[關(guān)鍵詞]
[摘要]
目的 建立兒童普通感冒的有效性評(píng)估工具加拿大急性呼吸道疾病和流感量表(CARIFS)的最小臨床重要差異(MCID)。方法 采用前瞻性、觀察性研究的方法,將納入的普通感冒患兒,記錄就診前和治療后1~3 d每日CARIFS量表和臨床療效總評(píng)量表(CGI-I)評(píng)分?;阱^定法分析,以CGI-I為校標(biāo),將受試者分為2組,報(bào)告為“極大改善”和“明顯改善”的病例為“有效”,其余為“無效”。根據(jù)CARIFS評(píng)分的變化,繪制受試者工作特征曲線(ROC),獲取“有效”的最佳截點(diǎn),其所對(duì)應(yīng)的CARIFS評(píng)分變化,即為MCID。然后通過Bootstrap法,進(jìn)行500次隨機(jī)抽樣,得到穩(wěn)健的MCID及其95%可信區(qū)間。結(jié)果 共87例患兒參與評(píng)估,獲得191份可用評(píng)估記錄,其中有效111份(58.12%),無效80份(41.88%)。CARIFS減分值和減分率與CGI-I的相關(guān)系數(shù)分別為-0.72和-0.78,提示兩者具有顯著性相關(guān)(P<0.001)。Bootstrap的分析結(jié)果顯示,CARIFS減分值的MCID為7(7~7),ROC面積0.87,敏感性70.45%,特異性88.7%,減分率的MCID為46.67%(41.18%~50%),ROC面積0.92,敏感性77.78%,特異性90.69%;CARIFS癥狀維度減分值的MCID為2(2~2)分,ROC面積0.86,敏感性92.79%,特異性63.75%,減分率的MCID為44.44%(44.44%~45.45%),ROC面積0.89,敏感性77.9%,特異性87.69%。上述結(jié)果中,僅有減分率的敏感性和特異性均大于75%。結(jié)論 基于保守的考慮,CARIFS總表和癥狀維度在兒童普通感冒中的MCID值,采用減分率表示,分別為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.
[中圖分類號(hào)]
R969.4
[基金項(xiàng)目]
“十三五”國家科技重大專項(xiàng)—重大新藥創(chuàng)制項(xiàng)目(2020ZX09201-008)