Annals of SBV Vol 6 ISS 2 july-dec 2017

ISSN 2395 - 1982

SRI BALAJI VIDYAPEETH ACADEMY OF HEALTH PROFESSIONS EDUCATION AND ACADEMIC DEVELOPMENT

ANNALS OF SBV Volume 6 - Issue 2 JULY - DEC 2017

Theme

RECENT ADVANCES IN THE FIELD OF MEDICINE

A Publication of

SRI BALAJI VIDYAPEETH

Annals of SBV Editorial Advisor K R. Sethuraman Editor-in-Chief N. Ananthakrishnan Core Committee M. Ravishankar

V.N. Mahalakshmi

Premnath Fakirayya Kotur

Karthiga Jayakumar

R. Saravana Kumar

Partha Nandi

K. Renuka

R. Jagan Mohan Issue Editor Joseph Philipraj S Executive Editor A.N. Uma Statistical Advisor G. Ezhumalai

Published, Produced and Distributed by Sri Balaji Vidyapeeth Editorial Correspondence To Managing Editor

Annals of SBV Sri Balaji Vidyapeeth (Deemed University, Accredited by NAAC with 'A' Grade)

Mahatma Gandhi Medical College and Research Institute Campus Pillaiyarkupam, Puduchery - 605 403 INDIA E.mail:annals@sbvu.ac.in | Phone : +91 413 2615449 to 58 | Fax : +91 413 2615457 Visit Annals of SBV Online at http://www.annals.sbvu.ac.in

INDEX From the Editors Desk Dr.S.Joseph Philipraj

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Review Articles 1. Recent Advances in Kidney Transplantation Moinuddin Z, Augustine T

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2. Dental Education Upgrade – Mapping of the New Path in Current Indian Context Shivasakthy Manivasakan, Sethuraman K R, SanthaDevy A, Saravanakumar R

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3. Overactive Bladder: Changing Paradigms in Current Guidelines and Pharmacotherapy Sanjay Sinha

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4. Recent Advances in the Approach to Disorders of Thought Sivaprakash B

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5. Recent Advances in Pediatric Urology Mitra A, Samalad VM, Sripathi V

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6. Advances in Laparoscopy Vibha Ramesh, K Lakshman

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7. Challenges in Ethical Medical Practice Joseph Thomas

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8. HemophiliaCare: The way forward Annamma Kurien

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9. Anatomy and its Impact on Current Education and Therapeutics - A Review Chandra Philip X

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Opinion 10. Optimal Healing Environment: A New Mantra for 21st Century K.R. Sethuraman

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From the Editors Desk Advances in Technology has helped in saving many innocent lives. Health sciences have improved leaps and bounds. Medical Professionals have embarked on medical technological tools to carry out extensive research on human health problems. The fruits of this research has resulted into the development of new drugs, and treatments which have helped in curing most challenging human diseases and it has also prolonged the human lifespan.

Rapidly changing technology and availability of new innovative technology in diagnostic and therapeutic fields together with changing practice pattern of clinicians has revolutionized the way health care is being delivered today globally.

New Innovations which can change the world. I have chosen few important innovations which can help health care delivery more scientifically.

Smart phone Ultrasound: Experts at the Washington University in St. Losuis managed to integrate a USB based ultrasound probe with a Smart phone. The main goal was to create an simple hand sized ”Ultrasound device ” that can enable doctors in remote areas to image a patients kidney, liver, bladder, eyes, veins and arteries so that they can easily detect any infections. This type of device can be of a good use in many developing countries and it can help in saving lives. Doctors without boundaries can use this mobile ultra sound to help out many patients in remote areas.

Technological advancements in communication: Communication is a major factor in both human lives and business. With years this technology has evolved and we have witnessed new mobile phones which made communication easier. With its technology, you can even do a live video call and see the people you’re communicating with.

Human Head Transplants: Sergio Canavero, an Italian neurosurgeon, intends to attempt the first human head transplant by 2017, though no successful animal transplants with long-term survival have yet been made.

Because of the difficulty of connecting the spinal cord, Canavero has suggested improvements in the process using a special blade and polyethylene glycol, a polymer used in medicine as well as in everything from skin cream to the conservation of the Mary Rose, can help start growth in spinal cord nerves. Being able to surgically remove the head in an orderly fashion should allow surgeons to then reattach all the nerves and blood vessels to the new body, once that pesky donor head is removed. A special bio-compatible glue will hold the spinal cord together so it can fuse with the donor body. The patient will then be put in a drug-induced coma for four weeks while the connection between the head and body heals. It’s the reattachment process that’s the most unlikely part of all this. There’s never been a successful procedure that reattached a fully severed primate spinal cord.

Heart in a Box: Warm Blood Perfusion System: Cardiac transplantation, also called heart transplantation, has evolved into the treatment of choice for many people with severe heart failure who have severe symptoms despite maximum medical therapy. Survival among cardiac transplant recipients has improved as a result of improvements in treatments that suppress the immune system and prevent infection.

Advanced Immunotherapies to Treat Cancer: Scientists at Juno Therapeutics reported at the American Society of Hematology (ASH) meeting that, in an ongoing Phase 1 trial, its chimeric antigen receptor (CAR) T-cell therapy, JCAR015, put 24 of 27 adults with refractive acute lymphoblastic leukemia (ALL) into remission, with six patients remaining disease free for more than a year (ASH 2014, Abstract 382, 2014).

Young Blood Antiaging – Fountain of Youth? Is the fountain of youth becoming a reality? A new treatment option maybe in our future in which blood of younger people under 25 could be used to reverse the effects of aging.

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From the Editors Desk

Review Article

Consumerism in Healthcare: Consumerism has been making inroads into the healthcare industry for at least a decade, with patients increasingly acting like consumers who have a choice in their healthcare options, trying to make the best decisions for quality and cost just as they do with any other commodity. The trend has been accelerated by the Patient Protection and Affordable Care Act, which left many consumers with large deductibles that put more pressure on them to find the most cost-effective care for the dollars coming out of their own pockets.

Genomics Editing/Splicing: Genome editing is a way of making specific changes to the DNA of a cell or organism. An enzyme cuts the DNA at a specific sequence, and when this is repaired by the cell a change or ‘edit’ is made to the sequence. Intellia is a leading genome editing company, focused on the development of proprietary, potentially curative therapeutics using a recently developed biological tool known as the CRISPR/Cas9 system.

Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course Bioabsorbable Stents: Every year, 600,000 people have metal coronary stents put into their chests to treat coronary artery blockage. Most of the time, that stent stays there forever, long after its mission is complete. The stents may inhibit natural blood flow and cause other complications, like blood clots.What if they could just disappear? That is a long-sought goal researchers have finally met. This past July, the first bioabsorbable stent was approved in the United States. Made of a naturally dissolving polymer, the stent widens the clogged artery for two years before it is absorbed into the body in a manner similar to dissolvable sutures.

However technology has also caused us concerns. Its poor application has resulted into the pollution of the environment which has serious threat to our lives and society. This calls for proper use of technology. The biggest challenge facing people is to determine the type of future we need to have and then create relevant technologies which will simplify the way we do things.

(Ref: 17 Amazing Healthcare Technology Advances of 2017- referral md.)

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Dr.S.Joseph Philipraj, MBBS, DipNB, MS, MCh,DipNB,MNAMS, MBA- Hosp management

Professor- Urology Sri Balaji Vidyapeeth - Mahatma Gandhi Medical College and Research Institute Campus Pillaiyarkuppam, Puducherry - 607403, India

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Recent Advances in Kidney Transplantation Moinuddin Z1, Augustine T 1,2 Access this article online Quick Response Code

Department of Transplantation, Manchester Royal Infirmary, Manchester University Foundations Hospitals NHS Trust, Oxford Road, Manchester, M13 9WL, UK 2 Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, M13 9PL, UK

Introduction Kidney transplantation is the treatment of choice for patients with end-stage renal failure (ESRF). Since the first kidney transplant was performed between identical twins in 19541, significant advances in the scientific and clinical aspects of transplantation have led to a consistent improvement in outcomes.

Kidney transplantation therefore confers significant survival benefit to patients when compared to dialysis2.

We explore some of the developments in kidney transplantation that have led to refinement in technique and improvement in outcomes over the years.

Expansion of the donor pool and outcomes Since the turn of the century, the number of cadaveric donors has increased significantly in the developed world. Concerted and focused initiatives at improving awareness and streamlining logistics has resulted in a significant improvement in donor numbers and organ utilisation. In addition to an increase in the number of standard criteria donors(SCD), the numbers of extended criteria donors (ECD) and kidneys transplanted from donors after cardiac (DCD) has also increased significantly. The increase in the number of DCD donors has seen the most marked rise in the recent past3.

Despite an increase in overall transplants, living donor transplants have remained relatively stable since 2004.

Patient survival following renal transplantation remains excellent, with one-year unadjusted survival rates ranging from 95% to 98% for recipients of deceased Ann. SBV, July-Dec 2017;6(2)

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donor and living donor transplants, respectively3.

Recipients of kidneys from living donors have better five-year patient survival (90%) when compared to recipients of non-ECD (83%) or ECD (69%) deceased donor kidneys3.

Immunological advances The combination of calcineurin inhibitors (CNI) and anti-metabolite with or without corticosteroids (CS) remains the most common maintenance immunosuppression regimen2. Since the turn of the century tacrolimus (TAC) has replaced cyclosporine (CYA) as the CNI of choice. This switch is mainly due to evidence from a variety of trials demonstrating less acute rejection (AR), improved blood pressure control and graft function with TAC at the expense of increased risk of new-onset diabetes, neurologic and gastro-intestinal side effects4. Based on the evidence from three large multicenter trials, Mycophenolate Mofetil (MMF) replaced Azathioprine (AZA)as the anti-metabolite of choice due to reduction in the rate of acute rejection (AR)5. However, more recently there appears to be a resurgence in the use of AZA in low immunological risk groups and living donor recipients due to follow up data from the trials not demonstrating any significant long-term difference in graft or patient survival between AZA and MMF use6.

The use of CS at the time of discharge has decreased from 97% to 68%4. The use of induction therapy has also significantly increased over the last decade. The current Kidney disease improving global outcomes guidelines (KDIGO) recommend IL-2 receptor antagonist (IL-2RA) as first line induction agents and www.annals.sbvu.ac.in

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Recent Advances in Kidney Transplantation

Annals of SBV

use lymphocyte depleting agents for patients at high immunological risk7.Prospective randomized trials have demonstrated reduced AR rates although higher incidence of adverse events in patients undergoing antiThymocyte globulin induction when compared to IL2RA induction in high immunological risk groups8.

Recently Alemtuzumab has shown efficacy in reduction of AR and short-term safety as an induction agent in high risk groups. However, more prospective long-term studies are necessary to establish long term safety and outcomes with Alemtuzumab use.

In recent years, there has been a significant increase in the HLA and ABO- incompatible transplantation9.

Successful incompatible transplant protocols are varied but include plasmapheresis or immunoadsorption to remove anti-HLA or –ABO group antibodies followed by infusion of low-dose IVIG for immunomodulatory effects10. Rituximab (anti-CD20 antibody) has also been used for sensitized patients at highest risk for severe AMR and has replaced splenectomy in most ABO-incompatible protocols. Induction therapy is either with a lymphocyte depleting agent or IL-2RA, followed by maintenance immunosuppression with TAC/MMF/CS4. Short-term outcomes following ABO incompatible transplants are comparable to compatible live donor transplants11. The safest and most costeffective avenue for living donor transplantation in incompatible patients is through Living Donor Exchange programmes. These have been shown to be especially effective in the United Kingdom, Europe and the USA. In India, there have been several reports of two and three way paired exchanges at single centres13.

However, a robust national or regional registry facilitating this process is still in its infancy.

Surgical Advances Since it was first described in the early 1990s, Laparoscopic donor nephrectomy has replaced open donor nephrectomy due to significantly reduced donor morbidity and hospital stay13. Various approaches to laparoscopic donor nephrectomy have been used which include laparoscopic intraperitoneal, laparoscopic retroperitoneal and Laparoscopic hand assisted approaches. The technique used is down to the expertise of the centre and all approaches seem to have equivalent safety and efficacy. Recently there have been reports of Laparoscopic single port donor nephrectomy through either a small peri-umbilical or flank incision with good results13. Over the last decade, robotic assisted donor nephrectomy has also

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been described with reduced post-operative hospital stay when compared to the laparoscopic hand-assisted technique14.However, the cost of a robotic procedure is a mitigating factor in its widespread use. Over the last two decades, minimally invasive donor surgery has had a significant impact in increasing the number of living donors and altruistic donors due to the minimal donor morbidity and reduced hospital stay.

The open approach is still the most widely used for the recipient of a kidney transplant. Over the decade last there have been case series reported of laparoscopic and robotic kidney transplantation. However, the disadvantages of laparoscopic and robotic approaches to kidney transplantation seem to be a longer duration of warm ischaemia due to longer anastomosis times with resultant lower rate of creatinine clearance in the immediate post-operative period and lack of haptic feedback. The robotic approach has the further disadvantage of higher cost15,16,17. The laparoscopic approach requires intraperitoneal placement of the kidney with fixing of the kidney in an extra-peritoneal pouch to prevent torsion17.Despite the slower reduction in creatinine and higher rate of delayed graft function the graft and patient outcomes after 6 months are similar between both open and minimally invasive approaches to kidney transplantation. However, in morbidly obese recipients, the minimally invasive approach may be beneficial by reducing morbidity from surgical site infections(SSIs) and reducing hospital stay15.

With the increased acceptance of organs from ECD donors there has been an increase in the number of dual kidney transplant over the last couple of decades.

While histologic and GFR based criteria for selection of donors as suitable for dual transplants exist, they are flawed and not completely reliable. Further studies are therefore needed to identify the best allocation criteria to ascertain similar outcomes in recipients of single and dual ECD kidneys18. Recently, a single centre from the UK, has reported enbloc-kidney transplantation from neonatal donors into adult recipients with successful outcomes19. This highlights that neonatal donors are an underutilised resource which can help improve access for patients to a kidney transplant.

Discussion With the improvement in immunosuppressive drugs and better understanding in the management of transplant recipients, graft and patient outcomes have steadily improved, further reinforcing renal transplantation

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as the treatment of choice for patients with ESRF. Expansion in the deceased donor pool with increased acceptance of marginal donors, extended criteria donors and use of dual transplantation has further increased the access to transplantation for patients on the kidney transplant waiting list. From an Indian perspective, while living donation is thriving and forms the major source of organs for transplantation, cadaveric donation is still not as well developed when compared to the western world. Recent progress in cadaveric donation in isolated regions in India, especially Tamil Nadu, is a promising prospect for the future of cadaveric donation in India. Increasing awareness about donation, improving the logistics and, replicating and improving existing regional cadaveric donation models nationally will further help in improving the numbers of cadaveric donors in India. Despite the high number of living donors, paired exchanges for incompatible donors can be improved by having a robust national or regional registry. With respect to surgical technique, India

is already on par if not ahead of several countries in embracing laparoscopic and robotic techniques. In future, India might be able to provide vital experience and training for future surgeons worldwide in these novel and advanced techniques. Furthermore, given the burden of diabetes and renal failure, and the relative infancy of the pancreas transplant program in India, there is abundant scope for increasing the number of pancreas and kidney transplants. This group of patients may be particularly suitable for pancreas after kidney transplant given the relative scarcity of cadaveric donors to ensure equitable access of cadaveric kidneys to all patients on the waiting list.

Conclusion In conclusion, there seems to be abundant scope for development in the field of renal transplantation in India and the next couple of decades will be interesting and may generate vital experience to aid future practice.

bbReferences 1. Murray JE. Surgery of the Soul: Reflections of a Curious Career. Canton, MA: Science History Publications; 2001.

2. Tonelli, M., Wiebe, N., Knoll, G., Bello, A., Browne, S., Jadhav, D., Klarenbach, S. and Gill, J. (2011), Systematic Review: Kidney Transplantation Compared with Dialysis in Clinically Relevant Outcomes. American Journal of Transplantation, 11: 2093–2109. doi:10.1111/j.1600-6143.2011.03686.

3. Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation.Rockville, MD: 2007 Annual Report of the U.S. Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients: Transplant Data 1997–2006.

4. Womer, Karl L., and Bruce Kaplan. “Recent Developments in Kidney Transplantation – A Critical Assessment.” American journal of transplantation: official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 9.6 (2009): 1265–1271. PMC. Web. 14 Nov. 2017.

5. Halloran P, Mathew T, Tomlanovich S, Groth C, Hooftman L, Barker C. Mycophenolate mofetil in renal allograft recipients: a pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection. The International Mycophenolate Mofetil Renal Transplant Study Groups. Transplantation. 1997;63:39–47.

6. Bansal, S. B. et al. “Comparison of Azathioprine with Mycophenolate Mofetil in a Living Donor Kidney Transplant Programme.”

Indian Journal of Nephrology 21.4 (2011): 258–263. PMC. Web. 15 Nov. 2017.

7. Kidney Disease: Improving Global Outcomes Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009;9 (Suppl 3):S1-155.

8. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D. Rabbit antithymocyte globulin versus basiliximab in renal transplantation.

N Engl J Med. 2006;355(19):1967–1977.

9. Magee CC. Transplantation across previously incompatible immunological barriers. Transpl Int. 2006;19(2):87–97.

10. Stegall MD, Dean PG, Gloor JM. ABO-incompatible kidney transplantation. Transplantation. 2004;78(5):635–640 11. Montgomery R, Locke J, King K, Segev D, Warren D, Kraus E, et al. ABO incompatible renal transplantation: A paradigm ready for broad implementation. Transplantation. 2009 12. Kute, V. B., Shah, P. S., Vanikar, A. V., Gumber, M. R., Patel, H. V., Engineer, D. P., Shah, P. R., Modi, P. R., Shah, V. R., Rizvi, S. J. and Trivedi, H. L. (2014), Increasing access to renal transplantation in India through our single-center kidney paired donation program: a model for the developing world to prevent commercial transplantation. TransplInt, 27: 1015–1021. doi:10.1111/tri.12373 13. CheguevaraAfaneh, Meredith J. Aull, Joseph J. Del Pizzo and SandipKapur (2012). Surgical Advances in Laparoscopic Donor Nephrectomy, Current Concepts in Kidney Transplantation, Dr. SandipKapur (Ed.), InTech, DOI: 10.5772/54283.

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Annals of SBV 14. Cohen, Ari J. et al. “Robotic-Assisted Laparoscopic Donor Nephrectomy: Decreasing Length of Stay.” The Ochsner Journal 15.1 (2015): 19–24. Print.

15. Modi, Pranjal et al. “Robotic Assisted Kidney Transplantation.” Indian Journal of Urology : IJU : Journal of the Urological Society of India 30.3 (2014): 287–292. PMC. Web. 15 Nov. 2017.

16. Rosales A, Salvador JT, Urdaneta G, Patiño D, Montlleó M, Esquena S, et al. Laparoscopic kidney transplantation. Eur Urol.

2010;57:164–7.

17. Modi P, Rizvi J, Pal B, Bharadwaj R, Trivedi P, Trivedi A, et al. Laparoscopic kidney transplantation: An initial experience. Am J Transplant. 2011;11:1320–4 18. Renaud Snanoudj; Marc-Olivier Timsit; Marion Rabant; Claire Tinel; Hélène Lazareth; Lionel Lamhaut; Frank Martinez; Christophe Legendre. Dual Kidney Transplantation: Is It Worth It? Transplantation. 101(3):488–497, Mar 2017 19. Wijetunga I, Pandanaboyana S, Farid SG, et al. Neonatal kidney donation and transplantation: a realistic strategy for the treatment of end-stage renal disease. Archives of Disease in Childhood - Fetal and Neonatal Edition 2014;99:F518-F519.

Review Article Dental Education Upgrade – Mapping of The New Pathin Current Indian Context Shivasakthy Manivasakan1, Sethuraman K R2, SanthaDevy A3, Saravanakumar R4 Reader, Dept. of Prosthodontics, Prof and Head, Dept. of Oral Pathology, 4 Principal, Indira Gandhi Institute of Dental Sciences 2 Vice Chancellor, Sri BalajiVidyapeeth 1

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About the Authors

Sri Balaji Vidyapeeth - Mahatma Gandhi Medical College and Research Institute Campus Pillaiyarkuppam, Puducherry - 607403, India

Zia Moinuddin FRCS: Post CCT Trainee in Transplant and Endocrine Surgery Manchester University Foundation Trust, Manchester UK. Titus Augustine MS; FRCSEd. : Consultant Transplant and Endocrine Surgeon, Clinical Director of Transplantation, Manchester University Foundation Trust, Manchester UK. Abstract

“Nothing is permanent except change”. Education is an open system that changes over time based on the needs of the stakeholders.

If it stops to change, the system will fail. The dental profession needs to upgrade itself with newer aspects in dental education.

The upgrade should involve all steps in the curriculum. For the process of upgrading to be successful,the faculty members need to be trained adequately in the curricular change area. The future of dental profession relies on upgrading the dental education.

Introduction The dental profession in India is facing a crisis in recent years owing to many reasons that include the alarming rise of the unemployment problem, introduction of common National Eligibility cum Entrance Test for selection of both medical and dental candidates, escalation of the fee structure and lack of government support. On the flip side, the students who have joined dental institutions are under a considerable amount of stress in accommodating themselves for the existing dental curriculum. A systematic review

by Elani et al (2014) states that the main source of stress for both the preclinical and clinical dental students were academic factors, out of which the examinations, grades and workload were identified as top stressors.1 The stress due to academic factors is due to misfit of the curriculum with the generation of the students.

