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Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS

Por: Trad · G. · Lenglet · T. · Ledoux · I. · Querin · G. · Blancho · S. · Marchand-Pauvert · V. · Hogrel · J.-Y. · Pradat · P.-F.
Introduction

Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.

Methods and analysis

EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.

Ethics and dissemination

This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.

NCT06199284.

Rationale and design of the REMECHOQUE multicentre registry protocol: evaluating therapeutic trends in cardiogenic shock

Introduction

Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

Methods and analysis

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethics and dissemination

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

Barriers and facilitators to implementing the living guideline development framework in oncology: a mixed methods study

Por: Ismaila · N. · Harvey · B. E. · Einhaus · K. · Mbuagbaw · L. · Ma · J. · Thabane · L.
Objective

To explore stakeholder experiences with implementing the living guideline (LG) development framework in oncology, and to identify barriers, facilitators and solutions to support its uptake and sustainability.

Design

An exploratory sequential mixed methods design was used, beginning with qualitative semi-structured interviews with guideline development stakeholders, analysed thematically; and followed by a cross-sectional survey to quantitatively rate the importance of factors identified in phase one.

Setting

National and international oncology guideline development programmes using the LG development framework.

Participants

Stakeholders involved in LG development, including expert panel co-chairs, panel members, patient representatives, methodologists and administrative staff.

Results

Nine stakeholders participated in qualitative interviews, and 45 completed the survey. Most participants were male (5/9:56% qualitative; 26/45:58% quantitative) and based in the US (7/9:78% and 29/45:64%, respectively). Overall, the results from both the qualitative and quantitative strand revealed seven themes (34 subthemes) as barriers and six themes (21 subthemes) as facilitators. Additionally, 9 themes were proposed as solutions. The most frequently reported barriers included evidence timeliness, interpretation and publication delays. Prominent facilitators included effective management, resource optimisation and panel engagement. Participants strongly endorsed investment in artificial intelligence enhanced tools to improve the speed and efficiency of evidence acquisition and review.

Conclusion

While the LG framework provides strong methodological guidance, its practical application presents notable challenges, particularly in resource demands and implementation logistics. Successful adoption requires adequate infrastructure, expertise and oversight. These findings highlight critical considerations for developers aiming to implement sustainable LG models in oncology and beyond.

Knowledge, attitude and practice towards glaucoma among ophthalmic inpatients: a cross-sectional study in Hunan, China

Por: Zhao · Y. · Wu · P. · Liao · L. · Zhang · J. · Zhou · D. · Sun · W. · Dong · F. · Ye · C. · Duan · X.
Objectives

Glaucoma is an optic neuropathy caused by the gradual degeneration of retinal ganglion cells. This study aimed to investigate the knowledge, attitude and practice (KAP) towards glaucoma among ophthalmic inpatients.

Design

A web-based questionnaire.

Setting

Local hospital.

Participants

Ophthalmic inpatients (n=1238).

Primary and secondary outcome measures

The primary outcome was the patients’ KAP.

Results

Multivariable logistic regression analysis showed that rural residence (OR=0.488, 95% CI 0.313 to 0.762, p=0.002), college education or above (OR=4.996, 95% CI 2.942 to 8.483, p

Conclusions

Ophthalmic inpatients might have moderate knowledge and attitude, but a proactive practice towards glaucoma. A history of glaucoma, previous glaucoma surgery, education level, residency and alcohol consumption were potentially associated with knowledge and attitudes towards glaucoma among ophthalmic inpatients.

Implementing multi-component intervention to reduce antibiotic prescribing in primary care of rural China: a qualitative process evaluation of the trial

Por: Zhang · T. · Shen · X. · Chai · J. · Liu · R. · Wang · D. · Yardley · L. · Lambert · H. · Cabral · C.
Objectives

The overuse of antibiotics for respiratory tract infections in primary healthcare in rural China is a particular challenge and is highly related to antibiotic resistance. Our research team designed a multi-component intervention focusing predominantly on health practitioners to reduce antibiotic prescriptions in rural communities of China. The effects of the intervention were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of the implementation of the intervention and related influencing factors.

