amwa indiana chapter newsletter 2014 apr
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Indiana Chapter NewsletterApril 2014
American Medical Wrtiters AssociationIndiana Chapter Newsletter
American Medical Writers AssociationIndiana Chapter 2013-2014
Let us know if there is anything we can do to helpyou benefit professionally from your AMWAmembership. Volunteering to help our chapter ornational association is a great way to have funwhile meeting some wonderful people, improvingyourself and the profession, and becoming andbeing the leader you were meant to be. Join ourLinkedIn group, come to the chapter events, orclick on the name of a chapter officer orcommittee chair above to join the conversationabout medical communication and our chapter.
Officers
Committee Chairs
Barbara Lightfoot, BS, CCRPGregory Adams, IIEllen Stoltzfus, PhD
Laura Town
Esther Brooks-Asplund, PhD
David Caldwell, PhDLinda Hughes, MA
Editor
Section Editors
David Caldwell, PhD
Esther Brooks-Asplund, PhD
Gregory Adams, II
Svetlana Dominguez, ELS
William Pietrzak, PhD
Esther Brooks-Asplund, PhD
Ellen Stoltzfus, PhDQing Zhou, PhD
Links
AMWA
Please let us hear your voice!
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AMWA Indiana Chapter LinkedIn
LG Hughes Blog
PresidentPresident-ElectSecretaryTreasurer
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Pharmaceutical
Publication
Karen Roberts
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Pam McClelland, PhD
Gregory Adams, II
April 2014 | AMWA Indiana Chapter Newsletter | 3
Contents
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.
The Most Commonly Misused Words and Phrases inScientific Writing
Greg Adams
Interview with Martha Tacker, PhD, ELS(D)
Educating the Market About a Pharmaceutical ProductAmanda Gellett, PhD
Cover
Indiana’s Medical Device Industry: Opportunities forMedical Writers (Part II)
William S. Pietrzak, PhD
Qing Zhou, PhD and David Caldwell, PhD
Transferrable Skills in Medical CommunicationsSvetlana Dominguez, ELS
Letter From the President, AMWA Indiana ChapterBarbara Lightfoot, BS, CCRP4
615
242731
4 | AMWA Indiana Chapter Newsletter | April 2014
First, let me extend a heartfelt thank you and job well done to ourEducation Committee, chaired by Laura Town, for organizing the2014 Indiana/Ohio Valley Chapters Conference!! The conferencewill be held June 6-7, 2014 at the historic Columbia Club onMonument Circle in downtown Indianapolis, IN.
Please see the attached conference brochure for a completedescription of the conference.
We have an exciting line-up of talks this year. Our Friday programfeatures the keynote address "Why Isn’t Alzheimer’s Cured Yet?Past Efforts and Future Approaches" by Dr. Ann Hake and a greatpanel discussion “Special Ethical Issues in Vulnerable Populations”by Dr. Peter Schwartz, Dr. Mary Ott, and Amy Waltz, JD. These willbe followed by dinner roundtables covering a variety of topicsincluding freelancing and medical devices. The Saturday programincludes 2 workshops given by Susan Aiello and 8 open sessions. Inaddition, we are offering the BELs Exam before the start of theconference on Friday afternoon.
May 3, 2014 is the deadline for receiving the discountedconference registration price and for registering for AMWA forcredit workshops.
Feel free to send this announcement to anyone who might beinterested in attending. Registration for the conference andworkshops is online only and can be completed at:http://www.amwa.org/calendar_day.asp?date=6/6/2014&event=1499.
Join us for this great educational and networking opportunity!!
From the President, AMWA Indiana Chapter
Join us for thisgreat
educationaland
networkingopportunity!!
April 2014 | AMWA Indiana Chapter Newsletter | 5
Barbara O. Lightfoot
Find updates tochapter andcommunity
events on ourWeb site
Warmest regards,Barbara O. Lightfoot, PresidentAmerican Medical Writers Association, Indiana ChapterPhone: (317) 651-6548Mobile: (706) 814-3289Email: [email protected]
Barbara Lightfoot
Editor's Note:Barbara is the 2013-2014 president of the AMWA Indiana chapter, anAssociate Consultant - Scientific Communication at Eli Lilly and Co., amember of the Society of Clinical Research Associates, and a past member ofthe Advances in Chronic Kidney Disease editorial board. She has also beenprincipal author and coauthor of medical abstracts and journal articles.
From the President, AMWA Indiana Chapter
6 | AMWA Indiana Chapter Newsletter | April 2014
Interview with Martha Tacker, PhD, ELS(D)
This telephone interview was conducted by Qing Zhou ([email protected])and David Caldwell ([email protected]) on February 20, 2014 for theAMWA Indiana chapter newsletter (AICN).
Interview With Martha Tacker
Martha M. Tacker, PhD, ELS(D) ([email protected])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 aPhD degree in biochemistry from Baylor College of Medicine in Houston, Texas. After graduation, she conducted post-doctoralresearch at the Lipid Research Institute in Houston and at the Gastrointestinal Research Unit of the Mayo Foundation inRochester, Minnesota, then joined the Department of Physiology at Baylor College of Medicine as an instructor. During heryears of study and research, Martha discovered her passion for clear, compelling scientific communication, and in the early1970s, 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 significantlyto the advancement of this profession through her extensive work with organizations including American Medical WritersAssociation (AMWA), Council of Biology Editors (CBE; now the Council of Science Editors), and Board of Editors in the LifeSciences (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 – 2010Annual conference workshop coordinator, 1976 – 77Member of the task force appointed to create the AMWA certificate program, 1977AMWA Fellow, 1977AMWA President, 1985 – 86Golden Apple outstanding teacher award recipient, 1988Harold Swanberg Distinguished Service Award recipient, 1992Department of Education, administratorWorkshop leader: “Organization of a Scientific Paper”, “Organizing the Biomedical Paper”, “Macroediting”,
“Microediting”
April 2014 | AMWA Indiana Chapter Newsletter | 7
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 scientificcommunication and wanted to improve my writing skills. Writingmy doctoral dissertation and research grant applications wasenjoyable and satisfying. I thought that mixing with people whocalled themselves medical writers and biological editors wouldhelp me improve.
