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Diabetic retinopathy treatment cascade and care continuum in the USA: a systematic review

Por: Fu · J. J. · Applebaum · S. S. · Granados · A. · Nwanyanwu · K.
Objectives

To characterise engagement across the diabetic retinopathy (DR) care continuum in the USA using a cascade-of-care framework and identify gaps contributing to preventable vision loss.

Design

Systematic review.

Data sources

From September to November 2025, with an updated search in March to April 2026 using the same eligibility criteria, we systematically searched Ovid MEDLINE and Ovid Embase supplemented by reviewing reference lists of relevant articles and opportunistic searches of the Centers for Disease Control and Prevention publications.

Eligibility criteria

We included English-language US-based cross-sectional, cohort and case–control studies and systematic reviews containing US-based data published between 1 January 2018 and 31 December 2025 relevant to one of the defined DR cascade stages: (1) diagnosis of diabetes, (2) adherence to DR screening, (3) diagnosis of DR, (4) adherence to DR care and (5) DR-related blindness. We included systematic reviews only to inform DR-related blindness, where primary data were limited and excluded them from other stages to avoid double-counting. Exclusion criteria included studies not relevant to one of the defined DR cascade stages and editorial, perspective or commentary pieces.

Data extraction and synthesis

Two reviewers independently screened studies, extracted data and assessed risk-of-bias using the Newcastle-Ottawa Scale and Risk of Bias in Systematic Reviews tool. We synthesised data narratively and organised via the DR treatment cascade framework.

Results

Of 14 893 studies screened, 46 met the inclusion criteria. Cascade analysis revealed substantial losses in patient engagement at three stages: (1) only 15.5%–78.7% (median 59.4%, IQR 33.9%–74.0%) of individuals with diabetes obtain biennial DR screening; (2) a substantial 54.9%–88.5% (median 70.1%, IQR 62.5%–79.3%) of individuals with DR are unaware of their diagnosis; (3) only 30.9%–62.7% (median 52.0%, IQR 40.9%–59.1%) of individuals diagnosed with DR are initially linked to care and 55.3%–77.8% (median 70.3%, IQR 59.2%–77.7%) have a lapse in DR follow-up.

Conclusions

This review identifies major gaps in the DR care continuum, particularly in diagnosis awareness, linkage to care and follow-up adherence. The cascade framework highlights key points of disengagement and provides a basis for prioritising future research.

Emergency Department-initiated standard versus high-dose buprenorphine induction (ENVISION): a randomised clinical trial protocol

Por: Hawk · K. · Herring · A. · Chawarski · M. · Anderson · E. S. · Baumann · M. · Dorey · A. · Holtyn · A. F. · Jones · C. · Martel · S. · Owens · P. · Kmiecik · K. · Strout · T. D. · Taillac · P. · Lofwall · M. · Walsh · S. L. · DOnofrio · G.
Introduction

The initiation of buprenorphine for patients with opioid use disorder (OUD) in the emergency department (ED) has been associated with improved outcomes including reduced ED visits and increased treatment engagement. Though both standard-dose (8 mg buprenorphine equivalent) and high-dose (24 mg buprenorphine equivalent) strategies to initiate buprenorphine have been used in the ED, no prospective trials comparing outcomes among patients receiving these treatments have been reported.

Methods and analysis

This multisite randomised clinical trial is a multisite double-blind, double-dummy, randomised clinical trial enrolling 360 emergency department patients with moderate-to-severe OUD. Enrolled patients will be randomised to one of two study arms: standard-dose induction or high-dose induction, both provided in the ED. This study will engage, train and provide resources to five EDs throughout the US to recruit patients with untreated OUD into a randomised clinical trial. The primary aim is to evaluate the effects of the standard-dose induction and high-dose induction on rates of OUD treatment participation within 10 days post-randomisation. The secondary aims are to evaluate differences between standard-dose induction and high-dose induction on the outcomes of opioid craving, opioid withdrawal symptoms and illicit drug use assessed during 10 days post randomisation and evaluate the effects between treatment arms on rates of OUD treatment participation within 30 days post randomisation.

