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AnteayerBMJ Open

Intranasal dexmedetomidine for perioperative sleep disturbance: a protocol for a systematic review with meta-analysis and trial sequential analysis

Por: Liu · D. · Huang · Y. · Du · L. · Zhang · W. · Li · T. · Zheng · J.
Introduction

Perioperative sleep disturbance (PSD) can adversely affect immunological and cognitive functions, can prolong hospital stays and have long-lasting effects on quality of life, ultimately increasing mortality rates. Unfortunately, PSD is common among surgical patients and can manifest at any stage during surgical care with a high incidence. Owing to the high incidence and severe adverse outcomes of PSD, effective management of PSD is imperative in clinical practice. Intranasal administration of dexmedetomidine is a safe and effective strategy for improving perioperative sleep quality. It is characterised by high bioavailability, a low incidence of adverse events and the avoidance of pain from venipuncture and intramuscular injection. However, this clinical evidence is insufficient due to the limited sample size, diverse outcome observation indicators and inconsistent research quality. Consequently, we will conduct a protocol for a systematic review and meta-analysis to offer clinical evidence on whether intranasal dexmedetomidine can be opted as an effective treatment for PSD.

Methods and analysis

English databases (PubMed, Web of Science, Ovid Medline, Embase and Cochrane Library), Chinese electronic databases (Wanfang database, VIP Database and China National Knowledge Infrastructure) and clinical trial registry platforms will be screened from their inception up to October 2025 to detect randomised controlled trials of intranasal dexmedetomidine for the management of PSD. We will compute the mean differences (MDs) or standardised MDs along with 95% CIs for continuous data, and the risk ratio with 95% CIs for dichotomous data using Review Manager V.5.4. Either the fixed-effects or random-effects model will be employed depending on the heterogeneity assessed by Cochran’s Q test and the I2 statistic. Risk of bias will be assessed by Cochrane risk-of-bias tool V.2, while evidence quality will be evaluated by the Grading of Recommendations Assessment, Development and Evaluation approach. The conclusiveness of evidence will be evaluated via trial sequential analysis. Moreover, publication bias will be assessed via funnel plot analysis supplemented with Egger’s regression test.

Ethics and dissemination

Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD420251002119.

Clinical impact of multimodal cardiac imaging in Kawasaki disease: a prospective Kawasaki disease cardiac imaging (KDCI) cohort study with follow-up data in a Chinese population

Por: Zhu · Y. · Zhou · Z. · Hu · L. · Azhe · S. · Deng · X. · Peng · S. · Guo · Y.-k. · Wang · C. · Ma · Y. · Wen · L.-y.
Purpose

Coronary artery involvement remains the primary focus in the long-term management of Kawasaki disease (KD). However, previous studies suggest that myocardial abnormalities frequently persist beyond coronary artery involvement in KD patients. Yet, their temporal evolution and clinical implications remain poorly characterised. To address this gap, we established the Kawasaki disease cardiac imaging (KDCI) cohort, integrating cardiac magnetic resonance (CMR) with echocardiography, coronary CT angiography (CCTA) and invasive angiography. These multimodal imaging approaches enable comprehensive assessment of cardiac abnormalities and elucidate the role of cardiac imaging in optimising long-term KD management.

Participants

The KDCI cohort is a prospective study aiming to enrol 400–500 KD patients diagnosed at West China Second University Hospital from September 2018 to September 2035. To date, 207 participants have been recruited. Participants will perform the multimodal cardiac imaging including echocardiography, CMR, CCTA, invasive angiography and comprehensive laboratory testing under a scheduled protocol in the follow-up.

Findings to date

The KDCI cohort has established baseline characteristics for 207 KD patients. Of those included to date, 72.0% (149/207) received intravenous immunoglobulin (IVIG) treatment, with 26.1% (54/207) demonstrating IVIG resistance, and 37.7% (78/207) exhibiting coronary artery dilatation. Longitudinal follow-up data are available for 80.7% (167/207) of participants, with a median follow-up duration of 2.7 years and a follow-up patient-years of 594 patient-years. Of the 207 patients, 16.9% (35/207) patients experienced endpoint events, encompassing coronary artery thrombosis (8.2%, 17/207), coronary stenosis/obstruction (5.3% 11/207) and clinical myocardial infarction (1.9%, 4/207). Based on the data collected, we have demonstrated the cardiac abnormalities beyond coronary artery involvement in KD by CMR and CCTA.

Future plan

The KDCI cohort will maintain ongoing recruitment and longitudinal follow-up, with a projected enrolment exceeding 400 participants by 2035. This expansion will yield a median follow-up duration of 10 years, providing robust long-term outcome data. We have implemented standardised protocols for scheduled follow-up assessments and data collection in newly enrolled patients. Furthermore, planned genomic analyses will be incorporated to investigate the molecular pathogenesis and prognostic determinants of KD.

