Indiana Chapter Newsletter July 2014
Executive Committee 2013-2014
Newsletter
Officers President President-Elect Secretary Treasurer
Editor
Barbara Lightfoot, BS, CCRP Gregory Adams, II Ellen Stoltzfus, PhD Pam McClelland, PhD
David Caldwell, PhD
Section Editors Editing
Gregory Adams, II Svetlana Dominguez, ELS
Committee Chairs
Freelance
Esther Brooks-Asplund, PhD
Education
Laura Town
Member Resources Program
Esther Brooks-Asplund, PhD
Pharmaceutical
Esther Brooks-Asplund, PhD
Gregory Adams, II
Medical Device
William Pietrzak, PhD
Publications Social Media
David Caldwell, PhD Linda Hughes, MA
Publication
Ellen Stoltzfus, PhD Qing Zhou, PhD
Karen Roberts
Coming Attractions Wednesday through Saturday, October 8 - 11 2014 AMWA Annual Conference Location: Memphis, TN
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Contents
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2014 AMWA Indiana Chapter Conference Summary David Caldwell, PhD Regulatory Affairs Scientist Wins AMWA’s First Twitter Hashtag Contest Linda G. Hughes, MA An Editor Can Add Value to a Scientific Grant Patti L. Raley, MTSC, ELS Indiana’s Medical Device Industry: Opportunities for Medical Writers (Part III) William S. Pietrzak, PhD My Career as an Epidemiologist Tammie L. Nelson, MPH, CPH
Cover Find AMWA members near you by searching the AMWA member directory by city or zip code. This map of the locations of our 101 chapter members was created with BatchGeo.
July 2014 | AMWA Indiana Chapter Newsletter | 3
Chapter Conference Summary
2014 AMWA Indiana Chapter Conference Summary David Caldwell, PhD (davidccaldwell@att.net) Editor’s Note: The conference was held June 6 and 7 at The Columbia Club in Indianapolis. An asterisk denotes a summary written by the conference speaker. Greg Adams summarized April Lavender's presentation. Photos are courtesy of Bill Pietrzak, PhD, Karen Roberts, and Linda Hughes, MA. Keynote Address: Why Isn’t Alzheimer’s Cured Yet? Ann Hake, MD Five drugs are available for treating the symptoms of Alzheimer’s disease (AD) but none for treating AD itself. Researchers have a hard time trying to rationally study and cure AD because they don’t yet know what its physical structure is – no animal naturally models the disease and the only definitive diagnosis of AD in humans requires autopsy. So they are asking five intuitive questions to help them learn how to diagnose, modify, or prevent the disease: what is the function (good or bad) of beta amyloid plaques (extracellular clumps of brain cell protein associated with AD); does regulation of tau protein cause or prevent plaques and neurofibrillary tangles (intracellular snarled threads of tau protein associated with AD); does preventing brain inflammation prevent AD; does AD prevent natural regeneration of neurons; and is AD a form of diabetes resulting from defective mitochondria. Researchers are also exploring the familial genetics of AD and searching for sensitive and reliable biomarkers of the disease. Panel: Special Ethical Issues in Vulnerable Populations Peter Schwartz, MD, PhD; Mary Ott, MD, MA; Amy Waltz, JD; Eric Felde (moderator) Ethics of clinical research is all about informed consent, about giving patients information they need to decide whether to 4 | AMWA Indiana Chapter Newsletter | July 2014
Chapter Conference Summary participate in a study. How do we create a document that makes them aware of the side effects and risks of participating in a study if they have a diminished ability to decide whether to participate or if they don’t like numbers and want something more than information? Should we create a “learning health care system” in which the same standards of informed consent apply to both medical treatment (such as routine surgery) and to a clinical trial? Panelists discussed these and related questions in the context of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT).
Healthcare Brand Journalism: Connect with Your Audience Through Storytelling* Linda G. Hughes, MA Conference goers learned how social media provides the stage to put a human face on healthcare issues. Participants also gained insight into how relevant, authentic, unbiased stories that develop an emotional connection and engagement can lead to more of the conversations you want. Registrants attending this interactive session completed exercises as if they were bloggers for a day, since a blog is the center of an online newsroom. [Slides of Linda's presentation are available on the chapter Web site.]
