Minimum clinically important difference and substantial clinical benefit in patients with chronic temporomandibular disorders.

ABSTRACT

BACKGROUND: Research on temporomandibular disorder (TMD) responsiveness is scarce and limited regarding patients' representativeness. OBJECTIVE(S) This study aimed to estimate minimum clinically important difference (MCID) and substantial clinical benefit (SCB) among a large and diverse patient population regarding sex and age. METHODS: In this study, 162 patients participated from five hospitals. MCID and SCB in pain, functional disability and quality of life were examined with anchor-based methods. Patients' global impression of change was used as the anchor. Area under the curve (AUC) values were determined for testing accuracy. Changes from baseline and coefficient of variation by responsiveness status were calculated to explain the results of accuracy. RESULTS: SCB was estimated to be 2.18 for the numeric rating scale (NRS) for pain (AUC 0.80 [95% CI 0.72-0.88]) in all patients and 2.50 in women (AUC 0.81 [95% CI 0.71-0.89]). The estimated SCB of NRS for discomfort (1.50) and Jaw Functional Limitation Scale for mastication (1.35) had wide CIs for AUCs. Likewise, the estimated MCIDs of NRS for pain (0.80) and NRS for discomfort (1.50) had wide CIs for AUCs. Among non-responders who did not achieve the MCID of NRS for pain, the coefficient of variation was very high for all outcomes other than the NRS for pain. CONCLUSION: This study investigated the responsiveness of patients with TMD using a large and diverse patient sample. SCB in pain decrease can be used to assess the responsiveness of patients with TMD. Composite outcomes should be developed to estimate MCID.