Creating a patient-based condition-specific outcome measure for Temporomandibular Disorders (TMDs): Oral Health Impact Profile for TMDs (OHIP-TMDs).

The aim of this study was to generate a putative patient-based outcome measure specifically for Temporomandibular Disorders (TMDs) using a mixed-method approach. A combined quantitative-qualitative methodology was used to identify the most relevant items in the Oral Health Impact Profile (OHIP-49) for TMDs. The quantitative study involved 110 patients with TMDs diagnosed using the Research Diagnostic Criteria for TMDs (RDC/TMD) and 110 age- and sex-matched controls. All subjects completed the OHIP-49. The qualitative study involved semi-structured interviews with a separate sample of patients with TMDs (n = 29). The two resultant data sets were analysed blinded and separately. Each data set used predetermined rules to select candidate items for the putative OHIP for TMDs. The two sets of selected items were then compared using a priori rules to make a final item selection for OHIP TMDs. Eighteen pre-existing items were selected through the quantitative process and fourteen by the qualitative process. On comparison of the two selections all but two of the items selected by the qualitative process had also been selected by the quantitative process. Two new candidate items emerged from the qualitative data that were not covered by OHIP-49. A 22 item putative OHIP-TMDs outcome measure emerged from the final selection process. A putative OHIP-TMDs outcome measure has been generated which requires further testing especially in relation to its responsiveness to change.