Roadmap For Medical Writing

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
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

Seldom Occasionally Frequently
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;327:741-744
Framing risk
Conditional probabilities Natural frequencies

The probability that a woman has Eight out of every 1000 women
breast cancer is 0.8%. If she has have breast cancer. Of these 8
breast cancer, the probability that a women with breast cancer 7 will
mammogram will show a positive have a positive mammogram.
result is 90%.
Of the 992 women who do not
If a woman does not have breast
have breast cancer some 70 will
cancer the probability of a positive
still have a positive mammogram.
result is 7%.
Take, for example, a sample of
Take, for example, a woman who
as a positive result. What is the
women who have positive
probability that she actually has mammograms. How many of these
breast cancer? 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;333:782
2007 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 secondary articles

articles create influence spread influence
peer review approves the science more likely to be read than

research
journal brand endorses message
especially if KOL authors
better than drug reps
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 • has anyone prompted or

paid you to write this
or offering unsolicited
article?
reviews and editorials on • would/did a professional
potentially commercial writer contribute to the
topics three questions article? to what extent?
• would the BMJ article be
original, or would it be
And every published article similar to articles
declares competing interests submitted or published
and provenance elsewhere?
GPP2 checklist
Publication agreements
Advice on submitting articles
Thanks
tgroves@bmj.com

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Roadmap to excelling

European Medical Writers Association policy:

• medical writers have a legitimate role in assisting named

Communalism - common ownership of scientific discoveries

Universalism - evaluation using universal, unbiased criteria

Disinterestedness - scientists should act selflessly

Organised scepticism - ideas tested and subjected to

For original research:

have a clear research question

keep it simple: use short, familiar words

avoid jargon and acronyms

be concrete, not abstract

say what you mean and mean what you say

Poorly written, excessive jargon

Poor description of design

Excessive zeal and self promotion

Rationale confused, contradictory

Essential data omitted, ignored

Important work of others ignored

Not transparent (sponsors’ roles, competing interests)

Conditional probabilities Natural frequencies

2006 BMJ paper found that industry supported

2007 BMJ paper found that sponsored meta-analyses

primary research secondary articles

peer review approves the science more likely to be read than

describe information sources and methods of selection

ideally, cite Cochrane and other systematic reviews

clarify type and strength of evidence for key statements

declare provenance, funding, and competing interests

BMJ asks authors submitting • has anyone prompted or

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