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A UK nationwide study of people with type 1 diabetes admitted to hospital with COVID-19 infection.
No full textAIMS/HYPOTHESIS
The aim of this work was to describe the clinical characteristics of adults with type 1 diabetes admitted to hospital and the risk factors associated with severe coronavirus disease-2019 (COVID-19) in the UK.
METHODS
A retrospective cohort study was performed using data collected through a nationwide audit of people admitted to hospital with diabetes and COVID-19, conducted by the Association of British Clinical Diabetologists from March to October 2020. Prespecified demographic, clinical, medication and laboratory data were collected from the electronic and paper medical record systems of the participating hospitals by local clinicians. The primary outcome of the study, severe COVID-19, was defined as death in hospital and/or admission to the adult intensive care unit (AICU). Logistic regression models were used to generate age-adjusted ORs.
RESULTS
Forty UK centres submitted data. The final dataset included 196 adults who were admitted to hospital and had both type 1 diabetes and COVID-19 on admission (male sex 55%, white 70%, with mean [SD] age 62 [19] years, BMI 28.3 [7.3] kg/m and last recorded HbA 76 [31] mmol/mol [9.1 (5.0)%]). The prevalence of pre-existing microvascular disease and macrovascular disease was 56% and 39%, respectively. The prevalence of diabetic ketoacidosis on admission was 29%. A total of 68 patients (35%) died or were admitted to AICU. The proportions of people that died were 7%, 38% and 38% of those aged <55, 55-74 and ≥75 years, respectively. BMI, serum creatinine levels and having one or more microvascular complications were positively associated with the primary outcome after adjusting for age.
CONCLUSIONS/INTERPRETATION
In people with type 1 diabetes and COVID-19 who were admitted to hospital in the UK, higher BMI, poorer renal function and presence of microvascular complications were associated with greater risk of death and/or admission to AICU. Risk of severe COVID-19 is reassuringly very low in people with type 1 diabetes who are under 55 years of age without microvascular or macrovascular disease. IN PEOPLE WITH TYPE 1 DIABETES AND COVID-19 ADMITTED TO HOSPITAL IN THE UK, BMI AND ONE OR MORE MICROVASCULAR COMPLICATIONS HAD A POSITIVE ASSOCIATION AND LOW SERUM CREATINE LEVELS HAD A NEGATIVE ASSOCIATION WITH DEATH/ADMISSION TO INTENSIVE CARE UNIT AFTER ADJUSTING FOR AGE
Publication output of National Health Service Bariatric centres in England.
No full textObesity has been identified as an independent risk factor for a wide range of health conditions. Therefore, there is a clear need for high quality Bariatric research in order to improve patient selection, outcomes and safety for patients with obesity. We sought to identify and compare the quantitative and qualitative publication output from Bariatric centres in England. We identified 42 National Health Service (NHS) Trusts and 162 surgeons providing Bariatric services in England. A median of 4 (range 1-7) Bariatric surgeons were identified per centre. Eight NHS Trusts (19%) and 75 surgeons (46.3%) had no Bariatric publications during the study period, while 87 surgeons published a total of 432 Bariatric papers. Only 15 surgeons (9%) had ≥10 publications within the study period. However, these surgeons produced >50% of all Bariatric publications. Departments with more than 4 surgeons produced a significantly higher number of Bariatric publications (median 8.5 vs 2, p = 0.01). There is significant variation in research contribution amongst Bariatric centres in England. Academia should be encouraged and promoted across all bariatric services in order to broaden our understanding on Bariatric outcomes by expanding the service and proportional increase in funding. Given that a number of health conditions can afflict individuals living with obesity, bariatric surgery research becomes all the more important
FeNO Non-Suppression Identifies Corticosteroid-Resistant Type-2 Signaling in Severe Asthma.
No full textRecurrence and survival following microwave, radiofrequency ablation, and hepatic resection of colorectal liver metastases: A systematic review and network meta-analysis.
No full textBACKGROUND
Gold standard for colorectal liver metastases (CRLM) remains hepatic resection (HR). However, patients with severe comorbidities, unresectable or deep-situated resectable CRLM are candidates for ablation. The aim of the study was to compare recurrence rate and survival benefit of the microwave ablation (MWA), radiofrequency ablation (RFA) and HR by conducting the first network meta-analysis.
DATA SOURCES
Systematic search of the literature was conducted in the electronic databases. Both updated traditional and network meta-analyses were conducted and the results were compared between them.
RESULTS
HR cohort demonstrated significantly less local recurrence rate and better 3- and 5-year disease-free (DFS) and overall survival (OS) compared to MWA and RFA cohorts. HR cohort included significantly younger patients and with significantly lower preoperative carcinoembryonic antigen (CEA) by 10.28 ng/mL compared to RFA cohort. Subgroup analysis of local recurrence and OS of solitary and ≤ 3 cm CRLMs did not demonstrate any discrepancies when compared with the whole sample.
CONCLUSIONS
For resectable CRLM the treatment of choice still remains HR. MWA and RFA can be used as a single or adjunct treatment in patients with unresectable CRLM and/or prohibitive comorbidities
Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials.
No full textBACKGROUND
The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4-12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered.
METHODS
We present data from three single-blind randomised controlled trials-one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)-and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005).
