Development of a PROMIS measure for adult dental patients

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Fourteen years ago, PROMIS, the Patient Reported Outcome Measurement Information System, was created as the most advanced system of patient-reported outcome (PRO) measures. It promises efficient, reliable, and valid assessments of how patients perceive their health; however, no measures specific to oral health are available. This situation impedes solid PRO measurement in dentistry and also prevents PROMIS from capturing health more comprehensively. We propose to develop for adults a set of four oral health instruments using PROMIS methodology, based on the recently determined dimensions of oral health-related quality of life, OHRQoL (Oral Function, Orofacial Pain, Orofacial Appearance, Psychosocial Impact). These dimensions represent the main areas where patients perceive the impact of oral disorders. More than 53 patient-reported oral health instruments for adult patients would merge into a standardized, flexible and precise metric to measure oral health impact across oral conditions and dental settings. A profile of four scores, based on the four dimensions, would form the patient-reported oral health metric and characterize a patient’s standing in the space of patient-reported oral health with four “coordinates” – one for each dimension. The goals of this proposal are (i) to explore how well available instruments cover the spectrum of the four patient-reported oral health dimensions Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact, (ii) to develop four preliminary item banks, one for each dimension, (iii) to develop four final item banks, one for each dimension, and (iv) to develop four fixed-length instruments based on the item banks, one for each dimension. Existing OHRQoL and other patient-reported oral health data from 2,115 dental patients will be used in secondary data analyses to explore the severity spectrum of the four patient-reported oral health dimensions and how well available questionnaire items cover this spectrum. Questionnaire items from 53 already identified self-report instruments will be supplemented by a systematic search for new questionnaires/items. All identified items will undergo a mixed-methods approach to be synthesized through focus groups and cognitive interviews with representative patient groups. Our process will follow the PROMIS Qualitative Item Review method to identify, evaluate, and revise items to create four preliminary item banks. Next, in a new sample of 2,000 dental patients covering the entire spectrum of functional, painful, aesthetical, and broader psychosocial problems related to oral disorders, the previously generated four preliminary item banks will be investigated and calibrated using item response theory analyses to derive four final item banks. A fixed-length instrument will be derived from each item bank, and its psychometric properties will be evaluated. This project will introduce PROMIS methodology to an important patient population, adult dental patients. Four scores characterizing Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact would become the standard tool for assessing oral conditions and treatment effects from the adult patient’s perspective.