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Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial – a protocol for a multicentre randomised controlled trial
Introduction
Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.
Methods and analysis
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.
Ethics and disseminationf
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.
Trial registration number
NCT06678438.
Prevalence and determinants of unsuppressed HIV viral loads among children and adolescents living with HIV on antiretroviral therapy in Lubumbashi, Democratic Republic of the Congo: a retrospective cross-sectional study
Background
Despite global improvements in antiretroviral therapy (ART) access for children and adolescents living with HIV (CALHIV), a significant proportion continue to experience unsuppressed viral load (USVL). Limited studies focus on the factors contributing to USVL among CALHIV in the Democratic Republic of the Congo (DRC), especially in the context of evolving treatment landscapes. Understanding these determinants is crucial for enhancing ART outcomes.
Objective
This study aimed to determine the prevalence of USVL and identify factors associated with USVL among CALHIV receiving ART in Lubumbashi, DRC.
Design
A multicentre retrospective cross-sectional study was conducted. Data were gathered using an observational checklist based on assessing patient file data and entered into Microsoft Excel. Analysis was performed using STATA V.16. Variables with a p value of 0.20 from the bivariable analysis were included in a multivariable logistic regression model, and significant variables (p
Use of an electronic medication management application to support Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC): a study protocol for a parallel cluster randomised controlled trial
Introduction
Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.
Methods and analysis
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.
Ethics and dissemination
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.
Trial registration number
ACTRN12624001409561.
Smoking cessation in people with multiple sclerosis: qualitative study on the current practices and barriers for delivering assistance from the perspective of healthcare professionals in Germany
Objectives
Smoking is a well-established risk factor that exacerbates multiple sclerosis (MS) progression and increases disease activity. Smoking cessation promotion practices of MS clinicians are not meeting the needs of people with MS (pwMS). This study aimed to explore the current practices and barriers faced by MS clinicians in Germany.
Design
A qualitative study design, using semi-structured interviews and thematic analysis.
Setting
Interviews with participants were held online, via telephone or face-to-face at our institute in Hamburg, Germany.
Participants
We recruited eight neurologists and four MS nurses from hospitals, neurology practices and rehabilitation facilities in Germany via purposive and snowball sampling.
Results
We identified 27 codes across four themes: (1) knowledge: the 12 participants demonstrated a satisfactory general knowledge of the negative impacts of smoking on MS (2) current practice: significant variability was reported in the current practices, with some clinicians providing detailed advice while others merely assessing smoking status without further advice or assistance. (3) Barriers: key barriers identified included limited consultation time, perceived lack of patient motivation and insufficient availability of resources, like information material, for effective smoking cessation support. (4) Needs and wishes: participants wished for specific smoking cessation courses to which they could refer patients, as well as information material to use during patient counselling.
Conclusion
The study reveals considerable gaps in the consistency and comprehensiveness of smoking cessation support provided by MS clinicians in Germany. Addressing these gaps through targeted interventions, and improving the availability of information materials could enhance smoking cessation promotion for pwMS.