The major cause being that “Physicians of tomorrow are taught by teachers of today using curricula of yesterday” as stated by Sethuraman.2 A probable solution would be to upgrade the dental education in all perspectives.

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The current students of the dental profession belong to the millennial generation whose perception of the world itself is digitalized. They are born technologists with a very short attention span, who prefers to learn on their go. Consequently, the same old methods of dental education may not be completely suitable for them. Innovative practices need to be incorporated for improving the educational process.

Teaching Learning experiences Utilization of technology in education has evolved over time. The millennial students would prefer multiple resources for learning instead of textbooks alone. Incorporating case reviews, problem-based learning, flipped classrooms, interactive class-quizzes, simulations, small group discussions, web-based learning, mobile-based learning etc., in the regular teaching promotes critical thinking and active learning by the students.3 Flipped classes enhance the retention of the subject as well as aids in greater depth of understanding by means of the problem-solving exercises and discussion.4

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Dental Education Upgrade – Mapping of The New Pathin Current Indian Context

Annals of SBV

Armin et al tested the efficacy of undergraduate students learning by integrating traditional and e-learning methods and proved e-learning to be a more effective supplement in learning histopathology.5 Customizing the mobile applications for the purpose of dental education has also been studied and proved to be useful.6 The infrastructure of the Institutions should be upgraded to have a Learning Management System (LMS), that connects the faculty members and the students in the digital world of learning, assessing and interacting. The content uploaded by the faculty members in the LMS would help the students in prepreparation for the classes as well as learn post-class.

The teaching-learning experiences should also focus on the development of communication skills, ethics and professionalism in the students. These skills favor the future dentists to be competent to provide patientcentered care in an interdisciplinary team applying evidence-based practice and quality improvement utilizing Information and Communication Technology.7 The teaching learning strategies should focus on the competencies that are to be acquired by the dental graduates at the completion of the course. The Dental council of India has mentioned the list of competencies for all branches of dentistry. Competency based training of the clinical students and testing the acquired competence in the internship will help the graduates to succeed in their career confidently. The competency to be acquired by the postgraduates are at a higher level and hence the training should focus on establishing and achieving Entrustable Professional activities (EPA).

The faculty members should identify the redundant areas of the curriculum that are outdated and reduce the curriculum time. More time should be spent to educate the recent advances to the students.

Evaluation The traditional practical exams test limited knowledge of the students and there is a lot of subjectivity in the evaluation. The use of Objective Structured Practical Exams (OSPE), Objective Structured Clinical Exams (OSCE) and Structured Oral Exams (SOE) provide an opportunity to reduce the subjectivity of the traditional exams and also allow more areas to be tested from the syllabus.

To be a health professional, it is not adequate to have the clinical acumen and theoretical knowledge, more important is the empathy towards patient care and professionalism. As mentioned earlier, apart from 11

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teaching those qualities to the students, they should also be assessed on the same, for, assessment drives learning. Work Place Based Assessments (WPBA) are the newer evaluation tools that allow to assess the affective domain in addition to the practical and clinical skills by the observing faculty for both undergraduate and post graduate students.8 Mini- CEX (Clinical Evaluation Exercise) is one of the tools of WPBA and it is used to assess the attitude of the students along with their clinical skills. Behere tested the mini-CEX for dental undergraduate students and found it to be a useful tool and also discussed the suggestions for improvement of the scale.9 One more useful tool of WPBA and tested widely in recent times is the Multi-Source Feedback (MSF).

This tool captures the feedback on the student by multiple people who are in the sphere of their influence.

It is also known as 360* assessment. It measures the professionalism and communication skills of the students.10 Usha et al studied and discussed the use of Multi-Source Feedback (MSF) for dental postgraduates.

The study concluded the expression of positive attitude by the postgraduate students towards the assessment process as well as valuing of the feedbacks by them.11 Training the students to do proper self-assessment and giving them repeated opportunity to do selfassessment aids in enhancing the critical self-reflective skills. Self-assessment with criteria for guidance and feedback from the faculty members in formative assessments would provide an opportunity for the students to introspect and improve their skills in both preclinical and clinical dental education. More weight age should be given to the formative assessments than the summative to increase the accountability of the students throughout the course.12,13 The maintenance of portfolio by the students encourages reflective practice, yet the time consumed for maintaining that and the effective evaluation of the teachers still debates the feasibility of the same in larger batch of students.14 However it is proven to be effective for the postgraduates for improving their personal responsibility and supporting their professional development.15

Curriculum There is a need for a paradigm shift in the curriculum to move towards a more learner-centered structure.

Adapting Choice Based Credit System in dentistry as proposed by Shivasakthy et al enables the students to learn at their own pace and place. The provision for Ann. SBV, July-Dec 2017;6(2)

electives makes the curriculum model more suitable for learners to choose their area of interest and get advanced training in the under graduation itself.16,17 Integrated curricular modules will help to break the professional silos and learn the subject in a more holistic aspect that assists better understanding of the dental science. In addition, it saves a lot of curricular time and reduces the work load of the students considerably.

Online teaching of students shall also be introduced in addition to the regular college classes. Cynthia et al reported positive outcomes with the curriculum delivery using a hybrid of face to face and online course for teaching oral histology.18 Use of web-based fixed prosthodontics material was also perceived to be a helpful supplement by the students in a different study by Elizabeth.19 To make the students survive in the future filled with uncertainty and to help them to be updated, the dental students should be exposed to research in their curriculum. Their knowledge should be enriched with scholarly experiences from the under graduation itself.20

Training of trainers Faculty development programs constitute an important area when education is considered. The teaching effectiveness of the Institutions depends upon the quality of the faculty development programs. The trainers need to be trained in pedagogical approaches and the evolving trends in dentistry constantly. Longer the training, more durable are the outcomes. The relationship of the change in teaching behaviour of the faculty members need to be compared with the students’ achievement of learning outcomes which can be identified as a metric to check the efficiency of the faculty development program.21 The program evaluation of any faculty development program should

extend to measure the changes in the instructional process of the teachers.

The faculty development programs should be carefully designed and put forth in an unambiguous manner to avoid resistance in the implementation of the curricular change. The programs should give the faculty members hands-on experience on the curricular modifications and on how to proceed with teaching in the new stream.22 The governing body should make faculty development program mandatory for all the teaching faculty in dental colleges, as existing in the medical profession.

Summary SWOT (Strength, Weakness, Opportunities and Threats) analysis of the curriculum by the students themselves in each Institute could give a valuable feedback on identifying the need for changes. Globalization of dental education by means of collaboration with foreign universities, student exchange programs, teledentistry, use of multimedia and simulation provides scope for improvement of dental education in India as discussed

by Sheeba et al.23 We need to think globally and act locally for enhancing professional growth.

Continuous professional development and constant renewal of the clinical practice license has become the demand of the day.24 It is the responsibility of the dental education system to instil values in students to enhance their continuous learning experiences and get updated in the recently available technology to apply evidence-based practice in patient care in order to stand the test of time.

The future of the dental profession is relying on the direction in which the dental education moves ahead.

The future dentists should be taught to be sensitive to the needs of the society and change accordingly for effective delivery of dental care.25

bbReferences 1. Elani HW, Allison PJ, Kumar RA, Mancini L, Lambrou A, Bedos C. A systematic review of stress in dental students. J Dent Educ.

2014;78:226–42.

2. Sethuraman KR. “Curriculum Planning” in Medical Education - Principles and Practice. Volume 1 (II edition) 2000. NTTC JIPMER publication. Pg-178.

3. William D. Hendricson, Sandra C. Andrieu, D. Gregory Chadwick, Jacqueline E. Chmar, James R. Cole, Mary C. George et al.

Educational Strategies associated with development of Problem-Solving, Critical Thinking, and Self-Directed Learning. ADEA Commission on Change and Innovation in Dental Education. J Dent Educ 2006;70(9):925-936.

4. Brenda S. Bohaty, Gloria J. Redford, Cynthia C. Gadbury-Amyot. Flipping the Classroom: Assessment of strategies to promote Student-Centered, Self-Directed Learning in a Dental School Course in Pediatric Dentistry. J Dent Educ 2016;80(11):1319.

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Annals of SBV 5. Armin Ariana, Moein Amin, SaharPakneshan, Elliot Dolan-Evans, Alfred K. Lam. Integration of traditional and e-learning methods to improve learning outcomes for dental students in histopathology. J Dent Educ 2016;80(9):1140-48.

6. Wisam Al-Rawi, Lauren Easterling, Paul C. Edwards. Development of a mobile device optimized cross platform-compatible Oral Pathology and Radiology spaced repetition system for Dental Education. J Dent Educ 2015;79(4):439-47.

7. Institute of Medicine (US) Committee on the Health Professions Education Summit; Greiner AC, Knebel E, editors. Health Professions Education: A Bridge to Quality. Washington (DC): National Academies Press (US); 2003. Chapter 3, The Core Competencies Needed for Health Care Professionals.

8. Norcini JJ, Blank LL, Duffy FD, Fortna GS. The mini-CEX: A method for assessing clinical skills. Ann Intern Med 2003;138:476-81.

9. Behere R. Introduction of Mini-CEX in undergraduate dental education in India. Educ Health 2014;27:262-8.

10. ACGME Outcomes Project. American board of medical specialties. ABMS toolbox of assessment methods. Med Educ 2000;85:555-86.

11. U Carounanidy, KR Sethuraman, ANilakantan, KA Narayan. Multisource feedback in dental postgraduation: A qualitative research. J Contemp Med Edu 2017;5(1):10-17.

12. Keith A. Mays, Grishondra L. Branch-Mays. A Systematic Review of the Use of Self-Assessment in Preclinical and Clinical Dental Education. J Dent Educ 2016;80(8):902-913.

13. Iain Colthart, GellisseBagnall, Alison Evans, Helen Allbutt, Alex Haig, Jan Illing et al. The effectiveness of self-assessment on the identification of learner needs, learner activity, and impact on clinical practice: BEME Guide no. 10. Med Teach 2008;30:124-145.

14. Sharon Buckley, Jamie Coleman, Ian Davison, Khalid S Khan, Javier Zamora, SadiaMalick et al. The educational effects of portfolios on undergraduate student learning: A Best Evidence Medical Edu cation (BEME) systematic review. BEME Guide No. 11 Med Teach 2009;31:282-298.

15. Claire Tochel, Alex Haig, Anne Hesketh, Ann Cadzow, Karen Beggs, Iain Colthart et al. The effectiveness of portfolios for postgraduate assessment and education: BEME Guide No 12. Med Teach 2009;31:299-318.

16. ShivasakthyManivasakan, Sethuraman KR, Narayan KA. The Proposal of a BDS Syllabus Framework to suit Choice Based Credit System (CBCS). J ClinDiagn Res 2016;10:JC01- JC05 17. ShivasakthyManivasakan, Sethuraman KR, Adkoli BV. Acceptability and feasibility of choice based credit system in BDS syllabus.

Int J InnovEduc Res. 2016;4 :73-80.

18. Cynthia C. Gadbury-Amyot, Amul H. Singh, Pamela R. Overman. Teaching with Technology: Learning outcomes for a combined dental and dental hygiene online hybrid oral histology course. J Dent Educ 2013;77(6):732-43.

19. Elizabeth S. Pilcher. Students’ evaluation of online course materials in Fixed Prosthodontics: a case study. Eur J Dent Educ 2001;5:53–59.

20. Peter J. Polverini. Why Integrating Research and Scholarship into Dental Education Matters. J Dent Educ 2014;78(3):332-3.

21. Yvonne Steinert, Karen Mann, Angel Centeno, Diana Dolmans, John spencer, Mark Gelula et al. A systematic review of faculty development initiatives designed to improve teaching effectiveness in medical education: BEME Guide No. 8. Med Teach 2006;28(6):497-526.

22. HeikoSpallek, Jean A. O’Donnell, Young Im J. Yoo. Preparing Faculty Members for Significant Curricular Revisions in a School of Dental Medicine. J Dent Educ 2010;74(3):275-88.

23. Sheeba Sharma, VasanthaVijayaraghavan, PiyushTandon, DRV Kumar, Hemant Sharma, YogeshRao. Dental education: Current scenario and future trends. J Contemp Dent Prac 2012;13(1):107-110.

24. Hammad HG, Hamed MS. Continuous dental education: A worldwide spreading trend. Indian J Multidiscip Dent [serial online] 2016 [cited 2017 Oct 26];6:28-33.

25. E. Kay. Dental education – Shaping the future. British Dental Journal 2014;216:447-448.

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Review Article Overactive Bladder: Changing Paradigms in Current Guidelines and Pharmacotherapy Access this article online Quick Response Code

Sanjay Sinha, MCh Honorary Professor and Consultant Urologist Email: drsanjaysinha@hotmail.com Apollo Hospitals, Hyderabad, India

Introduction Overactive bladder (OAB) is a common clinical condition affecting about 10% of the general population.

(1) While in itself the condition is not mortal, it can have a profound impact on those affected with a marked deterioration in the quality of life, psychosocial consequences and an economic burden. There is also a link between OAB and propensity to fall.(2) Given that OAB is more common in the elderly who might already be suffering from restricted mobility, such a fall can be a sentinel event in a sequence that leads inexorably from fracture of the femur to loss of ambulation and death.

its most simple format, the frequency-volume chart) is an important component of this management step and can serve both as a clinician’s guide as well as a simple biofeedback for the patient.

Treatment Recommendations

Patients who have significantly bothersome symptoms to start with or those who fail to respond to the first-line management discussed above are candidates for drug therapy.(4) The standard medication has hitherto been antimuscarinic drugs (AM). AM drugs act by blocking the muscarinic receptors of cholinergic nerve endings at various sites in the bladder including the urothelium and the detrusor. The drugs are efficacious in most patients but a significant subset of patients either fails to respond adequately or has intolerable side effects. Frail, elderly patients with a large co-prescription are more likely to have these adverse events. The usual limiting side effects are dry mouth, constipation, hyperthermia and cognitive changes.(4) There is an increasing concern about the latter especially in elderly patients on long-term therapy.

Additionally, AM drugs are contraindicated in some classes of problems such as narrow angle glaucoma, patients with delayed gastric emptying and those with a history of urinary retention and marginal voiding efficiency. In the event that an AM is ineffective, one of the possible steps is dose escalation, after confirming that other factors such as compliance or fluid balance are not responsible. In those with adequate efficacy but side-effects every attempt should be made to mitigate the side-effects by aggressive measures, often preemptively.

Current clinical guidelines recommend behavior modification, life-style changes, counseling regarding fluid management and pelvic floor exercises as the first step in management.(4) The bladder diary (including

In those failing AM for the reasons discussed, hitherto the only option in India was to proceed with treatment for refractory overactive bladder. This implied more invasive and markedly more expensive

Overactive bladder is defined as “urinary urgency with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia in the absence of infection or other proven pathology”.

(3) OAB can be associated with urinary incontinence, the “wet OAB”. OAB is a symptom complex, not a singular diagnosis. The same symptoms can be noted in a variety of diseases such as urinary tract infection, bladder or lower ureteric stone and carcinoma in situ of the urinary bladder. Hence, the condition is a diagnosis of exclusion. This cannot be emphasized enough. Each patient presenting with the symptom complex must traverse a clinical pathway to exclude other problems before a diagnosis of OAB is offered. In the appropriate patient, periodic re-examination of the diagnosis may be appropriate.

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therapies such as intravesical botulinum toxin injection or neuromodulation both of which have transient effects, are invasive, very expensive and yet, not universally effective.

The fall of 2017 has marked the availability of Mirabegron in the Indian market with DCGI approving the drug for sale in India. This is a singular event. The last time a new class of drug became available for OAB was over thirty years ago.

Clinical Pharmacology Mirabegron is a unique beta-3 adrenoceptor (AR) agonist.(5) It is highly selective and potent with an affinity that is x 150 for beta-3 as compared with beta-1 and x 33 as compared with beta-2.(5) Experimentally, beta-adrenergic stimulation had been shown to induce bladder relaxation several decades ago. However, it was only in the 1990s that the beta-3 mechanism was understood well enough to identify a drug that could work selectively against it. Another decade of clinical trials in the early 2000s was followed by approval for clinical use across the world over the last eight years.(6) Beta-ARs are ubiquitous in the human body. The human bladder has all three forms of beta-ARs but 97% of the mRNA found in experimental tests in the bladder is from beta-3 AR.(5) All three beta-ARs are found in the brain and heart. Some other tissues with beta-3 AR are gall bladder, gastrointestinal tract, uterus and adipose tissue.

Stimulation of beta-3 AR causes relaxation of the detrusor muscle of the bladder probably via Adenyl Cyclase stimulation and consequent cAMP production.

(7) Other potential mechanisms include activation of K+ channels causing hyperpolarization of the cell and inhibition of Ca2+ entry as well as a down regulation of Acetylcholine release via pre-junctional beta-3 ARs.(7)A recent study that looked at beta-AR in acetylcholinergic endings in the bladder found abundant expression suggesting a potential mechanism for beta-3AR agonists in the bladder.(8) Stimulation of beta-AR had no major impact on detrusor contractility during voiding or on post-void residuals.

Following oral intake there is rapid absorption of the drug. Mirabegron is highly lipophilic and is metabolized by the P450 system specifically the CYP2D6 pathway.(5) 55% of the drug is excreted in urine and 34% in feces. It has a terminal half-life of about 50 hours. The drug can be taken without regard 15

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to food and is approved for usage in overactive bladder in adults. It is not currently approved in children, pregnancy and lactating mothers. The recommended clinical dose is 25mg and 50mg. For patients with severe renal or moderate hepatic impairment, the lower dose should be used. It is not recommended in end stage kidney disease and severe liver failure.

While most of the published literature is on Mirabegron, several other drugs in the class have been studied. The most promising among these is Solabegron for which Phase II trials have been published. Vibegron was found to be toxic while Ritobegron has undergone Phase II and III trials that remain unpublished.(7)

Landmark trials and efficacy In a seminal phase IIA study published in 2008, Chapple et al compared Mirabegron 100mg, 150mg and Tolterodine against placebo in 314 patients over 4 weeks (BLOSSOM Study).(9) The study showed that both doses of the Mirabegron were effective and reduced frequency of micturitions by -2.2 (placebo -1.2) with an increase in mean voided volume. The drug was well tolerated but the higher dose of Mirabegron was associated with an increase in heart rate of 5 beats per minute. There was no tachycardia or palpitation.

A subsequent phase IIB dose ranging study compared four different doses of Mirabegron, 25mg, 100mg, 150mg, 200mg against placebo over 12 weeks and found that both frequency (reduced) and mean voided volume (increased) were impacted favorably by all doses of Mirabegron (DRAGON Study).(10) The discontinuation rate was about 3% in the treatment groups and similar to placebo. There was no episode of retention and no ECG changes. There was a mean increase of 1.6 beats per minute with 100mg and 4.1 beats per minute with the 200mg strength of the drug.

These studies were followed by large phase III trials in Europe and North America. Nitti et al compared placebo, Mirabegron 50mg and 100mg in a randomized control trial involving 1328 patients over 12 weeks (ARIES Study).(11) Entry criteria included overactive bladder symptoms for at least 3 months and the patients needed to have frequency of at least 8/day and urgency episodes at least 3 per 72 hours. Primary end point was change in the number of incontinence episodes per 24 hours and urinary frequency per 24 hours from baseline. The mean age of patients was about 60 years and 74% of patients were female. The study population was varied reflecting usual clinical Ann. SBV, July-Dec 2017;6(2)

practice and included patients with urgency urinary incontinence (30%), mixed urinary incontinence (38%) (urgency-predominant) and urgency-frequency (32%).

About 15% of patients were of 75years or above in age.

Over half the patients had used AM drugs before and the mean frequency was 11.7/day, mean urgency or urgency incontinence episodes was 5.8/day and mean voided volume was 157ml. Both the treatment groups showed a statistically significant improvement in the primary end-points and these improvements were seen at the 4 week assessment also. The adverse events included hypertension, urinary tract infection, nasopharyngitis, headache, diarrhea and dry mouth but all these were equivalent to placebo. The discontinuation rates were around 4% and similar in all the arms. A similar phase III study by Khullar et al included a fourth arm with Tolterodine 4mg and showed essentially similar results in a group of 1978 patients (SCORPIO Study).

(12) Mirabegron was not more effective than Tolterodine in this study.

A subsequent study by Herschorn et al included 25mg dose and showed efficacy with this dose equivalent to the 50mg dose (CAPRICORN Study).(13) A pooled analysis by Nitti et al in 2013 showed that there was ceiling effect at 50mg with no further beneficial effect in enhancing the dose. There was a reduction of urgency incontinence episodes of -1.49 and -1.50 and reduction of frequency by -1.75 and -1.74 per day in the 50mg and 100mg groups respectively.

These studies provided the foundation for the recommendation of 25mg and 50mg dosages in clinical practice.

Most of the studies examined predominantly female patients. Male patients with their propensity for benign prostatic hyperplasia related obstruction is potentially a different clinical setting for OAB. Otsuki et al examined 124 men as a part of a non-randomized relatively small OAB study that included a predominantly male (3/4th patients) population.(14) The study excluded those with a residual urine of >100ml. The drug was effective in men with significant improvement in OABSS and IPSS. There was no increase in the post-void residual and the drug was well tolerated.

