{"title":"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。","authors":"Saurabh R Patil, Shruti Shripad Bhide","doi":"10.4103/picr.PICR_19_21","DOIUrl":null,"url":null,"abstract":"<p><strong>Context: </strong>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.</p><p><strong>Aims: </strong>To understand the quality of trials being carried out in India in terms of RoB.</p><p><strong>Settings and design: </strong>We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.</p><p><strong>Subjects and methods: </strong>We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.</p><p><strong>Statistical analysis used: </strong>Descriptive statistics were used.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/c8/PCR-14-16.PMC10003580.pdf","citationCount":"0","resultStr":"{\"title\":\"Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.\",\"authors\":\"Saurabh R Patil, Shruti Shripad Bhide\",\"doi\":\"10.4103/picr.PICR_19_21\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Context: </strong>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.</p><p><strong>Aims: </strong>To understand the quality of trials being carried out in India in terms of RoB.</p><p><strong>Settings and design: </strong>We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.</p><p><strong>Subjects and methods: </strong>We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.</p><p><strong>Statistical analysis used: </strong>Descriptive statistics were used.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.</p>\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/c8/PCR-14-16.PMC10003580.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.PICR_19_21\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/12/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.PICR_19_21","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/12/1 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
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.
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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