Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

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Data extraction The review extracted data from accepted articles using a standardised instrument created for this assessment. Two independent reviewers examined each article. Discrepancies in evaluation were discussed and resolved through consensus. Assessment of quality All accepted articles underwent an assessment of study quality based on criteria that focus on important aspects of study design (Table 7). 24,25 Table 7 Domains and levels used in the assessment of methodologic quality. Randomisation Adequate Adequate measures to conceal allocations such as central randomisation; serially numbered, opaque, sealed envelopes; or other descriptions that contain convincing elements of concealment Unclear Unclearly concealed trials in which the author failed to describe the method of concealment with enough detail to determine its validity Inadequate Method of allocation is not concealed, such as alternation methods or the use of case numbers None No randomisation method was employed Masking Masking strategy applied (triple, double, etc.) Losses to Follow-up Losses specified. The review assessed evidence presented in the selected studies and classified it according to the National Health and Medical Research Council (NHMRC) revised hierarchy of evidence (Table 8). 26 Table 8 Designation of levels of evidence. I Evidence obtained from a systematic review of all relevant randomised controlled trials. II Evidence obtained from at least one properly designed randomised controlled trial. III-1 Evidence obtained from well-designed pseudo-randomised controlled trials (alternate allocation or some other method). III-2 Evidence obtained from comparative studies with concurrent controls and allocation not randomised (cohort studies), case-control studies or interrupted time series with control group. III-3 Evidence obtained from comparative studies with historical control, two and more single arm studies or interrupted time series without a parallel control group. IV Evidence obtained from case series, either post-test or pre-test and post-test. Source: NHMRC 26 Assessment of heterogeneity The review used a two-stage process to examine the heterogeneity of treatment effects. Firstly, the clinical and epidemiological attributes of the identified research in each indication category were examined to establish whether they were sufficiently similar to justify further analysis. If this was the case the second stage of assessment of heterogeneity moved on to statistical analysis. The review used the Cochran Q statistic 27 to test the hypothesis that the reported treatment effects for each indication were equal. The Q statistic is known to have low power in detecting heterogeneity. 28 For this reason, the review specified a Type I error rate of ten percent (α = 0.10) for this test, 29 and examined Galbraith diagrams 30 and L’Abbé plots 31 generated from the extracted data. All statistical analyses were performed using Stata version 6.0 (Stata Corporation, College Station, Texas, USA). 12 <strong>Hyperbaric</strong> oxygen therapy
Conduct of meta-analysis When the degree of homogeneity was acceptable on statistical and clinical grounds, summary estimates of odds ratios and weighted mean differences was derived using a random-effects model. 32 The review checked the robustness of the summary estimate by performing sensitivity analyses. Standard statistical convention was followed and a Type I error (the probability of detecting a difference when one is not present) was assumed for all analyses at five percent (α = 0.05). Expert advice A supporting committee with expertise in hyperbaric medicine, neurology, sports medicine, plastic surgery and radiation oncology was established to evaluate the evidence and provide advice to MSAC from a clinical perspective. In selecting members for supporting committees, MSAC’s practice is to approach the appropriate medical colleges, specialist societies and associations, and consumer bodies for nominees. Membership of the supporting committee is provided at Appendix B. <strong>Hyperbaric</strong> oxygen therapy 13
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: Phase of Search Initial Search Ful
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 and 40: offered ample details. The remainin
Page 41 and 42: characteristics compared to the tre
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 69 and 70: Table 50 Therapeutic protocols used
Page 71 and 72: Table 53 Patient criteria of includ
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
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assume that all participants knew o
Page 81 and 82:
Table 64 Therapeutic protocols used
Page 83 and 84:
Table 65 Descriptive characteristic
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Table 68 Therapeutic protocols used
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These contrasted with the conclusio
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Table 73 Patient criteria of includ
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Summary There are conflicting resul
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Summary separate and previously-stu
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need to insulate patients from outs
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Reactive effects A reactive effect
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Cost of major amputation The hospit
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Sensitivity analysis Table 79 shows
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Table 80 Estimation of incremental
Page 105 and 106:
Sensitivity analysis Table 83 shows
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Conclusions Safety Potential risks
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Recommendations MSAC recommended th
Page 111 and 112:
Appendix B Supporting committee Sup
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Appendix C Studies included in this
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Necrotising soft tissue infections:
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Soft tissue injuries: crush injurie
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Cancer: cervix First Author and Yea
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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
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22. Kunkler PB, Boulis-Wassif S, Sh
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45. Wiernik G, Perrins D. The radio
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Appendix E Calculation of monoplace
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Hence, the total operating costs of
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Appendix G Reviews received from ot
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Sechrist Industries -- Hyperbaric O
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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
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89. DiSabato F, Giacovazzo M, Crist
Page 147:
117.Plenk HP. Hyperbaric radiation
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