Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, ³Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

Sarcopenia is characterised by loss of muscle mass and strength. Although ageing is the most likely risk factor of sarcopenia, sarcopenia is prevalent even in non-elderly people. Type 2 diabetes (T2D) is a risk factor for sarcopenia, as T2D shares with sarcopenia several aetiological factors. Meanwhile, gestational diabetes mellitus (GDM) is characterised by metabolic alterations that resemble those observed in T2D, including increased insulin resistance (present even in physiologic pregnancies). Hence, GDM presents two major risk factors for sarcopenia, that is, dysglycaemia and insulin resistance. Moreover, the number of pregnancies at age >40 years is increasing, which is in an age range in which sarcopenia prevalence is already not negligible. However, data on the prevalence of sarcopenia prevalence in GDM and its effect on pregnancy outcomes are limited. Thus, this study aims to evaluate the prevalence of sarcopenia in women with GDM (and in pregnant women without GDM), identify risk factors and determine its effect on delivery and maternal and fetal outcomes.

For this study, 100 each of women with and without GDM will be recruited. Women will undergo an oral glucose tolerance test within weeks 24–28 for possible GDM diagnosis (in weeks 16–18 for high-risk women). Muscle/physical performance tests will be conducted at weeks 28–32 for possible diagnosis of sarcopenia/presarcopenia. Cognitive function will also be assessed. For all women, information regarding pregnancy progression, along with any complications, will be collected. Collected data will be analysed according to the main objectives of the study: (i) determine the prevalence of sarcopenia/presarcopenia in pregnancy with and without GDM, (ii) identify factors associated with sarcopenia risk, (iii) determine the effect of sarcopenia/presarcopenia on pregnancy outcomes, (iv) explore the relationship between sarcopenia and cognitive function. Therefore, this study will provide information on sarcopenia/presarcopenia prevalence in GDM and, possibly, in pregnancy not complicated by dysglycaemia. Furthermore, the study will provide knowledge on the main factors associated with sarcopenia/presarcopenia in GDM/pregnancy. The identification of such factors will be relevant for an initial guidance for treatments that may prevent sarcopenia in GDM/pregnant women. This will become of even greater interest if sarcopenia/presarcopenia influences pregnancy outcomes, especially in GDM women.

The study protocol has been approved by the Comitato Etico Regione Toscana - Area Vasta Nord Ovest (CEAVNO) on 25 July 2024 and by the Local Ethics Committee of the Medical University of Vienna on 17 June 2024. Participants’ enrolment began in May 2025. The results of the study will be presented at national and international conferences and in peer-reviewed journals.

ClinicalTrials.gov Identifier: NCT06876090; Registration Date: 2025-03-14

Gastric outlet obstruction syndrome (GOOS) is a clinically significant condition often associated with advanced malignancies, particularly gastric and pancreatic cancers. Management strategies focus on symptom relief, nutritional improvement and quality of life enhancement. Surgical gastrojejunostomy (GJ), especially laparoscopic GJ, is commonly recommended for patients with good functional status and life expectancy exceeding 2 months. The modified Devine partial stomach-partitioning gastrojejunostomy (PSPG) was introduced to address functional limitations of conventional GJ, including duodenogastric reflux and afferent loop syndrome. However, PSPG has not been widely adopted, and its role in malignant GOOS remains unclear.

This systematic review aims to synthesise the available evidence on the application, functional outcomes and oncological implications of the modified Devine technique in malignant GOOS.

This review follows Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The PICO framework was employed to define eligibility criteria, focusing on studies examining PSPG for malignant GOOS as palliative surgery or a bridge to resection. Literature searches were conducted across Medline, EMBASE, Cochrane Library, ClinicalTrials.gov and grey literature sources using a prospectively registered search strategy, between August and October 2025, following protocol submission. Two independent reviewers will screen articles, extract data and assess quality using the Newcastle-Ottawa Scale where applicable. Data will be synthesised narratively.

As this study is a systematic review of published literature, formal ethical approval was not strictly required. In accordance with institutional policy, the protocol was submitted to the Institutional Review Board of Hospital Prof. Doutor Fernando Fonseca, which confirmed that the study met criteria for ethical exemption. Findings will be disseminated through peer-reviewed publication.

