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Steerable versus Conventional flexible and navigable suction ureteral access sheath (FANS) flexible Ureteroscopy for Lower Pole stones Treatment: study protocol for a multicentre, randomised superiority trial (SCULPT trial)

Por: Yuen · S. K. K. · Liu · S. · Gauhar · V. · Mai · H. · He · W. · Hu · H. · Ke · C. · Dai · Y. · Shan · L. · Jiang · Y. · Yuan · J. · Cao · Z. · Zuo · L. · Yang · C. · Bai · B. · Bi · X. · Zhao · H. · Xi · M. · Ding · N. · Deng · S. · Tang · S. · Zeng · J. · Du · J. · Wu · W. · Ma · J. · Zhong · W. · Zhao
Introduction

Flexible ureteroscopy has advanced modern stone management; however, lower pole renal stones remain a challenge due to suboptimal ureteroscope deflection and navigation using conventional flexible and navigable suction ureteral access sheaths (FANS). The SCULPT trial is designed to assess whether the novel steerable FANS—which enables active controlled deflection—can improve the success rate of lower pole access during flexible ureteroscopy.

Methods and analysis

This multicentre, prospective, single-blinded, randomised controlled superiority trial will recruit 400 adult patients (aged 18–75 years) with solitary lower pole renal stones ≤2 cm diagnosed by CT from 20 high-volume urological centres in China. Participants will be randomised 1:1 to undergo flexible ureteroscopy with either steerable or conventional FANS. The primary outcome is the success rate of navigating into the lower pole calyx (defined as successful direct stone visualisation, laser lithotripsy and aspiration without adjunct use). Secondary outcomes include immediate and 1 month stone-free rates, operative time, complication profiles (graded by Clavien–Dindo), instrument damage rates, quality-of-life assessments and cost analysis. Statistical analysis will be performed using appropriate tests for continuous and categorical data, with their significance set by prespecified superiority margins.

Ethics and dissemination

The study protocol has been designed in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Ethical approval was centrally granted by the Institutional Review Board of The First Affiliated Hospital of Guangzhou Medical University and adopted by all participating centres following local feasibility review. The trial results will be disseminated via peer-reviewed publication and presentation at international conferences.

Trial registration number

NCT06898216.

Adherence to Choosing Wisely Africa recommendations in breast cancer care: a cross-sectional study across three Sub-Saharan African centres

Por: Rubagumya · F. · Rugengamanzi · E. · Nyagabona · S. K. · Ndumbalo · J. · Kwizera · V. · Uwimbabazi · A. · Celyna · K. · Ayettey · H. · Vanderpuye · V. · Hopman · W. M. · Hammad · N. · Booth · C. M.
Objective

The expenses associated with cancer treatment are increasing at a rapid pace. The financial strain of providing care is experienced worldwide, but is particularly pronounced in low and middle-income countries (LMICs). This has resulted in a growing acknowledgement of the importance of value-based cancer care. Choosing Wisely Africa (CWA) is an initiative aimed at reducing the excessive use and expenses associated with cancer treatment. In this study, we assessed adherence to CWA recommendations for the treatment of breast cancer in three high-volume cancer centres in Sub-Saharan Africa (SSA).

Design

A cross-sectional study across Rwanda, Ghana and Tanzania was conducted, involving a review of medical records to assess adherence to five measurable CWA practices in breast cancer care. The study used inferential statistics, such as 2 tests, to compare adherence among these countries.

Settings

This study was conducted in three cancer centres (Ocean Road Cancer Institute, Rwanda Military Hospital and Korle Bu Teaching Hospital) in three countries (Tanzania, Rwanda and Ghana, respectively).

Participants

A total of 542 patients were recruited. Eligible patients were those with a breast cancer diagnosis and complete data as pertaining to five CWA recommendations.