Ethics and dissemination

This study is funded by the National Institute on Drug Abuse and has been approved by the WCG Instutitional Review Board. It has been registered at clinicaltrials.gov. This study will inform the strategy for treatment initiation with buprenorphine among diverse ED settings and will provide ongoing evidence to support the safety and efficacy of initiating treatment for OUD in the ED.

Trial registration number

NCT06494904.

Process evaluation of a basic life support educational intervention (FirstCPR cluster randomised study) delivered at community organisations in New South Wales, Australia

Por: Munot · S. · Bauman · A. · Bray · J. · Redfern · J. · Angell · B. · Kancijanic · D. · Rock · Z. · Semsarian · C. · Jennings · G. · Coggins · A. · Denniss · A. R. · Chow · C.
Background

The FirstCPR cluster randomised trial delivered multimodal basic life support (BLS) learning opportunities to community organisations. An a priori process evaluation examined intervention implementation, including participation, reach, uptake and member engagement.

Methods

The study used a multimethod process evaluation. Data were collected via semistructured interviews, focus group discussions, participant surveys, study records, web analytics and in-field observations. These sources captured participation patterns and implementation measures (delivery, reach, uptake and engagement: opt-in to digital messages and attendance at training sessions), as well as reasons for refusals and withdrawals. Qualitative data were analysed thematically and organised using the UK Medical Research Council process-evaluation framework. Qualitative and quantitative data were analysed separately and subsequently interpreted collectively to contextualise implementation patterns and identify barriers and enablers that influenced trial successes and failures.

Results

Intervention uptake and engagement varied significantly across organisations, with greater success observed in social and faith-based groups. Of the 82 intervention clusters, 78 (95%) received intervention materials; 74 (90%) engaged in at least one activity and 15 (18%) engaged in all activities. Participation was primarily driven by the organisation’s leadership interest and support in providing BLS training to members, and by the time available to facilitate intervention activities. The presence of a dedicated liaison/champion emerged as the most critical enabler of member engagement and implementation. Feedback recommended concise, simple and culturally tailored modules, with practical components delivered in shorter, convenient sessions. Intervention delivery was affected by contextual challenges, including COVID-19 disruptions that limited in-field recruitment and group activities.

Conclusions

Process evaluation can strengthen community-based interventions by identifying mechanisms and contextual factors that shape implementation and engagement. Partnering with social and faith-based organisations may be an effective approach to disseminating educational programmes such as life-saving skills to lay communities. Minimising research burden and ensuring organisational leadership support may improve participation while brief, practical and culturally tailored training may enhance engagement.

Trial registration number

ACTRN12621000367842.

Caring beyond the procedure: a qualitative study on thoracic surgery nurses perspectives on chronic illness experiences of individuals with myasthenia gravis undergoing thymectomy

Por: Missel · M. · Donsel · P. O. · Nielsen · T. F. · Secher · E. L. · Medeiros · E. B. Z. · Rude · K. · Hojgaard · J. L. S. · Viby · N.-E. · Birnbaum · S. · Andersen · L. K. · Petersen · R. H. · Witting · N.
Objectives

To explore how thoracic surgical nurses perceive and respond to the chronic illness needs of individuals with myasthenia gravis undergoing thymectomy.

Methods

Data were collected through four focus group interviews using a semi-structured interview guide. The analysis followed a hermeneutic approach, identifying recurring themes through iterative interpretation and critical reflection. Nineteen thoracic surgical nurses from ward and postanaesthesia care unit settings participated, representing a diverse range of clinical experience. The study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist for reporting the findings of this study.

Results

The analysis identified three overarching themes reflecting nurses’ experiences of caring for individuals with myasthenia gravis undergoing thymectomy. First, nurses described how the chronic aspects of the illness often ‘disappeared’ within the surgical care process, with attention focused mainly on procedural recovery, leaving patients’ broader illness needs unaddressed. Second, nurses experienced a dilemma between providing acute surgical care and responding to patients’ chronic illness understanding, highlighting uncertainty due to limited knowledge and lack of clear guidelines. Third, nurses emphasised the difficulty of managing the invisible and unpredictable symptoms of myasthenia gravis, which created a heightened need for vigilance but also uncertainty in symptom assessment and support. Across all themes, the findings suggest that surgical care practices may insufficiently recognise patients’ ongoing illness experiences, emphasising the need for greater knowledge, interdisciplinary collaboration and chronic illness-sensitive care approaches.

