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Strengthening and Targeted Rehabilitation for Optimal Neuromuscular Gains for chronic BACK pain (STRONG-BACK): protocol for a randomised controlled trial in participants with primary nociceptive pain drivers

Por: Fortin · M. · Rosenstein · B. · Bertrand · C. · Vaillancourt · N. · Wright · A. · Montpetit · C. · Macedo · L. · Elliott · J. · Cook · C. E. · Tousignant-Laflamme · Y. · Ma · J. · Page · M. G. · Dover · G. · Dang-Vu · T. T. · Weber · M. H.
Introduction

Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.

Methods and analysis

A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.

Ethics and dissemination

This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.

Trial registration number

ISRCTN14864451.

Using a Modified Delphi Process to Develop an Intervention to Support Care Coordination of Patient Social Needs in Primary Care

ABSTRACT

Aims

To identify implementation strategies that effectively facilitate the adoption of social needs care coordination activities using enabling technologies among care management teams serving patients in community-based health centres.

Design

Modified Delphi process.

Methods

Discrete, feasible implementation strategies were identified through literature review and semi-structured interviews with care management staff and subject matter experts in clinical informatics, workflow redesign, and product engineering. A modified Delphi was conducted with eight subject matter experts and nine health centre care management staff. Iterative rounds of online surveys were used to achieve consensus on the most relevant implementation strategies and their delivery methods.

Results

The modified Delphi process achieved consensus on nine discrete implementation strategies needed to advance care management teams' ability to screen, refer and track social needs. Prioritised strategies included developing champions, enhancing quality improvement capacity, training staff on using enabling technologies and providing tailored technical assistance for workflow refinement. Consensus was also reached on a monthly cadence for most of the implementation strategies.

Conclusions

Consensus was reached on strategies to enhance care management teams' implementation of social needs screening, referrals and tracking using enabling technologies. These strategies will comprise an intervention to be pilot tested, refined and assessed in a cluster randomised clinical trial.

Implications for the Profession and/or Patient Care

Findings from this study will inform the development of strategies to further the adoption of enabling technologies to support social needs care coordination.

Impact

This work is key to the design of a type 2 hybrid implementation-effectiveness trial that will assess whether user-informed, evidence-based implementation strategies can improve care management teams' adoption of enabling technologies to facilitate social needs care coordination for patients.

Patient or Public Contribution

The research team includes a patient advisor with community-based nursing expertise and a nurse practitioner-clinical informaticist leader who was involved in data collection and interpretation of findings.

Trial registration: Clinicaltrials.gov registration # NCT06489002. Registered July 5, 2024, https://clinicaltrials.gov/study/NCT06489002?term=NCT06489002&rank=1.

Feasibility and Acceptability of the Smarthealth Intervention for Dementia Caregivers. A Qualitative Analysis of a Single‐Group Pilot Study

ABSTRACT

Aim(s)

To explore the feasibility and acceptability of acoustic monitoring and real-time recommendations for stress detection and management (i.e., smarthealth intervention).

Design

This qualitative study used a framework of acceptability for healthcare interventions.

Methods

From January 2021 to December 2023 in the U.S.A., we interviewed 10 family caregivers who had completed the 4-month smarthealth intervention. The caregivers shared their user experiences and feedback on the system's feasibility and acceptability. Data were analysed using abductive thematic analysis, incorporating the framework of acceptability for healthcare interventions and the collected data.

Results

Seven themes and 19 categories emerged: attitudes, burden, ethicality, intervention adherence, intervention coherence, perceived effectiveness and suggestions. Feedback on the smarthealth intervention was mixed. Some found it beneficial, citing accuracy, ease of use and increased awareness. However, others felt burdened during its use, primarily due to time constraints.

Conclusion

The smarthealth intervention can potentially improve caregivers' awareness of themselves and caregiving situations.

Implications for the Profession and/or Patient Care

Future directions should involve adapting the smarthealth intervention to consider diverse caregiving scenarios and incorporating a larger sample of caregivers.

Impact

This is the first study to offer a voice detection system and real-time stress management recommendations to caregivers of people living with dementia. An individualised approach should be considered to improve the system's effectiveness. This includes providing personalised intervention components, considering caregivers' time and establishing a user-friendly system with high accessibility. The findings can be a cornerstone for smarthealth interventions influencing dementia caregivers' self-care and emotional regulation.

