Design of the COMEBACK and BACKHOME Studies, Longitudinal Cohorts for Comprehensive Deep Phenotyping of Adults with Chronic Low-Back Pain (cLBP): a part of the BACPAC Research Program.
Design of the COMEBACK and BACKHOME Studies, Longitudinal Cohorts for Comprehensive Deep Phenotyping of Adults with Chronic Low-Back Pain (cLBP): a part of the BACPAC Research Program.
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COMEBACK 和 BACKHOME 研究的设计，对成人慢性腰痛 (cLBP) 进行全面深度表型分析的纵向队列：BACPAC 研究计划的一部分。
DOI：
10.1101/2024.04.09.24305574
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发表时间：
2024
期刊：
影响因子：
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通讯作者：
UCSFREACHCenter,theCoReCEnterforPAtie
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作者：
Hue,TrishaF;Lotz,JeffreyC;Zheng,Patricia;Black,DennisM;Bailey,Jeannie;Ewing,SusanK;Fields,AaronJ;Mehling,Wolf;Scheffler,Aaron;Strigo,Irina;Petterson,Thomas;Wu,LucyA;O'Neill,Conor;UCSFREACHCenter,theCoReCEnterforPAtie
加州大学旧金山弗朗西斯科（UCSF）慢性下腰痛以患者为中心的机制表型核心中心（REACH）是NIH背痛联盟（BACPAC）研究计划机制研究中心（MRC）的三个研究项目之一。UCSF REACH的目标是定义cLBP表型和疼痛机制，从而为整个人群的患者提供有效的个性化治疗。该研究项目的主要目标是解决对新的诊断和预后标志物的迫切需求，以及慢性下腰痛（cLBP）治疗的相关患者分类协议。设计为了实现这一目标，REACH正在进行两项大型的翻译研究队列研究，称为：慢性腰痛（cLBP）成人综合深度表型的纵向临床队列研究SettingcomeBACK是一项对450名患有慢性腰痛的成年人进行的纵向多中心现场观察研究，旨在进行全面的深度表型分析。而BACKHOME研究是一项无研究中心的纵向观察性e队列研究，纳入了约3000名患有cLBP的美国成年人。据我们所知，CIMHOME是最大的前瞻性远程注册全国成人与cLBP.MethodsBoth的comeBACK和CIMHOME研究收集了一个强大的和全面的一套风险因素，结果和协变量，以进行深表型的cLBP患者的基础上，结合生物心理社会变量：定义cLBP亚型，建立用于常规临床评价的表型分析工具，并在未来改善cLBP结局。这两项研究的数据将用于建立技术，以开发以患者为中心的治疗成功定义，并分析cLBP患者特征，以定义临床有用的cLBP表型，使用传统数据分析和深度学习方法的组合。我们将能够解决这个复杂多样的cLBP患者群体中的许多诊断和治疗问题。这些研究将有助于阐明cLBP的生物心理社会机制，旨在为改善治疗有效性的评估提供基础，并刺激治疗研究的新途径，包括对个体cLBP患者构成具有临床意义的治疗效果的个性化结局指标。
ObjectiveThe University of California, San Francisco (UCSF) Core Center for Patient-centric, Mechanistic Phenotyping in Chronic Low Back Pain (REACH) is one of the three NIH Back Pain Consortium (BACPAC) Research Programs Mechanistic Research Centers (MRCs). The goal of UCSF REACH is to define cLBP phenotypes and pain mechanisms that can lead to effective, personalized treatments for patients across the population. The primary objective of this research project is to address the critical need for new diagnostic and prognostic markers, and associated patient classification protocols for chronic low back pain (cLBP) treatment.DesignTo meet this objective, REACH is conducting two large investigator-initiated translational research cohort studies called: The Longitudinal Clinical Cohort for Comprehensive Deep Phenotyping of Chronic Low-Back Pain (cLBP) Adults Study (comeBACK) and the Chronic Low-Back Pain (cLBP) in Adults Study (BACKHOME).SettingcomeBACK is a longitudinal multicenter in-person observational study of 450 adults with chronic low back pain designed to perform comprehensive deep phenotyping. While, the BACKHOME study is a site-less longitudinal observational e-cohort of approximately 3000 U.S. adults with cLBP. To our knowledge, BACKHOME is the largest prospective remote registry of nationwide adults with cLBP.MethodsBoth the comeBACK and BACKHOME studies are collecting a robust and comprehensive set of risk factors, outcomes, and covariates in order to perform deep phenotyping of cLBP patients based on combined biopsychosocial variables to: define cLBP subtypes, establish phenotyping tools for routine clinical evaluation, and lead to improved cLBP outcomes in the future. The data from both studies will be used to establish techniques to develop a patient-centric definition of treatment success and to analyze cLBP patient traits to define clinically useful cLBP phenotypes, using a combination of traditional data analyses and deep learning methods.ConclusionsThese 2 pivotal studies, in conjunction with the ancillary studies being performed in both comeBACK and BACKHOME, and the other BACPAC-consortium research projects, we will be able to address a number of diagnostic and therapeutic issues in this complex and diverse patient population with cLBP. These studies will help clarify biopsychosocial mechanisms of cLBP with the aim to provide a foundation to improve the evaluation of treatment effectiveness and to spur new avenues of therapeutic research, including personalized outcome measures that constitute a clinically meaningful treatment effect for individual cLBP patients.