Tailoring a treatment fidelity framework for an intensive care unit clinical trial.
Tailoring a treatment fidelity framework for an intensive care unit clinical trial.
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DOI：
10.1097/nnr.0b013e31822cc0cf
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发表时间：
2011-09
期刊：
影响因子：
2.5
通讯作者：
Savik K
中科院分区：
文献类型：
--
作者：
Chlan LL;Guttormson JL;Savik K
治疗保真度是指用于监测和提高行为干预的可靠性和有效性的方法学策略和实践。治疗保真度监测提高了内部和外部有效性，是研究复制和推广所必需的。在一项以重症监护病房为基础的临床试验中，对机械通气患者进行焦虑自我管理测试音乐的实施、监测和治疗保真度的影响。标准的制定是基于治疗保真度工作组的五部分治疗保真度框架。描述性统计用于评估关键TF标准的依从率和不符合标准的原因。使用描述性和非参数统计来评估TF对参与者使用指定干预措施的影响。治疗保真度框架很容易适应研究干预措施。在监测的最初实施阶段之后，关键标准的遵守率保持在80%的目标水平。大多数依从性障碍影响了研究护士与参与者互动并鼓励使用干预措施的机会。在开始治疗忠实度后，与指定条件相关的设备的使用有增加的趋势；然而，这种差异在统计学上并不显著。治疗保真度监测是一个反复的过程，需要持续保持警惕。在ICU充满活力和挑战的研究环境中，为了提高临床试验的可靠性、有效性和普遍性，需要识别障碍并实施方法来增强协议的依从性。
Treatment fidelity refers to methodological strategies and practices used to monitor and enhance the reliability and validity of behavioral interventions. Treatment fidelity monitoring enhances internal and external validity and is needed for study replication and generalizability. To describe the implementation, monitoring, and impact of treatment fidelity in an intensive care unit-based clinical trial testing music for anxiety self-management with mechanically ventilated patients. Development of the criteria was based on the five-component Treatment Fidelity Framework from the Treatment Fidelity Workgroup. Descriptive statistics were used to evaluate adherence rates to the key TF criteria and the reasons criteria were unmet. Descriptive and nonparametric statistics were used to evaluate the impact of TF on participants’ use of the assigned intervention. The Treatment Fidelity Framework was adapted easily to fit the study interventions. After the initial implementation phase of monitoring, adherence to key criteria was maintained at the targeted level of 80%. The majority of barriers to adherence affected the research nurses’ opportunity to interact with the participant and encourage use of the intervention. There was a trend toward increased use of equipment associated with the assigned condition after initiation of treatment fidelity; however this difference was not statistically significant. Treatment fidelity monitoring is an iterative process that requires ongoing vigilance. Identification of barriers and the implementation of methods to enhance protocol adherence are needed in order to enhance reliability, validity, and generalizability of clinical trials in the dynamic and challenging research environment of the ICU.