Conectar
To develop and evaluate a standardised, fully automated assessment procedure for patient treatment preferences suitable for use in randomised controlled trials (RCTs) with remote or digital health interventions.
Multiphase developmental study followed by implementation in a fully randomised preference trial (FRPT).
University and outpatient cancer care settings in Switzerland; implementation in RCTs with a remote digital health intervention.
50 medical students for pilot testing; 11 patients with cancer for qualitative testing; 124 adult patients with cancer experiencing fatigue or sleep problems in an FRPT with a remote digital health intervention.
Primary outcome: feasibility and applicability of a standardised digital preference assessment procedure. Secondary outcomes: distribution and strength of treatment preferences, reasons for preference.
A procedure with three items for assessing treatment preferences was developed and refined based on pilot testing, stakeholder meetings and patient interviews. The stepwise procedure ensured that study participants with an initially unclear preference were finally able to report their preference. The majority of students (91.7%) indicated their preference already in the first assessment step. Similar in the RCT phase, 110 of 124 participants (88.7%) indicated their preference in the first step. Preference drivers included interest, perceived ease and conceptual appeal in addition to expected treatment benefits.
Our fully automated standardised preference assessment with three items appears feasible in trials with digital health interventions. Future trials with two active treatment conditions should consider implementation of such a preference assessment to evaluate non-specific treatment effects driven by the match of patients’ preferences with the respective treatment.
DRKS00035596; DRKS00035541; SNCTP000006209.
Staphylococcus aureus (S. aureus) bacteraemia is a common and severe infection. With mortality rates ranging from 20–30% and long-term impairments in over a third of survivors, better treatments are urgently needed. Linezolid, a well-established treatment for pneumonia and complicated skin infections, has been shown in preclinical studies to strongly suppress S. aureus virulence factors critical to bacterial persistence and tissue damage. Hence, we aim to investigate whether the addition of linezolid to standard therapy in patients with S. aureus bacteraemia leads to an overall improvement in patient-relevant outcomes.
We will conduct a two-arm, parallel-group, multicentre, randomised controlled trial (Linezolid Plus Standard of Care) in 12 hospitals in Switzerland with blinded treating physicians, patients and outcome assessors. Hospitalised patients aged ≥18 years with S. aureus bacteraemia will be eligible. Patients will receive standard antibiotic treatment as prescribed by the treating physician. Within 72 hours of collection of the blood sample yielding the first positive blood culture, patients will be enrolled and randomised 1:1 to receive either adjunctive linezolid (600 mg orally two times per day for 5 days) or placebo. To determine patient-relevant outcomes, we implemented a comprehensive patient-representative consultation process. Consequently, we will use the desirability of outcome ranking (DOOR) established for S. aureus bacteraemia as the primary outcome at 90 days. The hierarchical composite DOOR outcome includes the following four components, ranked from most to least important: (1) survival, (2) return to level of function before S. aureus infection, (3) complications leading to treatment changes and serious adverse reactions; and (4) hospital length of stay. This approach will allow us to analyse the win ratio, that is, whether patients receiving linezolid have a better DOOR rank compared to patients in the placebo group. We calculated a target sample size of 606 patients providing 90% power at a two-sided significance level of 0.05.
Ethical approval was received from the Ethics committee for Northern and Central Switzerland (BASEC number 2025-00655). Eligible patients will be informed about the study by the local study team and asked for written consent if they wish to participate. For patients unable to provide informed consent, an appropriate substitute (ie, a close relative or a physician not involved in the research project) may make decisions based on the presumed wishes and the best interest of the patient. The patient’s own consent will be obtained as soon as their condition permits. Results will be published in peer-reviewed journals and in laymen's terms through various channels (social media, Swiss national portal HumRes).
The surge in postsecondary students reporting mental health concerns, coupled with increased utilisation of on-campus and hospital-based mental healthcare, highlights a need to understand effective service navigation. To address this system gap, the University of Toronto and the Centre for Addiction and Mental Health (CAMH) leveraged their unique expertise and resources to develop the University of Toronto Navigation (UTN) service. UTN introduces care navigators to facilitate postsecondary student transitions from acute mental health services to community or campus mental healthcare. There has been limited implementation and evaluation of navigator models specific to the postsecondary context to date, which hinders scalability. This paper describes the study protocol of Navigation to Enhance Post-Secondary Students’ Acute Mental Health Care Transitions, a study that aims to collaborate with students, navigators and clinicians to evaluate the UTN service.
