Collection of Patient-Provided Information Through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research

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Details

Basic Details

Date Posted:

Tuesday, January 3, 2017

Status:

Complete

Description:

The purpose of this pilot project was to develop a generalizable mobile device application that can be used to collect data from patients in real-time and link it to existing electronic health data. This system will allow for creation, distribution, and modification of questionnaires on Android and iOS mobile phones, as well as the ability for specified administrators to download patient responses from a HIPAA and FISMA compliant storage environment. As an initial proof of concept, the project will not analyze a specific safety or comparative effectiveness issue. However, descriptive linked data as well as data related to usability and patient engagement will be presented.

Deliverable(s) (2)

The FDA MyStudies App: A Patient Centered Outcomes Research Trust Fund Enabler For Distributed Clinical Trials And Real World Evidence Studies

The FDA MyStudies App: Appendices

Additional Information

Information

Time Period:

September 2017 - December 2017

Population / Cohort:

Pregnant women

Data Source(s):

Kaiser Permanente Washington Health Research Institute Members and the Kaiser Permanente Washington Sentinel Distributed Database

Contributors

Workgroup Leader(s):

Zachary Wyner, MPH; Chayim Herzig-Marx, PhD; Juliane Reynolds, MPH; Jeffrey Brown, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

David Martin, MD, MPH; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Member(s):

Alison Kawai, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA;

Sascha Dublin, MD, PhD; Predrag Klasnja, PhD; Linda Kiel; Catherine Lim; Karen Byeman, Kacie Washington; Group Health Research Institute, Seattle, WA

Christina Chambers, MD; University of California San Diego, Family Medicine and Public Health Department, San Diego, CA

Adam Rauch, Bernard Lee, Brian Connolly, Susan Hert, Angelica Omaiye; LabKey Software, Seattle, WA

McKinley Hackett, Shyam Deval, Shanthala Rao, Will Crosby; Boston Technology Corporation, Marlborough, MA

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Collection of Patient-Provided Information Through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research

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