Conclusions

The study highlights the need for increased attention to chronic illness needs in surgical care, supporting interdisciplinary collaboration and tailored nursing practices that address the lived experiences of patients with chronic conditions.

Test to assess claims about treatment effects for Spanish primary school children: the development process and cross-sectional validation study of the test

Por: Samso Jofra · L. · Dahlgren · A. · Alonso-Coello · P. · Canovas Martinez · E. · Perez-Gaxiola · G. · Roque i Figuls · M. · Rosenbaum · S. · Sanz-Herranz · H. · Valenzuela Rubio · N. G. · Martinez Garcia · L.
Objectives

The aims of this study were (1) to develop and validate the interactive CLAIM Test (iCLAIM Test) to measure children’s ability to assess claims about treatment effects and make informed health choices and (2) to measure this ability in Spanish primary school children using the developed test.

Design

We followed a multistep process including (1) definition of the test scope, (2) selection of the questions, (3) translation process, (4) design and development of the online test, (5) external review with experts, (6) user-test with children and (7) cross-sectional validation study with Rasch analysis.

Setting

Spanish primary schools.

Participants

Twelve experts (75% women) participated in the review, 11 children (45% girls) participated in the user-test and 480 Spanish primary school children (46.5% girls) from fourth to sixth grades (9–12 years old) participated in the cross-sectional validation study.

Results

The iCLAIM Test is an online, interactive and user-friendly test in Spanish that measures children’s ability to understand and apply key concepts of the informed health choices (IHC) Project when assessing claims about treatment effects and making IHCs. The test includes 30 questions: six demographic questions and 24 questions from the Claim Evaluation Tools item bank. Less than 40% of the students who participated in the cross-sectional validation study showed basic knowledge of the IHC Key Concepts and how to apply them, and less than 4% showed a clear knowledge. The test showed a good fit to the Rasch model and was acceptable to the target audience.

Conclusions

The iCLAIM Test is the first instrument validated for measuring children’s ability to assess treatment claims in Spain. In the future, we can tailor IHC education interventions and improve critical thinking skills about the health of Spanish children.

Exploring the relationship between mental health and urban green space soundscapes: A scoping review

by Elham Ahmadi, Sophia Baierl, Stephan Voss, Ida Asenkerschbaumer, Ursula Berndt, Leonie Bernhard, Anita Hennig, Anna-Lena Würfele, Michaela Coenen

Urban soundscapes, particularly those experienced in green spaces, have been increasingly recognized as factors that influence human mental health. This scoping review explores the existing literature on soundscapes within urban green spaces and their associated mental health outcomes. It aims to classify the methodologies used in this domain, identify mental health outcomes related to urban green space soundscapes, and examine specific soundscape elements and their correlations with mental health. A systematic search of peer-reviewed studies was conducted. After screening titles, abstracts, and full texts, 22 studies met the inclusion criteria. Diverse methodological approaches were identified, with an emphasis on quantitative multi-method designs. Commonly studied mental health outcomes include stress reduction, mood enhancement, perceived restorativeness, and cognitive restoration. Standardized psychometric tools, such as the Perceived Stress Scale (PSS-14), Positive and Negative Affect Schedule (PANAS) and Perceived Restorativeness Soundscape Scale (PRSS) are frequently used as outcome measures. Natural soundscape elements such as birdsong, water sounds, and rustling leaves had a positive association with relaxation and perceived mental restoration throughout all studies, while mechanical sounds, such as traffic noise were linked to adverse mental health outcomes. These findings highlight that natural soundscapes in urban green spaces have a potential positive relationship with mental health by reducing stress and enhancing mood. However, the cross-sectional design and methodological heterogeneity of the included studies limit causal interpretation. Future research should explore multi-sensory experiences and examine soundscapes in diverse urban contexts to provide more robust insights into their relationship with mental health. The practical implications suggest that urban planners should prioritize integrating natural sound elements into urban areas to improve mental health. The study protocol of this scoping review had been registered at OSF (osf.io/4r7gd).

