Delivering an innovative multi-infection and female genital mutilation screening to high-risk migrant populations (ISMiHealth): study protocol of a cluster randomised controlled trial with embedded process evaluation

Introduction
ISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain).

Methods and analysis
This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice.
A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.

Ethics and dissemination
The study protocol has been approved by the institutional review boards at Hospital Clínic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almería Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.
Findings will be disseminated in peer-reviewed journals and communications to congresses.

Trial registration number
NCT05868005.

Leggi
Novembre 2024

Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries

Introduction
Microwave imaging presents several potential advantages including its non-ionising and harmless nature. This open, multicentric, interventional, prospective, non-randomised trial aims to validate MammoWave’s artificial intelligence (AI)-based classification algorithm, leveraging microwave imaging, to achieve a sensitivity exceeding 75% and a specificity exceeding 90% in breast screening.

Methods and analysis
10 000 volunteers undergoing regular mammographic breast cancer screening will be recruited across 9 European centres and invited to participate in the clinical study, involving MammoWave testing on both breasts. MammoWave results will be checked against the reference standard, to be intended as the output of conventional breast examination path (with histological confirmation of cancer cases) with 2 years follow-up. Anonymised clinical and MammoWave’s results, including microwave images, associated features and a label provided by the AI-based classification algorithm, will be collected and stored in a dedicated electronic case report form. The prospective study will involve a comparative analysis between the output of the conventional breast examination path (control intervention) and the labels provided by MammoWave’s AI system (experimental intervention). These labels will categorise breasts into two groups: breast With Suspicious Finding, indicating the presence of a suspicious lesion or No Suspicious Finding, indicating the absence of a lesion or the presence of a low-suspicion lesion. This trial aims to provide evidence regarding the novel MammoWave’s AI system for detecting breast cancer in asymptomatic populations during screening.

Ethics and dissemination
This study was approved by the Research Ethics Committee of the Liguria Region (CET), Italy (CET-Liguria: 524/2023—DB id 13399), the Research Ethics Committee of Complejo Hospitalario de Toledo (CEIC), Spain (CEIC-1094), the National Ethics Committee for Clinical Research (CEIC), Portugal (CEIC-2311KC814), the Bioethical Committee of Pomeranian Medical University in Szczecin, Poland (KB-006/23/2024) and the Zurich Cantonal Ethics Commission, Switzerland (BASEC 2023-D0101). The findings of this study will be disseminated through academic and scientific conferences as well as peer-reviewed journals.

Trial registration number
NCT06291896.

Leggi
Novembre 2024

Clinical Application of New Risk-Based Cancer Screening in Patients With Dermatomyositis

Dermatomyositis (DM) is an autoimmune disease of unknown etiology belonging to the family of idiopathic inflammatory myopathies (IIMs). The association of DM with cancer has long been established and there is increased prevalence of various cancers, including breast, ovarian, colorectal, lung, nasopharyngeal, and lung cancers. Cancers in IIMs are frequently diagnosed at later stages, making cancer the leading cause of death in adults with IIMs. Despite this increased prevalence of and worse prognosis associated with underlying cancer, screening recommendations for cancer detection in patients with IIM have been debated for many years, with wide variability in screening practices. This lack of clarity regarding ideal cancer screening practices became further complicated with the expanding knowledge of myositis-specific antibodies and their association with cancer risk, which raised the question of how to apply serology status to screening protocols. Finally, there has been a need to balance early cancer detection with avoidance of unnecessary screening procedures, given that cancer prevalence is best estimated at only 15% to 25% of patients with DM. Thus, applying screening to all patients is associated with many unnecessary procedures.

Leggi
Novembre 2024

A HIGH-RESOLUTION MICROENDOSCOPE IMPROVES ESOPHAGEAL CANCER SCREENING AND SURVEILLANCE: IMPLICATIONS FOR UNDERSERVED GLOBAL SETTINGS BASED ON AN INTERNATIONAL, RANDOMIZED CONTROLLED TRIAL

Lugol’s chromoendoscopy (LCE)-based detection of esophageal squamous cell neoplasia (ESCN) is limited by low specificity. High-resolution microendoscopy (HRME) was shown to improve specificity and reduce unnecessary biopsies when used by academic endoscopists. In this international, randomized controlled trial, we determined the clinical impact, efficiency, and performance of HRME in true global health contexts with a range of providers.

