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BMC Med. 2012; 10: 68.
Published online Jul 4, 2012. doi:  10.1186/1741-7015-10-68
PMCID: PMC3402984
Development and description of measurement properties of an instrument to assess treatment burden among patients with multiple chronic conditions
Viet-Thi Tran,1,2 Victor M Montori,3 David T Eton,3 Dan Baruch,4 Bruno Falissard,5,6 and Philippe Ravaudcorresponding author1,2,7
1Université Paris Descartes, Faculté de Médecine, Paris, France
2INSERM U738, Paris, France
3Division of Health Care and Policy Research, Department of Health Sciences Research and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA
4Université Paris Denis-Diderot, Faculté de Médecine, Paris, France
5INSERM U669, Paris, France
6Université Paris Sud, Paris, France
7Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA
corresponding authorCorresponding author.
Viet-Thi Tran: thitranviet/at/gmail.com; Victor M Montori: montori.victor/at/mayo.edu; David T Eton: eton.david/at/mayo.edu; Dan Baruch: dan.baruch001/at/gmail.com; Bruno Falissard: falissard_b/at/wanadoo.fr; Philippe Ravaud: philippe.ravaud/at/htd.aphp.fr
Received January 13, 2012; Accepted July 4, 2012.
Abstract
Background
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. We aimed to develop and validate an instrument for measuring treatment burden for patients with multiple chronic conditions.
Methods
Items 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.
Results
A 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).
Conclusions
This 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.
Keywords: chronic disease/therapy, patient participation, physician-patient relations, quality of life, questionnaires, workload
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