Factors associated with low levels of resilience among French university students during COVID-19 lockdown: results of the cross-sectional PIMS-CoV19 survey

Por: Todorovic · A. · Baumann · C. · Tarquinio · C. · Rotonda · C. · Rousseau · H. · Bourion-Bedes · S.
Objectives

To identify the factors associated with low psychological resilience among university students in the Grand Est region of France at the end of the first national COVID-19 lockdown.

Design

A cross-sectional online survey was conducted (May 2020) among students at the University of Lorraine using the LimeSurvey platform and institutional mailing lists.

Setting

Higher education setting in north-eastern France, involving students from the University of Lorraine (multicampus public university) and Sciences Po Nancy, a political science institute in the same region.

Participants

A total of 3708 students fully completed the online questionnaire, including the Brief Resilience Scale (BRS), resulting in an estimated response rate of 7.1%. All students enrolled at the University of Lorraine and Sciences Po Nancy during the 2019–2020 academic year were eligible to participate.

Primary and secondary outcome measures

The primary outcome was psychological resilience, measured using the BRS. Secondary measures included perceived social support assessed with the Multidimensional Scale of Perceived Social Support, quality of interpersonal relationships evaluated using the Quality of Interpersonal Relationships Scale (Échelle de la Qualité des Relations Interpersonnelles, EQRI) and frequency of positive and negative thoughts measured with the Thermometer of Thoughts Tool. Factors associated with low resilience were analysed using bivariable and multivariable logistic regression.

Results

Among 3708 students included in the sample, corresponding to a response rate of approximately 7.1%, 50.6% had normal resilience, while 37.3% reported low resilience. Female gender (OR=2.1, 95% CI: 1.8 to 2.6) and low social support (OR=1.7, 95% CI: 1.1 to 2.6) were the factors associated most strongly with low resilience. Negative thoughts (OR=1.4, 95% CI: 1.4 to 1.5), lower quality of relationships with people in general (OR=1.5, 95% CI: 1.3 to 1.8) and studying arts, humanities or languages (OR=1.4, 95% CI: 1.0 to 1.8) were identified as factors associated with low resilience. Increased age (OR=0.9, 95% CI: 0.9 to 1.0) and flat sharing (OR=0.6, 95% CI: 0.4 to 0.9) were inversely associated with low resilience levels.

Conclusions

Resilience seems to be impacted primarily by internal and micro-environmental factors. Consolidating levels of individual resilience of at-risk populations by acting on these factors could be the key to improving their mental health.

Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study: protocol for a multisite, prospective, open cohort study of pregnancy and postpartum health outcomes in South Asia and sub-Saharan Africa

Introduction

Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to meet the Sustainable Development Goals. South Asia and sub-Saharan Africa bear most of the burden of maternal and child morbidity and mortality. Major gaps persist in our understanding of the causes, timing, diagnostic thresholds and risk factors for adverse outcomes in these regions. Addressing these gaps requires new ways to prevent and treat disease, from novel diagnostics to precision public health strategies, all of which rely on high-quality clinical data from diverse populations. The Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study aims to estimate population-level prevalence of morbidities and mortality and to assess biological, clinical and sociodemographic risk among mother–infant pairs in India, Pakistan, Kenya, Ghana and Zambia.

Methods and analysis

This study is a prospective, open cohort study with a planned recruitment of about 6000 women annually across six research sites in five countries. Participants are pregnant women enrolled less than 20 weeks gestation, as determined by ultrasound, identified through active house-to-house and facility-based surveillance. Robust clinical data will be collected at 12 scheduled study visits during antenatal care, labour and delivery, and through 1 year postpartum. A total of 34 outcomes will be captured. The primary analysis will estimate the burden of adverse outcomes and examine associated risk factors to inform future intervention strategies. Data will also be used to develop normative values for pregnant and postpartum women, as well as predictive models to assess pregnancy risk.

Ethics and dissemination

PRISMA received institutional and national ethical approvals. Findings will be published in peer-reviewed open-access journals and disseminated at national and international forums to inform clinical guidelines and public health practice.

Trial registration number

NCT05904145.

