Yismaw Malede Berihun, Peterson Gregory M, Kefale Belayneh, Bezabhe Woldesellassie M
Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.
School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Private Bag 26, Hobart, Tasmania, Australia.
Drug Saf. 2025 May 28. doi: 10.1007/s40264-025-01563-4.
Opioids are the most frequently prescribed medications for managing moderate-to-severe pain and are associated with significant potential for harm. Several models have been developed to predict opioid-related harms (ORHs). This study aimed to describe and evaluate the methodological quality of predictive models for identifying patients at high risk of ORHs.
Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline, we reviewed published studies on developing or validating models for predicting ORHs, identified through a literature search of Scopus, PubMed, Embase, and Google Scholar. The quality of studies was assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). The models were assessed by area under the curve (AUC) or c-statistic, sensitivity, specificity, accuracy, and positive or negative predictive value. The study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD42024540456).
We included 36 studies involving participants aged 18 years or older. The frequently modeled ORHs were opioid use disorder (12 studies), opioid overdose (8 studies), opioid-induced respiratory depression (6 studies), and adverse drug events (4 studies). In total, 16 studies (44.4%) developed and validated tools. Most studies measured predictive ability using AUC (31, 86.1%), and some only reported sensitivity (14, 38.9%), specificity (11, 30.6%), or accuracy (4, 11.1%). Of the 31 studies that reported AUC values, 29 (93.5%) had moderate-to-high predictive ability (AUC > 0.70). History of opioid use (66.7%), age (58.3%), comorbidities (41.7%), sex (41.7%), and drug abuse and psychiatric problems (36.1%) were typical factors used in developing models.
The included predictive models showed moderate-to-high discriminative ability for screening patients at risk of ORHs. However, future studies should refine and validate them in various settings before considering the translation into clinical practice.
阿片类药物是治疗中重度疼痛最常用的处方药,且具有显著的潜在危害。已经开发了几种模型来预测阿片类药物相关危害(ORH)。本研究旨在描述和评估用于识别高风险ORH患者的预测模型的方法学质量。
使用系统评价和Meta分析的首选报告项目(PRISMA)指南,我们回顾了已发表的关于开发或验证预测ORH模型的研究,这些研究通过对Scopus、PubMed、Embase和谷歌学术进行文献检索来确定。使用预测模型偏倚风险评估工具(PROBAST)评估研究质量。通过曲线下面积(AUC)或c统计量、敏感性、特异性、准确性以及阳性或阴性预测值来评估模型。该研究方案已在国际前瞻性系统评价注册库(PROSPERO;CRD42024540456)中注册。
我们纳入了36项涉及18岁及以上参与者的研究。常见的建模ORH包括阿片类药物使用障碍(12项研究)、阿片类药物过量(8项研究)、阿片类药物引起的呼吸抑制(6项研究)和药物不良事件(4项研究)。总共有16项研究(44.4%)开发并验证了工具。大多数研究使用AUC测量预测能力(31项,86.1%),有些仅报告了敏感性(14项,38.9%)、特异性(11项,30.6%)或准确性(4项,11.1%)。在报告AUC值的31项研究中,29项(93.5%)具有中度至高度预测能力(AUC>0.70)。阿片类药物使用史(66.7%)、年龄(58.3%)、合并症(41.7%)、性别(41.7%)以及药物滥用和精神问题(36.1%)是开发模型时常用的典型因素。
纳入的预测模型在筛查高风险ORH患者方面显示出中度至高度的判别能力。然而,未来的研究应在各种环境中对其进行完善和验证,然后再考虑转化为临床实践。