Fang Ge, Wang Yaxin, Yan Zhenqian, Zhou Xiaowen, Fan Xingyu, Liao Xiaoqian, Hu Zhixi, Li Xiantao
College of Traditional Chinese Medicine, Hunan University of Chinese Medicine, Changsha 410208, China.
School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.
Evid Based Complement Alternat Med. 2021 Nov 16;2021:6291301. doi: 10.1155/2021/6291301. eCollection 2021.
Damp phlegm and blood stasis pattern (DPBSP) is the main pattern in coronary heart disease (CHD) patients. To quantify and standardize the diagnosis of DPBSP, questionnaires are usually administered. The CHD Damp Phlegm and Blood Stasis Pattern Questionnaire (CHD-DPBSPQ) is the standard metric for measuring CHD-DPBSP signs and symptoms in practice and clinical research. The CHD-DPBSPQ has moderate diagnostic efficiency, as evidenced by its receiver operating characteristic curves. Furthermore, and high reliability and validity have been shown in some studies but not in a multicenter clinical trial. Our purpose was to evaluate the test-retest reliability of a proprietary CHD-DPBSPQ.
The CHD-DPBSPQ uses a standard procedure for measuring symptoms. The (interrater) reliability and validity of this questionnaire have been previously studied. Here, we evaluated the test interval and weighted kappa value of items of test-retest (intrarater) reliability of the CHD-DPBSPQ. The test-retest reliability was evaluated by the intraclass correlation coefficient (ICC) for the total CHD-DPBSPQ score and the phlegm domain and blood stasis domain scores. Weighted kappa statistics were calculated for the individual CHD-DPBSPQ items.
Using the CHD-DPBSPQ, 79 patients with late-stage CHD who were participating in a multicenter clinical trial were assessed twice. The ICCs for the CHD-DPBSPQ score were as follows: 0.827 for the total CHD-DPBSPQ, 0.778 for the phlegm domain score, and 0.828 for the blood stasis domain score. The reliability was slightly better in patients whose test interval was ≤14 days. The weighted kappa values of individual items showed moderate consistency.
The CHD-DPBSPQ was found to have excellent test-retest reliability in this sample of patients.
痰湿血瘀证是冠心病（CHD）患者的主要证型。为了量化和规范痰湿血瘀证的诊断，通常会使用问卷。冠心病痰湿血瘀证问卷（CHD-DPBSPQ）是在实践和临床研究中测量冠心病痰湿血瘀证体征和症状的标准指标。CHD-DPBSPQ具有中等诊断效率，其受试者工作特征曲线证明了这一点。此外，一些研究表明其具有较高的信度和效度，但尚未在多中心临床试验中得到验证。我们的目的是评估一种专有的CHD-DPBSPQ的重测信度。
CHD-DPBSPQ采用标准程序测量症状。此前已对该问卷的（评分者间）信度和效度进行了研究。在此，我们评估了CHD-DPBSPQ重测（评分者内）信度项目的测试间隔和加权kappa值。通过组内相关系数（ICC）评估CHD-DPBSPQ总分、痰湿领域得分和血瘀领域得分的重测信度。计算CHD-DPBSPQ各个项目的加权kappa统计量。
使用CHD-DPBSPQ对79名参与多中心临床试验的晚期冠心病患者进行了两次评估。CHD-DPBSPQ总分的ICC如下：CHD-DPBSPQ总分0.827，痰湿领域得分0.778，血瘀领域得分0.828。测试间隔≤14天的患者信度略好。各个项目的加权kappa值显示出中等一致性。
在该患者样本中，CHD-DPBSPQ具有出色的重测信度。
