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.

Barriers and enablers to patient recruitment for randomised controlled trials on treatment of chronic wounds: A systematic review.

Randomised controlled trials represent the gold standard in intervention efficacy evaluation. However, suboptimal recruitment affects completion and the power of a therapeutic trial in detecting treatment differences. We conducted a systematic review to examine the barriers and enablers to patient recruitment for randomised controlled trials on chronic wound treatment. Review registration was under PROSPERO 2017:CRD42017062438. We conducted a systematic search of Ovid MEDLINE, EBSCOhost CINAHL, Ovid Cochrane Library, Ovid EMBASE, and Ovid PsycINFO databases in June 2017 for chronic wound treatment randomised controlled trials. Twenty-seven randomised controlled trials or qualitative studies met the inclusion criteria. Among the 24 randomised controlled trials, 21 were assessed as low quality in relation to recruitment, and 3 were assessed as high quality. All 27 studies reported barriers to recruitment in chronic wound randomised controlled trials. The reported barriers to recruitment were: study-related, patient-related, clinician-related, health system-related, and/or operational-related. No study reported recruitment enablers. To enhance randomised controlled trial recruitment, we propose the need for improved integration of research and clinical practice. To alleviate the problems arising from inadequate reporting of randomised controlled trials, the Consolidated Standards of Reporting Trials Statement could include an additional item on recruitment barriers. This approach will allow for increased awareness of the potential barriers to recruitment for Randomised controlled trials (RCTs) in both wound management and other health care research.

Review article: Effectiveness of ultra-brief interventions in the emergency department to reduce alcohol consumption: A systematic review.

To assess the effectiveness of ultra-brief interventions (ultra-BI) or technology-involved preventive measures in the ED to reduce alcohol harm and risky drinking. Medline, Embase, PsycINFO, CINAHL and EBM reviews were searched for articles published between 1996 and 2015. Randomised controlled trials and quasi-randomised trials, which compared an ultra-BI with screening, standard care or minimal intervention for adults and adolescents at risk for alcohol-related harm presenting to an ED, were included. Outcomes of interest were frequency of alcohol consumption, quantity of alcohol consumed, binge drinking and ED representation. Thirteen studies (nine single centre and four multicentre) were included. Six studies showed a significant reduction in the quantity consumed with intermediate effect size at 3 months (d = -0.40) and small effect size at 12 months (d = -0.15). Two studies showed a significant reduction in binge drinking with small effect size at 3 months (d = -0.12) and 12 months (d = -0.09). No studies showed an effect on frequency of alcohol consumption or ED representation. Heterogeneity in study design, definition of risky, harmful or hazardous alcohol use, intervention types, outcomes, outcome timeframes and outcome measures prevented the performance of quantitative meta-analysis. Despite its limited effectiveness in reducing alcohol use in the short-term, with the large number of people attending EDs with risky drinking, the use of an effective ultra-BI would have the potential to have a measurable population effect.

Discharging older patients from the emergency department effectively: a systematic review and meta-analysis.

BACKGROUND: a decline in health state and re-attendance are common in people aged ≥65 years following emergency department (ED) discharge. Diverse care models have been implemented to support safe community transition. This review examined ED community transition strategies (ED-CTS) and evaluated their effectiveness. METHODS: a systematic review and meta-analysis using multiple databases up to December 2013 was conducted. We assessed eligibility, methodological quality, risk of bias and extracted published data and then conducted random effects meta-analyses. Outcomes were unplanned ED representation or hospitalisation, functional decline, nursing-care home admission and mortality. RESULTS: five experimental and four observational studies were identified for qualitative synthesis. ED-CTS included geriatric assessment with referral for post-discharge community-based assistance, with differences apparent in components and delivery methods. Four studies were included in meta-analysis. Compared with usual care, the evidence indicates no appreciable benefit for ED-CTS for unplanned ED re-attendance up to 30 days (odds ratio (OR) 1.32, 95% confidence interval (CI) 0.99-1.76; n = 1,389), unplanned hospital admission up to 30 days (OR 0.90, 95% CI 0.70-1.16; n = 1,389) or mortality up to 18 months (OR 1.04, 95% CI 0.83-1.29; n = 1,794). Variability between studies precluded analysis of the impact of ED-CTS on functional decline and nursing-care home admission. CONCLUSIONS: there is limited high-quality data to guide confident recommendations about optimal ED community transition strategies, highlighting a need to encourage better integration of researchers and clinicians in the design and evaluation process, and increased reporting, including appropriate robust evaluation of efficacy and effectiveness of these innovative models of care.

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.