Sills MR. Overview of Comparative Effectiveness Research Using SAFTINet as an Example. Methods Talk presented to the Emergency Department Research Conference, Department of Pediatrics, 1 February 2011.

1. CER and SAFTINet
Marion R. Sills, MD, MPH
sills.marion@tchden.org
Lead, SAFTINet CER Project

2. Overview of
 Comparative Effectiveness Research (CER)
 Scalable Architecture for Federated
Therapeutic Inquiries Network (SAFTINet)

3. Overview of
 Comparative Effectiveness Research (CER)
 Scalable Architecture for Federated
Therapeutic Inquiries Network (SAFTINet)

4. CER Overview
 2009: The American Recovery and
Reinvestment Act
 allocated $1.1 billion for CER

5. CER Overview: Definition
 2009: The American Recovery and
Reinvestment Act
 allocated $1.1 billion for CER

6. CER Definition (Institute of Medicine, 2009)
Comparative Effectiveness Research (CER)
is the generation and synthesis of evidence that
compares the benefits and harms of alternative
methods to prevent, diagnose, treat and monitor
a clinical condition, or to improve the delivery
of care.

7. CER Definition (Institute of Medicine, 2009)
The purpose of CER is to assist consumers,
clinicians, purchasers, and policy makers to
make informed decisions that will improve
health care at both the individual and
population levels.
http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx

8. CER Overview
 2009: The American Recovery and
Reinvestment Act
 allocated $1.1 billion for CER
 3 recipients of the funds: NIH, AHRQ
 3 recipients issued requests for proposals
 to develop CER infrastructure
 to conduct CER studies
 mandated an Institute of Medicine (IOM) study to
establish national priorities for CER

9. CER Overview
 IOM report established national priorities

10. Overview of
 Comparative Effectiveness Research (CER)
 Scalable Architecture for Federated
Therapeutic Inquiries Network (SAFTINet)

11. CER and SAFTINet
 2009: The American Recovery and
Reinvestment Act
 allocated $1.1 billion for CER
 3 recipients of the funds: NIH, AHRQ, OS-DHHS
 3 recipients issued requests for proposals
 to develop CER infrastructure
 to conduct CER studies
 mandated an Institute of Medicine (IOM) study to
establish national priorities for CER
SAFTINet
research
infrastructure
SAFTINet
research
question

12. CER Study Question
 HEALTH CARE DELIVERY SYSTEM FACTORS, such as
the patient-centered medical home are important
to the CONTROL of
asthma (children, adults)
high blood pressure
hypercholesterolemia
PROCESSES OF
CARE
+
HEALTH CARE
DELIVERY SYSTEM
FACTORS
+ PATIENT FACTORS →
CHRONIC DISEASE
CONTROL

13. CER Study Question
How did we get here?
PROCESSES OF
CARE
+
HEALTH CARE
DELIVERY SYSTEM
FACTORS
+ PATIENT FACTORS →
CHRONIC DISEASE
CONTROL

14. CER Study Question
How did we get here?
Why the SAFTINet population?
Why these 4 cohorts?
Why this research question?

15. CER Study Question
How did we get here?
Why the SAFTINet population?
Why these 4 cohorts?
Why this research question?

16. CER Study Question
Priority Populations Priority Conditions

17. CER Study Question
1. Low-income groups
2. Minority groups
3. Women
4. Children
5. The elderly
6. Individuals with special
health-care needs (e.g.,
disabilities, need for
chronic care or end-of-
life care, or those who
live in inner-city and
rural areas)
1. Arthritis/joint disorders
2. Cancer
3. Cardiovascular disease
4. Dementia, including Alzheimer's
Disease
5. Depression; other mental health
disorders
6. Developmental delays, ADHD and
autism
7. Diabetes Mellitus
8. Functional limitations and disability
9. Infectious diseases including HIV/AIDS
10. Obesity
11. Peptic ulcer disease and dyspepsia
12. Pregnancy including pre-term birth
13. Pulmonary disease/Asthma
14. Substance abuse
Priority Populations Priority Conditions

18. CER Study Question
1. Low-income groups
2. Minority groups
3. Women
4. Children
5. The elderly
6. Individuals with special
health-care needs (e.g.,
disabilities, need for
chronic care or end-of-
life care, or those who
live in inner-city and
rural areas)
Priority Populations
Basis for defining
our SAFTINet
clinic population of
federally qualified
health centers

19. CER Study Question
1. Arthritis/joint disorders
2. Cancer
3. Cardiovascular disease
4. Dementia, including Alzheimer's
Disease
5. Depression; other mental health
disorders
6. Developmental delays, ADHD and
autism
7. Diabetes Mellitus
8. Functional limitations and disability
9. Infectious diseases including HIV/AIDS
10. Obesity
11. Peptic ulcer disease and dyspepsia
12. Pregnancy including pre-term birth
13. Pulmonary disease/Asthma
14. Substance abuse
Priority Conditions
Basis for defining
our 4 SAFTINet
cohorts:
•asthma (children,
adults)
•high blood pressure
•hypercholesterolemia

20. CER Study Question
How did we get here?
Why CER?
Why the SAFTINet population?
Why these 4 cohorts?
Why this research question?

21. Institutes of Medicine Top 100 Priority Areas
Igelhart al, NEJM(2009)

22. CER Study Question
HEALTH CARE
DELIVERY SYSTEM
FACTORS
→
CHRONIC DISEASE
CONTROL
First Quartile Priority:
“Compare the effectiveness of
comprehensive care coordination
programs, such as the medical
home, and usual care in managing
children and adults with severe
chronic disease, especially in
populations with known health
disparities.”

23. CER Study Question
HEALTH CARE
DELIVERY SYSTEM
FACTORS
→
CHRONIC DISEASE
CONTROL
“Compare the effectiveness of comprehensive
care coordination programs, such as the
medical home, and usual care in managing
children and adults with severe chronic
disease.”
HEALTH CARE DELIVERY SYSTEM
FACTORS, such as the patient-
centered medical home are
important to DISEASE CONTROL

24. CER Study Question
 HEALTH CARE DELIVERY SYSTEM FACTORS, such as
the patient-centered medical home are important
to the CONTROL of
asthma (children, adults)
high blood pressure
hypercholesterolemia
HEALTH CARE
DELIVERY SYSTEM
FACTORS
→
CHRONIC DISEASE
CONTROL

25. CER Study Question
 HEALTH CARE DELIVERY SYSTEM FACTORS, such as
the patient-centered medical home are important
to the CONTROL of
asthma (children, adults)
high blood pressure
hypercholesterolemia
HEALTH CARE
DELIVERY SYSTEM
FACTORS
→
CHRONIC DISEASE
CONTROL

26. Measures of Disease Control
HEALTH CARE
DELIVERY SYSTEM
FACTORS
→
CHRONIC DISEASE
CONTROL
 Existing electronic health
record data
 Medicaid data, death files, etc.
 Enhanced data: patient-
reported outcomes (PRO)

27. Relevance
HEALTH CARE
DELIVERY SYSTEM
FACTORS
→ CHRONIC DISEASE
CONTROL
 Measuring hospital utilization and cost as an
outcome (includes ED): first large-scale linkage
of EHR with claims data
 CER methods expertise
 Experience with AHRQ
 Future directions
 More pediatric cohorts
 Studies related to decreasing acute care
utilization, cost