Indiana Chapter Newsletter April 2014
American Medical Writers Association American Medical Wrtiters Association Indiana Chapter 2013-2014 Indiana Chapter Newsletter Officers President President-Elect Secretary Treasurer
Barbara Lightfoot, BS, CCRP Gregory Adams, II Ellen Stoltzfus, PhD Pam McClelland, PhD
Editor
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
Links
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Contents
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Letter From the President, AMWA Indiana Chapter Barbara Lightfoot, BS, CCRP Interview with Martha Tacker, PhD, ELS(D) Qing Zhou, PhD and David Caldwell, PhD The Most Commonly Misused Words and Phrases in Scientific Writing Greg Adams Educating the Market About a Pharmaceutical Product Amanda Gellett, PhD Indiana’s Medical Device Industry: Opportunities for Medical Writers (Part II) William S. Pietrzak, PhD Transferrable Skills in Medical Communications Svetlana Dominguez, ELS
Cover Find AMWA members near you by searching the AMWA member directory by city or zip code. This map of the locations of our 91 chapter members was created with BatchGeo.
April 2014 | AMWA Indiana Chapter Newsletter | 3
From the President, AMWA Indiana Chapter
First, let me extend a heartfelt thank you and job well done to our Education Committee, chaired by Laura Town, for organizing the 2014 Indiana/Ohio Valley Chapters Conference!! The conference will be held June 6-7, 2014 at the historic Columbia Club on Monument Circle in downtown Indianapolis, IN. Please see the attached conference brochure for a complete description of the conference.
Join us for this great educational and networking opportunity!!
We have an exciting line-up of talks this year. Our Friday program features the keynote address "Why Isn’t Alzheimer’s Cured Yet? Past Efforts and Future Approaches" by Dr. Ann Hake and a great panel discussion “Special Ethical Issues in Vulnerable Populations” by Dr. Peter Schwartz, Dr. Mary Ott, and Amy Waltz, JD. These will be followed by dinner roundtables covering a variety of topics including freelancing and medical devices. The Saturday program includes 2 workshops given by Susan Aiello and 8 open sessions. In addition, we are offering the BELs Exam before the start of the conference on Friday afternoon. May 3, 2014 is the deadline for receiving the discounted conference registration price and for registering for AMWA for credit workshops. Feel free to send this announcement to anyone who might be interested in attending. Registration for the conference and workshops is online only and can be completed at: http://www.amwa.org/calendar_day.asp?date=6/6/2014&event=149 9. Join us for this great educational and networking opportunity!!
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From the President, AMWA Indiana Chapter
Warmest regards, Barbara O. Lightfoot, President American Medical Writers Association, Indiana Chapter Phone: (317) 651-6548 Mobile: (706) 814-3289 Email: barbara.lightfoot@yahoo.com Barbara Lightfoot
Barbara O. Lightfoot Editor's Note:
Barbara is the 2013-2014 president of the AMWA Indiana chapter, an Associate Consultant - Scientific Communication at Eli Lilly and Co., a member of the Society of Clinical Research Associates, and a past member of the Advances in Chronic Kidney Disease editorial board. She has also been principal author and coauthor of medical abstracts and journal articles.
Find updates to chapter and community events on our Web site April 2014 | AMWA Indiana Chapter Newsletter | 5
Interview With Martha Tacker
Interview with Martha Tacker, PhD, ELS(D) This telephone interview was conducted by Qing Zhou (zhou@medinst.com) and David Caldwell (davidccaldwell@att.net) on February 20, 2014 for the AMWA Indiana chapter newsletter (AICN).
Martha M. Tacker, PhD, ELS(D) (mmtacker@gmail.com) Photo reprinted with permission of Kevin Doerr, Purdue Veterinary Medicine
Editor’s Note: Martha Tacker, PhD, ELS(D) is an accomplished medical writer, editor, and educator. Trained as a scientist, Martha received a PhD degree in biochemistry from Baylor College of Medicine in Houston, Texas. After graduation, she conducted post-doctoral research at the Lipid Research Institute in Houston and at the Gastrointestinal Research Unit of the Mayo Foundation in Rochester, Minnesota, then joined the Department of Physiology at Baylor College of Medicine as an instructor. During her years of study and research, Martha discovered her passion for clear, compelling scientific communication, and in the early 1970s, started her career in scientific writing and editing, a rarely known profession at the time. In the next 40 years or so, Martha not only developed a successful and rewarding career in scientific communication, but also contributed significantly to the advancement of this profession through her extensive work with organizations including American Medical Writers Association (AMWA), Council of Biology Editors (CBE; now the Council of Science Editors), and Board of Editors in the Life Sciences (BELS). Retired last year, Martha now enjoys warm Texas winters and pleasant Minnesota summers. A partial list of Dr. Tacker’s accomplishments includes: American Medical Writers Association (AMWA) Member, 1973 – present; Indiana chapter original member, 1996; 2006 – 2010 Annual conference workshop coordinator, 1976 – 77 Member of the task force appointed to create the AMWA certificate program, 1977 AMWA Fellow, 1977 AMWA President, 1985 – 86 Golden Apple outstanding teacher award recipient, 1988 Harold Swanberg Distinguished Service Award recipient, 1992 Department of Education, administrator Workshop leader: “Organization of a Scientific Paper”, “Organizing the Biomedical Paper”, “Macroediting”, “Microediting” 6 | AMWA Indiana Chapter Newsletter | April 2014
Interview With Martha Tacker Board of Editors in the Life Sciences (BELS) Founding member, 1991 Diplomate, 1991 Council of Biology Editors (CBE) President, 1993-94 CBE Views, editor, 1995-98 Distinguished Service Award recipient, 1992 and 1998 Freelance business owner Biomedical Communications Services; providing scientific writing and editing services, and training in scientific writing at universities, pharmaceutical and medical device companies, and scientific association meetings throughout North America and Europe. Author Purina research handbook for veterinary residents: A guide to successful research (2000)
I. Leadership and Career AICN: You are a long-time member of AMWA, CBE, and BELS. How did you become involved with these groups? Dr. Tacker: The short answer is that I was drawn to scientific communication and wanted to improve my writing skills. Writing my doctoral dissertation and research grant applications was enjoyable and satisfying. I thought that mixing with people who called themselves medical writers and biological editors would help me improve.