This study is registered in PROSPERO (CRD42024593540). Search strategy is registered in searchRxiv https://doi.org/10.1079/searchRxiv.2025.00838.

PROSPERO CRD42024593540

https://doi.org/10.1079/searchRxiv.2025.00838.

Acute pain following pulmonary surgery can affect the recovery process of patients. The use of intrathecal morphine (ITM) injections offers a long-lasting analgesic effect, but its clinical application remains controversial. This study aims to investigate the impact of combining bupivacaine with ITM injections on the quality of postoperative recovery in patients who have undergone pulmonary surgery.

This multicentre, randomised, double-blind, controlled trial will enrol 254 patients undergoing elective lung surgery, who will be randomly assigned in a 1:1 ratio to either group IT (receiving an intrathecal injection of 3 mg bupivacaine and 0.25 mg morphine before general anaesthesia induction) or the control group (C group). The primary outcome includes postoperative recovery quality on day 1 (quality of recovery, QoR-15), with secondary outcomes encompassing postoperative recovery quality on days 2 and 3 (QoR-15), pain scores within 72 hours postoperatively, analgesic rescue, intraoperative haemodynamic parameters, opioid consumption, postoperative adverse reactions, recovery metrics, complications, chronic pain incidence and sleep quality.

The results will be disseminated through peer-reviewed publications. This study protocol (V.2.0, 30 October 2024) involves human participants and has been approved by the Ethics Committee of Affiliated Hospital of Yangzhou University (number 2024-08-02-2), Taicang Hospital Affiliated to Soochow University (number 2025 SR-041) and Yichang Central People’s Hospital (number 2024-513-02). Each individual who agrees to participate in the research will provide written informed consent after the objectives and procedures of this study are explained to them.

ChiCTR2400092935. Registered on 26 November 2024.

Microcirculatory dysfunction drives the end-organ pathophysiology of circulatory shock but is not reflected within existing clinical indices of perfusion, such as blood pressure. The choroidal vasculature of the retina can be measured non-invasively and we hypothesised that this may reflect dysfunction in other organs. We tested the feasibility of measuring the choroid in intensive care and explored associations between choroidal measurements and clinical parameters.

A pilot study of optical coherence tomography conducted in a sample of general intensive care unit (ICU) patients.

A tertiary mixed ICU within the UK.

15 patients were recruited. One patient was excluded following withdrawal of active treatment. 12/14 (86%) of the remaining patients had successful baseline imaging and 6 (40%) of these had follow-up imaging within intensive care. These patients had a mean age of 56.3 years, were 71% (10/14) male and mean Acute Physiology and Chronic Health Evaluation 2 (APACHE2) score on ICU admission was 20.4.

Choroidal anatomy, including choroidal and suprachoroidal thickness, as well as volumetric analysis of intrachoroidal blood vessels, was assessed using automated image segmentation along with clinical, physiological and biochemical data at ICU admission and after an interval of 12–72 hours. Feasibility and safety data were assessed throughout ICU admission.

Baseline choroidal vascular index and choroidal thickness were positively associated with fluid balance, and negatively with APACHE2 score, haematocrit and albumin content. A measurable suprachoroidal space was seen in nine (75%) patients (range 25.0–110.0 microns) and was inversely associated with heart rate. There was substantial intraindividual variation in choroidal measurements over time. There were no safety concerns.

Measuring the choroid is feasible in patients with Intensive Care Society Level 2 or Level 3 requirements. The suprachoroidal space may be markedly enlarged in these patients. Exploratory associations with systemic variables suggest that the choroid may provide information about the microvascular function of other major organs. Size and change of choroidal measurements may reflect perfusion pressure and vascular leakage.

To understand how public health practitioners (PHPs) are using parental guidance on talking to children in their work with parents. In 2021, evidence-based guidance was produced for parents of young children to facilitate these conversations, but it is unclear how this guidance is being promoted to parents or used by PHPs.

Qualitative study, consisting of in-depth, semistructured interviews.

Local authority, National Health Service or other healthy weight service providers in the UK.

