Development of an Oral Health Status Patient-Reported Outcomes Instrument

Objectives: Patient-reported outcomes (PRO) can provide valuable insights into patients’ quality of life; however, no PRO instrument has been developed that adequately measures oral health status for cancer patients. The objective of this study was to develop a high-quality Oral Health Status Patient-Reported Outcomes (OHSPRO) instrument for patients diagnosed with cancer.
Methods: Data were obtained from the 2015-2016 National Health and Nutrition Examination Survey, a large national database representative of the US population. The database contained a total of 549 subjects with cancer, and 5,165 subjects without cancer. Self-reported questionnaires of oral health status of the adult population were utilized. Internal consistency, as well as concurrent and construct validities were examined. Formal psychometric evaluation using Rasch analysis was also conducted.
Results: Concurrent and construct validities and internal consistency were adequate. Model fit, ordered response categories, precision and item-person targeting were acceptable. Differential item functioning across age, gender and ethnicity was minimal.
Conclusions: We have developed a robust, cancer specific OHSPRO instrument that was sensitive to oral health issues of cancer patients of all ages and can be used cross-sectionally or longitudinally to assess changes in oral health outcomes in clinical trials and research. This study has the potential to greatly enhance the quality of life of patients and advance the implementation of evidence-based dentistry into dental education and clinical practices.