Lesion-Network Mapping of Poststroke Depressive Symptoms: Evidence From Two Prospective Ischemic Stroke Cohorts
Stroke, Ahead of Print. BACKGROUND:Poststroke depression affects up to one-third of stroke survivors, significantly impacting recovery and quality of life. However, its pathophysiology remains unclear.METHODS:We analyzed 2 independent, prospective ischemic stroke cohorts (PROSCIS-B [Prospective Cohort of Incident Stroke Berlin] and BAPTISe [Biomarkers and Perfusion-Training-Induced Changes After Stroke]; n=377) enrolled at the Charité Hospital, Germany, to identify brain regions and networks associated with depressive symptoms poststroke. Lesion-symptom mapping assessed associations between lesion location and depressive symptoms measured by the Center for Epidemiological Studies Depression Scale at 6 (BAPTISe) or 12 (PROSCIS-B) months poststroke. Lesion-network mapping evaluated lesion connectivity with brain networks. A mixed-effects model, including cohort as a random effect, assessed the relationship between network similarity (Pearson correlation) and Center for Epidemiological Studies Depression Scale scores. Dice coefficients (DC) quantified spatial overlap with canonical resting-state networks.RESULTS:Lesion-symptom mapping showed no significant associations between lesion location and depressive symptoms. In contrast, lesion-network mapping revealed that lesion connectivity to brain regions including the frontal pole, middle and inferior frontal gyri, inferior temporal gyrus, supramarginal gyrus, angular gyrus, frontal orbital cortex, and thalamus weakly correlated with Center for Epidemiological Studies Depression Scale scores (β, 11.4 [95%CI, 1.8–21.1];P=0.02). These regions overlapped with the frontoparietal (DC=0.28), salience (DC=0.27), and default mode (DC=0.20) networks, as well as a published depression circuit (DC=0.43). However, these findings did not replicate across data sets.CONCLUSIONS:Lesion location alone was not associated with poststroke depression. However, connectivity-based analyses implicated disruption of large-scale brain networks in the development of depressive symptoms. The failure to validate this association across data sets underscores the need for further studies with more comparable patient populations—particularly in terms of stroke severity and harmonized assessment time-points—to confirm these findings and their clinical relevance.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT01363856. URL:https://www.clinicaltrials.gov; Unique identifier: NCT01954797.
Prospective multicentre randomised controlled trial to assess the clinical effectiveness of the novel CirrhoCare digital therapeutic management system: a study protocol
Introduction
Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.
Methods and analysis
CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.
214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.
The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.
Ethics and dissemination
CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.
Trial registration number
ISRCTN11380842.
Neuropsychiatric complications 3-4 years after stroke: a population-based study of fatigue, depression and cognition
Objectives
To study the prevalence of and interplay between common neuropsychiatric sequelae 3–4 years after onset of first-ever stroke—specifically post-stroke fatigue (PSF), post-stroke depression (PSD) and post-stroke cognitive impairment (PSCI).
Design
Population-based cohort study.
Setting
Catchment area of a Swedish University Hospital.
Participants
We recruited individuals with first-ever ischaemic stroke or intracerebral haemorrhage in the initial cohort; 151 of these died prior to follow-up and 47 (12%) were lost to detailed follow-up. We followed up 202 individuals with median age: 72 (IQR 65–79), 40% female, either in clinic, via home visits or via telephone.
Primary and secondary outcome measures
Primary outcome measures included PSF (Fatigue Assessment Scale), PSD (Patient Health Questionnaire-9) and PSCI (Montreal Cognitive Assessment). Secondary outcome measures included dependency in activities of daily living (ADL; Barthel Index), health-related quality of life (HRQoL; Short-Form Questionnaire-36, EuroQoL-5D and Stroke Impact Scale) and stroke severity (National Institutes of Health Stroke Scale (NIHSS)).
Results
Significant PSF was present in 46/195 (24%), PSD in 21/191 (11%), and PSCI in 93/173 (54%) respondents. Among 169 participants with available data for all three domains, 100 (59%) had impairment in at least one domain. Participants with PSCI were older than those without (median: 75 vs 67 years; p
Mental health interventions for humanitarian volunteers: a scoping review
Objectives
The aim of this scoping review was to map the nature and extent of the existing literature on mental health interventions for humanitarian volunteers in disaster contexts. The study also explored how the interventions were evaluated.
Design
The methodology of this scoping review followed the extended guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.
Data sources
Five academic bibliographic databases (PubMed, Embase, Web of Science, EBSCOhost and Google Scholar), grey literature websites (Google Scholar, ProQuest, Policy Commons, etc.) and relevant organisational archives were systematically searched for eligible documents.