Global, regional and national burden and trends of sense organ diseases from 1990 to 2021: based on the Global Burden of Disease (GBD) study

Por: Zheng · M. · Yin · T. · Jiang · Z. · Li · X. · Fang · B. · Pan · M. · Xu · J. · Xu · Y. · Hendsun · H. · Xu · J. · Zhang · Y. · Kan · H. · Wang · X. · Chen · R. · Zheng · W. · Chen · A.
Objectives

Sense organ diseases (SODs) are among the leading causes of disability worldwide. They severely impact communication, mobility and quality of life, with rising prevalence and widening inequalities across populations. This study aims to provide an updated, comprehensive assessment of the global, regional and national burden and trends of SODs, and to inform strategies for prevention, treatment and health policy development.

Design

This is a population-based observational study using secondary data from the Global Burden of Disease (GBD) 2021 study. SODs, defined in the GBD framework as age-related and other hearing loss (AHL), blindness and vision loss (BVL), and other sensory impairments, were analysed in terms of prevalence and disability-adjusted life years (DALYs). We focused on SODs overall and conducted specific analyses for AHL and BVL, stratified by age, sex and sociodemographic index (SDI).

Setting

Global dataset covering 204 countries and territories across all regions and sociodemographic strata from 1990 to 2021.

Participants

This study covered the global population represented in the GBD 2021 dataset, using aggregated population-level estimates with no direct individual recruitment.

Interventions

Not applicable.

Primary and secondary outcome measures

Primary outcomes were prevalence (cases and age-standardised prevalence rates) and DALYs (number and age-standardised DALY rates). Secondary outcomes included age–period–cohort effects, decomposition of contributors (population growth, ageing and epidemiological change), inequality metrics and burden projections to 2030.

Results

Between 1990 and 2021, the global age-standardised rate (ASR) of DALYs for SODs increased from 884.07 to 912.8 per 100 000 population. The ASR of prevalence rose from 25 297.36 to 28 050.29 per 100 000. The disease burden increased across all age groups, with females experiencing a higher prevalence of SODs, and population growth and ageing as the leading contributors. AHL emerged as the predominant category of SODs. Socioeconomic disparities widened, with the slope index of inequality for DALYs rising from 128.82 in 1990 to 418.62 in 2021. In 2021, China reported the highest DALYs and case numbers. Predictive analysis showed a stable ASR of DALYs and prevalence, but a continued rise in cases through 2030, with COVID-19 further exacerbating the burden.

Conclusions

The global burden of SODs continues to rise, driven primarily by population ageing and growth, with widening disparities across sociodemographic levels. These findings emphasise the need for targeted prevention strategies, improved early detection and equitable access to sensory healthcare services. Monitoring the long-term impact of COVID-19 and demographic shifts remains a priority.

Trial registration number

Not applicable. This study is a secondary analysis of GBD data and is not linked to a clinical trial.

Study protocol for evaluating delayed antibiotic prescribing to promote rational antibiotic use in primary healthcare institutions in China: a pragmatic, multicentre, open-label, clustered-randomised controlled trial

Por: Chen · S. · Ko · W. · Li · W. · Xiao · R. · Du · F. · Zhang · J. · Wu · S. · Zheng · B. · Zhu · N. J. · Ahmad · R. · Little · P. · Guan · X. · Shi · L. · Wushouer · H.
Introduction

Delayed antibiotic prescribing (DAP) has demonstrated efficacy in reducing inappropriate antibiotic use for uncomplicated respiratory tract infections (uRTIs) in primary care across high-income countries. However, evidence regarding its effectiveness in low-income and middle-income countries remains limited. This cluster-randomised controlled trial (cRCT) aims to evaluate the effectiveness of DAP for optimising antibiotic use in primary healthcare institutions (PHIs) in China.

Methods and analysis

We designed a pragmatic, multicentre, open-label, three-arm cRCT in adult patients with uRTIs. The study will involve 12 PHIs in Korla City of China. Participating institutions will be randomised at a 1:1:1 ratio to three parallel arms: (1) DAP-intervention arm, (2) Immediate antibiotic prescribing comparator arm and (3) Usual care (observational arm). The primary outcome is symptom duration. Secondary outcomes include symptom severity, antibiotic use, adverse events, patient satisfaction and patient belief regarding antibiotic efficacy.

Ethics and dissemination

Ethics committee approval of this study was obtained from Peking University Institution Review Board (IRB00001052-24169). The findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Trial registration number

ChiCTR2500097330.

Recommendations for nursing diagnoses for burn victims undergoing prolonged field care in China: a Delphi study

Por: Lin · D. · Cao · Y. · Gao · J. · Zhu · Y. · He · J. · Qian · C. · Xiang · F. · Zheng · R. · Shu · Q.
Aim

To construct a nursing diagnosis index system for burn patients under prolonged field care (PFC).

