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Effects of opioid-free anaesthesia compared with balanced general anaesthesia on nausea and vomiting after video-assisted thoracoscopic surgery: a single-centre randomised controlled trial

Por: Bao · R. · Zhang · W.-s. · Zha · Y.-f. · Zhao · Z.-z. · Huang · J. · Li · J.-l. · Wang · T. · Guo · Y. · Bian · J.-j. · Wang · J.-f.
Objectives

Opioid-free anaesthesia (OFA) has emerged as a promising approach for mitigating the adverse effects associated with opioids. The objective of this study was to evaluate the impact of OFA on postoperative nausea and vomiting (PONV) following video-assisted thoracic surgery.

Design

Single-centre randomised controlled trial.

Setting

Tertiary hospital in Shanghai, China.

Participants

Patients undergoing video-assisted thoracic surgery were recruited from September 2021 to June 2022.

Intervention

Patients were randomly allocated to OFA or traditional general anaesthesia with a 1:1 allocation ratio.

Primary and secondary outcome measures

The primary outcome measure was the incidence of PONV within 48 hours post-surgery, and the secondary outcomes included PONV severity, postoperative pain, haemodynamic changes during anaesthesia, and length of stay (LOS) in the recovery ward and hospital.

Results

A total of 86 and 88 patients were included in the OFA and control groups, respectively. Two patients were excluded because of severe adverse events including extreme bradycardia and epilepsy-like convulsion. The incidence and severity of PONV did not significantly differ between the two groups (29 patients (33.0%) in the control group and 22 patients (25.6%) in the OFA group; relative risk 0.78, 95% CI 0.49 to 1.23; p=0.285). Notably, the OFA approach used was associated with an increase in heart rate (89±17 vs 77±15 beats/min, t-test: p

Conclusions

Our study findings suggest that the implementation of OFA does not effectively reduce the incidence of PONV following thoracic surgery when compared with traditional total intravenous anaesthesia. The opioid-free strategy used in our study may be associated with severe adverse cardiovascular events.

Trial registration number

ChiCTR2100050738.

Knowledge, attitude and practice on ovarian reserve function among women of childbearing age: a prospective cross-sectional study in Chongqing and surrounding regions

Por: Yuan · Y. · Yang · L. · Hu · J. · Deng · Y. · Zhang · H.
Objectives

To evaluate the knowledge, attitudes and practice (KAP) on ovarian reserve function among women of childbearing age in Chongqing and surrounding regions, China.

Design

Cross-sectional study.

Setting

Chongqing and surrounding regions, China.

Participants

Women of childbearing age (18–48 years) by convenience sampling.

Primary and secondary outcome measures

The demographic characteristics of the respondents and their KAP on ovarian reserve function were collected by administering 38-item questionnaires.

Results

A total of 510 valid questionnaires were collected. The mean knowledge score of all respondents was 7.56±2.03 (possible range: 0–10), the mean attitude score was 29.12±3.98 (possible range: 8–40) and the mean practice score was 23.45±3.58 (possible range: 6–30). The multivariable analysis showed knowledge level (OR 1.175, 95% CI 1.049 to 1.317, p=0.002), attitude level (OR 1.249, 95% CI 1.167 to 1.337, p

Conclusions

The women living in Chongqing and surrounding regions had good knowledge, moderate attitude and good practice towards ovarian reserve function. The knowledge aspect can be further improved by education, which in turn might also improve practice among women of childbearing age.

Evaluating the accuracy of the Ophthalmologist Robot for multiple blindness-causing eye diseases: a multicentre, prospective study protocol

Por: Li · Q. · Tan · J. · Xie · H. · Zhang · X. · Dai · Q. · Li · Z. · Yan · L. L. · Chen · W.
Introduction

Early eye screening and treatment can reduce the incidence of blindness by detecting and addressing eye diseases at an early stage. The Ophthalmologist Robot is an automated device that can simultaneously capture ocular surface and fundus images without the need for ophthalmologists, making it highly suitable for primary application. However, the accuracy of the device’s screening capabilities requires further validation. This study aims to evaluate and compare the screening accuracies of ophthalmologists and deep learning models using images captured by the Ophthalmologist Robot, in order to identify a screening method that is both highly accurate and cost-effective. Our findings may provide valuable insights into the potential applications of remote eye screening.

