全球范围内随机对照试验已发表方案的数量及质量趋势。
Worldwide trends in volume and quality of published protocols of randomized controlled trials.
作者信息
van Rosmalen Belle V, Alldinger Ingo, Cieslak Kasia P, Wennink Roos, Clarke Mike, Ahmed Ali Usama, Besselink Marc G H
机构信息
Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
出版信息
PLoS One. 2017 Mar 15;12(3):e0173042. doi: 10.1371/journal.pone.0173042. eCollection 2017.
INTRODUCTION
Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols.
METHODS
A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty.
RESULTS
The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40-0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09-3.45, p = 0.02).
CONCLUSION
Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology.
引言
发表随机对照试验（RCT）方案有助于更详细地描述研究原理、设计以及相关的伦理和安全问题，这应能提高透明度。对于发表方案的实践如何随时间发展，人们了解甚少。因此，本研究描述了已发表的RCT方案在数量和方法学质量方面的全球趋势。
方法
在PubMed和EMBASE中进行系统检索，识别2001年9月1日起十年间发表的RCT方案。提取RCT方案质量特征的数据。主要结局，即方法学质量，通过个体方法学特征（充分的随机化、随机化隐藏和意向性分析）进行评估。按发表时期（第一期，2001年9月 - 2004年12月；第二期，2005年1月 - 2008年5月；第三期，2008年6月 - 2011年9月）、地理区域和医学专业进行比较。
结果
已发表的RCT方案数量从第一期的69个增加到第三期的390个（p<0.0001）。内科和儿科是最常见的专业主题。虽然第一期发表的大多数RCT方案来自北美（n = 30，44%），但在第二期和第三期则来自欧洲（分别为n = 65，47%和n = 190，48%，p = 0.02）。与北美相比，欧洲和澳大拉西亚的RCT方案质量更高（OR = 0.63，CI = 0.40 - 0.99，p = 0.04）。随机化的充分性随时间有所改善（44%，58%，67%，p = 0.001），随机化隐藏也是如此（38%，53%，55%，p = 0.03）。在本研究使用的三个专业主题中，外科方案质量最高（OR = 1.94，CI = 1.09 - 3.45，p = 0.02）。
结论
发表RCT方案已变得普遍，在过去十年中增加了五倍。已发表的RCT方案质量也有所提高，尽管地理区域和医学专业之间存在差异。这强调了RCT方法学全面培训国际标准的重要性。
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