Conectar
Ageing is associated with declines in physical and cognitive function that increase the risk of disability and dependence. Intrinsic capacity (IC), proposed by the WHO, provides a multidimensional framework to assess health in older adults. This study aims to evaluate whether a multicomponent recreational exercise programme (Fun Exercise for Older Adults (FEXO)) improves IC, motivation and adherence compared with a conventional programme (OTAGO).
A randomised controlled trial with two groups (2:1 ratio) will be conducted among 120 community-dwelling older adults (≥60 years). Participants will be randomly assigned to FEXO (intervention) or OTAGO (control). Both programmes will consist of 3 weekly sessions for 14 weeks. Primary outcomes: IC, assessed through validated measures (Short Physical Performance Battery, Mini Nutritional Assessment, Mini-Mental State Examination, Cornell Scale for Depression in Dementia and sensory evaluation), motivation (BREQ-3) and adherence rate. Secondary outcomes include body composition, cardiovascular parameters, frailty, cognition and resilience (PRIFOR). Data will be analysed using two-way ANOVA (groupxtime) under an intention-to-treat approach. Effect sizes (p²) and 95% CIs will be reported. Additional analyses (correlation, regression, mediation and moderation) will explore associations and intervention effects.
Approved by the Ethics Committee of Universidad CEU Cardenal Herrera (Ref. CEEI23/487 and CEEI25/639). Results will be disseminated through peer-reviewed journals and scientific conferences. The findings of this study will contribute to improving evidence-based strategies for promoting healthy ageing and will support the development of more engaging and effective exercise interventions for older adults.
This study has been prospectively registered at ClinicalTrials.gov (identifier: NCT07133568).
Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy.
A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.
The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience.
The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.
Institutional delivery under skilled care is essential for reducing maternal mortality. Ghana has expanded maternal health services through policies such as the National Health Insurance Scheme and the free maternal healthcare policy. Inequalities in access to facility-based delivery, however, remain across socioeconomic groups. This study examined wealth-based inequities in institutional delivery and identified maternal and socioeconomic factors associated with facility delivery in Ghana.
A cross-sectional analysis of nationally representative survey data.
Ghana.
Data were drawn from the 2022 Ghana Demographic and Health Survey. The analysis included 5855 women aged 15–49 years who had at least one live birth in the 5 years preceding the survey.
Descriptive statistics were used to summarise participant characteristics, and weighted logistic regression models were applied to identify factors associated with institutional delivery.
84.3% of women delivered in a health facility. Wealth showed a strong gradient effect. Women in the richest wealth quintile had significantly higher odds of institutional delivery compared with those in the poorest quintile (odds ratio (OR) 2.71, p
Socioeconomic and geographic disparities in institutional delivery remain evident in Ghana. Wealth, education, antenatal care attendance and health insurance coverage influence access to facility-based childbirth. Targeted interventions are needed to improve equitable access to skilled delivery services.
Effective management of type 2 diabetes mellitus (T2DM) in older adults requires interventions that address both metabolic control and functional capacity. Exercise improves insulin sensitivity, glucose uptake and cardiometabolic health, while high-protein diets support muscle mass preservation, satiety and glycaemic regulation. Evidence suggests that integrating structured exercise with a high-protein diet may provide additive benefits; however, research evaluating this combined approach in older adults with T2DM, particularly in low-resource settings, is limited. This study aims to determine whether a 12-week multimodal exercise programme combined with a high-protein diet improves glycaemic control and broader health outcomes compared with exercise alone.
In this randomised controlled trial (RCT), 140 adults aged ≥60 years with T2DM will be allocated 1:1 to an experimental group (multimodal exercise with high-protein diet, n=70) or a control group (multimodal exercise alone, n=70). All participants will engage in three supervised exercise sessions per week for 12 weeks. Additionally, the experimental group will follow a high-protein diet that provides approximately 30% of total energy from protein, with a 500-kcal daily energy deficit. The primary outcome is glycaemic control, measured by Glycated haemoglobin (HbA1c). Secondary outcomes include anthropometric measures, fasting blood glucose, lipid profile, functional capacity (6-minute walk test) and health-related quality of life Short Form-36 Health Survey (SF-36). All outcomes will be assessed at baseline, postintervention (week 12) and follow-up (week 24). Participants, outcome assessors and statisticians will remain blinded. Intervention fidelity, adherence and safety will be systematically monitored, and final results will be analysed using SPSS (v.26.0). The study will follow ethical standards and comply with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines.
