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Protocol for the PATHOME study: a cohort study on urban societal development and the ecology of enteric disease transmission among infants, domestic animals and the environment

Por: Baker · K. K. · Simiyu · S. · Busienei · P. · Gutema · F. D. · Okoth · B. · Agira · J. · Amondi · C. S. · Ziraba · A. · Kapanka · A. G. · Osinuga · A. · Ouma · C. · Sewell · D. K. · Gaire · S. · Tumwebaze · I. K. · Mberu · B.
Introduction

Global morbidity from enteric infections and diarrhoea remains high in children in low-income and middle-income countries, despite significant investment over recent decades in health systems and water and sanitation infrastructure. Other types of societal development may be required to reduce disease burden. Ecological research on the influence of household and neighbourhood societal development on pathogen transmission dynamics between humans, animals and the environment could identify more effective strategies for preventing enteric infections.

Methods and analysis

The ‘enteric pathome’—that is, the communities of viral, bacterial and parasitic pathogens transmitted from human and animal faeces through the environment is taxonomically complex in high burden settings. This integrated cohort-exposure assessment study leverages natural socioeconomic spectrums of development to study how pathome complexity is influenced by household and neighbourhood infrastructure and hygiene conditions. We are enrolling under 12-month-old children in low-income and middle-income neighbourhoods of two Kenyan cities (Nairobi and Kisumu) into a ‘short-cohort’ study involving repeat testing of child faeces for enteric pathogens. A mid-study exposure assessment documenting infrastructural, behavioural, spatial, climate, environmental and zoonotic factors characterises pathogen exposure pathways in household and neighbourhood settings. These data will be used to inform and validate statistical and agent-based models (ABM) that identify individual or combined intervention strategies for reducing multipathogen transmission between humans, animals and environment in urban Kenya.

Ethics and dissemination

The protocols for human subjects’ research were approved by Institutional Review Boards at the University of Iowa (ID-202004606) and AMREF Health Africa (ID-ESRC P887/2020), and a national permit was obtained from the Kenya National Commission for Science Technology and Innovation (ID# P/21/8441). The study was registered on Clinicaltrials.gov (Identifier: NCT05322655) and is in pre-results stage. Protocols for research on animals were approved by the University of Iowa Animal Care and Use Committee (ID 0042302).

Association between preterm delivery and subsequent maternal risk of hypertension and type 2 diabetes mellitus in a UK population-based retrospective cohort study

Por: Song · A. · Okoth · K. · Adderley · N. J.
Objectives

Women with a history of preterm delivery (PTD) are at higher risk of developing cardiovascular diseases (CVD) later in life. However, it is not well established whether PTD is associated with CVD risk factors, hypertension and type 2 diabetes mellitus (T2DM). Therefore, in this study, we examined the associations between PTD compared with term delivery and subsequent risk of hypertension and T2DM.

Design

Retrospective matched population-based open cohort study.

Setting

Clinical Practice Research Datalink GOLD data in the UK.

Participants

A total of 3335 18–49-year-old women with preterm delivery were matched by age and region to 12 634 without a record of preterm delivery.

Primary outcome measures

Outcomes of interest were newly diagnosed hypertension or T2DM at least 6 months after delivery. During the study period (January 2000–December 2019), hypertension or T2DM events in the medical records of women with (exposed) and without (unexposed) preterm delivery were compared. HR and 95% CI were estimated using Cox proportional hazards models adjusted for potential confounders.

Results

Over a median follow-up period of 5.11 (IQR 2.15–9.56) years, the HRs for hypertension in women who delivered preterm compared with women who delivered at term were 1.42 (95%CI 1.09 to 1.80) and 1.18 (95%CI 0.90 to 1.56) in the unadjusted and adjusted models, respectively. For T2DM, over a median follow-up period of 5.17 (IQR 2.18–9.67) years, the HRs in women who delivered preterm compared with those who delivered at term were 1.67 (95%CI 1.12 to 2.48) and 1.10 (95%CI 0.72 to 1.68) in the unadjusted and adjusted models, respectively.

Conclusion

We found no independent effect of preterm delivery on risk of hypertension or type 2 diabetes in this study. While significant associations were observed in unadjusted analyses, associations were lost after adjustment and may be attributable to other reproductive complications. Additional studies are needed to confirm these findings.

