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Tiza-Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study

Por: Vollmer-Raschdorf · S. · Rashidi-Alavijeh · J. · Voigt · S. · Hengel · H. · Borchardt · B. · Huzly · D. · Hüssler · E.-M. · in der Schmitten · J. · Halenius · A. · Willuweit · K. · Botzenhardt · S. · Trilling · M. · Boettler · T. · Dehnen · D.
Introduction

Shingrix, an effective adjuvanted, recombinant herpes zoster vaccine (RZV), has been available since 2018. Immunocompromised patients are known to be predisposed to vaccine failure. In-vitro testing of immunological surrogates of vaccine protection could be instrumental for monitoring vaccination success. So far, no test procedure is available for vaccine responses to RZV that could be used on a routine basis.

Methods and analysis

This is a single-centre, three-arm, parallel, longitudinal cohort study aspiring to recruit a total of 308 patients (103 with a liver cirrhosis Child A/B, 103 after liver transplantation (both ≥50 years), 102 immunocompetent patients (60–70 years)). Blood samples will be taken at seven data collection points to determine varicella zoster virus (VZV) and glycoprotein E (gE)-specific IgG and T cell responses. The primary study outcome is to measure and compare responses after vaccination with RZV depending on the type and degree of immunosuppression using gE-specific antibody detection assays. As a secondary outcome, first, the gE-specific CD4+ T cell response of the three cohorts will be compared and, second, the gE-VZV antibody levels will be compared with the severity of possible vaccination reactions. The tertiary outcome is a potential association between VZV immune responses and clinical protection against shingles.

Ethics and dissemination

Ethical approval was issued on 07/11/2022 by the Ethics Committee Essen, Germany (number 22-10805-BO). Findings will be published in peer-reviewed open-access journals and presented at local, national and international conferences.

Trial registration number

German Clinical Trials Registry (number DRKS00030683).

Study protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-bli

Por: Hessler · N. · Kordowski · A. · Sasse · J. · Ahlemann · G. · Schulz · F. · Schröder · T. · Exner · A. · Jablonski · L. · Jappe · U. · Bischoff · S. C. · Grzegorzek · M. · König · I. R. · Sina · C.
Introduction

Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

Methods and analysis

The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

Ethics and dissemination

The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

German Clinical Trials Register (DRKS00029323).

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.

Intranasal antihistamines and corticosteroids in the treatment of allergic rhinitis: a systematic review and meta-analysis protocol

Por: Sousa-Pinto · B. · Vieira · R. J. · Brozek · J. · Cardoso-Fernandes · A. · Lourenco-Silva · N. · Ferreira-da-Silva · R. · Ferreira · A. · Gil-Mata · S. · Bedbrook · A. · Klimek · L. · Fonseca · J. A. · Zuberbier · T. · Schünemann · H. J. · Bousquet · J.
Introduction

Intranasal antihistamines and corticosteroids are some of the most frequently used drug classes in the treatment of allergic rhinitis. However, there is uncertainty as to whether effectiveness differences may exist among different intranasal specific medications. This systematic review aims to analyse and synthesise all evidence from randomised controlled trials (RCTs) on the effectiveness of intranasal antihistamines and corticosteroids in rhinitis nasal and ocular symptoms and in rhinoconjunctivitis-related quality-of-life.

Methods and analysis

We will search four electronic bibliographic databases and three clinical trials databases for RCTs (1) assessing patients ≥12 years old with seasonal or perennial allergic rhinitis and (2) comparing the use of intranasal antihistamines or corticosteroids versus placebo. Assessed outcomes will include the Total Nasal Symptom Score (TNSS), the Total Ocular Symptom Score (TOSS) and the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). We will assess the methodological quality of included primary studies by using the Cochrane risk-of-bias tool. Certainty in the body of evidence for the analysed outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We will perform a random-effects meta-analysis for each assessed medication and outcome, presenting results as pooled mean differences and standardised mean differences. Heterogeneity will be explored by sensitivity and subgroup analyses, considering (1) the risk of bias, (2) the follow-up period and (3) the drug dose.

Ethics and dissemination

Ethical considerations will not be required. Results will be disseminated in a peer-review journal.