I wanted to improve my writing skills
Personal connections led me to AMWA and CBE. In the early 1970s, I took a writing workshop at an American Heart Association meeting in Dallas, TX. The workshop was led by Lois and Selma DeBakey, medical editors and linguists at Baylor College of Medicine and sisters of Michael DeBakey, the famous heart surgeon. When I later visited them at their Houston office, they introduced me to AMWA, the first organization of medical writers that I heard of. I went to the next AMWA annual meeting in Bethesda, MD in 1973, where I met Charles Roland, MD, a past President of AMWA who also was the head of the editing group at the Mayo Clinic where I had been a postdoctoral fellow. Later that April 2014 | AMWA Indiana Chapter Newsletter | 7
Interview With Martha Tacker year I visited him in Rochester, MN, and Dr. Rowland and his wife, Barbara Cox, sponsored me for CBE membership. My involvement with AMWA in Indiana began in 1974 when my husband and I moved to West Lafayette and Indiana was still part of the Greater Chicago Area chapter. I met a few medical writers in Indianapolis and really enjoyed this group. At that time, there were only a very few medical writers at Eli Lilly and Company, one of whom was Jan Potvin, PhD. Three of us—Jan, another medical writer, and I—put together a workshop on medical writing. Lilly was very supportive, letting us hold the workshop and AMWA meetings at their facility. A few years later, the medical writing department at Lilly grew to about 30 writers and many of them joined AMWA. I was active in the chapter for a short time after the Indiana chapter began until we moved to Seattle, WA later in 1996. AICN: You were president of AMWA and of CBE. Why did you assume these leadership roles?
My leadership roles just evolved naturally
Dr. Tacker: My leadership roles just evolved naturally. I got involved with these organizations because I needed support as a freelance. AMWA and CBE were my corporate home – I could go to my friends and colleagues there for answers to my questions and for networking. I enjoyed working with them and they gave me a chance to develop courses and try out new ideas. I was asked to organize workshops for the 1976 AMWA annual conference, and in 1977 was appointed, along with Harriet Benson and Connie Mitchell, to be a member of a task force for developing the AMWA certificate program. One thing led to another, and I eventually became president. AICN: What were the main challenges medical writers and editors faced in the 1980s and 1990s? Dr. Tacker: One challenge was to expand the vision of what medical editors were beyond the role of an MD editor at a traditional medical journal and to overcome the obscurity of our largely hidden profession. The pharmaceutical industry employed
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Interview With Martha Tacker medical writers and editors, but academic researchers rarely acknowledged editing services openly. The only academic medical editing services that I knew of were at the Mayo Clinic and the MD Anderson Hospital. Only through AMWA and CBE did I become aware of individuals hired by medical school research departments to do medical editing. Medical editors who helped with scientific papers were virtually never openly acknowledged and were concerned with being accused of ghost writing. Journal editors were skeptical that academic editing services could have value. This obscurity of medical editing led me to write an article for CBE Views in 1980, “Author's editors: catalysts of scientific publishing,” in which I tried to describe what I thought was the legitimate role of a medical editor and to outline my own standards for being acknowledged in a paper. My article was a small, early chip in bringing the medical editing/writing profession out from behind this concrete wall. I had several responses from people around the country who told me they were glad to know what to call themselves (the term “author’s editor” hadn’t been used much) and to know that other people shared their profession.
One challenge was to overcome the obscurity of our largely hidden profession
Another challenge, still important to both organizations today, was ghost writing, part of the larger issue of developing ethics in biomedical communication. A third challenge was lack of training and standards. Anybody can market themselves as a medical editor or writer. Development of the AMWA curriculum, the Board of Editors in the Life Sciences (BELS) certification exam, and the CSE publication certificate program improved things. AICN: What results of your leadership mean the most to you? Dr. Tacker: I want to emphasize that what happened under my watch was certainly done by a team, not just by me. Helping to raise the visibility and acceptance of author’s editors, especially April 2014 | AMWA Indiana Chapter Newsletter | 9
Interview with Martha Tacker with journal editors and academia, was satisfying. So was developing the AMWA curriculum and my workshops, as well as growing CBE Views into a journal-like publication. I enjoyed working with people from all over the world who were talented and shared generously; some of them became my life-long friends. Actively participating in AMWA and CBE helped me develop both my skills and a network that were critical to the transition of my career from a research biochemist to a writer/editor/workshop teacher. I would never have done that without the support and training people in those organizations gave me.