Design

Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.

Setting

Primary healthcare in rural China.

Participants

27 health practitioners from township health centres assigned to the intervention arm.

Intervention

A complex intervention to reduce antibiotic prescriptions in rural communities of China, which includes the following components: training for health practitioners, a public letter of commitment, patient leaflets, a decision support system and a peer support group.

Primary and secondary outcome measures

Not applicable.

Analysis

Data were analysed using thematic analysis.

Results

The overall multi-component intervention was described as useful in reducing antibiotic prescribing, with a particularly high acceptance and use of patient leaflets and the public letter of commitment among health practitioners. There were mixed views on the decision support system and peer support group. Practitioners reported usability-related barriers to using the decision support system during consultations. Practitioners did not understand the role or benefits of the peer support group and found it difficult to initiate group discussions, due to the lack of any existing clinical team at the primary care level.

Conclusions

The multi-component intervention appears to be acceptable and useful in primary healthcare in rural China. Successful implementation requires a comprehensive understanding of the contextual characteristics of the setting. Interventions to reduce antibiotic prescribing in China in the future could consider wider stakeholders including patients, retail pharmacies and health authorities.

Trial registration number

ISRCTN30652037 (01/12/2020).

Intradialytic kinetics of cardiac biomarkers during high-flux haemodialysis and postdilution haemodiafiltration: study protocol for a randomised crossover trial

Por: Drivsholm · C. L. · Nygaard · L. · Glerup · R. I. · Birnum · A. T. S. · Jensen · J. D. · Svensson · M.
Introduction

Cardiovascular disease (CVD) is the leading cause of mortality in patients undergoing chronic haemodialysis (HD). However, relatively few data exist regarding the influence of dialysis treatment on cardiac biomarkers such as high-sensitivity cardiac troponin I and T (hs-cTnI and hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), complicating their interpretation in the diagnosis of acute coronary syndrome and heart failure. This study aims to investigate the intradialytic kinetics of hs-cTnT, hs-cTnI and NT-proBNP, during HD and haemodiafiltration (HDF), in patients treated with chronic HD.

Methods and analysis

Single-centre, randomised, open-label, crossover study, comparing high-flux HD (FX 100 dialyser) and postdilution HDF (FX 1000 dialyser), regarding their potential clearance of hs-cTnI, hs-cTnT and NT-proBNP, in 24 stable patients treated with in-centre HD without acute CVD. The study will investigate changes in concentrations during and after high-flux HD and postdilution HDF and calculate reduction ratios, dialyser clearance and clearance by adsorption to the membrane of the selected cardiac biomarkers. Blood samples will be collected at baseline, after 10, 30, 60, 120, 180 and 240 min of dialysis and 30 min postdialysis. After 120 min of dialysis, dialysate will also be collected from the dialyser outlet line. The primary outcome is change from baseline in concentrations of hs-cTnI, hs-cTnT and NT-proBNP during high-flux HD and postdilution HDF.

Ethics and dissemination

The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20240016). Results will be published in an international peer-reviewed journal and disseminated at national and international research meetings.

Trial registration number

NCT06526702.

Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol

Por: Mendes · R. G. · Leonardi · N. T. · Castello-Simoes · V. · Kawakami · D. M. d. O. · Souza · J. V. R. · Schafauser-Segundo · N. S. · Simoes · R. P. · Pinto · F. G. · Araujo · G. H. G. · da Silva · M. M. C. · Moriguchi · C. S. · Franco · F. J. B. Z. · Pires Di Lorenzo · V. A. · Jor
Introduction

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

Objective

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

Methods and analysis

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

Ethics and dissemination

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

Trial registration number

NCT07050823/NCT07093021/NCT07134855.

