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RESCUE Design and Analysis plans

RESCUE Design and Analysis plans. Constantine Gatsonis, PhD ACRIN Biostatistics and Data Management Center Brown University. Patient follow-up at 6-month intervals. R. 24 months m ax follow-up. 12 months m in follow-up 12. Primary endpoint : MACE ={MI, death, revascularization}.

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RESCUE Design and Analysis plans

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  1. RESCUE Design and Analysis plans • Constantine Gatsonis, PhD • ACRIN Biostatistics and Data Management Center • Brown University

  2. Patient follow-up at 6-month intervals R 24 months max follow-up 12 months min follow-up12 Primary endpoint: MACE ={MI, death, revascularization}

  3. Analysis and sample size, primary endpt • Analysis for primary endpoint • Comparison of time to MACE between arms • Intent-intent to treat perspective • Non-inferiority formulation Sample size considerations

  4. Analysis for other endpoints • Compare angina symptom status, SAQ scores and SF-36 scores between arms. (Longitudinal modeling) • Evaluate prognostic accuracy of modified Duke Prognostic Index to predict MACE in CCTA arm (ROC analysis) • Develop new prognostic index for MACE using CCTA results of 15-segment coronary artery model • Assess incremental cost-effectiveness of CCTA strategy vs SPECT strategy

  5. Building the outcomes enterprise: ACRIN in the CER era • Methodologic challenges CER calls for illuminating the complex path: Dx information Outcomes The main pathway goes through therapy

  6. Building the outcomes enterprise: ACRIN in the CER era • Randomized studies • address many of the methodologic difficulties • but can be large, lengthy, and costly. • ACRIN has unique scientific expertise, practical experience and infrastructure to pursue them Dx information Outcomes

  7. Building the outcomes enterprise: ACRIN in the CER era • Observational studies • Registries (e.g. NOPR) • Linkage of clinical trial data and secondary databases (CMS, EMR) • Important opportunities for ACRIN • Area for current GO grant (Dartmouth, Brown, NOPR, Tufts EPC), built around ACRIN’s Outcomes Committee and NOPR Dx information Outcomes

  8. Building the outcomes enterprise: ACRIN in the CER era • Modeling studies • To assess the impact on outcomes using the findings from ACRIN trials ( DMIST, NLST, NCTCC, 6666) • To combine information from ACRIN trials with others from the literature (CISNET ) • Area for to develop, with leadership from ACRIN’s Outcomes Committee Dx information Outcomes

  9. The scope of ACRIN research (if we can ensure appropriate funding !) CER era Dx information Outcomes

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