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Hoy — Mayo 14th 2024Tus fuentes RSS

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A.
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

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Impacts of income inequality and the mediation role of reporting delays on COVID-19 deaths during 2020 and 2021 in Hong Kong: an observational study

Por: Yuan · H.-Y. · Wong · W. H. · Khairunnasa · F. · Ho · H. C. · Chung · G. K.-K.
Objective

To estimate the impacts of demographic factors and income disparities on the case fatality rate (CFR) of COVID-19 in Hong Kong, taking into account the influence of reporting delays (ie, the duration between symptom onset and case confirmation).

Design

Retrospective observational longitudinal study.

Participants

A total of 7406 symptomatic patients with residence information reported between 23 January 2020 and 2 October 2021.

Main outcome measures

The study examined the disparity in COVID-19 deaths associated with the factors such as age (≥65 vs 0–64 years old groups), gender and the income level of districts (low income vs non-low income). The severe reporting delay (>10 days) was considered as the mediator for mediation analysis. A Cox proportional hazards regression model was constructed.

Results

We found that CFR was 3.07% in the low-income region, twofold higher than 1.34% in the other regions. Although the severe reporting delay was associated with a hazard ratio (HR) of about 1.9, its mediation effect was only weakly present for age, but not for gender or income level. Hence, high CFR in Hong Kong was largely attributed to the direct effects of the elderly (HR 25.967; 95% CI 14.254 to 47.306) and low income (HR 1.558; 95% CI 1.122 to 2.164).

Conclusion

The disparity in COVID-19 deaths between income regions is not due to reporting delays, but rather to health inequities in Hong Kong. These risks may persist after the discontinuation of test-and-trace measures and extend to other high-threat respiratory pathogens. Urgent actions are required to identify vulnerable groups in low-income regions and understand the underlying causes of health inequities.

DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia (DECONNECT): research protocol for a cross-sectional pilot study

Por: Brandt · Y. · Alers · R.-J. · Canjels · L. P. W. · Jorissen · L. M. · Jansen · G. · Janssen · E. B. N. J. · van Kuijk · S. M. · Went · T. M. · Koehn · D. · Gerretsen · S. C. · Jansen · J. F. · Backes · W. H. · Hurks · P. P. M. · van de Ven · V. · Kooi · M. E. · Spaanderman · M. E. A.
Introduction

Pre-eclampsia is a hypertensive disorder affecting up to 8% of pregnancies. After pre-eclampsia, women are at increased risk of cognitive problems, and cerebrovascular and cardiovascular disorders. These sequelae could result from microvascular dysfunction persisting after pre-eclampsia. This study will explore differences in cerebral and myocardial microvascular function between women after pre-eclampsia and women after normotensive gestation. We hypothesise that pre-eclampsia alters cerebral and myocardial microvascular functions, which in turn are related to diminished cognitive and cardiac performance.

Methods and analysis

The cross-sectional ‘DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia’ (DECONNECT) pilot study includes women after pre-eclampsia and controls after normotensive pregnancy between 6 months and 20 years after gestation. We recruit women from the Queen of Hearts study, a study investigating subclinical heart failure after pre-eclampsia. Neuropsychological tests are employed to assess different cognitive domains, including attention, processing speed, and cognitive control. Cerebral images are recorded using a 7 Tesla MRI to assess blood–brain barrier integrity, perfusion, blood flow, functional and structural networks, and anatomical dimensions. Cardiac images are recorded using a 3 Tesla MRI to assess cardiac perfusion, strain, dimensions, mass, and degree of fibrosis. We assess the effect of a history of pre-eclampsia using multivariable regression analyses.

Ethics and dissemination

This study is approved by the Ethics Committee of Maastricht University Medical Centre (METC azM/UM, NL47252.068.14). Knowledge dissemination will include scientific publications, presentations at conferences and public forums, and social media.

Trial registration number

NCT02347540.

Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial

Por: Li · M. C. M. · Cheng · Y. K. · Cui · C. · Chow · S. K. H. · Wong · R. M. Y. · Kwok · T. C. · Siu · P. M. · Yang · M. · Tian · M. · Rubin · C. · Welch · A. A. · Qin · L. · Law · S. W. · Cheung · W. H.
Introduction

Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.

Methods and analysis

In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.

Ethics and dissemination

This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.

Trial registration number

NCT05525039.

Analysis of maternal and child health spillover effects in PEPFAR countries

Por: Gaumer · G. · Crown · W. H. · Kates · J. · Luan · Y. · Hariharan · D. · Jordan · M. · Hurley · C. L. · Nandakumar · A.
Objectives

This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.

Design

Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.

Setting

All 157 LMICs from 1990 to 2018.

Participants

90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).

Interventions

PEPFAR aid to combat the HIV epidemic.

Primary outcome measures

Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.

Results

Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.

Conclusions

This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.

Interventions to reduce interpersonal stigma towards patients with a mental dysregulation for ambulance and emergency department healthcare professionals: review protocol for an integrative review

Por: Van de Glind · G. · Galenkamp · N. · Bleijenberg · N. · Schoonhoven · L. · Scheepers · F. E. · Crilly · J. · van Veen · M. · Ham · W. H. W.
Introduction

Worldwide, there is an increase in the extent and severity of mental illness. Exacerbation of somatic complaints in this group of people can result in recurring ambulance and emergency department care. The care of patients with a mental dysregulation (ie, experiencing a mental health problem and disproportionate feelings like fear, anger, sadness or confusion, possibly with associated behaviours) can be complex and challenging in the emergency care context, possibly evoking a wide variety of feelings, ranging from worry or pity to annoyance and frustration in emergency care staff members. This in return may lead to stigma towards patients with a mental dysregulation seeking emergency care. Interventions have been developed impacting attitude and behaviour and minimising stigma held by healthcare professionals. However, these interventions are not explicitly aimed at the emergency care context nor do these represent perspectives of healthcare professionals working within this context. Therefore, the aim of the proposed review is to gain insight into interventions targeting healthcare professionals, which minimise stigma including beliefs, attitudes and behaviour towards patients with a mental dysregulation within the emergency care context.

Methods and analysis

The protocol for a systematic integrative review is presented, using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols recommendations. A systematic search was performed on 13 July 2023. Study selection and data extraction will be performed by two independent reviewers. In each step, an expert with lived experience will comment on process and results. Software applications RefWorks-ProQuest, Rayyan and ATLAS.ti will be used to enhance the quality of the review and transparency of process and results.

Ethics and dissemination

No ethical approval or safety considerations are required for this review. The proposed review will be submitted to a relevant international journal. Results will be presented at relevant medical scientific conferences.

PROSPERO registration number

CRD42023390664 (https://www.crd.york.ac.uk/prospero/).

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