Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center

背痛联盟​​ (BACPAC) 研究计划数据集成、算法开发和运营管理中心

• 批准号: 10400459
• 负责人: Kevin J Anstrom
• 金额: $ 41.64万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400459
• 关键词: Address; Adult; Affect; African American; Algorithms; Back Pain; Brain; Characteristics; Chronic low back pain; Clinical Research; Collection; Development; Enrollment; Ensure; Evidence based treatment; Future; Health Care Costs; Hispanics; Individual; Learning; Low Back Pain; Medical History; Opiate Addiction; Participant; Pathogenesis; Patients; Pharmaceutical Preparations; Phenotype; Physical therapy; Population; Population Heterogeneity; Precision medicine trial; Recommendation; Research; Resources; Risk; Self Care; Sequential Multiple Assignment Randomized Trial; Site; Spinal; Strategic Planning; Time; Underrepresented Populations; United States; United States National Institutes of Health; addiction; algorithm development; base; data integration; disability; duloxetine; ethnic diversity; experience; imaging study; individual patient; insight; new technology; non-opioid analgesic; novel; operation; opioid overdose; optimal treatments; pain patient; patient population; precision medicine; precision medicine clinical trials; programs; racial diversity; recruit; socioeconomic diversity; treatment planning; treatment strategy

ABSTRACT Chronic low back pain (cLBP) affects over 10% of adults in the US, contributing to significant disability, substantial health care costs, and increasing the risk of opioid addiction or overdose for those suffering with cLBP. The NIH Back Pain Consortium (BACPAC), a key component of the NIH Helping to End Addiction Long- TermSM (HEAL) Initiative, is comprised of leading centers with expertise in the pathogenesis and treatment of cLBP. The Back Pain Consortium was assembled to advance understanding of the mechanisms that underlie cLBP as well as to identify novel treatments and treatment strategies for cLBP. Currently, there are a number of evidence-based treatments for low back pain that have been demonstrated to have modest effect sizes on average, but there is a dearth of guidance for clinicians regarding which treatments are best studied for specific patients based on the patient's own phenotypic characteristics. Accordingly, BACPAC is undertaking a large, multi-site, sequential, multiple assignment randomized trial (SMART) that will use existing and novel technologies to phenotype individuals experiencing cLBP. The primary objective of this trial is to estimate optimal precision medicine algorithms (i.e., dynamic treatment regimes) to assist clinicians in making treatment recommendations for future patients. The trial will evaluate a complementary set of treatments, including physical therapy, medication (duloxetine), enhanced self-care, and acceptance and commitment therapy, each of which may be used alone or to augment an existing treatment plan. Having racial, ethnic, and socioeconomic diversity of participants enrolled in this trial is crucial to our ability to learn optimal treatment strategies for individual patients and to ensure that what is learned is applicable to all individuals living with cLBP in the United States (US). This project aims to comprehensively address the challenges of recruiting and retaining a diverse population of cLBP patients that is reflective of the population of individuals who live with cLBP in the US. Through development of comprehensive recruitment and retention plans for strategically chosen study sites that have the capability to recruit from underrepresented populations (e.g., Black and Hispanic populations), and by providing dedicated financial resources to engage patients from these populations using tailored, culturally appropriate strategies, this first-in-kind precision medicine trial can provide unique insight into how we can better treat all cLBP patients, including those from racially and ethnically diverse backgrounds that have historically been excluded from clinical research.

抽象的 慢性腰痛 (cLBP) 影响超过 10% 的美国成年人，导致严重残疾， 巨额医疗费用，并增加阿片类药物成瘾或过量服用阿片类药物的风险 腰痛。 NIH 背痛联盟 (BACPAC) 是 NIH 帮助结束成瘾长期计划的关键组成部分 TermSM (HEAL) Initiative，由在发病机制和治疗方面具有专业知识的领先中心组成 腰痛。背痛联盟​​的成立是为了促进对背痛背后机制的理解 cLBP 以及确定 cLBP 的新疗法和治疗策略。目前，有许多 已证明对腰痛有一定效果的循证治疗方法 平均水平，但临床医生缺乏关于针对特定情况研究最佳治疗方法的指导 根据患者自身的表型特征。因此，BACPAC 正在开展一项大型的、 多中心、连续、多重分配随机试验 (SMART)，将使用现有的和新颖的 对患有 cLBP 的个体进行表型分析的技术。该试验的主要目的是估计最佳 精准医学算法（即动态治疗方案）协助临床医生进行治疗 对未来患者的建议。该试验将评估一套补充疗法，包括物理治疗 疗法、药物（度洛西汀）、增强自我护理以及接受和承诺疗法，其中每一项 可以单独使用或增强现有的治疗计划。 参加本试验的参与者的种族、民族和社会经济多样性对于我们的能力至关重要 学习针对个体患者的最佳治疗策略，并确保所学知识适用于所有人 在美国 (US) 患有 cLBP 的个人。该项目旨在全面解决 招募和留住多样化的 cLBP 患者群体所面临的挑战，这反映了 在美国患有 cLBP 的人。通过发展全面的招聘和保留 战略性选择研究地点的计划，这些地点有能力从代表性不足的人群中招募人员 （例如黑人和西班牙裔人口），并通过提供专门的财政资源来吸引来自 这些人群使用量身定制的、适合文化的策略，这项同类首创的精准医学试验可以 为我们如何更好地治疗所有 cLBP 患者（包括来自种族和民族的患者）提供独特的见解 历史上被排除在临床研究之外的不同背景。

项目成果

The Back Pain Consortium (BACPAC) Research Program: Cover.

背痛联盟​​ (BACPAC) 研究计划：封面。

• 发表时间: 2023-08-04
• 作者: Carter, Robert H;Criswell, Lindsey A
• 通讯作者: Criswell, Lindsey A

Magnetic Resonance Imaging of the Lumbar Spine: Recommendations for Acquisition and Image Evaluation from the BACPAC Spine Imaging Working Group.

腰椎磁共振成像：BACPAC 脊柱成像工作组对采集和图像评估的建议。

• 发表时间: 2023-08-04
• 作者: Sollmann, Nico;Fields, Aaron J;O'Neill, Conor;Nardo, Lorenzo;Majumdar, Sharmila;Chin, Cynthia T;Tosun, Duygu;Han, Misung;Vu, An T;Ozhinsky, Eugene;Shah, Lubdha M;Harris, Richard E;Lobo, Remy;Anderst, William;Herzog, Richard;Psioda, Matthew
• 通讯作者: Psioda, Matthew