Chlan Linda L, Ridgeway Jennifer L, Tofthagen Cindy S, Hamann Brianne R, Mele Kendra E, Dozois Donna, Ness Sheryl M, Peterson Laura J
Division of Nursing Research, Department of Nursing, Mayo Clinic 200 First St. SW, Rochester, MN, 55905, USA.
Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, USA.
Contemp Clin Trials Commun. 2021 Nov 19;24:100868. doi: 10.1016/j.conctc.2021.100868. eCollection 2021 Dec.
Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity.
保真度监测是指临床试验干预措施按照研究方案的预期实施的程度。现有保真度监测计划支持的研究方案的一致实施有助于研究结果的严谨性和有效性。保真度监测计划应全面且实用，以适应在具有异质患者群体的动态环境中开展研究（尤其是务实的临床试验）的实际情况。本文的目的是描述：（1）干预保真度监测方案的迭代开发与实施；（2）保真度监测计划的试点测试；（3）识别干预人员的培训缺陷；（4）通过电子健康记录患者门户网站和电话提供癌症症状管理干预措施的方案严谨性提升机会，该干预措施是一项复杂、多组件务实临床试验的一部分，旨在发现培训缺陷并加强方案完整性。该干预措施聚焦于肿瘤内科患者报告的突出症状，包括睡眠障碍、疼痛、焦虑、抑郁、精力不足（疲劳）和身体功能。在这项务实试验中，干预人员的角色是注册护士症状护理经理（RN SCM）。一个包含清单审核的三部分保真度监测计划：第一部分是RN SCM在研究组件、临床培训组件和方案模拟培训中的角色培训活动；第二部分是RN SCM对通过电话提供的干预核心组件的依从性；第三部分是对核心干预组件依从性的维持。目标是对三个清单中的每个组件的依从率≥80%。对保真度监测计划进行了初步试点测试，以评估清单以及RN SCM对核心方案组件的依从性。在试点阶段识别出了RN SCM的技能和培训缺陷，以及改善方案完整性的机会。总体而言，大约50%的经审核的RN SCM电话对核心组件的保真度≥80%。在行动计划方面，仍持续需要对RN SCM进行培训和技能培养。本文介绍的内容旨在开始填补在务实临床试验中测试并远程提供的复杂干预措施的保真度监测计划的空白，以加强方案完整性。
