Patil Saurabh R, Bhide Shruti Shripad
Department of Pharmacology and Therapeutics, Seth G S Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Perspect Clin Res. 2023 Jan-Mar;14(1):16-19. doi: 10.4103/picr.PICR_19_21. Epub 2021 Dec 1.
Number of trials in India shows an increasing trend. As these trials will shape clinical practice, their quality is of utmost importance. Among many tools to assess the quality of randomized control trials (RCTs), risk of bias (RoB) is most robust.
To understand the quality of trials being carried out in India in terms of RoB.
We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.
We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.
Descriptive statistics were used.
158 trials published in seven journals were evaluated in six different domains. Overall evaluation for 97% (153) trials was "high risk," while 3% (5) were in "some concerns" category, with no trials categorized as "low risk. 74% articles showed a high risk of bias in the domain of 'selection of reported results. Nearly half articles scored "low risk" in domains of "missing data" and "deviations in assignment to intervention." The study results showed a slowly increasing trend of average RoB over the last 10 years.
The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.
印度的试验数量呈上升趋势。由于这些试验将塑造临床实践，其质量至关重要。在众多评估随机对照试验（RCT）质量的工具中，偏倚风险（RoB）最为可靠。
从偏倚风险角度了解印度正在进行的试验的质量。
我们旨在评估印度药理学杂志上发表的一组随机试验的随机对照试验中的偏倚风险。
我们将已发表的期刊文章用作随机临床试验的信息来源，并使用Cochrane偏倚风险工具2.0对其进行评估。
采用描述性统计。
对在7种期刊上发表的158项试验在6个不同领域进行了评估。97%（153项）试验的总体评估为“高风险”，而3%（5项）属于“有些担忧”类别，没有试验被归类为“低风险”。74%的文章在“报告结果的选择”领域显示出高偏倚风险。近一半的文章在“缺失数据”和“干预分配偏差”领域得分“低风险”。研究结果显示，在过去10年中，平均偏倚风险呈缓慢上升趋势。
该研究表明，印度药理学杂志上发表的各类随机对照试验的偏倚风险令人担忧地上升。