A one-stage, single-arm multimethods study design will be used to evaluate the UTN service. We will recruit 103 students following their UTN intake appointment. Students will complete quantitative measures assessing health outcomes, experiences of care and service utilisation at baseline and at three subsequent time points across a 6-month follow-up period. The quantitative data will be linked to administrative healthcare data. The primary evaluation outcome will be defined as attending an appointment with an appropriate care provider (in person or virtually) within 30 days of discharge from the hospital. We will conduct interviews with students and referring clinicians to gather perspectives regarding their experiences and satisfaction with the UTN service in greater depth.
Research ethics board approvals have been obtained from the University of Toronto and CAMH. Results will be disseminated through publications and presentations, and a toolkit will be cocreated to support implementation and adaptation of hospital-based navigator interventions in postsecondary contexts.
This scoping review will evaluate and synthesise what is known about the impact of structural and social determinants of health on neurodegeneration among adults of African American or Black (AAB) racial identity with a history of traumatic brain injury (TBI). The primary objective is to examine how structural factors, such as healthcare access, influence disparities in neurodegeneration following TBI. Given higher rates of TBI and worse outcomes among Black individuals compared with White individuals, this review seeks to fill the gap in research concerning underrepresentation of AAB populations.
Guided by the Joanna Briggs Institute Evidence framework, this review will systematically search PubMed (MEDLINE), Embase and Cochrane CENTRAL Library (Wiley) for relevant studies. Eligible studies will involve adult human participants diagnosed with neurodegenerative conditions, including dementia and cognitive impairment, and with a history of TBI. Studies must include participants of AAB and non-Hispanic White (NHW) racial identity to facilitate comparisons. The review will focus on identifying potential factors contributing to disparities in neurodegeneration. Data synthesis will include narrative summaries, comparative tables and visualisations to highlight racial disparities in neurodegeneration risk and AAB representation in TBI research. This approach is its structured framework will evaluate the depth of racial inclusion across studies, allowing for a more nuanced understanding of how structural and social determinants shape outcomes.
As this review involves only previously published literature, institutional review board approval will not be required. The findings will be disseminated through peer-reviewed publications, conference presentations and lay summaries.
Stroke is a leading cause of death and disability in the Caribbean, yet there is limited published information on the availability and utilisation of diagnostic imaging and treatment methods. Inequities in healthcare infrastructure, access to neuroimaging and acute treatment options may contribute to poorer outcomes following stroke, particularly in the low-resource settings that characterise most of the Caribbean region. The objective of this review is to map the literature on access to diagnostic and therapeutic modalities for adult stroke care in the Caribbean to identify potential limitations in acute treatment and examine how restricted access may impact outcomes. The resulting data can help inform strategies for improving access to stroke care in resource-limited communities.
We will apply a three-step strategy based on the Joanna Briggs Institute methodological framework: first, a limited search to identify relevant articles; second, selection of key search terms; third, implementation into a comprehensive search strategy. The query will range from 1 January 1995 to 1 June 2025 (date of final search). Search results will be extracted and screened by two independent reviewers, and findings will be presented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. We will consider studies focusing on ischaemic and haemorrhagic stroke in the Caribbean, emphasising access to diagnostic imaging, stroke centres, prehospital management and emergent treatment. Studies examining acute stroke management capacity within the region will be considered. Studies will be excluded if they: focus exclusively on primary stroke prevention, postacute care, longitudinal care pathways for stroke victims or paediatric populations; are unrelated to stroke diagnosis or treatment or are conducted outside the Caribbean.
This protocol aims to perform secondary analysis of previously published literature; therefore, ethical approval is not required. The results of this review will be disseminated through academic conferences and peer-reviewed publication.
In a rapidly evolving world shaped by digital transformation, digital technologies are increasingly being used in healthcare. To use them effectively, nursing staff, patients and their caregivers need the appropriate skills. To date, digital literacy in general, digital skills and (digital) technologies have played a minor role in German nursing curricula. In addition, little is known about the use of technology in nursing education and about effective ways to enhance digital competence. This scoping review aims to identify current literature on innovative and experiential-based teaching and learning methods for developing competence in technology and digitalisation for nurses and informal caregivers, as well as digital technologies that are being used in this educational context.
This scoping review, which will be designed and conceptualised using the Joanna Briggs Institute methodology for conducting scoping reviews, will take place from April 2025 to January 2026. The search will be conducted on the databases CINAHL, Emcare, Embase, Medline and ERIC. Screening and extraction will be peer reviewed and follow predefined criteria, as well as opportunities for free-text responses. The extracted data will be analysed using absolute and relative frequencies. Free-text responses will be analysed using qualitative content Analysis.
As an ethics vote is not required to conduct a scoping review, this will not be obtained. The results will be disseminated via open access publication in a peer-reviewed journal and through presentations at conferences.
