预防和护理损伤方面随机对照试验的数量、内容和质量。

Stelfox Henry Thomas, Goverman Jeremy

Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada.

J Trauma. 2008 Dec;65(6):1488-93. doi: 10.1097/TA.0b013e3181568cfc.

BACKGROUND

Injuries represent an important and growing global burden of disease. The availability of evidence-based injury control interventions is unknown. We aimed to assess trends with respect to the number, content, and methodologic quality of reports of randomized controlled trials (RCTs) in the prevention and care of injuries.

METHODS

We searched MEDLINE and the Cochrane Central Register of Controlled Trials for reports of RCTs of interventions in the prevention and care of injuries published between January 1, 1966 and January 1, 2006. Ten percent of reports, stratified by year, were randomly sampled. Studies were abstracted using a standardized form for nature of intervention, sample size, patients studied, and methodologic quality.

RESULTS

The rate of publication of injury-related RCTs increased from 1.2 to 5.3 articles per 100 RCTs published in MEDLINE (p < 0.001) during the study period. A total of 308 reports were included in the analysis of content and methodologic quality. Poisonings (31 [10%]) were the single most common isolated mechanism of patient injury studied, whereas only 12 reports (4%) focused on road traffic injuries. The majority of interventions were hospital based (211 [68%]) and half (45%) were judged to be only available in high-income countries. Allocation concealment was deemed adequate in 73 articles (24%). One quarter of reports documented blinding of participants (77 [25%]), investigators (68 [22%]), and outcome assessors (83 [27%]). Only 44 articles (14%) reported intention-to-treat analyses.

CONCLUSIONS

The number of RCTs specific to the prevention and care of injuries is small, but increasing. The reporting of injury-related RCTs has important deficiencies including inadequate allocation concealment; failure to blind patients, investigators, and assessors; and per protocol analyses. In addition, many interventions studied are not available in low-income countries where the majority of the world's population resides and injury rates are highest.

背景

伤害是全球疾病负担中一个重要且不断增长的部分。基于证据的伤害控制干预措施的可及性尚不清楚。我们旨在评估关于随机对照试验（RCT）报告的数量、内容和方法学质量在伤害预防与护理方面的趋势。

方法

我们检索了MEDLINE和Cochrane对照试验中心注册库，以查找1966年1月1日至2006年1月1日期间发表的关于伤害预防与护理干预措施的RCT报告。按年份分层，随机抽取10%的报告。使用标准化表格对研究进行摘要，内容包括干预性质、样本量、研究对象以及方法学质量。

结果

在研究期间，MEDLINE中每100篇发表的RCT中，与伤害相关的RCT发表率从1.2篇增至5.3篇（p < 0.001）。共有308份报告纳入内容和方法学质量分析。中毒（31份[10%]）是研究的患者伤害最常见的单一独立机制，而仅有12份报告（4%）关注道路交通伤害。大多数干预措施以医院为基础（211份[68%]），且一半（45%）被判定仅在高收入国家可用。73篇文章（24%）的分配隐藏被认为是充分的。四分之一的报告记录了对参与者（77份[25%]）、研究者（68份[22%]）和结局评估者（83份[27%]）的盲法。仅有44篇文章（14%）报告了意向性分析。