This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic, 05-AT-102 Comparative Effectiveness Studies of Complementary and Alternative Medicine. In recent times, comparative effectiveness research (CER) has been taken to mean conventional randomized clinical trials (RCTs). It has been increasingly recognized, however, that RCTs work best in the case of narrowly-defined populations over relatively short time periods, for testing interventions that are easy to specify and deliver. Since both integrative medicine (IM) as well as clinical and community-based complementary and alternative medicine (CAM) frequently have none of these characteristics, it is natural to turn to other sources for CER. An obvious alternative consists of existing electronic medical records (EMR). It is, however, not true that the enormous volume of these records can be easily mobilized to answer clinical research questions. Applying the statistical methods of RCTs to clinical observational data is frequently a mistake, as any number of studies have asserted. It does not follow from this, however, that EMR data is of no clinical research use - instead the implication is that the statistical methods need to be modified. The focus of this proposal is to create a model project to establish the protocols, based on previously developed methods, by which clinical research from existing data (perhaps modestly supplemented with new data acquisition) can be envisioned, designed, carried out, and analyzed. The long-term goal of the project is to scale this model up to multiple clinics, cumulating an ever larger and more research-useful database for a broad variety of both disease states and therapeutic approaches, which provides patient-centered evidence-based recommendations that apply to the populations of patients who actually present themselves for medical care. This project will articulate the resources of two institutions. The Marino Center for Integrative Health (MC) has clinics in Wellesley and Cambridge MA, conducted 54,000 visits in 2008, in conventional primary care (50%) and nine specialty service units ranging from acupuncture to women's health. MC has had an EMR since 2002. The group of researchers from the University of Arizona (UA) combines experience in both conventional clinical practice and CAM research, and the PI of this application has also had extensive experience with large EMR and other administrative databases, including the development of the event- stream methodology proposed for use in this application. The elements of this proposal are as follows: """""""" to establish a research collaboration between a successful integrative medicine clinic, the Marino Center for Integrative Health near Boston, and a collection of experienced conventional and alternative medicine researchers at the University of Arizona in Tucson """""""" to develop an administrative structure for evaluating an existing database, envisioning and designing feasible observational clinical studies, providing the technical information for implementing those studies through rigorous data extraction principles, and to apply recently-developed methods of event- stream analysis to provide results that can be applied to individual patients """""""" to demonstrate the feasibility of this CER model by conducting clinically relevant studies in at least four selected disease conditions, based on the concept of the patient trajectory of care and providing patient-centered results, including fibromyalgia, back pain, irritable bowel syndrome, and peri- menopausal symptoms. CER Collaboration: University of Arizona and Marino Center for Integrated Health This comparative effectiveness research project will develop methods for the evaluation and comparison of conventional medical care and integrative medicine/complementary and alternative medicine, using an existing clinical database and previously developed programming techniques, with minor additional data acquisition. It will generate CER studies specific to irritable bowel syndrome, fibromyalgia, back pain, and peri-menopausal symptoms. The protocols will be designed to scale up to more clinics, more health conditions, and a wider collection of treatment modalities.
CER Collaboration: University of Arizona and Marino Center for Integrated Health This comparative effectiveness research project will develop methods for the evaluation and comparison of conventional medical care and integrative medicine/complementary and alternative medicine, using an existing clinical database and previously developed programming techniques, with minor additional data acquisition. It will generate CER studies specific to irritable bowel syndrome, fibromyalgia, back pain, and peri-menopausal symptoms. The protocols will be designed to scale up to more clinics, more health conditions, and a wider collection of treatment modalities.
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