Predicting the frequency of positive laboratory submissions for porcine reproductive and respiratory syndrome in Ontario, Canada, using autoregressive integrated moving average, exponential smoothing, random forest, and recurrent neural network

by Tatiana Petukhova, Maria Spinato, Tanya Rossi, Michele T. Guerin, Cathy A. Bauman, Pauline Nelson-Smikle, Davor Ojkic, Zvonimir Poljak

Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) is endemic in many pig-producing countries and poses significant health and economic challenges. Enhanced surveillance strategies are essential for effective disease management. This study aimed to evaluate and compare the performance of different time-series modeling techniques to predict weekly PRRSV-positive laboratory submissions in Ontario, Canada. Ten years of PRRSV diagnostic data were obtained from the Animal Health Laboratory at the University of Guelph and were processed into a weekly time series. The dataset was analyzed with autoregressive integrated moving average (ARIMA), exponential smoothing (ETS), random forest (RF), and recurrent neural network (RNN) models. Two validation strategies were employed: a traditional train-test split and a simulated prospective rolling forecast. Model accuracy was evaluated using common predictive error metrics. Descriptive analysis indicated a gradual increase in PRRSV positive submissions over time, with no consistent seasonal pattern. ARIMA and ETS models generally overpredict case counts, while RF and RNN tended to underpredict them. Among the evaluated models, the RF regression model most accurately captured the underlying time-series dynamics and produced the lowest prediction errors across both validation approaches. Despite outperforming other models, the RF model’s high relative prediction errors limit its suitability for accurate forecasting of PRRSV-positive submissions in Ontario’s routine surveillance system. Further data refinement and algorithm improvements are warranted.

Implementation of an Australian helpline for low back pain: protocol of a type 2 hybrid effectiveness-implementation trial

Por: Zouch · J. · Roberts · K. · Bauman · A. · Jentz · H. · Ho · E. K. · Hodges · P. · Maher · C. · Baysari · M. T. · Thompson · J. · Calder · R. · Luscombe · G. · Ceprnja · D. · Maka · K. · Tian · Y. · Chen · Y. · Chen · M. · Mork · P. J. · Li · Q. · Wise · S. · Gilbert · M. · Hall · M. · Ferreira
Introduction

Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

Methods and analyses

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

Ethics and dissemination

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

Differential contribution of α2δ auxiliary subunits of voltage-gated calcium channels in mouse models of pain and itch

by Joao M. Braz, Madison Jewell, Karnika Bhardwaj, Sian Rodriguez-Rosado, Veronica Craik, Allan I. Basbaum

Voltage-gated calcium channels (VGCCs) are multimeric proteins composed of alpha 1, β and γ subunits, as well as one of four auxiliary α2δ subunits. Although there is considerable preclinical and clinical evidence for a contribution of VGCCs to nociceptive processing, notably the gabapentin-targeted α2δ-1 subunit, unclear is the extent to which other α2δ subunits contribute to baseline or injury-altered pain and itch processing. Here, we investigated the anatomical and behavioral consequences of deleting α2δ-2, α2δ-3 or α2δ-4 in the mouse and report that selectively ablating each α2δ subunit leads to different, and in some cases, opposite effects on behavioral indices of pain and itch. Specifically, deleting α2δ2 resulted in mechanical and heat hypersensitivity, and an increase in spinal cord microglial immunoreactivity, but reduced scratching (presumptive) itch in response to a pruritogen. In contrast, ablation of α2δ3 led to thermal hyposensitivity, but no change in mechanical responsiveness or indices of itch. Mice deficient for α2δ4 exhibited hyposensitivity across pain modalities and only minor itch deficits. Interestingly, these differential effects were limited to baseline nociceptive responses, therefore we conclude that the α2δ-2, α2δ-3 and α2δ-4 subunits of VGCCs differentially contribute to pain and itch processing. The mechanisms underlying these differences remain however to be determined.

The Forgotten Caregivers: A Qualitative Study Exploring the Experiences of Fathers of Children With Medical Complexity

ABSTRACT

Aim(s)

To explore the caregiving experiences and support needs of fathers of children with medical complexity in Canada.

Design

A qualitative study guided by interpretive description methodology and informed by a Gender-Based Analysis Plus (GBA+) lens.

Methods

Data were collected through 60-min semi-structured interviews with seven fathers of children with medical complexity and analyzed using thematic analysis. The study followed the COREQ guidelines and checklist.

Results

Thematic analysis identified fathers' key roles as financial providers, hands-on caregivers, and as playing a key role in supporting their partners emotionally with the challenges of caregiving. Fathers prioritised the need for peer support, flexible workplace policies and improved access to mental health services.