Protocol for the development of a global core outcome set for the surgical treatment of sacrococcygeal teratoma in children: a systematic review and international Delphi study

Por: Dongen · M. C. · van Rijn · R. · Sharma · S. · Raphael · M. F. · de Vries · R. · Abouzeid · A. A. · Bugiani · M. · Chirdan · L. B. · van Heurn · E. L. W. · Derikx · J. P. M. · Kremer · M. E. B. · Steering Group · S.-C.
Introduction

Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

Methods and analysis

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

Ethics and dissemination

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

Effectiveness of poliovirus environmental surveillance in Ghana: an indicator-based performance evaluation across seven regions, 2018-2022

Por: Obodai · E. · Asante Ntim · N. A. · Duker · E. O. · Gberbi · E. · Antwi · C. N. · Mensah · J. Y. · Odame · D. · Boakye · J. D. · Bimpong · S. A. · Agbotse · G. D. · Odoom · N. · Adams · P. L. · Acquah · N. K. · Dickson · A. E. · Odoom · C. · Achempem · K. K. · Baffoe-Nyarko · I. · Egbi
Objective

To evaluate the performance of Ghana’s environmental surveillance (ES) system for poliovirus (PV) detection from 2018 to 2022 using standardised indicators developed by the WHO and the US Centers for Disease Control and Prevention.

Design

A retrospective performance evaluation using 10 key indicators benchmarked against global targets for PV surveillance.

Setting

Seven regions across Ghana, participating in the national ES programme implemented under the Global Polio Eradication Initiative.

Surveillance coverage

Wastewater sampling was conducted at designated ES sites, supported by field collection teams and laboratory personnel responsible for sample acquisition, processing and reporting of PV detection results.

Outcome measures

Detection rates of PV and non-polio enteroviruses (NPEVs), timeliness of sample collection and reporting, data quality and system stability.

Results

A total of 738 wastewater samples were collected. The system demonstrated high sensitivity, detecting circulating vaccine-derived PV type 2 in 51 (6.9%) of samples, Sabin PV types 1 and 3 in 61 (9.5%) and 114 (17.8%), respectively, and NPEVs in 491 (66.5%) of samples. Over 80% of samples met the recommended 21-day collection-to-reporting time frame. Data quality exceeded the ≥80% threshold, and workflows remained stable throughout the evaluation period.

Conclusions

Ghana’s ES system for PV was found to be flexible, stable and effective in generating high-quality data for early detection and public health response. These findings underscore the system’s critical role in supporting polio eradication efforts and highlight its potential as a model for surveillance in similar settings.

Traditional, integrative and complementary medicine use in the UK population: results of a nationally representative cross-sectional survey

Por: van der Werf · E. T. · Foley · H. · Carter · T. · Roberts · R. · Adams · J. · Steel · A.
Objectives

To describe the prevalence and characteristics of traditional, complementary and integrative medicine (TCIM) practice and product use by the population of the UK providing up-to-date data on the landscape of TCIM use in the UK.

Design, setting and participants

A cross-sectional online survey, administered using the Qualtrics platform, among adults (aged 18 years and over) residing in the UK (England, Wales, Scotland or Northern Ireland). Data were collected between May and October 2024. The 40-item instrument covered four domains: demographics, health status, use of health products and practices, and use of health services. Descriptive statistics were used to summarise survey responses, and ² tests were applied to assess associations between participant characteristics and TCIM use. Backwards stepwise logistic regression was conducted to identify predictors of TCIM use across four outcome categories (p≤0.05).

Results

The sample (n=1559) was broadly representative of the UK population. Prevalence of any TCIM use over a 12-month period was 65.9% with 19.1% consulting a TCIM practitioner and 63.3% using any TCIM product or practice. Bodywork therapists (massage therapists 9.4%, chiropractors 7.9%, yoga teachers 5.0%) and homeopaths (4.1%) were the most commonly consulted TCIM practitioners and Anthroposophic doctors were the least commonly consulted (2.1%). Among TCIM products, vitamin and mineral supplements were the most commonly used (37.3%) and relaxation or meditation practices were reported by 19.4% of respondents. TCIM users were more likely to be female, identify as Asian or Black, have a chronic disease diagnosis, report good health, possess private health insurance, have a higher education level, be employed (or seeking employment) and sometimes experience financial management difficulties.

