Transparency and Completeness in the Reporting of Stakeholder Involvement in the Development and Reporting of Research Reporting Guidelines

<p><b>Objective:</b> The Guidance for Developers of Health Research Reporting Guidelines recommend multidisciplinary stakeholder involvement, transparent and complete reporting, and updating guidelines based on feedback. Developers are accountable for stakeholder engagement, but how broad and meaningful is such engagement? Our objective was to provide empirical feedback to developers by investigating (1) the involvement of those ultimately affected by guidelines (eg, patients and carers) and regular end users of guidelines (eg, publication professionals), and (2) the transparency and completeness of reporting stakeholder involvement.</p> <p><b>Design:</b> For this prospective study, conducted from September 2016 to January 2017, we included every reporting guideline for the main study types, as listed on the EQUATOR Network website. We pilot-tested a standardized data collection spreadsheet to extract data from the corresponding guideline publications. We quantified patient, carer, and publication professional involvement and used statisticians (listed as stakeholders in the Guidelines) as a control group. We assessed reporting transparency and completeness using the AGREE Reporting Checklist for documenting stakeholder involvement. For qualitative insights, we interviewed leaders from nonprofit, international, patient advocacy (International Alliance of Patients’ Organizations [IAPO]) and publication professional (Global Alliance of Publication Professionals [GAPP]) organizations.</p> <p><b>Results:</b> Of the 33 guideline publications, the mean (SD) number of authors was 9 (SD 5.7, min 3, max 30) (median, 7; IQR, 5-11) and the mean (SD) number of working group members was 45 (SD 38.4, min 5, max 147) (median, 30; IQR, 23-43). Statisticians were authors for 24% (8/33) of the publications and were working group members for 15% (5/33). Patients, carers, and publication professionals were rarely identified, either as authors (0, 0, and 0, respectively) or working group members (0, 1 [3%], and 0, respectively). Reporting stakeholder involvement was deficient (eg, for statistician involvement, only 25% of publications met AGREE Recommendations). Leaders from IAPO and GAPP were not aware of having been invited to participate in developing guidelines, but thought that their stakeholders could provide unique and important insights. They encourage guideline developers to contact them to facilitate meaningful involvement.</p> <p><b>Conclusions:</b> Guideline developers have rarely involved stakeholders affected by guidelines (patients, carers) or those regularly using guidelines (publication professionals) in the development process. The involvement of these key stakeholders could enhance the credibility, dissemination, and use of guidelines. If patients, carers, and publication professionals were represented by other stakeholders (which is not ideal given potential conflicts of interest), this was not documented; readers do not know who represented whom. The transparency and completeness of reporting of stakeholder involvement should be improved.</p

Patient Involvement in Preparing Clinical Research Peer-Reviewed Publications or Results Summaries: A Systematic Review

<div><b>Objective</b></div><div>Although patient involvement in results reporting is being encouraged, relevant evidence must be assessed before developing best practice guidelines. Our objective was to conduct the first systematic literature review on the effects of patient involvement on results reporting.</div><div><br></div><div><b>Research design and methods</b></div><div>Patient experts and publication professionals co-created a PRISMA-P protocol (PROSPERO registration submitted). Using MeSH terms and OVID, we searched (10/09/2017) MEDLINE, EMBASE and Cochrane databases (all languages; 01/01/2015–10/09/2017) and secondary sources. Eligible articles had to report on the effects of having patients author or contribute to clinical research peer reviewed publications or summaries. The primary outcome was the number of articles investigating patient authorship or contribution to peer-reviewed publications. For included articles, we assessed bias risk (Newcastle-Ottawa Scale).</div><div><br></div><div><b>Results</b></div><div>Of the 105 database articles retrieved, 24 duplicates were removed. Title/abstract screening excluded 62 articles. From full-text screening of 19 articles, we could include 2. Both focused on the effects of patient involvement for preparing peer-reviewed publications. Evidence quality for each article was poor/fair (0 randomised controlled trials). Reported benefits of patient involvement included meeting funder requirements, critical and unique contributions, new research ideas, improved reporting, patient empowerment and new skill development (patients and researchers). Reported harms included the need for additional time, training, resources and budget. </div><div><br></div><div><b>Conclusions</b></div><div>This systematic review identified a major evidence gap that must be addressed to guide best practices for patient involvement in results reporting. Patients, sponsors and publication professionals could co-create a research priority list and use emerging evidence to draft interim guidelines for ethical and meaningful involvement of patients in results reporting.</div

Patient involvement...or not? Analysis of 'Patient Involvement' statements in clinical trial publications in The BMJ

<p><b>Objective</b></p> <p><i>In 2014, </i>The BMJ introduced a mandatory ‘Patient Involvement’statement in the Methods section of research articles. We investigated the extent of patient involvement described in clinical trial research publications in <i>The BMJ.</i> Our primary objective was to quantify patient authorship.</p><p><br></p> <p><b>Research design and methods</b></p> <p>We searched PubMed (journal: <i>The BMJ</i>; publication type: clinical trial; dates: 2015/01/01-2016/12/31) and electronically exported all retrieved articles. Non-research articles were removed. Two authors categorised patient involvement based on the verbatim ‘Patient Involvement’ and Acknowledgements sections in each publication. Results were cross-checked.</p><p><br></p> <p><b>Results</b></p> <p>Of the 62 articles retrieved, 10 were non-research articles. Reported patient involvement was generally low. Involvement was lowest for authorship (1.9%; 1/52) and highest for thanking patients for their participation (57.7%; 30/52).</p><p><br></p> <p><b>Conclusions</b></p> <p>Despite <i>The BMJ’s</i> requirement, reported patient involvement in clinical trial publications remains low. Patient authorship is being encouraged, but remains rare. Advocacy efforts for meaningful patient involvement during research, including publication planning and preparation, must continue.</p