A Microsimulation Model to Project the 5-Year Impact of Using Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Acute Flares.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) improves short-term outcomes for ulcerative colitis (UC) patients hospitalized for acute flares. Longer-term impacts and cost-effectiveness are unknown. METHODS: We compared disease outcomes and cost-effectiveness of HBOT in addition to standard of care versus standard of care alone for UC patients hospitalized for acute flares using a microsimulation model. Published literature was used for transition probabilities, costs, and quality-adjusted life year (QALY) estimates. We modeled 100,000 individuals in each group over a 5-year horizon and compared rates of re-hospitalization, rescue medical therapy, colectomy, death, and cost-effectiveness at a willingness-to-pay of $100,000/QALY. Probabilistic sensitivity analyses were performed with 500 samples and 250 trials, in addition to multiple microsimulation sensitivity analyses. RESULTS: The use of HBOT at the time of index hospitalization for an acute UC flare is projected to reduce the risk of re-hospitalization, inpatient rescue medical therapy, and inpatient emergent colectomy by over 60% (p < 0.001) and mortality by over 30% (p <0.001), during a 5-year horizon. The HBOT strategy costs more ($5600 incremental cost) but also yielded higher QALYs (0.13 incremental yield), resulting in this strategy being cost-effective ($43,000/QALY). Results were sensitive to HBOT costs and rates of endoscopic improvement with HBOT. Probabilistic sensitivity analyses observed HBOT to be more cost-effective than standard of care in 95% of iterations. CONCLUSION: The use of HBOT to optimize response to steroids during the index hospitalization for an acute UC flare is cost-effective and is projected to result in significant reductions in disease-related complications in the long term.

The cost of decompression illness: the case of lobster and sea cucumber fishery in Yucatan, Mexico.

Diving fisheries are an important source of income and protein for many coastal communities around the world. However, these fisheries are also the cause of both fatal and non-fatal injuries. The aim of this study is to estimate the costs of decompression sickness (DCS) in the diving small-scale fisheries that target benthic resources in the Yucatan, Mexico. The DCS cases that occurred during three fishing seasons for sea cucumber (Isostichopus badionotus) and one for spiny lobster (Panulirus argus) were used to calculate the direct medical costs. The catch data during the same fishing seasons were used to calculate the potential losses caused by disability as indirect costs. In the three years (from 2013 to 2016) the total number of fishermen treated in the region numbered 282; 116 during lobster fishing and 166 during sea cucumber season. The direct medical costs were estimated to be USD $120,269; the temporary loss of income in USD $724,377; and the permanent loss of income was USD $737,053. Considering the direct and indirect costs, the social costs of diving in both small-scale fisheries was USD $1,614,121. This is a first approach to estimate the cost of the use of diving in fisheries for the health services but for the fishing communities as well. Furthermore, this is an important first step on the road to a full economic evaluation of the benthic fisheries in order to improve their management.

Treatment with normobaric or hyperbaric oxygen and its effect on neuropsychometric dysfunction after carbon monoxide poisoning: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Carbon monoxide (CO) poisoning may result in acute neurological sequelae, cognitive sequelae, and delay neurological sequelae. The administration of hyperbaric oxygen (HBO) to prevent the development of delayed neurological sequelae in CO poisoning have extensively investigated but conflicting results have been reported. We performed a systematic literature review and meta-analysis of randomized controlled trials (RCTs) evaluating HBO treatment and its effect on neuropsychometric dysfunction after CO poisoning. METHODS: We searched Medline, Embase, Pubmed, and the Cochrane Register of Controlled Trials from inception to December 2017. Eligible studies compared HBO therapy with normobaric oxygen (NBO) in patients with CO poisoning. RESULTS: Six studies compared HBO with NBO in CO poisoning patients. Compared with patients treated with NBO, a lower percentage of patients treated with HBO reported headache (16.2% vs 16.5%, relative risk [RR] = 0.83, 95% CI = 0.38-1.80), memory impairment (18.2% vs 23.8%, RR = 0.80, 95% CI = 0.43-1.49), difficulty concentrating (15.0% vs 18.4%, RR = 0.86, 95% CI = 0.55-1.34), and disturbed sleep (14.7% vs 16.2%, RR = 0.91, 95% CI = 0.59-1.39). Two sessions of HBO treatment exhibited no advantage over one session. CONCLUSIONS: The meta-analysis indicated that compared with CO poisoning patients treated with NBO, HBO treated patients have a lower incidence of neuropsychological sequelae, including headache, memory impairment, difficulty concentrating, disturbed sleep, and delayed neurological sequelae. Taking into consideration the cost-effectiveness of one session of HBO, one session of HBO treatment could be an economical option for patients with CO poisoning with high severity.