Conclusions

There is substantial use of TCIM across the UK adult population and there is a need for more research on integrating TCIM into mainstream healthcare and the National Health Service. Clear strategies are necessary to enhance communication between TCIM and conventional healthcare providers, ensure patient safety and promote person-centred, coordinated models of care.

Study protocols for the GEPard project: systematic analysis of sex- and gender-specific differences in the efficacy of perioperative pain management - a two-pronged approach

Por: Floren · S. · Segelcke · D. · Machacek · P. A. · Vollert · J. · Norda · H. · Rohde · I. · Gilron · I. · Pogatzki-Zahn · E. M.
Introduction

Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.

Methods and analysis

The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.

Ethics and dissemination

No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.

PROSPERO registration number

The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).

Patient Agitation in the Intensive Care Unit: A Concept Analysis

ABSTRACT

Aim

Exploring the concept of patient agitation in the intensive care unit.

Background

Patient agitation in the intensive care unit is of widespread concern and linked to negative outcomes for patients, staff, and family members. There is currently no consensus on what constitutes agitation in the intensive care context, hindering effective and tailored prevention and management.

Design

Concept Analysis.

Method

Walker and Avant's eight-step concept analysis approach.

Data Sources

A comprehensive search was carried out in the databases MEDLINE, PsychINFO and CINAHL. A total of 32 papers published between 1992 and 2023 were included, reviewed, and analysed to explore definitions, attributes, antecedents and consequences of patient agitation.

Results

Patient agitation in the intensive care unit is characterised by excessive motor activity, emotional tension, cognitive impairment, and disruption of care, often accompanied by aggression and changes in vital signs. Antecedents encompass critical illness, pharmacological agents and other drugs, physical and emotional discomfort, patient-specific characteristics and uncaring staff behaviours. Consequences of agitation range from treatment interruptions and poor patient outcomes to the psychological impact on patients, families, and staff.

Conclusion

Agitation in the intensive care unit is a complex issue which significantly impacts patient treatment and clinical outcomes. For healthcare professionals, patient agitation can contribute to high workloads and job dissatisfaction. Due to the complex nature of agitation, clinicians must consider multifaceted strategies and not rely on medication alone. Further research is needed to fully understand patient agitation in the ICU. Such understanding will support the development of improved strategies for preventing and managing the behaviours.

Implications

A clearer understanding of patient agitation supports the development of tailored interventions that improve patient care, guide ICU training, and inform future research.

Patient or Public Contribution

This concept analysis was developed with input from a patient representative.

‘It's Skin Cancer’… a Rollercoaster of a Journey for Teenagers, Young People and Their Significant Other

ABSTRACT

Aim

To explore the lived experience of young people aged 16–24 years diagnosed with melanoma and that of their significant other in England.

Design

Interpretive phenomenological analysis.

Methods

Data were collected between August 2023 and January 2024 from one specialist cancer centre in England. Thirteen young people were approached, and 10 took part. Each young person was asked to nominate a significant other. Five nominated a significant other, and five nominated no one. Although interviews were offered face-to-face, virtual was the preferred method. In-depth semi-structured interviews were audio-recorded with the participant's consent. Interview data were transcribed verbatim and analysed.

Findings

The core conceptual thread woven throughout the findings was ‘It's like being on a rollercoaster,’ which is representative of the ups and downs of the treatment trajectory, often without the support of age-appropriate specialist care. Four superordinate themes were identified: ‘Is something wrong?’, ‘Suddenly it's serious’, ‘Out on a limb’ and ‘Finding our place’.

Conclusion

Although most young people were treated in a primary treatment centre for adults with cancer, their experience was challenging from route to diagnosis through their treatment and beyond. Few received age-appropriate care to support their physical, emotional, and social wellbeing to help them navigate the experience.

Impact

There is limited evidence exploring the experiences of teenagers and young adults living with melanoma or that of their significant other. This enriched understanding supports improvement of the care pathway and service delivery for these young people and their families.