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Chapter Conference Summary Life as a Freelance Juggler (of Deadlines and Clients)* Eric Metcalf, MPH Eric Metcalf shared some insight on how to thrive as a freelancer that he discovered over his career, both as an in-house writer for a publishing company and as a self employed writer and radio producer. The principles he credited with keeping him busy were to: always be diversifying (from your job skills to the type of outlets you work with to the geographic location of your clients); get to know as many industry contacts as possible; seek out work environments guarded by a high barrier to entry; and identify with your skills, not your job title.
The Orthopaedic Regulatory and Clinical Affairs (ORCA) Graduate Program at Grace College* Allyn Decker, MA; David Kreider, MS Allyn Decker (ORCA Program Director) and David Kreider (AMWA member and Medical Writer at Zimmer, Inc.) provided an informational session on Grace College's unique, industry-focused graduate program in Orthopaedic Regulatory and Clinical Affairs (ORCA). Mr. Decker provided a slide presentation overview of the one-year, accelerated master's program that equips professionals to support medical device development through regulatory submissions, compliance, after-market surveillance, and clinical study supervision. Mr. Kreider, a 2012 graduate of the ORCA program, provided a student’s perspective and high recommendations for this cutting edge program.
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Chapter Conference Summary Current Trends in U.S. and Global Regulatory Submissions for Medical Devices April Lavender, RAC April Lavender, the senior vice president of regulatory affairs at Cook Medical, gave an overview of the global regulatory landscape in the medical device industry. She talked about the challenges in keeping up with and meeting fast-changing regulatory and compliance requirements around the world, such as the Open Payments Act in the United States and the French Sunshine Act. She also discussed the risk classifications and approval processes for devices and offered some ideas for areas in which regulatory requirements could be streamlined or adjusted to benefit patients and industry.
Copyright and Trademark Law Brad Maurer, JD Copyrights, which last for the life of an author plus seven years, give the author the right to exclude others from using tangible forms of her or his work without permission. A trademark, which can last forever, is a legally protectable symbol (e.g., words, printed design, product design, packaging, sound, smell, texture, or taste) that uniquely identifies your goods or services to the public. Slides of this presentation describing these intellectual properties and their benefits to medical writers are available upon request from Mr. Maurer (brad.maurer@FaegreBD.com).
Strategies for Expediting Review of New Medicines* Esther Brooks-Asplund, PhD The FDA embodied its 1988 thinking about expediting the availability of promising new drugs and biologics for serious July 2014 | AMWA Indiana Chapter Newsletter | 7
Chapter Conference Summary conditions (21 CFR 312, subpart E) in four programs— breakthrough therapy (2012), priority review (1992), accelerated approval (1992), and fast track (1997)—detailed in the 2013 FDA Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. Likewise, the FDA embodied the 1983 Orphan Drug Act and corresponding rules (21 CFR Part 316), which promote development of new therapies for the treatment of rare diseases or conditions, by establishing the Office of Orphan Products Development. (Sponsors apply for orphan designation in both the US and EU through FDA form 3671 11/11.) Of the 27 drugs and biologics approved by the FDA in 2013, 15 (56%) were approved through the first three programs (Mullard A. 2013 FDA drug approvals. Nat Rev Drug Discov. 13(2): 85-89; 2014) and 9 (33%) were approved through the orphan program; sponsors received 70 fast track designations (FDA-TRACK).
How to Maximize Acceptance of Your Manuscript in a PeerReviewed Journal* William S. Pietrzak, PhD Peer-reviewed journals are extremely selective in what they publish making it imperative for medical writers to understand means to increase their chances of acceptance. The nuances of the peer-review process were described, the mind-set of reviewers was discussed, and effective approaches to responding to the editor's decision, be it "revise" or "reject", were examined. Real-world examples were provided for illustration.
