RESCUE Design and Analysis plans
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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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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

max follow-up

12 months

min follow-up12

Primary endpoint: MACE ={MI, death, revascularization}


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


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


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


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


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


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


The scope of ACRIN research (if we can ensure appropriate funding !) CER era

Dx information

Outcomes


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