Design

A modified Delphi study.

Setting

13 class A tertiary hospitals and 2 universities.

Participants

Nine experts were selected for expert interview: (1) bachelor’s degree or higher; (2) ≥10 years’ experience in burn care, nursing quality management or health service management, including participation in ≥3 PFC operations; (3) intermediate or higher professional title; (4) willingness to participate. 22 experts were selected for expert consultation: (1) bachelor’s degree or higher; (2) ≥3 years’ nurse management experience with theoretical expertise in burn nursing diagnosis; participation in ≥3 major non-combat military operations; (3) intermediate or higher professional title; (4) commitment to complete consultations.

Interventions

Including a two-stage process: (1) system construction: developed a preliminary index system using The North American Nursing Diagnosis Association international’s framework, guided by US military ‘10 PFC Core Competencies’ and UK military SHEEP VOMIT standards, via literature analysis and expert interviews. (2) Delphi refinement: conducted three Delphi rounds with 22 experts. Finalised indicators using Analytical Hierarchy Process to assign weights.

Results

The burn PFC nursing diagnosis index system established in this study comprises 7 primary indicators, 18 secondary indicators and 44 tertiary indicators. The valid questionnaire response rate for the expert consultation reached 100%, with an expert authority coefficient of 0.85. After three rounds of the Delphi expert consultation, Kendall’s coefficient of concordance (Kendall’s W) for indicators at all levels ranged from 0.104 to 0.305 (p

Conclusion

This systematic, scientific and rational index system provides a foundation for standardising burn PFC nursing plans, potentially enhancing care quality and efficiency in PFC settings.

Develop a personalised serious game applet for smoking cessation: protocol for enterprise-based cluster randomised controlled trial

Por: Kong · X. · Li · Z. · Chen · J. · Yun · Q. · Mao · Y. · Chen · Y. · Wang · X. · Zhou · W. · Zhao · L. · Wu · X. · Yang · C. · Zheng · Y. · Chang · C.
Introduction

Tobacco use causes approximately 8 million deaths worldwide each year. Against the backdrop of a rapidly expanding game market, there is growing potential to develop tailored gaming interventions for smoking cessation. This study protocol describes the development of a personalised Serious Game Applet based on an integrated TTM–PMT–HAPA framework (Transtheoretical Model, Protection Motivation Theory, Health Action Process Approach) and evaluates its effectiveness compared with conventionalShort Messaging Service (SMS) -based smoking cessation interventions.

Methods and analysis

Design: The study comprises two phases. The first involves developing the Serious Game Applet using the TTM–PMT–HAPA theoretical framework. The second phase consists of a multicentre, two-arm, single-blind cluster randomised controlled trial, which will enrol 1320 eligible smokers from various enterprises. Enterprises will be randomised to either the Serious Game Applet group or the SMS push control group. Eligible participants include daily smokers aged 18–45 years, working in non-tobacco-related enterprises, with exhaled carbon monoxide levels ≥6 ppm.

Outcomes: Primary outcomes are smoking abstinence rates at 3 and 6 months. Secondary outcomes include abstinence rates at 1, 2 and 9 months; point-prevalence cessation rates at 1, 2, 3, 6 and 9 months; changes in cigarette consumption; stage transitions in smoking cessation; nicotine dependence scores and withdrawal symptoms. The trial will be conducted as a field study targeting smartphone users across three cities in Fujian Province, China.

Ethics and dissemination

This study has been approved by the Biomedical Research Ethics Committee of Fujian Medical University (Approval No. 127, 2024). Results will be disseminated through peer-reviewed journals and academic conferences.

Trial registration number

ChiCTR2400088105.

Association between the atherogenic index of plasma and long-term prognosis in acute ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention: a retrospective cohort study

Por: Zheng · Y. · Wang · L. · Tan · X. · Chen · Z. · Zhang · Z. · Yu · W. · Jiang · X. · Yu · X. · Huang · J.
Objective

This study was aimed to evaluate the association between the atherogenic index of plasma (AIP) and long-term major adverse cardiovascular events (MACEs) in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI).

Design

A retrospective cohort study.

Setting

The study utilised data from two tertiary care centres in China, which were retrospectively analysed.

Participants

This retrospective cohort study initially enrolled 953 adult (≥18 years) patients with acute STEMI undergoing PCI. After applying exclusion criteria (including prior myocardial infarction, severe hepatic/renal dysfunction, lost follow-up and so on), 784 participants with complete clinical data comprised the final cohort and were divided into three AIP groups based on tertiles of AIP levels: low AIP group (n=260), medium AIP group (n=261) and high AIP group (n=263).

Results

High AIP patients exhibited significantly higher 2-year MACEs rates versus lower tertiles (p0.05).

