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Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical ResearchThe PRO Ethics Guidelines

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Key Points

Question  What ethical considerations should be considered by researchers, research ethics committees, and funders when conducting or reviewing patient-reported outcome (PRO) clinical research?

Findings  An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodology; 14 items addressing ethical considerations were recommended for inclusion in the PRO ethics guidelines.

Meaning  Addressing the items in the PRO ethics guidelines has the potential to improve the quality of PRO in clinical research while promoting and protecting participant autonomy and protecting participant and researcher welfare.


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.

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Article Information

Corresponding Author: Melanie J. Calvert, PhD, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham B15 2TT, England (

Accepted for Publication: April 5, 2022.

Author Contributions: Drs Cruz Rivera and Calvert had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Cruz Rivera, Aiyegbusi, Ives, Mercieca-Bebber, Hunn, Bhatnagar, Bottomley, Campbell, Collis, Golub, von Hildebrand, Mahendraratnam, Wilson, Stover, Calvert.

Acquisition, analysis, or interpretation of data: Cruz Rivera, Aiyegbusi, Ives, Draper, Mercieca-Bebber, Ells, Hunn, Scott, Fernandez, Dickens, Anderson, Bottomley, Campbell, Collett, Craig, Davies, Gosden, Gnanasakthy, Haf Davies, Lord, Miyaji, Monteiro, Morel, Zwisler, Peipert, Roydhouse, Wilson, Yap, Calvert.

Drafting of the manuscript: Cruz Rivera, Draper, Hunn, Dickens, Anderson, Campbell, Collett, Collis, Davies, Gosden, Gnanasakthy, Haf Davies, Monteiro, Stover, Calvert.

Critical revision of the manuscript for important intellectual content: Aiyegbusi, Ives, Draper, Mercieca-Bebber, Ells, Hunn, Scott, Fernandez, Dickens, Anderson, Bhatnagar, Bottomley, Campbell, Craig, Golub, von Hildebrand, Lord, Mahendraratnam, Miyaji, Monteiro, Morel, Zwisler, Peipert, Roydhouse, Wilson, Stover, Yap, Calvert.

Statistical analysis: Bottomley, Haf Davies, Calvert.

Obtained funding: Mercieca-Bebber, Calvert.

Administrative, technical, or material support: Aiyegbusi, Dickens, Gosden, Haf Davies, von Hildebrand, Mahendraratnam.

Supervision: Calvert.

Other - patient partner: Collis.

Other - patient viewpoint and contributor: Wilson.

Other - statistical advice: Yap.

Other - consensus meeting participation: Roydhouse.

Other - Providing options and opinions: Haf Davies.

Other - helped with formulation of interpretation and analysis regarding ethical values/principles: Draper.

Other - Delphi panel member, reviewed and commented on the study documents and publications: Scott.

