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☐ ☆ ✇ BMJ Open

Palliative medicine physicians experiences using the Numeric Rating Scale for pain assessment in patients with advanced cancer: a qualitative study

Por: Martinsson · L. · Brännström · M. · Fransson · P. · Andersson · S. — Enero 7th 2026 at 04:50
Objectives

This study aimed to describe palliative medicine physicians’ experiences performing pain assessment using the Numeric Rating Scale (NRS)—one of the most widely used pain assessment tools—for patients with cancer receiving specialised palliative care.

Study design

This qualitative study used reflexive thematic analysis.

Setting

The study was conducted in specialised palliative care settings.

Participants

Semi-structured interviews were conducted with 14 palliative medicine physicians in specialised palliative care.

Analysis

The interviews were transcribed and analysed using reflexive thematic analysis.

Results

Four themes were identified: ‘Striving to create a shared understanding’, ‘Meeting individual needs’, ‘Interpreting and managing ratings’ and ‘Importance of organizational structures’. This can be seen as a process that moves from creating a shared foundation through individual patient meetings and handling NRS ratings to organisational-level challenges.

Conclusions

The study shows the complexity needed within palliative cancer care when using the most common pain assessment tool in Sweden, the NRS. The tool may seem simplistic, but, as shown in this study, the physicians found interpreting the assessments challenging for the whole team. This complexity should be incorporated into future healthcare education and training within the palliative care area, where patients often have chronic pain conditions in combination with cognitive impairment. Future research needs to focus on developing reliable pain assessment methods for patients who are cognitively impaired because of the cancer.

☐ ☆ ✇ BMJ Open

STEM-PD trial protocol: a multi-centre, single-arm, first-in-human, dose-escalation trial, investigating the safety and tolerability of intraputamenal transplantation of human embryonic stem cell-derived dopaminergic cells for Parkinsons disease

Por: Paul · G. · Bjartmarz · H. · Björklund · A. · Cutting · E. · Evans · A. · Harry · B. · Hansson · O. · Kayhanian · S. · Kirkeby · A. · Lao-Kim · N. · Lindvall · O. · Nelander · J. · Piccini · P. · Smith · R. · Ullen · S. · Van Vliet · T. · Widner · H. · Parmar · M. · Barker · R. A. — Diciembre 30th 2025 at 15:31
Introduction

Parkinson’s disease (PD) is a common neurodegenerative disease, which has extensive pathology that critically includes the loss of midbrain dopaminergic neurons. This loss leads to debilitating motor features such as bradykinesia and rigidity, as well as some non-motor symptoms. Intracerebral dopamine cell transplants have been explored for many years as a new approach to treating PD and initially used human fetal ventral mesencephalic tissue with inconsistent results, related in part to major logistical challenges in sourcing enough tissue of the right quality and the limited possibilities for quality control and standardisation. Dopaminergic neurons can now be derived reliably from human stem cell sources, which may overcome some of the challenges associated with fetal tissue transplantations.

Methods and analysis

STEM-PD is a multi-centre, single-arm, dose-escalation, first-in-human advanced therapy investigational medicinal product (ATIMP) trial in Europe using a cell product that consists of dopaminergic neural progenitors derived from the RC17 human embryonic stem cell line. The aim of the study is to assess the safety, tolerability and feasibility of intraputamenal transplantation of this cell product in patients with moderately advanced PD. Eight participants will be recruited from two sites, Skånes University Hospital (Lund, Sweden) and Cambridge University Hospital (Cambridge, UK). The primary outcome of the trial is safety and tolerability, assessed by the number and nature of adverse events and serious adverse events, and the absence of space-occupying lesions on cranial MRI, in the first 12 months following transplantation. Secondary and exploratory outcomes, including clinical measures, changes in anti-Parkinson’s medication and measures of graft survival using positron emission tomography imaging, will be assessed at both 12 and 36 months post-grafting.

Ethics and dissemination

Ethical approval was obtained from the Swedish Ethical Review Authority (EPM dnr 2021-06945-01) and South Central - Oxford A Research Ethics Committee (reference 23/SC/0243). Clinical Trial Authorisation was given by the Swedish Medical Products Agency (Dnr: 5.1-2022-57953) and the Medicines and Healthcare products Regulatory Agency for clinical trials authorisation (reference CTA 40773/0001/001-0001). Authorisation for transfer to Clinical Trial Regulation (EU) 536/2014 was given by the Swedish Medical Products Agency (Dnr: 5.1.1-2024-100773). Potential participants will receive verbal and written information about the trial and written informed consent will be obtained prior to enrolment. A lay summary of the results of the trial will be uploaded to the trial website which is publicly accessible. Trial results will be published in peer-reviewed journals.

Trial registration numbers

NCT05635409.

☐ ☆ ✇ BMJ Open

How have generic large language models progressed in their ability to write clinic letters and provide accurate management plans in the virtual fracture clinic?

