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Enhancing palliative care in intensive care units: protocol of EPIC, a controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase

Por: Mentzelopoulos · S. D. · Hartog · C. S. · Tenge · T. · Schwenkglenks · M. · Piper · S. K. · Barbier · M. · Rusinova · K. · Neukirchen · M. · Schüürhuis · S. · Jensen · H. I. · van Heerden · V. · Dutzmann · J. · Drescher · D. · Zvara · M. · Metaxa · V. · Nachshon · A. · De Robertis
Introduction

Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.

Methods and analysis

This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.

The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.

Ethics and dissemination

EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.

Trial registration number

NCT06605079.

Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark - a stud

Por: Wolsing · S. K. · Hilberg · O. · Lokke · A. · Farver-Vestergaard · I. · Andersen · C. U. · Hansen · K. K.
Introduction

Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of 9-tetrahydrocannabinol (9-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.

Methods

This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.

Discussion

This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.

Ethics and dissemination

Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.

Trial registration number

The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701).

Development of prison-based parent-child joint intervention for incarcerated fathers: protocol for mixed-methods study

Por: Yiu · W. Y. · Fung · Y. L. · Tsang · S. K. M. · Chan · C. H. Y. · Wong · P. W. C.
Introduction

Paternal incarceration represents a significant stressor that disrupts family cohesion, undermines paternal identity and adversely affects children’s psychosocial well-being. While family-focused programmes show promise in improving outcomes for incarcerated parents and their children, culturally attuned prison-based parenting interventions remain underdeveloped and scarce, particularly in Asian contexts. To address this gap, a local parenting intervention grounded in the Double ABCX model of family resilience, the ‘Be My Hero’ programme, was designed for incarcerated fathers in Hong Kong, China.

Methods and analysis

A concurrent mixed-methods design will be used to evaluate the intervention. A convenience sample of 20–30 incarcerated fathers of children aged 3–11 will be recruited from three correctional facilities. Quantitative measures assessing paternal competence, father–child attachment, communication and resilience will be collected preintervention and postintervention. Qualitative data will be triangulated through semistructured interviews with participants, their children and social workers, supplemented by session logs documenting perceived shifts in paternal identity and programme feasibility. The intervention is expected to mitigate disruptions in paternal identity and strengthen father–child bonds. This may, in turn, reduce intergenerational disadvantage and improve overall family well-being.

Ethics and dissemination

This study has received ethical approval from The University of Hong Kong. Informed consent and assent will be obtained from the participants, their children and current guardians. Findings will be disseminated through peer-reviewed journals or conferences to inform correctional rehabilitation practices, encouraging the integration of family-focused and resilience-based approaches. Stakeholders, including practitioners and policymakers, may adopt similar interventions to promote healthier re-entry outcomes and reduce intergenerational disadvantage.

Understanding the impact of temporary childbirth migration on maternal and child health: study protocol of a community-based prospective cohort study in India

Por: Patil · R. · El Ayadi · A. M. · Tonde · K. · Choudhari · B. · Bhujbal · S. · Murro · R. · Agarwal · D. · Charlebois · E. · Bansal · P. · Nitnaware · N. · Kalantri · A. · Mundra · A. · Goyal · N. · Raut · A. · Rongsen-Chandola · T. · Juvekar · S. K. · Diamond-Smith · N.
Introduction

Temporary childbirth migration (TCM), where women return to their natal homes for pregnancy, delivery or postpartum for a limited duration, is a long-standing sociocultural practice in India. While often motivated by familial support and traditional norms, its implications for maternal and child health and health system engagement remain poorly understood. This study aims to quantify the impact of TCM on maternal and newborn outcomes and to explore how continuity of perinatal care and social support mediate these relationships.