I enjoyed working with people from all over the world who were talented and shared generously
AICN: What were your career goals? Did you achieve them? Dr. Tacker: I just wanted to keep getting editing and teaching assignments because the work was so stimulating and satisfying. I also wanted to keep interacting with stimulating and competent people who shared my interest in biomedical editing and writing. Staying active in AMWA and CBE was key to achieving both of those goals. I taught medical writing at MED Institute, Inc. and Purdue University in West Lafayette, and taught workshops in various places. One benefit of teaching I liked was keeping up with the frontiers of science. I learned a lot from students who brought writing about their own research to my workshops. AICN: Would you like to suggest any directions that AMWA and CBE could take? Dr. Tacker: I’m not very actively involved with those organizations now, but from what I can see, I would suggest that they keep doing what they are doing: promoting the development of ethical standards; developing, educating, and training people new to the profession; educating and training the users of medical editing and writing services; and promoting the value of competent medical writers and editors to organizations. ********************
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Interview with Martha Tacker
II. Professional Development of Editors and Writers AICN: What qualities do excellent editors and writers share? Dr. Tacker: In my view, they need to have a reader’s eye. They need to have a sufficient understanding not only of the topic, but also of the reader’s needs and interests, because the story must be clear and compelling to the reader. That requires a command of language skills (both general and biomedical) and of logical analysis and presentation. That also requires a curiosity that drives the writer/editor to learn enough about the topic to establish and maintain a writer’s credibility with the reader or an editor’s credibility with the author. AICN: What skills do we need to acquire during our professional development? Dr. Tacker: Writing and editing are like playing the piano – you have to practice to improve. Review and test your skills every so often by taking or teaching a workshop. Teaching forces you to identify what is important and to put your ideas together in a logical order. There’s an old saying, paraphrased as “How can I tell you what I think till I see what I say?” (E.M. Forster in “Aspects of the Novel”). The best way to really learn how to do something is to teach it to somebody else.
Have a reader's eye
AICN: What is your secret to collaborating successfully? Dr. Tacker: Try to establish and maintain credibility. If you are an editor, remember that you are working on the author’s paper. You have to negotiate and decide what is and isn’t important.
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Interview with Martha Tacker
I felt it would be useful to bring this new format to the attention of professional medical writers
III. Manuscript Formats AICN: At the 2008 AMWA annual conference in Louisville, you suggested developing guidelines for papers that describe translational and basic research. Would you tell us about that? Dr. Tacker: Virtually all of my workshops addressed clinical research, so I had been teaching students how to organize a paper with the familiar introduction, methods, results and discussion (IMRaD) format. I encouraged my students to bring their own research papers. In recent years, more and more of those papers were reporting translational and basic research and were written in a format that organized the results and discussion slightly differently from the traditional IMRaD. So I had to teach two formats. IMRaD organizes the report of a traditional clinical study well because the study is completely preplanned. But a nested IMRaD format is better for reporting a translational or basic study that is planned sequentially. A general plan may exist, but the result of one experiment informs the plan of the next. The Methods section is just a series of recipe cards. The Results section nests a set of mini-presentations, one for each experiment, with descriptions of the main finding and what it means, very similar to the Discussion section of a clinical paper. The Discussion section then joins all of the mini-stories to tell the whole story. The new format was just an observation that I made and put out there to see what would happen. Unfortunately, nothing much happened. I have asked several biomedical journal editors about it, but haven’t received any feedback or seen any discussion of this new format anywhere. Maybe this topic will receive more attention as professional writers and editors become more engaged with basic and translational research papers. I felt it would be useful to bring this new format to the attention of professional medical writers who may have been more familiar with the traditional IMRaD. I wanted them to see the difference in
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Interview with Martha Tacker the formats that I was seeing, especially at a time when translational research in molecular medicine is becoming more important to clinical practice. For example, genetic tests are now part of routine checkups. I believe that, like clinical researchers, translational and basic researchers also need help with their papers. In both instances, the researchers are often so steeped in their projects that it’s hard for them to realize what links readers need to follow a story. The researchers need to learn how to step back from this mass of information and to develop an introduction and discussion that create a context for the whole story. AICN: Developing guidelines for reporting sequentially planned research may become increasingly important as Bayesian adaptive designs and sequential, multiple assignment, randomized trial (SMART) designs start to form a spectrum between traditional clinical and basic research designs. Is the underlying variable experimental context? Is context developed during a sequential trial, but fully formed at the start of a traditional clinical trial? Dr. Tacker: Yes, that rings true, to me anyway. It is gratifying to see an increasing awareness of how research designs affect formats of research reports. ******************** AICN: Do you have any encouragement or advice for Indiana chapter members? Dr. Tacker: The Indiana chapter means much to me even though my time with the chapter was limited because of our move to Seattle. The Indiana chapter gave me the first opportunity I had to be so involved in a chapter, and I’m grateful for that. I hope members see the value in it and continue to support it. Workshops at chapter conferences are one benefit. Regional networking meetings within the chapter are another.
I hope members see the value in the Indiana chapter
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Interview with Martha Tacker AICN: Dr. Tacker, thank you for helping to establish our profession, for leading AMWA and contributing so many good ideas to its development, for contributing to the Indiana chapter, and for this interview. Dr. Tacker: You’re more than welcome. It was fun to think back over all of this.
