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dc.contributor.authorCruz Rivera, S
dc.contributor.authorAiyegbusi, OL
dc.contributor.authorIves, J
dc.contributor.authorDraper, H
dc.contributor.authorMercieca-Bebber, R
dc.contributor.authorElls, C
dc.contributor.authorHunn, A
dc.contributor.authorScott, JA
dc.contributor.authorFernandez, CV
dc.contributor.authorDickens, AP
dc.contributor.authorAnderson, N
dc.contributor.authorBhatnagar, V
dc.contributor.authorBottomley, A
dc.contributor.authorCampbell, L
dc.contributor.authorCollett, C
dc.contributor.authorCollis, P
dc.contributor.authorCraig, K
dc.contributor.authorDavies, H
dc.contributor.authorGolub, R
dc.contributor.authorGosden, L
dc.contributor.authorGnanasakthy, A
dc.contributor.authorHaf Davies, E
dc.contributor.authorvon Hildebrand, M
dc.contributor.authorLord, JM
dc.contributor.authorMahendraratnam, N
dc.contributor.authorMiyaji, T
dc.contributor.authorMorel, T
dc.contributor.authorMonteiro, J
dc.contributor.authorZwisler, A-DO
dc.contributor.authorPeipert, JD
dc.contributor.authorRoydhouse, J
dc.contributor.authorStover, AM
dc.contributor.authorWilson, R
dc.contributor.authorYap, C
dc.contributor.authorCalvert, MJ
dc.date.accessioned2022-06-01T11:56:52Z
dc.date.available2022-06-01T11:56:52Z
dc.date.issued2022-05-17
dc.identifier.citationJAMA, 2022, 327 (19), pp. 1910 - 1919en
dc.identifier.issn0098-7484
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5162
dc.identifier.eissn1538-3598en_US
dc.identifier.eissn1538-3598
dc.identifier.doi10.1001/jama.2022.6421en_US
dc.identifier.doi10.1001/jama.2022.6421
dc.description.abstract<h4>Importance</h4>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.<h4>Objective</h4>To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.<h4>Evidence review</h4>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.<h4>Findings</h4>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.<h4>Conclusions and relevance</h4>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.en
dc.formatPrinten_US
dc.format.extent1910 - 1919en_US
dc.languageengen_US
dc.language.isoengen
dc.rights.urihttp://www.rioxx.net/licenses/all-rights-reserveden
dc.subjectHumansen
dc.subjectConsensusen
dc.subjectMoralsen
dc.subjectBiomedical Researchen
dc.subjectResearch Designen
dc.subjectEthics, Clinicalen
dc.subjectDelphi Techniqueen
dc.subjectPractice Guidelines as Topicen
dc.subjectResearch Reporten
dc.subjectPatient Reported Outcome Measuresen
dc.titleEthical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.en
dc.typeJournal Article
dcterms.dateAccepted2022-05-17
rioxxterms.versionVoRen
rioxxterms.versionofrecord10.1001/jama.2022.6421en
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
dc.relation.isPartOfJAMAen_US
pubs.issue19en_US
pubs.notesNo embargoen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.publication-statusPublisheden_US
pubs.volume327en_US
pubs.embargo.termsNo embargoen_US
icr.researchteamClinical Trials & Statistics Unit
dc.contributor.icrauthorYap, Christinaen_US


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