk’s original crew and former refugees and members of the Vietnamese-American community.

Now fast forward to 2007. The ship is the USNS Comfort, a 1,000-bed hospital ship built on the chassis of a former supertanker. The ship had deployed on Operation Continuing Promise, a mission of goodwill and humanitarian assistance to 12 countries in Central and South America and the Caribbean. To provide medical support, the ship carried a medical treatment facility staffed by personnel from the Army, Navy, Air Force, Coast Guard, Public Health Service, Canadian Defense Forces, and two aid organizations, Project Hope and Operation Smile. The crew included dentists, engineers, physical therapists, optometrists, pharmacists, and veterinarians in addition to doctors and nurses. Working together, these healthcare professionals saw 98,000 patients and performed over 1,100 surgeries in four months.

Modern healthcare had come to impoverished people who previously had none.

Cataract removals allowed blind teenagers to see for the first time while adaptive splints permitted others to walk who had been told they would never do so. Dentists pulled thousands of decayed teeth while Navy Seabees painted schools and repaired roofs. The provision of care gave the crew new insights into the life and priorities of the people they served. In one such incident a veterinarian treated the ox of a farm family. The jubilant father explained that what he had done was even more important to the family than treating his child. “I can always get another child,” he said sadly, “but I cannot get another ox.” After exhausting his vaccines and supplies the veterinarian walked back to the improvised clinic where hundreds of people were in line awaiting care from other providers. Without supplies he could treat no more animals, but he could still do something; he walked up and down the lines, shaking everyone’s hand.

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Postlude Reviews When the early explorers returned to Europe they brought home stories of fabulous new lands that fired the imagination of their contemporaries. Therefore, it might be worthwhile to consider what lessons we have been learned from the voyages of the Kirk and Comfort. Here are some that are worth considering: 1. When we pull away from the pier we leave the safety of the world we know for terra incognita. Preparation is essential, but we cannot prepare for all the challenges or the opportunities that will come. When the Kirk was assigned radar picket duties, Commander Jacobs could not have imagined that his ship’s greatest contribution would be the heroic provision of humanitarian assistance.

2. Healthcare, and indeed all human interaction, cannot be divorced from the cultural context in which it is delivered. A successful healthcare program for one culture may be anathema to another.

3. Healthcare is not the sole domain of physicians and nurses. All disciplines have a role to play, and without them, the care that is delivered is unidimensional and may be misguided.

4. The need for healthcare is overwhelming and we will never have the resources to meet all the needs. What are our priorities for care?

5. Although our resources will be exhausted before the need is met, there will always be something we can do; we can reach out to our fellow human beings.

6. We will help others, but it is we, ourselves, who will be transformed.

In this, the inaugural issue of the Journal of Healthcare, Science and the Humanities, we, have embarked on a voyage of discovery; our goal is nothing less than understanding the phenomenology of illness, itself. Our studies will include not only biomedical science and the experience of illness in our world, but also the meaning of things within that experience. As Captain Ahab said at the beginning of Moby Dick, “All visible objects are but as pasteboard masks. Some inscrutable yet reasoning thing puts forth the molding of their features.” In the Journal we aim to explore what lies beneath the mask, behind the symptom, and beyond the clinical trial.

We invite you, our readers, to join us on this voyage of discovery. However, there is a caveat. You will not merely read the Journal. Rather we invite you to enter into its meaning. And in so entering, the Journal will provoke more questions than answers. As the Haitian proverb says, “Beyond the mountains, more mountains.” We are the inheritors of great explorers and healthcare pioneers, and through their discoveries lives have been changed and the burden of disease made more tolerable. Yet it is not only the recipents of healthcare who are benefited; we ourselves are transformed in the process. So we wonder about all of us who read and enter into the meaning of the articles in this edition and those to follow.

Will we be ready for the transformations yet to come?

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Navy Medicine Institute for the Medical Humanities and Research Leadership USN Bureau of Medicine and Surgery Code M00E 2300 E Street NW Washington, DC 20372