Indiana/Ohio Valley Chapters Conference June 6-7, 2014
The Columbia Club
121 Monument Circle Indianapolis
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Misused Words and Phrases
The Most Commonly Misused Words and Phrases in Scientific Writing By Greg Adams (greg.adams@cookmedical.com)
What if you ordered a bowl of soup in a restaurant and the waiter gave you a bowl of ingredients instead? “Here, make the soup yourself,” he might say. A lot of scientific writing is like that bowl of ingredients. Scientific writers often string together concepts without connecting the words and phrases in ways that help readers understand the relationships between the concepts. These writers don’t do the work of effectively combining the “ingredients”—they leave that work to their readers. George Gopen calls this kind of writing “splat prose,” because it’s splattered across the page without consideration of the reader’s needs.1 Readers, in order to understand the meaning of splat prose, have to understand the author’s intention. But a reader shouldn’t have to guess the author’s intention in order to understand the relationship between the words and phrases in scientific writing. A reader who doesn’t know anything about a subject should be able to read a scientific paper and say, “I understand that A is being compared to B, and that C is being used for the purpose of D, even though I don’t know what any of those things are.”
Help readers understand the relationships between the concepts
If you read Lewis Carroll’s famous nonsense poem “Jabberwocky,” from Alice in Wonderland, you can easily understand the grammar, even though most of the words don’t make sense. Carroll organized the words so that their functions and relationships are apparent, even if their meaning isn’t. The ability to write clearly like Carroll is a skill that takes work to acquire and is separate from subject-matter expertise. (In fact, April 2014 | AMWA Indiana Chapter Newsletter | 15
Misused Words and Phrases
Fields that aspire to precision and accuracy shouldn’t produce sentences that are incapable of meaning what they’re supposed to mean
subject-matter expertise can get in the way of the ability to communicate clearly, because of the “knowledge effect”: the tendency to overestimate how much your audience knows.)2 Learning to write clearly is worth the effort for writers, especially in the sciences. Fields that aspire to precision and accuracy shouldn’t produce literature that routinely contains sentences that, grammatically, are incapable of meaning what they’re supposed to mean I didn’t survey a corpus of scientific literature especially for this article, but I read a lot of scientific writing as a reader and an editor, and I’ve noticed that certain words and phrases are so commonly misused in scientific writing that whenever you see them, you can almost guarantee that ambiguity and error lurk nearby. By looking out for the following problems in your own writing, you can write more precisely and serve your readers soup instead of ingredients.
What’s wrong with using? The biggest problem with using is that it requires a user, but scientific writing is often written in the truncated passive voice, which omits the user. • • •
Active voice: The waiter gave me a bowl of ingredients. Passive voice: A bowl of ingredients was given to me by the waiter. Truncated passive voice: A bowl of ingredients was given to me.
When the word using appears in a sentence that is written in the truncated passive voice, something else in the sentence will usually be the user, grammatically speaking, and it will often be something ridiculous. 16 | AMWA Indiana Chapter Newsletter | April 2014
Misused Words and Phrases Look at this title of a journal article: Surgical and patient outcomes using mechanical bowel preparation before laparoscopic gynecologic surgery: a randomized controlled trial3 In this headline, using is both incorrect and ambiguous. The subject of the headline is surgical and patient outcomes, which can’t use anything. You could try to read using as part of a restrictive clause—outcomes using mechanical bowel preparation, as opposed to outcomes using public restrooms—but that reading is no better, because the outcomes are still using the preparation. A headline like this one makes readers work harder, because the literal meaning of the headline doesn’t make sense. Literally, the headline says that outcomes use preparation before surgery. These authors have given their readers a bowl of ingredients. A better title for this paper might have been “Mechanical bowel preparation before gynecologic surgery: surgical and patient outcomes from a randomized, controlled trial.” If you search PubMed, you’ll find thousands of examples of the misuse of using. You won’t have to search very deeply, either, because many of the examples are in the titles of the articles. (By the way, the problem with using also occurs with many other -ing verbs. If the thing that is performing the action of the -ing verb isn’t named in the sentence, then the sentence is probably unfinished, like that bowl of ingredients that I keep talking about.)
A movie can be based on a book, but you can’t watch a movie based on your eyes. Unless you watch a movie that is about your eyes, in which case you’re watching a weird movie.
Scientific writing is often written in the truncated passive voice
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Misused Words and Phrases
Based on has to modify a noun
Based on has to modify a noun, not a verb. Nevertheless, scientific writers constantly use based on to modify verbs. When you use based on to modify verbs, you create ambiguity and confusion, because your sentences also contain nouns that readers can mistakenly connect with based on. Here’s an example: The combination of these three preoperative conditions was identified as an independent parameter for early recurrence based on multivariate analysis.4 Many readers’ first interpretation of this sentence will be that the recurrence is based on multivariate analysis. But wait—that’s not right. So, the independent parameter is based on multivariate analysis? Or the combination of these … conditions is based on multivariate analysis? Those interpretations aren’t right either. The authors meant that the identification was based on multivariate analysis, but they incorrectly used based on to modify a verb (identified) instead of a noun (identification), and placed based on too far away from what it’s supposed to modify. As a result, some of their readers either misunderstood the sentence or had to reread and reinterpret it. The first time that you read this sentence, you might have understood what it’s supposed to mean, but it doesn’t actually say what it’s supposed to mean. Here’s an unambiguous revision: Multivariate analysis identified the combination of these three preoperative conditions as an independent parameter for early recurrence. Let’s look at one more example in which the authors misused based on: The results revealed that SIPT had more efficacy than medication based on both scales.5
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Misused Words and Phrases (SIPT, by the way, stands for spirituality integrated psychotherapy, and the two scales are qualitative and quantitative.) Many people will first read medication based on both scales as a single phrase. Based on isn’t only ambiguous and incorrect in this sentence, it’s also unnecessary. None of the concepts in the sentence—results, efficacy, medication, revelation—are based on both scales. The determination-of-SIPT-having-efficacy-on-bothscales is based on both scales, but based on adds nothing but confusion to this sentence. The authors could have omitted based on and fixed the problem: The results revealed that SIPT had more efficacy, on both scales, than medication. I searched PubMed for the phrase based on and received 1,080,091 results. I looked at the first 20 results to see whether based on was used correctly or incorrectly, and it was used incorrectly 60% of the time.