Eligibility criteria
Both peer-reviewed and grey literature studies on mental health interventions for humanitarian volunteers in the context of any type of disaster were eligible for inclusion. Research papers that evaluated any such intervention were also included. Documents that targeted professional humanitarian workers or explored physical health conditions or diseases in disaster contexts, letters to the editor, comments, correspondence and research protocols were excluded. There were no restrictions in terms of the date and language of the documents.
Data extraction and synthesis
A systematic search of the targeted databases was conducted from 12 May 2025 to 20 May 2025. Deduplication, screening and full-text evaluation for the selection of documents were done using the online version of Rayyan. Data were collected and recorded into a structured Microsoft Excel sheet. Two researchers individually conducted the selection of the articles and the extraction of data. A third researcher helped to resolve any discrepancies if required.
Results
A total of 2627 documents were retrieved by searching the targeted databases and websites. After matching them with the eligibility criteria, 20 documents were included in the final list. 14 of them were research papers; the rest was organisational literature. All the papers were from 2006 and later, except one that was from 1998. No documents were found from the Middle East, North Africa and Sub-Saharan regions. 10 broad categories of interventions were identified, which were either implemented in the field or suggested in the form of guidelines. Most of the interventions were postexposure and preventive in nature. Psychological first aid was the most widely used intervention in this context, being used by the national societies of the International Federation of Red Cross and Red Crescent Societies. Nine of the documents were research papers evaluating the effectiveness of the interventions using different scales and customised questionnaires. Four of them did not observe any notable effect on the mental health of the participants.
Conclusions
Over the past two decades, the evidence on mental health interventions for humanitarian volunteers has grown. The reviewed literature documented various interventions and guidelines that need further study and testing to both prove and improve their effectiveness. Organisational policies could incorporate and further evaluate these to ensure the psychosocial well-being of volunteers. A review of research papers on intervention effectiveness found heterogeneity in settings, designs, interventions and methods, precluding a systematic review. More research is needed on individual interventions, volunteer perceptions and comparing interventions to identify the most effective ones. Additionally, comparing pre-exposure and postexposure interventions with multimodal systems that support volunteers throughout deployment is recommended.
GRACE: protocol for a UK, secondary care, multicentre, assessor-blinded randomised controlled trial with a non-inferiority comparison to evaluate graduated compression stockings as an adjunct to extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention
Introduction
Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40–60% in those undergoing major orthopaedic procedures and around 15–40% in the general surgical population.
HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.
Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30–65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.
Methods and analysis
GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21–35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21–35 days post procedure to capture any asymptomatic DVT.
The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.
Ethics and dissemination
On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.
Trial registration number
ISRCTN11667770.
Impact of left ventricular end-diastolic pressure on clinical outcomes in patients with ST-elevation myocardial infarction (Hunter LVEDP Study): a prospective, single-centre study
Objectives
Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.
Design
Prospective, single-centre study.
Participants
Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.
Primary outcome measure
The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.
Results
A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p
OptiNeoCare: optimisation of routine care in the management of severe perinatal asphyxia in full-term or near-term newborns – study protocol for analysis of suboptimal care by confidential inquiries and e-self report
Introduction
Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.
Materials and methods
This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.
Ethics and dissemination
Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.
Trial registration number
ClinicalTrials.gov ID: NCT06322732.
Influence of concurrent oral calcium carbonate supplementation on steady-state pharmacokinetics of once daily oral raltegravir in persons with HIV: a protocol for a prospective open-label non-randomised study in Canada
Introduction
Raltegravir is a potent HIV-integrase strand transfer inhibitor (INSTI). Despite its strong activity against HIV-1 strains resistant to other antiretroviral drug classes, it is usually used in combination with other antiretroviral drugs due to the empirical requirement for anti-HIV drug combinations to ensure effective anti-retroviral therapy (ART). As an early-arriving INSTI, raltegravir is clinically familiar for its safety, tolerability and treatment effectiveness. High-dose calcium carbonate formulated as an antacid (as opposed to a supplement formulation) taken orally together with raltegravir is known to reduce systemic raltegravir exposure due to chelation and reduced absorption. This study aims to assess the effect of daily calcium carbonate antacid as TUMS Ultra Strength (US) administration in lower doses, as currently used for oral calcium supplementation, on the steady-state pharmacokinetics (PKs) of once-daily oral raltegravir.
