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No evidence of difference in mortality with amoxicillin versus co-amoxiclav for hospital treatment of community-acquired pneumonia.
OBJECTIVES: Current guidelines recommend broad-spectrum antibiotics for high-severity community-acquired pneumonia (CAP), potentially contributing to antimicrobial resistance (AMR). We aim to compare outcomes in CAP patients treated with amoxicillin (narrow-spectrum) versus co-amoxiclav (broad-spectrum), to understand if narrow-spectrum antibiotics could be used more widely. METHODS: We analysed electronic health records from adults (≥16 y) admitted to hospital with a primary diagnosis of pneumonia between 01-January-2016 and 30-September-2023 in Oxfordshire, United Kingdom. Patients receiving baseline ([-12 h,+24 h] from admission) amoxicillin or co-amoxiclav were included. The association between 30-day all-cause mortality and baseline antibiotic was examined using propensity score (PS) matching and inverse probability treatment weighting (IPTW) to address confounding by baseline characteristics and disease severity. Subgroup analyses by disease severity and sensitivity analyses with missing covariates imputed were also conducted. RESULTS: Among 16,072 admissions with a primary diagnosis of pneumonia, 9685 received either baseline amoxicillin or co-amoxiclav. There was no evidence of a difference in 30-day mortality between patients receiving initial co-amoxiclav vs. amoxicillin (PS matching: marginal odds ratio 0.97 [0.76-1.27], p = 0.61; IPTW: 1.02 [0.78-1.33], p = 0.87). Results remained similar across stratified analyses of mild, moderate, and severe pneumonia. Results were also similar with missing data imputed. There was also no evidence of an association between 30-day mortality and use of additional macrolides or additional doxycycline. CONCLUSIONS: There was no evidence of co-amoxiclav being advantageous over amoxicillin for treatment of CAP in 30-day mortality at a population-level, regardless of disease severity. Wider use of narrow-spectrum empirical treatment of moderate/severe CAP should be considered to curb potential for AMR.
The Effects of the Additional Roles Reimbursement Scheme (ARRS) staff in England on Prescription Patterns and Patient Satisfaction.
BACKGROUND: In 2019, the Additional Roles Reimbursement Scheme (ARRS) was introduced in England as a crucial component of the government's manifesto pledge to enhance access to general practice. The primary objective was to recruit 26,000 extra personnel through new roles into general practice. AIM: This study aimed to analyse the effects of ARRS staff on prescription rates and patient satisfaction. DESIGN AND SETTING: The study was a retrospective panel data analysis combining data from the General Workforce Minimum Dataset and National Health Service (NHS) Digital datasets about primary care practices and their activity from 2018 until 2022. The study included data from more than 6000 general practices. METHODS: A linear regression analysis was conducted to determine the association between ARRS staff and prescription rates and patient satisfaction, controlling for patient and practice characteristics. RESULTS: The results showed that ARSS roles tend to be more frequent in larger general practices, with fewer full-time general practitioners per patient, and with more overseas trained general practitioners. The use of ARRS staff was significantly associated with lower prescription rates (β=-0.52, p<0.000) and higher patient satisfaction (β=3.2, p<0.000), after controlling for patient and practice characteristics. CONCLUSION: This study suggests that ARRS has the potential to have a positive role in primary care, notably through reduced prescription rates and improved patient satisfaction. Further research is needed to explore the long-term effects of ARRS on primary care, including patient outcomes and health care costs, and the potential barriers to its implementation.
Artificial intelligence in orthopaedic surgery: transforming technological innovation in patient care and surgical training.
Artificial intelligence (AI) is an exciting field combining computer science with robust data sets to facilitate problem-solving. It has the potential to transform education, practice and delivery of healthcare especially in orthopaedics. This review article outlines some of the already used AI pathways as well as recent technological advances in orthopaedics. Additionally, this article further explains how potentially these two entities could be combined in the future to improve surgical education, training and ultimately patient care and outcomes.
