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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.