Conclusion

Our study demonstrates the AIP independently predicts 2-year MACEs in STEMI patients post-PCI, particularly recurrent acute coronary syndrome, suggesting its utility as a cost-effective prognostic tool complementary to traditional lipid metrics.

Implementability of a co-designed programme to increase tailored exercise to reduce falls in older people from culturally and linguistically diverse communities: protocol for a pilot randomised controlled trial

Por: Said · C. M. · Ramage · E. R. · Sharma · H. · Batchelor · F. · Bicknell · E. · Bongiovanni · L. · Brijnath · B. · Cahill · P. · Callisaya · M. · Celestino · S. · Chudecka · A. · Engel · L. · Lim · W. K. · McDonald · C. E. · Pinheiro · M. · Sherrington · C. · Vogrin · S. · Zanker · J. · Zhe
Introduction

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Methods and analysis

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethics and dissemination

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

Trial registration number

ACTRN12624000658516.

Tirzepatide for fertility-sparing treatment in obese/overweight patients with endometrial cancer and atypical hyperplasia: a phase II single-arm clinical trial protocol

Por: Zheng · J. · Yang · J. · Yang · J.
Introduction

Approximately 3–5% of patients with endometrial cancer (EC) are diagnosed under the age of 40 years, with 70% of these individuals being nulliparous. Consequently, fertility-sparing treatment for eligible young patients with endometrial lesions is increasingly being accepted. Obesity is a well-known factor closely associated with the incidence and prognosis of endometrial lesions. As obesity rates rise, weight loss interventions become particularly important in the treatment of these patients. Tirzepatide is currently the most effective glucagon-like peptide-1 receptor agonist for weight control. This trial aims to explore the synergistic effects and safety of tirzepatide combined with standard fertility-preserving treatment for endometrial lesions.

Methods and analysis

This single-arm, phase II clinical trial aims to evaluate the efficacy and safety profile of tirzepatide as an adjunctive therapy to standard fertility-sparing treatment in obese or overweight patients with atypical hyperplasia (AH) or EC. The study will enrol a total of 45 patients, each receiving a combination of standard fertility-sparing treatment for EC and AH alongside tirzepatide. The primary outcomes include the reversal rate and time to remission (in months) of endometrial lesions, which are determined through endometrial pathology sampling every 3 months, as well as the percentage of weight reduction. Secondary objectives include evaluating changes in body morphology and composition, alterations in metabolic parameters during the study, as well as reproductive outcomes and the rate of tumour recurrence during follow-up.

Ethics and dissemination

This study has received approval from the Ethics Committee of Peking Union Medical College Hospital (I-25PJ1055). Written informed consent will be obtained from all participants. The trial results will be disseminated through peer-reviewed medical journals and presented at an academic conference.

Trial registration number

ChiCTR2500102009.

Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in China: a nationwide registry (REFINE registry)

Por: Qi · W. · Yuan · S. · Liu · H. · Xu · M. · Yang · Y. · Peng · X. · Hu · Z. · Zhang · Y. · Zhao · Y. · Zheng · L. · Yao · Y. · Zheng · Z. · Investigators the REFINE Registry · investors · Ma · Yu · Chai · Dong · Wang · Gan · Zhao · Jin · Liu · Zhang · Wang · Yao · Zheng · Liu · Du · Guo · Zhang
Introduction

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.

Methods/analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT05598632.

Effect of rapid carbapenemase detection-directed antimicrobial therapy on clinical response in patients with intra-abdominal infections (RAPID): protocol for a randomised controlled trial

Por: Wang · J. · Tian · S. · Li · J. · Xu · L. · Wang · P. · Gu · G. · Han · Y. · Weng · Y. · Zheng · T. · Tao · Q. · Liu · Y. · Wang · H. · Jiang · Z. · Wang · J. · Zhang · P. · Wu · X. · Ren · J. · on behalf of RAPID investigators · Ren · Wu · Wang · Tian · Li · Xu · Wang · Gu · Han · Weng · Zheng · Ta
Introduction

Infections caused by carbapenemase-producing organisms have become a major problem during the treatment of secondary bloodstream infection in patients with severe intra-abdominal infection (sIAI). Early detection and identification of potential carbapenemases by colloidal gold immunochromatography assay kit can provide information about the susceptibility of pathogenic bacteria before conventional microbial testing results are obtained. This study aims to evaluate the effects of rapid carbapenemase detection-guided antibiotic therapy on patients with sIAI.

Methods and analysis

The RAPID study is a multicentre, single-blinded, randomised controlled trial. All patients with intra-abdominal infection will be screened for eligibility on any given day that the first gram-negative bacilli-positive blood culture is detected. In total, 640 eligible study participants assigned informed consent will be randomised to either carbapenemase detection-directed antimicrobial treatment or the conventional group, receiving antimicrobial agents based on different bacterial identification and susceptibility tests. Patients will be followed until discharge or death within a follow-up 28 days after randomisation. The primary outcome is all-cause 28-day mortality. Secondary outcomes include antibiotic duration, length of stay in the hospital and intensive care unit and bacterial clearance. The desirability of outcome ranking and response adjusted for duration of antibiotic risk will also be used to comprehensively assess treatment effectiveness at 28 days.

