Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000-2019: A review and meta-analytic approach.
Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000-2019: A review and meta-analytic approach.
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2000 - 2019年背痛的随机对照试验中的盲，假和治疗效果：综述和荟萃分析方法。
DOI：
10.1177/1740774520984870
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发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Park JJ
中科院分区：
文献类型：
--
作者：
Freed B;Williams B;Situ X;Landsman V;Kim J;Moroz A;Bang H;Park JJ
设盲旨在最大限度地减少参与者和研究人员所知道或相信的偏见。随机对照试验尽管是评价治疗效果的金标准，但通常不评估盲法的成功。我们调查了背痛试验中的盲法程度以及参与者猜测与治疗效果之间的关联。我们对PubMed/OvidMedline进行了回顾，2000-2019。合格标准是背痛试验，有关于治疗效果和参与者对治疗的猜测的数据。对于设盲，设盲指数用作过度正确猜测的机会校正指标（0表示随机猜测）。对于治疗效应，使用组内/组间效应量。对研究者的猜测/设盲或治疗方式进行探索性分析。纳入了40项试验（3，899名受试者）。活性治疗组和假治疗组的平均盲指数分别为0.26（95% CI：0.12，0.41）和0.01（-0.11，0.14），这意味着26%的活性治疗参与者认为他们接受了活性治疗，而只有1%的假治疗参与者认为他们接受了假治疗，超出了机会，即，随机猜测。接受活性治疗的信念越大，两组的组内效应量越大，理想盲法（即“随机猜测”和“一厢情愿”，表明两组都认为自己接受了活性治疗）显示的效应量越小，组间比较的效应量和汇总盲法指数的相关性为0.35（p=0.028）。我们观察到所有方式的一致大的假治疗效果，以及研究者（非）盲的更大相关性，0.53（p=0.046）。在背痛试验中，积极治疗的参与者更正确地猜测治疗身份，而那些假治疗的参与者则倾向于显示成功的盲法。参与者和研究者过度正确的猜测（可能反映较弱的盲法和/或明显的效应）显示出较大的效应量。在个体试验和荟萃分析中需要适当考虑盲法和假治疗对背痛的影响。
Blinding aims to minimize biases from what participants and investigators know or believe. Randomized controlled trials, despite being the gold standard to evaluate treatment effect, do not generally assess the success of blinding. We investigated the extent of blinding in back pain trials and the associations between participant guesses and treatment effects. We did a review with PubMed/OvidMedline, 2000–2019. Eligibility criteria were back pain trials with data available on treatment effect and participants’ guess of treatment. For blinding, Blinding Index was used as chance-corrected measure of excessive correct guess (0 for random guess). For treatment effects, within-/between-arm Effect Sizes were used. Analyses of investigators’ guess/blinding or by treatment modality were performed exploratorily. Forty trials (3,899 participants) were included. Active and sham treatment groups had mean blinding index of 0.26 (95% CI: 0.12, 0.41) and 0.01 (−0.11, 0.14), respectively, meaning 26% of participants in active treatment believed they received active treatment, whereas only 1% in sham believed they received sham treatment, beyond chance, i.e., random guess. A greater belief of receiving active treatment was associated with a larger within-arm effect size in both arms, and ideal blinding (namely, ‘random guess’, and ‘wishful thinking’ that signifies both groups believing they received active treatment) showed smaller effect sizes, with correlation of effect size and summary blinding indexes of 0.35 (p=0.028) for between-arm comparison. We observed uniformly large sham treatment effects for all modalities, and larger correlation for investigator’s (un)blinding, 0.53 (p=0.046). Participants in active treatments in back pain trials guessed treatment identity more correctly, while those in sham treatments tended to display successful blinding. Excessive correct guesses (that could reflect weaker blinding and/or noticeable effects) by participants and investigators demonstrated larger effect sizes. Blinding and sham treatment effects on back pain need due consideration in individual trials and meta-analyses.
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影响因子：
7.2
作者：
Boutron, I;Tubach, F;Ravaud, P
通讯作者：
Ravaud, P
影响因子：
168.9
作者：
Al-Lamee, Rasha;Thompson, David;Francis, Darrel P.
通讯作者：
Francis, Darrel P.
DOI：
10.1016/j.cct.2003.10.016
发表时间：
2004-04-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Bang, HJ;Ni, LY;Davis, CE
通讯作者：
Davis, CE
影响因子：
120.7
作者：
Begg, C;Cho, M;Stroup, DF
通讯作者：
Stroup, DF
影响因子：
--
作者：
Fergusson, D;Glass, KC;Shapiro, S
通讯作者：
Shapiro, S