Por: Smith · A. · Brock · J. · Jones · H. · Solari · F. · Anss · R. · Kimberley · C. · Joyner · C. · Yasin · T. · Basbous · O. · Poacher · A. T. — Diciembre 16th 2025 at 05:04
Objective

To explore whether large language models (LLMs), Generative Pre-trained Transformer (GPT)-3, GPT-3.5 and GPT-4 can autonomously manage a virtual fracture clinic (VFC) as a marker of their efficacy in an emergency department and with simple orthopaedic trauma.

Setting and participants

Simulated UK VFC workflow.

Design

11 clinical scenarios were generated, and GPT-4, GPT-3.5 and GPT-3 were prompted to write clinic letters and management plans.

Main outcome measures

The Readable Tool was used to assess the clarity of letters. Six independent orthopaedic surgeons then evaluated the accuracy of letters and management plans.

Results

Readability was compared using the Flesch-Kincaid grade level: GPT-4: 9.11 (SD 0.98); GPT-3.5: 8.77; GPT-3: 8.47, and the Flesch readability ease: GPT-4: 56.3; GPT-3.5: 58.2; GPT-3: 59.3. Surgeon-rated accuracy comparisons indicated that GPT-4 exhibited the highest accuracy for management plans (9.08/10 (95% CI 8.25 to 9.9)). This represents a statistically significant progression in the capacity of a LLM to provide accurate management plans compared with GPT-3 at 6.84 (95% CI 5.41 to 8.27) and GPT-3.5 at 7.63 (95% CI 7.23 to 8.13) (p

Conclusions

LLMs can produce high-quality, readable clinical letters for common VFC presentations, and GPT-4 can generate management plans to aid clinicians in their administration. With clinician oversight, appropriately trained LLMs could meaningfully reduce routine administrative work. However, while the results of this study are promising, further evaluation of LLMs is required before they can be deemed safe for managing simple orthopaedic scenarios.

☐ ☆ ✇ PLOS ONE Medicine&Health

Risk of emergency cesarean section when giving birth in Sweden: A nationwide cohort study comparing women born in countries practicing female genital mutilation, with Swedish-born women

Por: Bita Eshraghi · Jonas Hermansson · Lena Marions — Diciembre 17th 2025 at 15:00

by Bita Eshraghi, Jonas Hermansson, Lena Marions

Introduction

The impact of female genital mutilation (FGM) on obstetric outcomes in high-income countries remains unclear and is an area of ongoing research. This nationwide study aimed to examine the risk of emergency cesarean section among primiparous women from countries where FGM is practiced, in comparison to Swedish-born women. Additionally, the study explored whether a confirmed diagnosis of FGM contributes to this potential risk.

Materials and methods

A Swedish nationwide cohort study including primiparous singleton term deliveries (≥37 + 0–  Results

Women born in FGM-practicing countries (n = 13 246) had a significantly increased risk of emergency cesarean section (aOR 1.28, 95% CI: 1.21–1.35) compared to Swedish-born women (n = 199 914). Including FGM diagnosis as a covariate did not alter the result. When excluding women born in FGM-practicing countries outside Sub-Saharan Africa the aOR was amplified (aOR 1.58, 95% CI: 1.47–1.69). To further isolate the effect of FGM itself, we restricted the analysis to women born in FGM-practicing countries and compared those with a recorded FGM diagnosis to those without. This analysis showed no significant association between FGM diagnosis and emergency cesarean section (aOR 1.05, 95% CI: 0.90–1.23).

Conclusions

Primiparous women from FGM-practicing countries have an increased risk of emergency CS compared to Swedish-born women, when giving birth in Sweden. The presence of FGM diagnosis did not contribute to this risk. Further research is needed to understand the underlying mechanisms for this to be able to improve obstetric care for migrant populations.

☐ ☆ ✇ BMJ Open

Improving collaborative care networks for functional disorders and persistent somatic symptoms: a participatory action research study in the Netherlands

Por: Mamo · N. · Hanssen · D. J. C. · Korten · S. · Olde Hartman · T. C. · Rosmalen · J. G. · Tak · L. — Diciembre 12th 2025 at 18:11
Background

Persistent somatic symptoms and functional disorders are conditions requiring a biopsychosocial approach to care, often from multiple professionals. The fragmentation of care common in most health systems results in unsatisfactory and challenging care experiences. Collaborative care networks form an important route towards improving outcomes and the overall experience of care for patients and professionals. While we have a good idea of what such collaborative care networks can look like, we lack knowledge on the practicalities of implementing change in such networks.

Objectives

The core objective of this study is to implement change in a collaborative care network for persistent somatic symptoms and functional disorders care. Our questions were twofold: first, what are examples of realistic action processes to improve such collaborative care networks? Second, what are, in our experience, conditions for an effective change process in such a collaborative care network?

Design

Participatory action research approach embedded within an active regional network between May 2023 and May 2024. The process was led by an action group who selected objectives and related actions with the aim of improving the network, leading to better care for people with persistent somatic symptoms and functional disorders as well as improving satisfaction among professionals.

