Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Audiologic Rehabilitation Consulting Services, Jensen Beach, FL, USA.
Trials. 2020 Jul 23;21(1):670. doi: 10.1186/s13063-020-04530-9.
Treatment fidelity, defined as ensuring that the recipient receives the intended intervention, is a critical component for accurate estimation of treatment efficacy. Ensuring fidelity and protocol adherence in behavioral trials requires careful planning during the design phase and implementation during the trial. The Tinnitus Retraining Therapy Trial (TRTT) randomized individuals with severe tinnitus to tinnitus retraining therapy (TRT, comprised of tinnitus-specific educational counseling (TC) and sound therapy (ST) using conventional sound generators (SGs)); Partial TRT (TC and placebo SGs); or standard of care (SOC), using a patient-centered care approach. Study audiologists administered both types of counseling in the TRTT, creating a challenge for managing protocol adherence.
We developed methods to enhance treatment fidelity including training, competency assessment, scripts, visual aids, and fidelity monitoring. Protocol monitors identified critical topics and content to be addressed for each type of counseling session, prepared corresponding scripts, and developed training aids and treatment-specific checklists covering those topics. Study audiologists' competency assessment required submission and review by the protocol monitors of an audiotape of one TC and one SOC counseling session. Treatment-specific aids included scripts, a 3-D model of the ear, handouts, and for TC, an illustrated flip-chart with talking points that followed the scripted content. During the trial, audiologists completed treatment-specific checklists during each counseling session, indicating topics covered/discussed and submitted audiotapes of counseling sessions. Protocol monitors reviewed audiotapes using corresponding treatment-specific checklists. Results for individual checklist items were tabulated and proportions calculated.
Twenty-five audiologists were certified for TC and/or SOC counseling and 24 completed at least one counseling session. Adherence to each of 33 critical items on the TC checklist as assessed by the protocol monitor ranged from 70 to 100% across 37 counseling sessions (median 97%), with no difference between adherence for TRT (median, 97%) and partial TRT (median, 100%). Adherence to each of 44 critical items on the SOC checklist across 30 SOC counseling sessions ranged from 42 to 100% (median, 87.5%).
The TRTT used multiple methods to address treatment fidelity. The close adherence to each treatment type was critical for evaluating the efficacy of the study interventions in this randomized trial.
clinicaltrials.gov NCT01177137 . Registered on 5 August 2010.
治疗保真度，定义为确保接受者接受预期的干预，是准确估计治疗效果的关键组成部分。在行为试验中确保保真度和遵守方案需要在设计阶段进行仔细规划，并在试验期间实施。耳鸣再训练疗法试验（TRTT）将严重耳鸣的个体随机分配到耳鸣再训练疗法（TRT，包括耳鸣特异性教育咨询（TC）和使用传统声音发生器（SGs）的声音疗法（ST））；部分 TRT（TC 和安慰剂 SGs）；或标准护理（SOC），采用以患者为中心的护理方法。研究听力学家在 T RTT 中同时进行了这两种咨询，这给管理方案遵守情况带来了挑战。
我们开发了增强治疗保真度的方法，包括培训、能力评估、脚本、视觉辅助工具和保真度监测。方案监测员确定了每种咨询类型需要讨论的关键主题和内容，准备了相应的脚本，并开发了涵盖这些主题的培训辅助工具和特定于治疗的检查表。研究听力学家的能力评估需要由方案监测员提交和审查一份 TC 和一份 SOC 咨询会议的录音带。特定于治疗的辅助工具包括脚本、耳朵的 3D 模型、讲义，以及对于 TC，还有一个带有说明点的带插图的翻转图表，这些说明点遵循脚本内容。在试验期间，听力学家在每次咨询会议期间完成特定于治疗的检查表，指出涵盖/讨论的主题，并提交咨询会议的录音带。方案监测员使用相应的特定于治疗的检查表审查录音带。对每个检查表项目的结果进行了制表和比例计算。
有 25 名听力学家获得了 TC 和/或 SOC 咨询的认证，并完成了至少一次咨询会议。方案监测员评估 TC 检查表上 33 个关键项目中的每一个项目的依从率在 37 次咨询会议中从 70%到 100%不等（中位数为 97%），TRT（中位数为 97%）和部分 TRT（中位数为 100%）之间没有差异。方案监测员在 30 次 SOC 咨询会议中对 SOC 检查表上的 44 个关键项目中的每一个项目的依从率从 42%到 100%不等（中位数为 87.5%）。
TRTT 使用了多种方法来解决治疗保真度问题。严格遵守每种治疗类型对于评估这项随机试验中研究干预措施的疗效至关重要。
clinicaltrials.gov NCT01177137。于 2010 年 8 月 5 日注册。