Ethics and dissemination

The study has been approved by the Ethics Committee of Jinling Hospital (2023DZKY-069–01) and all participating centres. Written informed consent will be obtained from all participants or their legal representatives. The results of this trial will be disseminated through peer-reviewed publications and presented at national and international scientific conferences.

Trial registration number

ChiCTR2300076159.

Efficacy of transcutaneous electrical acupoint stimulation for the treatment of gastrointestinal dysfunction in patients after cardiac surgery with cardiopulmonary bypass: study protocol for a superiority, single-centre, single-blind, randomised controlle

Por: Liao · Y. · Gao · Q. · Chen · Y. · Li · H. · Wang · J. · Zheng · F. · Lin · S.
Objective

Gastrointestinal dysfunction is one of the most frequent complications in patients after cardiac surgery with cardiopulmonary bypass (CPB). It can seriously affect the patient’s quality of life, increase the length of hospitalisation and in severe cases trigger cardiac arrest. This single-centre randomised controlled study aims to investigate whether transcutaneous electrical acupoint stimulation (TEAS) can effectively relieve gastrointestinal discomfort and improve the quality of life of patients after cardiac surgery.

Methods and analysis

A total of 426 patients after cardiac surgery with CPB will be randomly assigned to the control group or intervention group (1:1 ratio) to receive either acupressure or TEAS for 3 days. The patients will be recruited from the Department of Cardiovascular Surgery of Nanfang Hospital. The primary outcome is the time of the first postoperative anal defecation, the secondary outcomes include the first postoperative anal exsufflation time, the number of bowel sounds, the proportion of postoperative laxatives used in the two groups, abdominal girth, stool frequency per day and length of postoperative hospital stay.

Ethics and dissemination

The procedures have been approved by the Guangdong Regional Medical Ethics Committee of Nanfang Hospital (NFEC-2023–404) and conformed to the Declaration of Helsinki. Written informed consent will be obtained from all the participants. Results will be disseminated through workshops, peer-reviewed publications and conferences.

Trial registration

Registered in Chinese Trial Registry (https://www.chictr.org.cn/) on 1 November 2023 (Registered number: ChiCTR2300077211). Pre-result.

Assessment of penicillin allergy evaluation practices among clinicians in China: a nationwide cross-sectional survey

Por: Ji · D. · Hu · B. · Chen · Z. · Gao · X. · Zhang · Y. · Zheng · Z. · Zhang · H. · Yuan · Z.
Objective

This study investigated the perceived clinicians’ roles in penicillin allergy assessment among medical staff in tertiary hospitals in China.

Design

This was a multicentre cross-sectional survey.

Setting

The study was conducted at 89 tertiary hospitals in eastern and western China from March to May 2024.

Participants

A survey was conducted involving 8493 medical staff from tertiary hospitals in eastern and western China using multistage sampling.

Outcome measures

A self-designed questionnaire was used to assess evaluation status of penicillin allergy assessment, including allergy history assessment and recording, skin test result evaluation during hospitalisation, allergic reaction recording at discharge and awareness of allergy assessment teams.

Results

Among 8493 healthcare professionals (doctors 40.0%, nurses 56.3%, pharmacists 3.7%), significant gaps existed in penicillin allergy documentation: while 92.0% acknowledged the need to document specific drug names, only 66.2% practised this (nurses 62.2% vs pharmacists 82.0%, p

Conclusions

Currently, the assessment and recording methods for antimicrobial allergies by the medical staff of tertiary hospitals in China are not sufficiently accurate. Nurses play a key role in the assessment of antimicrobial allergies. Thus, medical staff, especially nurses, should receive more vigorous training, and structured assessment tools for antimicrobial allergies based on clinical decision support systems should be devised for them. Our findings also reiterate the need to establish penicillin allergy assessment teams at the hospital level.

Sleep quality among pregnant women: a prospective longitudinal study of trajectories and bidirectional associations with physical activity

Por: Wang · Y. · Li · Y. · Zhang · R. · Mao · M. · Zheng · W. · Qiu · R. · Xu · J. · Feng · S.
Objectives

This study aimed to investigate the trajectory patterns and influencing factors of sleep quality and verify the bidirectional association between physical activity and sleep quality during pregnancy.

Design

This was a prospective longitudinal study.

Setting

The study was conducted at the obstetric clinic in a tertiary maternity hospital in Zhejiang Province, mainland China.

