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Seroprevalence of anti-SARS-CoV-2 antibodies and risk of viral exposure among healthcare workers in the South Kivu province, eastern Democratic Republic of the Congo: a cross-sectional study

Por: Chasinga · T. B. · Cikwanine · J.-P. B. · Kribi · S. · Yoyu · J. T. · Hofmann · N. · Grossegesse · M. · Nitsche · A. · Tomczyk · S. · Vietor · A. C. · Leendertz · F. H. · Eckmanns · T. · Kusinza · A. B. · Munguakonkwa · E. · Kalk · A. · Raha · M. · Kambale · N. S. · Ayagirwe · R. B. · Sc
Objectives

Healthcare workers (HCWs) are on the frontline of combating COVID-19, hence are at elevated risk of contracting an infection with SARS-CoV-2. The present study aims to measure the impact of SARS-CoV-2 on HCWs in central sub-Saharan Africa.

Setting

A cross-sectional serological study was conducted at six urban and five rural hospitals during the first pandemic wave in the South Kivu province, Democratic Republic of the Congo (DRC).

Participants

Serum specimens from 1029 HCWs employed during the first pandemic wave were collected between August and October 2020, and data on demographics and work-related factors were recorded during structured interviews.

Primary and secondary outcome measures

The presence of IgG antibodies against SARS-CoV-2 was examined by ELISA. Positive specimens were further tested using a micro-neutralisation assay. Factors driving SARS-CoV-2 seropositivity were assessed by multivariable analysis.

Results

Overall SARS-CoV-2 seroprevalence was high among HCWs (33.1%), and significantly higher in urban (41.5%) compared with rural (19.8%) hospitals. Having had presented with COVID-19-like symptoms before was a strong predictor of seropositivity (31.5%). Personal protective equipment (PPE, 88.1% and 11.9%) and alcohol-based hand sanitizer (71.1% and 28.9%) were more often available, and hand hygiene was more often reported after patient contact (63.0% and 37.0%) in urban compared with rural hospitals, respectively. This may suggest that higher exposure during non-work times in high incidence urban areas counteracts higher work protection levels of HCWs.

Conclusions

High SARS-CoV-2 seropositivity indicates widespread transmission of the virus in this region of DRC. Given the absence of publicly reported cases during the same time period at the rural sites, serological studies are very relevant in revealing infection dynamics especially in regions with low diagnostic capacities. This, and discrepancies in the application of PPE between urban and rural sites, should be considered in future pandemic response programmes.

Quantitative changes in the corneal endothelium and central corneal thickness during anterior chamber inflammation: A systematic review and meta-analysis

by Germán Mejía-Salgado, Paula Tatiana Muñoz-Vargas, Carlos Cifuentes-González, Gabriela Flórez-Esparza, Rebeca Paquentín-Jiménez, Miguel Ángel Castro-Monreal, Naomi Medina-Galindo, Gilma Norella Hernández-Herrera, Luz Elena Concha-del-Río, Alejandra de-la-Torre

Purpose

To establish the effects of anterior chamber inflammation (ACI) on the corneal endothelium parameters and central corneal thickness (CCT).

Methods

We conducted a comprehensive literature review using medical databases (PubMed, EMBASE, VHL, and medRxiv) on March 8, 2023, for studies that included patients with ACI who had undergone specular microscopy or pachymetry. Case series with >10 patients, cross-sectional, case-control, and cohort studies were included. The risk of bias was assessed using CLARITY tools and validated scales such as those by Hassan Murad et al. and Hoy et al. A narrative synthesis and a quantitative standardized mean difference meta-analysis, I2 heterogeneity assessment, and publication bias tests were conducted. The study was registered in PROSPERO (CRD42023420148) and approved by the Universidad del Rosario ethical committee (DVO005 2277- CV1712).

Results

Thirty-four studies, encompassing 1,388 eyes with ACI, were included. Compared with healthy controls, overall, ACI eyes show significant mean differences in endothelial parameters (endothelial cell density (ECD), coefficient of variation (CV), and hexagonality (HEX)) (P Conclusion

ACI leads to significant alterations in endothelial parameters and CCT. The primary contributors to these changes are increased IOP, uveitis duration, and intraocular surgeries. Further studies are needed to explore the impact of ACI etiology on the endothelium, potential biases in IOP measurements during acute ACI episodes, and the potential necessity for monitoring the endothelial parameters and CCT in patients with chronic ACI.

