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