Reporting Method

Standards for Reporting Qualitative Research.

Patient or Public Contribution

Members of the public and service users from a memory clinic and social media platforms contributed to the study by reviewing recruitment materials.

Trial Registration: This trial's study protocol was registered with ClinicalTrials.gov (ID No. NCT04536701) on 3 September 2020 (https://classic.clinicaltrials.gov/ct2/show/NCT04536701)

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.

Personal Family‐Centred Care for LGBTQ+ Individuals in Acute Hospital Settings: A Scoping Review

ABSTRACT

Aim

To identify and synthesise existing evidence on family-centred care for Lesbian, Gay, Bisexual, Transgender, Queer and other diverse identities (LGBTQ+) people in acute hospital settings, including hospital-based palliative care, oncology, general in-patient and intensive care.

Design

A scoping review guided by the JBI methodology.

Methods

Nine databases and grey literature sources were searched. Inclusion criteria focused on LGBTQ+ adults and family-related care experiences in hospital-based acute settings. After screening, qualitative, quantitative, and narrative data were extracted. Thematic analysis synthesised findings, with quantitative data narratively integrated.

Data Sources

Searches were conducted across nine databases and grey literature up to April 2025.

Results

Five studies met inclusion criteria: three qualitative, one quantitative, and one reflective narrative. Four themes emerged: (1) invisibility and disclosure dilemmas, (2) exclusion of chosen families from visiting and decision-making, (3) barriers to inclusive communication and provider competence, and (4) enabling conditions for affirming care. Challenges occurred at interpersonal (e.g., provider assumptions, discomfort) and structural (e.g., lack of inclusive protocols, failure to recognise legal surrogates) levels. In the two studies reporting gender identity, transgender participants described heightened misrecognition and exclusion.

Conclusion

LGBTQ+ individuals and their chosen families face relational and structural barriers in acute hospital care. Inclusive interventions, protocols, and training are urgently needed to ensure affirming care.

Implications for the Profession and/or Patient Care

Acute and intensive care providers should promote inclusive family engagement by using patient-preferred terminology, recognising chosen families, and advocating for inclusive policies and staff training.

Reporting Method

This scoping review adhered to PRISMA-ScR guidelines.

Patient or Public Contribution

No Patient or Public Contribution.

Trial Registration

Registered with the Open Science Framework: 10.17605/OSF.IO/FSU8D (23/02/2025)

EBP Beliefs, Competencies, Implementation Self‐Efficacy, and Access to Mentors in a Large U.S. Healthcare System: An Updated Assessment of Where We Are Now

ABSTRACT

Background

Evidence-based practice (EBP) has been in existence for more than 30 years and is recognized as the standard to achieve high quality care.

Purpose

To examine EBP beliefs, competence, implementation self-efficacy, organizational culture and readiness, access to mentors and assess relationships between nurse characteristics and EBP variables in a large healthcare system in six U.S. states.

Methods

A cross-sectional descriptive correlational design was used to conduct a web-based anonymous survey of registered nurses in a large multistate healthcare system throughout the western US. Measures included: EBP Competency Self-Assessment Scale, the EBP Mentoring Scale, and the Short forms of the EBP Beliefs Scale, EBP Implementation Scale, the Organizational Culture and Readiness Scale for System-Wide Integration of Evidence-Based Practice.

Results

A total of 1468 nurses completed the survey from 36 hospitals in six U.S. states. Overall, participants rated themselves competent in only one competency (asks clinical questions). EBP beliefs followed by implementation self-efficacy scores were highest. Total scores for EBP implementation showed the strongest positive correlation with EBP competency followed by beliefs and mentorship with culture and readiness, the least strong relationship. EBP competency, beliefs, and implementation increased with educational attainment. EBP mentorship scores were low across the system.

Linking Evidence to Action

The study continues to demonstrate nurses' low perceptions of their EBP competency. Compared to previous studies, nurses in this sample reported their EBP competency higher; however, they still rated themselves above competence in only one statement. This underscores an urgent need for comprehensive education and robust support mechanisms. It is imperative that healthcare organizations establish access to experienced mentors and cultivate organizational structures to empower nurses to master EBP, thereby enhancing patient outcomes and advancing overall quality of care.