Patient and Public Involvement

One young person with lived experience was paid as a consultant to be part of the research team. He helped develop the grant application and research questions, data analysis, and writing this paper.

Muslim communities perspectives and preferences regarding end-of-life symptom management: a systematic review and narrative synthesis

Por: Mourhli · J. · Sosnowski · K. · Kuhn · I. · Bowers · B.
Objectives

To provide a synthesis of the published research evidence on Muslims’ perspectives and preferences regarding end-of-life symptom management to inform future practice and research priorities aimed at providing sensitive end-of-life care.

Design

Systematic review and narrative synthesis.

Data sources

MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, ASSIA, The Cochrane Library and Global Health were searched from 1 January 1994 to 10 July 2024, alongside reference searches of included papers and hand searches of two journals.

Eligibility criteria

The included papers presented primary research on end-of-life care among Muslims in the British Isles.

Data extraction and synthesis

Data were collected on publication details, study aims, participants, methods and results. Studies were appraised using Gough’s weight of evidence framework. An inductive narrative synthesis consisting of three steps was conducted. This involved conducting a preliminary synthesis of findings, exploring relationships between studies and assessing the robustness of the synthesis.

Results

18 papers were included in the synthesis. Patients prioritised conformity between religion, culture and end-of-life symptom management. Symptom management preferences were also influenced by patients’ desire to maintain a sense of control at the end of life. Family-based care is culturally accepted, and indeed expected, to achieve a peaceful death. Healthcare professionals experienced challenges in providing sensitive symptom management given their unfamiliarity with the religious needs of Muslims.

Conclusions

Co-design research methods are essential to better understand care priorities within diverse Muslim communities. Meaningful collaboration among patients, families and healthcare professionals is necessary to identify mutually acceptable and beneficial approaches to promote culturally and religiously sensitive end-of-life symptom management.

Randomised controlled community trial assessing efficacy of the AWACAN-ED public toolkit to improve cancer symptom awareness and intention to seek help in South Africa and Zimbabwe: study protocol

Por: Scott · S. · Lurgain · J. G. · Day · S. · Guzha · B. T. · Pazukhina · E. · Arendse · K. D. · Govender · S. · Chirenje · M. · Sills · V. A. · Harries · J. · Jacobs · R. · Moodley · J. · Walter · F. M.
Introduction

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

Methods and analysis

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethics and dissemination

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

Trial registration number

PACTR202505475803308.

Assessing the utility of fractional excretion of urea in distinguishing intrinsic and prerenal acute kidney injury in hospitalised patients: a systematic review and meta-analysis

Por: Pan · H.-C. · Jiang · Z.-H. · Chen · H.-Y. · Liu · J.-H. · Chen · Y.-W. · Peng · K.-Y. · Wu · V.-C. · Hsiao · C.-C.
Objective

Acute kidney injury (AKI) is a significant challenge in hospital settings, and accurately differentiating between intrinsic and prerenal AKI is crucial for effective management. The fractional excretion of urea (FEUN) has been proposed as a potential biomarker for this purpose, offering an alternative to traditional markers such as fractional excretion of sodium. This study aimed to assess the diagnostic accuracy of FEUN for differentiating intrinsic from prerenal AKI in hospitalised patients.

Designs

We conducted a systematic review and bivariate random effects meta-analysis of diagnostic accuracy studies. The study followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Data sources

PubMed, Embase and Cochrane databases were searched from inception to 1 November 2023.

Eligibility criteria for selecting studies

We included observational studies that focused on patient with AKI and reported FEUN data sufficient to reconstruct a complete 2x2 contingency table (true positives, true negatives, false positives and false negatives) for evaluating its diagnostic accuracy.

Data extraction and synthesis

Two reviewers extracted data, assessed risk of bias with Quality Assessment of Diagnostic Accuracy Studies-2 and graded certainty of evidence using the GRADE approach. Pooled sensitivity, specificity, positive and negative likelihood ratios, and the area under the summary receiver operating characteristic curve (SROC) were calculated; heterogeneity was measured with I². A prespecified subgroup restricted to patients receiving diuretics served as a sensitivity analysis.

