Case Study: Evaluating the risk benefit of oral anti-diabetes agents given the recent FDA guidance in T2 diabetes Flashcards Preview

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Flashcards in Case Study: Evaluating the risk benefit of oral anti-diabetes agents given the recent FDA guidance in T2 diabetes Deck (7):
1

Background

-To quantify background risk of CVD in a variety of subpopulations
-Appraise RR of CVD of alternative treatments
-Infer risk in conjunction with benefit in absolute and relative terms

2

Rosiglitazone Meta analysis

-42 of 116 studies selected
-Fixed effects model
-Limitations (no original source data, no time to event analysis, no dose-response data, events in ineligible trials ignored)

3

Meta-analysis

-is the statistical procedure for combining data from multiple studies that address a set of related research hypotheses.
-when effect size is common, meta analysis can identify the common effect
-when effect size is not common meta analysis can identify the reason for the variation

4

Fixed effects model

stipulates that studies under analysis constitute the entire population of units (only within study variation considered to influence the uncertainty of results)

5

Random effects model

stipulates that both within study sampling error (variance) and between study variation are included in the assessment of uncertainty (gives wider (CI than fixed effects models)

6

Two faces of meta analyses

-Aggregation (combine study results)-->focus on chance (power)
-Explanation (compare study results)--> emphasis on validity and generalizability

7

RECORD Trial

Randomized, multi center open label active control safety study
-primary endpoint of time to first hospitalization for CVD event or death from CVD cause