Roadmap to excelling in medical writingDr Trish GrovesDeputy editor, BMJ

Programme for the dayIMRADStudy designsClear writingStructured abstractsStatistics testsSelf-editingGraphs, figuresImpact factorWhich journal?Publication ethicsClinical trial disclosure

The scope of medical writingInternal reports

Regulatory reports

Conference presentationsabstractoral presentationposter

Journal articlesoriginal research paperreview articlecase reportletter to editor

Follow the right road

Role of medical writersEuropean Medical Writers Association policy: medical writers have a legitimate role in assisting named authors in developing manuscripts for peer-reviewed journals and presentationssuch contributions and funding information should be openly acknowledgednot ghostwriter, which wrongly implies something secretiveexperts in scientific communication, data presentation, journal and congress requirements of journals, and publication ethics may therefore raise the standard of publications and accelerate the process

Excellent writing

Start with good scienceCommunalism - common ownership of scientific discoveries

Universalism - evaluation using universal, unbiased criteria

Disinterestedness - scientists should act selflessly

Organised scepticism - ideas tested and subjected torigorous, structured scrutiny by peers

US sociologist Robert Merton b1910

Plan effectivelyFor original research:

have a clear research questionseek statistical adviceuse the right study designact ethicallykeep an open mind and minimise biasagree who will be principal investigatoragree who will be authors and contributorsagree to publish even negative results

Behave ethically Research ethics declaration of Helsinki, ICH

Publication ethicsavoid misconductprotect patients identitiesreport clearly:informed consentany deviation from usual practice full burden imposed on participants total risks posed to participants or othersbenefits to participants, patients, society

Its not always enough to state that the study was approved by an ethicscommittee or IRB

Clear writing keep it simple: use short, familiar words

avoid jargon and acronyms

be specific

be concrete, not abstract

say what you mean and mean what you say

Editors reports of manuscript problems

Seldom Occasionally FrequentlyPoorly written, excessive jargonInadequate/inappropriate presentationPoor description of designExcessive zeal and self promotionRationale confused, contradictoryEssential data omitted, ignoredBoringImportant work of others ignored Byrne DW, Publishing Medical Research Papers, Williams and Wilkins, 1998

Spin: the dishonest drug trialNot transparent (sponsors roles, competing interests)Compares intervention with one known to be inferior with ineffective dose of competitor intervention with so much of competitor that ADRs likelyUses multiple endpoints and reports selectivelyReports results only from favourable centres Reports only favourable subgroup analyses Presents only most impressive results eg reduction in relative rather than absolute risk

On the left side the risk of stroke or bleeding during treatment for atrial fibrillation is shown relative to the class of people who have not had the treatment (as in relative risk reduction). The right side shows the treatment effect relative to a class of 100 untreated people who have not had a stroke or bleeding (as in absolute risk reduction) Gigerenzer G , Edwards A BMJ 2003;327:741-7442003 by British Medical Journal Publishing Grou

Framing riskConditional probabilitiesThe probability that a woman hasbreast cancer is 0.8%. If she hasbreast cancer, the probability that amammogram will show a positiveresult is 90%. If a woman does not have breastcancer the probability of a positiveresult is 7%. Take, for example, a woman who as a positive result. What is theprobability that she actually hasbreast cancer?

Natural frequenciesEight out of every 1000 womenhave breast cancer. Of these 8women with breast cancer 7 willhave a positive mammogram. Of the 992 women who do nothave breast cancer some 70 willstill have a positive mammogram.Take, for example, a sample ofwomen who have positivemammograms. How many of thesewomen have breast cancer?

Spin its not only in trials 2006 BMJ paper found that industry supported systematic reviews were of lower quality than Cochrane reviews of the same drugs, were less transparently reported, had fewer reservations about methodological limitations, and always recommended the sponsors drug without reservations Jrgensen AW et al. BMJ2006;333:782

2007 BMJ paper found that sponsored meta-analyses on antihypertensive drugs were not associated with favourable results but had overgenerous conclusions

Industry-commissioned reviewsprimary research articles create influence

peer review approves the science

journal brand endorses message

better than drug reps

secondary articlesspread influence

more likely to be read thanresearch

especially if KOL authors

can alter policy

The honest review articledescribe information sources and methods of selection

ideally, cite Cochrane and other systematic reviews

clarify type and strength of evidence for key statements "A large robust randomised controlled trial finds..." "The findings of a small case series suggest..."

declare provenance, funding, and competing interests

How can journals help? BMJ asks authors submittingor offering unsolicitedreviews and editorials onpotentially commercialtopics three questions

And every published articledeclares competing interestsand provenance

has anyone prompted or paid you to write this article? would/did a professional writer contribute to the article? to what extent? would the BMJ article be original, or would it be similar to articles submitted or published elsewhere?