HIV diagnostic implementation in the Dominican Republic: an in-depth qualitative context analysis for health technology developers

Por: Lee · K. · Arango · D. · Morel · S. · Sterling · K. · Agenor · M. · Tripathi · A. · Rodriguez · C. · Rosen · R. · Sanchez · M.
Objectives

To understand the political, economic, social and technological facilitators and barriers in obtaining an HIV diagnosis to inform implementation strategies for HIV diagnostics in the Dominican Republic (DR).

Design

In-depth, semi-structured qualitative interviews.

Setting

A high complexity public hospital in Santiago de los Caballeros, DR.

Participants

A convenience and purposive sample of 36 internal medicine physicians and laboratory personnel involved in sample collection, sample analysis or oversight of biological sample analysis.

Results

Using the Social Ecological Model, our results highlighted several interrelated barriers and facilitators to sample analysis at the individual (patient), interpersonal (interactions between laboratory personnel, physicians and patients), organisational (the hospital), community (Santiago de Los Caballeros) and societal (the DR) levels. Some key findings include the importance of psychological support in receiving an HIV diagnosis, how spoken language can be a barrier to care, how inconsistent access to laboratory supplies is a barrier for patients, laboratory personnel and clinicians, and the importance of government public health investment.

Conclusions

Employing qualitative methods to investigate a bioengineering challenge yielded rich data on the sociotechnical implementation context of HIV diagnostics in the DR. Several context-relevant suggestions were developed for HIV diagnostic developers which include incorporating psychological support into the diagnosis workflow, delivering information in multiple languages (ie, Haitian Creole and Spanish) and with non-stigmatising phrasing, working with the public sector to develop and implement technologies, and reducing the supply chain reliance on high-income countries to lessen delays in care. These findings can apply to other types of health technologies and settings and demonstrate the importance of utilizing human-centered design to understand implementation context and promote global health equity in health technology development and adoption.

Culture media affects accuracy of prediction of metallo-β-lactamases mediated resistance to imipenem

by Kexuan Chen, Sarah Miller, Kristine Goy, Tina Lam, Marlène Maeusli, Rosemary She, Brad Spellberg, Brian Luna

Metallo-β-lactamases (MBLs) hydrolyze the beta-lactam ring in beta-lactam antibiotics, rendering them ineffective. Infections caused by MBL-harboring bacteria result in higher mortality, more costs and prolonged hospital stays due to the limited treatment options. Recently, antimicrobial susceptibility testing using RPMI-1640 has been found to have more accuracy in predicting in vivo efficacy due to its zinc deficiency. We sought to expand the previous studies of accessing in vivo efficacy using zinc-limited media versus conventional media to more antimicrobial agents and MBL-producing strains. The susceptibility of isolates was determined by performing minimum inhibitory concentration (MIC) assays using traditional cation-adjusted Mueller Hinton broth (CAMHB) or zinc-limited media. In vivo outcomes were evaluated using the Galleria mellonella infection model and neutropenic mouse thigh infection model. The MICs of MBL-harboring strains decreased in zinc-limited media compared to in nutrient-rich media, suggesting susceptibility of a subset of resistant strains when tested in zinc-limited media. Notably, we observed statistically significant MICs decreasing against imipenem, which demonstrated the best efficacy among the six tested antibiotics. Additionally, the outcomes of in vivo tests in both the G. mellonella model and the mouse model were better predicted with in vitro MIC assays performing in zinc-limited media. The use of zinc-limited media may lead to increased accuracy of the prediction of in vivo efficacy of beta-lactams against MBL-harboring bacteria.

