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Feasibility and acceptability of therapist-guided, asynchronous, internet-delivered trauma-focused CBT for adolescents with PTSD: a single-group feasibility trial in Sweden

Por: Mattelin · E. · Weyler · H. · Andersson · R. · Paulsen · J. · Tielman · S. · Vikgren · A. · Bondjers · K. · Serlachius · E. · Mataix-Cols · D. · Bragesjö · M.
Objectives

Trauma-focused cognitive behavioural therapy (TF-CBT) is the established first-line treatment for paediatric post-traumatic stress disorder (PTSD), but access to evidence-based care remains limited. This study aimed to evaluate the feasibility and acceptability of a therapist-guided, 12 week, internet-delivered TF-CBT (iTF-CBT) programme for adolescents with PTSD and to explore preliminary changes in PTSD symptoms.

Design

Single-group feasibility trial.

Setting

Save the Children, Sweden.

Participants

Twenty-two adolescents (13–17 years, 82% female) with primary PTSD.

Interventions

A 12 week, therapist-guided, asynchronous, internet-delivered TF-CBT comprising eight modules and parallel caregiver modules with joint adolescent–caregiver activities.

Outcomes

Feasibility measures included recruitment pace, participant retention, treatment adherence (module completion) and therapist time. Acceptability was evaluated through satisfaction, credibility, negative effects and reported adverse events. Within-group changes in PTSD severity using independent evaluator-rated Clinician-Administered PTSD Scale (CAPS-CA-5) and the self-reported Child and Adolescent Trauma Screen 2 (CATS-2) were used as indicators of potential clinical change. Assessments occurred at baseline, during treatment, post-treatment and at 1 month follow-up (primary endpoint).

Results

Recruitment was completed after 7 months of active enrolment. Retention and adherence were high, satisfaction and credibility ratings were favourable, and no intervention-related serious adverse events occurred. Within-group improvements were observed at the primary endpoint, with large reductions on CAPS-CA-5 (Cohen’s d=1.27) and CATS-2 (Cohen’s d=1.51). At follow-up, 47.6% of participants no longer met criteria for PTSD.

Conclusions

Therapist-guided iTF-CBT for adolescents with PTSD was safe, feasible, acceptable and associated with potentially meaningful symptom improvements. These findings support further evaluation in larger, controlled trials to determine efficacy, cost-effectiveness and long-term outcomes.

Trial registration number

NCT06185244.

ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy

Por: Olsson · K. S. · Baekelandt · J. F. · Källen · K. · Matak · L. · Caretto · M. · Wassen · M. M. L. H. · Simoncini · T. · Stuart · A.
Introduction

Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy.

Methods and analysis

A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.

The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience.

Ethics and dissemination

The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.

Trial registration number

NCT06964594.

Family caregiver education programmes for safe home care: a scoping review

Por: Matarredona Perez · V. · Guilabert · M. · Navarro Macia · C. · Abed · N. · Strametz · R. · Tella · S. · Srulovici · E. · Mira · J. J.
Background

Population ageing and the rise in chronic diseases are driving a shift from residential models to home care where family carers play a key role. Although education programmes have shown benefits, limited attention has been paid to how family caregivers can be effectively trained to prevent unintentional mistakes in home care and to how they should be prepared to respond to them related to the care they provide.

Objectives

This scoping review aims to examine education programmes that enhance family caregivers’ knowledge and skills to promote safe home care, prevent unintentional mistakes and mitigate their impact on both care recipients and family caregivers.

Design

This study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) methodology for scoping reviews.

Data sources

Comprehensive searches were conducted in PubMed, Scopus and Embase in April 2024.

Eligibility criteria

The review included studies on family caregivers in home-based care, focusing on education programmes promoting safe practices; quantitative, qualitative and mixed-methods designs were eligible while studies on professional care or unrelated to home safety were excluded.

Data extraction and synthesis

Extracted data included study characteristics, education type, target population and safety-related outcomes, which were summarised descriptively to map the available evidence.

