Roadmap to excelling in medical writing Dr Trish Groves Deputy editor, BMJ

Programme for the day IMRAD Study designs Clear writing Structured abstracts Statistics tests Self-editing Graphs, figures Impact factor Which journal? Publication ethics Clinical trial disclosure

The scope of medical writing Internal reports Regulatory reports Conference presentations abstract oral presentation poster Journal articles original research paper review article case report letter to editor

Follow the right road

Role of medical writers European Medical Writers Association policy: medical writers have a legitimate role in assisting named authors in developing manuscripts for peer-reviewed journals and presentations such contributions and funding information should be openly acknowledged not ‘ghostwriter’, which wrongly implies something secretive experts 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 science Communalism - common ownership of scientific discoveries Universalism - evaluation using universal, unbiased criteria Disinterestedness - scientists should act selflessly Organised scepticism - ideas tested and subjected to rigorous, structured scrutiny by peers US sociologist Robert Merton b1910

Plan effectively For original research: have a clear research question seek statistical advice use the right study design act ethically keep an open mind and minimise bias agree who will be principal investigator agree who will be authors and contributors agree to publish even negative results

Behave ethically Research ethics – declaration of Helsinki, ICH Publication ethics avoid misconduct protect patients’ identities report clearly: informed consent any deviation from usual practice full burden imposed on participants total risks posed to participants or others benefits to participants, patients, society It’s not always enough to state that the study was approved by an ethics committee 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 Frequently Poorly written, excessive jargon Inadequate/inappropriate presentation Poor description of design Excessive zeal and self promotion Rationale confused, contradictory Essential data omitted, ignored Boring Important work of others ignored Byrne DW, Publishing Medical Research Papers, Williams and Wilkins, 1998

Spin: the dishonest drug trial Not 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 likely Uses multiple endpoints and reports selectively Reports 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: ©2003 by British Medical Journal Publishing Grou

Framing risk Conditional probabilities The probability that a woman has breast cancer is 0.8%. If she has breast cancer, the probability that a mammogram will show a positive result is 90%. If a woman does not have breast cancer the probability of a positive result is 7%. Take, for example, a woman who as a positive result. What is the probability that she actually has breast cancer? Natural frequencies Eight out of every 1000 women have breast cancer. Of these 8 women with breast cancer 7 will have a positive mammogram. Of the 992 women who do not have breast cancer some 70 will still have a positive mammogram. Take, for example, a sample of women who have positive mammograms. How many of these women have breast cancer?

Spin – it’s 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 sponsor’s drug without reservations Jørgensen AW et al. BMJ 2006;333: BMJ paper found that sponsored meta-analyses on antihypertensive drugs were not associated with favourable results but had overgenerous conclusions

Industry-commissioned reviews primary research articles create influence peer review approves the science journal brand endorses message better than drug reps secondary articles spread influence more likely to be read than research especially if KOL authors can alter policy

The honest review article describe 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 submitting or offering unsolicited reviews and editorials on potentially commercial topics three questions And every published article declares competing interests and 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

Thanks