Co-developing SHELTER (Safe, Healthy Environments and Local Transformation for Equity and Resilience) with families with lived experience of homelessness in the New York City shelter system: A community needs assessment and data collection protocol

by Diana Margot Rosenthal, Kate Guastaferro, Jasia Kubik, Melody Goodman

In January 2025, the nightly census revealed that over 120,000 people were staying in New York City (NYC) shelters, including more than 41,000 children, of whom almost half were aged 0–5 years. Children under five years old (under-5s) experiencing homelessness are especially vulnerable because the first five years of life are a critical period for child growth, including approximately 90% of brain development. Furthermore, under-5s experiencing homelessness have a higher risk for multiple adverse childhood experiences, developing chronic health conditions, and recurrent homelessness across the life course. Data available for under-5s experiencing homelessness is generally lacking, and what is available is of notably poor quality in the United States, leaving a wide evidence gap and an inability to determine the actual needs of this population. This proposed protocol employs community-based participatory research and was co-developed with families with under-5s who have lived experience of homelessness in NYC shelters. The aim is to determine what barriers exist in the physical and social environments to optimizing health and wellbeing (e.g., milestones, child mental health, parental mental health, safety) among under-5s living in NYC shelters. Using a sequential mixed-methods design, we propose to address a gap in the current literature by conducting an assets- and deficits-based health needs assessment comprising a quantitative survey and qualitative semi-structured interviews. In the long term, our objective is to enhance the quality and quantity of data for this vulnerable population, thereby laying the groundwork for the future co-development of a comprehensive, optimized intervention addressing the needs of under-5s experiencing homelessness.

Evaluation of an innovative family-centred care and prevention intervention for children with overweight and obesity: a mixed-methods study protocol of the randomised controlled fruehstArt study in Germany

Por: Hagemeier · A. · Oberste · M. · Rosenberger · K. D. · Roth · R. · Hellmich · M. · Fluegel · V. · Ruettger · K. · Dadaczynski · K. · Joisten · C. · Mause · L. · Scholten · N. · Glaubach · J. · Hehn · M. · Bernhard · I. · Aydemir · I. · Redaelli · M. · Simic · D. · Alayli · A. · Lemmen · C.
Introduction

Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).

Methods and analysis

fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.

Ethics and dissemination

The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.

Discussion

The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.

Trial registration number

DRKS00030749 (29-09-2023)

A Prospective Randomised Clinical Study Comparing Polygalacturonic and Caprylic Acid Ointment to Medical‐Grade Honey in the Management of Chronic Wounds

ABSTRACT

The aim in this human trial is to compare the efficacy and safety of polygalacturonic–caprylic acid (PG–CAP) ointment to MediHoney in chronic wounds at three international medical centres. In this prospective open-label study, patients with chronic full-thickness wounds were randomised to daily treatment with PG–CAP ointment or MediHoney. Assessments were obtained weekly for 6 weeks. The validated Pressure Ulcer Scale for Healing (PUSH) score was used to track healing. Efficacies were compared using the Wilcoxon rank-sum test for continuous variables and chi-square or Fisher's exact test for categorical variables. Twenty-six patients with chronic wounds were included. Baseline characteristics were comparable between the groups; however, the history of diabetes mellitus was higher in the PG–CAP group (p = 0.011). All 13 PG–CAP patients showed improvement (100%), compared to only 69% of the 13 MediHoney patients (p = 0.023). Half of the failures in the MediHoney arm were associated with death (15%). No failures, adverse events or deaths occurred in the PG–CAP arm. PG–CAP wound ointment is a novel combination of two plant-based compounds that pose minimal risk of promoting antimicrobial resistance, was highly effective for eradicating wound-pathogen biofilms in vitro and promoted chronic wound healing in vivo with minimal inflammatory reactions. Our findings support PG–CAP as safe, noninferior and possibly more effective than MediHoney in healing chronic contaminated wounds.

Tobacco use in the context of natural disasters: a scoping review pertinent to tobacco control in Indonesia

Por: Kodriati · N. · Wijaya · O. · Affan · A. · Nursholihah · U. F. · Rosemary · R.
Objective

In Indonesia, the second most natural disaster-prone country in the world, the tobacco industry exploits such crises via corporate social responsibility. The objective of this study was to map existing evidence on natural disasters and tobacco use in order to understand how tobacco control policies could be optimised in disaster-prone regions.

Design

Scoping review.

Data sources

ScienceDirect, PubMed and Google Scholar, with searches conducted twice: between January and April 2024 and again in August 2025.

Study selection

All studies examining natural disasters, smoking behaviours and the tobacco industry.

Data extraction

Studies were assessed primarily on reports of tobacco use change, tobacco control policy enforcement, tobacco industry interference and mention of the role of stress. Data on country, disaster type, type of research study and sample details were also collated.

