The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

This study aims to examine the longitudinal relationship between fear of disease recurrence and depressive symptoms in elderly patients who have experienced postoperative adjacent vertebral refractures, as well as in their spouses, using the actor-partner interdependence model (APIM) to assess both individual and mutual psychological influences.

A prospective longitudinal study in China.

A total of 230 osteoporotic vertebral compression fractures (OVCF) and their spouses were selected by convenience sampling method.

Simplified fear disease Progression Scale and 9-item Patient Health Questionnaire were used at admission (T1), before discharge (T2) and 1 month after discharge (T3), respectively. Equivalence test and cross-lagged analysis of APIM were used for statistical examination.

A total of 224 valid questionnaires were collected in this study, yielding an effective recovery rate of 97.31%. Across the measurement stages, both patients and their spouses exhibited a decreasing trend in scores for fear of disease recurrence and depressive symptoms. The subjective effect analysis revealed that, in elderly patients with postoperative adjacent vertebral refracture, fear of disease recurrence significantly and positively predicted depressive symptoms at the subsequent stage (T1->T2: β=0.18, T2->T3: β=0.17, pT2: β=0.16, T2->T3: β=0.17, pT2: β=0.21, T2->T3: β=0.20, pT2: β=0.20, pT3: β=0.18, pT2: β=0.21, T2->T3: β=0.20, pT2: β=0.17, T2->T3: β=0.16, all p

It is recommended that medical staff prioritise the assessment and management of fear of disease recurrence and depressive symptoms in elderly patients with OVCF and their spouses, and strategically leverage the mutual influence between them to minimise depressive symptom levels as much as possible.

Patients undergoing anterior cruciate ligament reconstruction (ACLR) and patellar fracture frequently present with substantial pain, swelling and inflammation. These pathophysiological changes not only intensify postoperative pain but also compromise the intra-articular environment via mechanical compression and localised microcirculatory deficits, thereby impeding recovery. Conventional interventions for postoperative swelling, such as cryotherapy and physical agent modalities, are commonly applied yet exhibit limited efficacy. Multilayer low-stretch bandage (MLB), with its gradient compression properties, has recently demonstrated superior swelling control and functional restoration; however, existing research primarily assesses short-term outcomes and lacks a systematic analysis across the postoperative continuum—acute, subacute and chronic phases—as well as long-term follow-up. This study therefore employs a multi-temporal intervention design and extended follow-up to evaluate the effectiveness of MLB in managing swelling, modulating pain and enhancing long-term knee function and activities of daily living across different recovery stages. The findings aim to furnish high-level evidence for knee rehabilitation protocols, refine clinical practice and ultimately improve patient quality of life.

This prospective, single-blind, randomised controlled trial will enrol 36 patients following ACLR and patellar fracture. Participants will be allocated at a 1:1 ratio through computerised randomisation to either an experimental group receiving MLB plus conventional rehabilitation, or a control group receiving conventional rehabilitation alone. The study spans 12 weeks, with follow-up assessments scheduled at baseline (T0), 4 weeks (T1), 8 weeks (T2) and 12 weeks (T3). Outcome measures comprise the Hospital for Special Surgery (HSS) Knee Rating Score, affected limb oedema regression rate, Visual Analogue Scale (VAS) pain score, knee range of motion, quadriceps and hamstring muscle strength, centre of pressure (COP) displacement parameters, proprioceptive testing, the 36-Item Short Form Health Survey (SF-36) and the Holden Walking Function Classification. A subsequent 1-year follow-up will assess long-term efficacy and patient satisfaction, while adverse events are strictly monitored throughout the entire study period. Adherence to Consolidated Standards of Reporting Trials guidelines is maintained, and a single-blind design ensures that both participants and assessors remain unaware of group assignments. This trial aims to establish an evidence-based foundation for optimising postoperative rehabilitation in this patient population.

Ethical approval for the study was obtained from the Medical Ethics Committee of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School (2025-0141-01). The results of the study will be published in a peer-reviewed medical journal.

ClinicalTrials.gov chiCTR2500100566. Registration date is 10 April 2025.