Methods and analysis

We are conducting a three-site, community-based, prospective cohort study across the Health and Demographic Surveillance System sites of Vadu (Maharashtra), Sevagram (Maharashtra) and DEESHA (Delhi). A total of 3000 pregnant women will be enrolled in pregnancy (

Ethics and dissemination

This study has been approved by the Ethics committees at the KEM Hospital Research Centre Pune (KEMHRC/RVM/EC/1931), Society for Applied Studies (SAS/ERC/TCM Study/2024), Mahatma Gandhi Institute of Medical Sciences (MGIMS/lEC/COMMED/8412023) and University of California San Francisco (22-36484). All research activities are conducted in accordance with Indian Council of Medical Research Guidelines for biomedical research and the Declaration of Helsinki. On study completion, findings will be disseminated to diverse local, national and global stakeholders and published in academic journals.

Trial registration number

CTRI/2024/02/062881.

Variations in bronchopulmonary dysplasia prevalence and outcomes by definition: a multicentre cohort study from the Chinese Neonatal Network

Por: Yang · G. · Wang · L. · Gao · C. · Li · W. · Zhao · F. · Cao · Y. · Zhou · W. · Du · L. · Chen · C. · Lee · S. K. · Yang · J. · Zhang · H.
Objectives

To examine bronchopulmonary dysplasia (BPD) epidemiological data in Chinese very preterm infants and compare agreement between four diagnostic definitions and their predictive accuracy for discharge outcomes.

Design

Observational epidemiologic study of a multicentre cohort of the Chinese Neonatal Network (CHNN).

Setting

Tertiary neonatal intensive care units participating in the CHNN.

Participants

42 664 preterm infants born at

Measures

BPD was diagnosed using four definitions: Shennan 1988, the National Institute of Child Health and Human Development (NICHD) 2001 and 2018, and the Neonatal Research Network (NRN) 2019 definitions. BPD prevalence and severity were examined. Agreement was assessed using kappa statistics. Predictive accuracy for discharge outcomes was evaluated using c-statistics from multivariable generalised estimating equation models.

Results

Among 42 664 infants (mean gestational age, 29.0 weeks; 43.1% females), BPD prevalence varied significantly: Shennan 1988: 37.0%, NICHD 2001: 51.1%, NICHD 2018: 37.0%, NRN 2019: 37.0%. NICHD 2001 and 2018 definitions classified more infants as severe BPD (16.4% and 10.1%, respectively), while NRN 2019 classified more as grade 2 (moderate; 15.0%). Shennan 1988 showed good agreement with NICHD 2018 (=1.0) and Jensen 2019 (=1.0). Shennan 1988 (c-statistic range: 0.921–0.974), NICHD 2018 (0.948-0.978) and NRN 2019 (0.949-0.982) demonstrated higher discriminative accuracy for discharge outcomes than NICHD 2001 (0.854–0.925).

Conclusions

This study found a high prevalence of BPD among very preterm infants in China, varying by definitions. The Shennan 1988, NICHD 2018 and NRN 2019 definitions showed good agreement and better predictive accuracy for outcomes at discharge compared with NICHD 2001. These definitions could be prioritised for clinical use in our population.

Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)

Por: Al Alawi · A. M. · Al Busaidi · S. · Al Rasbi · S. K. · Al Farsi · R. S. · Al Zeedy · K. · Al Huraizi · A. R. · Al-Maqbali · J. S.
Objectives

To evaluate the efficacy of melatonin, a neurohormone regulating the sleep–wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.

Design

Single-centre, double-blinded, randomised, placebo-controlled trial.

Setting

General medical wards of a tertiary hospital in Oman.

Participants

Patients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.

Interventions

Participants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first.

Primary and secondary outcome measures

The primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.

Results

The study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.

Conclusions

In this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study’s power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made.

Trial registration number

NCT06509191.

The journey to healing: exploring travel challenges and associated costs for cancer care at a tertiary care centre in Puducherry, Southern India - a mixed methods study

Por: Devaraj · L. · Ayiraveetil · R. · Arikrishnan · K. · Sahu · S. K. · Ganesan · P. · Karunanithi · G. · Auroprem · S. P. · Srinivasan · T. S. · Thulasingam · M.
Objectives

This study aims to assess travel time, associated costs, challenges and factors influencing healthcare facility choices among persons with cancer in Southern India.

Design

An explanatory sequential mixed methods study.