Results

27 of the 611 identified studies were included in the final analysis. Two-thirds of studies reported an increase in smoking rates following disasters. No studies mentioned tobacco control policy enforcement or tobacco industry interference during disasters. Most of the studies (74%) which examined the relationship between disaster-related stress and smoking found a positive association. About half (51.9%) of the studies described disasters in the Americas.

Conclusions

Smoking rates often rise after stress-inducing disasters. More evidence is urgently required to assist countries like Indonesia in enforcing tobacco control and preventing tobacco industry interference.

Implementation strategies for the WHO Safe Childbirth Checklist: a scoping review

Por: Gama · Z. A. d. S. · Semrau · K. E. A. · Rosendo · T. M. S. d. S. · Freitas · M. R. d. · Saraiva · C. O. P. d. O. · Westgard · C. M. · Mita · C. · Tuller · D. E. · Freitas · K. d. M. S. · Molina · R. L.
Background

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

Objectives

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

Eligibility criteria

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

Sources of evidence

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

Charting methods

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

Results

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

Conclusions

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Registration

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

Classroom air purifiers for reducing school absence: study protocol for a pragmatic, cluster-randomised, parallel, two-arm, group sequential superiority trial

Por: Solberg · R. B. · Holos · S. B. · Elgersma · I. H. · Elstrom · P. · Rose · C. J. · Helleve · A. · Gopinathan · U. · Fretheim · A.
Introduction

Respiratory infections like influenza and SARS-CoV-2 pose significant global health risks due to their high transmissibility and severity. SARS-CoV-2 has caused over 7 million deaths worldwide, and the Lancet Commission estimates a >20% chance of a similar respiratory virus pandemic within a decade. Schools, often poorly ventilated, are high-risk settings for transmission. While COVID-19 school closures may have reduced transmission, they likely caused learning loss, mental health issues and increased burdens on parents and caregivers. Air purifiers with High Efficiency Particulate Air (HEPA) filters may offer a non-disruptive mitigation strategy, but the evidence to support their effectiveness in reducing viral transmission is weak. This protocol describes a cluster-randomised, parallel, two-arm, group sequential superiority trial with an interim analysis—to allow early stopping for efficacy or futility—to estimate the effect of portable air purifiers with HEPA filters in primary school classrooms on student absenteeism.

Methods and analysis

This group sequential trial will randomise schools (clusters) 1:1 to intervention or control arms in two stages: winter 2025/2026 (N=32 schools; ~736 students) and winter 2026/2027 (N=30 schools; ~690 students). The study setting is Norway. Eligible schools must have classrooms suitable for portable air purifiers, >10 students in grades 5–7 (typically aged 10–13 years) and principal consent. Intervention and control classrooms will each receive two portable air purifiers with HEPA filters operating at a performance equivalent to 3.0 and 0.3 air changes per hour, respectively, with control purifiers acting as shams. Outcomes will be measured during and at the end of a 12-week period. The primary outcome is student absenteeism, measured as full child days of absence aggregated at the class level. An interim analysis is planned at the end of the first stage, with error-spending O’Brien-Fleming stopping boundaries that are binding for efficacy and non-binding for futility. The primary estimand is the marginal incidence rate ratio of student absences, estimated using generalised estimating equations with a negative binomial model to account for overdispersion. Prespecified stopping boundaries will determine stopping, with efficacy boundaries being binding. Treatment effects will be estimated using cluster-bootstrapped CIs adjusted to provide strong control on overall type I and II error probabilities, and a bias correction will be applied if the trial is stopped early for efficacy. All analyses will follow the intention-to-treat principle. The primary question is whether installing and operating air purifiers with HEPA filters (intervention) reduces student absenteeism due to sickness (primary outcome) compared with sham air purifiers (control). Secondary questions examine whether the intervention reduces teacher absenteeism due to respiratory infections, rate and 12-week risk of self-reported respiratory infections among teachers, and teachers’ perceptions of air quality, compared with sham air purifiers. If the trial estimates a statistically significant effect for the primary outcome, a cost-consequence analysis will evaluate the direct and indirect costs associated with operating air purifiers against the potential benefits of reduced student and teacher absenteeism. A process evaluation will explore mechanisms of effect.

