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Development and validation of multivariable prediction models for adverse COVID-19 outcomes in patients with IBD

Por: Sperger · J. · Shah · K. S. · Lu · M. · Zhang · X. · Ungaro · R. C. · Brenner · E. J. · Agrawal · M. · Colombel · J.-F. · Kappelman · M. D. · Kosorok · M. R.
Objectives

Develop an individualised prognostic risk prediction tool for predicting the probability of adverse COVID-19 outcomes in patients with inflammatory bowel disease (IBD).

Design and setting

This study developed and validated prognostic penalised logistic regression models using reports to the international Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease voluntary registry from March to October 2020. Model development was done using a training data set (85% of cases reported 13 March–15 September 2020), and model validation was conducted using a test data set (the remaining 15% of cases plus all cases reported 16 September–20 October 2020).

Participants

We included 2709 cases from 59 countries (mean age 41.2 years (SD 18), 50.2% male). All submitted cases after removing duplicates were included.

Primary and secondary outcome measures

COVID-19 related: (1) Hospitalisation+: composite outcome of hospitalisation, ICU admission, mechanical ventilation or death; (2) Intensive Care Unit+ (ICU+): composite outcome of ICU admission, mechanical ventilation or death; (3) Death. We assessed the resulting models’ discrimination using the area under the curve of the receiver operator characteristic curves and reported the corresponding 95% CIs.

Results

Of the submitted cases, a total of 633 (24%) were hospitalised, 137 (5%) were admitted to the ICU or intubated and 69 (3%) died. 2009 patients comprised the training set and 700 the test set. The models demonstrated excellent discrimination, with a test set area under the curve (95% CI) of 0.79 (0.75 to 0.83) for Hospitalisation+, 0.88 (0.82 to 0.95) for ICU+ and 0.94 (0.89 to 0.99) for Death. Age, comorbidities, corticosteroid use and male gender were associated with a higher risk of death, while the use of biological therapies was associated with a lower risk.

Conclusions

Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of patients with IBD. A free online risk calculator (https://covidibd.org/covid-19-risk-calculator/) is available for healthcare providers to facilitate discussion of risks due to COVID-19 with patients with IBD.

Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH)

Por: Brennan · P. N. · MacMillan · M. · Manship · T. · Moroni · F. · Glover · A. · Graham · C. · Semple · S. · Morris · D. M. · Fraser · A. R. · Pass · C. · McGowan · N. W. A. · Turner · M. L. · Lachlan · N. · Dillon · J. F. · Campbell · J. D. M. · Fallowfield · J. A. · Forbes · S. J.
Introduction

Liver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.

Methods and analysis

The efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.

Ethics and dissemination

The trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.

Trial registration numbers

ISRCTN10368050 and EudraCT; reference 2015-000963-15

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial

Por: Subhani · M. · Jones · K. A. · Sprange · K. · Rennick-Egglestone · S. · Knight · H. · Morling · J. R. · Enki · D. G. · Wragg · A. · Ryder · S. D.
Introduction

Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review suggested providing feedback to patients based on markers of liver injury can be an effective way to reduce harmful alcohol intake. This randomised control trial (RCT) aims to establish the feasibility of conducting a larger national trial to test the effectiveness of FibroScan advice and Alcohol Recovery Video Stories (ARVS) in changing high-risk drinking behaviour in community alcohol services common to UK practice.

Methods and analysis

This feasibility trial consists of three work packages (WP). WP1: To draft a standardised script for FibroScan operators to deliver liver disease-specific advice to eligible participants having FibroScan. WP2: To create a video library of ARVS for use in the feasibility RCT (WP3). WP3: To test the feasibility of the trial design, including the FibroScan script and video stories developed in WP1 and WP2 in a one-to-one individual randomised trial in community alcohol services. Semi-structured interviews will be conducted at 6 months follow-up for qualitative evaluation. Outcomes will be measures of the feasibility of conducting a larger RCT. These outcomes will relate to: participant recruitment and follow-up, intervention delivery, including the use of the Knowledge of LIver Fibrosis Affects Drinking trial FibroScan scripts and videos, clinical outcomes, and the acceptability and experience of the intervention and trial-related procedures. Data analysis will primarily be descriptive to address the feasibility aims of the trial. All proposed analyses will be documented in a Statistical Analysis Plan.

Ethics and dissemination

This trial received favourable ethical approval from the West of Scotland Research Ethics Service (WoSRES) on 20 January 2021, REC reference: 20/WS/0179. Results will be submitted for publication to a peer-reviewed journal.

Trial registration number

ISRCTN16922410.

Efficacy of anti-TNF dosing interval lengthening in adolescents and young adults with inflammatory bowel disease in sustained remission (FREE-study): protocol for a partially randomised patient preference trial

Por: Bouhuys · M. · Lexmond · W. S. · Dijkstra · G. · Lobaton · T. · Louis · E. · van Biervliet · S. · Groen · H. · Guardiola · J. · Rheenen · P. v.
Introduction

Anti-tumour necrosis factor (TNF) therapy has greatly improved treatment outcomes in patients with inflammatory bowel disease (IBD), but long-term use is associated with cutaneous reactions, susceptibility to infections and frequent injections or hospital visits. Several non-controlled studies have demonstrated that dose reduction is feasible for a subset of patients, provided that early detection of a disease flare is possible. Here, we aim to compare the effectiveness of interval lengthening with standard dosing in maintaining remission in young patients with IBD.

