Agreement of treatment effects in decentralised trials versus traditional trials: meta-epidemiological study.

Methods

Meta-epidemiological study.

元流行病学研究。

data_source

PubMed database.

PubMed数据库。

eligibility_criteria

Trials identified as decentralised and included in meta-analyses alongside corresponding non-decentralised trials, restricted to drug interventions across all populations and outcome types.

识别出的去中心化试验与相应的非去中心化试验一同被纳入元分析中，仅限于所有人群和结果类型的药物干预。

Results

51 decentralised trials and 86 non-decentralised trials regarding 11 clinical questions were compared.

比较了涉及11个临床问题的51个分散式试验和86个非分散式试验。

Decentralised trials were larger than non-decentralised trials (median sample size 1175 v 236 participants) and more recent than non-decentralised trials (median year of publication 2012 v 2007).

分散式试验的规模大于非分散式试验（中位样本量为1175比236名参与者），并且比非分散式试验更近期（中位发表年份为2012年比2007年）。

The level of significance agreed between decentralised and non-decentralised trials in nine of 11 clinical questions (82%).

在11个临床问题中，有9个问题上分散式和非分散式试验之间的一致性水平达成一致（82%）。

No systematic difference between effects from decentralised and non-decentralised trials was found (summary ratio of odds ratio 1.01; 95% confidence interval0.93 to 1.09; heterogeneity I2=8.6%) with a median absolute deviation of 1.3-fold (absolute ratio of odds ratio 1.30; interquartile range 1.13-1.51).

在分散式和非分散式试验的效果之间没有发现系统性差异（比值比汇总比值为1.01；95%置信区间为0.93至1.09；异质性I2=8.6%），中位绝对偏差为1.3倍（比值比绝对比值为1.30；四分位数范围为1.13-1.51）。

Conclusions

Decentralised trials provide similar answers to clinical questions as traditional, non-decentralised randomised trials.

去中心化试验对临床问题的回答与传统非去中心化随机试验相似。

They do not systematically overestimate or underestimate effect estimates, but modest absolute deviations occur that may lead to different conclusions.

它们不会系统性地高估或低估效应估计值，但会出现适度的绝对偏差，这可能导致不同的结论。

Beyond direct benefits to participants, decentralisation opens new avenues for randomised trials, including the facilitation of larger trials.

除了对参与者直接益处外，去中心化为随机试验开辟了新的途径，包括促进更大规模试验的实施。