Multicenter Registry for Hyperbaric Oxygen Therapy


Oxygen delivered at pressures higher than atmospheric, hyperbaric oxygen (HBO), is a therapy approved for several existing and emerging indications

Overview

What is the Multicenter Registry for Hyperbaric Oxygen Therapy and why do we need it?

Most hyperbaric providers have experienced insurance denials for indications approved by the Undersea and Hyperbaric Medical Society. The only cure for these denials is reliable data. The Multicenter Registry for Hyperbaric Oxygen Therapy is designed to provide these data.

The Registry is a database designed to gather a consistent set of measures about the use, outcomes, and safety of Hyperbaric Oxygen Treatments from hyperbaric centers around the world. The goal is to publish this information for quality improvement, patient care, research, and to document the outcomes from hyperbaric oxygen treatment. The Registry collects data for the 14 UHMS-approved indications for hyperbaric treatments as well as selected other emerging indications. The data from the participating centers are aggregated to provide information that no single center could collect on its own. Currently most of the data available about hyperbaric oxygen treatments are based on small numbers from a limited number of centers.

The database uses REDCap software (from Vanderbilt University). REDCap is a web-based, HIPAA-compliant data collection system that’s easy to use and widely available. The Registry contains a core set of data that needs to be completed for all patients being treated at participating centers. These data include basic demographic data, treatment information, safety, and defined outcome measures. The outcome data are tailored to the indication and are primarily routinely used clinical measures. It only takes a few minutes to enter the required data for each patient. Data do not need to be entered every day on every patient.

Importantly, no identifiable data leave a participating center. Only de-identified data are sent to the Multicenter Registry server. Identifiable demographic data are not shared with other centers and are for use only at the center generating it. Each participating center can use their own data to easily and quickly get reports about their treatments at any time. De-Identified data (no PHI) are sent quarterly to the registry. At least yearly a global report is generated. Centers can then benchmark their data with the aggregated data.

Currently, there is no cost to participate. Governance is through a steering committee made up of a participant from each enrolled center. The Steering Committee sets policies & procedures and oversees the operation of the registry. The steps to joining the Registry are:

  1. Have your institution read the Consortium Agreement and sign a New Member Agreement
  2. Obtain IRB approval (either use the Dartmouth IRB as the IRB of record or seek approval at your site)
  3. Get REDCap access (either use REDCap at your site or use Dartmouth REDCap through a Data Use Agreement)

If your center is interested in being part of this important project to improve the data available about hyperbaric oxygen treatments contact us at: HyperbaricRegistry@groups.dartmouth.edu

Documents

Consortium Agreement
This document provides an overview of the organization, governance, and data sharing requirements for the registry.
New Member Agreement
Last page of the registry agreement that each center signs to join the registry.
Dartmouth IRB Approval for Registry
This is the IRB approval at Dartmouth for the Multicenter Registry.
Dartmouth IRB Reliance Agreement and Request to Rely Forms
These are the forms needed to rely on the Dartmouth IRB for the project. IRB approval can also be sought individually at a particular site.
Research use of information form
This is the IRB form that provides information to the IRB about the study.

Participating Centers

  • Geisel School of Medicine at Dartmouth College
  • Dartmouth Hitchcock Medical Center
  • University of Rochester Medical Center
  • University of Maryland Medical Center
  • University of Pennsylvania Health System
  • The Hyperbaric Unit, Whipps Cross University Hospital, London, UK
  • Intermountain Healthcare
  • UC San Diego Health
  • Elliot Health System

  • Hyperbaric Medicine Unit, St Richard's Hospital, Chichester, UK
  • DDRC Healthcare, Hyperbaric Medical Centre, Plymouth, UK
  • East of England -Lhm Hyperbaric Unit, James Paget University Hospital, Great Yarmouth

Donate Now

Click the button below to make a donation to the Registry.

Administration

Jay C. Buckey, M.D.
Judy R. Rees, M.D.
Judy A. Ptak, R.N., C.H.T
Abigail M. Fellows, M.A.
Devin R. Cowan, B.S.

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