Conectar
Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.
This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.
This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.
This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).
Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.
Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.
Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.
Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.
A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.
Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.
The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.
NCT06916598 (clinicaltrials.gov).
This study aimed to investigate the association between food insecurity and dietary intake with anxiety and depression among residents of underserved urban settlements in Bangladesh.
This cross-sectional study was used to collect data from participants through face-to-face interviews using structured questionnaires. Food security status was assessed using the Household Food Insecurity Access Scale, while anxiety and depression levels were measured using the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9, respectively. Dietary intake was evaluated through a 24-hour dietary recall and Food Frequency Questionnaire method.
Five districts located within the Khulna Division of Bangladesh.
Residents of underserved urban areas in Bangladesh (n=749), aged ≥18 years old.
Results indicated that 22.1%, 74.6% and 44.5% of participants experienced severe food insecurity, mild to moderate food insecurity and low Household Dietary Diversity Score, with a significant portion also showing symptoms of anxiety (57.1%) and depression (57.9%). Food insecurity and Household Dietary Diversity Score were found to be positively associated with both anxiety (p
These findings highlight that food insecurity not only affects dietary habits but also exacerbates mental health outcomes. Addressing food insecurity and balanced dietary intake could therefore contribute to better mental health outcomes and overall well-being in underserved communities. Policymakers should prioritise comprehensive strategies that ensure access to nutritious foods and provide mental health support to vulnerable groups.
Progressive supranuclear palsy (PSP) is a devastating neurodegenerative disease characterised by cognitive, behavioural and motor problems. Motor symptoms are highly disabling, while cognitive and behavioural changes have a major impact on carer burden, quality of life and prognosis. Apathy and impulsivity are very common, often coexistent in PSP, and negatively predict survival. In preclinical models and other diseases, apathy and impulsivity are associated with noradrenergic deficits, which can be severe in PSP.
Noradrenaline for Progressive Supranuclear Palsy Syndromes trial is a randomised, double-blind, placebo-controlled, crossover design, Phase IIb clinical trial to evaluate the efficacy and safety of oral atomoxetine for the treatment of cognitive and behavioural changes in PSP. Participants receive atomoxetine 40 mg (10 mg/mL oral solution) once daily or a matched placebo solution, in random order, each for 8 weeks. An ‘informant’, who knows the patient with PSP well, is co-recruited to complete some of the trial outcome measures. Participants remain in the trial for 22 weeks after randomisation. The primary objectives are to assess (1) safety and tolerability and (2) efficacy versus placebo on challenging behaviours as reported in a subscale of the Cambridge Behavioural Inventory. Secondary and exploratory measures relate to cognition, the PSP Rating Scale, mood and potential baseline predictors of individual response to atomoxetine computed from imaging, genetic and cognitive measures at baseline.
The trial was approved by the South Central-Oxford B Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (REC reference: 20/SC/0416). Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences and engagement with patients, the public, policymakers and practitioners.
ISRCTN99462035; DOI:
This scoping review aims to map existing evidence on knowledge, attitudes and practices (KAP) and barriers to preconception care in low- and middle-income countries. The primary objective is to identify key gaps and research priorities to guide future efforts to improve maternal and child health.
This review followed Arksey and O'Malley’s scoping review framework, with a comprehensive search across Medline, EMBASE, CINAHL and Scopus from inception to May 2025. Eligible studies included original research on preconception care (PCC), KAP in low- and middle-income countries (LMICs) without date restrictions. Two independent reviewers conducted screening in Covidence. Findings were presented in graphical, tabular and narrative formats, adhering to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols Extension for Scoping Reviews (PRISMA-ScR) standard.
The review focused on PCC studies conducted in LMICs across various healthcare settings, emphasising primary and secondary levels of care. The geographical scope was global but limited to LMICs as defined by World Bank criteria.
A total of 62 studies were included in the review. Of these, 42 employed quantitative methods, 18 used qualitative approaches and 2 used a mixed-methods design. Regarding focus areas, 25 studies assessed knowledge, 14 assessed practices, 12 studies assessed KAP comprehensively and 10 assessed attitudes. Participants were mainly women of reproductive age (44 studies), with only five studies including men. Among healthcare providers, KAP varied, with midwives being the most frequently studied group. Stakeholders such as policymakers were notably under-represented. Identified barriers included limited training, cultural beliefs and inadequate policies. Facilitators highlighted were targeted education, spousal support and policy advocacy, emphasising the need for gender-sensitive and systemic interventions.