Public controversy and citizens’ attitude formation about animal research: A case for scholarship and recommendations on conflicts at the science-society interface

by Elena Link, Katharina Emde-Lachmund, Sophie Bruns, Anja Dittrich, Meike Stiesch, Axel Haverich, Stefan Treue, Christoph Klimmt

Activist groups attack animal research and put scientists and their institutions under pressure, whereas scientists often remain silent. We report an interdisciplinary research project driven by a communication science perspective on how citizens respond to news reports about animal research (3 experiments, overall N = 765) and a German science-initiated information platform (“Tierversuche verstehen”; controlled user study, N = 100). Findings demonstrate that a critical journalist perspective within neutral, two-sided news reports (e.g., skeptical expert statements or images of suffering animals) does not affect citizen opinion strongly. Information media provided by scientific institutions seem to be welcomed even by citizens who hold critical prior attitudes. From these results, we develop a set of recommendations for future public communication of animal research that builds on best practices in organizational and crisis communication. These suggestions are intended to empower animal researchers to actively participate in public debate to support citizens’ informed attitude formation.

ROS mediated anticandidal efficacy of 3-Bromopyruvate prevents vulvovaginal candidiasis in mice model

by Ravi Jothi, Seong-Tshool Hong, Munkhtur Enkhtsatsral, Shunmugiah Karutha Pandian, Shanmugaraj Gowrishankar

Candidal infections, particularly vulvovaginal candidiasis (VVC), necessitate effective therapeutic interventions in clinical settings owing to their intricate clinical nature and elusive understanding of their etiological mechanisms. Given the challenges in developing effective antifungal therapies, the strategy of repurposing existing pharmaceuticals has emerged as a promising approach to combat drug-resistant fungi. In this regard, the current study investigates molecular insights on the anti-candidal efficacy of a well-proven anticancer small molecule -3-bromopyruvate (3BP) against three clinically significant VVC causing Candida species viz., C. albicans, C. tropicalis and C. glabrata. Furthermore, the study validates 3BP’s therapeutic application by developing it as a vaginal cream for the treatment of VVC. 3BP exhibited phenomenal antifungal efficacy (killing >99%) with minimum inhibitory concentrations (MIC) and minimum fungicidal concentrations (MFC) of 256 μg/mL against all tested Candida spp. Time killing kinetics experiment revealed 20 min as the minimum time required for 3BP at 2XMIC to achieve complete-killing (99.9%) in all Candida strains. Moreover, the ergosterol or sorbitol experiment explicated that the antifungal activity of 3BP does not stem from targeting the cell wall or the membrane component ergosterol. Instead, 3BP was observed to instigate a sequence of pre-apoptotic cascade events, such as phosphatidylserine (PS) externalization, nuclear condensation and ROS accumulations, as evidenced by PI, DAPI and DCFH-DA staining methods. Furthermore, 3BP demonstrated a remarkable efficacy in eradicating mature biofilms of Candida spp., achieving a maximum eradication level of 90%. Toxicity/safety profiling in both in vitro erythrocyte lysis and in vivo Galleria mellonella survival assay authenticated the non-toxic nature of 3BP up to 512 μg/mL. Finally, a vaginal cream formulated with 3BP was found to be effective in VVC-induced female mice model, as it significantly decreasing fungal load and protecting vaginal mucosa. Concomitantly, the present study serves as a clear demonstration of antifungal mechanistic action of anticancer drug -3BP, against Candida species. This finding holds significant potential for mitigating candidal infections, particularly VVC, within healthcare environments.

Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis

Por: Munir · A. · Dahal · P. · Kumar · R. · Singh-Phulgenda · S. · Siddiqui · N. A. · Naylor · C. · Wilson · J. · Buck · G. · Rahi · M. · Alves · F. · Malaviya · P. · Sundar · S. · Ritmeijer · K. · Stepniewska · K. · Pandey · K. · Guerin · P. J. · Musa · A.
Introduction

Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.

Methods and analysis

The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.

Ethics and dissemination

This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (exempt granted on 29 March 2023, OxTREC REF: IDDO). Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (letter no.: RMRI/EC/30/2022) on 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.

PROSPERO registration number

CRD42021284622.

A comprehensive examination of research instruments utilized for assessing the attitudes of healthcare professionals towards the use of restraints in mental healthcare: A systematic review

Abstract

Aim

This systematic review aimed to identify, describe and evaluate questionnaires measuring health professionals’ attitudes towards restraints in mental healthcare.

