The COSTRIMS team

Katia Noyes, MPH, PhD (Principal Investigator), Assistant Professor in Health Services Research, Department of Community and Preventive Medicine, University of Rochester.
Dr. Noyes, a Health Services Researcher with expertise in economic and quality of life assessment in chronic illness such as Parkinson’s disease and cardiovascular disease, will direct the proposed research project. Dr. Noyes is responsible for the quality and scientific merit of the research activities and the overall supervision of the study including supervision of the research activities of the international study team, coordination of the data collection and dissemination efforts, development of CE model and data analyses.

Dr. Noyes completed AHRQ/NSRA Fellowship in cost-effectiveness research and has been involved in and led several cost-effectiveness studies of long-term interventions in chronically ill patients. She also studied remyelination and demyelination in animal MS models. Dr. Noyes served as a co-investigator on the cost effectiveness-quality of life sub-studies of several clinical-economic trials assessing effects of medications on patient health status in conditions with recurrent disease relapses. She received a 5-year career development award from the NIA to study economic and policy consequences of chronic illness. Together with her colleagues Drs. Dick and Holloway, Dr. Noyes developed the methodology for estimating incremental effectiveness of an intervention as the area between the normalized quality of life profiles of the two treatments, the work that received an Award from the International Society on Pharmacoeconomics and Outcomes Research.

Steven Schwid, MD (Investigator, MS clinical expert), Associate Professor of Neurology, Associate Chair for Clinical Research Co-Director, Rochester Multiple Sclerosis Center, University of Rochester. Dr. Schwid serves as a clinical MS expert on the COSTRIMS grant insuring clinical accuracy of modeling assumptions, relevance and quality of clinical data, and providing information about MS care in the USA. As a member of the National Multiple Sclerosis Society Advisory Committee on Clinical Trials of New Drugs in MS, National Multiple Sclerosis Society Medical Advisory Board, and Sylvia Lawry Centre for Multiple Sclerosis Research Clinical Working Group and as a principal investigator on numerous studies including a grant from the National Multiple Sclerosis Society to develop an international study group fostering the development and implementation of investigator-led multi-center clinical research studies (MS-CORE), Dr. Schwid has developed contacts and collaborations with other experts in the field of MS experimental therapeutics. These contacts and collaborative relations will be instrumental in identifying sources of MS data and facilitating dissemination efforts.

Dr. Schwid graduated from the University of Wisconsin Medical School, and completed his residency in neurology at the University of Rochester. He trained in an NIH-sponsored fellowship in Neuroimmunology and the Experimental Therapeutics of Neurological Disorders at the University of Rochester, and then joined the faculty there. He is now Associate Professor of Neurology, as well as Co-Director of the Rochester Multiple Sclerosis Center, and Associate Chair for Clinical Research. In addition to seeing MS patients, he supervises several multicenter clinical trials as Associate Director of the Clinical Trials Coordination Center, a division of the University of Rochester Department of Neurology.

Dr. Schwid has an active research program in the development of quantitative measures of neurologic function for use in clinical trials, especially measures of motor function, cognition, and fatigue. He is the principal investigator of a grant from the National Multiple Sclerosis Society to develop an international study group fostering the development and implementation of investigator-led multi-center clinical research studies. He is principal investigator or co-investigator for multi-center studies of disease modifying therapies for patients with clinically isolated demyelinating syndromes, relapsing, secondary progressive and primary progressive MS, and symptomatic therapies for motor impairment and cognition in patients with MS.

Dr. Schwid is Associate Editor of Neurology. He serves as an ad hoc reviewer for several other journals and regularly reviews grants for the National Institutes of Health and National Multiple Sclerosis Society. He is a member of the National Multiple Sclerosis Society Advisory Committee on Clinical Trials of New Drugs in MS, National Multiple Sclerosis Society Medical Advisory Board, and Sylvia Lawry Centre for Multiple Sclerosis Research Clinical Research Working Group.

Andrew Dick, PhD (Investigator, Health Economist), Rand Corporation.
Dr. Dick’s primarily responsibility on this project is developing and analyzing MS DMA cost-effectiveness model. In Phase I of the project, Dr. Dick is formulating best practice guidelines for CEA in MS DMAs, in particular, on the issues of modeling long-term outcomes, appropriate costs and sources of data. In Phase II, the main responsibility of Dr. Dick in collaboration with Dr. Noyes will be development of the DMA CE model and the CEA of MS DMAs. He will also be instrumental in dissemination of the findings to the research community.

Dr. Dick, a Health Economist by training, specializes in outcomes research and cost effectiveness analysis. He has experience working with clinical trial data as well as administrative datasets (Medicare and Medicaid) estimating health services use and expenditures models. As a PI, Dr. Dick recently received a grant from NCI to evaluate the consequences of various treatments for Ductal Carcinoma In Situ on outcomes, costs, and cost effectiveness. He has also been funded to lead projects that investigate the quality of life and cost effectiveness of implantable defibrillators (MADIT II) and structural relationships between treatments, biological factors, health status measures, and quality of life. He has published numerous articles on outcomes measurement and risk adjustment and has written about the importance of validating surrogate outcome measures for use in cost-effectiveness analysis and outcomes research.

