Conectar
by Julia Drespling, Steffen Heelemann, Selina Strathmeyer, Heike Kühn, Bianca Schwarz, Lars Mundhenk
Equine asthma is a chronic, non-infectious inflammatory disease of the lower airways in horses, classified as mild to moderate (MEA) or severe (SEA). Its pathogenesis is not fully understood and is influenced by environmental and seasonal factors. In this cross-sectional study, seasonal effects on the bronchoalveolar lavage fluid (BALF) metabolome were investigated in asthmatic and non-asthmatic horses. The metabolome of 230 BALF samples from horses across different seasons, classified as cytologically unremarkable (CUA), MEA, or SEA, was analyzed using proton nuclear magnetic resonance spectroscopy (1H-NMR). Principal component analysis was performed for each season, and metabolite profiles were statistically compared between seasons within each group. Altered metabolites were subjected to pathway enrichment analysis using the FELLA R package. Asthmatic horses showed significant seasonal changes in metabolite concentrations between warm and cold seasons, whereas only trends were observed in CUA horses. Pathway analysis indicated enrichment of cholesterol metabolism across all groups. The mTOR signaling pathway was only enriched in SEA horses. Several metabolites—including valine, taurine and carnitine —were altered during the transition from winter to spring in asthmatic horses. These findings indicate that the winter to spring transition significantly modulates the airway metabolome in asthmatic horses, particularly in SEA-affected animals.by Gift Treighcy Banda-Mtaula, Ibrahim Simiyu, Sangwani Nkhana Salimu, Stephen A. Spencer, Nateiya M. Yongolo, Marlen Chawani, Hendry Sawe, Jamie Rylance, Ben Morton, Adamson S. Muula, Eve Worall, Felix Limbani, Miriam Taegtmeyer, Rhona Mijumbi, on behalf of the Multilink consortium
Multimorbidity, the presence of multiple chronic health conditions, is a leading cause of death globally. In Malawi, chronic noncommunicable and communicable diseases such as HIV frequently co-exist, putting pressure on an under-resourced system. However, the health system is primarily structured around disease-specific [vertical] programs, which hinders person-centred care approaches to multimorbidity. Our study focuses on multimorbidity care and explores the perceptions of healthcare workers on the patient pathways and service organisation throughout the patient’s interaction with the health facilities. This cross-sectional qualitative study took an interpretivist approach. We conducted 13 days of clinical observations at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. We also conducted 13 days of clinical observations and semi-structured in-depth interviews with different cadres of purposively sampled healthcare workers (n = 22) at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. Through thematic analysis, we identified an understanding of the organisation of care and healthcare workers’ perspectives on the delivery of services. Findings showed both hospitals provided services for inpatients and outpatients with multimorbidity, including screening, management, prevention of secondary conditions and rehabilitation. Patient diagnosis and management for multimorbidity were often delayed due to frequent stockouts of medication and consumables necessary for diagnostic testing for NCDs at the hospital level. Some healthcare workers were not equipped with the knowledge, skills, or guidelines to manage multimorbidity. As HIV care is currently better resourced than other chronic conditions, healthcare facilities may strengthen the supply chain, healthcare workers’ training sessions and monitoring and evaluation tools to ensure NCDs are well managed, learning from HIV programmes.This paper aims to synthesise the current, global evidence on addressing psychological concerns of women presenting with domestic and family violence within the ED and suggest avenues for future research.
This discursive paper draws on clinical experience and research of the authors and critical synthesis of current literature on management of victim-survivors of DFV presenting with psychological symptoms in ED.
Academic databases and grey literature were systematically searched to identify relevant sources, and findings were narratively synthesised.
DFV victim-survivors often present with mental health symptoms in ED; however, many health professionals in EDs fail to correctly identify the underlying trauma and offer support to address DFV. The most reported barriers to DFV screening/identification include time constraints, privacy issues, and lack of education/training about DFV and its support mechanisms. As a result, only mental health symptoms are being treated, ignoring the broader psychosocial needs of DFV victim-survivors. Use of trauma-informed support models is recommended to address the mental and psychosocial needs of DFV victim-survivors visiting the ED.
DFV victim-survivors visiting the ED are often treated for their mental health symptoms without addressing their underlying trauma and risk of future victimisation. To address the ongoing adverse impact of DFV, it is necessary to ensure holistic and continual support from ED professionals for victims.