PROSPERO registration number

CRD42023416573.

Latent profile analysis of nurses perceived professional benefits in China: a cross-sectional study

Por: Sun · C. · Jiang · H. · Yao · Q. · Wang · X. · Wen · X. · Liu · H.
Objective

To identify profiles of nurses’ perceived professional benefits as well as their predictors.

Design

Cross-sectional study.

Setting

The study was carried out online in China.

Methods

From 6 July to 27 July 2022, a total of 1309 registered nurses participated in the survey by convenient sampling. We collected the Nurses’ Perceived Professional Benefits Questionnaire and demographic data. Using latent profile analysis (LPA), subgroups of nurses’ perceived professional benefits were identified. Moreover, univariate and multinomial logistic regression analyses were conducted to find the factors that were linked with the profiles.

Results

The survey was validly completed by 1309 nurses, with a 92.9% effective return rate. The findings of the LPA demonstrated three unique profiles: low-perceived professional benefits (11.8%), moderate-perceived professional benefits (57.1%) and high-perceived professional benefits (31.1%). There was a correlation between marital status, the number of night shifts per month and leadership role.

Conclusions

According to our research, registered nurses have three unique professional benefit profiles. In order to sustain the nursing workforce, despite the fact that nurses get a high level of professional benefits, interventions are necessary to increase nurses’ perception of their professional value.

Comparison of ultrasound-guided and traditional localisation in intraspinal anesthesia: a systematic review and network meta-analysis

Por: Zhang · Y. · Peng · M. · Wei · J. · Huang · J. · Ma · W. · Li · Y.
Objectives

The optimal puncture technique for neuraxial anaesthesia in different populations is unclear. We sought to obtain data from randomised controlled trials comparing the impact of ultrasound-guided technology and traditional positioning technology on the success rate of neuraxial anaesthesia.

Design

Systematic review and network meta-analysis using study populations, interventions, intervention comparisons, outcome measures and study types.

Data sources

PubMed, Embase, Cochrane Library and Web of science were searched until 31 September 2022.

Eligibility criteria

We included randomised controlled trials comparing three types of neuraxial anaesthesia: ultrasound-assisted, ultrasound real-time guidance and conventional positioning to describe which neuraxial anaesthesia modality is best for patients and to recommend the appropriate one for different populations.

Data extraction and synthesis

Five independent reviewers retrieved, screened and edited included studies using standardised methods. Assess risk of bias using the Cochrane Collaboration and Evidence Project tools. Network meta-analysis was performed using STATA V.15 statistical software.

Results

Twenty-two studies containing three different interventions were included. The SUCRA values of first-pass success rates for the three neuraxial anaesthesia methods were real-time guidance (82.8%), ultrasound-assisted (67.1%) and traditional positioning (0.1%). Both ultrasound techniques improved first-pass success rates compared with traditional localization, but there was no significant difference between the two. Subgroup analysis showed that the use of real-time ultrasound guidance for neuraxial anaesthesia in pregnant and patients with obesity improved first-pass success rates. Ultrasound-assisted technology can improve first-attempt success rates in older patients with abnormal lumbar spine anatomy.

Conclusion

Compared with conventional positioning, ultrasound guidance technology can improve the first-pass success rate of neuraxial anaesthesia, but there is no significant difference between ultrasound-assisted and real-time guidance technology. The results of subgroup analysis tell us that the most suitable neuraxial anaesthesia method is different for different groups of people.

PROSPERO registration number

PROSPERO number: CRD42022376041.

Protocol for a longitudinal cohort study of Lyme disease with physical, mental and immunological assessment

Por: Loeb · M. · Brison · R. · Bramson · J. · Hatchette · T. · Sander · B. · Stringer · E.
Introduction

There are limited data on the longitudinal impact of Lyme disease. Predictors of recovery have not been fully established using validated data collection instruments. There are sparse data on the immunological response to infection over time.

