Conectar
With the rapidly changing landscape of rectal cancer treatment, it is becoming increasingly challenging for clinicians to interpret and synthesise the vast amount of high-quality evidence being generated. A core outcome set (COS) for clinical trials in rectal cancer would help address issues surrounding outcome selection and reporting. The purpose of this research project is to develop a COS to be used in research comparing different treatment paradigms in the management of rectal cancer.
This will be a mixed-methods project, including a systematic review, semi-structured interviews and a Delphi consensus process. The project was designed in accordance with the COMET (Core Outcome Measures in Effectiveness Trials) Handbook, which provides a framework for COS development based on existing evidence. A multidisciplinary Study Advisory Group, composed of rectal cancer providers, methodologists and patients, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter V.2.0. Semi-structured interviews with rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals will be invited to participate in a Delphi process to develop the final COS.
The study has received full approval with the Research Ethics Committee at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) (REC: 2025-4377) and the Institutional Review Board of the Mount Sinai School of Medicine (IRB: STUDY-25-00515). The results of this study will be presented at national and international meetings and a manuscript will be submitted for publication in a high-impact surgery and/or oncology peer-reviewed journal.
The study was registered in the COMET database in December 2023 (https://www.comet-initiative.org/Studies/Details/2941). The full systematic review protocol, along with the search strategy and inclusion/exclusion criteria, was registered online in September 2023 (researchregistry.com; reviewregistry1705).
Patient and Observer Scar Assessment Scale Version 3.0 (POSAS 3.0) is a robust instrument for scar evaluation. Currently, no validated POSAS 3.0 in the Malay language is available. This study aimed to translate, culturally adapt, and psychometrically evaluate POSAS 3.0 for Malay-speaking populations in Malaysia. Malaysian patients were recruited between 31 October 2023, to 31 December 2024. Translation was conducted using a forward and backward translation approach. Reliability was assessed using internal consistency (Cronbach's alpha) and test–retest. Face validity was addressed with 10 patients, and content validity was evaluated by four clinical specialists. Content validity was evaluated using the item-content validity index (I-CVI) and content validity ratio (CVR). Construct validity was assessed using exploratory factor analysis (EFA). Seventy-eight participants with facial (n = 39, 50.0%) and non-facial (n = 39, 50.0%) soft tissue scars were recruited for the EFA. The Malay POSAS-O demonstrated acceptable internal consistency (α = 0.75) and excellent inter-rater reliability, with item-level intraclass correlation coefficient (ICCs) ranging from 0.91 to 1.00 and total score ICC of 0.99. Agreement for categorical scar severity ratings was almost perfect (κ = 0.89). The Malay POSAS-P showed excellent internal consistency (α = 0.89), and test–retest reliability for the total score was good to excellent (ICC = 0.89). Intermittent symptom items (painful, shooting, burning and fragile) exhibited lower stability, reflecting natural symptom variability. Content validity was excellent, with all items achieving I-CVI and CVR values of 1.00. EFA supported construct validity, with adequate Kaiser-Meyer-Olkin (KMO) values (POSAS-O: 0.88; POSAS-P: 0.85), significant Bartlett's tests, strong communalities and factor loadings. The cumulative variance explained was 79.05% for POSAS-O and 68.19% for POSAS-P. The Malay version of the POSAS 3.0 is a reliable, valid, and culturally appropriate instrument for scar assessment. Its strong psychometric properties support its application in clinical practice and research involving Malay-speaking populations.
by Jacqueline Muts, Danée Knevel, Dick den Hertog, Rachel K. Wong, Timothy C.Y. Chan, Britt J. van Keulen, Johannes B. van Goudoever, Chris H.P. van den Akker
Background and aimsThe macronutrient composition of donor human milk (DHM) can vary substantially due to several factors such as maternal age, diet, and lactation duration. However, consistent macronutrient levels in DHM facilitate the administration of the required amounts to preterm infants. The current pooling strategy at most human milk banks combines milk from different batches from a single donor. This study aims to stabilize the macronutrient quality of DHM by pooling milk from different donors by utilizing machine learning prediction and optimisation techniques.