The importance of not only education but the implementation of sustained education and training programs surrounding DFV identification, screening, and cannot be understood. DFV is a global problem whereby many victim-survivors become healthcare patients. It would be poor decision making for clinicians to not prioritise appropriate responses to this societal problem within their clinical practice.
To explore factors influencing the implementation of a nursing care delivery model in a hospital setting.
A qualitative evidence synthesis with a thematic synthesis was conducted.
The search string consisted of four ‘cluster topics’: (1) nursing, (2) care delivery models, (3) hospital setting, (4) qualitative and mixed methods designs. Four electronic databases were searched from January 2000 until July 2024: MEDLINE (PubMed interface), Embase (embase.com interface), CINAHL (EBSCOhost interface) and Web of Science. A thematic synthesis was conducted consisting of the following steps; the ‘line-by-line’ coding of the text, the development and allocation of ‘descriptive themes’ and the generation of ‘analytical themes’.
In total, 3976 references were screened, of which 25 were included in the qualitative evidence synthesis. Eight analytical themes were generated that influence the implementation of a nursing care delivery model in a hospital setting: shared understanding of the care delivery model, ownership of the change, scope of practice and role clarity, collaboration, communication, responsibility, a double-loop process and aggregated recommendations. The themes were categorised on four different levels: vision, process, interactional factors and contextual factors.
The eight themes identified in this qualitative evidence synthesis showed that during the implementation of a nursing care delivery model, a clear implementation strategy is often missing. It is advised that future implementation processes have a clear guide and goal.
The analytical themes can guide the future implementation of a new nursing care delivery model in a hospital setting. This review can support nurses, researchers, hospital management and policymakers when implementing organisational alternatives to reorganise nursing care in a hospital setting.
The qualitative evidence synthesis was reported according to the enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) statement.
No patient or public contribution.
Urgent and emergency care in Germany is delivered across multiple, loosely connected sectors. In the absence of coherent, time-resolved data on patient movements between emergency medical services (EMS), out-of-hours ambulatory care, emergency departments (EDs) and inpatient care, inefficiencies and coordination gaps remain difficult to quantify. A process-centric, trans-sectoral analysis is required to characterise real-world patient pathways and identify actionable levers for improvement. The study aims to reconstruct, model and analyse patient pathways for urgent health complaints across all relevant sectors of the healthcare system in a German model region.
We will employ a mixed-methods observational study design. Routine data from EMS, out-of-hours ambulatory care, EDs and subsequent inpatient care will be pseudonymised at source, linked via a trusted third party and analysed within a trusted research environment. Time-stamped event logs will support process mining for discovery, conformance and performance analysis alongside descriptive statistics with stratification by context, such as setting, time of day, urgency and patient cohorts. Anonymous cross-sectional surveys of patients and front-line professionals, complemented by quarterly snapshot surveys in out-of-hours ambulatory care and interviews, will provide convergent evidence on the motives, barriers and coordination of utilisation behaviour. Enrolment for surveys is anticipated from the fourth quarter of 2025; routine data capture covers 1 January–31 December 2026; analyses and dissemination run until 31 December 2027.
The study received ethical approval from the Ethics Committee of the Medical Faculty at RWTH Aachen University (EK 25-351). Survey modules are conducted anonymously with voluntary participation and without collection of direct identifiers; routine care data are processed in pseudonymised form and analysed within a trusted research environment. Stakeholder interviews will be conducted with informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summary reports for participating institutions and stakeholders, complemented by plain-language materials to support patient-centred navigation.
DRKS00035916.
Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.
The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.
Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.
Vaccines are our best defence against infectious diseases, yet uptake of childhood immunisation programmes has consistently declined in the UK, with growing concerns around socioeconomic inequalities. Liverpool, in particular, demonstrated some of the lowest uptake rates in England since 2019. In response, the Health Equity Liverpool Project (HELP) implemented a hyper-localised community-led initiative between September 2023 and June 2024 to tackle vaccine hesitancy. Activities included outreach events and school-based engagement across nine sites within Liverpool. Despite promising qualitative evidence, the intervention’s impact on childhood vaccine uptake has not yet been quantified. We aim to evaluate the population level impact of the HELP intervention on the uptake of five childhood vaccines (first and second doses of the measles, mumps and rubella vaccine (MMR1, MMR2), 6-in-1 vaccine (diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b and hepatitis B), pneumococcal conjugate vaccine booster dose (PCV) and rotavirus vaccine) using synthetic control methods.
