Université Paris Descartes, Faculté de Médecine, Paris, France.
BMC Med. 2012 Jul 4;10:68. doi: 10.1186/1741-7015-10-68.
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.
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.
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).
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.
患者在照顾自身健康时会面临各种治疗负担，例如就诊、医学检查、治疗管理和生活方式改变等。这些治疗负担可能会影响患者的治疗依从性、生活质量和预后。本研究旨在开发并验证一种适用于患有多种慢性疾病患者的治疗负担评估工具。
通过文献回顾和对慢性疾病患者的半结构化访谈获得项目内容。然后，在法国的医院和全科医生诊所招募慢性疾病患者对该工具进行验证。使用因子分析来检验问卷结构，通过评估工具的整体评分与治疗满意度问卷（TSQM）评分以及患者和医生评估的治疗复杂性之间的关系来研究构念效度。评估患者和医生之间的一致性。通过测试-重测法确定信度。
共有 502 名患者完成了治疗负担问卷（TBQ），该问卷由 7 个项目组成（其中 2 个项目有 4 个子项目），这些项目是在对 22 名患者进行访谈后确定的。问卷呈现出单一维度结构，Cronbach's α 为 0.89。该工具的整体评分与 TSQM 评分呈负相关（rs=-0.41 至-0.53），与治疗复杂性呈正相关（rs=0.16 至 0.40）。患者和医生（n=396）之间的一致性较弱（组内相关系数 0.38（95%置信区间 0.29 至 0.47））。211 名患者的重测信度为 0.76（0.67 至 0.83）。
本研究首次提供了一种适用于评估任何疾病或治疗背景下患者治疗负担的有效且可靠的工具。该工具可帮助制定对患者既有效又可接受的治疗策略。