A recent analysis of both pooled data (three trials) and direct comparison studies (one versus placebo, another versus Tolterodine), Mirabegron was effective in reducing frequency but not urgency and urgency incontinence in male patients in the pooled analysis.

Ann. SBV, July-Dec 2017;6(2)

The direct comparison study with placebo showed efficacy across all three parameters.

(15)

A Japanese study looked at urodynamic findings in males taking Tamsulosin offered add-on Mirabegron.

(16) There was an increase in cystometric capacity from 170ml to 212ml (p=0.01) with either resolution (25%) or reduction in amplitude of phasic contractions (remaining). There was no significant difference in the Pdet.max (79cm H20 versus 68cm H20) and bladder contractility index (126 versus 120).

Mirabegron has also been studied in children with OAB and was found to be well tolerated and efficacious as add-on therapy in 35 children with a mean age of 10.3 years refractory to AMs.(17) Recently, attempts have been made to compare Mirabegron with Onabotulinum toxin. A recent systematic review and network meta-analysis 56 RCTs and concluded that Onabotulinum was more effective on all parameters of efficacy at 12 weeks as compared with all oral therapies for OAB.(18)

Side effects, safety and persistence data To date over 27,000 patients have been studied in clinical trials involving Mirabegron and the drug has been well tolerated with no major adverse events.(19)The limiting side-effects of AM do not seem to be a problem with Mirabegron. Rates of dry mouth, constipation and urinary retention are equivalent to placebo.

Cardiovascular safety has been examined in detail given that adrenoceptors are important in the heart.

(5) In a pooled report of 20 beta-3 agonist studies (Mirabegron 16, Solabegron 2 and one each for AK 677 and BRL 35135) major cardiovascular events (APTC-MACE) were equivalent to Tolterodine and placebo at both 12 weeks and one year. Hypertension was noted in 8.7% equivalent to placebo (8.5%) with a mean ≤1mm Hg reversible rise in blood pressure. There was no orthostatic hypotension. QTc prolongation was noted in 0.4% again similar to Tolterodine and placebo.

Heart rate was increased by a mean of 1 beat per minute with 50mg dose. There was no increase in the incidence of palpitation or atrial fibrillation. Arrhythmias were noted in 4% similar to both Tolterodine and placebo.

In contrast Tolterodine and Trospium are associated with an increase in heart rate of one and three beats per minute.(5) Overall, the cardiovascular safety profile www.annals.sbvu.ac.in

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was considered to be satisfactory and comparable to existing drugs.

A 12month study examined the safety profile and found that Mirabegron and Tolterodine were equivalent in both safety and efficacy (TAURUS Study).(20) The drug shows a favorable safety profile in the elderly. A large study from Japan found no increase in cardiovascular or other major side effects in a “realworld” study over one year.(21) Persistence with therapy has been a problem with AMs. Although OAB is a chronic problem that is often incurable, most patients tend to stop drug therapy in the long term. A large study of 167,907 patients that examined persistence with therapy for six major chronic illnesses, glaucoma (prostaglandin analogues), hyperlipidemia (statins), osteoporosis (bisphosphonates), diabetes mellitus (oral hypoglycemic agents), hypertension (angiotensin receptor blockers) and OAB (AM) found that persistent with AMs was the worst of the six at one year.(22) Recently, Chapple et al studied time to discontinuation of therapy for different OAB medication in 21996 patients in the UK. Mirabegron had the longest time to discontinuation of 169 days as compared with Tolterodine (56 days) and 30-78 days for the other AMs.(23) The 12month persistence rate for Mirabegron was 38% versus 20% for Tolterodine, again a significant difference. This is possibly testimony to the better efficacy-tolerability ratio for Mirabegron although the study was not designed to evaluate the reasons for the finding. Similar persistence data has been reported recently from Japan in a large nationwide survey.(24)

Clinical utility and guidelines recommendations Mirabegron has been updated to second line management alongside AM in the 2015 American Urological Association Guidelines.(4) The guideline also states that Mirabegron has lower rates of dry mouth and constipation as compared to AM and is equivalent in efficacy. Mirabegron has been also been recommended in situations where AM are either ineffective or contraindicated.

The European Association of Urology Guidelines of 2017 give Mirabegron a grade A recommendation for management of OAB unless they have uncontrolled hypertension.(25) The drug has been recommended in the 17

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elderly, a group in which there are significant concerns regarding the long-term and potentially cumulative risk of cognitive dysfunction with AMs. Mirabegron has been noted to be as efficacious as AM with adverse events similar to placebo (Level 1a).

The National Institute for Health and Care Excellence (NICE) guidelines of 2013 state that Mirabegron should be prescribed only if AMs are ineffective, not tolerated or contraindicated.(26) However, this guidance seem dated with several key studies that have been published since its release.

The Sixth International Consultation on Incontinence of 2016 gives a grade A recommendation to Mirabegron for the treatment of OAB.(7)

Combination therapies in OAB Given the different mechanisms of action of AMs and Mirabegron as well as the unique side-effect profiles of each drug, combination of the two drugs would seem intuitive. Indeed, several key studies have attempted to address this question.

A large phase II study by Abrams et al examined 1306 adult patients (2/3rd women) across 141 sites in 20 countries over a 12-week period (SYMPHONY Study).(27) This detailed study compared 12 groups of patients: 6 combinations of Solifenacin (2.5, 5 and 10mg) and Mirabegron (25 and 50mg) as well as 5 monotherapy groups representing the same doses of these drugs and placebo. Combinations of Solifenacin 5mg and 10mg with Mirabegron were noted to be more effective than Solifenacin 5mg alone. All the groups were well tolerated with increase in the mean voided volume from baseline (primary end-point). Treatment associated adverse events were equivalent in between Mirabegron and placebo except for hypertension.

An even larger study of 2174 patients by Macdiarmid et al compared a combination of Mirabegron 50mg with Solifenacin 5mg with Solifenacin 5mg as well as 10mg (BESIDE Study).(28)Combination of Mirabegron 50mg along with Solifenacin 5mg seemed to perform better. A recent report of the pre-specified sub-analysis from this study of elderly patients showed that the combination was well tolerated and more efficacious compared to individual agents in patients ≥75 years age.(29) A study from Korea recently examined the benefits of adding low-dose AM in patients with inadequate response to 50mg of Mirabegron and found that 10mg Ann. SBV, July-Dec 2017;6(2)

of Propiverine resulted in significant improvement in symptoms with minor and tolerable increase in sideeffects.(30) Based on these studies, the EAU Guidelines of 2017 recommend that patients with inadequate symptom control with Solifenacin 5mg may benefit more from the addition of Mirabegron than dose escalation of Solifenacin (Grade 1b).(25) Certainly, the combination offers an option for escalating drug therapy without adding to the antimuscarinic load, an important consideration in some elderly patients.

Combination with other drugs Mirabegron has been combined with Tamsulosin, an alpha adrenergic blocker in men with benign prostatic hyperplasia and lower urinary tract symptoms. The drug was noted to be effective. Given that Tamsulosin has its own cardiovascular adverse event profile it was noteworthy that there was no potentiation of cardiovascular side effects in a small study of 48 men between 44-72 years.(5) Beta blockers are often used for hypertension and there have been concerns that there might be an adverse interaction with Mirabegron. However, this

does not seem to be the case. In various studies, 17% of patients in the shorter trials of 12 weeks and 19% in one-year studies have been on concomitant beta blockers.(5) Of these, between 11-18% have been on non-selective (beta-1 and beta-2) blockers. There was no reduction in the efficacy of Mirabegron and no effect of Mirabegron on the efficacy of the beta blocker Metoprolol. The tolerability of the combination was similar to Mirabegron alone.(5) Mirabegron interferes with the metabolism of Digoxin increasing the AUC and Cmax by 27 and 29 % respectively.(31) Hence, when the two drugs are combined, the lowest dose of Digoxin should be used to start with.

Conclusion Mirabegron is a valuable addition to armamentarium of clinical therapies for overactive bladder. It is as effective as antimuscarinic drugs and is better tolerated. The adverse events profile appears safe in the elderly and in male patients with benign prostatic hyperplasia.

Combinations of the drug with antimuscarinics appear to be more efficacious than either drug alone and this offers the opportunity for combination therapy.

bbReferences 1. Milsom I, Altman D, Cartright R, et al. Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal incontinence (AI) In: Abrams P, Cardozo L, Wagg A, et al., editors. Incontinence 6th International Consultation on Incontinence, ICS-ICUD, 2017:15–142.

2. Hunter KF, Wagg A, Kerridge T, Chick H, Chambers T. Falls risk reduction and treatment of overactive bladder symptoms with antimuscarinic agents: a scoping review. NeurourolUrodyn 2011;30:490-4.

3. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003;61:37–49.

4. Gormley EA, Lightner DJ, Faraday M, et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/ SUFU Guideline. J Urol;188:2455-2463 5. Rosa GM, Ferrero S, Nitti VW, et al. Cardiovascular Safety of β3-adrenoceptor Agonists for the Treatment of Patients with Overactive Bladder Syndrome. EurUrol 2016;69:311-23.

6. Sacco E, Bientinesi R, Tienforti D, et al. Discovery history and clinical development of mirabegron for the treatment of overactive bladder and urinary incontinence. Expert Opin Drug Discov 2014;9:433-48.

7. Andersson KE, Cardozo L, Cruz F, et al. Pharmacological treatment of urinary incontinence.In: Abrams P, Cardozo L, Wagg A, et al., editors. Incontinence - 6th International Consultation on Incontinence, ICS-ICUD, 2017. pp. 805-957.

8. Coelho A, Antunes-Lopes T, Gillespie J, et al. Beta-3 adrenergic receptor is expressed in acetylcholine-containing nerve fibers of the human urinary bladder: An immunohistochemical study. NeurourolUrodyn 2017;36:1972-1980.

9. Chapple CR, Yamaguchi O, Ridder A, et al. Clinical proof of concept study (Blossom) shows novel 3 adrenoceptor agonist YM178 is effective and well tolerated in the treatment of symptoms of overactive bladder. EurUrolSuppl 2008;7:239.

10. Chapple C, Wyndaele JJ, Van Kerrebroeck P, et al. Dose-ranging study of once-daily mirabegron (YM178), a novel selective 3-adrenoceptor agonist, in patients with overactive bladder (OAB). EurUrol 2010;9:249

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Annals of SBV 11. Nitti VW, Auerbach S, Martin N, et al. Results of a randomized phase III trial of mirabegron in patients with overactive bladder.

J Urol 2013;189:1388-95.

12. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63:283–295.

13. Herschorn S, Barkin J, Castro-Diaz D, et al. A phase III, randomized, double-blind, parallel-group, placebo controlled, multicentre study to assess the efficacy and safety of the beta3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013;82:313–320.

14. Otsuki H, Kosaka T, Nakamura K, et al. β3-Adrenoceptor agonist mirabegron is effective for overactive bladder that is unresponsive to antimuscarinic treatment or is related to benign prostatic hyperplasia in men. IntUrolNephrol. 2013;45:53-60.

15. Tubaro A, Batista JE, Nitti VW, et al. Efficacy and safety of daily mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies. TherAdvUrol 2017;9:137-154.

16. Wada N, Iuchi H, Kita M, et al. Urodynamic Efficacy and Safety of Mirabegron Add-on Treatment with Tamsulosin for Japanese Male Patients with Overactive Bladder. Low Urin Tract Symptoms 2016;8:171-6.

17. Morin F, Blais AS, Nadeau G, et al. Dual Therapy for Refractory Overactive Bladder in Children: A Prospective Open-Label Study.

J Urol 2017;197:1158-1163.

18. Drake MJ, Nitti VW, Ginsberg DA, et al. Comparative assessment of the efficacy of onabotulinumtoxinA and oral therapies (anticholinergics and mirabegron) for overactive bladder: a systematic review and network meta-analysis. BJU Int 2017;120:611-622.

19. Sharaf A, Hashim H. Profile of mirabegron in the treatment of overactive bladder: place in therapy. Drug Des DevelTher 2017;11:463-467.

20. Chapple C, Kaplan S, Mitcheson D, et al. Randomised, double-blind, active-controlled phase III study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder. EurUrol 2013;63:296–305.

21. Yoshida M, Nozawa Y, Kato D, et al. Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study. Low Urin Tract Symptoms 2017.doi: 10.1111/luts.12190. (Epub ahead of print) 22. Yeaw J, Benner JS, Walt JG, et al. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm 2009;15:728-40.

23. Chapple CR, Nazir J, Hakimi Z, et al. Persistence and Adherence with Mirabegron versus Antimuscarinic Agents in Patients with Overactive Bladder: A Retrospective Observational Study in UK Clinical Practice. EurUrol 2017;72:389-399.

24. Kato D, Uno S, Van Schyndle J, et al. Persistence and adherence to overactive bladder medications in Japan: A large nationwide real-world analysis. Int J Urol 2017;24:757-764.

25. Burkhard FC, Bosch JLHR, Cruz F, et al. European Association of Urology Guidelines on Urinary Incontinence 2017. Accessed on October 16, 2017 from https://uroweb.org/guideline/urinary-incontinence/ 26. Mirabegron for treating symptoms of overactive bladder. National Institute for Health and Care Excellence, 2013. Accessed on October 16, 2017 from https://www.nice.org.uk/guidance/ta290 27. Abrams P, Kelleher C, Staskin D, et al. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). EurUrol 2015;67:577–588 28. Macdiarmid S, Al-Shukri S, Barkin J, et al. Mirabegron as add-on treatment to solifenacin in patients with incontinent overactive bladder and an inadequate response to solifenacinmonotherapy. J Urol 2016;196:809–818.

29. Gibson W, MacDiarmid S, Huang M, et al. Treating Overactive Bladder in Older Patients with a Combination of Mirabegron and Solifenacin: A Prespecified Analysis from the BESIDE Study. EurUrol Focus 2017 Sep 12. pii: S2405-4569(17)30200-6. doi: 10.1016/j.euf.2017.08.008. (Epub ahead of print) 30. Shin JH, Kim A, Choo MS. Additional low-dose antimuscarinics can improve overactive bladder symptoms in patients with suboptimal response to beta 3 agonist monotherapy. InvestigClinUrol 2017;58:261-266.

31. Groen-Wijnberg M, van Dijk J, Krauwinkel W, et al. Pharmacokinetic Interactions Between Mirabegron and Metformin, Warfarin,Digoxin or Combined Oral Contraceptives. Eur J Drug MetabPharmacokinet 2017;42:417-429.

Review Article Recent Advances in the Approach to Disorders of Thought Sivaprakash B Access this article online Quick Response Code

Professor, Department of Psychiatry, Mahatma Gandhi Medical College and Research Institute, Email: prakashb1685@gmail.com Sri Balaji Vidyapeeth - Mahatma Gandhi Medical College and Research Institute Campus Pillaiyarkuppam, Puducherry - 607403, India

Introduction According to Kandel1 and Campbell’s Psychiatric Dictionary2, “the mind is a range of functions carried out by the brain. The actions of the brain underlie not only relatively simple motor behaviours, such as walking and eating, but all of the complex cognitive actions, conscious and unconscious, that we associate with specifically human behavior, such as thinking, speaking, and creating works of literature, music, and art. As a corollary, behavioral disorders that characterize psychiatric illness are disturbances of brain function, even in those cases where the causes of the disturbances are clearly environmental in origin.” In the words of Satcher,3 “the mind refers to all mental functions related to thinking, mood, and purposive behavior. The mind is generally seen as deriving from activities within the brain”.

Cognition is one of the most important broad domains of the mind. By definition, cognition includes thought. According to Campbell’s Psychiatric Dictionary2, cognition denotes a high level of processing of information, including thinking, memory, perception, motivation, language, etc. Thinking is defined as the mental activity and processes used to imagine, appraise, evaluate, forecast, plan, create, and will.4 Thought consists of patterns of neural firings in the brain; these patterns are translated into words when the person wishes to communicate them to a listener the process of language.2 Thought includes concepts, reasoning, problem-solving, imaginal operations and visual imagery etc.5 Descriptive psychopathology is the precise description, categorization and definition of abnormal experiences as recounted by the patient and observed

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in his behaviour.6 Assessment of thought is an integral component of the psychiatric assessment. Eliciting, comprehending, documenting and reporting disorders of thought is often perceived as a challenging and formidable task, especially by postgraduate residents starting their career in Psychiatry. This review explores some of the controversies and difficulties that postgraduate students typically encounter during the study of symptoms and signs pertaining to thought, and suggests methods to resolve some of these difficulties. This article can be used as a “study guide” or a companion while navigating through the complex territories of thought disorder. The neurobiology of disorders of thought is beyond the scope of this article. The focus of the review is entirely on clinical issues pertaining to the assessment and reporting of disorders of thought. The goal of this short review is not to reproduce all definitions of disorders of thought published elsewhere. However, useful “signposts” are provided in the form of explicit citations and references.

A few controversial definitions are analyzed, wherever relevant.

The need for a fresh and contemporary perspective Postgraduate training in Psychiatry usually places a strong emphasis on the concepts of psychopathology described in the classic psychiatric literature. It is understood that we “stand on the shoulders of giants”.

Classic approaches to psychopathology have laid the foundation for modern and state-of-the-art knowledge about mental symptoms. Modern approaches to the definitions of psychiatric symptoms and signs often rely a lot upon the classic descriptions. Budding psychiatrists must certainly be taught to understand, www.annals.sbvu.ac.in

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cherish and respect the history of psychiatry.

Nevertheless, postgraduate psychiatry residents need to understand that a thorough understanding of modern and contemporary definitions of psychiatric symptoms and signs is absolutely essential for the successful practice of psychiatry. Trainees need to comprehend how our knowledge about the manifestations of mental disorders has evolvedand been refined over the decades. Anexclusive and dogmatic focus on historical concepts that precludesan acknowledgement of recent advances and current literature is detrimental to the advancement of psychiatric practice, and can be unfair to our patients too. It is well-known to the medical profession that what was considered state-of-the-art and relevant several decades ago might not always have the same degree of relevance at the present time.

Science is dynamic and is in a state of perpetual flux.

Students of Psychiatry should have an open mind and must learn to discriminate between concepts that have historical value and concepts with current value, during their study of psychiatric symptoms and signs. They need to take pride in the acquisition of the latest and current clinical knowledge, while retaining a healthy respect for seminal and historical expositions. Modern medical practice places a high premium on “staying up-to-date”.Psychiatrists are expected to stay abreast of the most recent advances, with regard to the neurobiological and genetic basis of mental illness, and psychopharmacology. It stands to reason that a similar approach should apply to knowledge about definitions of psychiatric symptoms and methods of psychiatric assessment.

The problem of redundant terminology Postgraduate students of Psychiatry are strongly urged to consult the paper titled “Ordered thoughts on thought disorder” by Ashley Rule.7 This is an excellent reference that highlights the unfortunate redundancy in psychophenomenological terms used to describe thought disorder. Redundancyis the act of using a word, phrase, etc., that repeats something else and is therefore unnecessary. This author has identified 68 terms from several references (1978 to 2003) and concludes that there are more terms than significantly different concepts described. This implies that, though the author has identified 68 terms, this does not mean that there are actually 68 different phenomena. Thus, the psychopathology literature contains a significant amount of “noise” (information that is not wanted and that can make it difficult for the important or useful 21

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information to be seen clearly; irrelevant or meaningless data occurring along with desired information). Rule7 observes that many of the terms reviewed are similar, and “the differences are best explained by remembering that they were described by different psychiatrists, practising in different eras and writing in different languages”. This author emphasises that there is little difference between several psychopathological concepts defined, and highlights the existence of conflicting definitions. This can easily render the study of psychopathology confusing and unsatisfactory, and result in a difficult learning curve. Rule7 concludes that the recognition of a few broad categories of disordered thought is usually sufficient to allow a diagnosis to be made, in routine clinical practice, when taken in context with other symptoms.It is also interesting to note that many “redundant terms” listed by Rule7do not feature in the DSM-5 Diagnostic and Statistical Manual of Mental Disorders.8

definitions of the same psychopathological phenomenon.

This is quite surprising, and adds to the burden of the psychiatry resident grappling with the complexity of psychiatric symptoms and signs.

The need for simple, standard and uniformly accepted definitions

A strong case for a step-wise, simplified approach

The authors of the SCAN (Schedules for Clinical Assessment in Neuropsychiatry) glossary9 state that “the aim of the interviewer is to discover which of a comprehensive list of phenomena have been present during a designated period of timeand with what degree of severity”. They add that “the (psychiatric) examination is therefore based on a process of matching the respondent’s behaviour and description of subjective experiences against the clinical definitions provided”.9 These statements succinctly describe the cornerstone of the psychiatric evaluation. In addition to understanding and documenting the unique contextual (psychosocial/ environmental) factors playing a role in the patient’s illness and socio-occupational disability associated with the illness, it is imperative that a symptom-checklistbased approach is routinely incorporated into the psychiatric evaluation. Since psychiatrists are expected to match what they observe in a given patient to a definition of the phenomenon, and communicate with professional colleagues in a meaningful way, it is easy to understand why standardization of definitions is crucial to the scientific practice of Psychiatry. Attempting to match psychopathological phenomena observed in a patient to ambiguous and non-standard definitions can lead to errors in diagnosis and treatment. It is quite unfortunate that psychiatric symptoms are defined differently across various textbooks. Additionally, with regard to certain psychiatric symptoms, different chapters of the same textbook contain conflicting

It would be prudent for the postgraduate students to consult advanced references such as the classic textbooks of psychopathology in the second year of training and beyond. An unreasonable insistence upon the acquisition of a deep and thorough understanding of classic psychopathology in the first year of postgraduate training is both unreasonable and unnecessary, and can make some fresh trainees feel demoralized and intimidated. Inspiring the student and instilling a deep passion for the subject (if it does not already exist) should be the primary goals of postgraduate training, especially in the first year. It is also wrong to look down upon modern, simple and compact definitions of psychiatric symptoms and conclude that they are in some way inferior to verbose and tedious explanations.

