OBJECTIVES: Planning for the collection of patient-centric data in clinical trials, clinical outcome assessment (COA) methodologists prioritize concepts of interest to support the measurement of treatment benefits of novel medical products that are meaningful to clinicians, policymakers and ultimately patients. When multiple concepts are prioritized, what is the proper sequence in the schedule of assessment of patient reported outcomes (PRO)?

METHODS: A targeted review of the literature related to order effects, irrespective of disease area, in the context of COAs and more broadly, was conducted. Findings and proposals for recommendations were discussed at an internal meeting of IQVIA’s Patient Centered Endpoints scientists.

RESULTS: A set of recommendations was developed based on the literature review and expert discussion. Decisions about the order of administration of PROs are reliant on 3 key factors: 1) prioritization in the endpoint hierarchy, 2) leveraging potential risks of bias due to order effects, and 3) managing patient burden and cognitive load due to multiple assessments. The limits to flexibility in a regulatory context were discussed as well.

CONCLUSIONS: Multiple, and sometimes competing, considerations must be appreciated when determining the running order of PRO measures in a clinical trial. Striving to maximize data validity and minimize patient burden can drive decision making in the direction of overall beneficence.