Leggi
Ottobre 2024

Experiences across a genetic screening and testing programme pathway: a qualitative study of mammogram patient perspectives

Background
Population-based genetic screening and testing programmes have substantial potential to improve cancer-related outcomes through early detection and cancer prevention. Yet, genetic testing for cancer risk remains largely underused. This study aimed to describe barriers and facilitators to patient engagement at each stage of a California-based genetic screening programme, from completing the electronic screener to receiving the test and to identify potential improvements that could support precision medicine-based approaches to patient care.

Methods
We conducted 26 semistructured interviews among programme participants who did not complete the screener (n=9), those who did not receive the recommended test (n=7) and those who received a genetic test (n=10). Interviewees were selected from patients who recently received a mammogram through one of the participating Southern California clinics. Interviews were transcribed and coded using Atlas.ti. The study used a qualitative descriptive approach to identify similar and contrasting themes among the participant groups.

Results
This study found that barriers and facilitators to engagement were largely the same regardless of how far participants had moved through the process towards getting a genetic test. We identified four overarching themes: participants wanted clear communication of personal benefits at each stage; participants needed additional information and knowledge to navigate genetic screening and testing; a trusted provider could be instrumental in participants following a recommendation; and repetition and timing strongly impacted participants’ likelihood to engage.

Conclusions
Providing education about the benefits of genetic screening and testing to patients and their families, as well as clear communication about what each step entails may help patients engage with similar programmes. Strategies aimed at increasing coordination among a patient’s healthcare team can also help ensure information reaches patients in multiple ways, from multiple providers, to increase the likelihood that recommendations for testing come from trusted sources, which supports the uptake of genetic testing.

Leggi
Ottobre 2024

Implementing a remote self-screening programme for atrial fibrillation using digital health technology among community-dwellers aged 75 years and older: a qualitative evaluation

Objective
To examine the feasibility of implementing remote atrial fibrillation (AF) self-screening among older people supported by a remote central monitoring system.

Design
Process evaluation of the Mass AF randomised clinical trial (ACTRN12621000184875) with one-to-one semistructured interviews using interview guides underpinned by the Critical Realism approach and coded using the UK Medical Research Council Guidance of Process Evaluation Framework.

Setting and participants
Community-dwelling people aged ≥75 years from both genders (ratio 1:1) and urban/rural (ratio 2:1) in Australia.

Interventions
Participants were provided handheld single-lead electrocardiogram (ECG) devices and trained to self-record ECGs once daily on weekdays for at least 6 months. A remote central team notified participants and general practitioners (GPs) of AF.

Primary feasibility outcomes
The strengths, weaknesses, opportunities and threats (SWOT) analysis examined enablers (ie, strengths and opportunities) and barriers (ie, weaknesses and threats).

Results
Overall, 200 participants; 98.5% completed the 6-month programme, 96% reported being satisfied with screening and 48 were interviewed: mean age 79 years, 54% male and 71% urban. 11 GPs were interviewed: 55% female and 64% urban. Programme participants trusted the remote monitoring system that supported the screening programme and provided follow-up pathways where required. GPs saw opportunities to introduce this self-screening programme to at-risk patients and improve patients’ risk profiles. Programme participants reported that after being trained to use the device, they felt empowered to do self-screening and found it convenient. GPs saw empowerment could enhance the doctor–patient relationship. Participants and GPs valued screening in diagnosing AF that would otherwise be missed in usual care, but the uncertainty of effective screening duration could be a barrier.

Conclusions
This screening programme was feasible with the reinforcement of the underpinning enablers. Several implementation strategies were identified using SWOT analysis, including leveraging the opportunity for GPs to introduce this screening programme to at-risk patients.

Trial registration number
ACTRN12621000184875.

Leggi
Ottobre 2024