共找到 20 条结果
Worldwide, the population is ageing. As the population ages, so does the prevalence of age-related diseases such as arthritis, osteoporosis, diabetes, hypertension, cancer and dementia, increasing the demand on health and social care services. The evidence underpinning treatments and interventions for most health and social care issues is derived from populations younger than 80 years of age because this age group is often excluded from taking part in clinical trials. This raises concerns that many established treatments may not be the most suitable or effective approach for those aged 80 years or more. Our aim was to produce an interactive evidence and gap map to provide an overview of the volume, diversity and nature of the evidence on health and social care interventions that target adults over 80 years of age. We searched 18 databases: Medline, PsycINFO, HMIC, Social Policy and Practice, Ageline, CINAHL Complete, ASSIA, PQDT; Epistemonikos; Cochrane, CENTRAL, Campbell systematic reviews, Web of Science, SCI, SSCI, AHCI, CPCI-S, CPCI-SSH, and ESCI (in October 2022). Searches were updated in July 2024. Forward and backward citation searching was also undertaken in 2024 using CiteSearch, Scopus and Google Scholar. We included systematic reviews, randomised controlled trials (RCTs) and primary qualitative studies in the map that focused on the effectiveness and/or experience of any health or social care interventions for adults aged 80 years or more. All studies were independently screened for eligibility by two people at both title/abstract and full text stages. Interventions were categorised in line with the WHO definition of five domains that facilitate healthy ageing: building and maintaining intrinsic capacity, health services models and approaches, enabling environments and technologies, building and maintaining relationships and learning, growing and making decisions. Interventions could cut across multiple domains. The data extraction tool was developed on EPPI reviewer and was modified and tested through piloting and revising by the core team. The tool was informed by the research question and the structure of the map. As well as extracting data on population characteristics, intervention domain and sub-categories, we extracted additional data to enable filters, such as specific health conditions, and equity characteristics. Standardised tools were used to assess study quality for all studies: AMSTAR-2 for systematic reviews; Cochrane Risk of Bias tool (version 1) for RCTs; and the Wallace criteria for primary qualitative studies. Data extraction and quality appraisal were extracted by one person and checked by a second. We included 172 studies: 36 systematic reviews, 120 RCTs and 16 primary qualitative studies. Most of the systematic reviews were assessed as low or very low quality with only five assessed as moderate to high quality. Similarly, most of the RCTs were assessed to be at medium to high risk of bias, with only 27 RCTs assessed with an overall low risk of bias. Ten of the qualitative studies were assessed as high quality. Over a third of the studies (n = 67) in the map have been published since 2020. The majority of the evidence, over 90% (n = 157/172), was focused within the domain of building and maintaining intrinsic capacity, and within this domain, on either surgical and medical procedures (n = 75) or medicines and medical technologies (n = 54) in predominantly the cardiovascular, neuromuscular and digestive areas. Rehabilitation and behavioral interventions were also represented. Only a small number of studies focused on health conditions linked to ageing: frailty a focus of research in 14 studies, and falls in six studies. Only two studies addressed mental health therapies, and there were no studies focused on skin conditions, genitourinary health and or voice/speech conditions. The second most frequently represented domain was health service models and/or approaches (n = 38), predominantly relating to home visits (n = 15, all RCTs) and comprehensive geriatric assessment and integrated care (n = 5, all RCTs). The three intervention domains of enabling environments and technologies, building and maintaining relationships and learning, growing and making decisions were poorly represented in the evidence. The majority of studies measured physiological outcomes of health, such as measures of functional health, chronic health markers or symptoms, and adverse events; few studies assessed measures of well-being or psychosocial health. Sixteen studies reported on experiences of interventions, mostly from the experience of the older adult (n = 9) and were in relation to heart surgery and procedures, colon surgery, resuscitation, medicines review and preventative screening. Only 7% of outcomes in the map were in the psychological health and wellbeing category. Social health (including connectedness and participation) was not featured as an outcome in any studies. Studies were primarily conducted in Europe and Asia: these two regions representing over 75% of the evidence. There were several gaps evident in the map, including but not limited to, end-of-life care (including advance care planning) and healthcare delivery such as hospital-at-home and telehealth. Several potential research areas where synthesis might be valuable were also identified such as medicines optimisation, home visits, and specific health conditions such as osteoporosis treatments. As the worldwide population continues to age, it is increasingly important that we have evidence of appropriate effective interventions for those who have reached their 80s, 90s and beyond, a group often left out of trials. This evidence and gap map shows that currently there is a clear bias towards interventions orientated around a biomedical view of health focused on intrinsic capacity, and relatively little on the wider functional and psychosocial aspect of health, or on enabling environments, such as adaptations to health and care services, or models of care. There is also a clear need for more research to understand the experiences and preferences of interventions from adults aged 80 years or more. Research exclusively focussed on people aged over 80 targets medical treatments and surgical procedures, neglecting healthcare services or wellbeing, and much of it is poor quality. The Evidence and Gap Map (EGM) in brief: Most of the studies in people aged over 80 investigate medical procedures and treatments with a focus on basic health needs and the ability to function, with fewer studies about health and care services or wellbeing. What is this EGM about?: Our population is ageing, which means that people are living longer, and age-related illnesses such as arthritis, dementia and cancer are becoming more common. Studies investigating interventions (treatments, procedures, therapies and services) are often focused on people aged under 80, because those who are older are often excluded from taking part in trials. Therefore, the treatments that are considered best practice in a general population might not be the best option for people aged over 80. This EGM displays evidence of interventions from systematic reviews and randomised controlled trials (RCTs) and studies looking at experiences (qualitative studies) where the people being investigated