Expanding patient-reported outcomes to oral health complications from systemic cancer therapy.
60 Background: Cross-disciplinary patient reported outcomes (PROs) assess the full range of side effects from systemic cancer therapy. For oral health complications, however, the validity of oral-health specific and generic health-related quality-of-life (QoL) instruments is unknown for cancer patients. This study evaluates the performance, measurement, and prediction characteristics of the Oral Health Impact Profile (OHIP–14) and EQ–5D in cancer patients with bisphosphonate-associated Osteonecrosis of the Jaw (ONJ). Methods: 34 cancer patients assessed the QoL of their own ONJ with the OHIP–14 and evaluated the QoL of 4 standardized ONJ Health States with the EQ–5D, as previously published. For each instrument, the standard response mean (SRM), effect size (ES), and ability to distinguish minimally important differences (MID) were evaluated for ONJ compared to baseline (longitudinal responsiveness). Instrument MIDs (cross-sectional responsiveness) were also calculated. Performance of a published general dentistry algorithm to predict EQ–5D values from OHIP–14 results was tested. Results: The OHIP–14 and EQ-5D instruments demonstrated moderate to large longitudinal and cross-sectional responsiveness. Pain was one of the most responsive domains for both instruments. Ceiling/floor effects were most prominent for OHIP–14. A general dentistry algorithm did not adequately predict EQ–5D values for cancer patients. Conclusions: This study provides the first empirical evidence for the performance, measurement, and prediction characteristics of oral-health specific and generic QoL instruments for the oral health side effects of systemic cancer treatment. Instrument validity is supported for oral health complications in cancer patients. These results provide benchmarks for PROs at the intersection of oral medicine and surgery, dentistry, and oncology. [Table: see text]