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[1]馮天笑,肖想玉,秦曉寬,等.以手法為主要干預措施的隨機對照試驗在樣本量估計方面的常見問題分析[J].中醫(yī)正骨,2024,36(10):39-43,51.
　FENG Tianxiao,XIAO Xiangyu,QIN Xiaokuan,et al.Common problems in sample size estimation of randomized controlled trials with manipulation as the primary intervention measure[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2024,36(10):39-43,51.
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以手法為主要干預措施的隨機對照試驗在樣本量估計方面的常見問題分析()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第36卷
期數(shù):
2024年10期
頁碼:
39-43,51
欄目:
文獻研究
出版日期:
2024-10-20

文章信息/Info

Title:
Common problems in sample size estimation of randomized controlled trials with manipulation as the primary intervention measure
作者:
馮天笑1; 肖想玉1; 秦曉寬1; 孫傳睿1; 王旭1; 卜寒梅1; 朱立國1; 胡晶2; 魏戌1
1.中國中醫(yī)科學院望京醫(yī)院,北京 100102; 2.首都醫(yī)科大學附屬北京中醫(yī)醫(yī)院,北京 100191
Author(s):
FENG Tianxiao1; XIAO Xiangyu1; QIN Xiaokuan1; SUN Chuanrui1; WANG Xu1; BU Hanmei1; ZHU Liguo1; HU Jing2; WEI Xu1
1.Wangjing Hospital of CACMS,Beijing 100102,China 2.Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University,Beijing 100191,China
關鍵詞:
按摩(中醫(yī));  正骨手法;  舒筋整復手法;  推拿療法;  隨機對照試驗專題;  樣本量
Keywords:
massage(TCM);  bone setting manipulation;  muscle tendon relaxing reduction;  Tui Na therapy;  randomized controlled trials as topic;  sample size
摘要:
目的:分析以手法為主要干預措施的隨機對照試驗(randomized controlled trial,RCT)在樣本量估計方面存在的問題。方法:應用計算機檢索PubMed、Embase和Cochrane Library中以手法為主要干預措施的RCT,檢索時限均為2017年1月至2024年6月。依據(jù)文獻檢索及篩選方案篩選出符合要求的文獻后,由2名經(jīng)過培訓的研究人員獨立提取是否報告樣本量估計、假設檢驗類型、Ⅰ類錯誤概率α、把握度(1-β)、預期效應量、單側或雙側檢驗、最小臨床重要性差值(minimal clinically important difference,MCID)、脫落率、樣本量計算工具、主要結局指標及多重檢驗等信息,以頻數(shù)和百分比的形式進行描述性分析。結果:共檢索到48 688篇文獻,去除重復文獻后隨機抽取20%的文獻,通過篩選最終納入274篇文獻。在納入的274項研究中,192項(70.07%)報告了樣本量估計。在報告了樣本量估計的192項研究中,16項(8.33%)報告了假設檢驗類型,146項(76.04%)報告了Ⅰ類錯誤概率α,164項(85.42%)報告了把握度(1-β),98項(51.04%)報告了預期效應量,88項(45.83%)報告了單側或雙側檢驗,81項(42.19%)報告了MCID,156項(81.25%)報告了脫落率,167項(86.98%)報告了樣本量計算工具,131項(68.23%)報告了主要結局指標。16項報告了假設檢驗類型的研究均為優(yōu)效性試驗,其中9項采用單側檢驗,7項采取雙側檢驗; 37項報告了2個及以上主要結局指標的研究中,8項(21.62%)調整了Ⅰ類錯誤概率α; 23項報告了多個組別比較的研究中,1項(4.35%)調整了Ⅰ類錯誤概率α。結論:以手法為主要干預措施的RCT在樣本量估計方面,存在未報告樣本量估計、樣本量估計參數(shù)缺失或不明、樣本量估計方法與假設檢驗類型及主要結局指標不對應、多重檢驗時未調整Ⅰ類錯誤概率α等問題。
Abstract:
Objective:To analyze the common problems in sample size estimation of randomized controlled trial(RCT)with manipulation as the primary intervention measure.Methods:All the RCT articles with manipulation as the primary intervention measure included from January 2017 to June 2024 were retrieved from the PubMed,Embase and Cochrane Library through computer.The eligible articles were screened according to the retrieval and screening scheme,and the information,including whether reporting sample size estimation,hypothesis test type,typeⅠerror probability α,power of test(1-β),expected effect size,one-sided or two-sided test,minimal clinically important difference(MCID),dropout rate,sample size calculation tool,primary outcome indicators,and multiple tests,was extracted independently by two trained researchers for a descriptive analysis in the form of frequency or percentage.Results:Forty-eight thousand six hundred and eighty-eight RCT articles were searched out,after removing the duplicate articles,20% of the remained ones were randomly selected for further screening,and 274 RCTs were included in the final analysis,among which 192 ones(70.07%)reported the sample size estimation.Furthermore,among the 192 RCTs,16 ones(8.33%),146 ones(76.04%),164 ones(85.42%),98 ones(51.04%),88 ones(45.83%),81 ones(42.19%),156 ones(81.25%),167 ones(86.98%),and 131 ones(68.23%)reported the hypothesis test type,typeⅠerror probability α,power of test(1-β),expected effect size,one-sided or two-sided test,MCID,dropout rate,sample size calculation tool,and primary outcome indicators,respectively.In addition,16 RCTs that reported the type of hypothesis test were all superiority trials,with 9 ones using the one-sided test and 7 ones employing the two-sided test.Among the 37 RCTs that reported 2 or more primary outcome indicators,8 ones(21.62%)mentioned the adjustment of typeⅠerror probability α.Among the 23 RCTs that reported multiple comparisons,one RCT(4.35%)referred to the adjustment of typeⅠerror probability α.Conclusion:Problems,such as failure to report sample size estimation,missing or unclear sample size estimation parameters,mismatch of sample size estimation method with hypothesis test types and primary outcome indicators,and failure to adjust typeⅠerror probability α in multiple test,exist in the sample size estimation of RCTs with manipulation as the primary intervention measure.

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備注/Memo

備注/Memo:
基金項目:國家重點研發(fā)計劃項目(2021YFC1712800,2021YFC1712802); 北京市科技新星計劃交叉合作課題(20220484228); 中國中醫(yī)科學院望京醫(yī)院高水平中醫(yī)醫(yī)院建設項目——中醫(yī)藥臨床循證研究專項(WJYY-XZKT-2023-05)
通訊作者:魏戌 E-mail:[email protected]
更新日期/Last Update: 1900-01-01