A historical review of the U.S. Navy's busiest recompression chamber in the Pacific theater with a current perspective on caring for civilian divers within its area of responsibility: short communication.

On the island Nation of Guam, the United States Department of Defense has stationed military personnel from every service branch. Guam is utilized as a strategic waypoint for the U.S. military in the Pacific theater. As the largest service branch in the region, the Navy has placed a few Diving Medical Officers in Guam to collectively manage and treat patients with recompression therapy. Guam is also a popular tourist destination, with multiple recreational diving companies certifying individuals who are looking to take advantage of the beautiful warm water and exotic marine life. Unfortunately, with an increase in training and certifying inexperienced divers, came an increase in the operational tempo of the U.S. Navy's recompression chamber on Guam. The recompression chamber on Naval Base Guam (NBG) has been treating patients since 1971. With the only multiplace chamber in the Mariana Islands, Diving Medical Officers, with the accompanying chamber staff, treat military personnel, active-duty sponsored patients and civilian patients. Treating civilian patients by military providers through military treatment facilities presents multiple issues that must be addressed in an effort to provide efficient quality medical care. This article reviews the records, documents, and activity of the NBG chamber over the last four decades. Through the obtained data the information provides projected financial reimbursement from civilian patients. The article also sheds light on areas of needed improvement with regard to data collection, third-party financial collection efforts and the necessity of an inclusive electronic health record (EHR) for military and civilian patients.

Hyperbaric medicine today: an historically noble discipline challenged by loss of critical access and overutilization - invited commentary.

As the title implies, much appears amiss with hyperbaric medicine. Long recognized for its life-saving, CNS-sparing,infection-fighting and tissue-salving attributes, its current application has been rightly called into question by a broad cross-section of health care delivery system stakeholders [1, 2, 3, 4, 5]. This paper will examine what lies behind the stunning loss of availability for a majority of the Federal Drug Administration-approved uses, arguably those for which patients have the most to gain. It will address overutilization in the context of an erosion of practice standards and widespread manipulation of the reimbursement process. It will make suggestions aimed at restoring its broader availability across the full extent of FDA-approved uses. Finally, it offers guidance to ensure that HBO2 therapy is employed only when medically necessary by adoption of the drug administration "rights" principle, namely the right indication for the right patient at the right time and only for the right amount of time.

Hyperbaric Oxygen Therapy for the Treatment of Diabetic Foot Ulcers: A Health Technology Assessment.

