The development of 'Quality of Life Instrument for Indian Diabetes patients (QOLID): a validation and reliability study in middle and higher income groups.

Purpose: To develop a reliable and valid quality of life questionnaire for Indian patients with diabetes.

Methods: A draft of 75 questions was prepared on the basis of expert opinion, focus group discussions, review of existing literature and detailed semi-structured interviews of patients with diabetes with the intention of including all aspects of diabetes-specific and quality of life considered relevant by patients and care providers to enable constrict validity. A Stage 2 questionnaire was then prepared with 13 domains and 54 items (questions) after expert panel review for obvious irrelevance and duplication of issues. It was administered to 150 participants visiting a diabetes center at New Delhi. Factor analysis was done using principal component method with varimax rotation. Reliability analysis was done by calculating Cronbach's Alpha. For evaluating concordant validity the questionnaire was co-administered with DQL-CTQ to 30 participants. The discriminant validity of the questionnaire was tested using 't' test for metabolic control, co-morbidities, insulin use and gender.

Results: Using principal component method 8 domains were identified on the basis of an apriori hypothesis and the scree plot. These 8 domains explained 49.9% of the total variation. 34 items (questions) were selected to represent these domains on the basis of extraction communality, factor loading, inter-item and item-total correlations. The final questionnaire has an Overall Cronbach's Alpha value of 0.894 (subscale- 0.55 to 0.85) showing high internal consistency. The questionnaire showed good concordance (product moment correlation 0.724; p = 0.001; subscale correlation - 0.457 to 0.779) with the DQL-CTQ. The overall standardized questionnaire score showed good responsiveness to metabolic control and co-morbidities establishing discriminant validity.

Conclusion: The final version of questionnaire with 8 domains and 34 items is a reliable and valid tool for assessment of quality of life of Indian patients with diabetes.