Design

A systematic review was undertaken in accordance with the COSMIN protocol for systematic review and the relevant sections of the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Data Sources

OVID Medline, OVID nursing, Psychinfo, Embase and Cinahl were systematically searched from databases inception, with an initial search in December 2021 and updated in April 2022.

Review Methods

The inclusion criteria compromised articles reporting on self-reported instruments of attitudes or perceptions, development or validation of instruments and the evaluation of one or more measurement properties. Articles using multiple instruments in one study or not published in English were excluded. Two researchers independently extracted the data and appraised the methodological quality using the COSMIN guidelines and standards (consensus-based standards for the selection of health measurement instrument). A narrative synthesis without meta-analysis was performed. The systematic review was registered in PROSPERO Protocol ID CRD42022308818.

Results

A total of 23 studies reporting ten instruments were included. The findings revealed a broad variation in the content of the questionnaires, the use of terms/constructs and the context in which the various instruments measure attitudes towards coercive measures. Many studies lacked sufficient details on report of psychometric properties. Finally, the results were not summarized and the evidence not GRADED.

Conclusions

There is a need for updated and adapted instruments with origins in theory and clear joint definitions such that attitudes towards coercive measures can be reliably assessed regarding the validity and reliability of instruments, which will be of importance to facilitate the use of instruments in research and clinical settings.

Impact

Reviews addressing surveys, self-reported attitudes towards restraints in mental healthcare and examination of psychometric properties seem limited. We highlight distinct complexity, psychometric limitations and broad variation in the context and content measuring attitudes towards coercive measures, and their various use of terms/constructs in the existing questionnaires. These findings contribute to further research regarding the development of questionnaires and the need of representing the concept well – carefully denoted by the indicators, likewise the importance of applying questionnaires with properly reported measurement properties in terms of validity and reliability to ensure the use in research and clinical settings.

Prevalence and molecular heterogeneity of glucose-6-phosphate dehydrogenase (G6PD) deficiency in the Senoi Malaysian Orang Asli population

by Danny Xuan-Rong Koh, Mohamed Afiq Hidayat Zailani, Raja Zahratul Azma Raja Sabudin, Sanggari Muniandy, Nur Awatif Akmal Muhamad Hata, Siti Noor Baya Mohd Noor, Norhazilah Zakaria, Ainoon Othman, Endom Ismail

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an X-linked genetic disorder characterized by reduced G6PD enzyme levels in the blood. This condition is common in populations exposed to malaria; an acute febrile disease caused by Plasmodium parasites. G6PD-deficient individuals may suffer from acute hemolysis following the prescription of Primaquine, an antimalarial treatment. The population at risk for such a condition includes the Senoi group of Orang Asli, a remote indigenous community in Malaysia. This study aimed to elucidate the G6PD molecular heterogeneity in this subethnic group which is important for malaria elimination. A total of 662 blood samples (369 males and 293 females) from the Senoi subethnic group were screened for G6PD deficiency using a quantitative G6PD assay, OSMMR2000-D kit with Hb normalization. After excluding the family members, the overall prevalence of G6PD deficiency in the studied population was 15.2% (95% CI: 11–19%; 56 of 369), with males (30 of 172; 17.4%) outnumbering females (26 of 197; 13.2%). The adjusted male median (AMM), defined as 100% G6PD activity, was 11.8 IU/gHb. A total of 36 participants (9.6%; 26 male and 10 female) were deficient (G)(39.1%; n = 34), G6PD Viangchan (c.871G>A)(25.3%; n = 22), G6PD Union (c.1360C>T)(21.8%; n = 19), c.1311C>T(20.7%; n = 18), G6PD Kaiping (c.1388G>A)(8.0%; n = 7), and G6PD Coimbra (c.592C>T)(2.3%; n = 2). Our analysis revealed 27 hemizygote males, 18 heterozygote females, 7 homozygote females, and 2 compound heterozygote females. This study confirms the high prevalence of G6PD deficiency among the Senoi Malaysian Orang Asli, with a significant degree of molecular heterogeneity. More emphasis should be placed on screening for G6PD status and proper and safe use of Primaquine in the elimination of malaria among this indigenous population.

The effect of a mindfulness‐based intervention on stress overload, depression, and mindfulness among nurses: A randomized controlled trial

Abstract

Background

Nurses experience various health-related issues due to the nature of their work.

Aim

This study aimed to examine the effect of a mindfulness-based intervention on stress overload, depression and mindfulness among nurses. A secondary objective was to examine the role of the setting (i.e., in and out of the hospital as a natural setting) on mindfulness-based intervention effectiveness.