Maintenance of hiPSC-derived Hepatocytes in a Perfusion Bioreactor Integrated with Stem Cell Hepatic Intuitive Apparatus
In clinical terms, end-stage liver disease is a group of liver diseases that includes advanced liver disease, liver failure, and decompensated cirrhosis. Liver transplantation has been the most effective treatment for cirrhosis. The limited number of available and suitable living liver donors is a significant limitation in liver transplantation. Acute or chronic rejection could be the cause of liver transplant failure. To overcome rejection, usage of the long-term immunosuppressive drug is a standard post-transplant regimen. However, this therapy can increase the risk of severe viral or fungal infection and malignancy. Various attempts were made to address the liver transplant shortage. One of them is liver tissue engineering. This research was conducted with an artificial liver prototype of Stem Cell Hepatic Intuitive Apparatus (SHiNTA) with a perfusion bioreactor, whose manufacturing process is simple in the form of a liver microstructure consisting of differentiated hepatocytes from an hiPSCs from a modification of the Blackford protocol in a liver biologic scaffold. Liver biologic scaffolds were made from pieces of rabbit liver stored in the Stem Cell and Tissue Engineering (SCTE) laboratory, Fakultas Kedokteran Universitas Indonesia, by decellularization. This study aimed to develop the SHiNTA BALs to sustain the viability of hiPSC-derived hepatocytes in the artificial liver prototype. SHiNTA artificial liver prototype with a perfusion bioreactor connected to a perfusion pump with a specific perfusion rate of 2mL/min showed a higher cell count and confluence, with evenly distributed in the extracellular matrix than SHiNTA blood bag with orbital shaker group up to day 7. Furthermore, the SHiNTA artificial liver with perfusion bioreactor showed a positive signal of cell maturation in the scaffold (ASGPR, HNF4-α, and CEBP-α) through immunofluorescence.
Changes in intestinal permeability and gut microbiota following diet-induced weight loss in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis.
Weight loss improves metabolic dysfunction-associated steatohepatitis (MASH). We investigated whether there were associated changes in intestinal permeability, short-chain fatty acids (SCFAs), and gut microbiota, which are implicated in the pathophysiology of MASH. Sixteen adults with MASH, moderate fibrosis, and obesity received a low-energy total diet replacement program for 12 weeks and stepped food re-introduction over the following 12 weeks (ISRCTN12900952). Intestinal permeability, fecal SCFAs, and fecal microbiota were assessed at 0, 12, and 24 weeks. Data were analyzed using mixed-effects linear regression and sparse partial least-squares regression. Fourteen participants completed the trial, lost 15% (95% CI: 11.2-18.6%) of their weight, and 93% had clinically relevant reductions in liver disease severity markers. Serum zonulin concentrations were reduced at both 12 and 24 weeks (152.0 ng/ml, 95% CI: 88.0-217.4, p p p
SIGNET: protocol for a multicentre, single-blind prospective, group sequential, randomised controlled trial to evaluate the benefits of a single dose of simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients.
