Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery

Project Title Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery
Date Posted
Friday, November 30, 2018
Status
In progress
Deliverables
Description

The aim of this methods project is to compare the relative performance of three analytic methods, TreeScan, Sequence Symmetry Analysis (SSA), and Information Component Temporal Pattern Discovery (ICTPD) in signal detection capability (both type I and type II error) using a simulated dataset as well as concordance in alerting when using an empiric dataset. The Workgroup will use the same dataset(s) to examine health outcomes of interest using all three methods.

The Workgroup will select at least one drug evaluation example with a well-known safety profile for evaluation of TreeScan, SSA, and ICTPD.

For the primary analysis the Workgroup will use the CDER-curated Multi-Level Clinical Classification Software (MLCCS) outcome tree. This tree contains thousands of hierarchically grouped adverse events based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes.  For the secondary analysis the Workgroup will scan the same outcomes defined by a single ICD-9-CM diagnosis code, i.e. absent any clinically related groupings. 

The Sentinel Operations Center has posted this final draft protocol for public comment. Comments must be received by the Sentinel Operations Center no later than December 28, 2018.

Submit comments by clicking on the Submit Comment link above and filling out the Comment Form or by sending an email directly to info@sentinelsystem.org. Please include the following information along with your comments:

  • Protocol title
  • Section(s) and page number(s) of protocol,if appropriate
  • Optional (but preferred):
    • Your name
    • Your organization and title
    • Your email address

The workgroup will consider all comments, but under most circumstances will not reply directly to commenters.

Any revisions done to this protocol after it has been posted for public comment will be noted in the change log document included in the amended protocol. Posting of the revised document will be listed on the Sentinel homepage, on the relevant assessments project details page, and in the Sentinel RSS feed.

Workgroup Leader(s)

Judith C. Maro PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Shirley V. Wang PhD, ScM; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

Michael Nguyen MD; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Members

Elande Baro PhD; Sai Dharmarajan PhD;  Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Monica Munoz PharmD, MS; Division of Pharmacovigilance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Danijela Stojanovic PharmD, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Esther Zhou MD, PhD; Office of Pharmcovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Joshua J. Gagne PharmD, ScD; Sushama Kattinakere MBBS, MSPH: Martin Kulldorff PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

David Cole BM, Inna Dashevsky MS; Sandra DeLuccia MPH; Ella Pestine MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Jesper Hallas MD, DrMedSc; Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense, Denmark

Niklas Noren PhD; PhD, MSc, Uppsala Monitoring Centre, Uppsala, Sweden

Medical Product
lamotrigine
levetiracetam
Health Outcome
Multi-Level Clinical Classification Software (MLCCS) outcome tree