MethodsThe current pooling strategy is compared with a new theoretical approach that pools milk batches from up to 5 donors. To predict the crude protein and energy content, we used the following variables: body mass index, the donor’s diet (vegetarian or non-vegetarian), maternal age, full-term or preterm delivery, lactation stage, and volume pumped. These predictions are then used within an optimisation model to create milk pools that minimize the deviations from the target macronutrient levels (1.0 g protein/100 mL and 70 kcal/100 mL).
ResultsThe prediction model is based on 2236 created single-donor pools from 480 donors. Random forest regression models provided the most accurate predictions of macronutrient content. The new pooling strategy using multiple donors shows reduced deviations from target values compared to the current single-donor approach (average total absolute deviation 0.402 versus 0.664).
ConclusionThis study proves the potential of data-driven methods to improve operational efficiency in human milk banks, and improving the consistency of donor human milk.
by Simon Söderholm, Martin Ulander, Vanessa William Toma, Sara Kaufmann, Xiangyu Qiao, Daniel Berglind, Susanna Calling, Bledar Daka, Ludger Grote, Mats Martinell, Frida Bergman, Pontus Henriksson, Carl-Johan Östgren, Wen Zhong, Claudio Cantù, Fredrik Iredahl
Coffee is the most common drink in the world, second only to water. This makes caffeine, the ingredient of coffee known for its wakefulness-promoting effects, one of the most used psychoactive substances. The psychoactive property of caffeine is well-characterized, and entails its interaction with the adenosine receptors, involved in sleep regulation. While studies have shown a deleterious immediate effect of caffeine on sleep, less is known about the effects of chronic caffeine exposure. In the present cross-sectional study, we investigated this relationship across a large cohort of 30,154 individuals participating in the Swedish Cardiopulmonary Bioimage Study (SCAPIS), which allowed us to compare habitual coffee intake with sleep habits, subjective estimate of daytime sleepiness, and underlying genetic variants. According to our analyses, different degrees of coffee consumption, confirmed by statistical association with previously reported genetic variants, showed very low association with estimated patterns of sleep habits or perceived daytime sleepiness. These results indicate that coffee may be less impactful on sleep habits than previously thought, or that other mechanisms, such as the adaptive capabilities of the adenosine system in adult coffee users, may dampen its psychoactive potency.by Xuying Zhang, Johanna Mainzer, Isabella Giambra, Tong Yin, Petra Engel, Hannah Hümmelchen, Henrik Wagner, Axel Wehrend, Christiane Egerer, Katharina Gerhards, Gerald Reiner, Sven König
Long tails trigger tail biting in pigs and increase the risk of flystrike infections in sheep. Tail docking has been a common management practice in both species for decades, but increasingly conflicts with legal animal welfare guidelines. Sustainable solutions require breeding strategies targeting shorter tails. In consequence, the aims were to conduct whole-genome sequencing (WGS)-based genome-wide association studies (GWAS) and comparative genomic analyses (CGA) to explore functional elements influencing tail traits. Phenotypically divergent experimental populations of pigs and sheep were established through unified selection and mating experiments. Tail traits included tail length (TL) measured at birth, and tail abnormalities (TA) assessed radiographically at 14 weeks of age. WGS-based GWAS identified a significant locus on SSC18 in pigs and suggestive loci for TL in both species, which, together with previously reported loci for TA, were further analyzed by CGA. The genomic windows of the significant locus on SSC18 in pigs and the TL GWAS locus on OAR4 in sheep were found to be conserved, harboring six common genes with predicted functional variants. These variants were jointly associated with TL (Plm ) in both species in linear regression models adjusted for sex, age of the dam, body length, and body weight. In other GWAS locus windows (±1 Mb), species-specific TL candidate genes were identified in sheep (HOXB13, MUC5B, EPB41L3, MTCL1, PIEZO2, MPPE1, and LOXHD1) and in pigs (KNL1, DISP2, SPRED1, TGFB2, and HAND1), each harboring associated putative functional variants. For TA, sheep-specific candidates (PGM2, LRRC66, CRACD, LOC105601916, and SH2D4B) and pig-specific candidates (MYOT, TMCO6, and PCDHAC2) were revealed using logistic regression models (Pglm ). GO analyses of candidate genes predicted shared biological processes between sheep and pigs, whereas pathway analyses indicated that common carbohydrate metabolism pathways, along with species-specific immune and inflammatory signaling, and pig-specific TGF-β signaling and endochondral ossification, may contribute to tail length variation and abnormalities. These findings provided deeper insights into the genetic basis of differential embryonic tail morphogenesis and perinatal tail development across species.Across medicine, new therapies are shifting treatment from clinic to home settings. At-home subcutaneous immunoglobulin treatment for immunodeficiency is an example of one such therapy. In this qualitative interview study, we investigated experiences of patients living an everyday life with subcutaneous immunoglobulin at-home treatment.
