Centre for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada.
Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.
BMJ Open. 2023 May 31;13(5):e068729. doi: 10.1136/bmjopen-2022-068729.
Urine drug tests (UDTs) are commonly used for monitoring opioid agonist treatment (OAT) responses, supporting the clinical decision for take-home doses and monitoring potential diversion. However, there is limited evidence supporting the utility of mandatory UDTs-particularly the impact of UDT frequency on OAT retention. Real-world evidence can inform patient-centred approaches to OAT and improve current strategies to address the ongoing opioid public health emergency. Our objective is to determine the safety and comparative effectiveness of alternative UDT monitoring strategies as observed in clinical practice among OAT clients in British Columbia, Canada from 2010 to 2020.
We propose a population-level retrospective cohort study of all individuals 18 years of age or older who initiated OAT from 1 January 2010 to 17 March 2020. The study will draw on eight linked health administrative databases from British Columbia. Our primary outcomes include OAT discontinuation and all-cause mortality. To determine the effectiveness of the intervention, we will emulate a 'per-protocol' target trial using a clone censoring approach to compare fixed and dynamic UDT monitoring strategies. A range of sensitivity analyses will be executed to determine the robustness of our results.
The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.
尿液药物检测(UDT)常用于监测阿片类激动剂治疗(OAT)的反应,为患者带药回家提供临床决策支持,并监测潜在的药物滥用情况。然而,目前支持强制性 UDT 的效用的证据有限,特别是 UDT 频率对 OAT 保留的影响。真实世界的数据可以为 OAT 患者为中心的方法提供信息,并改进当前解决持续的阿片类公共卫生紧急情况的策略。我们的目标是确定在加拿大不列颠哥伦比亚省从 2010 年到 2020 年期间,在 OAT 患者中观察到的替代 UDT 监测策略的安全性和比较效果。
我们提出了一项针对所有 18 岁及以上于 2010 年 1 月 1 日至 2020 年 3 月 17 日期间开始 OAT 的个体的人群水平回顾性队列研究。该研究将利用不列颠哥伦比亚省的八个链接健康管理数据库。我们的主要结局包括 OAT 中断和全因死亡率。为了确定干预措施的有效性,我们将使用克隆删失方法模拟一个“按方案”目标试验,以比较固定和动态 UDT 监测策略。将执行一系列敏感性分析,以确定我们结果的稳健性。
该方案、队列创建和分析计划已被普罗维登斯医疗保健研究伦理委员会和西蒙弗雷泽大学研究伦理办公室归类并批准为质量改进计划。结果将传播给当地倡导团体和决策者、国家和国际临床指南制定者,并在国际会议上进行演示,以及通过电子和印刷方式在同行评审期刊上发表。