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Cost-Benefit and Cost-Efficiency Evaluation of Hyperbaric Oxygen Therapy
Abstract
Hyperbaric oxygen therapy, apart from some acute and very specialized indications regarding the treatment of decompression disorders and arterial air/gas embolism, is generally aimed at treating serious and complex disorders, generally reluctant to standard treatment and requires prolonged and reiterated hospitalization/rehabilitation periods as well as elevated technical, social and human costs.
... The costs of the technique must, of course, also be taken into account. Data reported by Marroni et al. (27) suggest that the cost of HBO is equivalent to other new treatments (local topic of human growth factor) in the diabetic foot and may be more effective. ...
To study the effect of systemic hyperbaric oxygenation (HBO) therapy on the healing course of nonischemic chronic diabetic foot ulcers.
From 1999 to 2000, 28 patients (average age 60.2 +/- 9.7 years, diabetes duration 18.2 +/- 6.6 years), of whom 87% had type 2 diabetes, demonstrating chronic Wagner grades I-III foot ulcers without clinical symptoms of arteriopathy, were studied. They were randomized to undergo HBO because their ulcers did not improve over 3 months of full standard treatment. All the patients demonstrated signs of neuropathy. HBO was applied twice a day, 5 days a week for 2 weeks; each session lasted 90 min at 2.5 ATA (absolute temperature air). The main parameter studied was the size of the foot ulcer measured on tracing graphs with a computer. It was evaluated before HBO and at day 15 and 30 after the baseline.
HBO was well tolerated in all but one patient (barotraumatic otitis). The transcutaneous oxygen pressure (TcPO(2)) measured on the dorsum of the feet of the patients was 45.6 +/- 18.1 mmHg (room air). During HBO, the TcPO(2) measured around the ulcer increased significantly from 21.9 +/- 12.1 to 454.2 +/- 128.1 mmHg (P < 0.001). At day 15 (i.e., after completion of HBO), the size of ulcers decreased significantly in the HBO group (41.8 +/- 25.5 vs. 21.7 +/- 16.9% in the control group [P = 0.037]). Such a difference could no longer be observed at day 30 (48.1 +/- 30.3 vs. 41.7 +/- 27.3%). Four weeks later, complete healing was observed in two patients having undergone HBO and none in the control group.
In addition to standard multidisciplinary management, HBO doubles the mean healing rate of nonischemic chronic foot ulcers in selected diabetic patients. The time dependence of the effect of HBO warrants further investigations.
Medical practice is changing and the change, which involves using the medical literature more effectively in guiding medical practice, is profound enough that it can appropriately be called a paradigm shift. To get rid of the blame being “a therapy in search of disease” [1], hyperbaric oxygen therapy (HBOT) has to prove its effectiveness in comparison with alternative therapeutic procedures, as well as to be technically feasible and safe, with a minimum of possible adverse effects. It is now accepted that virtually no drug — and hyperbaric oxygen must be considered as a drug — can enter clinical practice without a demonstration of its efficacy in clinical trials.
Hyperbaric Oxygen Therapy (HBO) is currently widely used for the treatment of many disease conditions. Although considered
effective at both obtaining a rapid healing and a reduction in overall treatment costs, not many studies are available to
determine the cost-effectiveness value of the use of this treatment modality. This chapter examines the cost-benefit ratio
of using HBO for some of the most common currently accepted indications. The use of HBO can imply significant saving for a
nation’s health-care system, in the order of hundreds of millions Euro per year
Cutaneous nonhealing ulceration is a threatening manifestation of vasculitis. Hyperbaric oxygen (HBO), frequently used as adjuvant therapy for patients with ischaemic ulcers, exerts additional beneficial effects on the vascular inflammatory response.
To evaluate the effect of HBO on vasculitis-induced nonhealing skin ulcers.
The study population comprised 35 patients aged >or= 18 years with severe, nonhealing, vasculitis-induced ulcers that had not improved following immunosuppressive therapy. Baseline ulcer tissue oxygenation was evaluated at room air concentration (21% O2), at 1 atmosphere absolute (ATA) breathing 100% O2, and at 2 ATA breathing 100% O2. The baseline treatment protocol consisted of a 4-week course of 100% O2 for 90 min at 2 ATA, five times/week.