Setting

ALK Netwerk Salland, a regional network of professionals and experts-by-experience, focused on care of persistent somatic symptoms. This network is based in the Salland region in the east of the Netherlands, centred around the city of Deventer.

Participants

The action group was made up of local stakeholders including experts-by-experience and health and social care professionals, facilitated by a researcher-in-residence. Other participants included members of the regional network who provided input towards the different objectives.

Results

Over the course of a year, three objectives were selected and enacted, including assessing the resources of the network, improving knowledge of treatment options and improving the shared vision of care. The process faced some challenges, such as changes in action group members and a lack of resources and time to enact changes. However, by having a trusted and engaged team, working with an active network, we were able to enact significant changes to the network, which may be sustained and built on through the ongoing action group.

Conclusions

Future participatory action research studies would benefit from a trusted and embedded researcher-in-residence, meaningful involvement early in the process of experts-by-experience, and serious consideration of realistic outcome measures to monitor for evaluation of changes made.

☐ ☆ ✇ BMJ Open

Effect of the FoodSwitch application on type 2 diabetes in Sweden: a study protocol for the randomised controlled DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP)

Por: af Geijerstam · P. · Johansson · E. · Fägerstam · S. · Wu · J. H. · Ghafouri · B. · Karlsson · K. · Hebib · L. · Kastbom · L. · Wennberg · P. · Gustafson Hedov · E. · Storgärds · M. · Sundström · J. · Radholm · K. — Noviembre 17th 2025 at 05:17
Introduction

A healthy diet improves glycaemic control and reduces cardiovascular risk in type 2 diabetes (T2D). However, access to dietitians is limited. Several countries have implemented mandatory interpretive front-of-pack labelling to guide consumers towards healthier food choices, but Sweden has not. Smartphone applications may offer an alternative platform to provide such information. This study evaluates the dietary and clinical impact of a novel application providing interpretive labelling to Swedish adults with T2D.

Methods and analysis

This is a fully decentralised randomised controlled trial. 900 individuals with T2D for ≥2 years who regularly shop for groceries will be recruited via general practices and community advertisements. Participants will be randomised to receive either: (1) access to the FoodSwitch mobile application plus standard written dietary advice, or (2) standard written dietary advice only. The FoodSwitch application allows users to scan barcodes on packaged foods to receive recommendations of healthier alternatives within the same category. The primary outcome is the difference in change in mean self-measured glycated haemoglobin between groups after 6 months. Secondary outcomes include differences in changes in waist circumference, body weight, quality of life, medication use, hospitalisations and all-cause mortality at 26 weeks. Exploratory outcomes include omics analyses. Recruitment is ongoing. Expected study completion on 31 December 2026.

Ethics and dissemination

The trial has received ethical approval from the Swedish Ethical Review Authority (2023-06622-01, 2024-06668-02, 2024-07357-02 and 2025-01095-02) and is performed in line with World Medical Association Declaration of Helsinki and the General Data Protection Regulation. Results will be published in a peer-reviewed international journal.

Trial registration number

NCT05977218.

☐ ☆ ✇ BMJ Open

Design and methods of the Ixekizumab Diabetes Intervention Trial (I-DIT): protocol for a phase 2, randomised, multicentre, placebo-controlled, double-blind trial of anti-interleukin 17 as a treatment option for adults with new-onset type 1 diabetes

Por: Seyed Ahmadi · S. · Korsgren · O. · Jansson · P.-A. · Lind · M. — Noviembre 12th 2025 at 10:55
Introduction

Type 1 diabetes is characterised by progressive loss of pancreatic beta cells. Studies have shown that interleukin (IL)–17 is likely a mediator for this destruction. Whether inhibition of IL-17 could preserve beta cell function in people with new-onset type 1 diabetes is unknown.

Methods and analysis

In this phase 2, randomised, multicentre, placebo-controlled, double-blind trial conducted at 17 study sites in Sweden, 127 adults aged 18–45 years old with newly diagnosed type 1 diabetes will be enrolled. Participants will be randomised to receive either subcutaneous IL-17 inhibitor or placebo for 52 weeks, in addition to their conventional therapy. The primary endpoint will be change in residual insulin secretion measured by the area under the curve for C-peptide in response to 2-hour mixed meal tolerance test between baseline and week 52. Additionally, masked continuous glucose monitoring will be performed during 14 days at the run-in period, week 13, week 26 and week 52. Secondary endpoints will be change in time in glucose range (3.9–10 mmol/L), time in hypoglycaemia (

Ethics and dissemination

Approvals were obtained from the Swedish Ethical Review Authority (Dnr 2020–05098) and the Swedish Medical Products Agency (Dnr 5.1-2021-105808) before participant enrolment. Participants provide informed consent before inclusion. Results of this study will be submitted for publication in international peer-reviewed journals and key findings will be presented at international scientific conferences.

Trial registration number

ClinicalTrials.gov, NCT04589325.

