Project Title

Comparative Outcomes Management with Electronic Data Technologies (COMET)

Shortened Title

COMET

Publication Date

2013

Author Information

Clete A. Kushida, MD, PhD, RPSGT
Professor, Psychiatry and Behavioral Science
Stanford Sleep Medicine Center

Abstract

The goal of this project is to develop a new electronic data network infrastructure that will prospectively enable access to and the sharing of clinical and research data between four sleep medicine Clinical Centers (CCs) across the United States. The development of this new, broad, scalable, and sustainable electronic data network will enable the collection of longitudinal data content (both digital and physical) by each of the four CCs. The electronic network infrastructure developed through COMET will link the prospective information collected from a comparative effectiveness trial via multiple CCs, diverse patient and research participant populations, different patient comorbidities and disease severities, various equipment and test types, and several patient visits. Ultimately, the project will design a single-point access Sleep Research Application that can be sustained by hosting subsequent prospective cohort research projects using a template-based approach. Initial data in the network will be collected from a pilot comparative effective­ness project comparing sleep apnea devices and treatments. For more information, visit comet.stanford.edu.

Infrastructure Aims

  1. Develop a new electronic data network to enable sharing and access across a network of clinical centers;
  2. Utilize an informatics platform that integrates data across the clinical centers and builds domain-specific taxonomies, meta data, and content types across the network;
  3. Utilize a comprehensive, web-based questionnaire to improve patient care and support ongoing research efforts in the field of sleep medicine; and
  4. Integrate various diverse patient-cen­tered data sources, including a variety of device-generated data.

Primary Research Aims

To conduct a randomized two-arm CER trial to compare two treatments in patients with obstructive sleep apnea: Positive airway pressure (PAP) and Oral Appliances.

Healthcare Settings

Specialty clinics

Geographic scope type

National

Locations of Focus

Main sites are located in: Stanford, CA; Philadelphia, PA; Madison, WI; and Boston, MA.

Population Network Size

The estimated size of the network is 20,000 patients annually. The study population size for the comparative effectiveness trial is 190 participants.

Informatics Platform/Tools

The COMET informatics platform is based on centralized servers and a federated/distributed network of servers located at various Sleep Alliance clinical centers. The centralized servers consist of three hardware platforms which house Microsoft SQL Server database server, Microsoft SharePoint content management system, Microsoft Web application server, two ftp servers, and a Linux server with a MySQL database server. Servers located at Sleep Alliance clinical centers consist of Linux servers with a MySQL database server and a web application server and various file systems. Internetworking communications includes federated query, file transfer, automated email notification, and database reporting systems.

Grant Type

PROSPECT Studies

Major Partners

Stanford Sleep Medicine Center (Lead Site); Academic Alliance for Sleep Research (AASR); participating institutions Stanford University, University of Pennsylvania, University of Wisconsin- Madison, Harvard University); Microflow DBMS, Inc. (Informatics Consultants)

CER/PCOR Study Priority Populations

Minority groups, Women, The elderly, Cardiovascular disease, including stroke and hypertension (Heart and blood vessel conditions), Obesity, Pulmonary disease/asthma (Breathing conditions)

Outcome(s) of Interest

Mean nocturnal blood pressure; Flow-mediated vasodilatation (FMD) of the brachial artery; sleep-disordered breathing, sleepi­ness, mood, and quality of life; cost-effective­ness of PAP and oral appliances; cardiovas­cular biomarkers; genetic polymorphisms

Acknowledgement of Funders

This project is supported by grant number 1R01HS019738 from the Agency for Healthcare Research and Quality, and is one of the ARRA-funded PROSPECT (Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies) studies.

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