Barnes Karen L, Kirkham Jamie J, Clarke Mike, Williamson Paula R
MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, United Kingdom.
MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, United Kingdom.
J Clin Epidemiol. 2017 Jun;86:153-159. doi: 10.1016/j.jclinepi.2017.03.003. Epub 2017 Mar 23.
The aim of the study was to evaluate citation analysis as an approach to measuring core outcome set (COS) uptake, by assessing whether the number of citations for a COS report could be used as a surrogate measure of uptake of the COS by clinical trialists.
Citation data were obtained for COS reports published before 2010 in five disease areas (systemic sclerosis, rheumatoid arthritis, eczema, sepsis and critical care, and female sexual dysfunction). Those publications identified as a report of a clinical trial were examined to identify whether or not all outcomes in the COS were measured in the trial.
Clinical trials measuring the relevant COS made up a small proportion of the total number of citations for COS reports. Not all trials citing a COS report measured all the recommended outcomes. Some trials cited the COS reports for other reasons, including the definition of a condition or other trial design issues addressed by the COS report.
Although citation data can be readily accessed, it should not be assumed that the citing of a COS report indicates that a trial has measured the recommended COS. Alternative methods for assessing COS uptake are needed.
本研究旨在通过评估核心结局集(COS)报告的被引次数能否作为临床试验人员采用该COS的替代指标,来评价文献引用分析作为一种衡量COS采用情况的方法。
获取了2010年前在五个疾病领域(系统性硬化症、类风湿性关节炎、湿疹、败血症与重症监护以及女性性功能障碍)发表的COS报告的引用数据。对那些被确定为临床试验报告的出版物进行检查,以确定该试验是否测量了COS中的所有结局。
测量相关COS的临床试验在COS报告的总被引次数中占比很小。并非所有引用COS报告的试验都测量了所有推荐的结局。一些试验引用COS报告是出于其他原因,包括疾病的定义或COS报告所涉及的其他试验设计问题。
尽管引用数据易于获取,但不应假定引用COS报告就表明试验已测量了推荐的COS。需要采用其他方法来评估COS的采用情况。