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- W4280537076 abstract "<h3>Importance</h3> Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. <h3>Objective</h3> To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. <h3>Evidence Review</h3> The PRO ethics guidelines were developed following the Enhancing the 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 March 2020. The keywords<i>patient reported outcome*</i>and<i>ethic*</i>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 2-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. <h3>Findings</h3> Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 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 12 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 on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and 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. <h3>Conclusions and Relevance</h3> 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 minimizing participant risk, burden, and harm and protecting participant and researcher welfare." @default.
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- W4280537076 date "2022-05-17" @default.
- W4280537076 modified "2023-10-01" @default.
- W4280537076 title "Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research" @default.
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- W4280537076 cites W2031470922 @default.
- W4280537076 cites W2036809936 @default.
- W4280537076 cites W2039874228 @default.
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- W4280537076 cites W2087202287 @default.
- W4280537076 cites W2093038967 @default.
- W4280537076 cites W2132685163 @default.
- W4280537076 cites W2149208658 @default.
- W4280537076 cites W2150060517 @default.
- W4280537076 cites W2155341071 @default.
- W4280537076 cites W2189916683 @default.
- W4280537076 cites W2218926431 @default.
- W4280537076 cites W2423702537 @default.
- W4280537076 cites W2428073895 @default.
- W4280537076 cites W2436814281 @default.
- W4280537076 cites W2620925856 @default.
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- W4280537076 cites W2770261385 @default.
- W4280537076 cites W2782908833 @default.
- W4280537076 cites W2795348608 @default.
- W4280537076 cites W2913465166 @default.
- W4280537076 cites W2914157560 @default.
- W4280537076 cites W2915228510 @default.
- W4280537076 cites W2995850904 @default.
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- W4280537076 doi "https://doi.org/10.1001/jama.2022.6421" @default.
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