24 Danish patients participated in semistructured interviews. Six patients were interviewed in individual home-visit interviews, while the remaining 18 participated in one of six subsequent group interviews using an online video format. Participants represented three patient groups: patients with primary immunodeficiency, patients with secondary immunodeficiency, and patients with chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy.
According to the interviewed patients, at-home treatment provided a high degree of flexibility and freedom in everyday life. When transitioning to at-home treatment, a sense of security had been achieved through individualised training and access to healthcare professionals. Some patients experienced uncertainty or insecurity during the initial period of administering treatment at home; however, this typically receded over time. For the patients, at-home treatment had become embedded in everyday life either through incorporation into existing everyday routines or through the development of new routines. The time-related and place-related flexibility of the at-home treatment had benefits for several arenas of everyday life: work, family, and leisure. Patients associated at-home treatment with a sense of freedom, which they ascribed both to independence from the hospital and to not being confronted with medical conditions and other patients in the hospital setting. A small minority of the patients viewed the reduced contact with healthcare professionals as a disadvantage, describing feelings of being alone and responsible for their treatment.
Patients who had established at-home treatment routines in their everyday lives found the benefits of at-home treatment to outweigh the challenges.
Open femoral vessel access is commonly performed in vascular surgery, but surgical site complications (SSCs) occur frequently. The aim of this study is to evaluate the incidence and identify potential risk factors by applying a new standardised definition and grading of various types of groin wound complications. This retrospective analysis includes 201 consecutive patients with 219 vertical groin incisions to expose the femoral vessels for different vascular interventions. A prophylactic drain was placed intraoperatively in almost all incisions (91%). Groin SSCs were defined and graded into four categories according to a modified Clavien-Dindo classification. Potential risk factors were evaluated using univariable analysis. For multivariable analysis, a multiple logistic regression was performed. Cutoff values were determined through ROC analysis. According to the proposed definition, regular postoperative course grade 0 (no SSC) occurred in 163 patients (74.4%), grade 1 (minor SSC) in 10 (4.6%), grade 2 (moderate SSC) in 14 (6.4%), and grade 3/4 (major or life-threatening SSC) in 32 (14.6%) incisions. The incidence of clinically relevant SSCs (grade 2–4) was 21%. Drainage volume was an independent parameter that predicted relevant SSCs with a threshold value of 70 mL/24 h on postoperative day 4 (sensitivity 100%; specificity 67%; AUC = 0.835; p = 0.0004). Groin wound complications following vascular procedures are common. Lymphatic leakage appears to be the most significant, potentially preventable condition associated with relevant SSCs. Prophylactic or early therapeutic interventions should focus on reducing lymphatic morbidity.
Mothers’ mental health and life satisfaction may have been negatively affected due to challenges during the COVID-19 pandemic. Given the risk of future crises, knowledge of possible mitigating factors in this population is essential. This study aims to examine whether the pandemic affected the level of protective factors such as social support, physical activity and employment situation, and how these factors are associated with mental distress and life satisfaction.
Longitudinal cohort study.
