Identifying areas for improvement in paediatric trauma care in NSW Australia using a clinical,system and human factors peer-review tool

BackgroundThere is known variability in the quality of care delivered to injured children. Identifying where care improvement can be made is critical. This study aimed to review paediatric trauma cases across the most populous Australian State to identify factors contributing to clinical incidents.MethodsMedical records from three New South Wales Paediatric Trauma Centres were reviewed for children <16 years requiring intensive care; with an injury severity score of ≥9, or who died following injury between July 2015 and September 2016. Records were peer-reviewed by nurse surveyors who identified cases that might not meet the expected standard of care or where the child died following the injury. A multidisciplinary panel conducted the peer-review using a major trauma peer-review tool. Records were reviewed independently, then discussed to establish consensus.ResultsA total 535 records were reviewed and 41 cases were peer-reviewed. The median (IQR) age was 7 (2–12) years, the median ISS was 25 (IQR 16–30). The peer-review identified a combination of clinical (85%), systems (51%) and communication (12%) problems that contributed to difficulties in care delivery. In 85% of records, staff actions were identified to contribute to events; with medical task failure the most frequently identified cause (89%).ConclusionThe peer-review of paediatric trauma cases assisted in the identification of contributing factors to clinical incidents in trauma care resulting in 26 recommendations for change. The prioritisation and implementation of these recommendations, alongside a uniform State-wide trauma case review process with consistent criteria (definitions), performance indicators, monitoring and reporting would facilitate improvement in health service delivery to children sustaining severe injury.     

Review of the renal endpoints used in cardiovascular safety clinical trials in type 2 diabetes mellitus patients and their importance in primary care

Chronic kidney disease (CKD) is one of the most common complications of type 2 diabetes mellitus (T2DM). Furthermore, CKD confers a considerable increase in the risk of cardiovascular (CV) morbidity and mortality. In line with the need to improve knowledge in this field, this article aims to describe the renal endpoints used in the different cardiovascular outcome trials (CVOTs). The objective is to better know the renal variables used in the different CVOTs in order to optimize the implementation of advances in the prevention of progressive diabetic kidney disease in patients with T2DM in clinical practice.     

肉毒毒素注射引起的不良反应

肉毒毒素注射引起的不良反应,是药物本身的组成成分引起的与用药目的无关的有害反应,与医生注射方式和注射技术无关。尽管肉毒毒素生产厂家的药品说明书上也有提示,但其所提供的信息不够全面,也未必能引起医生的足够重视。目前文献上多为散发病例。为此作者对过去20年有关肉毒毒素注射引起的过敏反应、肉瘤样肉芽肿、眼睑水肿、流感样症状等相关不良反应的临床表现、发病机制与治疗方法进行综述。     

COVID-19 vaccine induced interstitial lung disease

A 60-year-old man presented with dyspnea four days after the second dose of the coronavirus disease (COVID-19) vaccine. Imaging revealed extensive ground-glass opacification. Blood tests were notable for elevated KL-6 levels. Bronchoalveolar lavage fluid analysis showed increased lymphocyte-dominant inflammatory cells and decreased CD4/CD8 ratio. These findings were consistent with the diagnosis of drug-induced interstitial lung disease (DIILD). To the best of our knowledge, this has never been reported in previous literature. Treatment with glucocorticoids relieved his symptoms. This paper highlights that although extremely rare, COVID-19 vaccine could cause DIILD, and early diagnosis and treatment are crucial to improve patient outcomes.     

Safety and Immunogenicity of mRNA Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Lung Cancer Receiving Immune Checkpoint Inhibitors: A Multicenter Observational Study in Japan