were aged over 80. What is the aim of this EGM?: The aim of this EGM is to provide easy access to studies that investigate interventions for people aged over 80. The studies are grouped by types of interventions and outcomes. Overall, the EGM provides an overview of the volume and nature of evidence on interventions for this age group. What studies are included?: The EGM contains 172 studies investigating interventions for people aged over 80. The interventions are organized into five groups: building and maintaining intrinsic capacity (ability to function both physically and mentally), health services an/or approaches, enabling environments and technologies, building and maintaining relationships and learning, growing and making decisions. The EGM contains 36 systematic reviews, 120 RCTs and 16 qualitative studies. What are the main findings of this gap map?: Research in older people is becoming more common as the population ages. Over a third of studies (n = 67) in the map have been published since 2020. However, most of the research was moderate to poor quality. Most of the systematic reviews (n = 31) and RCTs (n = 93) were rated as low or very low quality. Only a small number of studies focused on health conditions linked to ageing, with frailty covered in 14 studies, and falls in 6 studies. Most of the studies (n = 157) were about building and maintaining intrinsic capacity, focusing on the treatment and/or prevention of diseases and health disorders. The categories with most studies were those that involved surgery (n = 75 studies), and those that involved medicines or medical devices (n = 54). Only two studies addressed mental health therapies, and no studies examined ‘end of life’, skin conditions, genitourinary health and or voice/speech conditions. Several studies (n = 38) examined health services and/or health approaches. Some of these (n = 15) were RCTs assessing the effectiveness of home visits and a smaller number (n = 5) assessed geriatric assessment. Surprisingly, there were no systematic reviews in the map covering those topics. The only systematic review in the health services category investigated admitting older adults with sepsis into intensive care units. Similarly, there were no systematic reviews in the categories of enabling environments and technologies and learning, growing and making decisions. The most common outcomes reported in the studies were physiological measures of health (such as blood cholesterol levels, or blood pressure), measures of physical function (such as strength, balance), chronic health symptoms and side effects and complications. Only 7% of outcomes in the map were in the psychological health and wellbeing category. Social health (including connectedness and participation) was not featured as an outcome in any studies. Sixteen studies reported on experiences of interventions, mostly from the experience of the older adult (n = 9) and were in relation to heart surgery and procedures, colon surgery, resuscitation, medicines review and preventative screening. What do the findings of the map mean?: This EGM provides information on systematic reviews, RCTs and qualitative studies that have examined the effectiveness of interventions for people aged over 80. This is important because people in older age groups are often excluded from research, meaning the interventions that are best for the general population might not be most suitable for them. While studies in people aged over 80 focus on basic health needs, older people are under-represented in studies about psychosocial aspects of health or enabling environments such as adaptations to health and care services. There is also a need for more studies examining how people aged over 80 experience treatments, therapies and services. How up-to-date is this EGM?: The EGM contains studies published up until July 2024.
The role of the nurse in the heart failure (HF) multi-disciplinary team (MDT) has become well-established, with clear evidence of improved patient outcomes and recommended by professional guidelines. Recognizing the change in the HF landscape since the publication of the first Heart Failure Association (HFA) of the European Society of Cardiology (ESC) HF nurse curriculum in 2016, and the expanding role of HF nurses of in the HF MDT, the HFA in collaboration with the Association of Cardiovascular Nursing and Allied Professions (ACNAP) of the ESC prioritized this update to the curriculum. Standardized training programmes for HF nurses improve the quality of care provided to patients with HF and their caregivers. Recognizing the variability of education background and clinical autonomy across Europe and beyond, this curriculum is designed in a flexible way to be able to be adapted and adjusted based on individual country regulations and forms. Endorsement of this curriculum from national professional bodies or Nursing Councils would ensure uniformity and enhance the profession's contribution to HF care. The updated specialist HF nurse curriculum provides the basis for the advanced level of knowledge, skills and attitudes required for the appropriate expansion of the role of the HF nurse that can be adapted across Europe and beyond, while complying with professional legislation of different healthcare systems and supporting nurses who move between countries.
To describe the clinical characteristics, etiologies, management patterns, and outcomes of hospitalized heart failure patients in a tertiary care military hospital in United Arab Emirates (UAE), and to benchmark guideline directed medical therapy (GDMT) uptake and care models against regional and international registries. We retrospectively reviewed all consecutive patients admitted with a primary diagnosis of heart failure between January and December 2024, at Zayed Military Hospital, UAE. Clinical data were extracted from electronic medical records. The GDMT adherence was assessed according to the 2022 American Heart Association (AHA)/ American College of Cardiology (ACC) and 2023 European Society of Cardiology (ESC) heart failure guidelines, and outcomes were compared between cardiology-led and non-cardiology services. Among 152 patients (69% male; mean age 68.5 years), 57% had heart failure with reduced ejection fraction (HFrEF), 24% mildly reduced, and 19% preserved ejection fraction. Ischemic heart disease was the most common etiology (58.6%). Compared with published Gulf registries, GDMT uptake in HFrEF was high: angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blocker (ARB)/ angiotensin receptor-neprilysin inhibitors (ARNI) (82.8%), beta-blockers (94.3%), and sodium-glucose co-transporter 2 (SGLT2) inhibitors (74.7%). In contrast, mineralocorticoid receptor antagonists were markedly underused (21.8%). HFpEF patients had the highest 180-day readmission rate (41.4%). Cardiology-led care was associated with higher GDMT uptake, shorter length of stay, and improved follow-up and readmission outcomes. This cohort demonstrates improved adoption of evidence-based heart failure therapies compared with regional data, but highlights a persistent mineralocorticoid receptor antagonists (MRA) treatment gap. Cardiology-led inpatient management is associated with superior GDMT implementation and clinical outcomes, underscoring the importance of specialist-driven care pathways.