Results

12 studies involving 1240 patients were included, with an overall occurrence rate of intrinsic AKI of 38.8%. FEUN had a pooled sensitivity of 0.74 (95% CI 0.60 to 0.84) and specificity of 0.78 (95% CI 0.66 to 0.87), with positive predictive value and negative predictive value of 0.76 (95% CI 0.68 to 0.83) and 0.74 (95% CI 0.66 to 0.81), respectively. The SROC curve showed a pooled diagnostic accuracy of 0.83. Heterogeneity was substantial (I²>90%) for sensitivity and specificity. In a diuretic-only subgroup (six studies) specificity rose to0.87 and heterogeneity declined (I²=56%). Overall certainty of evidence was low owing to inconsistency.

Conclusions

FEUN is a biomarker with moderate diagnostic accuracy for differentiating between intrinsic and prerenal AKI in hospitalised patients. Its application could enhance AKI management; however, the high heterogeneity observed in our study highlights the need for further research to evaluate its utility across diverse patient populations and clinical settings.

PROSPERO registration number

CRD42024496083.

Trajectory, healthcare utilisation and recovery in 3590 individuals with long covid: a 4-year prospective cohort analysis

Por: Prashar · J. · Hillman · T. · Wall · E. C. · Sarna · A. · Mi · E. · Bell · R. · Sahota · J. · Zandi · M. · McNamara · P. · Livingston · R. · Gore · R. · Lunken · C. · Bax · E. · Nyam · R. · Rafie Manzelat · A. M. · Hishmeh · L. · Attree · E. · Cone · S. · Banerjee · A. · Heightman · M.
Objective

To characterise long-term trajectory of recovery in individuals with long covid.

Design

Prospective cohort.

Setting

Single-centre, specialist post-COVID service (London, UK).

Participants

Individuals aged ≥18 years with long covid (hospitalised and non-hospitalised) from April 2020 to March 2024.

Main outcome measures

Routine, prospectively collected data on symptoms, quality of life (including Fatigue Assessment Scale (FAS) and EuroQol 5 Dimensions (EQ-5D), return to work status and healthcare utilisation (investigations, outpatient and emergency attendances). The primary outcome was recovery by self-reported >75% of ‘best health’ (EQ-5D Visual Analogue Scale) and was assessed using Cox proportional hazards regression models over 4 years. Linked National Health Service England registry data provided secondary care healthcare utilisation and expenditure.

Results

We included 3590 individuals (63.3% female, 73.5% non-hospitalised, median age 50.0 years, 71.9% with ≥2 doses of COVID-19 vaccination), who were followed up for a median of 136 (0–346) days since first assessment and 502 (251–825) days since symptom onset. At first assessment, 33.2% of employed individuals were unable to work. Dominant symptoms were fatigue (78.7%), breathlessness (68.1%) and brain fog (53.5%). 33.4% of individuals recovered to >75% of best health prior to clinic discharge (recovery occurred median 202 (94–468) days from symptom onset). Vaccinated individuals were more likely to recover faster (pre: HR 2.93 (2.00–4.28) and post: HR 1.34 (1.05–1.71) COVID-19 infection), whereas recovery hazard was inversely associated with FAS (HR 0.37 (0.33–0.42)), myalgia (HR 0.59 (0.45–0.76)) and dysautonomic symptoms (HR 0.46 (0.34–0.62)). There was high secondary care healthcare utilisation (both emergency and outpatient care). Annual inpatient and outpatient expenditure was significantly lower in hospitalised individuals while under the service. When compared with the prereferral period, emergency department attendances were reduced in non-hospitalised patients with long covid, but outpatient costs increased.

Conclusions

In the largest long covid cohort from a single specialist post-COVID service to date, only one-third of individuals under follow-up achieved satisfactory recovery. Fatigue severity and COVID-19 vaccination at presentation, even after initial COVID-19 infection, was associated with long covid recovery. Ongoing service provision for this and other post-viral conditions is necessary to support care, progress treatment options and provide capacity for future pandemic preparedness. Research and clinical services should emphasise these factors as the strongest predictors of non-recovery.