Robert Holloway, MPH, MD (Investigator, Neurologist and Cost-Effectiveness expert), Associate Professor and Vice Chair, Departments of Neurology and Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry.
In Phase I of this project, Dr. Holloway is involved in developing the criteria for systematic review and helping to finalize the best practice guidelines. In Phase II of the project, he will be involved with developing CE MS DMA model, particularly, combing information about MS natural history and available treatments and translating it into the modeling assumptions about disease progression, long-term treatment efficacy and associated costs. Because of his ties to both clinicians and researchers, Dr. Holloway will be also involved in the dissemination efforts presenting the study findings to the clinical and research communities as well as MS patients.

Dr. Holloway is a Neurologist and Health Services Researcher at the University of Rochester with 10 years of experience in planning, implementing and reporting on cost effectiveness research. He is the director of the Cost-Effectiveness Research Center within the Department of Community and Preventive Medicine, and has published extensively on cost-effectiveness research and its application to a variety of multiple neurological conditions including multiple sclerosis, stroke, Parkinson’s disease, and epilepsy.

Christopher McCabe, PhD, MS CE modeling consultant, Senior Lecturer, University of Sheffield.
Through his well-established contacts in the field, Dr. McCabe will facilitate collection of unpublished literature on CE and MS modeling and information about relevant data sources and will be involved in drafting the best practice guidelines for CEA of MS DMAs. He will also facilitate assembly of the peer-review panel and preparation of the final report to the NMSS. In phase II, Dr. McCabe will consult with the research team on the issues around CE modeling in MS, and will be involved in testing and validating the model and interpreting the results. He will also be involved in the dissemination activities focusing on the researchers and MS clinicians in the UK.

As the Director of the Decision Support Unit of the National Institute for Clinical Excellence (NICE), Dr. McCabe has extensive expertise in modeling cost-effectiveness of MS DMAs and in estimating uncertainty in such analyses and served as principal investigator on the United Kingdom Cost Effectiveness of Multiple Sclerosis Therapies Study Group. His own research is focused on economic evaluation to inform resource allocation decision, on valuation of the Health Utilities Index (MRC UK PICOS) and on economic evaluations alongside clinical trials. Through the Centre for Bayesian Statistics and Health Economics, Dr. McCabe is connected to the world’s leading experts on the analysis of uncertainty in CE research.

Martin Daumer, PhD, Sylvia Lawry Centre for Multiple Sclerosis Research (SLCMSR), Scientific Director, MS data expert
Dr. Daumer will serve as the subcontract director to coordinate the activities of the SLCMSR on this project. His responsibilities will include consulting with the study team on modeling MS natural history and about data available through the SLCMSR and other sources as well as timely reporting of deliverables to the study PI.

Dr. Daumer is theoretical physicist and mathematician by training, who has worked in the intersection of biometry and informatics for 8 years. Dr. Daumer serves on several MS trials and acts as an ad-hoc reviewer for mathematical and neurological journals. At the SLCMSR he is actively involved and overseeing the development of tools and methods useful for exploring, modeling and predicting the course of MS.

Deborah Miller, PhD (MS QOL consultant), Director of Comprehensive Care, Mellen Center, Cleveland Clinic Foundation.
On this project, Dr. Miller is assisting with the systematic review of the literature addressing outcome assessment in MS, including quality of life assessment, and will consult on choices of long-term MS outcomes for CE modeling. Dr. Miller is also identifying sources of data for MS DMA CEA. In addition, she will be involved in the dissemination activities.

Dr. Miller is a clinical social worker with primary interest in developing and applying patient reported outcomes in clinical and research settings. She was part of the team that developed the Multiple Sclerosis Quality of Life Inventory and has used it in a number of contexts (the Impact Trial, a NMSS study of the benefit of rehabilitation in Multiple Sclerosis) and now is a PI on a study funded by the NIH.

As Director of Comprehensive Care at the Mellen Center for MS Treatment and Research of The Cleveland Clinic, her responsibilities include program development and outcomes research, providing clinical care, conducting psychosocial research and assuring integration of the Center's clinical, research and operational activities. She obtained her MSSA and PhD from the School of Applied Social Sciences, Case Western Reserve University. With more that 20 years experience in the area of chronic disability, she has been a member of the Mellen Center's interdisciplinary care team since 1985. She is currently the principal investigator for a NIH funded study “Using the Internet to Improve Patients’ Self-Management of Chronic Illness.” Her practice interests focus on marital and family adjustment to the consequences of MS. Using her clinical experience, Dr. Miller has developed and facilitated group treatment programs for school age children and teenagers whose parents have MS and for adults who have parenting concerns because of MS. She has lectured nationally on these subjects. She has extensive affiliations with the National Multiple Sclerosis Society. She is a member of the Northeast Ohio Chapter's Client Services Committee and won that Chapter's "Health Care Professional" award in 1991. In addition, she is a past president and a current member of the Board of Trustees of the Long Term Care Ombuds Program in Cleveland.

Pluma W. (Scotti) Kluess, Senior Health Project Coordinator.
As the project coordinator, Ms. Kluess is responsible for the day-to-day operations, including preparing drafts of progress reports and ensuring coordination of peer-review panel activities. Other responsibilities include facilitation of communication between the study team and the NMSS, and with the study consultants and the subcontract, coordination of the two research assistants, maintaining and updating records of the MS and CE systematic review literature and MS data sources, tracking the project deliverables, and assisting with activities outlined in the dissemination plan.

Ms. Kluess has a Masters Degree in Community and Preventive Medicine from the University of Rochester and over twenty years experience in health services research, grant management, program design, development and management, with special expertise in long term care.