Results

A total of 542 participants with a mean age of 51 years were included. Participants were well distributed across Ghana (37%), Rwanda (34%) and Tanzania (29%). Female patients represented 97% of the study cohort. Half (51%) of the participants had some form of insurance. The study observed high adherence to cancer staging (94%) before treatment and histological confirmation (91%) before breast lump removal across all sites. Hypofractionation was used in 0% of cases in Rwanda, 42% in Ghana and 70% in Tanzania.

Conclusion

This study provides critical insights into the implementation of CWA recommendations in breast cancer care in SSA. It highlights the disparities in adherence to CWA recommendations across different centres, showing the need for policy-driven changes and healthcare infrastructure improvement to standardise cancer care practices in LMICs.

Long-term effects of psychotherapy in children and adolescents: protocol for database development and a systematic review in the LaKiJu META project

Por: Schäfer · S. K. · Burmeister · C. F. · Lottermoser · E. · Schäfer · C. G. · Cascant Ortolano · L. · Stoffers-Winterling · J. · Flasinksi · T. · Equit · M. · Schneider · S. · Lieb · K. · de Haan · A.
Introduction

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

Methods and analysis

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethics and dissemination

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

PROSPERO registration number

CRD420251003208 (preregistered on 10 March 2025).

Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

Implementation determinants of LGBTQ+ inclusive practices in US health systems: a qualitative descriptive study of nurse leaders

Por: Yu · H. · Ancheta · A. J. · Flores · D. D. · Bonett · S. · Meanley · S. · Choi · S. K. · Bauermeister · J. A.
Objectives

Despite efforts to implement lesbian, gay, bisexual, transgender, queer or questioning, and other sexual and gender diverse (LGBTQ+) inclusive practices to address health disparities faced by LGBTQ+ individuals, factors that facilitate the uptake of these practices remain underexplored. Informed by the Consolidated Framework for Implementation Research (CFIR), this study explores nurse leaders’ perspectives across diverse US healthcare systems regarding the facilitators and barriers to implementing LGBTQ+ inclusive practices.

Design

We used a qualitative descriptive design. Semistructured interviews guided by the CFIR framework were conducted from October to December 2023. The data were analysed using thematic analysis.

Setting

Diverse healthcare settings (eg, acute care hospitals and public health centres) across the USA.

Participants

We purposively recruited 21 nurse leaders, such as chief nursing officers or chief nurse executives, who oversee nursing strategy, staffing and quality across their organisations.

Results

Consistent with prior frontline-focused studies, nurse leaders confirmed key inner setting and individuals facilitators (eg, LGBTQ+ specific training, electronic health record adaptation, visible executive engagement). Our findings add system-level detail from an executive perspective. Leaders identified actionable levers such as establishing LGBTQ+ clinical and social services, allocating protected time and budgets, and deploying dedicated implementation teams. We also identified a cross-cutting barrier: a reactive, crisis-driven organisational culture that hinders proactive inclusion efforts. Beyond the organisation, sociopolitical and legal climates shaped readiness and resourcing, with anti-LGBTQ+ laws influencing inclusion initiatives. Finally, nurse leaders highlighted the need for rigorous multilevel evaluation (eg, patient, staff, institution) and noted that common surveys inadequately capture LGBTQ+ inclusion, revealing measurement gaps that impede continuous improvement.

Conclusions

Implementing LGBTQ+ inclusive practices in healthcare is essential for optimal health outcomes and social justice. Understanding the context of implementation at multiple levels is crucial. Future research should focus on testing implementation strategies, developing inclusive healthcare surveys, and supporting the role of organisational culture and leadership in promoting LGBTQ+ inclusivity.

Attitudes towards and willingness to work with older adults among nurses in a university hospital, Sri Lanka: a cross-sectional study

Por: Balachandra · R. · Hansamali · R. · Dhananjaya · S. · Premarathna · W. · Wijesiri · H. S. M. S. K. · Rathnayake · S.
Background

With the rapid increase in the number of older adults living with chronic diseases and disabilities, there is a growing need to prepare nurses with positive attitudes and a willingness to work with older adults. This study aims to examine attitudes towards and willingness to work with older adults among nurses.