Methods and analysis

This study is a longitudinal cohort study that will recruit 120 participants with Lyme disease in Ontario and Nova Scotia, Canada, with follow-up for up to 24 months. Data will be collected using the Short-Form 36 physical and mental component summaries, Depression and Anxiety Severity Scale Questionnaire, Fatigue Severity Scale and a battery of neuropsychological tests. Mononuclear cells, gene expression and cytokine profiling from blood samples will be used to assess immunological response. Analyses will include the use of non-linear mixed-effects modelling and proportional hazards models.

Ethics and dissemination

Ethics approval has been obtained from ethics boards at McMaster University (Hamilton Integrated Research Ethics Board) (7564), Queens University (EMD 315-20) and Nova Scotia Health Research Ethics Board (1027173), and the study is enrolling participants. Written informed consent is obtained from all participants. The results will be disseminated by publication in a peer-reviewed journal and presented at a relevant conference. A brief report will be provided to decision-makers and patient groups.

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/).

Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study

Por: Joeris · A. · Sprague · S. · Blauth · M. · Gosch · M. · Wattanapanom · P. · Jarayabhand · R. · Poeze · M. · Wong · M. K. · Kwek · E. B. K. · Hegeman · J. H. · Perez-Uribarri · C. · Guerado · E. · Revak · T. J. · Zohner · S. · Joseph · D. · Phillips · M. R.
Introduction

Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.

Methods

The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.

Results

GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (–$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (–$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).

Conclusions

This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.

Level of evidence

Economic, level 2.

Trial registration number

NCT02297581.

Financing networks of care: a cross-case analysis from six countries

Por: Villalobos Dintrans · P. · Roder-DeWan · S. · Wang · H.
Objectives

Describe experiences of countries with networks of care’s (NOCs’) financial arrangements, identifying elements, strategies and patterns.

Design

Descriptive using a modified cross-case analysis, focusing on each network’s financing functions (collecting resources, pooling and purchasing).

Setting

Health systems in six countries: Argentina, Australia, Canada, Singapore, the United Kingdom and the USA.

Participants

Large-scale NOCs.

Results

Countries differ in their strategies to implement and finance NOCs. Two broad models were identified in the six cases: top-down (funding centrally designed networks) and bottom-up (financing individual projects) networks. Despite their differences, NOCs share the goal of improving health outcomes, mainly through the coordination of providers in the system; these results are achieved by devoting extra resources to the system, including incentives for network formation and sustainability, providing extra services and setting incentive systems for improving the providers’ performance.

Conclusions

Results highlight the need to better understand the financial implications and alternatives for designing and implementing NOCs, particularly as a strategy to promote better health in low- and middle-income settings.

Predictive model for estimating the risk of high-altitude pulmonary edema: a single-centre retrospective outcome-reporting study

Por: Suona · Y. · Gesang · L. · Danzeng · Z. · Ci · B. · Zhaxi · Q. · Huang · J. · Zhang · R.
Objective

To develop the first prediction model based on the common clinical symptoms of high-altitude pulmonary edema (HAPE), enabling early identification and an easy-to-execute self-risk prediction tool.

Methods

A total of 614 patients who consulted People’s Hospital of Tibet Autonomous Region between January 2014 and April 2022 were enrolled. Out of those, 508 patients (416 males and 92 females) were diagnosed with HAPE and 106 were patients without HAPE (33 females and 72 males). They were randomly distributed into training (n=431) and validation (n=182) groups. Univariate and multivariate analysis were used to screen predictors of HAPE selected from the 36 predictors; nomograms were established based on the results of multivariate analysis. The receiver operating characteristic curve (ROC) was developed to obtain the area under the ROC curve (AUC) of the predictive model, and its predictive power was further evaluated by calibrating the curve, while the Decision Curve Analysis (DCA) was developed to evaluate the clinical applicability of the model, which was visualised by nomogram.

Results

All six predictors were significantly associated with the incidence of HAPE, and two models were classified according to whether the value of SpO2 (percentage of oxygen in the blood) was available in the target population. Both could accurately predict the risk of HAPE. In the validation cohort, the AUC of model 1 was 0.934 with 95% CI (0.848 to 1.000), and model 2 had an AUC of 0.889, 95% CI (0.779 to 0.999). Calibration plots showed that the predicted and actual HAPE probabilities fitted well with internal validation, and the clinical decision curve shows intervention in the risk range of 0.01–0.98, resulting in a net benefit of nearly 99%.

