EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents

Introduction
The identification of type 1 diabetes at an early presymptomatic stage has clinical benefits. These include a reduced risk of diabetic ketoacidosis (DKA) at the clinical manifestation of the disease and a significant reduction in clinical symptoms. The European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception (EDENT1FI) represents a pioneering effort to advance early detection of type 1 diabetes through public health screening. With the EDENT1FI Master Protocol, the project aims to harmonise and standardise screening for early-stage type 1 diabetes and care.

Methods and analysis
Public health islet autoantibody screening is conducted in the Czech Republic, Denmark, Germany, Italy, Poland, Portugal, Sweden and the UK. Between November 2023 (start date) and October 2028 (planned end date), an estimated number of 200 000 children and adolescents aged 1–17 years are expected to be screened. Screening is performed in capillary blood, examining different islet autoantibodies (autoantibodies against insulin, glutamic acid decarboxylase-65, insulinoma-associated antigen-2 and/or zinc transporter-8). Positive screening results undergo confirmation through a second antibody method. A second (venous) blood sample is requested if at least two autoantibodies are detected, to confirm the autoantibody status. Children and adolescents with confirmed two or more autoantibodies are invited to metabolic staging (oral glucose tolerance test, haemoglobin A1c (HbA1c), random glucose, optionally continuous glucose monitoring); an educational programme and recommendations for monitoring are provided. The feasibility and acceptability of screening are evaluated by feedback questionnaires. Pseudonymised data is collated in the EDENT1FI Registry. Study outcomes include country-specific screening rates, prevalences of stage 1 and stage 2 type 1 diabetes, number in EDENT1FI Registry, proportion with DKA and symptoms at clinical diagnosis and median HbA1c.

Ethics and dissemination
Following the EDENT1FI Master Protocol, site-specific protocols are developed and approved by local ethics committees (Technical University of Munich, Medical Faculty, Nr. 70/14; Medizinische Hochschule Hannover, Nr. 9588_BO_S_2021; Technische Universität Dresden, Nr. BO-EK-356082020; Center for Sundhed Region Hovedstaden, Nr. H-22053116; Swedish Ethical Review Authority, Nr. 2023-00312-01; National Health Service Health Research Authority and Health Care Research Wales, IRAS (Integrated Research Application System) project ID 309252; Italian National Institute of Health, National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions, Prot. PRE BIO CE Nr. 0059835; Charles University in Prague, Ethics Committee for Multi-Centric Clinical Trials of the University Hopital Motol and 2nd Faculty of Medicine, Nr. 1271/23; Bioethics Committee at the Medical University of Warsaw, Nr. 21/2024 and KB/6/R/2024; Associacão Protectora dos Diabéticos de Portugal, Nr. 211/2024). Results are disseminated through peer-reviewed journals and conference presentations and will be shared openly.

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Gennaio 2025

Is the Multitarget Stool DNA Test Just a Better “FIT” for Colorectal Cancer Screening?

Both the fecal immunochemical test (FIT) and multitarget stool DNA test (mt-sDNA) are stool-based screening tests for colorectal cancer (CRC) that are reported qualitatively as positive or negative, even though both tests are quantitative, producing a precise value on a continuous scale. The FIT quantifies the globin portion of human hemoglobin in either per milliliter of buffer or per gram of stool, while the mt-sDNA test generates a score from a multivariable algorithm that measures human hemoglobin as well as specific abnormalities in human DNA. For both tests, the threshold (ie, the cut point) determines how the test performs, ie, its sensitivity and specificity. Lowering the threshold increases sensitivity for CRC, advanced precancerous lesions (APLs), or both and would likely decrease specificity, resulting in a higher false-positive rate and more (unnecessary) colonoscopies.

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Gennaio 2025

Factors associated with foot self-care behaviour and foot screening attendance in people with type 2 diabetes: a cross-sectional study in primary care

Objectives
To assess the factors associated with foot self-care behaviour and non-adherence to foot screening among patients with type 2 diabetes mellitus (T2DM).

Design and setting
A multicentre cross-sectional study was undertaken in seven primary care polyclinics in Singapore between October 2020 and December 2021.