We will analyse publicly available quarterly vaccine uptake data (between April 2019 and March 2025) from the Cover of Vaccination Evaluated Rapidly programme for general practices (GPs) in England. The intervention group will be defined as practices located within a 1 km radius of the intervention sites. A synthetic control group will be constructed using non-intervention GPs matched on pre-intervention vaccine uptake, and linked demographic, socioeconomic and healthcare capacity covariates. Primary outcomes are the uptake of MMR1 and MMR2 vaccines. Secondary outcomes include the uptake of 6-in-1, PCV and rotavirus vaccines. Average treatment effects will be estimated as the post-intervention difference in uptake between intervention and synthetic control groups. Sensitivity analyses will examine spillover effects, alternative spatial definitions of exposure, the biasing effect of concurrent interventions and the feasibility of analysis at small area neighbourhood level.
This study will be conducted as part of the ReCITE project, which has received ethical approval from the Liverpool School of Tropical Medicine Research Ethics Committee (Reference: 24–018) and is funded by the UK Arts and Humanities Research Council (Project Number: AH/Z505341/1). Findings will be shared with the project funder and submitted for publication in a peer-reviewed journal.
To determine the prevalence of burnout and back pain in homecare workers in Switzerland and assess their associations with psychosocial work environment factors.
National multicentre cross-sectional study.
Using paper-pencil questionnaires, data were collected from January 2021 to September 2021 from employees of 88 homecare agencies across Switzerland. Respondents who identified themselves as administrators, apprentices, or trainees, who were in leadership positions, or who were not involved in the provision of care or housekeeping were excluded from this analysis. Burnout was assessed with the Copenhagen Burnout Inventory Scale (possible score range 0–100) and back pain with a single item from the Federal Statistical Office's Swiss Health Survey. Multilevel regression analyses were used to assess burnout and back pain's associations with psychosocial work environment factors.
We included 2514 homecare workers. More than two-thirds (68.6%) reported back pain in the past 4 weeks. The overall mean burnout score was 36.0 (SD 18.3). Poorer work-life balance, higher perceived workload and verbal aggression from clients were positively associated with both outcomes. Better leadership and social support from colleagues were negatively associated with burnout. Higher role conflict levels correlated with higher burnout levels.
Our findings indicate that the psychosocial work environment should be considered when designing interventions to reduce the prevalence of burnout and back pain among homecare workers.
The high reported burnout and back pain prevalences among homecare workers highlight an urgent need to design and implement psychosocial work environment-improving interventions. In addition to contributing to homecare employees' long-term attraction and retention, protecting and promoting their health and well-being will likely not only benefit them, but also contribute to patient safety, quality of care and homecare sustainability.
The study reports the prevalence of burnout and back pain among homecare workers and their associations with psychosocial work environment factors. The results indicate that six psychosocial work environment factors—work-life balance, perceived workload, leadership quality, levels of social support from colleagues, role conflict levels, and verbal aggression from clients—all correlate with burnout and/or back pain in homecare workers. For policy makers, researchers, healthcare managers, and homecare agencies, this study's findings will inform the development of interventions to enhance homecare work environments, leading to improvements both in workers' health and in the quality of their care.
We have adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting checklist for cross-sectional studies.
Our stakeholder group included patient representatives, policy makers, researchers, clinicians and representatives of professional associations. Throughout the study, all provided support and input on topics including questionnaire development, result interpretation and the design of strategies to improve response rates.
Leprosy remains a significant public health challenge in many low and middle-income countries, including India. People affected by leprosy face multifaceted challenges: physical, psychological, social and economic. In response, donors support self-help groups (SHGs) to improve health, social integration and economic circumstances for marginalised people, including those with leprosy. This study aims to assess the sustainability of SHGs in India after the withdrawal of donor support by examining whether they remain functional and exploring the key factors, barriers and facilitators that influence their long-term social and economic viability.
To examine the functionality of SHGs after withdrawal of donor support, and to explore the factors, barriers and facilitators influencing their long-term social and economic sustainability.
Using qualitative methods, we conducted semistructured interviews with 40 key informants associated with five SHGs formed under the Self-Help Community Development Project implemented in an endemic state of India and funded by The Leprosy Mission Trust India.
It was an exploratory qualitative study using interviews with SHG members and key informants, situated within the self-help community-based project.
