Development of an International, Multicenter, Hyperbaric Oxygen Treatment Registry and Research Consortium: Protocol for Outcome Data Collection and Analysis

Abstract

Background Hyperbaric oxygen (HBO2)—oxygen at pressures higher than atmospheric—is approved for 14 indications by the Undersea and Hyperbaric Medical Society. HBO2’s main effect is to increase oxygen content in plasma and body tissues, which can counteract hypoxia or ischemia. Laboratory studies show that HBO2 has effects beyond relieving hypoxia (eg, promoting angiogenesis in irradiated tissue, anti-inflammatory effects, radiosensitization of tumors, hypoxia preconditioning, and fungal growth inhibition) and has potential to treat conditions such as inflammatory bowel disease and pyoderma gangrenosum. Lack of consistently collected outcome data on a large cohort of individuals receiving HBO2 therapy limits its use for both established and new indications. A course of therapy often involves 30-40 visits to a hyperbaric chamber, so the number of patients seen at any given center is constrained by chamber capacity. As a result, published HBO2 outcome data tend to be from small case series because few patients with a particular condition are treated at a given center. To solve this problem, a registry that collects and pools data systematically from multiple institutions has been established. Objective The aim of this study is to collect consistent outcome data across multiple hyperbaric centers to assess treatment effectiveness and establish a research consortium. Methods A consortium of hyperbaric centers who have agreed to collect consistent outcome data on all patients seen has been assembled. Data are collected at each participating center using Research Electronic Data Capture (REDCap), a web-based, data collection system used frequently for research. Standard outcome measures have been defined for each condition, which are programmed into the REDCap data collection templates. Governance is through a consortium agreement that defines data security, data sharing, publications, liability, and other issues. Centers obtain Institutional Review Board (IRB) and ethics approval to participate, either from their own institutions or by relying on the IRB at the coordinating center at Dartmouth College. Dissemination will occur through a yearly report and by publications based on the data in the registry. Results Early results from some common indications show significant pretreatment to posttreatment changes. Additional indications and outcome measures are being added using the procedures outlined in the consortium agreement. Conclusions The registry collects consistent outcome information for a therapy that needs further study and a stronger evidence base. It also overcomes the challenge of collecting data from an adequate number of patients for both established and emerging indications by combining data collection from multiple centers. The data entry requirements should be within the capabilities of existing staff at any given hyperbaric center. By using REDCap, the registry can be expanded to include detailed information on particular indications and long-term follow-up on selected patients without significantly increasing the basic data entry requirements. Through the registry, a network of enrolled hyperbaric centers has been established that provides the basis for a clinical trial network. International Registered Report Identifier (IRRID) DERR1-10.2196/18857

Retracted: Design, development, and evaluation of a registry system for hyperbaric oxygen therapy: A methodological study

“…Soft tissue injuries, wound healing, and underwater medicine are only a few of the indications for HBOT. 6 , 31 recent research has revealed that hyperbaric oxygen treatment is effective in the treatment of a number of ailments. The development of a patient information registration system for undersea medicine and HBOT could be advantageous.…”

“… 32 Accuracy and completeness of data are the most critical factors affecting the quality and value of any registration system. 6 , 16 , 31 , 32 …”

“…23 Additionally, HBOT study and research have its own particular difficulties because; it is a long‐standing treatment process with a daily session for a few months, and most centers do not have enough numbers of engaged cases to form a reasonable sample size and carry out a research study, and most patients are followed by other specialties so their outcomes are mostly unavailable. 6 Thus, to gather information regarding HBOT outcomes, long‐term follow‐up, and efficacy assessment a multicenter computerized data collection system is needed. One high‐yield system is the registration system that is used in hospitals and clinics to record information about patients with specific conditions.…”

Renal Effects of Hyperbaric Oxygen Therapy in Patients with Diabetes Mellitus: A Retrospective Study

“…The Dartmouth–Hitchcock Institutional Review Board (IRB) approved this retrospective chart review, and collected data were deidentified as mandated. A list of all patients with diabetes mellitus at the Dartmouth–Hitchcock Medical Center who underwent hyperbaric oxygen therapy (HBOT) was obtained from the institutional HBOT registry [ 7 ]. Data on proteinuria, serum creatinine, use of angiotensin-converting enzyme inhibitors (ACEIs), and use of angiotensin receptor blockers (ARBs) was obtained from electronic medical records.…”

Efficacy and safety of hyperbaric oxygen therapy for moderate-to-severe ulcerative colitis: a protocol for a systematic review and meta-analysis

“…Hyperbaric oxygen therapy (HBO 2 ) is defined as breathing close to 100% oxygen in a hyperbaric oxygen chamber, where the pressure exceeds 1.4 absolute atmospheres (ATA). 21 HBO 2 therapy is performed in 2–3 absolute atmospheric pressure chambers 2–3 times daily. The length of treatment varies according to distinct indications but is usually between 1.5 and 2 hours.…”