Observational Health Data Sciences and Informatics (OHDSI): An - - PowerPoint PPT Presentation

observational health data
SMART_READER_LITE
LIVE PREVIEW

Observational Health Data Sciences and Informatics (OHDSI): An - - PowerPoint PPT Presentation

Observational Health Data Sciences and Informatics (OHDSI): An International Network for Open Science and Data Analytics in Healthcare Patrick Ryan, PhD Janssen Research and Development Columbia University Medical Center 27 June 2016 What


slide-1
SLIDE 1

Observational Health Data Sciences and Informatics (OHDSI): An International Network for Open Science and Data Analytics in Healthcare

Patrick Ryan, PhD Janssen Research and Development Columbia University Medical Center 27 June 2016

slide-2
SLIDE 2

What is the quality of the current evidence from observational analyses?

2

April2012: “Patients taking oral fluoroquinolones were at a higher risk of developing a retinal detachment” Dec2013: “Oral fluoroquinolone use was not associated with increased risk of retinal detachment”

slide-3
SLIDE 3

Would you rather?

<insert favorite exposure here> <insert favorite outcome here>

<insert your name here>

Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert favorite outcome here> is a known serious effect, but has not been robustly investigated. Objective To investigate the association between <insert favorite exposure here> use and <insert favorite outcome here>. Design, Setting, and Participants Analyses were performed against patient-level data from the <insert your dataset here>. <insert your favorite statistical model> was used to calculate relative risk and 95% confidence interval for the risk of <insert favorite

  • utcome here> in <insert favorite exposure here> use

as compared with <insert favorite comparator here>, with adjustment for potential confounders.

An observational database study in <insert location>

slide-4
SLIDE 4

Or…

<insert favorite exposure here> <insert favorite outcome here>

<insert your name here> <insert the names of your data collaborators here>

Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert favorite outcome here> is a known serious effect, but has not been robustly investigated. Objective To investigate the association between <insert favorite exposure here> use and <insert favorite outcome here>. Design, Setting, and Participants Analyses were performed against patient-level data from a network of

  • bservational databases, including the <insert your

dataset here> and <insert the names of datasets from your collaborator>. <insert your favorite statistical model> was used to calculate relative risk and 95% confidence interval for the risk of <insert favorite

  • utcome here> in <insert favorite exposure here> use

as compared with <insert favorite comparator here>, with adjustment for potential confounders.

An international observational database network study

slide-5
SLIDE 5

What is the quality of the current evidence from observational analyses?

5

August2010: “Among patients in the UK General Practice Research Database, the use of oral bisphosphonates was not significantly associated with incident esophageal or gastric cancer” Sept2010: “In this large nested case- control study within a UK cohort [General Practice Research Database], we found a significantly increased risk of oesophageal cancer in people with previous prescriptions for oral bisphosphonates”

slide-6
SLIDE 6

Would you rather?

<insert favorite exposure here> <insert favorite outcome here>

<insert your name here>

Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert favorite outcome here> is a known serious effect, but has not been robustly investigated. Objective To investigate the association between <insert favorite exposure here> use and <insert favorite outcome here>. Design, Setting, and Participants Analyses were performed against patient-level data from the <insert your dataset here>. <insert your favorite statistical model> was used to calculate relative risk and 95% confidence interval for the risk of <insert favorite

  • utcome here> in <insert favorite exposure here> use

as compared with <insert favorite comparator here>, with adjustment for potential confounders.

An observational database study in <insert location>

slide-7
SLIDE 7

Or…

<insert favorite exposure here> <insert favorite outcome here>

<insert your name here> <insert the names of your data collaborators here> <insert the names of your methods collaborators here>

Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert favorite outcome here> is a known serious effect, but has not been robustly investigated. Objective To investigate the association between <insert favorite exposure here> use and <insert favorite outcome here>. Design, Setting, and Participants Analyses were performed against patient-level data from a network of

  • bservational databases, including the <insert your

dataset here> and <insert the names of datasets from your collaborator>. A library of open-source methods for population-level effect estimation, including cohort and self-controlled designs, were used to calculate and empirically calibrate relative risk and 95% confidence interval for the risk of <insert favorite outcome here> in <insert favorite exposure here> use as compared with <insert favorite comparator here>, with adjustment for

