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Immersive virtual reality for cognitive rehabilitation in patients who had a stroke: study protocol for a randomised controlled trial

Por: Li · J.-L. · Meng · F.-L. · Ma · J. · Wu · J.-J. · He · S. · Zhang · J.-P. · Xu · Z.-J. · Zheng · Y.-X. · Mei · Y.-D. · Hua · X.-Y. · Xu · J.-G.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ChiCTR2600116040.

Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate cancer (REDOOM): study protocol for an open-label, parallel-cohort, multicentre clinical study

Por: Chen · Z.-J. · Zhu · X.-X. · Huang · H. · Ding · Y.-Z. · Zhuang · Y.-D. · Wang · L. · Li · P. · Yu · K.-Y. · Chen · H.-D. · Wang · H.-L. · Li · H.-Y. · Cai · B. · Deng · Z.-X. · Pan · Y. · Yang · Y. · Li · P. · Huang · K.-T. · Ji · X.-W. · Lin · Q. · Chen · W.
Objective

This trial investigates the efficacy of neoadjuvant therapy using rezvilutamide combined with androgen deprivation therapy (ADT), with or without docetaxel, in treating oligometastatic hormone-sensitive prostate cancer (omHSPC).

Methods and analysis

This prospective, open-label, multicentre trial aims to enrol 100 patients newly diagnosed with omHSPC (defined as ≤5 bone or lymph node metastases confirmed by conventional imaging, without visceral metastasis) who must express a desire to undergo surgery. All patients undergo a prostate-specific membrane antigen positron emission tomography/CT (PSMA-PET/CT) scan at enrolment or within 4 weeks before enrolment to assess and confirm the number of metastases at baseline. Scans should be performed before initiating ADT to avoid compromising test sensitivity. Then patients will be allocated into groups in parallel according to their own preferences: one group will receive an LHRH agonist or antagonist for 24 weeks to maintain continuous ADT or have undergone bilateral orchiectomy. Treatment with rezvilutamide will be maintained daily. The other group will be scheduled to complete up to six cycles of docetaxel within 24 weeks, with maintenance of continuous ADT and rezvilutamide for 24 weeks. Both groups will receive a conventional imaging evaluation at the 12th week. After neoadjuvant therapy, patients will undergo conventional imaging and a second PSMA-PET/CT assessment, followed by cytoreductive radical prostatectomy within the subsequent 6 weeks. After surgery, patients may choose to continue with ADT or rezvilutamide at their own discretion, until disease progression. The primary endpoint is pathological complete response, defined as the absence of residual viable tumour cells in the tumour bed on pathological evaluation of the postoperative specimen. Secondary endpoints include 1 year biochemical progression-free survival, overall survival, radiographic progression-free survival, time to prostate-specific antigen progression, quality of life scores (total and subscale) assessed using the Functional Assessment of Cancer Therapy-Prostate questionnaire, time to symptomatic progression, time to deterioration in Eastern Cooperative Oncology Group performance status, the interval from enrolment to an increase in score from baseline, the proportion of patients with a ≥30% reduction in prostate volume on imaging before cytoreductive surgery compared with pre-neoadjuvant therapy, minimal residual disease and major pathological response. The study plans to enrol a total of 100 patients. Patient recruitment for this study is scheduled to begin in May 2025.

Ethics and dissemination

This has been approved by the Ethics Committee in Clinical Research of the First Affiliated Hospital of Wenzhou Medical University (number KY2024-231). Results will be published in peer-reviewed publications.

Discussion

This study is expected to provide prospective evidence on the feasibility and potential clinical value of rezvilutamide combined with ADT, with or without docetaxel, as neoadjuvant treatment for newly diagnosed omHSPC.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2400093262).

Experience of patients with total knee arthroplasty for knee osteoarthritis in China: a patient journey map based on qualitative research

Por: Zhan · Y.-f. · Yang · L. · Zhang · S.-z. · Wu · B.-y. · Li · H.-w. · Zhai · Z.-j. · Bian · W.-w. · Liu · Y.
Objectives

This study aimed to address the lack of a holistic understanding of the total knee arthroplasty (TKA) journey in China by systematically mapping patient experiences to identify interconnected needs, emotional transitions and critical pain points across the entire care continuum.

Design

A longitudinal descriptive qualitative study using patient journey mapping methodology. Data from three sequential one-on-one semistructured interviews (preoperative, in-hospital postoperative and home rehabilitation phases) were chronologically coded into journey stages.

Setting

A tertiary hospital in Shanghai, China.

Participants

Twelve patients scheduled for elective TKA, aged 61–80 years (mean 70.25±5.86).

Results

Five categories with 17 subcategories were identified: (1) declining quality of life drives the need for change, (2) trust compensates for information gaps in decision-making, (3) hospital adaptation challenges heighten anxiety, (4) strong support needs emerge post-surgery and (5) navigating complex home recovery needs with insecurity. The patient journey was mapped across four stages: intention to change, consultation and decision-making, hospitalisation and surgery and rehabilitation and recovery. Analysis revealed several cross-stage issues: (1) the influence of disease status and treatment decision quality on postoperative outcomes, (2) inadequate preadmission preparation hindering hospital adaptation and comorbidity management and (3) insufficient predischarge planning leading to negative post-hospital rehabilitation experiences.

