Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study

Background
During adolescence, behaviours are initiated that will have substantial impacts on the individual’s short-term and long-term health and well-being. However, adolescents rarely have regular contact with health services, and available services are not always appropriate for their needs. We co-developed with adolescents a health and well-being check-up programme (Y-Check). This paper describes the methods to evaluate the feasibility, acceptability, short-term effects and cost-effectiveness of Y-Check in three African cities.

Method
This is a multi-country prospective intervention study, with a mixed-method process evaluation. The intervention involves screening, on-the-spot care and referral of adolescents through health and well-being check-up visits. In each city, 2000 adolescents will be recruited in schools or community venues. Adolescents will be followed-up at 4 months. The study will assess the effects of Y-Check on knowledge and behaviours, as well as clinical outcomes and costs. Process and economic evaluations will investigate acceptability, feasibility, uptake, fidelity and cost effectiveness.

Ethics and dissemination
Approval has been received from the WHO (WHO/ERC Protocol ID Number ERC.0003778); Ghana Health Service (Protocol ID Number GHS-ERC: 027/07/22), the United Republic of Tanzania National Institute for Medical Research (Clearance No. NIMR/HQ/R.8a/Vol.IX/4199), the Medical Research Council of Zimbabwe (Approval Number MRCZ/A/2766) and the LSHTM (Approval Numbers 26 395 and 28312). Consent and disclosure are addressed in the paper. Results will be published in three country-specific peer-reviewed journal publications, and one multicountry publication; and disseminated through videos, briefs and webinars. Data will be placed into an open access repository. Data will be deidentified and anonymised.

Trial registration number
NCT06090006.

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Is screening for motor skill deficits in Tyrolean preschool children warranted and feasible? A protocol for a two-stage cross-sectional study

Introduction
Children with developmental coordination disorder (DCD) show deviations in motor development and motor skills in early childhood where the learning and execution of coordinated motor skills are below the level expected for their age. Early detection of DCD is critical to provide an opportunity for intervention and support, yet many cases remain undetected until school age. The study described aims to determine the warranty, feasibility and validity of a mobility screening in Tyrolean kindergartens and evaluate its potential benefit to enhance the motor development prospects of affected children.

Methods and analysis
This research employs a two-stage cross-sectional approach with 6 months of follow-up assessments. The initial stage involves a playful mobility screening for all participating kindergarten children, followed by individual assessments for those displaying conspicuous motor skills. Motor skills will be evaluated using MobiScreen 4–6 and the Movement Assessment Battery for Children-2. Prior to the screening, informed consent is obtained from kindergarten bodies and authorities, parents and the children themselves. Parents are provided with information sheets and questionnaires to assess their attitudes and their child’s eligibility. The study described aims to form a representative sample of kindergarten children, aged 4–6, in Tyrol. To target approximately 20–40 children with DCD for follow-up, the goal is to include 650 children, assuming an incidence of 3%–6%. For the follow-up, matching control groups will be formed and information about how identified motor deficits were addressed, including therapies or sports, will be gathered. Quantitative data will mainly be analysed descriptively, while feedback from kindergarten teachers regarding the practical implementation will be analysed using qualitative content analyses, according to Mayring.

Ethics and dissemination
The study has been approved by the Research Committee for Scientific Ethical Questions (RCSEQ 3369/24). Findings will be disseminated through contributions, peer-reviewed journals, and conferences.

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Screening for adverse social conditions in child healthcare settings: protocol for a systematic review

Introduction
Adverse social conditions affect children’s development and health outcomes from preconception throughout their life course. Early identification of adverse conditions is essential for early support of children and their families. Healthcare contacts with children provide a unique opportunity to screen for adverse social conditions and to take preventive action to identify and address emerging, potentially harmful or accumulating social problems. The aim of our study is to identify and describe available screening tools in outpatient and inpatient healthcare settings that capture social conditions that may affect children’s development, health or well-being.

