[关键词]
[摘要]
目的 建立儿童普通感冒的有效性评估工具加拿大急性呼吸道疾病和流感量表(CARIFS)的最小临床重要差异(MCID)。方法 采用前瞻性、观察性研究的方法,将纳入的普通感冒患儿,记录就诊前和治疗后1~3 d每日CARIFS量表和临床疗效总评量表(CGI-I)评分。基于锚定法分析,以CGI-I为校标,将受试者分为2组,报告为“极大改善”和“明显改善”的病例为“有效”,其余为“无效”。根据CARIFS评分的变化,绘制受试者工作特征曲线(ROC),获取“有效”的最佳截点,其所对应的CARIFS评分变化,即为MCID。然后通过Bootstrap法,进行500次随机抽样,得到稳健的MCID及其95%可信区间。结果 共87例患儿参与评估,获得191份可用评估记录,其中有效111份(58.12%),无效80份(41.88%)。CARIFS减分值和减分率与CGI-I的相关系数分别为-0.72和-0.78,提示两者具有显著性相关(P<0.001)。Bootstrap的分析结果显示,CARIFS减分值的MCID为7(7~7),ROC面积0.87,敏感性70.45%,特异性88.7%,减分率的MCID为46.67%(41.18%~50%),ROC面积0.92,敏感性77.78%,特异性90.69%;CARIFS症状维度减分值的MCID为2(2~2)分,ROC面积0.86,敏感性92.79%,特异性63.75%,减分率的MCID为44.44%(44.44%~45.45%),ROC面积0.89,敏感性77.9%,特异性87.69%。上述结果中,仅有减分率的敏感性和特异性均大于75%。结论 基于保守的考虑,CARIFS总表和症状维度在儿童普通感冒中的MCID值,采用减分率表示,分别为50%、45%。
[Key word]
[Abstract]
Objective To establish the minimum clinically important difference (MCID) of the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) for evaluating the effectiveness of common cold in children. Methods T his study adopts the method of prospective observational study. Children with common cold were included and recorded their daily CARIFS and CGI-I scores before treatment and 3 consecutive days after treatment. Based on anchoring method analysis, the subjects were divided into two groups with CGI-I as calibration standard. The cases reported as "very much improvement" and "much improvement" were "effective", and the others were "ineffective". According to the changes of CARIFS score, the receiver operating characteristic (ROC) curve was drawn to obtain the best cut-off point of "effective", and the corresponding CARIFS score change was MCID. Then, using Bootstrap method to take 500 random samples and obtain 95% interval estimation of MCID. Results A total of 87 children participated in the evaluation, and 191 available evaluation records were obtained, including 111 (58.12%) times in the effective group and 80 (41.88%) times in the ineffective group. The correlation coefficients between the relative and absolute changes of CARIFS and CGI-I were -0.78 and -0.72, respectively, indicating that there was a significant correlation between CARIFS and CGI-I (P<0.001).Bootstrap analysis showed that the MCID of CARIFS decreased value was 7 (7-7), ROC area was 0.87, sensitivity was 70.45%, specificity was 88.7%; the MCID of reduction rate was 46.67% (41.18%-50%), ROC area was 0.92, sensitivity was 77.78%, specificity was 90.69%.;The MCID of the symptom dimension was 2 (2-2) points, ROC area was 0.86, sensitivity was 92.79%, specificity was 63.75%, and the MCID of reduction rate was 44.44% (44.44%-45.45%), ROC area was 0.89, sensitivity was 77.9%, specificity was 87.69%. Of these results, only the subtraction rate had a sensitivity and specificity greater than 75%. Conclusion Based on conservative considerations, the MCID of the CARIFS and its symptom dimensions in children with common cold were represented by the reduction rate that was 50% and 45%, respectively.
[中图分类号]
R969.4
[基金项目]
“十三五”国家科技重大专项—重大新药创制项目(2020ZX09201-008)