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44 Hyperbaric Oxygenation Therapy KCE Reports 74 Table 7. Ulcers description and outcome group treatment control p value Ulcer size (mm²)* 106 (12-823) 78 (18-866) NS Ulcer depth (mm)* 2.3 (0.5-4) 1.6 (0.5-4) NS Wagner Grade I 0 1 NS Wagner Grade II 8 7 NS Signs of infection 3/8 2/8 NS Ulcer duration (months) 6 (2-18) 9 (3-60) NS Ulcers healed: At 6 weeks 5/8 1/8 NS At 6 months 5/8 2/8 NS At one year 5/8 0/8 p=0.026 Reduction in ulcer size At 6 weeks 100% (34-100) 52% ((-29)-100) p=0.027 At 6 months 100% ((-206)-100) 95% (0-100) NS Major amputation 1 1 NS Minor amputation 1 0 NS * Results as median and (range). Adapted from Abidia et al. 80 With respect to QoL, patients in both the treatment and control groups showed a significant improvement in the depression score in the HAD scale (p=0.011 and 0.023 respectively) while only the control group had a significant reduction in their anxiety score (p=0.042). In summary, hyperbaric oxygen did not produce any significant improvements in QoL measures greater than those seen in patients in the control group as measured by the SF-36 and HAD scale. The authors suggest this was because the physical functioning of patients was not mainly limited by the ulcers, but also by other co-morbid conditions, e.g. intermittent claudication, arthritis, and cardiac problems. They also mention that a disease-specific QoL measure instead of a generic one would have been more appropriate in detecting benefit achieved with ulcer healing. With respect to costs, the mean number of visits for dressing of the study ulcer was 33.75 (±62) and 136.5 (±126) per year per patient in respectively the treatment and the control group. The mean total cost per patient per year for ulcer dressing visits was £1 972 and £7 946, respectively. Since the cost of the entire hyperbaric oxygen treatment course per patient was £3 000 there was a significant potential cost saving by using adjunctive hyperbaric oxygen amounting to an average of £2 960 for each patient treated. In conclusion, HBOT may have the potential to enhance healing of ischemic diabetic lower-extremity ulcers and the cost-effectiveness analysis showed that despite the extra cost involved in using hyperbaric oxygen, there was a potential saving in the total cost of treatment for each patient during the study. 4.3.1.2 Guo et al. 81 The US study of Guo et al. (2003) described a decision tree model constructed to estimate the cost-effectiveness of HBOT in the treatment of diabetic ulcers. The hypothetical cohort of 1000 patients sixty years of age with severe diabetic foot ulcers could receive conventional wound care with or without adjunctive use of HBOT. Results were expressed as costs per QALY. QALYs for each patient were derived from assigning EuroQol weights 97 to four different treatment outcomes: primarily healed: 0.6; healed with minor lower extremity amputations (LEA): 0.6; healed with major LEA: 0.31; and death: 0. Table 8 describes some other input parameters from this study.
KCE Reports 74 Hyperbaric Oxygenation Therapy 45 Table 8. Base case model parameters 81 healing minor LEAs major LEAs HBOT treatment 55% a 35% a 10% a No HBOT treatment 33% a 26% a 41% a Mortality b 2.8% c 2.8% 16.3% d LEA: lower extremity amputations a: based on the average of four prospective, controlled clinical studies: Faglia et al., 98 Doctor et al., 99 Baroni et al., 100 and Zamboni et al. 101; b: the mortality rate was assumed to be constant over the 12-year period; c: Bild et al. 102; d: Baddeley et al. 103 The time window of the analysis was 1, 5 and 12 years. The 5-year interval was chosen to represent the private payers’ perspective, because 5 years later the patients automatically become Medicare beneficiaries. The 12-year interval was selected to represent the societal perspective, because the life expectancy for people at age 60 was approximately 20 years, 104 and the life expectancy for people with diabetes would be approximately 8 years shorter than that of people without diabetes. 105 A discount rate of 3% was applied to adjust QALYs gained in future years. Cost items included were costs for HBOT ($407 per treatment, inclusive technical and physician fees), and costs for a minor or major LEA ($40 673 and $39 404 respectively, inclusive surgery, inpatient care, rehabilitation, first-year outpatient visits, and physician fees). An average of 29 HBOT sessions per case was taken into account. Costs were inflated to 2001 dollars. Finally, scenario analysis was conducted to measure the range of CE ratios between the least and most efficacious input parameters of the four prospective, controlled studies. Due to HBOT, 155 cases of major LEAs were averted (205 versus 50 LEAs in the control and HBOT group, respectively) and approximately 50.2, 265.3, and 608.7 QALYs were gained at years 1, 5, and 12, respectively, in the hypothetical cohort. There was also an increase of 45 cases of minor LEAs (130 versus 175 LEAs in the control and HBOT group, respectively). The incremental cost-effectiveness ratio (ICER) was estimated to be $27 310, $5 166, and $2 255 per QALY, at years 1, 5, and 12, respectively. In the scenario analyses, the ICERs varied substantially. Results were very sensitive to the efficaciousness probabilities. For example, the CE ratio at year 1 was $142 923, $27 310 per QALY, and cost saving ($-72 799) in the worst, base, and best case scenarios, respectively. Results were also sensitive to the quality weights, especially for major LEA, the number of HBOT sessions per case, the HBOT cost per treatment, and the treatment costs of major and minor LEA per case. The authors concluded that HBOT in the treatment of diabetic ulcers was cost effective, especially in the long term. They also acknowledged that results were limited by the clinical studies that provide the basis of the estimates. 4.3.1.3 Hailey et al. 79 The Canadian study of Hailey et al. (2007) used a decision model to estimate the costeffectiveness of adjunctive HBOT in comparison with standard care alone. The model used a 65-year-old patient cohort with diabetic foot ulcers. The model was very similar to that of Guo et al. 81 with the addition of one extra health state, i.e. unhealed. Results were expressed in costs per QALY. The related utilities for the health states were 0.6 for a primarily healed wound, 0.61 for healed with a minor LEA, 0.31 for healed with a major LEA, 0.44 if unhealed with no related surgery, and 0 for death. 97, 106 Table 9 presents outcome probabilities in the first year and mortality parameters.
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