Results

31 studies on home safety education programmes for family caregivers across oncological, neurological, chronic and paediatric conditions were identified, mostly from the USA and conducted in hospital, home and other health and care facilities. Randomised controlled trials predominated and were generally high quality. Education programmes targeting technical, daily living and self-care skills improved caregiver burden, knowledge, preparedness and quality of life although physical health outcomes showed limited change.

Conclusions

Evidence indicates that structured education programmes enhance family caregivers’ knowledge, preparedness, competence and psychological well-being, supporting safer home care. While current education programmes are mostly short-term and caregiver-centred, this review identifies core technical, daily life and self-care competencies to guide future education programmes, highlighting the need for co-designed, rigorously evaluated education programmes that include patient safety outcomes and caregiver emotional support.

Digital Life Stories Within Residential Aged Care Settings: Implications for Staff Knowledge and Person‐Centred Care Practices

ABSTRACT

Aims

First, to investigate residential aged care staff's knowledge and understanding of residents after viewing their digital life story. Second, to examine the stability of this knowledge and understanding. Third, to explore staff's self-reported care practices following digital life story viewing.

Background

Australian aged care quality standards include person-centred care practices, although opportunity for residents' identity expression can be limited by the facility environment. Staff cannot implement such practices without first understanding residents' history, preferences, and values.

Design

The study used a convergent mixed methods design.

Methods

Residential aged care staff (n = 61) viewed a resident's digital life story and completed a measure of their knowledge and understanding of the resident at pre-test, post-test, and follow-up. At post-test and follow-up, staff were also asked to indicate if viewing the story had improved their interactions and care practices with the resident and to describe changes in their practice. Pre-test, post-test and follow-up scores of the measure were compared using a repeated measures analysis of variance with post hoc comparisons. Qualitative responses were analysed using thematic analysis.

Results

Scores at post-test and follow-up were significantly higher than at pre-test, showing a stable improvement in knowledge and understanding of residents. Staff responses indicated their knowledge and understanding of residents' life story enhanced their care towards the residents.

Conclusion

Watching digital life stories was associated with stable improvements in staff's knowledge of residents, with staff feeling better equipped to personalise care practices.

Impact on Clinical Practice

Digital life stories about aged-care residents may support staff's improved knowledge and understanding of their care-recipients. With such understanding, staff are more equipped to implement person-centred care practices by Australian aged care quality standards.

Reporting Method

The study adhered to guidelines for Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0).

Patient or Public Contribution

No patient or public contribution.

Early-life infectious and nutritional exposures and cardiovascular risk in early adulthood in Uganda: protocol for a new round of data collection in the Entebbe Mother and Baby Study birth cohort at 21 years (EMaBS@21)

Por: Sekitoleko · I. · Komata · R. · Ssali · I. · Kyasanku · R. · Nakyesige · R. · Sewankambo · M. · Akello · F. · Twinamasiko · N. · Namutebi · M. · Tumusiime · J. · Akantorana · C. · Akurut · H. · Balungi · P. A. · Akello · M. · Atkinson · S. H. · Niwaha · A. · Wajja · A. · Kyegombe · N. · Ny
Introduction

Non-communicable diseases, particularly cardiovascular diseases (CVDs), have become major contributors to morbidity and mortality in sub-Saharan Africa (SSA) and are projected to surpass infectious diseases as the leading cause of death among adults by 2030. Although CVDs have traditionally been associated with older age and obesity, adverse cardiovascular phenotypes are increasingly being observed in younger and leaner individuals in SSA. This pattern suggests that pathways to CVD risk in SSA may differ from those described in high-income countries. Early-life infectious exposures, undernutrition and socio-demographic conditions common in many SSA settings have been proposed as potential risk factors. Still, empirical evidence linking these exposures to cardiovascular risk in early adulthood remains limited due to a scarcity of long-running birth cohorts in the region.

