Title: What EHRs Can Deliver that Randomized Clinical Trials Cannot
1What EHRs Can Deliver that Randomized Clinical
Trials Cannot
- Retrospective studies with long-term follow-up
- Robert W. Grundmeier, MD
- July 13, 2009
2Disclosures
- No conflicts of interest
- No off-label uses of commercial products will be
discussed
3Overview
- Re-use of existing clinical data in electronic
health records for research - The potential and challenges
- Past experience with successful retrospective
cohort studies in the EHR - Urinary tract infections
- Asthma
- The path ahead
4Before Paper-Based Poetry
Fabricated Chart...Based on a true story
5After Detailed Semi-Structured EHR Template
6The PotentialRich and Fresh Data
- Thousands of repeated observations recorded for
each potential subject over time - Longitudinal health problem diagnoses
- Billing diagnoses
- Vital signs and measurements
- Prescriptions
- Immunizations
- Structured preventive health visits
- Laboratory and radiology data
- Procedures
- And many more!
7The PotentialLarge Volume of Data
- 7 Years of data
- 9 Subspecialty centers
- 9 Subspecialty divisions
- 32 Primary care sites
- 300,000 Patients
- 2,500,000 Visits
- 65,000,000 Observations
8Case Study 1
- Antibiotics for UTI prophylaxis
- (Conway PH. JAMA 2007)
- Pediatric Asthma Hospitalizations and the Quality
of Ambulatory Care
9Urinary Tract Infection (UTI) Study Cohort
- Almost 75,000 subjects
- 30 practices
- 5 years of EHR data
- Urine culture results from 3 laboratories
- Hospital and specialty center radiology data
- One Robert Wood Johnson Fellow
10Urinary Tract Infection (UTI) Study Findings
- 12 annual incidence of recurrent UTI in children
with an initial UTI - Significantly higher rates in children with high
grades of vesico-ureteral reflux - Antimicrobial prophylaxis
- Did not change the rate of recurrent UTI
- Increased prevalence of resistant organisms in
recurrent UTI from 53 to 90!
11Urinary Tract Infection (UTI) Study Challenges
- Diagnosis codes only had moderate agreement
with culture results - Kappa 0.46
- Interpreting urine culture data required some
natural language processing - Validation proved this approach superior to using
diagnosis
Cx Cx - Total
Dx 1,401 1,629 3,030
Dx- 738 12,536 13,274
Total 2,139 14,165 16,304
These kids really had a UTI
12Urinary Tract Infection (UTI) Study Challenges
- Uncertainty about whether or not we had
accurately identified the first UTI - Considered using a birth cohort with complete
data in EHR - Instead chose to review all paper charts for
patients with UTI (N775) - 91 cases excluded due to documentation of prior
UTI before EHR implementation - Only 1 case considered a false positive
13Case Study 2
- Antibiotics for UTI prophylaxis
- (Conway PH. JAMA 2007)
- Pediatric Asthma Hospitalizations and the Quality
of Ambulatory Care
14Asthma Study
- Questions
- Does quality of asthma care affect
hospitalization rate? - Are there disparities in asthma healthcare?
- Methods
- Almost 6,000 subjects from 5 practices
- 5 years of EHR data
- 24 independent variables
- 1 outcome (hospitalization)
- One AHRQ Contract
15Asthma Study Preliminary Results
16Univariate Predictors of Asthma Hospitalization
- Age lt 4 years
- .128 vs .063 hospitalizations per subject per
month - Moderate to severe persistent asthma
- .075 vs .044 hospitalizations per subject per
month - African American Race
- .072 vs .055 hospitalizations per subject per
month - Public Insurance
- .073 vs .065 hospitalizations per subject per
month
17Asthma Study Challenges Unmeasured Attributes
- Marginally adequate socioeconomic status (SES)
markers for retrospective studies - Public vs. private insurance is about as good as
it gets - Geocoding may help
- Median census tract income
- Housing type
18Bad Luck Simultaneous QI Efforts Inseparable
19Asthma Misclassification across time and space
- Common conditions are coded commonly, and
reasonably well - 57,820 Patients billed for asthma care
- 53,824 Patients with asthma on problem list
- 54,993 Patients with at least 2 albuterol
prescriptions - This is EXCELLENT correlation
20Persistent Asthma
- What about persistent asthma?
- 16,949 Patients billed for persistent asthma
- 11,943 With persistent asthma as a problem
- But
- 23,673 Patients with at least 2 inhaled
corticosteroid prescriptions which implies
persistent asthma - And
- Only 3,553 With persistent symptoms based on
questionnaire - Huh?
21Non-Random Misclassification By Care Location
- It is OK to compare organizations using their
electronic data because everyone has the same
problems with their data the playing field is
level - Anonymous (Hospital Executive)
- Oh, really? Svetlana (CBMi Data Analyst)
Persistent Asthma PC KF Allergy TOTAL
Encounter Dx 8,087 8,167 754 16,949
Problem List 6,399 5,229 1,038 11,943
Inhaled Steroid 7,073 11,439 3,862 23,673
Persistent Symptoms 2,461 843 261 3,553
22Non-Random Misclassification By Care Location
(Mistake in Query)
- Svetlana And do you really think that all the
players will write their queries correctly?
Persistent Asthma PC KF Allergy TOTAL
Encounter Dx 8,087 8,167 754 16,949
Problem List 6,399 5,229 1,038 11,943
Inhaled Steroid 7,458 12,754 4,003 23,673
Persistent Symptoms 2,461 843 261 3,553
WRONG!
23Non-Random Misclassification Over Time
- And, the playing field changes over time
- In 2004 one could have been lulled into a false
sense of security over the reliability of
encounter or problem list data Actually, WE
WERE!
Persistent Asthma 2004 2005 2006 2007
Encounter Dx 3,695 6,026 7,923 8,707
Problem List 3,188 4,866 6,508 7,689
Inhaled Steroid 3,696 6,237 10,067 13,980
Persistent Symptoms 0 0 982 2,450
24Good News! Statistical Magic for Missing Data
- Asthma severity is correlated with many variables
available in the EHR - Frequency, type, and dose of preventive treatment
- Frequency of quick relief prescriptions
- Frequency of oral steroid prescriptions
- Hospitalizations
- We recently imputed severity for the 20 of our
population that is unclassified - The results were unbelievably accurate like magic
25The Bottom Line
- Retrospective studies can and should be done with
EHR data captured for routine care - When data are suspicious or missing, look for
corroborating evidence - You dont know what you dont know, until you
read the charts - Find cohorts enriched in the disease, brew some
strong coffee, and read! - Pound the pavement, go to where data are
collected
26The Way Forward Improve Data Collection
- Must think about how to make the clinician want
to use the new data capture tool - We are doing a comprehensive decision support
intervention regarding ear infections for this
reason
27Thank You