Stroke volume is a major determinant of tissue perfusion and, therefore, a key parameter to monitor in patients with haemodynamic instability and hypoperfusion. Left ventricular outflow tract (LVOT) velocity-time integral (VTI) measurement using pulsed-wave Doppler is widely used as an estimation of stroke volume and should be a competence required for every intensive care unit (ICU) physician. Artificial intelligence (AI) applied to ultrasound facilitates the acquisition of adequate images. The aim of the present study is to evaluate the interchangeability of LVOT VTI measurements obtained by minimally trained operators and expert physicians, both guided by AI.
This is a prospective multicentre randomised controlled trial. ICU patients in whom fluid administration is considered necessary will be included. A minimally trained operator and an expert will independently measure LVOT VTI, guided by the UltraSight AI software to obtain the best five-chamber view, before and after a 250 mL fluid challenge. The order of acquisition between each operator will be randomised. 100 patients will be included.
The primary endpoint is the relative difference in LVOT VTI between operators. Secondary outcomes include the concordance of the therapeutic decision made by the blinded physician in charge of the patient based on the measures obtained by each operator, and the agreement between absolute values of LVOT VTI obtained by minimally trained and expert operators.
The study has been reviewed and approved by a regional ethics committee (Comité de Protection des Personnes—Ile de France II—n°24.00671.000291). An information note will be given to the participant before he or she participates in the study. The present study will be disseminated through peer-reviewed publications and academic and medical conferences.
Traumatic brain injury (TBI) is a leading cause of mortality and disability worldwide. In the USA, individuals who racially identify as African American or Black experience disproportionately higher rates of TBI and sustain worse prognosis compared with White patients; however, this population continues to be under-represented in contemporary translational research agendas. This protocol aims to comprehensively evaluate and synthesise what is currently known about the molecular epidemiology of TBI outcome among individuals of Black racial identity or African ancestry.
This review will use the established scoping review framework from the Joanna Briggs Institute. The search strategy will be implemented in PubMed (MEDLINE) and expanded to Embase and Cochrane CENTRAL Library (Wiley) databases in the final review. The date range will span from database inception to 20 July 2025 (date of final search). A two-stage screening process will be performed first at the title and abstract level before full-text assessment. Screening will be performed by two independent reviewers and discrepancies will be reconciled by a third reviewer. Articles that meet the following inclusion criteria will be considered: we will include human studies that investigate molecular and biochemical markers associated with TBI outcome. Studies must include individuals who are (A) of Black or African American racial identity, (B) of African ancestry and/or (C) performed in Sub-Saharan African countries. There is no eligibility criteria related to participant age, sex or gender. Eligible studies will be limited to English, Spanish or French. Data extracted from will be analysed and presented as written narrative, summary statistics of study characteristics and graphical or tabular displays.
Ethical approval is not required for this scoping review. The results of this review will be disseminated through peer-reviewed publications and academic conferences.
Black adults are generally exposed to more stressors over the life course and, due to the intersections of racism and economic and social resources, they tend to have more limited resources to cope with social stressors than white adults. This mismatch between stress exposures and resources may lead to dysregulated responses or reactivity to stressors and contribute to persistent racial disparities seen in adverse pregnancy outcomes (APOs). Prior studies examining stress exposures have been hampered by the challenge of capturing stress exposures comprehensively, given they are manifold, dynamic and accumulate over time. The Stress Reactivity and Maternal Health Study seeks to overcome this limitation by examining the impact of physiological and psychological stress reactivity to everyday stressors on APOs.
We are recruiting 700 nulliparous self-identified non-Hispanic black and white pregnant individuals from academic medical centres in the USA. We use ecological momentary assessments administered via smartphones to collect repeated measurements of exposure to everyday stressors throughout the day over the course of seven consecutive days at two different time points mid-pregnancy (14–22 weeks and 22–28 weeks). At the same time, we collect intensive measurements of heart rate variability, blood pressure, salivary cortisol and positive and negative affect. We will use mixed-effects models to estimate personalised indicators of cardiovascular, neuroendocrine and affective reactivity to everyday stressors. We will then use linear and logistic regression modelling to examine associations of these personalised indicators of stress reactivity with placental histological lesions and the occurrence of APOs. Finally, we will use the gap-closing estimand method to quantify the extent to which racial disparities in adverse placental and pregnancy outcomes are explained by differences in prenatal stress exposure and prenatal stress reactivity.
The Northwestern University institutional review board (IRB) approved this study and serves as the single IRB of record (STU00218683). All participants will sign an informed consent document prior to participation, and data will be treated confidentially. Findings will be disseminated in peer-reviewed scientific journals, briefs, infographics and presentations.
This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.
A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.
Data were sourced from the published literature and input from international stakeholders.
pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.
A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.
We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.
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