Methodology

A cross-sectional survey was conducted among a purposive sample of 267 nurses at the University Hospital of Kotelawala Defence University, Sri Lanka. Participants completed a self-administered questionnaire consisting of socio-demographic variables, Kogan’s Attitudes Toward Old People Scale and questions related to willingness to work with older adults. Descriptive statistics and linear and logistic regression analyses were used in data analysis.

Results

The majority were female nurses (71.9%, n=192) and held slightly negative (58%, n=155) or slightly positive (41.9%, n=122) attitudes towards working with older adults. Only 35.2% (n=94) were willing to work with older adults in this study. A male nurse (beta coefficient (β)=4.644, CI 2.392 to 6.896, p

Conclusions

Most nurses express slightly negative to positive attitudes and have little interest in working with older adults. Various socio-demographic factors have an impact on attitudes towards and willingness to work with older adults. Since nurses play a significant role in providing care for older adults, the development of positive attitudes is essential, and interventions and strategies are crucial to increasing their willingness to work with older adults.

Associations between gestational diabetes mellitus and survival without bronchopulmonary dysplasia in very preterm infants: a multicentre cohort study

Por: Lei · X. · Du · J. · Jiang · S. · Zhou · J. · Hu · L. · Xiao · T. · Zhu · Y. · Shi · W. · Qian · A. · Bai · R. · Dang · D. · Han · Y. · Li · S. · Gu · X. · Du · L.-Z. · Hei · M. · Lee · S. K. · Zhou · W. · Dong · W. · Chinese Neonatal Network · Lee · Chen · Du · Zhou · Cao · Xu · Tian · Zhang · Ji · L
Objective

To investigate whether gestational diabetes mellitus (GDM) was associated with survival without bronchopulmonary dysplasia (BPD) in very preterm infants (VPIs).

Design

Retrospective multicentre cohort study.

Setting

A total of 79 neonatal intensive care units across China, January 2019 to December 2021.

Participants

A total of 23 752 VPIs (

Main outcome measures

The primary outcomes are survival without BPD at 36 weeks’ postmenstrual age (PMA) and its components.

Results

Infants exposed to GDM were associated with a higher rate of survival without BPD (aOR 1.12, 95% CI 1.04 to 1.21) at 36 weeks PMA and lower mortality (aOR 0.75, 95% CI 0.64 to 0.84) before 36 weeks PMA than unexposed infants. However, no significant association was observed between GDM and BPD at 36 weeks PMA (aOR 0.94, 95% CI 0.87 to 1.02), respiratory distress syndrome, need for advanced resuscitation or mechanical ventilation. After propensity score matching, GDM-exposed VPIs maintained higher survival without BPD (aOR 1.13, 95% CI 1.02 to 1.26) and lower mortality (aOR 0.81, 95% CI 0.68 to 0.97). These associations were strongest in infants born before 28 weeks (aOR 1.32, 95% CI 1.11 to 1.57) and those small for gestational age (aOR 1.41, 95% CI 1.11 to 1.80).

Conclusions

GDM was not associated with worsened BPD in VPIs. The positive association with survival and survival without BPD warrants could reflect a selection bias.

Co-designing, evaluating and implementing online supportive care for endometriosis in Australia: study protocol for the hybrid type 1 effectiveness, cost-effectiveness and implementation randomised controlled trial of the CodeEndo program

Por: Mikocka-Walus · A. · Naude · C. · Coitinho Biurra · Y. · Blake · L. · Bowring · J. · De Araugo · S. · Bassili · A. · Bennetts · S. K. · Hutchinson · A. M. · Ng · C. H. M. · Prasertsung · C. · Skvarc · D. · Aras · D. · Ciccia · D. · O · E. · Jacka · F. · Staudacher · H. M. · Varney · J. · A
Introduction

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

Methods and analysis

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

Ethics and dissemination

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

Trial registration number

ACTRN12623000598684p.