Participants were PHPs working on children’s healthier lifestyles programmes in the UK as part of the UK’s National Child Measurement Programme (NCMP). Invitations to participate were distributed via the Department of Health and Social Care and regional and national networks.

24 participants were interviewed. Practice varied between organisations with the guidance being used in NCMP letters to parents, in follow-up phone calls with parents and in training NCMP staff and other health or education professionals. Participants valued the evidence-based guidance and its compassionate tone, feeling it gave them and parents, confidence in addressing a sensitive topic. Some felt it was too lengthy for parents with learning disabilities or low literacy levels. Others identified a need for similar guidance for older children. Though helpful, participants acknowledged the guidance was only one small part of a necessary systems-wide approach to promoting healthy weight.

The guidance is a useful tool but needs systematic promotion to increase use and effectiveness. Further work is warranted to develop adapted versions for other populations.

Unplanned hospital readmissions within 30 days of discharge measure the quality of healthcare. This study aims to identify the characteristics of patients at higher risk of readmission.

Retrospective cohort study.

North-east Italy (Marca Trevigiana Local Health Authority).

The study examined a total of 39 467 index admissions from hospital discharges (SDO) in the 890 000-inhabitant area during 2022.

Readmission rates and 95% CIs were computed by risk factor, age and type of admission (surgical or medical). A logistic mixed-effects model was used to estimate readmission OR, adjusting for potential confounders.

A total of 2197 readmissions occurred within 30 days of the index admission, resulting in an overall rate of 30-day readmissions of 6.7% (CI 6.4% to 7.0%). The median time to readmission was 11 days (IQR 5 to 20). In the multivariate analysis, after adjusting for age and sex, the following clinical conditions were associated with a higher risk of readmission: alcohol-related disease (OR=2.06, CI 1.36 to 3.13), metastatic cancer (OR=1.98, CI 1.57 to 2.50), epilepsy (OR=1.93, CI 1.36 to 2.75), dialysis or end-stage kidney disease (OR=1.92, CI 1.39 to 2.66), chronic obstructive pulmonary disease (OR=1.88, CI 1.49 to 2.36), stoma (OR=1.72, CI 1.22 to 2.44), transplant (OR=1.62, CI 1.03 to 2.55), being bedridden (OR=1.57, CI 1.28 to 1.93), anaemia (OR=1.57, CI 1.35 to 1.83), urinary tract infection (OR=1.54, CI 1.30 to 1.83), pneumonia (OR=1.52, CI 1.31 to 1.75), dementia (OR=1.49, CI 1.24 to 1.79), diabetes (OR=1.37, CI 1.17 to 1.61) and transfusion (OR=1.34, CI 1.03 to 1.73).

Several chronic and acute conditions at index admission significantly increased the risk of readmission. Strengthening transitional care, outpatient services and palliative care could mitigate readmissions.

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

To examine differences in physical health conditions among female veterans compared with male veterans and female civilians.

Cohort analysis using data from the UK Biobank, incorporating self-reported and hospital-derived health information.

Veteran status was identified using Standard Occupational Classification codes. The study included female veterans (n=546), male veterans (n=2722) and female civilians (n=66 305).

Physical health conditions were identified through self-report and hospital records. Multivariable logistic regression models estimated associations between veteran status and selected health conditions, adjusting for age, sociodemographic factors, time in service, body mass index and current smoking status.

Compared with female civilians, female veterans had increased odds of chronic obstructive pulmonary disease (adjusted OR (aOR) 1.79, 95% CI 1.04 to 3.08) and lower odds of hypertension (aOR 0.74, 95% CI 0.59 to 0.93), with no significant difference in musculoskeletal conditions or osteoarthritis. Compared with male veterans, female veterans had significantly higher odds of osteoarthritis (aOR 1.61, 95% CI 1.25 to 2.08), migraine (aOR 2.63, 95% CI 1.66 to 4.19) and thyroid disorders (aOR 4.42, 95% CI 2.83 to 6.89).

Female veterans have distinct physical health profiles, including a greater burden of musculoskeletal and respiratory conditions compared with male veterans and female civilians. These findings highlight the need for targeted prevention and clinical interventions for women with a history of military service.

Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.

