A SYSTEMATIC REVIEW OF THE CONTENT VALIDITY OF PATIENT-REPORTED OUTCOME MEASURES (PROMS) FOR ADULTS HAVING LOWER LIMB RECONSTRUCTIVE SURGERY

Abstract

IntroductionThere are concerns that patient-reported outcome measures (PROMs) currently used for adults requiring, undergoing or after undergoing lower limb reconstruction (LLR) are not adequately capturing the range of experiences important to these patients. The ‘Patient-Reported Outcome Measure for Lower Limb Reconstruction’ (PROLLIT) study developed a conceptual framework of outcomes identified as important and relevant by adult LLR patients. This review explored whether existing PROMs address these outcomes, and exhibit content validity in this population.Materials & MethodsA range of key PROMs was selected (n=32). Systematic and hand-searches were employed to find studies assessing content validity of these PROMs in the adult LLR population, along with PROM content and development information. A systematic review of content validity of the measures was carried out following ‘COnsensus-based Standards for the selection of health Measurement Instruments’ (COSMIN) guidance, alongside conceptual mapping of the content of the PROMs against the PROLLIT conceptual framework.ResultsThe searches uncovered very few content validity studies assessing the PROMs when applied in adult LLR patients. The COSMIN review found that these measures lacked content validity when applied in this population. The conceptual mapping found that PROMs did not capture all concepts identified as important and relevant in the PROLLIT framework.ConclusionsExisting PROMs applied in the adult LLR population lack content validity and fail to adequately capture relevant outcomes for this patient group. There is a need for a new, dedicated PROM designed for adult LLR patients.