Patient navigation programmes in cancer care in Africa: protocol for a scoping review

Por: Igibah · C. O. · Asogun · D. O. · Okoduwa · B. · Uzoma · V. I. · Agbabi · O. M. · Osinaike · T. · Shittabey · M.-S. K. · Oigiangbe · M. E. · Lawal · Q. O.
Introduction

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

Methods and analysis

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

Ethics and dissemination

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

From bedside to bug side: clinical, haematological and genetic markers of antibiotic-resistant bacterial isolates from children admitted with sepsis in Kaduna State, Nigeria - a protocol for a cross-sectional study

Por: Musa · S. · Aliyu · S. · Abdullahi · N. B. · Khalid · H. L. · Salihu · S. K. · Dahiru · A. U. · Muhammad · A. A. · Abdullahi · K. · Salisu · S. · Gumbi · S. A. · Tanko · Z. L. · Umaru · H. M. · Bello-Manga · H. · Dogara · L. G. · Musa · A. · Usman · I. K. · Lawal · U. W. · Cleary · D. W.
Introduction

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

Methods and analysis

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethics and dissemination

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Challenges and opportunities for expediting ALS diagnosis in Alberta, Canada: a human-centred design approach

Por: Ofosu · N. N. · Luth · W. · Genuis · S. K. · Tymkow · K. · Budiyanto · I. · McGuckin · T. · Campbell-Scherer · D. · Johnston · W. S.
Introduction

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease. Diagnostic delay severely impairs patient access to ALS multidisciplinary clinics, available disease-modifying medications and therapies that may prolong survival.

Objectives

To investigate how patient and physician perspectives might be leveraged to promote timely ALS diagnosis, and how system-level barriers might be addressed to promote appropriate referral to ALS multidisciplinary care.

Design and setting

A qualitative study in Alberta, Canada, used human-centred design and interviews to map the diagnostic journeys of ALS patients and identify individual-level and system-level diagnostic barriers and opportunities.

Participants and analysis

30 semistructured interviews (10 patients; 20 physicians) were conducted. Data were inductively analysed with the aid of Miro board software. Patient and physician data were triangulated to identify key phases of the journey from symptom onset to confirmed ALS diagnosis and themes related to the diagnostic barriers and opportunities. Journey maps were created to visualise the diagnostic journey.

Results

Patient journeys were comprised of five phases and commonly involved iterative cycles of referral and testing before an ALS diagnosis was confirmed. Four primary themes related to diagnostic barriers: difficulty recognising and responding effectively to early-stage ALS symptoms, absence of a single definitive diagnostic test, long wait times between referrals and clinical visits, and physician reluctance to pronounce an ALS diagnosis. Analysis indicated three approaches for improving diagnostic processes: increase ALS awareness; improve communication between referring physicians and physicians receiving referrals (consultants); and develop physician, diagnostic testing and multidisciplinary clinic referral forms that will guide symptom assessment and accurate referral.

Conclusions

Timely ALS diagnosis is challenging for patients navigating the frequently prolonged, circuitous diagnostic journey and physicians who struggle with referral pathways and the efficient diagnosis of this rare disease. Findings demonstrate the importance of increased ALS awareness and effective communication and response within referral pathways. Recommendations include strengthening the clinical approach of community-based physicians and supporting access and referral pathways. Current initiatives arising from this investigation seek to achieve meaningful change in timely referrals for progressive neurological diseases like ALS.

