When medical device companies are developing instruments to measure patient-reported outcomes (PROs) in their product trials, the FDA encourages them to use cognitive interviews to help ensure they are on the right track, the agency says in a draft guidance scheduled to be published Aug. 31.

The agency urges sponsors to “ensure patient-reported outcome instruments are understandable to patients,” which they can do by “using plain language to help ensure that patients with varying levels of overall literacy and health literacy understand and are able to provide informed responses.” For example, if a sponsor is interested in checking patients’ eyesight, it could provide PRO “items assessing difficulties patients have with activities they may do in everyday life, such as reading books, menus and labels on medicine bottles. The FDA recommends conducting cognitive interviews to generate evidence supporting the wording of these elements.”

Comments on the draft guidance are due Oct. 30.

Read the draft guidance here: https://bit.ly/3b2JHwC.