FINDINGS
Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more than 14 days after the second dose. Overall vaccine efficacy more than 14 days after the second dose was 66·7% (95% CI 57·4-74·0), with 84 (1·0%) cases in the 8597 participants in the ChAdOx1 nCoV-19 group and 248 (2·9%) in the 8581 participants in the control group. There were no hospital admissions for COVID-19 in the ChAdOx1 nCoV-19 group after the initial 21-day exclusion period, and 15 in the control group. 108 (0·9%) of 12 282 participants in the ChAdOx1 nCoV-19 group and 127 (1·1%) of 11 962 participants in the control group had serious adverse events. There were seven deaths considered unrelated to vaccination (two in the ChAdOx1 nCov-19 group and five in the control group), including one COVID-19-related death in one participant in the control group. Exploratory analyses showed that vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 after vaccination was 76·0% (59·3-85·9). Our modelling analysis indicated that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 (geometric mean ratio [GMR] 0·66 [95% CI 0·59-0·74]). In the participants who received two standard doses, after the second dose, efficacy was higher in those with a longer prime-boost interval (vaccine efficacy 81·3% [95% CI 60·3-91·2] at ≥12 weeks) than in those with a short interval (vaccine efficacy 55·1% [33·0-69·9] at <6 weeks). These observations are supported by immunogenicity data that showed binding antibody responses more than two-fold higher after an interval of 12 or more weeks compared with an interval of less than 6 weeks in those who were aged 18-55 years (GMR 2·32 [2·01-2·68]).
INTERPRETATION
The results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those seen in the interim analysis of the trials and confirm that the vaccine is efficacious, with results varying by dose interval in exploratory analyses. A 3-month dose interval might have advantages over a programme with a short dose interval for roll-out of a pandemic vaccine to protect the largest number of individuals in the population as early as possible when supplies are scarce, while also improving protection after receiving a second dose.
FUNDING
UK Research and Innovation, National Institutes of Health Research (NIHR), The Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca
Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population.
No full textSevere Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5-9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications
Erratum: Preoperative assessment for percutaneous and open surgical arteriovenous fistula creation in patients for haemodialysis.
No full text[This corrects the article DOI: 10.1093/ckj/sfz121.][This corrects the article DOI: 10.1093/ckj/sfz121.]
European Resuscitation Council Guidelines 2021: Executive summary.
No full textInformed by a series of systematic reviews, scoping reviews and evidence updates from the International Liaison Committee on Resuscitation, the 2021 European Resuscitation Council Guidelines present the most up to date evidence-based guidelines for the practice of resuscitation across Europe. The guidelines cover the epidemiology of cardiac arrest; the role that systems play in saving lives, adult basic life support, adult advanced life support, resuscitation in special circumstances, post resuscitation care, first aid, neonatal life support, paediatric life support, ethics and education
Raising the bar for Randomized Trials involving Artificial Intelligence: The SPIRIT-AI and CONSORT-AI Guidelines.
No full textArtificial intelligence (AI)-based applications have the potential to improve the quality and efficiency of patient care in dermatology. Unique challenges in the development and validation of these technologies may limit their generalizability and real-world applicability. Before widespread adoption of AI interventions, randomized trials should be conducted to evaluate their efficacy, safety, and cost effectiveness in clinical settings. The recent SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - AI extension) and CONSORT-AI (Consolidated Standards of Reporting Trials - AI extension) guidance provide recommendations for reporting the methods and results of trials involving AI interventions. High-quality trials will provide gold standard evidence to support the adoption of AI for the benefit of patient care
Editor's Choice - Fenestrated or Branched Endovascular versus Open Repair for Complex Aortic Aneurysms: Meta-Analysis of Time to Event Propensity Score Matched Data.
No full textOBJECTIVE
The aim of this review was to investigate comparative outcomes of fenestrated or branched endovascular aneurysm repair (F/BEVAR) with open repair for juxta/para/suprarenal or thoraco-abdominal aortic aneurysms.
METHODS
Electronic bibliographic sources (MEDLINE and Embase) were interrogated using the Healthcare Databases Advanced Search interface. Eligible studies compared F/BEVAR with open repair for complex aortic aneurysms using propensity score or Cox regression modelling/multivariable logistic regression analysis. Pooled estimates of peri-operative outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI). The result of time to event analysis was reported as summary hazard ratio (HR) and 95% CI. Random effects models and the inverse variance method were applied. The quality of evidence was graded using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group.
RESULTS
Eleven studies published between 2014 and 2019 were selected for inclusion in qualitative and quantitative synthesis reporting a total of at least 7 061 patients. The odds of peri-operative mortality after F/BEVAR were lower, although not significantly, than after open repair (OR 0.56, 95% CI 0.28-1.12), whereas the hazard of overall mortality during follow up was higher following F/BEVAR, but, again, without reaching statistical significance (HR 1.25, 95% CI 0.93-1.67). The hazard of re-intervention was significantly higher after endovascular therapy (HR 2.11, 95% CI 1.39-3.18). The certainty for the body of evidence for peri-operative and overall mortality during follow up was judged to be very low and moderate, respectively, and for re-intervention it was judged to be high.
CONCLUSION
The evidence is uncertain about the effect of F/BEVAR on peri-operative mortality when compared with open repair. There is probably no difference in overall survival, but F/BEVAR results in an increased re-intervention hazard. There is a need for high level evidence to inform decision making and vascular/aortic service provision