From Medical Editing to Business Logistics: How Transferable Skills Can Enhance Your Career Svetlana (Lana) Dominguez, BA, ELS Give others your best and give yourself room to move by developing skills (such as negotiation, critical thinking, project and 8 | AMWA Indiana Chapter Newsletter | July 2014
Chapter Conference Summary time management, and the ability to see the big picture or to deal with shades of gray) needed for many different careers. For help with identifying your skills, take a look at these resources: Marcus Buckingham, Donald O. Clifton. Now, Discover Your Strengths. The Free Press, 2001. Tom Rath. StrengthsFinder 2.0 (from Gallup’s Now, Discover Your Strengths). Gallup Press, 2007. Transferrable Skills Checklist: Rouge Community College Transferrable Skills: Bringing Your Skills to a New Career How to Identify Your Transferrable Skills.
Chapter Conference Committee Members Laura Town (conference organizer; chapter education chair) Ellen Stoltzfus, PhD (committee member; chapter secretary) Barbara Lightfoot, BS, CCRP (committee member, chapter president) July 2014 | AMWA Indiana Chapter Newsletter | 9
Chapter Conference Summary
Lunch at The Columbia Club
Conversation with new and old friends
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Contest Winner
Regulatory Affairs Scientist Wins AMWA’s First Twitter Hashtag Contest Linda G. Hughes, MA (linda@lghughes.com) Zhengbin “Justin” Xu, PhD, follows the US Food and Drug Administration (FDA) on Twitter. So, Justin hears their news before others who only visit the FDA website. “It’s very convenient. And I can get the newest thinking earlier, on the go, wherever I am,” says the regulatory affairs scientist at MED Institute in West Lafayette. Smartphones. Forget the name, they’re only as bright as you program them to be. This biotechnology whiz kid has his smartphone serving as a mind-reading personal assistant. He mutes his phone so he doesn’t hear FDA notifications while he’s working. Then when he’s ready, he checks the queue or messages in reminders for FDA updates. During a normal working day, he gets about five tweets from the FDA and he might check one or two of them. “For me, Twitter is a time-saving way to screen the most important information,” says the China native. Justin says he can quickly screen out what is most important or what he wants to follow up on.
Justin learns FDA news on his phone earlier, on the go
Thanks to the Internet, anybody can publish. But he says nobody can ever read everything, not even everything they’re interested in. So, Justin bookmarks articles he likes. Then whenever he comes across a problem or an issue, he’ll remember reading something about that on Twitter and he’ll search for that information again. The patent-holding inventor wants to stay informed about important things, so he follows top experts as they have a higher probability of influencing our lives. You’ll be the first to get news if you follow the right people on Twitter. Contest winner Zhengbin “Justin” Xu July 2014 | AMWA Indiana Chapter Newsletter | 11
Contest Winner
You’ll be the first to get news if you follow the right people on Twitter
Justin also likes the character limit on Twitter, a concise 140 characters. This keeps the Purdue Boilermaker focused on the most important information. Then he doesn't have to spend a lot of time deciding what he wants to say when he tweets. Congratulations, Justin, for winning AMWA’s first hashtag contest in its history. The hashtag #amwainoh giveaway promoted our chapter conference in June. I'm working with AMWA now to scale the promotion for the 74th Annual Conference in Memphis, October 8-11. So, Twitter account holders, stay tuned to @AmMedWriters and hashtag #AMWA14. Zhengbin “Justin” Xu, PhD (zxu@medinst.com) is a regulatory affairs scientist at MED Institute, Inc. in West Lafayette. Linda G. Hughes, MA is a healthcare brand journalist at LG Hughes, LLC in Indianapolis.
Indiana Chapter Conference Survey We appreciate all of you who attended our 2014 chapter conference at the Columbia Club. To better understand and meet your needs next year, please take five minutes to complete and return this survey by email (linda@lghughes.com) or anonymously by mail (see the survey).