Conclusion

The recommended prediction model (nomogram) could estimate the risk of HAPE with good precision, high discrimination and possible clinical applications for patients with HAPE. More importantly, it is an easy-to-execute scoring tool for individuals without medical professionals’ support.

Predictors on outcomes of cardiovascular disease of male patients in Malaysia using Bayesian network analysis

Por: Juhan · N. · Zubairi · Y. Z. · Mahmood Zuhdi · A. S. · Mohd Khalid · Z.
Objectives

Despite extensive advances in medical and surgical treatment, cardiovascular disease (CVD) remains the leading cause of mortality worldwide. Identifying the significant predictors will help clinicians with the prognosis of the disease and patient management. This study aims to identify and interpret the dependence structure between the predictors and health outcomes of ST-elevation myocardial infarction (STEMI) male patients in Malaysian setting.

Design

Retrospective study.

Setting

Malaysian National Cardiovascular Disease Database-Acute Coronary Syndrome (NCVD-ACS) registry years 2006–2013, which consists of 18 hospitals across the country.

Participants

7180 male patients diagnosed with STEMI from the NCVD-ACS registry.

Primary and secondary outcome measures

A graphical model based on the Bayesian network (BN) approach has been considered. A bootstrap resampling approach was integrated into the structural learning algorithm to estimate probabilistic relations between the studied features that have the strongest influence and support.

Results

The relationships between 16 features in the domain of CVD were visualised. From the bootstrap resampling approach, out of 250, only 25 arcs are significant (strength value ≥0.85 and the direction value ≥0.50). Age group, Killip class and renal disease were classified as the key predictors in the BN model for male patients as they were the most influential variables directly connected to the outcome, which is the patient status. Widespread probabilistic associations between the key predictors and the remaining variables were observed in the network structure. High likelihood values are observed for patient status variable stated alive (93.8%), Killip class I on presentation (66.8%), patient younger than 65 (81.1%), smoker patient (77.2%) and ethnic Malay (59.2%). The BN model has been shown to have good predictive performance.

Conclusions

The data visualisation analysis can be a powerful tool to understand the relationships between the CVD prognostic variables and can be useful to clinicians.

Perception of and legal compliance with the law prohibiting cigarette sales to minors in Thailand following the raising of the minimum selling age to 20 years: a cross-sectional survey

Por: Phetphum · C. · Chomson · S. · Wangwonsin · A. · Prajongjeep · A. · Keeratisiroj · O.
Objectives

The minimum age for cigarette sales in Thailand was increased from 18 to 20 years, as stipulated in the Tobacco Products Control Act B.E. 2017. This study investigated tobacco retailers’ perceptions, cigarette sales behaviour and other factors relevant to selling cigarettes to people younger than 20 years in areas surrounding schools in Thailand.

Design

Cross-sectional survey.

Setting

Tobacco shops within a radius of 500 m of secondary schools across four regions of Thailand. Data collection took place between May and August 2019.

Participants

1440 tobacco retailers (grocery or convenience stores) were sampled via a stratified, two-stage cluster sampling method. 1021 retailers completed the self-administered questionnaire.

Outcome measures

Tobacco sales to people younger than 20 years.

Results

The prevalence of the retailers’ cigarette sales to youth younger than 20 years was 38.20% (95% CI 35.2% to 41.3%). Multivariable logistic regression analysis revealed associations with sale of single cigarettes (adjusted OR (AOR) 23.14, 95% CI 15.13 to 35.39), self-service sale of cigarettes (4.21, 2.59 to 6.86) and display of cigarettes at the point of sale (2.39, 1.47 to 3.89). Cigarette sales to underage youth were higher among retailers located in the northeast region (AOR 2.09, 95% CI 1.20 to 3.64) and among those who did not perceive the prosecution of violators in the past year (1.85, 1.16 to 2.96).

Conclusion

A large percentage of cigarette retailers violated the laws related to underage cigarette sales. Measures to minimise retailers’ legally non-compliant sales behaviours should be implemented along with improved legal enforcement.

