Development and validation of the Diabetes Bowel Symptom Questionnaire.

Abstract

Although gastrointestinal symptoms occur frequently, there is no validated measure of gastrointestinal symptoms in patients with diabetes mellitus. To develop the Diabetes Bowel Symptom Questionnaire. A questionnaire derived from previously validated symptom measures was compiled to assess all relevant gastrointestinal and diabetes items. Face and content validity were ascertained by expert review. One hundred and sixty-eight patients with diabetes mellitus completed the instrument, and reliability was evaluated by a test-re-test procedure 1 week later. Concurrent validity was evaluated by an independent physician interview (n = 33). Measures of glycaemic control (glycated haemoglobin and plasma glucose) were compared with self-reported glycaemic control on a five-point Likert scale in diabetic out-patients (n = 166). The questionnaire had adequate face and content validity. There was good to excellent test-re-test reliability for the gastrointestinal and diabetes items (median kappa: 0.63 and 0.79, respectively); concurrent validity was good to excellent (median kappa: 0.47 and 0.65, respectively), except for the items assessing the severity of gastrointestinal symptoms. Both glycated haemoglobin (P < 0.0001) and plasma glucose (P = 0.005) correlated significantly with self-reported glycaemic control. The Diabetes Bowel Symptom Questionnaire appears to be a useful measure of gastrointestinal symptoms and glycaemic control in diabetes mellitus, and should have applicability in epidemiological and clinical studies.