Chapter Conference Workshop Leader Susan Aiello, DVM, ELS (editor-in-chief of The Merck Veterinary Manual; medical publishing consultant and trainer; winner of AMWA's Golden Apple Award for teaching excellence) Workshops: Organizing the Medical Paper, and Sentence Structure and Patterns 12 | AMWA Indiana Chapter Newsletter | July 2014
Grant Applications
An Editor Can Add Value to a Scientific Grant Application Patti L. Raley, MTSC, ELS (praley@goodmancampbell.com)
What Is a Grant? Have you heard about grant proposals, but are not sure what they are? While many types of grants are available for purposes that span the arts, education, humanities, and sciences, this brief article provides a glimpse into grants for scientific research, characteristics of effective grant proposals, and ways an editor can add value to the grant application process. A clinical or basic scientist writes a grant proposal to request money to do research and submits it to an agency that may fund the work. If the proposal receives funding, then the scientist begins the research project described in the proposal. At the end of the project, the scientist writes and submits a final report to the group who provided the funding. The scientist also will write and publish a manuscript to share the results of the project in a peer-reviewed journal. These results give rise to more research questions that begin a new cycle of grant writing. Depending on the requirements of the funding agency, a grant proposal may be a simple letter, a brief, 3- to 5-page description of the project, or a more complex application that includes a 15- to 20-page description of the project, along with many forms and appendices. The following links will take you to sites that list available grants, requirements for applying, application deadlines, and the process for submitting documents electronically. • Proposal Central (smaller agencies and foundations): https://proposalcentral.altum.com/. • Grants.gov (large government grants): http://www.grants.gov/web/grants/search-grants.html. July 2014 | AMWA Indiana Chapter Newsletter | 13
Grant Applications
Only the most persuasive proposals receive funding
Research scientists who need large grants to fund long-term projects often apply to government agencies, such as the Department of Defense (DOD) or the National Institutes of Health (NIH). The following links will take you to NIH sites where you may explore the types of grants and the application process: • National Institutes of Health (NIH): http://grants.nih.gov/grants/guide/index.html?CFID=516365 74&CFTOKEN=24157527&jsessionid=f630ba89216f73efb045 1c565d682662a595 • NIH grant process: http://grants.nih.gov/grants/grants_process.htm#process. Grant Proposals Must be Clear, Succinct, and Compelling Regardless of the type of grant or the amount of funding requested, a grant must describe the project clearly and succinctly within a strict page limit. The description must be compelling enough to convince reviewers to fund the project. Because the application process is competitive and many people apply, only the most persuasive proposals receive funding. The audience for a grant proposal is a review committee. At a private foundation, an internal committee will review the applications. These reviewers are people who sit on the board of the organization and who may or may not be scientific experts. At a large agency, such as NIH, scientific experts from the professionat-large review grant applications and score each proposal according to a set of criteria. In addition to a score, these reviewers provide feedback about the strengths and weaknesses of the proposal. Proposals with a favorable score and feedback receive funding. To aid reviewers, a grant proposal must be free of distractions such as typographical errors, faulty syntax, and awkward language.
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Grant Applications How Can an Editor Add Value to the Grant Process? Typically, the scientist who will conduct the project writes the grant. However, scientists have many more responsibilities that include preparing progress reports and manuscripts for previous projects, conducting research, teaching, consulting, and attending and presenting at conferences. They can benefit from having an editor review their grants before submitting them. Here are ways an editor can add value to a grant application:
The quality of the narrative is critical
• An editor can ensure the grant adheres to the specifications for font, type size, page length, margins, and figure formats. • An editor can review the description of the project, also called the narrative, to ensure that the writing is clear and concise. The narrative tells the reviewer why, what, how, and when the project will be conducted. The quality of the narrative is critical for helping the grant reviewer decide whether to fund the project. • If an author’s first language is not English, an editor may need to do additional editing to ensure clear, succinct writing. However, an editor needs to be cautious: edit for clarity, but be careful to maintain the author’s style throughout the narrative. Use of queries is a good strategy for suggesting alternative phrasing or word choices. With grants, it is important to let the author choose. • An editor can help by preparing the nontechnical descriptions of facilities and equipment in required templates. This information can be used in other grants. • An editor can prepare brief biographical descriptions, also called biosketches, from lengthy curricula vitae. A specific format or template may be required for biosketches. • If a proposal deadline is looming and time is limited, an editor who can do an excellent job of proofreading may be of immense help. Reviewers of proposals are detail-oriented and many are editors of journals—the little things will jump out at them. They may forgive a long paragraph or an occasional awkward sentence, but they may reject a proposal that has too many misspelled words or typographical errors. July 2014 | AMWA Indiana Chapter Newsletter | 15
Grant Applications
A clear, succinct, compelling grant has a better chance of being funded
Because grants are a major source of funding for research scientists, a grant that is clear, succinct, and compelling will have a better chance of being funded. Well-written grant proposals also will enhance the scientist’s credibility, which, in turn, will make reviewers look forward to future grants from the same person. Your own credibility as a grant editor will build over time. One of the highest compliments—and a testament to the value an editor can add—is to receive a comment from a reviewer who thought a proposal was extremely well edited and is worthy of being funded. Patti Raley has been a biologist, a scientific writer, and a medical writer since the 1980s. She has been a board-certified editor in the life sciences since 1996. She now reviews and edits grants and manuscripts for traumatic brain and spinal cord injury research at the IU School of Medicine.