Chronic diseases account for most global morbidity and mortality, increasing the need for effective long-term self-care support. Digital health interventions, such as mobile apps, telemonitoring, and connected devices, are increasingly used to promote self-care; yet, their overall effectiveness across chronic conditions remains unclear. This systematic review and meta-analysis evaluated whether digital health interventions improve self-care in adults with chronic diseases. We searched PubMed, CINAHL, Scopus, and PsycINFO for randomized controlled trials (RCTs; January 1, 2013, to December 31, 2025) that assessed digital health interventions targeting self-care outcomes, as measured with validated instruments, in patients with chronic conditions. Standardized mean differences (SMDs) were pooled using random-effects models, while results not suitable for meta-analysis were synthesized narratively. Risk of bias was assessed with the Cochrane Risk of Bias 2.0 tool for RCTs and certainty of evidence with Grading of Recommendations Assessment, Development and Evaluation. A total of 55 RCTs involving 5889 participants were included. Most interventions were multicomponent and mainly based on mobile or web-based applications, telemonitoring, connected devices, and text-messaging support. In diabetes, pooled analyses showed little to no clear improvement across self-care domains measured with the Summary of Diabetes Self-Care Activities, including general diet (3 studies), specific diet (3 studies), exercise (5 studies), foot care (5 studies), and glucose monitoring (4 studies), with low to very low certainty of evidence. In heart failure, digital interventions probably improved self-care monitoring measured with the Self-Care of Heart Failure Index (5 studies, 364 participants; SMD=0.49, 95% CI 0.13-0.85; low certainty), whereas effects on self-care maintenance (5 studies) and on self-care measured with the European Heart Failure Self-Care Behaviour Scale (3 studies) were not clearly demonstrated. In other chronic conditions, narrative synthesis suggested possible benefits in some cardiovascular conditions, chronic hepatitis B, epilepsy, and hypertension, while no significant effects were found in chronic obstructive pulmonary disease and multimorbidity, and mixed findings emerged in Parkinson disease. Across 17 studies, medication adherence showed little to no overall improvement (SMD=0.06, 95% CI -0.31 to 0.42, 95% prediction interval -0.98 to 1.09; very low certainty), indicating that future studies could plausibly show either benefit or no effect. Overall, heterogeneity was substantial, and most evidence was of low or very low certainty. This review is innovative in providing an up-to-date, cross-condition synthesis focused specifically on self-care as a multidimensional outcome, rather than on clinical end points alone or single diseases. The findings suggest that digital health interventions may be more effective for supporting self-care monitoring than for promoting broader behavioral maintenance or medication adherence. Evidence is limited by methodological heterogeneity, small sample sizes, short follow-up periods, and varied outcome measures. Larger designed trials using standardized self-care metrics and equity-focused approaches are needed to clarify effectiveness and guide implementation.
Heart failure (HF) remains a leading cause of morbidity and mortality worldwide, with particularly poor outcomes in low- and middle-income countries (LMICs). Despite strong evidence for guideline-directed medical therapy in terms of mortality/morbidity reduction and improvement in quality of life, the real-world implementation remains suboptimal, even in high-income settings. In LMICs, barriers are compounded by limited access to diagnostics, essential pharmaceutical and device therapy, alongside socioeconomic constraints and fragmented healthcare systems. Structural inequities, including the underrepresentation of LMIC populations in clinical trials, further restrict the applicability of evidence-based interventions. This position document highlights key challenges to guideline implementation in resource-limited settings, including affordability, workforce shortages, cultural practices, and gaps in infrastructure and insurance coverage. Strategies to address these barriers include the use of accessible diagnostics, decentralization of care, expanded roles for non-specialist providers, and telemedicine-supported continuity of care. Broader systemic reforms, including improved insurance systems, stronger referral networks and the integration of primary prevention, are critical. Finally, equitable representation of LMIC populations in clinical research should be prioritized to ensure the safety and efficacy of future therapies. Bridging the gaps in HF care at the global level requires context-specific adaptation of international guidelines, targeted healthcare system strengthening, and innovative care delivery models that make evidence-based HF treatment accessible, affordable, and sustainable.