Primary outcomes were mental distress (measured by the eight-item version of the Hopkins Symptom Checklist) and life satisfaction (measured by the Satisfaction With Life Scale). As the first step, we investigated changes in the levels of social support (defined by the number and frequency of social contact), physical activity (average hours of physical activity during a week), employment situation (actively working vs sick leave or unemployed), alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption) and relationship satisfaction (measured by the five-item version of the Relationship Satisfaction Scale).
We analysed data from two waves of the Norwegian Mother, Father and Child Cohort Study (n=~18 000 mothers); one pre-pandemic wave and one wave where half of the sample responded after the onset of the pandemic, with pandemic exposure being defined by questionnaire response timing rather than cohort recruitment. To assess changes in protective factors over time and pandemic exposure, we used difference-in-differences analyses and regression discontinuity design. Associations between protective factors with mental distress and life satisfaction, and possible moderation by pandemic exposure, were investigated using multiple regression models with interaction terms adjusted for potential confounders.
Apart from physical activity, which declined less across time in the pandemic group (B=0.09, 99% CI 0.05 to 0.12), protective factors did not change during the pandemic. Social support, employment situation and relationship satisfaction were associated with mental distress and life satisfaction, whereas physical activity showed a unique relationship with mental distress. Most associations were similar across pandemic exposure groups, except employment situation which appeared to have a stronger protective effect in the pandemic group (β=–0.12, 99% CI –0.24 to –0.00).
Changes over time in self-reported levels of protective factors were generally consistent among mothers independent of the pandemic. These factors appear to play an equally important role for mental distress and life satisfaction both under ordinary circumstances and during public health crises. Our findings enhance the understanding of how potential protective factors among mothers are associated with mental distress and life satisfaction in the context of a global stressor. Future studies should investigate additional mitigating factors that may be particularly relevant during global crises and explore the causal relationship between protective factors, mental health and life satisfaction.
To explore differences in health-related benefit status over 3 years, focusing on patterns of sick leave, work assessment allowance and disability benefits, between people who underwent rehabilitation and a matched control group.
Prospective longitudinal multicentre cohort study using registry data over three consecutive years.
Secondary specialist rehabilitation services at 17 institutions across Norway.
Patients (n=2710), 42% with rheumatic and musculoskeletal diseases, aged 18–65 years referred for multidisciplinary rehabilitation at one of the participating institutions. They were propensity score matched with 37 760 controls from the national sick leave registry, based on sociodemographic factors and health-related benefit status.
Multidisciplinary rehabilitation programmes, commonly lasting 3 weeks (range: 1 week to 6 months), tailored to individual needs.
Days on health-related benefits (sick leave, work assessment allowance (WAA) and disability benefits) were quantified as lost workdays per month. Differences between groups were analysed using Generalised Estimating Equations across three consecutive years: the year before rehabilitation, the rehabilitation year and the year after rehabilitation.
The rehabilitation group had more days on health-related benefits per month than controls throughout the observation period. During the rehabilitation year, they had on average 1.7 more days on sick leave (95 % CI 1.3 to 1.9), 2.3 more WAA days (95% CI 1.9 to 2.7) and 0.2 more days on disability benefits (95% CI 0.1 to 0.3). In the year after rehabilitation, they had 0.6 fewer days on sick leave (95% CI –0.8 to –0.3), but 3.7 more days on WAA (95% CI 3.1 to 4.2) and 0.6 more days on disability benefits (95% CI 0.4 to 0.8). Patterns were similar for the subgroup with rheumatic and musculoskeletal diseases.
