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干预研究如何衡量药物安全相关临床决策支持系统在初级保健和长期护理中的有效性:系统评价。

How intervention studies measure the effectiveness of medication safety-related clinical decision support systems in primary and long-term care: a systematic review.

机构信息

Department of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitätsstraße 25, Bielefeld, 33615, Germany.

Vandage GmbH, Bielefeld, Germany.

出版信息

BMC Med Inform Decis Mak. 2024 Jul 4;24(1):188. doi: 10.1186/s12911-024-02596-y.

Abstract

BACKGROUND

Medication errors and associated adverse drug events (ADE) are a major cause of morbidity and mortality worldwide. In recent years, the prevention of medication errors has become a high priority in healthcare systems. In order to improve medication safety, computerized Clinical Decision Support Systems (CDSS) are increasingly being integrated into the medication process. Accordingly, a growing number of studies have investigated the medication safety-related effectiveness of CDSS. However, the outcome measures used are heterogeneous, leading to unclear evidence. The primary aim of this study is to summarize and categorize the outcomes used in interventional studies evaluating the effects of CDSS on medication safety in primary and long-term care.

METHODS

We systematically searched PubMed, Embase, CINAHL, and Cochrane Library for interventional studies evaluating the effects of CDSS targeting medication safety and patient-related outcomes. We extracted methodological characteristics, outcomes and empirical findings from the included studies. Outcomes were assigned to three main categories: process-related, harm-related, and cost-related. Risk of bias was assessed using the Evidence Project risk of bias tool.

RESULTS

Thirty-two studies met the inclusion criteria. Almost all studies (n = 31) used process-related outcomes, followed by harm-related outcomes (n = 11). Only three studies used cost-related outcomes. Most studies used outcomes from only one category and no study used outcomes from all three categories. The definition and operationalization of outcomes varied widely between the included studies, even within outcome categories. Overall, evidence on CDSS effectiveness was mixed. A significant intervention effect was demonstrated by nine of fifteen studies with process-related primary outcomes (60%) but only one out of five studies with harm-related primary outcomes (20%). The included studies faced a number of methodological problems that limit the comparability and generalizability of their results.

CONCLUSIONS

Evidence on the effectiveness of CDSS is currently inconclusive due in part to inconsistent outcome definitions and methodological problems in the literature. Additional high-quality studies are therefore needed to provide a comprehensive account of CDSS effectiveness. These studies should follow established methodological guidelines and recommendations and use a comprehensive set of harm-, process- and cost-related outcomes with agreed-upon and consistent definitions.

PROSPERO REGISTRATION

CRD42023464746.

摘要

背景

药物错误和相关的药物不良事件(ADE)是全球发病率和死亡率的主要原因。近年来,预防用药错误已成为医疗保健系统的重中之重。为了提高用药安全性,越来越多的计算机化临床决策支持系统(CDSS)被整合到用药过程中。因此,越来越多的研究调查了 CDSS 与药物安全相关的有效性。然而,所使用的结果衡量指标存在差异,导致证据不明确。本研究的主要目的是总结和分类评估 CDSS 对初级和长期护理中药物安全性影响的干预研究中使用的结果。

方法

我们系统地检索了 PubMed、Embase、CINAHL 和 Cochrane Library 中评估 CDSS 对药物安全性和患者相关结果影响的干预研究。我们从纳入的研究中提取了方法学特征、结果和经验发现。结果被分配到三个主要类别:过程相关、伤害相关和成本相关。使用 Evidence Project 偏倚风险工具评估偏倚风险。

结果

32 项研究符合纳入标准。几乎所有研究(n=31)都使用了过程相关的结果,其次是伤害相关的结果(n=11)。只有三项研究使用了成本相关的结果。大多数研究仅使用了一个类别的结果,没有研究使用了所有三个类别的结果。纳入研究之间的结果定义和操作差异很大,即使在同一类别内也是如此。总体而言,CDSS 有效性的证据参差不齐。有 15 项以过程相关的主要结果为研究对象的研究中有 9 项(60%)显示出显著的干预效果,但以伤害相关的主要结果为研究对象的研究中只有 1 项(20%)显示出显著的干预效果。纳入的研究存在许多方法学问题,限制了其结果的可比性和普遍性。

结论

由于文献中存在不一致的结果定义和方法学问题,CDSS 的有效性证据目前尚无定论。因此,需要更多高质量的研究来全面说明 CDSS 的有效性。这些研究应遵循既定的方法学准则和建议,并使用一套全面的与伤害、过程和成本相关的结果,并使用商定的和一致的定义。

PROSPERO 注册号:CRD42023464746。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0d87/11225126/a656a7339559/12911_2024_2596_Fig1_HTML.jpg

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