Search Results for: Low Back Pain: raccomandazioni

Circulation, Ahead of Print. Alcohol is one of the most commonly consumed substances in the world, exhibiting complex relationships with multiple aspects of cardiovascular health and disease. The majority of the research on the topic is observational and therefore prone to bias and confounding. The available evidence suggests no risk to possible risk reduction when alcohol is consumed in low amounts (such as no more than 1 to 2 drinks a day) in regard to coronary artery disease, stroke, sudden death, and possibly heart failure. The risk associated with consuming 1 to 2 drinks a day on atrial fibrillation remains unknown. More randomized trials of low to moderate alcohol consumption are needed for more definitive conclusions. In stark contrast, heavier alcohol consumption such as binge drinking or consuming on average ≥3 drinks/d is consistently associated with worse outcomes in every cardiovascular disease entity studied. Considering the level of evidence, it remains unknown whether drinking is part of a healthy lifestyle and therefore clinicians should reinforce healthy lifestyle behaviors such as regularly engaging in physical activity, avoiding tobacco use, and maintaining healthy body weight.

Objective
To explore primary care patients’ and practitioners’ views and experiences of remote consulting for common mental disorders (CMDs), to optimise their management in primary care.

Design
Qualitative study using in-depth interviews and thematic analysis. A topic guide was used to ensure consistency across interviews. The interviews were audio-recorded, transcribed verbatim and analysed thematically. There was patient and public input throughout.

Setting
Participants were recruited from general practices. Interviews were held by telephone or videocall between March 2023 and October 2023.

Participants
We interviewed 20 practitioners and 21 patients.

Results
Interviewees suggested benefits included convenience, increased anonymity and were easier for those feeling very low or anxious. Challenges included practitioners finding it hard to assess risk, which lengthened consultation duration or led to further contact, increasing practice workload and patients feeling anxious waiting for the practitioner to call. In-person appointments were viewed as important for initial consultations and providing a safe space. Continuity of care and practitioner training were identified as facilitators for telephone consultations, and both patients and practitioners identified training needs around how to deliver mental healthcare remotely.

Conclusions
Practitioners should aim to offer continuity of care and in-person appointments when patients initially seek help. Remote consultations may not be more time or cost-efficient for individuals with CMDs as risk is harder to assess. There is a need to evaluate existing training on delivering remote consultations to identify whether remote mental healthcare is included or should be incorporated in the future.

Objectives
To understand healthcare professionals’ and patients’ views and experiences of septoplasty and medical management (ie, nasal steroid and saline sprays) for nasal obstruction.

Design
Nested qualitative study as part of the Nasal Airway Obstruction Study (NAIROS) trial. We used in-depth interviews to develop a coding framework based on thematic analysis.

Setting
NAIROS was a trial based in the UK from January 2018 to December 2020 that aimed to compare the effectiveness of septoplasty versus medical management.

Participants
We purposively sampled and interviewed 14 healthcare professionals (surgeons, research nurses) and 31 patients involved in the NAIROS trial across 14 UK hospital sites.

Results
In usual practice, surgeons’ decisions regarding treatment for nasal obstruction are based on a complex assessment of patients’ symptoms, history and anatomy. Surgeons viewed septoplasty as a complex although routine operation, which is not guaranteed to improve symptoms of nasal obstruction. Some patients saw septoplasty, intuitively, as a ‘fix’ for a bent septum, whereas others were keen to avoid surgery if possible. Healthcare professionals welcomed the increased use of standard measurements if these were shown to provide a reliable guide to patient outcomes. However, they felt that it was important to retain an element of clinical judgement. Despite generally good outcomes from septoplasty, some patients still felt they had received little to no benefit from the operation. Patients also reported being underprepared for postsurgery recovery. Experiences were more varied with medical management, with some experiencing symptom improvement, but others discontinuing treatment due to difficulty or pain using the sprays, or perceived ineffectiveness. Remembering to use the sprays could be perceived as burdensome, although most patients were able to incorporate this into their daily routines.

Conclusions
Our qualitative study demonstrated varied individual experiences among patients undergoing septoplasty and medical management. Surgeons welcomed more standard measurements to guide decision-making for septoplasty. For patients, better information about treatment mechanisms, treatment delivery and aftercare, and the development of decision support tools would enable shared decision-making and help to provide optimal patient experience of the treatments.

