Department of Pharmacology, Heritage Institute of Medical Sciences, Varanasi, Uttar Pradesh, India.
Indian J Pharmacol. 2019 Jan-Feb;51(1):11-16. doi: 10.4103/ijp.IJP_536_18.
Good reporting of experimental research is a vital part of research process. Although the reporting guidelines such as Animal research: Reporting experiments (ARRIVE) require the authors to stick to a standard format, they do not guarantee study reports' validity. For assessing the study reports validity, critical appraisal tools are required.
The evaluation of the methodological quality of animal studies of Indian Journal of Pharmacology (IJP) published between 2011 and 2017 through critical appraisal was the primary objective. The secondary objective was to evaluate the adherence of selected studies to the ARRIVE guidelines.
All animal studies published as full-text articles in IJP from January 2011 to December 2017 and satisfying the inclusion norms were included. A checklist based on the underlying principles of ARRIVE statement was applied to animal research (AR) published in IJP. For critical appraisal of reports, risk-of-bias domains were also applied on studies from AR.
One hundred and sixty-one studies satisfied the inclusion criteria. Seventy-three articles (45.34%, 95% confidence interval [CI]: 0.37-0.53) discussed about randomization procedure. Eighteen articles (11.18%, 95% CI: 0.07-0.16) gave details about blinding when assessing results. None of the studies provided details of sample size calculation. Eight articles (4.97%, 95% CI: 0.02-0.09) commented on the study limitations.
It was found that adherence to only some criteria of ARRIVE guidelines was subpar. There is a need for optimal reporting of random distribution of animals to experimental groups, concealment of allocation, blinded outcome evaluation, computation of sample size, and attrition of animals for improving the validity of AR.
良好的实验研究报告是研究过程的重要组成部分。尽管报告指南(如动物研究:报告实验(ARRIVE))要求作者坚持标准格式,但它们并不能保证研究报告的有效性。为了评估研究报告的有效性,需要使用批判性评价工具。
通过批判性评价,评估 2011 年至 2017 年期间在《印度药理学杂志》(IJP)上发表的动物研究的方法学质量。次要目标是评估选定研究对 ARRIVE 指南的遵守情况。
纳入 2011 年 1 月至 2017 年 12 月期间以全文形式发表在 IJP 上且符合纳入标准的所有动物研究。使用基于 ARRIVE 声明基本原则的检查表对发表在 IJP 上的动物研究(AR)进行评估。对于报告的批判性评价,也在 AR 中应用了风险偏倚领域。
有 161 项研究符合纳入标准。73 篇文章(45.34%,95%置信区间[CI]:0.37-0.53)讨论了随机分组程序。18 篇文章(11.18%,95%CI:0.07-0.16)在评估结果时详细说明了盲法。没有研究提供样本量计算的详细信息。8 篇文章(4.97%,95%CI:0.02-0.09)评论了研究的局限性。
发现仅部分符合 ARRIVE 指南的标准。需要优化报告动物随机分配到实验组、分配隐藏、盲法结果评估、计算样本量和动物失访,以提高 AR 的有效性。