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Kaiser Permanente National Guideline Program Implications of IOM SR Standards. Wiley Chan, MD Physician, Internal Medicine Methodologist, KP National Guideline Program. Kaiser Permanente: Largest Non-Profit Health Care Program in the United States. Founded in 1945
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Kaiser PermanenteNational Guideline ProgramImplications of IOM SR Standards Wiley Chan, MD Physician, Internal Medicine Methodologist, KP National Guideline Program
Kaiser Permanente: Largest Non-Profit Health Care Program in the United States Founded in 1945 8 regions in 9 states and District of Columbia 8.6 million members (as of 12/09) 15,129 physicians (as of 12/09) 164,098 employees (as of 12/09) KP Care Management Institute (CMI) KP National Guideline Program (NGP) Permanente Medical Groups Kaiser Permanente Kaiser Foundation Hospitals Kaiser Foundation Health Plan
Kaiser Permanente Evidence Network • 15 KP National Evidence-Based Guidelines • Supported by full Systematic Reviews • 3.5 Staff FTEs dedicated to KP NGP work • 1 Principal Consultant , 2 Analysts, 2 Project Managers • 1.5 Physician FTEs dedicated to KP NGP work • 7 Physician EBM Methodologists • External vendor: Doctor Evidence • Search & Data Extraction • Technology platform • Data repository, analysis & documentation
Kaiser Permanente National Guideline Program: Process & Methodology New Clinical Issue ScheduledUpdate • Key to Abbreviations: • CQ Clinical Question • SR Systematic Review • GDT Guideline Development Team • GQ Guideline Quality Committee • NGD KP National Guideline Directors Clinical Questions (CQ) • Overview Existing Guideline? No Yes CQ Match? Existing SR by CQ? Evidence Search Abstract Article Review Inclusion/ Exclusion Data Extraction Critical Appraisal No No Yes Yes Assess Guideline Assess SR Qualitative/ Quantitative Synthesis Assess Evidence Quality Evidence Summary Rationale Recommendations Acceptable? Acceptable? No No Assess Implementability of Recommendations GDT Approval Internal Review GQ NGD Approval Yes Yes New Relevant Studies? National Guideline Yes No Implementation
Kaiser Permanente National Guideline Program: Process & Methodology New Clinical Issue ScheduledUpdate Clinical Questions (CQ) • Acceptable External Guideline • ADAPTE/AGREE Existing Guideline? Yes CQ Match? Yes Assess Guideline Acceptable? GDT Approval Internal Review GQ NGD Approval Yes National Guideline Implementation
Kaiser Permanente National Guideline Program: Process & Methodology New Clinical Issue ScheduledUpdate Clinical Questions (CQ) • No Acceptable External Guideline • Acceptable External Systematic Review • No New Relevant Studies • AMSTAR • GRADE Existing Guideline? No Yes CQ Match? Existing SR by CQ? No Yes Yes Assess Guideline Assess SR Evidence Summary Rationale Recommendations Acceptable? Acceptable? No Assess Implementability of Recommendations GDT Approval Internal Review GQ NGD Approval Yes New Relevant Studies? National Guideline No Implementation
Kaiser Permanente National Guideline Program: Process & Methodology New Clinical Issue ScheduledUpdate Clinical Questions (CQ) • No Acceptable External Guideline • No Acceptable External Systematic Review • Internal Systematic Review • GRADE Existing Guideline? No Yes CQ Match? Existing SR by CQ? Evidence Search Abstract Article Review Inclusion/ Exclusion Data Extraction Critical Appraisal No No Yes Yes Assess Guideline Assess SR Qualitative/ Quantitative Synthesis Assess Evidence Quality Evidence Summary Rationale Recommendations Acceptable? Acceptable? No No Assess Implementability of Recommendations GDT Approval Internal Review GQ NGD Approval National Guideline Implementation
Kaiser Permanente Systematic ReviewProcesses, Responsibilities, & Tools • Clinical Questions • KP: Population, Intervention, Comparison, Outcome • Timing, Setting • Evidence Search • Doctor Evidence with KP input • Masters-trained Medical Librarians (MLIS) • Abstract/Article Review & Inclusion/Exclusion • Doctor Evidence • Dual Inclusion/Exclusion with 3rd party adjudication • KP: Evaluate exclusions
Kaiser Permanente Systematic ReviewProcesses, Responsibilities, & Tools • Data Extraction • Doctor Evidence • Dual extraction with adjudication & 3rd party independent QA • Masters-trained & graduate student data extractors • Contact authors to clarify discrepancies in published data • KP: Quality Assurance • Critical Appraisal • KP: Cochrane Risk of Bias, Doctor Evidence platform • Qualitative/Quantitative Analysis • KP: Doctor Evidence platform
Doctor Evidence Meta-Analysis Study Selection Detailed study- and outcome-specific descriptions of Cochrane Risk of Bias are exposed by hovering Select and de-select studies and Recalculate
Doctor Evidence Study Summary Detailed study-specific descriptions of characteristics and outcomes are exposed by hovering
Kaiser Permanente Systematic ReviewProcesses, Responsibilities, & Tools • Evidence Grading • KP: GRADE, GRADEPro • Developing functionality in Doctor Evidence platform • Evidence Summary (SR) • Rationale • Recommendations & Guideline • KP: GRADE, GRADEPro, Word • Developing functionality in Doctor Evidence platform
Kaiser Permanente National Guideline Program: Process & Methodology • Guideline Implementation National Guideline Regions (EHR, CDS, Operations) Patient Education Tools (KP.ORG, National Patient Instructions Clinician & Staff Education Tools (Clinical Library) Disease Management Accreditation (NCQA) • Key to Abbreviations: • EHR Electronic Health Record • CDS Clinical Decision Support • KP.ORG KP publicly-accessible Internet site • NCQA National Committee for Quality Assurance
IOM Systematic Review StandardsProblem Areas for KP • 2.6 Develop a systematic review protocol • 2.7 Submit the protocol for peer review • 2.7.1 Provide a public comment period for the protocol • 2.8 Make the final protocol publicly available • 5.2.1 Use a 3rd party to manage peer review • 5.2.2 Provide a public comment period for the report • 5.3 Publish the final report with free public access
IOM Systematic Review StandardsChallenges • Very resource-intensive • Infinite needs - Finite resources • Balance between efficiency versus rigor • Investment in developing expertise & infrastructure • Migration of existing SRs & CPGs to new methods • Updating SRs & CPGs • Every 2 years? • Dynamic updating, based on evidence & impact? • External review • Patient & public involvement in SRs and CPGs
IOM Systematic Review StandardsOpportunities • Improved SR & CPG rigor & transparency • Common evidence-grading & recommendation strength language • Collaborate with other SR & CPG developers • Prioritize & coordinate topics • Avoid duplication • Target funding • Share data extractions? • Devote more energy to CPG implementation • Collaborate with performance metric developers
Implications of IOM SR Standards Wiley.Chan@kp.org