Development of intersectoral medical care for patients with 'chronic critical illness: protocol for a telemedicine interventional study with a pre-post design in out-of-hospital intensive care facilities (E=MC{superscript 2})

Por: Edel · A. · Jöbges · S. · Weiss · B. · Paul · N. · Lyall · M. L. · Hoffmann · C. · Schüürhuis · S. · Piper · S. K. K. · Konietschke · F. · Berger · E. · Busse · R. · Marschall · U. · Kraufmann · B. · Witzenrath · M. · Eckardt · K.-U. · Spies · C.
Introduction

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

Method and analysis

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

Ethics and dissemination

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

Trial registration number

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

A cross-sectional quantitative analysis of production and requirements of medical oxygen during the COVID-19 pandemic in Nepal

Por: Adhikari · S. K. · Aryal · Y. · Nepal · A. · Bingham · M. B. · Neupane · S. · Basnet · A. · Singh · A. K. · Prajapati · B. · Sthapit · D. · Devkota · G. · Rana · S.
Objectives

Medical oxygen supplementation is essential for treating severe illnesses and plays a critical role in managing life-threatening conditions, especially during the period of increased demand, such as the delta wave of COVID-19. The study aims to evaluate oxygen requirements and production to support effective capacity planning for future health crises.

Design and setting

Cross-sectional quantitative study. Data collection was carried out between 15 March and 19 December 2021.

Main outcome measures

The study used secondary data from Nepal’s Health Emergency Operation Centre. Regarding medical oxygen production, calculations included oxygen generated from both hospital-based oxygen plants and private companies, using their highest capacities for comparison. These production capacities were then assessed using three levels of efficiency (100%, 80% and 50%), revealing significant gaps when compared against the oxygen requirements of hospitalised COVID-19 patients, as guided by WHO recommendations. The results were communicated in terms of J-size cylinders, alongside average daily COVID-19 hospitalizations. Data was inputted and analysed using Microsoft Excel and presented in numbers and percentage.

Results

The country’s oxygen demand relies largely on the production from private enterprises, with meeting approximately 85.2% of the total requirement. Optimal production ensures that national oxygen needs will be met. The analysis highlighted that at 80% operational efficiency, 90.8% of the hospital’s requirements could be fulfilled. However, if operational efficiency drops to 50%, the fulfilment rate diminishes to 56.7%. The differences in requirement and production of oxygen are consistent across the provinces; however, a huge disparity was notable in Karnali and Sudurpaschim.

Conclusion

Continuous assessment of production capacities in both hospital and private enterprises producing oxygen is necessary to plan and address the gaps.

Quantitative retinal morphology and mortality in individuals with proliferative diabetic retinopathy: a retrospective cohort study in a large real-world population

Por: Khan · A. Z. · Ribeiro Reis · A. P. · Olvera-Barrios · A. · Zhou · Y. · Williamson · D. J. · Struyyen · R. R. · Khalid · H. · Egan · C. · Denniston · A. K. · Keane · P. A. · Wagner · S. K.
Objectives

To investigate whether quantitative retinal markers, derived from multimodal retinal imaging, are associated with increased risk of mortality among individuals with proliferative diabetic retinopathy (PDR), the most severe form of diabetic retinopathy.

Design

Longitudinal retrospective cohort analysis.

Setting

This study was nested within the AlzEye cohort, which links longitudinal multimodal retinal imaging data routinely collected from a large tertiary ophthalmic institution in London, UK, with nationally held hospital admissions data across England.

Participants

A total of 675 individuals (1129 eyes) with PDR were included from the AlzEye cohort. Participants were aged ≥40 years (mean age 57.3 years, SD 10.3), and 410 (60.7%) were male.

Outcome measures

The primary outcome was all-cause mortality. Quantitative retinal markers were derived from fundus photographs and optical coherence tomography using AutoMorph and Topcon Advanced Boundary Segmentation, respectively. We used unadjusted and adjusted Cox-proportional hazards models to estimate hazard ratios (HR) for the association between retinal features and time to death.

