Closing the loop in CER
Victor M. Montori, MD, MSc
Professor of Medicine
KER UNIT
Center for Science of Healthcare Delivery
Mayo Clinic, Rochester, Minnesota
CER and Decision Makers: the loop
Decision makers need answers to make decisions
CER meets needs of decision makers
Decision makers use CER to make decisions
How to make evidence-based
decisions
Context
Values
Policy approach
Evidence
Decisions
Patient‐
centered approach
Some CER findings
Moderate vs. intensive glycemic control
Metformin vs. antihyperglycemic agents
Gliptins vs. sulfonylureas vs. glitazones
Pioglitazone vs. rosiglitazone
Diabetologia 2009; 52: 2288-98
Treat 1000 people (bring A1c down from 8 to 7%) for 5 y:
No fewer deaths
7fewer nonfatal coronary events,
Maybe 4 fewer pts blind in one eye
Maybe 2 fewer pts with end-stage renal failure
45 more pts having hypoglycemia requiring assistance
Avg patient will perceive loss in quality of life of 30%
Diabetologia (2010) 53:2079–2085
Moderate vs. intensive glycemic control
Moderate (HbA1c 7-8%)
Intensive (HbA1c <7%)
Weight gain and
hypoglycemia
More
Less nonfatal MI (15%)
Same
Less microvascular
(small, subgroup)
Burdensome
Lesser(indirect,
inconsistent)
More
QoL unchanged
Less (indirect)
More cardiovascular deaths
(inconsistent)
Comparative Effectiveness and Safety of Medications for Type 2 Diabetes: An Update Including New Drugs and 2‐Drug Combinations
Ann Intern Med. 2011 May 3;154(9):602‐13 Metformin vs. other antihyperglycemic agents
Metformin
Other orals
No weight gain
Weight gain w SU and
glitazones
No hypoglycemia
Hypoglycemia w SU
Reducedmacrovascular
risk (inconsistent)
Increased risk rosi,
unclear others
Reduced risk of cancer
(weak)
Cheap
Cheap: SU | 60x
expensive: others
Gliptins vs. other other oral agents
Gliptins
Glitazones
Sulfonylureas
No weight gain
Large weight gain
Some
No hypos
No hypos
Some hypos
Unknown effect
on complications
Unclear
Unclear
Risk of
pancreatitis/canc
er (weak)
Risk of cancer
(weak), edema,
bone
loss(glitazones)
Expensive
None
Expensive
Cheap
Rosi vs. pioglitazone
Rosiglitazone
Pioglitazone
Weight gain
No hypoglycemia
Same
Increased MI risk
Decreased MI risk (weak)
Increased risk of heart
failure
Expensive
Same
Unknown
Same
Increased risk of bladder
cancer (very weak)
Policy makers perspective
• Evidence is at moderate to high risk of
bias
• Suggests (weak recommendation):
– moderate glycemic control,
– metformin as first line,
– Second line: unclear, don’t use rosi
• Cannot be used to judge quality of care
Back to reality
• Strong recommendations for intensive
glycemic control.
• Some make conditional (e.g., VA guidelines:
life expectancy, comorbidity)
• Strongly recommend metformin as first line
• Algorithms for use of second line treatments
• FDA / GSK all but pulled rosi off the market
• HbA1c targets as quality of care measures
ADA – EASD 2009 algorithm
Shah ND et al N Engl J Med 363;22
3‐6%
<3%
6‐9%
Shah ND et al N Engl J Med 363;22
A fundamental recognition
An unlikely
outcome of
CER:
a clearwinner.
Context
Values
Evidence
Decisions
Shah ND et al. Med Care 2010; 48, 6: S153‐8
A patient-centered approach
Inform: Identify applicable options
Deliberate: consider options in context
Decide: choose, appraise, modify
19
Mullan et al Ach Intern Med 2009
Decision aid
Knowledge
Conversation
Decision
Satisfaction
Choice
6 mo
Adherence
HbA1c
Knowledge
Conversation
Decision
Satisfaction
Choice
6 mo
Adherence
HbA1c
n= 48 patients
21 clinicians
DM2 patients seen in 11
primary care sites
R
n= 37 patients
19 Clinicians
Usual care
Arch Intern Med. 2009;169(17):1560-1568
Arch Intern Med. 2009;169(17):1560-1568
Significantly improved patient knowledge about diabetes medications
Doubled the involvement of patients in decision making
No change in adherence (near perfect) or HbA1c (7.3%) or health status
Arch Intern Med. 2009;169(17):1560-1568
Conclusions
• CER needs to be designed to meet needs
of decision makers
< 20% of diabetes trials measure patient
important outcomes*
Largest ongoing CER DM2 trial: A1c target!
CER can be translated by policy or clinical
decision makers
Methods to more effectively accomplish
this need to be developed.
* Montori et al, Diabetes Care 2006; Gandhi et al, JAMA 2008
Conclusions
• Methods:
–
–
–
–
–
Representation of evidence (in face or low quality)
Transparency (in face of COI)
Nuanced execution (in face of context/values)
Accountability (in face of weak CER evidence)
When should level be policy or clinical?
• Patient-Centered Outcomes Research Institute
(www.pcori.org)
– Goal: to help make better decisions
– Approach: commission research
• Responsive to values and preferences of patients
• Provide patients and caregivers with reliable evidence to
inform their decisions
CER and Decision Makers: the loop
Decision makers need answers to make decisions
CER meets needs of decision makers
Decision makers use CER to make decisions