Regular readers will recall my previous post on framework for Real World Data (RWD)/Real World Evidence (RWE) and its potential role(s) in drug approvals. Patient-Reported Outcomes Measures (PROM) can fill a similar role in medical device submissions. A PROM is a instrument or tool, typically a questionnaire or diary, used to gather the health status of the patient. They are used to capture the patient’s experience with the device and important measures that are difficult to quantify (such as the experience of pain). Evidence gathered through PROMs may be used for regulatory decision making and may also assist decision making by payers, health care systems, and providers on device usage.
CDRH encourages sponsors to consider PROMs in their device strategy and has provided a web page with information and links to resources. There’s links to studies and articles on PROMs, a list (compendium) of PROMs that have been successfully used in submissions, and links to case studies and the device development tools page. The agency also recommends that sponsors use the Q-Sub program (see my previous post) o discuss their plan to use, adapt, or develop PROMs with CDRH.
Text Copyright © 2019 Katrina Rogers
Postscript – March 15, 2022
CDRH, in its wisdom, removed the web page with the PROM information. Here are two resources to partially fill the gap: