1. Fundamentals of good medical writing
Dr Trish Groves
Deputy editor
BMJ

2. What I will cover Introductions and course agenda
The scope of medical writing
Qualities of effective medical writing
The writer's role
Assessing the audience
Identifying and placing key messages

3. Course agenda Lectures Workshops Test
Good medical writing and controlling the sentence
Study reports for regulatory submissions
Journal peer review and publication
Presenting different types of clinical evidence
Presenting statistical data for publication
Transparency initiatives
Medical communication for promotions
New frontiers in publishing
Tips for using MS Office
Workshops
Presenting at a conference
Writing up a clinical trial for journal publication
Test

4. 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

5. Introductions and course agenda
The scope of medical writing
Qualities of effective medical writing
The writer's role
Assessing the audience
Identifying and placing key messages

6. 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
Sociologist Robert Merton b1910
Professor at Columbia University
Sociology of science
Merton 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]).

7. 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
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

8. 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

9. Protect patients’ confidentiality
Beware identifiers:
age, sex, location
clinical details, test results
unusual personal story or
context
photo (even if of a body
part or clinical image)
Don’t use disguises to anonymise – remove details
black eye bands don’t work
altered personal details – may be clinically misleading
false names – may be OK for some publications, but not BMJ or student BMJ

10. Guidance on writing research papers
International Committee of Medical Journal Editors uniform requirements for manuscripts submitted to biomedical journals
reporting guidelines for research, at the EQUATOR
network resource centre

13. 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

14. How frequently do editors encounter 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

15. Introductions and course agenda
The scope of medical writing
Qualities of effective medical writing
The writer's role
Assessing the audience
Identifying and placing key messages

16. Who did what and why? authors contributors competing interests
publication ethics

17. Authorship Avoid guest- and ghost-writers
Authorship credit is based only on substantial contribution to:
conception and design, or data analysis and interpretation
drafting the article or revising it critically for important intellectual content
and final approval of the version to be published
All these conditions must be met
Solely acquiring funding or collecting data does not justify authorship 
All authors included on a paper must fulfil the criteria
No one who fulfils the criteria should be excluded

18. Contributorship
contributors who took part in planning, conducting, and
reporting the work, including professional medical writers
guarantors (one or more) who accept full
responsibility for the work and/or the conduct of the
study, had access to the data, and controlled the
decision to publish
researchers must decide among themselves the precise
nature of each contribution

19. Who did what?
Helen C Eborall, post-doctoral research fellow1, Simon J Griffin,
programme leader2, A Toby Prevost, medical statistician1, Ann-Louise
Kinmonth, professor of general practice1, David P French, reader in
health behaviour interventions3, Stephen Sutton, professor of
Behavioural science1
Contributors: SS, DPF, ATP, A-LK, and SJG conceived and designed the original
protocol. All authors were involved in amending the protocol. HCE coordinated the
study throughout. Data entry was carried out by Wyman Dillon Ltd, Lewis Moore,
and HCE. HCE cleaned the data and ran preliminary analysis with input from Tom
Fanshawe. ATP analysed the data. ADDITION trial data were supplied by Lincoln
Sargeant and Kate Williams. HCE wrote the first draft of the manuscript with ATP
and SS. All authors contributed to subsequent and final drafts. HCE is guarantor of
the paper.
Example from a real BMJ paper

20. Competing interests
A person has a competing interest when he or she has an attribute that is invisible to the reader or editor but which may affect his or her judgment
Always declare a competing interest, particularly one that would embarrass you if it came out afterwards
Evidence that competing interests affect the reporting of research (and probably its conduct):
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;289:
Kjaergard LL, Als-Nielsen B. Association between competing interests and authors’ conclusions: epidemiogical study of randomised clinical trials published in the BMJ. BMJ 2002;325:249-53
Jorgensen AW, Hilden J, Gotzsche PC. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. BMJ 2006;333:782-5.
Lise L Kjaergard and Bodil Als-Nielsen Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ BMJ, Aug 2002; 325: 249 ; doi: /bmj
RESEARCH: Veronica Yank, Drummond Rennie, and Lisa A Bero Financial ties and concordance between results and conclusions in meta-analyses: retrospective cohort study BMJ, Dec 2007; 335: ; doi: /bmj BE
Also affect readers’ judgments:
Samena Chaudhry, Sara Schroter, Richard Smith, and Julie Morris Does declaration of competing interests affect readers' perceptions? A randomised trial BMJ, Dec 2002; 325: ; doi: /bmj
Sara Schroter, Julie Morris, Samena Chaudhry, Richard Smith, and Helen Barratt Does the type of competing interest statement affect readers' perceptions of the credibility of research? Randomised trial BMJ, Mar 2004; 328: ; doi: /bmj F6

21. Misconduct
Fabrication: making up data or results and recording or reporting them Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record Plagiarism: the appropriation of another person's ideas, processes, results, or words without giving appropriate credit
US Office of Research Integrity
The Council of Science Editors defines plagiarism as "a form of piracy that involves the use of text or other items (figures, images, tables) without permission or acknowledgment of the source of these materials."