The problem with due to is the same as with based on. The phrase due to is supposed to modify nouns, and because of is supposed to modify verbs. For example, the baseball game was canceled (a verb) because of rain, but the cancellation (a noun) was due to rain. This is one of those picky, seemingly arbitrary rules of grammar that is rooted in the etymology of the phrases. In casual speech, people use due to and because of interchangeably, and few people distinguish between them or even know what the distinction between them might be. I don’t like rules like this one very much, because I’m a pragmatist, not a grammar policeman. Nevertheless, even though few people know the difference between because of and due to, due to can confuse your reader whenever you use it to modify a verb but your reader can also read
Due to is supposed to modify nouns
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Misused Words and Phrases it as modifying a noun. Here’s an example from another journal article title: The risk of biomaterial-associated infection after revision surgery due to an experimental primary implant infection.6 Grammatically, this title says that the reason for the surgery was the infection (“surgery due to … infection”), but the authors intended for the title to say that one kind of infection created a risk of another kind of infection after surgery. Here’s a revision that eliminates the ambiguity:
When we compare things, we compare things
The risk of biomaterial-associated infection from an experimental primary-implant infection after revision surgery. I eliminated due to and replaced it with a simpler “risk of X from Y after Z” construction. I also hyphenated primary-implant infection, because biomaterial-associated infection is hyphenated, and parallelism helps your readers understand the relationships between concepts.
The phrases compared to and compared with are also like based on and due to: scientific writers attach them, vaguely, to verbs and nouns. As a result, readers can have difficulty interpreting sentences that contain compared with or compared to. When we compare things, we compare things—we compare nouns to nouns. If you want to compare actions, like the verbs chew and swallow, then you first have to change those verbs to nouns: chewing and swallowing. Now you can compare the act of chewing to the act of swallowing, but you can’t compare chew to swallow. And you can’t chew faster compared to swallowing, either, because what is being compared to the verb chew in that construction? The 20 | AMWA Indiana Chapter Newsletter | April 2014
Misused Words and Phrases noun swallowing? The speed of swallowing? The comparison is unclear. Here’s an example from the literature: Pathogen identification using Kiestra TLA combined with MS resulted in a 30.6 hr time gain per isolate compared to CM.7 What two things are being compared in this sentence? The two methods or the relative speed of their results? (Notice, too, that pathogen identification is “using” Kiestra TLA.) The article from which I took this sentence compares the two methods, but this particular sentence compares the speed at which the two methods identified pathogens. The authors didn’t structure their comparison very well, though, because the sentence compares the speed of the results (a 30.6 hr time gain) to one of the methods, CM. They gave their reader a bowl of ingredients. Here’s an unambiguous revision: The combination of Kiestra TLA and MS identified pathogens 30.6 hours faster per isolate than CM.
Dangling modifiers are everywhere in scientific writing
In these examples, using, based on, due to, compared to, and compared with “dangle.” They are said to dangle because they’re not clearly attached to the words that they’re supposed to be attached to. Scientific writers dangle their modifiers so often that doing so “has become standard usage in scientific English,” says Joseph M. Williams.8 Williams’ point isn’t that dangling modifiers are now acceptable in scientific writing, but that dangling modifiers are everywhere in scientific writing. Williams blames the truncated passive voice. He says that if scientific conventions “both deprive their authors of a first-person April 2014 | AMWA Indiana Chapter Newsletter | 21
Misused Words and Phrases subject and rule out dangling modifiers, they put their writers into a damned-if-you-do, damned-if-you-don’t predicament.” I disagree. Every communication problem has more than one solution, so we, as writers, can always find multiple ways to write coherent sentences in the truncated passive voice without dangling our modifiers. Just be aware of the problem and fix it wherever you can.
Clearly written sentences demonstrate clear thinking
Reducing ambiguity isn’t the only benefit of writing clearly. Readers approach texts with finite energy, and you can quickly exhaust them with confusing and poorly structured sentences.9 When sentences clearly establish the relationships between concepts, “[r]eaders … process sentences swiftly and efficiently, and display better recall....”10 Clearly written sentences translate better and more easily, and enhance your arguments by demonstrating clear thinking. In regulated and highly technical industries, clearly written content can reduce risk. The FDA says that “poorly written documents … can impact or slow down the review process…,” so content that is clearly written might be processed and approved more quickly.11 If what we have to say is important, then it is important to our readers that we say it clearly! Greg Adams manages the editing department at Cook Medical, a medical device manufacturer that is based in Bloomington, Indiana, and is president-elect of the Indiana chapter of AMWA. He writes about Global English at GEforEveryone.com and about music at musicweird.com. References 1. Gopen GD. Expectations: Teaching Writing from the Reader’s Perspective. New York, NY; Pearson Longman: 2004:137. 2. Hayes JR, Bajzek D. Understanding and reducing the knowledge effect: implications for writers. Written Communication. 2008;25(1):104-118.