INTRODUCTION: Successful organ transplantation in patients with end-stage organ failure improves long-term survival, improves quality of life and reduces costs to the NHS. Despite an increase in the number of deceased organ donors over the last decade, there remains a considerable shortfall of suitable organs available for transplantation. Over half of UK donors are certified dead by neurological criteria following brain stem compression, which leads to severe physiological stress in the donor, combined with a hyperinflammatory state. Brain stem death-related dysfunction is an important reason for poor organ function and hence utilisation. For example, more than 30% of donation after brain stem death cardiac transplant recipients need short-term mechanical cardiac support, reflecting donor heart dysfunction.A small, randomised study previously showed improved outcomes for cardiac transplant recipients if the donor was given simvastatin. SIGNET takes inspiration from that study and hypothesises a potential reduction in damage to the heart and other organs during the period after diagnosis of death and prior to organ retrieval in donors that receive simvastatin. METHODS AND ANALYSIS: SIGNET is a multicentre, single-blind, prospective, group sequential, randomised controlled trial to evaluate the benefits of a single high dose of simvastatin given to potential organ donors diagnosed dead by neurological criteria on outcomes in all organ recipients. The trial will run across a minimum of 89 UK sites with a recruitment target of 2600 donors over 4 years. ETHICS AND DISSEMINATION: SIGNET received a favourable opinion from the London, Queen Square Research Ethics Committee (Ref: 21/LO/0412) and following approval of substantial amendment 1 in January 2023, the current protocol is version 2 (7 December 2022). Substantial amendment 1 clarified consent procedures and added additional sites and prescribers. Findings from the study will be publicly available and disseminated locally and internationally through manuscript publications in peer-reviewed journals and conference presentations at national and international platforms. TRIAL REGISTRATION NUMBER: ISRCTN11440354.
Peri-operative administration of tranexamic acid in lower limb arthroplasty: a multicentre, prospective cohort study.
In the UK, tranexamic acid is recommended for all surgical procedures where expected blood loss exceeds 500 ml. However, the optimal dose, route and timing of administration are not known. This study aimed to evaluate current practice of peri-operative tranexamic acid administration. Patients undergoing primary total hip arthroplasty, total knee arthroplasty or unicompartmental knee arthroplasty during a 2-week period were eligible for inclusion in this prospective study. The primary outcome was the proportion of patients receiving tranexamic acid in the peri-operative period. Secondary outcomes included: dose, route and timing of tranexamic acid administration; prevalence of pre- and postoperative anaemia; estimated blood loss; and red blood cell transfusion rates. In total, we recruited 1701 patients from 56 NHS hospitals. Out of these, 1523 (89.5%) patients received tranexamic acid and of those, 1052 (69.1%) received a single dose of 1000 mg intravenously either pre- or intra-operatively. Out of the 1701 patients, 571 (33.6%) and 1386 (81.5%) patients were anaemic (haemoglobin
Complications following hip fracture: Results from the World Hip Trauma Evaluation cohort study.
INTRODUCTION: Hip fractures are common in people over 60 years of age, and are associated with significant disability, morbidity and mortality. The aim of this study was to record the incidence of complications in the first 120 days following hip fracture. METHODS: The World Hip Trauma Evaluation (WHiTE) study is a multicentre, prospective cohort study conducted in National Health Service (NHS) hospitals in England and Wales. Participants are 60 years and older who received operative treatment for a hip fracture. We report the incidence of complications recorded by hospital staff until discharge from hospital and by participants at 120-days post-surgery. RESULTS: An analysis of 8673 consecutive participants enrolled in the WHiTE study revealed the following risks of complications within the first 120 days: signs of wound infection (3.1%); dislocation (0.5%); failure of fixation (0.6%); peri‑prosthetic fracture (0.3%); overall revision surgery (0.9%); blood loss requiring transfusion (6.1%); chest infection (6.3%); urinary tract infection (5.0%); deep vein thrombosis/pulmonary embolus (1.8%); cerebrovascular accident (0.6%); acute coronary syndrome/myocardial infarction (0.6%); acute kidney injury (1.3%). CONCLUSION: The rates of complications reported here provide a reference range against which future studies might be assessed. Registration: ISRCTN63982700.
Service availability and readiness for hip fracture care in low- and middle-income countries in South and Southeast Asia.