Results

After adjusting for sociodemographic factors, each 1-SD decrease in arterial fractal dimension (HR: 1.54, 95% CI: 1.18 to 2.04), arterial vessel density (HR: 1.59, 95% CI: 1.15 to 2.17), arterial average width (HR: 1.35, 95% CI: 1.02 to 1.79), central retinal arteriolar equivalent (HR: 1.39, 95% CI: 1.05 to 1.82) and ganglion cell-inner plexiform layer (GC-IPL) thickness (HR: 1.61, 95% CI: 1.03 to 2.50) was associated with increased mortality risk. When also adjusting for hypertension, arterial fractal dimension (HR: 1.45, 95% CI: 1.08 to 1.92), arterial vessel density (HR: 1.47, 95% CI: 1.05 to 2.08) and GC-IPL thickness (HR: 1.56, 95% CI: 1.03 to 2.38) remained significantly associated with mortality.

Conclusions

Several quantitative retinal markers, relating to both microvascular morphology and retinal neural thickness, are associated with increased mortality among individuals with PDR. The role of retinal imaging in identifying those individuals with PDR most at risk of imminent life-threatening sequelae warrants further investigation.

Positive mental states and their relation to psychosocial resources: protocol of a systematic review focusing on cultural moderators

Por: Supke · M. · Schäfer · S. K. · Meier · J. · Hamada · H. T. · Yamada · M. · Wessa · M. · Lieb · K.
Introduction

Fostering well-being and positive mental states are major aims of many strategies for the promotion of public mental health. Such strategies become increasingly important since many people worldwide suffer from psychological distress and mental disorders, resulting in substantial individual and societal costs. Within the last years, there is a shift from strategies solely focusing on the reduction of mental distress to those also aiming at the promotion of positive mental states. Correlates, that is, psychosocial resources, of positive mental states may represent a starting point for those interventions. To date, a comprehensive systematic review on those correlates is still missing as well as knowledge on culture-related differences.

Methods and analysis

A systematic review and meta-analysis on the longitudinal link between psychosocial resources (eg, income, optimism, social support and community coherence) and hedonic and eudaimonic positive mental states (eg, life satisfaction, happiness and forward-looking attitude) will be conducted. Using Hofstede’s dimensions of culture and global metrics of Education, Industrialisation, Richness and Democratic values (EIRDness), we will examine culture-related moderators of these associations. The systematic review will be conducted following standards of the Cochrane Collaboration and will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyse guidelines. Literature searches for primary studies will be carried out across four databases (APA PsycNet, Embase, Scopus and the Web of Science Core Collection), including all publications up to 27 January 2025. Screening at the level of titles and abstracts will be performed with the help of artificial intelligence software (ASReview). Study quality will be assessed using an adapted version of the Newcastle Ottawa Scale. We will employ multilevel meta-analyses of correlation coefficients, with cultural variables being examined as moderators.

Ethics and dissemination

This systematic review does not require ethics approval, as it solely uses previously published data. Materials and data used for this review will be shared via open repositories (https://osf.io/2xkhs/). Results will be published in an international, peer-reviewed journal and presented at conferences including plain language summaries.

OSF registration DOI

https://doi.org/10.17605/OSF.IO/K7X52

Protocol for the economic evaluation alongside the PARTICIPATE (PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion) multicenter cluster randomized trial

Por: John · D. · Reddy · P. · Jha · A. · Gupta · H. · Verma · V. · Kumar · D. · Bansal · A. K. · Mahapatra · S. · Rehman · T. · Parida · S. K. · Jena · M. · Pon Ruban · A. C. · Kalyanaraman · S. · Sunitha · K. · Cherian · J. J. · Anand · T.
Introduction

Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.

Methods and analysis

A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.

Ethics and dissemination

The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.

Trial registration number

Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.

