Duffy Sonia A, Cummins Sharon E, Fellows Jeffrey L, Harrington Kathleen F, Kirby Carrie, Rogers Erin, Scheuermann Taneisha S, Tindle Hilary A, Waltje Andrea H
Ohio State University, College of Nursing, Newton Hall, 1585 Neil Ave, Columbus, OH 43210 USA ; VA Center for Clinical Management Research, HSR&D Center of Excellence, 2215 Fuller Road, Ann Arbor, MI 48105 USA.
Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, MC0905, La Jolla, CA 92093 USA.
Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.
This paper describes fidelity monitoring (treatment differentiation, training, delivery, receipt and enactment) across the seven National Institutes of Health-supported Consortium of Hospitals Advancing Research on Tobacco (CHART) studies. The objectives of the study were to describe approaches to monitoring fidelity including treatment differentiation (lack of crossover), provider training, provider delivery of treatment, patient receipt of treatment, and patient enactment (behavior) and provide examples of application of these principles.
Conducted between 2010 and 2014 and collectively enrolling over 9500 inpatient cigarette smokers, the CHART studies tested different smoking cessation interventions (counseling, medications, and follow-up calls) shown to be efficacious in Cochrane Collaborative Reviews. The CHART studies compared their unique treatment arm(s) to usual care, used common core measures at baseline and 6-month follow-up, but varied in their approaches to monitoring the fidelity with which the interventions were implemented.
Treatment differentiation strategies included the use of a quasi-experimental design and monitoring of both the intervention and control group. Almost all of the studies had extensive training for personnel and used a checklist to monitor the intervention components, but the items on these checklists varied widely and were based on unique aspects of the interventions, US Public Health Service and Joint Commission smoking cessation standards, or counselor rapport. Delivery of medications ranged from 31 to 100 % across the studies, with higher levels from studies that gave away free medications and lower levels from studies that sought to obtain prescriptions for the patient in real world systems. Treatment delivery was highest among those studies that used automated (interactive voice response and website) systems, but this did not automatically translate into treatment receipt and enactment. Some studies measured treatment enactment in two ways (e.g., counselor or automated system report versus patient report) showing concurrence or discordance between the two measures.
While fidelity monitoring can be challenging especially in dissemination trials, the seven CHART studies used a variety of methods to enhance fidelity with consideration for feasibility and sustainability.
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本文描述了美国国立卫生研究院资助的七项烟草研究促进医院联盟（CHART）研究中的保真度监测（治疗区分、培训、实施、接受和践行）情况。该研究的目的是描述监测保真度的方法，包括治疗区分（无交叉）、提供者培训、提供者实施治疗、患者接受治疗以及患者践行（行为），并提供这些原则的应用示例。
CHART研究在2010年至2014年期间进行，共招募了9500多名住院吸烟患者，测试了不同的戒烟干预措施（咨询、药物治疗和随访电话），这些干预措施在Cochrane协作评价中已被证明是有效的。CHART研究将其独特的治疗组与常规护理进行比较，在基线和6个月随访时使用共同的核心指标，但在监测干预措施实施保真度的方法上有所不同。
治疗区分策略包括使用准实验设计以及对干预组和对照组进行监测。几乎所有研究都对人员进行了广泛培训，并使用清单来监测干预措施的组成部分，但这些清单上的项目差异很大，基于干预措施的独特方面、美国公共卫生服务和联合委员会的戒烟标准或咨询师的融洽关系。各研究中药物的发放率从31%到100%不等，免费发放药物的研究发放率较高，而在现实世界系统中试图为患者获取处方的研究发放率较低。在使用自动化（交互式语音应答和网站）系统的研究中，治疗实施率最高，但这并没有自动转化为治疗接受和践行。一些研究通过两种方式测量治疗践行情况（例如，咨询师或自动化系统报告与患者报告），显示两种测量结果之间的一致性或不一致性。
虽然保真度监测可能具有挑战性，尤其是在传播试验中，但七项CHART研究使用了多种方法来提高保真度，同时考虑了可行性和可持续性。
住院吸烟者烟草策略的传播。临床试验注册号：NCT01309217。住院吸烟者戒烟。临床试验注册号：NCT01289275。使用“温暖交接”将住院吸烟者出院后与烟草治疗联系起来：一项随机对照试验的研究方案。临床试验注册号：NCT01305928。从住院过渡到门诊的基于网络的戒烟干预。临床试验注册号：NCT01277250。城市医院患者戒烟干预措施的有效性。临床试验注册号：NCT01363245。住院吸烟者出院后干预措施的比较有效性。临床试验注册号：NCT01177176。两家大型医院中为住院吸烟者将床边和门诊戒烟服务联系起来的健康和经济影响。临床试验注册号：NCT01236079。