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Misused Words and Phrases 3. Won H, Maley P, Salim S, Rao A, Campbell NT, Abbott JA. Surgical and patient outcomes using mechanical bowel preparation before laparoscopic gynecologic surgery: a randomized controlled trial. Obstet Gynecol. 2013;121(3):538-546. 4. La Torre M, Nigri G, Lo Conte A, et al. Is a preoperative assessment of the early recurrence of pancreatic cancer possible after complete surgical resection? Gut Liver. 2014;8(1):102-108. 5. Ebrahimi A, Neshatdoost HT, Mousavi SG, Asadollahi GA, Nasiri H. Controlled randomized clinical trial of spirituality integrated psychotherapy, cognitive-behavioral therapy and medication intervention on depressive symptoms and dysfunctional attitudes in patients with dysthymic disorder. Adv Biomed Res. 2013;2:5. 6. Engelsman AF, Saldarriaga-Fernandez IC, Nejadnik MR, et al. The risk of biomaterial-associated infection after revision surgery due to an experimental primary implant surgery. Biofouling. 2010;26(7):761-767. 7. Mutters NT, Hodiamont CJ, de Jong MD, Overmeijer HP, van den Boogaard M, Visser CE. Performance of Kiestra Total Laboratory Automation combined with MS in clinical microbiology practice. Ann Lab Med. 2014;34(2):111-117. 8. Williams JM. Style: Toward Clarity and Grace. Chicago, Illinois; University of Chicago Press; 1990. 9. Gopen GD. Expectations: Teaching Writing from the Reader’s Perspective. New York, NY; Pearson Longman; 2004:10-11. 10. Douglas Y. How Plain Language fails to improve organizational communications. Warrington College of Business Administration Web site. http://warrington.ufl.edu/centers/cmc/docs/rp_TheProblemW ithPlainLanguage.pdf. Published 2008. Accessed April 4, 2014. 11. Wessling M, Seaman L. Strategies for working successfully with ESL authors. Presented at: American Medical Writers Association 72nd Annual Conference; October 6, 2012; Sacramento, CA.
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Educating the Market
Educating the Market About a Pharmaceutical Product By Amanda Gellett, PhD (gelletta@gmail.com)
Have you ever wondered what happens to a pharmaceutical product once the US Food and Drug Administration (FDA) approves it for an indication? It seems straightforward: patients are administered the treatment following the prescription orders of their healthcare professional (HCP). But HCPs are busy, they see a lot of patients, and if what they prescribe now is working well enough, then they don’t really have a need to try a new product. This is when promotional education and peer-to-peer programs can become important to industry. Most often, this promotional education is done as a dinner program that HCPs attend at a nearby hotel or restaurant to hear a key opinion leader (KOL) in the field present information on the new product. This content is promotional education because while it educates the HCPs on a new pharmaceutical product, it also promotes the product’s use. And since the KOL, an HCP, presents the material to other HCPs, the program is considered peer-to-peer.
Promotional education educates health care providers and promotes a product's use
As a medical director at Avant Healthcare Marketing, a part of DWA Healthcare Communications Group, I create the content that the KOL presents at the dinner program. Promotional education is highly regulated by the FDA, so the HCPs do not create their own content as they would for a continuing medical education program. Instead, I work closely with the product’s brand team at the pharmaceutical company to convey their message in a medically accurate and fair-balanced manner. My clients for these projects are typically members of the brand’s marketing team, so they rely primarily on my expertise of the product and therapeutic area when creating the presentations. Depending on the content, I may consult with the brand’s medical team or KOLs. Once the presentation is complete, it must be reviewed by medical, legal, and regulatory (MLR) representatives from the brand to ensure
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Educating the Market that it is fair-balanced, accurate, and follows FDA guidelines for promotional education. After discussions with the review team, I incorporate their feedback and make updates to the content as needed; I repeat the review process until the content is approved by the review team to be used in peer-to-peer programs. While I create the scientific content and represent the content in the MLR review sessions, the completed presentation actually involves a large cross-functional team at Avant. The Avant team is led by a project manager and, depending on the project, may include library scientists, editors, graphic designers, videographers, and presentation specialists. All of these roles are valuable toward creating a piece but since it is of the utmost importance that all the content is medically accurate, I have to approve the final piece before it is submitted externally. As the only cross-functional team member who interacts directly with the client, I may also serve as a liaison between the cross-functional team and the client or MLR review team to ensure any feedback is properly incorporated.
