Center for Enhancing Quality of Life, School of Nursing, Indiana University, Indianapolis, IN 46202, USA.
Nurs Res. 2013 Jan-Feb;62(1):59-65. doi: 10.1097/NNR.0b013e31827614fd.
Treatment fidelity, also called intervention fidelity, is an important component of testing treatment efficacy. Although examples of strategies needed to address treatment fidelity have been provided in several published reports, data describing variations that might compromise efficacy testing have been omitted.
The aim of this study is to describe treatment fidelity monitoring strategies and data within the context of a nursing clinical trial.
A three-group, randomized, controlled trial compared intervention (paced respiration) to attention control (fast, shallow breathing) to usual care for management of hot flashes and other menopausal symptoms. Data from both staff and participants were collected to assess treatment fidelity.
Staff measures for treatment delivery indicated good adherence to protocols. Participant ratings of expectancy and credibility were not statistically different between intervention and attention control; however, the attention control was significantly more acceptable (p < .05). Intervention participant data indicated good treatment receipt and enactment with mean breath rates at each time point falling within the target range. Practice log data for both intervention and attention control indicated lower adherence of once-daily rather than twice-daily practice.
Despite strengths in fidelity monitoring, some challenges were identified that have implications for other similar intervention studies.
治疗保真度，也称为干预保真度，是测试治疗效果的一个重要组成部分。尽管在几个已发表的报告中提供了一些需要解决治疗保真度的策略的例子，但省略了可能影响疗效测试的数据。
本研究旨在描述护理临床试验中治疗保真度监测策略和数据。
一项三臂、随机、对照试验将干预（ paced respiration）与注意对照（快速、浅呼吸）进行比较，以治疗热潮红和其他更年期症状。收集来自工作人员和参与者的数据以评估治疗保真度。
治疗提供的工作人员措施表明对方案有很好的依从性。参与者对预期和可信度的评分在干预组和注意对照组之间没有统计学差异；然而，注意对照组明显更被接受（p<.05）。干预组参与者的数据表明治疗的接受和实施情况良好，每个时间点的平均呼吸频率都在目标范围内。干预组和注意对照组的练习日志数据都表明，每日一次的练习比每日两次的练习的依从性更低。
尽管在保真度监测方面有优势，但仍发现了一些挑战，这些挑战对其他类似的干预研究具有影响。