On careful scrutiny, it is clear that these modern and compact definitions have, in fact, been worded very carefully and usually do not contain redundant words.

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Consider the postgraduate examination scenario wherein the candidate is expected to complete a full psychiatric evaluation (including a written report) in approximately 45-60 minutes. Also consider busy psychiatric outpatient facilities where time is in short supply. In such situations, there is an urgent need to quickly understand the patient and his/her unique sociocultural milieu, accurately label psychopathological phenomena, arrive at the most appropriate diagnosis and treatment plan in the shortest possible time. In these scenarios, simple and lucid diagnostic criteria and compact and uncomplicated definitions of psychopathological terms can be real life-savers.

A lofty and blanket disdain for simplicity is to be condemned. It is high time we abandoned rigid academic orthodoxy in favour of simpler, more “userfriendly” and clinically relevant methods of teaching and learning psychiatric symptoms and signs. It is true that the mind is deep and complex, and it is wellknown that psychopathology can be hard to fathom.

But academic approaches that make something that is inherently complex appear even more complicated should be discouraged. The study of psychopathology Ann. SBV, July-Dec 2017;6(2)

should not be over-simplified, but can certainly be simplified, at least for the sake of first year postgraduate residents in Psychiatry. The study of psychiatric symptoms and signs should have tight integration with practical psychiatric assessment and diagnosis in outpatient and inpatient scenarios, and should not be conceptualized as an independent, theoretical, “standalone” sub-speciality of psychiatry.

An overview of relevant resources There are currently two widely established systems for classifying mental disorders - Chapter 5 of the International Classification of Diseases (ICD-10) produced by the World Health Organization (WHO)10 and the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)8 published by the American Psychiatric Association (APA). Both systems have developed excellent glossaries - the ICD-10 Symptom Glossary for Mental Disorders11 and the DSM-5 glossary of technical terms8.SCAN (Schedules for Clinical Assessment in Neuropsychiatry)12 is a set of instruments and manuals developed by the World Health Organization, aimed at assessing, measuring and classifying psychopathology. The SCAN glossary9 provides very useful differential definitions of various psychiatric symptoms and signs. Many of the definitions provided in the ICD-10 glossary are based on the SCAN glossary. Unfortunately, the exemplary ICD-10 symptom glossaryis now approximately two decades old. It is hoped that a new and enhanced symptom glossary will be released along with ICD11 in 2017. Since the DSM-5 glossary is the most “recent” glossary at the present, it is cited frequently in this review.

The advantage of a modern glossary such as the one available in DSM-5 is that it is clearly linked to diagnosis, and is designed for practical application.

Glossaries and clinical acumen complement each other, and are the two primary forces that facilitate a quick and reliable diagnosis.It is noteworthy that the DSM5 glossary8 and the ICD-10 symptom glossary11 focus on presenting clear definitions and explanations of psychiatric symptoms and signs that are used in their diagnostic criteria - nothing more and nothing less.

In other words, these definitions are tailor-made for application in the clinical scenario.

It is strongly recommended that 1st year postgraduate residents first read simple and fundamental references such as the DSM-5 glossary,8 and the lucid,userfriendly Introductory Textbook of Psychiatry by Black www.annals.sbvu.ac.in

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and Andreasen13 for crisp and simple definitions of psychiatric symptoms and signs. Additionally, the Introductory Textbook of Psychiatry by Black and Andreasen13 gives excellent examples. These basic references can serve as stepping stones towards more advanced resources such as Sims’ Symptoms in the Mind - Textbook of Descriptive Psychopathology,6 which is consulted ideally in the 2nd and 3rd years of postgraduate training.

At the beginning of the chapter titled “Schizophrenia spectrum and other psychotic disorders” (pages 87-88) in DSM-58, the authors have provided excellent and compact descriptions of psychotic symptoms, including delusions and disorganized thinking (speech). When used along with the glossary provided at the end of the book (pages 817-831), these descriptions are reasonably adequate.Resources such as Introductory Textbook of Psychiatry by Black and Andreasen13, Kaplan and Sadock’s Synopsis of Psychiatry by Sadock et al14 and structured interviews such as the MiniInternational Neuropsychiatric Interview (M.I.N.I.)15 also provide several structured clinical questions that can be used to elicit psychopathology. In addition to these, postgraduate residents can develop their own personal database of reliable questioning techniques, aided by their teachers.

It is strongly recommended that postgraduate students consult the DSM-5 glossary8 for the following definitions in the context of disorders of thought and speech: Alogia (p. 817), compulsion (p. 819), delusion (with 13 types) (p. 819), echolalia (p. 821), flight of ideas(p. 821), ideas of reference (p. 823), incoherence (p. 823), magical thinking(p. 824), obsession (p. 826), overvalued idea (p. 826), pressured speech(p. 827) and racing thoughts(p. 828). DSM-58 defines tangentiality in p.88, though this term does not feature as a main entry in the DSM-5 glossary.

The ICD-10 symptom glossary also contains lucid definitions of “pressure of speech” and “flight of ideas”.

This glossary considers “flight of ideas” to be equivalent to “thoughts racing”. However, the DSM-5 glossary8 provides distinct definitions for “pressured speech”, “flight of ideas”and “racing thoughts”.

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The SCAN glossary9 provides simple definitions of other terms pertaining to thought disorder such as thought blocking, circumstantiality, neologisms, perseveration, poverty of content of speech, etc.

Alternative definitions of pressure of speech, flight of ideas and incoherence too are available in the SCAN 23

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glossary.9 This glossary uses the term “knight’s move” in the context of derailment.9 Additionally, postgraduate students are encouraged to refer to Andreasen’s popular Scale for the Assessment of Thought, Language, and Communication16 for lucid definitions and examples of the following 18 terms: Poverty of speech, poverty of content of speech, pressure of speech, distractible speech, tangentiality, derailment, incoherence, illogicality, clanging, neologisms, word approximations, circumstantiality, loss of goal, perseveration, echolalia, blocking, stilted speech and self-reference.

Certain published rating scales can serve as excellent aids to the study of psychiatric symptoms, in addition to glossaries. For example, the Scale for the Assessment of Positive Symptoms17 has lucid descriptions of delusions. Other good examples are the explicit descriptions of derailment and incoherence provided in the Scale for the Assessment of Thought, Language, and Communication (TLC)16. Such rating scales have specifically been designed for the purpose of psychiatric assessment and thus provide simple, practical and applicable definitions of psychopathology. Therefore, postgraduate students can take heart from the fact that the study of psychiatric symptoms and signs does not always have to involve tiresome wading through copious amounts of long-winded and abstruse text.

Assessment of thought and speech Postgraduate residents need to remember an important point with regard to the assessment of thought and speech. Examination of thought and speech happens nearly throughout the interview session. Though thought and speech are reported under a particular section of the mental status examination, it does not mean that we wait till we get to a particular stage of the interview before we elicit and document thought disorder. For example, evidence for derailment might be evident 5 minutes into the psychiatric interview; suicidal thought content might emerge towards the end of the interview. Information about the patient’s speech and thought elicited/observed/reported during the interview will be documented as a part of the mental status examination. Information about the patient’s speech and thought prior to the interview will be documented as part of history. A designated space is kept ready in the template for noting down clinically useful speech samples, whenever they become available. The interviewer needs to keep a blank and comprehensive template with “placeholders” ready, so that information about psychopathology can be documented in exclusive slots, in whatever sequence Ann. SBV, July-Dec 2017;6(2)

the symptoms/signs happen to be expressed/elicited.

Such a template will also ensure that vital components are not missed. Of course, such a template can easily be incorporated into a printed psychiatric workup form. The shuffling of the sequence to conform to the standard and accepted method of reporting can be done in real-time, during the presentation. In other words, symptomatology need not be, or sometimes cannot be elicited in the same sequence as it has to be reported during a case presentation; often, symptomatology cannot be presented in the same sequence as it was elicited.

Several authorities 18–20 include thought in tandem with speech in the format for reporting the mental status examination. This seems absolutely rational.

The “speech - mood/affect - thought” sequence doesn’t, in fact, make perfect sense. It does not seem quite logical to speak about the patient’s mood/affect right after presenting details about the patient’s speech, before talking about the patient’s thought.

This format conveys the erroneous impression that speech is somehow completely distinct from thought.

Thought and speech go hand in hand, since it is only through the patient’s speech that we usually derive inferences about the patient’s thought. From a broad perspective, the patient’s language (speech and writing) is a window into the patient’s thought.

This logic is brought forth clearly in the popular phrase “Thought, language and communication” propounded by Andreasen, 16,21 a distinguished leader in the field of thought disorder. Andreasen emphasizes that thought disorder is usually inferred from the patient’s language behaviour; we can only infer a person’s thoughts from his/her speech, though thought and language are not perfectly correlated.21 Though thought is not dependent on words,2 the association between thought and speech holds good In the context of practical psychiatric assessment. Of course, in a typical mental status examination, a large proportion of the data is derived from the patient’s speech, apart from information about thought. This includes details about mood, perception, sensorium and judgement too. It is also well known that findings recorded under various domains of the mind clearly influence each other. All things considered, it is advisable for postgraduate residents to present details about patient’s thought right after describing patient’s speech, in tandem.A sample of the patient’s speech and a recent written sample, if available, will make a vital contribution towards the assessment and interpretation of thought.

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A vital issue needs to be borne in mind during the assessment of thought and speech. Certain neurological conditions may be associated with a speech disorder that may be mistaken for “thought disorder”. Neurological speech disturbances and “organic” disorders of language will always have to be considered in the differential diagnosis and ruled out, before concluding that the “thought disorder” is part of a primary psychiatric disorder. Of course, this is in line with one of the cardinal tenets of clinical psychiatry Psychiatric disorders due to another medical condition (“secondary mental disorders”) need to be ruled out before considering a primary mental disorder.The broad categories of “organic”speech disturbance are as follows: dysphonia, which is caused by a local problem in the larynx; dysarthria, which can occur in association with lesions affecting the brain stem, muscle or cerebellum; and dysphasia (also termed aphasia), which is due to lesions of the cerebral cortex.22 The relationship between thinking and language is as complicated for “organic” disorders as it is for schizophrenia: there can be quite marked disturbance in the use of language with no apparent thought disorder.6 Postgraduate residents are urged to consult standard textbooks of neurology to update their knowledge about various neurological speech disturbances and “organic” disorders of language.

Sims’ Symptoms in the Mind - Textbook of Descriptive Psychopathology6 also contains useful material that assists in the differentiation of “organic” disorders of language from schizophrenic lan guage disorder. (Note: According to ICD-1010, the term “organic” means simply that the syndrome so classified can be attributed to an independently diagnosable cerebral or systemic disease or disorder. Example: Cerebrovascular disease)

A bipartite approach to thought disorder The bipartite assessment and reporting of thought disorder under the categories of process and content is supported and endorsed by the following contemporary and authoritative references • APA Guidelines on Psychiatric Evaluation of Adults23 • Kaplan and Sadock’s Comprehensive Textbook of Psychiatry by Sadock et al24 • Kaplan and Sadock’s Synopsis of Psychiatry by Sadock et al14

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• The Psychiatric Interview: Evaluation and Diagnosis by Tasman et al 25 • Psychiatryby Tasman et al20 • American Psychiatric Publishing Textbook of Psychiatry by Hales et al18 • The Medical Basis of Psychiatry by Fatemi et al19 Thought process refers to how thoughts are formulated, organized and expressed.14 According to Akiskal,19 thought form/process refers to how ideas or associations are put together in an observed sample of speech and in what sequence and speed.Thought content is essentially what thoughts are occurring to the patient.4 This is inferred by what the patient spontaneously expresses, as well as responses to specific questions aimed at eliciting particular pathology.4Disorders of content of thought include abnormalities in beliefs and in interpretation of experiences.26 It is useful to remember, at this juncture, that the various functional components of the mind such as emotion, thought, perception etc., are artificial and abstract. These are not like, for instance, the chambers of the heart or the lobes of the lung. These domains of the mind have profound interconnections. Because the mind is so incredibly complex and deep, we certainly need a convenient framework for the practical assessment and reporting of psychopathology. But, the same system can become counter-productive and complicate matters by the introduction of too many headings and sub-headings.

The postgraduate resident needs to focus on eliciting and documenting psychopathology rather than become confused over “where do I fit this sign/symptom”! Our primary aim is to diagnose and treat the patient who has approached us or has been brought to us for relief of suffering. This needs to be done in the shortest possible time. The goal of psychiatric assessment should be to understand the patient and arrive at a reliable diagnosis as quickly as possible and should not merely be an academic exercise involving the laborious and futile slotting of mental symptoms into innumerable compartments that have poor validity and dubious clinical utility.

The traditional method of reporting disorders of thought under four headings - stream (tempo and continuity), possession (obsessions, compulsions and thought alienation), content (delusions) and form - does not have adequate support in the current psychiatric literature. This scheme can safely be replaced by the broad, contemporary, bipartite “process and content” 25

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format without any loss of clinical data. The term “thought process” appears to be much more frequently used, in contrast to the term “form of thought” in contemporary textbooks. Andreasen has attempted to clarify the distinction between these terms, but admits that the boundary is not clear.26 A few authors14,19 use these two terms interchangeably. Based on this review, it is safe to conclude that formal thought disorder can be considered to be equivalent to and subsumed under disorders of thought process.

Postgraduate students should note that the formcontent distinction is employed in another context too, which can be a source of confusion. This is the larger context of phenomenology as a whole. Sims’ Symptoms in the Mind - Textbook of Descriptive Psychopathology6 provides a description of the form-content distinction with reference to phenomenology in general, in the introductory chapter. This can be illustrated through an example. In a given patient, is a particular phenomenon a disorder of perception, or a disorder of thought? Is the patient “hearing voices” or “having strange thoughts?”

Is it a hallucination or a delusion, or an overvalued idea? This is the “form” of the psychopathology. What are the voices saying? This is the “content” of the psychopathology. What are the strange thoughts about?

Once again, this is the “content” of the psychopathology.

This can be clarified further using an example provided in Sims’ Symptoms in the Mind - Textbook of Descriptive Psychopathology6 - “Hypochondriacal content can occur in more than one form. It could take the form of an auditory hallucination in which the patient hears a voice saying ‘you have cancer’. It could be a delusion, in that he holds with conviction the false belief that he has cancer.”

Recommended template for describing speech and thought Speech Comment on the following parameters: Fluency, amount, rate, tone, and volume4 Look for pressured speech, poverty of speech, poverty of content of speech etc.

Thought process (form) Is the patient’s thought process linear, organized and goal-directed?14

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Are the patient’s responses relevant? Is his/her speech coherent?

Look for major signs of disorganized thought such as derailment, incoherence, tangentiality Look for circumstantiality, clanging, flight of ideas, illogicality, neologisms, perseveration, racing thoughts, thought blocking etc. (listed here in alphabetical order) Thought content Delusions, overvalued ideas, ideas of reference, magical thinking, obsessions, compulsions, worries andpreoccupations, suicidal themes, phobias etc.

It is noteworthy that, in routine case presentation formats, there exists overlap between various parameters used to describe speech and parameters used to describe thought process. This overlap is apparent in several contemporary textbooks, and is visible in the template provided above. For example, postgraduate residents are often expected to comment about relevance and coherence of the patient’s speech. These two parameters are actually related to thought process. There does not seem to be a simple solution to this problem, other than merging the sections pertaining to speech and thought process. Akiskal combines speech and thought into one section, in his description of the format of the mental status examination.19

Notes on certain controversial / complex thought phenomena Thought insertion, withdrawal, broadcastingand passivity phenomena According to several contemporary and modern references4,8,13,14,19,27, thought insertion, thought withdrawal and thought broadcasting are clearly classified as delusions. All delusions are always reported under content of thought. Therefore, it follows that thought insertion, thought withdrawal and thought broadcasting have to be reported under thought content. The fact that ICD-1010 has listed these symptoms under a separate group “(a)” in the list of diagnostic criteria for schizophrenia without actually calling them delusions can be a source of confusion. It is noteworthy that the SCAN glossary adopts a complex approach and uses the term “delusional physical explanations” to represent “delusional explanations” of “experiences” such as thought insertion or broadcast.9It Ann. SBV, July-Dec 2017;6(2)

would be interesting to see how these controversial issues are resolved in ICD-11. However, it is clear that the majority of current references classify the aforementioned phenomena as delusions and it safe for postgraduate residents to adopt this approach. Passivity of affect(‘made’ feelings), passivity of impulse(‘made’ drives) and passivity of volition(‘made’ volitional acts) are all equivalent to delusions of control.6 Passivity of thought is a delusion of control of thought.6 Thus, all passivity phenomena can conveniently be reported under content of thought.

Derailment and incoherence Point “(f)” in the ICD-10 criteria10 for schizophrenia reads as follows: “breaks or interpolations in the train of thought, resulting in incoherence or irrelevant speech, or neologisms.” It is apparent that ICD-10 implies disorder of form of thought through this statement, but does not use terms such as derailment or loosening of association. Correspondingly, the ICD-10 symptom glossary11 does not contain an entry for derailment or loosening of association. Instead the ICD-10 symptom glossary11 provides a simple and succinct definition of incoherence - “Incoherence is a disorder of speech (and thought), in which the main features are distortion of grammar, unexplained shifts from topic to topic and lack of logical connection between parts of speech.”

The ICD-10 symptom glossary’s concept of incoherence is thus, quite broad. It seems to encompass both derailment and incoherence as described by DSM58and Andreasen13,16,26.The DSM-5 glossary8 does not have a separate entry for derailment, though the term is explained clearly in the context of incoherence. It is noteworthy that this distinction between incoherence and derailment provided by the DSM-5 glossary is in concordance with that provided by Andreasen.16,26 According to DSM-58, “incoherence is speech or thinking that is essentially incomprehensible to others because words or phrases are joined together without a logical or meaningful connection. This disturbance occurs within clauses, in contrast to derailment, in which the disturbance is between clauses. This is sometimes referred to as word salad”.

In this context, it is pertinent to point out that the DSM-58 criterion A for schizophrenia exemplifies how evolution and simplification can happen simultaneously.

There are just five straightforward components listed - delusions, hallucinations, disorganized speech (e.g., frequent derailment or incoherence), grossly disorganized or catatonic behavior and negative symptoms. Of these, two (1 and 3) are primarily disorders of thought. www.annals.sbvu.ac.in

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Of course, these are similar to what appeared in DSM-IV too. It is also noteworthy that the terms “disorganized thought”, “disorganized speech” and “formal thought disorder” are used interchangeably.8,13 DSM-58suggests derailment and incoherence as examples for disorganized speech, implying the importance of these two terms.

Postgraduate students are urged to read the excellent examples of derailment and incoherence provided in the Introductory Textbook of Psychiatry by Black and Andreasen,13 and the Scale for the Assessment of Thought, Language, and Communication.16 Andreasen does not recommend usage of the term “loose associations” and states that the term “derailment” is to be preferred and describes reasons for the same.21 The term “loosening of association”, frequently used in psychiatric case presentations, is not a main entry in the DSM-5 glossary, though it is mentioned as a synonym for derailment,within parentheses, in the section describing disorganized thinking in p.88 of DSM-5.8 Thought echo, loud thoughtsand audible thoughts Point “(a)” in the ICD-10 criteria10 for schizophrenia includes the term “thought echo.”The SCAN glossary9 classifies both loud thoughts and thought echo as “subjectively described” thought disorder. It is interesting to note that neither of these terms are included in the DSM-5 glossary and index8.

According to the ICD-10 symptom glossary11 and the SCAN glossary,9thought echo is “the experience of one’s own thoughts being repeated or echoed (but not spoken aloud), with a few seconds’ interval between the original and the echo. This must be differentiated from auditory hallucinations of voices repeating one’s thoughts. In thought echo, the repetition itself is perceived as a thought.”

The SCAN glossary9 defines loud thoughts as follows: “Respondents say that their own thoughts seem to sound ’aloud’ in their head. Respondents recognize that thinking, which is normally a silent process, is now taking the form of sound. The symptom has to be distinguished from auditory hallucinations, where respondents no longer experience the loud thoughts as their own. Hallucinations of voices repeating one’s thoughts are classified under hallucinations (voices commenting on thoughts or actions).”The SCAN glossary9 emphasizes that loud thoughts are distinct from thought echo. It is also evident from 27

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the aforementioned descriptions that neither of these phenomena are to be interpreted as perceptual abnormalities.

Oyebode6 defines audible thoughts as “the patient’s experience of hearing his own thoughts said out loud.

The symptom sometimes carries its German name, Gedankenlautwerden, or its French one, écho de pensées.

