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Addressing clinical appropriateness and priorities across the continuum of care Rod Hayward, MD VA Ann Arbor HSR&D Center of Excellence, & University of Michigan Schools of Medicine and Public Health Research Directed at Improving Patient Outcomes Early Evidence Validating Causality Interpreting the Pt Outcomes & Health Policy Implications Basic Science Clinical Trials Epidemiology Clinical Epidemiology How to Optimize Care Health Services Research Important, & Often Competing, Goals • High value • Reasonable costs • Respect patient autonomy • Equitable treatment Healthcare quality cannot be dichotomized Questionable Low Moderate (Net Value) Cost Containment Patient Autonomy High Basic Right Net Value = Benefits/Gains – Costs/Losses Stringent Dichotomous Measures • Don’t target patients most likely to benefit – Ignore the heterogeneity of patient risk factors • Don’t help providers do the “right” thing – Blunt instruments with little or no clinical nuance • Don’t take into account patient preferences – Often mandate care not wanted well-informed patients • Provide perverse incentives – Polypharmacy, hypoglycemia, worse outcomes, wasteful spending Lenient Dichotomous Measures • Help target patients most likely to benefit • Don’t help providers do the “right” thing – Do not consider optimal care or underuse • Don’t take into account patient preferences – Ignores low-moderate net value that may be wanted by patients • Could result in unintended consequences – Clinicians/patients may only focus on bad care Avoid Simple Dichotomous Performance Measures (PMs), and Avoid “Quality Measures” Altogether INVEST Trial (Ann Intern Med 2006) Relationship Between A1c & Microvascular Complications (Vijan Ann Intern Med 1997) Diagram by J. Meddings No More Dichotomies • High Net Value Standards/Priorities • Low-Moderate Net Value Shared Decision-making • Questionable Net Value Cost Containment PM Types: Outcomes • Risk-adjusted outcomes (hospital mortality, nosocomial infections, etc) • Simple risk-adjusted intermediate outcomes (LDL levels, smoking rates, pt medication adherence, etc) • Weighted intermediate outcome measures (Continuous weighted A1c, QALYs at risk, etc) PM Types: Processes • Simple process measures (annual eye exam, discussion of PSA testing, etc) • Tailored process measure (eye exam as per risk, STD screening in high risk areas or patients & shared decision-making in low-risk situations, etc) • Tightly-linked clinical action rates (credit given for appropriate response to high-BP) Most Guidelines are Insensitive to Untreated Risk A 55 year-old woman not on a statin: Baseline 5yr CV Risk Intensive NCEP Net Benefit for Treatment 40mg simvastatin (NNT X 5yrs to gain 1 Decision QALY)* LDL = 165 2% Treat ∞ LDL = 115 9% Do Not Treat 29 * Assumes HarmRx = 0.001 CV Mortality Risk in US Diabetics (UKPDS Calculator for NHANES sample) Most Guidelines are Insensitive to Treatment-related RRR RRR No Rx 40mg simvastatin (~$200/yr) 40mg simva 40mg atorva (~$500/yr) 40mg 80mg atorvastatin (~$500/yr) Non-fatal CV events Total Mortality 38% 12% 14% 0% 7% 0% Most Guidelines are Insensitive to Treatment-related RRR Examples of a 65 yearold man with 3 RFs: Baseline 5yr CV Risk Intensive NCEP Net Benefit for Treatment 40mg simvastatin (NNT X 5yrs to gain Decision 1 QALY)* LDL = 90 Not on a statin LDL = 110 on 40mg atorvastatin 9% Do not start moderate potency statin 33 9% Increase to 80 mg atorvastatin ∞ * Assumes HarmRx = 0.001 CV Mortality Risk in US Diabetics (UKPDS Calculator for NHANES sample) PM Types: Structure • Systems in place (PSL’s up-to-date, drug-drug interaction system active, etc) • Participation in CQI program (NSQIP, ADA/NCQA DM Recognition Program, etc) What is high performances? 1. High Net-Value: A. Strong recommendation and low barriers B. Substantive proactive outreach programs 2. Low to Moderate Net-Value: Clear informed consent and no unreasonable barriers to receipt of care 3. Questionable Net-Value: Clear informed consent, and higher barriers to receipt of care. Political Barriers Critics (the evidence isn’t perfect, not all of the exceptions/contra-indications are considered, can’t etc) Providers/Plans (it’s too hard, complex, expensive, etc) Disease Advocates (all the experts agree, set the goal high and realize not everyone will achieve it, shouldn’t consider $$ or pt preferences, etc) Logistical Barriers Data: Will usually require clinically detailed data Complexity: More expensive and complex to convey Intangibles: Some of the most important things in healthcare are difficult to measure well Example BP Measurement: High Net-Value = Priority Care If High CV risk: At least moderate doses of 3 BP meds if SBP >130 If Moderate risk: At least moderate doses of 2 BP meds if BP >135 All patients: * Documentation of med. adherence reviewed if patient not at goal * Referral to accessible case-mgt program must be made if persistent SBP > 145 & DBP >70 Example BP Measurement: Questionable Net-Value = Safety/Costs • • If pt on two or more BP medications, must be on ACE/ARB or diuretic or have documented intolerance/contraindication. Do not use high dose beta-blocker or thiazide diuretic in patients with T2DM.