Cognitive impairment is a common consequence after stroke. Intermittent theta burst stimulation (iTBS) has emerged as a promising cognitive therapy. However, traditional iTBS typically employs lower doses and one-size-fits-all stimulation targets, which may not fully capitalise on the potential of this therapy and warrants further evaluation for both efficacy and safety. This study aims to evaluate the efficacy and safety of high-dose iTBS targeting the individualised frontoparietal cognitive network (FCN) identified by precision functional neuroimaging for post-stroke cognitive impairment (PSCI).

This is a prospective, double-blind, sham-controlled, parallel-group randomised controlled trial. 60 eligible participants with PSCI will be randomly assigned (1:1) to an active iTBS or a sham-controlled group. The active group will receive high-dose iTBS (3600 pulses/day) at 80% resting motor threshold targeting the left individualised FCN, guided by a real-time neuronavigation system. The sham group will follow identical procedures using a sham coil. Both groups will also undergo conventional computerised cognitive training. The intervention will be administered on workdays over a period of 3 weeks, totalling 15 workdays. The primary outcome is the change in Montreal Cognitive Assessment scores from baseline to immediately post-treatment. Secondary outcomes include long-term change in global cognition, activities of daily living and specific cognitive domains (assessed by a comprehensive neuropsychological battery covering memory, attention, executive function and language), as well as mood. Assessments occur at baseline, post-treatment and 3-month follow-up. Safety outcomes, specifically the number of adverse events related to iTBS, will be monitored and recorded throughout the trial.

This study has been approved by the Medical Ethics Committee of the China Rehabilitation Research Center. The results of this study will be published in peer-reviewed scientific journals and disseminated at academic conferences.

NCT05953415.

Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.

This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.

This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).

Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.

This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.

The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.

ChiCTR2400090542.

To gain an in-depth understanding of the experience of elderly joint replacement patients in making surgical decisions and to identify the needs of patients in the decision-making process.

A qualitative study, semistructured interviews were used and analysed by Colaizzi’s seven-step method.

This study was conducted in the orthopaedics department of a tertiary hospital in Wuhan.

Eligible participants were aged 60 years or older, scheduled for elective joint replacement surgery, cognitively intact and voluntarily consented to participate in the study.

We conducted interviews with a total of 25 elderly patients who underwent joint replacement surgery. This study reveals three themes and eight subthemes regarding the surgical decision-making experiences of elderly patients undergoing joint replacement. The three themes summarise three stages of the decision-making experience, respectively, trade-offs before decisions, feelings during decision-making and expectations after the decision. In the first stage, three subthemes were identified: (1) weighing the surgical risks and benefits, (2) assessment of medical proficiency and (3) low patient involvement in decision-making. In the second stage, three subthemes emerged: (1) internal fear, (2) self-doubt and (3) a heavy burden. In the third stage, two subthemes were identified: (1) a recovery process filled with confidence and (2) a desire for improved quality of life.

This study delves deep into the experiences of elderly patients undergoing joint replacement surgery during the surgical decision-making process. It provides a theoretical basis for decision-making assistance for elderly joint replacement patients, which is conducive to reducing patients’ decision-making conflicts and enhancing their decision-making capabilities.

Hypertension and depression frequently co-occur, complicating patient management and worsening outcomes. This scoping review aims to systematically map non-pharmacological interventions for managing comorbid hypertension and depression, providing insights into current practices and guiding future research.

Following the Joanna Briggs Institute guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews standards, a comprehensive search was conducted across multiple databases, including PUBMED, Embase, PsycINFO, CINAHL, Cochrane Library, Chinese Biomedical Literature Database and Chinese National Knowledge Infrastructure, covering the literature from January 2004 to December 2023. Studies were selected based on predefined inclusion criteria focusing on non-pharmacological or complex interventions. Data extraction was performed using the Template for Intervention Description and Replication checklist to ensure detailed and structured summaries of each intervention.

Fifteen quantitative studies were included, most of which were pilot randomised control trials, pre-post studies and with generally small sample sizes (20 to 2365). Interventions were categorised into integrated and coordinated care, behavioural and psychological interventions and physical and lifestyle interventions. Delivery methods varied, with most interventions being face-to-face, while a few used digital platforms such as mobile apps and telephone support. Disease-level and patient-level outcomes were mainly reported, while only three examined system-level outcomes. 13 of 15 included studies showed positive results in managing comorbidity. The variability in follow-up periods (ranging from 1 week to 12 months) and measurement instruments across studies limited the ability to draw consistent long-term conclusions.

