Summary Background Since December, 2019, Wuhan, China, has experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Epidemiological and clinical characteristics of patients with COVID-19 have been reported but risk factors for mortality and a detailed clinical course of illness, including viral shedding, have not been well described. Methods In this retrospective, multicentre cohort study, we included all adult inpatients (≥18 years old) with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China) who had been discharged or had died by Jan 31, 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. We used univariable and multivariable logistic regression methods to explore the risk factors associated with in-hospital death. Findings 191 patients (135 from Jinyintan Hospital and 56 from Wuhan Pulmonary Hospital) were included in this study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p Interpretation The potential risk factors of older age, high SOFA score, and d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future. Funding Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Science Grant for Distinguished Young Scholars; National Key Research and Development Program of China; The Beijing Science and Technology Project; and Major Projects of National Science and Technology on New Drug Creation and Development.

Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1001885&type=printable

[The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement].

The Clinical Practice Research Datalink (CPRD) is an ongoing primary care database of anonymised medical records from general practitioners, with coverage of over 11.3 million patients from 674 practices in the UK. With 4.4 million active (alive, currently registered) patients meeting quality criteria, approximately 6.9% of the UK population are included and patients are broadly representative of the UK general population in terms of age, sex and ethnicity. General practitioners are the gatekeepers of primary care and specialist referrals in the UK. The CPRD primary care database is therefore a rich source of health data for research, including data on demographics, symptoms, tests, diagnoses, therapies, health-related behaviours and referrals to secondary care. For over half of patients, linkage with datasets from secondary care, disease-specific cohorts and mortality records enhance the range of data available for research. The CPRD is very widely used internationally for epidemiological research and has been used to produce over 1000 research studies, published in peer-reviewed journals across a broad range of health outcomes. However, researchers must be aware of the complexity of routinely collected electronic health records, including ways to manage variable completeness, misclassification and development of disease definitions for research.

Data Resource Profile: Clinical Practice Research Datalink (CPRD)

https://www.journal-of-hepatology.eu/article/S0168-8278(18)32388-2/pdf

Burden of liver diseases in the world

A total of 225 patients assigned to the restrictive strategy (51%), as compared with 61 assigned to the liberal strategy (14%), did not receive transfusions (P<0.001). The probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group (95% vs. 91%; hazard ratio for death with restrictive strategy, 0.55; 95% confidence interval [CI], 0.33 to 0.92; P = 0.02). Further bleeding occurred in 10% of the patients in the restrictive-strategy group as compared with 16% of the patients in the liberal-strategy group (P = 0.01), and adverse events occurred in 40% as compared with 48% (P = 0.02). The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer (hazard ratio, 0.70; 95% CI, 0.26 to 1.25) and was significantly higher in the subgroup of patients with cirrhosis and Child–Pugh class A or B disease (hazard ratio, 0.30; 95% CI, 0.11 to 0.85), but not in those with cirrhosis and Child–Pugh class C disease (hazard ratio, 1.04; 95% CI, 0.45 to 2.37). Within the first 5 days, the portal-pressure gradient increased significantly in patients assigned to the liberal strategy (P = 0.03) but not in those assigned to the restrictive strategy. Conclusions As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. (Funded by Fundacio Investigacio Sant Pau; ClinicalTrials.gov number, NCT00414713.)

/pdf/transfusion-strategies-for-acute-upper-gastrointestinal-4cve0qnwwf.pdf

Transfusion strategies for acute upper gastrointestinal bleeding.

