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      Treatment adaptations and outcomes of patients experiencing inflammatory bowel disease flares during the early COVID‐19 pandemic: the PREPARE‐IBD multicentre cohort study

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          Summary

          Background

          The COVID‐19 pandemic offered a unique opportunity to understand inflammatory bowel disease (IBD) management during unexpected disruption. This could help to guide practice overall.

          Aims

          To compare prescribing behaviour for IBD flares and outcomes during the early pandemic with pre‐pandemic findings

          Methods

          We performed an observational cohort study comprising patients who contacted IBD teams for symptomatic flares between March and June 2020 in 60 National Health Service trusts in the United Kingdom. Data were compared with a pre‐pandemic cohort after propensity‐matching for age and physician global assessment of disease activity.

          Results

          We included 1864 patients in each of the pandemic and pre‐pandemic cohorts. The principal findings were reduced systemic corticosteroid prescription during the pandemic in Crohn's disease (prednisolone: pandemic 26.5% vs. 37.1%; p < 0.001) and ulcerative colitis (UC) (prednisolone: pandemic 33.5% vs. 40.7%, p < 0.001), with increases in poorly bioavailable oral corticosteroids in Crohn's (pandemic 15.6% vs. 6.8%; p < 0.001) and UC (pandemic 11.8% vs. 5.2%; p < 0.001). Ustekinumab (Crohn's and UC) and vedolizumab (UC) treatment also significantly increased. Three‐month steroid‐free remission in each period was similar in Crohn's (pandemic 28.4% vs. 32.1%; p = 0.17) and UC (pandemic 36.4% vs. 40.2%; p = 0.095). Patients experiencing a flare and suspected COVID‐19 were more likely to have moderately‐to‐severely active disease at 3 months than those with a flare alone.

          Conclusions

          Despite treatment adaptations during the pandemic, steroid‐free outcomes were comparable with pre‐pandemic levels, although concurrent flare and suspected COVID‐19 caused worse outcomes. These findings have implications for IBD management during future pandemics and for standard practice.

          Abstract

          PREPARE‐IBD—treatment adaptations to treat IBD flares during the COVID‐19 pandemic compared to an age‐ and disease activity‐matched pre‐pandemic cohort.

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          Most cited references33

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          Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

          Summary Background A recent cluster of pneumonia cases in Wuhan, China, was caused by a novel betacoronavirus, the 2019 novel coronavirus (2019-nCoV). We report the epidemiological, clinical, laboratory, and radiological characteristics and treatment and clinical outcomes of these patients. Methods All patients with suspected 2019-nCoV were admitted to a designated hospital in Wuhan. We prospectively collected and analysed data on patients with laboratory-confirmed 2019-nCoV infection by real-time RT-PCR and next-generation sequencing. Data were obtained with standardised data collection forms shared by WHO and the International Severe Acute Respiratory and Emerging Infection Consortium from electronic medical records. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Outcomes were also compared between patients who had been admitted to the intensive care unit (ICU) and those who had not. Findings By Jan 2, 2020, 41 admitted hospital patients had been identified as having laboratory-confirmed 2019-nCoV infection. Most of the infected patients were men (30 [73%] of 41); less than half had underlying diseases (13 [32%]), including diabetes (eight [20%]), hypertension (six [15%]), and cardiovascular disease (six [15%]). Median age was 49·0 years (IQR 41·0–58·0). 27 (66%) of 41 patients had been exposed to Huanan seafood market. One family cluster was found. Common symptoms at onset of illness were fever (40 [98%] of 41 patients), cough (31 [76%]), and myalgia or fatigue (18 [44%]); less common symptoms were sputum production (11 [28%] of 39), headache (three [8%] of 38), haemoptysis (two [5%] of 39), and diarrhoea (one [3%] of 38). Dyspnoea developed in 22 (55%) of 40 patients (median time from illness onset to dyspnoea 8·0 days [IQR 5·0–13·0]). 26 (63%) of 41 patients had lymphopenia. All 41 patients had pneumonia with abnormal findings on chest CT. Complications included acute respiratory distress syndrome (12 [29%]), RNAaemia (six [15%]), acute cardiac injury (five [12%]) and secondary infection (four [10%]). 13 (32%) patients were admitted to an ICU and six (15%) died. Compared with non-ICU patients, ICU patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα. Interpretation The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of disease need fulfilment by future studies. Funding Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission.
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            Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

            Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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              Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

              Abstract Background Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. Results A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). Conclusions In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)
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                Author and article information

                Contributors
                m.saifuddin@nhs.net
                Journal
                Aliment Pharmacol Ther
                Aliment Pharmacol Ther
                10.1111/(ISSN)1365-2036
                APT
                Alimentary Pharmacology & Therapeutics
                John Wiley and Sons Inc. (Hoboken )
                0269-2813
                1365-2036
                05 October 2022
                November 2022
                05 October 2022
                : 56
                : 10 ( doiID: 10.1111/apt.v56.10 )
                : 1460-1474
                Affiliations
                [ 1 ] London North West University Healthcare NHS Trust London UK
                [ 2 ] Department of Gastroenterology King's College Hospital NHS Foundation Trust London UK
                [ 3 ] Department of Gastroenterology Barts Health NHS Trust London UK
                [ 4 ] Department of Gastroenterology Imperial College Healthcare NHS Trust London UK
                [ 5 ] Department of Inflammatory Bowel Disease Hull University Teaching Hospitals NHS Trust Hull UK
                [ 6 ] Department of Gastroenterology University of Hull Hull UK
                [ 7 ] Department of Gastroenterology Royal Wolverhampton NHS Trust Wolverhampton UK
                [ 8 ] Faculty of Science and Engineering University of Wolverhampton Wolverhampton UK
                [ 9 ] Department of Gastroenterology Royal Liverpool and Broadgreen University Hospitals NHS Trust Liverpool UK
                [ 10 ] Department of Gastroenterology University of Liverpool Liverpool UK
                [ 11 ] Department of Gastrointestinal Medicine Queen Elizabeth Hospital Birmingham NHS Foundation Trust Birmingham UK
                [ 12 ] Institute of Applied Health Research, Institute of Translational Medicine University of Birmingham Birmingham UK
                [ 13 ] Department of Gastroenterology St George's University Hospitals NHS Foundation Trust London UK
                [ 14 ] Translational and Clinical Research Institute Newcastle University Newcastle upon Tyne UK
                [ 15 ] Department of Gastroenterology Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne UK
                [ 16 ] Department of Gastroenterology Torbay and South Devon NHS Foundation Trust Torquay UK
                [ 17 ] Department of Inflammatory Bowel Disease Royal Devon and Exeter NHS Foundation Trust Exeter UK
                [ 18 ] Exeter Inflammatory Bowel Disease and Pharmacogenetics Research Group University of Exeter Exeter UK
                Author notes
                [*] [* ] Correspondence

                Aamir Saifuddin, St. Mark's Hospital and Academic Institute, London North West University Healthcare NHS Trust, London HA1 3UJ, UK.

                Email: m.saifuddin@ 123456nhs.net

                Author information
                https://orcid.org/0000-0002-5888-5556
                https://orcid.org/0000-0003-0577-6177
                https://orcid.org/0000-0002-7002-293X
                https://orcid.org/0000-0002-3065-1635
                https://orcid.org/0000-0003-0559-0807
                https://orcid.org/0000-0002-9668-0316
                https://orcid.org/0000-0002-8782-0292
                https://orcid.org/0000-0002-6483-1730
                https://orcid.org/0000-0003-2502-1177
                https://orcid.org/0000-0002-0604-0770
                https://orcid.org/0000-0003-2611-4260
                https://orcid.org/0000-0002-7271-4956
                https://orcid.org/0000-0002-3883-8816
                https://orcid.org/0000-0003-4368-1961
                https://orcid.org/0000-0002-3670-6545
                Article
                APT17223 APT-0845-2022.R1
                10.1111/apt.17223
                9874879
                36196569
                19580820-b0e0-47c8-8270-7a28c0124afe
                © 2022 John Wiley & Sons Ltd.

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                : 06 July 2022
                : 20 May 2022
                : 05 September 2022
                Page count
                Figures: 7, Tables: 0, Pages: 15, Words: 9312
                Funding
                Funded by: Hull University Teaching Hospitals NHS Trust
                Categories
                Original Article
                IBD Flares and the Covid‐19 Pandemic
                Custom metadata
                2.0
                November 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.3 mode:remove_FC converted:25.01.2023

                Pharmacology & Pharmaceutical medicine
                Pharmacology & Pharmaceutical medicine

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