BACKGROUND: About 15% to 25% of people with diabetes will develop a foot ulcer. These wounds are often resistant to healing; therefore, people with diabetes experience lower limb amputation at about 20 times the rate of people without diabetes. If an ulcer does not heal with standard wound care, other therapeutic interventions are offered, one of which is hyperbaric oxygen therapy (HBOT). However, the effectiveness of this therapy is not clearly known. The objectives of this health technology assessment were to assess the safety, clinical effectiveness, and cost-effectiveness of standard wound care plus HBOT versus standard wound care alone for the treatment of diabetic foot ulcers. We also investigated the preferences and perspectives of people with diabetic foot ulcers through lived experience. METHODS: We performed a review of the clinical and economic literature for the effectiveness and cost-effectiveness of hyperbaric oxygen therapy, as well as the budget impact of HBOT from the perspective of the Ministry of Health and Long-Term Care. We assessed the quality of the body of clinical evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. To better understand the preferences, perspectives, and values of patients with diabetic foot ulcers and their experience with HBOT, we conducted interviews and administered an online survey. RESULTS: Seven randomized controlled trials and one nonrandomized controlled trial met the inclusion criteria. Comparing standard wound care plus HBOT with standard wound care alone, we found mixed results for major amputation rates (GRADE quality of evidence: low), a significant difference in favour of standard wound care plus HBOT on ulcers healed (GRADE quality of evidence: low), and no difference in terms of adverse events (GRADE quality of evidence: moderate). There is a large degree of uncertainty associated with the evaluation of the cost-effectiveness of standard wound care plus HBOT. However, results appear to suggest that this treatment results in lower costs and better outcomes than standard wound care alone. Funding HBOT will result in a budget impact of $4 million per year in immediate treatment costs for the Ontario Ministry of Health and Long-Term Care. This cost decreases to $0.5 million per year when downstream costs are considered. There is a substantial daily burden of care and emotional weight associated with living with diabetic foot ulcers, both of which are compounded by concern regarding possible amputation. Patients feel that HBOT is an effective treatment and reported that they were satisfied with how their ulcers healed and that this improved their quality of life. CONCLUSIONS: The evidence makes it difficult to draw any definitive conclusions on the clinical and cost effectiveness of standard wound care plus HBOT versus standard wound care alone for the treatment of diabetic foot ulcers.

Identifying and acting on inappropriate metadata: a critique of the Grattan Institute Report on questionable care in Australian hospitals.

INTRODUCTION: In an era of ever-increasing medical costs, the identification and prohibition of ineffective medical therapies is of considerable economic interest to healthcare funding bodies. Likewise, the avoidance of interventions with an unduly elevated clinical risk/benefit ratio would be similarly advantageous for patients. Regrettably, the identification of such therapies has proven problematic. A recent paper from the Grattan Institute in Australia (identifying five hospital procedures as having the potential for disinvestment on these grounds) serves as a timely illustration of the difficulties inherent in non-clinicians attempting to accurately recognize such interventions using non-clinical, indirect or poorly validated datasets. AIM: To evaluate the Grattan Institute report and associated publications, and determine the validity of their assertions regarding hyperbaric oxygen treatment (HBOT) utilisation in Australia. METHODS: Critical analysis of the HBOT metadata included in the Grattan Institute study was undertaken and compared against other publicly available Australian Government and independent data sources. The consistency, accuracy and reproducibility of data definitions and terminology across the various publications were appraised and the authors' methodology was reviewed. Reference sources were examined for relevance and temporal eligibility. RESULTS: Review of the Grattan publications demonstrated multiple problems, including (but not limited to): confusing patient-treatments with total patient numbers; incorrect identification of 'appropriate' vs. 'inappropriate' indications for HBOT; reliance upon a compromised primary dataset; lack of appropriate clinical input, muddled methodology and use of inapplicable references. These errors resulted in a more than seventy-fold over-estimation of the number of patients potentially treated inappropriately with HBOT in Australia that year. CONCLUSION: Numerous methodological flaws and factual errors have been identified in this Grattan Institute study. Its conclusions are not valid and a formal retraction is required.

Cost and mortality data of a regional limb salvage and hyperbaric medicine program for Wagner Grade 3 or 4 diabetic foot ulcers.

