Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

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were RCTs, the rest were comparative studies. Most study participants were males and the mean age of participants was above 50 years. Table 16 Descriptive characteristics of included studies focusing on the use of HBOT in diabetic wounds.* First Author and Year of Publication Faglia 1998 48 Zamboni 1997 50 Faglia 1996 47 Doctor 1992 49 Baroni 1987 46 NHMRC Level III-2 III-2 Study Design Location Comparative study Comparative study II RCT Italy II RCT India III-2 Comparative study Dates of Enrolment Size Characteristics of Study Population † Age (years) Mean (SD) Sex Ratio (M:F) Italy 1990 to 1993 115 63.4 (9.9) 84:31 USA ? ‡ 10 Aug 1993 to Aug 1995 2 years. No specific dates. I=63.6 (8.9) C=53.8 (7.8) I=4:1 C=4:1 24 Hyperbaric oxygen therapy Italy Jan 1982 to Dec 1984 68 30 28 I=61.7 (10.4) C=65.6 (9.1) I=56.2 (45-70) § C=59.8 (48-70) I=57.7 (7.4) C=59.4 (7.6) * Abbreviations: C = comparison group, F = female, I = intervention group, M = male, RCT = randomised controlled trial, SD = standard deviation. † Information is given for treatment and control groups, if available. Otherwise, total study population values are stated. ‡ Unstated, unclear, or unknown. § Figures in parentheses are ranges. I=27:8 C=21:12 I=3:1 C=2:1 I=11:7 C=6:4 Study quality All RCTs failed to provide enough detail to assess the adequacy of randomisation (Table 17). None of the studies provided enough details to assess masking. All of the five collected studies reported complete follow-up of participants. Table 17 Methodological quality of included studies focusing on the use of HBOT in diabetic wounds First Author and Year of Publication Study Design Randomisation Masking Losses to Follow-up Faglia 1998 48 Comparative study None Unclear No losses Zamboni 1997 50 Comparative study None Unclear† No losses Faglia 1996 47 RCT Unclear Unclear† No losses Doctor 1992 49 RCT Unclear Unclear No losses Baroni 1987 46 Comparative study None Unclear† No losses * Abbreviation: RCT = Randomised controlled trial † A portion of the outcome assessment is reported to be masked. However, neither the nature of the masking nor the extent to which masking is applied is unclear. Patient criteria Most studies enrolled consecutive patients. The criteria for inclusion was generally standard across studies — long standing foot gangrene, ulceration or infection in a population of chronic diabetic patients (Table 18). The review made the assumption that the definition of these conditions had not changed significantly between 1987 and 1998. The method of enrolment and allocation employed in two studies was unusual. 48,50 In these studies, patients who refused HBOT subsequently served as a control group against which the outcomes of the subjects undergoing HBOT were compared. This method of allocation was potentially a source of bias since the control group may have had different
characteristics compared to the treatment group, which may be predictive of outcome independent of allocation. Table 18 Patient criteria of included studies focusing on the use of HBOT in diabetic wounds.* First Author and Year of Publication Patient Criteria Faglia 1998 48 Consecutive diabetic patients with foot ulcers seen during enrolment period Zamboni 1997 50 Consecutive, insulin-dependent diabetic patients with non-healing lower extremity wounds referred for HBOT. Refusals (n=3) and claustrophobic patients (n=2) served as controls Faglia 1996 47 Consecutive patients hospitalised for diabetic foot ulcer. Patients had full-thickness gangrene or abscesses. Subjects with less deep ulcers were included if the ulcer was large, infected, and showed defective healing in 30 days of outpatient therapy. Exclusions: refusal (n=1), stroke death (n=1) Doctor 1992 49 All diabetic patients with chronic foot lesions admitted over the enrolment period. Baroni 1987 46 All diabetic patients with ulceronecrotic foot lesions seen during the enrolment period. * Abbreviation: n = sample size Interventions examined Three of the five studies46-48 used similar HBOT protocols that involved a two-phase exposure regimen first described by Baroni and colleagues in 1987. 46 Similar pressures (2.2 to 2.5 ATA) and exposure durations (90 minutes) were used, and two of the three studies reported that subjects were exposed to about 35 HBO sessions on average. 46,47 The remaining two studies 49,50 used pressures above or below those used in the first group (2 or 3 ATA), and exposure times were half as long or a third longer (45 or 120 minutes). The comparison procedures used consisted of general measures of surgical, infection and diabetic control, and were similar across studies. Lesions underwent debridement and topical antimicrobials were applied to local dressings. Empirical antibiotic therapy was used in the first instance, with the results of microbiological sensitivity guiding subsequent therapy. For most studies, glycaemic control was achieved using insulin. Table 19 summarises the therapeutic protocols used. Hyperbaric oxygen therapy 25
Page 1 and 2: Hyperbaric Oxygen Therapy November
Page 3 and 4: Contents Executive summary.........