The patient may hear people repeating his thoughts out loud just after he has thought them, answering his thoughts, talking about them having said them audibly or saying aloud what he is about to think so that his thoughts repeat the voices. The patient knows that they are his thoughts, yet he hears them audibly while he is thinking them, just before or just after.”Oyebode6 reiterates that this is a disorder of perception, an auditory hallucination. Synopsis of Psychiatry14 defines audible thought as “a form of auditory hallucination in which everything the patient thinks or speaks is repeated by the voices, and adds that’s this is also known as thought echoing.”It is noteworthy that this term does not appear in the DSM-5 glossary and index.8 The passages presented above bear clear testimonyto the tenacious controversies that continue to plague certain areas of psychopathology. Definitions of “audible thoughts” provided in Sims’ Symptoms in the Mind6 and Synopsis of Psychiatry14 thus seem to be somewhat different from the definition of “loud thoughts” provided by the SCAN glossary.9 Besides, Synopsis of Psychiatry14 considers “audible thoughts” to be equivalent to “thought echo”. The clinical/ diagnostic utility of these confusing terms and the prevalence of these phenomena remain unclear. A search was conducted across all fields of the PubMed database using these terms, with no filters activated, to ascertain the approximate frequency of appearance of these terms in published research literature. A search for the term “thought echo” yielded 6 citations. A search for the term “loud thoughts” yielded one citation. A search for the term “audible thoughts” returned 2 citations. In comparison, a search for the term “delusion” yielded10, 234 results, while a search for the term “hallucination” returned 14,667 results. Note that PubMed comprises more than 24 million citations for biomedical literature, according to the statement that appears on the PubMed website.

A word of caution Postgraduate students need to be warned about mislabelling, “false positives” and “false negatives”.

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difficult to comprehend their complex psychotic experiences. Key relatives of such psychotic patients too are likely to be puzzled, and are often not aware of the precise nature of the psychotic thought phenomena being experienced by the patient. Often, patients find it difficult to understand the questions the clinician asks, even if the clinician and patient share the same degree of fluency in the language being used for the interview. An impatient postgraduate resident, armed with a handful of glossary terms and a list of structured questions, glancing anxiously at the clock ticking away, can easily lead or “mislead” a psychotic patient into giving inaccurate and superficial responses. In addition,

socio-cultural factors contribute significantly to this problem. We have seen eager postgraduate residents perform a seemingly thorough psychiatric assessment and report phenomena such as delusions of control or derailment, when they, in fact, do not exist in the given patient. These are complex symptoms that need to be elicited with extreme care and diligence. Sometimes, crucial symptoms are missed too. Needless to say, empathy, rapport, language, practice and sociocultural sensitivity are of paramount importance.These vital elements increase the probability that the assessment of thought will be a fruitful and productive endeavour.

bbReferences 1. Kandel ER. A new intellectual framework for psychiatry. Am J Psychiatry. 1998 Apr;155(4):457–69.

2. Campbell RJ. Campbell’s psychiatric dictionary. 9th ed. Oxford ; New York: Oxford University Press; 2009. 1051 p.

3. Satcher DS. Executive summary: a report of the Surgeon General on mental health. Public Health Rep Wash DC 1974. 2000 Feb;115(1):89–101.

4. Sadock BJ, Sadock VA, Ruiz P, editors. Kaplan & Sadock’s comprehensive textbook of psychiatry. 9th ed. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2009.

5. Nolen-Hoeksema S, Fredrickson B, Loftus GR, Lutz C. Atkinson & Hilgard’s psychology: An introduction. New Delhi: Cengage learning; 2009.

6. Oyebode F. Sims’ symptoms in the mind: Textbook of descriptive psychopathology. 5th ed. Edinburgh ; New York: Saunders/ Elsevier; 2015. 388 p.

7. Rule A. Ordered thoughts on thought disorder. The Psychiatrist. 2005 Nov 30;29(12):462–4.

8. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, D.C: American Psychiatric Association; 2013. 947 p.

9. World Health Organization. Schedules for clinical assessment in neuropsychiatry: Version 2: Glossary. Geneva: World Health Organization, Division of Mental Health; 1994. 237 p.

10. World Health Organization. ICD-10, the ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization; 1992.

11. Isaac M, Janca A, Sartorius N. ICD-10 symptom glossary for mental disorders [Internet]. Geneva: World Health Organization, Division of Mental Health; 1994 [cited 2015 Jun 2]. Available from: http://whqlibdoc.who.int/hq/1994/WHO_MNH_MND_94.11.pdf 12. Wing JK, Babor T, Brugha T, Burke J, Cooper JE, Giel R, et al. SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Arch Gen Psychiatry. 1990 Jun;47(6):589–93.

13. Black D, Andreasen N. Introductory textbook of psychiatry. 5th ed. Washington, DC: American Psychiatric Pub.; 2011.

14. Sadock BJ, Sadock VA, Ruiz P. Kaplan & Sadock’s synopsis of psychiatry: behavioral sciences/clinical psychiatry. 11th ed.

Philadelphia: Wolters Kluwer; 2015. 1472 p.

15. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry.

1998;59 Suppl 20:22–33;quiz 34–57.

16. Andreasen NC. Scale for the assessment of thought, language, and communication (TLC). Schizophr Bull. 1986;12(3):473–82.

17. Andreasen NC. Scale for the Assessment of Positive Symptoms (SAPS). Iowa City: University of Iowa; 1984.

18. Hales RE, Yudofsky SC, Roberts LW, editors. The American Psychiatric Publishing textbook of psychiatry. 6th ed. Washington, DC: American Psychiatric Publishing; 2014. 1473 p.

19. Akiskal HS. The Mental Status Examination. In: Fatemi SH, Clayton PJ, editors. The medical basis of psychiatry. 3rd ed. Totowa, NJ: Humana Press; 2008.

20. Tasman A, Kay J, Lieberman JA, First MB, Riba MB, editors. Psychiatry. 4th ed. Chichester, West Sussex: John Wiley & Sons, Inc; 2014.

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Annals of SBV 21. Andreasen NC. Thought, language, and communication disorders. I. Clinical assessment, definition of terms, and evaluation of their reliability. Arch Gen Psychiatry. 1979 Nov;36(12):1315–21.

22. Colledge NR, Walker BR, Ralston SH, editors. Davidson’s principles and practice of medicine. 21st ed. Edinburgh ;New York: Churchill Livingstone/Elsevier; 2011. 1360 p.

23. Work Group on Psychiatric Evaluation, American Psychiatric Association Steering Committee on Practice Guidelines. Psychiatric evaluation of adults. Second edition. American Psychiatric Association. Am J Psychiatry. 2006 Jun;163(6 Suppl):3–36.

24. McIntyre KM, Norton JR, McIntyre JS. Psychiatric interview, history, and mental status examination. In: Sadock BJ, Sadock VA, Ruiz P, editors. Kaplan & Sadock’s comprehensive textbook of psychiatry. 9th ed. Philadelphia: Wolters Kluwer Health/ Lippincott Williams & Wilkins; 2009.

25. Tasman A, Kay J, Ursano RJ, editors. The psychiatric interview: evaluation and diagnosis. Chichester, West Sussex: John Wiley & Sons; 2013.

26. Andreasen NC. Thought disorder. In: Fatemi SH, Clayton PJ, editors. The medical basis of psychiatry. 3rd ed. Totowa, NJ: Humana Press; 2008.

27. Cowen P, Harrison PJ, Burns T. Shorter Oxford textbook of psychiatry. 6th ed. Oxford: Oxford University Press; 2012. 818 p.

Acknowledgements The author acknowledges, with gratitude, the valuable suggestions & inputs provided by Dr. Eswaran S, Professor, Dr. Sukanto Sarkar, Associate Professor, and Dr. Abu Backer S, Senior Resident, Department of Psychiatry, Mahatma Gandhi Medical College and Research Institute, Pondicherry.

Review Article Recent Advances in Pediatric Urology Access this article online Quick Response Code

Department of Pediatric Urology, Apollo Children’s Hospital, Chennai

Introduction This article aims to introduce the reader to some interesting innovations in the field of Pediatric Urology over the past few years. The topics are not discussed in detail but are briefly touched upon to stimulate interest. The article is unstructured and each heading may be read independently.

Testes Sparing - enucleation of benign tumours – a norm in children?

Pediatric testicular tumours are uncommon and account for approximately 1% of all pediatric solid tumours. The overall incidence of germ cell tumours is lower in children than in adults. Malignant subtypes like seminoma or embryonal carcinoma are practically never encountered in the pre-pubertal age-group.

Teratomas, which are uniformly benign in children, may be malignant in adults (1). In children with bilateral and metachronous lesions, one must endeavour to spare the uninvolved testicular parenchyma and attempt a testicular sparing surgery (TSS). This is aided by the fact that these lesions are quite distinct from normal tissue.

The current European Association of Urology (EAU 2011) Guidelines consider organ-sparing surgery as an alternative to radical orchiectomy only for patients with synchronous bilateral testicular tumours, metachronous contralateral tumours, or with a lesion in a solitary testis with normal preoperative testosterone levels, provided that the tumour volume is <30% of testicular volume and surgical rules are respected (2).

This appears to be an ‘adult oriented recommendation’. In children most testicular tumors are benign – we would therefore tend towards testicular 29

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Mitra A, Samalad VM, Sripathi V

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preservation irrespective of volume of tumor. It has been shown by A Shukla et al that after enucleation, testicular volume restoration is swift and almost complete(1).

The operative technique of enucleation has evolved significantly since it was first described by Stoll et al (3) . US-guided needle localization and microsurgical exploration (4) using an operating microscope are recent innovations. The latter allows precise microdissection of the tumour and sperm extraction in case of azoospermia in adult patients. A discussion about TSS is incomplete without mentioning that frozen section assessment has proven to be highly accurate in differentiating malignant from benign tumours (5).

Corpora sparing clitoral recession in feminising genitoplasty This procedure should be part of the arsenal of every reconstructive urologist. In chidren with Congential Virilising Adrenal Hyperplasia, clitoridectomy (the removal of both the corpora and the glans) was done till the late 1980s as it was wrongly believed that it would have no great long-term effect on sexual function.

As the understanding of the clitoral anatomy, its physiology and its unique role in sexual gratification improved, techniques to preserve the blood and nerve supply to the clitoris were developed. The paired clitoral corpora were removed (thereby reducing its size) but the glans and its innervation was preserved(7).

Pippe Salle et al have described a technique of corpora sparing dismembered clitoroplasty (8) which involves retaining the corporal bodies rather than excision at their bifurcation. Corpora preserving clitoroplasty demonstrated that cosmetically acceptable www.annals.sbvu.ac.in

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feminizing genitoplasty can be performed in children with disorders of sexual differentiation (DSD) but still be potentially reversible at puberty or thereafter.

Minimally Invasive Surgery (MIS) in Pediatric Urology The term “Minimally invasive techniques” has now come to encompass a large number of modalities in pediatric urology, from sub-ureteral injection for abolishing vesicoureteric reflux to robot-assisted laparoscopic pyeloplasty. There is no doubt a dearth of well-planned randomized studies comparing the relative benefits of MIS over standard open techniques.

While there are enough publications detailing the evolution of MIS and techniques in our field, a few points which are rarely brought to the fore are worth mentioning. Firstly the pursuance of MIS should not be at the cost of open surgical training for residents especially in index cases. Simulators and wet labs may help circumvent this particular problem. However the ethics of operating for the first time on a live patient using a technique practised on a simulator is an unanswered question. The medico-legal implications of such training and surgery should be seriously questioned(9). Secondly, blind persistence with a MIS technique in reconstructive procedures while keeping the child under anesthesia for a prolonged period of time should be strongly discouraged.

Single-Incision Laparoscopic surgery (SILS) and Natural Orifice Transluminal Surgery (NOTES) are not applicable in children as the perceived advantages are small when compared to the risks of an adverse / inadequate outcome.

Role of robotics – revolutionised minimal invasive management Robotic-assisted laparoscopic surgery offers the benefits of laparoscopy with reduced anesthesia time and ease of suturing. This has led to its widespread use for many common pediatric urological condiitions.

The day is not far off when it may become the MIS procedure of choice even in infants.

Robotic Assisted Laparoscopic Pyeloplasty (RALP) Conventionally, the gold standard surgical method for the treatment of pelviureteric junction obstruction 31

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(PUJO) is open dismembered pyeloplasty. The steps of surgery have been successfully translated into the minimally invasive approach and RALP is the natural extension of laproscopic pyeloplasty. It is the most commonly reported robotic procedure in children to date (10). A transperitoneal or retroperitoneal approach can be used depending on the surgeon’s preference.

The advantages of robotic surgery have become increasingly apparent, especially with regard to intracorporeal suturing and a shortened learning curve. A growing body of evidence suggests that RALP is appropriate for small infants and reoperation after a failed pyeloplasty. The bottomline is that robotic technology has allowed more surgeons to offer a minimally invasive approach to their patients, compared to the limited number of surgeons able to perform a pure laparoscopic pyeloplasty (11).

Extravesical ureteric reimplantation While open surgery remains the gold standard definitive therapy for VUR, there has been increased interest in minimally invasive therapy for VUR, including endoscopic subureteral injections and minimally invasive surgery (12). The laparoscopic approach, though as effective as open surgery, has not been widely adopted due to increased technical complexity. Robot assisted laparoscopic extravesical ureteric reimplantation (RALEUR) has sparked a renewed interest in minimally invasive surgery for the correction of VUR (13).

A recent comparative analysis of postoperative outcomes in a cohort of 92 patients – 57 and 35 unilateral and bilateral RALUR, respectively reported no significant differences in terms of postoperative complications including incidence of UTIs, presence of new voiding dysfunction or urinary retention. It was concluded that RALEUR is a safe technique to use in the surgical correction of unilateral VUR and that bilateral extravesical RALUR is not associated with an increased risk of postoperative morbidity when compared with unilateral surgery (14). If tapering is required this can be done in-situ or by exteriorisation via a lower abdominal port site.

Robot assisted laparoscopic augmentation cystoplasty and appendicovesicostomy This is perhaps the most challenging procedure that can be undertaken by a robotic paediatric urologist (15) . Before tackling a surgery of this magnitude, an Ann. SBV, July-Dec 2017;6(2)

extensive experience in robotic procedures is mandatory.

The first robot assisted appendico-vesicostomy was performed in 2004, with subsequent multiple, small, single-center studies reporting favourable outcomes (16).

Continence rates have been achieved in 85% of children after the first procedure and in 92% of children with additional procedures using the robot (17). Robot assisted laparoscopic appendicovesicostomy is considered a safe and effective means of creating a continent catheterizable channel in a pediatric population. Continence rates are comparable to previous open series with acceptable complication rates.

Robot assisted nephrectomy and heminephrectomy Partial and total nephrectomy have both been performed by transperitoneal and retroperitoneal approaches using the robotic system. No comparative studies of robotic and laparoscopic or open nephrectomy in children had been conducted until recently.

Performing a robot-assisted total nephrectomy has been debated, as the procedure is excessively expensive and does not offer any added advantages over conventional laparoscopy (18). The robotic approach could be more valuable for partial nephrectomy, which is technically more difficult and the enhanced visualization and dexterity of a robotic system could offer improved efficiency and safety over standard laparoscopy.

Other procedures that have been performed routinely include bladder diverticulectomy, uretero-ureterostomy, ureterocalycostomy, ureterolithotomy and procedures on the bladder neck. Robotic paediatric procedures are evolving. Available literature and results have been encouraging and the advantages of this approach are quite obvious. But further large randomised studies are required to compare the operating times and outcomes in comparison to the laparoscopic approach (15).

Pediatric Surgical Uro-Oncology Radical excision of tumour in Neuroblastoma (NB) Neuroblastoma (NB) is the most common solid tumour of childhood and the most common malignancy in the first year of life. The median age at onset is 2 years, and one-third of the patients are <1 year of age. During the last few decades, the combination of multi-agent chemotherapy, radiotherapy and radical surgery has improved the prognosis for children with neuroblastoma. Despite the advances in multidrug therapy, surgery is still important in the treatment Ann. SBV, July-Dec 2017;6(2)

of neuroblastoma. There is no doubt that complete surgical resection in locally confined tumours is the treatment of choice. There is, however, an ongoing discussion about the value of radical surgery for extended (stage 3) and disseminated (stages 4 and 4s) neuroblastomas. Some studies have shown improved survival rates after radical excision and various protocols of chemotherapy (19), while others have questioned the role of extensive radical surgeries especially with recent advances in intensive preoperative and postoperative chemotherapy regimens (20). A recent study by von Schweinitz et al, showed a significant correlation between the radicality of extirpation of the primary tumour and prognosis during the early follow-up.

However there was no difference in outcome between complete or partial resection during the later followup (>5 years). Zwaveling et al found four studies that explicitly compared survival between patients undergoing either complete total resection (CR) or gross total resection (GTR). A significant survival benefit (for CR) was shown in one case only(21).

Despite recent advances, 50 to 60% of patients with high-risk neuroblastoma have a relapse, and to date there are no salvage treatment regimens known to be curative. Over the past decade, several highly active agents have been identified that may help such patients.

The issue of survival after relapse is a delicate one for clinicians who treat patients with neuroblastoma. It is necessary to offer hope for a cure but also to acknowledge that, at least until recently, long-term disease-free survival after a relapse was rarely seen, if ever. Recent advances in our understanding of the molecular basis of high-risk neuroblastoma have identified therapeutic tumortargets that may respond to novel agents with unprecedented anti-tumour activity(22).

Rhabdomyosarcoma (RMS) Although the outcomes for children with low- or intermediate risk disease seems to have plateaued in recent years, those with metastatic or refractory/ relapsed disease continue to have a poor prognosis (23).

Great strides have been taken in the area of genetics with the elucidation of many important genes such as MYOD1. A mutation in this may be responsible for treatment failure in those with sclerosing/spindle cell variant of RMS (11). The knowledge of these genes and of the oncogenic fusion proteins which are the products of chromosomal translocations in alveolar RMS may assist with risk stratification and application of chemotherapeutic protocols.

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In terms of imaging, Positron Emission Tomography (PET) imaging has made staging more accurate. In a recent study (25), the sensitivity and specificity of PETCT or PET for lymph node involvement and also for the detection of distant metastasis was found to be far higher than conventional imaging.

There has been a significant shift in the treatment paradigm from radical surgery advocated till the eighties to organ preservation in the current era.

Advances in chemotherapy and radiation therapy have allowed oncologists to even consider forgoing primary excision if local control has been achieved. The current outcomes include a 90% FFS (Failure Free Survival) rate for low-risk patients and an approximately 70% 4-year FFS for intermediate-risk patients. High-risk RMS patients still have poor overall survival with a 3-year OS of approximately 30%.

Wilms Tumour The most common primary renal malignancy in children has been written about extensively. Its management has evolved considerably over the years and is especially interesting because of the ideological differences between the two major treatment groups, the National Wilms Tumour Study Group (NWTS) and the International Society of Pediatric Oncology (SIOP). While a discussion about the treatment protocols is beyond the scope of this article, a few new concepts(some controversial) will be touched upon.

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Recent developments in neuropsychological research in (DSD) Disorders of Sexual Differentiation This area of study is fraught with controversy and multiple opinions have muddied the waters.

Multidisciplinary management is the key with a therapeutic protocol customized to every individual patient. A consensus statement on the management of intersex disorders put forth by Hughes, Houk, Ahmed and Lee in 2006 (30), identified a major shortcoming in terms of lack of information regarding long-term outcomes. It also advocated the need to amalgamate hard-core science with in-depth psychosocial studies in order to provide the best management outcomes.

Most of the current knowledge about the behaviourial differences between the sexes has been derived from studies in patients with DSD as well as animal experiments. This has provided the foundation for therapeutic options which are now being offered to these children. The creation of a normal genital appearance became synonymous with a “good outcome”. This approach has been challenged in a recent publication (31). It now appears that we weren’t asking the appropriate questions. There is currently no evidence that corrective surgery at the youngest possible age leads to better psychological development especially in cases like hypospadias (32). It is painfully obvious that we need better tools to assess psychological development in order to do the best for our patients.

Radical nephrectomy usually encompasses the ipsilateral adrenal gland as well but two recent studies have shown enough evidence for sparing the adrenal unless there is a high degree of suspicion (26), (27). There is a growing body of work with minimally invasive modalities including laparoscopy and robot-assisted laparoscopy, and it can be expected that these will be used more frequently not just for those tumours downsized by chemotherapy but for upfront nephrectomy as well (28) . This becomes even more exciting when considered with advances in hemostatic agents and intra-operative ultrasonography.

Recent advances in the field of Bladder Exstrophy/Episapdias Complex (BEEC)

There is a lot of work underway to discover a tumour marker for Wilms tumour and MicroRNAs seem promising in this regard. Salvage chemotherapy with a combination of irinotecan, vincristine, bevacizumab and temozolomide has shown good results in relapsed Wilms tumour(29).

The gene p63 probably has an important role in the ventrocaudal formation of the urogenital tract. There is an increased apoptotic activity of the ventral urothelium if it is under-expressed and this appears to be important in the etiology of BEEC (34). The elucidation of such key players in organ development pave the way for the development of gene therapies. As Tourchi et al (35) surmised, the identification of the genes associated

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One can expect the outcomes of this condition to be impacted positively by advances in four key areas including pathophysiology (and genetics), radiology, psychological aspects of gender identity and regenerative medicine. An example of this is the finding that the bony pelvis in exstrophy has the same potential for growth as a normal pelvis (33).