Participants

A total of 645 pregnant women were selected through simple random sampling and completed follow-up assessments during the first, second and third trimesters of pregnancy from January to December 2024.

Outcome measures

The desired data were collected using the Pittsburgh Sleep Quality Index and the International Physical Activity Questionnaire Short Form. Latent class growth analysis was applied to identify sleep quality trajectories, multiple logistic regression was used to determine the influencing factors, and cross-lagged panel analysis was used to explore the bidirectional association between sleep quality and physical activity.

Results

Three distinct sleep quality trajectories were identified: the constantly poor sleep quality group (21.40%), the constantly decreasing sleep quality group (50.70%) and the constantly good sleep quality group (27.90%). Multiple logistic regression analyses indicated that being underweight (OR=3.013, 95% CI: 1.308 to 6.942) and having insufficient physical activity levels during the first (OR=3.346, 95% CI: 2.009 to 5.573) and second phases (OR=37.515, 95% CI: 20.215 to 69.620) were associated with an increased risk of exhibiting a consistently declining pattern. Being underweight (OR=2.679, 95% CI: 1.041 to 6.893), passive smoking (OR=11.433, 95% CI: 2.220 to 58.883) and having insufficient physical activity levels during the first (OR=12.624, 95% CI: 6.285 to 25.356) and second phases (OR=23.773, 95% CI: 11.745 to 48.118) were associated with an increased risk of exhibiting a consistently poor pattern. Additionally, results from the cross-lagged panel analysis revealed a bidirectional association between sleep quality and physical activity.

Conclusions

This study demonstrates heterogeneity in changes in sleep quality among pregnant women. Interventions aimed at promoting maternal and infant health during pregnancy should consider both sleep quality and physical activity. Earlier interventions are associated with better outcomes.

Trial registration number

ChiCTR2300078952.

Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study

Por: Jiang · Y. · Sun · Z. · Yu · B. · Liu · W. · Gao · H. · Li · J. · Jin · Z. · Yu · H. · Zheng · B. · Guan · C. · Zhang · H. · Zhang · Y. · Gao · L. · Cui · C. · Song · Y. · Xu · J. · Dou · K. · Yang · W. · Qian · J. · Wu · Y. · Song · L.
Introduction

Patients with acute myocardial infarction (AMI) and multivessel disease are at elevated risk of recurrent events. Radial wall strain (RWS), a novel indicator derived from angiography, has emerged as a potentially useful adjunct to optical coherence tomography (OCT) for assessing plaque vulnerability. The NASCENT trial is a prospective, multicentre cohort study designed to assess the natural history of coronary plaque in this high-risk AMI population and investigate the predictive value of angiography-based RWS for lesion progression, compared with OCT-assessed vulnerable plaque.

Methods and analysis

Following successful culprit lesion revascularisation for AMI patients with multivessel disease, we assessed eligible non-culprit lesions (30%–80% diameter stenosis) in non-flow-limiting, non-infarct-related arteries (Murray law-based quantitative flow ratio >0.80) using OCT and offline RWS analysis. The primary endpoint is lesion progression at 1 year, defined as a ≥20% increase in diameter stenosis percentage measured by quantitative coronary angiography. Between April 2024 and April 2025, 131 patients were enrolled. The 1-year angiographic and OCT follow-ups will be completed by May 2026. Clinical follow-ups are planned at 1 month, 6 months, 1 year and annually up to 3 years. As the first prospective trial comparing angiography-based RWS with OCT for predicting lesion progression in the AMI population, this study may provide crucial evidence for RWS as a valuable tool for risk stratification and clinical decision-making.

Ethics and dissemination

The protocol has been approved by the Institutional Review Board and Ethics Committee (Fuwai Hospital Approval No. 2023-2039) and will be conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all participants. The study results will undergo peer-reviewed publication.

Trial registration number

NCT06040073.

Ketogenic diet strategy in patients with sepsis: a multicentre prospective randomised interventional trial protocol

Por: Wang · J. · Song · L. · Jiang · W. · Li · X. · Shi · K. · Chen · Y. · Yu · J. · Zheng · R.
Introduction

Sepsis is defined as a dysregulated host response to infection, associated with high morbidity and mortality rates globally. Recent studies have indicated that increasing ketone levels may be beneficial for patients with sepsis. Existing research has established the feasibility, effectiveness and safety of the ketogenic diet in sepsis patients. This study aims to further clarify the organ-protective effects of a ketogenic diet in sepsis patients through a multicentre randomised controlled trial.

Methods

This is a multicentre, prospective, randomised controlled trial conducted in five intensive care units (ICUs) in China. The intervention group will receive a ketogenic diet, while the control group will receive standard enteral nutrition. The primary outcome is the protective effect of the ketogenic diet on the heart, kidneys and liver in septic patients. Secondary outcomes include ICU and hospital mortality rate, ICU and hospital length of stay, rate and duration of mechanical ventilation, blood glucose levels and the rate of renal replacement therapy.

