Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

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.

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.

This quasi-experimental study aimed to evaluate the impact of a flipped classroom (FC) combined with case-based learning (CBL) on the academic performance of first-year clinical medicine students in a human anatomy course in China, with a specific focus on higher-order cognitive skills and self-efficacy.

A quasi-experimental design was implemented, with participants randomly assigned to an intervention group (flipped classroom case learning (FCCL), n=64) or a control group (traditional lecture-based instruction, n=64). Learning outcomes and cognitive levels were compared between the two groups.

The study was conducted at a medical school in Meizhou, China, over an 18-week period. The curriculum covered the anatomy of nine major organ systems (excluding the nervous system).

A total of 128 first-year clinical medicine students participated. The FCCL group (63.5% male) had a mean age of 19.13±1.351 years, and the traditional group (67.1% male) had a mean age of 19.33±1.481 years. No significant differences were found in gender (p=0.580) or age (p=0.414) between the groups.

The FCCL group engaged in pre-class activities via the ChaoXing platform, which included instructional videos, key concept outlines and clinical cases. In-class sessions were dedicated to group discussions, specimen practice and case analysis. The control group received traditional PowerPoint-based lectures and completed post-class assignments. Both groups were taught by the same instructors, shared identical learning objectives and used the same laboratory materials.

Outcomes included scores on a theoretical examination (TCE) and a laboratory examination (LCE), both designed based on Bloom’s taxonomy; responses on a self-efficacy questionnaire (incorporating Likert-scale and open-ended items); and qualitative analysis of reflective journals from the FCCL group.

No significant difference was observed in TCE scores between the FCCL and traditional groups (59.52%±15.67% vs 55.5%±14.31%, p=0.136). However, the FCCL group scored significantly higher on the LCE (65.94%±13.71% vs 57.27%±16.95%, p=0.004). Furthermore, the intervention group demonstrated superior performance on higher-order cognitive questions (application-type: +8%, p=0.036; analysis-type: +11%, p=0.009). Questionnaire results indicated that the FCCL approach enhanced students’ learning motivation, critical thinking and collaborative skills (mean Likert scores >4.5).

The integration of FC with CBL effectively enhanced medical students’ higher-order cognitive abilities in anatomy, particularly in practical application and analytical skills, although its effect on the short-term retention of theoretical knowledge was limited. This approach offers a viable pathway for reforming anatomy education, though future studies with larger samples and longer follow-up are warranted.

Economic evaluations in healthcare can guide practice and inform policy. The objective of this paper is to present the protocol for a health economic evaluation comparing the cost-effectiveness of prophylactic treatment using pantoprazole 40 mg daily compared with no pantoprazole to prevent upper gastrointestinal (GI) bleed among invasively ventilated patients.

This is an economic evaluation conducted alongside the Re-Evaluating the Inhibition of Stress Erosions (REVISE) trial (ClinicalTrials.gov NCT03374800). The primary outcome is the incremental cost per clinically important upper GI bleed prevented. The base-case analysis will focus on the entire international cohort of 4821 REVISE patients. The analysis will be conducted from a healthcare payer perspective over a time horizon of ICU admission to hospital discharge or death. To facilitate comparisons across countries given the international scope of the REVISE trial, costs will be presented in United States dollars. The study protocol was developed following the Professional Society for Health Economics and Outcomes Research guidelines.

The trial was approved by each participating institution; this economic evaluation was approved by the Hamilton Integrated Research Ethics Board. Given widespread daily use of proton pump inhibitors for critically ill patients, the results of this economic evaluation will be of high relevance to patients, family members, physicians, pharmacists, policymakers and guideline developers. Integrated knowledge translation will involve periodic progress reports to collaborators. End-of-study knowledge translation will include rounds, videoconferences, abstracts and slide-decks for intensive care unit quality councils and healthcare organisations, and open-access publications. Patient and family partners will co-create lay language summaries for traditional and social media to help inform all interest groups.

Many clinical practice guidelines (CPGs) claim to use Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, but its implementation varies. This suggests that CPG developers, methodologists and users would benefit from an instrument to evaluate the extent to which CPGs adhere to GRADE approach. Such a structured instrument is currently unavailable. Accordingly, this study will develop an evaluation instrument for assessing guideline adherence to the GRADE approach, which we have named ‘GRADE-Check’. The goal is to target items to which CPGs fail to adhere and that potentially have serious consequences resulting in inaccuracies in certainty of evidence and inappropriate direction or strength of recommendations, thereby discriminating across CPGs in issues of importance.