☐ ☆ ✇ BMJ Open

Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol

Por: Larsson-Lund · M. · Karlsson Sundbaum · J. · Mansson Lexell · E. · Spinord · L. — Octubre 22nd 2025 at 07:34
Introduction

Proactive and easily accessible interventions are needed to support people with long-term health conditions who experience limitations in activities of everyday life. However, there is a lack of interventions that promote self-management skills that prevent deterioration and improve health. The internet-based programme ‘Strategies for Empowering Activities in Everyday Life’ (SEE) supports people with long-term health conditions in developing self-management skills through knowledge, self-analysis and management strategies, promoting active and healthy daily life. This study protocol aims to evaluate the feasibility of SEE 2.0 and the study design.

Methods and analysis

This feasibility study employs a pretest and post-test design with no control group, embedded within a mixed-method approach. The participants will include 30–40 clients, occupational therapists and managers involved in delivering SEE 2.0 in primary healthcare and hospital-based services. Data will be collected through assessments and forms at baseline, 4 months and 12 months after inclusion. Additionally, qualitative methods will be used to enhance the understanding of participants’ experiences.

Ethics and dissemination

The study was approved by the Swedish Ethical Review Authority. The results will inform the refinement of SEE 2.0 and guide decisions on whether to proceed with planning a full-scale evaluation to assess the intervention’s effect. The results will be published in peer-reviewed scientific journals on websites and presented at conferences and seminars to reach various user groups.

Trial registration number

NCT06484322.

☐ ☆ ✇ BMJ Open

Impact of dextroamphetamine substitution on the use of illicit amphetamines in adults with amphetamine dependence: a study protocol for the multicentre double blind randomised controlled trial ATLAS4Dependence

Por: Chalabianloo · F. · Fadnes · L. T. · Mordal · J. · Spigset · O. · Loberg · E.-M. · Halmoy · A. · Lid · T. G. · Andersen · C. D. · Daltveit · J. T. · Assmus · J. · Erga · A. H. · K Solli · K. · Askjer · J. F. · Hansen · M. A. K. · Ohldieck · C. · Ezard · N. · Lintzeris · N. · Johansson · K — Octubre 21st 2025 at 08:30
Introduction

There is limited evidence on how to effectively treat individuals from marginalised populations with dependence on amphetamine and/or methamphetamine (collectively referred to hereafter as amphetamine dependence). The disease burden is extremely high in this population, especially related to psychiatric comorbidities, cardiovascular complications, injection-related infections and poor social functioning. ATLAS4Dependence is a multi-centre randomised, placebo-controlled, double-blind trial that will investigate the effectiveness and safety of substitution treatment with dextroamphetamine compared with placebo in people with amphetamine dependence.

Methods and analysis

The trial will recruit 226 adult patients in several outpatient clinics in Norway.Inclusion criteria comprise individuals with amphetamine dependence, defined as use on three or more days per week during the past 28 days, who currently inject or have formerly injected drugs. This includes individuals both with and without comorbid opioid dependence, as well as those currently receiving or not receiving opioid agonist treatment. Participants will be randomly assigned 1:1 to receive either dextroamphetamine or placebo for 12 weeks. Flexible doses within the range of 30–120 mg daily will be provided based on individual assessments. The participants in both arms will be offered standard psychosocial and medical follow-up in accordance with current clinical practice. The endpoint assessments will be conducted at 12 weeks with weekly self-reports and safety assessments and a follow-up assessment at 52 weeks. The primary objective of the study is to assess the impact of 12 weeks daily prescribed oral dextroamphetamine versus placebo on the use of illicit amphetamines as well as on the total amount of amphetamines used (including both illicit and prescribed sources). Secondary outcomes are the differences between the groups at 12 weeks regarding psychological distress, symptoms of psychosis, quality of life, cardiovascular risk factors, injection-related infections, executive functioning, attention-deficit hyperactivity disorder-related symptoms, sleep, violence risk, fatigue, symptoms of craving and withdrawal, treatment retention, days of use of illicit amphetamines and use at 4 weeks and 8 weeks during the intervention period, use of other illicit substances and alcohol, as well as a cost-effectiveness analysis (using private economy, criminal activity and health service utilisation) and a qualitative approach to assess overall experiences with the study intervention. Analysis and reporting will follow the Consolidated Standards of Reporting Trials guidelines. All tests will be two-sided. Descriptive results and the estimated effectiveness will be presented with 95% CIs. The difference between the groups at the primary time point (at the end of the 12-week trial) will be assessed using 2 test (for use of illicit amphetamines measured by monthly urine tests) and Analysis of Covariance (ANCOVA) (for weekly self-reported total amount of amphetamines). Analyses for the primary endpoint will be undertaken on an intention-to-treat basis and reported on as such, but sensitivity analyses with per protocol analyses will also be presented.

Ethics and dissemination

The study is approved by European Medicines Agency, Clinical Trial Information System (CTIS). Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.

Trial registration number

CTIS 2023-510404-44-00.

