Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures
Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures
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DOI：
10.1007/s11136-011-9886-7
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发表时间：
2011-11-01
影响因子：
3.5
通讯作者：
Bushnell, Donald M.
中科院分区：
文献类型：
--
作者：
Brod, Meryl;Christensen, Torsten;Bushnell, Donald M.
响应性被定义为仪器在变化发生时准确检测变化的能力，是患者报告结果 (PRO) 测量的重要心理测量属性，用于理解和解释研究结果。本研究检查了 2 种治疗相关影响测量 (TRIM) 的反应性：TRIM-糖尿病 (TRIM-D) 和 TRIM-糖尿病装置 (TRIM-DD)，并在随机对照试验 (RCT) 设计中确认了它们的测量模型。数据是在 1 型或 2 型受试者中对两个预填充笔进行的多中心、随机、开放标签（2 x 12 周）交叉研究中收集的 糖尿病，18 岁或以上。检查内部和外部反应能力。为了确认之前研究中确定的测量模型，对本特勒比较拟合指数（CFI）和RCT样本评分的内部一致性进行了检查和比较。根据先验标准，响应性测试得到了证实，患者随着时间的推移有显着改善，范围从2.7（心理健康）到11.1（治疗负担）（P <0.01）（效应大小范围从0.2到0.8）。确认了先前的测量模型因子结构（CFI范围为0.8至1.0），TRIM的内部一致性与发育结果相似。随着时间的推移，TRIM的总分以及所有领域得分均显着响应，因此得出TRIM-D和TRIM-DD可接受的内部和外部响应性。迄今为止，所有验证证据都支持在未来的临床试验中使用这两种措施。
Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design.The data were collected in a multi-center, randomized, open-label (2 x 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older. Internal and external responsiveness were examined. To confirm the measurement model identified in the previous study, the Bentler comparative fit index (CFI) and internal consistency for the RCT sample scores were examined and compared.Based on a priori criteria, tests of responsiveness were confirmed with patients having significant improvements over time ranging from 2.7 (Psychological Health) to 11.1 (Treatment Burden) (P < 0.01) (effect sizes ranging from 0.2 to 0.8). The previous measurement model factor structure was confirmed (CFI ranging from 0.8 to 1.0), and internal consistency of the TRIMs was similar to the developmental findings.The total score as well as all domain scores of the TRIMs was significantly responsive over time, thus acceptable internal and external responsiveness of TRIM-D and TRIM-DD are concluded. To date, all validation evidence supports the use of these two measures in future clinical trials.