Poor compliance with reporting research results – we know it’s a problem … how do we fix it?

Woolley, Karen L.; Gertel, Art; Hamilton, Cindy W.; Jacobs, Adam; Snyder, Gene

doi:10.1185/03007995.2012.739152

Cited by 13 publications

(15 citation statements)

References 10 publications

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“…However, clinical trials and their publication involves many players, and other surveys suggest that healthcare professionals (investigators and academics) and journal editors would benefit from greater knowledge of published guidelines and may, in fact, be less familiar with such guidelines than publication professionals. Given the financial and human resources required to ensure timely, accurate and complete reporting of research results,28 it is likely that the demand for, and use of, publication professionals will increase. Our survey findings indicate that further involvement of knowledgeable and experienced medical publication professionals, who are familiar with guidelines on reporting clinical trials and publication ethics, should be viewed as a positive step in achieving timely and reliable reporting.…”

Section: Recommendationsmentioning

confidence: 99%

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

Wager¹,

Woolley

Adshead

et al. 2014

BMJ Open

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ObjectiveTo gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry.Design/settingWeb-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013.Participants469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies (‘industry’, n=144), communication agencies (‘agency’, n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD.ResultsOver 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors’ Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents’ companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents’ departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results.ConclusionsWithin this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices.

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Section: Recommendationsmentioning

confidence: 99%

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

Wager¹,

Woolley

Adshead

et al. 2014

BMJ Open

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“… 33 In fact, it has been proposed that professional medical writing support should be used to address the backlog of unreported clinical study results. 34 The results of this study suggest that this support could also improve the quality of RCT reporting. Medical writing support is often funded by industry and, as a result, has sometimes attracted controversy.…”

Section: Discussionmentioning

confidence: 67%

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study

et al. 2016

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ObjectivesAuthors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs).DesignCross-sectional study.Study samplePrimary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123).Main outcome measuresProportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined.ResultsThe number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5–231 days) vs 136 days (IQR 77–193 days)).ConclusionsIn this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting.

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“…The apparent predominance of women as patient authors may reflect their strong representation in patient advocacy organizations (Bharadia et al, 2022;Merakoi.com, 2022), including governance roles (www.iapo.org.uk/ governing-board) and their greater involvement as patient peer reviewers (Chatfield et al, 2021). A recent analysis of participants in our 'Patients in Publications' course (Woolley et al, 2021) has also shown that most (65%) participants are women. While the 'leaky pipeline' hypothesis can help explain why men outnumber women as academic authors (Fig.…”

Section: Patient Authors: Evidence From Our Recent Researchmentioning

confidence: 92%

Patient authorship of medical research publications: An evolution, revolution, and solution?

Woolley,

Stones,

Stephens

et al. 2024

Learned Publishing

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Key points Patient authorship is a new topic in medical publishing, with the number of patient‐authored publications growing rapidly. Publication stakeholders (e.g., editors, publishers, funders, researchers) should be aware of the legitimacy of patient authorship. Practical actions can be taken by different publication stakeholders to encourage and support patient authorship—ethically and effectively. Patient authorship can contribute to enhancing diversity, equity, and inclusion in medical publishing. Research on patient authorship could be strengthened with consensus on publication tagging practices (e.g., affiliation terms) and the use of artificial intelligence. A plain language summary of this article and the GRIPP2 form for reporting patient involvement are available as supplementary information.

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Poor compliance with reporting research results – we know it’s a problem … how do we fix it?

Cited by 13 publications

References 10 publications

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study

Patient authorship of medical research publications: An evolution, revolution, and solution?

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