Development and validation of health related quality of life questionnaire (Indian scenario) in diabetic foot ulcer patients

Aim To develop and validate Health Related Quality of Life Questionnaire in Diabetic Foot Ulcer Patients (HRQLQDFU) for Indian scenario. Materials and methods This study was conducted in two phases. First phase was Development of HRQLQDFU which included literature search and expert interview. Second phase was validation of HRQLQDFL which included face validation, content validation and construct validation. Face validation was done by ten diabetic foot ulcer patients, ten practicing nurses and ten care givers. They were asked to read and respond to questionnaire and report any difficulty in understanding the questions. Further they were asked to add any item to the questionnaire which according to them has a significant effect on quality of life. Content validation was done by six subject experts who judged the content relevance of questionnaire with score ranging from zero to four; zero being least relevant and four being most relevant. Content validity index was calculated for each question. Questions having content validity index ≥ 0.8 were selected for the study. Reliability was tested by calculating Cronbach's alpha. Results In the development phase a questionnaire containing 37 questions with six domains was developed. None of patient had difficulty in understanding questions. After content validation a new questionnaire containing 20 questions was developed. Cronbach's alpha was 0.86 which shows good reliability. Conclusion The new health related quality of life questionnaire on diabetic foot ulcer patients for an Indian scenario is validated and can be a reliably measure for quality of life in diabetic foot ulcer patients.