Methods and analysis

In this international, prospective, non-inferiority, partially randomised patient preference trial, we aim to recruit 148 patients aged 12–25 years with luminal Crohn’s disease or ulcerative colitis in sustained remission (ie, three consecutive in-range faecal calprotectin (FC) results or recently confirmed endoscopic remission). In the interventional arm, the dosing interval will be lengthened from 8 to 12 weeks for infliximab users and from 2 to 3 weeks for adalimumab users. In the control group, standard dosing will be continued. Rapid tests will be performed for FC every 4 weeks and for anti-TNF trough levels every 12 weeks. The primary outcome is the cumulative incidence of out-of-range FC results at 48-week follow-up. Secondary endpoints include time to get out-of-range FC results, cumulative incidence of adverse effects, proportion of patients progressing to loss of response and identification of predictors of successful interval lengthening.

Ethics and dissemination

The protocol has been approved by the Medical Ethics Review Committee of the University Medical Centre Groningen and is pending at the other participating centres. Results will be disseminated in peer-reviewed journals and presented at scientific meetings.

Trial registration number

EudraCT number: 2020-001811-26; ClinicalTrials.gov Identifier: NCT04646187. Protocol version 4, date 17 September 2021.

Aetiology and risk factors of bacterial gastroenteritis among febrile outpatients at the Dschang District Hospital, West Region of Cameroon: a cross-sectional study

Por: Ousenu · K. · Sama · L. F. · Ali · I. M. · Fonbah · J. L. · Nadine · O. S. · Dabou · S. · Tume · C.
Objectives

To investigate the bacterial aetiologies and associated risk factors of gastroenteritis among typhoid suspected cases.

Design

Cross-sectional study.

Setting

This study was conducted at Dschang District Hospital of the Menoua Division, West Region of Cameroon, between April–November 2019 and June 2020.

Participants

Participants aged ≥2 years (mean 34±18.77 years) and of both sex suspected of having typhoid fever were included, while non-suspected typhoid cases were excluded. Self-reported sociodemographic and health information at recruitment was obtained from 556 participants.

Methods

Collected stool samples were examined macroscopically and microscopically and subjected to culture. After culture, Gram staining was performed, followed by biochemical testing and characterisation using the Analytical Profile Index (API-20E) test kit.

Interventions’

No intervention was done during the period of study.

Outcome measures

We identified bacterial causing gastroenteritis, and associated risk factors calculated using binary regression, adjusting for sociodemographic and health variables.

Results

Of 556 patients, 74.28% tested positive for gastroenteritis. Among pathogens responsible for gastroenteritis, Escherichia coli was found to be the main cause (21.1%), followed by Salmonella typhi (10.4%), Citrobacter diversus (8.2%), and Proteus mirabilis (8.2%), Proteus vulgaris (7.3%), whereas Citrobacter spp and Yersinia enterocolitica were less represented among pathogens causing the disease among patients. A significant difference (p=0.002) was observed between abdominal pain and all the micro-organisms isolated from the patients. Patients having primary level of education were significantly associated (p=0.017; 3.163 (95% CI 1.228 to 8.147)) with the prevalence of gastroenteritis. Consumption of beverages (Wald statistic: 4.823; OR: 2.471; 95% CI (1.102 to 5.539); p=0.028), use of modern toilet (Wald statistic: 4.471; OR: 1.723; 95% CI (1.041 to 2.852); p=0.034) were strongly associated with gastroenteritis and rearing of bird (Wald statistic: 4.880; OR: 0.560; 95% CI (0.335 to 0.937); p=0.027), was found to be protective.

Conclusion

Acute bacterial gastroenteritis is a significant cause of morbidity in Dschang, with the prevalence of 74.28%. Many pathogens accounted for gastroenteritis, and E. coli (21.1%) could be a major cause, followed by S. typhi (10.4%), C. diversus (8.2%), P. mirabilis (8.2%), P. vulgaris (7.3%), whereas Citrobacter spp and Y. enterocolitica were less represented. Gastroenteritis was highly associated with primary level of education, consumption of beverages, use of modern toilet while rearing of birds was unexpectedly found to be protective against Gastroenteritis. Further characterisation is planned.

Impact of early life nutrition on gut health in children: a prospective clinical study

Por: Ley · D. · Beghin · L. · Morcel · J. · Flamein · F. · Garabedian · C. · Accart · B. · Drumez · E. · Labreuche · J. · Gottrand · F. · Hermann · E.
Introduction

The first 1000 days of life could contribute to individual susceptibility to the later development of chronic non-communicable diseases. Nutrition in early life appears to be an important determinant factor for a sustainable child’s health. In this study, we propose to investigate the impact of exclusive breast feeding on gut health in children.

Methods and analysis

A prospective cohort of newborns (n=350) will be recruited at birth and followed up to 4 years of age. The main objective is to evaluate the link between exclusive breast feeding for at least 3 months and the gut health of the child at 4 years. The primary endpoint of assessment of gut health will be based on the non-invasive measurement of faecal secretory IgA (sIgA) as a sensitive biomarker of the intestinal ecosystem. The presence of gastrointestinal disorders will be defined according to the clinical criteria of Rome IV. Information on parent’s nutritional habits and life style, breastfeeding duration and child’s complementary feeding will be collected along the follow-up. Cord blood cells and plasma at birth will be purified for further analysis. The meconium and stools collected at birth, 6 months, 2 years and 4 years of age will allow sIgA analysis.

Ethics and dissemination

This clinical study has obtained the approval from the national ethical committee. We plan to publish the results of the study in peer-review journals and by means of national and international conference.

Trial registration number

NCT04195425.

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