Poststroke cognitive impairment (PSCI) is a prevalent complication of stroke, characterised by deficits in one or more cognitive domains (eg, memory, attention, executive function). Beyond increasing mortality and disability risks, PSCI frequently co-occurs with motor dysfunction, which impairs activities of daily living and reduces quality of life. Due to the complexity of neural networks involved in PSCI, clinical practice currently lacks targeted therapeutic strategies; existing interventions (eg, pharmacotherapy, traditional cognitive training) are limited in scope and variable in efficacy. Here, we developed an innovative dynamic cognitive training system integrated with virtual reality (VR) technology, based on principles of neuroplasticity and multisensory integration. This study aimed to explore the intervention effects of this system on cognitive function in patients with PSCI while incorporating exploratory neuroimaging assessments to provide descriptive and hypothesis-generating information regarding brain functional changes associated with the intervention.

This single-centre, randomised controlled, evaluator-blinded clinical trial will assess the rehabilitative efficacy of VR-based cognitive training in patients with PSCI. A total of 60 patients who had a stroke will be enrolled and randomised to either a conventional rehabilitation group or a VR intervention group. The intervention will last 2 weeks, with five sessions of 60 min each training session per week. During the 60-minute training session, both groups will receive 30 min of conventional rehabilitation training. For the remaining 30 min, the control group will undergo traditional cognitive rehabilitation while the experimental group will be subjected to VR-based cognitive rehabilitation training. The primary outcome measure is the Montreal Cognitive Assessment; secondary outcomes include the Mini-Mental State Examination, Trail Making Test and Stroop Test. Assessments will be conducted at three time points: baseline (T0), immediately postintervention (T1) and 4 weeks after completing the intervention (T2). This study aims to evaluate the preliminary effectiveness of a VR-based intervention in improving multidimensional cognitive function, while incorporating exploratory neuroimaging outcomes to generate hypothesis-forming insights into potential neural correlates.

The trial was approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (2025–1933-273-02).

The results will be submitted to a peer review journal or at a conference.

ChiCTR2600116040.

Infertility affects millions of people globally. The presence of key indicators of infertility and fertility care is critical to monitoring access and utilisation of services as part of universal health coverage. In the area of infertility, it is important to track both clinical and non-clinical outcomes of care. Previous reviews have examined clinical indicators for infertility and fertility care; however, non-clinical indicators have received limited attention. This systematic scoping review aims to map the literature related to the non-clinical indicators of fertility care and their types and dimensions.

This review will adhere to the established reporting guidelines for systematic scoping reviews and has been registered in the PROSPERO database to avoid duplication. A systematic literature search strategy will be developed and adapted to four electronic bibliographic databases (Medline [PubMed], EMBASE [Embase.com], CINAHL [EBSCOhost] and Web of Science [Clarivate]). Supplemental searches will be performed to obtain relevant grey literature from major health research institutes and international organisations. The search will be limited to literature published from 1990 to date. This review will cover all non-clinical interventions relevant to human infertility and fertility care. Two reviewers will independently screen papers and identify relevant studies for inclusion using predetermined criteria and extract data based on a predefined template. Types and dimensions of non-clinical indicators will be identified and a descriptive narrative synthesis will be used to describe the overall landscape. This review is expected to start on 1 June 2026 and conclude by 15 December 2026. A preliminary search strategy has been developed.

As this study is based on a review of publicly available literature, ethical approval is not required. This scoping review will provide a comprehensive overview of the existing non-clinical indicators used to measure, report and monitor infertility and fertility care services. The findings will provide a comprehensive evidence base for developing a set of core indicators to monitor infertility and fertility care that can be adopted globally. Results will be disseminated through peer-reviewed publications, scientific conferences and webinars.

CRD420251177901.

Global increases in armed conflict, forced displacement, pandemics and economic instability have contributed to rising levels of psychological distress worldwide, placing relevant segments of the population at increased risk of developing mental health conditions. This burden is particularly pronounced in humanitarian and low-resource settings where access to specialist mental health services is limited. Scalable, low-intensity, evidence-based psychological interventions are therefore urgently needed. In response, the WHO has developed transdiagnostic programmes, including Self-Help Plus (SH+) and Doing What Matters in Times of Stress (DWMS). Although these interventions are increasingly implemented across humanitarian and public health contexts, evidence for their effectiveness and implementation has not yet been systematically synthesised.