The mean baseline ulcer tissue oxygenation (3.1 +/- 2.4 kPa at room air concentration), was significantly increased to 13.9 +/- 11.9 kPa at 1 ATA breathing 100% O2 (P < 0.001), and subsequently increased further to 59.1 +/- 29.8 kPa at 2 ATA breathing 100% O2 (P < 0.001). At the end of the hyperbaric therapy, 28 patients (80%) demonstrated complete healing, 4 (11.4%) had partial healing and 3 (8.6%) had no improvement. None of the patients had any side-effects related to the HBO therapy.
HBO therapy may serve as an effective safe treatment for patients with vasculitis having nonhealing skin ulcers. Further studies are needed to evaluate its role as primary therapy for this group of patients.
The purpose of this technical report is three-fold. First, it provides a review of the design criteria used to determine the size of the clinical hyperbaric chamber. The upright cylinder chamber arrangement had been selected for this purpose after careful consideration of the available options. Secondly, it provides a method for determining the cost of air transportation between DoD regions which has been reviewed and validated by the Military Airlift Command Surgeon in November 1983. Thirdly, it describes a method to predict patient treatments in advance of facility availability which is crucial to facility planning. A system based on inpatient International Classification for Disease Nomenclature - 9th Edition (ICD-9) criteria has been developed and is presented in detail in the Patient Population Data paragraph. This report provides the various planning data necessary for future design and construction of clinical hyperbaric facilities in the U.S. Air Force. The concepts presented are suitable for application to DoD, VA, and civilian medical centers that are planning clinical hyperbaric facilities.
Twenty-nine patients with necrotizing fasciitis were treated from 1980 to 1988. This study evaluates how the addition of hyperbaric oxygen (HBO) therapy to surgical treatment has affected mortality and the number of debridements required to achieve wound control in these patients. Two groups of patients were viewed: group 1 (n = 12) received surgical debridement and antibiotics only; group 2 (n = 17) received HBO (90 minutes at 2.5 atm, average 7.4 treatments) in addition to surgery and antibiotics. Both groups were similar in age, race, sex, wound bacteriology, and antimicrobial therapy. Body surface area affected was similar, however, perineal involvement was more common in group 2 (53%) than in group 1 (12%). The admitting conditions of patients in group 1 (non-HBO) were diabetic, 33%; white blood cell count more than 12,000, 50%; and shock, 8%. The admitting conditions of patients in group 2 (HBO) were diabetic, 47%; white blood cell count more than 12,000, 59%; and shock, 29%. Although group 2 patients receiving HBO were more seriously ill on admission, mortality was significantly lower (23%) compared to group 1 (66%) (p less than 0.02). In addition, only 1.2 debridements per group 2 patient were required to achieve wound control versus 3.3 debridements per group 1 patient (p less than 0.03). The addition of HBO therapy to the surgical and antimicrobial treatment of necrotizing fasciitis significantly reduced mortality and wound morbidity (number of debridements) in this study, especially among nonclostridial infections. We conclude that HBO should be used routinely in the treatment of necrotizing fasciitis.
We treated a group of 18 hospitalized adult diabetic patients (all with retinopathy, 17 with symptomatic neuropathy, and 6 with macroangiopathy) presenting with gangrenous lesions of the foot by a combined regime consisting of strict metabolic control, daily debridement of necrotic tissues, and daily hyperbaric oxygen (HBO) treatments given in a multiplace oxygen chamber. Another group of 10 adult subjects with comparable foot lesions (all with retinopathy, 9 with symptomatic neuropathy, and 4 with macroangiopathy) was treated in exactly the same way except for HBO. In the test treatment group, 16 patients were healed, and the remaining 2 showed no improvement and later underwent amputation.
The number of HBO treatments required for healing was significantly related to the size of gangrenous lesions. In the non-HBO-treated group, only 1 patient improved, 5 of 10 showed no change, and 4 of 10 worsened until leg amputation was unavoidable. Comparison of the two groups by X2-test revealed a highly significant difference (P = .001). In practical terms, HBO treatment drastically reduced leg amputations in patients so treated in the last 3 yr compared with earlier and current figures for patients not receiving HBO treatment.
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