Participants and outcomes
275 adults (male 55.3%) with T2DM were included and assessed with the foot self-care behaviour questionnaire, including two aspects of foot care behaviour-preventative behaviour and potential damaging behaviour, and foot care confidence scale. Non-adherence to diabetic foot screening (DFS) attendance was also collected and assessed.

Results
The average preventive behaviour score was 0.65 (SD 0.13, range 0–1) and potential damaging behaviour score was 0.43 (SD 0.09, range 0–1). Patients with greater foot care confidence (β=0.272) and being married (β=0.141) were more likely to adopt preventive behaviours, while patients aged between 21 and 45 years (β=0.136), having shorter DM duration (

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Dicembre 2024

Impact of COVID-19 and recovery of routine diabetic retinopathy digital screening across different regions in England: an analysis of publicly available data

Objective
This study aims to examine the reduction and subsequent recovery of routine digital screening (RDS) uptake in England from 2018 to 2022, exploring national, regional and individual Diabetic Eye Screening Programme (DESP) levels. The COVID-19 lockdown in most areas of England was from 26 March 2020 to 23 June 2020 (first national lockdown), 5 November 2020 to 2 December 2020 (second national lockdown) and 6 January 2021 to 8 March 2021 (third national lockdown).

Design
Retrospective data analysis.

Setting
DESPs of England.

Participants
Individuals with diabetes who were invited to take part in the DESP programmes.

Methods
Publicly available data from Public Health England (2018–2019) and National Health Service England (2019–2022) were examined to identify the rate of uptake (proportion of those who attended the DESPs to those who were invited) of RDS at national and regional levels and by each DESP in England.

Primary outcome measures
Rate of uptake of RDS.

Results
The national uptake of RDS decreased from 82% (2019–2020) to 68% (2020–2021) and then increased to 78% (2021–2022). At the regional level, the sharpest drop was in the Midlands which decreased from 79% (2019–2020) to 53% (2020–2021), increasing to 73% (2021–2022) but did not reach pre-COVID-19 levels. At individual DESP levels across England, the greatest drop in attendance (2020–2021) was recorded in Derbyshire (79% to 45%), Barnsley and Rotherham (78% to 45%) and Arden, Herefordshire and Worcestershire (78% to 46%). Although these DESPs showed an increase in 2021–2022 of 33%, 21% and 31%, they did not reach prepandemic (2018–2019) rates of 81%, 85% and 82%, respectively. Data suggest that West Sussex, East Sussex and East and North Hertfordshire DESPs maintained relatively higher uptake rates (86%–89%) in 2020–2021.

Conclusion
COVID-19 had an impact on England’s diabetic eye screening attendance, with notable variations across regions and DESPs. Different regions and DESPs showed variable post-COVID-19 recovery. More importantly, what was not evident is the increased uptake that should have occurred after the COVID-19 lockdown to compensate for the low uptake during the lockdown. In some areas, addressing some of the barriers that affect retinal screening uptake may improve future attendance.

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Dicembre 2024

Cardiovascular-Liver-Metabolic Health: Recommendations in Screening, Diagnosis, and Management of Metabolic Dysfunction-Associated Steatotic Liver Disease in Cardiovascular Disease via Modified Delphi Approach

Circulation, Volume 151, Issue 1, Page 98-119, January 7, 2025. There is a new awareness of the widespread nature of metabolic dysfunction–associated steatotic liver disease (MASLD) and its connection to cardiovascular disease (CVD). This has catalyzed collaboration between cardiologists, hepatologists, endocrinologists, and the wider multidisciplinary team to address the need for earlier identification of those with MASLD who are at increased risk for CVD. The overlap in the pathophysiologic processes and parallel prevalence of CVD, metabolic syndrome, and MASLD highlight the multisystem consequences of poor cardiovascular–liver–metabolic health. Metabolic dysfunction and associated insulin resistance, together with the predilection for ectopic fat deposition in the liver and surrounding tissues, are associated with elevated risk of endothelial dysfunction, systemic inflammatory response, and ectopic fat deposition in the epicardium. This complex pathophysiology can accelerate atherogenic dyslipidemia, atherogenesis, diastolic dysfunction, valvular calcification, and cardiac arrhythmias. Despite the mounting evidence of mechanistic pathways underpinning MASLD and CVD, current recommendations have not clearly focused upon MASLD as a risk factor or target for intervention in CVD. We have brought together a diverse range of international experts committed to promoting cardiovascular–liver–metabolic health and related outcomes across the globe. The overarching goal of this document is to offer a construct for clinicians in the cardiovascular field with regards to (1) diagnosis and screening of MASLD through the use of noninvasive serum and imaging tests; (2) screening for CVD in all individuals with MASLD regardless of established atherosclerotic risk factors; and (3) the approach to management of MASLD with respect to prevention of CVD through lifestyle, as well as pharmacologic and surgical strategies. To achieve this, the modified Delphi method was applied and a series of evidence-based quality standard recommendations have been identified.

