using the nih collaboratory'sand pcornet's distributed ... slides 11-14-14.pdf · using...
TRANSCRIPT
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Using the NIH Collaboratory's and PCORnet's distributed data networks for clinical trials and observational research - A preview
Jeffrey Brown, PhD, Lesley Curtis, PhD, Richard Platt, MD, MS
Harvard Pilgrim Health Care Institute and Harvard Medical School
Duke University
November 14, 2014
Millions of people. Strong collaborations. Privacy first.
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The Collaboratory DRN’s goal
Facilitate multi-site research collaborations between investigators and data partners by creating secure networking capabilities and analysis tools for electronic health data
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Improve the nation’s capacity to conduct rapid, efficient, and economical comparative effectiveness research
3
PCORnet’s goal
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Three critical elements
• Privacy protections
• Reusable analysis tools
• Analysis-ready data
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Three critical elements
• Privacy protections
• Reusable analysis tools
• Analysis-ready data
![Page 6: Using the NIH Collaboratory'sand PCORnet's distributed ... Slides 11-14-14.pdf · Using the NIH Collaboratory'sand PCORnet's distributed data networks for clinical trials and observational](https://reader034.vdocuments.mx/reader034/viewer/2022042123/5e9e0d58599ee42b9565410b/html5/thumbnails/6.jpg)
6
Distributed analysis
Datapartner1
Coordina ngCenter
SecureNetworkPortal
1
52 EnrollDemographicsU liza on
Etc
Review&RunQuery
3
Review&ReturnResults
4
6
DatapartnerN
EnrollDemographicsU liza on
Etc
Review&RunQuery
3
Review&ReturnResults
4
1.Usercreatesandsubmitsquery(acomputerprogram)2.Individualdatapartnersretrievequery3.Datapartnersreviewandrunqueryagainsttheirlocaldata4.Datapartnersreviewresults5.Datapartnersreturnresultsviasecurenetwork6.Resultsareaggregated
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• Each organization can participate in multiple networks• Each network controls its governance and coordination• Other networks can participate• Networks share infrastructure, data curation, analytics, lessons, security, software
development
Health Plan 2
Health Plan 1
Health Plan 5
Health Plan 4
Health Plan 7
Hospital 1
Health Plan 3
Health Plan 6
Health Plan 8
Hospital 3Health Plan 9
Hospital 2
Hospital 4
Hospital 6
Hospital 5
Outpatient clinic 1
Outpatient clinic 3
Patient network 1
Patient network 3
Patient network 2
Outpatient clinic 2
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Multiple networks sharing infrastructure
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• Each organization can participate in multiple networks• Each network controls its governance and coordination• Other networks can participate• Networks share infrastructure, data curation, analytics, lessons, security, software
development
Health Plan 2
Health Plan 1
Health Plan 5
Health Plan 4
Health Plan 7
Hospital 1
Health Plan 3
Health Plan 6
Health Plan 8
Hospital 3Health Plan 9
Hospital 2
Hospital 4
Hospital 6
Hospital 5
Outpatient clinic 1
Outpatient clinic 3
Patient network 1
Patient network 3
Patient network 2
Outpatient clinic 2
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Multiple networks sharing infrastructure
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Use cases
• Pragmatic clinical trial design
• Observational studies
• Single study private network
• Pragmatic clinical trial follow up
• Reuse of research data
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Use cases
• Pragmatic clinical trial design
• Observational studies
• Single study private network
• Pragmatic clinical trial follow up
• Reuse of research data
10
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www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_Methods_CTTI_Developing-Approaches-to-Conducting-Randomized-Trials-Using-MSDD.pdf
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Use Case: IMPACT-AF Cluster Randomized Trial
• Proposed by Christopher Granger, MD, and colleagues
• Primary Aim: Test a multilevel educational intervention to increase the rate of initiation of oral anticoagulants among patients with atrial fibrillation.
• Design: Cluster randomized trial
• Intervention:
• For patients – Mailed educational material, and recommendation to discuss their anticoagulation status with their clinician
• For physicians – Notification of eligible patients. Reports regarding their eligible patients’ rate of anticoagulation benchmarked to other providers
• Population: Patients >18 years with atrial fibrillation without anticoagulation AND>1 CHADS2 (congestive heart failure, hypertension, age > 75 yrs, diabetes, stroke or TIA) risk factor OR>2 CHA2DS2 VASc (congestive heart failure, hypertension, age, diabetes, stroke or TIA, vascular disease, female) risk factors
www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_Methods_CTTI_Developing-Approaches-to-Conducting-Randomized-Trials-Using-MSDD.pdf
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• Proposed by Christopher Granger, MD, and colleagues
• Primary Aim: Test a multilevel educational intervention to increase the rate of initiation of oral anticoagulants among patients with atrial fibrillation.
• Design: Cluster randomized trial
• Intervention:
• For patients – Mailed educational material, and recommendation to discuss their anticoagulation status with their clinician.
• For physicians – Notification of eligible patients. Reports regarding their eligible patients’ rate of anticoagulation benchmarked to other providers.