Addressing the needs and identifying supports for parents of chronically ill adolescents and young adults in their shared transition from paediatric to adult care: a scoping review protocol

Por: Maini · P. · Tersigni · C. · Micsinszki · S. K. · Cairns · S. · Murray · K. · Frost · K.
Introduction

The transition from paediatric to adult healthcare marks a pivotal period for chronically ill adolescents, as they transition from a highly supportive and family-oriented environment to an adult-oriented and a more individual-oriented healthcare system that places a greater emphasis on personal responsibility and independence. Parents, given their firsthand experience managing their child’s healthcare, play a central role in ensuring a smooth and successful transition, yet their perspectives on the barriers and facilitators of this complex process remain vastly underexplored. This scoping review aims to assess and provide comprehensive insights into parents’ perceptions of the successes and challenges during their adolescents’ transition from paediatric to adult healthcare.

Methods and analysis

This scoping review is led by patient partners and will be guided by the Peters et al and the Joanna Briggs Institute guidelines for scoping reviews. The preliminary search strategy will be developed and calibrated in Ovid MEDLINE and will be subsequently replicated in the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychInfo, Embase, Web of Science and Sociological Abstracts from inception through 18 December 2024, including all types of studies. Grey literature sources recommended by patient partners and clinical and qualitative research experts will also be included. Two reviewers will independently perform the title and abstract review of all studies against the predefined inclusion and exclusion criteria, followed by the full-text review of included studies. The reference list of all included studies will also be screened to maximise the retrieval of relevant sources. Data will be extracted and analysed quantitatively and qualitatively, with the study procedural and reporting format following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This scoping review, through the broad and systematic mapping of existing literature, aims to provide a foundation for developing targeted support systems, strategies and interventions to address the unique needs and barriers faced by parents and caregivers of chronically ill adolescents during this critical transition to adult care.

Imaging analysis using Artificial Intelligence to predict outcomes after endovascular aortic aneurysm repair: protocol for a retrospective cohort study

Por: Lareyre · F. · Raffort · J. · Kakkos · S. K. · DOria · M. · Nasr · B. · Saratzis · A. · Antoniou · G. A. · Hinchliffe · R. J. · on behalf of the European Research Hub Working Group · Venermo · Boyle · Pherwani · Trenner
Introduction

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

Methods and analysis

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

Ethics and dissemination

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

Development of a supportive care framework for breast cancer survivor's unmet needs: A modified Delphi study

Abstract

Aim

To establish a supportive care framework for addressing unmet needs among breast cancer survivors, providing practical guidance for healthcare providers to assess and manage these needs, ultimately enhancing the health outcomes and quality of life of breast cancer survivors.

Design

We conducted a two-round Delphi survey to gather expert opinions regarding the unmet needs supportive care framework for breast cancer survivors.

Methods

Initial framework identification and inquiry questionnaire creation was achieved via literature search and expert group discussions, which included 15 experts from nursing practice, clinical medicine, nursing management and nursing education was conducted using a Delphi survey. To establish consensus, a two-round Delphi poll was done, using criteria based on the mean (≥4.0), coefficient of variation (CV < 0.25) and percentage for entire score (≥20%).

Results

Experts reached a consensus, leading to six care modules, and 28 care entries: Tumour Detection Support (three care entries), Management of Complications of Antitumor Therapy (seven care entries), Healthy Lifestyle Management (five care entries), Sexual and Fertility Support (four care entries), Psychosocial Support (four care entries) and Resource and Linkage Support (five care entries).

Conclusion

To address breast cancer survivors' unmet needs, a supportive framework was developed to actively enhance their health outcomes. However, further refinement and feasibility testing using mobile devices or artificial intelligence are required.

Implications for the Profession and Patient Care

This pioneering framework prioritises addressing unmet needs and equips healthcare providers to assess and manage these needs effectively, facilitating the implementation of programs aimed at improving the well-being of breast cancer survivors.

Reporting Method

This study was guided by a modified guideline for the Conducting and Reporting of Delphi Studies (CREDES) (Palliative Medicine, 31(8), 684, 2017).

Patient or Public Contribution

No Patient or Public Contribution.

Trial and protocol registration

The Delphi study methodology does not require registration.

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