Personal connections led me to AMWA and CBE. In the early1970s, I took a writing workshop at an American Heart Associationmeeting in Dallas, TX. The workshop was led by Lois and SelmaDeBakey, medical editors and linguists at Baylor College ofMedicine and sisters of Michael DeBakey, the famous heartsurgeon. When I later visited them at their Houston office, theyintroduced me to AMWA, the first organization of medical writersthat I heard of. I went to the next AMWA annual meeting inBethesda, MD in 1973, where I met Charles Roland, MD, a pastPresident of AMWA who also was the head of the editing group atthe Mayo Clinic where I had been a postdoctoral fellow. Later that
Interview With Martha Tacker
Board of Editors in the Life Sciences (BELS)Founding member, 1991Diplomate, 1991
Council of Biology Editors (CBE)President, 1993-94CBE Views, editor, 1995-98Distinguished Service Award recipient, 1992 and 1998
Freelance business ownerBiomedical Communications Services; providing scientific writing and editing services, and training in scientific writing
at universities, pharmaceutical and medical device companies, and scientific association meetings throughoutNorth America and Europe.
AuthorPurina research handbook for veterinary residents: A guide to successful research (2000)
I wanted toimprove mywriting skills
8 | AMWA Indiana Chapter Newsletter | April 2014
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 myhusband and I moved to West Lafayette and Indiana was still partof the Greater Chicago Area chapter. I met a few medical writers inIndianapolis and really enjoyed this group. At that time, there wereonly a very few medical writers at Eli Lilly and Company, one ofwhom was Jan Potvin, PhD. Three of us—Jan, another medicalwriter, and I—put together a workshop on medical writing. Lillywas very supportive, letting us hold the workshop and AMWAmeetings at their facility. A few years later, the medical writingdepartment at Lilly grew to about 30 writers and many of themjoined AMWA. I was active in the chapter for a short time after theIndiana chapter began until we moved to Seattle, WA later in 1996.
AICN: You were president of AMWA and of CBE. Why did youassume these leadership roles?
Dr. Tacker: My leadership roles just evolved naturally. I gotinvolved with these organizations because I needed support as afreelance. AMWA and CBE were my corporate home – I could goto my friends and colleagues there for answers to my questionsand for networking. I enjoyed working with them and they gaveme a chance to develop courses and try out new ideas. I was askedto organize workshops for the 1976 AMWA annual conference, andin 1977 was appointed, along with Harriet Benson and ConnieMitchell, to be a member of a task force for developing the AMWAcertificate program. One thing led to another, and I eventuallybecame president.
AICN: What were the main challenges medical writers andeditors faced in the 1980s and 1990s?
Dr. Tacker: One challenge was to expand the vision of whatmedical editors were beyond the role of an MD editor at atraditional medical journal and to overcome the obscurity of ourlargely hidden profession. The pharmaceutical industry employed
Interview With Martha Tacker
My leadershiproles justevolved
naturally
April 2014 | AMWA Indiana Chapter Newsletter | 9
medical writers and editors, but academic researchers rarelyacknowledged editing services openly. The only academic medicalediting services that I knew of were at the Mayo Clinic and the MDAnderson Hospital. Only through AMWA and CBE did I becomeaware of individuals hired by medical school researchdepartments to do medical editing. Medical editors who helpedwith scientific papers were virtually never openly acknowledgedand were concerned with being accused of ghost writing. Journaleditors were skeptical that academic editing services could havevalue.
This obscurity of medical editing led me to write an article forCBE Views in 1980, “Author's editors: catalysts of scientificpublishing,” in which I tried to describe what I thought was thelegitimate role of a medical editor and to outline my ownstandards for being acknowledged in a paper. My article was asmall, early chip in bringing the medical editing/writingprofession out from behind this concrete wall. I had severalresponses from people around the country who told me they wereglad to know what to call themselves (the term “author’s editor”hadn’t been used much) and to know that other people sharedtheir profession.
Another challenge, still important to both organizations today, wasghost writing, part of the larger issue of developing ethics inbiomedical communication.
A third challenge was lack of training and standards. Anybody canmarket themselves as a medical editor or writer. Development ofthe AMWA curriculum, the Board of Editors in the Life Sciences(BELS) certification exam, and the CSE publication certificateprogram improved things.
AICN: What results of your leadership mean the most to you?
Dr. Tacker: I want to emphasize that what happened under mywatch was certainly done by a team, not just by me. Helping toraise the visibility and acceptance of author’s editors, especially
Interview With Martha Tacker
Onechallenge wasto overcomethe obscurityof our largely
hiddenprofession
10 | AMWA Indiana Chapter Newsletter | April 2014
Interview with Martha Tacker
with journal editors and academia, was satisfying. So wasdeveloping the AMWA curriculum and my workshops, as well asgrowing CBE Views into a journal-like publication. I enjoyedworking with people from all over the world who were talentedand shared generously; some of them became my life-longfriends. Actively participating in AMWA and CBE helped medevelop both my skills and a network that were critical to thetransition of my career from a research biochemist to awriter/editor/workshop teacher. I would never have done thatwithout the support and training people in those organizationsgave me.
