Session Summary: ISCTM 2010 National Mental Health Research-to-Policy Forum: Comparative Effectiveness Trials in CNS Disorders: Rationale, Elements and Challenges

Chairs: Nina Schooler, Ph.D., State University of New York; Charles Bowden, M.D., University of Texas Health Science Center at San Antonio

Speakers:  T Ten Have PhD, MPH, University of Pennsylvania SOM; B Heinssen PhD, National Institute of Mental Health; N Schooler PhD, State University of New York; L Dixon MD, MPH, University of Maryland School of Medicine

Discussants:  D Meltzer MD, PhD, University of Chicago; M Rawlins MD, National Institute for Health and Clinical Excellence (NICE)

Summary

Comparative effectiveness studies generally try to answer the question “How do different treatments compare as utilized in clinical practice?”  They use a variety of strategies to compare alternative interventions for a diverse group of stakeholders.  Speakers in the session will define the settings and key methodological elements for comparative effectiveness research. The example of large-scale comparative effectiveness trials now being planned, the NIMH RAISE initiative, will be discussed.  The session will include consideration of analytical methodologies which may be particularly useful in synthesizing and conveying results from such studies in ways that yield more effective new treatments and adequately manage multidimensional outcome variables.

Key Issues in CER of Design and Analysis

T. Ten Have, PhD, MPH

Goals and Strategies of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Initiative

B. Heinssen, PhD

RAISE will test whether early, aggressive and pre-emptive intervention can slow or halt clinical and functional deterioration in schizophrenia.  This has substantial potential cost savings for society (2002 cost of schizophrenia in US:  $62B).

The NIMH RAISE Initiative.  Two Parallel Approaches to a CER Question:  Case Study I

N. Schooler, PhD

Key concepts:  1) study populations will be chosen to be representative of clinical practice, 2) interventions will focus on the individual rather than the average patient, 3) we will compare two or more interventions directly.  N=400, 2 years of treatment, site-level randomization to either community care or multi-dimentional psychopharmacologic and psychosocial treatment intervention.

The NIMH RAISE Initiative.  Two Parallel Approaches to a CER Question:  Case Study II

H. Goldman

One key difference between Case Studies I & II is that case II will be run in NY & MD states, to provide public funding for treatments.  N=370, 2 years of treatment.  Individual-level randomization will be to a “Connection Team” (recovery, skills training, and employment/education specialists, as well as psychopharmacologist) or “Connection Partnership” (recovery-oriented care coordinator).  Assessments occur every 3 months.

Academic Discussant

D. Meltzer, MD, PhD

1.    Emphasis on Prevention is important