混合1型实施性研究结局评估指标集的构建与验证:以糖尿病共享门诊优化试验为例

Construction and Validation of Outcome Indicators Set for Hybrid Type 1 Implementation Research:Based on the SMART Study

  • 摘要: 目的 以混合1型实施性研究“中国糖尿病共享门诊的优化试验研究”为例,介绍混合1型研究结局指标集的构建与验证方法。方法 基于多维性、可操作性等原则,选取RE-AIM(reach, effectiveness, adoption,implementation, maintenance)框架、实施结局框架(implementation outcomes framework, IOF)及格林模式(PRECEDEPROCEED) 3个常用结局评估框架,通过比较筛选形成结局评估指标条目池。经两轮专家咨询,采用条目水平内容效度指数(item-level content validity index, I-CVI)、变异系数(coeffiicient of variation, CV)和调整Kappa值评估内容效度,并结合专家定性意见及现场实施情况优化指标。结果 本研究融合了RE-AIM与IOF框架中用于预评估的3个维度,形成了含共享门诊(shared medical appointment, SMA)可接受性、适宜性、可行性、覆盖度、有效性、采纳、实施和维持8个维度、 14个二级指标和24个三级指标的初始条目池。两轮专家共识问卷回收率为100%,专家权威系数为0.90;I-CVI为0.75~1.00, CV为0~0.32, Kappa值为0.75~1.00,内容效度较好,专家意见一致性高。经两轮专家函询,删除1个二级指标和3个三级指标,新增1个二级指标,调整1个指标的归属维度。在预实验现场进行应用后,根据实施反馈增加2个三级指标,删除4个三级指标,调整1个指标的测量工具,最终形成包含8个维度、 14个二级指标和19个三级指标的实施结局评估指标集。结论 本研究构建的结局评估指标集效度与可操作性良好,其构建与验证过程可供其他研究者参考。不同实施性研究结局评估框架的适用场景不同,研究者应结合自身需求选用适宜框架或融合使用,以系统全面评估结局,提升研究的系统性与可比性。

     

    Abstract: Objective Using the hybrid type 1 implementation study "The Shared Medical Appointment for diabetes in China:an optimization trial (SMART) " as an example, this study introduces the methods of constructing and validating an outcome indicator set for hybrid type 1 studies. Methods Based on principles such as comprehensiveness and operability, we selected the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, the Implementation Outcomes Framework (IOF), and the PRECEDEPROCEED model. After comparison and screening, an outcome evaluation indicator item pool was formed. Two rounds of expert consultation were conducted, and the content validity was evaluated using the item-level content validity index (I-CVI), coefficient of variation (CV), and adjusted Kappa value, combined with experts􀆳 qualitative opinions and on-site implementation to optimize the indicators. Results This study integrated the RE-AIM framework and three pre-evaluation dimensions from the IOF, forming an initial item pool for shared medical appointments (SMA) that included 8 dimensions (acceptability, appropriateness, feasibility, reach, effectiveness, adoption, implementation, and maintenance), 14 secondary indicators, and 24 tertiary indicators. The response rate of the two rounds of expert consultation was 100%, with an expert authority coefficient of 0.90.The I-CVI ranged from 0.75 to 1.00, the CV from 0 to 0.32, and the adjusted Kappa from 0.75 to 1.00, indicating good content validity and high expert consensus. After two rounds of consultation, one secondary indicator and three tertiary indicators were deleted, one new secondary indicator was added, and the dimension attribution of one indicator was adjusted. Following pilot implementation and stakeholder feedback, two tertiary indicators were added, four were deleted, and the measurement tool of one indicator was adjusted. The finalized implementation outcome indicator set for the SMART study comprises 8 dimensions, 14 secondary indicators, and 19 tertiary indicators. Conclusions The outcome indicator set constructed in this study demonstrates good validity and operability, and the construction and validation process can serve as a reference for other researchers. Different implementation outcome frameworks have different applicable scenarios; researchers should select appropriate frameworks or integrate them according to their own needs to comprehensively evaluate outcomes and enhance the systematization and comparability of research.

     

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