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[1]馮天笑,肖想玉,秦曉寬,等.以手法為主要干預(yù)措施的隨機(jī)對(duì)照試驗(yàn)在樣本量估計(jì)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(yù)措施的隨機(jī)對(duì)照試驗(yàn)在樣本量估計(jì)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(xiàn)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(xué)院望京醫(yī)院,北京 100102; 2.首都醫(yī)科大學(xué)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(guān)鍵詞:
按摩(中醫(yī));  正骨手法;  舒筋整復(fù)手法;  推拿療法;  隨機(jī)對(duì)照試驗(yàn)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(yù)措施的隨機(jī)對(duì)照試驗(yàn)(randomized controlled trial,RCT)在樣本量估計(jì)方面存在的問題。方法:應(yīng)用計(jì)算機(jī)檢索PubMed、Embase和Cochrane Library中以手法為主要干預(yù)措施的RCT,檢索時(shí)限均為2017年1月至2024年6月。依據(jù)文獻(xiàn)檢索及篩選方案篩選出符合要求的文獻(xiàn)后,由2名經(jīng)過培訓(xùn)的研究人員獨(dú)立提取是否報(bào)告樣本量估計(jì)、假設(shè)檢驗(yàn)類型、Ⅰ類錯(cuò)誤概率α、把握度(1-β)、預(yù)期效應(yīng)量、單側(cè)或雙側(cè)檢驗(yàn)、最小臨床重要性差值(minimal clinically important difference,MCID)、脫落率、樣本量計(jì)算工具、主要結(jié)局指標(biāo)及多重檢驗(yàn)等信息,以頻數(shù)和百分比的形式進(jìn)行描述性分析。結(jié)果:共檢索到48 688篇文獻(xiàn),去除重復(fù)文獻(xiàn)后隨機(jī)抽取20%的文獻(xiàn),通過篩選最終納入274篇文獻(xiàn)。在納入的274項(xiàng)研究中,192項(xiàng)(70.07%)報(bào)告了樣本量估計(jì)。在報(bào)告了樣本量估計(jì)的192項(xiàng)研究中,16項(xiàng)(8.33%)報(bào)告了假設(shè)檢驗(yàn)類型,146項(xiàng)(76.04%)報(bào)告了Ⅰ類錯(cuò)誤概率α,164項(xiàng)(85.42%)報(bào)告了把握度(1-β),98項(xiàng)(51.04%)報(bào)告了預(yù)期效應(yīng)量,88項(xiàng)(45.83%)報(bào)告了單側(cè)或雙側(cè)檢驗(yàn),81項(xiàng)(42.19%)報(bào)告了MCID,156項(xiàng)(81.25%)報(bào)告了脫落率,167項(xiàng)(86.98%)報(bào)告了樣本量計(jì)算工具,131項(xiàng)(68.23%)報(bào)告了主要結(jié)局指標(biāo)。16項(xiàng)報(bào)告了假設(shè)檢驗(yàn)類型的研究均為優(yōu)效性試驗(yàn),其中9項(xiàng)采用單側(cè)檢驗(yàn),7項(xiàng)采取雙側(cè)檢驗(yàn); 37項(xiàng)報(bào)告了2個(gè)及以上主要結(jié)局指標(biāo)的研究中,8項(xiàng)(21.62%)調(diào)整了Ⅰ類錯(cuò)誤概率α; 23項(xiàng)報(bào)告了多個(gè)組別比較的研究中,1項(xiàng)(4.35%)調(diào)整了Ⅰ類錯(cuò)誤概率α。結(jié)論:以手法為主要干預(yù)措施的RCT在樣本量估計(jì)方面,存在未報(bào)告樣本量估計(jì)、樣本量估計(jì)參數(shù)缺失或不明、樣本量估計(jì)方法與假設(shè)檢驗(yàn)類型及主要結(jié)局指標(biāo)不對(duì)應(yīng)、多重檢驗(yàn)時(shí)未調(diào)整Ⅰ類錯(cuò)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:
基金項(xiàng)目:國家重點(diǎn)研發(fā)計(jì)劃項(xiàng)目(2021YFC1712800,2021YFC1712802); 北京市科技新星計(jì)劃交叉合作課題(20220484228); 中國中醫(yī)科學(xué)院望京醫(yī)院高水平中醫(yī)醫(yī)院建設(shè)項(xiàng)目——中醫(yī)藥臨床循證研究專項(xiàng)(WJYY-XZKT-2023-05)
通訊作者:魏戌 E-mail:[email protected]
更新日期/Last Update: 1900-01-01