Abstract
BackgroundThe prevalence of diabetes mellitus (DM) is increasing dramatically, placing considerable financial burden on the healthcare budget of each country. Patient self-management is crucial for the control of blood glucose, which largely determines the chances of developing diabetes-related complications. Self-management interventions vary widely, and a method is required for assessing the impact of self-management. This paper describes the development of a questionnaire intended for use to measure the impact of self-management in diabetes.MethodsAn iterative development process was undertaken to identify the attributes of self-management using 5 steps. First, a literature review was undertaken to identify and understand themes relating to self-management of DM to inform a topic guide. Second, the topic guide was further refined following consultation with a Patient and Public Involvement group. Third, the topic guide was used to inform semi-structured interviews with patients with Type 1 DM (T1DM) and Type 2 DM (T2DM) to identify how self-management of DM affects individuals. Fourth, the research team considered potential attributes alongside health attributes from an existing measure (Diabetes Health Profile, DHP) to produce an instrument reflecting both health and self-management outcomes simultaneously. Finally, a draft instrument was tested in a focus group to determine the wording and acceptability.ResultsSemi-structured interviews were carried out with 32 patients with T1DM and T2DM. Eight potential attributes were identified: fear/worry/anxiety, guilt, stress, stigma, hassle, control, freedom, and feeling supported. Four of these self-management attributes were selected with four health attributes (mood, worry about hypos (hypoglycaemic episodes), vitality and social limitations) to produce the Health and Self-Management in Diabetes (HASMIDv1) questionnaire.ConclusionsHASMIDv1 is a short questionnaire that contains eight items each with four response levels to measure the impact of self-management in diabetes for both T1DM and T2DM. The measure was developed using a mixed-methods approach that involved semi-structured interviews with people with diabetes. The measure has high face validity. Ongoing research is being undertaken to assess the validity of this questionnaire for measuring the impact of self-management interventions in economic evaluation.
Highlights
The prevalence of diabetes mellitus (DM) is increasing dramatically, placing considerable financial burden on the healthcare budget of each country
Patient self-management is crucial for the control of blood glucose, which largely determines the chances of developing DM complications over the long-term
Cost-effectiveness analyses have been undertaken to examine the impact of self-management on DM in terms of cost per quality adjusted life year (QALY), where quality of life is assessed on a scale from zero for states as bad as being dead to one for full health [6]
Summary
The prevalence of diabetes mellitus (DM) is increasing dramatically, placing considerable financial burden on the healthcare budget of each country. Cost-effectiveness analyses have been undertaken to examine the impact of self-management on DM in terms of cost per quality adjusted life year (QALY), where quality of life is assessed on a scale from zero for states as bad as being dead to one for full health [6] These analyses have typically taken the United Kingdom (UK) NHS healthcare perspective, where the within-trial (short-term) and lifetime (long-term) modelling outcomes had focussed strictly on the improvements in clinical outcomes and health-related QALYs, such as the EQ-5D, or used utility estimates obtained for descriptions of the processes of care, such as the insulin regimen, rather than the consequences of self-management on quality of life [7,8,9,10]. All potential themes that were reported are shown in Additional file 1: Appendix 2, and these were used to produce an initial long list of themes for consideration for the topic guide
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