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Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

Por: Stehlik · P. · Dowsett · C. · Camacho · X. · Falster · M. O. · Lim · R. · Nasreen · S. · Pratt · N. L. · Pearson · S.-A. · Henry · D.
Background

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning—specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

Methods and analysis

We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).

Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.

By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

Ethics and dissemination

As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

Registration

https://doi.org/10.17605/OSF.IO/ZHDKR

Uptake of community health care provision by community health entrepreneurs for febrile illness and diarrhoea: a cross-sectional survey in rural communities in Bunyangabu district, Uganda

Por: van der Hoeven · M. · van Lettow · M. · Boonstra · P. · Hoekstra · T. · Rutebemberwa · E. · Tweheyo · R. · Kok · M. O.
Objective

To assess the uptake of services provided by community health workers who were trained as community health entrepreneurs (CHEs) for febrile illness and diarrhoea.

Design

A cross-sectional survey among households combined with mapping of all providers of basic medicine and primary health services in the study area.

Participants

1265 randomly selected households in 15 rural villages with active CHEs.

Setting

Bunyangabu district, Uganda.

Outcome measures

We describe the occurrence and care sought for fever and diarrhoea in the last 3 months by age group in the households. Care provider options included: CHE, health centre or clinic (public or private), pharmacy, drug shop and other. Geographic Information Ssystem (GIS)-based geographical measures were used to map all care providers around the active CHEs.

Results

Fever and diarrhoea in the last 3 months occurred most frequently in children under 5; 68% and 41.9%, respectively. For those who sought care, CHE services were used for fever among children under 5, children 5–17 and adults over 18 years of age in 34.7%, 29.9% and 25.1%, respectively. For diarrhoea among children under 5, children 5–17 and adults over 18 years of age, CHE services were used in 22.1%, 19.5% and 7.0%, respectively. For those who did not seek care from a CHE (only), drug shops were most frequently used services for both fever and diarrhoea, followed by health centres or private clinics. Many households used a combination of services, which was possible given the high density and diversity of providers found in the study area.

Conclusions

CHEs play a considerable role in providing care in rural areas where they are active. The high density of informal drug shops and private clinics highlights the need for clarity on the de facto roles played by different providers in both the public and private sector to improve primary healthcare.

Impact of heat on mental health emergency visits: a time series study from all public emergency centres, in Curitiba, Brazil

Por: Corvetto · J. F. · Federspiel · A. · Sewe · M. O. · Müller · T. · Bunker · A. · Sauerborn · R.
Objectives

Quantify the risk of mental health (MH)-related emergency department visits (EDVs) due to heat, in the city of Curitiba, Brazil.

Design

Daily time series analysis, using quasi-Poisson combined with distributed lag non-linear model on EDV for MH disorders, from 2017 to 2021.

Setting

All nine emergency centres from the public health system, in Curitiba.

Participants

101 452 EDVs for MH disorders and suicide attempts over 5 years, from patients residing inside the territory of Curitiba.

Main outcome measure

Relative risk of EDV (RREDV) due to extreme mean temperature (24.5°C, 99th percentile) relative to the median (18.02°C), controlling for long-term trends, air pollution and humidity, and measuring effects delayed up to 10 days.

Results

Extreme heat was associated with higher single-lag EDV risk of RREDV 1.03(95% CI 1.01 to 1.05—single-lag 2), and cumulatively of RREDV 1.15 (95% CI 1.05 to 1.26—lag-cumulative 0–6). Strong risk was observed for patients with suicide attempts (RREDV 1.85, 95% CI 1.08 to 3.16) and neurotic disorders (RREDV 1.18, 95% CI 1.06 to 1.31). As to demographic subgroups, females (RREDV 1.20, 95% CI 1.08 to 1.34) and patients aged 18–64 (RREDV 1.18, 95% CI 1.07 to 1.30) were significantly endangered. Extreme heat resulted in lower risks of EDV for patients with organic disorders (RREDV 0.60, 95% CI 0.40 to 0.89), personality disorders (RREDV 0.48, 95% CI 0.26 to 0.91) and MH in general in the elderly ≥65 (RREDV 0.77, 95% CI 0.60 to 0.98). We found no significant RREDV among males and patients aged 0–17.

Conclusion

The risk of MH-related EDV due to heat is elevated for the entire study population, but very differentiated by subgroups. This opens avenue for adaptation policies in healthcare: such as monitoring populations at risk and establishing an early warning systems to prevent exacerbation of MH episodes and to reduce suicide attempts. Further studies are welcome, why the reported risk differences occur and what, if any, role healthcare seeking barriers might play.

Protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant: a systematic review and meta-analysis

Por: Rahman · M. O. · Kamigaki · T. · Thandar · M. M. · Haruyama · R. · Yan · F. · Shibamura-Fujiogi · M. · Khin Maung Soe · J. · Islam · M. R. · Yoneoka · D. · Miyahara · R. · Ota · E. · Suzuki · M.
Objectives

The rapid spread of the SARS-CoV-2 Omicron variant has raised concerns regarding waning vaccine-induced immunity and durability. We evaluated protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant and its sublineages.

Design

Systematic review and meta-analysis.

Data sources

Electronic databases and other resources (PubMed, Embase, CENTRAL, MEDLINE, CINAHL PLUS, APA PsycINFO, Web of Science, Scopus, ScienceDirect, MedRxiv and bioRxiv) were searched until December 2022.