AICN: What were your career goals?Did you achieve them?
Dr. Tacker: I just wanted to keep getting editing and teachingassignments because the work was so stimulating and satisfying. Ialso wanted to keep interacting with stimulating and competentpeople who shared my interest in biomedical editing and writing.Staying active in AMWA and CBE was key to achieving both ofthose goals.
I taught medical writing at MED Institute, Inc. and PurdueUniversity in West Lafayette, and taught workshops in variousplaces. One benefit of teaching I liked was keeping up with thefrontiers of science. I learned a lot from students who broughtwriting about their own research to my workshops.
AICN: Would you like to suggest any directions that AMWA andCBE could take?
Dr. Tacker: I’m not very actively involved with thoseorganizations now, but from what I can see, I would suggest thatthey keep doing what they are doing: promoting the developmentof ethical standards; developing, educating, and training peoplenew to the profession; educating and training the users of medicalediting and writing services; and promoting the value ofcompetent medical writers and editors to organizations.
********************
I enjoyedworking withpeople fromall over theworld who
were talentedand sharedgenerously
April 2014 | AMWA Indiana Chapter Newsletter | 11
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. Theyneed to have a sufficient understanding not only of the topic, butalso of the reader’s needs and interests, because the story must beclear and compelling to the reader. That requires a command oflanguage skills (both general and biomedical) and of logicalanalysis and presentation. That also requires a curiosity that drivesthe writer/editor to learn enough about the topic to establish andmaintain a writer’s credibility with the reader or an editor’scredibility with the author.
AICN: What skills do we need to acquire during our professionaldevelopment?
Dr. Tacker: Writing and editing are like playing the piano – youhave to practice to improve. Review and test your skills every sooften by taking or teaching a workshop. Teaching forces you toidentify what is important and to put your ideas together in alogical order. There’s an old saying, paraphrased as “How can I tellyou what I think till I see what I say?” (E.M. Forster in “Aspects ofthe Novel”). The best way to really learn how to do something is toteach it to somebody else.
AICN: What is your secret to collaborating successfully?
Dr. Tacker: Try to establish and maintain credibility. If you are aneditor, remember that you are working on the author’s paper. Youhave to negotiate and decide what is and isn’t important.
********************
Have areader's eye
12 | AMWA Indiana Chapter Newsletter | April 2014
Interview with Martha Tacker
III. Manuscript Formats
AICN: At the 2008 AMWA annual conference in Louisville, yousuggested developing guidelines for papers that describetranslational and basic research. Would you tell us about that?
Dr. Tacker: Virtually all of my workshops addressed clinicalresearch, so I had been teaching students how to organize a paperwith the familiar introduction, methods, results and discussion(IMRaD) format. I encouraged my students to bring their ownresearch papers. In recent years, more and more of those paperswere reporting translational and basic research and were written ina format that organized the results and discussion slightlydifferently from the traditional IMRaD. So I had to teach twoformats.
IMRaD organizes the report of a traditional clinical study wellbecause the study is completely preplanned. But a nested IMRaDformat is better for reporting a translational or basic study that isplanned sequentially. A general plan may exist, but the result ofone experiment informs the plan of the next. The Methods sectionis just a series of recipe cards. The Results section nests a set ofmini-presentations, one for each experiment, with descriptions ofthe main finding and what it means, very similar to the Discussionsection of a clinical paper. The Discussion section then joins all ofthe mini-stories to tell the whole story.
The new format was just an observation that I made and put outthere to see what would happen. Unfortunately, nothing muchhappened. I have asked several biomedical journal editors about it,but haven’t received any feedback or seen any discussion of thisnew format anywhere. Maybe this topic will receive moreattention as professional writers and editors become moreengaged with basic and translational research papers.
I felt it would be useful to bring this new format to the attention ofprofessional medical writers who may have been more familiarwith the traditional IMRaD. I wanted them to see the difference in
I felt it wouldbe useful to
bring this newformat to theattention ofprofessional
medicalwriters
April 2014 | AMWA Indiana Chapter Newsletter | 13
Interview with Martha Tacker
the formats that I was seeing, especially at a time whentranslational research in molecular medicine is becoming moreimportant to clinical practice. For example, genetic tests are nowpart of routine checkups.
I believe that, like clinical researchers, translational and basicresearchers also need help with their papers. In both instances, theresearchers are often so steeped in their projects that it’s hard forthem to realize what links readers need to follow a story. Theresearchers need to learn how to step back from this mass ofinformation and to develop an introduction and discussion thatcreate a context for the whole story.
AICN: Developing guidelines for reporting sequentially plannedresearch may become increasingly important as Bayesianadaptive designs and sequential, multiple assignment,randomized trial (SMART) designs start to form a spectrumbetween traditional clinical and basic research designs. Is theunderlying variable experimental context? Is context developedduring a sequential trial, but fully formed at the start of atraditional clinical trial?
Dr. Tacker: Yes, that rings true, to me anyway. It is gratifying to seean increasing awareness of how research designs affect formats ofresearch reports.
********************AICN: Do you have any encouragement or advice for Indianachapter members?
Dr. Tacker: The Indiana chapter means much to me even thoughmy time with the chapter was limited because of our move toSeattle. The Indiana chapter gave me the first opportunity I had tobe so involved in a chapter, and I’m grateful for that. I hopemembers see the value in it and continue to support it. Workshopsat chapter conferences are one benefit. Regional networkingmeetings within the chapter are another.
