发表在印度药理学杂志上的随机对照试验中偏倚风险评估。

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2023-01-01 Epub Date: 2021-12-01 DOI:10.4103/picr.PICR_19_21
Saurabh R Patil, Shruti Shripad Bhide
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引用次数: 0

摘要

背景:印度的试验数量呈上升趋势。由于这些试验将影响临床实践,其质量至关重要。在许多评估随机对照试验(RCT)质量的工具中,偏倚风险(RoB)最为稳健。目的:了解印度正在进行的RoB试验的质量。设置和设计:我们旨在评估《印度药理学》上发表的一组随机对照试验中的RoB,这些随机对照试验来自药理学杂志。受试者和方法:我们使用已发表的期刊文章作为随机临床试验的信息来源,并使用Cochrane RoB工具2.0对其进行评估。使用的统计分析:使用描述性统计。结果: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)的试验的总体评估为“高风险”,而3%(5)的试验属于“一些问题”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”领域显示出高风险的偏见。近一半的文章在”缺失数据“和”干预分配偏差“领域得分为”低风险“。“研究结果显示,在过去10年中,平均RoB呈缓慢上升趋势。结论:该研究显示,在印度药理学杂志上发表的随机对照试验中,各个领域的RoB都出现了令人担忧的上升。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.

Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.

Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.

Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.

Context: 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.

Aims: To understand the quality of trials being carried out in India in terms of RoB.

Settings and design: We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.

Subjects and methods: We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.

Statistical analysis used: Descriptive statistics were used.

Results: 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.

Conclusions: The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.

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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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