☐ ☆ ✇ BMJ Open

Instruments for assessing social support in social networks and in the self-management and rehabilitation process of persons poststroke: a scoping review protocol

Por: Falk Johansson · M. · Taei · A. · McCarthy · L. · Gustavsson · C. · Tomsone · S. · Kylen · M. · Elf · M. — Octubre 15th 2025 at 09:50
Introduction

As care and rehabilitation poststroke are increasingly moving into persons’ home environment, the importance of support from social networks in self-management and rehabilitation has emerged as an important topic for research and practice. While there are instruments used to assess social support and collective efficacy, a clearer scope of the availability and quality of these instruments is needed. This clarification will enable the development of interventions integrating social network perspectives in poststroke rehabilitation.

Methods and analysis

To assess the availability and quality of instruments assessing social support and collective efficacy, a scoping review will be conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews guidelines (PRISMA-ScR). Literature searches conducted between 14 November 2024 and 15 November 2024 in the CINAHL and PubMed/Medline databases resulted in 4631 articles potentially eligible. After removing duplicates, 4121 articles’ titles and abstracts were initially screened. Full-text screening, searches of reference lists and data extraction started in June 2025. Starting August 2025, two reviewers will assess the full texts against the inclusion criteria in Covidence using a coding template. Identified instruments will be appraised following the COSMIN (Consensus-based Standards for the selection of health Measurement INstruments guidelines) and analysed using a narrative descriptive method. Results will be reported in February 2026 according to PRISMA-ScR guidelines.

Ethics and dissemination

Ethical approval is not required for this scoping review, as it does not involve primary data. However, this review follows established ethical guidelines and best practices, and included studies will be reviewed to ensure that they received ethical approval and included informed consent. Results from the review will be disseminated through an article in a scientific journal, at relevant conferences and surmised to stroke organisations. A policy brief will be developed for health and social care professionals and policy makers.

☐ ☆ ✇ PLOS ONE Medicine&Health

Midlife and old-age cardiovascular risk factors, educational attainment, and cognition at 90-years – population-based study with 48-years of follow-up

by Anni Varjonen, Toni Saari, Sari Aaltonen, Teemu Palviainen, Mia Urjansson, Paula Iso-Markku, Jaakko Kaprio, Eero Vuoksimaa

We examined the associations of midlife and old-age cardiovascular risk factors, education, and midlife dementia risk scores with cognition at 90 + years, using data from a population-based study with 48 years of follow-up. Participants were 96 individuals aged 90–97 from the older Finnish Twin Cohort study. Individual cardiovascular risk factors assessed via questionnaires in 1975, 1981, 1990, and 2021–2023 included blood pressure, body mass index, physical activity, and cholesterol, and self-reported educational attainment. The Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) score and an educational-occupational attainment score were used as midlife dementia risk scores. Cognitive assessments included semantic fluency, immediate and delayed recall from a 10-word list learning task, and a composite cognitive score. Regression analyses were conducted with dementia risk factors predicting cognition at 90 + years, adjusting for age, sex, education, follow-up time, and apolipoprotein E genotype (ε4-carrier vs non-carriers). Results showed that higher education and higher educational-occupational score were associated with better cognitive performance in all cognitive measures. Those with high midlife blood pressure scored significantly higher in all cognitive tests than those with normal blood pressure. Conversely, those with high old-age blood pressure scored lower in semantic fluency and composite cognitive score, but not in immediate or delayed recall. Other cardiovascular risk factors and the CAIDE score did not show consistent associations with cognition. Education appears to have a long-lasting protective effect in cognitive aging, whereas midlife and old-age cardiovascular risk factors were not significantly associated with cognition at 90 + years.
☐ ☆ ✇ BMJ Open

Occurrence of advance care planning for persons with dementia, cancer and other chronic-progressive diseases in general practice: longitudinal analysis of data from health records linked with administrative data

Por: Hommel · D. · Azizi · B. · Visser · M. · Bolt · S. R. · Blom · J. W. · Janssen · D. J. A. · van Hout · H. P. J. · Francke · A. L. · Verheij · R. A. · Joling · K. J. · van der Steen · J. T. — Octubre 1st 2025 at 08:29
Objectives

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Design

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Setting and participants

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Outcome measure

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

Results

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Conclusions

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

☐ ☆ ✇ BMJ Open

Dengue epidemic alert thresholds for surveillance and decision-making in Puerto Rico: development and prospective application of an early warning system using routine surveillance data

Por: Thayer · M. B. · Marzan-Rodriguez · M. · Torres Aponte · J. · Rivera · A. · Rodriguez · D. M. · Madewell · Z. J. · Rysava · K. · Paz-Bailey · G. · Adams · L. E. · Johansson · M. A. — Septiembre 25th 2025 at 11:09
Objectives

The Puerto Rico Department of Health (PRDH) seeks to identify dengue epidemics as early as possible with high specificity.

Design

Development and prospective application of an early warning system for dengue epidemics using routine historical surveillance data. A weekly intercept-only negative binomial regression model was fitted using historical probable and confirmed dengue data. A range of threshold definitions was explored using three model-estimated percentiles of weekly dengue case counts.