Methods and analysis

This protocol describes a new round of data collection nested within the Entebbe Mother and Baby Study (EMaBS), a population-based Ugandan birth cohort established originally as a clinical trial (ISRCTN32849447) between 2003 and 2006 with prospective follow-up from pregnancy through adolescence. All participants currently under follow-up will be invited to participate at approximately 21 years of age. Primary outcomes are physiological determinants of CVD measured in early adulthood, including blood pressure, blood lipid levels, body mass index, body composition and markers of glucose metabolism. Secondary outcomes include behavioural CVD risk factors (diet, physical inactivity, alcohol use and tobacco use) and qualitative measures of CVD knowledge and risk perception. Key exposures of interest include prospectively collected early-life and childhood infectious exposures (malaria and helminth infections), markers of growth and undernutrition, micronutrient status, inflammatory markers, socio-demographic factors and selected genetic variants. Quantitative analyses will use multivariable regression and causal modelling approaches and will be complemented by qualitative interviews and focus group discussions.

Ethics and dissemination

The study protocol has been reviewed and approved by the Uganda Virus Research Institute Research and Ethics Committee (UVRI REC Ref: GC/127/35), the Uganda National Council for Science and Technology (UNCST Ref: MV625), and the London School of Hygiene & Tropical Medicine Research Ethics Committee (LSHTM Ethics Ref: 8811). Written informed consent will be obtained from all participants before study activities. Study findings will be shared and discussed with participants and community stakeholders through established engagement platforms. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations, and data will be made available to other researchers via established data-sharing platforms. We will engage policymakers at the district, national and international levels to facilitate the translation of findings into policy-relevant outputs.

Self-reported sexually transmitted infections among adolescents and adults in Zambia and Zimbabwe: evidence from Demographic and Health Surveys, 2005-2018

Por: Rotsaert · A. · Smekens · T. · Dziva Chikwari · C. · Phiri · M. M. · Matambanadzo · P. · Hensen · B.
Objectives

Globally, curable sexually transmitted infections (STIs) are increasing, particularly in sub-Saharan Africa, yet epidemiological data remain limited, hindering progress towards the 2030 global STI targets. This study assessed the prevalence of self-reported STIs in the last 12 months among adolescent girls and women (AGW) and adolescent boys and men (ABM) aged 15–59 who ever had sex in Zambia and Zimbabwe at three time points. It also assessed whether observed changes across survey rounds persisted after adjusting for sociodemographic and sexual behaviour characteristics.

Design

We analysed six rounds of Demographic and Health Surveys, three per country, collected between 2005 and 2018, using descriptive statistics and logistic regression, while accounting for survey design.

Setting

Zambia and Zimbabwe.

Participants

A total weighted sample of 86 366 AGW and ABM was included in the study.

Outcome measure

Self-reported STIs in the last 12 months.

Results

Overall, self-reported STI prevalence was higher in Zimbabwe than Zambia. Among Zambian ABM, self-reported STIs increased from 6.2% in 2007 to 7.1% in 2018 (adjOR=1.28, 95% CI 1.05 to 1.57, p=0.005). Among Zimbabwean AGW, prevalence decreased from 11.7% in 2005/2006 to 8.3% in 2015 (adjOR=0.72, 95% CI 0.61 to 0.85, p

Conclusion

These findings highlight differences in STI prevalence by sex and country across survey rounds, underscoring the need for tailored STI prevention, diagnostic and treatment strategies, particularly for high-risk groups.

Microbial Contamination of Open‐But‐Unused Portions of Wound Dressings in Healthcare Facilities

ABSTRACT

To assess the potential for microbial contamination of open-but-unused portions of wound dressings stored under real-life conditions in healthcare facilities, to inform safer and evidence-based wound care practices. Observational, descriptive, longitudinal, prospective study. Eleven types of non-adhesive wound dressings were sampled after opening and storage under usual clinical conditions in a hospital inpatient unit and a primary care centre in Andalusia, Spain. Samples were collected on six predefined sampling days (Days 0, 2, 3, 4, 5 and 6 after opening), cultured under standardised laboratory conditions and microorganisms were identified using mass spectrometry. Differences in contamination were examined by dressing type, healthcare setting, storage time and handling conditions. Microbial growth was frequently detected in open-but-unused dressings from the first day after opening, particularly after enrichment culture and increased with handling and time. The most frequent microorganisms were coagulase-negative staphylococci and Staphylococcus aureus. Contamination patterns were similar across settings, although microbial diversity was higher in the hospital. Silver-containing dressings showed slightly lower contamination, but not enough to indicate protection. Scissors used for cutting dressings had high microbial loads, suggesting a potential source of cross-contamination. Open-but-unused dressings may become contaminated shortly after opening under routine clinical practice conditions, across different healthcare settings and dressing types.