The protocol has been approved by the Institutional Review Board of the Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (Approval No.: PTR-JUST/IRB/2025/09/192404) and registered with the Clinical Trials Registry of India. Findings will be disseminated via peer-reviewed journals, conference presentations and structured knowledge-sharing sessions to inform clinical practice in diabetes management.
Trial registration number: CTRI/2025/08/092509
To define subaxial cervical spine vertebral body and canal dimensions in a paediatric cohort and to assess the influence of age and ethnicity.
Retrospective radiological observational study.
Single-centre tertiary level trauma care setting in New Zealand.
CT scans of children under 18 years of age were reviewed. A total of 111 participants were included (63 New Zealand European (NZE) and 48 Māori). Patients with cervical spine pathology or deformity were excluded.
Not applicable.
Primary outcomes were anteroposterior and transverse vertebral body and spinal canal dimensions measured at the mid-pedicle level from C3 to C7. Secondary outcomes included canal-to-vertebral body (canal:VB) ratios. Associations with age and ethnicity were assessed using correlation analysis and analysis of covariance (ANCOVA).
Absolute vertebral body and canal dimensions were larger in NZE children compared with Māori. Canal:VB ratios were smaller in NZE children, reaching statistical significance at C7 (p=0.011). Age demonstrated a strong positive correlation with mean vertebral body anteroposterior diameter and a moderate correlation with canal:VB ratio. ANCOVA showed ethnicity (NZE) to be a significant predictor of vertebral body dimensions, particularly transverse diameter at C4–C6, while age had a lesser effect. Canal:VB ratios decreased with increasing age from C3 to C7, with low coefficients of determination indicating additional influencing factors.
In this paediatric cohort, vertebral body dimensions were more strongly associated with age than spinal canal dimensions. Ethnicity was associated with modest differences in cervical spine morphology, particularly transverse vertebral body diameter. These findings suggest cervical spine development is multifactorial and may have implications for trauma assessment and spinal cord injury risk evaluation in adolescents. Further studies incorporating anthropometric and sex-specific variables are warranted.
Shared decision making (SDM) is advocated as an approach for patient-centred asthma care. However, this approach may not always be feasible or preferred by patients and/or healthcare professionals (HCPs). Knowledge and insights into whether and how the preferred collaboration style in medical decision making is discussed and managed during consultations for severe asthma are limited.
To investigate how HCPs’ and patients’ preferred collaboration styles in treatment decision making are experienced, discussed and managed during consultations.
Qualitative research using semi-structured interviews with HCPs specialised in severe asthma and a focus group with severe asthma patients in The Netherlands. Inductive thematic analysis was used, with results reported according to the COREQ checklist.
Four themes concerning HCPs’ and patients’ experiences were identified: (1) overall preference for SDM, yet (2) ambiguity of SDM’s content, (3) variation in application of SDM and (4) friction between medical focus and patient autonomy in SDM. A fifth theme concerned the discussion and management of collaboration style preferences: limited metacommunication. HCPs and patients seem unable to identify each other’s preferences in collaboration styles. Overall, a lack of communication regarding how to collaborate in making treatment decisions was found. Varying views on meaning and content of collaboration styles, especially SDM, and HCPs’ medical focus seemed to contribute to the lack of communication.
With the lack of communication regarding preferences in collaborating, HCPs and patients are likely to miss out on effective collaboration. Future studies should explore how views and preferences regarding HCP-patient collaboration can be bridged.
To describe (1) the proportion of deaths that were in recently hospitalised children and (2) causes of mortality among deceased children aged 0–59 months with preceding hospitalisations who enrolled in a mortality surveillance programme.
Descriptive study using prospectively collected data.
Eight Child Health and Mortality Prevention Surveillance (CHAMPS) community and healthcare sites in sub-Saharan Africa and South Asia.
Deaths among children aged 0–59 months enrolled in CHAMPS 2016–2023.
None.
Deaths with antecedent hospitalisations within 180 days of death. Causes of death determined by expert panels who reviewed clinical data and histopathologic and microbiologic results from postmortem minimally invasive tissue sampling.