I hopemembers seethe value inthe Indiana
chapter
14 | AMWA Indiana Chapter Newsletter | April 2014
Interview with Martha Tacker
AICN: Dr. Tacker, thank you for helping to establish ourprofession, for leading AMWA and contributing so many goodideas 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 backover all of this.
Indiana/Ohio Valley Chapters ConferenceJune 6-7, 2014 The Columbia Club 121 Monument Circle Indianapolis
l l l l
April 2014 | AMWA Indiana Chapter Newsletter | 15
Misused Words and Phrases
The Most Commonly Misused Words and Phrases in
Scientific Writing
By Greg Adams ([email protected])
What if you ordered a bowl of soup in a restaurant and the waitergave you a bowl of ingredients instead? “Here, make the soupyourself,” he might say.
A lot of scientific writing is like that bowl of ingredients. Scientificwriters often string together concepts without connecting thewords and phrases in ways that help readers understand therelationships between the concepts. These writers don’t do thework of effectively combining the “ingredients”—they leave thatwork to their readers.
George Gopen calls this kind of writing “splat prose,” because it’ssplattered across the page without consideration of the reader’sneeds.1 Readers, in order to understand the meaning of splatprose, have to understand the author’s intention.
But a reader shouldn’t have to guess the author’s intention in orderto understand the relationship between the words and phrases inscientific writing. A reader who doesn’t know anything about asubject should be able to read a scientific paper and say, “Iunderstand that A is being compared to B, and that C is being usedfor the purpose of D, even though I don’t know what any of thosethings are.”
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. Carrollorganized the words so that their functions and relationships areapparent, even if their meaning isn’t.
The ability to write clearly like Carroll is a skill that takes work toacquire and is separate from subject-matter expertise. (In fact,
Help readersunderstand
therelationshipsbetween the
concepts
16 | AMWA Indiana Chapter Newsletter | April 2014
Misused Words and Phrases
subject-matter expertise can get in the way of the ability tocommunicate clearly, because of the “knowledge effect”: thetendency to overestimate how much your audience knows.)2
Learning to write clearly is worth the effort for writers, especiallyin the sciences. Fields that aspire to precision and accuracyshouldn’t produce literature that routinely contains sentences that,grammatically, are incapable of meaning what they’re supposed tomean
I didn’t survey a corpus of scientific literature especially for thisarticle, but I read a lot of scientific writing as a reader and aneditor, and I’ve noticed that certain words and phrases are socommonly misused in scientific writing that whenever you seethem, you can almost guarantee that ambiguity and error lurknearby. By looking out for the following problems in your ownwriting, you can write more precisely and serve your readers soupinstead of ingredients.
What’s wrong with using?
The biggest problem with using is that it requires a user, butscientific 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 thetruncated passive voice, something else in the sentence will usuallybe the user, grammatically speaking, and it will often be somethingridiculous.
Fields thataspire to
precision andaccuracyshouldn’tproduce
sentencesthat are
incapable ofmeaning what
they’resupposed to
mean
April 2014 | AMWA Indiana Chapter Newsletter | 17
Misused Words and Phrases
Look at this title of a journal article:
Surgical and patient outcomes using mechanical bowelpreparation 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, whichcan’t use anything. You could try to read using as part of arestrictive clause—outcomes using mechanical bowel preparation, asopposed to outcomes using public restrooms—but that reading is nobetter, because the outcomes are still using the preparation.
A headline like this one makes readers work harder, because theliteral meaning of the headline doesn’t make sense. Literally, theheadline says that outcomes use preparation before surgery. Theseauthors have given their readers a bowl of ingredients.
A better title for this paper might have been “Mechanical bowelpreparation before gynecologic surgery: surgical and patientoutcomes from a randomized, controlled trial.”
If you search PubMed, you’ll find thousands of examples of themisuse 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 -ingverb isn’t named in the sentence, then the sentence is probablyunfinished, like that bowl of ingredients that I keep talking about.)
A movie can be based on a book, but you can’t watch a moviebased on your eyes. Unless you watch a movie that is about youreyes, in which case you’re watching a weird movie.
Scientificwriting is
often writtenin the
truncatedpassive voice
18 | AMWA Indiana Chapter Newsletter | April 2014
Misused Words and Phrases
Based on has to modify a noun, not a verb. Nevertheless, scientificwriters constantly use based on to modify verbs. When you usebased on to modify verbs, you create ambiguity and confusion,because your sentences also contain nouns that readers canmistakenly connect with based on.
Here’s an example:
The combination of these three preoperative conditions wasidentified as an independent parameter for early recurrencebased on multivariate analysis.4
Many readers’ first interpretation of this sentence will be that therecurrence is based on multivariate analysis. But wait—that’s notright. So, the independent parameter is based on multivariateanalysis? Or the combination of these … conditions is based onmultivariate analysis? Those interpretations aren’t right either.
The authors meant that the identification was based onmultivariate analysis, but they incorrectly used based on to modifya verb (identified) instead of a noun (identification), and placed basedon too far away from what it’s supposed to modify. As a result,some of their readers either misunderstood the sentence or had toreread and reinterpret it. The first time that you read thissentence, 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 thesethree preoperative conditions as an independent parameterfor early recurrence.
Let’s look at one more example in which the authors misused basedon:
The results revealed that SIPT had more efficacy thanmedication based on both scales.5
Based on hasto modify a
noun
April 2014 | AMWA Indiana Chapter Newsletter | 19
Misused Words and Phrases
(SIPT, by the way, stands for spirituality integrated psychotherapy, andthe two scales are qualitative and quantitative.)
