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 is the quality of the current evidence from observational analyses? 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” 2
Would you rather? <insert favorite exposure here> <insert favorite outcome here> An observational database study in <insert location> <insert your Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert name here> 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 outcome here> in <insert favorite exposure here> use as compared with <insert favorite comparator here> , with adjustment for potential confounders.
Or… <insert favorite exposure here> <insert favorite outcome here> An international observational database network study <insert your Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert name here> favorite outcome here> is a known serious effect, but <insert the has not been robustly investigated. names of your data Objective To investigate the association between <insert favorite exposure here> use and <insert collaborators favorite outcome here> . here> Design, Setting, and Participants Analyses were performed against patient-level data from a network of observational 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 outcome here> in <insert favorite exposure here> use as compared with <insert favorite comparator here> , with adjustment for potential confounders.
What is the quality of the current evidence from observational analyses? 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” 5
Would you rather? <insert favorite exposure here> <insert favorite outcome here> An observational database study in <insert location> <insert your Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert name here> 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 outcome here> in <insert favorite exposure here> use as compared with <insert favorite comparator here> , with adjustment for potential confounders.
Or… <insert favorite exposure here> <insert favorite outcome here> An international observational database network study <insert your Context Use of <insert favorite exposure here> has increased dramatically in the United States. <insert name here> favorite outcome here> is a known serious effect, but <insert the has not been robustly investigated. names of your data Objective To investigate the association between <insert favorite exposure here> use and <insert collaborators favorite outcome here> . here> <insert the Design, Setting, and Participants Analyses were names of your performed against patient-level data from a network of methods observational databases, including the <insert your dataset here> and <insert the names of datasets from collaborators your collaborator> . A library of open-source methods here> 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
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 of 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 .
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
OHDSI’s mission To improve health, by empowering a community to collaboratively generate the evidence that promotes better health decisions and better care.
OHDSI’s approach to open science Data + Analytics + Domain expertise Open Generate science evidence Enable users Open to do source something software • 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
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?
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 open-source tools across the OHDSI international data network – Promote open-science strategies for transparent study design and evidence dissemination
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