Biochemical urine analysis by liquid chromatography-mass spectrometry analysis (ie, chemical adherence testing [CAT]) is an objective method of detecting non-adherence to antihypertensive treatment. We aimed to assess whether an intervention based on providing non-adherent patients with hypertension with information on their urine analysis results combined with a discussion of the main reasons for non-adherence (CAT-guided intervention) would lead to a cost-effective improvement in adherence, blood pressure, and urinary excretion of albumin. OUTREACH was a multicentre, randomised controlled trial in 12 UK secondary or tertiary outpatient centres and primary care services. We recruited non-pregnant patients with hypertension who were older than 18 years and were on at least two antihypertensive medications. Participants who were non-adherent to antihypertensive treatment based on the results of their first urine CAT were randomly assigned (1:1) either to the intervention (discussion of the results of the urine CAT; group A) or standard of care (group B) after visit 2. The sequence of randomisation was computer-generated through an automated randomisation service (Sealed Envelope), which used minimisation as a method of allocation based on recruitment site, baseline systolic blood pressure, age, sex, number of antihypertensive medications prescribed at visit 1, the improvement in biochemical adherence to antihypertensive treatment between visits 1 and 2, and a random element to ensure the unpredictability of the assignment. The primary outcome was the mean clinic systolic blood pressure measured at visit 4. All analyses were based on the intention-to-treat principle. The trial was registered with ClinicalTrials.gov (NCT03293147) and is completed. Between Feb 4, 2019, and Feb 1, 2023, 879 patients were assessed for eligibility, 748 of whom were excluded after visit 1; 720 because they were either adherent or had unconfirmed adherence status on urine CAT. 70 adherent individuals were retained on the study for masking purposes but were not a part of the two-arm randomised component of the study. 130 non-adherent patients included in the study were randomly assigned to the intervention group (A; n=65) or the standard of care group (B; n=65). 71 (55%) participants were male and 59 (45%) were female; 57 (44%) were White, 22 (17%) were Asian or Asian British, 49 (38%) were Black, African, Caribbean, or Black British, and two (2%) were other ethnicities. The median follow-up after the intervention to visit 4 was 2·8 months (IQR 2·2-4·3). Mean clinic systolic blood pressure at visit 4 was 150·9 mm Hg (SD 24·7) in 56 participants in group A and 151·1 mm Hg (24·4) in 55 participants in group B (adjusted mean difference -5·1 mm Hg [95% CI -12·7 to 2·5]; p=0·19). 33 adverse events were reported (11 in group A and 22 in group B). 12 serious adverse events were recorded during the trial, occurring in five (8%) of 65 participants in group A and five (8%) of 65 participants in group B (two participants in group B had two serious adverse events each). CAT-guided intervention did not show a significant effect on clinic systolic blood pressure, but the study was underpowered. Larger studies are required to better understand the effect of urine CAT-guided interventions on blood pressure. British Heart Foundation, National Institute for Health and Care Research Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, and Omron.
Disparities in arrhythmia care are increasingly recognized, yet remain incompletely characterized across the patient pathway. This European Heart Rhythm Association (EHRA) survey explored clinician-reported perceptions of inequity across diagnosis, pharmacological management, procedural referral, and follow-up. A 30-question survey was disseminated via the EHRA between November 2025 and January 2026, with 212 responses from professionals across 35 countries. Respondents were predominantly consultant electrophysiologists (67.5%), with 39.6% identifying as female. Most (68.4%) reported no prior training in equity or inclusive care. Across the arrhythmia care pathway, disparities were most frequently attributed to patient vulnerability, particularly cognitive impairment (72.5%), age >80 years (63.8%), and mental health disease (61.3%). Differences related to socioeconomic status, language, and other social factors were also commonly reported. Female sex and minority ethnic background were each reported to influence care in 24.1% of responses. Age >80 years was consistently identified as the strongest determinant of disparities in referral, diagnosis, and outcomes, influencing referral for arrhythmia evaluation (65.8%), catheter ablation (77.9%), and outcomes following ablation (68.1%). Socioeconomic and ethnic factors showed more modest but consistent effects, while sex-based differences were less frequently reported. However, female respondents were more likely than male respondents to report delayed referral (female respondents: 41.8%; male respondents: 19.8%) and late or incorrect diagnosis (49.4 vs. 15.8%) in female patients, as well as delayed referral for catheter ablation (36.5 vs. 10.3%) and device implantation (23.0 vs. 7.0%). Only one-third of respondents (33.3%) felt that current international guidelines adequately address diversity, equity, and inclusion in arrhythmia care. Clinicians perceive disparities in arrhythmia care across multiple patient and social factors. Whilst age and vulnerability were most frequently perceived to influence care, sex and ethnicity were also recognized by a substantial proportion of respondents. Perceptions varied according to respondent characteristics, with female clinicians more likely to report disparities amongst female patients. Limited training and institutional frameworks highlight opportunities for targeted interventions.
With the rapid increase in percutaneous left heart interventions, transseptal access to the left atrium has become a widely used procedure. This technique is crucial for electrophysiological procedures, particularly for atrial fibrillation ablation, which is estimated to be performed in more than 250 000 patients per year worldwide, as well as for various structural heart interventions, like percutaneous mitral valve repair. Although transseptal puncture (TSP) is generally considered a simple technique, it is associated with a small risk of potentially life-threatening complications. To ensure a successful and safe procedure, a thorough understanding of TSPs' clinical use, and the anatomy of the interatrial septum-including the fossa ovalis and its anatomical variants-is critical. Since the first fluoroscopy-guided TSP, advancements in echocardiographic imaging have enhanced the precision of the puncture, allowing targeting of specific regions of the fossa ovalis and facilitating difficult procedures. While most TSPs are performed using a Brockenbrough needle and a (steerable) sheath, wide variation in technique exists, and alternative methods have been developed initially aiming for complex cases but now routinely used. Understanding potential complications-such as cardiac tamponade, aortic puncture, and embolism-is essential for prevention, early recognition, and effective management, ultimately improving patients' outcomes. Finally, understanding how to approach specific complex scenarios is crucial for procedural success.
Dual antiplatelet therapy (DAPT) is required to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). The default DAPT strategy, namely a potent P2Y12 inhibitor combined with aspirin for 12 months, exposes many patients to excess bleeding risk. Over the past years, alternative antithrombotic regimens have been proposed to reduce bleeding (DAPT abbreviation or de-escalation) or ischaemic (prolonged dual antithrombotic therapy) events. Abbreviation or de-escalation of DAPT is supported by (i) multiple trials showing these strategies to significantly reduce bleeding, particularly for the 20-40% of patients classified as high bleeding risk (HBR); (ii) low prevalence of stent thrombosis and recurrent myocardial infarction beyond 1-3 months post-ACS with the latest generation of drug-eluting stents, and (iii) the recognition that HBR is far more prevalent than high ischaemic risk. Amongst patients at HBR, standard DAPT, in comparison to abbreviated or de-escalated DAPT, increases the net risk of major adverse events, even in the presence of high ischaemic risk. Conversely, amongst patients at high ischaemic risk, without HBR, prolonged dual antithrombotic therapy reduces longer-term thrombotic risk. Recognizing risk factors and assessing the magnitude of bleeding and ischaemic risks are essential. Since there are no ideal scoring systems to balance ischaemic and bleeding risks, and many overlap, focus should be on managing the risk most amenable to modification, namely bleeding, which should dominate the decision-making over ischaemic risk when choosing a DAPT regimen. This document provides practical advice regarding best practice for personalizing DAPT in patients with ACS undergoing PCI, with evidence-based clinical consensus statements on selecting the most appropriate antiplatelet strategy to optimize clinical outcomes.