While some SHGs demonstrated resilience and adaptability, others faced challenges such as internal discord, loss of members to migration and lack of access to government schemes. Thematic analysis revealed key drivers and barriers to sustainability and realising the benefits of SHGs, highlighting variations in leadership, governance, economic performance and social engagement across groups.
SHGs are often sustained after the funding and managerial donor support have been withdrawn. The findings emphasise the importance of strong leadership, community support and external facilitation in sustaining SHGs and enhancing their impact on marginalised populations. This study contributes to understanding the role of SHGs in addressing the socioeconomic challenges faced by individuals affected by leprosy and offers insights for improving their long-term viability.
Mobilisation and mobility in clinical settings are essential to the recovery process after surgery and trauma-related hospital admission. In addition to personal support from physiotherapists and nursing staff, aids such as walkers are applied. Walkers equipped with smart features have the potential to benefit geriatric patients by facilitating routine clinical workflows and, where appropriate, by providing health professionals with information on gait patterns and vital parameters.
The overarching goal of this project is to develop an innovative smart walker for clinical use, guided by three objectives: (a) Identify the feature requirements of the smart walker from the perspectives of patients and health professionals, (b) Co-design the smart walker using a user-centred approach involving older patients, health professionals and clinical engineers and (c) Pilot-test the smart walker in real time with older patients admitted to German clinics.
We will employ a three-phased exploratory sequential mixed-methods approach in this project. Phase I explores potentially useful characteristics of a smart walker via a scoping literature review (part 1 of phase I) and a qualitative interview and observational study, including questionnaires on sociodemographic data and technology readiness, involving four to six patients and four to eight nurses and physiotherapists (part 2 of phase I). Phase II focuses on developing and validating a smart walker through a user experience design, with at least three iterative test cycles involving a minimum of three asymptomatic participants and three to seven potential users in each cycle. Phase III comprises a pilot study conducted at a University Hospital in Germany involving at least twelve patients. Data integration takes a data-building approach, combining qualitative and quantitative results in the final analysis to generate a comprehensive understanding and to create and refine insights into the feature needs and use of a smart walker by patients.
The study was approved by the Ethics Committee of University Medicine Halle, Germany (Approval No. 2025-032; date of approval: 03/04/2025). Study results will be disseminated through peer-reviewed journals and conferences.
The study protocol was registered at the Open Science Framework Platform (OSF, register number: 10.17605/OSF.IO/CTPF4).
Few artificial intelligence (AI) clinical decision support systems (CDSSs) are ever evaluated in practice. Although some signal of clinical effectiveness may be needed to justify AI deployment and testing, such data are typically unavailable in early-stage research. This conundrum is especially relevant in the intensive care unit (ICU), where conditions like sepsis and acute respiratory distress syndrome (ARDS) require high-stakes decisions. Our group developed the AI ventilator assistant (AVA), a novel AI CDSS for patients with sepsis ARDS receiving invasive mechanical ventilation. But the promising results of predictive performance estimates are not sufficient to assess AVA’s clinical safety and appropriateness prior to future evaluation and deployment. Therefore, we propose a Clinician Turing Test as a novel validation approach to determine whether clinicians can distinguish AVA-generated treatment recommendations from those enacted by real human clinicians. If AVA’s recommendations are consistently indistinguishable from those of real clinicians, thereby ‘passing’ this Turing test, this would provide a strong preclinical signal of safety and appropriateness.
This multisite, randomised, electronic, vignette-based Phase 1b study will use a Clinician Turing Test design. We aim to recruit 350 critical care clinicians, including physicians and advanced practice providers from six US hospitals. Participants will review nine clinical vignettes of patients with sepsis and ARDS derived from the Molecular Epidemiology of Severe Sepsis in the ICU cohort and an associated profile of a suggested treatment plan. For each participant–vignette combination, the source of the treatment profile will be randomly assigned (AI-generated by AVA vs the actually enacted treatment from real human clinicians) in a 1:1 allocation. The primary endpoint is the participants’ accuracy in identifying whether a treatment profile was AI-generated or human-generated, assessed using equivalence testing through a mixed-effects logistic regression model with random effects for participants and vignettes. Secondarily, a fitted binary classifier will assess discrimination ability using the C-statistic. Secondary endpoints include clinicians’ perceptions of the safety and appropriateness of the treatment profiles, confidence in distinguishing AI-generated and human-generated recommendations, interest in AI CDSSs for sepsis and ventilator management and the time to complete the survey. This novel Phase 1b design provides preliminary but essential information about an AI CDSS’s clinical appropriateness without the risk or cost of actual deployment, thereby informing decisions about future clinical implementation and evaluation in real clinical environments.
