Fundamentals of Good Medical Writing
Fundamentals of Good Medical Writing
Fundamentals of Good Medical Writing
Course agenda
Lectures
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
Test
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
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
Its not always enough to state that the study was approved by an ethics committee or IRB
http://www.icmje.org/
reporting guidelines for research, at the EQUATOR network resource centre
http://www.equator-network.org/
Clear writing
Keep it simple: use short, familiar words Avoid jargon and acronyms
Be specific
Be concrete, not abstract
Byrne DW, Publishing Medical Research Papers, Williams and Wilkins, 1998
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
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
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
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
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
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
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
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?
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)
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
Industry-commissioned reviews
primary research articles create influence
peer review approves the science journal brand endorses the message better than drug reps
Thanks
tgroves@bmj.com