Methods and analysis

This is a multicentre, prospective study that will recruit approximately 1578 participants from 3 hospitals. All participants will undergo ocular surface and fundus images taken by the Ophthalmologist Robot. Additionally, 695 participants will have their ocular surface imaged with a slit lamp. Relevant information from outpatient medical records will be collected. The primary objective is to evaluate the accuracy of ophthalmologists’ screening for multiple blindness-causing eye diseases using device images through receiver operating characteristic curve analysis. The targeted diseases include keratitis, corneal scar, cataract, diabetic retinopathy, age-related macular degeneration, glaucomatous optic neuropathy and pathological myopia. The secondary objective is to assess the accuracy of deep learning models in disease screening. Furthermore, the study aims to compare the consistency between the Ophthalmologist Robot and the slit lamp in screening for keratitis and corneal scar using the Kappa test. Additionally, the cost-effectiveness of three eye screening methods, based on non-telemedicine screening, ophthalmologist-telemedicine screening and artificial intelligence-telemedicine screening, will be assessed by constructing Markov models.

Ethics and dissemination

The study has obtained approval from the ethics committee of the Ophthalmology and Optometry Hospital of Wenzhou Medical University (reference: 2023-026 K-21-01). This work will be disseminated by peer-review publications, abstract presentations at national and international conferences and data sharing with other researchers.

Trial registration number

ChiCTR2300070082.

Association between asymptomatic hyperuricemia and risk of arthritis, findings from a US National Survey 2007-2018

Por: Liang · Z. · WU · D. · Zhang · H. · Gu · J.
Background

Arthritis is thought to be closely related to serum uric acid. The study aims to assess the association between asymptomatic hyperuricemia (AH) and arthritis.

Methods

A multistage, stratified cluster was used to conduct a cross-sectional study of adult US civilians aged≥20 years from the 2007–2018 National Health and Nutrition Examination Survey. Participants with hyperuricemia and without hyperuricemia prior to gout were included. A questionnaire was used to determine whether participants had arthritis and the type of arthritis. Logistic regression was used to investigate the association between hyperuricemia and arthritis.

Result

During the past 12 years, the percentage of participants with arthritis changed from 25.95% (22.53%–29.36%) to 25.53% (21.62%–29.44%). The prevalence of osteoarthritis (OA) increased from 8.70% (95% CI: 6.56% to 10.85%) to 12.44% (95% CI: 9.32% to 15.55%), the prevalence of AH changed from 16.35% (95% CI: 14.01% to 18.40%) to 16.39% (95% CI: 13.47% to 19.30%). Participants with AH were associated with onset of arthritis (OR=1.34, 95% CI: 1.07 to 1.69), but the association was muted after adjusting demographic and socioeconomic factors. For participants aged 40–49 years, AH is associated with incident arthritis (OR=1.96, 95% CI: 1.23 to 2.99) and the relationship remained after adjusting for education level, income to poverty ratio, body mass index, diabetes, hypertension and smoking (OR=2.00, 95% CI: 1.94 to 3.36). Compared with male, female participants with AH are more likely to develop arthritis, especially in OA (OR=1.35, 95% CI: 1.14 to 1.60).

Conclusion

Our data identified AH as the risk factor for incident arthritis, especially for OA, which might be exaggerated in aged population and female population.

Role of HDL cholesterol in anthracycline-induced subclinical cardiotoxicity: a prospective observational study in patients with diffuse large B-cell lymphoma treated with R-CHOP

Por: Ou · W. · Jiang · T. · Zhang · N. · Lu · K. · Weng · Y. · Zhou · X. · Wang · D. · Dong · Q. · Tang · X.
Objectives

Anthracycline-induced cardiotoxicity is a debilitating cardiac dysfunction for which there are no effective treatments, making early prevention of anthracycline-induced subclinical cardiotoxicity (AISC) crucial. High-density lipoprotein cholesterol (HDL-C) plays a role in cardioprotection, but its impact on AISC remains unclear. Our study aims to elucidate the protective capacity of HDL-C in AISC in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab).

Design

Prospective observational study.

Setting

Conducted in China from September 2020 to September 2022.

Participants

70 chemotherapy-naïve patients newly diagnosed with DLBCL who were scheduled to receive the standard dose of R-CHOP; 60 participants included in a case–control study (DOI: 10.1186/s12885-022-10085-6).

Primary outcome measures

Serum biomarkers, 2D speckle tracking echocardiography and conventional echocardiography were measured at baseline, at the end of the third and sixth cycles of R-CHOP and 6 and 12 months after chemotherapy.

Results

24 patients experienced AISC, while 10 did not. 36 patients were lost to follow-up and death. Cox regression analysis showed that higher levels of HDL-C were associated with a significantly lower risk of AISC (unadjusted HR=0.24, 95% CI 0.09 to 0.67, p=0.006; adjusted HR=0.27, 95% CI 0.09 to 0.79, p=0.017). Patients without AISC had a more stable and higher HDL-C level during the follow-up period. HDL-C levels significantly decreased from the end of the third cycle of chemotherapy to the end of the sixth cycle of chemotherapy in all patients (p=0.034), and particularly in the AISC group (p=0.003). The highest level of HDL-C was significantly higher in patients without AISC than in those with AISC (1.52±0.49 vs 1.22±0.29, p=0.034).