IntroductionPatients with cancer have been prioritized for vaccination against severe acute respiratory syndrome coronavirus 2. Nevertheless, there are limited data regarding the safety, efficacy, and risk of developing immune-related adverse events (irAEs) associated with mRNA vaccines in patients with lung cancer, especially those being actively treated with immune checkpoint inhibitors.MethodsThis multicenter observational study was conducted at nine hospitals in Japan. Patients with lung cancer (≥20 y) actively treated with immune checkpoint inhibitors between 4 weeks prefirst vaccination and 4 weeks postsecond vaccination were enrolled. The primary end point was the incidence of irAEs of any grade on the basis of an assumed incidence without vaccination rate of 35%. Immunogenicity was assessed by measuring anti–spike (S)-IgG antibody levels against severe acute respiratory syndrome coronavirus 2.ResultsA total of 126 patients with lung cancer (median age, 71 y; interquartile range, 65–74) were enrolled from May to November 2021 and followed up until December 2021. There were 26 patients (20.6%, 95% confidence interval: 13.9%–28.8%) and seven patients (5.6%, 95% confidence interval: 2.3%–11.1%) who developed irAEs of any grade pre- and postvaccination, respectively, which was lower than the predicted incidence without vaccination. None of the patients experienced exacerbation of preexisting irAE postvaccination. S-IgG antibodies were seroconverted in 96.7% and 100% of the patients with lung cancer and controls, respectively, but antibody levels were significantly lower in patients with lung cancer (p < 0.001).ConclusionsPatients with lung cancer who were actively treated with ICIs were safely vaccinated without an increased incidence of irAEs; however, their vaccine immunogenicity was lower. This requires further evaluation.     

舒巴坦治疗老年心力衰竭患者肺部感染的临床效果及不良反应发生率分析

目的本研究分析舒巴坦治疗老年心力衰竭患者肺部感染的临床效果及不良反应发生情况,为临床治疗提供参考。方法160例老年心力衰竭肺部感染患者为研究对象,分为两组:对照组(n=80)患者在常规治疗的基础上采用头孢曲松钠治疗,观察组(n=80)患者在常规治疗的基础上采用头孢哌酮钠舒巴坦治疗。分析两组患者的细菌清除率、治疗前后心功能和肺功能的改善及不良反应的发生情况。结果观察组患者在细菌清除率明显高于对照组患者的细菌清除率(对照组vs观察组=84.35%vs 87.92%,χ²=5.654,P<0.05);两组患者治疗后心功参数LVEDD、LVESD、LVEF和肺功参数用力呼气容积和用力肺活量均得到显著的改善(P<0.05),且与对照组相比,观察组患者的上述指标改善显著(P<0.05);两组研究对象的不良反应包括凝血功能障碍、肝功能障碍、轻度皮疹和呕吐。结论舒巴坦治疗老年心力衰竭患者肺部感染安全性高,且临床疗效值得认可,可在临床推广应用。     

Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older

BackgroundThe MenB-FHbp vaccine (Trumenba®) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals ≥ 10 years of age. The clinical development program included 11 completed trials where, in each trial, MenB-FHbp had an acceptable safety profile after a primary vaccination series was administered to individuals 10–65 years of age. However, the detection of potential rare events was limited because of individual clinical trial size. The current safety analysis evaluates pooled reactogenicity and other adverse events (AEs) reported in these trials to identify new safety signals not detectable in individual trials.MethodsEleven trials contributed safety data, of which 10 recorded local and systemic reactogenicity events; 8 of the trials were controlled, and reactogenicity data were pooled for 7 of these 8 trials. Additional AE evaluations included immediate AEs (IAEs), medically attended AEs (MAEs), serious AEs (SAEs), newly diagnosed chronic medical conditions (NDCMCs), and autoimmune or neuroinflammatory conditions.ResultsLocal and systemic reactions were more frequent in the MenB-FHbp group (n = 15,294) compared with controls (n = 5509), although most reactions were transient and mild to moderate in severity. Frequencies of IAEs, SAEs, MAEs, NDCMCs, and autoimmune or neuroinflammatory conditions were similar between the MenB-FHbp and control groups.ConclusionsMenB-FHbp demonstrated a favorable safety and tolerability profile in the clinical development program of > 15,000 vaccine recipients ≥ 10 years of age. No new safety signals were identified in the pooled analysis compared with data from the individual trials. Continued postmarketing safety surveillance is important for the identification of rare events.Clinicaltrials.gov: NCT01299480; NCT000808028; NCT00879814; NCT00780806; NCT01352845; NCT01352793; NCT01461993; NCT01323270; NCT01830855; NCT01461980; NCT01768117.     

