Primary care nurses (PCNs) are the second largest workforce in primary care and play a critical role in facilitating access to coordinated care and reducing health disparities. There is renewed interest in team-based primary care as a solution for health workforce challenges. Some team models enable PCNs (ie, nurse practitioners, registered nurses, licensed/registered practical nurses) to leverage one another’s expertise to work to optimal scope; the extent to which this happens depends on multiple context-dependent factors. We will conduct an umbrella review to synthesise and compare international knowledge syntheses focused on scope of practice enactment (ie., roles and activities) of PCNs in primary care.

We will conduct the umbrella review according to the Joanna Briggs Institute methodology, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines, and using the Nursing Care Organization Framework as guidance. We will search a wide range of scientific electronic databases and grey literature sources, and consider articles published in English and French by the Organization for Economic Cooperation and Development and designated key partner countries for inclusion, with no publication date limits. Two independent reviewers will screen titles, abstracts and full-text articles, and any disagreements will be resolved through discussion or by a third reviewer. We will use the Risk of Bias Assessment Tool for Systematic Reviews to assess the quality and risk of bias in the included systematic and scoping reviews.

Results will be presented in a PRISMA Scoping Review flow diagram. We will synthesise data from included studies in a detailed literature review table and develop visual aids to communicate the shared and unique roles and activities of PCN scope of practice. We will disseminate the results of the review through peer-reviewed publications and conferences related to this field. Ethics approval is not required.

Dyspnoea affects 10% of the general population, and 12% of hospitalised patients report experiencing dyspnoea at rest. It is a common and distressing symptom experienced by people living with chronic obstructive pulmonary disease (COPD). Neuromodulation, which uses electrical stimulation to modulate neural pathways, is a validated clinical procedure offering a potential therapeutic approach. We speculate that non-invasive transcutaneous vagus nerve stimulation (tVNS) and trigeminal transcutaneous electric nerve stimulation (TENS) could improve dyspnoea management by targeting relevant neural circuits.

We will conduct a feasibility cross-over trial in people with severe COPD and significant exertional dyspnoea referred for pulmonary rehabilitation. Patients will be recruited following the prerehabilitation assessment visit comprising a clinical evaluation and a maximal cardiopulmonary exercise testing on ergocycle. Subsequently, two study visits will be conducted within 2 weeks apart from each other. Eight participants will perform a submaximal constant work rate at 80% workload of the VO₂ max, either with cervical tVNS (n=4) or trigeminal TENS (n=4). In a cross-over design, both patient groups will undergo sham and active treatment of the neuromodulation technique in a randomly assigned order. The main outcome will be feasibility, assessed by the percentage of patients who attend all visits and complete all tests. Secondary outcomes include other feasibility endpoints, the acceptability and suitability of the interventions (including an evaluation of sham as an exploratory outcome), and the incidence of adverse or undesirable events related to the procedures. Exploratory outcomes include changes in dyspnoea symptoms, measured using standardised questionnaires, such as Borg scale and the Visual Analogue Scale.

The protocol is approved by the institutional research ethics committee of the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Estrie—CHUS, Sherbrooke, Quebec, Canada (#2025-5604) and follows 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Results will be communicated in international meetings and submitted to peer-reviewed journals with respect to the 2010 CONsolidated Standards Of Reporting Trials (CONSORT) statement for feasibility studies.

NCT06985628.

Despite being a leading cause of female morbidity and mortality, female-specific cardiovascular disease (CVD) is understudied, underdiagnosed and undertreated. Pregnancy complications involving the placenta, including pre-eclampsia, pregnancy-induced hypertension and foetal growth restriction, are thought to reflect global maternal vascular derangements that indicate a twofold to eightfold increased risk of future CVD. This calls for a better understanding of female cardiovascular pathophysiology to allow development of targeted screening and prevention strategies.

Acute atherosis is a placental vascular lesion, which histologically resembles systemic atherosclerosis. The PlacEntal Acute atherosis RefLecting Subclinical atherosclerosis study investigates the association between placental acute atherosis lesions and subclinical systemic atherosclerosis up to 20 years postpartum.

This study will improve our understanding of the relationship between pregnancy complications and CVD to identify potential prevention targets and treatments. In addition, it could determine whether the placenta can improve identification of young women at high risk of CVD. These women could benefit from risk-reducing interventions.

This longitudinal prospective cohort study will include women who are either currently pregnant or from a historical cohort. Both groups will have placental histopathology and a single postpartum CVD assessment. The CVD assessment will include medical history taking, blood tests, electrocardiography and echocardiography. Additionally, coronary CT angiography focusing on the presence of atherosclerotic plaques and calcium score will be carried out.

The currently pregnant women will either have a pre-eclamptic pregnancy (pre-eclamptic group) or an uncomplicated normotensive pregnancy (uncomplicated group), and their placenta will be collected prospectively. The single CVD assessment will be carried out 6–36 months postpartum.

Women from the historical cohort had a pre-eclamptic pregnancy 10–20 years ago. Placental tissue is available for reanalysis. The single CVD assessment will take place immediately and corresponds with 10–20 years postpartum.

Exclusion criteria are contraindications to diagnostic assessment necessities: iodinated contrast, beta-blockers or glyceryl trinitrate. Women with uncomplicated pregnancies will be excluded if they have a pre-existing auto-immune condition, chronic hypertension or diabetes mellitus. In the pre-eclamptic group, there are no additional exclusion criteria.

Ethical approval was granted by the Medical Ethics Committee in Maastricht University Medical Centre+ (NL52556.068.15/METC152019). Participants will give written informed consent. Results will be shared in peer-reviewed journals and conference presentations.

NCT05500989; ClinicalTrials.gov Identifier.

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.

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.

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.

NCT04765943.

Greater trochanteric pain syndrome (GTPS) is a common and disabling condition characterised by lateral hip pain. The condition often persists for several months, and there is low evidence for any superior treatment. The aim of this study protocol is to describe a randomised controlled trial (RCT) investigating the effectiveness of a self-management programme versus usual care for patients with GTPS.

The study is designed as an observer-blinded, parallel group, superiority RCTcomparing a self-management programme (n=55) with usual care (n=55). Eligible patients with GTPS will be included based on reproduction of pain on palpation in the greater trochanteric region and at least one positive clinical provocation test. The self-management programme includes 3–5 individual sessions with a physiotherapist over 12 weeks, addressing physical, emotional and behavioural factors deemed relevant by the patient. Usual care will receive general information about GTPS, activity management and are free to seek further treatment in primary care as wanted. The primary outcome measure is the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian). Outcomes will be assessed at baseline, 3, 6 and 12 months. A longitudinal mixed effects model will be used to assess the effectiveness of treatment on pain and disability across all time points, with the primary endpoint at 6 months. Cost-effectiveness will be expressed by mean incremental cost-effectiveness ratios (ICERs) from a societal and healthcare perspective. Bootstrapping will be used to estimate ICER uncertainty.

The Norwegian Regional Committees for Medical and Health Research Ethics have approved the project (2023/590816), and it will be in accordance with recommendations from the Data Inspectorate at Oslo University Hospital (22/26396). The results from the study will be disseminated through publications in peer-reviewed journals, in conference presentations and through the user representative.

NCT06297148.