Integrating care in a childrens hospital: a qualitative interview study with mental and physical health professionals in England

Por: Morgan · T. · Pilimatalawwe · D. · Mannes · J. · Morse · I. · Folwell · J. · Hain · P. · Walsh · C. M. · OCurry · S. · Duschinsky · R.
Objective

To explore physical and mental health professionals' hopes and concerns around integrating their services in a colocated children’s hospital.

Methods

One-off semi-structured interviews were conducted with 31 participants (16 mental health and 15 physical health professionals). Participants were purposively sampled to ensure representation across each trust and professional background. Participants included allied health professionals, nurses, team managers, paediatricians, psychiatrists and psychologists.

Results

Staff described integration as both promising and ambiguous. While many welcomed the potential for improved collaboration and holistic care, others expressed uncertainty about what integration would entail. Six key themes were identified: (a) siloed and patchy beginnings, (b) one whole child, (c) day-to-day of colocation, (d) the integrated worker, (e) patients not in the same boat and (f) extending integration.

Conclusions

This novel analysis offers insights around the practical and emotional processes involved in integrating care systems. Staff valued the potential for holistic, child-centred care, improved collaboration and shared learning but expressed concerns around ambiguity, shifting professional identities and the practicalities of colocating services. These tensions underscore the need for clearer communication, relationship-building and support structures during service redesign. Our findings also support integrating wider community and social care systems and call for future research involving young people’s perspectives to ensure meaningful, inclusive integration.

Cohort profile: Sub-cohort study on the second phase of the Chiba Study of Mother and Child Health (C-MACH), Japan

Purpose

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Participants

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Findings to date

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Future plans

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

Relationship Between Weight Loss and Problems With Oral Intake in Institutionalised Older Adults: A Japanese Multi‐Institutional 1‐Year Follow‐Up Study

ABSTRACT

Aim

To examine the relationship between weight loss and problems with oral intake in institutionalised older adults.

Design

A 1-year longitudinal observational study.

Methods

Data were obtained from a prospective study conducted in three nursing homes and two long-term care facilities in Japan. Participants' problems with oral intake were assessed using items published in 2021 by the Japanese Ministry of Health, Labour and Welfare. Baseline and follow-up factors were compared between individuals who experienced a weight loss of 5% or more and those who did not. Separate multivariable logistic regression models were constructed for each oral intake assessment item to examine its independent association with weight loss of 5% or more, accounting for transitions in each item between baseline and the 1-year follow-up.

Results

In total, 172 institutionalised older adults were included in the analysis. Among them, 57 (33.1%) participants experienced a weight decrease of 5% or more. The emergence of somnolence or clouding of consciousness during meals at the 1-year follow-up in participants without these signs at baseline was independently associated with a weight loss of 5% or more, after adjustment for baseline characteristics.

Conclusion

Recognising signs of somnolence or clouding of consciousness during meals may be useful for the early detection and prevention of weight loss in institutionalised older adults.

Implications for the Profession and/or Patient Care

Early detection of individuals at risk is essential to prevent significant weight loss and its associated adverse outcomes. Recognising somnolence or clouding of consciousness during meals may enable earlier detection and intervention to prevent weight loss and improve the quality of care for older adults.

Reporting Method

Strengthening the Reporting of Observational Studies in Epidemiology.

Patient or Public Contribution

No patient or public contribution.

Experiencias de enfermería en el uso de herramientas informáticas de Planes de Cuidados

Introducción. Los planes de cuidados en enfermería (PCE) son instrumentos para documentar e informar las actividades de enfermería. Actualmente existen varias herramientas digitales totalmente de PCE (softwares y/o aplicaciones móviles).

Objetivo: Comprender los significados de las experiencias vividas por los profesionales de enfermería que laboran en servicios de hospitalización de unidades de segundo y tercer nivel de atención de Sevilla y Alicante (España) con el uso de herramientas informáticas de PCE.