This scoping review highlights the role of psychosocial and non-pharmacological interventions, particularly collaborative/integrated care and behavioural therapies, in managing comorbid hypertension and depression. These interventions consistently improve depressive symptoms, with mixed effects on blood pressure control. Further research is needed to standardise core outcomes and evaluate the long-term effectiveness and scalability of these interventions.

Ischaemic stroke, the most prevalent stroke subtype, imposes a significant long-term disease burden. However, patients with first-ever stroke exhibit substantial individual variability in poststroke health trajectories, manifesting heterogeneous clinical presentations. We therefore started with the overall health of patients in order to delineate heterogeneous clusters characterised by distinct demographic profiles, clinical features and behavioural determinants and elucidate shared longitudinal trajectories in the temporal development of adverse health outcomes.

We designed a multicentre, cross-sectional and longitudinal study focusing on patients with first-ever ischaemic stroke. We will employ patient self-reported outcomes and objective measurements to comprehensively evaluate patients’ health status from a multidimensional perspective. Following baseline assessments, participants will undergo follow-up evaluations at 1 month, 3 months and 6 months post inclusion. The primary objective is twofold: (1) to identify distinct patient clusters with heterogeneous multidimensional health profiles using the k-prototype clustering algorithm and (2) to characterise synergistic trajectories of core health attributes within the largest cluster through parallel process latent class growth modelling. By combining cross-sectional and longitudinal analyses, this phased study should elucidate static heterogeneity and dynamic recovery patterns following a first-ever ischaemic stroke.

The project conforms to the ethical principles enshrined in the Declaration of Helsinki (2013 amendment) and all local ethical guidelines. The ethics committee at the University of South China approved the study (approval no. 2024 NHHL023). The ethics committee of Gansu Provincial Hospital approved the study (approval no. 2025–023). The ethics committee of the Central Hospital of Shaoyang approved the study (approval no.KY-2025–12). The findings will be published and presented at conferences for widespread dissemination.

Trial registration number: ChiCTR2500098442

Diabetes distress (DD) constitutes a negative emotional experience for patients with diabetic retinopathy (DR), having a detrimental impact on their physical and mental health.

The aim of this study was to understand the current status and influencing factors of DD in patients with DR and to explore the relationship between self-efficacy, coping styles and DD.

A cross-sectional study.

The study was conducted at the Eye Hospital of Wenzhou Medical University, Zhejiang Province, China.

Patients diagnosed with DR.

The Diabetes Distress Scale was used to assess DD.

DD was present in more than half (53.07%) of patients with DR. There were significant differences in DD among patients with DR who reported different employment statuses, modes of residence and body mass index. Coping styles partially mediated the relationship between self-efficacy and DD, with the mediating effect accounting for 71% of the total effect.

Considering the high prevalence of DD among patients with DR, healthcare professionals should pay more attention to the psychological needs of patients with DR. Effective interventions could be used to promote self-efficacy and coping styles of patients with DR, leading to lower levels of DD.

This study aimed to compare the predictive performance of novel adiposity indices (a body shape index (ABSI) and visceral adiposity index (VAI)) with traditional anthropometrics (body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR)) for cardiovascular disease (CVD) risk in urban China. Secondary objectives included evaluating composite indices derived from principal component analysis (PCA) and evaluating optimised risk stratification strategies.

A community-based cross-sectional study.

Urban and rural communities in Nanjing, China, from 2020 to 2023.

38 427 adults aged 35–79 years, recruited via stratified sampling. Individuals aged 79 years, who were pregnant or had severe illness or cognitive impairment were excluded.

The primary outcome was a CVD high-risk status (defined by Chinese guidelines). Secondary outcomes included detection rates, area under the curve (AUC), ORs and multicollinearity diagnostics.

Among participants, 23.3% (n=8905) were classified as high risk for CVD. In this study, WHtR demonstrated the greatest discriminative power (AUC=0.826, 95% CI 0.819 to 0.832), followed by a PCA-derived composite obesity index (COI; AUC=0.822). ABSI showed a clear risk gradient, with a 38.5% detection rate in the high-risk group (ABSI≥0.085), and VAI exhibited a modest but statistically significant effect (OR=1.026, p=0.001). Severe multicollinearity among traditional indices (variance inflation factor >40) was mitigated by COI. Combined models (eg, COI+ABSI+ VAI) achieved comparable AUC (0.825) with improved parsimony (AIC=17 4010.34). Age, hypertension and dyslipidaemia were key covariates (ORs=1.15–3.88, p

WHtR and composite indices (eg, COI) appeared to perform better than other indicators in predicting CVD risk, whereas ABSI and VAI enhance stratification in specific subgroups. Implementing WHtR-based screening in primary care, supplemented by composite indices and novel markers for high-risk individuals, may help optimise prevention strategies in urbanising Chinese populations.