Scoping review of African health histories: a protocol

Por: Karamagi · H. C. · Oduwole · E. O. · Sy · S. · Adamu · A. A. · Seydi · A. B. W. · Wiysonge · C. S.
Introduction

The history of African health is closely entwined with the history of the continent itself—from precolonial times to the present day. A study of African health histories is critical to understanding the complex interplay between social, economic, environmental and political factors that have shaped health outcomes on the continent. Furthermore, it can shed light on the successes and failures of past health interventions, inform current healthcare policies and practices, and guide future efforts to address the persistent health challenges faced by African populations. This scoping review aims to identify existing literature on African health histories.

Methods and analysis

The Arksey and O’Malley’s framework for conducting scoping reviews will be utilised for the proposed review, which will be reported in compliance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. The main review question is ‘What literature exists on the history of health practices and healthcare delivery systems in Africa from the precolonial era through to the sustainable development goal era?’ Keywords such as Africa, health and histories will be used to develop a search strategy to interrogate selected databases and grey literature repositories such as PubMed, Scopus, Web of Science and WHOLIS. Two authors will independently screen titles and abstracts of retrieved records. One author will extract data from articles that meet the inclusion criteria using a purposively designed data charting. The data would be coded and analysed thematically, and the findings presented narratively.

Ethics and dissemination

The scoping review is part of a larger project which has approval from the WHO AFRO Ethics Research Committee (Protocol ID: AFR/ERC/2022/11.3). The protocol and subsequent review will be submitted to the integrated African Health Observatory and published in a peer-reviewed journal.

Registration details

https://osf.io/xsaez/

How digital health translational research is prioritised: a qualitative stakeholder-driven approach to decision support evaluation

Por: Bamgboje-Ayodele · A. · McPhail · S. M. · Brain · D. · Taggart · R. · Burger · M. · Bruce · L. · Holtby · C. · Pradhan · M. · Simpson · M. · Shaw · T. J. · Baysari · M. T.
Objectives

Digital health is now routinely being applied in clinical care, and with a variety of clinician-facing systems available, healthcare organisations are increasingly required to make decisions about technology implementation and evaluation. However, few studies have examined how digital health research is prioritised, particularly research focused on clinician-facing decision support systems. This study aimed to identify criteria for prioritising digital health research, examine how these differ from criteria for prioritising traditional health research and determine priority decision support use cases for a collaborative implementation research programme.

Methods

Drawing on an interpretive listening model for priority setting and a stakeholder-driven approach, our prioritisation process involved stakeholder identification, eliciting decision support use case priorities from stakeholders, generating initial use case priorities and finalising preferred use cases based on consultations. In this qualitative study, online focus group session(s) were held with stakeholders, audiorecorded, transcribed and analysed thematically.

Results

Fifteen participants attended the online priority setting sessions. Criteria for prioritising digital health research fell into three themes, namely: public health benefit, health system-level factors and research process and feasibility. We identified criteria unique to digital health research as the availability of suitable governance frameworks, candidate technology’s alignment with other technologies in use,and the possibility of data-driven insights from health technology data. The final selected use cases were remote monitoring of patients with pulmonary conditions, sepsis detection and automated breast screening.

Conclusion

The criteria for determining digital health research priority areas are more nuanced than that of traditional health condition focused research and can neither be viewed solely through a clinical lens nor technological lens. As digital health research relies heavily on health technology implementation, digital health prioritisation criteria comprised enablers of successful technology implementation. Our prioritisation process could be applied to other settings and collaborative projects where research institutions partner with healthcare delivery organisations.

Cohort profile: the longitudinal National Growth and Health Study (NGHS) of black and white girls from Northern California tracking how behavioural and psychosocial risk factors predict cardiovascular risk and biological ageing in midlife and in offspring

Por: Laraia · B. · Brownell · K. · Friebur · R. · Perera · R. · Brown · E. · Mayer · S. E. · Feng · I. · Clermont · S. · Ritchie · L. D. · Epel · E.
Purpose

The National Heart, Lung and Blood Institute Growth and Health Study (NGHS) prospectively collected anthropometric, biospecimens, clinical, health behaviour and psychosocial measures associated with cardiovascular disease from childhood to young adulthood. The aim of the current study was to assess the impact of stress, dysregulated eating and social genomic biomarkers on cardiometabolic risk factors among the original participants now in midlife and their children.

