research:angioedema
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research:angioedema [2016/05/03 02:56] jduke [Customizable OHDSI-Formatted IRB] |
research:angioedema [2017/12/14 05:54] (current) schuemie |
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| **Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|recently announced]] that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health. | **Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|recently announced]] that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health. | ||
| - | **Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, Martijn Schuemie | + | **Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, [Stanford- Juan?], Martijn Schuemie. |
| - | **Coordinating Institution(s):** Regenstrief Institute | + | **Coordinating Institution(s):** Regenstrief Institute / Georgia Tech |
| - | ** Additional Participants (currently seeking additional collaborators):** | + | **Participating Institution(s):** Regenstrief Institute, Georgia Tech, Janssen Research and Development, Columbia University, University of California Los Angeles, University of Texas Houston, Stanford University, QuintilesIMS. |
| - | * George Hripcsak | + | |
| - | + | ||
| - | Any interested collaborators please contact Jon Duke at jonduke@regenstrief.org and I will be happy to add you to the collaborator list. | + | |
| - | + | ||
| - | **Participating Institution(s):** Regenstrief Institute, Janssen Research and Development, Columbia University, University of California, Los Angeles | + | |
| - | **Full Protocol:** [[https://drive.google.com/open?id=0BxVdB7jYnXcDWndwUmxrUUtjbUk|Keppra and Angioedema Risk Protocol]] | + | **Full Protocol:** [[https://github.com/OHDSI/StudyProtocols/blob/master/KeppraAngioedema/extras/KeppraandAngioedemaRiskStudyProtocolv0.5.docx?raw=true|Keppra and Angioedema Risk Protocol]] |
| **Initial Proposal Date:** 5/3/2016 | **Initial Proposal Date:** 5/3/2016 | ||
| - | **Launch Date:** TBD | + | **Launch Date:** 5/18/2016 |
| - | **Receive Results for Analysis Date:** TBD | + | **Receive Results for Analysis Date:** 7/15/2016 |
| - | **Study Closure Date:** TBD | + | **Study Closure Date:** 12/1/2016 (**Study closed**) |
| - | **Results Submission:** [[mailto:jonduke@regenstrief.org|Email]] or SFTP | + | **Results Submission:** Via the OHDSI Sharing module embedded in study or via [[mailto:jonduke@regenstrief.org|Email]]. |
| </WRAP> | </WRAP> | ||
| - | |||
| - | |||
| - | ===== Customizable OHDSI-Formatted IRB ===== | ||
| - | **IRB:** | ||
| - | |||
| ===== Requirements ===== | ===== Requirements ===== | ||
| - | **CDM:** V4 or V5 (both versions fully tested) | + | **CDM:** V5 only |
| - | **Table Accessed:** CONDITION_OCCURRENCE, CONDITION_ERA, CONCEPT, PERSON | + | **Table Accessed:** CONCEPT, CONCEPT_ANCESTOR, CONDITION_ERA, CONDITION_OCCURRENCE, DRUG_ERA, DRUG_EXPOSURE, MEASUREMENT, OBSERVATION, OBSERVATION_PERIOD, PERSON, PROCEDURE_OCCURRENCE, VISIT_OCCURRENCE |
| **Database Dialects:** SQL Server, Postgres, Oracle | **Database Dialects:** SQL Server, Postgres, Oracle | ||
| - | **Software:** SQL and R | + | **Software:** R (>= 3.2.2, RTools), Java |
| + | |||
| + | **Hardware:** Recommended 8-core, 32GB memory, 100GB free space | ||
| + | |||
| + | **How to Run:** Full installation and run instructions are provided on the GitHub page below. | ||
| ===== Code ===== | ===== Code ===== | ||
| - | [[https://github.com/maryreginaboland/SeaWAS|GitHub code for Proposed Study 4 - SeaWAS Across OHDSI]] | + | [[https://github.com/OHDSI/StudyProtocols/tree/master/KeppraAngioedema|GitHub code for Proposed Study - Keppra and Angioedema Risk]] |
| - | ===== Discussion ===== | ||
| - | [[http://forums.ohdsi.org/t/ohdsi-study-4-investigating-birth-month-disease-risk-relationships-across-the-ohdsi-network/742/3|SeaWAS-OHDSI Discussion Thread]] | ||
| ===== Datasets Run ===== | ===== Datasets Run ===== | ||
| - | * Columbia University - CUMC/NYP | + | * CCAE (Janssen) |
| - | * Taipei Medical University | + | * MDCD (Janssen) |
| - | * Ajou University School of Medicine | + | * MDCR (Janssen) |
| + | * Optum (Janssen) | ||
| + | * Columbia University | ||
| + | * IMS (French) | ||
| + | * IMS Ambulatory | ||
| + | * IMS PPLUS | ||
| + | * Stanford | ||
| + | * UT Blue Cross Blue Shield | ||
| + | * UT Cerner | ||
| ===== Waiting for Datasets From ===== | ===== Waiting for Datasets From ===== | ||
| - | * Stanford University | + | * CPRD (Janssen) |
| - | * University of Colorado | + | |
| - | * University of California, Los Angeles | + | |
| - | * Possibly - Children's Hospital of Philadelphia | + | ===== Results ===== |
| - | * Possibly - Erasmus University Medical Center | + | |
| + | Results will be posted here shortly. | ||
| + | |||
| + | |||
| ~~NOTOC~~ | ~~NOTOC~~ | ||
research/angioedema.1462244194.txt.gz · Last modified: 2016/05/03 02:56 by jduke
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