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Ten hospitals across four Canadian provinces.

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Domain-specific recruitment rates and protocol adherence.

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

NCT05893147.

Atrial fibrillation (AF) constitutes a growing public health challenge. Consequently, the exploration of modifiable risk factors is essential for advancing AF prevention and management. While obstructive sleep apnoea is established as a risk factor for AF recurrence following catheter ablation, and its treatment with continuous positive airway pressure therapy reduces recurrence rates, the influence of non-sleep apnoea-related sleep indicators remains unclear. This systematic review aims to elucidate the association between these non-sleep apnoea-related sleep indicators and AF recurrence to inform optimised management strategies.

A comprehensive search will be performed in databases, including PubMed, Embase, the Cochrane Library, Chinese National Knowledge Infrastructure, VIP Database and Wanfang Data, covering publications from database inception to 27 August 2024. Study selection will be performed independently by two reviewers using predefined eligibility criteria, with the screening process documented in a referred Reporting Items for Systematic Review and Meta-Analysis-compliant flow diagram. Data will be extracted using standardised forms and risk of bias of included studies will be assessed with the Risk Of Bias In Non-randomised Studies-of Interventions tool. Non-sleep apnoea-related sleep indicators, including sleep duration, sleep quality, sleep latency, sleep efficiency, REM (Rapid Eye Movement)/NREM (Non-Rapid Eye Movement), etc, serve as exposure factors. The primary outcome is defined as AF recurrence, whereas the secondary outcome comprises quality of life measures among AF patients. Should sufficient data be available, a meta-analysis will be performed using appropriate statistical methods; otherwise, a narrative synthesis will be conducted.

This study uses publicly available data, so ethical approval is not required. The findings will be disseminated through peer-reviewed journals and scholarly platforms to inform clinical practice and future research.

CRD42024607124.

Emergence agitation (EA), defined as acute postoperative restlessness after general anaesthesia, is a common complication in the post-anaesthesia care unit (PACU). The reported incidence of EA is nearly 30% in neurosurgical surgery, which bears tremendous risks for neurosurgical patients. Although current evidence suggests that remifentanil may reduce EA risk in non-cardiac settings, its preventive efficacy in patients undergoing intracranial surgery remains unclear.

In this single-centre, randomised, double-blind, parallel-group prospective clinical trial, patients scheduled for elective craniotomy will be screened to confirm their eligibility. After surgery under general anaesthesia, patients will be assigned to groups to receive either remifentanil or placebo infusion on admission to the PACU. The remifentanil group will be given remifentanil infusion at a dose of 0.1 µg/(kgxmin), whereas the control group will be given the same volume of normal saline. The primary outcome is the effect of remifentanil on EA incidence during the emergence period. Secondary outcomes include the following: time to regain consciousness, extubation time, total PACU duration, extubation comfort score measured by the modified Minogue Scale, postoperative pain intensity assessed using a Numerical Rating Scale, awakening quality and postoperative delirium assessed by alertness and orientation score, and a 3-Minute Diagnostic Interview for Confusion Assessment Method.

The study protocol (V.4.0, dated 14 August 2025, No. 2025–0954) has been approved by the Institutional Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine and complies with the Declaration of Helsinki and relevant regulations for research involving human participants. Findings will be disseminated through peer-reviewed publications and conference presentations.

ChiCTR2500096691.

Falls are among the most common adverse events in hospitals, causing significant harm to patients and increasing healthcare costs. In 2023, over 160 000 falls were reported in China, with 62.5% of hospitalised patients suffering fall-related injuries. Falls not only prolong hospital stays but also negatively impact nursing quality and healthcare system efficiency.

This study explored the lived experiences of nurse managers in preventing and managing inpatient falls in hospital settings and examined the contextual and managerial factors influencing fall prevention practices.