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Dicembre 2024

AGA Clinical Practice Update on Screening and Surveillance in Individuals at Increased Risk for Gastric Cancer in the United States: Expert Review

Gastric cancer (GC) is a leading cause of preventable cancer and mortality in certain US populations. The most impactful way to reduce GC mortality is via primary prevention, namely Helicobacter pylori eradication, and secondary prevention, namely endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM). An emerging body of evidence supports the possible impact of these strategies on GC incidence and mortality in identifiable high-risk populations in the United States.

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Dicembre 2024

The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care

Introduction
Early lung cancer screening (LCS) through low-dose CT (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centred intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision-making.

Methods and analysis
MyLungHealth is a multisite pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centred design process, informed by patient and provider focus groups and interviews. The intervention’s effectiveness will be evaluated through a patient-randomised trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused shared decision-making intervention) against DecisionPrecision+ alone. The first study hypothesis is that among patients aged 50–79 with uncertain LCS eligibility (eg, 10–19 pack-years or unknown pack-years or unknown quit date for individuals who used to smoke), MyLungHealth eligibility questionnaires will result in increased identification of LCS-eligible patients (n~26 729 patients). The second study hypothesis is that among patients aged 50–79 with documented LCS eligibility (20+ pack-years, quit within the last 15 years if individuals who used to smoke, and no recent screening or screening discussion), MyLungHealth education will result in increased LDCT ordering (n~4574 patients). Primary outcomes will be identification of LCS-eligible patients among individuals with uncertain LCS eligibility and LDCT ordering rates among individuals with documented LCS eligibility.

Ethics and dissemination
The protocol was approved by the University of Utah Institutional Review Board (# 00153806). The patient data collected for this study will not be shared publicly due to the sensitive nature of the patient health information and the fact that we will not be obtaining written informed consent to allow public sharing of their data. Results will be disseminated through peer-reviewed publications.

Trial registration number
Clinicaltrials.gov, NCT06338592.

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Dicembre 2024

[Review] The effectiveness of community-wide screening for pulmonary tuberculosis: a systematic review

This systematic review evaluated the effectiveness of community-wide screening for pulmonary tuberculosis (TB) in high-burden areas by analysing randomised controlled trials (RCTs). The review focused on interventions offering TB screening to entire communities, comparing them to standard care or alternative approaches. The main outcome assessed was microbiologically confirmed TB diagnoses, including rates and prevalence. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, WHO Global Index Medicus, Web of Science, and trial registries up to 27 May 2024, without language restrictions.

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Dicembre 2024

Knowledge and attitudes towards cervical cancer and screening among migrant women: a qualitative study in Portugal

Objective
To explore the perceptions of migrant women, healthcare professionals and community workers regarding migrant women’s knowledge and attitudes about cervical cancer (CC) and screening and how these influence cervical cancer screening (CCS) uptake.

Design
Qualitative study with seven focus groups, using a semistructured guide.

Setting
Five focus groups were conducted online and two in community associations in Lisbon, Portugal.

Participants
This study included 23 migrant women, 12 healthcare professionals and 10 community workers.

Results
A lack of knowledge and negative attitudes towards screening among migrants were discussed as important factors leading to a lower CCS uptake. For participants, many migrant women are unaware of the disease and CCS. Feelings of uneasiness related to screening and reservation from their husbands towards consultations underlie negative attitudes towards CCS. Disparities among migrant women regarding uptake of CCS rooted on sociocultural factors were highlighted, with women from African origin and older tending to engage less. Healthcare professionals were identified as the preferred source of information; nevertheless, difficulties in delivering information on sensitive topics were reported by professionals. Additionally, participants agreed that peers and social networks may play a role in promoting screening among communities.