Prospective, observational and simulation study.

Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.

This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.

Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.

In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).

Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.

To identify the drivers of changes in modern contraceptive use (MCU) among women of reproductive age in three selected sub-Saharan African countries.

This is a secondary analysis of cross-sectional Demographic and Health Survey (DHS) data using a multivariable Blinder-Oaxaca decomposition approach.

The sample consisted of 73 777 women aged 15–49 years from the two most recent DHSs conducted in Gabon (2012, 2019–2021), Senegal (2018, 2023), and Tanzania (2015, 2022). Pregnant women were excluded from the sample.

We assessed the change in MCU over the two most recent DHS waves for the three countries.

MCU declined in Gabon from 26.5% to 18.4%, in Senegal from 20.5% to 18.5% and in Tanzania from 29.7% to 27.6%. Across the three countries, the contributions of compositional changes to trends in MCU varied significantly. In Senegal, characteristics explained 181% of the change, driven by reduced exposure to family planning information (157%), high parity (147%) and employment (9%), while education, urbanisation, union type and lower parity mitigated the decline. In Gabon, the overall characteristics included led to an increase in MCU (–44%), rather than a decline, reflecting the effect of favourable changes toward higher education (–19%) and urban residence (–10%). However, the behavioural effect was predominant (144%). This suggests that modifications in individual attitudes, practices and preferences regarding contraception outweighed structural changes, leading to the overall downward trend observed in Gabon. In Tanzania, neither characteristics nor coefficients significantly explained observed changes. Results for Tanzania indicate that none of the factors included in the model made a significant contribution to the change in MCU. Conversely, increases in educational attainment and urbanisation contributed to an increase in MCU in both Senegal and Gabon.

Interventions promoting MCU should consider the role of receiving family planning information at a health facility, parity, work status, educational attainment and urbanisation in informing changes in the use of modern contraceptive methods.

The standard treatment for high-grade squamous intraepithelial lesions is excisional involving the uterine cervix, while surveillance is an acceptable approach for low-grade squamous intraepithelial lesions. There is controversy about excisional treatment on pregnancy outcomes. The objective of this study was to determine pregnancy outcomes in women living with and without HIV who underwent excisional treatment for high-grade cervical intraepithelial lesions.

This retrospective cohort study compared the pregnancy outcomes of women with and without HIV who were or were not treated for cervical intraepithelial lesions. A cohort of 488 women with and without HIV infection who did or did not receive excisional treatment for cervical intraepithelial lesions between 2009 and 2022 was enrolled. Adverse pregnancy outcomes (preterm delivery and pregnancy loss) in women with and without HIV, untreated or treated for cervical dysplasia, were recorded and analysed. The significance of the obtained results was judged at the 5% level.

The study was conducted at all Academic Model Providing Access to Healthcare-Kenya satellite sites, which offer cervical cancer screening and treatment for cervical dysplasia in western Kenya. The Moi Teaching and Referral Hospital was also included.

A cohort of 488 women aged between 20 years and 49 years, with and without HIV, diagnosed and treated for high-grade cervical intraepithelial neoplasia, and those followed up for low-grade cervical intraepithelial neoplasia between 2009 and 2022, were included.

The study was interested in adverse pregnancy outcomes, particularly pregnancy loss and preterm delivery following cervical excision treatment for high-grade cervical intraepithelial lesions.

After adjustment for confounding factors, excisional treatment involving the uterine cervix—particularly cold knife conisation—was associated with higher odds of adverse pregnancy outcomes (OR 13.1; 95% CI 1.1 to 137.1; p=0.032). A prior history of adverse pregnancy outcomes was also strongly associated with subsequent adverse outcomes after treatment (OR 37.7; 95% CI 13.8 to 102.7; p

Adverse pregnancy outcomes after excisional treatment of the uterine cervix for high-grade squamous intraepithelial lesions are multifactorial and were associated with cold knife conisation and prior adverse pregnancy outcomes, while maternal HIV infection was not independently associated with adverse outcomes.

The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.

An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.

Two tertiary stroke care centres in South India participated in the study.

Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.

High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.

The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).

The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.

The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.

Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).

Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.

This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.

The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.

jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).