The panel will include up to 25 individuals with specific knowledge and expertise, including experienced authors, educators and methodologists on CPGs methodology and GRADE approach from relevant organisations. The instrument will focus on the key elements of GRADE, aiming for clarity for GRADE experts and non-GRADE experts to apply. The development process for GRADE-Check will consist of the following five phases: (1) recruitment of a panel of GRADE experts; (2) development of objectives and scope for the development of GRADE-Check and criteria for item selection; (3) generation of candidate items through a literature review and panel consultation; (4) panellist discussion to construct the initial draft and extended explanation manual and (5) user testing.

This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no. (2025047K)). Our research findings will be published in peer-reviewed journal articles and presented at academic conferences. Additionally, the dissemination plan will include considerations for the development of implementation manuals, a dedicated project website and training tools.

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterised as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, we planned a randomised controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in patients with liver cirrhosis and overt HE.

This RCT will be conducted in the Departments of Gastroenterology or Hepatology of 16 tertiary hospitals in China. Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE and a serum albumin level of 23–30 g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary end point is the improvement of overt HE within 3–5 days after treatment. The secondary end points include recurrence of overt HE, survival and adverse events. We expect that this RCT will provide high-quality evidence on the optimal dosage of human albumin infused, which can achieve more clinical benefits to patients with liver cirrhosis and overt HE.

The study has been approved by the Medical Ethical Committee of the General Hospital of Northern Theater Command (ethical approval number Y2024-148). The study findings will be published in academic journals.

NCT06483737.

Atrial fibrillation (AF), the most common sustained arrhythmia globally, necessitates effective strategies for stroke prevention. Although current risk stratification tools, such as the CHA₂DS₂-VASc score, are widely used to guide anticoagulation therapy, their limited predictive accuracy underscores the urgent need for more precise and reliable models. This study aims to establish a nationwide AF registry incorporating multi-dimensional data to identify novel risk factors and develop a more accurate stroke prediction model to improve risk stratification and guide anticoagulation therapy in patients with AF.

The risk factors for stroke in patients with non-valvular AF in China (REFINE) registry is a nationwide, multicentre, observational registry integrating retrospective (n=20 000) and prospective (n=5000) cohorts. Demographics, lifestyle, medical history, physical examination, laboratory tests, ECG, echocardiography, contrast-enhanced CT scan and blood samples will be collected at baseline. Long-term follow-up will be performed to identify clinical events and treatment at the timepoint. We aim to use the multidimensional dataset to establish a more precise stroke risk predictive tool.

The study is approved by the Ethics Committee of Fuwai Hospital, CAMS&PUMC (No. 2022–1845; No. 2024–2489) and registered at ClinicalTrials.gov, identifier NCT05598632. The results of this study will be disseminated through publications in peer-­reviewed journals and conference presentations.

NCT05598632.

The internet of things (IoT) is widely used in nursing care for older adults as it improves the efficiency and quality of care, especially in real-time health monitoring, disease management and remote patient supervision. However, no studies have been identified that map the evaluation methods used in existing IoT technology applications for nursing care interventions. This scoping review will map and categorise the evaluation methods used in nursing care interventions examining the IoT for older adults.

This scoping review will be conducted using the Joanna Briggs Institute framework, which encompasses defining inclusion criteria, developing a search strategy, identifying information sources, selecting source of evidence, extracting data, collating data, summarising findings and presenting results. English, Chinese and Japanese databases will be searched (PubMed, Embase, CINAHL, PsycInfo, Cochrane Library, WanFang Data, VIP, SinoMed, China National Knowledge Infrastructure, Ichu-shi Web and CiNii research) for sources published from 1 January 2015 to 31 December 2024. The results will be reported descriptively and thematically according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines for reporting. Descriptive statistics and narrative analysis methods will be conducted to summarise the relevant topics.

Ethics approval is not required for this scoping review, as it encompasses a secondary analysis of previously published literature and does not involve the collection of primary data pertaining to human subjects. The findings of this review will be published in a peer-reviewed journal.