We conducted a qualitative study using a phenomenological approach to explore the lived experiences of nurse managers in managing inpatient falls. Semistructured interviews were conducted with 16 participants from a tertiary hospital in Shanghai. While data collection followed phenomenological principles to elicit rich experiential narratives, thematic analysis was guided by grounded theory coding techniques to inductively identify and categorise themes. NVivo 12 software was used for data management.

Six interrelated themes emerged, reflecting nurse managers’ experiences across the stages of patient admission, hospitalisation and discharge. At admission, participants emphasised the limitations of existing fall risk assessment tools and the need for multidisciplinary collaboration and intelligent technologies to achieve precise stratification. During hospitalisation, they described ongoing challenges in conducting dynamic reassessments, implementing personalised interventions, managing limited staffing and environmental constraints and promoting patient compliance through effective education. In the discharge phase, nurse managers reflected on the emotional and ethical tensions between ensuring patient safety and respecting autonomy, underscoring the importance of cultivating a strong safety culture and reinforcing nurses’ sense of responsibility. Collectively, these findings reveal that fall prevention is not merely a procedural task but a dynamic, interpretive process shaped by professional accountability, emotional strain and systemic limitations.

Nurse managers’ experiences reflect the complex interplay between managerial responsibility, cultural caregiving norms and organisational limitations in fall prevention. Strengthening multidisciplinary collaboration, integrating intelligent technologies and promoting a proactive safety culture are crucial for improving fall management. Policymakers should also consider China’s evolving caregiver-free ward initiatives to transition towards more nurse-led and patient-centred safety systems. Future research should further explore patient and family perspectives and evaluate strategies for sustainable cultural and structural change in fall prevention.

Colorectal cancer (CRC) incidence is increasing, and treating low rectal cancer poses challenges in balancing oncological control with functional preservation. While preoperative chemoradiotherapy (CRT) improves sphincter preservation, anastomotic leakage (AL) remains a major complication. This trial aims to compare the efficacy of modified pull-through procedure versus coloanal anastomosis (CAA) with temporary stoma in low rectal cancer patients following preoperative CRT.

This is a multicentre, assessor-blinded, randomised controlled trial. A total of 216 patients with low rectal cancer (≤7 cm from the anal verge) after preoperative CRT will be enrolled and randomly assigned (1:1) to undergo either the modified pull-through procedure or CAA with temporary stoma. The primary outcome is the incidence of AL within 1 month. Secondary outcomes include complications (Clavien-Dindo classification), length of hospital stay, anorectal function (LARS score (Low Anterior Resection Syndrome Score)), and quality of life (EQ-5D questionnaire (EuroQol five dimensions questionnaire)). Patients will be followed for 36 months.

The study has obtained ethics approval from the Biomedical Ethics Committee of West China Hospital, Sichuan University (ethics approval ID: 2025-Review-(144)). All centres have obtained local institutional review board approval. Results will be disseminated via academic conferences and peer-reviewed journals to optimise clinical practice for low rectal cancer surgery.

ChiCTR2500100246.

Research investigating the efficacy of spinal muscular atrophy type II rehabilitation has yielded conflicting conclusions, underscoring the need for high-quality research to validate the role of physical therapy. Furthermore, exercise training should be considered as a potential non-pharmacological strategy to enhance motor function in SMA type III patients. Hence, this study is designed to explore the effectiveness of physical therapy for improving motor function in individuals with SMA type III.

This study is an open-label, randomised controlled trial. We will first stratify patients by disease severity (mild=independent walking, severe=non-ambulatory) and then randomly assign 428 participants to either the treatment group or the control group for a period of 12 weeks using a computer-generated randomisation schedule with a 1:1 allocation ratio. The intervention group will undergo a combination of cycling, resistance training, balance exercises, postural control training and locomotion exercises, while the control group will receive education sessions and a standard home exercise programme consisting of stretching and relaxation exercises. Outcome measurements will be assessed at baseline, immediately postintervention and at 3-month and 6-month follow-up assessments. The primary outcome will be assessed using the Hammersmith Functional Motor Scale Expanded, while secondary outcomes will include: Manual Muscle Test, Six-Minute Walk Test, 10 Metre Walk/Run Test, adverse events monitoring, Paediatric Quality of Life Inventory Multidimensional Fatigue Score and active and passive range of motion measurements.