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive disease predominantly affecting older men and is associated with increasing care needs. Previous international studies have reported that, as ATTR-CM progresses, caregivers experience substantial physical and emotional burden, as well as productivity impairment. However, real-world evidence on caregiver burden in Japan remains limited. This study aimed to characterize multidimensional caregiver and patient burden in Japan. Data were drawn from the Adelphi ATTR Disease Specific Programme™, a cross-sectional survey of cardiologists and their consulting patients with ATTR-CM, conducted in Japan between October 2024 and January 2025. Cardiologists completed patient record forms, including patient demographics, clinical characteristics, and caregiving status. Patients and their non-professional caregivers also completed voluntary self-reported questionnaires. Caregiver outcomes included caregiving time, work productivity, and activity impairment (WPAI), and Zarit Burden Interview (ZBI) scores. Patient health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Analyses were descriptive. Twenty-five physicians provided data for 120 patients (mean age 74.7 years; 78.3% male). Over half of patients (55.9%) had a caregiver, most commonly a spouse (72.6%). Caregivers (n = 22; mean age 64.0 years; 95.5% female) primarily lived with the patient (81.8%). Caregivers reported a median (interquartile range) of 20.0 (5.0-40.0) hours/week caregiving, and experienced substantial overall work productivity impairment [36.2% (SD 37.3%)] and daily activity impairment [47.7% (SD 31.5%)]. The mean ZBI score was 38.3 (SD 19.3), with 85% experiencing at least mild burden. This real-world study describes substantial burden among a sample of predominantly female spouses caring for patients with ATTR-CM in Japan. Furthermore, these findings underscore the importance of timely diagnosis and treatment for patients, alongside strengthening support for their caregivers within the Japanese healthcare system.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have emerged as an important therapeutic class for the management of type 2 diabetes mellitus (T2DM) and obesity owing to their ability to improve glycemic control, promote weight loss, reduce cardiometabolic parameters, and have the added advantage of a low risk of hypoglycemia due to glucose-independent insulin secretion. Semaglutide, a long-acting GLP-1 RA developed using a semi-recombinant process, has demonstrated significant benefits across metabolic and cardiovascular outcomes. Amid the increasing need for affordable therapies, there has been a rising interest in developing synthetic peptide versions of glucagon-like peptide-1 (GLP-1)-based drugs originally produced using recombinant deoxyribonucleic acid (rDNA) technology. However, the transition from recombinant production to chemical peptide synthesis raises important considerations about regulatory pathways, manufacturing processes, and potential clinical implications. Regulatory approaches for synthetic peptides vary across regions. The European Union and the United States follow distinct frameworks, with India adopting a risk-based regulatory approach that may require extensive quality, safety, and clinical data. Manufacturing processes can influence impurity profiles, stability, and immunogenicity, potentially affecting clinical outcomes. Therefore, the approval of follow-on versions of semaglutide requires a rigorous demonstration of both quality and clinical comparability with the originator, consistent with principles applied to biosimilars. Online databases such as PubMed, Scopus, and Google Scholar were used to source relevant research articles. This narrative review aims to discuss the development of semaglutide, examine global and national regulatory perspectives on synthetic and recombinant peptides, and explore the clinical implications of manufacturing variability. It also highlights the expanding therapeutic potential of semaglutide beyond obesity and T2DM.
People with pulmonary fibrosis (PF) live with persistent dyspnea, chronic cough, and fatigue. Symptoms that impair their exercise capacity and quality of life. The need for frequent outpatient clinic visits to evaluate disease progression and treatment response can impose a substantial burden on people with PF. Online home monitoring has the potential to replace some of these visits. However, structural implementation and evidence on its impact on patient outcomes are lacking. Here, we describe the design of the SUITS study, a multicenter randomized controlled trial (RCT) which aims to evaluate the impact of partly replacing conventional outpatient clinic visits with home monitoring and video consultations on clinically relevant patient outcomes and efficiency of healthcare systems. Patients will be randomized to either standard care (3-monthly outpatient clinic visits) or hybrid care. Hybrid care consists of a home monitoring program and video consultations that alternately replace outpatient clinic visits. In an online application, patients perform weekly home spirometry and pulse-oximetry measurements, fill out patient reported outcome measures (PROMs) on a regular basis, and have access to an information library with disease specific information. The primary endpoint of this RCT is the change in patient self-management from baseline to 12 months, assessed with the validated patient activation measure (PAM). In light of the insufficient implementation of a hybrid care pathway for people with PF, there is pressing need for a trial to confirm if partly replacing outpatient clinic visits with home monitoring and video consultations is both feasible and effective. Clinicaltrials.Gov: NCT06883448, date of registration: 13-03-2025. The study was retrospectively registered. No changes were made to the IRB approved study protocol (version 1, 11-01-2024) prior to registration at ClinicalTrials.gov.