Participants

Beginning in 1987–1988, NGHS recruited black and white girls (age 9–10 years) from socioeconomically diverse backgrounds from from three sites: Cincinnati, Ohio; Washington, DC; and Western Contra Costa County, California (N=2379) and followed them for 10 years. The study maintained an 89% retention rate. The current study is 30 years after the start of the original study and focused on the participants of California (n=887) and their children aged 2–17 years. We re-enrolled 624 of 852 eligible participants (73%): 49.2% black and 50.8% white. The mean age was 39.5 years. Among the 645 eligible biological children, 553 were enrolled; 49% black and 51% white, with 51.5% girls and 48.5% boys. The mean age was 9.3 years.

Findings to date

Longitudinal analysis of adolescent drive for thinness predicted higher scores for drive for thinness during midlife, which was indirectly associated with greater adult body mass index through adult drive for thinness. Latent trajectory modelling of adolescent growth over 10 years found that women with persistently high weight trajectory had twice the odds of having children who met the definition for obesity compared with the persistently normal group, adjusting for adult weight.

Future plans

New studies on neighbourhood socioeconomic status, food insecurity and additional biomarkers of chronic stress, microbiome and accelerated ageing (ie, telomere length and epigenetic clock) are underway. We are developing a 10-year follow-up to understand changes in ageing biomarkers of the participants and their children.

Trial registration number

NCT00005132.

Impact of the COVID-19 pandemic on the cost of chronic diseases treatment and care at public hospitals in Wallaga zones, Oromia Regional State, Ethiopia: a hospital-based, cross-sectional study

Por: Terefa · D. R. · Tesfaye · E. · Tolessa · B. E. · Desisa · A. E. · Olani · W. · Fetensa · G. · Chego · M. · Abdisa · E. · Turi · E. · Bekuma · T. T. · Getachew · M. · Tesfaye · L. · Tilahun · T.
Objective

Globally, around one-third of the population has at least one long-term health condition that could be affected by the COVID-19 pandemic. Despite the fact that studies have revealed the direct impact of COVID-19 on healthcare provision and utilisation, the impact of the pandemic on the cost of chronic disease treatment and care from a patient perspective was scanty. So, the study aimed to determine the impact of the COVID-19 pandemic on cost of chronic diseases treatment and care at public hospitals in Wallaga zones, Oromia Regional State, Ethiopia, from 1 August to 31 August 2020.

Methods

An institutional-based cross-sectional study design was used, and the sample size for the study (n=642) was determined using a single population mean formula. Data were collected using interviews and analysed using SPSS V.25. Descriptive statistics were performed, and the cost of follow-up care before and after the pandemic was compared using a related-samples Wilcoxon signed-rank test, declaring the level of significance of the median cost difference at p

Results

A total of 642 patients were included in the study, of whom 605 (94.2%) responded to the interviews. There was a significant median cost difference (n=593, Z=5.05, p=0.001) between the cost of chronic diseases among follow-up patients during the pandemic and the costs incurred by these patients before the pandemic.

Conclusion

The cost of follow-up care among chronic disease patients during the COVID-19 pandemic was significantly higher compared with before the pandemic era. Therefore, healthcare providers should arrange special fee waiver mechanisms for chronic disease healthcare costs during such types of pandemics and provide the services at proximal health facilities.

Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial

Introduction

Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses.

Methods and analysis

We designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised controlled trial assigning 205 patients each to intervention and control in one of Mexico’s largest public oncology hospitals. The intervention will be provided for 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months.

Ethics and dissemination

The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences.

Trial registration number

NCT05925257.

Prevalence and determinants of high-risk human papilloma virus among men who have sex with men in Benin: a cross-sectional study embedded in a demonstration project on pre-exposure prophylaxis against HIV

Por: Diabate · S. · Behanzin · L. · Guedou · F. · Olodo · M. · Goma-Matsetse · A. E. · Aza-Gnandji · M. · Dossouvo · A. · Akpaca · A. · Chagas · E. · Gangbo · F. A. · Zannou · D. M. · Alary · M.
Objectives

This study aims to assess the prevalence and factors associated with anal high-risk human papilloma virus (HR-HPV).

