OBJECTIVES: To develop self-report questionnaires for physician use in the evaluation of diabetic patient reluctance to start or step up insulin regimens. METHODS: An Advisory Committee (AC) was set up. It consisted of 3 diabetes specialists/endocrinologists, 1 behavioural psychiatrist and 2 general practitioners. Three patient focus groups were formed from a pool of 23 type 1 and 2 diabetic patients. Interviewees were asked to list fears, constraints and benefits associated with insulinization, injection and insulin regimen step-up. After analysis of the focus groups, a list of detailed concepts and two test questionnaires were developed and independently validated by the AC with content validity being assessed on 16 type 1 and 2 diabetic patients. Patients completed the questionnaires before being systematically asked to comment on the questionnaire as a whole and more specifically on each element of the questionnaire. Questionnaires were then redrafted and tested on 16 other patients. After analysis of patient tests, a revised questionnaire was produced and validated by the AC. RESULTS: 11 elements (Insulinization: symbolic, fears, constraints, benefits, product physical characteristics. Injection: symbolic, fears, constraints, positive points. Insulin regimen intensification: symbolic, fears) and 31 detailed concepts were identified using the patient focus groups. Each test questionnaire contained 22 items (20 relating to insulin regimen start or insulin regimen step-up plus 2 relating to inhaled insulin). After initial cognitive debriefing, one item was added, taking each questionnaire to 23 items and response choices were significantly modified in both questionnaires by the AC. After second cognitive debriefing 2 items were excluded from both questionnaires by the AC. The pilot questionnaires therefore included 21 items. CONCLUSION:These pilot questionnaires may help physicians to assess the hurdles faced by diabetic patients in starting or stepping up insulin regimens. The questionnaires are now undergoing item reduction, scoring and validation in two case-report studies.