Noble Adam J, Snape Darlene, Ridsdale Leone, Morgan Myfanwy, Nevitt Sarah J, Goodacre Steve, Marson Anthony
Department of Health Services Research, University of Liverpool, Liverpool, UK.
Department of Basic and Clinical Neuroscience, King's College London, London, UK.
Behav Neurol. 2019 Feb 3;2019:5048794. doi: 10.1155/2019/5048794. eCollection 2019.
To measure fidelity with which a group seizure first aid training intervention was delivered within a pilot randomized controlled trial underway in the UK for adults with epilepsy who visit emergency departments (ED) and informal carers. Estimates of its effects, including on ED use, will be produced by the trial. Whilst hardly ever reported for trials of epilepsy interventions-only one publication on this topic exists-this study provides the information on treatment fidelity necessary to allow the trial's estimates to be accurately interpreted. This rare worked example of how fidelity can be assessed could also provide guidance sought by neurology trialists on how to assess fidelity.
53 patients who had visited ED on ≥2 occasions in prior year were recruited for the trial; 26 were randomized to the intervention. 7 intervention courses were delivered for them by one facilitator. Using audio recordings, treatment "adherence" and "competence" were assessed. Adherence was assessed by a checklist of the items comprising the intervention. Using computer software, competence was measured by calculating facilitator speech during the intervention (didacticism). Interrater reliability was evaluated by two independent raters assessing each course using the measures and their ratings being compared.
The fidelity measures were found to be reliable. For the adherence instrument, raters agreed 96% of the time, PABAK-OS kappa 0.91. For didacticism, raters' scores had an intraclass coefficient of 0.96. In terms of treatment fidelity, not only were courses found to have been delivered with excellent adherence (88% of its items were fully delivered) but also as intended they were highly interactive, with the facilitator speaking for, on average, 55% of course time.
The fidelity measures used were reliable and showed that the intervention was delivered as attended. Therefore, any estimates of intervention effect will not be influenced by poor implementation fidelity.
在英国正在进行的一项针对就诊于急诊科的癫痫成人患者及其非正式护理人员的试点随机对照试验中，测量群体癫痫急救培训干预措施的实施保真度。该试验将得出包括对急诊科就诊情况影响在内的干预效果评估。虽然癫痫干预试验中很少有关于保真度的报告——关于这一主题仅有一篇出版物——但本研究提供了准确解释试验评估所需的治疗保真度信息。这个评估保真度的罕见实例还可为神经学试验人员提供关于如何评估保真度的指导。
招募了53名在前一年至少两次就诊于急诊科的患者参与该试验；26名被随机分配至干预组。由一名主持人针对他们开展了7次干预课程。通过音频记录评估治疗“依从性”和“胜任力”。依从性通过包含干预措施的项目清单进行评估。使用计算机软件，通过计算主持人在干预过程中的讲话时长（说教性）来测量胜任力。由两名独立评估人员使用这些测量方法对每门课程进行评估，并比较他们的评分，以此评估评估人员间的可靠性。
发现保真度测量方法可靠。对于依从性工具，评估人员在96%的时间内达成一致，PABAK - OS卡方值为0.91。对于说教性，评估人员的评分组内相关系数为0.96。在治疗保真度方面，不仅发现课程的实施具有出色的依从性（88%的项目得到了充分实施），而且正如预期的那样，它们具有高度的互动性，主持人平均讲话时间占课程时间的55%。
所使用的保真度测量方法可靠，表明干预措施按计划实施。因此，任何干预效果评估都不会受到实施保真度差的影响。