AIMS: The aim of this study was to describe the current pathways of care for patients with a fracture of the hip in five low- and middle-income countries (LMIC) in South Asia (Nepal and Sri Lanka) and Southeast Asia (Malaysia, Thailand, and the Philippines). METHODS: The World Health Organization Service Availability and Readiness Assessment tool was used to collect data on the care of hip fractures in Malaysia, Thailand, the Philippines, Sri Lanka, and Nepal. Respondents were asked to provide details about the current pathway of care for patients with hip fracture, including pre-hospital transport, time to admission, time to surgery, and time to weightbearing, along with healthcare professionals involved at different stages of care, information on discharge, and patient follow-up. RESULTS: Responses were received from 98 representative hospitals across the five countries. Most hospitals were publicly funded. There was consistency in clinical pathways of care within country, but considerable variation between countries. Patients mostly travel to hospital via ambulance (both publicly- and privately-funded) or private transport, with only half arriving at hospital within 12 hours of their injury. Access to surgery was variable and time to surgery ranged between one day and more than five days. The majority of hospitals mobilized patients on the first or second day after surgery, but there was notable variation in postoperative weightbearing protocols. Senior medical input was variable and specialist orthogeriatric expertise was unavailable in most hospitals. CONCLUSION: This study provides the first step in mapping care pathways for patients with hip fracture in LMIC in South Asia. The previous lack of data in these countries hampers efforts to identify quality standards (key performance indicators) that are relevant to each different healthcare system.
The acute management of ankle fractures (Augment) study: A prospective trainee led national collaborative audit of the Boast 12 guidelines.
BACKGROUND: Ankle fractures are one of the most common fractures in adults aged 20-65 years. The British Orthopaedic Association (BOA) and British Orthopaedic Foot and Ankle Society (BOFAS) jointly produced Standards for Trauma (BOAST) BOAST 12, with the aim of reducing morbidity by standardising care of these injuries. The primary aim of the AUGMENT study was to determine the extent and clinical effect of variation from BOAST 12. METHODS: AUGMENT was a multi-centre prospective trainee led audit of consecutive patients presenting with an ankle fracture within a four-week period. Data were collected on patient demographics, comorbidities, management and 12-week outcome. The BOAST 12 standards were divided into four subgroups; documentation, imaging, management and follow-up. Percentage compliance with each subgroup was analysed. A multivariate logistic regression analysis was used to determine impact of overall compliance on likelihood of discharge in follow-up period. FINDINGS: 971 patients were included across 52 sites. The overall rate of BOAST 12 compliance was 41.7%. Variations in practice were observed in clinical documentation, especially of neurovascular status, (40.7%) and VTE assessment (61.5%). Patient management compliance with all 16 of the BOAST 12 standards was associated with a higher rate of discharge during the 12-week follow-up period (p = 0.005). CONCLUSION: AUGMENT has demonstrated that the management of ankle fractures is variable across the UK. Over half of patients had aspects of their care that were not BOAST 12 compliant. When compliance was observed, it was associated with earlier discharge from orthopaedic care.
Timing of Surgery for Hip Fracture in Patients on Direct Oral Anti-coagulants: A Population-Based Cohort Study.
BACKGROUND: In patients with hip fracture on direct oral anti-coagulants (DOACs), timely surgery is important in optimising outcomes but the safety of early surgery is unclear. This study aims to evaluate the timing of surgery on peri- and post-operative outcomes in patients with hip fracture on DOAC therapy. METHODS: Single-centre, retrospective, population-based cohort study of patients on DOAC therapy compared to standard care with low-molecular-weight heparin (LMWH) undergoing surgery for hip fracture. Data obtained: patient demographics, fracture classification, American Society of Anaesthesiologists (ASA) classification, time to surgery, procedure performed, type of DOAC, timing of last DOAC dose, use of reversal agents or pro-coagulants and length of stay. Outcomes assessed: pre- and post-operative haemoglobin levels, incidence of blood transfusion, major haemorrhage, venous thromboembolism (VTE) and death within 30 days of surgery. RESULTS: A total of 755 patients were included. Compared to standard treatment, DOAC use was associated with a similar change in pre- and post-operative haemoglobin levels (P = .90), risk of blood transfusion (RR: 1.04, 95% CI: .70-1.54, P = .84), haemorrhage (RR: 1.51, 95% CI: .53-4.28, P = .44), VTE (RR: .92, 95% CI: .12-7.20, P = .94) and mortality (RR: 1.85, 95% CI: .89-3.84, P = .10), all of which were independent of the timing of surgery. CONCLUSION: This study builds on growing evidence that surgery for hip fracture in patients on DOAC therapy is not associated with an excessive risk of haemorrhage, irrespective of the timing of surgery. Timely surgical fixation of the hip fracture in this population is indicated in the absence of other risk factors for haemorrhage.