Many people will first read medication based on both scales as a singlephrase. Based on isn’t only ambiguous and incorrect in thissentence, it’s also unnecessary. None of the concepts in thesentence—results, efficacy, medication, revelation—are based onboth scales. The determination-of-SIPT-having-efficacy-on-both-scales is based on both scales, but based on adds nothing butconfusion to this sentence. The authors could have omitted basedon and fixed the problem:
The results revealed that SIPT had more efficacy, on bothscales, than medication.
I searched PubMed for the phrase based on and received 1,080,091results. I looked at the first 20 results to see whether based on wasused correctly or incorrectly, and it was used incorrectly 60% of thetime.
The problem with due to is the same as with based on. The phrasedue to is supposed to modify nouns, and because of is supposed tomodify verbs. For example, the baseball game was canceled (averb) because of rain, but the cancellation (a noun) was due to rain.
This is one of those picky, seemingly arbitrary rules of grammarthat is rooted in the etymology of the phrases. In casual speech,people use due to and because of interchangeably, and few peopledistinguish between them or even know what the distinctionbetween 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 differencebetween because of and due to, due to can confuse your readerwhenever you use it to modify a verb but your reader can also read
Due to issupposed to
modifynouns
20 | AMWA Indiana Chapter Newsletter | April 2014
Misused Words and Phrases
it as modifying a noun. Here’s an example from another journalarticle title:
The risk of biomaterial-associated infection after revisionsurgery due to an experimental primary implant infection.6
Grammatically, this title says that the reason for the surgery wasthe infection (“surgery due to … infection”), but the authorsintended for the title to say that one kind of infection created a riskof another kind of infection after surgery.
Here’s a revision that eliminates the ambiguity:
The risk of biomaterial-associated infection from anexperimental primary-implant infection after revisionsurgery.
I eliminated due to and replaced it with a simpler “risk of X from Yafter Z” construction. I also hyphenated primary-implant infection,because biomaterial-associated infection is hyphenated, andparallelism helps your readers understand the relationshipsbetween concepts.
The phrases compared to and compared with are also like based on anddue to: scientific writers attach them, vaguely, to verbs and nouns.As a result, readers can have difficulty interpreting sentences thatcontain compared with or compared to.
When we compare things, we compare things—we compare nounsto nouns. If you want to compare actions, like the verbs chew andswallow, then you first have to change those verbs to nouns:chewing and swallowing. Now you can compare the act of chewingto the act of swallowing, but you can’t compare chew to swallow.And you can’t chew faster compared to swallowing, either, becausewhat is being compared to the verb chew in that construction? The
When wecompare
things, wecompare
things
April 2014 | AMWA Indiana Chapter Newsletter | 21
Misused Words and Phrases
noun swallowing? The speed of swallowing? The comparison isunclear.
Here’s an example from the literature:
Pathogen identification using Kiestra TLA combined with MSresulted in a 30.6 hr time gain per isolate compared to CM.7
What two things are being compared in this sentence? The twomethods or the relative speed of their results? (Notice, too, thatpathogen identification is “using” Kiestra TLA.)
The article from which I took this sentence compares the twomethods, but this particular sentence compares the speed at whichthe two methods identified pathogens. The authors didn’tstructure their comparison very well, though, because the sentencecompares the speed of the results (a 30.6 hr time gain) to one of themethods, CM. They gave their reader a bowl of ingredients.
Here’s an unambiguous revision:
The combination of Kiestra TLA and MS identified pathogens30.6 hours faster per isolate than CM.
In these examples, using, based on, due to, compared to, and comparedwith “dangle.” They are said to dangle because they’re not clearlyattached to the words that they’re supposed to be attached to.
Scientific writers dangle their modifiers so often that doing so “hasbecome standard usage in scientific English,” says Joseph M.Williams.8 Williams’ point isn’t that dangling modifiers are nowacceptable in scientific writing, but that dangling modifiers areeverywhere in scientific writing.
Williams blames the truncated passive voice. He says that ifscientific conventions “both deprive their authors of a first-person
Danglingmodifiers areeverywhere in
scientificwriting
22 | AMWA Indiana Chapter Newsletter | April 2014
Misused Words and Phrases
subject and rule out dangling modifiers, they put their writers intoa damned-if-you-do, damned-if-you-don’t predicament.”
I disagree. Every communication problem has more than onesolution, so we, as writers, can always find multiple ways to writecoherent sentences in the truncated passive voice without danglingour modifiers. Just be aware of the problem and fix it whereveryou can.
Reducing ambiguity isn’t the only benefit of writing clearly.Readers approach texts with finite energy, and you can quicklyexhaust them with confusing and poorly structured sentences.9When sentences clearly establish the relationships betweenconcepts, “[r]eaders … process sentences swiftly and efficiently, anddisplay better recall....”10 Clearly written sentences translate betterand more easily, and enhance your arguments by demonstratingclear thinking. In regulated and highly technical industries, clearlywritten content can reduce risk. The FDA says that “poorly writtendocuments … can impact or slow down the review process…,” socontent that is clearly written might be processed and approvedmore quickly.11 If what we have to say is important, then it isimportant to our readers that we say it clearly!
Greg Adams manages the editing department at Cook Medical, amedical 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 aboutmusic at musicweird.com.
References
1. Gopen GD. Expectations: Teaching Writing from the Reader’sPerspective. New York, NY; Pearson Longman: 2004:137.
2. Hayes JR, Bajzek D. Understanding and reducing the knowledgeeffect: implications for writers. Written Communication.2008;25(1):104-118.
