A scoping review of guidance on sharing trial results with patients and the public finds inconsistent recommendations and limited methodological development

Objectives To identify, analyze and summarize existing guidance on sharing trial results with patients and the public and to provide recommendations for developing a high-quality reporting guideline that is user-friendly, effective, and accessible. Study Design and Setting We included English-language documents providing guidance or recommendations on sharing research study results with patients and/or the public, published anytime, in journals or gray literature. We systematically searched Ovid MEDLINE® and Web of Science Core Collection, performed citation tracking in PubMed®, and conducted extensive gray literature searches, including Google and Google Scholar, and other key websites (eg, EQUATOR Network, government and research organizations, publishing groups, research and policy centers). Titles and abstracts were screened for eligibility, followed by full-text review. The results were thematically analyzed. Results A total of 2289 potentially eligible records were screened, and 24 met eligibility criteria and included in the review. Of these, only 9 were broadly applicable to clinical trial designs. No specific guidance or reporting guideline was identified focusing on sharing results of randomized trials with patients and the public. Recommendations on content, presentation, timelines, and dissemination varied in quality and specificity. Most guidance documents lacked details on tailoring information for diverse audiences, with minimal focus on cultural sensitivity or inclusivity. Only five of the documents had been pilot-tested prior to implementation, and stakeholder involvement was reported in 13, though often inconsistently. Conclusion Althougb there has been progress in developing guidance for sharing research results, many existing documents lack a standardized approach, do not sufficiently address diversity considerations and have not undergone formal evaluation. Future efforts should focus on coproducing a tailored reporting guideline following established methodology with meaningful stakeholder-involvement and pilot-testing to ensure that recommendations meet the diverse needs of patients and the public. Plain Language Summary Sharing results in a clear, respectful way is an important part of doing good research. Evidence suggests that people who take part in research are routinely not told what the study found. However, there is little guidance available for researchers on how to do this in a meaningful way. In this review, we looked for any existing guidance on how to share research results with patients, and the public. We looked for both published and unpublished guidance documents. We found 24 documents, some of them had useful suggestions, but many were hard to find, vague, or missing important details. Many of them did not include input from patients or the public. None were made specifically for sharing results from randomized trials. Although there is some guidance available, there are still significant gaps. Our findings show that researchers need better and clearer guidance on how to share trial results. This would help make the information easier to understand, more inclusive, and more helpful for both patients and the public.