This preregistered systematic review and meta-analysis will be conducted in accordance with Cochrane Collaboration standards and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will include randomised controlled trials evaluating the effectiveness of SH+ or DWMS, alongside qualitative and mixed-methods studies examining their implementation among stressor-exposed individuals of any age. Outcomes will include symptoms of depression and anxiety, general distress and post-traumatic stress symptoms. Moreover, we will examine effects on well-being, psychosocial functioning, adverse events and implementation outcomes (eg, acceptability, feasibility, fidelity). We will search Cochrane CENTRAL, APA PsycNet, Web of Science Core Collection, Embase and Scopus for records published from 2016 onwards. Searches will be supplemented by hand-searching preprint repositories and citation tracking. Risk of bias will be assessed using the Revised Cochrane Risk of Bias Tool and a customised appraisal tool for studies on implementation. Quantitative data will be synthesised using random-effects multilevel meta-analyses, with meta-regression models applied to examine moderators. Bayesian meta-analyses will be conducted where appropriate as sensitivity analyses to assess the robustness of the findings. Certainty of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Ethical approval is not required. Findings will be disseminated through an open-access peer-reviewed publication, a plain-language summary, and the Open Science Framework, where all materials will be made publicly available.

CRD420251168521.

To systematically review qualitative studies on the self-management experiences and needs of patients with chronic obstructive pulmonary disease (COPD) and to provide evidence for developing needs-based self-management intervention strategies.

A systematic review and meta-aggregation of qualitative studies conducted in accordance with the Enhancing Transparency in Reporting the Synthesis of Qualitative Research statement.

PubMed, Cochrane Library, Web of Science, Scopus, CINAHL, Embase, CNKI, Wanfang Database, VIP Database and CBM were searched from database inception to March 2025 for qualitative studies on COPD self-management experiences and needs.

Qualitative studies involving adults (≥18 years) with a confirmed diagnosis of COPD that reported patients’ real feelings, experiences and needs during the self-management process in any setting (hospital, community or home). Studies were excluded if the full text could not be obtained or data were incomplete, if they were duplicate publications or if they were not published in Chinese or English.

Two reviewers independently screened titles, abstracts and full texts, extracted data using a standardised form and assessed methodological quality using the 2016 Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research. Findings (participants’ quotations and authors’ interpretive statements) were synthesised using a JBI meta-aggregation approach to develop categories and overarching synthesised findings.

15 qualitative studies were included, comprising 251 patients with COPD. A total of 52 findings were identified, grouped into 13 categories and synthesised into 4 overarching findings: (1) physical symptom burden strongly shapes psychological well-being during COPD self-management; (2) patients face multiple and interrelated barriers to effective self-management; (3) some patients develop active coping strategies and self-management resources; and (4) patients express multidimensional and continuing support needs.

Patients with COPD experience substantial physical and psychological distress and face multiple challenges in the self-management process. Healthcare professionals should prioritise patients’ lived experiences, establish comprehensive and coordinated support systems and develop diversified, needs-based intervention strategies to address patients’ multidimensional needs, thereby enhancing self-management capacity and improving quality of life.

CRD42024607051.

To develop, train and test a deep learning model Image-based PROgnostication applied to Chest X Rays (IPRO-X) tool that predicts the inpatient (IP) admission risk in patients with suspected pneumonia presenting to the emergency department (ED).

The study consists of a retrospective (training) and prospective non-interventional shadow deployment (validation) of a deep learning model.

Three-hospital tertiary care system with two EDs.

Consecutive adult patients (18 years old or older) who presented to the ED from December 2022 to February 2023 with a chief clinical complaint potentially related to pneumonia were reviewed for eligibility (n=5567), with a final number of 3677 included in the validation study.

