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To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

Triangle 006: Recall of patient-reported symptoms and function in episodic disease/conditions, specifically temporomandibular disorders (TMDs)

Research

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

CERSI P.I.s and Collaborators
Antonia V. Bennett, PhD (UNC); Theresa Coles, PhD (Duke); Pei Feng Lim, DDS, MS (UNC); Lesley Skalla, PhD; Laura Mkumba, MSc; Deborah Usinger, BA

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

The overarching goal of this research program is to identify the influence of recall periods on measurement of patient-reported symptoms and function for episodic diseases/conditions such as temporomandibular disorders (TMD) and make recommendations for recall periods in the measurement of PROs in clinical trials.

Project Description and Goals

In Year 1 of this research program, the project goals are to conduct a literature review and qualitative interviews with patients and clinicians in preparation for the design of a prospective study to empirically evaluate candidate recall periods. Objectives: 

  1. Describe strengths and limitations of measurement strategies for recall of episodic diseases/conditions 
  2. Elucidate the pattern/periodicity of symptoms and functional limitations common to TMD.
Anticipated Outcomes of Interest

This work will produce a literature review and a manuscript describing the qualitative interviews. These findings will inform the design of a prospective study to empirically evaluate candidate recall periods. The goal of this line of research is to provide information to FDA and clinical trial investigators regarding the impact of various recall periods for measurement of TMD experiences, and recommendations of appropriate recall periods for symptoms and function of TMD. The results of this work (the literature review, qualitative interviews and the subsequent prospective study) will guide researchers on how to optimally pose questions to patients to yield the most accurate information about their experiences while balancing burden on patient time and study feasibility.

How does this project fit into the FDA's Regulatory Science Framework?

This project will modernize development and evaluation of FDA-regulated products by influencing how we assess treatment benefit in clinical trials for individuals with episodic conditions to ensure that we obtain reliable estimates of patient-centered outcomes while minimizing response burden.

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