Setting

Dengue is endemic in Puerto Rico with irregular occurrence of large epidemics with substantial impact on health burden and health systems. Probable and confirmed dengue data are routinely collected from all hospitals and private clinics.

Participants

A total of 86 282 confirmed or probable dengue virus cases were reported from 1 January 1986 to 30 June 2024, with an annual mean of 2212 cases (median: 1533; range: 40–10 356).

Primary and secondary outcome measures

The model was fitted retrospectively to mimic real-time epidemic detection and assessed based on sensitivity and specificity of epidemic detection.

Results

The 75th percentile threshold aligned best with historical epidemic classifications, balancing false alarms and missed detections. This model provides a robust method for defining thresholds, accounting for skewed data, using all historical data and improving on traditional methods like endemic channels.

Conclusions

In March 2024, PRDH declared a public health emergency due to an early, out-of-season surge in cases that exceeded the epidemic alert threshold developed in this study. This real-time application highlights the value of these thresholds to support dengue epidemic detection and public health response. Integrating thresholds with other tools and strategies can enhance epidemic preparedness and management.

☐ ☆ ✇ BMJ Open

Development of methods to identify digitally excluded older people, and tailoring of interventions to meet their digital needs: a protocol for a mixed-methods study (the INCLUDE study)

Por: Brundle · C. · Johansson · J. F. · Best · K. · Clegg · A. · Forster · A. · Atkinson · T. · Foster · M. · Humphrey · S. · Iliff · A. · Inglis · J. · Walker · C. · Graham · L. — Septiembre 19th 2025 at 06:54
Introduction

Digital inclusion (which includes skills, accessibility and connectivity to the internet and digital devices) is a ‘super social determinant of health’ because it affects many aspects of life that influence health. Older people are especially vulnerable to digital exclusion. Existing digital inclusion interventions are commonly offered opportunistically to people who come into contact with services, or in specific locations. The lack of systematic identification of need unintentionally excludes older people who may be most in need of support, and that support is not addressing their needs.

Methods and analysis

This multi-method project includes six workstreams: (1) A survey of people aged 65+ to ask about digital use and engagement. Survey data will be used to develop a model that predicts digital exclusion from data available in primary care records. (2) Testing, via a further survey, the external validity of the model to identify those who are digitally excluded. (3) Interviews with community service providers to identify, understand and define the components of existing digital inclusion services for older people. Concurrently, a rapid review of the literature will identify evidence for interventions aimed at supporting digitally excluded adults aged 65+. (4) Interviews with people aged 65+ representing a range of digital use will explore factors from the COM-B model that influence digital behaviours—their capability (C), opportunity (O) and motivation (M) relating to digital engagement. Analysis outputs will identify the intersectional nature of barriers or facilitators to digital inclusion. (5) Co-production workshops with older people and community service providers will identify key components of interventions that are required to address digital exclusion. Components will be mapped against existing interventions, and the ‘best fit’ intervention(s) refined. An implementation plan will be developed in parallel. (6) Feasibility testing of the refined intervention(s) to assess acceptability and obtain feedback on content and delivery mechanisms.

Ethics and dissemination

This study was approved by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee on 23 October 2023 (ref. 23/YH/0234). Findings will be disseminated in academic journals and shared at webinars, seminars, conferences and events arranged by organisations operating across the digital inclusion and older people fields.

Trial registration

https://www.isrctn.com/ISRCTN18306736

☐ ☆ ✇ BMJ Open

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J. — Septiembre 12th 2025 at 05:14
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

☐ ☆ ✇ BMJ Open

Development and validation of clinical vignettes to inform an educational intervention for physiotherapists to detect serious pathologies: a mixed-methods study

Por: Lackenbauer · W. · Gasselich · S. · Lickel · M. E. · Schabel · L. · Beikircher · R. · Keip · C. · Wieser · M. · Selfe · J. · Mazuquin · B. · Yeowell · G. · Janssen · J. — Agosto 19th 2025 at 15:52
Objectives

To develop and validate educational clinical vignettes (CVs) based on real-life patients with serious pathology from the disciplines of oncology, internal medicine and orthopaedics that are relevant for physiotherapists (PTs) working in a non-direct access system.

Design

A mixed-methods study using an iterative design was employed to develop and validate CVs that focused on serious pathology.

Setting

Academic and clinical settings within health faculties at three universities in Austria and the UK.

Participants

Medical doctors (MD) (n=3) and PTs (n=4) developed CVs in the disciplines of internal medicine, oncology and orthopaedics. Validation of the CVs was undertaken in three stages: internal validation by the research team (n=7), external validation by MDs (n=3) and external validation by PTs (n=18).

Results

25 CVs focusing on internal medicine (9), oncology (8) and orthopaedics (8) were developed. Results of the consensus method of Haute Autorité de Santé ranged between 7 and 9 in the internal validation stage. In the external validation stage with MDs, one orthopaedic CV was excluded, resulting in a final total of 24 validated CVs.

