Presentation on theme: "Fundamentals of good medical writing"— Presentation transcript:
1 Fundamentals of good medical writing Dr Trish GrovesDeputy editorBMJ
2 What I will cover Introductions and course agenda The scope of medical writingQualities of effective medical writingThe writer's roleAssessing the audienceIdentifying and placing key messages
3 Course agenda Lectures Workshops Test Good medical writing and controlling the sentenceStudy reports for regulatory submissionsJournal peer review and publicationPresenting different types of clinical evidencePresenting statistical data for publicationTransparency initiativesMedical communication for promotionsNew frontiers in publishingTips for using MS OfficeWorkshopsPresenting at a conferenceWriting up a clinical trial for journal publicationTest
4 The scope of medical writing Internal reportsRegulatory reportsConference presentationsabstractoral presentationposterJournal articlesoriginal research paperreview articlecase reportletter to editor
5 Introductions and course agenda The scope of medical writingQualities of effective medical writingThe writer's roleAssessing the audienceIdentifying and placing key messages
6 Start with good science Communalism - common ownership of scientific discoveriesUniversalism - evaluation using universal, unbiased criteriaDisinterestedness - scientists should act selflesslyOrganised scepticism - ideas tested and subjected torigorous, structured scrutiny by peersUS sociologist Robert Merton b1910Sociologist Robert Merton b1910Professor at Columbia UniversitySociology 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 ).
7 Plan effectively For original research: have a clear research question seek 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 resultsThe 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 ethicsavoid misconductprotect patients’ identitiesreport clearly:informed consentany deviation from usual practicefull burden imposed on participantstotal risks posed to participants or othersbenefits to participants, patients, societyIt’s not always enough to state that the study was approved by an ethicscommittee or IRB
9 Protect patients’ confidentiality Beware identifiers:age, sex, locationclinical details, test resultsunusual personal story orcontextphoto (even if of a bodypart or clinical image)Don’t use disguises to anonymise – remove detailsblack eye bands don’t workaltered personal details – may be clinically misleadingfalse 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 journalsreporting guidelines for research, at the EQUATORnetwork resource centre
13 Clear writing Keep it simple: use short, familiar words Avoid jargon and acronymsBe specificBe concrete, not abstractSay what you mean and mean what you say
14 How frequently do editors encounter manuscript problems? Poorly written, excessive jargonInadequate/inappropriate presentationPoor description of designExcessive zeal and self promotionRationale confused, contradictoryEssential data omitted, ignoredBoringImportant work of others ignoredSeldom Occasionally FrequentlyByrne DW, Publishing Medical Research Papers, Williams and Wilkins, 1998
15 Introductions and course agenda The scope of medical writingQualities of effective medical writingThe writer's roleAssessing the audienceIdentifying 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 interpretationdrafting the article or revising it critically for important intellectual contentand final approval of the version to be publishedAll these conditions must be metSolely acquiring funding or collecting data does not justify authorship All authors included on a paper must fulfil the criteriaNo one who fulfils the criteria should be excluded
18 Contributorshipcontributors who took part in planning, conducting, andreporting the work, including professional medical writersguarantors (one or more) who accept fullresponsibility for the work and/or the conduct of thestudy, had access to the data, and controlled thedecision to publishresearchers must decide among themselves the precisenature 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-LouiseKinmonth, professor of general practice1, David P French, reader inhealth behaviour interventions3, Stephen Sutton, professor ofBehavioural science1Contributors: SS, DPF, ATP, A-LK, and SJG conceived and designed the originalprotocol. All authors were involved in amending the protocol. HCE coordinated thestudy 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 TomFanshawe. ATP analysed the data. ADDITION trial data were supplied by LincolnSargeant and Kate Williams. HCE wrote the first draft of the manuscript with ATPand SS. All authors contributed to subsequent and final drafts. HCE is guarantor ofthe paper.Example from a real BMJ paper
20 Competing interestsA 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 judgmentAlways declare a competing interest, particularly one that would embarrass you if it came out afterwardsEvidence 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;325:249-53Jorgensen 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: /bmjRESEARCH: 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 BEAlso 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: /bmjSara 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 MisconductFabrication: 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 creditUS Office of Research IntegrityThe 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 postpublicationspecialist search engine (iThenticate)uses “text fingerprinting” and “string matching”gets behind access controls (unlike free tools) tosearch >9 billion articles in CrossRef databaseCrossCheck developed jointly by iThenticate and Cross RefHow 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 writingQualities of effective medical writingThe writer's roleAssessing the audienceIdentifying and placing key messages
25 Assessing the audience RegulatorsMarketsConferencesJournalsClinicians
26 How to please editors and peer reviewers make sure the message is clear in the paper andabstract, not just in the cover letteralso send:extra materials eg CONSORT checklistdetails of any closely related papersprevious peer review reportscommunicate clearly and promptly
27 Introductions and course agenda The scope of medical writingQualities of effective medical writingThe writer's roleAssessing the audienceIdentifying 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?andDiscussion: what might it mean?
29 What makes a good research question? FINER criteriaFeasible (answerable with a robust method)InterestingNovelEthicalRelevant
30 What makes a poor research question? a question you don’t care about, nor does anyone elselooking at routine clinical data and trying to think of a questionthe records will be biased and confoundedthey may lack the information you need to answer your question reliably, because they were collected for another reasona fishing expedition/data dredging – gathering lots of information andhoping a question will emergestatistical 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 inferiorwith ineffective dose of competitor interventionwith so much of competitor intervention that ADRs likelyUses multiple endpoints and reports selectivelyReports results only from favourable centresReports only favourable subgroup analysesPresents only most impressive results — eg reduction inrelative rather than absolute riskBased on:Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138 doi: /journal.pmedBMJ 2006;333:1248 (16 December), doi: /bmj C (published 23 October 2006)ResearchRatio measures in leading medical journals: structured review of accessibility of underlying absolute risksLisa 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 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 patientsWhat makes a drug trial suitable for the BMJ?Original research question to aid doctors' decisionsHead to head - comparative effectivenessClinically valid doses/administration in all trial armsMain outcome measure that matters to patients andPractice - phase III or IVImportant 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 reservations2007 BMJ paper found that sponsored meta-analyses on antihypertensive drugs were not associated with favourable results but had overgenerous conclusionsBMJ 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 reviewAnders W Jørgensen, Jørgen Hilden, Peter C Gøtzsche
33 Industry-commissioned reviews primary researcharticles create influencepeer review approves thesciencejournal brand endorses themessagebetter than drug repssecondary articlesspread influencemore likely to be read thanresearchespecially if KOL authorscan alter policyDavid Impey, European Director of Marketing, Eisai, speaking in London Autumn 2006The pharmaceutical industry needs to spend more time with doctors and other healthcare professionalsThe number of rep contacts with doctors is decliningPage 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 doctorsAnd a prime medium for doing this is through medical journals/publicationsOther 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 selectionideally, cite Cochrane and other systematic reviewsclarify 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 unsolicitedreviews and editorials onpotentially commercialtopics three questionsAnd every published articledeclares competing interestsand provenancehas 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 elsewhereBMJ’s transparency policy aims to help authors report work honestly and fullyresources.bmj.com/bmj/authors/editorialpolicies/transparency-policy