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Evaluating physical functioning using patient-reported outcome measures: how does the question form and recall period influence patients’ interpretation?

External Institution: Duke University

External Collaborators: Theresa Coles, PhD; Bryce Reeve, PhD; Tom LeBlanc, MD; Lagoo-Deenadayalan, MD, PhD; Rory Goodwin MD

FDA Collaborators: Erica Horodniceanu, MPH; Vishal Bhatnagar, MD; Paul Kluetz, MD; Caitlin Drew, MSN, RN 

Project Start Date: October 2020

Regulatory Science Challenge

Physical functioning is crucial for the quality of life of adults who are diagnosed with and treated for cancer. Physical function is the level with which persons engage in activities that involve physical effort. One important way to evaluate physical function in cancer clinical trials is through the use of patient-reported outcomes (PROs). PROs allow patients to directly share their own perspectives on their health without any interpretation by others (e.g., clinicians). 

Within PRO measures or questionnaires, there are different ways to ask about physical function, including the subtopic of physical function, and the period of time patients are asked to think about when answering questions, called the “recall period”. Subtopics of physical function may include patients’ ability to conduct activities, satisfaction with conducting activities, difficulty with conducting activities, completion of activities, etc. Patients can be asked to report their physical function as far back as is helpful in a trial (e.g., “now”, “last 24 hours”, “past 7 days”, “typical day”, no time period defined). The choice of the subtopic and recall period should be matched to the clinical trial’s goals. 

Project Description and Goals

The objective of this study is to describe how patients understand and choose responses on patient-reported physical function questions with different subtopics or recall periods and offer recommendations on which specific subtopics or recall periods are most useful for different clinical trial settings. To accomplish this objective, the study research team reviewed existing published literature, directly asked patients with cancer questions about physical functioning, and asked a group of experts about their perspectives. 

The results of this study will impact clinical trials in three ways: (1) Ensure that questionnaires used to evaluate physical function in future trials are addressing the most important aspects of physical function from the patient perspective; (2) Provide consensus-based recommendations for clinical trial designers, outcomes researchers, clinicians, and FDA on which approaches for evaluating physical function are best suited for different cancer clinical trial uses. (3) Provide the evidence for which future studies will need to use physical function subtopics and recall periods in their approach.

Further Information

 
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