Percutaneous coronary intervention (PCI) has evolved significantly over the past decade with approximately 30% of patients presenting with complex coronary artery disease, posing heightened procedural and long-term risks. Complexity in PCI is increasingly recognised as multifactorial, encompassing lesion, procedural and patient-related characteristics. The Ultimaster Nagomi sirolimus-eluting coronary stent system is designed to address the challenges of complex PCI. The NAGOMI COMPLEX study aims to assess its safety and clinical performance in a comprehensively defined complex PCI population, reflecting routine clinical practice. This is a prospective, multicentre, single-arm cohort study enrolling 3000 subjects undergoing complex PCI across 52 European sites. Eligible patients must meet at least one complex PCI criterion, such as multivessel PCI, bifurcation lesions, chronic total occlusions or long total stent length implantation (>60 mm). Patients will undergo PCI using the Ultimaster Nagomi sirolimus-eluting coronary stent system, with follow-up assessments conducted at 30 days, 6 months, 1 year and 2 years. The primary endpoint is Target Lesion Failure at 1 year, defined as a composite of cardiovascular death, target-vessel myocardial infarction and clinically driven target lesion revascularisation. Secondary endpoints include device success, lesion success, procedure success, rates of stent thrombosis, bleeding complications (Bleeding Academic Research Consortium (BARC 3-5)), patient-reported outcomes (EQ-5D-5L, Seattle Angina Questionnaire (SAQ-7)) and resource utilisation for health-economic analysis. Subgroup analyses will explore outcomes across clinical and procedural complexity criteria. Clinical events will be adjudicated by an independent Clinical Events Committee, while a Data Monitoring Committee will oversee safety. The study complies with the Declaration of Helsinki, EU MDR 2017/745, ISO 14155:2020, EU Regulation 2016/679 (General Data Protection Regulation), GCP and applicable national regulations. Ethics Committee approval has been obtained at all participating sites. Written informed consent is required from all subjects. Results will be disseminated through peer-reviewed publications and scientific conferences. NCT05705973.
Coronary obstruction (CO) during transcatheter aortic valve replacement (TAVR) is rare but potentially fatal. Computed tomography (CT)-based risk assessment algorithms aim to identify high-risk patients, but their utility remains underexplored. The aim of this study was to examine the clinical utility of a CT-derived algorithm for predicting CO during TAVR and identify predictors of CO despite coronary protection (CP). In this prospective study, 164 patients at risk for CO during TAVR were enrolled. Preprocedural CT was used to classify risk using a published algorithm. A novel volumetric parameter, valve-to-coronary volume (VTCV), was calculated in high-risk cases using sinus width and valve-to-coronary (VTC) distance. The decision to use CP was left to the heart team. Clinical endpoints followed Valve Academic Research Consortium 3 definitions. According to the CT-based algorithm, 58.5% of patients (96 of 164) were at low risk, 24.4% (40 of 164) at intermediate risk, and 17.1% (28 of 164) at high risk. CP was performed in 12.8% of low-risk patients (16 of 125), 52.8% of intermediate-risk patients (28 of 53), and 93.9% of high-risk patients (31 of 33). All CO events (n = 7) occurred in the high-risk group. VTC distance and VTCV were significantly lower in patients with CO (P = 0.006 and P = 0.005, respectively). VTCV independently predicted CO (area under the curve, 0.841; 95% CI: 0.702-0.979; P < 0.001), outperforming VTC distance alone. The predictive value of VTCV was validated in an external cohort including 11 European centers. A CT-based algorithm stratifies patients into 3 CO risk categories, though the decision for CP in clinical practice seems to incorporate additional clinical and procedural variables. Although CP reduces CO risk, its efficacy is limited in patients with very small VTCV, which can be predicted preprocedurally via CT. (Leipzig TAVR Registry; NCT05015452).
National income level influences the prevalence and outcomes of cardiovascular disease (CVD), with lower-income countries contributing disproportionately to the global CVD burden. Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) requires specialised equipment, increasing procedural costs. However, whether national income level contributes to disparities in managing patients with CTO remains unclear. To compare the clinical profiles, procedural settings and outcomes of patients undergoing CTO-PCI in middle-income countries (MICs) and high-income countries (HICs). This cross-sectional study included 15,329 patients who underwent CTO-PCI between 2021 and 2023. Data were obtained from the European Registry of Chronic Total Occlusions (ERCTO). Of the 24 enrolling countries, 7 were classified as MICs and 14 as HICs. Patients in HICs were older (67 ± 10 vs 61 ± 10 years; p < 0.001) and presented with greater CTO complexity (J-CTO score: 2.31 ± 1.25 vs 1.99 ± 1.17; p < 0.001). Conversely, patients in MICs were more likely to have diabetes (35% vs 29%; p < 0.001) and to be active smokers (59% vs 49%; p < 0.001). Patients in MICs had lower use of mechanical cardiac support (0.1% vs 0.8%; p < 0.001), advanced calcific plaque modification devices (1% vs 6.1%; p < 0.001), and intravascular ultrasound (14% vs 25%; p < 0.001). MICs achieved higher procedural success (89.5% vs 90.5%; p = 0.07) but higher mortality compared to HICs (0.6% vs 0.2%; p < 0.001). Among a selected population of patients undergoing CTO-PCI, notable clinical, anatomical, and procedural differences exist between MICs and HICs. These findings highlight the importance of tailoring public health strategies to optimise cardiovascular care across diverse economic settings.