Metodología: Se realizó un estudio fenomenológico en unidades de segundo y tercer nivel de atención en salud de Sevilla y Alicante (España). Mediante muestreo intencional se incluyeron 9 profesionales de enfermería de servicios de hospitalización. Los datos se obtuvieron en septiembre y octubre de 2023 mediante una entrevista semiestructurada y fueron analizados mediante un enfoque fenomenológico interpretativo.

Resultados: Se comprendieron las siguientes categorías descritas por los profesionales de enfermería: experiencias positivas tales como generación de Planes de Cuidados Estandarizados de Enfermería, experiencias negativas como ambigüedad de las herramientas informáticas e inadecuada accesibilidad a las herramientas y la propuesta ideal para desarrollar un software de Planes de Cuidados Individualizado de Enfermería (PCIE).

Conclusiones: Se lograron comprender los significados de las experiencias vividas de los profesionales de enfermería acerca del uso de las herramientas informáticas de PCE, las cuales posteriormente sirvieron para generar un software de PCIE que permita responder a las necesidades actuales en salud de individualizar el cuidado de enfermería.

Multifactorial approach training for anterior shoulder instability after a Latarjet procedure: protocol for a randomised controlled trial

Por: Soares · M. N. · Shirinskiy · I. J. · Schachner · J. · MATASI collaborator group · M. c. g. · Macken · A. A. · Kling · A. · Lafosse · T. · van den Bekerom · M. P. J. · Buijze · G. A.
Introduction

The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.

Methods and analysis

This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.

The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.

Ethics and dissemination

This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.

Registration details

The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.

Trial registration number

NCT06154889.

Indicators for effective glaucoma care coverage in adults: protocol for a scoping review

Por: Matayan · E. Y. · Burn · H. · Gordon · I. · Evans · J. · Toews · I. · Ramke · J. · Burton · M. J. · Philippin · H. · Mtuy · T. · Hu · V. H.
Introduction

Glaucoma is the leading cause of irreversible blindness worldwide and the number of people with glaucoma is expected to increase to more than 112 million by the year 2040, making it a disease of public health interest. However, there is no consensus on public health indicators to monitor glaucoma care coverage. This scoping review aims to summarise published indicators for monitoring effective glaucoma care coverage globally, focusing on care needs, use of care services and outcomes achieved.

Methods and analysis

We will include studies that report the development and use of public health indicators for effective glaucoma care coverage in patients aged 18 years and older. Studies published from 1 January 2000, in all languages, will be included, provided they can be accurately and easily translated into English using Google Translate. Searches will be conducted by an information specialist on MEDLINE, Embase, Global Health and CENTRAL in the Cochrane Library. Two reviewers working independently will screen the search results, select studies for inclusion and extract data; any disagreements will be discussed with or resolved by a third reviewer. Data will be presented in tabular form, followed by a narrative synthesis based on the review objectives.

Ethics and dissemination

Ethical approval is not required as the review will use published data. Results will be published in a peer-reviewed journal, and summarised results will be available and contribute to the development of standardised glaucoma care indicators.

Registration

OSF registration on 19 May 2025: https://osf.io/zsyw9/

Ambulatory management of primary spontaneous pneumothorax in the emergency department: EFFI-PNO protocol - a multicentre, cluster-controlled, stepped-wedge, randomised interventional study

Por: Kepka · S. · Wilme · V. · Duracinsky · M. · Matau · C. · Nze Ossima · A. · Gil Jardine · C. · Le Borgne · P. · Marjanovic · N. · Marx · T. · Ohana · M. · Peyrony · O. · Philippon · A.-L. · Viglino · D. · Chenou · A. · Clere-Jehl · R. · Bilbault · P. · Durand-Zaleski · I. · Sauleau · E. A.
Introduction

For large primary spontaneous pneumothorax (PSP), drainage or simple aspiration are the two first-line treatment options. Outpatient ambulatory strategies have a success rate of almost 80% with few complications. New French recommendations suggest that an outpatient strategy should be preferred if an appropriate care network is in place. However, establishing this care network remains the main obstacle to the use of this strategy. Thus, outpatient management of PSP remains rare, which is neither optimal for the patient, with a likely impact on quality of life (QOL) and satisfaction with care, nor for the healthcare system, with increased costs. We hypothesise that outpatient treatment of PSP compared with usual inpatient management could improve quality of care and represent a more efficient, generalisable and sustainable strategy.