Clearlywritten
sentencesdemonstrateclear thinking
April 2014 | AMWA Indiana Chapter Newsletter | 23
Misused Words and Phrases
3. Won H, Maley P, Salim S, Rao A, Campbell NT, Abbott JA.Surgical and patient outcomes using mechanical bowelpreparation before laparoscopic gynecologic surgery: arandomized controlled trial. Obstet Gynecol. 2013;121(3):538-546.
4. La Torre M, Nigri G, Lo Conte A, et al. Is a preoperativeassessment of the early recurrence of pancreatic cancerpossible after complete surgical resection? Gut Liver.2014;8(1):102-108.
5. Ebrahimi A, Neshatdoost HT, Mousavi SG, Asadollahi GA, NasiriH. Controlled randomized clinical trial of spiritualityintegrated psychotherapy, cognitive-behavioral therapy andmedication intervention on depressive symptoms anddysfunctional 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 revisionsurgery due to an experimental primary implant surgery.Biofouling. 2010;26(7):761-767.
7. Mutters NT, Hodiamont CJ, de Jong MD, Overmeijer HP, vanden Boogaard M, Visser CE. Performance of Kiestra TotalLaboratory Automation combined with MS in clinicalmicrobiology 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’sPerspective. New York, NY; Pearson Longman; 2004:10-11.
10. Douglas Y. How Plain Language fails to improve organizationalcommunications. Warrington College of BusinessAdministration Web site.http://warrington.ufl.edu/centers/cmc/docs/rp_TheProblemWithPlainLanguage.pdf. Published 2008. Accessed April 4, 2014.
11. Wessling M, Seaman L. Strategies for working successfully withESL authors. Presented at: American Medical WritersAssociation 72nd Annual Conference; October 6, 2012;Sacramento, CA.
24 | AMWA Indiana Chapter Newsletter | April 2014
Educating the Market About a Pharmaceutical
Product
By Amanda Gellett, PhD ([email protected])
Have you ever wondered what happens to a pharmaceuticalproduct once the US Food and Drug Administration (FDA)approves it for an indication? It seems straightforward: patients areadministered the treatment following the prescription orders oftheir healthcare professional (HCP). But HCPs are busy, they see alot of patients, and if what they prescribe now is working wellenough, then they don’t really have a need to try a new product.This is when promotional education and peer-to-peer programscan become important to industry. Most often, this promotionaleducation is done as a dinner program that HCPs attend at anearby hotel or restaurant to hear a key opinion leader (KOL) inthe field present information on the new product. This content ispromotional education because while it educates the HCPs on anew 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.
As a medical director at Avant Healthcare Marketing, a part ofDWA Healthcare Communications Group, I create the content thatthe KOL presents at the dinner program. Promotional education ishighly regulated by the FDA, so the HCPs do not create their owncontent as they would for a continuing medical educationprogram. Instead, I work closely with the product’s brand team atthe pharmaceutical company to convey their message in amedically accurate and fair-balanced manner. My clients for theseprojects are typically members of the brand’s marketing team, sothey rely primarily on my expertise of the product and therapeuticarea when creating the presentations. Depending on the content, Imay consult with the brand’s medical team or KOLs. Once thepresentation is complete, it must be reviewed by medical, legal,and regulatory (MLR) representatives from the brand to ensure
Promotionaleducationeducates
health careproviders and
promotes aproduct's use
Educating the Market
April 2014 | AMWA Indiana Chapter Newsletter | 25
that it is fair-balanced, accurate, and follows FDA guidelines forpromotional education. After discussions with the review team, Iincorporate their feedback and make updates to the content asneeded; I repeat the review process until the content is approvedby the review team to be used in peer-to-peer programs.
While I create the scientific content and represent the content inthe MLR review sessions, the completed presentation actuallyinvolves a large cross-functional team at Avant. The Avant team isled by a project manager and, depending on the project, mayinclude library scientists, editors, graphic designers,videographers, and presentation specialists. All of these roles arevaluable toward creating a piece but since it is of the utmostimportance that all the content is medically accurate, I have toapprove the final piece before it is submitted externally. As theonly cross-functional team member who interacts directly with theclient, I may also serve as a liaison between the cross-functionalteam and the client or MLR review team to ensure any feedback isproperly incorporated.
Creating promotional education content requires a thoroughunderstanding of the product itself as well as the entire diseasespace or therapeutic area to which the product contributes and theimpact the new product may have on clinical guidelines andpatient care. Consequently, my role is not strictly limited tocreating slide presentations. I may also attend scientific or medicalcongresses on behalf of the brand team and generate acompetitive intelligence report; I may work with KOLs to gatherfeedback and insight on topics ranging from the most meaningfulmarketing message for a product to potential analysis of clinicaltrial data. Attending congresses and communicating with KOLshelps to keep me abreast of the field’s most current information,but I also seek information through journal subscriptions andnewsletters that highlight the important breakthroughs or thelatest trends in the field.
Successfully writing promotional education content requires theability to quickly understand a new disease space and company
My clientrelies
primarily onmy expertise
of the productand
therapeuticarea
Educating the Market
26 | AMWA Indiana Chapter Newsletter | April 2014
specific guidelines for promotional education, to balance multipleprojects with multiple brands, and to communicate scientificconcepts to individuals with different levels of scientificknowledge. For example, I need to be able to review a medicalpresentation with someone whose background is business ormarketing so that they can understand the presentation and feelcomfortable with the content that is presented even though thecontent is intended for HCPs. These types of skills can be gainedfrom many experiences, so promotional education writers canhave varied backgrounds. Some writers come directly fromacademia, others from continuing medical education, industry, ormedical associations; nearly all have advanced science degrees in avariety of fields.