Conflict of Interest Disclosures: Dr Cruz Rivera reported receiving funding from UK SPINE and European Regional Development Fund–Demand Hub and personal fees from Merck. Dr Aiyegbusi reported receiving grants from the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, NIHR Applied Research Collaboration West Midlands, UK Research and Innovation (UKRI), Health Foundation, Janssen, Gilead, and GlaxoSmithKline and personal fees from Gilead Sciences Ltd, Merck, and GlaxoSmithKline outside the submitted work. Dr Draper reported receiving unrelated research funding from UK SPINE (UKRI), AHRC, and the University of Warwick and being a member of the Defence Medical Services ethics committee, Birmingham Women’s and Children’s NHS Foundation Trust clinical ethics committee, and NHS Blood and Transplant Deceased Donor Family Tissue Advisory Group. Dr Scott reported receiving a pension from Janssen and holding stock in Johnson & Johnson. Drs Ells and Fernandez are members of the Canadian Interagency Panel on Research Ethics, which is responsible for the interpretation and evolution of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ms Anderson reported receiving funding from the Health Education England/NIHR Integrated Clinical Academic Program Clinical Doctoral Research Fellowship. Dr Haf Davies reported owning an ePRO software platform called Atom5 through Aparito. Dr Lord reported being a member of the Nuffield Bioethics Working Group on the Future of Ageing. Dr Mahendraratnam reported owning stock options at Aetion Inc. Mr Miyaji reported grants (paid to the Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo) from AC Medical, A2 Healthcare, New Age Trading, Japan Tobacco Inc, Japan Media Corp, Medidata Solutions, Ono Pharmaceutical, FMD K&L Japan, 3H Medi Solution, NOBORI, Medrio Inc, Welby Inc, Nipro Corp, and Intellim and personal fees from Pfizer Japan Inc, Takeda Pharmaceutical Co, Merck, Ayumi Pharmaceutical, and Welby Inc. Dr Morel reported owning shares of UCB Pharma. Dr Zwisler reported being chair of the national clinical coordinating group on PRO in cardiac diseases. Dr Peipert reported receiving unrelated research funding from the National Cancer Institute, the National Institutes of Health, the Food and Drug Administration, the ECOG-ACRIN Medical Research Foundation, the Peter G. Peterson Foundation, Veloxis Pharmaceuticals, Pfizer, and the Northwestern University George M. O’Brien Kidney Core Center. He has received unrelated personal fees from AstraZeneca, IMPAQ International, and; in addition, he is the International Society for Quality of Life Research’s psychometric special interest group chair. Through his institution, he is supported by unrelated grants and contracts from Bristol Myers Squibb, Clovis Oncology, Pfizer, and Veloxis Pharmaceuticals. Dr Roydhouse reported receiving unrelated personal fees in the last 24 months from Amgen. Through her institution, she is supported by an unrelated Select Foundation Fellowship and has received unrelated research funding from the Royal Hobart Hospital and the Food and Drug Administration. Dr Stover reported receiving unrelated consulting fees or speaking honoraria in the last 24 months from Navigating Cancer, Association of Community Cancer Centers, Genentech, Purchaser Business Group on Health, and Henry Ford Cancer Center and unrelated research funding from Sivan Innovation and UroGen Pharma Ltd. Dr Yap reported receiving unrelated consulting fees and speaking honoraria from Faron Pharmaceuticals and Celgene, respectively, and being an expert advisor for the Medicines and Healthcare products Regulatory Agency’s Clinical Trials, Biologicals and Vaccines Expert Advisory Group and a funding panel member for the Medical Research Council Experimental Medicine and Cancer Research UK Clinical Research Committee. Dr Calvert reported serving as director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for Patient Reported Outcome Research, and an NIHR senior investigator and receiving funding from the NIHR, UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, UK SPINE, European Regional Development Fund–Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GlaxoSmithKline, and Gilead. Dr Calvert has received personal fees from Astellas, Aparito Ltd, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline, and the Patient-Centered Outcomes Research Institute outside the submitted work. In addition, a family member owns shares in GlaxoSmithKline. No other disclosures were reported.

Funding/Support: This work was sponsored by the University of Birmingham, the NIHR Birmingham Biomedical Research Centre, UK Research and Innovation, UK SPINE, and the European Regional Development Fund.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Several authors are employees of the University of Birmingham; however, beyond the declared author contributions, the sponsor had no additional role.

Disclaimer: The views expressed in this article are those of the author(s) and not necessarily those of national agencies (eg, the NIHR, Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Health Research Authority, Canadian Institutes of Healthcare Research, the Department of Health and Social Care, Canadian Interagency Panel on Research Ethics, or the Canadian Tri-Council Policy Statement 2. Dr Golub is Executive Deputy Editor of JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance.

Additional Information: Dr Scott retired from Janssen Global Services in March 2021; however, she was still involved in the development of the guideline until its final stage. Coauthor Amanda Hunn, MA, died February 8, 2022.

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