Conclusions

Our study suggests that higher HDL-C levels may associate with lower AISC risk in patients with DLBCL treated with R-CHOP. HDL-C could be a cardioprotective target, but further research is needed to confirm its benefits and limitations.

Study registration number

Study registration number: ChiCTR2100054721

Prevalence and correlates of depression and anxiety symptoms among older adults in Shenzhen, China: a cross-sectional population-based study

Por: Peng · X. · Zhang · S. · You · L. · Hu · W. · Jin · S. · Wang · J.
Objectives

To investigate the prevalence of depression and anxiety symptoms among older adults in an urban district in China, as well as their associated factors.

Design

Cross-sectional study.

Setting

General communities in Shenzhen, Guangdong, China.

Participants

A total of 5372 community-dwelling older adults aged 65 years or older were initially recruited. Ultimately, 5331 participants met the inclusion criteria and were included in this study.

Methods

Participants completed a sociodemographic questionnaire, along with assessments including the Patient Health Questionnaire-9, Generalised Anxiety Scale-7, UCLA Loneliness Simplification Scale, Insomnia Severity Index Scale (ISI), Community Dementia Brief Screening Scale and the 8-item Dementia Screening Questionnaire. Statistical analyses included the Shapiro-Wilk test, independent t-test, Wilcoxon rank test, 2 test and univariate and multivariate linear regression analysis.

Results

The prevalence of depression and anxiety symptoms among older adults in Shenzhen communities was 10.4% and 11.3%, respectively. In multivariate analysis, age (B=–0.01, p

Conclusions

We observed a high prevalence of depression and anxiety symptoms among older adults in this study. The existing welfare system and infrastructure should remain and targeted mental health programmes addressing the identified risk factors should be proposed.

Effectiveness of musculoskeletal manipulations in patients with neck pain: a protocol for a systematic review and network meta-analysis

Por: Gong · Z. · Gao · Y. · Liu · W. · Liu · X. · Chen · Q. · Zhang · S. · Liu · L. · Li · J. · Li · W.
Introduction

Neck pain is a common problem that severely affects physical and mental health. While musculoskeletal manipulations are recommended as the first-line treatment for adults with neck pain, the comparative effectiveness of different musculoskeletal manipulations remains unclear. This systematic review and network meta-analysis of randomised controlled trials (RCTs) will compare the effectiveness of different types of musculoskeletal manipulations, with the overarching aim of guiding clinical practice.

Methods and analysis

Two independent reviewers will search four English electronic databases (Web of Science, Cochrane Library, EMBASE, PubMed) and three Chinese electronic databases (China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang) for relevant RCTs published from 1 January 2013 to 30 April 2023. The Clinical Trials Registry (ClinicalTrials.gov) will be searched for completed but unpublished RCTs. English and Chinese will be used to search English databases and Chinese databases, respectively. RCTs of musculoskeletal manipulations for adults (aged ≥18 years) with neck pain will be considered eligible for inclusion. A pairwise meta-analysis and network meta-analysis will be performed, and pooled risk ratios, standardised mean differences and 95% CIs will be determined.

Ethics and dissemination

Ethics approval is not required as this study is a literature review. The results of this review will be published in peer-reviewed journals or disseminated at conferences.

PROSPERO registration number

CRD42023420775.

Which aspects of patient experience are the 'moment of truth in the healthcare context: a multicentre cross-sectional study in China

Por: Chen · X. · Yuan · J. · Zhao · W. · Qin · W. · Gao · J. · Zhang · Y.
Objective

This study aimed to examine the differential magnitude of associations between specific dimensions of patient experience and overall patient satisfaction.

Design

A descriptive, cross-sectional design was used to collect patient experience and overall satisfaction data.

Setting

Participants were recruited at one tertiary general hospital, one tertiary specialised hospital, and one secondary hospital in Shanghai, China. These three institutes represent the main kinds of hospitals in the Chinese healthcare system.

Participants

1532 inpatients were recruited, and 1469 were included. The inclusion criteria were as follows: (1) having received inpatient service for at least 2 days; (2) able to understand the questions in the questionnaires; and (3) aged>18 years old. Patients who had impaired cognitive function and completed the questionnaires with missing information were excluded.

Primary and secondary outcome measure

Patient experience was measured using the Inpatient Experience with Nursing Care Scale, which is widely used in the China. The overall patient satisfaction was measured with 10-point response option.

Results

The LASSO (least absolute shrinkage and selection operator) regression results showed that as the penalty factor () = 0.0162, age, marriage status, financial status, length of hospital stay and numbers of previous of hospitalisation and six dimensions of nursing care remained in the model. As increases to 0.1862, only four patient experience variables, potentially the most influential on patient satisfaction, remained in the model. Patient experience with emotional support was the most significant dimension explaining patient satisfaction (β=0.1564), the second most significant dimension was admission and discharge management (β=0.1562), and the third was monitoring and coping with the progress of diseases (β=0.0613).