This protocol was approved by the Institutional Review Board of the University of Pennsylvania (Protocol #858201). Results are expected in 2026 and will be submitted for publication in peer-reviewed journals and presented at scientific conferences.
To synthesise the perspectives of healthcare professionals and patients/residents of hospitals/nursing homes about determinants of inappropriate indwelling urinary catheter (IUC) use and strategies for reduction.
Qualitative evidence synthesis.
We searched MEDLINE, Scopus and CINAHL for studies published between 1 January 2000 and 23 May 2025.
Studies were eligible if they used qualitative methods to explore the perceptions and experiences of healthcare professionals and patients/residents of hospitals/nursing homes or their family members regarding the determinants of IUC use and reduction. Included studies focused on behavioural drivers or strategies to reduce inappropriate IUC use.
Two independent authors reviewed the search results, extracted and coded data, and assessed methodological strengths and limitations of studies. We used a thematic synthesis approach following the Cochrane–Campbell Handbook for Qualitative Evidence Synthesis and applied the Grading of Recommendations Assessment, Development and Evaluation–Confidence in the Evidence from Reviews of Qualitative Research approach to assess confidence in the findings.
We synthesised 24 studies. Perceived determinants of inappropriate IUC use included non-adherence to guidelines due to vague indications for initial IUC insertion, differing perspectives on benefits and risks, low priority given to the topic, limited accessibility or perceived unsuitability of alternatives, high nurse workload and staff shortages (moderate confidence). Ineffective nurse–physician communication, documentation difficulties and lack of training were also assumed to be linked to inappropriate IUC use (low confidence). Mentioned strategies for the reduction of inappropriate IUC use included additional training for healthcare professionals, clinician reminders to review or remove catheters, improved electronic documentation systems, increased staffing and greater use of IUC alternatives.
Key drivers of inappropriate IUC use are vague indications and routine decisions, lack of suitable and available alternatives, staff shortages and perceived lack of importance of the topic. Addressing these barriers is important for deimplementing inappropriate IUC use, and multifaceted strategies appear to be the most promising approach to address the multiple factors that drive current IUC misuse.
CRD42024531522.
by Nadeen Ibrahim, Shaifer Jones, Katherine Rich, Lisandra Alvarez, Carolina Price, Natalie Kil, Frederick L. Altice, Jaimie P. Meyer
BackgroundPeople who inject drugs (PWID) experience high risk for HIV and HCV infection, which can be mitigated by harm reduction strategies, including syringe service programs (SSP). Understanding individuals’ patterns of substance use and SSP utilization is important for optimizing harm reduction strategies and disease prevention for PWID.
MethodsWe evaluated demographic characteristics and service utilization from the New Haven Syringe Services Program (NHSSP), a low-threshold service delivery site in New Haven, Connecticut that provides fully integrated harm reduction and primary healthcare services to PWID. Site-specific data were extracted from the e2ctprevention database, managed by the Connecticut Department of Public Health, and EvaluationWeb from January 2017 to October 2023. We conducted a descriptive analysis of basic demographic and social characteristics of SSP clients, transaction characteristics, and service utilization. Statistical analyses were conducted using STATA v 16.1 and IBM SPSS Statistics (v 29.0.2.0).
ResultsAmong 1,189 unique individuals utilizing SSP during the observation period, most (65.2%) identified as men and white (73.3%), consistent with SSP clients regionally and nationally. The mean age of clients was 41 years (SD = 9.8); approximately half of participants were unstably housed and 80% were unemployed at intake. From June 2020 to October 2023, there were 7,238 transactions, which increased throughout the COVID-19 pandemic period. During this period, the program dispensed 1,860,621 syringes, in addition to other materials, including overdose education and naloxone distribution (OEND), and provided patient education on safer injecting techniques and wound care.
ConclusionIn this first comprehensive analysis of a large SSP since its inception and through the COVID-19 pandemic, we described important client characteristics and utilization of an array of syringe services from an integrated SSP. Findings suggest the SSP attracts a high volume of clients, provides on-demand services, and reaches a wide range of clients. Future research is needed to evaluate the impact of the program’s home-delivery service and increased outreach efforts. Despite limitations, the program’s success demonstrates the SSP can serve as a model for other harm reduction programs nationally.