Methods

A randomized controlled trial with three groups' pretest–posttest design was used in this study. A total of 195 nurses were recruited—65 intervention-inside hospital, 60 intervention-outside hospital, and 63 control. The mindfulness-based intervention was delivered by a certified mindfulness practitioner over 4 weeks in Jordan. Data were collected using a demographics questionnaire, the Stress Overload Scale Short, the Center for Epidemiologic Studies Depression Scale-Revised, and the Five Facet Mindfulness Questionnaire.

Results

Multivariate analysis showed a statistically significant effect of the intervention on the linear combination of the dependent variables V = 0.44, F[6, 368] = 17.56, p < .001. Follow-up analyses showed that a mindfulness-based intervention significantly decreased stress overload, depression, and increased mindfulness levels among nurses in intervention groups compared with the control group. In addition, conducting a mindfulness-based intervention outside the hospital has a better effect on mindfulness levels than the inside hospital.

Linking Evidence to Action

The effect of a mindfulness-based intervention on stress overload, depression, and mindfulness should be considered when planning for nurses' well-being and the quality of care provided. Nurse managers are encouraged to use the study's findings to promote nurses' well-being.

Los cuidados enfermeros de San Juan de Dios según el Modelo de las necesidades humanas de Henderson

Consultando manuales de Historia de la Enfermería, se puede apreciar cómo es a partir de Nightingale cuando se considera el nacimiento de la Enfermería moderna o profesional. Sin embargo, esta creencia podría ser leyenda negra, pues antes del S. XIX ya existía conciencia de Enfermería como profesión, siendo esta iniciada por Juan de Dios, el de Granada, en el S. XVI español. Por ello, en el presente artículo hemos marcado como objetivo el describir los cuidados de Juan de Dios siguiendo el modelo de necesidades humanas descritas por Henderson. Para ello, utilizamos la metodología historiográfica siguiendo la corriente de la historia de las mentalidades, de manera que podamos ir del pasado al presente, y viceversa. En el análisis documental hemos podido observar como lo que hoy encontramos sistematizado de manera teórica, ya se realizaba en el inicio de la reforma enfermera del S. XVI español, siendo un modelo válido para la Enfermería actual, pues se encuentra en su ser, saber, y hacer, los conceptos del metaparadigma enfermero actuales aunque no de manera explícita, puesto que su intención, más que teórica, era asistencial, aunque detrás de ella hubo un corpus doctrinal independiente a otras disciplinas socio-sanitarias.

Validation of maternal recall of number of antenatal care visits attended in rural Southern Nepal: a longitudinal cohort study

Por: Xie · X. · Munos · M. K. · Lama · T. P. · Bryce · E. · Khatry · S. K. · LeClerq · S. C. · Katz · J.
Objectives

This study aimed to examine the validity of maternal recall of total number of antenatal care (ANC) visits during pregnancy and factors associated with the accuracy of maternal recall.

Design

This was a longitudinal cohort study conducted from December 2018 through November 2020.

Setting

Five government health posts in the Sarlahi district of Southern Nepal.

Participants

402 pregnant women between ages 15 and 49 who presented for their first ANC visit at the study health posts.

Main outcomes

The observed number of ANC visits (gold standard) and the reported number of ANC visits at the postpartum interview (maternal recall).

Results

On average, women in the study who had a live birth attended 4.7 ANC visits. About 65% of them attended four or more ANC visits during pregnancy as recommended by the Nepal government, and 38.3% of maternal report matched the categorical ANC visits as observed by the gold standard. The individual validity was poor to moderate, with the highest area under the receiver operating characteristic curve (AUC) being 0.69 (95% CI: 0.65 to 0.74) in the 1–3 visits group. Population-level bias (as distinct from individual-level bias) was observed in the 1–3 visits and 4 visits groups, where 1–3 visits were under-reported (inflation factor (IF): 0.69) and 4 ANC visits were highly over-reported (IF: 2.12). The binary indicator ANC4+ (1–3 visits vs 4+ visits) showed better population-level validity (AUC: 0.69; IF: 1.17) compared with the categorical indicators (1–3 visits, 4 visits, 5–6 visits and more than 6 visits). Report accuracy was not associated with maternal characteristics but was related to ANC frequency. Women who attended more ANC visits were less likely to correctly report their total number of visits.

Conclusion

Maternal report of number of ANC visits during pregnancy may not be a valid indicator for measuring ANC coverage. Improvements are needed to measure the frequency of ANC visits.