People undergoing rehabilitation had more days on health-related benefits and a greater increase in long-term benefits, even after matching, indicating a higher disease and support burden than controls. Tailoring interventions and health-related benefits is an essential aspect of rehabilitation for people with complex work participation needs. Future research should include longer observation periods to explore long-term outcomes of rehabilitation.
by Elizabeth Youens, Dan G. O’Neill, Zoe Belshaw, Johanna Neufuss, Mickey S. Tivers, Rowena M. A. Packer
Extreme conformation and reduced genetic diversity are recognised to lead to severely reduced health, welfare and longevity in certain dog breeds. There is growing interest in applying strategic crossbreeding to promote more moderate conformations and greater genetic diversity within currently problematic breeds. Crossbreeding could therefore lead to more rapid and effective improvements in welfare compared to current practices of within-breed selection. Deliberate crossbreeding between distinct different dog breeds is not a new concept; it was historically commonly used to create the current pure breeds, to increase genetic diversity and to bring new physical and/or temperament traits into existing breeds. However, a recent surge in the popularity of ‘designer crossbreeds’ (intentional crosses between established purebreds) has elicited fresh interest around the potential positives and negatives of crossbreeding practices. Further research on crossbred brachycephalic dogs is urgently required for a greater understanding of the motivators and barriers to their acquisition. An online survey explored factors that motivate dog breed choice and acquisition of both crossbreed and purebred dogs. In addition, the survey used both closed and open questioning to explore the UK public’s perceptions of crossbreeding, specifically (i) between a brachycephalic breed and a non-brachycephalic breed, and (ii) between two non-brachycephalic breeds. Free-text results were analysed using content analysis and subsequently quantified. Results from 4,899 participants identified that key motivators to acquire a brachycephalic crossbreed vs a brachycephalic purebred included perceptions of improved health, including the reduction in risk of breed and conformation-related disorders, and increased genetic diversity. However, the desire to acquire a purebred dog, or even a specific breed, remained a significant barrier to crossbreed acquisition, alongside concerns surrounding the ethics of crossbreeding. Other barriers included perceived negative changes to appearance and temperament of the offspring from crossbreeding. The current study identified a common set of acquisition decision-making factors across all ownership groups, including desiring a dog who the owner perceives to enjoy being loved and to enjoy physical affection, but further demonstrated that good health is of motivational low priority to some dog owners, particularly to owners of purebred brachycephalic dogs. The mix of positive and negative public perceptions and beliefs around crossbreeding and crossbreed dogs demonstrate the need for further research into the health, temperament and appearance of brachycephalic crossbreed dogs. The suitability of crossbreed dogs as an alternative to certain current purebred breeds with high risk of genetic or conformational disorders depends on both public desire and on evidence-based selection of suitable breeds to encourage crosses which maximise canine welfare.by Mary O’Keeffe, Nathan Skidmore, Arianna Bagnis, Przemysław Bąbel, Elżbieta A. Bajcar, Alessandra De Palma, Andrea W.M. Evers, Eveliina Glogan, Julia W. Haas, Stefanie H. Meeuwis, Marek Oleszczyk, Antonio Portolés, Johan W.S. Vlaeyen, Katia Mattarozzi, on behalf of PANACEA Consortium
BackgroundPlacebo and nocebo effects significantly influence health outcomes, yet healthcare professionals receive limited training and guidance on their mechanisms and clinical application, creating a gap in education and practical understanding. Conducted within the European PANACEA Consortium, this study evaluated healthcare professionals’ knowledge, attitudes, and practices regarding placebo and nocebo effects, and assessed their needs in further education.
MethodsAn online cross-sectional survey among a European multi-country convenience sample of healthcare professionals collected data assessing participants’ knowledge, perceptions, and experiences regarding placebo and nocebo effects; their application and ethical considerations in clinical practice; and investigated educational needs and interest in further training. Quantitative data were analyzed using descriptive statistics, and thematic analysis was applied to the free-text responses.
ResultsAmongst 807 participants, 71.7% reported taking advantage of placebo effects in their practice, and over half of participants (55.8%) observing nocebo effects. Participants reported feeling somewhat confident (53.3%) in harnessing placebo effects with 47.5% feeling confident in preventing nocebo effects. The majority of respondents had not received formal training on placebo and nocebo effects, with most expressing an interest in further training in areas such as healthcare education, emphasizing communication skills to enhance placebo effects, and knowledge to recognize and reduce nocebo effects.
ConclusionsThere is a significant need for more comprehensive training on placebo and nocebo effects, particularly in early health professional education. These findings informed the development of educational resources and best practice recommendations developed as part of the outcomes from the PANACEA Consortium, improving the understanding and application of these effects among healthcare professionals across Europe.
