In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

This study aimed to investigate the factors influencing health-related quality of life (HRQoL) in patients undergoing haemodialysis, focusing on the association between HRQoL dimensions and sociodemographic variables, clinical parameters, mental health status and biochemical indicators.

A multicentre cross-sectional study conducted over 30 months.

The study was carried out in secondary care centres across multiple locations in the Community of Extremadura, Spain.

A total of 150 patients undergoing haemodialysis were recruited between March 2022 and September 2023. Inclusion criteria required patients to be diagnosed with chronic kidney disease (CKD) and undergoing haemodialysis. Patients unable to provide informed consent or with severe cognitive impairment were excluded.

HRQoL was assessed using the Kidney Disease Quality of Life 36-item Short Form scale. Mental health parameters, specifically anxiety and depression, were evaluated using the Hospital Anxiety and Depression Scale. Biochemical markers such as haemoglobin and haematocrit levels, as well as sociodemographic and clinical data, were analysed for their influence on HRQoL.

Symptoms of anxiety and depression were prevalent among patients undergoing haemodialysis. Anxiety had the greatest negative effect on HRQoL, being significantly associated with lower scores in the mental component summary (MCS) (β = –2.06; 95% CI –2.78 to –1.33; R² = 0.106; p

Depression and anxiety, along with older age, were identified as key factors negatively affecting HRQoL of patients undergoing haemodialysis. Management of mental health, alongside optimisation of clinical care to minimise complications, could enhance the HRQoL in this patient population. Further research is recommended to develop targeted interventions addressing anxiety and other modifiable factors influencing HRQoL in haemodialysis patients.

Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.

This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.

This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.

Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg

ClinicalTrials.gov Identifier: NCT06633614

Undergoing pancreatic surgery represents an exceptional situation for the individual patient who therefore requires appropriate preoperative information. In daily clinical practice, however, there is often a lack of time for adequate patient information and education, which may be associated with stress, fears and worries with potentially negative impact on patient-reported and postoperative outcomes. The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical outcomes in patients scheduled for elective pancreatic resection.

The INFORM trial is an open-label, randomised controlled pilot trial with two parallel study groups and a planned sample size of 80 patients with any indication for pancreatic resection. The intervention group will receive access to videos providing detailed information on the planned surgery and the perioperative procedures within 2 weeks before surgery in addition to the standard preoperative preparations. The control group will only receive the standard preoperative preparations without video. Quality of life (QLQ), satisfaction with information on disease and treatment as well as disease symptoms will be assessed using the European Organisation For Research and Treatment of Cancer QLQ INFO25, C30 and PAN26 questionnaires. Surgical complications will be assessed according to appropriate classifications by Clavien and Dindo and the International Study Group of Pancreatic Surgery (ISGPS). To account for the potential impact of cancer treatment on the outcome parameters, a subgroup analysis including only patients without malignancy will be performed. In addition, potential influencing factors on QLQ scores will be investigated by comparing QLQ scores among appropriate subsets of patients.

This trial was approved by the institution’s Ethics Committee (reference number 1479/2024). All trial procedures are performed in accordance with the ICH E6 harmonised tripartite guideline on Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Once the study has been completed, the results will be published in due course.

German Clinical Trial Register number: DRKS00035173. Registered 14 October 2024 (https://drks.de/search/de/trial/DRKS00035173/details).

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Multi-national cohort study using routinely collected electronic healthcare data

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m²) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

NCT06457750.

Ages of attainment for early gross motor milestones have been widely studied, but definitions and measurement methods have varied greatly. Since delays in motor milestones have been used extensively as one of the earliest indicators of atypical development, it is imperative to establish a universal understanding of the methods and results reported on motor milestones in typically developing children. Therefore, the primary aim of this scoping review is to provide an overview of recent studies reporting ages of onset for independent sitting and walking in typically developing children worldwide; this will be achieved by summarising how these milestones have been operationalised and evaluated, the samples from whom these data have been drawn, and the reported ages of acquisition.

To meet inclusion criteria, articles must: be original research papers published in any language since 2003, contain a sample of typically developing children and report actual ages of onset for independent sitting and/or walking. To conduct this scoping review, the Joanna Briggs Institute methodological framework will be used. Search terms will include variations of the following concepts: acquisition of motor milestone (independent sitting and/or walking), age of onset, infancy. Six databases (CINAHL Plus, Embase, PsycNet: PsycINFO & PsycArticles, PubMed, Scopus, Web of Science: Core Collection) will be searched. Records from these databases will be screened for eligibility. Two people will independently review each record during title and abstract screening, and three people will independently screen full texts and extract data. Results will be displayed in tables, graphs and narrative summaries in the scoping review.

As the review will only include previously published data, ethics approval is not required. Findings will be shared at scientific conferences and in a peer-reviewed journal.

Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.

The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.

Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.

The rapid growth in the cancer survivor population in Chile and Latin America raises new challenges in addressing their care needs. This study assesses the health status and compares the quality of care and quality of life in cancer survivors at a primary care network and a private cancer centre in Santiago, Chile.

Retrospective cohort study.

Three primary care clinics and one cancer centre in Chile.