IPRO-X was developed using standard two-dimensional convolutional neural network InceptionNet architecture and processes chest radiographs (CXRs) acquired at admission generating a continuous value from 0 (IP-negative) to 1 (IP-positive). We examined IPRO-X’s ability to predict IP admission using accuracy, area under the curve (AUC), receiver operating characteristic, sensitivity, specificity, positive predictive value and negative predictive value. IPRO-X scores were compared against observed outcomes (admission and discharge) to determine clinical utility in an ED setting. Four thresholds were defined from the retrospective phase: Youden optimal, highest specificity and thresholds equivalent to 30-day mortality rates of Pneumonia Severity Index (PSI) Risk class IV and Confusion, Respiratory Rate, Blood Pressure and Age 65 or older Score (CRB-65) scores 1 and 2. Performance was also analysed per group of chief complaints.

In the validation set, 3677 patients (1777 (48%) female, median age 56 years (min 18, max 99)) were included. IPRO-X predicted IP admissions with an AUC of 0.795, and in the pneumonia-specific chief complaints, AUC increased to 0.828, whereas in non-related pneumonia chief complaints, the AUC decreased to 0.755. IPRO-X score was significantly higher in admitted patients compared with discharged patients (p

IPRO-X applied to CXR of patients with signs and symptoms commonly related to pneumonia in the ED can accurately predict IP admission.

To evaluate the feasibility, acceptability and potential efficacy of the culturally adapted Educate, Nurture, Advise Before Life Ends (ENABLE) programme in Singapore for patients with heart failure (HF) and their family caregivers.

Non-blinded randomised wait-list controlled pilot study, using Simon’s randomised phase II trial design.

Specialist outpatient clinics in a tertiary cardiac centre in Singapore.

Patients had a diagnosis of American Heart Association Stage C or D HF, were symptomatic with New York Heart Association functional class 2 and above symptoms, had a prognosis of 6 months, a hospitalisation in prior 6 months and were on disease-directed HF management. Patients already known to palliative care (PC) were excluded. Recruited caregivers were family caregivers of patients.

ENABLE integrates PC early into HF care. It starts with a comprehensive PC assessment with a PC physician and nurse. This is followed by a series of nurse coach-led health coaching sessions for both patients and caregivers. After the completion of health coaching, participants would receive follow-up phone calls to review their coping up to 6 months post-enrolment.

Feasibility was defined by the proportion of approached patient-caregiver dyads who consented to participate and the proportion of participants who completed health coaching. Acceptability was defined by a score of at least 12 out of a maximum of 16 for the Client Satisfaction Questionnaire 4-Item Survey. Primary efficacy outcome measure was the change in patient quality of life (QOL) at 6 months as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) total score, with the target effect size (Cohen’s d) being at least 0.25 SD in favour of ENABLE. Other secondary outcomes included patient/caregiver anxiety and depression scores on the Hospital Anxiety and Depression Scale, spirituality scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale and caregiver QOL on the Singapore Caregiver Quality of Life Scale.

Feasibility: recruitment was carried out from February 2022 to October 2023. We approached 164 patient-caregiver dyads and 60 patient-caregiver dyads (36.6%) consented. A total of 48 patients and 44 caregivers started on health coaching, of which 44 patients (91.7%) and 43 caregivers (97.7%) completed health coaching.

Acceptability: patients’ satisfaction was high, at 85.7% and 87.5% in the intervention and wait-list arm, respectively. Caregivers were similarly satisfied, at 100% and 87.5% in the two arms, respectively.

Efficacy: intervention-arm patients had a higher mean total KCCQ score at 6 months than wait-list-arm patients (difference in means=12.4; 95% CI 0.9 to 24.0; Cohen’s d=0.43). There was no difference in caregiver QOL changes between trial arms at 3 months and 6 months. Both patients and caregivers had improvements in anxiety at 3 months and sustained improvements in depression and spirituality at 6 months.

Proportion of participants who completed health coaching was high, though proportion of approached participants who consented was lower than expected. Our acceptability and efficacy targets were met. Further phase III testing is planned.

NCT05211882.

To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes.

Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026.

Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes.

Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Severe hypoglycaemia, ketoacidosis and serious adverse events.

10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I²=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I²=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I²=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered.

Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain.

CRD42024508625.

