IMPORTANCE: Patient-reported outcomes (PROs) can inform healthcare decisions, regulatory decisions, and healthcare policy, and also can be used for audit/benchmarking and to monitor symptoms and provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.
OBJECTIVE: To develop an international, consensus-based, PRO-specific ethical guidelines for clinical research.
EVIDENCE REVIEW: The PRO ethics guidelines were developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), EMBASE, AMED and CINAHL were searched from inception until May 2020. The keywords 'patient reported outcome*' and 'ethic*' were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a two-round international Delphi process (n=96 participants; May and August 2021) and a consensus meeting (n=25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.
FINDINGS: Twenty-three items were considered in the first round of the Delphi process: six relevant candidate items from the systematic review and seventeen additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and twelve additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n=25 participants). The final wording of the PRO ethical guidelines was agreed by consensus meeting participants with input from six additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts/domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data and dissemination plans.
CONCLUSIONS AND RELEVANCE: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimising participant risk, burden and harm and protecting participant and researcher welfare.