Angiotensin II in liver transplantation (AngLT-1): protocol of a randomised, double-blind, placebo-controlled trial

Por: Bokoch · M. P. · Tran · A. T. · Brinson · E. L. · Marcus · S. G. · Reddy · M. · Sun · E. · Roll · G. R. · Pardo · M. · Fields · S. · Adelmann · D. · Kothari · R. P. · Legrand · M.
Introduction

Catecholamine vasopressors such as norepinephrine are the standard drugs used to maintain mean arterial pressure during liver transplantation. At high doses, catecholamines may impair organ perfusion. Angiotensin II is a peptide vasoconstrictor that may improve renal perfusion pressure and glomerular filtration rate, a haemodynamic profile that could reduce acute kidney injury. Angiotensin II is approved for vasodilatory shock but has not been rigorously evaluated for treatment of hypotension during liver transplantation. The objective is to assess the efficacy of angiotensin II as a second-line vasopressor infusion during liver transplantation. This trial will establish the efficacy of angiotensin II in decreasing the dose of norepinephrine to maintain adequate blood pressure. Completion of this study will allow design of a follow-up, multicentre trial powered to detect a reduction of organ injury in liver transplantation.

Methods and analysis

This is a double-blind, randomised clinical trial. Eligible subjects are adults with a Model for End-Stage Liver Disease Sodium Score ≥25 undergoing deceased donor liver transplantation. Subjects are randomised 1:1 to receive angiotensin II or saline placebo as the second-line vasopressor infusion. The study drug infusion is initiated on reaching a norepinephrine dose of 0.05 µg kg-1 min-1 and titrated per protocol. The primary outcome is the dose of norepinephrine required to maintain a mean arterial pressure ≥65 mm Hg. Secondary outcomes include vasopressin or epinephrine requirement and duration of hypotension. Safety outcomes include incidence of thromboembolism within 48 hours of the end of surgery and severe hypertension. An intention-to-treat analysis will be performed for all randomised subjects receiving the study drug. The total dose of norepinephrine will be compared between the two arms by a one-tailed Mann-Whitney U test.

Ethics and dissemination

The trial protocol was approved by the local Institutional Review Board (#20–30948). Results will be posted on ClinicalTrials.gov and published in a peer-reviewed journal.

Trial registration number

ClinicalTrials.govNCT04901169

Assessing the burden of HPV-related head and neck cancers in mainland China: protocol of a nationwide, multisite, cross-sectional study

Por: Wang · W. · Song · C. · Su · Z. · Kothari · S. · Chen · Y.-T. · Liu · Y. · Wu · S.-Y. · Panchal · R. · Morais · E. · Zhang · S.-K. · Yin · J. · Qiao · Y.-L. · Roberts · C.
Background

Persistent human papillomavirus (HPV) infection is a known cause of a subset of head and neck cancers (HNCs). In the last two decades, the proportion of HNCs attributable to HPV infection has increased worldwide, notably the oropharyngeal cancers. However, the trend of HPV-related HNC burden is not clearly understood yet in China. Thus, the absolute burden of HPV-related head and neck cancers in China (BROADEN-China) will be conducted to estimate the proportion of HNCs attributable to HPV infection, per anatomic site, by genotype, in three time periods (2008–2009, 2013–2014 and 2018–2019).

Methods and analysis

BROADEN-China is a nationwide, multisite, cross-sectional study. A stratified, multistage, non-randomised cluster sampling method will be used to select 2601 patients with HNC from 14 hospitals across seven regions, based on population density in China. Patients with formalin-fixed paraffin-embedded tissue samples collected prior to treatment induction during three time periods will be included, and factors (eg, smoking status, alcohol consumption, betel nut chewing, Epstein-Barr virus, teeth loss, etc) associated with HNC will be assessed. HPV testing (HPV-DNA, HPV-mRNA and p16INK4a immunohistochemistry) and histological diagnosis of the tissue samples will be conducted at a central laboratory.

The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. The informed consent was waived for all participants and all the recorded data will be treated as confidential.

We have included 14 hospitals as our participating sites, of which Henan Cancer Hospital is the leading site. The study has been approved by the independent ethics committees of the leading site on 3 December 2020. The other 13 participating site names of ethics committee and IRB that have approved this study.

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