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Patient reported outcome assessment must be inclusive and equitable

Updated: May 18, 2022

Patient-reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies must be taken to include underserved groups to avoid increasing health disparities.

Patient-reported outcomes (PROs) collected in clinical trials can provide valuable evidence of the risks and benefits of treatment from a patient perspective, to inform regulatory approvals, clinical guidelines and health policy. PROs are increasingly collected routinely in clinical settings, at an aggregate level for audit and benchmarking, for real-world evidence generation, and as an input or predicted output for clinical decision tools and artificial intelligence (AI) in health1,2. At an individual patient level, PROs can be used to facilitate shared decision making, screen or monitor symptoms, and provide timely care tailored to individual needs3. PROs are also increasingly used in value-based healthcare initiatives4.

Efforts to capture and report PRO data should be inclusive and equitable, addressing the diverse needs of all patients with the condition of interest, including groups historically and currently underserved by research5,6. Issues of diversity, equity and inclusion (Box 1) have recently been highlighted in PRO ethical guidelines, which have identified a number of concerns to be addressed in PROs research5.


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