Abstract
BackgroundPatients experience an increasing treatment burden related to everything they do to take care of their health: visits to the doctor, medical tests, treatment management and lifestyle changes. This treatment burden could affect treatment adherence, quality of life and outcomes. We aimed to develop and validate an instrument for measuring treatment burden for patients with multiple chronic conditions.MethodsItems were derived from a literature review and qualitative semistructured interviews with patients. The instrument was then validated in a sample of patients with chronic conditions recruited in hospitals and general practitioner clinics in France. Factor analysis was used to examine the questionnaire structure. Construct validity was studied by the relationships between the instrument's global score, the Treatment Satisfaction Questionnaire for Medication (TSQM) scores and the complexity of treatment as assessed by patients and physicians. Agreement between patients and physicians was appraised. Reliability was determined by a test-retest method.ResultsA sample of 502 patients completed the Treatment Burden Questionnaire (TBQ), which consisted of 7 items (2 of which had 4 subitems) defined after 22 interviews with patients. The questionnaire showed a unidimensional structure. The Cronbach's α was 0.89. The instrument's global score was negatively correlated with TSQM scores (rs = -0.41 to -0.53) and positively correlated with the complexity of treatment (rs = 0.16 to 0.40). Agreement between patients and physicians (n = 396) was weak (intraclass correlation coefficient 0.38 (95% confidence interval 0.29 to 0.47)). Reliability of the retest (n = 211 patients) was 0.76 (0.67 to 0.83).ConclusionsThis study provides the first valid and reliable instrument assessing the treatment burden for patients across any disease or treatment context. This instrument could help in the development of treatment strategies that are both efficient and acceptable for patients.
Highlights
Patients experience an increasing treatment burden related to everything they do to take care of their health: visits to the doctor, medical tests, treatment management and lifestyle changes
We aimed to develop a measure of treatment burden for patients with at least one chronic condition
We presented the concept of treatment burden to patients and asked them about their diseases, their treatment and the burden of treatment, with open-ended questions: ‘Could you tell us about your health problems?’ ‘Could you tell us about what you have to do to take care of your health?’ ‘What aspects of your care have the most impact on your life?’ we asked them about the burden associated with the different topics highlighted earlier by asking them (1) to rate each of these items, (2) to explain why they would rate it like that and (3) if they found the item relevant in the assessment of treatment burden generally
Summary
Patients experience an increasing treatment burden related to everything they do to take care of their health: visits to the doctor, medical tests, treatment management and lifestyle changes This treatment burden could affect treatment adherence, quality of life and outcomes. Being a patient implies more investment of time and effort than just taking medicines It involves drug management, self-monitoring, visits to the doctor, laboratory tests and changes of lifestyle. Patients with type 2 diabetes controlled by oral agents could spend 143 minutes daily in recommended self-care [5] This workload can affect quality of life as severely as the illness itself, and patients rate this treatment burden equal to that of diabetic neuropathy or nephropathy [6]
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