Using a novel ambulatory monitoring system to support patient safety on an acute infectious disease ward during an unfolding pandemic

Abstract

Aim

To gain staff feedback on the implementation and impact of a novel ambulatory monitoring system to support coronavirus patient management on an isolation ward.

Design

Qualitative service evaluation.

Methods

Semi-structured interviews were conducted with 15 multidisciplinary isolation ward staff in the United Kingdom between July 2020 and May 2021. Interviews were audio-recorded, transcribed and analysed using thematic analysis.

Findings

Adopting Innovation to Assist Patient Safety was identified as the overriding theme. Three interlinked sub-themes represent facets of how the system supported patient safety. Patient Selection was developed throughout the pandemic, as clinical staff became more confident in choosing which patients would benefit most. Trust In the System described how nurses coped with discrepancies between the ambulatory system and ward observation machines. Finally, Resource Management examined how, once trust was built, staff perceived the ambulatory system assisted with caseload management. This supported efficient personal protective equipment resource use by reducing the number of isolation room entries. Despite these reported benefits, face-to-face contact was still highly valued, despite the risk of coronavirus exposure.

Conclusion

Hospital wards should consider using ambulatory monitoring systems to support caseload management and patient safety. Patients in isolation rooms or at high risk of deterioration may particularly benefit from this additional monitoring. However, these systems should be seen as an adjunct to nursing care, not a replacement.

Implications for the Profession and/or Patient Care

Nurses valued ambulatory monitoring as a means of ensuring the safety of patients at risk of deterioration and prioritizing their workload.

Impact

The findings of this research will be useful to all those developing or considering implementation of ambulatory monitoring systems in hospital wards.

Reporting Method

This manuscript follows the Consolidated criteria for Reporting Qualitative Research (COREQ) guidelines with inclusion of relevant SQUIRE guidelines for reporting quality improvement.

Patient or Public Contribution

No Patient or Public Contribution.

Estimating the frequency of inpatient adverse events using a two-step retrospective chart review: a study protocol

Por: ul Hassan · S. S. · Asif · F. · Haque · G. · Ayub · F. · Munir · T. · Khan · F. · Siddiqi · S. · Latif · A.
Introduction

Adverse events are a major cause of patient harm in the hospitalised setting. Low-income and middle-income countries account for a disproportionate share of the global burden of adverse events. However, patient safety research is still centred around high-income countries and high-resource health systems. The methods and data produced from these efforts are ill-suited to low-income and middle-income systems due to the social and technical differences between these settings. We aim to use our pilot-tested, locally developed methodology to estimate the frequency and characteristics of adverse events in hospitalised patients in a lower-middle-income country to inform patient safety policies and initiatives.

Methods and analysis

This multi-centre study will employ a two-step chart review methodology to identify adverse events in a representative sample of patients admitted at five hospitals between 1 January 2019 and 31 December 2019. The first step will include assessing patient files against a list of triggers to detect adverse events and the second step will involve an in-depth review of the events to capture pertinent characteristics. The triggers have been adapted from validated tools used in other studies. The reviewing team will be trained on the use of research tools and operational definitions to ensure that data are collected uniformly. The main outcome of interest is the rate at which adverse events occur in hospitalised patients. Further analysis will look to identify and quantify associations between the main outcome of interest and a variety of variables such as patient age and gender using tests of independence and regression techniques.

Ethics and dissemination

This study protocol has been approved by the Ethics Review Committee at Aga Khan University (Reference number: 2023-6324-24566). The findings of this study will be published in a peer-reviewed journal and disseminated to the public through national and international conferences, workshops, websites and social media.

Impact of mobile connectivity on students’ wellbeing: Detecting learners’ depression using machine learning algorithms

by Muntequa Imtiaz Siraji, Ahnaf Akif Rahman, Mirza Muntasir Nishat, Md Abdullah Al Mamun, Fahim Faisal, Lamim Ibtisam Khalid, Ashik Ahmed

