Leeuw M, Goossens M E J B, de Vet H C W, Vlaeyen J W S
Department of Clinical Psychological Science, Faculty of Psychology, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.
J Clin Epidemiol. 2009 Jan;62(1):81-90. doi: 10.1016/j.jclinepi.2008.03.008. Epub 2008 Aug 22.
Treatment outcome studies ought to assess the fidelity of their treatments, including treatment delivery, but practical guidelines and examples for this are lacking. Based on general recommendations in available literature, this study proposes and illustrates the design and application of a Method of Assessing Treatment Delivery (MATD) in a behavioral medicine trial comparing two treatments for chronic low back pain.
In designing MATD, two experts identified several feasible treatment elements. Agreement between the experts in classifying these elements into five categories (essential and unique, essential but not unique, unique but not essential, compatible, prohibited) was assessed. In applying MATD, treatment recordings were evaluated by two independent raters, who coded the (non)-occurrence of MATD elements and who categorized each session as belonging to one of the two treatments.
MATDs content validity was supported by adequate agreement between the experts' classifications of the treatment elements. MATDs interrater reliability was good.
Comprehensive illustrations of designing and applying MATD may encourage the verification of treatment delivery as a partial reflection of treatment fidelity in forthcoming treatment outcome studies.
治疗效果研究应该评估其治疗的保真度，包括治疗实施，但目前缺乏对此的实用指南和示例。基于现有文献中的一般建议，本研究提出并阐述了一种治疗实施评估方法（MATD）在一项行为医学试验中的设计与应用，该试验比较了两种治疗慢性下腰痛的方法。
在设计MATD时，两位专家确定了几个可行的治疗要素。评估了专家们在将这些要素分为五类（基本且独特、基本但不独特、独特但不基本、兼容、禁止）时的一致性。在应用MATD时，由两名独立的评估者对治疗记录进行评估，他们对MATD要素的（未）出现进行编码，并将每个疗程归类为两种治疗方法之一。
MATD的内容效度得到了专家对治疗要素分类之间充分一致性的支持。MATD的评估者间信度良好。
MATD设计与应用的全面示例可能会促使在未来的治疗效果研究中验证治疗实施情况，以此作为治疗保真度的部分反映。
