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Fracture-related infection (FRI) remains a challenging complication that creates a heavy burden for orthopaedic trauma patients, their families and treating physicians, as well as for healthcare systems. Standardization of the diagnosis of FRI has been poor, which made the undertaking and comparison of studies difficult. Recently, a consensus definition based on diagnostic criteria for FRI was published. As a well-established diagnosis is the first step in the treatment process of FRI, such a definition should not only improve the quality of published reports but also daily clinical practice. The FRI consensus group recently developed guidelines to standardize treatment pathways and outcome measures. At the center of these recommendations was the implementation of a multidisciplinary team (MDT) approach. If such a team is not available, it is recommended to refer complex cases to specialized centers where a MDT is available and physicians are experienced with the treatment of FRI. This should lead to appropriate use of antimicrobials and standardization of surgical strategies. Furthermore, an MDT could play an important role in host optimization. Overall two main surgical concepts are considered, based on the fact that fracture fixation devices primarily target fracture consolidation and can be removed after healing, in contrast to periprosthetic joint infection were the implant is permanent. The first concept consists of implant retention and the second consists of implant removal (healed fracture) or implant exchange (unhealed fracture). In both cases, deep tissue sampling for microbiological examination is mandatory. Key aspects of the surgical management of FRI are a thorough debridement, irrigation with normal saline, fracture stability, dead space management and adequate soft tissue coverage. The use of local antimicrobials needs to be strongly considered. In case of FRI, empiric broad-spectrum antibiotic therapy should be started after tissue sampling. Thereafter, this needs to be adapted according to culture results as soon as possible. Finally, a minimum follow-up of 12 months after cessation of therapy is recommended. Standardized patient outcome measures purely focusing on FRI are currently not available but the patient-reported outcomes measurement information system (PROMIS) seems to be the preferred tool to assess the patients’ short and long-term outcome. This review summarizes the current general principles which should be considered during the whole treatment process of patients with FRI based on recommendations from the FRI Consensus Group.Level of evidence: Level V.

A judicious, well-planned bone and soft tissue debridement remains one of the cornerstones of state-of-the-art treatment of fracture-related infection (FRI). Meticulous surgical excision of all non-viable tissue can, however, lead to the creation of large soft tissue defects. The management of these defects is complex and numerous factors need to be considered when selecting the most appropriate approach. This narrative review summarizes the current evidence with respect to soft tissue management in patients diagnosed with FRI. Specifically we discuss the optimal timing for tissue closure following debridement in cases of FRI, the need for negative microbiological culture results from the surgical site as a prerequisite for definitive wound closure, the optimal type of flap in case of large soft tissue defects caused by FRI and the role of negative pressure wound therapy (NPWT) in FRI. Finally, recommendations are made with regard to soft tissue management in FRI that should be useful for clinicians in daily clinical practice. Level of evidence Level V.

MANY REASONS have been put forward for John Howard's failure to win the 2007 election negative reaction to Work- Choices, his refusal to abdicate in favour of Peter Costello, even a sense that he had just been in power too long but there was another issue which suf- fused the Opposition campaign and which played a major part in persuading voters: climate change, in par- ticular the recent drought.

IntroductionAntenatal care addressing alcohol consumption during pregnancy is not routinely delivered in maternity services. Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. This study aims to assess the effectiveness of an iteratively developed and delivered implementation support package in: (1) increasing the proportion of pregnant women who receive antenatal care addressing alcohol consumption and (2) sustaining the rate of care over time.Methods and analysisA stepped-wedge cluster trial will be conducted as a second phase of a previous trial. All public maternity services within three sectors of a local health district in Australia will receive an implementation support package that was developed based on an assessment of outcomes and learnings following the initial trial. The package will consist of evidence-based strategies to support increases in care provision (remind clinicians; facilitation; conduct educational meetings) and sustainment (develop a formal implementation blueprint; purposely re-examine the implementation; conduct ongoing training). Measurement of outcomes will occur via surveys with women who attend antenatal appointments each week. Primary outcomes will be the proportion of women who report being asked about alcohol consumption at subsequent antenatal appointments; and receiving complete care (advice and referral) relative to alcohol risk at initial and subsequent antenatal appointments. Economic and process evaluation measures will also be reported.Ethics and disseminationEthical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health service decision makers to inform the feasibility of conducting additional cycles to further improve antenatal care addressing alcohol consumption as well as at scientific conferences and in peer-reviewed journals.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ACTRN12622000295741).

BackgroundArterial and venous thromboembolic events (TEEs) have been associated with intravenous Ig use, but the risk has been poorly quantified. We aimed to calculate the risk of TEEs associated with exposure to intravenous Ig.MethodsWe included participants from UK Biobank recruited over 3 years, data extracted September 2020.The study endpoints were incidence of myocardial infarction, other acute ischaemic heart disease, stroke, pulmonary embolism and other venous embolism and thrombosis.Predictors included known TEE risk factors: age, sex, hypertension, smoking status, type 2 diabetes mellitus, hypercholesterolaemia, cancer and past history of TEE. Intravenous Ig and six other predictors were added in the sensitivity analysis.Information from participants was collected prospectively, while data from linked resources, including death, cancer, hospital admissions and primary care records were collected retrospectively and prospectively. Findings14 794 of 502 492 individuals had an incident TEE during the study period. The rate of incident events was threefold higher in those with prior history of TEE (8 .7%) than those without previous history of TEE (3.0%).In the prior TEE category, intravenous Ig exposure was independently associated with increased risk of incident TEE (OR=3.69 (95% CI 1.15 to 11.92), p=0.03) on multivariate analysis. The number needed to harm by exposure to intravenous Ig in those with a history of TEE was 5.8 (95% CI 2.3 to 88.3).Intravenous Ig exposure did not increase risk of TEE in those with no previous history of TEE.InterpretationIntravenous Ig is associated with increased risk of further TEE in individuals with prior history of an event with one further TEE for every six people exposed. In practice, this will influence how clinicians consent for and manage overall TEE risk on intravenous Ig exposure.

