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AnteayerBMJ Open

Mapping behavioural interventions to reduce sugar-sweetened beverage (SSB) consumption among US adults: a scoping review protocol

Por: Cruz · J. · Palma · H. · Marshall · C. D. · Castellon-Lopez · Y. · Datta · G. D. · Torres · V.
Introduction

Sugar-sweetened beverages (SSBs) are sugary drinks such as sodas, fruit drinks and sweetened teas and are the leading source of added sugars in the American diet. SSBs are also linked to chronic diseases like type 2 diabetes, cardiovascular disease and certain cancers. Despite their well-known health risks, SSB consumption remains high in the United States of America (USA), with 63% of adults consuming them daily, often exceeding the recommended limit of 50 g of added sugar per day. Though efforts to reduce SSB intake through educational programmes, policy initiatives and taxes exist, further research is needed to assess the effectiveness of interventions to reduce SSB consumption in the USA. Understanding the role of behavioural interventions in lowering SSB consumption among adults is critical to address public health strategies.

Methods and analysis

The proposed scoping review will be conducted in accordance with the Joanna Briggs Institute methodological framework for scoping reviews. An advanced search will be conducted in three electronic databases: PubMed, PsycINFO and Scopus. The reference lists of included studies will also be reviewed to identify additional relevant literature. All identified citations will be compiled in EndNote, and duplicate citations will be eliminated. Identification of studies will occur through the three-step search process: (1) initial screening of studies according to inclusion criteria, (2) eligibility determined through full-text assessment and (3) inclusion of qualified studies meeting the criteria. To be included, studies must report on an existing behavioural intervention to reduce SSB consumption. All studies will undergo screening by two independent reviewers. Any disagreements that arise will be resolved through discussion or with an additional reviewer. A data extraction tool has been developed to extract relevant data from all eligible studies. The extracted data will be presented in a diagrammatic form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews reporting guidelines.

Ethics and dissemination

Ethics approval was not sought as all data will be collected from published literature. We will present our findings at relevant conferences and submit manuscripts for publication in peer-reviewed journals.

Prenatal detection of congenital heart defects using the deep learning-based image and video analysis: protocol for Clinical Artificial Intelligence in Fetal Echocardiography (CAIFE), an international multicentre multidisciplinary study

Por: Patey · O. · Hernandez-Cruz · N. · DAlberti · E. · Salovic · B. · Noble · J. A. · Papageorghiou · A. T. · CAIFE Research Group · Adu-Bredu · Ahuja · Aye · Black · Bo · Brent · Carvalho · Craik · Cavallaro · SivaCosta · DAlberti · Eccleston · Everingham · FreitasPaganoti · Farmer
Introduction

Congenital heart defect (CHD) is a significant, rapidly emerging global problem in child health and a leading cause of neonatal and childhood death. Prenatal detection of CHDs with the help of ultrasound allows better perinatal management of such pregnancies, leading to reduced neonatal mortality, morbidity and developmental complications. However, there is a wide variation in reported fetal heart problem detection rates from 34% to 85%, with some low- and middle-income countries detecting as low as 9.3% of cases before birth. Research has shown that deep learning-based or more general artificial intelligence (AI) models can support the detection of fetal CHDs more rapidly than humans performing ultrasound scan. Progress in this AI-based research depends on the availability of large, well-curated and diverse data of ultrasound images and videos of normal and abnormal fetal hearts. Currently, CHD detection based on AI models is not accurate enough for practical clinical use, in part due to the lack of ultrasound data available for machine learning as CHDs are rare and heterogeneous, the retrospective nature of published studies, the lack of multicentre and multidisciplinary collaboration, and utilisation of mostly standard planes still images of the fetal heart for AI models. Our aim is to develop AI models that could support clinicians in detecting fetal CHDs in real time, particularly in nonspecialist or low-resource settings where fetal echocardiography expertise is not readily available.

