Cost effectiveness of manipulation for spine pain using individual patient data

 描述（由申请人提供）：背景：脊柱疼痛是一种持续性和致残性疾病，在美国占慢性疼痛的很大比例。脊柱疼痛的常规管理策略成本高，大多无效，有时有害。有证据表明，补充性和综合性健康干预措施（如脊柱推拿）可以减少脊柱疼痛的临床和成本负担;然而，目前证据的质量有限，并且存在对美国脊柱疼痛人群的普遍性的担忧。目标和目的：Leininger博士的长期职业目标是成为一名独立研究科学家，专注于进行严格且相关的研究，调查针对脊柱疼痛病症的补充和综合健康干预措施的临床和成本效益。两年半前，莱宁格博士收到了露丝L。Kirschstein国家研究服务奖个人博士后奖学金（F32），用于临床研究培训并获得成本效益分析介绍。拟议的K 01申请的总体目标是为Leininger博士提供受保护的时间，以获得实现其长期职业目标所需的临床和健康服务研究方面的高级技能和经验。拟议的职业发展计划将使Leininger博士能够实现他的短期和中期目标，即在高级统计分析方面获得更多的知识、培训和经验;卫生服务研究方法;使用个体患者数据进行成本效益分析;使用大型全国调查进行数据分析;临床和卫生经济结果的系统审查方法;以及科学写作和交流。职业发展/培训活动：K 01应用程序将建立在博士Leininger的培训作为一个脊椎按摩师，以及他的研究教育和发展的一部分，他的F32。Leininger博士与他的导师一起制定了一个全面的职业计划，适合他的发展水平，并与他的长期职业目标保持一致。Leininger博士将参与强有力的培训活动，包括：1）导师; 2）课程; 3）研究项目; 4）出版和演示; 5）讲习班和研讨会; 6）赠款写作;和7）负责任的研究行为。导师：Leininger博士的导师团队由来自临床研究，卫生服务研究和社会流行病学领域的有成就的科学家组成，他们在与他的研究项目和职业目标相关的主题方面拥有广泛的专业知识。他的导师在随机临床试验，系统评价，分层统计分析，基于试验的成本效益分析，经济评估建模方法，大型复杂调查数据管理和分析以及代表性不足的人群方面具有专业知识。除了为Leininger博士提供科学指导外，他的导师还将提供职业建议，并促进新的研究合作，这将使他能够扩大他的专业网络。工作环境：Leininger博士将受益于明尼苏达大学（UMN）有抱负的研究人员所拥有的丰富资源，该大学在美国所有公立大学中排名前9位。基于创新中心 作为UMN学术健康中心内的一个大学范围的灵性与治疗中心，Leininger博士将继续与公共卫生，护理和医学学院的教师发展有意义的合作和跨学科关系。他还将利用来自临床和转化科学研究所（UMN的NIH资助的CTSA）的智力，设施和资金资源。研究：Leininger博士提出的K 01研究项目将解决美国脊柱疼痛管理的重大和昂贵的问题。Leininger博士将通过结合他的主要导师在美国进行的8项实用随机临床试验的现有数据，使用新的个体患者数据荟萃分析方法（具体目标1）确定脊柱推拿治疗脊柱疼痛的成本效益。该项目将解决我们目前对美国医疗保健系统内脊柱操作的成本效益的理解存在的重大差距。Leininger博士还将通过确定临床试验参与者相对于美国脊柱疼痛人群的普遍性来解决基于试验的成本效益分析的常见局限性（具体目标2）。最后，Leininger博士将使用这些重要的美国分析结果更新现有的系统综述，使用严格的当代系统综述方法确定偏倚风险和总体证据（具体目标3）。

 DESCRIPTION (provided by applicant): Background: Spine pain is a persistent and disabling condition responsible for a large proportion of chronic pain in the U.S. Conventional management strategies for spine pain are costly, largely ineffective, and at times harmful. There is evidence suggesting complementary and integrative health interventions, such as spinal manipulation, can reduce the clinical and cost burden of spinal pain; however, the quality of current evidence is limited and there are concerns regarding generalizability to the U.S. spine pain population. Goals & Objectives: Dr. Leininger's long-term career objective is to become an independent research scientist focused on conducting rigorous and relevant research investigating the clinical and cost-effectiveness of complementary and integrative health interventions for spinal pain conditions. Two and half years ago, Dr. Leininger received a Ruth L. Kirschstein National Research Service Award Individual Postdoctoral Fellowship (F32) to train in clinical research and gain an introduction to cost-effectiveness analysis. The overall objective of the proposed K01 application is to provide Dr. Leininger protected time to gain advanced skills and experience in clinical and health services research necessary for reaching his long-term career objective. The proposed career development plan will enable Dr. Leininger to achieve his short and intermediate-term goals of gaining additional knowledge, training and experience in advanced statistical analyses; health services research methods; cost-effectiveness analyses using individual patient data; data analyses using large national surveys; systematic review methods for clinical and health economic outcomes; and scientific writing and communication. Career Development/Training Activities: The K01 application will build on Dr. Leininger's training as a chiropractor, as well his research education and development as part of his F32. With his mentors, Dr. Leininger has crafted a comprehensive career plan appropriate for his level of development and consistent with his long term career objectives. The plan will engage Dr. Leininger in robust training activities including: 1) mentorship; 2) coursework; 3) a research project; 4) publishing and presenting; 5) workshops and seminars; 6) grant-writing; and 7) responsible conduct of research. Mentors: Dr. Leininger's mentorship team consists of accomplished scientists from clinical research, health services research and social epidemiology fields with a diverse range of expertise in topics relevant to his research project and his career goals. His mentors have expertise in randomized clinical trials, systematic reviews, hierarchical statistical analyses, trial based cost-effectiveness analyses, modeling methods for economic evaluations, large complex survey data management and analyses, and under-represented populations. In addition to providing Dr. Leininger scientific guidance, his mentors will also offer career advice and facilitate new research collaborations which will allow him to broaden his professional network. Environment: Dr. Leininger will benefit from a wealth of resources available to aspiring researchers at the University of Minnesota (UMN), which is ranked in the top 9 of all public universities in the United States. Based in the innovative Center for Spirituality & Healing, a university-wide center within the UMN's Academic Health Center, Dr. Leininger will be well situated to continue to develop meaningful collaborative and interdisciplinary relationships with faculty from the Schools of Public Health, Nursing and Medicine. He will also capitalize on intellectual, facility and funding resources available from th Clinical and Translational Science Institute (the UMN's NIH funded CTSA). Research: Dr. Leininger's proposed K01 research project will address the significant and costly issue of spinal pain management within the United States. Dr. Leininger will determine the cost-effectiveness of spinal manipulation for spine pain conditions by combining existing data from eight pragmatic randomized clinical trials conducted in the U.S. by his primary mentor, with comparable interventions and outcomes using a novel individual patient data meta-analysis approach (Specific Aim 1). The project will address significant gaps in our current understanding of the cost-effectiveness of spinal manipulation within the U.S. healthcare system. Dr. Leininger will also address a commonly cited limitation of trial based cost-effectiveness analyses by determining the generalizability of clinical trial participants in relation to the U.S. spine pain population (Specific Aim 2). Finally, Dr. Leininger will update existing systematic reviews with the results of these important U.S. based analyses using rigorous and contemporary systematic review methods for determining risk of bias and the overall evidence (Specific Aim 3).