Worldwide trends in volume and quality of published protocols of randomized controlled trials.
Worldwide trends in volume and quality of published protocols of randomized controlled trials.
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DOI：
10.1371/journal.pone.0173042
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发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Besselink MG
中科院分区：
文献类型：
--
作者：
van Rosmalen BV;Alldinger I;Cieslak KP;Wennink R;Clarke M;Ahmed Ali U;Besselink MG
发表随机对照试验（RCT）的方案有助于更详细地描述研究的合理性、设计以及相关的伦理和安全问题，这应该有助于提高透明度。关于发布协议的实践是如何随着时间的推移而发展的，我们知之甚少。因此，本研究描述了已发表RCT方案的数量和方法学质量的全球趋势。在PubMed和EMBASE中进行了系统检索，确定了自2001年9月1日起十年内发表的RCT方案。提取RCT方案质量特征数据。通过个体方法学特征（充分生成分配、隐藏分配和意向治疗分析）评估主要结局（方法学质量）。按出版时间（第一次，2001年9月至2004年12月;第二次，2005年1月至2008年5月;第三次，2008年6月至2011年9月）、地理区域和医学专业进行比较。发表的RCT方案数量从第一阶段的69个增加到第三阶段的390个（p<0.0001）。内科和儿科是最常见的专业主题。第一阶段大多数已发表的RCT方案来自北美（n = 30，44%），而第二和第三阶段则来自欧洲（分别为n = 65，47%和n = 190，48%，p = 0.02）。欧洲和澳大拉西亚的RCT方案质量高于北美（OR = 0.63，CI = 0.40-0.99，p = 0.04）。随着时间的推移，分配的充分生成得到改善（44%，58%，67%，p = 0.001），分配的隐藏也得到改善（38%，53%，55%，p = 0.03）。在本研究中使用的三个专业主题中，手术方案的质量最高（OR = 1.94，CI = 1.09-3.45，p = 0.02）。发表RCT协议已经变得流行，在过去十年中增加了五倍。发表的RCT方案的质量也有所提高，尽管地理区域和医学专业之间存在差异。这就强调了在RCT方法学方面全面培训的国际标准的重要性。
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. 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. 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). 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.