I began working at Avant Healthcare Marketing after earning myPhD in Pharmacology from the University of Virginia. While ingraduate school, I published in peer-reviewed journals and wrotearticles for the science section of the university’s newspaper. I havefound promotional education to be a satisfying space to writemedical content. In addition to challenging myself to consider themedical, marketing, and regulatory aspects of each piece, I viewmy role as improving patient care by raising awareness amongHCPs of the newest treatments available for their patients.
Contentcommunicates
scientificconcepts toindividuals
with differentlevels ofscientific
knowledge
Educating the Market
New Fall 2014 Course on Medical Writing at IUPUIMHHS-M 492: Medical Writing T, Th 4:30-5:45p For more information, contact Ana Traversa ([email protected])
An overview of the biomedical writing profession, including the contexts where writers work, kinds of texts theyproduce, 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.
April 2014 | AMWA Indiana Chapter Newsletter | 27
Indiana’s Medical Device Industry: Opportunities
for Medical Writers (Part II)
By William S. Pietrzak, Ph.D. ([email protected])
The last issue of the AMWA Indiana Chapter Newsletter (January,2014) presented an overview of the medical device industry inIndiana. We learned that Indiana’s Medical Device industry is thefifth largest in the country and includes pretty much the fullgamut of types of devices. As such, Indiana is ripe withopportunity for Medical Writers. Here I will focus on some of thetypes of medical writing projects relevant to device manufacturers.
At the outset I will say that medical writing as a discipline isprobably a relatively new concept for many medical devicemanufacturers. This is not because medical writing isn’t animportant and necessary function, but rather, that theorganization may be structured around individual departmentswhose 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 Associatewill produce clinical study annual reports; the MarketingDepartment will likely have one, or more, individuals that createbrochures, surgical techniques, and journal advertisements; andsurgeons may be recruited to publish their work in peer-reviewedjournals or presented at professional meetings. The list can go on.What the medical writer brings to the table, however, is theexpertise to create a document, whatever its purpose, that issuccinct, organized, compelling, and achieves its goal. It is oftendifficult to find individuals with such a skill set in manyorganizations, perhaps because for most positions medical writingis 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 difficultto achieve the highest level of proficiency in medical writing.
Following are some of the most common examples of medicalwriting that are relevant to the medical device industry.
Medical writingas a discipline
is a newconcept for
many medicaldevice
manufacturers
Indiana's Medical Device Inndustry
28 | AMWA Indiana Chapter Newsletter | April 2014
1. Clinical Evaluations. The Medical Device Directive (MDD)sets the requirements for a manufacturer to legally market amedical device in the European Union (EU). A Design Dossiermust be prepared by the manufacturer and submitted to aNotified Body (for example, BSI, the British StandardsInstitution) 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 isthe Clinical Evaluation that demonstrates the device’sperformance and safety and shows it to have an acceptablerisk/benefit ratio. This includes, among other things, anevaluation of sales and complaint data, review of any ongoingclinical studies, an examination of relevant national medicalregistries, and a literature review using search engines such asPubMed and Google Scholar. If little or no clinical data isavailable for the device under review, then other EquivalentDevices can be identified and clinical evidence for thosepresented as a surrogate for the subject device. Many medicaldevices are complex systems comprised of numerouscomponents, e.g., a family of implants of different sizes alongwith a myriad of instruments. This, combined with the manydisparate types of clinical data evaluated, can make a qualityClinical Evaluation Report a challenge to prepare. The need,however, is great and ongoing since the CE Mark must berenewed at intervals, typically every 3 years or 5 yearsdepending on the classification of the device. Also, manyother countries have regulatory requirements of their ownwhich may resemble those of the EU to various degrees andrequire Clinical Evaluations. Clinical Evaluations representone of the greatest opportunities for Medical Writers in thedevice industry.
2. Peer-reviewed journal manuscripts. Peer-reviewed papersare highly coveted by device manufacturers as a means togain credibility for their products. A great deal of work goesinto the preparation of the manuscript, starting with ananalysis of the clinical data and folding the results and theirinterpretation into the fabric of the existing literature. While
Clinicalevaluation
reportsrepresent one
of thegreatest
opportunitiesfor medical
writers in thedevice
industry
Indiana's Medical Device Industry
April 2014 | AMWA Indiana Chapter Newsletter | 29
some surgeons are highly skilled in this endeavor and like totake the lead, not all surgeons have the time or inclination todo this. Consequently, a Medical Writer skilled in clinical dataanalysis and the peer-review publication process can do muchof the “heavy lifting” in drafting a manuscript before sendingit to the surgeons for critical review and clinical input. Themanuscript should be written objectively because the journalpeer-reviewers will be quick to detect company bias and canuse that as grounds for rejection. It is important to be aware ofand conform to the journal’s criteria for authorship. Thedevice company will typically require a formal in-houserouting of the manuscript prior to journal submission toensure that all legal and regulatory requirements are met, e.g.,no promotion of off-label indications, proper use oftrademarks, etc. Being able to draft a credible manuscriptimplies expert-level knowledge of the area of medicine forwhich the device is used. Considering that each area ofmedicine has its own anatomy, physiology, pathology,technology, and vernacular, there can be a considerablelearning curve as one undertakes a new medical device area.This is probably less of a challenge for an in-house MedicalWriter employed by the company if the company has alimited spectrum of devices in its portfolio. On the otherhand, a freelance Medical Writer may face more of achallenge if he/she elects to take on manuscript projects innew areas of medicine for which they have little background.That said, the more experience one has with different types ofmedical devices, the shorter the learning curve becomes whenworking with new devices.
