Department of Respiratory Medicine, Repatriation General Hospital, Daw Park, The Netherlands.
Int J Chron Obstruct Pulmon Dis. 2012;7:337-44. doi: 10.2147/COPD.S27646. Epub 2012 May 25.
To assess the adherence of physiotherapists to the study protocol and the occurrence of contamination bias during the course of a randomized controlled trial with a recruitment period of 2 years and a 1-year follow-up (COPE-II study).
In the COPE-II study, intervention patients received a standardized physiotherapeutic reactivation intervention (COPE-active) and control patients received usual care. The latter could include regular physiotherapy treatment. Information about the adherence of physiotherapists with the study protocol was collected by performing a single interview with both intervention and control patients. Patients were only interviewed when they were currently receiving physiotherapy. Interviews were performed during two separate time periods, 10 months apart. Nine characteristics of the COPE-active intervention were scored. Scores were converted into percentages (0%, no aspects of COPE-active; 100%, full implementation of COPE-active).
Fifty-one patients were interviewed (first period: intervention n = 14 and control n = 10; second period: intervention n = 18 and control n = 9). Adherence with the COPE-active protocol was high (median scores: period 1, 96.8%; period 2, 92.1%), and large contrasts in scores between the intervention and control group were found (period 1: 96.8% versus 22.7%; period 2: 92.1% versus 25.0%). The scores of patients treated by seven physiotherapists who trained patients of both study groups were similar to the scores of patients treated by physiotherapists who only trained patients of one study group.
The adherence of physiotherapists with the COPE-active protocol was high, remained unchanged over time, and no obvious contamination bias occurred.
评估物理治疗师在一项为期 2 年招募期和 1 年随访期的随机对照试验（COPE-II 研究）中遵守研究方案的情况和发生污染偏倚的情况。
在 COPE-II 研究中，干预组患者接受标准化的物理治疗再激活干预（COPE-活跃），对照组患者接受常规护理。后者可能包括常规的物理治疗。通过对干预组和对照组患者进行一次单独访谈来收集关于物理治疗师遵守研究方案的信息。只有当患者正在接受物理治疗时，才对患者进行访谈。访谈在两个单独的时间段进行，间隔 10 个月。对 COPE-活跃干预的 9 个特征进行评分。评分转换为百分比（0%，没有 COPE-活跃的方面；100%，完全实施 COPE-活跃）。
共对 51 名患者进行了访谈（第一期：干预组 n = 14，对照组 n = 10；第二期：干预组 n = 18，对照组 n = 9）。COPE-活跃方案的依从性很高（中位数评分：第一期 96.8%；第二期 92.1%），并且干预组和对照组之间的评分差异很大（第一期：96.8%比 22.7%；第二期：92.1%比 25.0%）。接受同时培训两组患者的 7 名物理治疗师治疗的患者的评分与仅培训一组患者的物理治疗师治疗的患者的评分相似。
物理治疗师对 COPE-活跃方案的依从性很高，随着时间的推移保持不变，并且没有明显的污染偏倚发生。