Methods and analysis

We have designed the Clinical Artificial Intelligence Fetal Echocardiography (CAIFE) study as an international multicentre multidisciplinary collaboration led by a clinical and an engineering team at the University of Oxford. This study involves five multicountry hospital sites for data collection (Oxford, UK (n=1), London, UK (n=3) and Southport, Australia (n=1)). We plan to curate 14 000 retrospective ultrasound scans of fetuses with normal hearts (n=13 000) and fetuses with CHDs (n=1000), as well as 2400 prospective ultrasound cardiac scans, including the proposed research-specific CAIFE 10 s video sweeps, from fetuses with normal hearts (n=2000) and fetuses diagnosed with major CHDs (n=400). This gives a total of 16 400 retrospective and prospective ultrasound scans from the participating hospital sites. We will build, train and validate computational models capable of differentiating between normal fetal hearts and those diagnosed with CHDs and recognise specific types of CHDs. Data will be analysed using statistical metrics, namely, sensitivity, specificity and accuracy, which include calculating positive and negative predictive values for each outcome, compared with manual assessment.

Ethics and dissemination

We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals. The study was approved by the Health Research Authority, Care Research Wales and the Research Ethics Committee (Ref: 23/EM/0023; IRAS Project ID: 317510) on 8 March 2023. All collaborating hospitals have obtained the local trust research and development approvals.

Prospective study of continuous rhythm monitoring in patients with early post-infarction systolic dysfunction: clinical impact of arrhythmias detected by an implantable cardiac monitoring device with real-time transmission--the TeVeO study protocol

Introduction

Updated primary prevention strategies are needed for post-infarction sudden cardiac death (SCD) based on implantable cardioverter-defibrillator (ICD). Current recommendations, based on left ventricular systolic function and functional class, may be obsolete because they are derived from ancient studies that do not incorporate the potential benefit of either current comprehensive treatment of ischaemic heart disease or modern device programming. Among patients with post-infarction left ventricular dysfunction, modern implantable cardiac monitoring devices (ICM) allow a unique opportunity to determine in real-time the burden of non-sustained ventricular tachycardias and their relationship to the subsequent occurrence of sustained or symptomatic events.

Methods and analysis

Approximately 200 patients with left ventricular ejection fraction (LVEF) equal to or less than 40% after acute myocardial infarction will be included in the study. They will be implanted with a Confirm RX, an ICM with real-time remote connection via a smartphone. At 6 months, LVEF and functional status will be re-evaluated and cardiac morpho-functional characterisation will be performed by MRI. At this time, and following current European guidelines, patients with an indication will receive an ICD; the others will continue to be monitored using an ICM for a minimum of 2 years. Patients are expected to be followed up for 4 years after the index event. More than 20 000 remote transmissions are expected to be analysed. The study will focus on the relationship between the detection of non-sustained ventricular tachycardias by ICMs (defined as at least 8 R-R intervals at 160 beats per minute) and the subsequent occurrence of symptomatic arrhythmic events. An advanced statistical analysis will be performed using machine and deep learning techniques to determine the clinical variables, those that are derived from monitoring and imaging tests and related to mid-term prognosis.

Ethics and dissemination

The study was approved by the Ethical Committee of the University Hospital of Salamanca (protocol number PI 2019 03 246) on 30 April 2020. Each patient will be informed about the study in both oral and written form by a physician and will be included in the study after written consent is obtained.

For the first time, a study will provide real-time information on the arrhythmic burden of patients with post-infarction ventricular dysfunction and its prognostic implications in the medium term. Several publications in scientific journals are planned.

Trial registration number

NCT04765943.

Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA st

Por: Negredo · E. · Hernandez-Sanchez · D. · Alvarez-Lopez · P. · Falco · V. · Rivero · A. · Jusmet · J. · Cuerda Palomo · M. A. · Flores de la Cruz · A. B. · Pavon · J. M. · Llavero · N. · Campany · D. · Faus · V. · Broto-Cortes · C. · Bailon · L. · Aguilar · D. · Ruiz · F. · Miranda · C.
Introduction

The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA).

Methods

A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres).

Ethics and dissemination

The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.

Trial registration number

NCT06185452/EUCT number: 2023-503963-41-00.

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