Violence against women (VAW) is a public health, gender equality and human rights issue, with women with disabilities facing heightened risks due to intersecting discrimination. However, research on violence against people with disabilities often lacks sex-disaggregated data and primarily focuses on intimate partner violence, neglecting other perpetrators like family members or caregivers and leading to potential underestimation of its prevalence.
This protocol outlines the methods for a systematic review and meta-analysis to estimate the global prevalence of VAW with disabilities, focusing on intimate partner violence by intimate partners, domestic violence and sexual violence by any perpetrator. The review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and will include population-based quantitative studies focusing on women with disabilities aged 15 and older. 12 databases will be searched, and records will be screened by two independent reviewers. The risk of bias will be assessed. The global prevalence and pooled ORs comparing women with and without disabilities will be calculated.
Findings will contribute to global efforts in addressing VAW with disabilities, informing the development of targeted, evidence-based policies and programmes and ensuring that interventions are responsive to their specific needs and circumstances.
Ethics approval is not required, as this review analyses previously published data. Findings will inform ongoing World Health Organization (WHO)/Human Reproductive Programme (HRP) work on strengthening the measurement of VAW with disabilities and will be disseminated through a peer-reviewed publication, conference presentations and sharing with relevant organisations.
CRD42023427512.
Internationally, the vision of a ‘Digital Trustworthy Evidence Ecosystem’ is being pursued with clinical practice guidelines (CPGs) as one element of such a system. Consequently, CPGs and CPG repositories need to be digitalised.
The objective of this prospective, before-after study is to evaluate the impact of digitalising a quality-assured CPG registry using the international data format standard ‘Fast Healthcare Interoperability Resources’ (FHIR). This includes the architecture of the registry, the format of individual guidelines and application programming interfaces to import and export CPG content. The study is guided by a scoping review.
The primary outcome is the usability of the digitalised CPG registry and CPG content for different user groups comprising CPG developers, CPG administrators, health care professionals and patients—including at the point of care in in- and outpatient settings—and technical professionals as users of CPG content in digital applications.
For the before-after comparison, semi-quantitative (surveys) and qualitative (focus groups) methods are applied. All user groups will be involved in a baseline analysis to assess user expectations and technical requirements. According to the results, the digitalised guideline registry will be implemented. The intervention comprises the testing of the digitalised registry with guideline content by all user groups. Analysis of outcomes will include formative and summative evaluation. Final results and further research needs will be discussed in a World Café with all stakeholders.
The Ethics Committee of the Berlin chamber of physicians, in accordance with its code of conduct §15 section 1 (Eth-KB-24-11) confirmed that no ethical approval is needed for this study. The study is registered in the German Clinical Trials Registry (No: DRKS00034111). Results will be presented at national and international conferences, published in peer-reviewed journals and on the website of the funding institution.
German Clinical Trials Registry (No: DRKS00034111).
Type 2 diabetes is a prevalent chronic disease, associated with health complications, premature morbidity and significant healthcare costs. Optimal lifestyle behaviour control and patient self-management are crucial for improving diabetes control; however, they are difficult to achieve in primary care. There is limited research on the use of information from wearable devices to encourage behaviour change. This study will examine the effectiveness and cost-effectiveness of a multi-component health behaviour intervention in achieving clinically significant reductions in haemoglobin A1c (HbA1c) among general practice patients with type 2 diabetes.
The study uses a cluster-randomised controlled design, with general practices randomly assigned to either the Wearables Integrated Technology (WEAR-IT) intervention (n=15) or usual care (n=15). To achieve a sample size of 375 participants, 12–13 patients per practice will be recruited. Patients diagnosed with type 2 diabetes will be eligible to participate if they are aged 18–75 years; have had poorly controlled diabetes (HbA1c≥7.5%), with the cognitive capacity and ability to access the intervention application via an iOS or Android smart device. The WEAR-IT self-management intervention combines information from wearable devices (physical activity, blood glucose and blood pressure) and the electronic medical record, with goal setting and coaching support. The intervention will be primarily delivered by the general practice nurse, with review and confirmation of goals by the general practitioner. Participants attending the usual care practices will receive standard care. Outcome measures, including HbA1c, lipids, blood pressure, quality of life, dietary and exercise behaviours and cost-effectiveness, will be collected at baseline, 6-month (primary endpoint) and 12-month post-randomisation. The primary analysis will compare the change in HbA1c between the intervention and control groups at 6-month follow-up, with long-term outcomes assessed at 12-month post-randomisation.