We obtained costs and mortality data in two retrospective cohorts totaling 159 patients who have diabetes mellitus and onset of a diabetic foot ulcer (DFU). Data were collected from 2005 to 2013, with a follow-up period through September 30, 2014. A total of 106 patients entered an evidence-based limb salvage protocol (LSP) for Wagner Grade 3 or 4 (WG3/4) DFU and intention-to-treat adjunctive hyperbaric oxygen (HBO2) therapy. A second cohort of 53 patients had a primary lower extremity amputation (LEA), either below the knee (BKA) or above the knee (AKA) and were not part of the LSP. Ninety-six of 106 patients completed the LSP/HBO2with an average cost of USD $33,100. Eighty-eight of 96 patients (91.7%) who completed the LSP/HBO2had intact lower extremities at one year. Thirty-four of the 96 patients (35.4%) died during the follow-up period. Costs for a historical cohort of 53 patients having a primary major LEA range from USD $66,300 to USD $73,000. Twenty-five of the 53 patients (47.2%) died. The difference in cost of care and mortality between an LSP with adjunctive HBO2therapy vs. primary LEA is staggering. We conclude that an aggressive limb salvage program that includes HBO2 therapy is cost-effective.

Rapid analysis of hyperbaric oxygen therapy registry data for reimbursement purposes: Technical communication.

OBJECTIVE: To explain how Hyperbaric Oxygen Therapy Registry (HBOTR) data of the US Wound Registry (USWR) helped establish a fair analysis of the physician work of hyperbaric chamber supervision for reimbursement purposes. METHODS: We queried HBOTR data from January 1, 2013, to December 31, 2013, on patient comorbidities and medications as well as the number of hyperbaric oxygen (HBO2) therapy treatments supervised per physician per day from all hyperbaric facilities participating in the USWR that had been using the electronic medical record (EHR) for more than six months and had passed data completeness checks. RESULTS: Among 11,240 patients at the 87 facilities included, the mean number of comorbidities and medications was 10 and 12, respectively. The mean number of HBO2 treatments supervised per physician per day was 3.7 at monoplace facilities and 5.4 at multiplace facilities. Following analysis of these data by the RUC, the reimbursement rate of chamber supervision was decreased to $112.06. CONCLUSIONS: Patients undergoing HBO2 therapy generally suffer from multiple, serious comorbidities and require multiple medications, which increase the risk of HBO2 and necessitate the presence of a properly trained hyperbaric physician. The lack of engagement by hyperbaric physicians in registry reporting may result in lack of adequate data being available to counter future challenges to reimbursement.

Commentary: Hyperbaric oxygen treatment for wounds - evidence and the Sword of Damocles.

Increased access to any treatment sensibly follows the clinical and cost benefit being established. For many treatments this requires multiple, high-quality clinical trials and supporting cost analysis. Cost analysis may be applied to a single treatment or used to compare two or more treatments. Clinical efficacy and cost benefit are best scrutinised and validated by publication in the peer-reviewed literature. True peer review is most effectively achieved 'after publication' by the wider scientific community, i.e., the journal readers. However, initially an editor, usually advised by referees, is asked to make a judgment on a paper's suitability for publication. It follows that medical journals are in a position of power and responsibility. Researchers and editors know publications are currency; effectively they are the equivalent of academic bitcoins. Regarding the paper in this issue by Santema et al., the same authors, in designing a prospective randomised controlled trial (RCT) of the role of hyperbaric oxygen treatment (HBOT) in diabetic wounds, included the name "Damocles" in that trial's title. Readers will perhaps appreciate from my comments below as a referee for the Santema et al. paper, that behind the scenes "the Sword of Damocles" (an allusion to the imminent and ever-present peril faced by those in positions of power) hangs over researchers, treating physician, journal editors and referees alike. Whilst positive about its content, upon reflection, my concern was the anticipated reception of this paper by the journal readership. This is, of course, a matter for the Editor; however, herewith is my reasoning. Further to the body of published work by Bennett et al., and others that has focused attention on the lack of good quality evidence for the use of HBOT for most indications, I think this regrettable state of affairs is now both known and accepted by mainstream healthcare purchasers and providers. I speculate that all these bodies already acknowledge and accept this manuscript's conclusions. Accordingly, this situation detracts from an opportunity for it to stand out from existing publications. The authors are addressing this known lack of evidence with their planned DAMOCLES multicentre RCT. Others in mainstream medicine in a position to design and implement clinical research (to whom the paper is presumably aimed) will also be acutely aware of the shortcomings in the available evidence. Accepting the sample size required for economic evaluation may be greater than that required to establish only clinical effectiveness, it remains the case it would be all but impossible to secure research funding for a trial in the absence of such analysis. This means the conclusions of the present paper are already widely acknowledged. If one accepts the above, it follows that its impact on the journal readership will be relatively light. The journal's review process asks referees to consider if the manuscript is "within the journal's scope", and about "the importance (clinical or otherwise) of the work". I think this paper is within the scope and is important. However, in the light of the known and accepted need for further research that includes an economic evaluation, I find myself questioning the 'importance' and 'utility' to the journal readership of the information provided.