Ethics and dissemination

This study has been approved by the Ethics Committee of Northern Jiangsu People’s Hospital Affiliated to Yangzhou University (No. 2024ky290-2). Upon completion, the researchers will disseminate the results to the public through publication in peer-reviewed journals

Trial registration number

Chinese Clinical Trial Registry in December 2024 (Registration Number: ChiCTR2400093805).

Efficacy of Adaptive Blood Purification for Septic Shock (EABPSS): protocol for a randomised, multicentre, parallel controlled study

Por: Jia · H. · Li · X. · Zheng · Y. · Cui · N. · Ronco · C. · Li · W.
Introduction

There is a lack of evidence on the efficacy of extracorporeal blood purification (EBP) to reduce the mortality rate in septic shock. We have designed the EABPSS (Efficacy of Adaptive Blood Purification for Septic Shock) study to confirm whether adaptive blood purification (ABP) intervention could confer a clinical benefit.

Methods and analysis

In this multicentre, open-label, randomised controlled trial, we are recruiting a total of 276 patients with septic shock. Eligible patients who provide informed consent will be randomly assigned in a 1:1 ratio to either the control group or the intervention group. Patients in the control group will receive standard care according to the Surviving Sepsis Guidelines. Patients in the intervention group will receive two 6-hour sessions of ABP treatment within 24 hours of enrolment, based on standard care. ABP is a novel, adaptive EBP strategy proposed by our research team. Specifically, for patients with septic shock who do not require renal replacement therapy (RRT), plasmafiltration-adsorption (PFAD) will be used alone, and for patients with septic shock and acute kidney injury meeting RRT indications, a combination of PFAD–RRT will be employed. The primary endpoint of this study is all-cause mortality at 90 days after enrolment. Secondary endpoints of the study include the declining proportion of serum cytokines such as tumour necrosis factor-α (TNF-α), IL-4, IL-6, IL-8, IL-10 and high-mobility group box 1 within 24 hours after enrolment. Additionally, the study will evaluate the improvement of the Sequential Organ Failure Assessment score on day 7 postenrolment, as well as the 30-day mortality rate.

Ethics and dissemination

The study was approved by the respective ethical committees of the participant centres, including: Ethics Committee of Beijing Chaoyang Hospital, Capital Medical University (2024-KE-348); Ethics Committee of PLA General Hospital (S2024-716-01); Ethics Committee of China–Japan Friendship Hospital (2024-KY181); Clinical Research Ethics Committee of Peking University First Hospital (2024YAN258-001); Ethics Committee of Beijing Hospital (2024BJYYEC-KY106-02); Ethics Committee of Air Force Medical Center, PLA (KONGTE2024-29-PJ01); Ethics Committee of Beijing Jishuitan Hospital, Capital Medical University (JILUN(K2023)(370)-00). The findings of the study will be disseminated in peer-reviewed journals and presented at national and international conference presentations.

Trial registration number

NCT06692036.

Hospital Outcome of Host Heterogeneity, Organ dysfunction and Trajectory in sepsis (HOHHOT): A cohort study in the critical care unit

Por: Zhang · F. · Yang · D.-G. · Liu · W. · Liu · S.-J. · Liu · W. · Zhang · C.-D. · Hou · W.-J. · Hao · X.-L. · Gao · Y. · Zheng · W.-Q. · Bao · R.-T. · Xu · Y.-N. · Wu · Q. · Wang · L. · Zhao · Z.-W. · Dong · Y.-H. · Zhang · L.-P. · Hu · Z.-D.
Introduction

Prognosis estimation is the basis for establishing the personal interventions in sepsis patients. Serum biomarkers are potential tools for predicting the outcomes of sepsis patients admitted to the intensive care unit (ICU). Here, we plan to perform a prospective study to investigate the prognostic value of serum biomarkers. We named this study Hospital Outcome of Host Heterogeneity, Organ dysfunction and Trajectory in sepsis (HOHHOT).

Methods and analysis

This prospective cohort study is being performed in several hospitals in the Inner Mongolia Autonomous Region between 2025 and 2027. The inclusion criteria were adult sepsis patients admitted to the ICU. A serum specimen will be collected at the onset of sepsis and stored at –80°C for future use. The endpoint of the HOHHOT study includes, but is not limited to, hospital outcome (eg, mortality, occurrence of organ dysfunction, treatment response and the progression of sepsis). We will analyse the predictive value of serum biomarkers for outcomes using a receiver operating characteristic curve and decision curve analysis. The association between baseline characteristics and serum biomarkers will be estimated using a logistic regression model, net reclassification index and integrated discriminatory index. We will also construct some predictive models using machine learning algorithms.

