Abstract
OBJECTIVE: To improve the assessment of physical function by enhancing precision of physical function assessment as it pertains to subjects at extreme ends of the health continuum (i.e., subjects with extremely poor function ["floor"] or extremely good health ["ceiling"]). METHODS: Under the Patient-Reported Outcomes Measurement Information System (PROMIS) (a National Institutes of Health initiative), we developed new items to assess floor and ceiling physical function in order to supplement the existing item bank. Using item response theory and standard PROMIS methodology, we developed 31 floor items and 31 ceiling items and administered the items during a 12-month prospective, observational study of 737 subjects whose health status was at either extreme. Effect size was calculated and change over time was compared across anchor instruments and across items. Using the observed changes in scores, we back-calculated sample size requirements for the new and comparison measures. RESULTS: We studied 444 subjects who had been diagnosed as having a chronic illness and/or were of old age and 293 generally fit subjects (including athletes in training). Item response theory analyses confirmed that the new floor and ceiling items outperformed reference items (P < 0.001). The estimated post hoc sample size requirements were reduced by a factor of 2-4 for the floor population and a factor of 2 for the ceiling population. CONCLUSION: Extending the range of items by which physical function is measured can substantially improve measurement quality, reduce sample size requirements, and improve research efficiency. The paradigm shift from assessing disability to assessing physical function focuses assessment on the entire spectrum of physical function, signals improvement in the conceptual base of outcome assessment, and may be transformative as medical goals more closely approach societal goals for health.