CHAMPS enrolled 8548 deaths; we excluded 3688 neonates who died before discharge or ≤24 hours of birth and 482 with unclear information on antecedent hospitalisations. Out of the 4378 remaining deaths, 16.7% (95% CI 15.7% to 17.9%) were deaths that occurred within 180 days of a hospitalisation (n=733/4378). Of these, 55.7% (95% CI 52.0% to 59.3%) occurred outside healthcare facilities. Among included deaths with minimally invasive tissue sampling completed (n=337), lower respiratory tract infections (41.2%, 95% CI 36.0% to 46.7%), sepsis (39.8%, 95% CI 34.5% to 45.2%) and undernutrition (n=92, 27.3%, 95% CI 22.7% to 32.4%) were most common causes of death among cases with antecedent hospitalisations. The greatest proportion of deaths with antecedent hospital admissions occurred among cases aged 1–11 months (48.0%, 95% CI 44.4% to 51.7%), compared with those aged 0–1 months (21.7%, 95% CI 18.8% to 24.9%) and those aged 1–5 years (30.3%, 95% CI 27.0% to 33.8%). Moreover, the greatest proportion of deaths with antecedent hospital admissions occurred among infants/children with weight-for-age Z-score of
We observed a high proportion of deaths with antecedent hospitalisations within 180 days among young children across eight sites in sub-Saharan Africa and Asia. Among those deaths, children aged 1–11 months and undernourished infants were over-represented, suggesting early follow-up as a potential point to focus targeted support and future research.
To examine which information sources medical specialists use to answer clinical questions in daily practice and to describe the relative frequency of use for each source.
Systematic review with narrative synthesis and meta-analysis.
Academic Search Premier, APA PsycINFO, CINAHL, Emcare, Cochrane Library, Web of Science, Embase and PubMed were searched for relevant studies published from 2000 to 1 June 2025.
We included peer-reviewed English-language studies reporting on the frequency of information source usage by medical specialists when addressing clinical questions. Studies reporting usage on a continuous (0–100%) scale were eligible for meta-analysis.
Two reviewers independently screened studies. Data were extracted by one reviewer and checked by a second. Study quality was assessed using the Quality Assessment tool with Diverse Studies tool. A narrative synthesis was conducted for studies that were not eligible for quantitative pooling to summarise patterns in information-seeking behaviour and reported barriers. A random-effects meta-analysis was performed for studies reporting continuous usage percentages and assessing at least four information sources. Sensitivity analyses were conducted using a leave-one-out approach. Potential publication bias was explored descriptively using funnel plots.
25 studies were included, of which 6 (with 8641 participants) were eligible for meta-analysis. The narrative synthesis of non-pooled studies showed a consistent reliance on standalone information sources and identified barriers to the use of aggregated sources. In the meta-analysis, digital databases such as PubMed were the most frequently used information source (74%, 95% CI 63% to 85%), followed by textbooks (71%, 95% CI 57% to 85%) and consultation with colleagues (43%, 95% CI 15% to 71%). Systematically aggregated sources, including clinical practice guidelines (38%, 95% CI 27% to 49%) and point-of-care websites (49%, 95% CI 17% to 81%), were used less frequently. Sensitivity analyses indicated that pooled estimates were generally robust, although results should be interpreted cautiously given methodological variability across studies.
Medical specialists predominantly rely on standalone information sources when addressing clinical questions, while systematically aggregated and interpreted sources such as clinical practice guidelines and point-of-care tools are used less frequently. These findings highlight the need to better understand and address barriers to the use of aggregated information sources in clinical practice.
CRD42022267431.
Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.
This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.
The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.
To assess the impact of the non-reimbursement policy on vitamin D therapy discontinuation in patients from the general and rheumatic populations.
A cross-sectional study.
Research institute specialised in health research and two outpatient pharmacies in the Netherlands.
Patients from the general and rheumatic population with an active prescription for vitamin D supplementation therapy were included.
Data were collected between April and May 2023 through self-reported questionnaires. Descriptive statistics and logistic regression were performed using STATA V. 17. P value
The primary outcome was the proportion of patients who discontinued vitamin D supplementation therapy following the implementation of the non-reimbursement policy. Secondary outcomes included patient-reported reasons for therapy discontinuation and the association between patient-related characteristics and the risk of therapy discontinuation. In addition, the proportion of patients who switched to an alternative supplement and whether this switch had been made in consultation with a healthcare provider was examined.
