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2005 HSR&D National Meeting Abstract

2005 — Designing Effectiveness Studies for Chronic Mental Illness: Lessons from CSP #430

Author List:
Bauer MS (Providence VAMC)
Kilbourne AM (Pittsburgh VAMC)

Workshop Objectives:
Most clinical trials seek to establish the impact of interventions under best-practice conditions. Such "efficacy studies" seek to maximize the internal validity of the study. In contrast, studies to establish the impact of such interventions in wider use, under "general clinical practice" conditions, are much rarer. This latter type of study is required to establish the ultimate public health impact of an intervention and to guide decision-making by clinicians, administrators, and policy-makers. Such "effectiveness studies" are designed to maximize external validity, i.e., generalizabilty to the population who would be treated by the intervention. It is reasonable to consider efficacy and effectiveness trials not to represent distinct types of studies, but rather opposite poles on a continuum along which specific design decisions must be made. Such design decisions typically involve trade-offs between internal and external validity and between efficacy and effectiveness characteristics. Neither type of characteristic is "preferable" to the other; such decisions should be made on the basis of the state of the knowledge base and the specific purposes of the protocol. Participants will be able to identify efficacy/effectiveness design decisions for clinical trials, understand the implications of trade-offs, and develop design strategies to preserve internal validity while maximizing external validity as appropriate to their protocol.

Workshop leaders will initially review Nine Principles of Effectiveness Study Design relating to Sample, Intervention, Data Collection, and Data Analysis, illustrated by specific examples from CSP #430. Participants and workshop leaders will interactively discuss these principles with regard to design decisions in their own protocols.

Target Audience:
Investigators and post-doctoral trainees involved, or wishing to become involved, in designing effectiveness trials for chronic illnesses, "mental" or "physical."

Assumed Audience Familiarity with Topic:
Familiarity with basic (not necessarily advanced) principles of clinical trial design; some familiarity with psychiatric assessment beneficial but not required.

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