Methods and analysis

In this multicentre, cluster-controlled, randomised interventional study with stepped wedge implementation, patients aged 18–50 presenting to the emergency department (ED) with a first episode of large PSP will be enrolled in seven university hospitals in France. The main objective of this study is to evaluate the impact on changes in QOL of an ambulatory strategy for the management of large PSP in the ED compared with usual inpatient management. The primary outcome is the difference in QOL as measured by SF-36 score, between drain placement and 6 months. Clinical criteria (pulmonary expansion at 6 days, pain, dyspnoea, complications, recurrence), perceived quality of care (satisfaction, patient preference, anxiety) and ease of implementation of the care pathway will also be assessed. A cost-utility analysis will be carried out to evaluate the incremental cost-utility ratio at 1 year, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores.

Ethics and dissemination

Ethics approval has been obtained by the Comité de Protection des Personnes Nord Ouest III N° 2024-36. Study findings will be disseminated by publication in a high-impact international journal. Results will be presented at national and international emergency healthcare meetings, and participating patients notified of the main conclusions.

Trial registration number

This trial is registered with Clinical Trials Registry NCT06471608. The trial protocol and statistical design are fully described in this study protocol. Additional data can be provided on reasonable request to the sponsor. Protocol version: V2.1 - 21/11/2024.

Chronic illness experiences for young adults: a qualitative study

Por: Harper · I. · Broom · A. · Baur · L. · Stamatakis · E.
Objectives

To explore the experience and impact of physical chronic illnesses in the lives of young people.

Design

Qualitative study using semi-structured interviews.

Setting

Interviews were conducted between March 2023 and February 2024 either via video call (14) or face-to-face (19). Recruitment was done primarily through flyers in public spaces, specialists’ waiting rooms and research pages of chronic disease websites and supplemented through snowballing.

Participants

Young adults aged 19–29 years (n=33, mean age 23 years) who had lived with a physical chronic illness for 6 months or more. All participants lived in Australia.

Results

Three key findings were identified: (i) chronic illness impacts the lives of young people in a particular way, as participants reported that their young age, and the youth of their peers, influenced their interactions with healthcare professionals, their access to support and their sense of isolation; (ii) participants struggled to come to terms with, and describe, the influence of their chronic illness on their overall life and lifestyle, particularly when outside of the ‘expected’ symptoms of disease; (iii) the lack of education and guidance about the wide range of impacts that chronic illness can have seemed to compound participants’ reported sense of guilt, self-blame and exhaustion.

Conclusions

This study illustrates how youth is a critical contextual element when considering different population groups’ challenges in managing chronic illnesses. It finds that young people may internalise blame for these challenges despite the fact they are structural issues. Understanding this context will aid the provision of better healthcare experiences and support programmes. Further research could help establish better expert and peer support models to help adults and young people better anticipate, understand and manage the wide-reaching impacts of chronic illness.

Genitourinary syndrome of menopause induced by breast cancer treatments: a randomised clinical trial protocol comparing multimodal pelvic floor physiotherapy and fractional CO2 laser therapy (PILME study)

Introduction

Genitourinary syndrome of menopause (GSM) is a prevalent condition among breast cancer survivors, often exacerbated by oncological treatments. Hormonal therapies are typically contraindicated in this population, necessitating effective non-hormonal interventions.

Methods and analysis

This randomised controlled trial aims to compare the effectiveness and cost-effectiveness of multimodal pelvic floor physiotherapy—comprising pelvic floor muscle training, non-ablative radiofrequency, therapeutic pelvic health education and the use of vaginal moisturisers—versus fractional CO2 laser therapy combined with vaginal moisturisers in alleviating GSM symptoms in breast cancer survivors. Participants will be randomly assigned to one of the two intervention groups. Primary outcomes include measures of sexual function (assessed by the Female Sexual Function Index), subjective pelvic perineal pain intensity (measured with a 100 mm Visual Analogue Scale) and health-related quality of life (assessed by the Functional Assessment of Cancer Therapy-Breast), assessed at baseline, post-intervention and at 3, 6 and 12 months of follow-up. Statistical analyses will be conducted to evaluate the clinical efficacy and cost-effectiveness of the interventions.