Testing a mobile peer support intervention for persons with serious mental illness (DigiPer) in community mental health services: a feasibility study protocol

Por: Wang · B. · Mundal · I. · Fortuna · K. · Gronvik · C. K. U. · Eines · T. F. · Muzny · M. · Skjaerpe · J. N. · Storm · M.
Introduction

Persons with serious mental illness (SMI) often have coexisting medical conditions and experience a significantly reduced life expectancy compared with the general population. Peer support is considered an effective care approach for this population, and with rapid technological advancements, digital peer support, such as the DigiPer mobile application, can be a feasible self-management tool for persons with SMI. The study aims to assess the feasibility of DigiPer for persons with SMI in the Norwegian community mental health service settings.

Methods and analysis

This feasibility study will incorporate both qualitative and quantitative methods. The study consists of three phases: (1) simulation-based training among peer support workers using qualitative individual interviews; (2) pre–post study of DigiPer among peer support workers and service users using quantitative questionnaires and (3) process evaluation for peer support workers and service users using qualitative individual interviews. Peer support workers (n=5) and service users with SMI (n=15) will be recruited to evaluate the feasibility of DigiPer.

Ethics and dissemination

Ethics approval was granted from the Regional Committee for Medical Research Ethics (reference no. 853041), along with an assessment of processing of personal data by the Norwegian Agency for Shared Services in Education and Research (reference no. 810990). Findings will be disseminated through peer-reviewed publications and presentations at relevant national and international scientific conferences.

Protocol for the development of the WHO gestational weight gain charts

Por: Rangel Bousquet Carrilho · T. · Oladapo · O. T. · Hutcheon · J. A. · Gatica-Dominguez · G. · Rasmussen · K. M. · Flores-Urrutia · M. C. · Kumapley · R. · Tuncalp · O. · Bahya-Batinda · D. · Fayed · A. A. · Bogaerts · A. · Papageorghiou · A. T. · Munoz-Manrique · C. · Farias · D. R
Introduction

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

Methods and analysis

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

Ethics and dissemination

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

Healthcare utilisation among mothers of newborns with invasive group B Streptococcus disease: a 20-year national cohort study

Por: Lykke · M. R. · Sorensen · H. T. T. · Lawn · J. · Horvath-Puho · E.
Objective

Long-term healthcare utilisation (HCU) among mothers of infants with neonatal, invasive group B Streptococcus disease (iGBS) remains understudied; identifying these patterns could provide better support for affected families and address the iGBS public health burden.

Design

Cohort study.

Setting

Population of Denmark.

Participants

1565 mothers of infants with iGBS and 44 976 matched comparators from 1997 through 2021, with follow-up until 2022, using national health and social registry data.

Primary and secondary outcome measures

HCU including primary, inpatient, outpatient, psychiatric and surgical care was evaluated as period prevalence ratio (PPR) and rate ratios compared across three time periods (0–6 years, 7–13 years and 14–20 years) using a modified Poisson regression model and negative binomial regression with 95% CIs.

Results

Mothers of newborns with iGBS had higher PPRs of psychiatric care contacts in the first 0–6 years and 14–20 years following iGBS compared with the comparison cohort (RR0–61.12 (95% CI 0.93 to 1.35), RR14–201.24 (95% CI 0.97 to 1.58)). Exposed mothers had similar PPRs of primary, inpatient and outpatient care use as comparators, except for a slightly higher inpatient care use 7–13 years following iGBS. Exposed mothers had higher RRs for primary, inpatient, outpatient and psychiatric care contacts than mothers in the comparison cohort.

Conclusion

Mothers of iGBS-exposed infants had elevated psychiatric healthcare use and increased primary, and outpatient care visits compared with matched comparators, suggesting heightened healthcare needs and psychosocial burden of caregiving up to 20 years post-iGBS.

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