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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 • 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