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一项关于戒烟随机对照试验质量相关因素的评估。

An assessment of factors associated with quality of randomized controlled trials for smoking cessation.

作者信息

Fan Hong, Song Fujian, Gu Hai, Wang Jianming, Jia Guizhen, Lu Moyuan, Qian Jiao, Wang Lei, Shen Jiemiao, Ren Zhewen

机构信息

Center for Health Policy and Management Research, Nanjing University, Nanjing, P.R.China.

Department of Social Medicine and Health Education, School of Public Health, Nanjing Medical University, Nanjing, P.R.China.

出版信息

Oncotarget. 2016 Aug 16;7(33):53762-53771. doi: 10.18632/oncotarget.10742.

DOI:10.18632/oncotarget.10742
PMID:27449103
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5288219/
Abstract

To reduce smoking-related diseases, a research priority is to develop effective interventions for smoking cessation, and evidence from randomized controlled trials (RCTs) is usually considered to be the most valid. However, findings from RCTs may still be misleading due to methodological flaws. This study aims to assess the quality of 1083 RCTs of smoking cessation interventions in 41 relevant Cochrane Systematic Reviews (CSRs). Logistic regression analysis was performed to identify significant variables associated with the quality of RCTs. It was found that evidence for smoking cessation from RCTs was predominantly from high income countries, and the overall quality was high in only 8.6% of the RCTs. High quality RCTs tended to have a larger sample size, to be more recently published, and conducted in multiple countries belonging to different income categories. In conclusion, the overall quality of RCTs of smoking cessation interventions is far from perfect, and more RCTs in less developed countries are required to generate high grade evidence for global tobacco control. Collaboration between researchers in developed and less developed countries should be encouraged.

摘要

为减少与吸烟相关的疾病,一个研究重点是开发有效的戒烟干预措施,而随机对照试验(RCT)的证据通常被认为是最有效的。然而,由于方法上的缺陷,RCT的结果可能仍然具有误导性。本研究旨在评估41项相关Cochrane系统评价(CSR)中1083项戒烟干预RCT的质量。进行逻辑回归分析以确定与RCT质量相关的显著变量。研究发现,RCT的戒烟证据主要来自高收入国家,只有8.6%的RCT总体质量较高。高质量的RCT往往样本量更大、发表时间更近,且在属于不同收入类别的多个国家进行。总之,戒烟干预RCT的总体质量远非完美,需要在欠发达国家开展更多RCT,以生成用于全球烟草控制的高级别证据。应鼓励发达国家和欠发达国家的研究人员开展合作。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d9d5/5288219/5d692796827b/oncotarget-07-53762-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d9d5/5288219/5d692796827b/oncotarget-07-53762-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d9d5/5288219/5d692796827b/oncotarget-07-53762-g001.jpg

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本文引用的文献

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To RCT or not to RCT? The ongoing saga of randomised trials in quality improvement.进行随机对照试验还是不进行?质量改进中随机试验的持续故事。
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An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries.对非传染性疾病随机对照试验的评估:欠发达国家需要开展更多且质量更高的研究。
Sci Rep. 2015 Aug 14;5:13221. doi: 10.1038/srep13221.
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Interventions for waterpipe smoking cessation.水烟戒烟干预措施。
Cochrane Database Syst Rev. 2015 Jul 31;2015(7):CD005549. doi: 10.1002/14651858.CD005549.pub3.
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Risk of bias of randomized trials over time.随机试验的偏倚风险随时间变化。
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Cochrane Database Syst Rev. 2015 May 18(5):CD004307. doi: 10.1002/14651858.CD004307.pub5.
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