Abstract：
PURPOSE:It is uncertain whether, in critical care medicine, non-blinded trials are associated with a bias toward a different effect size. The aim of our study was to assess if conducting non-blinded/open label studies leads to greater effect size than blinded studies, and to provide an estimate of the weight of this difference. MATERIALS AND METHODS:We systematically searched all papers published in peer-reviewed journals between January 2000 and December 2015, dealing with non surgical interventions in critically ill adults and reporting a statistically significant difference in mortality. We assessed the number needed to treat (NNT) of each trial to estimate the treatment effect size and we divided studies into non-blinded, single-blinded and double-blinded. We searched for correlation between the treatment effect size and blinding, and adjusted for the other trial variables. RESULTS:We identified 119 critically ill randomized controlled trials. Of these, 69 studies were non-blinded and 50 were blinded. The median NNT in non-blinded studies was 5 [IQR 4-7] while it was 7 [IQR 5-7] in the blinded studies (p < .001). CONCLUSIONS:The NNT for blinded studies is 40% higher than for unblinded studies. This should be taken into account when planning and interpreting the findings of non-blinded studies performed in critically ill settings.
journal_name
J Crit Carejournal_title
Journal of critical careauthors
Baiardo Redaelli M,Belletti A,Monti G,Lembo R,Ortalda A,Landoni G,Bellomo Rdoi
10.1016/j.jcrc.2018.09.031subject
Has Abstractpub_date
2018-12-01 00:00:00pages
414-417eissn
0883-9441issn
1557-8615pii
S0883-9441(18)31128-6journal_volume
48pub_type
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pub_type： 杂志文章,随机对照试验
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pub_type： 杂志文章,评审
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更新日期：2009-03-01 00:00:00
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pub_type： 杂志文章
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更新日期：2009-09-01 00:00:00
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journal_title：Journal of critical care
pub_type： 杂志文章
doi：10.1016/j.jcrc.2012.02.002
更新日期：2012-10-01 00:00:00
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更新日期：2014-12-01 00:00:00
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更新日期：2000-09-01 00:00:00
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doi：10.1016/j.jcrc.2015.06.013
更新日期：2015-10-01 00:00:00
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pub_type： 杂志文章,多中心研究
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更新日期：2015-06-01 00:00:00
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更新日期：2012-08-01 00:00:00
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更新日期：2013-08-01 00:00:00
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更新日期：2019-10-01 00:00:00
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更新日期：2014-02-01 00:00:00
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更新日期：2018-04-01 00:00:00
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pub_type： 杂志文章,随机对照试验
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更新日期：2018-08-01 00:00:00
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更新日期：2012-12-01 00:00:00
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journal_title：Journal of critical care
pub_type： 杂志文章
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更新日期：2006-06-01 00:00:00
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journal_title：Journal of critical care
pub_type： 杂志文章
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更新日期：2016-12-01 00:00:00
