Safety and performance of intravenous pumps and syringe drivers in hyperbaric environments.

INTRODUCTION: Critically ill patients require continuation of their care when receiving hyperbaric oxygen treatment. This care may be facilitated via portable electrically powered devices such as intravenous (IV) infusion pumps and syringe drivers, which may create risks in the absence of a comprehensive safety evaluation. We reviewed published safety data for IV infusion pumps and powered syringe drivers in hyperbaric environments and compared the evaluation processes to key requirements documented in safety standards and guidelines. METHODS: A systematic literature review was undertaken to identify English language papers published in the last 15 years, describing the safety evaluations of IV pumps and/or syringe drivers for use in hyperbaric environments. Papers were critically assessed in relation to the requirements of international standards and safety recommendations. RESULTS: Eight studies of IV infusion devices were identified. There were deficiencies in the published safety evaluations of IV pumps for hyperbaric use. Despite a simple, published process for evaluating new devices, and available guidelines for fire safety, only two devices had comprehensive safety assessments. Most studies focused only on whether the device functioned normally under pressure and did not consider implosion/explosion risk, fire safety, toxicity, oxygen compatibility or risk of pressure damage. CONCLUSIONS: Intravenous infusion (and other electrically powered) devices require comprehensive assessment before use under hyperbaric conditions. This would be enhanced by a publicly accessible database hosting the risk assessments. Facilities should conduct their own assessments specific to their environment and practices.

Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial.

BACKGROUND: Randomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have reported improved anxiety and depression symptoms; however, no adequately powered sham-controlled trials in major depression are available. We investigated whether active Alpha-Stim AID is superior to sham Alpha-Stim AID in terms of clinical effectiveness for depression symptoms in major depression. METHODS: The Alpha-Stim-D trial was a multicentre, parallel group, double-blind, randomised controlled trial, recruiting participants from 25 primary care centres in two regions in England, UK. Eligible participants were aged 16 years or older with a current diagnosis of primary major depression, a score of 10-19 on the nine-item Patient Health Questionnaire, and had been offered or prescribed and reported taking antidepressant medication for at least 6 weeks in the previous 3 months. Main exclusion criteria were contraindications to Alpha-Stim AID device use, having persistent suicidal ideation or self-harm, neurological conditions, a substance use disorder or dependence, an eating disorder, bipolar disorder, or non-affective psychosis, or receiving psychological treatment in the past 3 months. Eligible participants were randomly assigned (1:1, minimised by region, anxiety disorder, and antidepressant use) to 1 h daily use of active (100 µA) or sham Alpha-Stim AID treatment for 8 weeks. Randomisation was via an independent web-based system, with participants, outcome assessors, and data analyst masked to treatment assignment. The primary outcome was change from baseline in score on the 17-item Hamilton Depression Rating Scale (HDRS-17, GRID version) at 16 weeks after randomisation, with participants analysed by intention to treat (ITT; all randomly assigned participants). Safety was assessed in all randomly assigned participants. The trial is registered with the ISRCTN registry (ISRCTN11853110); status completed. FINDINGS: Between Sept 8, 2020, and Jan 14, 2022, 236 eligible participants were randomly assigned to active or sham Alpha-Stim AID (n=118 each). 156 (66%) participants were women, 77 (33%) were men, and three (1%) self-reported as other gender; 200 (85%) were White British or Irish; and the mean age was 38·0 years (SD 15·3; range 16-83). 102 (86%) participants in the active Alpha-Stim AID group and 98 (83%) in the sham group were followed up 16 weeks after randomisation. In the ITT population, mean change in GRID-HDRS-17 at 16 weeks was -5·9 (95% CI -7·1 to -4·8) in the active Alpha-Stim AID group and -6·5 (-7·7 to -5·4) in the sham group (mean change difference -0·6 [95% CI -1·0 to 2·2], p=0·46). Among the 236 participants, 17 adverse events were reported in 17 (7%) participants (nine [8%] participants in the active Alpha-Stim AID group; and eight [7%] participants in the sham group). One serious adverse event of suicidal ideation leading to hospitalisation was reported in the sham group, which was judged to be unrelated to the device. INTERPRETATION: Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression. FUNDING: National Institute for Health Research Applied Research Collaboration East Midlands and Electromedical Products International.

Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multi-centre randomised clinical trial.

