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Abstract：
BACKGROUND: Fidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg\'s popular Treatment Fidelity model, this paper aims to increase understanding of how to practically and comprehensively assess fidelity in complex, group-level, interventions.
UNASSIGNED: Drawing on our experience using a mixed methods approach to assess fidelity in the INFORM study (Improving Nursing home care through Feedback On perfoRMance data-INFORM), we report on challenges and adaptations experienced with our fidelity assessment approach and lessons learned. Six fidelity assessment challenges were identified: (1) the need to develop succinct tools to measure fidelity given tools tend to be intervention specific, (2) determining which components of fidelity (delivery, receipt, enactment) to emphasize, (3) unit of analysis considerations in group-level interventions, (4) missing data problems, (5) how to respond to and treat fidelity \'failures\' and \'deviations\' and lack of an overall fidelity assessment scheme, and (6) ensuring fidelity assessment doesn\'t threaten internal validity.
UNASSIGNED: Six guidelines, primarily applicable to group-level studies of complex interventions, are described to help address conceptual, methodological, and practical challenges with fidelity assessment in pragmatic trials. The current study offers guidance to researchers regarding key practical, methodological, and conceptual challenges associated with assessing fidelity in pragmatic trials. Greater attention to fidelity assessment and publication of fidelity results through detailed studies such as this one is critical for improving the quality of fidelity studies and, ultimately, the utility of published trials.
BACKGROUND: ClinicalTrials.gov NCT02695836. Registered on February 24, 2016.
UNASSIGNED: Drawing on our experience using a mixed methods approach to assess fidelity in the INFORM study (Improving Nursing home care through Feedback On perfoRMance data-INFORM), we report on challenges and adaptations experienced with our fidelity assessment approach and lessons learned. Six fidelity assessment challenges were identified: (1) the need to develop succinct tools to measure fidelity given tools tend to be intervention specific, (2) determining which components of fidelity (delivery, receipt, enactment) to emphasize, (3) unit of analysis considerations in group-level interventions, (4) missing data problems, (5) how to respond to and treat fidelity \'failures\' and \'deviations\' and lack of an overall fidelity assessment scheme, and (6) ensuring fidelity assessment doesn\'t threaten internal validity.
UNASSIGNED: Six guidelines, primarily applicable to group-level studies of complex interventions, are described to help address conceptual, methodological, and practical challenges with fidelity assessment in pragmatic trials. The current study offers guidance to researchers regarding key practical, methodological, and conceptual challenges associated with assessing fidelity in pragmatic trials. Greater attention to fidelity assessment and publication of fidelity results through detailed studies such as this one is critical for improving the quality of fidelity studies and, ultimately, the utility of published trials.
BACKGROUND: ClinicalTrials.gov NCT02695836. Registered on February 24, 2016.
摘要：
背景：复杂行为干预措施中的保真度研究不足，很少有全面或详细的保真度研究报告监测保真度的具体程序。使用Bellg流行的治疗保真度模型，本文旨在增加对如何在复杂的环境中实际和全面评估保真度的理解，组级,干预措施。
■借鉴我们在INFORM研究中使用混合方法方法评估保真度的经验（通过对perfoRMance数据的反馈-INFORM改善疗养院护理），我们报告了我们在保真度评估方法中遇到的挑战和适应措施以及吸取的经验教训。确定了六个保真度评估挑战：（1）需要开发简洁的工具来测量保真度，因为工具往往是干预特定的，(2)确定保真度的哪些组成部分(交付，收据,颁布)强调，(3)小组层面干预中的分析考虑因素单元，(4)数据缺失问题,（5）如何应对和处理保真度\'失败\'和\'偏差\'和缺乏整体保真度评估方案，(6)确保保真度评估不威胁内部有效性。
■六个准则，主要适用于复杂干预措施的小组级研究，被描述为帮助解决概念上的问题，方法论,以及务实试验中保真度评估的实际挑战。当前的研究为研究人员提供了关于关键实践的指导，方法论,以及与在语用试验中评估忠实度相关的概念挑战。更多的关注保真度评估和保真度结果的公布，通过详细的研究，如这一个是提高保真度研究的质量至关重要的，最终,已发表试验的实用性。
背景：ClinicalTrials.govNCT02695836。2016年2月24日注册
■借鉴我们在INFORM研究中使用混合方法方法评估保真度的经验（通过对perfoRMance数据的反馈-INFORM改善疗养院护理），我们报告了我们在保真度评估方法中遇到的挑战和适应措施以及吸取的经验教训。确定了六个保真度评估挑战：（1）需要开发简洁的工具来测量保真度，因为工具往往是干预特定的，(2)确定保真度的哪些组成部分(交付，收据,颁布)强调，(3)小组层面干预中的分析考虑因素单元，(4)数据缺失问题,（5）如何应对和处理保真度\'失败\'和\'偏差\'和缺乏整体保真度评估方案，(6)确保保真度评估不威胁内部有效性。
■六个准则，主要适用于复杂干预措施的小组级研究，被描述为帮助解决概念上的问题，方法论,以及务实试验中保真度评估的实际挑战。当前的研究为研究人员提供了关于关键实践的指导，方法论,以及与在语用试验中评估忠实度相关的概念挑战。更多的关注保真度评估和保真度结果的公布，通过详细的研究，如这一个是提高保真度研究的质量至关重要的，最终,已发表试验的实用性。
背景：ClinicalTrials.govNCT02695836。2016年2月24日注册