Ethics and dissemination

The HOHHOT study has been approved by the Ethics Committee of the Affiliated Hospital of Inner Mongolia Medical University (NO: KY2025005). The findings derived from the HOHHOT study will be submitted to international academic journals.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2500100770); pre-results.

Neoadjuvant camrelizumab combined with chemoradiotherapy and watch-and-wait strategy versus neoadjuvant chemoradiotherapy followed by surgery in locally advanced oesophageal squamous cell carcinoma: study protocol of a randomised controlled trial (PALACE-

Por: Wang · X. · Li · C. · Cao · Y. · Kang · X. · Leng · X. · Zheng · Y. · Zheng · B. · Guo · W. · Jing · H. · Han · Y. · Chen · C. · Li · Y. · Li · H.
Introduction

Combining immunotherapy with neoadjuvant chemoradiotherapy (neoCRT) has been shown to be safe, achieving a pathological complete response (pCR) rate of 56% in patients with locally advanced oesophageal squamous cell carcinoma (ESCC) in the PALACE-1 trial. This high pCR rate encourages us to explore the feasibility of postponing surgery after immunotherapy combined with neoCRT under active surveillance. This study aims to assess the efficacy, safety and patient-reported quality of life (QOL) of camrelizumab combined with neoCRT and watch-and-wait strategy versus neoCRT followed by surgery in locally advanced resectable ESCC.

Methods and analysis

The PALACE-3 trial is a multicentre, open-label, randomised non-inferiority trial expected to recruit 356 patients from six high-volume centres in China. The study is planned to start in May 2024 and end in December 2028. Eligible patients will be randomly assigned (1:1 ratio) to either camrelizumab combined with neoCRT and watch-and-wait strategy or neoCRT followed by surgery (standard surgery). In the active surveillance group, patients achieving a clinical complete response (cCR) to camrelizumab combined with neoCRT will undergo active surveillance, while those with residual disease or locoregional recurrence will undergo immediate surgery. Patients in the standard surgery group will proceed to surgery after neoCRT. The primary endpoint is the 3-year overall survival (OS) rate. The secondary endpoints include cCR rate, salvage surgery incidence, objective response rate, adverse events during the neoadjuvant therapy, pCR, tumour regression grade, R0 resection rate, lymph node ratio, perioperative complications, disease-free survival (DFS) and 3-year DFS rate, OS and health-related QOL.

Ethics and dissemination

This study has been approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital (Shanghai, China), as well as the ethics committees of the following participating centres: National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (Beijing, China); Sichuan Cancer Hospital and Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science and Technology of China (Chengdu, China); The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital (Zhengzhou, China); Fujian Medical University Union Hospital (Fuzhou, China). Complete information about the study status, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. Written informed consent (Supplemental Material) will be obtained from each participant. All research outputs will be published in peer-reviewed journals and presented at national or international conferences.

Trial registration number

The trial was meticulously registered in advance on 1 April 2024 and can be accessed through the following link: https://www.clinicaltrials.gov/study/NCT06339060. The current protocol version number is V.2.0, and the protocol date is 30 June 2024.

Qualitative study of stakeholder perspectives on dementia policy implementation in Macao: progress, challenges and future directions

Por: Zheng · Y. · Tang · P. K. · Zhao · Y. · Song · M. · Hu · H. · Ung · C. O. L.
Objectives

To better inform dementia management, it is important to understand how individuals experience, interpret and respond to dementia policy in real life. This study aimed to explore key stakeholders’ perspectives on the critical determinants of effective implementation of the first dementia policy in Macao, and the impact of policy implementation on dementia care.

Design

Semi-structured individual interviews were conducted in person with key stakeholders identified in earlier phases of the research. The participants were encouraged to share their opinions on the significance and objectives of the dementia policy, the changes in dementia care related to the launch of the policy, and how to better implement the policy for continuous improvement.

Setting

Interviews were conducted face-to-face at the participants’ office or at a location of their choice.

Participants

Individuals involved in the planning, establishing, leading, managing, operating, implementing, participating in, using and/or advocating for dementia policies and/or comprehensive dementia care models.

Results

All participants perceived the Macao Dementia Policy as a landmark initiative that raised public awareness, fostered inter-professional collaboration and established a foundational service network. At the service level, they reported improvements in the accessibility of diagnostic pathways and greater attention to caregiver support. Nevertheless, implementation challenges remained, including fragmented service information, inadequate non-pharmacological treatment options and limited service capacity. Participants recommended that future actions should focus on optimising long-term policy planning and resource allocation, strengthening the direct support network for caregivers, and enhancing public education and research-informed innovation.

Conclusion

Macao’s experience suggests that the successful implementation of a dementia policy requires not only the establishment of formal service structures but also a concerted focus on optimising resource allocation and strengthening caregiver support. To further enhance the policy’s effectiveness, future efforts should prioritise designing and assessing targeted interventions.

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