Methods and analysis
We will conduct a systematic review and will report the results following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. A systematic search of three databases (PubMed (Ovid), PsycInfo (EBSCOhost) and Web of Science Core Collection (Clarivate)) for English-language and German-language articles from 2014 to date will be conducted. We will include peer-reviewed articles that develop, describe, test or use an instrument to screen children for multiple social conditions in paediatric clinics or other outpatient or inpatient child healthcare settings. Key study characteristics and information on screening tools will be extracted and presented in structured tables to summarise the available evidence. We will assess the methodological quality of the instruments with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.

Ethics and dissemination
Ethical approval is not required for this study as we will not be collecting any personal data. Dissemination will consist of publications, presentations, and other knowledge translation activities.

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Performance of CADM1, MAL and miR124-2 methylation as triage markers for early detection of cervical cancer in self-collected and clinician-collected samples: an exploratory observational study in Papua New Guinea

Objective
WHO recommends human papillomavirus (HPV) testing for cervical screening, with triage of high-risk HPV (hrHPV) positive women. However, there are limitations to effective triage for low-resource, high-burden settings, such as Papua New Guinea. In this exploratory study, we assessed the performance of host methylation as triage tools for predicting high-grade squamous intraepithelial lesions (HSIL) in self-collected and clinician-collected samples.

Design
Exploratory observational study.

Setting
Provincial hospital, same-day cervical screen-and-treat trial, Papua New Guinea.

Participants
44 hrHPV+women, with paired self/clinician-collected samples (4 squamous cell carcinomas (SCC), 19 HSIL, 4 low-grade squamous intraepithelial lesions, 17 normal).

Primary and secondary outcome measures
Methylation levels of CADM1, MAL and miR124-2 analysed by methylation-specific PCRs against the clinical endpoint of HSIL or SCC (HSIL+) measured using liquid-based-cytology/p16-Ki67 stain.

Results
In clinician-collected samples, MAL and miR124-2 methylation levels were significantly higher with increasing grade of disease (p=0.0046 and p

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A single-cell atlas of the murine pancreatic ductal tree identifies novel cell populations with potential implications in pancreas regeneration and exocrine pathogenesis.

Pancreatic ducts form an intricate network of tubules that secrete bicarbonate and drive acinar secretions into the duodenum. This network is formed by centroacinar cells, terminal, intercalated, intracalated ducts, and the main pancreatic duct. Ductal heterogeneity at the single-cell level has been poorly characterized; therefore, our understanding of the role of ductal cells in pancreas regeneration and exocrine pathogenesis has been hampered by the limited knowledge and unexplained diversity within the ductal network.

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What is the association between the microbiome and cognition? An umbrella review protocol

Introduction
Cognitive impairment is reported in a variety of clinical conditions including Alzheimer’s disease, Parkinson’s and ‘long-COVID’. Interestingly, many of these clinical conditions are also associated with microbial dysbiosis. This comanifestation of cognitive and microbiome findings in seemingly unrelated maladies suggests that they could share a common mechanism and potentially presents a treatment target. Although a rapidly growing body of literature has documented this comorbid presentation within specific conditions, an overview highlighting potential parallels across healthy and clinical populations is lacking. The objective of this umbrella review, therefore, is to summarise and synthesise the findings of these systematic reviews.

Methods and analysis
On 2 April 2023, we searched MEDLINE (Pubmed), Embase (Ovid), the Web of Science (Core Collection), the Cochrane Library of Systematic Reviews and Epistemonikos as well as grey literature sources, for systematic reviews on clinical conditions and interventions where cognitive and microbiome outcomes were coreported. An updated search will be conducted before completion of the project if the search-to-publication date is >1 year old. Screening, data abstraction and quality assessment (AMSTAR 2, A MeaSurement Tool to Assess systematic Reviews) will be conducted independently and in duplicate, with disagreements resolved by consensus. Evidence certainty statements for each review’s conclusions (eg, Grading of Recommendations Assessment, Development and Evaluation (GRADE)) will be extracted or constructed de novo. A narrative synthesis will be conducted and delineated by the review question. Primary study overlap will be visualised using a citation matrix as well as calculated using the corrected covered area method.

Ethics and dissemination
No participant-identifying information will be used in this review. No ethics approval was required due to our study methodology. Our findings will be presented at national and international conferences and disseminated via social media and press releases. We will recruit at least one person living with cognitive impairment to collaborate on writing the plain language summary for the review.

