Use of the WOMAC questionnaire in Mumbai and the challenges of translation and cross cultural adaptation.

Patient-reported outcome measures (PROMs) are disease specific questionnaires that are being increasingly used in clinical practice and research. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), is a widely used PROM in patients with hip or knee osteoarthritis. A validated WOMAC was used by us, and significant challenges were faced in administering it as several questions did not have a cultural connect. Functionally equivalent items in the Indian context had then to be used to complete the score. With greater emphasis today on the use of patient-reported outcome measures, and with data from multi-centric studies being pooled, cross-cultural adaptation becomes very important if the pooled data are to be really relevant. In India, with several languages being spoken, and a significant proportion of the population being illiterate, the physician and/ or the impartial witness must provide considerable explanation without attempting to influence the response. The key to the effective and correct use of PROMs thus lies not just in translation, but also in a stepwise validation of the questionnaire, and modification in the context of the country where it is used. Scores like WOMAC are often primary efficacy endpoints in clinical trials; are gaining greater importance to support label claims; have ethical implications, and directly impact regulatory decision making and thus, eventually, evidence-based practice.