INTRODUCTION: Hyperbaric oxygen treatment (HBOT) is sometimes used in the management of open fractures and severe soft tissue crush injury, aiming to reduce complications and improve outcomes. METHODS: Patients with open tibial fractures were randomly assigned within 48 hours of injury to receive standard trauma care or standard care plus 12 sessions of HBOT. The primary outcome was the incidence of necrosis or infection or both occurring within 14 days of injury. RESULTS: One-hundred and twenty patients were enrolled. Intention to treat primary outcome occurred in 25/58 HBOT assigned patients and 34/59 controls (43% vs 58%, odds ratio (OR) 0.55, 95% confidence interval (CI) 0.25 to 1.18, P = 0.12). Tissue necrosis occurred in 29% of HBOT patients and 53% of controls (OR 0.35, 95% CI 0.16 to 0.78, P = 0.01). There were fewer late complications in patients receiving HBOT (6/53 vs 18/52, OR 0.22, 95% CI 0.08 to 0.64, P = 0.007) including delayed fracture union (5/53 vs 13/52, OR 0.31, 95% CI 0.10 to 0.95, P = 0.04). Quality of life measures at one and two years were superior in HBOT patients. The mean score difference in short form 36 was 2.90, 95% CI 1.03 to 4.77, P = 0.002, in the short musculoskeletal function assessment (SMFA) was 2.54, 95% CI 0.62 to 4.46, P = 0.01; and in SMFA daily activities was 19.51, 95% CI 0.06 to 21.08, P = 0.05. CONCLUSIONS: In severe lower limb trauma, early HBOT reduces tissue necrosis and the likelihood of long-term complications, and improves functional outcomes. Future research should focus on optimal dosage and whether HBOT has benefits for other injury types.

A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial).

BACKGROUND: Major depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation. METHODS: The aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions. DISCUSSION: This study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms. TRIAL REGISTRATION: ISRTCN ISRCTN11853110 . Registered on 14 August 2020.

Proliferative retinopathy during hyperbaric oxygen treatment.

A 43-year-old male with type 2 diabetes mellitus, treated with insulin for 28 years and with an HbA1c of 7.9% six months prior, suffered from bilateral plantar ulcers refractory to specialised wound care. He underwent a planned 40 sessions of hyperbaric oxygen treatment (HBOT) at 243 kPa for 90 minutes. Consent was given for this report. The patient's ophthalmic history included bilateral proliferative diabetic retinopathy (PDR) identified on routine diabetic eye screening three years previously. This was treated with pan-retinal photocoagulation (PRP). Three months before starting HBOT, he underwent phacoemulsification and intra-ocular lens insertion of his left eye, having had the same procedure done to his right eye a year prior, without complication. He was reviewed again one week prior to his first HBOT and fundoscopy confirmed non-proliferative diabetic retinopathy (NPDR) without evidence of PDR. The patient had a routine follow up by the ophthalmologist following his fifth HBOT when fundoscopic examination revealed pre-retinal haemorrhage, a form of PDR, in his left eye. This was treated with PRP at the time. His visual acuity, 6/9 bilaterally, had not changed, nor did he describe any changes in his visual field despite these findings. He was seen three weeks later (following 12 further HBOT) when fundoscopy showed worsening proliferative changes, this time in both eyes. Bevacizumab was injected at the time and fill-in PRP performed the following week. His visual acuity remained unchanged in both eyes. At this point, HBOT was withheld to allow the proliferative phase of the patients' retinopathy to remit. The potentially adverse effects of hyperbaric oxygen to the retinal vasculature of diabetic patients was postulated in 1994 following a similar experience, albeit without a baseline fundoscopic examination. In particular, the concern was of accelerating the proliferative process of retinopathy with subsequent irreversible loss of vision. Thereafter, routine screening and treatment of all diabetic patients for PDR was adopted at our facility. Until now, there have been no further cases of NPDR evolving into PDR at three-month review following HBOT. Indeed, a brief literature search using the terms "retinopathy", "complications", "adverse effects", "vitreous", "hemorrhage", "haemorrhage", "hyperbaric" and "oxygen" has not found any other cases described. In a double blind, randomised trial (meeting abstract only) of 15 diabetic patients with both NPDR and PDR, patients in neither the HBOT (243 kPa for 90 min) nor the control arm had evidence of neovascularisation nor worsening of their proliferative retinopathy at three-month follow up. The significance of PDR following cataract surgery has also been considered. A review article consistently found that NPDR progression occurred in up to a third of such patients. Despite this, there were no cases of NPDR progressing to PDR at 12-month follow up. Whether this patient's sudden progression to PDR was related to HBOT, recent cataract surgery or another unknown factor is unclear. However, the temporal relationship to 17 HBOT is difficult to explain and appears more rapid than available data regarding vascular regrowth in wound healing would suggest.

