DAT-Emulating target trials with big data to strengthen the evidence base for the clinical management of opioid use disorder

利用大数据模拟 DAT 目标试验，加强阿片类药物使用障碍临床管理的证据基础

基本信息

批准号：
10551310
负责人：
Bohdan Nosyk
金额：
$ 48.68万
依托单位：
SIMON FRASER UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-03-15 至 2026-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10551310
关键词：
Accident and Emergency department Adherence Admission activity American Antiviral Agents Articulation Big Data Biometry British Columbia Canada Caring Case Mixes Cessation of life Chronic Client Clinical Clinical Management Communities Complement Consultations Data Data Science Databases Disease Dose Drug Controls Drug Screening Economics Elements Ensure Epidemic Epidemiology Fentanyl Florida Guidelines HIV Seropositivity HIV/AIDS Health Health system Healthcare Systems Hepatitis C virus Hospitalization Illicit Drugs Imprisonment Income Individual Influentials International International AIDS Level of Evidence Link Measures Medical Medicine Mental Health Methadone Methodology Methods Michigan National Institute of Drug Abuse New Jersey Ohio Outcome Pain Pennsylvania Performance Perinatal Care Persons Pharmaceutical Preparations Physicians Policy Maker Population Positioning Attribute Probability Protocols documentation Province Public Health Recommendation Recording of previous events Records Regimen Reporting Research Rhode Island Safety Series Societies Specific qualifier value Standardization Structural Models Suboxone Testing US State United States National Institutes of Health United States Substance Abuse and Mental Health Services Administration Update Urine West Virginia Work addiction antiretroviral therapy care fragmentation clinical practice combat comorbidity comparative effectiveness data sharing design evidence base experience fentanyl contamination flexibility healing high dimensionality improved integrated care mortality opioid agonist therapy opioid epidemic opioid overdose opioid use disorder overdose death patient subsets public health emergency response screening social factors structural determinants synergism synthetic opioid theories therapy adherence tool treatment effect uptake

项目摘要

ABSTRACT DAT18-06 In 2016, following a dramatic increase in opioid-related overdose deaths, the province of British Columbia (BC), Canada declared a public health emergency. BC reported 1,510 illicit drug overdose deaths in 2018, a rate of 31.0 per 100,000, placing it 10th among US states, equal to Rhode Island (31.0), behind West Virginia (57.8), Ohio (46.3) and Pennsylvania (44.3) but ahead of New Jersey (30.0), Michigan (27.8) and Florida (25.1). While the four-fold increase in overdose deaths observed since 2012 is largely attributable to the contamination of fentanyl and other synthetic opioids in the illicit drug supply, many decedents had sought treatment in the past and experienced relapses. Opioid agonist treatment (OAT) is among the most effective tools available to combat the epidemic. However, OAT uptake and retention is sub-optimal in BC and internationally, compromised largely by social and structural factors but also deviations from evidence-based standards of care and fragmented care, particularly for those with concurrent disorders. Furthermore, a number of aspects of Canadian and US clinical guidelines for the management of opioid use disorder (OUD) are based on limited and low-quality evidence. Even basic evidence on the comparative effectiveness of available treatment options overall and for key populations in the fentanyl era is lacking. This proposal aims to apply cutting-edge methods for causal inference in emulating a series of ‘target trials’ in three immediate aims: (1) to determine the comparative effectiveness of methadone versus buprenorphine/naloxone for different patient subgroups presenting for OAT; (2) to determine the impact of urine drug screening – a ubiquitous and non-evidence- based element of OUD care – on OAT retention and mortality; and (3) to determine the complementary effects of OAT on uptake and adherence to directing-acting antivirals for people with opioid use disorder (PWOUD) with concurrent Hepatitis C Virus. The ‘target trial’ framework channels counterfactual theory in providing a flexible basis for comparing the effects of treatment and clinical management strategies on either an intent-to-treat or per-protocol basis. We have identified a number of additional questions related to the clinical management of PWOUD where guidelines are supported by weaker empirical evidence and will endeavor to answer as many of these questions as possible, prioritizing analysis using a common framework focused on methodological rigor and

抽象的 DAT18-06在2016年，在阿片类药物相关的过量死亡人数急剧增加之后，英国省加拿大哥伦比亚（BC）宣布公共卫生紧急情况。卑诗省报告了2018年的1,510种非法药物过量死亡，这一比率在每10万人31.0的情况下，在美国州中排名第十，等于罗德岛（31.0），落后于西弗吉尼亚州（57.8），俄亥俄州（46.3）和宾夕法尼亚州（44.3），但在新泽西州（30.0），密歇根州（27.8）和佛罗里达州（25.1）之前。而增加了四倍在自2012年以来观察到的过量死亡中，在很大程度上归因于芬太尼和其他合成阿片类药物的污染在非法药物供应中，许多决定在过去解决了治疗，并经历了接力。阿片类激动剂治疗（OAT）是应对流行病的最有效工具之一。但是，燕麦在卑诗省和国际上的摄取和保留率是亚最佳的，在很大程度上受到社会和结构因素的损害偏离基于证据的护理标准和分散的护理标准，特别是对于并发疾病的人。此外，阿片类药物使用障碍管理（OUD）的加拿大和美国临床指南的许多方面基于有限和低质量的证据。甚至有关可用治疗的比较有效性的基本证据总体而言，缺乏芬太尼时代的关键人群。该建议旨在应用尖端方法来为因果推断，以模拟三个中的一系列“目标试验” 直接目的：（1）确定不同的方法载体与丁丙诺啡/纳洛酮的比较有效性出现燕麦的患者亚组；（2）确定尿液药物筛查的影响 - 无处不在和非证据 OUD护理的基于燕麦保留和死亡的元素；（3）确定燕麦的完成效果对患有阿片类药物使用障碍患者（PWOUD）并发性肝炎的人的指导作用抗病毒药的吸收和遵守 C病毒。 “目标试验”框架渠道渠道反事实理论提供了比较效果的灵活基础根据意图对治疗或每项协议的治疗和临床管理策略。我们已经确定了与Pwoud的临床管理有关的其他问题的数量，该指南受到较弱的支持经验证据，并将努力回答尽可能多的此类问题，并使用共同的分析确定分析的优先级框架重点是方法论严格和