<h3>Background</h3> Upper gastrointestinal bleed (UGIB) is the most common acute medical emergency seen by gastroenterologists in the UK. <h3>Methods</h3> A population-based nationwide data analysis was carried out using Hospital Episode Statistics data and Office for National Statistics data from March 2012 to March 2021. Data from 2021 has been merged with 2020 data, hence will be referred to as 2020 data. Patients in England with ICD-10 codes relating to UGIB were included. Statistical management and analysis were carried out with RStudio software. Rates were calculated and Poisson Distribution Model was used to calculate 95% Confidence Intervals (CI). Hospitalisations and trends in each year were stratified by age and gender. Incidence rate ratios of UGIB hospitalization were adjusted for age, gender and year using the Poisson Regression Model. <h3>Results</h3> All 4 subgroups analysed (melena, haematemesis, ulcer and variceal) portrayed different trends from 2012 to 2019, but total codes decreased by 19% from 2019 to 2020. While variceal codes had the lowest percentage decrease, 12.1% from 2019 to 2020, ulcer codes had the highest percentage decrease, 22.2% from 2019 to 2020. Overall, males presented with up to 1.8 times higher hospitalisation rates than females. In melena, haematemesis and ulcer subgroups 65+ age group had the highest rates throughout the 9-year study period, with rates per 100,000 of 403.43 (95% CI: 402.11, 404.76), 354.68 (353.44, 355.93), and 153.07 (152.26, 153.89) respectively. After adjusting for confounders (age, gender, and years), the trends previously described did not change. Hence, these covariates did not impact the decline in UGIB hospital admissions observed from 2019 to 2020. <h3>Conclusion</h3> To our knowledge, this is the first nation-wide cohort study to analyse UGIB hospital admission throughout the COVID-19 pandemic. We hypothesise that the decrease in UGIB hospitalisations is associated with a decrease in endoscopic procedures performed as well as an increase in fear of being hospitalised. However, since UGIB is an acute presentation and no risk factors decreased to this extent during the pandemic, we predict that hospital admissions decreased but not overall UGIB presentation rates. Therefore, as stated in previous literature, we anticipate a rebound period where UGIB presentations will increase as previously minor bleeds will likely require urgent medical attention. 

P325 Upper gastrointestinal haemorrhages and COVID-19: a nationwide cohort study of the pandemic’s impact on hospitalisations

Reply: To PMID 23470619.

<h3>Introduction</h3> <i>Helicobacter pylori</i> (H. pylori) may be pivotal in the pathogenesis of upper gastrointestinal (UGI) ulcer bleeding from aspirin therapy. The Helicobacter Eradication Aspirin Trial (HEAT) investigated whether <i>H. pylori</i> eradication reduces the risk of UGI ulcer bleeding in aspirin users. <h3>Methods</h3> HEAT was conducted using novel real-world methodology developed by the Simple Trials for Academic Research (STAR) group. Participants aged over 60 and taking aspirin ≤325mg daily for at least 4 months were recruited from primary care between 2012 and 2017. <i>H. pylori</i> positive participants were randomised to receive 7 days of eradication treatment (lansoprazole 30mg bd, clarithromycin 500mg bd and metronidazole 400mg bd) or matching placebos. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. It identified all suitable patients and automatically sent trial information and an invitation to participate. Effectiveness of <i>H. pylori</i> eradication was evaluated in a prospectively selected 10% sample by end of trial breath testing. Electronic follow up identified events in Hospital Episodes Statistics (HES), GP databases and patient reports. All episodes mentioning GI bleeding or peptic ulcer were evaluated by a blinded adjudication committee. The primary endpoint was a first hospitalisation due to definite or probable peptic ulcer bleeding, analysed using a Cox proportional hazards model. Data are still blinded and presented as Group A and B. <h3>Results</h3> In total, 1,208 GP practices across the UK sent 188,875 invitation letters; 30,166 patients were consented to the trial, of whom 5,353 <i>H</i><i>. pylori</i> positive participants (17.8%) were randomised. Mean age at consent was 73.6 ± 7.0 (SD) years and 72.1% of participants were male. In the 10% retest subjects 90.7% had become <i>H. pylori</i> negative in Group A vs 24.3% in Group B. The rate of presentation of UGI ulcer bleeding varied significantly by time. The rate of presentation varied significantly by time. Events occurred most frequently in the first 2–3 years of follow up in Group B when there appeared to be a significant difference between the groups. Fully analysed data will be available for presentation to the meeting <h3>Conclusions</h3> Very large-scale real-world trials of clinical importance, such as <i>H. pylori</i> eradication in aspirin users can be successfully conducted in primary care using STAR methodology. 

O3 Large-scale helicobacter pylori (H. pylori) eradication aspirin trial (HEAT): results of a real-world outcomes study

We thank M.J. Tobin and A. Jubran for their interest in our data [1]. As they state, it is an extension of a body of work that they helped establish over 30 years ago. Inaccuracy of pulse oximetry measurements of oxygen saturation in darker-skinned individuals https://bit.ly/3rVzRpN

Colin J Crooks

Papers

P325 Upper gastrointestinal haemorrhages and COVID-19: a nationwide cohort study of the pandemic’s impact on hospitalisations

Reply: To PMID 23470619.

O3 Large-scale helicobacter pylori (H. pylori) eradication aspirin trial (HEAT): results of a real-world outcomes study

Reply to: Inaccuracy of pulse oximetry in darker-skinned patients is unchanged across 32 years

Haemphagocytic Lymphohistiocytosis in an English Nationwide Cohort Confirms Increasing Incidence and Variation in Trigger Factors