Trial registration number
ISRCTN16168569.

Background
People experiencing homelessness (PEH) often die at a younger age than the general population. Advanced ill-health often occurs late in its trajectory (if at all), leaving many PEH to die without adequate support from hospital-based, hospice-based or community-based palliative care services. Despite the high rate of bereavement and exposure to death among PEH, there are rarely opportunities for them to reflect on their experiences, thoughts and preferences around death or receive bereavement support. Death cafés are a global social franchise, providing a space for people to participate in an open group discussion about death, dying and bereavement. They are free to attend and unstructured but facilitated.

Objectives
To explore the perspectives of PEH and the professionals that support them with regards to the potential acceptability, benefits and challenges of death cafes.

Methods
A qualitative study comprising of interviews with nine homelessness and/or palliative care professionals with experience of running death cafés for, or supporting PEH in other ways, and two focus groups with nine people with lived experience of homelessness. The research was co-produced with a lived experience co-researcher forming a core part of the research team. Reflexive thematic analysis was utilised to develop themes.

Results
Five themes were developed to highlight the perspectives and experiences of death cafés for PEH: choice; expertise in facilitation: recognising risk and the unstructured nature; promoting safety against potential risk; potential benefits and potential practical considerations. Themes highlight the need for a trauma-informed approach. Death cafés could be impactful, where done well, but they are not without risk.

Conclusions
Death cafés for PEH pose risks that require comprehensive consideration and trauma-informed, expert facilitation. However, this research highlighted that a low-pressure space to explore thoughts around death, dying and bereavement is currently an unmet need within this population.

Background
Mast cell activation is an important driver of abdominal pain in irritable bowel syndrome (IBS). While evidence supports the role of IgE-mediated mast cell activation in visceral pain development in IBS, the role of pseudoallergic MRGPRX2-mediated mast cell activation in this process remains unknown.

Objective
We investigated whether MRGPRX2-mediated mast cell activation plays a role in abdominal pain development in patients with IBS.

Design
MRGPRX2 expression in mast cells and other immune cells was characterised across colon layers using flow cytometry. We evaluated whether MRGPRX2 agonists trigger mast cell degranulation and transient receptor potential vanilloid 1 (TRPV1) sensitisation in healthy human colonic submucosal plexus samples using live imaging. Rectal biopsies were then collected from patients with IBS and healthy volunteers (HV) and MRGPRX2+ mast cell frequency, MRGPRX2 expression per cell, mast cell degranulation kinetics in response to MRGPRX2 agonists, MRGPRX2 agonistic activity and presence of MRGPRX2 agonists in biopsy supernatants were assessed.

Results
MRGPRX2+ mast cells are enriched in the submucosa and muscularis of the healthy human colon. MRGPRX2 agonists induce mast cell degranulation and TRPV1 sensitisation in the healthy colon submucosa. While the frequency of rectal MRGPRX2+ mast cells was unaltered in IBS, submucosal mast cells showed increased degranulation in response to MRGPRX2 agonists in IBS compared with HV. MRGPRX2 agonistic activity was increased in IBS rectal biopsy supernatant compared with HV, which was associated with increased levels of substance P.

Conclusion
The MRGPRX2 pathway is functionally upregulated in the colon of patients with IBS, supporting its role in abdominal pain in IBS.

Basic scienceSensing pain in the gut: new insights into enterochromaffin cells Touhara K, Rossen N, Deng F et al Topological segregation of stress sensors along the gut crypt-villus axis. Nature 2025; 640(8059): 732-742. doi: 10.1038/s41586-024-08581-9. The gut barrier is monitored by enterochromaffin (EC) cells, epithelial sensory enteroendocrine cells which release serotonin in response to stimuli. TRPA1 (transient receptor potential cation channel, subfamily A, member 1—also known as the wasabi receptor), which detects electrophilic irritants, is present in the crypts. TRPM2 (transient receptor potential cation channel, subfamily M, member 2), which measures oxidative stress, is in the villi. The EC-pain circuit is not well understood. Touhara et al used a new mouse model to study this. Serotonin receptors were labelled in a way that fluorescence intensity increased after serotonin release. Tonic (low-level) serotonin release was observed in crypts where TRPA1 was expressed. This activated metabotropic 5-HT4 (5-hydroxytryptamine receptor…

Background
Recent meta-analyses suggested diclofenac may be superior to indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The aim of our study was to compare the efficacy of 100 mg rectal indomethacin versus diclofenac on PEP incidences.

