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"study size"

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Study Size Planning for Observational Comparative Effectiveness Research

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: comparative effectiveness research | observational | study size | background
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Outline of Material

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: outline | comparative effectiveness research | key considerations | study size planning
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Introduction

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: introduction | feasibility | study size | rationale | interpretation
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Study Size and Power Calculations in Randomized Controlled Trials (1 of 3)

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: study size | power calculations | randomized controlled trials
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Study Size and Power Calculations in Randomized Controlled Trials (2 of 3)

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: clinically meaningful difference | data variability | minimum detectable difference | power calculations | study size
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Study Size and Power Calculations in Randomized Controlled Trials (3 of 3)

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: study size | power calculation | statistical significance | type 1 error
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Considerations for Observational Comparative Effectiveness Research Study Size Planning

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: observational comparative effectiveness research | study size
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Conclusions

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: conclusion | study size | statistical methods
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Summary Checklist (1 of 2)

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: summary checklist | study size | statistical methods
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Summary Checklist (2 of 2)

Presentation: Study Size Planning for Observational Comparative Effectiveness Research
Keywords: summary checklist | study size | statistical methods
Characteristics of Comparative Studies on Off-Label rFVIIa Use With the exception of use in ICH, study sample sizes were small (median of 24 treated patients). The doses used in the studies that are the focus of this effectiveness review varied from 5 to 956 mcg/kg of patient weight, and only for intracranial hemorrhage was there a sufficient range of doses to assess the impact of rFVIIa dosing on outcomes. Most studies used indirect endpoints as their primary outcomes, particularly red blood cell (RBC) transfusion requirements. Direct outcomes, such as mortality, functional status, or thromboembolic events, were frequently reported, but most studies were individually underpowered to evaluate them. Most clinical research on rFVIIa has been directed and sponsored by Novo Nordisk, the product’s manufacturer. The strength of evidence available from existing studies was thereby compromised by small study size, use of indirect outcomes, and heterogeneity in dosage and indication. The applicability was diminished by less acutely ill patients and a mismatch between existing research and real-world patterns of indication and types of use.
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Characteristics of Comparative Studies on Off-Label rFVIIa Use

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | strength of evidence
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Considerations for Statistical Analysis in Observational Comparative Effectiveness Research

Presentation: Considerations for Statistical Analysis in Observational Comparative Effectiveness Research
Keywords: comparative effectiveness research | observational | statistical analysis | background
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