Patient-reported outcome measures (PROMs) provide valuable data to inform regulatory decision making, health technology assessment and routine clinical care. We aimed to develop a feasibility item checklist for PROMs and their selection, beyond their psychometric properties (FACTOR3). We followed a five-stage method to select parameters for PROM evaluation. 1) A scoping literature review identified candidate items for consideration; 2) round 1 modified Delphi was used to select items for inclusion or exclusion, conducted by the design group (n = 14); 3) feedback on the checklist was provided by representatives from the European Medicines Agency and National Institute for Health and Care Excellence; 4) round 2 modified Delphi was used to finalise item selection, conducted by the clinical domains group (n = 21) and 5) evaluation of the feasibility item checklist using a selection of PROMS (EQ5D-5L, HeartQOL, the Oxford Hip Score, The EORTC Core Questionnaire QLQ-C30, Re-QOL-10 and NEI-VFQ-25) (Fig. 1). The scoping review identified 13 items relating to the intrinsic feasibility of using PROMs which were considered in the modified Delphi. The final FACTOR3 checklist included eight unique candidate items: price; licensing, comprehensibility, duration, coverage, translations, electronic device compatibility; and minimal important difference. Of the six PROMS evaluated, the intraclass correlation coefficient was 0.81, suggesting good reliability. FACTOR3 is a feasibility item checklist to assess the implementation characteristics of PROMs in research, regulation and routine clinical care. It may be used in conjunction with existing psychometric evaluation and user guides for PROMS to facilitate their use in health care.
Randomised controlled trials (RCTs) of COPD management assess heterogeneous outcomes with diverse instruments and often omit those important to patients and healthcare professionals, limiting interpretability and comparability. This review aimed to identify the outcomes and instruments used in phase III/IV COPD maintenance management RCTs and assess their consistency. We systematically reviewed all phase III/IV RCTs registered on ClinicalTrials.gov between 2010 and 2025 evaluating COPD maintenance management. Outcomes and measurement instruments were extracted from registry entries and categorised using the COMET (Core Outcome Measures in Effectiveness Trials) taxonomy. Registered outcomes from a random 10% sample were compared with the corresponding publications to assess concordance. Outcome frequencies were summarised across intervention types and sponsor categories. 43 unique outcomes were identified across 240 eligible RCTs. Physiological (89.5%), clinical (85.0%) and life impact outcomes (63.8%) were most frequently assessed, whereas resource use (39.6%), safety (36.7%) and mortality (16.7%) outcomes were less commonly reported. Only lung function (76.3%) and health-related quality of life (57.5%) appeared in over half of the trials. Exacerbations were reported in 40.4% of studies, while several patient-prioritised outcomes, particularly activities of daily living (5.4%) and exercise tolerance (18.3%), were infrequently assessed. Industry-sponsored RCTs more often reported lung function, resource use and adverse events; non-industry trials more frequently included biomarkers. Concordance between registered and published outcomes was acceptable (79.7%), although safety outcomes and instruments were sometimes under-reported. COPD maintenance management RCTs show substantial heterogeneity and incomplete assessment of patient-prioritised outcomes. An internationally representative, multi-stakeholder core outcome set is urgently needed to improve consistency and patient-centred evaluation in future trials.
Background/Objectives: Diabetes mellitus and hypertension are major chronic conditions that markedly affect patients' health and quality of life worldwide. With the rapid development of technology, there has been a growing interest in exploring the potential role of artificial intelligence (AI) in the management of such diseases. This study aims to assess the accuracy and reliability of artificial intelligence tools in providing information for diabetes mellitus and hypertension management. Methods: This study assessed the accuracy and reliability of the information provided by major AI tools such as ChatGPT, Gemini, POE, Claude, Consensus, and Perplexity. Twenty questions that are essential for the management of diabetes mellitus and hypertension were constructed based on the chapters of the respective guidelines and were fed to the AI tools. The outcomes were compared with evidence-based treatment guidelines, such as those from the American Diabetes Association (ADA), the American Heart Association (AHA), the European Society of Cardiology (ESC), and the National Institute for Health and Care Excellence (NICE). Answers were classified into "accurate ", "inaccurate", and "accurate with missing information". Three rounds of six-week intervals were conducted to assess accuracy and reliability. In addition, they were conducted to evaluate data updates by comparing answers across the rounds. Results: In round one of the evaluations, ChatGPT and Poe showed the highest accuracy, both at 65% (95% CI: 41.0-83.7), followed by Claude at 60% (95% CI: 41.0-83.7). ChatGPT had the lowest inaccuracy rate at 5% (95% CI: 1.75-33.1), while Claude demonstrated the smallest percentage of responses with missing information at only 6%. (95% CI: 12.8-54.3). In round 2, Claude markedly outperformed all other tools, achieving an accuracy rate of 95% (95% CI: 73.0-99.7) and no responses with missing information (0%). In round 3, ChatGPT came second with 70% (95% CI: 45.70-87.2) accuracy and maintained the lowest inaccuracy rate of 5% (95% CI: 0.26-26.9). Consensus had the largest inaccuracy rate at 40% (95% CI: 20.0-63.6) and the lowest accuracy rate at 40% (95% CI: 20.0-63.6). Overall, statistically significant pairwise comparisons showed that Cloud in the second round has the highest accuracy compared to Poe (p = 0.0154), Gemini (p = 0.0421), Consensus (p = 0.0035), and Perplexity (p = 0.0302). In the assessment of performance shift from round 1 to round 2, Claude achieved the greatest improvement in accuracy at 40%. In the assessment of performance shift from round 2 to round 3, Poe improved the most with an accuracy increase of 25%, while ChatGPT followed with 20%. When evaluating the unprompted and guideline-prompted questions for all AI tools using McNemar's test, it did not reveal a statistically significant distinction in the proportion of accurate responses (p > 0.05). Conclusions: Throughout the three rounds, ChatGPT maintained the best performance, with the fewest missing data. Claude and Poe followed, showing high accuracy with relatively low inaccuracy rates. On the other hand, Perplexity and Gemini performed moderately, while Consensus had the lowest accuracy.