Direct Oral Anticoagulants in the Prevention of Venous Thromboembolism Following Surgery for Hip Fracture in Older Adults: A Population-Based Cohort Study.
INTRODUCTION: Direct oral anticoagulants (DOACs) decrease the risk of venous thromboembolism (VTE) without increasing the risk of hemorrhage in elective lower limb orthopedic surgery. However, the role of DOACs in preventing VTE following hip fracture surgery in the older adults remains unclear. This study aims to evaluate the efficacy and safety of DOACs in older adults undergoing surgery for hip fracture. MATERIALS AND METHODS: Single-center, retrospective, population-based cohort study of patients receiving either a DOAC or low-molecular-weight heparin (LMWH) for VTE prophylaxis following hip fracture surgery. Data obtained included patient demographics, comorbidities, fracture classification, time to surgery, procedure performed, and length of stay. Main outcomes assessed were incidence of VTE, incidence of major hemorrhage, and death within 30 days of surgery. RESULTS: A total of 321 patients were included. Incidence of VTE was 0% in the DOAC group and 3.4% in the LMWH group (risk ratio [RR]:0.26, 95% confidence interval [CI]: 0.02-4.34, P = .35). Hemorrhage occurred in 7.4% and 3.0% of patients in the DOAC and LMWH groups, respectively (RR: 2.47, 95% CI: 0.77-7.91, P = .13). Mortality from VTE was 0% in the DOAC group and 0.7% in the LMWH group (RR: 0.97, 95% CI: 0.05-20.02, P = .99). Mortality from hemorrhage was 1.9% in the DOAC group and 0.7% in the LMWH group (RR: 2.47, 95% CI: 0.23-26.78, P = .46). DISCUSSION: The use of DOACs for VTE prophylaxis following surgery in older adults with hip fracture was associated with a similar rate of VTE compared to LMWH. However, there was a worrying trend toward an increased risk of hemorrhage. CONCLUSION: In the present study of a carefully selected cohort of patients, the effect of DOACs in reducing the risk of VTE following surgery for hip fracture in the older adults was comparable to LMWH. However, a trend toward increased risk of hemorrhage was noted. Larger prospective studies will be required to identify patients who will benefit the most from treatment.
The role of joint distraction in the treatment of knee osteoarthritis: a systematic review and quantitative analysis.
INTRODUCTION: Knee osteoarthritis is a major cause of pain and disability for which joint distraction is a potential treatment to delay the need for knee arthroplasty. This systematic review aims to assess the short- and long-term clinical and structural outcomes following knee joint distraction (KJD). METHODS: MEDLINE, EMBASE, Scopus, and Web of Science databases were searched from the date of inception to 26th June 2019. Clinical studies investigating joint distraction for knee osteoarthritis with outcomes including ∆WOMAC index, ∆VAS pain score, and ∆joint space width were included. The review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) - CRD42018087032. RESULTS: Nine studies comprising a total of 507 patients were included. There were four randomized controlled trials (RCTs), five open prospective cohort studies, and one case series. Overall, there were significant improvements in WOMAC index, VAS pain score and joint space width following KJD, which persisted up to 9 years. KJD also demonstrated comparable clinical outcomes with high tibial osteotomy and total knee arthroplasty. CONCLUSION: There is moderate quality evidence supporting the beneficial outcomes of joint distraction for knee osteoarthritis. Larger RCTs with longer follow-up (>1 year) are necessary to establish the true effect size of this procedure.