The study protocol and consent form have been approved by the Ethics Committee on Biomedical Research of West China Hospital of Sichuan University (#2025-56) on 19 February 2025. Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Chinese rare disease support groups.

ChiCTR2500101177.

Gastric cancer (GC) remains a leading cause of cancer-related mortality worldwide, with most Chinese patients diagnosed at a locally advanced stage. Neoadjuvant chemotherapy (NAC) is increasingly used to improve resectability and survival. Laparoscopy-assisted distal gastrectomy (LADG) provides short-term recovery benefits compared with open distal gastrectomy (ODG), but its safety and oncologic efficacy following NAC remain uncertain. This trial aims to determine whether LADG is non-inferior to ODG in terms of long-term survival outcomes in patients with locally advanced distal gastric cancer (LAGC) after NAC.

This is a multicentre, randomised, controlled, non-inferiority trial conducted at high-volume GC centres in China. Eligible patients (aged 18–75 years; cT3–4a, N0/+, M0) with histologically confirmed distal gastric adenocarcinoma who have completed standard NAC will be randomised 1:1 to LADG or ODG with D2 lymphadenectomy. Surgical quality will be standardised through operative manuals, intraoperative video recording and central auditing. The primary endpoint is 3-year disease-free survival. Secondary endpoints are 3- and 5-year overall survival. A total of 998 patients (499 per arm) will be enrolled, providing 80% power to test non-inferiority with an absolute 8% margin, accounting for 15% attrition. Analyses will follow the intention-to-treat principle, with Cox models used for survival comparisons and subgroup analyses according to nodal status, tumour size and pathological response.

This trial has been reviewed and approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University (Approval No. 2025 (865), 16 July 2025). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals and international conferences, providing high-level evidence to guide the surgical management of LAGC after NAC.

Chinese Clinical Trial Registry, ChiCTR2500109677; registered on 23 September 2025. Protocol V.2.1, dated 29 June 2025.

Flexible ureteroscopy has advanced modern stone management; however, lower pole renal stones remain a challenge due to suboptimal ureteroscope deflection and navigation using conventional flexible and navigable suction ureteral access sheaths (FANS). The SCULPT trial is designed to assess whether the novel steerable FANS—which enables active controlled deflection—can improve the success rate of lower pole access during flexible ureteroscopy.

This multicentre, prospective, single-blinded, randomised controlled superiority trial will recruit 400 adult patients (aged 18–75 years) with solitary lower pole renal stones ≤2 cm diagnosed by CT from 20 high-volume urological centres in China. Participants will be randomised 1:1 to undergo flexible ureteroscopy with either steerable or conventional FANS. The primary outcome is the success rate of navigating into the lower pole calyx (defined as successful direct stone visualisation, laser lithotripsy and aspiration without adjunct use). Secondary outcomes include immediate and 1 month stone-free rates, operative time, complication profiles (graded by Clavien–Dindo), instrument damage rates, quality-of-life assessments and cost analysis. Statistical analysis will be performed using appropriate tests for continuous and categorical data, with their significance set by prespecified superiority margins.

The study protocol has been designed in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Ethical approval was centrally granted by the Institutional Review Board of The First Affiliated Hospital of Guangzhou Medical University and adopted by all participating centres following local feasibility review. The trial results will be disseminated via peer-reviewed publication and presentation at international conferences.

NCT06898216.

This study examined the knowledge, attitudes and practices of pregnant women regarding hypothyroidism during pregnancy.

A cross-sectional study.

Conducted at the Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan Province, China, between 10 March 2024 and 15 May 2024.

Data were obtained from 411 valid questionnaires (valid response rate: 74.46%). The average age of participants was 31.43±5.42 years.

Data were collected using a specifically designed knowledge, attitudes and practices questionnaire.

The median (IQR) scores for knowledge, attitude and practice were 14 (10, 17), 30 (23, 35) and 41 (33, 47), respectively. Awareness of thyroid hormone replacement safety during pregnancy, postpartum hypothyroidism risks and potential intellectual development issues in newborns was less than 50%.

Multivariable logistic regression indicated that knowledge score (OR=1.068, p=0.008), attitude score (OR=1.075, p

The study finds that pregnant women generally possess good knowledge, positive attitudes and proactive practices regarding hypothyroidism. It emphasises the need for healthcare providers to implement educational interventions to improve understanding and health outcomes for pregnant women with hypothyroidism.