LMICs face complex challenges in utilising PCC, influenced by socioeconomic, cultural, and healthcare system factors. To address these challenges, nuanced approaches incorporating intersectional perspectives and practical qualitative methodologies are essential for improving couples' and child health outcomes.
The study protocol was registered in the Open Science Framework (OSF) on December 23, 2022, with DOI: 10.17605/OSF.IO/H3MK6.
Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.
This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.
Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.
To compare the effectiveness of buprenorphine-naloxone (bup/nal) and methadone maintenance therapy (MMT) in the treatment of patients with opioid use disorder (OUD) during the fentanyl era.
Secondary analysis of prospective cohort study data.
Data for the study were collected from 54 clinical sites across Ontario, Canada, between May 2018 and January 2023.
To be included in the present study, participants had to be at least 16 years of age, have provided written informed consent and be receiving either MMT or bup/nal therapy for OUD. This study includes data from 2601 participants, of whom 2068 were receiving MMT and 533 were receiving bup/nal for OUD. The mean age of participants was 39.4 years (SD: 10.9), and 45% were female.
MMT or bup/nal treatment for OUD.
We employed a propensity score matched analysis to compare treatment outcomes among patients receiving MMT compared with bup/nal. We used ongoing illicit opioid use as an indicator of treatment outcome. We considered participants with >50% of urine drug screens in the past 12 months positive for non-prescribed opioids to be ‘non-responders’. We conducted subgroup analyses to identify whether treatment type was associated with ongoing non-prescribed opioid use among patients with and without a history of intravenous drug use (IVDU), and whether treatment type was associated with retention in treatment.
Eight per cent of patients on bup/nal were considered non-responders, compared with 11.9% of patients on MMT. We did not find a statistically significant association between treatment type and treatment response. However, we did find that patients on MMT were more likely to stay in treatment for 12 months (OR 1.79, 95% CI 1.45 to 2.22, p
Among a cohort of patients with OUD receiving treatment during the fentanyl era, we find that there is no statistically significant difference in ongoing non-prescribed opioid use between patients receiving MMT compared with bup/nal. Future studies should aim to further compare treatment effectiveness using patient-centred outcomes and pragmatic trial designs.
To compile and compare the Comprehensive Geriatric Assessment (CGA) models that exist worldwide and their applicability in primary healthcare (PHC).
The world’s population is ageing rapidly, but health systems are slow to keep up with this trend, making it difficult to provide care for older adults. The broad concept of frailty has prompted a comprehensive and holistic approach to patients, where the assessment is related not only to functional, physical and cognitive abilities of the older adults, but also their social, environmental and economic context. In recent decades, the approach to frailty has taken the CGA as the gold standard. With this project, we intend to carry out a scoping review to identify and describe tools to help standardise and generalise CGA in PHC.
Individuals aged 65 years or over; CGA in a PHC setting; the CGA methods reported must include at least three domains: physical, cognitive and social; Articles without language restrictions; Articles published in the last 30 years.
All studies that refer to CGA models and fulfil the inclusion criteria will be selected. A bibliographic search of articles will be carried out using the following electronic scientific publication databases: MEDLINE-PubMed, Embase, Cochrane Library and Web of Science. We will search for grey literature on sites such as ‘OpenGrey’ and thesis repositories such as RCAAP, EBSCO and EThOS, as well as on the WHO pages. The articles will be independently selected by two reviewers, and the data will be presented in narrative format, structured according to the objective, focus and question of the review.
Approved by the ethics committee of the regional health administration of the centre, registered as Project 11/2024 and approved on 8 May 2024. The findings of this study will be disseminated through peer-reviewed publications and national or international conference presentations. Updates of the review will be conducted, as necessary.
Open Science (DOI 10.17605/OSF.IO/REH43).
Postoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient’s satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.
The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events.
This study was approved by the University Health Network Research Ethics Board (REB 23–5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results.
Clinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment.
Version 2.0: August 26, 2024.
This systematic review investigates the effectiveness of different communication strategies to increase COVID-19 vaccine uptake and willingness.
Systematic review and meta-analysis of randomised controlled trials (RCTs), following recommendations from the Cochrane Handbook and reporting according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline.
