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兽医学中随机对照试验的赞助偏差与质量

Sponsorship bias and quality of randomised controlled trials in veterinary medicine.

作者信息

Wareham K J, Hyde R M, Grindlay D, Brennan M L, Dean R S

机构信息

Centre for Evidence-based Veterinary Medicine, School of Veterinary Medicine and Science, The University of Nottingham, Sutton Bonington campus, Loughborough, LE12 5RD, UK.

Centre of Evidence-based Dermatology, University ofNottingham, Kings Meadow campus, Lenton Lane, Nottingham, NG7 2NR, UK.

出版信息

BMC Vet Res. 2017 Aug 14;13(1):234. doi: 10.1186/s12917-017-1146-9.

Abstract

BACKGROUND

Randomised controlled trials (RCTs) are considered the gold standard form of evidence for assessing treatment efficacy, but many factors can influence their reliability including methodological quality, reporting quality and funding source. The aim of this study was to examine the relationship between funding source and positive outcome reporting in veterinary RCTs published in 2011 and to assess the risk of bias in the RCTs identified.

METHODS

A structured search of PubMed was used to identify feline, canine, equine, bovine and ovine clinical trials examining the efficacy of pharmaceutical interventions published in 2011. Funding source and outcomes were extracted from each RCT and an assessment of risk of bias made using the Cochrane risk of bias tool.

RESULTS

Literature searches returned 972 papers, with 86 papers (comprising 126 individual RCTs) included in the analysis. There was found to be a significantly higher proportion of positive outcomes reported in the pharmaceutical funding group (P) compared to the non-pharmaceutical (NP) and 'no funding source stated' (NF) groups (P = 56.9%, NP = 34.9%, NF = 29.1%, p < 0.05). A high proportion of trials had an unclear risk of bias across the five criteria examined.

CONCLUSIONS

We found evidence that veterinary RCTs were more likely to report positive outcomes if they have pharmaceutical industry funding or involvement. Consistently poor reporting of trials, including non-identification of funding source, was found which hinders the use of the available evidence.

摘要

背景

随机对照试验(RCTs)被认为是评估治疗效果的黄金标准证据形式,但许多因素会影响其可靠性,包括方法学质量、报告质量和资金来源。本研究的目的是探讨2011年发表的兽医随机对照试验中资金来源与阳性结果报告之间的关系,并评估所识别的随机对照试验中的偏倚风险。

方法

采用结构化检索PubMed的方法,识别2011年发表的关于猫、犬、马、牛和羊药物干预疗效的临床试验。从每个随机对照试验中提取资金来源和结果,并使用Cochrane偏倚风险工具对偏倚风险进行评估。

结果

文献检索返回972篇论文,其中86篇论文(包括126个独立的随机对照试验)纳入分析。结果发现,与非制药(NP)组和“未说明资金来源”(NF)组相比,制药资金组(P)报告的阳性结果比例显著更高(P = 56.9%,NP = 34.9%,NF = 29.1%,p < 0.05)。在所检查的五个标准中,很大比例的试验存在不明确的偏倚风险。

结论

我们发现有证据表明,兽医随机对照试验如果有制药行业的资金支持或参与,更有可能报告阳性结果。研究发现,试验报告一直很差,包括未识别资金来源,这阻碍了现有证据的使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e2e/5557072/563d5b858e06/12917_2017_1146_Fig1_HTML.jpg

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