Study Design Rigor in Animal-Experimental Research Published in Anesthesia Journals.
Study Design Rigor in Animal-Experimental Research Published in Anesthesia Journals.
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DOI：
10.1213/ane.0000000000001907
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发表时间：
2018-01
影响因子：
5.7
通讯作者：
Bartels K
中科院分区：
文献类型：
--
作者：
Hoerauf JM;Moss AF;Fernandez-Bustamante A;Bartels K
Lack of reproducibility of preclinical studies has been identified as an impediment for translation of basic mechanistic research into effective clinical therapies. Indeed, the National Institutes of Health have revised their grant application process to require more rigorous study design, including sample size calculations, blinding procedures, and randomization steps. We hypothesized that the reporting of such metrics of study design rigor has increased over time for animal-experimental research published in anesthesia journals. PubMed was searched for animal-experimental studies published in 2005, 2010, and 2015 in primarily English-language anesthesia journals. A total of 1466 publications were graded on the performance of sample size estimation, randomization, and blinding. Cochran-Armitage test was used to assess linear trends over time for the primary outcome of whether or not a metric was reported. Inter-rater agreement for each of the three metrics (power, randomization, and blinding) was assessed using the weighted kappa coefficient in a 10% random sample of articles re-rated by a second investigator blinded to the ratings of the first investigator. A total of 1466 manuscripts were analyzed. Reporting for all three metrics of experimental design rigor increased over time (2005–2010–2015): For power analysis from 5% (27/516), to 12% (59/485), and to 17% (77/465), for randomization from 41% (213/516), to 50% (243/485), and to 54% (253/465), and for blinding from 26% (135/516), to 38% (186/485), and to 47% (217/465). The weighted kappa coefficients and 98.3%CI indicate almost perfect agreement between the two raters beyond that which occurs by chance alone [Power: 0.93 (0.85,1.0), Randomization: 0.91 (0.85,0.98), Blinding: 0.90 (0.84,0.96)]. Our hypothesis that reported metrics of rigor in animal-experimental studies in anesthesia journals have increased over the past decade was confirmed. More consistent reporting - or explicit justification for absence - of sample size calculations, blinding techniques, and randomization procedures could better enable readers to evaluate potential sources of bias in animal-experimental research manuscripts. Future studies should assess if such steps lead to improved translation of animal-experimental anesthesia research to successful clinical trials.