Methods and analysis
This is an open-label, three-treatment series in three periods in a single group, fixed-sequence PK study in 12 healthy adult volunteers with HIV on ART. Subjects will take 1200 mg of raltegravir single QD oral dose alone for 7 days (period one), then raltegravir 1200 mg with calcium carbonate 500 mg from day 8 to day 14 (period two) and raltegravir 1200 mg with calcium carbonate 1000 mg from day 15 to day 22 (period three). We will conduct serial PK sampling from observed dosing on days 7, 14 and 21, with 24-hour PK sampling scheduled for days 8, 15 and 22. Follow-up will continue until day 51.
Ethics and dissemination
This study will adhere to the ICH GCP Guidelines and the Declaration of Helsinki. Ethics approval was obtained from the Ottawa Health Science Network Research Ethics Board under study ID 20190750–01 hour. Informed consent will be obtained from all participants prior to enrolment. This protocol will be published in a peer-reviewed journal prior to the study’s completion and closure. Results generated from this activity will also be reported in a peer-reviewed journal.
Trial registration number
NCT04258475.
[Articles] Efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in postmenopausal women with osteoporosis: a multi-center, randomized, double-blind, placebo- and active-controlled, phased II study
In this phase II trial of postmenopausal women with osteoporosis, narlumosbart demonstrated superiority over placebo in increasing BMD at 12 months following administration at 6-month intervals, with a tolerable safety profile in the short term, consistent with that of anti-RANKL monoclonal antibodies.
Participative research for individualised care in cardiovascular diseases (PRIC-CVD): study protocol for a non-interventional, multicentre mixed-methods study as part of iCARE4CVD
Introduction
Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.
Methods and analysis
Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.
Ethics and dissemination
This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.
Trial registration number
DRKS00034899.
Protocol version
V2.1, 6 June 2024.
Trends in educational inequality in healthy life expectancy in Denmark between 2010 and 2021: a population-based study
Objectives
For several decades, mortality has decreased more rapidly among individuals with a higher socioeconomic position than among those with a lower position. This widening social inequality gap has increasingly been recognised as an important aspect of public health research and policies. The objective of this study was to examine trends in educational inequality in healthy life expectancy (HLE) in Denmark between 2010 and 2021 at the age of 30 years.
Design
The study is a population-based study based on register data on longest attained education, standard life tables and self-reported health information from nationwide health surveys.
Setting
The study is conducted among the general adult population in Denmark.
Participants
Participants include respondents from the Danish National Health Survey and the Danish Health and Morbidity Survey in 2010, 2013, 2017 and 2021 aged ≥30 years.
Primary and secondary outcome measures
Expected lifetime in good self-rated health, with no long-standing illness and with no activity limitations was estimated by Sullivan’s method, and educational inequality was expressed by the Slope Index of Inequality.
Results
Between 2010 and 2021, educational inequality in HLE increased among both men and women for long-standing illness (5-year trend: +1.1 and +1.2 years) and activity limitations (+2.4 and +2.6 years) but remained stable among men (+0.1 year) and decreased among women (–0.3 year) for self-rated health. For the latter two indicators, the inequality gap narrowed after 2017.
Conclusion
Trends in educational inequality in HLE in Denmark 2010–2021 vary by health indicator. Steadily widening gaps were demonstrated for long-standing illness, while narrowing gaps were seen after 2017 for activity limitations and self-rated health. Future studies are encouraged to explore potential health risk behaviours that may explain or modify these inequality trends.