Design
This multicentre, double-blinded, randomised controlled trial was conducted in nine tertiary centres in China. Patients with low and high risk for PEP and native papilla were randomly allocated (1:1) to receive 100 mg diclofenac or 100 mg indomethacin rectally before ERCP. The primary outcome was the occurrence of PEP defined by the Cotton consensus. The intention-to-treat principle was conducted for the analysis.

Results
The trial was terminated early for futility after the predetermined first interim analysis. Between June 2023 and May 2024, 1204 patients were randomised into the diclofenac group (n=600) or indomethacin group (n=604). Baseline characteristics were balanced. The primary outcome occurred in 53 patients (8.8%) of 600 patients allocated to the diclofenac group and 37 patients (6.1%) of 604 patients allocated to the indomethacin group (relative risk 1.44; 95% CI 0.96 to 2.16, p=0.074). PEP occurred in 35 (14.2%) of 247 high-risk patients in the diclofenac group and 26 (9.8%) of 266 high-risk patients in the indomethacin group (p=0.124). PEP incidences were also comparable in low-risk patients between the two groups (18/353 (5.1%) vs 11/338 (3.3%), p=0.227). Other ERCP-related complications did not differ between the two groups.

Conclusion
Pre-procedure 100 mg rectal diclofenac was not superior to the same dose of rectal indomethacin regarding preventing PEP. These findings supported current clinical practice guidelines of 100 mg indomethacin or diclofenac for PEP prophylaxis in patients without contraindications.

Trial registration number
ClinicalTrials.gov (NCT05947461).

Introduction
Earthen floors are often damp or dusty and difficult to clean, providing an ideal environment for faecal pathogens and parasites. Observational studies have revealed associations between household flooring and health outcomes, but robust experimental evidence is scant. This study will evaluate the impact of an improved household flooring intervention on enteric infections, soil-transmitted helminth (STH) infections and tungiasis through implementation of a cluster-randomised trial in two rural settings in Kwale and Bungoma Counties, Kenya.

Methods and analyses
440 clusters (households) across both sites are allocated to control or intervention group, in which a low-cost, sealed, washable, cement-based floor is installed in eligible buildings of the dwelling, alongside a floor-care guide provided during an induction meeting. Following baseline assessments in both groups, all individuals over 1 year receive albendazole and those infected with tungiasis receive benzyl benzoate. Primary outcomes are as follows: prevalence of enteric infections in children under 5 years assessed via stool surveys and PCR; prevalence of tungiasis infection in children 1–14 years based on clinical exam; and prevalence of STH infection in all household members over 1 year assessed via Kato-Katz. Secondary outcomes include the following: intensity of STH and tungiasis infections; prevalence of caregiver-reported gastrointestinal illness in children under 5; quality of life and well-being measures; and environmental contamination. A process evaluation investigates intervention acceptability, durability, practicality and cost.

Ethics and dissemination
The protocol has been approved by ethics committees of The Kenya Medical Research Institute, The Kenya National Commission for Science Technology and Innovation, and The London School of Hygiene & Tropical Medicine. Following the 12-month implementation period and final assessments, control households are offered improved floors. Results will be disseminated within Kenya, to the Ministries of Health and of Lands, Public Works, Housing and Urban Development, and to subnational leadership and communities. Dissemination will also occur through publications and conference presentations.

Trial registration number
NCT05914363.

Objectives
We aimed to analyse the trends, age distribution and disease burden of maternal sepsis and other maternal infections (MSMI) to improve management strategies.

Design
We extracted data from the global burden of disease (GBD) 2021 database to evaluate MSMI burden with different measures for the whole world, 21 GBD regions and 204 countries from 1990 to 2021.