At birth, major circulatory and pulmonary adaptations are required for a successful foetal-to-neonatal transition. In newborns with transposition of the great arteries (TGA), this transition is often impaired, leading to severe hypoxemia. This may also result in persistent pulmonary hypertension of the newborn (PPHN), worsening hypoxemia, and increasing the risk of urgent invasive interventions after birth. Physiological-based cord clamping (PBCC), delaying cord clamping until after lung aeration and ventilation are established, promotes a more stable circulatory transition and has shown benefits in both preterm and term neonates. PBCC may also provide advantages in infants with congenital heart disease. In TGA, combining PBCC with early supplemental oxygen may reduce the incidence and severity of PPHN, decrease related complications, and minimize the need for invasive interventions. To evaluate the feasibility, safety, and clinical outcomes of the stabilisation approach, we have initiated a stepwise quality improvement initiative comprising 2 sequential studies. Study phase 1, a single-centre study at Leiden University Medical Centre will assess feasibility, protocol adherence, and safety. Study phase 2, an observational cohort study across multiple European centres will evaluate clinical outcomes, focusing on incidence and severity of PPHN and the need for urgent interventions. All TGA newborns will be stabilised with an intact umbilical cord while receiving 2 L/min nasal high flow (fraction of inspired oxygen 1.0) as supplemental oxygen. Cord clamping will occur once the infant is considered stable, defined as a heart rate >100 bpm and preductal SpO2 >75% with supplemental oxygen. This study will inform guidelines for delivery room management and early preoperative care in TGA newborns. À la naissance, des adaptations circulatoires et pulmonaires majeures sont nécessaires pour assurer la transition du fœtus au nouveau-né. Cette transition est souvent compromise chez les nouveau-nés qui présentent une transposition des grandes artères (TGA), un état qui génère une hypoxémie sévère susceptible de provoquer une hypertension pulmonaire persistante du nouveau-né (HTPNN), une aggravation de l’hypoxémie et un risque accru d’interventions invasives urgentes après la naissance. Le clampage physiologique du cordon (CPC), qui consiste à retarder le clampage du cordon jusqu’à ce que l’aération et la ventilation pulmonaires soient établies, favorise une transition circulatoire plus stable et s’est avéré bénéfique, tant chez les prématurés et que chez les bébés nés à terme. Le CPC peut également présenter des avantages pour les nourrissons atteints d’une cardiopathie congénitale. En présence d’une TGA, le CPC combiné à une supplémentation précoce en oxygène permet de réduire l’incidence et la gravité de l’HTPNN ainsi que les complications qui lui sont associées, et de minimiser la nécessité de recourir à des interventions invasives. Nous avons entrepris un programme d’amélioration graduelle de la qualité comprenant deux études séquentielles afin d’évaluer la faisabilité, la sécurité d’utilisation et les conséquences cliniques du protocole de stabilisation. L’étude de phase I, une étude unicentrique menée au centre médical universitaire de Leiden, visera à évaluer la faisabilité, l’observance et la sécurité d’utilisation du protocole. L’étude de phase II, une étude de cohorte observationnelle menée dans plusieurs centres européens, visera à évaluer les conséquences cliniques et plus particulièrement l’incidence et la gravité de l’HTPNN ainsi que la nécessité de recourir à des interventions pratiquées d’urgence. Les nouveau-nés présentant une TGA seront tous stabilisés en maintenant leur cordon ombilical intact et recevront une supplémentation en oxygène, à raison de 2 L/min administrés à haut débit par voie nasale (fraction d’oxygène inspiré : 1,0). Le cordon sera clampé une fois que l’état du nourrisson sera jugé stable, l’état stable étant défini comme une fréquence cardiaque > 100 bpm et une saturation en oxygène (SpO2) préductale > 75 % avec supplémentation en oxygène. Cette étude permettra d’éclairer les lignes directrices de prise en charge en salle d’accouchement et les soins préopératoires précoces chez les nouveau-nés présentant une TGA.
Critical care ultrasound (CCUS) is an essential tool for managing critically ill patients at bedside, improving diagnostic accuracy and reducing procedural risks. However, its global adoption remains inconsistent due to variability in training, certification, and organizational support. This study explores current CCUS use, training practices, and associated facilitators and barriers, aiming to identify opportunities for improving its implementation. A worldwide online survey was conducted between June 2023 and June 2024. The survey was endorsed and distributed by several (inter)national critical care societies. Participation was fully anonymous and open to all healthcare professionals affiliated with a critical care department. The survey consisted of four sections: demographic data, CCUS practice, CCUS training, and possible facilitators and barriers to CCUS. Facilitators and barriers were assessed using an evidence-based framework: the Measurement Instrument for Determinants of Innovation (MIDI). A total of 277 participants (73.3% intensivists, 60.3% European) across 62 countries completed the survey. Most participants (93.5%) used CCUS, predominantly for lung, vascular and basic cardiac assessments (>95% for each). However, the majority lacked formal CCUS certification (73.6%). Facilitators included CCUS's perceived value in improving patient outcomes, including faster diagnosis or treatment. Key barriers included lack of adequate training, absence of formal certification, and limited organizational support. Despite widespread recognition of CCUS's clinical benefits, significant barriers in training, certification, and organizational infrastructure hinder its full implementation. Addressing these challenges and engaging identified facilitators provides a strong foundation for promoting the introduction and integration of CCUS into routine clinical practice.