An international observational database network study

slide-8
SLIDE 8

ICMJE authorship guidelines necessitate an open science approach

The ICMJE recommends that authorship be based on the following 4 criteria:

  • Substantial contributions to the conception or design
  • f the work; or the acquisition, analysis, or

interpretation of data for the work; AND

  • Drafting the work or revising it critically for important

intellectual content; AND

  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the

work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

slide-9
SLIDE 9

Introducing OHDSI

  • The Observational Health Data Sciences and

Informatics (OHDSI) program is a multi- stakeholder, interdisciplinary collaborative to create open-source solutions that bring out the value of observational health data through large-scale analytics

  • OHDSI has established an international

network of researchers and observational health databases with a central coordinating center housed at Columbia University

http://ohdsi.org

slide-10
SLIDE 10

OHDSI’s mission

To improve health, by empowering a community to collaboratively generate the evidence that promotes better health decisions and better care.

slide-11
SLIDE 11

OHDSI’s approach to open science

Open source software Open science Enable users to do something Generate evidence

  • Open science is about sharing the journey to evidence generation
  • Open-source software can be part of the journey, but it’s not a final destination
  • Open processes can enhance the journey through improved reproducibility of

research and expanded adoption of scientific best practices Data + Analytics + Domain expertise

slide-12
SLIDE 12

What evidence does OHDSI seek to generate from observational data?

  • Clinical characterization

– Natural history: Who are the patients who have diabetes? Among those patients, who takes metformin? – Quality improvement: what proportion of patients with diabetes experience disease-related complications?

  • Population-level estimation

– Safety surveillance: Does metformin cause lactic acidosis? – Comparative effectiveness: Does metformin cause lactic acidosis more than glyburide?

  • Patient-level prediction

– Precision medicine: Given everything you know about me and my medical history, if I start taking metformin, what is the chance that I am going to have lactic acidosis in the next year? – Disease interception: Given everything you know about me, what is the chance I will develop diabetes?

slide-13
SLIDE 13

What is OHDSI’s strategy to deliver reliable evidence?

  • Methodological research

– Develop new approaches to observational data analysis – Evaluate the performance of new and existing methods – Establish empirically-based scientific best practices

  • Open-source analytics development

– Design tools for data transformation and standardization – Implement statistical methods for large-scale analytics – Build interactive visualization for evidence exploration

  • Clinical evidence generation

– Identify clinically-relevant questions that require real-world evidence – Execute research studies by applying scientific best practices through

  • pen-source tools across the OHDSI international data network

– Promote open-science strategies for transparent study design and evidence dissemination

slide-14
SLIDE 14

Methodological research Open-source analytics development Clinical applications Observational data management Population-level estimation Patient-level prediction

  • Data quality assessment
  • Common Data Model evaluation
  • ATHENA for standardized

vocabularies

  • WhiteRabbit for CDM ETL
  • Usagi for vocabulary mapping
  • HERMES for vocabulary exploration
  • ACHILLES for database profiling
  • CohortMethod
  • SelfControlledCaseSeries
  • SelfControlledCohort
  • TemporalPatternDiscovery
  • PatientLevelPrediction
  • APHRODITE for predictive

phenotyping

  • Empirical calibration
  • LAERTES for evidence synthesis
  • PENELOPE for patient-centered

product labeling

  • Chronic disease therapy pathways
  • HOMER for causality assessment

Clinical characterization

  • CIRCE for cohort definition
  • CALYPSO for feasibility assessment
  • HERACLES for cohort

characterization

  • Phenotype evaluation
  • Evaluation framework and

benchmarking

OHDSI ongoing collaborative activities

slide-15
SLIDE 15

Standardizing workflows to enable reproducible research

Open science Generate evidence

Database summary Cohort definition Cohort summary Compare cohorts Exposure-

  • utcome

summary Effect estimation & calibration Compare databases

Defined inputs:

  • Target exposure
  • Comparator group
  • Outcome
  • Time-at-risk
  • Model specification

