Lecture #5: Analytic Epidemiology Studies

Lecture #5: Analytic Epidemiology Studies - • Placebo-...

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1 EPIDEMIOLOGIC STUDY DESIGNS EXPERIMENTAL STUDIES CASE SERIES OBSERVATIONAL STUDIES CASE- CONTROL COHORT CLINICAL TRIAL COMMUNITY INTERVENTION CROSS- SECTIONAL
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2 Strength of Causal Inference Clinical trials Cohort Community trial Case- Control X-sectional Experimental Observational Cost
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6 Design variations 1. Crossover trial 1. Participants are given two treatments (may include placebo) 2. Treatments are given in alternating fashion. 3. May require a “washout” period between drugs
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7 More Design Variations Factorial Design 1. For example in a 2 by 2 factorial design, two drugs are being tested against placebo and participants are separately randomized to both. 2. Four possible interventions 3. Physician’s Health Study 1. Physicians randomized to aspirin or placebo, beta-carotene or placebo.
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8 Factorial Design: Physicians Health Study 22,071 randomized 11,037 Aspirin 11,034 Asp Placebo 5517 Beta-carotene 5520 BC placebo 5520 Beta Carotene 5514 BC placebo
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9 Jargon of Clinical Trials
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Unformatted text preview: • Placebo- inactive treatment with no anticipated therapeutic effect • Single Blind- patient or participant is unaware of treatment group • Double Blind- participant and the provider are unaware of the treatment group 10 Jargon of Clinical Trials • Intention to treat analysis- data are analyzed according to how participants were assigned • Experimental Protocol- written document containing objectives and procedures • Data Safety and Monitoring Board (DSMB )- group of experts that review the progress of the trial 11 Jargon of Clinical Trials • Consolidated Standards Of Reporting Trials (CONSORT)- formal guidelines for reporting results from large trials • Clinical Equipoise- state of genuine uncertainty about the merits of each arm of a trial • Adverse effects-- unintended consequences of participating in the study 12 CONSORT Diagram FM Trial...
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This note was uploaded on 05/12/2008 for the course EPI 420 taught by Professor Goldberg during the Spring '08 term at University of Washington.

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Lecture #5: Analytic Epidemiology Studies - • Placebo-...

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