Abstract
This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [( 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 −0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes.
Highlights
Type 1 diabetes is a chronic disease caused by autoimmune destruction of the beta cells in the pancreas, leading to an absolute insulin deficit
Specific questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes: the ViDa questionnaire for type 1 diabetes (ViDa1)
The information obtained from these interviews was examined and the answers were grouped together to create the following 19 themes: 1: self-perception of general HRQoL, 2: social and family relationships, 3: leisure and leisure time, 4: limitations on work, 5: sex life, 6: physical activity, 7: chronic complications, 8: physical/psychological well-being, 9: sleep, 10: satisfaction with treatment, 11: glucose measurement, 12: involvement in and satisfaction with glycemic control, 13: acceptance of disease, 14: motivation, 15: flexibility in diet, 16: satisfaction with the level of knowledge of diabetes, 17: daily stress caused by self-care, 18: fear of/worry about hypoglycemia, and 19: worry about hyperglycemia
Summary
Type 1 diabetes is a chronic disease caused by autoimmune destruction of the beta cells in the pancreas, leading to an absolute insulin deficit. People with type 1 diabetes need to inject insulin in order to survive (Atkinson et al, 2014). The discovery of insulin in 1921 represented a decisive breakthrough in the prognosis of type 1 diabetes, which had previously been a fatal disease. The publication of the results of the Diabetes Control and Complications Trial (DCCT) in the early 1990s was another milestone in the management of type 1 diabetes; intensive treatment with multiple (3–6) injections or a continuous subcutaneous insulin infusion pump in order to reach near normal concentrations of blood glucose was shown to reduce the development of chronic complications and to improve disease control (DCCT Research Group, 1993). Thereafter, intensive insulin therapy became the standard of care in type 1 diabetes. The complexity and intensity of self-care in diabetes has been reported to interfere with the patient’s health-related quality of life (HRQoL; Wolpert and Anderson, 2001; Escudero-Carretero et al, 2007)
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