Identifying and acting on potentially inappropriate care? Inadequacy of current hospital coding for this task.

INTRODUCTION: Recent Australian attempts to facilitate disinvestment in healthcare, by identifying instances of 'inappropriate' care from large Government datasets, are subject to significant methodological flaws. Amongst other criticisms has been the fact that the Government datasets utilized for this purpose correlate poorly with datasets collected by relevant professional bodies. Government data derive from official hospital coding, collected retrospectively by clerical personnel, whilst professional body data derive from unit-specific databases, collected contemporaneously with care by clinical personnel. AIM: Assessment of accuracy of official hospital coding data for hyperbaric services in a tertiary referral hospital. METHODS: All official hyperbaric-relevant coding data submitted to the relevant Australian Government agencies by the Royal Hobart Hospital, Tasmania, Australia for financial year 2010-2011 were reviewed and compared against actual hyperbaric unit activity as determined by reference to original source documents. RESULTS: Hospital coding data contained one or more errors in diagnoses and/or procedures in 70% of patients treated with hyperbaric oxygen that year. Multiple discrete error types were identified, including (but not limited to): missing patients; missing treatments; 'additional' treatments; 'additional' patients; incorrect procedure codes and incorrect diagnostic codes. Incidental observations of errors in surgical, anaesthetic and intensive care coding within this cohort suggest that the problems are not restricted to the specialty of hyperbaric medicine alone. Publications from other centres indicate that these problems are not unique to this institution or State. CONCLUSIONS: Current Government datasets are irretrievably compromised and not fit for purpose. Attempting to inform the healthcare policy debate by reference to these datasets is inappropriate. Urgent clinical engagement with hospital coding departments is warranted.

Identifying and acting on inappropriate metadata: a critique of the Grattan Institute Report on questionable care in Australian hospitals.

INTRODUCTION: In an era of ever-increasing medical costs, the identification and prohibition of ineffective medical therapies is of considerable economic interest to healthcare funding bodies. Likewise, the avoidance of interventions with an unduly elevated clinical risk/benefit ratio would be similarly advantageous for patients. Regrettably, the identification of such therapies has proven problematic. A recent paper from the Grattan Institute in Australia (identifying five hospital procedures as having the potential for disinvestment on these grounds) serves as a timely illustration of the difficulties inherent in non-clinicians attempting to accurately recognize such interventions using non-clinical, indirect or poorly validated datasets. AIM: To evaluate the Grattan Institute report and associated publications, and determine the validity of their assertions regarding hyperbaric oxygen treatment (HBOT) utilisation in Australia. METHODS: Critical analysis of the HBOT metadata included in the Grattan Institute study was undertaken and compared against other publicly available Australian Government and independent data sources. The consistency, accuracy and reproducibility of data definitions and terminology across the various publications were appraised and the authors' methodology was reviewed. Reference sources were examined for relevance and temporal eligibility. RESULTS: Review of the Grattan publications demonstrated multiple problems, including (but not limited to): confusing patient-treatments with total patient numbers; incorrect identification of 'appropriate' vs. 'inappropriate' indications for HBOT; reliance upon a compromised primary dataset; lack of appropriate clinical input, muddled methodology and use of inapplicable references. These errors resulted in a more than seventy-fold over-estimation of the number of patients potentially treated inappropriately with HBOT in Australia that year. CONCLUSION: Numerous methodological flaws and factual errors have been identified in this Grattan Institute study. Its conclusions are not valid and a formal retraction is required.

Poorly designed research does not help clarify the role of hyperbaric oxygen in the treatment of chronic diabetic foot ulcers.