Economic outcomes in clinical studies assessing hyperbaric oxygen in the treatment of acute and chronic wounds.

INTRODUCTION: Hyperbaric oxygen treatment (HBOT) is used to treat acute and chronic wounds. This systematic review was conducted to summarise and evaluate existing evidence on the costs associated with HBOT in the treatment of wounds. METHODS: We searched multiple electronic databases in March 2015 for cohort studies and randomised clinical trials (RCTs) that reported on the clinical effectiveness and treatment costs of HBOT in the treatment of acute or chronic wounds. RESULTS: One RCT and three cohort studies reported on economic as well as clinical outcomes. These studies comprised different disorders (ischaemic diabetic foot ulcers, thermal burns, Fournier's gangrene and necrotising soft tissue infections) and employed different clinical and economic outcome measures. Only the RCT had a good methodological quality. Three of the included studies reported that their primary clinical outcomes (wound healing, hospital stay, complications) improved in the HBOT group. The effects of HBOT on costs were variable. CONCLUSIONS: Currently, there is little direct evidence on the cost-effectiveness of HBOT in the treatment of acute and chronic wounds. Although there is some evidence suggesting effectiveness of HBOT, further studies should include economic outcomes in order to make recommendations on the cost-effectiveness of applying HBOT in wound care.

[The future of hyperbaric oxygen therapy: added value in the treatment of late radiation injury?]. / De toekomst van hyperbare zuurstoftherapie: Toegevoegde waarde bij de behandeling van late radiatieschade?

There is some evidence for the benefit of hyperbaric oxygen therapy in late radiation tissue injury (LRTI) affecting the head, neck and lower bowel, but there is little evidence for or against the benefit in other tissues (e.g. the breast) affected by LRTI. There is a need for large prospective trials including quality-of-life and cost-effectiveness studies, because hyperbaric oxygen therapy is becoming more popular.

Is additional hyperbaric oxygen therapy cost-effective for treating ischemic diabetic ulcers? Study protocol for the Dutch DAMOCLES multicenter randomized clinical trial?

BACKGROUND: The value of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic ulcers is still under debate. Available evidence suggests that HBOT may improve the healing of diabetic ulcers, but it comes from small trials with heterogeneous populations and interventions. The DAMOCLES-trial will assess the (cost-)effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care. METHODS: In a multicenter randomized clinical trial, including 30 hospitals and all 10 HBOT centers in the Netherlands, we plan to enroll 275 patients with Types 1 or 2 diabetes, a Wagner 2, 3 or 4 ulcer of the leg present for at least 4 weeks, and concomitant leg ischemia, defined as an ankle systolic blood pressure of <70 mmHg, a toe systolic blood pressure of <50 mmHg or a forefoot transcutaneous oxygen tension (TcpO2) of <40 mmHg. Eligible patients may be candidates for revascularization. Patients will be randomly assigned to standard care with or without 40 HBOT-sessions. RESULTS: Primary outcome measures are freedom from major amputation after 12 months and achievement of, and time to, complete wound healing. Secondary endpoints include freedom from minor amputations, ulcer recurrence, TcpO2 , quality of life, and safety. In addition, we will assess the cost-effectiveness of HBOT for this indication. CONCLUSION: The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers, and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions. This matches the treatment dilemma in current clinical practice.