My client relies primarily on my expertise of the product and therapeutic area
Creating promotional education content requires a thorough understanding of the product itself as well as the entire disease space or therapeutic area to which the product contributes and the impact the new product may have on clinical guidelines and patient care. Consequently, my role is not strictly limited to creating slide presentations. I may also attend scientific or medical congresses on behalf of the brand team and generate a competitive intelligence report; I may work with KOLs to gather feedback and insight on topics ranging from the most meaningful marketing message for a product to potential analysis of clinical trial data. Attending congresses and communicating with KOLs helps to keep me abreast of the field’s most current information, but I also seek information through journal subscriptions and newsletters that highlight the important breakthroughs or the latest trends in the field. Successfully writing promotional education content requires the ability to quickly understand a new disease space and company April 2014 | AMWA Indiana Chapter Newsletter | 25
Educating the Market
Content communicates scientific concepts to individuals with different levels of scientific knowledge
specific guidelines for promotional education, to balance multiple projects with multiple brands, and to communicate scientific concepts to individuals with different levels of scientific knowledge. For example, I need to be able to review a medical presentation with someone whose background is business or marketing so that they can understand the presentation and feel comfortable with the content that is presented even though the content is intended for HCPs. These types of skills can be gained from many experiences, so promotional education writers can have varied backgrounds. Some writers come directly from academia, others from continuing medical education, industry, or medical associations; nearly all have advanced science degrees in a variety of fields. I began working at Avant Healthcare Marketing after earning my PhD in Pharmacology from the University of Virginia. While in graduate school, I published in peer-reviewed journals and wrote articles for the science section of the university’s newspaper. I have found promotional education to be a satisfying space to write medical content. In addition to challenging myself to consider the medical, marketing, and regulatory aspects of each piece, I view my role as improving patient care by raising awareness among HCPs of the newest treatments available for their patients.
New Fall 2014 Course on Medical Writing at IUPUI MHHS-M 492: Medical Writing T, Th 4:30-5:45p For more information, contact Ana Traversa (antraver@iupui.edu) An overview of the biomedical writing profession, including the contexts where writers work, kinds of texts they produce, and ethical issues they face. Students will translate concepts into practice by engaging in the analysis, production, revision, and adaptation of academic, commercial, and informational/educational biomedical texts.
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Indiana's Medical Device Inndustry
Indiana’s Medical Device Industry: Opportunities for Medical Writers (Part II) By William S. Pietrzak, Ph.D. (billsp@uic.edu)
The last issue of the AMWA Indiana Chapter Newsletter (January, 2014) presented an overview of the medical device industry in Indiana. We learned that Indiana’s Medical Device industry is the fifth largest in the country and includes pretty much the full gamut of types of devices. As such, Indiana is ripe with opportunity for Medical Writers. Here I will focus on some of the types of medical writing projects relevant to device manufacturers. At the outset I will say that medical writing as a discipline is probably a relatively new concept for many medical device manufacturers. This is not because medical writing isn’t an important and necessary function, but rather, that the organization may be structured around individual departments whose responsibility is to produce their own written deliverables, e.g., a Regulatory Affairs Associate will draft 510(k) and PMA (Premarket Approval) submissions to the FDA; a Clinical Associate will produce clinical study annual reports; the Marketing Department will likely have one, or more, individuals that create brochures, surgical techniques, and journal advertisements; and surgeons may be recruited to publish their work in peer-reviewed journals or presented at professional meetings. The list can go on. What the medical writer brings to the table, however, is the expertise to create a document, whatever its purpose, that is succinct, organized, compelling, and achieves its goal. It is often difficult to find individuals with such a skill set in many organizations, perhaps because for most positions medical writing is more incidental to the job rather than part and parcel to it. Without it being the major focus of one’s work, it is very difficult to achieve the highest level of proficiency in medical writing. Following are some of the most common examples of writing that are relevant to the medical device industry.
Medical writing as a discipline is a new concept for many medical device medical manufacturers
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Indiana's Medical Device Industry
Clinical evaluation reports represent one of the greatest opportunities for medical writers in the device industry
1. Clinical Evaluations. The Medical Device Directive (MDD) sets the requirements for a manufacturer to legally market a medical device in the European Union (EU). A Design Dossier must be prepared by the manufacturer and submitted to a Notified Body (for example, BSI, the British Standards Institution) for review. Once accepted by the Notified Body, the device receives the CE Mark and can be sold in the EU. One of the most important sections of the Design Dossier is the Clinical Evaluation that demonstrates the device’s performance and safety and shows it to have an acceptable risk/benefit ratio. This includes, among other things, an evaluation of sales and complaint data, review of any ongoing clinical studies, an examination of relevant national medical registries, and a literature review using search engines such as PubMed and Google Scholar. If little or no clinical data is available for the device under review, then other Equivalent Devices can be identified and clinical evidence for those presented as a surrogate for the subject device. Many medical devices are complex systems comprised of numerous components, e.g., a family of implants of different sizes along with a myriad of instruments. This, combined with the many disparate types of clinical data evaluated, can make a quality Clinical Evaluation Report a challenge to prepare. The need, however, is great and ongoing since the CE Mark must be renewed at intervals, typically every 3 years or 5 years depending on the classification of the device. Also, many other countries have regulatory requirements of their own which may resemble those of the EU to various degrees and require Clinical Evaluations. Clinical Evaluations represent one of the greatest opportunities for Medical Writers in the device industry. 2. Peer-reviewed journal manuscripts. Peer-reviewed papers are highly coveted by device manufacturers as a means to gain credibility for their products. A great deal of work goes into the preparation of the manuscript, starting with an analysis of the clinical data and folding the results and their interpretation into the fabric of the existing literature. While