• Population: Patients >18 years with atrial fibrillation without anticoagulation AND>1 CHADS2 (congestive heart failure, hypertension, age > 75 yrs, diabetes, stroke or TIA) risk factor OR>2 CHA2DS2 VASc (congestive heart failure, hypertension, age, diabetes, stroke or TIA, vascular disease, female) risk factors
www.mini-sentinel.org/work_products/Statistical_Methods/Mini-Sentinel_Methods_CTTI_Developing-Approaches-to-Conducting-Randomized-Trials-Using-MSDD.pdf
Use Case: IMPACT-AF Cluster Randomized Trial
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Use cases
• Pragmatic clinical trial design
• Observational studies
• Single study private network
• Pragmatic clinical trial follow up
• Reuse of research data
14
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Toh Arch Intern Med.2012;172:1582-1589.
• Used data for 3.9 million new users of anti-hypertensives in 18 organizations
• Propensity score matched analysis
• No person-level data was shared
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New program development process
Principal Programmer
1. Draft functional programming specification
Managing Programmer
2. Review and approve functional
specification
4. Review and approve technical programming
specification
Principal Programmer
7.Submit programming package to Managing Programmer for QC
Auditing Programmer
8. Implement QC plan
9 & 10.Track,
resolve and close all QC
issues
11.Submit finalprogramming package to Managing Programmer
12. Beta-test programming
package
3. Draft technical programming specification
5. Develop QC plan and test case
scenarios
6. Develop programming package (code, documentation)
Managing Programmer
Data Partners
13. Review logs and
output from each site
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Toh Arch Intern Med.2012;172:1582-1589.
• Used data for 3.9 million new users of anti-hypertensives in 18 organizations
• Propensity score matched analysis• No person-level data was shared• Five months and $250,000 required for programming and
analysis – compared to 1-2 years and $2 million without analysis-ready distributed dataset
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Toh Arch Intern Med.2012;172:1582-1589.
• Used data for 3.9 million new users of anti-hypertensives in 18 organizations
• Propensity score matched analysis• No person-level data was shared• Five months and $250,000 required for programming and
analysis – compared to 1-2 years and $2 million without analysis-ready distributed dataset
![Page 19: Using the NIH Collaboratory'sand PCORnet's distributed ... Slides 11-14-14.pdf · Using the NIH Collaboratory'sand PCORnet's distributed data networks for clinical trials and observational](https://reader034.vdocuments.mx/reader034/viewer/2022042123/5e9e0d58599ee42b9565410b/html5/thumbnails/19.jpg)
Yes
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Three critical elements
• Privacy protections
• Reusable analysis tools
• Analysis-ready data
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Reusable analysis tools
Two levels of querying complexity and analysis
• Level 1: Identify and characterize cohorts (eg, treatments, outcomes, etc)
• Level 2: Comparative analyses with analytic adjustment for confounding using available analytic adjustment tools (eg, propensity score matching)
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• Parameterized program “template” to identify cohorts based on an array of available parameter options• Exposure, outcome, inclusion/exclusion criteria, covariate
definitions; incidence assessment, age range and groups• Sample uses
• Background rates• Exposures and follow-up (outcome rates)• Concomitant exposure characterization
• Complex exposure and outcome definitions (“combo tool”)• Rhabdomyolysis definition example: inpatient diagnosis of
rhabdomyolysis AND creatine kinase (CK) total value > 1,000 U/L in the +/- 14 days
• Generates standard output for reporting and for use by additional tools
Cohort Identification and Descriptive Analysis Tool
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Query
Start
Date
Query End
Date
Available person time
Query Period 1/1/2006- 12/31/2013Coverage Requirement Medical and Drug CoverageEnrollment Requirement 183 daysEnrollment Gap 45 daysAge Groups 18-34, 35-44, 45-64 65-74, 75+
Query parameters
Patient A (IMPACT-AF example)
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Query
Start
Date
Query End
DateAtrial fibrillation
diagnosis
(Index Date)
Atrial Fibrillation diagnosis in any care setting at any time in observation period
Two Atrial Fibrillation diagnosis codes on different days in any care setting at any time in observation period; index is first observation
Two cohort definitions
Patient A (IMPACT-AF example)
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Query
Start
Date
Query End
Date
Observation
Time
Observation time: Identify anticoagulant use at any time after index date
Atrial fibrillation
diagnosis
(Index Date)
Patient A (IMPACT-AF example)
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Query
Start
Date
Query End
Date
Inclusion/Exclusion Criteria
Observation
Time
• At least one CHADS2 risk factor OR at least two CHA2DS2-VASc risk factors, EXCLUDE mechanical prosthetic valve and life-threatening bleeding
• At least two CHADS2 risk factors OR at least three CHA2DS2-VASc risk factors, EXCLUDE mechanical prosthetic valve and life-threatening bleeding
• At least one CHADS2 risk factor, EXCLUDE mechanical prosthetic valve and life-threatening bleeding (only relevant for 75+ group)
• At least two CHADS2 risk factors OR at least one CHA2DS2-VASc risk factors, EXCLUDE mechanical prosthetic valve and life-threatening bleeding (only relevant for 75+ group)
• At least two CHADS2 risk factors OR at least two CHA2DS2-VASc risk factors, EXCLUDE mechanical prosthetic valve and life-threatening bleeding
Multiple inclusion/exclusion criteria (n=8)
Atrial fibrillation
diagnosis
(Index Date)
Patient A (IMPACT-AF example)
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Complete specifications
• 16 different cohorts with different definitions for diagnosis and pre-existing condition requirements
• Once specifications are complete, results available within weeks
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Toh Arch Intern Med.2012;172:1582-1589.