Burn injuries constitute a significant health concern, requiring immediate first aid to mitigate further tissue damage and complications. Most countries worldwide recommend application of 20 min of cool running water (20CRW) within 3 hours of the burn as the cornerstone in burn first aid management. Despite its widespread acceptance and proven benefits in reducing the severity of burns and subsequent interventions, concerns regarding the risk of hypothermia following this intervention persist, representing at least a perceived barrier to the delivery of 20CRW. When it does occur, hypothermia in patients with burns has been associated with higher mortality rates, even after controlling for burn injury severity. Developing an understanding of the incidence of post-burn hypothermia following 20CRW, with a specific focus on potential predictive and/or causative factors, is quintessential.

A retrospective cohort study of all adult and paediatric patients with thermal burn injuries presenting to one of 11 participating Australian or New Zealand hospitals between 1 January 2024 and 31 December 2024 will be conducted. The primary outcome is the incidence of hypothermia in patients with burns following their arrival at the emergency department (ED). Secondary outcomes include influence of burn first aid cooling, risk factors influencing hypothermia, impact of hypothermia on clinical patient outcomes and incidence of hypothermia in patients with burns in non-ED settings.

Ethical approval was granted by the Children’s Health Queensland Human Research Ethics Committee (CHQHREC; HREC Ref No: HREC/25/QCHQ/114285) as well as Health and Disability Ethics Committees, New Zealand (HDEC; Ref No: 2026 EXP 23892). The study findings will be formally disseminated through peer-reviewed journals and conference presentations.

Enhancing Quality of Life for Individuals with Stroke (EQL-stroke) is an international, collaborative multiphase project aiming to strengthen supported self-management for older adults recovering from stroke at home in Sweden, Latvia and the Netherlands. Existing poststroke pathways may provide insufficient support for self-management during the transition from hospital to home, and there is limited evidence on interventions that integrate social networks and everyday environmental context.

EQL-stroke uses a participatory, multimethod design across three phases. Phase I generates knowledge through policy review, qualitative interviews and people–place mapping (~25 participants per country) and includes cross-cultural adaptation of the Collective Efficacy of Networks Scale. Phase II co-designs and specifies a tailored social network-informed supported self-management intervention (the Network-Based Intervention), including core components and principles for local adaptation (~15 participants per country). Phase III will recruit approximately 20–40 stroke survivors for a single-arm pilot feasibility study with an 8-week follow-up and embedded process evaluation to assess feasibility, acceptability and fidelity in routine practice.

Ethical approval has been obtained from the Swedish Ethical Review Authority (reg. no. 2025-00083-01), the Rīgas Stradina Universitāte Research Ethical Committee (reg. no. Rīgas Stradina Universitāte Research Ethical Committee) and the Research Ethics Committee of the Faculty of Spatial Sciences, University of Groningen (reg. no. 2025-07). Findings will be disseminated through peer-reviewed publications, stakeholder engagement activities and patient/public channels.

With a prevalence of around 7.6%, developmental language disorders (DLDs) without comorbidities are among the most common and most frequently treated childhood disorders. Standard DLD therapy in Germany consists of individual therapy sessions once per week within speech–language therapy practices. In reality, these sessions only take place every 10–14 days on average. Online therapy may be beneficial but is not yet standard practice in Germany. Although DLD group therapy has been proven to be effective, it is rarely undertaken in Germany. The aim of this study is to compare the effectiveness of online DLD therapy for small groups of children with standard one-to-one therapy.

The effectiveness of two treatment settings is evaluated in 212 children with moderate-to-severe DLD (ages 3 years to 6 years 11 months) in the multicentre, block randomised controlled trial (RCT) THErapy ONline. Five centres in Germany participate. Children are randomly assigned to the intervention group (online interval-intensive therapy, IG1, n=106) or the control group (extensive standard in-person therapy, IG2, n=106). A speech and language assessment is conducted at baseline (study entry, T0), 12 months (T1) and 18 months (T2) after therapy start. The co-primary outcome parameters are the speech and language test scores of phonological speech sound production, expressive vocabulary, grammar production and language comprehension at T1. The secondary outcome parameters comprise two composite speech and language test scores at T1 and T2, including phonological working memory scores and the individual scores of the aforementioned tests at T2, as well as process evaluation parameters (time expenditure, resource utilisation, such as salary costs of speech–language therapists, additional costs of the online therapy, adherence to appointments and therapy acceptance).

This study has been approved by the Institutional Ethics Review Board of Westphalia-Lippe (2022-282 f-S). Parents provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences.

DRKS00030068