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Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines
Samantha Cruz Rivera1,2,3, Olalekan Lee Aiyegbusi1,2,4, Jonathan Ives5
1Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
JAMA
|May 17, 2022
Summary
New ethical guidelines for patient-reported outcomes (PROs) in clinical research aim to ensure high-quality data. These guidelines address key ethical issues to protect participants and researchers, enhancing PRO use in healthcare decisions and policy.
Area of Science:
- Health Services Research
- Clinical Research Ethics
- Patient-Reported Outcomes
Background:
- Patient-reported outcomes (PROs) are crucial for healthcare decisions, policy, and personalized care.
- The increasing use of PROs necessitates addressing associated ethical considerations in clinical research.
- Existing ethical frameworks may not fully encompass the unique challenges of PRO implementation.
Purpose of the Study:
- To develop international, consensus-based ethical guidelines specifically for the use of PROs in clinical research.
- To provide a standardized framework for addressing ethical issues throughout the PRO lifecycle in research.
- To enhance the responsible and effective integration of PROs into healthcare and research.
Main Methods:
- A systematic review of ethical implications of PROs in clinical research was conducted.
- International Delphi process with 96 participants and a consensus meeting with 25 participants were employed.
- Guideline development followed the EQUATOR Network's framework, incorporating SPIRIT-PRO Extension recommendations.
Main Results:
- A comprehensive set of PRO-specific ethical guidelines was developed through consensus.
- Key areas addressed include research rationale, data monitoring, participant burden, and dissemination.
- The guidelines cover issues such as PRO assessment schedules, missing data, and the involvement of patient partners.
Conclusions:
- The developed PRO ethics guidelines offer recommendations for ethical issues in PRO clinical research.
- Adherence to these guidelines can ensure high-quality PRO data collection.
- Addressing these ethical issues minimizes participant risk and harm, protecting overall welfare.
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