ARAMIS: Pharmaccutical collaborations
ARAMIS: Pharmaccutical collaborations
Stanford University
The objectives of ARAMIS pharmaceutical collaborations are to examine real-life outcomes that are difficult to answer solely with randomized clinical trials, such as effectiveness of treatment, health care resource utilization, and compression of morbidity in patients with rheumatic diseases and in normal, healthy aging populations. ARAMIS projects build upon the large high-quality, multi-disciplinary data sets that are comprised of more than two decades of patient data. Past research has included the development and validation of outcome assessment instruments and their widespread use, development of aggregate measures for drug toxicity and effectiveness, preliminary explorations of alternative treatment strategies, and application of pharmacoeconomic techniques in the rheumatic diseases. Pharmaceutical collaborations are an integral part of ARAMIS activities.
ARAMIS data emanate from 17 North American databank centers, that include the University of Pittsburgh, Pittsburgh, PA (university clinic, university-affiliated private practice, and HMO); University of Cincinnati, Cincinnati, OH (university clinic); Stanford University, Stanford, CA (university clinic and multiple sets of community patients); University of Memphis, Memphis, Tennessee, Santa Clara Valley Medical Center, Santa Clara, California, and the University of Saskatoon, Saskatoon, Saskatchewan, Canada (community sample from the province). Healthy aging populations are drawn from a study of alumni from the University of Pennsylania and a study of aging exercisers versus non-exercisers.
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Available data are comprised of more than 1,200 variables that are associated with or that which may influence outcomes. They include assessment of demographics, physical function, pain, global health, the biology of disease, co-morbidity, health behaviors, health care resource utilization, and mortality. Patient data are collected regularly with the Health Assessment Questionnaire (HAQ) (see DATA ELEMENTS below).
ARAMIS DATA ELEMENTS
The HAQ is a comprehensive, generic outcome assessment instrument developed by and for ARAMIS. The HAQ has been employed in studies regularly since 1980. It conceptualizes health outcomes in patient-centered dimensions: disability, pain and other symptoms, adverse effects of drugs, procedures and hospitalizations, surgery, and economic impact. It also enables studies of mortality. The HAQ includes items on medication use (over 40 rheumatic disease specific medications and 15 classes of other medications, with new medications added as they become available), drug side effects, co-morbid conditions, health behaviors, and health care utilization.
A toxicity index for comparing drug toxicity, aggregating adverse symptoms, laboratory tests, and hospitalizations into a single value, has been developed and is used to analyze NSAID and DMARD therapy, based upon clinical and HAQ data. A methodology for comparing treatment effectiveness in the domains of disability, pain, and patient global assessment, based upon the HAQ, has also been developed. These techniques find important use in the ARAMIS program.
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CURRENT STUDIES
ARAMIS
ARAMIS is entering its 30th year of NIH funding. The overall objectives are to improve patient outcomes in rheumatoid arthritis by identifying and documenting more optimal treatment strategies, encouraging use of more effective medications, reducing drug toxicity, and making patient education programs widely available over the internet, and thus providing effective self-management treatment adjuncts. The projects address these questions:
ARTHRITIS AND CHRONIC DISEASE OUTCOMES-What are the effects of aspirin, traditional NSAIDs, newer Cox-1 sparing NSAIDs, disease activity, exercise, and other factors upon risk of atherosclerotic complications? What are the effects of aspirin and NSAIDs on incidence of solid tumors, especially colon cancer? What are the effects of immunosuppressive treatments, including new anti-cytokine treatments, on the incidence of leukemia and lymphoma? Does methotrexate treatment, through reduction in homocysteine, predispose to atherosclerotic events?
MINORITY OUTCOMES IN RHEUMATOID ARTHRITIS (RA) - Are outcomes of RA (disability, patient, global, costs) at 5, 10, and 15 years of disease, different across Caucasian, Hispanic, African-American, Native American, and Asian patients? May differences be explained by factors such as education level, genetics, compliance, lack of focus, specific medications prescribed, number of doctor visits, number of rheumatologist visits, self-efficacy, or other variables?
PATIENT EDUCATION AND THE INTERNET - Will persons with OA, RA or fibromyalgia take part in an internet-based Arthritis Self-Management Program which incorporates a closed web site, bulletin board, and email discussion group? Will participants randomized to receive an internet-based Arthritis Self-Management Program demonstrate improved health status (disability, pain, fatigue, health distress, and activity limitations) and health behaviors (exercise, use of cognitive pain management techniques, communication with physicians), and reduced health care utilization (number of visits to physicians, days in hospital) when compared to randomized controls? Will improvements in health status and health care utilization be associated with changes in self-efficacy?
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The grant also continues to follow a national inception cohort of 1,000 RA patients seen by approximately 160 rheumatologists within the first year of disease. It extends the ARAMIS RA cohort experience to up to 9 years of longitudinal study, with clinical, outcome, and genetic information. This cohort will facilitate studies of early RA including the effectiveness of early treatment with disease-modifying drugs. Use of new protein micro-array technology to analyze the autoantibody response in RA will enable search of hundreds of specific viral, microbial, and filaggrin-related antigen and antibodies using our serum data banks, in a search for causal agents for RA.
For further information, please contact:
Bonnie Bruce, DrPH, MPH, RD
Senior Medical Scientist
(650) 723-7921
©2005 Stanford University. All Rights Reserved.
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