22. CrossCheck web tool searches for overlapping content: prepublication
postpublication
specialist search engine (iThenticate)
uses “text fingerprinting” and “string matching”
gets behind access controls (unlike free tools) to
search >9 billion articles in CrossRef database
CrossCheck developed jointly by iThenticate and Cross Ref
How does iThenticate compare to Turnitin?
iParadigms developed both solutions. iThenticate is designed to accommodate corporate organizations, while Turnitin is designed for classroom use in educational institutions. Since 1996, our company has provided the most widely used verification technology, and established itself as expert in the promotion of content integrity.
iThenticate is a web-based application. Users can access their accounts from any Internet-ready computer by logging in at our website. This has proved extremely advantageous for customers who have multiple locations, various dispersed departments working on projects, or employees working remotely.

24. Introductions and course agenda
The scope of medical writing
Qualities of effective medical writing
The writer's role
Assessing the audience
Identifying and placing key messages

25. Assessing the audience
Regulators
Markets
Conferences
Journals
Clinicians

26. How to please editors and peer reviewers
make sure the message is clear in the paper and
abstract, not just in the cover letter
also send:
extra materials eg CONSORT checklist
details of any closely related papers
previous peer review reports
communicate clearly and promptly

27. Introductions and course agenda
The scope of medical writing
Qualities of effective medical writing
The writer's role
Assessing the audience
Identifying and placing key messages

28. The message For original research:
Introduction: why ask this research question?
Methods: what did I do?
Results: what did I find?
and
Discussion: what might it mean?

29. What makes a good research question?
FINER criteria
Feasible (answerable with a robust method)
Interesting
Novel
Ethical
Relevant

30. What makes a poor research question?
a question you don’t care about, nor does anyone else
looking at routine clinical data and trying to think of a question
the records will be biased and confounded
they may lack the information you need to answer your question reliably, because they were collected for another reason
a fishing expedition/data dredging – gathering lots of information and
hoping a question will emerge
statistical analysis of many outcomes post-hoc may yield false positives (type I errors) or false negatives owing to lack of power (type II errors)
The two main problems introduced by multiple analyses are, firstly, the increased probability of detecting intervention effects where none exist (“false positives” owing to multiple comparisons — type I errors), and secondly, the limited capability (“power”) of trials to detect a true treatment effect in secondary outcomes if not enough participants are enrolled to show a statistically significant difference in these outcomes (“false negatives” — type II errors).

31. 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 intervention 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
Based on:
Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138 doi: /journal.pmed
BMJ  2006;333:1248 (16 December), doi: /bmj C (published 23 October 2006)
Research
Ratio measures in leading medical journals: structured review of accessibility of underlying absolute risks
Lisa M Schwartz, Steven Woloshin, Evan L Dvorin, H Gilbert Welch
Unless 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 risks—the chance of death in each group—the 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 % to %. 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 patients
What makes a drug trial suitable for the BMJ?
Original research question to aid doctors' decisions
Head to head - comparative effectiveness
Clinically valid doses/administration in all trial arms
Main outcome measure that matters to patients and
Practice - phase III or IV
Important results (may be a "negative" trial)

32. 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
2007 BMJ paper found that sponsored meta-analyses on antihypertensive drugs were not associated with favourable results but had overgenerous conclusions
BMJ  2006;333:782 (14 October), doi: /bmj B (published 6 October 2006)
Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review
Anders W Jørgensen, Jørgen Hilden, Peter C Gøtzsche

33. Industry-commissioned reviews
primary research
articles create influence
peer review approves the
science
journal brand endorses the
message
better than drug reps
secondary articles
spread influence
more likely to be read than
research
especially if KOL authors
can alter policy
David Impey, European Director of Marketing, Eisai, speaking in London Autumn 2006
The 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 it’s his opinion that this is the case!)
It’s 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

34. The honest review article
describe sources of information and methods of selection
ideally, cite Cochrane and other systematic reviews
clarify type and strength of evidence for key statements
"A large well conducted randomised conducted trial finds..."
"The findings of a small case series suggest..."
declare provenance, funding, and competing interests

35. 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?
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
BMJ’s transparency policy aims to help authors report work honestly and fully
resources.bmj.com/bmj/authors/editorialpolicies/transparency-policy

36. Thanks