Institute of Nursing Science (INS), Department Public Health (DPH), Faculty of Medicine, University of Basel, Basel, Switzerland.
Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
PLoS One. 2022 Sep 1;17(9):e0273800. doi: 10.1371/journal.pone.0273800. eCollection 2022.
Adverse event (AE) detection is a major patient safety priority. However, despite extensive research on AEs, reported incidence rates vary widely.
This study aimed: (1) to synthesize available evidence on AE incidence in acute care inpatient settings using Trigger Tool methodology; and (2) to explore whether study characteristics and study quality explain variations in reported AE incidence.
Systematic review and meta-analysis.
To identify relevant studies, we queried PubMed, EMBASE, CINAHL, Cochrane Library and three journals in the patient safety field (last update search 25.05.2022). Eligible publications fulfilled the following criteria: adult inpatient samples; acute care hospital settings; Trigger Tool methodology; focus on specialty of internal medicine, surgery or oncology; published in English, French, German, Italian or Spanish. Systematic reviews and studies addressing adverse drug events or exclusively deceased patients were excluded. Risk of bias was assessed using an adapted version of the Quality Assessment Tool for Diagnostic Accuracy Studies 2. Our main outcome of interest was AEs per 100 admissions. We assessed nine study characteristics plus study quality as potential sources of variation using random regression models. We received no funding and did not register this review.
Screening 6,685 publications yielded 54 eligible studies covering 194,470 admissions. The cumulative AE incidence was 30.0 per 100 admissions (95% CI 23.9-37.5; I2 = 99.7%) and between study heterogeneity was high with a prediction interval of 5.4-164.7. Overall studies' risk of bias and applicability-related concerns were rated as low. Eight out of nine methodological study characteristics did explain some variation of reported AE rates, such as patient age and type of hospital. Also, study quality did explain variation.
Estimates of AE studies using trigger tool methodology vary while explaining variation is seriously hampered by the low standards of reporting such as the timeframe of AE detection. Specific reporting guidelines for studies using retrospective medical record review methodology are necessary to strengthen the current evidence base and to help explain between study variation.
不良事件(AE)检测是患者安全的主要重点。然而,尽管对 AE 进行了广泛的研究,但报告的发生率差异很大。
本研究旨在:(1)使用触发工具方法综合急性护理住院环境中 AE 发生率的现有证据;(2)探讨研究特征和研究质量是否可以解释报告的 AE 发生率的差异。
系统回顾和荟萃分析。
为了确定相关研究,我们在 PubMed、EMBASE、CINAHL、Cochrane 图书馆和患者安全领域的三个期刊(最后一次更新搜索 2022 年 5 月 25 日)中进行了查询。符合条件的出版物符合以下标准:成年住院患者样本;急性护理医院环境;使用触发工具方法;关注内科、外科或肿瘤学专业;以英文、法文、德文、意大利文或西班牙文出版。系统评价和专门研究药物不良反应或仅死亡患者的研究被排除在外。使用诊断准确性研究质量评估工具 2 的改编版本评估偏倚风险。我们主要关注的结果是每 100 例住院患者的 AE。我们使用随机回归模型评估了九个研究特征和研究质量作为潜在的变异来源。我们没有收到任何资金,也没有对这项审查进行注册。
筛选了 6685 篇文献,得到了 54 项符合条件的研究,涵盖了 194470 例住院患者。AE 的累积发生率为每 100 例住院患者 30.0(95%CI 23.9-37.5;I2=99.7%),且研究间异质性很高,预测区间为 5.4-164.7。总体而言,研究的偏倚风险和适用性相关问题被评为低。九个方法学研究特征中有八个解释了报告的 AE 率的一些变化,例如患者年龄和医院类型。此外,研究质量也解释了变异。
使用触发工具方法进行 AE 研究的估计值有所不同,而解释差异受到严重阻碍,因为报告的 AE 检测时间框架等标准很低。需要针对使用回顾性病历审查方法的研究制定具体的报告指南,以加强当前的证据基础,并帮助解释研究之间的差异。