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with key cellular structures will eventually allow for “re-engineering” of the diseased tissue of the bladder into healthy tissues. This can be done by targeting the under-expressed genes and inhibiting the overexpressed genes. It may eventuallly be possible to do this when bladder exstrophy (or the OEIS complex) is identified antenatally.

3D Printing and tissue engineering in Urological Practice The ability to print in three dimensional space is proving to be a game-changer in the field of medicine.

The usefulness of this technology in the manufacturing of surgical prostheses, fabricated biomaterials and models for education and pre-operative planning has been established (36). However applications in pediatric urology are evolving.

The technology was introduced in the late 1980s and was aimed at the creation of three dimensional (3D) objects from two-dimensional slices of a computeraided design template. 3D printed ureteric stents and laparoscopic trocars have been successfully tried in porcine and human cadaver models (37). This means it is now possible to customize the surgical device to the patient which will be enormously useful in children. However Limitations low tensile strength of the materials prevents adequate sterilisation and long term durability is a concern.

The pinnacle of 3D printing application will be the creation of transplantable organs(38). The challenges are many and include the arrangement of cells and extracellular matrix in a functional form and enabling this biological material to withstand the mechanical stress of the bioprinting process. In addition the cells must also retain their proliferative potential. Once these problems are overcome the current shortage of transplantable organs will be completely eliminated.

In fact the very shape of surgery will be altered forever.

Sacral neuromodulation: Therapy of the future?

Sacral neuromodulation (SNM), which received FDA approval in 1997, is gradually gaining acceptance as the standard of care in patients with refractory overactive bladder and non-obstructive urinary retention (39). Such patients have an imbalance of inhibitory and excitatory signals on the voiding reflex. The same treatment may Ann. SBV, July-Dec 2017;6(2)

be effective for both voiding and retentive issues. Thus, this therapy may act by modulating responses at a central nervous system level.

Schmidt and Tanagho’s elegant canine experiments uncovered the response to sacral stimulation. The key finding was that stimulation-induced contraction of the urethral sphincter abolished detrusor contractions. The primitive voiding reflex is orchestrated by the pudendal nerve and has a significant role to play in SNM which seems to work by coordinating the bladder, sphincter and pelvic floor (40).

The recent advances in this field have been the production of the tined permanent lead, routine use of fluoroscopy and a smaller implantable pulse generator (IPG) (39). A prospective worldwide study on the outcomes of SNM have thrown up favourable results in selected patients. With the advent of these advances, the field is set to grow in leaps and bounds.

The percutaneous, self-anchored tined permanent leads do not need large incisions to insert and can be placed even under conscious sedation hence allowing one to utilize the patient’s response to sensory stimulation as a guide to placement. Further, the use of fluoroscopy has made placement even more accurate. The smaller IPG makes pediatric use even more appealing.

In the pediatric context, those with dysfunctional elimination syndrome may be specifically benefitted.

Reinberg et al used SNM in those refractory to medical therapy and found resolution or improvements in urinary incontinence (88%), frequency and urgency (89%), nocturnal enuresis (69%) and constipation (71%) with a median 27 months follow-up in a group of 20 patients (41).

bbReferences 1. Shukla AR, Woodard C, Carr MC, Huff DS, Canning DA, Zderic SA, et al. Experience with testis sparing surgery for testicular teratoma. J Urol. 2004 Jan; 171(1):161–3.

2. Albers P, Albrecht W, Algaba F, Bokemeyer C, CohnCedermark G, Fizazi K, et al. EAU guidelines on testicular cancer: 2011 update. Eur Urol. 2011 Aug;60(2):304–19.

3. Stoll S, Goldfinger M, Rothberg R, Buckspan MB, Fernandes BJ, Bain J. Incidental detection of impalpable testicular neoplasm by sonography. AJR Am J Roentgenol. 1986 Feb;146(2):349–50.

4. Hopps CV, Goldstein M. Ultrasound guided needle localization and microsurgical exploration for incidental nonpalpable testicular tumors. J Urol. 2002 Sep;168(3):1084–7.

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6. Minto CL, Liao L-M, Woodhouse CRJ, Ransley PG, Creighton SM. The effect of clitoral surgery on sexual outcome in individuals who have intersex conditions with ambiguous genitalia: a cross-sectional study. Lancet Lond Engl. 2003 Apr 12;361(9365):1252–7.

7. Oyama IA, Steinberg AC, Holzberg AS, Maccarone JL. Reduction clitoroplasty: a technique for debulking the enlarged clitoris. J Pediatr Adolesc Gynecol. 2004 Dec;17(6):393–5.

8. Pippi Salle JL, Braga LP, Macedo N, Rosito N, Bagli D. Corporeal sparing dismembered clitoroplasty: an alternative technique for feminizing genitoplasty. J Urol. 2007 Oct;178(4 Pt 2):1796–1800; discussion 1801.

9. Ostlie DJ. 25th Anniversary State-of-the-Art Expert Discussion With Ralph C. Cohen, MBBS, BMedSci, MS, FRACS, on the Advances of Surgical Practice in Pediatric Urology. J Laparoendosc Adv Surg Tech. 2015 Jun 1;25(6):455–9.

10. Cundy TP, Shetty K, Clark J, Chang TP, Sriskandarajah K, Gattas NE, et al. The first decade of robotic surgery in children. J Pediatr Surg. 2013 Apr;48(4):858–65.

11. Hollis MV, Cho PS, Yu RN. Pediatric Robot-Assisted Laparoscopic Pyeloplasty. Am J Robot Surg. 2015 Dec;2(1):1– 8.

12. Marchini GS, Hong YK, Minnillo BJ, Diamond DA, Houck CS, Meier PM, et al. Robotic assisted laparoscopic ureteral reimplantation in children: case matched comparative study with open surgical approach. J Urol. 2011 May;185(5):1870–5.

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Stec AA, Pannu HK, Tadros YE, Sponseller PD, Fishman EK, Gearhart JP. Pelvic floor anatomy in classic bladder exstrophy using 3-dimensional computerized tomography: initial insights. J Urol. 2001 Oct;166(4):1444–9.

Ching BJ, Wittler L, Proske J, Yagnik G, Qi L, Draaken M, et al. p63 (TP73L) a key player in embryonic urogential development with significant dysregulation in human bladder exstrophy tissue. Int J Mol Med. 2010 Dec;26(6):861– 7.

Tourchi A, Inouye BM, Carlo HND, Young E, Ko J, Gearhart JP. New advances in the pathophysiologic and radiologic basis of the exstrophy spectrum. J Pediatr Urol. 2014 Apr 1;10(2):212–8.

Youssef RF, Spradling K, Yoon R, Dolan B, Chamberlin J, Okhunov Z, et al. Applications of three-dimensional printing technology in urological practice. BJU Int. 2015 Nov 1;116(5):697–702. del Junco M, Okhunov Z, Yoon R, Khanipour R, Juncal S, Abedi G, et al. Development and Initial Porcine and Cadaver Experience with Three-Dimensional Printing of Endoscopic and Laparoscopic Equipment. J Endourol. 2015 Jan 1;29(1):58–62.

Murphy SV, Atala A. 3D bioprinting of tissues and organs.

Nat Biotechnol. 2014 Aug;32(8):773–85.

Thompson JH, Sutherland SE, Siegel SW. Sacral neuromodulation: Therapy evolution. Indian J Urol IJU J Urol Soc India. 2010;26(3):379–84.

Tanagho EA, Schmidt RA. Electrical stimulation in the clinical management of the neurogenic bladder. J Urol. 1988 Dec;140(6):1331–9.

Roth TJ, Vandersteen DR, Hollatz P, Inman BA, Reinberg YE. Sacral neuromodulation for the dysfunctional elimination syndrome: a single center experience with 20 children. J Urol. 2008 Jul;180(1):306–311; discussion 311.

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by attempting to send the view from each laparoscopic lens separately to each of the surgeon’s eyes.

Review Article Advances in Laparoscopy Vibha Ramesh, MBBS, DNB, Surgical Associate, K Lakshman, MBBS, FRCS, Consultant Surgeon, Access this article online Quick Response Code

Introduction It was in 1987 that French surgeon Phillipe Mouret performed the first laparoscopic cholecystectomy and made an epistemological leap, and ushered in the era of laparoscopic surgeries. Though deemed a revolution or a laparoscopic explosion, it was in every sense a gradual evolution from the traditional large incisions to minute or no incision surgeries. At first, this pace was seemingly slow owing to either limitations in technology or scepticism of the medical and surgical fraternities, not to forget the steepness of the learning curve. But this persistent growth has led to a profound and dramatic change in the scene of surgery today.From a single eyepiece rigid scope to a 3-dimensional, multi-image capturing robotic ensemble, it has been a long journey with many advances. This paper focuses on the advances pertaining to advances in imaging, ergonomics and advances in gastrointestinal surgery only. Robotic surgery is another big leap. Laparoscopy in many different fields of surgery has taken major strides.

This paper does not address these advances.

Imaging in Laparoscopy “Stereopsis is the phenomenon of perception of an object of three dimensions by means of the two dissimilar pictures projected by it on the two retinae …” said Wheatstone in the late 1800s. Single eyepiece rigid scope provided a monocular view. This meant that only the operating surgeon would peer through his instrument to glance at the interiors of the abdomen using one eye. There was no magnification or recording and there was discomfort due to posturing and being glued continuously to the eye piece.

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Bangalore

“Chip on the tip” technology places small camera chips at the tip of the laparoscope and then transmits it to an image processor. The technology for 3D characteristics has an additional image processor. Single channel systems split the view of the operating field from a single point with a prism or a filter and therefore attempt to excerpt two perspectives of the field.

Address for correspondence drvibharamesh@gmail.com, klakshman58@gmail.com

Dual channel systems produce two truly different view which are transmitted separately to each eye independently. The two lenses of the stereoscope are separated by 6 mm and have a focal length of around 10 cm, providing a true binocular image.

The introduction of television removed most of this handicap and when relayed onto a screen via a camera, it gave birth to “videoscopic” viewing. This monocular vision and screen viewing meant that the surgeon was denied of the normal binocular vision of depth perception, thereby the laparoscopists unintentionally trained themselves to see only in 2 -dimensions. The present technology has sought out to fill this lacuna.

Though stereoptic scopes were used as early as 1922, they did not gain popularity till the last decade.

Early projection systems used active shuttering projection where the operator wears an active shuttering glasses and alternate left and right views are displayed at high frequency on a display. Robotic systems evolved to use a fixed viewing environment wherein the observer has a separate image displayed to each eye. More recently there has been the experimental development of complex waveform projection systems, auto stereoscopic “glass-free” displays and holographic displays. High quality experimental studies have shown that the latest 3D systems using dual channel stereoendoscopes and passive polarizing technology provide a “near natural” view. However, their clinical application has yet to be addressed with Level 1 evidence.

The old system offered either a telescopic rod lens system that connected to a video camera (single-chip or three-chip) or a digital laparoscope where a charged coupled device (CCD) is used.

Single chip cameras meant that sensors for red, green and blue light were contained on a single CCD chip. Triple chip designs utilise a prism located in the camera head unit to split the incoming image into red, green and blue components, and direct those beams of light into three separate CCD chips. If there was blood in the peritoneal cavity, the image of the three-chip camera was superior.

The video monitor displayed the final image with the final resolution which was the end result of what the wire cables would relay. There was visual-motor axis disruption, pictorial depth anti-cues, spatial disorientation, all of which brought down a surgeon’s efficiency. This explained the steepness of the learning curve.

To provide the surgeon a 3 -dimensional picture, the newer systems simply mimic the dual lens system of the human eyes. This is what robotic surgery offers Ann. SBV, July-Dec 2017;6(2)

Ergonomics in Laparoscopy Ergonomics is “the concept of designing the working environment to fit the worker, instead of forcing the worker to fit the working environment.” It has been very well shown that ergonomic interventions positively affect health outcomes. Compared with other surgical approaches, laparoscopy creates unique musculoskeletal risks for surgeons.

Laparoscopic surgeons fix their head and trunk placing strain on the neck and trunk. This static positioning causes less weight shifting compared to open surgery. Though open surgeries are being replaced by laparoscopic procedures, the tables are not so friendly as to accommodate for various positions and body habitus of the surgeon. The fulcrum effect necessitates exaggerated arcing movements, arm abduction or forced rotation movements to create fine movements inside the abdomen. Laparoscopic surgery also causes greater

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eye strain compared with open surgery. Laparoscopic ergonomics has, therefore, to be learnt and practiced by surgeons. This is done preferably, first, at a simulated setting rather than in the operating room. Factors like optimal working instrument angles, instrument grips, table height, monitor position, and surgeon positioning are considered and form the basis of current ergonomic guidelines for laparoscopic surgeons. ‘Work-related musculoskeletal disorders’ is the term preferred to address the injuries in which the work environment and performance of work contribute significantly to the condition.

Ergonomic interventions are being targeted at modifying awkward postures of surgeons, awareness and education, setting guidelines, optimising instruments and developing tables and consoles which have more degrees of movement. Several novel innovations have been developed. These include modified scopes or instrument handles which favour minimal effort and posturing for efficient outcome and have been the focus of change in recent years.

Laparoscopy in Acute Abdomen and Trauma Laparoscopy today has faced many technological improvements, perfection of laparoscopic instruments, the development of modern laparoscopic techniques and the acquisition of these skills by growing number of surgeons in elective surgeries. However, laparoscopy for emergency surgery is still considered too challenging and is not usually recommended.

Acute abdomen or trauma face technical difficulties due to various reasons such as hemoperitoneum or large purulent collections and adhesions or even fitness for general anaesthesia. Planning an emergency laparoscopic approach is often difficult especially during a night shift as the procedure is restricted by time as well as by the accessibility of equipment and surgical personnel, especially in rural hospitals. Even so, the potential advantages of laparoscopy, its safety, both as a diagnostic procedure and therapeutic procedure for acute abdomen have been established today.

Laparoscopy can be safely performed in various situations commonly encountered. Acute complicated appendicitis with purulent abscess or diffuse peritonitis, or gangrenous or perforated cholecystitis can similarly be managed laparoscopically.

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A perforated peptic ulcer (PPU), now a rarer entity can also be approached laparoscopically wherein it may diagnose the cause of acute abdomen and allow closure of perforation, and subsequently permit lavage of the peritoneal cavity. This minimally invasive approach proves to be advantageous by causing less postoperative pain, faster recovery and earlier return to work.

Laparoscopy has presently shown excellent usefulness in cases of peritoneal carcinomatosis, allowing diagnosis as well as palliative treatment when appropriate. No longer does the patient require large midline incisions when even peritonitis is present.

Laparoscopy has also revolutionized the approach to complicated bowel pathology, even when intestinal perforation is present. Recent studies show that laparoscopic lavage is equally effective for perforated diverticula or purulent peritonitis as in open surgeries with lesser incidence of wound infection.

Colorectal It was not only laparoscopic cholecystectomy or appendicectomy, but in all other abdominal diseases, the advantages of laparoscopy have been well delineated.

In Colorectal surgeries, the enthusiasm for minimally invasive techniques grew slower than expected. The application of laparoscopic methods was not easy owing to the complexity of colorectal surgeries, requiring largesize specimen removal, highly effective vascular control and ability to obtain adequate oncological margins for various multi-quadrant surgeries, and the construction of an anastomosis. This hesitation has now been reduced owing to advanced instrumentation, documented evidence on outcomes and more importantly, the understanding of the surgical technique despite the long learning curves.

Several trials have addressed the oncological safety of the laparoscopic approach. The Clinical Outcomes of Surgical Therapy (COST) trial, Colon cancer Laparoscopic or Open Resection (COLOR) and Conventional versus Laparoscopic Assisted Surgery In Colorectal Cancer (CLASICC) have all demonstrated that there was no compromise in lymph node clearance, with similar overall and disease-free survival rates between the open and laparoscopic groups. Even large, multicentre, prospective, randomized trials have shown that the concerns of oncological clearance or recurrence have been similar to open surgery in rectal carcinoma, with respect to circumferential resection margin involvement rates. The laparoscopic approach to rectal 39

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cancer for a complete mesorectal excision demands unique and advanced technical expertise. Laparoscopic approach groups go a step further to establish lesser blood loss, quicker bowel recovery and lesser hospital stay but the operation times are longer.

learning curve and a large scope for continued innovation both in operative techniques and post-operative care.

Most studies performed on liver operations laparoscopically have been observational with low quality evidence.

Hand-assisted laparoscopic surgery (HALS) includes a minilaparotomy—made through either a mid-line or Pfannenstiel incision, with consequent placement of a hand port to permit insertion of the surgeon’s hand into the peritoneal cavity. This allows tactile sensation that is missing with laparoscopy. Easier dissection and retraction has been shown with HALS. However, HALS technique may encourage blind and blunt dissection of the rectum, which contradicts the fundamental principles of total mesorectal excision (TME). Any deviation from established oncological principles, which in this case involves precise, sharp dissection in the areolar tissue plane under direct visualization, puts the approach at risk of local recurrence. HALS has been demonstrated to be inferior due to this aspect.

As long as the surgeon is sufficiently trained and has sound knowledge of the oncological principles, laparoscopic colectomy can be as safe as an open surgery.

Laparoscopic anterior resection and abdominoperineal resection are technically more challenging than other colonic surgeries. Patient risk factors such as obesity, previous pelvic radiation or prior abdominal surgery are not a contraindication to a minimally invasive approach despite adding difficulty for the surgeon.

Major hepatic resection is made proficient only by a thorough comprehension of the segmental anatomy and its relationship to the major vascular structures. Blood loss is one of the most important factors influencing postoperative outcome from hepatic resection. As the number of hepatectomies have increased, so too have the techniques to minimise blood loss, including the armamentarium of surgical devices available to facilitate the different aspects of liver surgery. Ultrasonic scalpels, bipolar cautery forceps, and staplers, and cavitron ultrasonic dissector are the devices being used at present.

Hepatobiliary The recent practice of laparoscopic in the field of hepatobiliary disease has seen a tremendous change compared to the technique first established more than 2 decades ago. Technology has overcome many challenges and the surgical outcomes have been excellent.

The scope of laparoscopic liver resection has seen a considerable change since the early 1990s. It was at first, used for resection of small and superficial lesions. Today, laparoscopic left lateral sectionectomy has become a standard operation and more complex liver operations are being performed. The most ideal situation for laparoscopic liver resections have been solitary lesions anatomically situated in the peripheral liver segments especially for tumours less than 5 cm.

Major laparoscopic liver resection is the resection of three or more segments of liver and minor is the resection of one or two liver segments. Major resection is in the phase of exploration and development, with a steep Ann. SBV, July-Dec 2017;6(2)

In laparoscopy, the surgeon approaches caudally - which provides a better exposure around the great vessels and hilar structures including identification of the Glissonian pedicle at the hilum. Understanding of various transections ensures better identification of vascular structures. Advances in technology of surgical instruments and optimal patient positioning has made resections in posterosuperior segments feasible. Development of superior haemostatic devices, with better understanding of hemodynamic and anticoagulation mechanisms in the post-operative period has made minimally invasive hepatectomy a safe procedure in the hands of a skilful surgeon.

The present treatment of common bile duct stones remains a constant debate between use of endoscopic cholangiopancreatography (ERCP) and common bile duct exploration. Stones in the CBD can be managed in a single- stage procedure by laparoscopy itself. This is the most appealing concept as it reduces postoperative stay and total costs. Hence laparoscopic bile duct exploration has been increasingly advocated in the primary management of common bile duct stones in spite of its technically challenging nature.

Two main options have been described to perform laparoscopic CBD exploration, and both the techniques rely upon a choledocoscope. This is becoming more available in larger centres. The technique of entry to bile duct differs. The approaches may be via a transcystic approach through the cystic duct or with a choledocotomy on the bile duct itself. Clinical outcome and practicability of minimally invasive common bile duct (CBD) exploration via both approaches Ann. SBV, July-Dec 2017;6(2)

have been reported with high efficiency and minimal morbidity. Surgeons are expected to have skills both in laparoscopy as well as in endoscopy. A metaanalysis to compare two staged (ERCP followed by laparoscopic cholecystectomy) and single staged laparoscopic CBD exploration demonstrated equivalence in stone clearance from the CBD, postoperative morbidity, length of hospital stay, and total operative time.

Expert laparoscopic skills must be matched with individualised management of patients with CBD stones, determined appropriately on the condition of the patient, expertise of operators, and local resources.

Though not advocated in the setting of sepsis, laparoscopic CBD exploration shows potential to be efficient and cost effective in the non-septic patient with CBD stones.

Hybrid Procedures When dealing with tumours, the oncological safety margin is imperative but the removal of excessive normal tissue is unacceptable. There exists a fine line between sound margins of resection and unnecessary removal of normal surrounding tissue. Accomplishing this target is made easier by combining two well established procedures – Endoscopy and Laparoscopy.

In case of gastric tumours such as gastrointestinal stromal tumours, it becomes a challenge to determine the line of incision especially when the lesions are intraluminal. Abnormal tissue must be removed with oncological safety margins and excessive stomach wall removal results in complications and increased morbidity.

The appropriate incision line for local resection of the stomach can be determined by lesion-lifting gastrectomy, hand-assisted laparoscopic surgery, the tumour eversion method, and laparoscopic-endoscopic rendezvous resection. Endoscopic submucosal dissection (ESD) which has been popularised in the eastern part of the world for early stomach cancers has been used to convert a morbid organ-saving treatment into an equally effective minimally destructive surgical procedure. The amalgamation of these two techniques namely ESD and laparoscopy has paved way for “Hybrid “surgeries and seeks to be a less invasive and less destructive treatment of the future.