Depression is a psychological state of mind that often influences a person in an unfavorable manner. While it can occur in people of all ages, students are especially vulnerable to it throughout their academic careers. Beginning in 2020, the COVID-19 epidemic caused major problems in people’s lives by driving them into quarantine and forcing them to be connected continually with mobile devices, such that mobile connectivity became the new norm during the pandemic and beyond. This situation is further accelerated for students as universities move towards a blended learning mode. In these circumstances, monitoring student mental health in terms of mobile and Internet connectivity is crucial for their wellbeing. This study focuses on students attending an International University of Bangladesh to investigate their mental health due to their continual use of mobile devices (e.g., smartphones, tablets, laptops etc.). A cross-sectional survey method was employed to collect data from 444 participants. Following the exploratory data analysis, eight machine learning (ML) algorithms were used to develop an automated normal-to-extreme severe depression identification and classification system. When the automated detection was incorporated with feature selection such as Chi-square test and Recursive Feature Elimination (RFE), about 3 to 5% increase in accuracy was observed by the method. Similarly, a 5 to 15% increase in accuracy has been observed when a feature extraction method such as Principal Component Analysis (PCA) was performed. Also, the SparsePCA feature extraction technique in combination with the CatBoost classifier showed the best results in terms of accuracy, F1-score, and ROC-AUC. The data analysis revealed no sign of depression in about 44% of the total participants. About 25% of students showed mild-to-moderate and 31% of students showed severe-to-extreme signs of depression. The results suggest that ML models, incorporating a proper feature engineering method can serve adequately in multi-stage depression detection among the students. This model might be utilized in other disciplines for detecting early signs of depression among people.

Association of biomarkers of enteric dysfunction, systemic inflammation, and growth hormone resistance with seroconversion to oral rotavirus vaccine: A lasso for inference approach

by Katayi Mwila-Kazimbaya, Samuel Bosomprah, Obvious Nchimunya Chilyabanyama, Caroline Cleopatra Chisenga, Mwelwa Chibuye, Natasha Makabilo Laban, Michelo Simuyandi, Bert Huffer Jr, Miren Iturriza-Gomara, Robert K. M. Choy, Roma Chilengi

Background

Rotavirus gastroenteritis remains a leading cause of morbidity and mortality despite the introduction of vaccines. Research shows there are several factors contributing to the reduced efficacy of rotavirus vaccines in low- and middle-income settings. Proposed factors include environmental enteric dysfunction (EED), malnutrition, and immune dysfunction. This study aimed to assess the effect of these factors on vaccine responses using a machine learning lasso approach.

Methods

Serum samples from two rotavirus clinical trials (CVIA 066 n = 99 and CVIA 061 n = 124) were assessed for 11 analytes using the novel Micronutrient and EED Assessment Tool (MEEDAT) multiplex ELISA. Immune responses to oral rotavirus vaccines (Rotarix, Rotavac, and Rotavac 5D) as well as a parenteral rotavirus vaccine (trivalent P2-VP8) were also measured and machine learning using the lasso approach was then applied to investigate any associations between immune responses and environmental enteric dysfunction, systemic inflammation, and growth hormone resistance biomarkers.

Results

Both oral and parenteral rotavirus vaccine responses were negatively associated with retinol binding protein 4 (RBP4), albeit only weakly for oral vaccines. The parenteral vaccine responses were positively associated with thyroglobulin (Tg) and histidine-rich protein 2 (HRP2) for all three serotypes (P8, P6 and P4), whilst intestinal fatty acid binding protein (I-FABP) was negatively associated with P6 and P4, but not P8, and soluble transferrin receptor (sTfR) was positively associated with P6 only.

Conclusion

MEEDAT successfully measured biomarkers of growth, systemic inflammation, and EED in infants undergoing vaccination, with RBP4 being the only analyte associated with both oral and parenteral rotavirus vaccine responses. Tg and HRP2 were associated with responses to all three serotypes in the parenteral vaccine, while I-FABP and sTfR results indicated possible strain specific immune responses to parenteral immunization.

Six-month post-intensive care outcomes during high and low bed occupancy due to the COVID-19 pandemic: A multicenter prospective cohort study

by Ana Castro-Avila, Catalina Merino-Osorio, Felipe González-Seguel, Agustín Camus-Molina, Felipe Muñoz-Muñoz, Jaime Leppe, on behalf of the IMPACCT COVID-19 study group

Introduction

The COVID-19 pandemic can be seen as a natural experiment to test how bed occupancy affects post-intensive care unit (ICU) patient’s functional outcomes. To compare by bed occupancy the frequency of mental, physical, and cognitive impairments in patients admitted to ICU during the COVID-19 pandemic.

Methods

Prospective cohort of adults mechanically ventilated >48 hours in 19 ICUs from seven Chilean public and private hospitals. Ninety percent of nationwide beds occupied was the cut-off for low versus high bed occupancy. At ICU discharge, 3- and 6-month follow-up, we assessed disability using the World Health Organization Disability Assessment Schedule 2.0. Quality of life, mental, physical, and cognitive outcomes were also evaluated following the core outcome set for acute respiratory failure.