Volunteer? AMWA exists only because medical communicators like you volunteer to build and maintain their profession. Our chapter offers lots of opportunities to meet interesting people, share your wisdom, learn more about our profession, and improve your leadership skills. Distance is not an obstacle; most volunteer activities can be performed electronically. Don’t worry about whether you know enough to participate – you do! If you would like to join in the fun and help our chapter while helping yourself, please let our incoming president, Greg Adams (Greg.Adams@CookMedical.com), know as soon as possible.
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Clinical Device Evaluation
Indiana’s Medical Device Industry: Opportunities for Medical Writers (Part III) William S. Pietrzak, PhD (billsp@uic.edu) The April (2014) issue of the AMWA Indiana Chapter Newsletter summarized several of the more common types of services that medical writers perform for the medical device industry. The first one that was described, i.e., Clinical Evaluations, will be examined a bit more in-depth here. In a nutshell, foreign countries typically require documented clinical evidence that supports the safety and performance of a medical device before it can be sold, or can continue to be sold, in that country. The European Union (EU) represents one of the largest foreign markets for medical devices. As such, preparing Clinical Evaluation Reports (CERs) for the EU is one of the primary functions of medical writers in the device industry and will be our focus here. The EU Medical Device Directive (2007/47/EC revision to Medical Device Directive 93/42/EEC) was established to provide the harmonized standards to be met for a manufacturer to legally place a medical device on the European market. In general, the manufacturer prepares a Design Dossier which is a large, multisection document that provides the required information, with the CER being one of the sections. The Design Dossier is reviewed by a Notified Body, which is an accredited third-party organization. Following successful review, the Notified Body will issue an EC Design-Examination Certificate, which states that the design conforms to the requirements of 93/42/EEC and then enables the manufacturer to place the CE Mark on the device so that it can be sold and distributed in the EU. Once the CE Mark is obtained for a new product, the story is not over. The CE Mark will still require subsequent CERs in the future to support CE Mark renewals at 5 year intervals.
Preparing clinical evaluation reports is a primary function of medical writers in the device industry
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Clinical Device Evaluation
Remember that many medical devices are part of complex systems
Per the MDD, devices are classified according to risk, in the order Class I < Class IIa/b < Class III. Class III device CERs require Notified Body approval. CERs written for Class I and IIa/b devices are maintained in the medical device company’s technical files, which can be audited by the Notified Body. It is important to be familiar with MDD Annex I which lists the Essential Requirements that must be considered in the context of the medical device being evaluated. MEDDEV 2.7.1 Rev 3 (December, 2009) provides the guidelines pertaining to the creation of CERs which are defined as ‘the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device’. (See also MDD Annex X.) The CER is meant to be a comprehensive, objective evaluation of the clinical performance of the device based on clinical data available in the public domain as well as that contained within the company. So as not to be redundant with the guidance provided in MEDDEV 2.7.1 Rev 3, I will focus on some lessons learned after years of writing and reviewing CERs as well as dealing with Notified Bodies. It is important to remember that many medical devices are part of complex systems that can include implants of various sizes and configurations, as well as the instruments required to surgically place them. As such, it is important to describe the device(s) with sufficient detail and clarity so that the reviewer gains sufficient understanding to be able to make sense of the rest of the document. The CER should have a beginning, middle, and an end so that it logically flows to the conclusion. Whereas the conclusion ideally will be that the device(s) is safe and performs as expected, with a favorable risk/benefit ratio, you must go where the data takes you and should not work backward from your desired conclusion. The types of clinical data to consider include peer-reviewed papers obtained through a PubMed and/or Google Scholar search, the complaint and sales history obtained within the company, and internal data regarding IDE (Investigational Device Exemption)