Ethics and dissemination

The trial has been approved by the Regional Committees for Medical and Health Research Ethics and the National Research Ethics Committee (ref. 737650). Absence data, routinely collected and fully anonymised at the class level, will serve as the primary outcome and does not require informed consent. Informed consent will be obtained from teachers participating in weekly surveys or interviews. Results will be disseminated to stakeholders, participants and the public through peer-reviewed journals, scientific meetings and social media.

Trial registration number

NCT07119333.

A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intel

Por: Willner · P. · Anderson · P. · Bisson · J. I. · Clifford · C. · Cooper · V. · Farrell · D. · Harris · S. · Hiles · S. · Holland · G. · Hutchings · H. A. · Murphy · G. H. · Rose · J. · Stenfert-Kroese · B. · Unwin · G. L. · Watkins · A. · Willott · S. · Langdon · P. E.
Introduction

The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.

Methods

This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ

Analysis

The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.

Ethics and dissemination

This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.

Trial registration number

ISRCTN35167485.

Uncovering age-related differences in communication by people with persistent pain when interacting with a pain history assessment chatbot in Australia: an exploratory mixed-methods study using a comparative analysis

Por: Hay · E. · Ireland · D. · Claus · A. · Rose · T. · Strong · J. · Westerman · D. · Schlumpf · M. · Vijayakumar · P. · Burvill · L. · Andrews · N.
Objectives

There is limited research exploring the age-related difference in communication when describing pain experiences. This project aimed to identify key differences between adolescents’, young adults’ and adults’ (i) preferred communication method, (ii) language content and (iii) lexical amount and variety when discussing their persistent pain experience using chatbot technology.

Design

An exploratory concurrent nested mixed-methods design using a comparative analysis.

Setting

Participants were recruited through a convenience sampling strategy from two tertiary multidisciplinary pain centres in Australia.

Participants

20 adolescents, 20 young adults and 20 adults completed a pain history assessment using the Dolores application. The inclusion criteria for this study were (i) persistent non-cancer pain for at least 3 months, (ii) 10 years of age and over and (iii) adequate expressive and receptive language skills to complete the required tasks in English, as determined by clinicians in the treating team.

Results

Drawn, voice and typed responses provided by participants during the chatbot interaction were analysed using content analysis. Fisher’s exact tests and 2 tests were used to examine differences between age groups. Strong effect size estimates generated from comparative analyses suggested that adolescents were the most likely age group to utilise drawing (p=0.153, Cramer’s V=0.268), preferred typing over speaking (p==0.007, Cramer’s V=0.433). Young adults used the greatest number and variety of words in response to chatbot questions including evaluative language (p=0.097, Cramer’s V=0.296). Adults tended to use more metaphors (p=0.085, Cramer’s V=0.305) and had a strong preference for speaking over typing (p=

Conclusions

The results of this study provide insights into age-related differences in communication and preferences when using technology to communicate about persistent pain. Future research exploring individualised age-related approaches to pain assessment, supported by the findings of this study, in comparison to current standardised assessments administered by clinicians are warranted.

Contextualisation and Evaluation of the Preliminary Effectiveness, Feasibility and Acceptability of the safeTALK Suicide Prevention Programme for Secondary School Students: Protocol for a Multi‐Method Study

ABSTRACT

Aims

To contextualise an existing suicide prevention programme, and to assess the effectiveness, feasibility and acceptability of the contextualised suicide prevention programme among secondary school students in eastern Nepal.

Methods and Analysis

A multi-method study is planned across four phases. The study will be informed by the Socio-Ecological Model. The first phase is a systematic review to identify available suicide prevention programmes, their effects and their contextualisation status. The second phase will be a descriptive qualitative study to contextualise the safeTALK suicide prevention programme for use among adolescents in a public school of Eastern Nepal, involving adolescents, teachers, parents, healthcare providers and policymakers. The third phase will be a single-group pre-post-test design to test the preliminary effects of the contextualised safeTALK programme among 110 adolescents at the public school. Outcomes measured in the third study will be suicidal ideation and help-seeking behaviours, using the Suicidal Ideation Attributes Scale, and General Help-Seeking Questionnaire. The final phase will evaluate the feasibility and acceptability of the safeTALK suicide prevention programme through in-depth interviews with adolescents, teachers, parents, healthcare providers and policymakers. Quantitative and qualitative data will be analysed using the Statistical Package of Social Sciences v.30 and NVivo v.14 respectively.