Ethics and dissemination

The study protocol has been approved by the Ethics and Health Research Committee of the University of Alcalá (Reference: CEIP/2024/1/012). All participants will provide informed consent prior to inclusion in the study. Findings will be disseminated through peer-reviewed journals and conference presentations, and by engaging with patient associations and survivor groups through tailored materials.

Trial registration number

NCT06721936.

Older Adults' Self‐Care and Family Caregiver Contribution in Multiple Chronic Conditions: A Dyadic Qualitative Study

ABSTRACT

Aims

To explore how older adult-family caregiver dyads jointly manage multiple chronic conditions. Specifically, it investigates how dyads (i) prioritise chronic diseases, (ii) make and negotiate decisions related to self-care and (iii) define and distribute self-care tasks and caregiver contributions.

Design

A qualitative descriptive study using dyadic data collection and analysis.

Methods

Semi-structured interviews were conducted separately with chronically ill older adults and their family caregivers between July and December 2024. A hybrid inductive-deductive content analysis was applied. Dyadic analysis compared intra-dyad perspectives to identify patterns of agreement and disagreement.

Results

Thirty-four dyads (n = 68 participants) were interviewed. Older adults had a mean age of 80.09 years (SD = 6.95) and were affected by a median of four chronic conditions. Family caregivers had a mean age of 51.71 years (SD = 14.59), with most being the older adults' children (66.67%) and women (82.35%). Five categories, comprising 25 subcategories, were derived from the data. Disease prioritisation varied within dyads: older adults often focused on conditions with the most disabling symptoms, while caregivers emphasised those with higher risks of complication. Decision-making roles ranged from older adult-led to caregiver-led to shared. Care organisation followed three models: collaborative, older adult-directed, or caregiver-directed. Challenges in managing diseases included treatment adherence, care coordination, emotional burden and addressing multiple symptoms simultaneously. Role distribution in disease management and decision-making was complex and occasionally misaligned, sometimes resulting in conflict. Collaborative dyads reported greater adaptability and balance, while incongruent dyads experienced relational and organisational strain.

Conclusion

Managing multiple chronic conditions in older adults is a relational process shaped by interpersonal dynamics and shared responsibilities with family caregivers. Recognising dyadic relational patterns is essential for designing targeted educational interventions. Nurses should incorporate dyadic assessments into routine care to improve outcomes for older adults and reduce caregiver burden.

Implications for the Profession and/or Patient Care

This study highlights the importance of viewing chronic disease management as a dyadic process, rather than an individual task, involving both the older adult and the family caregiver. Tailored strategies that account for the relational dynamics within dyads, such as decision-making roles and care task distribution, are essential for effective chronic disease management.

Reporting Method

Consolidated criteria for reporting qualitative studies (COREQ).

Patient or Public Contribution

None.

Cost analysis of integrating depression treatment into chronic care in Malawi: evidence from a cluster randomised controlled trial

Por: Mwale · O. · Mpinga · K. · Rukundo · T. · Kamwiyo · M. · Kayira · W. · Matanje · B. · Munyaneza · F. · Ruderman · T. · Raviola · G. · Smith · S. · Okunogbe · A. · Kachimanga · C. · McBain · R. K.
Objective

To quantify the costs associated with a stepped model of depression care—Integrated Chronic Care Clinics-Depression Module (IC3D)—in rural Malawi.

Design

Cross-sectional cost analysis.

Setting

Integrated chronic care clinics (n=14) throughout Neno District, Malawi.

Interventions

The stepped model of depression care provided behavioural therapy (Problem Management Plus (PM+)) to adults (aged 18+) with moderate depression and joint PM+ and antidepressant therapy (ADT) to those with moderate-to-severe and severe depression. The model incorporated two cost-saving features: treatment was integrated into existing chronic care services within the health system, and PM+ was group-based rather than one-on-one.