• Used data for 3.9 million new users of anti-hypertensives in 18 organizations
• Propensity score matched analysis• No person-level data was shared• Five months and $250,000 required for programming and
analysis – compared to 1-2 years and $2 million without analysis-ready distributed dataset
![Page 29: Using the NIH Collaboratory'sand PCORnet's distributed ... Slides 11-14-14.pdf · Using the NIH Collaboratory'sand PCORnet's distributed data networks for clinical trials and observational](https://reader034.vdocuments.mx/reader034/viewer/2022042123/5e9e0d58599ee42b9565410b/html5/thumbnails/29.jpg)
• Output of the “Cohort Identification and Descriptive Analysis Tool (CIDA)” is the input for the propensity score matched tool
• Effect estimation based on exposure propensity-score matched parallel new user cohorts defined using the “CIDA” tool
• Three Propensity Score (PS) estimation options
• Predefined: requesters specify code lists
• Empirically identified (through high-dimensional PS): empirically selected covariates
• Predefined + empirically identified (through high-dimensional PS): all predefined and empirically selected covariates included in the model
• Two matching options
• 1:1; 1:100 variable
• Three caliper options
• .01, .025, .05
Propensity Score Matched tool
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Propensity Score Matched tool
• High-dimensional propensity score options
• Ranking algorithm
• Number of covariates considered by data dimension
• Number of covariates to select for hdPS model
• Subgroup analysis
• Using any predefined covariate
• Decile stratification
• Output• Diagnostics, effect estimates, confidence intervals
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Overview
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Specifications
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Table 1 Unmatched cohorts
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Table 2 Matched cohorts
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Table 3 Rates, differences, hazard ratios
Subsequent workbook sheets show histograms of unmatched and matched propensity scores for each of 13 data partners
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Propensity scores before match: One site
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Propensity scores before match: One site
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Three critical elements
• Privacy protections
• Reusable analysis tools
• Analysis-ready data
![Page 39: Using the NIH Collaboratory'sand PCORnet's distributed ... Slides 11-14-14.pdf · Using the NIH Collaboratory'sand PCORnet's distributed data networks for clinical trials and observational](https://reader034.vdocuments.mx/reader034/viewer/2022042123/5e9e0d58599ee42b9565410b/html5/thumbnails/39.jpg)
Common data model—guiding principles
• Accommodates project requirements and can evolve to meet expanded objectives
• Able to incorporate new data types and data elements as needs change
• Leverages existing and evolving data standards
• Uses existing native coding systems and minimizes ontology mapping
• Captures values found in source data
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Common data model—guiding principles
• Transparent, intuitive design that is easily understood by analysts and investigators
• Local implementation may include “site-specific” variables
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Common data model
• Relational structure provides analysis-ready platform
• Encounter basis incorporates EHR and claims-type data
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Technical Analyst
Data QA review process
Data Quality Analyst 1
Data Quality Analyst 2
Data Manager
1. Perform Data Update
9. Review and finalize report
7. Review #2 of data quality output
8. Annotate initial report of findings
12. Approve Data Update
Data Partner
MSOC
Data Quality Analyst
2. Execute data quality program package
3. Review output; identify and resolve issues
4. Deliver summary output to MSOC
5. Review #1 of data quality output
6. Prepare initial report of findings
10. Review report; resolve issues, respond to MSOC
11. Review Data Partner’s response to report; send additional questions if needed
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Rigorous data checking and characterization
• ~1500 data checks per refresh
• ~ 1500 checks
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Why QA after every refresh?
• Underlying data sources are dynamic
• Verify compliance with data model
• Identify changes in data sources or transformation processes
• Identify problems and/or differences in data transformation methods
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Why QA after every refresh?
Green: records from prior refresh
Red: record from new refresh under review
Problem:
Enrollment data from 2010 was archived between refreshes and not included in latest refresh.
Outcome:
Data Partner was asked to recreate the refresh including 2010 data.
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The DRN is ready for NIH to use
• Assess disease burden/outcomes
• Pragmatic clinical trial design
• Single study private network
• Pragmatic clinical trial follow up
• Reuse of research data
46
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Thank You
For more information
• nihcollaboratory.org/Pages/distributed-research-network.aspx
• PopMedNet.org
Prior Grand Rounds on the NIH Collaboratory Distributed Research Network
https://www.nihcollaboratory.org/Pages/Grand-Rounds-03-15-13.aspx
https://www.nihcollaboratory.org/Pages/Grand-Rounds-09-13-13.aspx
https://www.nihcollaboratory.org/Pages/Grand-Rounds-06-13-14.aspx
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