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42 Hyperbaric Oxygenation Therapy KCE Reports 74 Figure 22. Identification and selection of studies Inclusion of relevant economic evaluations from reference lists and hand searching: 2 Potentially relevant citations identified (Medline, Embase, CRD, CDSR, Econlit databases): 325 Studies retrieved for more detailed evaluation: 70 Relevant studies: 5 7 full economic evaluations on the cost-effectiveness of HBOT Based on title, abstract, and keywords: citations excluded: Reasons: - design - intervention - comparator Based on full text evaluation: studies excluded: Reasons: - design - intervention - payed report - outcome - others CRD: Centre for Reviews and Dissemination; CDSR: Cochrane Database of Systematic Reviews; HBOT: hyperbaric oxygen therapy a: the study of Cianci and Hunt 84 looked at the recurrence of wounds after being treated with HBOT b: the study of Boykin et al. 85 was a case report in which the case of a soft-tissue radiation necrosis ulceration of the leg successfully treated with adjunctive HBOT was presented. The study of Dolezal 86 could not be retrieved. Not all selected economic evaluations expressed results in costs per LYG, costs per QALY gained, or cost for a disease specific outcome. If HBOT would be more effective than its comparator and costs less, this results in a dominant strategy. As such, even though the studies look as cost analyses, they could be seen as full economic evaluations (looking at both costs and consequences of two alternative treatments) and were included in our overview. Several references referred to book chapters. 87-91 The analyses of Marroni were obtained. 88, 89 The quality of the input data on mortality, morbidity and hospitalization was assessed as not being of high enough quality since no sources were provided for the rough estimates. Therefore, the studies were not retained. The reference to the German study of Rychlik was not found. Another study by Rychlik, however, which included the cost-effectiveness analysis of HBOT as an example, was retrieved. 92 The quality of this study was also assessed to be of low quality since sources for the input variables were not always mentioned, sensitivity analysis was reportedly performed but no results were given, and no conclusion or discussion with respect to the costeffectiveness of HBOT was presented. 255 244 10 1 65 56 3 3 1(a) 2(b)
KCE Reports 74 Hyperbaric Oxygenation Therapy 43 The original publication, 93 which was mentioned in the references of this article as being submitted to a German journal, was not found in any database. Another document of Rychlik could be obtained. 94 The input values of this non-peer reviewed document contained contradictions. For example, the control group consisted of 33 patients, of which 22, 12 and 11 patients had no, minor or major amputations, respectively. Another document 95 using data from Rychlik was also excluded. It was assessed as not being a good economic evaluation with reliable input parameters. Finally, the book chapter of Persels 90 was not an economic evaluation comparing both costs and effectiveness of HBOT and alternative treatment. The study of Mulla et al. 96 applying a regression method to determine the predictors of length of stay and total patient charges for necrotizing fasciitis was not taken into account. In this analysis HBOT was not associated with increased costs, nor with an improvement in survival. As acknowledged by the authors, however, these results were difficult to interpret due to the small number of patients who received HBOT (n = 19) and the small number of deaths overall. The economic evaluations included in our overview are arranged according to indication. In this part, we provide a short description of the study, results and conclusions of the authors. Details are provided as far as the raw data are mentioned in the studies. As a result, more or less detailed data will be provided for each study. In a following part, we will discuss the economic analyses. 4.3.1 Diabetic foot ulcers 4.3.1.1 Abidia et al. 80 The UK study of Abidia et al. (2003) described a double-blind RCT including a limited cost comparison for HBOT versus no HBOT in the treatment of diabetic patients with ischemic, non-healing lower extremity ulcers. Eighteen diabetic patients were recruited of which two patients withdrew during the course of the study (one in the control group required urgent vascular intervention and one in the treatment group dropped out for personal reasons). All patients, their carers and medical assessors were blinded to the treatment. Patients were randomly assigned either to receive 100% oxygen (treatment group) or air (control group), at 2.4 ATA for 90 minutes daily for a total of 30 treatments. Wound care was standardised for all patients (including offloading, aggressive debridement and dressing, and antibiotic therapy if there were clinical signs of infection). The mean total cost of visits for ulcer dressing (£58 per outpatient hospital visit) per patient in the control group was compared with the respective cost in the treatment group in addition to the cost of HBOT (£100 for each session) per patient and the cost of dealing with any complications arising from the treatment. Patients were assessed at baseline, after 15 and after 30 treatments, and 6 weeks later. Two more follow-up visits were performed at 6 months and 1 year. Quality of life (QoL) was measured using the generic form SF-36 and Hospital Anxiety and Depression scale (HAD scale). The follow-up was discontinued after 1 year because the authors felt that any difference observed between the two groups beyond one year could not be confidently attributed to HBOT and was more likely to be due to natural progression of peripheral arterial disease. 80 Outcomes of this study are shown in Table 7. At 1 year follow up, complete healing was achieved in five out of eight ulcers in the treatment group compared with none out of eight ulcers in the control group (p=0.026). Furthermore, the median decrease of the wound areas was 100% in the treatment group at six weeks follow up compared with 52% in the control group (p=0.027). However, values at 6-month follow-up were 100 and 95% respectively. This study did not show any significant differences in major or minor amputation rates between the two groups.
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