Health Outcomes Core

The Health Outcomes Core brings together an interdisciplinary group of researchers from the clinical, biomedical, quantitative, behavioral, and social sciences. Individual Core personnel are currently engaged in research to evaluate acupuncture, biofeedback, chiropractic manipulation, cognitive-behavioral therapies, placebo response, and more. Members have advanced training and expertise in observational and clinical study design and analysis, medical decision-making, health economics, and health utility assessment. Recent applications include appropriate diagnostic decision-making in irritable bowel syndrome (IBS), dyspepsia, and gastrointestinal tract hemorrhage. Thus, the Health Outcomes Core is a resource for the translation of successful interventions into programs that can be carried out within a wide array of clinical settings. The aims of the Core are as follows.

Aim 1. Develop a universal surveillance system and centralized database across several clinical sites that provide various mind-body interventions to patients with the full spectrum of stress-related conditions (functional GI disorders, chronic pain, stress, anxiety and depression) providing data flow, data maintenance, secure access, and data quality control.

Aim 2. Facilitate synergistic interactions between investigators while maintaining data security and confidentiality.

Aim 3. Provide statistical and epidemiologic consulting concerning research questions, study designs and analytic methods best suited to the overall Health Outcomes database or the individual Clinics.

Aim 4. Foster collaborative research among treatment providers and clinical researchers for research questions best addressed by hypothesis-driven data collection and analysis of new or existing data.

Aim 5. To participate in the expansion of successful feasibility studies by providing preliminary observational data, summaries of patient characteristics, consultation on the design and analysis of those studies, and as needed and as feasible, the core statistical and database functions for those studies.

Services

The Health Outcomes Core has developed a Web-based data system to collect and manage patient outcome data. The system is called PROCAIM, for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine. PROCAIM allows for the assessment of most modes of integrative therapies across the full spectrum of conditions. Patient-centered outcomes (e.g. symptom relief, satisfaction, health-related quality-of-life, attitudes and values) will be evaluated along with patients' prior beliefs and expectations and psychological characteristics (affective symptoms and coping styles). The database will also serve as a research resource for effectiveness research and hypothesis-driven collaborative studies on the pathophysiological mechanisms involved in symptom presentation and treatment response.

The PROCAIM Network will include patient populations treated at the CNS/WH Integrative Medicine Clinic and Women's Digestive Health Center, the UCLA Behavioral Medicine and Anxiety Disorders Clinics, the UCLA Center for East West Medicine, and the Chiropractic and Multi-Specialty Clinic of the Los Angeles College of Chiropractic and to other interested clinics. Thus, the PROCAIM Network and resulting database will facilitate large scale studies in the following areas.

• Effectiveness research. The first will be to evaluate the effectiveness of the various modes of mind/body interventions and to identify characteristics of patients who may be most likely to improve with each type of treatment.
  
  
• Hypothesis-driven research. The second will be to facilitate research to enhance understanding of the complex pathophysiology underlying some of the most common chronic stress-related diseases (such as visceral and somatic pain syndromes, disorders of mood and affect and addictive behaviors).
  
  
• Clinical management. The third will be to assist in the clinical management of patients treated at participating clinics that treat patients with various mind/body therapies and other forms of complementary and alternative medicine

Eligibility and Fees
The Health Outcomes Core can participate in the expansion of successful feasibility studies by providing preliminary observational data, summaries of patient characteristics, consultation on the design and analysis of those studies, and as needed and as feasible, the core statistical and database functions for those studies.

Investigators are required to provide a brief, 1-2 page, overview that will include: the specific research questions, analysis methods, required data elements, funding source, and proof of IRB exemption from review. Each request for data will be reviewed by the CNS/WH Executive Committee. Criteria for approval will include: scientific merit, credentials of the requestor, documentation of Certification of Exemption from IRB Review, compensation for computer programmers to download requested data, and procedures for storing and maintaining data. In general, only requests will be considered if the research questions are consistent with the central and overarching theme of the CNS/WH: the neurobiology of the stress response in health and in chronic disease. Investigators will be expected to have at least post-doctoral appointments at UCLA or with CNS/WH members at the UC Irvine, USC, Ohio State University, University of Pittsburgh, Emory University, or the Max Planck Institute in Munich, Germany.

The Core is available to all UCLA faculty interested and qualified in mind body research. Potential Core users should first contact the Director or Co-Directors. Specific projects for which files must be constructed will be charged for staff time at an hourly rate and reimbursed via intra-campus recharge on funded projects. Compensation of Core personnel for consultation services will require intra-campus recharge and/or inclusion on extramural grant applications.

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