PROSPERO registration number
CRD42023412903

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Nutritional interventions and related efforts addressing undernutrition during rehabilitation after acquired brain injury: a scoping review protocol

Introduction
Patients with an acquired brain injury (ABI) are at an increased risk of undernutrition due to the disease-related inflammation and other numerous symptoms that impact their nutrition. Unfortunately, recommendations related to nutritional interventions and related efforts vary. The objective of this scoping review is to map the body of literature on nutritional interventions and related efforts provided by health professionals, such as screening or assessments, addressing undernutrition in adults with a moderate to severe ABI during the subacute rehabilitation pathway.

Methods and analysis
The review follows the Joanna Briggs Institute methodology for scoping reviews. The librarian-assisted search strategy will be conducted in the bibliographical databases: MEDLINE (PubMed), Embase, CINAHL, Web of Science and OpenGrey. Indexed and grey literature in English, German or Scandinavian languages from January 2010 will be considered for inclusion. Two independent reviewers will conduct the iterative process of screening the identified literature, paper selection and data extraction. Disagreements will be resolved by discussion until a consensus is reached. A template will be used to guide the data extraction. This scoping review will include research articles, methodological papers and clinical guidelines reporting on nutritional interventions or related efforts to prevent or address undernutrition in adult patients (≥18 years) with moderate to severe ABI within the first year after admission to rehabilitation hospital. We will map all kinds of nutritional efforts provided by professionals in different settings within high-income countries, including interventions targeting relatives.

Ethics and dissemination
This review will involve the collection and analysis of secondary sources that have been published and/or are publicly available. Therefore, ethics approval is not required. The results will be published in an international peer-reviewed journal, presented at scientific conferences and disseminated through digital science communication platforms.

Study registration
Open Science Framework: https://doi.org/10.17605/OSF.IO/H5GJX.

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Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women

Introduction
In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with ‘gold-standard’ reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries.

Method and analyses
Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer’s instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022.

Ethics and dissemination
Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.

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Prevalence of mental, behavioural or neurodevelopmental disorders according to the International Classification of Diseases 11: a scoping review protocol

Introduction
Due to a change in diagnostic prerequisites and the inclusion of novel diagnostic entities, the implementation of the 11th revision of the International Classification of Diseases (ICD-11) will presumably change prevalence rates of specific mental, behavioural or neurodevelopmental disorders and result in an altered prevalence rate for this grouping overall. This scoping review aims to summarise the characteristics of primary studies examining the prevalence of mental, behavioural or neurodevelopmental disorders based on ICD-11 criteria. The knowledge attained through this review will primarily characterise the methodological approaches of this research field and additionally assist in deciding which psychiatric diagnoses are—given the current literature—most relevant for subsequent systematic reviews and meta-analyses intended to approximate the magnitude of prevalence rates while providing a first glimpse of the range of expected (differences in) prevalence rates in these conditions.

Methods and analysis
MEDLINE, Embase, Web of Science and PsycINFO will be searched from 2011 to present without any language filters. This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review guidelines.
We will consider (a) cross-sectional and longitudinal studies (b) focusing on the prevalence rates of mental, behavioural or neurodevelopmental disorders (c) using ICD-11 criteria for inclusion. The omission of (a) case numbers and sample size, (b) study period and period of data collection or (c) diagnostic procedures on full-text level is considered an exclusion criterion.
This screening will be conducted by two reviewers independently from one another and a third reviewer will be consulted with disagreements. Data extraction and synthesis will focus on outlining methodological aspects.

Ethics and dissemination
We intend to publish our review in a scientific journal. As the primary data are publicly available, we do not require research ethics approval.

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Scalable Transdiagnostic Early Assessment of Mental Health (STREAM): a study protocol

Introduction
Early childhood development forms the foundations for functioning later in life. Thus, accurate monitoring of developmental trajectories is critical. However, such monitoring often relies on time-intensive assessments which necessitate administration by skilled professionals. This difficulty is exacerbated in low-resource settings where such professionals are predominantly concentrated in urban and often private clinics, making them inaccessible to many. This geographic and economic inaccessibility contributes to a significant ‘detection gap’ where many children who might benefit from support remain undetected. The Scalable Transdiagnostic Early Assessment of Mental Health (STREAM) project aims to bridge this gap by developing an open-source, scalable, tablet-based platform administered by non-specialist workers to assess motor, social and cognitive developmental status. The goal is to deploy STREAM through public health initiatives, maximising opportunities for effective early interventions.