Conclusion

The findings indicate that there is a critical need for more inclusive and flexible support systems and workplace policies that acknowledge and accommodate the important caregiving roles of fathers of children with medical complexity.

Relevance to Clinical Practice

The implications for healthcare professionals include actively involving fathers in care planning and providing targeted support services that recognise their roles to enhance child and family outcomes.

Patient or Public Contribution

We worked closely with our community advisory team, comprised of a physician, social worker and community organisation leader, who contributed to the study design, supported participant recruitment, and assisted in disseminating the findings back to the community, helping to ensure the research was grounded in and responsive to the needs of families of children with medical complexity.

Evaluating the scale-up of the Play Active programme for childrens physical activity in early childhood education and care services: a national type III hybrid effectiveness-implementation trial protocol

Por: Christian · H. · Maher · C. · Trost · S. G. · Schipperijn · J. · Murray · K. · Li · I. · Nathan · A. · Papageorgiou · A. · Mclaughlin · M. · Bauman · A.
Introduction

Physical activity is crucial for young children’s health and development. Many young children do not meet the recommended 3 hours of daily physical activity, including 60 min of energetic play. Early childhood education and care (ECEC/childcare) is a key setting to intervene to improve children’s physical activity. The Play Active programme is a scalable evidence-informed ECEC-specific physical activity policy intervention with implementation support strategies to improve educators’ physical activity-related practices.

Methods and analysis

This hybrid type III effectiveness-implementation trial will use a quasi-experimental repeated measures design to assess the real-world effectiveness of Play Active’s scalable implementation support strategies in helping ECEC services adopt the practices included in the Play Active policy. Secondary aims will examine changes in educator-reported and device-measured children’s physical activity; assess the sustainability of the programme; identify effective dissemination strategies; assess cost-effectiveness; and involve comprehensive process evaluation. All ECEC services in Western Australia (n=776), Queensland (n=1744) and South Australia (n=445) will be invited to participate. Data will be collected at baseline, 6, 12, 18, 24 and 30 months.

Ethics and dissemination

Ethics approval has been provided by The University of Western Australia Human Research Ethics Committee (HREC) (2023/ET000187), the University of Queensland HREC (2024/HE000076) and the University of South Australia HREC (206023). This real-world trial of Play Active is vital for understanding its implementation in practice and to generate evidence for further scale-up and roll-out nationally. Key findings will be disseminated to stakeholders, collaborators, policy-makers as well as families and practitioners in the ECEC sector.

Trial registration number

ACTRN12624000406505.

Participants experiences of potential adverse effects of an intervention to improve critical thinking about health choices: a qualitative cross-trial process evaluation in Kenya, Rwanda and Uganda

Por: Oxman · M. · Chesire · F. · Mugisha · M. · Ssenyonga · R. · Nsangi · A. · Oxman · A. D. · Fretheim · A. · Rosenbaum · S. · Kaseje · M. · Sewankambo · N. · Melby-Lervag · M. · Lewin · S.
Objectives

To explore participants’ experiences of potential adverse effects of the Informed Health Choices secondary school intervention across three trial sites and to revise a framework of potential adverse effects of interventions to improve critical thinking about health choices.

Design

This was a qualitative study. We extracted and analysed relevant data from separate process evaluations in each country. Data came from surveying teachers, observing lessons and group and individual interviews with students, teachers and other stakeholders. We modified and applied framework analysis, including five stages: (1) development of an initial framework of potential adverse effects, (2) familiarisation with the data, (3) indexing, (4) abstraction and synthesis and (5) revising the framework. We applied reflexive strategies individually and as a team.

Setting

Lower secondary school in five randomly sampled subcounties of Kisumu County in Kenya, districts representing all five provinces in Rwanda, and six districts in the central region of Uganda, between 2022 and 2024.

Participants

Students and teachers in the intervention arms of the trials, parents of students in the intervention arms and administrators at intervention schools, as well as curriculum developers and policy-makers.

Intervention

The intervention involved providing teachers with a 2–3-day training workshop, and digital classroom resources, including lesson plans for 10 lessons to be delivered over the course of one semester.