Primary and secondary outcome measures

We conducted time-driven activity-based costing to quantify the marginal economic cost of implementing PM+ and ADT, inclusive of training and supervision. We measured all costs in 2025 US dollars and quantified costs from a societal perspective—including human resources, infrastructure, equipment, consumables, indirect costs and opportunity costs.

Results

The marginal cost of PM+ was $90 per patient treated for five sessions over 2 months, while ADT was $138 for eight sessions over 8 months. In both instances, human resources (45% from PM+, 52% for ADT) and consumables (30% for PM+, 31% for ADT) represented primary health system cost drivers. In the first year of implementation, 15 002 depression screenings were conducted, 724 adults were evaluated with a diagnostic tool and 398 adults subsequently received care: 263 received PM+ alone, 31 received ADT alone and 104 received both PM+ and ADT. The total cost of introducing operations throughout Neno District was $62 806.

Conclusions

These findings indicate that integrating depression care services into the Malawian health system is financially feasible and successfully reached many individuals with major depressive disorder.

Trial registration number

NCT04777006.

Development and psychometric validation of the womens empowerment in dealing with intimate partner violence (WED-IPV) scale: a mixed-method study

Por: Mataji-Amirroud · M. · Ramezankhani · A. · Ghaffari · M.
Objectives

The present study aimed to develop and psychometrically validate a culturally sensitive instrument, the women’s empowerment in dealing with intimate partner violence (WED-IPV) scale, in Iran.

Design

A mixed-methods research study to collect and analyse quantitative and qualitative data.

Setting

Social emergency centres, healthcare centres and psychotherapy clinics in three Iranian metropolises.

Participants

The participants were 31 married women in the qualitative phase and 420 in the quantitative phase.

Primary and secondary outcome measures

The primary outcome was the validation of the WED-IPV scale, including the assessment of face, content, construct validity and the assessment of internal consistency through Cronbach’s alpha, test–retest reliability through intraclass correlation coefficients (ICC) and stability of the factor structure. Secondary outcomes included the assessment of WED-IPV indicators in women using values obtained from levels specified according to the Interval of SD from the Mean formula for each indicator and total empowerment.

Results

The scale development process refined the initial 72 items down to 28 key items through expert review and validity testing. Exploratory factor analysis identified five factors: self-esteem, attitude, self-efficacy, access to support resources and economic empowerment that explained 65.72% of the variance. The scale showed excellent reliability (Cronbach’s α=0.97; ICC=0.95) and valid associations with related measures. Analysis of completed questionnaires of 412 women revealed that a significant portion scored low or moderate in each domain: 41% in self-esteem, 35% in self-efficacy, 39% in attitude, 47% in access to support and 45% in economic empowerment.

Conclusions

The WED-IPV scale is a psychometrically robust, reliable and valid instrument for assessing women’s empowerment concerning IPV in Iranian contexts. Its brevity and user-friendly design facilitate routine application in primary and secondary care settings. Future research should explore cross-cultural validation and predictive validity in longitudinal studies to inform targeted interventions and policy formulation.

Home-blended gastrostomy-delivered diets can supply similar nutritional intake to commercial formulas in children

Por: El-Matary · W.

Commentary on: Fraser LK, Bedendo A, O'Neill M, et al. Safety, resource use and nutritional content of home-blended diets in children who are gastrostomy fed: findings from ‘YourTube’ – a prospective cohort study. Arch Dis Child. 2023:archdischild-2023–3 26 393. Online ahead of print.

Implications for practice and research

  • Home-blended diets are safe alternatives to commercial formulas, provided there is no specific clinical contraindication.

  • High-quality randomised controlled studies are required to examine any differences in long-term outcomes in children who are fed home-blended gastrostomy-delivered diets versus those on commercial formulas.

  • Context

    Gastrostomy tube feeding is a well-established safe and relatively common way of delivering nutrients to the gastrointestinal tract in individual who cannot use the oral route. In children, there are several indications for using chronic gastrostomy tube feeding, including neurodevelopmental conditions, cardiac problems, metabolic conditions, gastrointestinal diseases and malignancy.1 Nutrients delivered through the gastrostomy...

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