整合语用学和实施科学随机临床试验方法：实用解释连续体指标综合-2（PRECIS-2）分析。
Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis.
机构信息
Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA.
Department of Children, Youth, and Families, California School of Social Work, University of Southern, Los Angeles, CA, USA.
出版信息
Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.
BACKGROUND
Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact.
METHODS
The investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit.
RESULTS
The ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14-3.43, SD range = 0.49-0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings.
CONCLUSIONS
The investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development.
TRIAL REGISTRATION
DO-SBIS ClinicalTrials.gov NCT00607620. registered on January 29, 2008. TSOS ClinicalTrials.gov NCT02655354, registered on July 27, 2015.
背景
在过去的二十年中，实用主义和实施科学临床试验研究方法取得了实质性的进展。实用主义和实施研究自然有重叠的领域，特别是在利用临床试验数据来推动医疗保健系统政策变革方面。很少有研究探讨实用主义和实施科学随机试验方法的发展，同时考虑到政策影响。
方法
该研究使用了实用性解释连续性指标摘要-2（PRECIS-2）和 PRECIS-2-Provider 策略（PRECIS-2-PS）工具来评估两个针对患者水平效果结局、提供者水平实践变化和医疗保健系统政策的多地点随机临床试验的设计。七名评分者接受了 PRECIS-2 培训，并在两个试验的编码中应用了这些工具。为两个试验都生成了描述性统计数据，并构建了 PRECIS-2 车轮图。采用组内相关系数（ICC）和 Kappa 统计量评估了组内评分者之间的一致性。应用快速评估程序知情临床民族志（RAPICE）定性方法来理解来自 PRECIS-2 评分的综合主题以及结束时的政策峰会。
结果
在患者和提供者关注的 PRECIS-2 领域的综合评分中，ICC 值范围为 0.77 到 0.87，Kappa 值范围为 0.25 到 0.37，这表明两个试验的评分者之间的总体一致性为良好到中等。所有四个 PRECIS-2 车轮的实用性评分均高于解释性评分，综合平均和中位数评分均≥4。在两个试验中，主要的意向治疗分析领域始终被评为最实用（平均值=5.0，标准差=0），而随访/数据收集领域被评为最具解释性（平均值范围=3.14-3.43，标准差范围=0.49-0.69）。RAPICE 实地记录确定了与潜在 PRECIS-2 培训改进相关的主题，以及与利用试验数据为美国创伤护理系统实践变革提供信息相关的政策主题；这些政策主题无法通过 PRECIS-2 评分捕捉到。
结论
该研究记录表明，PRECIS-2 和 PRECIS-2-PS 可以同时用于对具有患者和提供者水平目标的临床试验进行可行且可靠的描述。通过使用 PRECIS-2 和 PRECIS-2-PS 等共同指标，可以进一步推进实用主义和实施科学临床试验研究方法。未来的研究可以集中在临床试验政策研究方法的发展上。
试验注册
DO-SBIS ClinicalTrials.gov NCT00607620. 于 2008 年 1 月 29 日注册。TSOS ClinicalTrials.gov NCT02655354. 于 2015 年 7 月 27 日注册。
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