Results

We generated findings about potential increases in adverse misunderstandings, anxiety related to transfer of learning, adversely experienced cognitive dissonance, work or schoolwork-related stress, inequity, conflicts and waste. The revised framework includes the same categories of potential adverse effects as our initial framework: decision-making harms, psychological harms, equity harms, group and social harms, waste and other harms. We revised other elements of the framework, including definitions of the categories and its structure.

Conclusions

This study provides insight into the potential adverse effects of interventions to improve critical thinking about health choices. The findings complement those of the trials and country-level process evaluations.

Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol

Por: Larsson-Lund · M. · Karlsson Sundbaum · J. · Mansson Lexell · E. · Spinord · L.
Introduction

Proactive and easily accessible interventions are needed to support people with long-term health conditions who experience limitations in activities of everyday life. However, there is a lack of interventions that promote self-management skills that prevent deterioration and improve health. The internet-based programme ‘Strategies for Empowering Activities in Everyday Life’ (SEE) supports people with long-term health conditions in developing self-management skills through knowledge, self-analysis and management strategies, promoting active and healthy daily life. This study protocol aims to evaluate the feasibility of SEE 2.0 and the study design.

Methods and analysis

This feasibility study employs a pretest and post-test design with no control group, embedded within a mixed-method approach. The participants will include 30–40 clients, occupational therapists and managers involved in delivering SEE 2.0 in primary healthcare and hospital-based services. Data will be collected through assessments and forms at baseline, 4 months and 12 months after inclusion. Additionally, qualitative methods will be used to enhance the understanding of participants’ experiences.

Ethics and dissemination

The study was approved by the Swedish Ethical Review Authority. The results will inform the refinement of SEE 2.0 and guide decisions on whether to proceed with planning a full-scale evaluation to assess the intervention’s effect. The results will be published in peer-reviewed scientific journals on websites and presented at conferences and seminars to reach various user groups.

Trial registration number

NCT06484322.

Development and Evaluation of Precision Health Competencies

ABSTRACT

Aim

To develop precision health (PH) competencies and evaluate their comprehensiveness and fit into nursing practice.

Design

A modified e-Delphi technique was used to gather perceptions and achieve consensus on the inaugural set of PH domains, competency statements and sub-competencies developed by a workgroup formed under the aegis of the American Nurses Association (ANA).

Methods

A set of PH competencies and sub-competencies was developed by the ANA workgroup, beginning with a literature review, followed by a multi-step work process of the group over 3 years (2022–2025). Then, a modified e-Delphi technique was conducted via a four-point Likert scale Qualtrics survey, using a purposive sample of PH experts. The respondents were asked to agree or disagree with each competency or sub-competency statement and suggest modifications. The threshold of concordance was set at 80%.

Results

The ANA workgroup reached consensus on six domains, six competency statements and 43 sub-competency statements to represent PH in nursing practice in its entirety. Forty experts in the field evaluated and offered revisions to the final 44 sub-competencies that represent the knowledge and skills necessary for PH in general nursing practice. A majority of the competency statements obtained favourable agreement from the expert panel, and a typical pattern of convergence was observed over two rounds of evaluation.

Conclusions

The development of PH competencies is the essential first step in the attempt to integrate PH into nursing practice.

Implications

The competency statements will inform nursing curricula, clinical practice guidelines, funding opportunities and role expectations in all healthcare settings.

Impact

This work sets the stage for subsequent interprofessional practice initiatives and research exploring how these competencies influence patient outcomes, workforce readiness and the practical integration of advanced technologies into precise care.

Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol

Por: Ranard · B. L. · Qian · M. · Cummings · M. J. · Zhang · D. Y. · Lee · S. M. · Beitler · J. R. · Applebaum · J. R. · Schenck · E. J. · Mohamed · H. · Trepp · R. · Hsu · H. · Scofi · J. · Southern · W. N. · Rossetti · S. C. · Yip · N. H. · Brodie · D. · Sharma · M. · Fertel · B. S. · Adelman
Introduction

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

Methods and analysis

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics and dissemination

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

Trial registration number

ClinicalTrials.gov: NCT06117605 and NCT06117618.

