Sweeney-Magee Molly, Kale Dimitra, Galton Simon, Hamill Andrea, Gilbert Hazel
Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.
Smokefree Camden (Public Health), NHS Camden, London, UK.
Implement Sci. 2016 Dec 28;11(1):166. doi: 10.1186/s13012-016-0498-z.
Implementation fidelity refers to the extent to which a proposed intervention is enacted as designed and is necessary to determine how much the intervention in question is the primary mechanism in any changes observed. Start2quit was a randomised controlled trial that aimed to improve attendance at the English Stop Smoking Service (SSS). The complex intervention combining computer-tailored personal risk letters and no-commitment ("taster") sessions aimed at encouraging attendance at the SSS doubled attendance at the SSS and significantly increased abstinence rates, although attendance and abstinence varied between participating SSSs. Assessment of the fidelity of the delivery of the taster sessions to the protocol was embedded into the trial and is the focus of this study.
Eighteen SSSs participated in the study. Taster sessions were delivered by SSS advisors in the area. Of the 131 sessions delivered, 93 (71 %) were recorded and 41 (31.3 %) were selected for transcription and analysis. The taster session protocol contained 73 specified behaviours, which were independently classified into component behaviour change techniques (BCTs) using an established taxonomy for smoking cessation. All transcripts were coded by two authors with 25 % additionally coded by a third. The fidelity of each taster session was expressed as the percentage of overall protocol-specified behaviours that were delivered. Adherence to each BCT was measured as the number of behaviours applied by the advisors within each BCT divided by the total number classified within each.
Adherence of protocol-specified behaviours was relatively high (median 71.23 %), though there was considerable variation (28.76 to 95.89 %) in individual sessions. Median fidelity to specific BCTs across sessions also varied from 50 to 100 %. Shorter sessions, sessions run jointly by two advisors, by female advisors, or by advisors aged 45 to 54 were associated with higher levels of adherence. There was no association between adherence and subsequent attendance at the SSS.
These results suggest that the delivery of the intervention of this study is not likely to have been impacted by issues of fidelity. As such, we can have greater confidence that variability in the main outcome is not due to variability in SSS advisor adherence to the protocol of the taster sessions.
Current Controlled Trials ISRCTN76561916.
实施保真度是指所提议的干预措施按设计执行的程度,对于确定所讨论的干预措施在观察到的任何变化中是主要机制的程度而言至关重要。Start2quit是一项随机对照试验,旨在提高参加英格兰戒烟服务(SSS)的人数。该复杂干预措施结合了计算机定制的个人风险信函和无承诺(“体验”)课程,旨在鼓励人们参加SSS,使SSS的参与人数增加了一倍,并显著提高了戒烟率,尽管参与的SSS之间的参与率和戒烟率有所不同。对体验课程按照方案进行交付的保真度评估已纳入试验,并且是本研究的重点。
18个SSS参与了该研究。体验课程由该地区的SSS顾问进行授课。在授课的131节课程中,93节(71%)进行了记录,41节(31.3%)被选出来进行转录和分析。体验课程方案包含73种特定行为,使用既定的戒烟分类法将其独立分类为组成行为改变技术(BCTs)。所有转录本由两位作者进行编码,第三位作者额外编码25%。每个体验课程的保真度表示为所交付的总体方案规定行为的百分比。对每个BCT的依从性通过顾问在每个BCT内应用的行为数量除以每个BCT内分类的总数来衡量。
方案规定行为的依从性相对较高(中位数为71.23%),尽管各个课程之间存在相当大的差异(28.76%至95.89%)。各课程对特定BCT的中位数保真度也在50%至100%之间变化。较短的课程、由两位顾问联合授课的课程、由女性顾问授课的课程或由45至54岁顾问授课的课程,其依从性水平较高。依从性与随后参加SSS之间没有关联。
这些结果表明,本研究干预措施的实施不太可能受到保真度问题的影响。因此,我们可以更有信心认为主要结果的变异性不是由于SSS顾问对体验课程方案的依从性差异所致。
当前受控试验ISRCTN76561916。