Department of Intensive Care, Northern Clinical School, University of Sydney, Sydney, NSW, Australia.
Trials. 2010 Feb 23;11:17. doi: 10.1186/1745-6215-11-17.
Enrolment of patients into a randomised controlled trial (RCT) in violation of key inclusion or exclusion criteria, may lead to excess avoidable harm. The purpose of this paper was to systematically identify and review techniques and interventions proven to prevent or avoid inappropriate enrolment of patients into RCTs.
EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Methodology Register, online abstract repositories, and conference websites were searched. Experts were contacted and bibliographies of retrieved papers hand-searched. The search cut-off date was 31 August 2009.
No primary publications were found. We identified one study in the grey literature (conference abstracts and presentations) reporting the results of an evaluation of the effectiveness of an intervention designed to prevent or avoid inappropriate enrolment of patients into an RCT. In the context of a multicentre trial, use of a dummy enrolment run-in phase was shown to reduce enrolment errors significantly (P < 0.001), from 16.1% during the run-in phase to < 1% after trial initiation.
Our systematic search yielded only one technique or intervention shown to improve adherence to eligibility criteria during enrolment into RCTs. Given the potential harm involved in recruiting patients into a clinical trial in violation of key eligibility criteria, future research is needed to better inform those conducting clinical trials of how best to prevent enrolment errors.
违反关键纳入或排除标准将患者纳入随机对照试验（RCT）可能导致不必要的伤害。本文的目的是系统地识别和回顾已证明可预防或避免不恰当地将患者纳入 RCT 的技术和干预措施。
检索 EMBASE、MEDLINE、Cochrane 系统评价数据库、Cochrane 方法学注册库、在线摘要库和会议网站。联系了专家，并对检索到的论文的参考文献进行了手工检索。搜索截止日期为 2009 年 8 月 31 日。
未发现主要出版物。我们在灰色文献（会议摘要和演示文稿）中确定了一项研究，报告了一项评估干预措施有效性的研究结果，该干预措施旨在防止或避免不恰当地将患者纳入 RCT。在多中心试验的背景下，使用模拟纳入预试验阶段可显著减少纳入错误（P < 0.001），从预试验阶段的 16.1%降至试验启动后的 < 1%。
我们的系统搜索仅发现一种技术或干预措施可改善 RCT 纳入过程中对纳入标准的遵守情况。鉴于违反关键纳入标准将患者招募到临床试验中所涉及的潜在危害，需要进行未来的研究，以便更好地为那些进行临床试验的人提供有关如何最好地预防纳入错误的信息。
