The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): Method and design considerations

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): Method and design considerations
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DOI:
10.1016/j.cct.2013.05.008
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发表时间:
2013-09-01
影响因子:
2.2
通讯作者:
Camargo, Carlos A., Jr.
Camargo, Carlos A., Jr.
中科院分区:
医学4区
文献类型:
--
作者:
Boudreaux, Edwin D.;Miller, Ivan;Camargo, Carlos A., Jr.

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背景资料:由于自杀风险人群集中,急诊科就诊是进行自杀风险筛查和干预的最佳时机。目的:急诊科安全评估和随访评估(ED-SAFE)使用准实验性,中断时间序列设计,以评估(1)普遍筛查艾德患者自杀风险的实用方法是否能改善自杀风险的检测,以及(2)在艾德访视期间和之后提供的多组分干预改善了自杀相关的outcomes.Methods:本文总结了ED-SAFE的研究设计和方法的背景下考虑相关的自杀预防和相关的人类参与者的关注的有效性研究。将在三个连续的数据收集阶段(480例个体/阶段)入组来自全国8个普通艾德的1440例自杀个体:(1)作为自杀者治疗;(2)全面筛查;和(3)干预。三个阶段的数据将为两项单独的评价提供信息:筛选结果(第1和2阶段)和干预(第2和3阶段)。个人将被跟踪12个月。主要研究结果是反映自杀完成、自杀未遂、流产或中断尝试以及在结果评估期间实施抢救程序的复合结果。虽然“经典”随机对照试验(RCT)通常是在准实验设计中选择的,但伦理和方法学问题可能使RCT不适合应用环境中的复杂干预措施,ED-SAFE代表了一种创新的方法,通过嵌入“真实的世界”临床环境中的多阶段、准实验设计来研究预防自杀这一复杂的公共卫生问题。(C)2013 Elsevier Inc. All rights reserved.
Background: Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention.Purpose: The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes.Methods: This paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment.Conclusions: While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings. (C) 2013 Elsevier Inc. All rights reserved.