Design

A cross-sectional study conducted from 24 August 2020 to 24 November 2020.

Setting

Primary care, Cotonou, Benin.

Participants

204 HIV-negative men who have sex with men initiating oral pre-exposure prophylaxis.

Primary outcome measure

Anal HR-HPV genotypes using GeneXpert HPV assay. Fourteen HR-HPV were evaluated: HPV-16 and HPV-18/45 in 2 distinct channels and the 11 other genotypes as a pooled result (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68). The potential independent variables analysed included anal gonorrhoea and chlamydia infections, and sociodemographic and sexual behaviour factors. To assess the determinants of HR-HPV, univariate and multivariate Poisson regression models were performed by using SAS V.9.4.

Results

Mean age±SD was 25.9±4.8 years. 131/204 men claimed insertive sex procured more pleasure. Thirty-two participants, accounting for 15.7% of the study sample, had gonorrhoea and/or chlamydia. The prevalence of any HR-HPV genotype was 36.3% (95% CI 30.0% to 43.0%). In total, 7.8% of men had HPV-16 and 7.4% had HPV-18/45. The prevalence for the pooled genotypes (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68) was 29.9%. Receptive anal sex during the last 6 months was strongly associated with prevalent HR-HPV infections. The adjusted proportion ratio (aPR) was 1.93 (95% CI 1.31 to 2.83). Gonorrhoea and chlamydia were also associated with the outcome of interest; p value for both infections was

Conclusions

In Benin, anal HR-HPV was common among HIV-negative men who have sex with men. Among this highly vulnerable population, there is a need for integrated preventive and management strategies targeting HPV and other sexually transmitted infections.

Systematic review of seroprevalence of SARS-CoV-2 antibodies and appraisal of evidence, prior to the widespread introduction of vaccine programmes in the WHO European Region, January-December 2020

Por: Vaughan · A. · Duffell · E. · Freidl · G. S. · Lemos · D. S. · Nardone · A. · Valenciano · M. · Subissi · L. · Bergeri · I. · K Broberg · E. · Penttinen · P. · Pebody · R. · Keramarou · M.
Objectives

Systematic review of SARS-CoV-2 seroprevalence studies undertaken in the WHO European Region to measure pre-existing and cumulative seropositivity prior to the roll out of vaccination programmes.

Design

A systematic review of the literature.

Data sources

We searched MEDLINE, EMBASE and the preprint servers MedRxiv and BioRxiv in the WHO ‘COVID-19 Global literature on coronavirus disease’ database using a predefined search strategy. Articles were supplemented with unpublished WHO-supported Unity-aligned seroprevalence studies and other studies reported directly to WHO Regional Office for Europe and European Centre for Disease Prevention and Control.

Eligibility criteria

Studies published before the widespread implementation of COVID-19 vaccination programmes in January 2021 among the general population and blood donors, at national and regional levels.

Data extraction and synthesis

At least two independent researchers extracted the eligible studies; a third researcher resolved any disagreements. Study risk of bias was assessed using a quality scoring system based on sample size, sampling and testing methodologies.

Results

In total, 111 studies from 26 countries published or conducted between 1 January 2020 and 31 December 2020 across the WHO European Region were included. A significant heterogeneity in implementation was noted across the studies, with a paucity of studies from the east of the Region. Sixty-four (58%) studies were assessed to be of medium to high risk of bias. Overall, SARS-CoV-2 seropositivity prior to widespread community circulation was very low. National seroprevalence estimates after circulation started ranged from 0% to 51.3% (median 2.2% (IQR 0.7–5.2%); n=124), while subnational estimates ranged from 0% to 52% (median 5.8% (IQR 2.3%–12%); n=101), with the highest estimates in areas following widespread local transmission.

Conclusions

The low levels of SARS-CoV-2 antibody in most populations prior to the start of vaccine programmes underlines the critical importance of targeted vaccination of priority groups at risk of severe disease, while maintaining reduced levels of transmission to minimise population morbidity and mortality.

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