Setting
Studies from the GBD 2021 database generated by population-representative data sources identified through a literature review and research collaborations were included.

Participants
Patients with an MSMI diagnosis.

Outcomes
Total numbers, age-standardised rates (ASRs) of incidence, prevalence, mortality and disability-adjusted life years (DALYs) on MSMI from the GBD 2021 study and their estimated annual percentage changes (EAPCs) were the primary outcomes.

Results
There were 19 047 404 (95% uncertainty interval (UI) 14 608 563 to 24 086 486) annual incident cases, 2 376 876 (95% UI 1 678 868 to 3 421 377) prevalent cases at a single time point, 17 665 (95% UI 14 628 to 21 191) death cases and 1 144 233 (95% UI 956 988 to 1 352 034) DALYs of total MSMI in 2021. From 1990, the case number and ASRs of incidences and prevalence showed decreasing trends, while the case number and ASRs of mortality and DALYs gradually increased with time, reaching the peak in 2001, and then declined. In 2021, the ASRs of incidence, prevalence, mortality and DALYs sharply increased with age, which reached the peak in the 20–24 age group. The ASRs were decreased with increasing sociodemographic index (SDI). In 2021, it showed a positive correlation between EAPC and ASR of DALYs (r=0.3398, p

Objective
To explore rehabilitation training adherence as well as its related influencing factors among adult patients with traumatic limb fractures to provide a basis for clinical intervention strategies.

Design
Cross-sectional study.

Setting
Department of Rehabilitation Medicine.

Participants
Adults within 1 year postoperative for traumatic limb fractures and who underwent rehabilitation training were included in this study.

Interventions
Not applicable.

Main outcome measures
Patient information was collected using a self-designed general information form. Rehabilitation training adherence was evaluated using the Exercise Adherence Rating Scale (0/64, higher values=higher adherence). Barriers to and facilitators of rehabilitation were assessed using sociodemographic data, ability to perform daily life (ADL), General Self-Efficacy Scale (GSES) and Visual Analogue Scale. Pearson’s (r) and determination (R2) correlation coefficients were calculated to determine the strength of associations between variables. Potential correlates were explored using multiple linear regression analysis.

Results
Between December 2022 and December 2023, 180 subjects were recruited. The age of the participants ranged from 18 to 93 years, with a mean age of 41.5 years (SD 15.6). The mean Exercise Adherence score was 30.31 (SD 5.8). Adherence to postoperative rehabilitation training tended to be lower in participants of older age (–1.30; 95% CI –2.14 to –0.46; p=0.003), and those who had higher pain scores on the movement (moderate pain (–3.25; 95% CI –4.56 to –1.95; p

Background
Despite the growth of the population of older people living with HIV (PLWH), data on cognitive disorders among older PLWH, particularly in low- and middle-income countries, are scarce. These data are especially underrepresented in the literature from eastern Europe and central Asia (EECA).

Objectives
This scoping review aimed to describe the peer-reviewed literature on cognitive health among PLWH in the EECA region.

Eligibility criteria
We selected articles from peer-reviewed journals that reported on cognitive assessments or the prevalence and characteristics of cognitive disorders among adult (≥18 years) PLWH in EECA countries (Armenia, Azerbaijan, Belarus, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan). Studies assessing cognition among PLWH related to traumatic brain injury, brain tumours, COVID-19, meningitis, neurosyphilis and/or other central nervous system infections were excluded.

Source of evidence
We searched for relevant data published up to March 2025 using four online databases (PubMed, CINAHL, Web of Science and PsycINFO).

Charting methods
Covidence, a web-based collaborative software platform, was used for data screening and extraction. Two independent reviewers screened abstracts and full texts, resolving disagreements through consensus. The data were extracted based on the predefined data extraction criteria.

Results
A total of 1388 peer-reviewed articles were identified; 295 articles were removed due to duplication; and 1053 and 25 articles were excluded based on the abstract/title and full-text screenings, respectively. Finally, 15 articles met the inclusion criteria. All 15 studies used different neuropsychological assessments to measure cognitive performance by domain and/or cognitive disorders among various subgroups of PLWH. One cross-sectional study focused on older populations (≥40 years old), using standardised cognitive performance assessment tests. However, it neither provided information about the prevalence estimate of cognitive disorders nor identified risk factors.