Population-level estimation for comparative effectiveness research: Is <intervention X> better than <intervention Y> in reducing the risk of <condition Z>? Consistent outputs:

  • analysis specifications for transparency and

reproducibility (protocol + source code)

  • nly aggregate summary statistics

(no patient-level data)

  • model diagnostics to evaluate accuracy
  • results as evidence to be disseminated
  • static for reporting (e.g. via publication)
  • interactive for exploration (e.g. via app)
slide-16
SLIDE 16

OHDSI community in action

Coordinating center: CUMC

Data partner Researcher

OHDSI Collaborators:

  • >140 researchers in academia, industry, government, health systems
  • >20 countries
  • Multi-disciplinary expertise: epidemiology, statistics, medical

informatics, computer science, machine learning, clinical sciences Databases converted to OMOP CDM within OHDSI Community:

  • >50 databases
  • >660 million patients

Ask clinical question Design protocol Develop standardized analytics Generate and disseminate evidence

Standardized process for network analyses:

slide-17
SLIDE 17

OHDSI community in action

  • 11 databases from 4 countries in US, Europe, Asia-Pacific regions
  • 250 million patient records
  • 17 co-authors
  • 1 common protocol with 1 standardized analytic program run against 1 data model

http://www.pnas.org/content/early/2016/06/01/1510502113.full

slide-18
SLIDE 18

T2DM : All databases

Treatment pathways for diabetes

First drug Second drug Only drug

Hripcsak et al, PNAS, 2016

slide-19
SLIDE 19

Type 2 Diabetes Mellitus Hypertension Depression OPTUM GE MDCD CUMC INPC MDCR CPRD JMDC CCAE

Population-level heterogeneity

Hripcsak et al, PNAS, 2016

slide-20
SLIDE 20

Would you rather?

<insert favorite exposure here> <insert favorite outcome here>

<insert your name here>

Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert favorite outcome here> is a known serious effect, but has not been robustly investigated. Objective To investigate the association between <insert favorite exposure here> use and <insert favorite outcome here>. Design, Setting, and Participants Analyses were performed against patient-level data from the <insert your dataset here>. <insert your favorite statistical model> was used to calculate relative risk and 95% confidence interval for the risk of <insert favorite

  • utcome here> in <insert favorite exposure here> use

as compared with <insert favorite comparator here>, with adjustment for potential confounders.

An observational database study in <insert location>

x1

slide-21
SLIDE 21

Or…

<insert an important exposure here> <insert an important outcome here>

<insert name of study lead> <insert your name here> <insert the names of your data collaborators here> <insert the names of your methods collaborators here>

Context Use of <insert important exposure here> has increased dramatically in the United States. <insert important outcome here> is a known serious effect, but has not been robustly investigated. Objective To investigate the association between <insert important exposure here> use and <insert important outcome here>. Design, Setting, and Participants Analyses were performed against patient-level data from a network of

  • bservational databases, including the <insert your

dataset here> and <insert the names of datasets from your collaborator>. A library of open-source methods for population-level effect estimation, including cohort and self-controlled designs, were used to calculate and empirically calibrate relative risk and 95% confidence interval for the risk of <insert important outcome here> in <insert important exposure here> use as compared with <insert relevant comparator here>, with

An international observational database network study

x7

slide-22
SLIDE 22

Network studies across OHDSI community

http://www.ohdsi.org/web/wiki/doku.php?id=research:ongoing_studies

slide-23
SLIDE 23

Everyone can contribute to an open science collaborative

Got research questions? Got observational data? Got methods? Got clinical interpretation? Got hacking skills? Join the journey

slide-24
SLIDE 24

Concluding thoughts

  • Observational databases can be a useful tool for

generating evidence to important clinical questions in…

– Clinical characterization – Population-level estimation – Patient-level prediction

  • …but ensuring that evidence is reliable requires

developing scientific best practices, and transparent and reproducible processes to conduct analyses across the research enterprise

  • An open science community allows all stakeholders to

contribute to and benefit from a shared solution…anyone can get involved…that means YOU!

slide-25
SLIDE 25

Join the journey

Interested in OHDSI? Questions or comments? ryan@ohdsi.org