Conclusions

This is the first time educational CVs have been developed and validated across such a broad range of pathologies for countries without direct access to physiotherapy, for use in the education of PTs. Furthermore, the approach described in the Methods section of this paper may serve as a template in similar future projects.

☐ ☆ ✇ BMJ Open

Arrhythmia burden, symptoms and quality of life in female and male endurance athletes with paroxysmal atrial fibrillation: a multicentre cohort study in Norway, Australia and Belgium

Por: Apelland · T. · Letnes · J. M. · Janssens · K. · Claessen · G. · Tveit · A. · Sellevold · A. B. · Mitchell · A. · Willems · R. · Onarheim · S. · Enger · S. · Kizilkilic · S. E. · Miljoen · H. · Elliott · A. · Loennechen · J. P. · La Gerche · A. · Myrstad · M. · The NEXAF Investigators — Agosto 5th 2025 at 19:02
Objectives

To assess atrial fibrillation (AF) burden, symptoms and quality of life (QoL) in endurance athletes with paroxysmal AF.

Design

Prospective cohort study.

Setting and participants

Otherwise healthy endurance athletes with paroxysmal AF in Norway, Australia and Belgium. The current study presents baseline measurements collected before the intervention of a randomised controlled trial on effects of individually tailored training adaptation.

Methods

AF burden (percentage time in AF) was measured by insertable cardiac monitors (Confirm Rx, Abbott). AF-related symptoms and QoL were assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) with any score

Results

43 athletes (age 57±10 (mean±SD), range 33–75 years, 3 women) were included. The athletes were monitored for 50±18 days. Median AF burden was 0.18% (IQR 0%–2.6%). Out of 29 athletes with at least one AF episode, 21 (72%) had AF episodes >60 min. 13 athletes (30%) had AFEQT overall score 60 min were associated with reduced QoL (mean AFEQT score 78 vs 90, p=0.001 and 78 vs 90, p=0.001, respectively). There were large individual variations between the athletes concerning AF burden, symptoms and QoL.

Conclusions

Although most athletes were still competing, more than half had troublesome symptoms. One-third had reduced QoL, which was associated with higher AF burden and longer duration of AF episodes. Variations between the athletes highlight the need for individually tailored AF management in athletes with paroxysmal AF.

Trial registration number

NCT04991337.

☐ ☆ ✇ BMJ Open

Implementing heart failure disease management in primary care: a mixed-methods analysis of the IMPACT-B study

Por: Raat · W. · Smeets · M. · Van Pottelbergh · G. · Van de Putte · M. · Janssens · S. · Vaes · B. — Julio 21st 2025 at 02:01
Objectives

Heart failure is an important health problem and patients are generally older with several comorbidities. Multidisciplinary heart failure care is therefore recommended. However, there is little evidence in real-world settings on how to involve primary care health professionals and how to evaluate such programmes. The main objective of this study is to integrate and evaluate several disease management interventions in a primary care setting.

Design

Prospective, non-randomised, observational implementation study with a mixed-methods process evaluation conducted over 3 years (2020–2022).

Setting

Primary care practices and two regional hospitals (one tertiary, one secondary) in the Leuven region, Belgium, serving approximately 100 000 inhabitants.

Participants

100 general practitioners (GPs) from 19 practices participated. A total of 96 patients were included in the disease management programme. Inclusion criteria for patients included high-risk status for heart failure (HF) readmission, based on clinical criteria. Exclusion criteria were not explicitly defined but participation required informed consent.

Interventions

Four interventions were implemented: (1) online HF education for GPs, (2) reimbursed natriuretic peptide (NP) testing, (3) patient education by trained primary care HF educators and (4) a structured transitional care protocol posthospital discharge.

Primary and secondary outcome measures

Primary outcomes included GP self-efficacy in HF management, NP testing rates, HF registration in electronic health records and patient self-efficacy (9-item European Heart Failure Self-Care Behaviour Scale (EHFScB-9)). Secondary outcomes included patient quality of life (Short Form-12 questionnaire (SF-12)), hospital readmission rates and provider satisfaction.

Results

GPs felt more competent in the management of HF after an online education (eight point increase in self-efficacy score after 6 months follow-up, (CI 2.9 to 13, p

Conclusions

The IMPACT-B study demonstrated that an integrated disease management programme for HF could be implemented and assessed in routine clinical practice. The programme resulted in increased awareness and registration of HF in primary care, increased self-management of patients and improved follow-up after discharge, although these results should be interpreted cautiously given the uncontrolled pre-post study design.

Trial registration

Trial registration NCT04334447 (clinicaltrials.gov).

☐ ☆ ✇ BMJ Open

Cardiovascular disease and beta-cell function at diagnosis of serologically defined adult-onset type 1 and type 2 diabetes in two Swedish cohorts 15 years apart

Por: Ritsinger · V. · Gunnarsson · R. · Melin · E. · Hillman · M. · Stogianni · A. · Holmberg · S. · Johansson · K. · Nilsson Neumark · A.-S. · Krol · H. · Rööst · M. · Landin-Olsson · M. · Neumark · T. · Wanby · P. · Thunander · M. — Julio 16th 2025 at 09:42
Objectives

To describe the prevalence of cardiovascular disease (CVD) at the time of diagnosis of adult-onset type 1 (T1D) and type 2 (T2D) diabetes, in a recent cohort and compare to a previous cohort from the same region. Further, to explore factors influencing the prevalence of pre-existing CVD, including age, sex, body mass index (BMI) and C-peptide; in the later cohort also heart failure, hyperlipidaemia, tobacco use and physical activity.