3. White papers. White papers are self-published by thecompany and typically undergo no external peer review. Assuch, they generally have less objective credibility than peer-reviewed journal articles, but can serve to quickly put keyinformation in the hands of surgeons for educationalpurposes such as summarizing clinical results, explainingdevice design rationale, and comparing and contrasting thecompany’s products to competitive devices. Since the
A medicalwriter skilled
in clinical dataanalysis and
the peer-review
publicationprocess cando much ofthe “heavylifting” indrafting a
manuscript
Indiana's Medical Device Industry
30 | AMWA Indiana Chapter Newsletter | April 2014
company controls the content and distribution of the whitepaper, the uncertainty of the peer-review process iseliminated. As with manuscripts destined for journalsubmission, white papers require internal routing to ensurethat all regulatory and legal requirements are met. Whitepapers can be written with internal resources only, or with theassistance of surgeons who have participated in thedevelopment and/or clinical study of the device. One usefulstrategy is for the company to self-publish a short white paperof a study in parallel with submission of the full paper to apeer-reviewed journal. Since the peer-reviewed publicationprocess is protracted and fraught with uncertainty, the whitepaper can serve as a useful interim publication. However,before employing this strategy it can be prudent to confirmthat this is not contrary to journal policy.
4. Other. Other potential projects for Medical Writers in themedical device industry include other portions of the DesignDossier (besides the Clinical Evaluation), FDA submissions,direct-to-patient educational materials, and composingposters and presentations for professional meetings. The firsttwo would require, in addition to excellent medical writingskills, regulatory expertise.
In summary, there are many opportunities for Medical Writers inIndiana’s medical device industry. Many of these opportunities,however, require specialized skills and/or knowledge in addition tosuperb writing skills. As such, it can be an advantage to havespecialized competence in at least one area such as peer-reviewpublication, regulatory writing, clinical evaluations, or specificareas of medicine. Nevertheless, excellent medical writing skillsare a necessary component to all such activities making MedicalWriters a valuable asset to the device industry.
William Pietrzak is a research scientist at Biomet, Inc. and anadjunct research professor of bioengineering at the University ofIllinois at Chicago.
Manyopportunities
for medicalwritersrequire
specializedskills or
knowledge
Indiana's Medical Device Industry
April 2014 | AMWA Indiana Chapter Newsletter | 31
Transferrable Skills in Medical Communications
By Svetlana Dominguez, ELS, Associate Consultant/Scientific Communications, Eli Lillyand Company ([email protected])
Do transferrable skills matter for medical communicators?Absolutely! Do we sometimes take our own skills and experiencesfor granted? I certainly think so.
Transferrable skills have been on my mind quite a bit in the lastcouple of years. After having been mainly a proofreader or amedical editor for about 15 years, I decided to switch gears andmove to an operational role within my company. That decisiondid not come easy, as I am a proverbial creature of habit, but therewards have been numerous. I do believe that the transferrableskills that I had developed during my editorial career were one ofthe main reasons why I was chosen for the operational role. Iwanted to share some of my observations and insights toencourage you to develop those transferrable skills, and to mostimportantly, recognize your own strengths.
In my current operational role, I help solve logistical issues formedical communicators (both within my company and for ouroutsourced partners). Those detective skills (ie, research as well ascritical and logical thinking skills) that I developed as a medicaleditor come in very handy now.
The most important aspect of my job, though, is relationshipmanagement. This means really knowing the people both withinmy organization and with our outsourced partners, andunderstanding their day-to-day challenges to help put matters intoperspective and be able to “walk in their shoes.” As an editor, Ilearned to be mindful about the audience, which now translatesinto being mindful and knowledgeable about my customers.
Even with the structured processes and guidance documents inplace, no medical writing project is alike, and the best answer to alogistical situation is not always clear. What helps me deal with the
Transferrable Skills
Relationshipmanagementmeans really
knowingpeople
32 | AMWA Indiana Chapter Newsletter | April 2014
ambiguity of my current job is the concept of the “shades of gray”that I practiced widely as a medical editor. When dealing with acomplex situation, I find it helpful to assess whether this situationmay be governed by a structured process, or whether a judgmentcall needs to be made using the information you have at yourfingertips at the moment.
What helps tie it all together are the communication skills that Ihoned as a medical editor (and as a Russian-English translatorpreviously).In my experience, communication issues are the rootcause of most of the situations I’ve had to address in myoperational role. Knowing when and how much backgroundinformation to provide, identifying gaps in understanding, readingbetween the lines and connecting the dots can really improve thebusiness relationships and increase efficiencies.
I will say that one of the most important traits of a successfuleditor, attention to detail, can be both precious and challenging tomanage in an operational role. What I strive for is balance and aholistic view of the situation—would the world come to ascreeching halt if I miss this one detail, or does this nuance reallymatter in the grand scheme of things?
You, too, may be contemplating about changing your focus in themedical communications field. I encourage you to take theinventory of all the valuable skills, experiences, and wisdom thatyou have developed in your current career. You may be pleasantlysurprised 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 willbe facilitating at the upcoming Indiana/Ohio Valley ChaptersConference on June 7. The title of the session is “From MedicalEditing to Business Logistics: How Transferrable Skills CanEnhance Your Career.”
Transferrable Skills
Communicationskills improve
businessrelationshipsand increaseefficiencies