Cross-cultural adaptation of self-report measures

A PRO is a measurement of any aspect of a patient’s health status that is reported directly by the patient, free of interpretation by a physician, researcher, or other person. With increased international collaboration and the growing use of Health-related Quality of Life (HRQL) and Patient Reported Outcomes (PRO) evaluation in clinical research, the need for international measures has grown. As most are developed in English, they need to be culturally adapted to obtain equivalence between the source and target measures. In response to European regulators’ concern about the methodology employed to achieve this, the European Regulatory Issues on Quality of Life Assessment (ERIQA) group and Mapi Research Institute are investigating current guidelines for crosscultural adaptation of Health-related Quality of Life measures. The standard translation guidelines are needed to be followed for cultural adaption. The use of original as well as translated version of HRQOL instruments is gaining more importance in multiculture country like India and may demand few more instruments in Indian languages for the assessment of health status of patient. An attempt was made by our team was the translation and validation of KDQOL-SFTM1.2 instrument for use in Indian kidney disease patients. Face, discriminant and content validity was observed.