Acute total hip arthroplasty for older patients with acetabular fractures: A meta-analysis

ObjectiveMultiple treatment options for acetabular fractures in geriatric patients exist. However, no large-scale studies have reported the outcomes of acute total hip arthroplasty (THA) in this patient population. We systematically evaluated all available evidence to characterize clinical outcomes, complications, and revisions of acute THA for acetabular fractures in geriatric patients.MethodsMeta-analysis of 21 studies of 430 acetabular fractures with mean follow-up of 44 months (range, 17−97 months). Two independent researchers searched and evaluated the databases of Ovid, Embase, and United States National Library of Medicine using a Boolean search string up to December 2019. Population demographics and complications, including presence of heterotopic ossification (HO), dislocation, infection, revision rate, neurological deficits, and venous thromboembolic event (VTE), were recorded and analyzed.ResultsWeighted mean Harris Hip Score was 83.3 points, and 20% of the patients had reported complications. The most common complication was HO, with a rate of 19.5%. Brooker grade III and IV HO rates were lower at 6.8%. Hip dislocation occurred at a rate of 6.1%, 4.1% of patients developed VTE, deep infection occurred in 3.8%, and neurological complications occurred in 1.9%. Although the revision rate was described in most studies, we were unable to perform a survival analysis because the time to each revision was described in only a few studies. The revision rate was 4.3%.ConclusionsAcute THA is a viable option for treatment of acetabular fracture and can result in acceptable clinical outcomes and survivorship rates in older patients but with an associated complication rate of approximately 20%. Considering the limited treatment options, THA might be a viable alternative for appropriately selected patients.     

Predicting gait events from tibial acceleration in rearfoot running: A structured machine learning approach

BackgroundGait event detection of the initial contact and toe off is essential for running gait analysis, allowing the derivation of parameters such as stance time. Heuristic-based methods exist to estimate these key gait events from tibial accelerometry. However, these methods are tailored to very specific acceleration profiles, which may offer complications when dealing with larger data sets and inherent biological variability.Research questionCan a structured machine learning approach achieve a more accurate prediction of running gait event timings from tibial accelerometry, compared to the previously utilised heuristic approaches?MethodsForce-based event detection acted as the criterion measure in order to assess the accuracy, repeatability and sensitivity of the predicted gait events. 3D tibial acceleration and ground reaction force data from 93 rearfoot runners were captured. A heuristic method and two structured machine learning methods were employed to derive initial contact, toe off and stance time from tibial acceleration signals.ResultsBoth a structured perceptron model (median absolute error of stance time estimation: 10.00 ± 8.73 ms) and a structured recurrent neural network model (median absolute error of stance time estimation: 6.50 ± 5.74 ms) significantly outperformed the existing heuristic approach (median absolute error of stance time estimation: 11.25 ± 9.52 ms). Thus, results indicate that a structured recurrent neural network machine learning model offers the most accurate and consistent estimation of the gait events and its derived stance time during level overground running.SignificanceThe machine learning methods seem less affected by intra- and inter-subject variation within the data, allowing for accurate and efficient automated data output during rearfoot overground running. Furthermore offering possibilities for real-time monitoring and biofeedback during prolonged measurements, even outside the laboratory.     

Recanalization of Chronic Noncirrhotic,Nonmalignant Splanchnic Thromboses is Feasible: A Transsplenic Assisted Patient-Tailored Approach

The purpose of this study was to evaluate the feasibility of recanalization of chronic noncirrhotic, nonmalignant splanchnic thromboses with a transsplenic assisted patient-tailored approach with or without transjugular intrahepatic portosystemic shunt (TIPS) creation. In this retrospective study, 10 patients (median age, 48.4 years; interquartile range, 5.1 years) underwent revascularization between November 2016 and August 2020. Portal cavernoma was present in all patients, with complete splenic vein thrombosis in 70%. The technical success rate was 80%. Additional TIPS creation was performed in 5 (50%) patients. At a median follow-up of 19.3 months (interquartile range, 17.9 months), the primary and secondary patency rate was 70% and 100%, respectively. During follow-up, 1 patient died due to recurrent upper gastrointestinal variceal hemorrhage. In conclusion, percutaneous transsplenic assisted recanalization of chronic noncirrhotic, nonmalignant splanchnic thromboses is feasible. However, multiple access points may still be needed. Additional TIPS creation appears to be necessary only in case of insufficient portal venous flow into the liver.