Methods and analysis
The STREAM project will enrol and assess 4000 children aged 0–6 years from Malawi (n=2000) and India (n=2000). It integrates three established developmental assessment tools measuring motor, social and cognitive functioning using gamified tasks, observation checklists, parent-report and audio-video recordings. Domain scores for motor, social and cognitive functioning will be developed and assessed for their validity and reliability. These domain scores will then be used to construct age-adjusted developmental reference curves.

Ethics and dissemination
Ethical approval has been obtained from local review boards at each site (India: Sangath Institutional Review Board; All India Institute of Medical Science (AIIMS) Ethics Committee; Indian Council of Medical Research—Health Ministry Screening Committee; Malawi: College of Medicine Research and Ethics Committee; Malawi Ministry of Health—Blantyre District Health Office). The study adheres to Good Clinical Practice standards and the ethical guidelines of the 6th (2008) Declaration of Helsinki. Findings from STREAM will be disseminated to participating families, healthcare professionals, policymakers, educators and researchers, at local, national and international levels through meetings, academic journals and conferences.

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Can the 128-Hz tuning fork be an alternative to the biothesiometer for diabetic peripheral neuropathy screening? A cross-sectional study in a tertiary hospital in East India

Introduction
Diabetic neuropathy is frequently underdiagnosed and undertreated. Logistic problems accompany the routine use of the biothesiometer. Hence, we attempted to find a more easily available alternative.

Research design and methods
149 patients with diabetes visiting the outpatient endocrinology clinic were assessed for vibration sense using a 128-Hz tuning fork (absolute timing method) and a biothesiometer. A reading of >25 V on the biothesiometer (known as vibration perception threshold or VPT) was taken as the diagnostic criterion for severe neuropathy while >15 V was used as an indicator of the mild form. The sensitivity and specificity were calculated by constructing the receiver operating characteristic curve (ROC). A p value of

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Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia

Introduction
Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens (Schistosoma haematobium (Sh)). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia.

Methods and analysis
This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15–50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel.

Ethics and dissemination
The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

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Global prevalence of Borrelia burgdorferi and Anaplasma phagocytophilum coinfection in Ixodes tick populations: protocol for a systematic review and meta-analysis

Introduction
Ixodes ticks are pivotal in transmitting diseases like Lyme disease and human granulocytic anaplasmosis, caused by Borrelia burgdorferi and Anaplasma phagocytophilum, respectively. These pathogens not only affect humans through single or multiple tick bites but also pose risks to animal hosts, leading to potential coinfections. Despite regional studies indicating significant prevalence, their global coinfection data remain sparse. This study aims to bridge this gap through a systematic review and meta-analysis of B. burgdorferi and A. phagocytophilum coinfections in Ixodes ticks worldwide. Addressing data limitations and study variability, it seeks to provide a nuanced understanding of coinfection patterns, their epidemiological implications and inform targeted prevention strategies.

Methods and analysis
Following Preferred Reporting Items for Systematic Review and Meta-analysis Protocols 2015 guidelines and PROSPERO registration, this study will undertake a thorough database search without constraints on language or publication date, using standardised screening and data extraction protocols. The quality and bias of studies will be evaluated using Joanna Briggs Institute tools. In the statistical analysis phase, conducted in R, we will initially determine the use of fixed or random-effects models based on the assessment of data heterogeneity. This choice will guide the framework for subsequent analyses. Within the selected model’s framework, we will perform subgroup analyses and meta-regression to investigate the effects of various factors, ensuring that each step is tailored to the initial model selection to maintain analytical consistency.

Ethics and dissemination
As this study does not involve clinical research or data collection from subjects, ethical approval is not required. We will uphold ethical standards in synthesising and reporting data. Study outcomes will be published in peer-reviewed journals, communicating findings to the scientific community and contributing to the understanding of Ixodes tickborne diseases.

PROSPERO registration number
CRD42023449735.

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