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Indiana's Medical Device Industry some surgeons are highly skilled in this endeavor and like to take the lead, not all surgeons have the time or inclination to do this. Consequently, a Medical Writer skilled in clinical data analysis and the peer-review publication process can do much of the “heavy lifting” in drafting a manuscript before sending it to the surgeons for critical review and clinical input. The manuscript should be written objectively because the journal peer-reviewers will be quick to detect company bias and can use that as grounds for rejection. It is important to be aware of and conform to the journal’s criteria for authorship. The device company will typically require a formal in-house routing of the manuscript prior to journal submission to ensure that all legal and regulatory requirements are met, e.g., no promotion of off-label indications, proper use of trademarks, etc. Being able to draft a credible manuscript implies expert-level knowledge of the area of medicine for which the device is used. Considering that each area of medicine has its own anatomy, physiology, pathology, technology, and vernacular, there can be a considerable learning curve as one undertakes a new medical device area. This is probably less of a challenge for an in-house Medical Writer employed by the company if the company has a limited spectrum of devices in its portfolio. On the other hand, a freelance Medical Writer may face more of a challenge if he/she elects to take on manuscript projects in new areas of medicine for which they have little background. That said, the more experience one has with different types of medical devices, the shorter the learning curve becomes when working with new devices. 3. White papers. White papers are self-published by the company and typically undergo no external peer review. As such, they generally have less objective credibility than peerreviewed journal articles, but can serve to quickly put key information in the hands of surgeons for educational purposes such as summarizing clinical results, explaining device design rationale, and comparing and contrasting the company’s products to competitive devices. Since the
A medical writer skilled in clinical data analysis and the peerreview publication process can do much of the “heavy lifting” in drafting a manuscript
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Indiana's Medical Device Industry
Many opportunities for medical writers require specialized skills or knowledge
company controls the content and distribution of the white paper, the uncertainty of the peer-review process is eliminated. As with manuscripts destined for journal submission, white papers require internal routing to ensure that all regulatory and legal requirements are met. White papers can be written with internal resources only, or with the assistance of surgeons who have participated in the development and/or clinical study of the device. One useful strategy is for the company to self-publish a short white paper of a study in parallel with submission of the full paper to a peer-reviewed journal. Since the peer-reviewed publication process is protracted and fraught with uncertainty, the white paper can serve as a useful interim publication. However, before employing this strategy it can be prudent to confirm that this is not contrary to journal policy. 4. Other. Other potential projects for Medical Writers in the medical device industry include other portions of the Design Dossier (besides the Clinical Evaluation), FDA submissions, direct-to-patient educational materials, and composing posters and presentations for professional meetings. The first two would require, in addition to excellent medical writing skills, regulatory expertise. In summary, there are many opportunities for Medical Writers in Indiana’s medical device industry. Many of these opportunities, however, require specialized skills and/or knowledge in addition to superb writing skills. As such, it can be an advantage to have specialized competence in at least one area such as peer-review publication, regulatory writing, clinical evaluations, or specific areas of medicine. Nevertheless, excellent medical writing skills are a necessary component to all such activities making Medical Writers a valuable asset to the device industry. 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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Transferrable Skills
Transferrable Skills in Medical Communications By Svetlana Dominguez, ELS, Associate Consultant/Scientific Communications, Eli Lilly and Company (dominguez_svetlana@lilly.com)
Do transferrable skills matter for medical communicators? Absolutely! Do we sometimes take our own skills and experiences for granted? I certainly think so. Transferrable skills have been on my mind quite a bit in the last couple of years. After having been mainly a proofreader or a medical editor for about 15 years, I decided to switch gears and move to an operational role within my company. That decision did not come easy, as I am a proverbial creature of habit, but the rewards have been numerous. I do believe that the transferrable skills that I had developed during my editorial career were one of the main reasons why I was chosen for the operational role. I wanted to share some of my observations and insights to encourage you to develop those transferrable skills, and to most importantly, recognize your own strengths. In my current operational role, I help solve logistical issues for medical communicators (both within my company and for our outsourced partners). Those detective skills (ie, research as well as critical and logical thinking skills) that I developed as a medical editor come in very handy now. The most important aspect of my job, though, is relationship management. This means really knowing the people both within my organization and with our outsourced partners, and understanding their day-to-day challenges to help put matters into perspective and be able to “walk in their shoes.� As an editor, I learned to be mindful about the audience, which now translates into being mindful and knowledgeable about my customers. Even with the structured processes and guidance documents in place, no medical writing project is alike, and the best answer to a logistical situation is not always clear. What helps me deal with the
Relationship management means really knowing people
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Transferrable Skills ambiguity of my current job is the concept of the “shades of gray” that I practiced widely as a medical editor. When dealing with a complex situation, I find it helpful to assess whether this situation may be governed by a structured process, or whether a judgment call needs to be made using the information you have at your fingertips at the moment.
Communication skills improve business relationships and increase efficiencies
What helps tie it all together are the communication skills that I honed as a medical editor (and as a Russian-English translator previously).In my experience, communication issues are the root cause of most of the situations I’ve had to address in my operational role. Knowing when and how much background information to provide, identifying gaps in understanding, reading between the lines and connecting the dots can really improve the business relationships and increase efficiencies. I will say that one of the most important traits of a successful editor, attention to detail, can be both precious and challenging to manage in an operational role. What I strive for is balance and a holistic view of the situation—would the world come to a screeching halt if I miss this one detail, or does this nuance really matter in the grand scheme of things? You, too, may be contemplating about changing your focus in the medical communications field. I encourage you to take the inventory of all the valuable skills, experiences, and wisdom that you have developed in your current career. You may be pleasantly surprised when you see that list, and it might give you the strength, courage, and confidence to pursue your next dream. I will be sharing additional insights during the open session I will be facilitating at the upcoming Indiana/Ohio Valley Chapters Conference on June 7. The title of the session is “From Medical Editing to Business Logistics: How Transferrable Skills Can Enhance Your Career.”
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