Of the 4800 patients, 302 (6.4%) patients discontinued their vitamin D therapy. The three most frequently reported reasons for therapy discontinuation were the inability to afford supplements without reimbursement, not willing to pay for supplements without reimbursement and being unaware of the alternative vitamin D supplements to switch to. Younger age, financial constraints and limited health literacy were significantly associated with vitamin D therapy discontinuation (p
The implementation of the non-reimbursement policy resulted in a small proportion of patients discontinuing their vitamin D therapy. Elevated discontinuation rates were associated with specific patient-related characteristics including patients aged
This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.
A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.
16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.
Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.
Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.
A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.
It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.
This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).
Venous thromboembolism (VTE) contributes to hospitalisation-associated morbidity. Although guidelines recommend limiting VTE prophylaxis to high-risk patients, some physicians prescribe it broadly. We compared beliefs of low and high prescribing physicians.
We surveyed hospitalists and medical residents who had the opportunity to prescribe prophylaxis ≥50 times. Best-worst scaling was used to assess their beliefs. Using a balanced incomplete block design, we created seven choice tasks with seven statements regarding prophylaxis beliefs each presented four times. For each task, physicians selected the statement that most and least reflected their beliefs. We used a count method to calculate best-worst scores and a conditional logistic regression choice model to compare low and high prescribers.
Of 434 invitees, 172 (40%) completed all survey questions between June and November 2023. Low (n=86, ≤62.5% prescribing rate) and high (n=86, >62.5 prescribing rate) prescribers endorsed similar beliefs with differing levels of agreement. All felt confident to prescribe prophylaxis appropriately (low: +1.13, high: +1.10, p=0.81). High prescribers expressed more concern about VTE without prophylaxis (+1.02 vs +0.65, p=0.002). Low prescribers disagreed more that prophylaxis had no downside (–1.03 vs –0.73, p=0.01). High prescribers worried less about prophylaxis risks (–0.49 vs –0.22, p=0.01), and overuse (–0.61 vs –0.34, p=0.02).
Compared with low prescribers, high prescribers were more concerned about VTE without prophylaxis and less about harms. These differences in beliefs may underlie physician behaviour and could be targets for interventions to reduce inappropriate prophylaxis.
To explore and understand the disease priorities and preferences for rapid diagnostic testings (RDTs) among community members and stakeholders.
Qualitative study using focused group discussions and in-depth interviews. Thematic analysis was applied to identify themes of disease priorities and RDT preferences.
uMsunduzi Municipality, KwaZulu-Natal, South Africa.
49 community members and five community stakeholders were recruited through a combination of convenience and purposeful sampling using community events and meetings.
Participants prioritised both communicable diseases (HIV, tuberculosis) and non-communicable diseases (diabetes, cardiovascular disease, hypertension and cancer), aligning with national health priorities. They supported RDTs for early diagnosis and home-based testing to mitigate barriers to accessing diagnostic care. A need for post-test support, such as digital support tools, was also highlighted.
Community perspectives highlighted a demand for accessible, rapid and decentralised diagnostic tools for high-burden diseases in KwaZulu-Natal. RDTs have the potential to improve health outcomes and reduce health disparities through improved access to diagnostic healthcare services. The community members are potential end users of RDTs, especially in resource-constrained settings. Therefore, their perspectives should be considered in the development and implementation of RDTs to enhance acceptability and public health impact.
Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?
This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.
This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.
Health systems must guarantee access to quality, safe and effective medicines. Essential medicine lists (EMLs) are crucial prioritisation tools to inform coverage decisions and steward limited health resources under the context of universal healthcare. This study aims to develop a consolidated framework for prioritising the assessment of health technologies to review and update EML for treating diseases or health problems managed in primary healthcare (PHC).
A mixed-methods approach was designed to validate the framework. An initial scoping systematic review will be conducted to search for studies that describe criteria used to prioritise the assessment of health technologies for PHC. The relevant studies will be examined using the Joanna Briggs Institute methodological framework for scoping review studies. A comprehensive search was conducted in the following sources: PubMed, Embase, Cochrane Library, Virtual Health Library (LILACS, WHO IRIS, IBECS, PAHO-IRIS, PAHO, LIS, BRISA), Health System Evidence, Global Healths, Health Evidence and Epistemonikos from the inception until February 2025. Two review authors will screen and extract data independently. The extracted data will be qualitatively analysed and presented in a diagrammatic or tabular form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Reviews reporting guidelines. An iterative process online using the Delphi hybrid with stakeholders through predetermined consensus thresholds, a combination of a four-point Likert scale and open-ended questions will be conducted to select and validate the criteria identified in the scoping review.