Conclusion
Existing literature on cognitive disorders among older PLWH in the EECA region is limited and insufficient to estimate prevalence, or identify risk factors, and ultimately develop appropriate policy addressing the needs of older PLWH in this region. This scoping review underscores the urgent need for large-scale, longitudinal studies employing standardised, culturally adapted neuropsychological batteries and adherence to rigorous reporting standards.

Objectives
Prediction models for post-stroke mortality can support medical decision-making. Although numerous models have been developed, external validation studies determining the models’ transportability beyond the original settings are lacking. We aimed to assess the performance of two prediction models for post-stroke mortality in Berlin, Germany.

Design
We used data from the Berlin-SPecific Acute Treatment in Ischaemic or hAemorrhagic stroke with Long-term follow-up (B-SPATIAL) registry.

Setting
Multicentre stroke registry in Berlin, Germany.

Participants
Adult patients admitted within 6 hours after symptom onset and with a 10th revision of the International Classification of Diseases discharge diagnosis of ischaemic stroke, haemorrhagic stroke or transient ischaemic attack at one of 15 hospitals with stroke units between 1 January 2016 and 31 January 2021.

Primary outcome measures
We evaluated calibration (calibration-in-the-large, intercept, slope and plot) and discrimination performance (c-statistic) of Bray et al’s 30-day mortality and Smith et al’s in-hospital mortality prediction models. Information on mortality was supplemented by Berlin city registration office records.

Results
For the validation of Bray et al’s model, we included 7879 patients (mean age 75; 55.0% men). We observed 763 (9.7%) deaths within 30 days of stroke compared with 680 (8.6%) predicted. The model’s c-statistic was 0.865 (95% CI: 0.851 to 0.879). For Smith et al’s model, we performed the validation among 1931 patients (mean age 75; 56.2% men), observing 105 (5.4%) in-hospital deaths compared with the 92 (4.8%) predicted. The c-statistic was 0.891 (95% CI: 0.864 to 0.918). The calibration plots of both models revealed an underestimation of the mortality risk for high-risk patients.

Conclusions
Among Berlin stroke patients, both models showed good calibration performance for low and medium-risk patients and high discrimination while underestimating risk among high-risk patients. The acceptable performance of Bray et al’s model in Berlin illustrates how a small number of routinely collected variables can be sufficient for valid prediction of post-stroke mortality.

Objectives
To systematically estimate the prevalence and influencing factors of fear of disease progression (FoP) in patients who had a stroke, with a focus on China.

Design
Systematic review and meta-analysis of observational clinical studies.

Data sources
Eight databases (China National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database (VIP), CBM, Web of Science, PubMed, Cochrane Library, Embase) were searched from inception to March 2024, supplemented by manual reference screening.

Eligibility criteria
Cross-sectional studies reporting FoP incidence or influencing factors in Chinese stroke patients using the Fear of Progression Questionnaire-Short Form scale were included.

Data extraction and synthesis
Two reviewers independently screened studies, extracted data and assessed study quality using the Agency for Healthcare Research and Quality tool (score range: 0–11 points). Random-effects models were applied to address substantial heterogeneity. Stata 17.0 software was used for meta-analysis.

Results
A total of 20 studies (15 medium-quality, 5 high-quality) involving 7156 patients were included. The pooled incidence of FoP in Chinese stroke patients was 56% (95% CI=45% to 66%), derived from a random-effects model despite significant between-study heterogeneity (I²= 98.7%), with subgroup analyses and leave-one-out sensitivity analysis confirming result robustness. Subgroup analysis revealed that the incidence was highest in East China (70%, 95% CI=56% to 83%), followed by Central China (55%, 95% CI=36% to 73%) and North China (43%, 95% CI=38% to 47%). The incidence of FoP in haemorrhagic stroke (72%, 95% CI=49% to 95%) was higher than that in ischaemic stroke (45%, 95% CI=27% to 64%). The incidence of FoP after 2020 (59%, 95% CI=48% to 70%) was higher than that before 2020 (40%, 95% CI=32% to 47%). Meta-regression identified publication year (p=0.004) and research region (p=0.001) as key heterogeneity sources. The main influencing factors of FoP in Chinese stroke patients included age (OR=0.94, 95% CI=0.92 to 0.97, p

