Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, Canada, K1H 8L6; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, Victoria 3004, Australia.
J Clin Epidemiol. 2020 Aug;124:75-84. doi: 10.1016/j.jclinepi.2020.05.003. Epub 2020 May 11.
Identifying pragmatic trials from among all randomized trials is challenging because of inconsistent reporting. Our objective was to develop and validate a search filter to identify reports of pragmatic trials from Ovid MEDLINE.
Two sets of known and probable pragmatic trial records were analyzed using text mining to generate candidate terms. Two large population sets comprising clinical trials and explanatory trials were used to select discriminating terms. Various combinations of terms were tested iteratively to achieve optimal search performance. Two externally derived sets were used to validate sensitivity and specificity of the derived filters.
Our validated sensitivity-maximizing filter (combines trial design terms with terms relating to attributes of pragmatic trials) retrieves over 42,000 records in MEDLINE and has sensitivity of 46.4% (95% confidence interval (CI) 37.2 to 55.7%) and estimated specificity of 98.1% (95% CI 93.4 to 99.8%). Search performance is superior to other ad hoc filters for pragmatic trials. The Cochrane search for randomized trials has much better sensitivity (98.2%), but poorer specificity (1.9%) and retrieves 4.5 million records.
A highly specific filter (low false positive rate) with moderate sensitivity is available for identifying reports of trials more likely to be pragmatic.
由于报告不一致,从所有随机试验中识别实用临床试验具有挑战性。我们的目的是开发和验证一种搜索筛选器,以从 Ovid MEDLINE 中识别实用临床试验报告。
使用文本挖掘分析两组已知和可能的实用试验记录,以生成候选术语。使用两个大型人群集(临床试验和解释性试验)来选择有区别的术语。各种术语组合被反复测试,以达到最佳的搜索性能。使用两个外部衍生集来验证衍生筛选器的敏感性和特异性。
我们验证的敏感性最大化筛选器(将试验设计术语与与实用试验属性相关的术语相结合)在 MEDLINE 中检索到超过 42000 条记录,敏感性为 46.4%(95%置信区间[CI] 37.2 至 55.7%),估计特异性为 98.1%(95% CI 93.4 至 99.8%)。搜索性能优于其他针对实用试验的特定筛选器。Cochrane 随机试验搜索具有更高的敏感性(98.2%),但特异性较差(1.9%),检索到 450 万条记录。
一种具有中等敏感性和高度特异性(低假阳性率)的筛选器可用于识别更有可能是实用试验的报告。