Design

Two prospective cross-sectional cohort studies compared.

Setting

All primary health care centres and hospitals in Kalmar and Kronoberg counties in Southeastern Sweden.

Participants

Adults with newly diagnosed T1D or T2D (classified by combination of islet antibodies and C-peptide) in 1998–2001 and 2016–2017.

Primary and secondary outcome measures

Prevalence of hypertension and CVD at diagnosis of diabetes, and associations with beta-cell function, in two cohorts collected 15 years apart. Further, to explore factors influencing the prevalence of hypertension and CVD, and level of C-peptide.

Results

In patients with newly diagnosed T2D, mean age-at-onset had decreased (66±14.1 years vs 63±12.6, p≤0.001) and mean BMI had increased (29.0±5.4 vs 31.4±5.8 kg/m2, p≤0.001). Prevalence of pre-existing myocardial infarction had decreased in both T1D (18% vs 7%, p=0.03) and T2D (25% vs 11%, p≤0.001). Pre-existing hypertension had increased in both T1D (23% vs 40%, p=0.01) and T2D (44% vs 61%, p≤0.001). C-peptide level was lower and was associated with several cardiovascular conditions in newly diagnosed T2D in 2016–2017 (p=0.048 p≤0.001).

Conclusions

Patients with newly diagnosed T2D were younger, with higher BMI, compared with 15 years earlier, a challenge for diabetes care. Prevalence of pre-existing myocardial infarction had decreased notably, in line with, but still less than in the general population; while pre-existing hypertension had increased, in both diabetes types. C-peptide was associated with several cardiovascular conditions in newly diagnosed T2D in the recent cohort, which warrants further investigation.

☐ ☆ ✇ BMJ Open

Increased direct oral anticoagulant use and event rates in non-valvular atrial fibrillation: a nationwide retrospective registry study in Sweden

Por: Kadhim · H. · Jansson · M. · Själander · S. · Sjögren · V. · Björck · F. · Renlund · H. · Eriksson · M. · Norrving · B. · Själander · A. — Julio 15th 2025 at 09:31
Rationale

The use of direct oral anticoagulants (DOACs) as stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) has increased steadily since the introduction in 2011. In Sweden today, more patients are treated with DOACs than with warfarin. However, it is not shown that an increased proportion of DOAC prescriptions correlates to lower event rates of stroke and systemic embolism.

Objectives

This study aims to investigate whether the increased prescription of DOACs in Sweden correlates with lower event rates for all-cause stroke, systemic embolism and bleeding complications, using real-life data for the whole NVAF population.

Design

Nationwide retrospective register study.

Setting

Data were obtained from the Swedish National Patient Registry, covering patients aged 18 years or older with NVAF, between 1 January 2014, and 31 December 2017. Exposure to oral anticoagulants was determined based on pharmaceutical data, calculating treatment duration by the number of pills dispensed and the prescribed daily usage rate. Baseline characteristics and endpoints were collected from hospital administrative registers using International Classification of Diseases, 10th edition (ICD-10) codes.

Participants

All patients with NVAF were identified using ICD-10 codes during the study period. Entry criteria included having a first recorded atrial fibrillation diagnosis after 1 January 2014 or being previously diagnosed with atrial fibrillation before 2014 but still receiving care after this date.

Outcome measures

The outcomes were event rates (per 100 person-years) of ischaemic stroke, systemic embolism, all-cause stroke, major bleeding and intracranial bleeding (including haemorrhagic stroke). Event rates were calculated and compared across the study period using Cox proportional hazard models.

Results

In the total NVAF population, the proportional decrease in event rates (per 100 treatment years) in 2017 compared with 2014 was ischaemic stroke 24% (1.70–1.30), all-cause mortality 4% (9.40–9.00), all-cause stroke 24% (2.10–1.60) and all-cause stroke and systemic embolism 23% (2.20–1.70). During the same time, the proportion of major bleeding and intracranial bleeding rates, including haemorrhagic stroke, also decreased: 5% (2.00–1.90), 6% (0.68–0.64) and 17% (0.30–0.25), respectively. DOACs use increased from 4.1% to 28.3% in the total population and from 22.7% to 60.9% in newly diagnosed patients.

Conclusions

In the initial years following the introduction when DOAC uptake in the population was high, an increasing proportion of Swedish NVAF patients receiving DOACs was accompanied by lower event rates of all-cause stroke and systemic embolism, ischaemic stroke and all-cause mortality, intracranial bleeding and major bleeding, highlighting the improved risk-benefit balance of DOACs in stroke prophylaxis.

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