Trauma care has evolved rapidly over the past decade. The benefits of operative fracture management in major trauma patients are well recognised. Concerns over early total care arose when applied broadly. The burden of additional surgical trauma could constitute a second hit, fuelling the inflammatory response and precipitating a decline into acute respiratory distress syndrome, sepsis and multiple organ dysfunction syndrome. Temporary external fixation aimed to deliver the benefits of fracture stabilisation without the risk of major surgery. This damage control orthopaedics approach was advocated for those in extremis and a poorly defined borderline group. An increasing understanding of the physiological response to major trauma means there is now a need to refine our treatment options. A number of large scale retrospective reviews indicate that early definitive fracture fixation is beneficial in the majority of major trauma patients. It is recommended that patients are selected appropriately on the basis of their response to resuscitation. The hope is that this approach (dubbed ‘safe definitive fracture surgery’ or ‘early appropriate care’) will herald an era when care is individualised for each patient and their circumstances. The novel Damage Control in Orthopaedic Trauma Surgery course at The Royal College of Surgeons of England aims to equip senior surgeons with the insights and mindset necessary to contribute to this key decision making process as well as also the technical skills to provide damage control interventions when needed, relying on the improved techniques of damage control resuscitation and advances in the understanding of early appropriate care.

Adaptive clinical trials have designs that evolve over time because of changes to treatments or changes to the chance that participants will receive these treatments. These changes might introduce confounding that biases crude comparisons of the treatment arms and makes the results from standard reporting methods difficult to interpret for adaptive trials. To deal with this shortcoming, a reporting framework for adaptive trials was developed based on concurrently randomised cohort reporting. A concurrently randomised cohort is a subgroup of participants who all had the same treatments available and the same chance of receiving these treatments. The reporting of pre-randomisation characteristics and post-randomisation outcomes for each concurrently randomised cohort in the study is recommended. This approach provides a transparent and unbiased display of the degree of baseline balance and the randomised treatment comparisons for adaptive trials. The key concepts, terminology, and recommendations underlying concurrently randomised cohort reporting are presented, and its routine use in adaptive trial reporting is advocated.

ObjectivesArterial and venous thromboembolic events (TEEs) have been associated with intravenous immunoglobulin (IVIg) use, but the risk has been poorly quantified. We aimed to calculate the risk of TEEs associated with IVIg exposure.MethodsWe included participants from UK Biobank. Study endpoints: incidence of myocardial infarction, other acute ischemic heart disease, stroke, pulmonary embolism, other venous embolism, and thrombosis. Predictors included known TEE risk factors: age, sex, hypertension, smoking status, type 2 diabetes mellitus, hypercholesterolemia, cancer, and history of TEE (phx). IVIg was added in the sensitivity analysis.Results14 794 of 502 543 individuals had an incident TEE during the study period. In the phx category, IVIg exposure was independently associated with increased risk of incident TEE (OR= 3·69, p=0·03) on multivariate analysis. The number needed to harm in phx group was 5·8 (95% CI, 2·3–88·3).IVIg exposure did not increase risk of TEE in those without phx. If everyone in the phx group was exposed to IVIg, the median risk of recurrent event in those <60 years of age increases from 6.1% to 19.3% and in those >60 from 9.1% to 26.9% (moving nearly 50% of individuals into >20% risk of recurrent TEE). A similar change in risk was seen if the cohort was divided by gender.ConclusionIVIg is associated with increased risk of further TEE in individuals with phx. In practice, this will influence how clinicians consent for and manage overall TEE risk upon IVIg exposure in high-risk patients.

While traditional application of quantitative microbial risk assessment (QMRA) models usually stops at analyzing the microbial risk under typical operating conditions, this paper proposes the use of scenario-based risk assessment to predict the impact of potential challenges on the expected risk. This study used a QMRA model developed by Health Canada to compare 14 scenarios created to assess the increase in risk due to potential treatment failures and unexpected variations in water quality and operating parameters of a water treatment plant. Under regular operating conditions, the annual risk of illness was found to be substantially lower than the acceptable limit. Scenario-based QMRA was shown to be useful in demonstrating which hypothetical treatment failures would be the most critical, resulting in an increased risk of illness. The analysis demonstrated that scenarios incorporating considerable failure in treatment processes resulted in risk levels surpassing the acceptable limit. This reiterates the importance of robust treatment processes and the multi-barrier approach voiced in drinking water safety studies. Knowing the probability of failure, and the risk involved, allows designers and operators to make effective plans for response to treatment failures and/or recovery actions involving potential exposures. This ensures the appropriate allocation of financial and human resources.