GPP2 checklist

Publication agreements

Advice on submitting articles

Thankstgroves@bmj.com

http://news.bbc.co.uk/sport1/hi/cricket/7084514.stm

Sachin Tendulkar overcomes a nervous start to unveil some high-class cover drives among his 14 boundaries

2007*http://www.emwa.org/Mum/EMWAguidelines.pdf

http://www.emwa.org/Home/Ghostwriting-Positioning-Statement.html

**Sociologist Robert Merton b1910Professor at Columbia University

Sociology of scienceMerton carried out extensive research into the sociology of science, developing the Merton Thesis explaining some of the causes of the scientific revolution, and the Mertonian norms of science, often referred to by the acronym "Cudos". This is a set of ideals that are dictated by what Merton takes to be the goals and methods of science and are binding on scientists. They include:Communalism - the common ownership of scientific discoveries, according to which scientists give up intellectual property rights in exchange for recognition and esteem (Merton actually used the term Communism, but had this notion of communalism in mind, not Marxism); Universalism - according to which claims to truth are evaluated in terms of universal or impersonal criteria, and not on the basis of race, class, gender, religion, or nationality; Disinterestedness - according to which scientists are rewarded for acting in ways that outwardly appear to be selfless; Organized Skepticism - all ideas must be tested and are subject to rigorous, structured community scrutiny. The CUDOS set of Mertonian scientific norms is sometimes identified as Communism, Universalism, Disinterestedness, *Originality* (novelty in research contributions), and Skepticism (instead of Organized Skepticism). This is a subsequent modification of Merton's norm set, as he did not refer to Originality in the essay that introduced the norms (The Normative Structure of Science [1942]).http://en.wikipedia.org/wiki/Robert_K._Merton#Sociology_of_science

*The researcher asks a very specific question and tests a specific hypothesis. Broad questions are usually broken into smaller, testable hypotheses or questions.

Often called an objective or aim, though calling it a question tends to help with focusing the hypothesis and thinking about how to find an answer

***Based on:Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138 doi:10.1371/journal.pmed.0020138

BMJ2006;333:1248(16December), doi:10.1136/bmj.38985.564317.7C (published 23 October 2006) ResearchRatio measures in leading medical journals: structured review of accessibility of underlying absolute risks Lisa M Schwartz, Steven Woloshin, Evan L Dvorin, H Gilbert WelchUnless ratio measures are reported with the underlying absolute risks, readers cannot judge the clinical significance of the effect. Consider the following example. Readers may be told that the relative risk of death with drug A compared with placebo is 0.5; in other words, people who take drug A are half as likely to die as people who take placebo. But without the underlying absolute risksthe chance of death in each groupthe information is incomplete.1 A relative risk of 0.5, for example, is compatible with a wide range of changes in the risk of death: from 20% to 10%, from 1% to 0.5%, and from 0.0004% to 0.0002%. Effects presented in relative terms alone have been repeatedly shown to seem more impressive than the same effects presented in absolute terms in studies of physicians,2 3 policy makers,4 and patientsWhat makes a drug trial suitable for the BMJ?Original research question to aid doctors' decisionsHead to head - comparative effectiveness

Clinically valid doses/administration in all trial arms Main outcome measure that matters to patients andPractice - phase III or IV

Important results (may be a "negative" trial)

Different representations of the same benefits of treatment: the reduction after treatment in the number of people who have a stroke or major bleeding looks much larger on the left, where the reference class of 100 patients who have not had a stroke or bleeding is not shown

On the left side of the figure the effect of treatment on a particular event (stroke or bleeding) is shown relative to the class of people who have not had the treatment (as in relative risk reduction). On the right side the patient can see the treatment effect relative to a class of 100 untreated people who have not had a stroke or bleeding (as in absolute risk reduction).

Simple tools for understanding risks: from innumeracy to insight Gerd Gigerenzer, Adrian Edwards BMJ 2003;327:741-744 doi:10.1136/bmj.327.7417.741 (Published 25 September 2003)Snakes, ladders, and spin: HARLOT plc: an amalgamation of the world's two oldest professions David L Sackett, Andrew D Oxman BMJ 2003;327:1442-1445 doi:10.1136/bmj.327.7429.1442 (Published 18 December 2003)**BMJ2006;333:782(14October), doi:10.1136/bmj.38973.444699.0B (published 6 October 2006) Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review Anders W Jrgensen, Jrgen Hilden, Peter C Gtzsche*David Impey, European Director of Marketing, Eisai, speaking in London Autumn 2006The pharmaceutical industry needs to spend more time with doctors and other healthcare professionals The number of rep contacts with doctors is declining Page traffic in terms of advertising may also have gone down (he needs to know any figures or background information we can supply him with on this, but its his opinion that this is the case!) Its only really doctors who can turn the tide against specific products (who can challenge NICE for example, and get decisions overturned) So the industry needs to spend more time on its relationships with doctors And a prime medium for doing this is through medical journals/publications

Other sessions at same meeting: What are the opportunities to extract maximum value from published clinical trials?How journal review papers can support original research?How to develop journal supplements and special issues?The value of special book projects

*http://resources.bmj.com/bmj/authors/article-submission

Even if the answers to all of these questions were "yes", we wouldn't necessarily reject the proposal or article. We appreciate that companies can commission some excellent evidence based work and that professional writers can present that evidence in a particularly readable and clear way that benefits readers and learners. We would, however, expect such companies' and writers' contributions to be mentioned in the article. And we would want to know that the BMJ article did not overlap by more than 15% with any similar publications or submissions written by the same authors elsewhere

BMJs transparency policy aims to help authors report work honestly and fully

resources.bmj.com/bmj/authors/editorialpolicies/transparency-policy

http://www.gpp-guidelines.org/*http://www.mpip-initiative.org/*http://www.idma-assn.org/publications.html*