Diabetic foot ulcers (DFUs) are one of the most common indications for hyperbaric oxygen treatment (HBOT). The role of HBOT in DFUs is often debated. Recent evidence based guidelines, while recommending its use, urge further studies to identify the patient subgroups most likely to benefit from HBOT. A recent study in Diabetes Care aimed to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with chronic DFUs. In this study, patients with Wagner grade 2-4 diabetic foot lesions were randomly assigned to have HBOT (30 sessions/90 min/244 kPa) or sham treatment (30 sessions/90 min/air/125 kPa). Six weeks after the completion of treatment (12 weeks after randomization) neither the fulfillment of major amputation criteria (11/49 vs. 13/54, odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846) nor wound-healing rates (20% vs. 22%, 0.90 [0.35, 2.31], P = 0.823) significantly differed between groups. The authors concluded that HBOT does not offer any additional advantage over comprehensive wound care. Since this paper was published in Diabetes Care, one of the most prestigious diabetes journals, it is likely it will have a major impact on the clinical practice of many physicians dealing with diabetic foot problems. Although from a methodological standpoint the conduct of the study (prospective, double-blind, randomized, controlled) seems to be close to ideal, several significant flaws render the conclusions weak. Firstly, there were some problems with the assessment of the primary outcome of "meeting the criteria for amputation". In their published protocol paper, the trial lists indicated that "At the end of the 6-week follow-up phase……, the patient is sent to the participating vascular surgeon for an amputation evaluation". However, in the published report in Diabetes Care, it is evident that patients were not assessed in a face-to-face consultation, but rather by the remote examination of wound photographs and clinical data "Participant clinical data together with digital photographs of the study wound progress were presented to the vascular surgeon". This departure from the original intent undermines the primary outcome of the study significantly. Fedorko et al claim this method of assessment has been validated, but neither of their supporting citations appear to substantiate this claim. Wirthlin et al assessed the level of agreement about a collection of wounds between surgeons who were present at the bedside and a remote group who assessed the wounds using a short clinical account and digital photography. There was reasonable agreement between onsite and remote, although the specificity for particular signs ranged from just 27% (erythema) to 100% (ischaemia). Importantly, only a subset of eight of the 24 included patients had non-healing wounds and the proportion of those that were associated with diabetes mellitus is unknown. Further, the need for amputation was not among the management decisions examined. Wirthlin et al concluded "a prospective trial of remote wound management …. is needed to further validate this technology." The authors of the second supposedly supporting citation were mainly interested in the assessment of pressure ulcers by digital photography using the Photographic Wound Assessment Tool (PWAT) compared to the Pressure Sore Status Tool (PSST). Of the 81 included lower leg ulcers, it is not clear how many were associated with diabetes mellitus. Indications for amputation were not considered. The authors concluded "The PWAT may be valuable when a bedside assessment cannot be made. However, the size of circular wounds, wound depth, undermining/tunneling, and odor cannot be assessed using photographs." In the Fedorko paper, the decision that there was an indication for amputation was made by the remote vascular surgeon by meeting any of the following criteria: "persistent deep infection involving bone and tendons (antibiotics required, hospitalization required, pathogen involved); ongoing risk of severe systemic infection related to the wound; inability to bear weight on the affected limb; or pain causing significant disability". We are particularly concerned that the criteria, "persistent deep infection involving bone and tendons", is subjective. Recent studies have demonstrated that diabetic foot osteomyelitis may not necessarily require amputation and some cases may be cured with antibiotic therapy alone. It is interesting to note that despite the high numbers of participants assessed as fitting the requirements for amputation (23% overall), no patient actually had a major amputation. The amputation outcome is inappropriately assessed, done at the wrong time, and the study is grossly underpowered to find any difference in the rate of true major amputation. Finally, whether the surgeon performed a baseline assessment of amputation prior to the randomised intervention is unknown. A comparison between the pre- and post-study estimates of amputation rates could have contributed to the interpretation of the results. Secondly, the authors fail to provide a clear comparison of peripheral arterial disease (PAD) between the groups. Although patients were randomized and those who were possible candidates for major vessel revascularization were excluded from the study, microvascular status was not assessed. No transcutaneous oxygen measurements were made on any of the patients. Given that, firstly, the risk of microvascular vessel compromise increases with diabetes duration, and secondly, transcutaneous oxygen measurements correlate with the possibility of good response to HBOT, it is possible that clinically significant differences between groups were undetected. As an example, patients in the HBOT group had a markedly longer mean duration of diabetes (19.1 vs. 12.4 years) and would be likely to have more severe microvascular disease. Thirdly, the follow-up period of six weeks after completion of treatment is very short. The study to which the authors refer to justify this follow-up period enrolled only patients with ulcers of Wagner grade 1 or 2 and specifically excluded patients with infection or ischaemia. These are not representative of the patient population treated with HBOT. The outcomes in patients with DFUs treated with HBOT should be assessed over a longer period. One such randomized controlled study demonstrated that patients receiving HBOT had significantly higher healing rates than placebo at one-year follow-up (25/48 (52%) versus 12/42 (29%); P 〈 0.03), but not at 12 weeks. Fourthly, the authors also failed to describe the experience of the vascular surgeon who adjudicated the wounds for amputation; how many years he was involved in the management of diabetic foot wounds or how specialized his practice was with these patients. Objective and universally recognized indications for amputation are yet to be established. Therefore, a multidisciplinary decision-making approach, rather than a single physician's decision, would have increased the credibility of the conclusion the authors reached. Notably, all previous studies of HBOT in this area have used actual amputation rates in order to have a clear clinical endpoint. Careful patient selection is paramount for the cost-effective use of HBOT as an adjunct to normal wound care in diabetic wounds. As it is possible to identify wounds that have no potential to heal despite HBOT, all studies should incorporate transcutaneous oxygen measurements in their baseline evaluation. As the wounds in this study tended to be small (6.1cm² and 5.8cm² on average) and had persisted for (on average) one year despite state-of-the-art previous wound care, it is likely that at least some of these would not meet the predictive minimal criteria for healing potential with HBOT. The findings of this study do indeed show that the indiscriminate treatment of all diabetic wounds with HBOT is probably not (cost-) effective; however, the study conclusion that "HBO has no benefit in the treatment of chronic diabetic foot wounds" is erroneous.

Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial.

INTRODUCTION: Open fractures with significant soft tissue injury are associated with high rates of complications, such as non-union, infection, chronic pain and disability. Complications often require further inpatient care, and in many cases, multiple operations and prolonged rehabilitation. Use of hyperbaric oxygen therapy as an adjunct to standard orthopaedic trauma care has the potential to reduce the complications of musculoskeletal injury and thus improve outcomes. Two previous randomised trials have suggested some positive effect, but neither functional measures nor long-term outcomes were reported. METHODS AND ANALYSIS: An international, multicentre, randomised, open-label, clinical trial. Patients with trauma with an acute open fracture of the tibia with severe soft tissue injury (Gustilo grade 3) and high risk of injury-related complications were recruited from participating major trauma hospitals with hyperbaric facilities. Patients were enrolled with the expectation of commencing 12 sessions of hyperbaric oxygen therapy within 48 h of injury. The primary outcome measure is the incidence of acute complications of the open fracture wound at 14 days. Other short-term outcome measures include amputation, need for fasciotomy, time until wound closure, breakdown of closed wounds, time until definitive orthopaedic fixation, number of operative procedures, intensive care stay and hospital stay. Long-term follow-up will continue for 2 years postinjury. ETHICS AND DISSEMINATION: Ethics approval was given by The Alfred Health Human Ethics Committee (206/04) and the Monash University Human Research Ethics Committee (CF07/4208). Approval was also obtained from the institutional research ethics committee at each participating site. This study will make a significant contribution to the trauma literature and should answer the question of whether hyperbaric oxygen therapy can significantly improve outcomes in severe lower limb trauma. Collective study results will be published in international journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT00264511; Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12607000559415.

Performance of the Baxter Infusor LV10 under hyperbaric conditions.

INTRODUCTION: Elastomeric drug delivery devices are a simple way to provide long-term IV therapy to patients in the outpatient setting. Patients receiving hyperbaric oxygen therapy occasionally need these devices. This study compared the performance of the Baxter infusor LV10 elastomeric device in repetitive conditions at pressures of 101.3 kPa and 243 kPa. METHODS: Ten Baxter infusor LV10 elastomeric devices were pressurised in a hyperbaric chamber to 243 kPa over a two-hour period consistent with a standard medical treatment run. This process was repeated 10 times for each device giving a total of 20 hours under pressure. The fluid delivered by each device was measured and the device weighed at the end of each pressurisation. Ten control devices containing identical drugs were tested in the same manner at 101.3 kPa over the same time period. RESULTS: No significant differences in output of the devices were observed between hyperbaric and control conditions. The flow rates measured in both study groups were 35% lower than the manufacturer's stated flow rate, possibly due to lower test environment temperature and outdated devices used in the tests. CONCLUSION: Despite lower than expected flow rates, this study demonstrated no significant difference in the delivery rate of the Baxter infusor LV10 under 243 kPa hyperbaric conditions compared with room pressure.

A cost-analysis case study of radiation cystitis treatment including hyperbaric oxygen therapy.