The study was approved by Bond University (BH00137). Results will be disseminated through peer-reviewed journal publications, conference presentations and summaries to participating sites and patients.
Australian New Zealand Clinical Trials Registry (ACTRN12624000957594).
Type 2 diabetes mellitus (T2DM) is a fast-growing chronic disease, with at least 1.3 million people diagnosed in Australia. In the Western Sydney Local Health District (WSLHD), an estimated 13.1% of all adults have T2DM. The condition significantly contributes to cardiovascular, heart and kidney diseases and causes a large disease burden. Lifestyle modifications, such as improved nutrition, increased physical activity and stress reduction, are recommended as first-line treatments for T2DM management. However, the current primary care system cannot meet the growing demands for diabetes care, necessitating the development of innovative, scalable, cost-effective solutions. Digital health technologies present a promising approach for promoting self-management in individuals with T2DM.
This cluster-randomised controlled trial aims to evaluate the feasibility and effectiveness of Gro-AUS, a localised version of the Gro Health app in Australia, to support T2DM management in Australian primary care settings. The trial will be conducted across multiple general practice clinics within the WSLHD, an area with a high prevalence of T2DM and significant cultural diversity in patient populations. Participants will be randomly assigned by clinic to either the intervention group (digital health programme) or control group (standard care). Primary outcomes include improvements in glycaemic control, cardiovascular risk factors and diabetes remission, with secondary outcomes such as weight loss, physical activity and mental well-being. Data will be collected using electronic and paper methods, with secure storage and de-identification ensuring participant privacy. The study’s mixed-method approach ensures inclusivity for patients with varying levels of digital literacy. Data will be securely stored, de-identified and used to assess the effectiveness of the intervention. Findings are expected to inform future models of diabetes care in Australia, providing evidence for the scalability of digital health technologies in chronic disease management.
This trial is by nature unblinded. The recruitment style for a stepped-wedge trial may also bias participant engagement. However, it has direct implications for clinical practice as an effectiveness implementation trial. The design also allows for a much larger sample and more statistical power to examine outcomes.
This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. Ethical approval has been granted by the WSLHD Human Research Ethics Committee prior to data collection. Results will be disseminated through publication in a peer-reviewed medical journal and shared via the Agency for Clinical Innovation, the Primary Care Health Network and through community engagement initiatives.
ANZCTR388639.
The aim of this study was to prioritise a set of indicators to measure World Health Organization (WHO) quality-of-care standards for small and/or sick newborns (SSNB) in health facilities. The hypothesis is that monitoring prioritised indicators can support accountability mechanisms, assess and drive progress, and compare performance in quality-of-care (QoC) at subnational levels.
Prospective, iterative, deductive, stepwise process to prioritise a list of QoC indicators organised around the WHO Standards for improving the QoC for small and sick newborns in health facilities. A technical working group (TWG) used an iterative four-step deductive process: (1) articulation of conceptual framework and method for indicator development; (2) comprehensive review of existing global SSNB-relevant indicators; (3) development of indicator selection criteria; and (4) selection of indicators through consultations with a wide range of stakeholders at country, regional and global levels.
The indicators are prioritised for inpatient newborn care (typically called level 2 and 3 care) in high mortality/morbidity settings, where most preventable poor neonatal outcomes occur.
The TWG included 24 technical experts and leaders in SSNB QoC programming selected by WHO. Global perspectives were synthesised from an online survey of 172 respondents who represented different countries and levels of the health system, and a wide range of perspectives, including ministries of health, research institutions, technical and implementing partners, health workers and independent experts.
The 30 prioritised SSNB QoC indicators include 27 with metadata and 3 requiring further development; together, they cover all eight standard domains of the WHO quality framework. Among the established indicators, 10 were adopted from existing indicators and 17 adapted. The list contains a balance of indicators measuring inputs (n=6), processes (n=12) and outcome/impact (n=9).
The prioritised SSNB QoC indicators can be used at health facility, subnational and national levels, depending on the maturity of a country’s health information system. Their use in implementation, research and evaluation across diverse contexts has the potential to help drive action to improve quality of SSNB care. WHO and others could use this list for further prioritisation of a core set.
Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.
The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.
This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.
FreshRSS 