Development of a novel scale to assess the quality of life in type 1 diabetic patients for beta cell replacement therapy

Abstract

The main purpose of beta cell replacement therapy for type 1 diabetic patients is to improve their health-related quality of life (HR-QoL). Previous HR-QoL surveys for beta cell replacement therapy on the point of familial support and public understanding have not been studied adequately. We hypothesize that familial support and public understanding have a significant impact on HR-QoL of type 1 diabetic patients, and low HR-QoL assessed with a new scale is associated with seeking a new therapy. The initial questionnaire with 26 items was created after content validation based on 778 inquiries from patients or associates. One hundred five type 1 diabetic patients answered the questionnaire as well as separate questions about their opinions on beta cell replacement therapy. Finally, the new scale, named the Japanese Insulin-Dependent Diabetic Patient QoL (JAPID-QoL) scale, consisted of 19 items with the following three subscales: diabetes status, familial support and social acceptance. Cronbach’s α for overall scale was 0.878, and those for three subscales were over 0.70. All items were satisfied with convergent validity. Lower scores on the JAPID-QoL scale were associated with higher interest in and acceptance of beta cell replacement therapy (Spearman’s coefficients; r = −0.25, p < 0.001 and r = −0.33, p < 0.001, respectively) and also correlated with the necessity of psychosomatic care (r = −0.49, p < 0.001). Our newly proposed JAPID-QoL scale showed enough reliability and validity to assess HR-QoL of type 1 diabetic patients. The patients who had a low HR-QoL on the JAPID-QoL scale desired to receive beta cell replacement therapy and psychosomatic care.