However, the open approach ispreferable in the setting of for large tumours, tumours located at

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posterior gastric wall, esophagogastric junction, and the area near the pylorus, to ensure negative margins Laparoscopic and endoscopic cooperative surgery (LECS) overrides the disadvantages of laparoscopyonly procedures. Currently, LECS has evolved into several other procedures such as laparoscopy-assisted endoscopic full-thickness resection (LAEFR) and several nonexposure techniques, such as inverted LECS, a combination of laparoscopic and endoscopic approaches to the treatment of neoplasia with a nonexposure technique (CLEANNET), nonexposed endoscopic wall-inversion surgery (NEWS), and laparoscopic transgastric surgery (LTGS).

All these advances avoid making an opening in the gastric wall leading to the peritoneal cavity. However, laparoscopy-assisted endoscopic resection (LAER) and other techniques have been dependably used for colonic polyp removal. Conventional surgical techniques have now been challenged by these combined approaches.

Laparoendoscopic full thickness resection is wellthought-out to be an appropriate decision for removal of upper gastrointestinal stromal tumours in view of technical feasibility. This is true, predominantly in GISTs, and it is superior to procedures involving endoscopy alone. Nevertheless, the sentinel lymph node concept is underdeveloped owing to the complexity of the lymphatic flow of the stomach. This makes the usage of hybrid procedures questionable. In terms of treating difficult colon polyps, laparoendoscopic collaborative procedures seem to be feasible and safe.

This paper outlines some of the recent concepts in laparoscopy. Understanding issues like imaging and ergonomics help the surgeon achieve better efficiency and safety. Advances described in the field of GI surgery should stimulate surgeons to learn and take up these procedures in their practice. This will improve the quality of life of our patients further.

1. Schwab K, Smith R, Brown V, Whyte M, Jourdan I. Evolution of stereoscopic imaging in surgery and recent advances. World Journal of Gastrointestinal Endoscopy. (2017);9(8):368-377.

2. Abu Gazala M, Wexner SD. Re-appraisal and consideration of minimally invasive surgery in colorectal cancer. Gastroenterology Report. (2017);5(1):1-10.

3. Parker JM, Feldmann TF, Cologne KG. Advances in Laparoscopic Colorectal Surgery Surg Clin N Am 97 (2017) 547–560.

4. Choi, Sae Byeol et al. Current status and future perspective of laparoscopic surgery in hepatobiliary disease The Kaohsiung Journal of Medical Sciences. (2016); 32, (6), 281 – 291.

5. Hybrid NOTES Combined Laparo-endoscopic Full-thickness Resection Techniques Kim H H, Uedo N, Gastrointest Endoscopy Clin N Am 26 (2016) 335–373.

6. Mandrioli M, Inaba K, Piccinini A, et al. Advances in laparoscopy for acute care surgery and trauma. World Journal of Gastroenterology. (2016) ;22(2):668-680.

7. Shabbir A, Dargan D Advancement and benefit of energy sealing in minimally invasive surgery Asian J Endosc Surg 7 (2014) 95–101.

8. Rivas H, Díaz-Calderón D Present and future advanced laparoscopic surgery. Asian J Endosc Surg 6 (2013) 59–67.

9. Catanzarite T, Tan-Kim J Whitcomb EL, Menefee S. Ergonomics in Surgery: A Review. Female Pelvic Med ReconstrSurg 2017Sep 13. doi: 10.1097/SPV.0000000000000456. [Epub ahead of print] 10. Kaiser AM. Evolution and future of laparoscopic colorectal surgery. World Journal of Gastroenterology: WJG. (2014) ;20(41):1511915124.

11. Di Saverio S. Emergency laparoscopy: a new emerging discipline for treating abdominal emergencies attempting to minimize costs and invasiveness and maximize outcomes and patients’ comfort. J Trauma Acute Care Surg. (2014); 77:338–350

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Challenges in Ethical Medical Practice Joseph Thomas MS, MCh, DNB, FRCS, PGMLE, PGDBE Access this article online Quick Response Code

Professor of Urology, Kasturba Medical College, Manipal Head Centre for Bioethics, Manipal University

Conclusion

bbFurther Reading

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Introduction Ethics refers to the ones actions that are determined by moral decisions. Medical Ethics is the moral conduct and principles that govern members of the medical profession and uses a system of moral principles that apply values and judgments in the practice of medicine. Bioethics is the systematic study of the moral dimensions of life sciences and healthcare employing a variety of ethical methodologies in an interdisciplinary setting.

Medical practice is one of the most challenging professions which tries to help a person in his suffering and bring him back to health. At the centre of this “noble” profession is a compassionate doctor who is always at the service of the suffering person.

The special doctor patient relationship empowers the doctor to use his knowledge and skills for the wellbeing of the unwell and vulnerable patient who trusts the doctor’s judgment. This relationship mandates the highest standards of ethical behaviour from the doctor in order to foster this trust. First and foremost it is important that the doctor gets the adequate level of technical competence that is needed for performing this responsibility. At the same time it is important get trained in value judgments on the best course of action that is needed in the best interests of the patient. Although these ethical decisions are subconsciously made all the time, a conscious awareness is also important to make the right ethical choices and improve patient satisfaction and safety. Medical practice can be perceived differently by members of the profession.

1) Occupation – gainfully occupied earning a living, 2) Profession – adheres to a higher standard of conduct, 3) Vocation – needing the highest level of Ann. SBV, July-Dec 2017;6(2)

commitment and dedication. But unfortunately not everybody considers Medical Practice as a vocation.

There are many reason for this erosion of values and it is high time that one ponders on why this has happened and think of ways of bringing it back as a vocation.

Principles of Bioethics Autonomy, beneficence, non-maleficence and justice are the basic Ethical Principles that govern not only Medical Practice but also Research involving Human participants. The concepts of informed consent and confidentiality arise out of the basic principle of autonomy. It is very important to adhere to the provisions of informed consent. This is an important legal requirement. It is not advisable to provide treatment against ones wishes except in emergency situations and when the doctor feels that the capacity of the patient to be autonomous is lost. The patient’s disagreement to the treatment that is offered should be honoured by the treating physician. Maintaining confidentiality of the medical data of a patient is a very important component of a healthy doctor patient relationship. There is an increasing number of health care personnel who will be accessing the patient data during the course of the treatment. Insurance companies and employers also demand the medical data as mandated by the provisions of the insurance policies or employment. Patient relatives may be interested in getting the medical records for other vested interests than medical care. The electronic record keeping also should restrict access only to the authorised personnel.

It is very important for the medical establishment to have guidelines for maintaining and accessing the patient medical data without breaking the principles of confidentiality. www.annals.sbvu.ac.in

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The principles of beneficence and non-maleficence are often followed diligently in medical practice.

However sometimes treatment can result in harm to the patient either accidently and unintentionally.

Disclosing medical and surgical errors are a challenge to any health team and very often efforts are made to cover it up. However it is important to convey these in an appropriate way and steps taken to mitigate the suffering due this misfortune. This will go a long way in maintaining an effective doctor patient relationship for the benefit of all. The higher incidences of attacking the medical personnel and the Institutions are partly due the frustration of the patient and relatives. It is very important that healthcare professionals take special efforts to be sensitised to the needs of the vulnerable population. These issues are now becoming of an increasing concern with a larger number of migrants into the cities and refugees from conflict situations.

People suffering from stigmatising diseases like HIV raises special ethical concerns during their medical treatment.

There are many ethical challenges and conflicts that the medical personnel face in the practice of their profession. These challenges and conflicts are due to a variety of related issues that has come about in the recent times. It includes the advances in the medical technologies that has made medical care more complex, decreasing role of the Government in health care and increasing cost of medical treatment. A few of these ethical challenges are discussed for the point of view of ethical issues.

Multi-specialityhealthcare In the past medical care was often a personal care of a suffering patient by the doctor –“healer” who tried to comfort the suffering patient, often with the God as a mediator in the process. The rapid advancements in the medical field necessitate a large number of specialists who are involved to provide a total and holistic care for the patient. This ever expanding field usually includes doctors, allied health specialists, nursing professionals, pharmacists and social scientists. The increased use of technology in healthcare also needs specialists in engineering, biotechnology, molecular biology and genetic engineering. It also becomes important that each of the team members identify their specific role in the total management of a patient. The patients are often at a disadvantage as they cannot identify themselves with anyone in the team of specialists as their care provider. It is prudent to have one person in the team to play a leadership role. This person can interact with 43

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the various specialists and can be more in contact with the patient helping him to take appropriate decisions.

There should be good interpersonal relationship and mutual respect among the various specialists to achieve a successful patient outcome. It is also necessary to incorporate training in communication skills. Training is also needed to work as an efficient medical team in thecurrent interprofessional multispecialty approach to medical care. Though this aspect has been mentioned in the various Professional Acts much needs to be desired about the actual practice.

Regulatory Bodies The first and foremost part of the health care delivery is the training facilities that are available in India and abroad. The training offered in India is supervised by the appropriate Regulatory Body who is empowered by the various Acts. The Medical Council of India, Dental Council of India, Nursing Council of India, Pharmacy Council of India and the Disability Council of India controls the training of Allopathic Doctors, Dentists, Nurses, Pharmacists and Allied Health Professionals.

Some of these Acts specifically mentions the nature of Unethical Acts that should not be followed by their registered professional and the punitive actions that can be taken against them. The Medical Council of India Act is more detailed in this regard. But it is of concern that these Acts do not incorporate a curriculum for Bioethics training during the training period for their respective professional student. But it is heartening to note that some of these bodies have taken steps to include bioethics in the curriculum during the training period. It may be prudent that it is included as a mandatory skill that is required and notas an optional subject. This will make better Professionals with skills that will equip them to deal with actual ethical challenges during their future practice.

Training Institutions Training of Health care professionals was earlier predominantly in the Government owned Institutions in India. However with the liberalisation of Healthcare training, there has been an explosion of Private Institutions that offer a variety of training facilities in all the Undergraduate, Postgraduate and Super speciality specialisation in almost all the branches of Medicine and its allied specialities. This is a welcome development which makes training facilities accessible to a large number of aspiring health care professionals across India. But there is a great disparity in the training that is given that questions the quality of the Ann. SBV, July-Dec 2017;6(2)

professionals that get qualified from these Institutions.

It is of great concern that these fresh trainees may not be fit enough to practice their speciality without further training. The training facilities that are available in the recognised Institutions vary significantly across both the Government and Private Sectors. It is high time that the standards are made uniform across all the Institutions across India so that the minimum standard of a fresh graduate remains the same at the time of qualification. It is worth noting that the Government of India is contemplating a Registering exams after the qualifying exams to make one eligible for their registration number allotted by the Registering Authority. While this is a welcome move to bring standardisation it is of concern that improving the standards of training is not appropriately addressed.

Specialisation and super specialisation With the advancement in medical field it has become impossible for a general practitioner to be well versed in all the advancements and offer it in the care of the patients. This has led to development of specialities and super specialities. It is important to identify the role that has to played by each of these in the health care delivery. In India this is unregulated and patient choose their own doctors. This leads to patients with even minor ailments going to specialists. Part of this anomaly is due to the glorification of the specialists with a higher pay package. This leads to more and more specialists and less and less generalists who could have done a better delivery of care at a local level.

Updating knowledge – reaccreditation – continuing education The current scene in India sanctions a professional to continue practice as long as he has his valid registration that was given during the first accreditation. The medical field is unique in its rapid advancements that needs constant updating of one’s knowledge and skills.

There are programs conducted by the Professional bodies and Institutions to continue learning and to update about the developments and improve knowledge and skills. But most of these programs are not structured to satisfy the diverse types of practice in India which ranges from individual practice to Institutional Practice. There have been efforts by various bodies that mandates their registrants to attend continuing education and get mandatory hours of relearning. But its strict implementation needs a lot to be thought off as reaccreditations are not made mandatory. A proper structured training program planned and implemented Ann. SBV, July-Dec 2017;6(2)

by a regulatory body keeping in mind the varying levels of practice will go a long way in providing better advanced care to the patients.

Training in Newer procedures and technologies The advanced technologies used in medical practice needs one to be trained before using these in a clinical situation. It is always an ethical challenge to train one in these without harming the patients during this process of training. Are the patients been informed that this new procedure is being tried on the patient and that the person is also is in training? It is better to have a system of simulated training and even animal training before using in human. This is the only way newer technologies can be introduced to replace or modify the existing technology for the betterment of patient care. However it is important that the health professional takes adequate care that the patient is not put into unnecessary risk and adequate precautions are taken.

Performing procedures one is not trained to do It is very important that a health care professional does not do a procedure that one is not trained to do. However the medical practice is too vast for one to be proficient in all aspects during the training period. Thus medical practice is one of continuing training. There should be a system where one can be judged based on his skills to be doing some procedures under supervision, before they are done on their own. This is an ideal situation which may be possible only in larger institutions with more man power. But in majority of the circumstance it is not possible. At the same how to ensure that one gets appropriately trained before doing the procedure on his own. This needs training institutes that can offer structured training. Unfortunately this continuing training is often not possible in India after the initial training for the qualifying degree.

Spectrum of health care facilities Most of the health care institutions in India were mainly under the Government Sector. This ranged from the Primary Health Centre to Taluk and District Hospital and the Medical College Hospitals. This catered to the preventive and curative health care of a large group of people across India. The rapid expansion of the Private www.annals.sbvu.ac.in

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Sector in the Health care saw the establishment of large Corporate Hospitals offering advanced treatment.

Most of these corporate hospitals were established in the big cities and the medical costs were usually high for the facilities that were offered. The work culture also varied widely in these facilities in the Government and Private sectors. The remuneration that is offered also significantly varies. A fresh graduate has to decide between these vastly differing situations and is expected not to forget the basic ethical values to work ethically in both these differing situations. The training period is usually deficient in exposing the trainees to the actual practical situations.

Conflicts in decision making Modern medical practice necessitates the involvement of many specialists to complete treatment for the patients. This can often lead to various suggestions that can confuse the patient in taking a proper decision making regarding their treatment. In a multi-speciality hospital set up it is better that the primary treatment specialist takes the responsibility to explain and help the patient in taking decisions involving many technical aspects. At the same time it cannot be ignored that any complaints that come from the treatment involving multiple specialists has to be handled by that specialist who had managed that aspect. It is better that there is one healthcare specialist which can be a family practitioner who will be in a better position to give proper advices. It is common to have differing opinions among the patient and relatives about medical care issues. It needs special skills from the health care professionals to balance these differing views and act in the best interest of the patient. A hospital based Clinical Ethics Committee can be useful in giving a balanced advice in cases with complex ethical issues.

Treatment costs The cost of medical treatment has increased many times.

This is partly due to the newer technologies that is often associated with higher costs. It is important to note that in India, majority of patients do not have medical insurance to cover the cost of treatment. Thus majority of the patients bear the cost of medical treatment on their own which is often beyond their means of income.

This leads to a conflict situation where the doctor has to offer cheaper investigative and management options to poor patients when he knows that the costlier option is the better one. At the same time he knows that the costlier option can also financially drain the patient.

This puts a lot of ethical dilemma on the doctor to 45

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balance the efficacy and cost of treatment according to the financial status of the patient.

End of life issues There are many ethical challenges concerning issues about end of life care. Now the modern technology can keep a patientâ&#x20AC;&#x2122;s life longer even in very critical medical care situations. On one side this has given hope to patients who are on life support with the hope that they will come back and lead a normal life. On the other side this only prolongs the suffering of many people.

This bring in the questions of withholding treatment and withdrawing treatment. A medical professional is within his professional right to withhold advanced and costly treatment in conditions which he considers futile to treat. But withdrawing treatment is akin to passive euthanasia which is illegal in India. The legal position in India is for the High Court to decide on withdrawing treatment considering the facts of an individual case based on set guidelines. But is a known fact that withdrawing life support at the request of relatives is a common situation in daily practice. It puts a big responsibility on the health care providers to withdraw the life support in the absence of specific guidelines. The suggestion to have a prior living will regarding end of life issues may a welcome step in this line. Transplantation of Human Organs Act legalises declaration of brain death with a possibility of multi- organ donation. But brain death declaration without organ donation is not allowed at present.

Communication of death is another important challenge and all health care professionals should be trained to handle this grief situation. But it is challenging and emotionally draining to handle a situation when there is allegation of negligence on the part of health team. It is better to have a hospital protocol of who will declare death and convey it in these kind of special emotionally charged situations. A health care team member who was actively involved in the case will have a better rapport with the patient family and will be in a better position to convey the bad news.

Less importance to preventive care Modern medical care is advanced and is more oriented to curative care. However it is equally important to promote preventive health care. Unfortunately not much importance is given to this aspect of medical care.

It is imperative that the medical practitioners highlight the importance of these and give appropriate preventive advices also. It will go a long way in preventing illnesses by targeting the root cause.

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Insurance schemes There is an increasing presence of Insurance facilities that cover treatment for most of the medical conditions.

This is available both as a personal insurance or Governmental Insurance schemes for special populations. These schemes will defray to a large extent the cost of medical treatment and makes it affordable to people. At the same time the medical profession has to tailor their practices to suit the rules and regulations of the insurance companies. The investigations and management are often dictated by these companies and these have to be followed. This makes it important for the health professionals to change their management and hospitalization to suit the guidelines. It has to be noted that some medical conditions like alcoholism or HIV Diseases are not covered by insurance schemes.

These are the people who will benefit more from these insurance schemes.

Other systems of Medicine

from these companies. There are many surreptitious ways of overcoming these guidelines which have more of an ethical bearing rather than a legal binding. It cannot be ignored that the final burden of these will be borne by the patients and this is highly unethical.

Device industry The advances in technology has brought in many newer instruments and devices that are of immense benefit to patients in managing their medical conditions. Cardiac stents, valves and Orthopaedic prosthesis are some of the examples of this technological advancement.

However there is a higher and varying cost for most of these products. It is challenging to the healthy professional to select the optimal one according to the finances of the patient and not fully according to the merits of the device. The professional has to make a balanced decision which makes it financially viable for the patient and at the same time not using an inferior one to a poor patient.

India has a diverse array of registered medical practitioners in Allopathy, Homeopathy, Ayurveda, Siddha and Unani. Each of these systems have their own regulatory bodies. There are many self-styled indigenous healers using various other forms of treatment without much regulatory control. It is unethical and often illegal to practice a system than of your own registration it is common practice in India where cross practice is rampant. The patients also often ask advice regarding the alternate forms of medicine. It is unethical to comment on the advantages or disadvantages of another system of medicine than the one in which one is trained.

Web or app based consultation, telephone consultations

Pharmaceutical companies

It is considered as an ethical duty of all health care professionals to bring to the notice of appropriate authorities about professionals who are incapacitated due to various reasons and may be considered as a hazard to practice. This necessary duty is usually painful as it is often against a colleague and one considers as a duty to stand by their colleagues. However it is important that the welfare of the patient also has to be considered and he cannot be put to risk due this incapacitated professional. While a sympathetic approach can be taken it is imperative that this should not affect the treatment of the patient. Malpractice is also of concern and it is often necessary to bring this out. However this often results in many hardships to the whistle-blower as it often against the authorities and the system that one has to fight with.

Pharmaceutical companies have played an important role in the development of new drugs and vaccines.

They also play a crucial role in disseminating this information among the practitioners. Most of the academic teaching programs are also conducted with the educational financial support of these companies.

From a distance this looks like an important supportive role for academic purposes. But it puts pressure on the Institutions and the Organisers to promote the products of these supporting companies. With the proliferation of these companies it became an important marketing strategy to favour medical practitioners to selectively promote their products. This has reached a level where the Regulatory bodies have laid down principles about the nature of favours that can be taken Ann. SBV, July-Dec 2017;6(2)

These have been considered as a necessity of the present era, defining the concept of a patient doctor relationship. While it is useful and convenient for the patients to contact the doctor and get advices about their treatment. However it is too early to conclude that this is a successful alternative to the conventional doctor patient relationship with its personal contacts.

Incapacitated health care personnel.

Whistle blowing about malpractice

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Strike for benefits / Protests The strikes and protests by the various health care professionals to meet their demands is becoming a common situation now. On the protestors side they feel that a crisis situation like boycotting delivery of health care will open the eyes of the administrators to take actions to meet their demands. But the other side is that the patients are put in a difficult situation which often may end deleterious to the patients. The efforts by the Government and the Judiciary to ban these strikes may not be a proper solution. There should be a mechanism whereby the just demands of the health care professional is reasonably met. This will prevent the professionals from being pushed into a desperate situation of leaving their patients unattended. This will go a long way in preventing unnecessary burden to the already suffering patient Commissions, Advertisement The Medical Council of India Act considers as unethical cuts and commissions that are given for the referrals for investigations and higher care. It is high time that a concerted effort is taken by all the health care personnel to see that this evil is routed out from medical practice.

The MCI Act also specifically considers as unethical advertisement by Doctors about their services, except in certain specific situations where it is allowed. This was probably intended to avoid misguiding patients by these advertisements. But the other argument is that this will give patients a chance for informed choices and they are in a better position to make a proper choice to get the best treatment available in the best facilities.

Web based advertisements and other surreptitious methods are being increasingly being used to counter this restriction from the regulatory body.

