The NCDR and Clinical Practice Guideline Development Gregory J. Dehmer, MD, FACC, FACP, FSCAI Professor of Medicine Texas A&M HSC College of Medicine Director, Cardiology Division Baylor Scott & White Health, Central Texas Guidelines These Days, We Have Many Sources of Information that Provide Structure Around the Practice of Cardiology Where and how does the NCDR fit in? The NCDR and Clinical Practice Guidelines Clinical Studies Adapted from: Antman & Peterson, Circulation 2009:119:1180-1185. 1185. 1
Clinical Practice Guidelines (CPGs) Before the 1980 s physicians relied upon experience and intuition to guide patient care First ever guideline was in 1984 J Am Coll Cardiol 1984; 4:434-42. 42. Clinical Practice Guidelines (CPGs) ACC/AHA partner with other professional organizations to provides guidelines and other documents Rely on evidencebased care/randomized trials If no evidence available, expert opinion Clinical Practice Guidelines Clinical Practice Guidelines (CPG) (State of Science) Exhaustive review of the literature and knowledge base Heavy reliance on RCTs, if any Best practices Should do, should not do Class I = you should do this Class III = don t do this no benefit or harm Class II = conflicting data Maybe OK, sometimes (we re not sure, need more research, debatable, etc...) Level of evidence A: multiple populations studied, multiple RCT, meta-analyses B: limited populations, one RCT C very limited populations, expert consensus opinion 2
Guidelines Don t Just Happen http://assets.cardiosource.com/methodology_manual_for_acc_aha_writing_committees.pd f Are the Guidelines Perfect? JAMA 2009;301:831-41 In the 16 current guidelines: Only 11% of all recommendations were LOE = A 48% LOE C Only 19% of Class I recommendations were LOE = A The Link Between CPGs and the NCDR Science -tells us what we cando; Guidelines tells us what we shoulddo; Then how do we know what we are doing? Are we following the guidelines? Are we improving outcomes for patients? Roe MT, et al. J Am Coll Cardiol 2010 2009:56:254 :56:254-263. 263. 3
Clinical Outcomes? We can only manage what we measure The Link Between CPGs and the NCDR Science -tell us what we cando; Guidelines tell us what we shoulddo; Registries -tell us what we aredoing The clinical yardstick of our performance The Link Between CPGs and the NCDR Science -tells us what we can do; Guidelines tells us what we should do; Registries -tells us what we are actually doing Examined: 131,980 STEMI and NSTEMI patients from ACTION-GWTG Registry 1,708,247 patients from the Cath PCI Registry Roe MT, et al. J Am Coll Cardiol 2010 2009:56:254 :56:254-263. 263. 4
Registries Tell Us What We Are Doing We Are Improving! AMI Performance Composite Trend STEMI trend p value < 0.0001 NSTEMI trend p value < 0.0002 AMI Defect Free Care Trend STEMI trend p value < 0.0001 NSTEMI trend p value < 0.0008 AMI Risk-Adjusted Mortality Trend STEMI trend p value < 0.025 NSTEMI trend p value < 0.026 NCDR Contributions to CPGs NCDR model for in-hospital mortality cited Peterson ED, et al. Contemporary mortality risk prediction for percutaneous coronary intervention: results from 588,398 procedures in the National Cardiovascular Data Registry. J Am Coll Cardiol. 2010;55:1923 32. NCDR Helps Change CPG NCDR CathPCI Registry Data: January 2004 March 2006 299,429 patients at 405 facilities with on-site surgery 8,736 patients at 60 facilities without onsite surgery J Am Coll Cardiol 2009;54:16 24. 5
Class IIb Class III Data from 14,821 patients from the ACTION-GWTG Registry Median DIDO time was 68 minutes with only 11% < 30 minutes Analysis of 412,617 PCIs STEMI excluded Grouped by Guideline indication class Circulation 2005;112:2786-91. 6
Relationship Between Procedure Indications and Outcomes of PCI by ACC/AHA Guidelines % 2 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 All p<0.001 MI CABG Death Class I Class IIa Class IIb Class III Anderson et al. Circulation 2005; 112:2786 The Feedback Cycle Clinical Trials Guidelines Performance Measures AUC Measurement New Gaps Identified Registries Adapted from: Califf RM, et al. J Am Coll Cardiol 2002; 40:1895-901. 901. When the Referee does this in football it means... 7
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