AIM: To undertake an economic analysis of the direct costs of treating radiation cystitis from a purchaser perspective, comparing conservative, non-operative and surgical interventions with hyperbaric oxygen treatment (HBOT). METHODS: A male in his 60s with prostatic carcinoma consented to this study. Full details of treatment costs in AUD were obtained (AUD 1.0, approx. EUR 0.6). A detailed patient diary accurately cross-referenced the consultations, investigations, admissions and treatment. Costs were recorded on a spreadsheet, dated and grouped under eight major headings related to treatment. Costs were compared for radiation cystitis treatment pre- and post-HBOT, to calculate savings or losses. RESULTS: The study covered three years (including 2.5 years post successful HBOT). Costs prior to HBOT (139 days) were AUD32,571.42 at an average of AUD231.09 per day, 70% from inpatient fees. Direct HBOT costs were AUD12,014.95 for 38 treatments, AUD316.18 per treatment. Post-HBOT (897 days), healthcare costs were AUD17,113.42 (AUD19.08 per day), with no emergency admissions. HBOT reduced costs of inpatient admissions, consultations, investigations and procedures and provided a projected healthcare saving of AUD187,483.96 over a 2.5 year follow up. CONCLUSIONS: The cost of HBOT compared favourably against other costs, and HBOT may provide major health cost savings in this condition. There are significant hidden costs associated with radiation cystitis, not apparent to health funders, because the reasons for admissions and procedures are not easily captured with current information systems.

Magnesium sulphate versus phenytoin for eclampsia.

BACKGROUND: Eclampsia, the occurrence of a seizure in association with pre-eclampsia, remains a rare but serious complication of pregnancy. A number of different anticonvulsants have been used to control eclamptic fits and to prevent further seizures. OBJECTIVES: The objective of this review was to assess the effects of magnesium sulphate compared with phenytoin when used for the care of women with eclampsia. Magnesium sulphate is compared with diazepam and with lytic cocktail in other Cochrane reviews. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2010). SELECTION CRITERIA: Randomised trials comparing magnesium sulphate (intravenous or intramuscular administration) with phenytoin for women with a clinical diagnosis of eclampsia. DATA COLLECTION AND ANALYSIS: Two review authors assessed trial quality and extracted data. MAIN RESULTS: We have included data from seven trials, involving 972 women. One large trial (775 women) was of good quality. Magnesium sulphate was associated with a substantial reduction in the recurrence of seizures, when compared to phenytoin (six trials, 972 women; risk ratio (RR) 0.34, 95% confidence interval (CI) 0.24 to 0.49). The trend in maternal mortality favours magnesium sulphate, but the difference does not reach statistical significance (three trials, 847 women; RR 0.50, 95% CI 0.24 to 1.05). There were reductions in the risk of pneumonia (one trial, RR 0.44, 95% CI 0.24 to 0.79), ventilation (one trial, RR 0.68, 95% CI 0.50 to 0.91) and admission to an intensive care unit (one trial, RR 0.67, 95% CI 0.50 to 0.89) associated with the use of magnesium sulphate rather than phenytoin.For the baby, magnesium sulphate was associated with fewer admissions to a special care baby unit (SCBU) (one trial, 518 babies; RR 0.73, 95% CI 0.58 to 0.91) and fewer babies who died or were in SCBU for more than seven days (one trial, 643 babies; RR 0.77, 95% CI 0.63 to 0.95) than phenytoin. There was no clear difference in perinatal deaths (two trials, 665 babies; (RR 0.85, 95% CI 0.67 to 1.09). AUTHORS' CONCLUSIONS: Magnesium sulphate, rather than phenytoin, for women with eclampsia reduces the risk ratio of recurrence of seizures, probably reduces the risk of maternal death, and improves outcome for the baby. Magnesium sulphate is the drug of choice for women with eclampsia. The use of phenytoin should be abandoned.

ANZHMG statement on the administration of mild hyperbaric oxygen therapy.

'Mild' hyperbaric therapy (MHT) and hyperbaric oxygen therapy are easily confused. Essentially the difference lies in the effective oxygen dose. Oxygen is an extremely useful and efficacious drug in a wide range of medical conditions. MHT does not typically provide more available oxygen to the body than is possible with oxygen administration at one atmosphere (sea level), and there is no known therapeutic benefit of mild compression alone. There is, therefore, no documented, biologically plausible evidence for the use of MHT over delivery of oxygen by a simple facemask at one atmosphere of pressure. MHT is advocated for a wide range of clinical conditions, in particular for chronic neurological conditions and as part of a suite of 'wellbeing' therapies. The Australia and New Zealand Hyperbaric Medicine Group, a standing sub-committee of the South Pacific Underwater Medicine Society, is not aware of any reliable clinical evidence for therapeutic benefit from mild hyperbaric therapy and does not recommend the use of this modality for any medical purpose.