All breast and colorectal cancer patients identified from a primary care retrospective cohort of 61 174 were followed from 2018 to 2023 and compared with an equivalent sample of patients from a university cancer centre identified during the same period.

Quality of care was assessed based on American Cancer Society standards, while quality of life was measured using the EuroQol 5 Dimensions-5 Levels survey instrument.

A total of 420 cancer survivors participated in the study; 208 from primary care and 212 from the cancer centre. All participants received substandard care. Patients in primary care had lower educational levels and higher rates of comorbidity. They reported a lower quality of life score (72.22 vs 78.43, p

Cancer survivors face a significant disease burden and receive substandard care in Chile. As the primary source of care for this population, primary care is challenged to better integrate with speciality care to develop an effective shared care model for cancer survivors.

Dyspnoea affects 10% of the general population, and 12% of hospitalised patients report experiencing dyspnoea at rest. It is a common and distressing symptom experienced by people living with chronic obstructive pulmonary disease (COPD). Neuromodulation, which uses electrical stimulation to modulate neural pathways, is a validated clinical procedure offering a potential therapeutic approach. We speculate that non-invasive transcutaneous vagus nerve stimulation (tVNS) and trigeminal transcutaneous electric nerve stimulation (TENS) could improve dyspnoea management by targeting relevant neural circuits.

We will conduct a feasibility cross-over trial in people with severe COPD and significant exertional dyspnoea referred for pulmonary rehabilitation. Patients will be recruited following the prerehabilitation assessment visit comprising a clinical evaluation and a maximal cardiopulmonary exercise testing on ergocycle. Subsequently, two study visits will be conducted within 2 weeks apart from each other. Eight participants will perform a submaximal constant work rate at 80% workload of the VO₂ max, either with cervical tVNS (n=4) or trigeminal TENS (n=4). In a cross-over design, both patient groups will undergo sham and active treatment of the neuromodulation technique in a randomly assigned order. The main outcome will be feasibility, assessed by the percentage of patients who attend all visits and complete all tests. Secondary outcomes include other feasibility endpoints, the acceptability and suitability of the interventions (including an evaluation of sham as an exploratory outcome), and the incidence of adverse or undesirable events related to the procedures. Exploratory outcomes include changes in dyspnoea symptoms, measured using standardised questionnaires, such as Borg scale and the Visual Analogue Scale.

The protocol is approved by the institutional research ethics committee of the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Estrie—CHUS, Sherbrooke, Quebec, Canada (#2025-5604) and follows 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Results will be communicated in international meetings and submitted to peer-reviewed journals with respect to the 2010 CONsolidated Standards Of Reporting Trials (CONSORT) statement for feasibility studies.

NCT06985628.

Adolescents living with HIV (ALHIV) are a priority population for achieving global HIV prevention and treatment targets but experience poorer outcomes than adults. Long-term follow-up is essential to understand their transition into adulthood. By linking self-reported survey data with routine laboratory records, we established a social science clinical cohort of ALHIV South Africa’s Eastern Cape to explore factors shaping their long-term health and well-being.

Eligible participants were adolescents who were part of a three-wave quantitative cohort of ALHIV and not living with HIV (2014–2018) and had consented (adolescent and caregiver) to having their self-reported interviews linked with routine health records (n=1563). Adolescents were recruited into the existing three-wave cohort through clinic and community-based methods (97% enrolment, >90% retention over three waves). Between 2019 and 2022, we abstracted laboratory test records from the National Health Laboratory Services database for all eligible participants, with matching based on demographic variables. Individuals with at least one HIV-related record form our ‘lifelong social science cohort’, a total of 956 ALHIV (852 of 1107 ALHIV and 104 of 456 HIV-uninfected).

A total of 32 886 laboratory test records from 2004 to 2023 were matched through three rounds of data extraction, using iteratively refined record-linking searches. Most records were viral load (8864) and CD4 count (6801) results, with a median of 10 (IQR: 7–14) and 8 (IQR: 5–11) tests per matched adolescent, respectively. Overall, 956 of 1563 adolescents (61%) were successfully linked to laboratory data, including 852 of 1107 (77%) ALHIV. Analysis of the matched cohort survey-laboratory data provided several insights. Self-reported antiretroviral therapy adherence was strongly associated with viral suppression, even after adjusting for covariates. The strongest predictors of suppression were not reporting missed doses in the past 3 days, past week and not missing clinic appointments in the past year. Among adolescent girls and young women living with HIV, access to safe and affordable facilities, and kind and respectful staff were associated with a higher likelihood of multiple improved HIV-related outcomes, including viral suppression. Exposure to sexual and intimate partner violence predicted worse viral load outcomes among adolescents.

This integrated prospective cohort provides an opportunity to characterise long-term HIV treatment outcomes among ALHIV in Africa. We will investigate how individual, familial, community and healthcare experiences in childhood, and adolescence shape these outcomes. Since the COVID-19 pandemic happened during the period of matched data, we will also investigate the potential effect of the COVID-19 pandemic on adolescent HIV treatment outcomes, with potential subgroup analyses for individuals with available COVID-19-related results.