在前性观察性研究中,对刺激性肠综合征症状-便秘的日记进行心理测量评估
Lori McLeod1, Claire Ervin1, Sheri E Fehnel1
1RTI Health Solutions, Research Triangle Park, NC, USA.
刺激性肠综合征症状-便秘 (DIBSS-C) 的日记显示了在临床试验中评估症状的强烈心理测量特性. 这种经过验证的工具支持对便秘刺激性肠综合征 (IBS-C) 治疗方法的评估.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验方法论 临床试验方法论
- 心理测量 心理测量 心理测量
背景情况:
- 过敏性肠综合征与占主导地位的便秘 (IBS-C) 需要对临床试验进行可靠的结果测量.
- 刺激性肠综合征症状-便秘日记 (DIBSS-C) 是为了评估IBS-C症状而开发的.
- 验证DIBSS-C对于其在临床研究中的使用至关重要.
研究的目的:
- 为了评估DIBSS-C.的心理测量特性.
- 确定用于IBS-C临床试验的DIBSS-C的可靠性和有效性.
主要方法:
- 108名IBS-C成年人通过智能手机完成了17天的DIBSS-C.
- 收集的数据包括肠道排便,便形式,腹部症状,全球状态和经过验证的IBS尺度.
- 评估的心理测量属性包括项目级性能,内部一致性,测试-重新测试可靠性和构造有效性.
主要成果:
- 对于腹部症状,DIBSS-C表现出高的内部一致性 (克朗巴赫α=0.96-0.98) 和测试复试可靠性 (ICC=0.93).
- 对排便结果的试验-重复试验可靠性中等 (ICC = 0.54-0.66).
- 构造有效性得到了与其他IBS措施的相关性支持,并证明了已知组的有效性.
结论:
- DIBSS-C表现出强大的心理测量特性,包括可靠性和有效性.
- 这些发现支持FDA对DIBSS-C进行IBS-C临床试验的资格.
- 在IBS-C研究中,DIBSS-C是评估IBS-C研究中初级和二级终点的一个有价值的工具.
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