Patient involvement in preparing clinical research peer-reviewed publications or results summaries: a systematic review

Objective: 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 for reporting clinical research results. Research design and methods: 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 results summaries. The primary outcome was the number of articles investigating patient authorship or contribution to peerreviewed publications. For included articles we assessed bias risk (Newcastle Ottawa Scale). Results: 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 patient involvement in preparing peer-reviewed publications. Evidence quality was poor/fair (0 randomized controlled trials). Reported benefits of patient involvement included improved reporting, critical and unique contributions by patients (including new research ideas), meeting funder requirements, patient empowerment, and new skill development (patients and researchers). Reported harms included the need for additional time, training, resources, and budget. Conclusions: 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