We searched the following databases until 27 July 2022: Cochrane COVID-19 Study Register, PsycINFO, CINAHL, Web of Science Core Collection and WHO COVID-19 Global literature.
We included RCTs investigating, any population, communication-based interventions to increase COVID-19 vaccine uptake and comparing these with no intervention (with or without placebo), another communication strategy or another type of intervention.
Screening, data extraction and bias assessment, using the Cochrane ROB 1.0 tool, were conducted by two authors independently. We performed meta-analyses if studies were homogeneous using the Review Manager (RevMan 5) software, synthesised the remaining results narratively and assessed the certainty in the evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.
We identified 49 studies reporting on the predefined four categories of communication interventions. Evidence from our meta-analyses shows that COVID-19 vaccine uptake may increase when education and information strategies are applied (risk ratio (RR) 1.23, 95% CI 1.17 to 1.28; high-certainty evidence) or social norms are communicated (RR 1.28, 95% CI 1.23 to 1.33; high-certainty evidence) compared with no intervention. The different communication strategies mostly have little to no impact on vaccine intention; however, there may be a slight increase in vaccine confidence when gain framing is applied compared with no intervention.
Overall, we found that education and information-based interventions or social norm-framing strategies are most effective compared with no intervention given. Our findings show that some of the investigated communication strategies might influence policy decision-making, and our results could be useful for future pandemics as well.
PROSPERO (CRD42021296618).
To evaluate the role of using outputs from patient-facing online triage tools in clinical decision-making in primary care.
Systematic review.
Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Scopus were searched for literature published between 1 January 2002 and 31 December 2022 and updated for literature published up to end of November 2024.
Studies of any design are included where the study investigates how primary care clinicians make clinical decisions in response to patient concerns reported using online triage tools.
Data were extracted, and quality assessment was conducted using the Mixed Methods Appraisal Tool. Narrative synthesis was used to analyse the findings.
14 studies were included, which were conducted in the UK (n=9), Sweden (n=3) and Spain (n=2). There were no studies that examined clinical decision-making as an outcome. Outcomes relating to the impact on clinical decision-making were grouped into three categories: patient clinical outcomes (n=9), primary care practitioner experience (n=11) and healthcare system outcomes (n=14). Studies reported faster clinical decisions made in response to patient concerns. Other studies reported clinicians offering unnecessary urgent appointments as patients learnt to ‘game’ the system. Clinicians felt confident managing patient requests as they can access additional information (such as a photo attachment). Moreover, clinicians’ time was freed up from appointments with limited clinical value. Contrarily, online triage was perceived as an additional step in the workflow.
Clinicians should be aware that their decision-making processes are likely to differ when using online triage tools. Developers can use the findings to improve the usability of the tools to aid clinical decision-making. Future research should focus on patient-facing online triage tools in general practice and the process of clinical decision-making.
CRD42022373944.
Cardiac surgery is frequently associated with vasoplegia and vasopressor treatment. Both may be associated with postoperative complications and prolonged length of stay. The most frequently used vasopressor is norepinephrine. However, in a pilot, double-blind, randomised controlled trial (RCT) in cardiac surgery patients, angiotensin II was effective in maintaining blood pressure and was associated with a shorter duration of hospital stay than norepinephrine. Furthermore, hyperreninaemic patients were more sensitive to angiotensin II. These findings support the need for a larger RCT to determine whether angiotensin II is superior to norepinephrine as a first-line treatment for low blood pressure after cardiac surgery.
We will conduct a double-blind RCT comparing an infusion of either angiotensin II or norepinephrine intraoperatively and for up to 48 hours after the start of surgery. We will randomly allocate 400 cardiac surgery patients at multiple centres in two countries to either an equipotent angiotensin II or norepinephrine infusion, titrated to a mean arterial pressure of 70–80 mm Hg. The primary outcome will be length of hospital stay. Secondary outcomes will include a composite of renal, cardiovascular and neurological events. A subgroup analysis of patients with elevated baseline renin levels will be undertaken.
Ethical approval has been granted by the Alfred Human Research Ethics Committee on 14 July 2023 (HREC/97814/Alfred-2023). Results will be published on completion of the trial.
Australian and New Zealand Clinical Trials Registry: ACTRN12623000848606.
FreshRSS 