Study eligibility criteria

We included studies that assessed the effectiveness of mRNA vaccine booster doses against SARS-CoV-2 infection and severe COVID-19 outcomes caused by the subvariant.

Data extraction and synthesis

Estimates of vaccine effectiveness (VE) at different time points after the third-dose and fourth-dose vaccination were extracted. Random-effects meta-analysis was used to compare VE of the third dose versus the primary series, no vaccination and the fourth dose at different time points. The certainty of the evidence was assessed by Grading of Recommendations, Assessments, Development and Evaluation approach.

Results

This review included 50 studies. The third-dose VE, compared with the primary series, against SARS-CoV-2 infection was 48.86% (95% CI 44.90% to 52.82%, low certainty) at ≥14 days, and gradually decreased to 38.01% (95% CI 13.90% to 62.13%, very low certainty) at ≥90 days after the third-dose vaccination. The fourth-dose VE peaked at 14–30 days (56.70% (95% CI 50.36% to 63.04%), moderate certainty), then quickly declined at 61–90 days (22% (95% CI 6.40% to 37.60%), low certainty). Compared with no vaccination, the third-dose VE was 75.84% (95% CI 40.56% to 111.12%, low certainty) against BA.1 infection, and 70.41% (95% CI 49.94% to 90.88%, low certainty) against BA.2 infection at ≥7 days after the third-dose vaccination. The third-dose VE against hospitalisation remained stable over time and maintained 79.30% (95% CI 58.65% to 99.94%, moderate certainty) at 91–120 days. The fourth-dose VE up to 60 days was 67.54% (95% CI 59.76% to 75.33%, moderate certainty) for hospitalisation and 77.88% (95% CI 72.55% to 83.21%, moderate certainty) for death.

Conclusion

The boosters provided substantial protection against severe COVID-19 outcomes for at least 6 months, although the duration of protection remains uncertain, suggesting the need for a booster dose within 6 months of the third-dose or fourth-dose vaccination. However, the certainty of evidence in our VE estimates varied from very low to moderate, indicating significant heterogeneity among studies that should be considered when interpreting the findings for public health policies.

PROSPERO registration number

CRD42023376698.

NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease

Por: Green · Z. · Mayberry · E. · Ashton · J. J. · Beattie · R. M. · Evans · A. · Wahid · A. · Edwards · M. O.
Introduction

Incidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.

We aim to examine the feasibility of a non-invasive monitoring tool—bowel ultrasound (BUS)—in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.

We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.

Methods and analysis

This prospective observational feasibility study will be carried out over 24 months at the Noah’s Ark Children’s Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2–18 years with a modified Porto criteria diagnosis of IBD will be included.

Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.

Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.

The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and 2 analysis, correlation analysis, regression analysis.

Ethics and dissemination

Ethical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.

Trial registration number

NCT05673278.

Sleep quality and associated factors among patients with chronic kidney disease in Nigeria: a cross-sectional study

Por: Adejumo · O. A. · Edeki · I. R. · Mamven · M. · Oguntola · O. S. · Okoye · O. C. · Akinbodewa · A. A. · Okaka · E. I. · Ahmed · S. D. · Egbi · O. G. · Falade · J. · Dada · S. A. · Ogiator · M. O. · Okoh · B.
Objective

Poor sleep quality adversely affects the overall well-being and outcomes of patients with chronic kidney disease (CKD). However, it has not been well studied in Africans with CKD. We determined the prevalence of poor sleep quality and associated factors among patients with CKD.

Design

This was a cross-sectional study that involved patients with CKD .

Settings

The study was carried out in the outpatient clinic of nine hospitals in Nigeria.

Methods

Sleep quality, depressive and anxiety symptoms and quality of life (QoL) were assessed among 307 patients with CKD using Pittsburgh Sleep Quality Index Questionnaire, Hospital Anxiety Depression Scale Questionnaire and 12-item Short Form Health Survey Quality of Life Questionnaire, respectively. The prevalence of poor sleep quality and associated factors were determined. A p

Results

The mean age of the study participants was 51.40±15.17 years. The male:female ratio was 1.5:1 One hundred and twenty-one (39.4%) of the patients were on maintenance haemodialysis (MHD). The prevalence of poor sleep quality, anxiety symptoms and depressive symptoms among the patients was 50.2%, 37.8% and 17.6%, respectively. The prevalence of poor sleep quality in the CKD stages 3, 4, 5 and 5D was 38.1%, 42.6%, 52.2% and 58.7%, respectively. The prevalence of poor sleep quality was significantly higher in MHD patients compared with predialysis CKD (59.5% vs 43.6%; p=0.008). Factors associated with poor sleep quality were CKD stage (p=0.035), anaemia (p=0.003), pruritus (p=0.045), anxiety symptoms (p≤0.001), depressive symptoms (p≤0.001) and reduced QoL (p≤0.001). On multivariate analysis, factors associated with poor sleep were anxiety (AOR 2.19; 95% CI 1.27 to 3.79; p=0.005), anaemia (AOR 5.49; 95% CI 1.43 to 21.00;p=0.013) and reduced physical component of QoL (AOR 4.11; 95% CI 1.61 to 10.47; p=0.003).

Conclusion

Poor sleep quality is common among patients with CKD especially in the advanced stage. The significant factors associated with poor sleep quality were QoL, anaemia and anxiety symptoms. These factors should be adequately managed to improve the overall outcomes of patients with CKD.

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