Ethics and Dissemination

Ethical approval has been obtained from the Western Sydney University Human Research Ethics Committee and the Nepal Health Research Council. The findings will be disseminated via conference presentations and peer-reviewed publications.

Implications for the Profession and/or Patient Care

There are no reported structured suicide prevention programmes for adolescents in low-middle-income countries, including Nepal. This study is expected to assist in mitigating the shortfall of contextualised adolescent suicide prevention programmes in low-middle-income countries. Additionally, evidence will be added to the global nursing literature, helping to contribute to evidence-based nursing practice.

Trial Registration

Australian New Zealand Clinical Trials Registry (ANZCTR): 12624000634572

Patient-reported experience measures for person-centred care: a survey for the development and psychometric testing of a targeted measure, the EPCC-14

Por: Statton · R. · Rosenlund · L. · Close · J. · Dencker · A. · Lloyd · H.
Objectives

This study aims to develop a robust, targeted measure of patient experiences of person-centred care (PCC), informed by the lived experiences of patients with chronic illness using the psychometric theory of Rasch measurement.

Design

The Rasch measurement model was used to analyse the psychometric functioning of 57 candidate items and select appropriate items for a targeted measure.

Setting

Participants were recruited from Prolific.com, having experience of both chronic or long-term illness and first-hand experience of primary or secondary care in the UK healthcare setting and completed a survey containing PCC items and descriptors of healthcare experience.

Participants

Data from 501 adult persons (49.5% men and 49.7% women) with different types of long-term conditions recruited from the prolific web panel.

Results

For an initial analysis of all 57 candidate items, there were several indicators of misfit, such as signs of local dependence and multidimensionality. The response options worked as intended according to threshold ordering. After removal of misfitting items and refinement for the best spread of locations, a 14-item solution showed good fit to the Rasch model in this UK sample.

Conclusions

The results support a unidimensional measurement of patients’ experiences of PCC, once the local dependency was accommodated. The present work thus offers a 14-item measure of PCC experience. The present work also contains a robust item bank for the further development of dynamic computerised adaptive testing.

Comparisons of healthcare personnel relating to awareness, concern, motivation, and behaviours of climate and health: A cross‐sectional study

Abstract

Aim(s)

To describe a sample of healthcare professionals' responses to the valid and reliable Climate and Health Tool and compare participant characteristics relating to Climate and Health Tool subscales.

Design

Observational, cross-sectional, multi-site study.

Methods

An electronic survey containing the Climate and Health Tool was administered to healthcare professionals across a large, multi-state health system in the Western United States with a committed effort to reducing carbon emissions.

Results

One thousand three hundred and sixty-three participants reported moderately elevated levels of awareness and concern around climate impacts on health and motivation to participate in climate protective actions. Respondents reported moderate levels of climate-protecting behaviours at home and low levels at work. Females were more concerned and motivated. Medical staff and respondents reporting familiarity with system environmental initiatives reported more awareness and behaviours at home to preserve climate health.

Conclusion

Healthcare professionals are concerned and motivated to decrease climate impacts on health yet take little action at work to preserve the climate. Because of the intersection of climate change, health, and healthcare, healthcare organizations should prioritize and support meaningful action for healthcare professionals to meet community climate health needs.

Implications for the Profession and/or Patient Care

Healthcare organizations committed to contributing to climate solutions can use this research to increase healthcare professionals' education, engagement, and impact to preserve the climate and health of communities.

Impact

Healthcare is a major contributor to carbon emissions, yet healthcare professionals' awareness, motivation, concern, and behaviours related to climate change and health were not clear. Our research showed healthcare professionals are aware and concerned about climate impacts on health but reported low levels of workplace behaviours to protect the climate. The findings of our research will impact healthcare professionals and healthcare organizations to focus efforts on climate-preserving behaviours.

Reporting Method

This manuscript followed the STROBE guidelines.

Patient or Public Contribution

None.

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