Acute lower limb ischaemia (ALI) is a life- and limb-threatening vascular emergency requiring urgent intervention. Despite advancements in therapeutic strategies, outcome reporting for ALI remains inconsistent, limiting evidence synthesis and guideline development. The CORE-ALI study aims to develop a Core Outcome Set (COS) to standardise outcome reporting and ensure the inclusion of both clinical and patient-centred metrics.
CORE-ALI will use a structured, multi-phase methodology guided by the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Core Outcome Set-STAndards for Reporting (COS-STAR) guidelines. Phase 1 involves stakeholder engagement through semi-structured interviews with patients, clinicians and policymakers from diverse European healthcare systems. Qualitative data will be analysed using thematic analysis to generate a preliminary list of outcomes. In Phase 2, a multi-round Delphi survey (anticipated two to three rounds) will prioritise and refine outcomes through consensus building, with quantitative data analysed using descriptive and non-parametric statistical methods. Phase 3 will culminate in a consensus meeting to finalise the COS. Multilingual accommodations will ensure inclusivity, and General Data Protection Regulation (GDPR)-compliant platforms will secure data handling.
The study has received ethics approval from the Ethics Committee of the Medical University of Innsbruck (EK Nr: 1082/2025) on 20/05/2025. Additional local ethics approvals are required and will be obtained at all participating sites prior to the initiation of recruitment. The final Core outcome set will be disseminated through peer-reviewed publications, presentations at international conferences and engagement with professional societies and patient organisations.
COMET initiative (Registration No. 3346).
by Jonas Österlind, Johan Birnefeld, Elin Birnefeld, Magnus Hultin, Sara Qvarlander, Anders Wåhlin, Petter Holmlund, Laleh Zarrinkoob
BackgroundMaintaining cerebral perfusion during anesthesia and intensive care is critical, yet the relationship between mean arterial pressure (MAP) and cerebral blood flow (CBF) remains poorly defined. In patients with aneurysmal subarachnoid hemorrhage (aSAH), pharmacologically induced hypertension is commonly applied to support cerebral perfusion, but its effects are uncertain.
MethodsThis protocol describes two parallel clinical studies using identical methodology. The first study population includes adults undergoing elective general anesthesia (MAP-ANE), and the second comprises sedated intensive care patients with aSAH (MAP-SAH). In both study populations, MAP will be increased stepwise with norepinephrine (NE) infusion under continuous invasive blood pressure monitoring, and CBF measured with phase-contrast MRI (PCMRI) and arterial spin labeling (ASL), while near-infrared spectroscopy (NIRS) will be performed in parallel to evaluate its validity as a surrogate marker. The primary outcome is the change in total CBF between baseline and elevated MAP, directly testing whether induced hypertension increases CBF. Secondary outcomes include ASL perfusion changes, the slope of the MAP–CBF relationship, systemic–cerebral hemodynamic correlations, and NIRS responses.
Expected impactThese studies test the hypothesis that pharmacological MAP augmentation does not predictably increase CBF. By combining quantitative MRI with invasive monitoring, it aims to clarify MAP–CBF interactions, define the physiological basis of induced hypertension, and assess whether NIRS can serve as a clinically useful proxy. Findings are expected to inform safer and more individualized blood pressure management in perioperative and neurocritical care. The studies are registered at ClinicalTrials.gov (MAP-ANE: NCT06855407; MAP-SAH: NCT06033378).
Trial registrationClinicalTrials.gov, MAP-ANE NCT06855407, MAP-SAH NCT06033378
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.
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.
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.
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.
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.
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.
CTIS 2023-510404-44-00.
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.
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.
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.
The Puerto Rico Department of Health (PRDH) seeks to identify dengue epidemics as early as possible with high specificity.
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.
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.
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).
The model was fitted retrospectively to mimic real-time epidemic detection and assessed based on sensitivity and specificity of epidemic detection.
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.
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.
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.
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.
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.
FreshRSS 