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Clinical Device Evaluation studies or post-market studies. In the case of total joint replacement devices (arthroplasty), many countries have national joint registries that provide data on usage and survivorship that should be consulted. Some of this information will be provided to you by others within the company such as sales data from the post-market surveillance department, clinical study data from the clinical department, complaints from the complaint department, etc. You may obtain some of the information yourself, by performing PubMed searches, obtaining the papers, and summarizing and evaluating the studies. How much clinical evidence you obtain yourself or is provided to you by others will depend on how your company is structured. In any event, it will be beneficial for you to create a generic checklist to help ensure that you don’t inadvertently overlook a piece of clinical evidence for your CER. Ideally, one would want to have long-term (10-year) clinical data available for the Subject Device. However, if there is little data available, then one or more Equivalent Devices will have to be identified and compared to the Subject Device per MEDDEV 2.7.1 Rev 3 to establish such equivalence. Then clinical evidence for the Equivalent Devices can be used as a surrogate for the Subject Device. It is important, however, to critically examine the differences between the Subject Device and Equivalent Device and suggest how these differences may, or may not, affect the clinical performance. Many medical devices have multiple indications listed on their Package Inserts or Instructions for Use. Ideally, clinical evidence should be presented on behalf of each of the indications. It can be difficult, though, to find clinical data on each indication all of the time. However, if a sound clinical argument can be made that suggests one of the indications is “worst case”, then clinical evidence for that indication may be sufficient for the “lesser” indications as well, but this is a grey area. When evaluating the disparate types of clinical evidence that are obtained, it is not uncommon to come across a study whereby the
Critically examine the differences between the subject device and equivalent device
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Clinical Device Evaluation
Tell a compelling, welldocumented story of safety and performance
outcomes were poor and/or there was a large complication profile. While such negative studies must be included in the CER, it is important to not minimize them, but rather, objectively evaluate them and build them into the fabric of the CER. Such negative studies should be scrutinized closely. It may be the case that the results were negative because the patient population was especially challenging, e.g., elderly, with significant co-morbidities, or being in an otherwise severely compromised state. Discussing this in the CER will help put the negative results into perspective and can help the reviewer understand the extenuating circumstances. While the various types of clinical data are often placed in their own sections of the CER, e.g., one section for complaints, one for sales data, one for the literature search, one for literature summaries, etc., it is important that all of this data be integrated and cross-referenced toward the end of the CER to tell a compelling, well-documented story of safety and performance. I like to call this the â&#x20AC;&#x153;30,000 foot viewâ&#x20AC;?. After the CER is written, it is helpful to have it reviewed by others within the company to ensure that it is both comprehensive and clear, and that nothing was inadvertently omitted. Once the Design Dossier, which contains the CER, is submitted the Notified Body has 90 working days to respond. There are ways to speed up the process, such as a fast-track review, expedited review, or on-site review by the Notified Body, but these incur additional costs. It is typically the exception, rather than the rule, that the Notified Body will accept the CER without any questions. More commonly there were will be questions regarding the Design Dossier in general and the CER in particular. It may take multiple rounds of questions and responses before all issues are finally closed. Sometimes you may not understand the question. In that case, it can be beneficial to place a call to the reviewer and obtain clarification. Eventually, you will have a CER that is accepted by the Notified Body. But you wonâ&#x20AC;&#x2122;t be able to get comfortable for
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Clinical Device Evaluation long, because you likely have a backlog of several more CERs waiting for you to write! As a final note, it is apparent that much coordination and interaction between various groups within the device company is required for the medical writer to properly write a CER. This is challenging enough for a medical writer employed by the device company. It is even more challenging for an outside medical writer, either freelance or from an agency, since that writer is typically off-site. As such, it is important that there be someone at the company that is primarily responsible for gathering and sending the input data to the outside writer, with the writer having a listing of key contacts (e.g., Engineering, Marketing, Clinical, Regulatory, etc.) within the company to directly interface with should questions or issues arise.
Coordination and interaction between groups within the company is required to write a CER
Additional references Achakri H, Fennema P, Udofia I, Generating clinical evaluation reports. A guide to effectively analysing device safety and performance. BSI/UK/417/ST/0314/en/HL Tariah I, Pine R, Effective post-market surveillance. Understanding and conducting vigilance and post-market clinical follow-up. BSI/UK/440/ST/0614/en/HL
William Pietrzak is a research scientist at Biomet, Inc. and an adjunct research professor of bioengineering at the University of Illinois at Chicago.
