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  1. Advancing Regulatory Science

Recall of patient-reported symptoms and function in episodic disease/conditions, specifically temporomandibular disorders

CERSI Collaborators: Triangle CERSI: Antonia Bennett, PhD; Theresa Coles, PhD; Pei Feng Lim, DDS; Lesley Skalla, PhD; Laura Mkumba, MSc; Deborah Usinger, BA.

FDA Collaborators: Caiyan Zhang; Jeffery Toy; Beth Stirling; Andrew Steen; Devon Allison; Fraser Bocell; Lexie Perreras; Eva Rorer; Srinivas Nandkumar

Project Start Date: September 1, 2023

Regulatory Science Framework

Charges: Modernize Development & Evaluation of FDA-Regulated Products; Clinical Outcome Assessment

Regulatory Science Challenge

Patient-reported outcome (PRO) questionnaires ask patients about their symptoms and how their condition may interfere with activities of daily living (functional limitations). This information can be important inputs when evaluating medical products, for example, for medical device safety and effectiveness. Sometimes, the questions ask patients to remember and report the information within a certain time frame. For example, “How do you feel now?”, “How do you feel in the past 7 days”, “How do you feel in the last month?”. This time frame is the “recall period.” The recall period needs to be long enough for a patient’s recollection to be complete, but also short enough for patients to more easily remember information. For conditions like temporomandibular disorders (TMDs) where symptoms might vary over time, the appropriate recall period for TMD PRO questionnaires is unclear.

Project Description and Goals

Patients with conditions like TMD may have symptoms that vary over time in how intense or frequent they are and how much they interfere with activities of daily living. This project aims to find the best ways to measure these patient-reported symptoms and functional limitations. Investigators will first look at results of scientific studies to see what is already known about recall periods for TMD symptoms and TMD PRO questionnaires. Then, investigators will survey adult TMD patients and clinicians who treat TMD to learn more about the patterns and timing of symptoms and functional limitations that are common in TMDs. A diverse sample of patients will be surveyed, with a mix of age, gender, race, and disease length and severity. Clinicians will have a wide range of specialties and relevant experience with treating TMD. Results will be analyzed and serve as a basis for developing recall period recommendations for TMD symptoms and functional limitations.

 

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