Setting

The study was conducted in the cancer care outpatient department at a tertiary care centre in Puducherry, Southern India.

Participants

A total of 192 persons with cancer aged 18 to 65 years, diagnosed with breast, lip and oral cavity, cervical, lung or upper gastrointestinal cancers, and attending the cancer care centre between 2023 and 2024, were enrolled in the study through systematic random sampling. Additionally, 10 in-depth interviews were conducted using purposive sampling.

Results

Of the 192 participants, 89 (46.4%) belonged to a lower socioeconomic group, and 178 (92.7%) reported experiencing financial hardship while undergoing cancer treatment. The median travel time to a tertiary care centre was 4.3 hours (IQR: 2.07–7.3), with a median direct non-medical cost of Indian Rupees (INR) 453 (IQR: 200–987). Median expenditures for travel, food and accommodation were INR 200 (IQR: 123–400), INR 360 (IQR: 150–613) and INR 30 (IQR: 20–60), respectively, per single visit. A significant proportion of participants (n=146, 76%) were unaware of nearby cancer treatment centres and relied on peer recommendations when choosing their place of treatment. Key challenges identified included long-distance travel, financial burden due to high food and transportation costs and limited affordability for accommodation.

Conclusion

The study highlights that prolonged travel time and associated costs pose substantial financial strain on cancer-affected families. Enhancing awareness of available healthcare facilities, implementing patient-friendly travel and accommodation support systems and decentralising cancer care services can improve accessibility and mitigate both travel and financial burdens.

Defining chronic ambulatory care sensitive conditions in Malaysia: a collaborative consensus study

Por: Md.Sharif · S. · Fun · W. H. · Chidambaram · S. K. · Saw · P. S. · Mohd Nasarruddin · A. · Mohd Fauzi · N. · Azali · A. · Jailani · A.-S. · Sararaks · S.
Objective

This paper aims to describe the development of an inventory of chronic ambulatory care sensitive conditions (ACSCs) relevant to the Malaysian context and identify potentially preventable hospitalisations in the Malaysian Ministry of Health (MOH) facilities based on the developed list.

Design

Consultative panel discussion, multi-panel modified Delphi and secondary health data analysis.

Setting: Malaysian MOH healthcare facilities.

Participants

42 experts from the family medicine and internal medicine specialties (modified Delphi), and 2022 inpatient data from MOH hospitals (secondary health data analysis).

Outcome measures

A list of chronic ACSCs tailored to the Malaysian context and the proportion of potentially preventable hospitalisation in MOH hospitals.

Results

10 conditions were identified as chronic ACSCs for Malaysia, namely angina, asthma, chronic kidney disease, convulsions and epilepsy, chronic obstructive pulmonary disease, diabetes mellitus, heart failure, hypertension, iron deficiency anaemia and ischaemic heart disease. In 2022, these conditions accounted for 8.6% of potentially preventable hospitalisations among the total hospitalisations in MOH hospitals.

Conclusion

This study provides a base list of chronic ACSCs tailored to the Malaysian context, which enables monitoring of potentially preventable hospitalisations due to chronic conditions. The findings underscore a proportion of hospital admissions that could potentially be avoided through interventions that enhance outpatient care. The conditions identified as ambulatory care sensitive provide specific targets for policy action and resource allocation to optimise outpatient health services and thus reduce the burden of hospitalisations in the country.

Trial registration number

Malaysian National Medical Research Register, NMRR ID-23–02149-TBZ (https://nmrr.gov.my/research-directory/45c901d6-f121-4e79-9f38-dd7d283ec9a6).

Implementation of the community health system innovation project in three low- and middle-income countries: COHESION-I study protocol

Por: Lazo-Porras · M. · Bernabe-Ortiz · A. · Damasceno · A. · Sharma · S. K. · Praveen · D. · Mayo-Puchoc · N. · Aya Pastrana · N. · Bazan Maccera · M. · Chauque · A. · Cahuana-Hurtado · L. · Cardenas · M. K. · Gautam · U. · Khanal · V. K. · Jessen · N. · Mugabe · N. · Pereyra · R. · Pesant
Background

The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru).

Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities.

As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the context-specific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1.

Methods and analysis

A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only co-designed intervention and (3) the usual care arm. Data will be collected longitudinally over 18 months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others.

Ethics and dissemination

Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences.

Trial registration number

NCT06989502.

Measuring and monitoring safety of older adults living in retirement homes: a scoping review protocol

Por: Backman · C. · Engel · F. D. · Tonjock Kolle · A. · Papp · R. · Lam · A. · Freeman · L. · Li · W. · Sterling · E. · Fung · S. G. · Sinha · S. K. · Manis · D. R. · Wang · T.-F. · Kehoe MacLeod · K. · Hecimovich · C. · Webber · C. · Maskerine · C. · Syrowatka · A. · Fancott · C. · Kobewka · D
Background

The global population of older adults has grown at an unprecedented rate, and projections indicate that the number of older adults will continue to increase considerably in the coming decades. The clinical complexity of older adults living in retirement homes, also known as assisted living settings, is also increasing, and the regulations to ensure quality and safety standards in retirement homes are highly variable. The purpose of this scoping review is to map and summarise the methods used to monitor and measure the safety of older adults living in retirement homes, providing an overview of existing approaches and areas requiring further investigation.

Methods

This scoping review will follow the five stages of the Arksey and O’Malley scoping review process. We will report this review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A comprehensive search of four electronic databases (MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Web of Science Core Collection) will be performed, and reference lists of included articles will be searched. We will conduct a two-step screening process, data extraction and analysis of the included studies. We will include all primary study designs that report on safety measurement and monitoring of any type of harms. Relevant grey literature will also be identified. We will exclude studies that only report results from facilities providing 24-hour skilled nursing care or specialised care services, and those not published in English or French. This protocol is registered on the Open Science Framework (osf.io/8rheq).

Ethics and dissemination

No ethical approval is needed for the review, and we plan to present the results at research conferences and in a peer-reviewed article. Our findings may inform future research studies that seek to support and improve safety practices in retirement homes.

Maximizing Ageing Using Volunteer Engagement (MAUVE): one health systems journey to spread a volunteer-based intervention for acutely ill older adults - a prospective observational study

Por: Kokorelias · K. M. · Foster · N. · Gali · A. · Ellis · B. · Melady · D. · Sinha · S. K.
Objectives

Older inpatients face a higher risk of delirium, falls and functional decline during hospital stays. Volunteer programmes have been shown to improve patient outcomes in single settings, but little is known about their implementation and spread across multiple care environments. This study describes the implementation and system-wide spread of Maximizing Ageing Using Volunteer Engagement (MAUVE)—a volunteer-based programme supporting older patients’ cognitive, physical and social well-being—and evaluates its impact on healthcare staff satisfaction.

Design

A prospective observational service evaluation.

Setting

Emergency department, seven acute in-patient care units and two transitional care units within a Canadian hospital system from January to December 2019.

Participants

Older patients receiving care, volunteers delivering interventions and front-line nursing staff.

Interventions

Trained volunteers delivered up to six types of interventions targeting patients’ cognitive stimulation, physical activity, social engagement, functional support, orientation and companionship.

Outcome measures

Staff satisfaction with the MAUVE programme was measured using a structured survey administered 6 months after programme implementation. Data on patients and volunteers—including the number and type of interventions delivered, volunteer hours and patient reach—were also collected to assess feasibility and programme uptake.

Results

Over 12 months, 94 volunteers delivered 31 593 interventions to 3568 unique patients across three care settings. Front-line staff reported high satisfaction with the MAUVE programme, noting that volunteers enhanced patient care and enabled more direct patient interaction by staff.

Conclusions

The MAUVE programme is the first known volunteer-led patient engagement programme to be successfully implemented across acute, emergency and transitional care settings. This service evaluation demonstrates that structured volunteer engagement can support older patients’ well-being while enhancing staff satisfaction and enabling front-line care providers to deliver more direct care.

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.

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