Reporting of Harm in Randomized Controlled Trials Published in the Urological Literature
Reporting of Harm in Randomized Controlled Trials Published in the Urological Literature
复制标题
DOI：
10.1016/j.juro.2010.01.030
复制
发表时间：
2010-05-01
影响因子：
6.6
通讯作者：
Dahm, Philipp
中科院分区：
文献类型：
--
作者：
Breau, Rodney H.;Gaboury, Isabelle;Dahm, Philipp
目的：循证决策寻求平衡卫生保健干预措施对个别患者的潜在益处和危害(不利影响)。材料和方法：我们对1996年和2004年发表在《泌尿外科杂志》、《泌尿外科杂志》、《欧洲泌尿外科杂志》和《BJU国际》上的所有治疗干预的随机对照试验进行了系统的文献检索。每篇文章都由2名独立调查人员根据配偶小组推荐的10项伤害报告标准进行审查。结果：共有152个随机对照试验符合纳入标准，其中109个(72%)报告不良事件结局。从1996年到2004年，满足伤害报告标准的中位数略有改善(2.8到3.3，p=0.36)。很大一部分研究未能从抽象(55，36%)、介绍(71，47%)和讨论(52，34%)三个方面解决危害问题。很少有研究具体说明评估哪些不良事件(21%，14%)，何时收集伤害信息(3221%)，或如何将伤害归因于干预(5.3%)。只有48篇(32%)文章提供了患者退出的原因，1/5(33，22%)报告了不良事件的严重性。结论：发表在泌尿外科文献中的随机对照试验在不良事件报告方面存在显著缺陷。这些发现表明，有必要在泌尿外科杂志上报告伤害的标准。不良事件报告的改进将允许对干预措施进行更平衡的评估，并将加强以证据为基础的泌尿外科实践。
Purpose: Evidence-based decision making seeks to balance potential benefits and harms (adverse effects) of health care interventions for an individual patient. We determined the prevalence and completeness of harm reporting in randomized controlled trials in the urological literature.Materials and Methods: We performed a systematic literature search of all randomized controlled trials of therapeutic interventions published in The Journal of Urology (R), Urology (R), European Urology and BJU International in 1996 and 2004. Each article was reviewed by 2 independent investigators for 10 harm reporting criteria recommended by the CONSORT group. Discrepancies were settled by discussion and consensus.Results: A total of 152 randomized controlled trials met the inclusion criteria, of which 109 (72%) reported adverse event outcomes. The median number of harm reporting criteria satisfied improved marginally from 1996 to 2004 (2.8 to 3.3, p = 0.36). A large proportion of studies failed to address harm in the abstract (55, 36%), introduction (71, 47%) and discussion (52, 34%). Few studies specified which adverse events were evaluated (21, 14%), when harm information was collected (32, 21%) or how the harm was attributed to the intervention (5, 3%). Only 48 (32%) articles provided reasons for patient withdrawal and 1 in 5 (33, 22%) reported the severity of adverse events.Conclusions: Randomized controlled trials published in the urological literature contain significant deficiencies in adverse event reporting. These findings suggest the need for reporting standards for harm in urological journals. Improvements in adverse event reporting would permit a more balanced assessment of interventions and would enhance evidence-based urological practice.