LHM Healthcare is participating in the REDCap Multicentre Registry as part of our commitment to Research and Development in Hyperbaric Oxygen Therapy

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

Most hyperbaric providers in the UK have experienced Individual Funding Request (IFR) denials for indications previously commissioned by NHSE due to ‘insufficient evidence to support the routine commissioning’ of these indications. The only solution to these denials is reliable and robust multicentre data. The Multicenter Registry for Hyperbaric Oxygen Therapy is designed to provide these data to inform commissioners (and insurers) when deciding on their commissioning intentions.

The REDCap Hyperbaric registry is a database designed to collect a consistent dataset of measures about the details of various conditions as well as the use, outcomes, and safety of Hyperbaric Oxygen Treatments from hyperbaric centres 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 centres are aggregated to provide information that no single centre could collect on its own. Currently most of the data available about hyperbaric oxygen treatments are based on research involving small numbers of cases as these are uncommon conditions. The solution to studying rare and uncommon conditions has been shown to be by multinational, multicentre registers of such conditions or therapeutic modalities.

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 centres. These data include basic demographic data, detail of the various conditions, treatment information, safety, and defined outcome measures, including evidence of sustained improvement.

Importantly, no identifiable data leave a participating centre. Only de-identified data are sent to the Multicenter Registry server. Identifiable demographic data are not shared with other centres 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.

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.

at: HyperbaricRegistry@groups.dartmouth.edu

To enable UK centres to participate in this research project, initial start-up costs were funded by: NHS England and National Institute for Health Research (NIHR) Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.

NHSE only commissions and the treatment of two indications:

Decompression Illness and Gas Embolism.   Data collected from the treatment of these two conditions is included in the REDCap submissions. The collection of data for these two indications is covered by LHM’s funding agreement with NHSE.

Prior to 2018, NHSE authorised the treatment of a number of internationally approved and emerging indications on an IFR basis. This funding was withdrawn in 2018 for all non-commissioned indications due to the perceived lack of strong evidence required by NHSE to support routine commissioning. Providers were encouraged to adopt a clinician-led and clinically driven approach to data collection for these elective and other emerging indications, which would not be funded through NHS contracts.

The collection of data through national and International database has been included in NHSE’s Service Specification for Hyperbaric Oxygen Therapy (HBOT) since its publication in 2018.

Outcomes:

As data is submitted for each condition by participating centres, scientific outcomes are identified by the Lead clinicians and publications prepared for peer review and publication.

The first significant publication based on data submitted by LHM to the REDCap database was made in 2023 in the Journal of Urology.

Participating UK centres are now in the process of preparing a formal submission to NHSE to consider approving routine funding for Radiation Cystitis for which robust evidence has been published and is supported by Redcap outcomes reported and published recently.

LHM Healthcare’s Participating centres: 

East of England Hyperbaric Unit – James Paget University Hospital

Whipps Cross Hyperbaric Unit – Whipps Cross University Hospital, London