Conclusions
Healthcare professionals and community actors are paramount to promote CCS among migrant women, especially through culturally adapted awareness interventions and health-promoting activities engaging local communities and social networks of women. Training on cross-cultural communication skills of healthcare professionals may contribute to improving migrant women’s knowledge and uptake of CCS.

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Dicembre 2024

Diagnostic accuracy of screening tests for eating disorders in adolescents and adults in primary health care: protocol for systematic review and meta-analysis

Introduction
Eating disorders can be irreversible and, in many cases, fatal. However, the symptoms full recovery is possible, and early diagnosis is one, of many, important factors for the success of treatment. In this sense, the screening of risk behaviours arises as a relevant alternative to improve the prognosis of patients. This review will analyse the diagnostic accuracy of self-administered screening tests for eating disorders in adolescent and adult users of primary healthcare.

Methods and analysis
A systematic review will be performed by independent reviewers. The databases used will be Medline, Embase, the Latin American and Caribbean Health Sciences Literature, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, PsycINFO, ProQuest Dissertations and Theses Database and Google Scholar without restrictions on the year of publication and language. Studies that compared the results of self-administered screening tests for eating disorders in adolescents and adults in primary care with the results of clinical interviews will be included. Data extraction will consist of the identification of the publication, study and participant characteristics, general information about the tools and data on the diagnostic accuracy properties. The risk of bias in the studies will be assessed via the Quality Assessment of Diagnostic Accuracy Studies. Qualitative data will be presented in narrative form. The meta-analysis will be conducted via the random effects model with the metadata command of Stata. The summary statistics for sensitivity and specificity, as well as their 95% CI, will be generated.

Ethics and dissemination
This systematic review is based on published literature; therefore, submission to an ethics committee is not necessary. The dissemination of the study will be carried out through technical reports, scientific articles, posters, meeting presentations, specific forums, national congresses and international media.

PROSPERO registration number
CRD42023476156.

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Dicembre 2024

Vestibular Infant Screening-Rehabilitation (VIS-REHAB): protocol for a randomised controlled trial on Vestibular Rehabilitation Therapy (VRT) in vestibular-impaired children

Introduction
A vestibular deficit can have a substantial impact on the overall development of children. Therefore, it is of utmost importance that vestibular-impaired problems are treated early and effectively through Vestibular Rehabilitation Therapy (VRT). Although VRT is sufficiently proven and standardised in adults, there remains a lack of research examining its efficacy in children. To assess the effectiveness of VRT in vestibular-impaired children, the Vestibular Infant Screening-Rehabilitation (VIS-REHAB) protocol was developed with the following objectives: (1) to investigate the short-term effect of a combined postural control and gaze stabilisation protocol, compared with receiving no therapy and (2) to investigate the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol in a group of vestibular-impaired children. This study aims to address lingering questions in the existing literature in a standardised manner, with the ultimate objective to establish evidence-based rehabilitation guidelines.

Methods and analysis
The VIS-REHAB study is a two-parallel group, superiority, randomised controlled crossover trial with 1:1 allocation ratio. The study includes patients aged 3–17 years old with identified peripheral vestibular dysfunction. Primary and secondary outcome measures assess gaze stability, postural stability, motor performance and quality of life. The effectiveness of the VIS-REHAB protocol will be evaluated through parallel group and crossover analyses using analysis of covariance (ANCOVA). Additionally, prespecified subgroup analyses will be conducted to assess influencing factors that may impact the outcome and effect of VIS-REHAB.

Ethics and dissemination
At the start of the VIS-REHAB study, an amendment will be submitted to the ethics committee of Ghent University Hospital for the following applications: (EC2018/0435), (EC2018/0959), (EC2015/1441) and (EC2015/1442). The trial is registered at Clinical Trials (clinicaltrials.gov) with registry name VIS-REHAB and identifier NCT06177132. All research findings will be disseminated in peer-reviewed journals.

Trial registration number
NCT06177132.

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Dicembre 2024