Introduction
Dyslipidaemia, affecting approximately 39% of adults worldwide, is a major risk factor for cardiovascular disease. Individuals with dyslipidaemia are often prescribed statins, which effectively lower plasma low-density lipoprotein cholesterol (LDL-C), thereby reducing the risk of cardiovascular events and mortality. Although statins lower LDL-C, emerging evidence suggests that they may counteract the beneficial adaptations to exercise in skeletal muscle mitochondria and whole-body aerobic capacity. The underlying mechanisms remain unclear, and there is a need for studies investigating how statins influence molecular adaptations to exercise. The primary objective of this study is to investigate the combined effects of statin therapy and focused exercise training on mitochondrial function and whole-body aerobic capacity in people with dyslipidaemia. The untargeted proteomic analysis will be incorporated to provide detailed insights into how statins may affect mitochondrial proteins and other muscle metabolic traits, offering molecular explanations for altered functional readouts at both the muscle and whole-body levels.

Methods and analysis
A total of 100 women and men (aged 40–65 years) diagnosed with dyslipidaemia without atherosclerotic cardiovascular disease will be enrolled in this 12-week, double-blinded, randomised, placebo-controlled trial. Participants will be randomised into one of four groups using a block randomisation approach to ensure an allocation ratio of 60:40 for exercise and non-exercise conditions, respectively. The four groups will be: (1) exercise+placebo, (2) exercise+atorvastatin (80 mg/day), (3) atorvastatin (80 mg/day) and (4) placebo. The primary outcome is mitochondrial function, measured by changes in skeletal muscle citrate synthase activity from baseline to post-intervention. Secondary outcomes include whole-body aerobic capacity (VO2peak) and proteomic analyses. Genetic analysis will be conducted to assess the role of genetic polymorphisms in individual responses to statins and exercise.

Ethics and dissemination
The trial has received ethical approval from the Faroe Islands Ethical Committee (2024-10) and adheres to the Declaration of Helsinki and General Data Protection Regulation (GDPR). Results will be published in peer-reviewed international journals.

Trial registration number
NCT06841536.

Background
Adolescent girls living in low-income urban informal settlements face unique challenges that elevate their susceptibility to early childbearing. However, there has been limited research attention, especially qualitative studies, on their use or non-use of antenatal care (ANC) services. Informed by the socioecological theory, we examined the obstacles to and facilitators of ANC services use among pregnant adolescent girls in a low-income urban informal settlement in Kenya.

Methods
The study adopted a qualitative explanatory design. We purposively selected 22 adolescent girls aged 13–19 who were either pregnant or had given birth, 10 parents and three health providers to participate in individual interviews. We employed inductive and deductive thematic analyses informed by socioecological theory to explain the barriers to enablers of antenatal services use among pregnant adolescent girls in low-income informal settlements.

Findings
Most adolescent girls interviewed faced barriers at multiple socioecological levels, resulting in delayed ANC initiation and fragmented engagement with services. At the intrapersonal level, girls grappled with internalised stigma and late pregnancy recognition and acceptance, often dismissing early signs due to fear or denial. Their young age and limited knowledge of maternal health left them terrified in fear, caught between societal judgement and the daunting prospect of confronting their condition. At the interpersonal level, societal stigma and discrimination pushed many into secrecy, hindering their access to antenatal services. However, parents, other family members, and health providers played a key role in enabling access to care by offering various forms of support to pregnant girls, including offering counselling and accompanying girls to clinics. At the organisational level, user fees and condescending health providers’ attitudes hindered ANC use. Yet, good patient-provider communication, privacy and confidentiality played a key role in enabling ANC attendance.

Conclusion
Pregnant adolescent girls face unique challenges that prevent them from accessing ANC early and completing the recommended number of visits. These challenges range from intrapersonal factors to interpersonal and organisational factors. Programmes to improve early initiation of ANC for pregnant adolescents should include interventions that address the social stigma associated with early and unintended pregnancy, promote family support and make health facilities responsive to the needs of pregnant girls.

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.