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).
Spinal pain accounts for a large proportion of chronic pain in the United States resulting in substantial individual and societal burden. Spinal manipulation is a commonly used complementary and integrative approach with promising evidence of clinical effectiveness; however, high quality cost-effectiveness research is lacking. The proposed research and career development plan will address this gap and meet the National Center for Complementary and Integrative Health's goal of improving the capacity to conduct rigorous research in mind-body interventions for symptom management.