Results

We enrolled 252 participants, 103 (41%) during low and 149 (59%) during high bed occupancy. Patients treated during high occupancy were younger (P50 [P25-P75]: 55 [44–63] vs 61 [51–71]; p Conclusions

There were no differences in post-ICU outcomes between high and low bed occupancy. Most patients (>90%) had at least one mental, physical or cognitive impairment at ICU discharge, which remained high at 6-month follow-up (57%).

Clinical trial registration

NCT04979897 (clinicaltrials.gov).

Perioperative hypothermia prevention: development of simple principles and practice recommendations using a multidisciplinary consensus-based approach

Por: Munday · J. · Duff · J. · Wood · F. M. · Sturgess · D. · Ralph · N. · Ramis · M.-A.
Objectives

To develop a consensus on evidence-based principles and recommendations for perioperative hypothermia prevention in the Australian context.

Design

This study was informed by CAN-IMPLEMENT using the ADAPTE process: (1) formation of a multidisciplinary development team; (2) systematic search process identifying existing guidance for perioperative hypothermia prevention; (3) appraisal using the AGREE II Rigor of Development domain; (4) extraction of recommendations from guidelines meeting a quality threshold using the AGREE-REX tool; (5) review of draft principles and recommendations by multidisciplinary clinicians nationally and (6) subsequent round of discussion, drafting, reflection and revision by the original panel member team.

Setting

Australian perioperative departments.

Participants

Registered nurses, anaesthetists, surgeons and anaesthetic allied health practitioners.

Results

A total of 23 papers (12 guidelines, 6 evidence summaries, 3 standards, 1 best practice sheet and 1 evidence-based bundle) formed the evidence base. After evidence synthesis and development of draft recommendations, 219 perioperative clinicians provided feedback. Following refinement, three simple principles for perioperative hypothermia prevention were developed with supporting practice recommendations: (1) actively monitor core temperature for all patients at all times; (2) warm actively to keep body temperature above 36°C and patients comfortable and (3) minimise exposure to cold at all stages of perioperative care.

Conclusion

This consensus process has generated principles and practice recommendations for hypothermia prevention that are ready for implementation with local adaptation. Further evaluation will be undertaken in a large-scale implementation trial across Australian hospitals.

Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort

Por: Hanumunthadu · B. · Kanji · N. · Owino · N. · Ferreira Da Silva · C. · Robinson · H. · White · R. · Ferruzzi · P. · Nakakana · U. · Canals · R. · Pollard · A. J. · Ramasamy · M. · Vacc-iNTS Consortium · Agyapong · Breghi · Crump · Fiorino · Gordon · Jacobs · Kariuki · Malvolti · Mante
Introduction

Invasive non-typhoidal Salmonellosis (iNTS) is mainly caused by Salmonella enterica serovars Typhimurium and Enteritidis and is estimated to result in 77 500 deaths per year, disproportionately affecting children under 5 years of age in sub-Saharan Africa. Invasive non-typhoidal Salmonellae serovars are increasingly acquiring resistance to first-line antibiotics, thus an effective vaccine would be a valuable tool in reducing morbidity and mortality from infection. While NTS livestock vaccines are in wide use, no licensed vaccines exist for use in humans. Here, a first-in-human study of a novel vaccine (iNTS-GMMA) containing S. Typhimurium and S. Enteritidis Generalised Modules for Membrane Antigens (GMMA) outer membrane vesicles is presented.

Method and analysis

The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.

The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.

Ethics and dissemination

Ethical approval for this study has been obtained from the South Central—Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.

Trial registration number

EudraCT Number: 2020-000510-14.

Psychometric properties of parental stress scales used in paediatric health care settings: A systematic review

Abstract

Aim

To identify scales that assess parental stress in the paediatric clinical population and to analyse their psychometric properties.

Methods

Four electronic databases (PubMed, Web of Science, PsycINFO, and Scopus) and metasearch engines (Google Scholar and Open Grey) were searched with no time period limitations. Methodological quality was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach modified by COSMIN. Finally, recommendations were made for the instruments with the highest quality of evidence.

Results

A total of 38 studies reporting on 11 different instruments for assessing parental stress in the paediatric clinical setting were included. Six instruments were ‘A’ rated (recommended) in the final phase in line with COSMIN guidelines. The Paediatric Inventory for Parents was the instrument that evaluated the highest number of psychometric properties and obtained the highest methodological quality, global assessment, and quality of evidence for the different psychometric properties.