We will provide a consolidated framework to inform decision-makers for prioritising the assessment of health technologies for the national EML for PHC. This is an important step in using evidence to inform public health policies. We plan to share findings through a variety of means, including publications in peer-reviewed journals, presentations at national conferences, invited workshops and webinars, email discussion lists affiliated with our institutions and professional associations, and academic social media.
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.
Advancements in technology for treating diabetes mellitus (DM) are progressing rapidly. With the growing availability and use of continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion (CSII), glucose regulation is improved in individuals with DM, which will lead to less long-term complications and reduce the overall disease burden on patients with DM. Collecting vast amount of biomedical data, these devices combined with clinical outcome data provide more insight into the development and treatment of the disease. The objective of the DIABASE initiative is to collect and examine real-world data from medical devices and clinical practice in a registry.
The ongoing study is structured as an observational study registry. Clinical data and real-world data from diabetes wearable devices, such as CGM and CSII, are aggregated in the database. Clinical data is automatically extracted from the hospital’s electronic health record. Data from wearables is periodically collected manually from the various online data platforms for sharing and automatically added to the database.
This study is exempted from ethics approval by the Medical Research Ethics Committees United (MEC-U) since participants are not subject to procedures and are not required to follow rules of behaviour (approval ID: AW23.009/W20.197). The execution of this study has been approved by the board of the study site Hospital Group Twente (ZGT) (ZGT20-40). Results will be shared through scientific meetings and publications and through articles for the general public.
Preventing loss of autonomy has become a public health issue due to the increase in healthcare costs associated with ageing. It has become even more pressing with the arrival of the baby-boomer generation. This has given rise to several initiatives. This is the background to the VIVADOM project. The project provides a complete kit for older adults aged 60 years and over living at home. First, the kit includes a technological package (telecare, light path and digital tablet). Then, these older adults benefit from personalised human support provided by postal workers trained in gerontology. The aim of this study will be to carry out a health economic assessment (HEA) of the VIVADOM project as part of the prevention of frailty and/or dependency (by comparing beneficiaries of the complete kit with non-beneficiaries). The comparator will be the fact of not benefiting from the complete kit. In addition, the efficiency of the project in preventing falls and cognitive problems will be studied. We will calculate three incremental cost-effectiveness ratios (ICER) for these three issues.
The economic model used will be the Markov model. Transition probabilities, average costs and average quality-adjusted life year (QALY) will be calculated for the two groups being compared. The ICER will be obtained by dividing the difference in average costs by the difference in average QALYs. Finally, ICERs will be compared with willingness-to-pay (WTP) to assess the efficiency of the system. Thus, the VIVADOM project will be efficient when these ICERs are lower than the WTP. Univariate and probabilistic sensitivity analysis will be carried out to ensure the robustness of the analysis results.
The HEA of the VIVADOM project has been approved by the research unit of the University of Limoges in France. The results will be published in a peer-reviewed journal and presented at relevant national and international conferences.
Mediastinal and/or hilar lymphadenopathy (MHL) is increasingly identified owing to various underlying conditions. Minimally invasive biopsy techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), transbronchial mediastinal cryobiopsy (TBMC) and transbronchial forceps biopsy (TBFB), are common diagnosis tools. However, their safety and diagnostic efficiency remain unclear. This trial aims to compare the diagnostic yield and safety of these three techniques.
This study is a three-arm, parallel-design, randomised controlled trial involving 972 adult patients with MHL recruited from multiple medical centres. Participants will be randomly assigned to the EBUS-TBNA, TBMC via a tunnel or TBFB via a tunnel group. The primary outcome is diagnostic yield, and the secondary outcomes include diagnostic sensitivity, sample quality and procedure-related complications. Statistical analyses will be conducted using the appropriate methods. An independent sample ² test will be used to test the differences in the diagnostic yield and incidence of procedure-related complications.
Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2022-KY-194).
Written informed consent will be obtained from all patients or their guardians before their enrolment in the study. This study will be conducted per the principles established in the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice.
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