Training in bioethics The doctors and other health care professionals are traditionally held in high esteem and are supposed

to conduct themselves ethically not only in their personal life but also more importantly so in their professional practice. These ethical values were an integral part of medical care and was inculcated into the students by their teachers during their period of training. But in the current broad system of training it is impossible to train the students in all the ethical values in an unplanned manner by few practitioners.

It is necessary to have a structured training program throughout ones professional training period. This can be achieved through regular lectures, case studies during their training with actual patients in the daily case scenarios. It requires the teachers and the other specialists in the field to identify the ethical principles that have to be taught in their speciality that can be incorporated into the curriculum all over India.

As a next step, concerted efforts are needed to train adequate staff members in more advanced areas of bioethics, who can deliver it their own Institutions.

The regulatory bodies also have to frame rules to make ethical education mandatory in teaching and evaluation of the various health science courses. They also have to oversee its proper implementation in all the Institutions.

Conclusion There are many ethical challenges that the members of the health care sector faces in their everyday practice.

As the health of the patient is of primary importance a high level of professional ethics is needed from all the members of the healthcare team.

The principles of the Medical Ethics should be included in the curriculum of health science courses.

It is also necessary to practice this on a daily basis.

This will go a long way in restoring the healthy doctor patient relationship and will restore medical practice to its Noble traditions.

Review Article HemophiliaCare: The way forward

Professor and Head, Dept. of Pathology and Associate Dean, Melaka Manipal Medical College, Manipal University President, Hemophilia Society, Manipal

Introduction Hemophilia is an inherited X linked disorder due to deficiency ordysfunction of coagulation factor VIII causing hemophilia A and factor IX causing hemophilia B. As per the global survey of the World Federation of Hemophilia, the prevalence of hemophilia is 1 in 5000 male births and 1 in 30,000 male births in hemophilia A and B respectively. It is estimated that there are more than 400,000 people with hemophilia (pwh) in the world. There are more than 3000 mutations in the factor VIII and IX genes causing varying clinical severity of the disorder. Around 70% of patients have a positive family history. However, in one third of the pwh, a spontaneous mutation can cause the disorder when there will be no prior family history. Hemophilia A and B are clinically indistinguishable heterogeneous disorders. Their clinical manifestations are identical, with an increased tendency for musculoskeletal, soft tissue and mucocutaneous bleeding. Bleeding into other organs can also occur. The severity of bleeding symptoms correlates with the coagulant activity of the deficient factor.

This article is intended to provide a brief account of the present management strategies, complications and advances in hemophilia care with a note on the present Indian scenario.

Diagnosis A correct diagnosis is essential to ensure that the patient is treated appropriately. Different bleeding disorders may have similar symptoms though their product for treatment is different. A prolonged activated partial thromboplastin time(APTT)with measurement of factor VIII or factor IX clotting factor activity in 47

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Annamma Kurien DCP, MD

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blood is required for the diagnosis of hemophilia. The clotting factor activity is needed to calculate the dose of the factor to be infused and also to monitor the response to treatment. The clotting factor activity of factor VIII /IX can be assessed by one stage, two stage, or chromogenic assays using automatic coagulation analysers. Recent methods of testing also include thrombin generation tests and global assays.

Based on the coagulant activity of factor VIII or IX, hemophilia is classified into 3 types- severe, moderate and mild. Patients with coagulation factor level of less than 1 IU/dl (<1% of normal) are classified as severe and constitute about half of the diagnosed cases.

Moderate haemophilia is defined as factor levels of 1â&#x20AC;&#x201C;5 IU/dl (1â&#x20AC;&#x201C;5% of normal), and mild disease has factor VIII levels of 6-40IU/dl(6-40%of normal).The normal level of factor VIII/IX is 50 to 150%.It has been found that there is heterogeneity in about 30% of patients where the severity of the disease is not concurrent with the clotting factor activity by the different methods of testing.

Genetic analysis Genetic analysis to identify the causative mutations is recommended in all patients as it helps to identify female carriers in the family. More than 2000 unique molecular defects have been described in the factor VIII gene of which inversions of intron 22 and intron 1 are the common mutations. In the factor IX gene about 1095 unique mutations have been described.

DNA based mutation analysis is now available in many centres. Prenatal diagnosis is usually offered when termination of pregnancy would be considered if the fetus is found to be affected. Genetic counselling prior to prenatal testing is imperative. Prenatal testing by www.annals.sbvu.ac.in

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chorionic villi sampling is best done between 9 to 14 weeks of gestation or amniocentesis can be done at 15 to 17weeks of gestation. Preimplantation genetic diagnosis also provides an opportunity for selection of embryos without the specific mutation so that couples or carriers can have pregnancy with an unaffected child.

Management of hemophilia The primary aim of hemophilia care is to prevent and treat bleeding with administration of the deficient clotting factor or the specific factor concentrate.

The factor replacement therapy protocols include episodic (on demand) treatment when infusions are given at the time of clinical bleeding. The dose,frequency and number of infusions depend on the severity of the bleed. Prophylaxis is treatment with intravenous infusions 2 to 3 times a week to prevent bleeding and joint damage. Primary, secondary and tertiary prophylaxis is long term treatment before 2 years,before joint disease or after onset of joint disease respectively. Low dose prophylaxis as is practised in developing countries including India with limited supply of concentrates is by infusion of 10 â&#x20AC;&#x201C; 20 IU/kg once or twice a week. However there are uncertainties regarding prophylaxis about the age of initial treatment, duration of treatment, dosing regimens and long term outcomes.

Treatment products The World Federation of Hemophilia (WFH) recommends the use of virally inactivated plasma derived or recombinant concentrates in preference to cryoprecipitate and fresh frozen plasma as replacement therapy for hemophilia. However cryoprecipitate and frozen plasma are being used in countries around the world where it is the only available or affordable option.

The short half-life of factors (8-12hours for factor VIII and 18-24 hours for factor IX) requires that the factor infusions need to be given frequently.

Bioengineering technology has increased the half-life of recombinant factors by processes like PEGylation whereby the half-life of recombinant factor IX has been improved 3-6 times and factor VIII 1.5-1.6 times. Clinical research is underway of technologies to enhance hemostasis by products other than replacement factor concentrates. There are also ongoing clinical trials on subcutaneous administration

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of products which would simplify prophylaxis in children with poor venous access.

inhibitors, black ethnic origin and polymorphisms of immune-response genes like IL-10 and TNFA.

Other pharmacological products which are useful include

b. Treatment-related factors like number of exposure days, intensity of exposure, product type ie plasma derived versus recombinant,age at first exposure and prophylaxis with factor replacement therapy.

1. Desmopressin (DDAVP) synthetic analogue of vasopressin that boosts plasma levels of factor VIIIand von Willebrandfactor. It is used in the treatment of mild or moderate hemophilia A and also in the treatment and prevention of bleeding in carriers.

2. Tranexamic Acid is an antifibrinolytic agent used as an adjuvant in the control of bleeding from skin, mucosal surfaces and oral bleeds.

Gene therapy A curative treatment for hemophilia is possible with gene therapy whereby there can be clinical/phenotypic improvement and increase in in-vivo coagulation activity. Various vector delivery systems were in use of which adeno associated virus(AAV) mediated approach attracted attention in spite of limitations. The promising results in hemophilia B whereby patients treated with gene therapy had a stable expression of factor IX levels for about 5 years without side effects is the hope for a cure for hemophilia A too.

Inhibitor development The major complications of hemophilia include chronic hemophilicarthropathy,inhibitor development and transfusion transmitted diseases.

Inhibitors are polyclonal IgG antibodies against the clotting factors. It is suspected when a patient fails to respond clinically to the administered clotting factors. It is frequently encountered in patients with severe hemophilia compared to moderate or mild hemophilia. The incidence or lifetime risk of inhibitor development is 20-30% in severe hemophiliaand about 5-10% in mild disease.

Inhemophilia B it is much rarer, the risk being less than 5%. The risk factors for inhibitor development include a. Patient related factors like severity ofhemophilia, factor VIIIgene mutation, family history of

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The screening for inhibitors is done using APTT mixing where factor VIII inhibitor is a delayed type of inhibitor(APTT with pooled normal plasma mix remains not corrected after 2 hours of incubation). The confirmation and quantification of inhibitor is done using the Nijmegan modified Bethesda Assay.

Inhibitor testing needs to be done in children more frequently according to the exposure days to factors. In adults, inhibitor testing is done in non-responsiveness to factors, intense treatment of more than 5 days or at 6-12 monthly review after more than 150 exposure days.

Inhibitor level that are persistently less than 5 BU/ml (Bethesda unit/ml) are low responding inhibitors whereas in high responding inhibitors, the level is â&#x2030;Ľ 5 BU/ml. Low responding inhibitors may be transient and may respond to high doses of factor concentrates which will neutralise the inhibitor with the excess factor activity. High responding inhibitors may be persistent and respond to bypassing agents which circumvent the need for factor VIII or factor IX by generating thrombin through other mechanisms.

Bypassing agents available are activated prothrombin complex concentrate (APCC, FEIBA) and recombinant activated factor VII (rFVIIa). Eradication of inhibitors in severe hemophilia A is possible through immune tolerance induction therapy.

Comprehensive care Hemophilia though rare is a complex disease to manage.

Optimal care is not just about treating acute bleeds.

Being a lifelong disease, improvement of health and quality of life of pwh is a necessity.

This includes treatment of bleeding, prevention of joint damage, management of complications, physiotherapy and exercise to maintain joint health, psychosocial support and oral health. Education about the disease and monitoring quality of life are all of

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utmost importance to the patientsâ&#x20AC;&#x2122; health. These needs of the pwh can be met through comprehensive care delivered through a multidisciplinary team of health care professionals. The core team members include a medical expert (hematologist, paediatrician, physician), orthopaedic surgeon, physiotherapist/ occupational therapist, laboratory specialist and psychologist/ social worker. The pwh need to be evaluated by the comprehensive care team at least yearly whereby the problems and complications can be adequately addressed. The comprehensive team is also responsible for the education of the pwh, their families and monitoring the outcome of the disease.

The Indian scenario In India, there is an estimated 1,00,000 people with haemophilia of which only about 16,000 have been identified. The Hemophilia Federation of India (HFI) is the registered national patient member organisation founded in 1983 working for the welfare of pwh through its 79 chapters in the four regions of the country. HFI in New Delhi is affiliated to the World Federation of Hemophilia (WFH) located in Montreal, Canada. HFI aims to reach out to pwh and provide total quality care, education,help to make treatment available at affordable cost, psycho-social support and economic rehabilitation. It also helps to locate undiagnosed persons with hemophilia and provide proper information on hemophiliacare to both pwh, their families and the medical fraternity.

In India, progress is being made to achieve these goals. While there are centres of excellence in government and private sector, there is no uniformity of care at the grass root level. The lobbying of the organisation have helped to muster governmental support for factors. It is heartening to note that about 20 states in India are having funds allotted through the government for hemophilia care so that factor concentrates are available in the district hospitals mostly free of cost.

Many comprehensive care centres too are now being established.

Conclusion To summarise haemophilia is the genetic disease that is treatable but not yet curable. The advance in research is facilitating the treatment with newer

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recombinant products and products of long life.

However complications due to inhibitors is on the rise and problems of the ageing population of hemophilia patients is also increasing. Prevention of hemophilia through genetic counselling is the need of the hour.

The collective efforts of the health care professionals along with patient organisations can help to realise the vision of Hemophilia Federation of India “Haemophilia without disability and children free of pain.”

Review Article Anatomy and its Impact on Current Education and Therapeutics - A Review

bbFor Further Reading 1. Guidelines for the management of hemophilia, Dr.Alok Srivastava etal; Blackwell Publishing in Haemophilia; Epub 6 JUL 2012.

DOI: 10.1111/j.1365-2516.2012.02909.x.

2. The past and future of haemophilia: diagnosis, treatments,and its complications, Flora Peyvandi, Isabella Garagiola, Guy Young.

Lancet 2016; 388: 187–97Published OnlineFebruary 2016http://dx.doi.org/10.1016/S0140-6736(15)01123-X 3. Jayandharan GR, Srivastava A (2011) Hemophilia: Disease, Diagnosis and Treatment. J Genet Syndr Gene Ther S1:005. doi:10.4172/2157-7412.S1-005 4. World Federation of HaemophiliaTreatment Guidelines Working Group. see http//:www.wfh.org 5. Hemophilia Federation of India; http://hemophilia.in

Chandra Philip X, MBBS,MD

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Professor of Anatomy, Sri Balaji Vidyapeeth - Mahatma Gandhi Medical College and Research Institute Campus Pillaiyarkuppam, Puducherry - 607403, India

Introduction The study of Anatomy involves the study of Body structure. Anatomy as a subject has advanced leaps and bounds due to advances in imaging. Studying anatomy is not just for preclinical period. The recent and future advances,along with medicine is changing the way anatomy is being translated to the student1.

Educational perspective The subject of Anatomy is taught in Undergraduate, Postgraduate and Phd Scholars. Some important issues are, the much awaited educational breakthroughs have a direct impact on the way anatomy is taught for both undergraduate students as well as postgraduates.

Anatomical knowledge is a fundamental component of medical science. Anatomical studies done by Leonardo da Vinci enabled him see a clearer picture the way body functioned. It also enabled an understanding of the structures which are below the surface. When Vesalius published “De Humani Corporis Fabrica”(1543) “Descriptive anatomy” became a discipline on its own. That work opened new vista’s for documenting human structure in detail ably facilitated by meticulous Cadaver dissection. some of the newer therapeutic and diagnostic modalities have happened due to advances in research in Anatomy.

E-Learning (computer simulation) is becoming popular in teching anatomy. Earlier students use to be taught anatomy through the use of human cadavers.

The knowledge imparted through this has been shown

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to be better than E-Learning as shown in the research work done by Cary Roseth, Associate professor of educational psychology at Michigan State University.

This research (Anatomical Sciences Education) is the only study which is also scientifically correct directly compared the effects of cadaver-based and computersimulation teaching on students' learning. Their findings indicated that “educational technology can enhance anatomy instruction but is unlikely to fully replace cadavers”. The digital representations did not work as well as the cadaver. Newer insights with more Evidence based studies may help to solve this issue.

Therapeutic and Diagnostic Implications Imaging Techniques: Innovative developments and improvements are occurring regularly in imaging studies. Interventional techniques are also making giant strides like Robotics and Minimally Invasive, reconstructive and microsurgical techniques. The new modalities of treatment have been helped by research describe the appearance of the relevant anatomical structures and organs. The interpretation essentially needs the Anatomical knowledge.

Concept of Angiosome: Taylor and Palmer conceptualized the body in to 3-dimensional vascular territories. These territories are supplied by specific source arteries and drained by specific veins2. The structural unit made up of skin, subcutaneous tissue, fascia, muscle, and bone which are fed by a specific artery and drained by specific vein is known as

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“Angiosome”. According to Taylor and Palmer the entire body can be divided into 40 angiosomes.

The angiosomes are linked by a compensatory collateral web, or "choke vessels". Peripheral vascular Diseases as a new branch has gained stature due to this concept. The premise on which it works is that revascularization of the source artery to the angiosome might result in better wound healing and limb salvage rates. Direct revascularization(DR) of arteries feeding the angiosome (wound area) is more successful in complete wound healing than indirect revascularization3. This has been shown in a larger cohort studies have confirmed this. The Angiosome model and direct revascularisation (DV) has revolutionised the field of plastic surgery.

Angiosome Concept- Lower Limb

OPINION Optimal Healing Environment: A New Mantra for 21st Century Access this article online Quick Response Code

Vice-Chancellor, Sri Balaji Vidyapeeth - Mahatma Gandhi Medical College and Research Institute Campus Pillaiyarkuppam, Puducherry - 607403, India

Conclusion

Introduction

To summarise Anatomy is the basis of entire medical education including diagnostics and therapeutics.

Making the teaching of Anatomy more interesting is the need of the hour. Integrated and Innovative teaching methods will go a long way in the educational journey of aspiring medical professionals.

In this post-modern era, healing practices in Health Care Institutions are gaining importance. Fostering wellness by Salutogenesis1 and promoting healing by creating Optimal Healing Environment (OHE) are two major initiatives in innovative and forward-looking Healthcare Institutions2.

Healing vs Cure

bbReferences 1. Anatomy and its impact on medicine: Will it continue? Norman Eizenberg ; AMJ 2015;8(12):373–377.

2. Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental studies and clinical applications. Br J PlastSurg. 1987;40:113-141.

3. Faglia E, Clerici G, Clerissi J, et al. Long-term prognosis of diabetic patients with critical limb ischemia: a population-based 4. cohort study. Diabetes Care. 2009;32:822-827 5. Berceli SA, Chan AK, Pomposelli FB Jr, et al. Efficacy of dorsal pedal artery bypass in limb salvage for ischemic heel ulcers. J Vasc Surg. 1999;30:499-508.

6. Attinger CE, Evans KK, Mesbahi A. Angiosomes of the foot and angiosome—dependent healing. In: Sidawy AN, ed. Diabetic Foot, Lower Extremity Disease and Limb Salvage. Philadelphia, PA: Lipincott Williams & Wilkins; 2006:341-350 7. Iida O, Nanto S, Uematsu M, et al. Importance of the angiosome concept for endovascular therapy in patients with critical limb ischemia. CathetCardiovascInterv. 2010;75:830-836.

8. Varela C, Acin F, de Haro J, et al. The role of foot collateral vessels on ulcer healing and limb salvage after successful endovascular and surgical distal procedures according to an angiosome model. VascEndovasc Surg. 2010;44:654-660 9. Neville RF, Attinger CE, Bulan EJ, et al. Revascularisation of a specific angiosome for limb salvage: does the target artery matter? Ann Vasc Surg. 2009;23:367-373

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Four Domains of Optimal Healing Environment There are four domains described as the components of OHE. • • • •

Internal domain Interpersonal domain Behavioural domain External domain

Many of us do not differentiate between cure and healing. Often, it is assumed that effecting cure will automatically lead to healing. It is not so; one can be cured but not healed. A guru once explained the difference to me, which is worth sharing with others: The guru said, “Let us assume that when you go back home today, your apartment door is broken and some thieves have stolen all your possessions. You report it to the police; they are able to quickly catch the thieves and get back all your possessions. So, as far as the police is concerned ‘the case is closed successfully’; this is like curing an illness that you do in hospital. However, the next day, while sitting in the office, are you the same person of composure as you were before the theft? Definitely not! Your mind is still fearful of any further theft. This means that your social problem has been ‘cured’ by the Police but it has still not ‘healed’. Only when you return back to your original state of composure and equanimity, can you consider yourself as personally and wholly ‘cured’. I hope the difference between curing and healing is clear now”. Therefore, curing and healing are mutually complementary and both are essential.

I. Internal Domain

OHE practices promote healing in addition to curing3.

This domain involves 1) cultivating healing relationships and 2) creating a ‘healing organisation’. 3

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This domain is based on 1. Developing Healing Intention and 2. Experiencing personal wholeness A patient must want to get well (healing intention); otherwise, all the activities undertaken by the healthcare professionals may not yield the expected result. Healing Intention can be promoted in a patient by enhancing his/her i) ii) iii) iv)

Self Belief, Understanding, Expectation and Hope

Experiencing personal wholeness involves holistic development of the mind, the body, the spirit, and the energy. It often needs a multi-disciplinary approach.

II. Interpersonal Domain

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1. Healing relationship is between the patient and his/her healthcare provider. This is based on the provider showing empathy and compassion, providing social support to the patient and achieving all this through effective communication.

2. Healing organisation can be created by adopting it as a mission statement, with forwardâ&#x20AC;&#x201C;looking leadership, the use of technology and through effective team work. The ultimate goal of a healing organisation is to promote holistic healing.

III. Behavioural Domain Behavioural domain refers to the positive changes in the behaviour that promote healing. It involves: 1. Practicing Healthy lifestyle (Healthy Diet, exercise, relaxation & avoiding substance abuse) 2. Applying collaborative health care practices (Patient centred and culturally appropriate integrative practices for holistic care).

Annals of SBV

This domain applies to both the patient and the care provider in terms of making positive changes in behaviour to foster holistic healing.

IV. External Domain External domain refers to creating aesthetic buildings and interior decor that create an ambience that promote healing. This involves appropriate use of colour and light, Aroma and Art, Music and sound, Art Objects and Architecture (In fact, architectural design for Salutogenesis is active area of research right now).

External domain also involves being eco-friendly, energy efficient and to be it tune with nature in a sustainable way.

As evidence about the benefits of healing environments accumulates, forward-looking health care providers are starting to incorporate features into the hospital design that reduce stress and promote optimal healing4.

bbReferences 1. Antonovsky A. The salutogenic perspective: toward a new view of health and illness. Advances. 1987;4:47-55.

2. Christianson J, Finch M, Findlay B, Jonas WB, Goertz Choate C. Reinventing the patient experience: strategies for hospital leaders. Chicago: Health Administration Press; 2007.

3. Jonas WB, Chez RA,Smith K, Sakallaris B. Salutogenesis: The Defining Concept for a New Healthcare System. Global Adv Health Med. 2014;3(3):82-91. DOI:10.7453/gahmj.2014.005.

4. Zborowsky T1, Kreitzer MJ. Creating optimal healing environments in a health care setting. Minn Med. 2008 Mar;91(3):35-8.

Annals of SBV Sri Balaji Vidyapeeth (Deemed University, Accredited by NAAC with 'A' Grade) Visit us Online at www.annals.sbvu.ac.in

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