Conclusions

This systematic review provides an overview of the measurement properties of the parental stress instruments used in the paediatric clinical setting. The Paediatric Inventory for Parents stands out as being one of the most robust instruments for measuring stress in parents with a hospitalised or sick child. Evidence needs to be generated for all the parental stress scales used in the clinical setting.

Impact

Given that the psychometric properties of the existing parental stress scales used in paediatric health care settings have not been systematically assessed, the present review utilised comprehensive methods according to COSMIN.

No Patient or Public Contribution

Reporting method

PRISMA statement and COSMIN reporting guidelines for studies on measurement properties of patient-reported outcome measures.

What is the association between adverse childhood experiences and late-life cognitive decline? Study of Healthy Aging in African Americans (STAR) cohort study

Por: Lor · Y. · George · K. M. · Gilsanz · P. · Meunier · C. C. · Peterson · R. L. · Hayes-Larson · E. · Barnes · L. L. · Mungas · D. · Whitmer · R. A.
Objectives

Adverse childhood experiences (ACEs) are associated with higher risk of chronic disease, but little is known about the association with late life cognitive decline. We examined the longitudinal association between ACEs and late-life cognitive decline in the Study of Healthy Aging in African Americans (STAR).

Design

Linear mixed models with random intercepts and slope examined the association of individual and composite ACEs with cognitive change adjusting for years from baseline (timescale), baseline age, sex, parental education, childhood socioeconomic status and childhood social support. Participants reported whether they had experienced nine types of ACEs. Executive function and verbal episodic memory were measured up to three times over a 3-year period using the Spanish and English Neuropsychological Assessment Scales.

Settings

Kaiser Permanente Northern California members living in the Bay Area.

Participants

STAR is a cohort study of cognitive ageing launched in 2018 that has enrolled 764 black Americans ages ≥50 years (mean age=67.5; SD=8.5).

Results

Twenty-one per cent of participants reported no ACEs, 24% one ACE, 20% two ACEs, 17% three ACEs and 17% four or more ACEs. Compared with no ACEs, two ACEs (β=0.117; 95% CI 0.052 to 0.182), three ACEs (β=0.075; 95% CI 0.007 to 0.143) and four or more ACEs (β=0.089; 95% CI 0.002 to 0.158) were associated with less decline in executive function. There were no significant associations between number of ACEs and baseline or longitudinal verbal episodic memory or between individual ACEs and executive function or verbal episodic memory.

Conclusion

In this cohort of older black Americans, there was no association between ACEs and baseline cognition or cognitive change in verbal episodic memory; however, experiencing ≥ 2 ACEs was associated with less decline in executive function. These results may indicate that participants who survived to age 50+ and experienced ACEs may have cognitive resilience that warrants further investigation.

Effects of Eurycoma longifolia Jack standardised water extract (Physta) on well-being of perimenopausal and postmenopausal women: protocol for a randomised, double-blinded, placebo-controlled, parallel group study

Por: Muniandy · S. · Yahya · H. M. · Shahar · S. · Kamisan Atan · I. · Mahdy · Z. A. · Rajab · N. F. · George · A. · Chinnappan · S. M.
Introduction

Eurycoma longifolia Jack (EL), profoundly recognised as ‘Tongkat Ali’, is a medicinal herb originating from Southeast Asia. It is commonly used in traditional ‘antiageing’ treatments to address decreased energy, mood, libido and hormonal imbalances. While the benefits of EL have been extensively studied among the male population, less attention has been given to its effects on women. Menopause can impact the overall well-being of middle-aged women and incorporation of herbal supplements can aid them in managing the menopausal symptoms.

Methods and analysis

This 12-week randomised double-blind, placebo-controlled, parallel-group study aims to evaluate the efficacy of the standardised water extract of EL known as Physta in increasing the quality of life of perimenopausal and postmenopausal women. The study involves 150 women aged 40–55 years who score more than 61 on the Menopause-Specific Quality of Life (MENQOL) assessment. These participants will be randomised into three groups, receiving Physta at either 50 mg or 100 mg or a placebo. The outcomes measures include mood state, quality of life, fatigue, sleep quality, sexual function and pain score assessed using Profile of Mood State, MENQOL, Chalder Fatigue Scale, Pittsburgh Sleep Quality Index, Female Sexual Function Index and the Brief Pain Inventory questionnaires, respectively. The secondary outcome of the study includes full blood analysis, urine analysis, female reproductive hormone profiling, inflammatory and oxidative stress biomarkers analysis.

Ethics and dissemination

The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2021-898). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.

Trial registration number

ACTRN12622001341718.

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