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Ethical considerations for the inclusion of patient-reported outcomes in clinical research: The PRO ethics guidelines

Cruz Rivera, S, Aiyegbusi, OL, Ives, J, Draper, H, Mercieca-Bebber, R, Ells, C, Hunn, A, Scott, JA, Fernandez, CV, Dickens, AP, Anderson, N, Bhatnagar, V, Bottomley, A, Campbell, L, Collett, C, Collis, P, Craig, K, Davies, H, Golub, R, Gosden, L, Gnanasakthy, A, Haf Davies, E, Von Hildebrand, M, Lord, JM, Mahendraratnam, N, Miyaji, T, Morel, T, Monteiro, J, Olsen Zwisler, AD, Peipert, JD, Roydhouse, JP ORCID: 0000-0002-8025-5841, Stover, AM, Wilson, R, Yap, C and Calvert, MJ 2022 , 'Ethical considerations for the inclusion of patient-reported outcomes in clinical research: The PRO ethics guidelines' , JAMA - Journal of the American Medical Association, vol. 327, no. 19 , pp. 1910-1919 , doi:

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Importance 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.Objective To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.Evidence Review 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 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 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.Findings 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.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 minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Item Type: Article
Authors/Creators:Cruz Rivera, S and Aiyegbusi, OL and Ives, J and Draper, H and Mercieca-Bebber, R and Ells, C and Hunn, A and Scott, JA and Fernandez, CV and Dickens, AP and Anderson, N and Bhatnagar, V and Bottomley, A and Campbell, L and Collett, C and Collis, P and Craig, K and Davies, H and Golub, R and Gosden, L and Gnanasakthy, A and Haf Davies, E and Von Hildebrand, M and Lord, JM and Mahendraratnam, N and Miyaji, T and Morel, T and Monteiro, J and Olsen Zwisler, AD and Peipert, JD and Roydhouse, JP and Stover, AM and Wilson, R and Yap, C and Calvert, MJ
Keywords: patient-reported outcomes, ethics, guidelines
Journal or Publication Title: JAMA - Journal of the American Medical Association
Publisher: Amer Medical Assoc
ISSN: 0098-7484
DOI / ID Number:
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© 2022 American Medical Association. All rights reserved.

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