Conclusions

Quality deficits in early-stage interactions can trigger a cascading effect on subsequent patient experience and clinical outcomes. During the two critical phases of selecting a healthcare provider and deciding on surgery, patients undergo a transition from ‘insufficient information support’ to ‘reliance on trust’. However, irrational decision-making and unrealistic expectations collectively form a potential risk for postoperative decisional regret and dissatisfaction. Underused preoperative preparation leads to difficulties during hospitalisation, while inadequate discharge support hinders home recovery. Identifying these cross-stage pain points highlights timely intervention opportunities. Future improvements can be achieved through process redesign and technology integration, such as intelligent decision aids and remote rehabilitation systems, to enhance overall patient experience and outcomes.

Unmet needs for non-communicable diseases and sexual and reproductive health services among women of reproductive age in low-and-middle-income countries: evidence from the Demographic and Health Surveys

Por: Yin · Y. · Du · Y. · Zheng · Z.-J. · Ren · M. · Wang · M. · Jin · Y.
Introduction

Despite international efforts to address women’s long-term health and well-being, significant gaps in sexual and reproductive health (SRH) services and non-communicable diseases (NCDs) prevention remain, particularly in low-and-middle-income countries (LMICs).

Methods

We analysed data from 726 278 women aged 15–49 from six national surveys (2017–2021, Benin, Cameroon, Gabon, India, Madagascar and Mauritania) on unmet needs for NCD prevention (blood pressure, glucose, cervical cancer screening) and SRH services (contraception, antenatal, postnatal care). Unmet needs prevalence was calculated as the percentage of participants with specific unmet needs and estimated across demographics and socioeconomic groups using multivariable logistic regression models.

Results

Unmet needs were strikingly high for NCD prevention: 36.6% for blood pressure, 70.0% for blood glucose and 98.5% for cervical cancer screening. In contrast, unmet needs for contraception, antenatal care and postnatal care were relatively lower: 7.5%, 14.5% and 14.5%, respectively. Significant variations were observed across countries. India had the lowest unmet needs for SRH services: 6.7% for contraception, 13.1% for antenatal care and 13.1% for postnatal care. Gabon had lower unmet needs for prenatal (16.8%) and postnatal care (14.8%) compared with other African countries and the lowest unmet need for cervical screening at 84.7% (95% confidential interval 83.1% to 86.2%), over 10 percentage points lower than others. Furthermore, socioeconomic factors like higher education, better economic status, healthcare access, insurance and internet use significantly lowered unmet needs, especially for antenatal and postnatal care. Employed women had higher unmet needs for antenatal (35.7%) and postnatal (37.3%) care than unemployed women (28.1%, 27.8%) but lower for NCDs prevention (98.9%, 71.8%) under two definitions than unemployed women (99.3%, 79.2%).

Conclusion

This study highlights the urgent need to address high unmet needs for NCD prevention among women in LMICs, particularly cervical cancer screening. Unmet SRH needs are also a major concern, given significant disparities across countries. Especially, governments should prioritise measures to focus on vulnerable groups.

Development and validation of a prediction model for in-hospital mortality in patients with intra-abdominal sepsis: a dual-database study using MIMIC-IV and eICU databases

Por: Zhang · J. · Chen · Y. · Zhao · C.-c. · Wang · J. · Hu · Z.-j.
Objectives

To develop and validate a predictive model for assessing in-hospital mortality in patients with intra-abdominal sepsis (IAS), a leading cause of sepsis.

Design

Secondary analysis of two retrospective critical care databases.

Setting

Data extracted from the Intensive Care Medicine Information Marketplace IV (MIMIC-IV) and the eICU Collaborative Research Database.

Participants

Patients with IAS from MIMIC-IV (2008–2019; 1300 patients, 264 deaths) for model training and internal validation, and eICU (2014–2015; 149 patients, 33 deaths) for external validation.

Interventions

Clinical data were used for constructing a predictive model. Variable selection was performed using least absolute shrinkage and selection operator regression, followed by model development with multivariable logistic regression. The model was visualised as a nomogram.

Primary and secondary outcome measures

The primary outcome was in-hospital mortality. Secondary outcomes were model performance metrics, including the area under the receiver operating characteristic curve (AUC), calibration curves, decision curve analysis and clinical impact curves.

Results

Six predictors (lactate, age, activated partial thromboplastin time, blood urea nitrogen, total bilirubin and platelets) were identified. The predictive model showed good performance with an AUC of 0.795 (95% CI 0.758 to 0.831) in the training set (n=910) and 0.846 (95% CI 0.772 to 0.919) in the external validation set (n=149).

Conclusion

A robust predictive model was developed to estimate the risk of in-hospital mortality in patients with IAS. This tool may assist clinicians in enhancing patient management and decision-making.

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