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Epidemiologist
My Career as an Epidemiologist Tammie L. Nelson, MPH, CPH (TNelson@MarionHealth.org) As a graduate student working toward a career in clinical medicine, I learned of an upcoming presentation about the Indiana University School of Medicine’s public health program (now the IU Fairbanks School of Public Health). I attended with an interest in learning more, and found myself excited about the possibility of improving population health, as compared to caring for a subset of patients in clinic. I pursued further information, finally deciding that public health was a better match for me. I chose the path towards epidemiology for the same reasons I had pursued medicine—to study the cause, effect, and patterns of disease, and to support the development of evidence-based strategies by which to address threats to population health. William Foege (Epidemiologist credited with the strategy leading to smallpox eradication) called epidemiology the “Scientific base”1 of public health and the data-rich, evidence-based, multidiscipline focus satisfies me intellectually. In other words, I get to geek-out!
Epidemiology is the scientific base of public health
Most organizations require that their epidemiologists hold at least a Master’s degree. My degree is a Master of Public Health, with epidemiology as my study concentration. In further preparation, I completed two doctoral level epidemiology courses on study design and advanced biostatistical methods, as well as several programming and writing courses (both technical and medical). Experience with advanced statistical software is essential. In my experience, SAS is the software of choice. It is used exclusively within my organization, as well as among others with which I have collaborated. Finally, while not yet required, public health practitioners may sit for a qualifying board exam in order to set themselves apart from others in the field. I earned my Certified Public Health credential and complete mandatory continuing education units in order to maintain it.
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Epidemiologist Epidemiologists typically have a specialty area in which they focus. My primary area of expertise is HIV/AIDS, sexually-transmitted infections (STI), and their related comorbidities. In addition to morbidity and mortality throughout the Indianapolis-Carmel Metropolitan Statistical Area, I investigate and report on social determinants, behavioral risk factors, and interventions; racial, ethnic, and socioeconomic disparities; and, availability and utilization of core medical and supportive services for people living with HIV/AIDS. My duties in these areas include data collection; providing quality control over complex databases; epidemiological and situational analyses; preparing various reports; providing health department staff and community organizations with information needed for decisions that affect health throughout Central Indiana; developing and assisting development of research projects and special studies; serving as subject matter expert for internal and external stakeholders; and, supporting various grants.
Epidemiologists typically specialize
While it may sound as if I pore over data at every available moment, that is not the case. Some of my time is spent working with external stakeholders and community-based organizations delivering educational/awareness presentations and/or data required for external grants. I offer consultations on study design and program evaluation. I also, of course, write and edit. Some of these activities are for routine or ad hoc reports and grants. The bulk of my writing in this position so far, however, has been as coauthor of our Ryan White Part A, Minority AIDS Initiative, and Part C grant applications each year, some of the largest grants awarded to the health department ($4-$4.5 million annually). If you would like to know more about epidemiology, or public health in general, feel free to contact me.
Foege, W.H. (2011). House on fire: The fight to eradicate smallpox. (1st ed.). University of California Press. p. 16. 1
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Epidemiologist Tammie Nelson is an epidemiologist with the Marion County Public Health Department (3901 Meadows Drive, H108 Indianapolis, IN 46205 Tel: (317) 221-3556).
Thank You! We sincerely thank our education committee for planning our excellent 2014 Indiana chapter conference: Laura Town (chair), Sarah Felde, Barbara Lightfoot, Rachael Mann, Kit Solotkin, and Ellen Stoltzfus. Special thanks to: The Columbia Club (who squeezed us in without their typical required notice); Markeyâ&#x20AC;&#x2122;s AV (who, without being contracted/compensated, went above and beyond the call of duty to help people practice their talks); Jennifer Kost-Barker (who served as our workshop proctor and on-point hospitality person); Eric Felde (who lined up our Friday panelists); Susan Aiello (who led two workshops); and All open session speakers and roundtable leaders (Laura Town, Greg Adams, and Laura Oberthur Johnson).
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