Association of part-time clinical work of hospitalists with efficiency and quality of care on medical wards: a retrospective study

Por: Bretagne · L. · Roten · C. · Mosimann · S. · Blum · M. R. · Debieux · M. · Martin · A. · Kraege · V. · Beck · T. · Aujesky · D. · Mancinetti · M. · Mean · M. · Baumgartner · C.
Background

Physicians are increasingly interested in part-time employment. However, the impact of part-time work on efficiency and quality of care of inpatients is unknown.

Objectives

To investigate the association between part-time clinical work of hospitalists in General Internal Medicine (GIM) and resource utilisation and short-term patient outcomes.

Design

Retrospective study.

Setting

GIM wards of 3 Swiss teaching hospitals.

Participants

Each inpatient was categorised as having received care mainly (>50%) by part-time or full-time hospitalists. Part-time clinical work was defined as employment of

Primary and secondary outcome measures

Primary outcome was length of hospital stay, secondary outcomes included 30-day readmission, in-hospital mortality, hospitalisation cost and time to completion of the discharge letter. We assessed the association between both groups and outcomes using generalised estimating equations, clustering for individual patients and adjusting for patient and hospitalist characteristics.

Results

There was no statistically relevant difference in length of stay in cases cared for mainly by part-time (mean 7.3 days, 95% CI 7.1 to 7.6) compared with full-time hospitalists (mean 7.6 days, 95% CI 7.3 to 7.8; p=0.18). Time to completion of the discharge letter was longer in the part-time (mean 11.4 days, 95% CI 11.0 to 11.8) versus full-time group (mean 10.9 days, 95% CI 10.6 to 11.2, p=0.049). There was no statistically significant difference between groups for the other outcomes.

Conclusion

We found no evidence that part-time clinical work of hospitalists negatively affects resource utilisation and short-term patient outcomes compared with full-time work.

Development of a core outcome set for the trials of complementary therapies in people with multiple sclerosis: international survey and consensus meetings

Por: Lopez-Alcalde · J. · Tietjen · A. K. · Yan · Y. · Canella · C. · Barth · J. · Steinemann · N. · Hägele-Link · S. · Bolt · S. · Baum · C. · Rettenmund · G. · von Wyl · V. · Nonino · F. · Wieland · L. S. · Wang · X. · Schmick · A. · Pagnini · F. · Kesselring · J. · Khazaei · H. · Perez-Ner
Objectives

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.

Design

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.

Setting

Data were sourced from the published literature and input from international stakeholders.

Participants

pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.

Results

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.

Conclusion

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.

Study registration number

https://osf.io/ys7xt/.

Efficacy of non-surgical treatments for acute non-specific low back pain: protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Trager · R. J. · Baumann · A. N. · Bejarano · G. · Burton · W. · Blackwood · E. R. · Holmes · B. D. · Goertz · C. M.
Introduction

Acute low back pain (LBP) is a prevalent condition with various non-surgical treatment options, yet no comprehensive network meta-analysis has systematically compared their relative efficacy for pain and disability. This study aims to fill that gap by synthesising available evidence on the efficacy of different types of non-surgical interventions for acute LBP, such as various medications, manual therapies and education-based therapies. Our coprimary objectives are to (1) compare each active treatment to an inert reference for measures of LBP and related disability and (2) rank the efficacy of treatments.

Methods and analysis

We will conduct a systematic search across multiple databases, including grey literature, to identify randomised controlled trials evaluating non-surgical treatments for acute LBP. Eligible studies must report on pain and/or disability outcomes in adults. The risk of bias will be assessed using the Risk of Bias tool, and the certainty of evidence will be graded using CINeMA (Confidence in Network Meta-Analysis). We will use a frequentist network meta-analysis to pool standardised mean differences in pain and disability, employing random-effects models to account for heterogeneity. A qualitative analysis will assess study characteristics and transitivity, while a quantitative analysis will evaluate efficacy and inconsistency. Results will be presented using network geometry, p-scores, forest plots, funnel plots, Egger’s test, Q-statistics and league tables to visualise both direct and indirect evidence and to identify potential biases.

Ethics and dissemination

This review protocol does not involve any primary research with human participants, animal subjects or medical record review. Consequently, this work did not require approval from an institutional review board or ethics committee. Results will be submitted to a peer-reviewed journal and presented at conference(s). De-identified data will be made available in a public repository.

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