Page 5 and 6: Tables Table 1 Measures of disease
Page 7 and 8: Table 45 Functional neurologic scor
Page 9 and 10: Figures Figure 1. Outline of search
Page 11 and 12: Effectiveness Published guidelines
Page 13 and 14: evidence that exposure to HBO may b
Page 15 and 16: No available evidence No evidence w
Page 17 and 18: Introduction The Medicare Services
Page 19 and 20: Multiplace chambers can accommodate
Page 21 and 22: Marketing status of the device The
Page 23 and 24: Table 3 1998 - 1999 self-reported d
Page 25 and 26: Table 6 retrieval. Indication-speci
Page 27 and 28: Phase of Search Initial Search Ful
Page 29 and 30: Conduct of meta-analysis When the d
Page 31 and 32: early as 1995. The guidelines - kno
Page 33 and 34: Table 10 Minimum staff qualificatio
Page 35 and 36: Is it effective? The review assesse
Page 37 and 38: Table 14 Patient criteria of includ
Page 39: offered ample details. The remainin
Page 43 and 44: Assessment of heterogeneity All the
Page 45 and 46: Odds ratio 10 1 0.1 0.01 A sensitiv
Page 47 and 48: Wound healing Two of the five ident
Page 49 and 50: Studies of necrotising soft tissue
Page 51 and 52: Summary Table 25 Survival in patien
Page 53 and 54: Table 29 Therapeutic protocols used
Page 55 and 56: Osteomyelitis The study by Esterhai
Page 57 and 58: Summary The HBO group showed a stat
Page 59 and 60: Summary These results are difficult
Page 61 and 62: outcomes or that decreased the risk
Page 63 and 64: Anderson et al 80 recruited non-pre
Page 65 and 66: Summary The collected evidence exam
Page 67 and 68: Table 46 Major outcomes following t
Page 73 and 74: Thirty-seven subjects (comparison g
Page 75 and 76: whose hearing loss was not secondar
Page 77 and 78: tinnitus (6 versus 3 subjects). Non
Page 79 and 80: assume that all participants knew o
Page 83 and 84: Table 65 Descriptive characteristic
Page 87 and 88: These contrasted with the conclusio
Page 91 and 92:
Summary There are conflicting resul
Page 93 and 94:
Summary separate and previously-stu
Page 95 and 96:
need to insulate patients from outs
Page 97 and 98:
Reactive effects A reactive effect
Page 99 and 100:
Cost of major amputation The hospit
Page 101 and 102:
Sensitivity analysis Table 79 shows
Page 103 and 104:
Table 80 Estimation of incremental
Page 105 and 106:
Sensitivity analysis Table 83 shows
Page 107 and 108:
Conclusions Safety Potential risks
Page 109 and 110:
Recommendations MSAC recommended th
Page 111 and 112:
Appendix B Supporting committee Sup
Page 113 and 114:
Appendix C Studies included in this
Page 115 and 116:
Necrotising soft tissue infections:
Page 117 and 118:
Soft tissue injuries: crush injurie
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Cancer: cervix First Author and Yea
Page 121 and 122:
Appendix D Studies excluded in this
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2. Shandling AH, Ellestad MH, Hart
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5. Woo TCS, Joseph D, Oxer H. Hyper
Page 127 and 128:
22. Kunkler PB, Boulis-Wassif S, Sh
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45. Wiernik G, Perrins D. The radio
Page 131 and 132:
Appendix E Calculation of monoplace
Page 133 and 134:
Hence, the total operating costs of
Page 135 and 136:
Appendix G Reviews received from ot
Page 137 and 138:
Sechrist Industries -- Hyperbaric O
Page 139 and 140:
References 1. Hampson N. Hyperbaric
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31. L'Abbe K, Detsky A, O'Rourke K.
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61. Perrins DJ. Influence of hyperb
Page 145 and 146:
89. DiSabato F, Giacovazzo M, Crist
Page 147:
117.Plenk HP. Hyperbaric radiation
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