Conclusion

Patient experience with emotional support, admission and discharge management, monitoring and coping with the progress of diseases, and information and education are the most significant dimensions explaining patient satisfaction.

Prevalence of and risk factors for myopia among urban and rural children in Northeast China: protocol for a school-based cross-sectional study

Por: Zheng · T. · Jiang · S. · Fu · W. · Liu · H. · Ding · S. · Xv · D. · Zhang · H. · Zheng · T. · Yang · X.
Introduction

The worldwide prevalence of myopia is high and continues to increase. In this study, a school screening programme for myopia will be implemented using the whole-process information method. The purpose of this study is to investigate the prevalence of myopia in urban and rural areas of Northeast China and to determine the factors related to myopia.

Methods and analysis

This is a school-based cross-sectional study. Our study population will include 6000 school-aged children from 2 urban and 2 rural schools in Jinzhou, China. The study will be conducted using our self-developed internet-based intelligent data collection, transmission, storage and analysis system. Examination parameters include uncorrected distance visual acuity, presenting distance visual acuity, non-cycloplegic autorefraction, height, weight, waist circumference, hip circumference, spinal curvature and dental caries. The examination report will be automatically sent to parents, who will complete the questionnaire, and appropriate statistical analysis will be performed. The main outcome is the prevalence of myopia, defined as an equivalent spherical degree ≤–0.5 D.

Ethics and dissemination

Ethical approval was obtained from the Third Affiliated Hospital of Jinzhou Medical University (number: JYDSY-KXYJ-IEC-2023-018). Findings will be published in a peer-reviewed journal. Subjects and their parents (or other authorised agents) give informed consent prior to study participation.

Trial registration number

ChiCTR2300072893.

Sexual orientation and gender identity measures and viral suppression for people living with HIV: a protocol for a population-based cohort study

Por: Yang · X. · Olatosi · B. · Weissman · S. · Li · X. · Zhang · J.
Introduction

The measure of sexual orientation and gender identity (SOGI) data in electronic health records (EHR) has been critical for addressing health disparities and inequalities, especially for HIV care. Given that gender and sexual minorities (eg, transgender, men who have sex with men and intersex) are key groups in people living with HIV (PLWH), SOGI data can facilitate a more accurate understanding about the HIV outcomes (eg, viral suppression) among this key group and then lead to tailored therapeutic services. The two-step SOGI collection method as an emerging gender measurement can be used to measure SOGI status in medical settings. Using the statewide cohort of PLWH in South Carolina (SC), this project aims to: (1) integrate statewide PLWH cohort data with their birth certificate data to evaluate SOGI measurements from multiple EHR sources; and (2) examine differences in viral suppression based on SOGI measurements.

Methods and analysis

Our EHR database includes several HIV data sources with patients’ gender information, such as SC Department of Health and Environmental Control Centre (DHEC), Health Sciences South Carolina (HSSC) and Prisma as well as birth certificate data to retrieve the sex at birth. The SC Enhanced HIV/AIDS Reporting System (e-HARS) from DHEC will provide longitudinal viral load information to define a variety of viral suppression status. Datasources like the SC office of Revenue and Fiscal Affairs (RFA) will extract longitudinal EHR clinical data of all PLWH in SC from multiple health systems; obtain data from other state agencies and link the patient-level data with county-level data from multiple publicly available data sources.

Ethics and dissemination

The study was approved by the Institutional Review Board at the University of South Carolina (Pro00129906) as a Non-Human Subject study. The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through social media.

Quantitative assessments of retinal macular structure among rural-dwelling older adults in China: a population-based, cross-sectional, optical coherence tomography study

Por: Zhang · Q. · Zhang · C. · Wang · Y. · Cong · L. · Liu · K. · Xu · Z. · Jiang · C. · Zhou · W. · Zhang · C. · Dong · Y. · Feng · J. · Qiu · C. · Du · Y.
Objectives

To quantitatively assess and compare retinal macular structures of rural-dwelling older adults in China using two different optical coherence tomography (OCT) scanners and to examine their associations with demographic, lifestyle, clinical and ocular factors.

Design, setting and participants

This population-based, cross-sectional study included 971 participants (age ≥60 years) derived from the Multimodal Interventions to Delay Dementia and Disability in Rural China study. We collected data on demographics, lifestyle factors, clinical conditions (eg, cardiovascular disease (CVD)) and ocular factors (eg, visual acuity and spherical equivalent). We used two models of spectral-domain OCT to measure macular parameters in nine Early Treatment Diabetic Retinopathy Study subfields. Data were analysed using the multiple general linear models.

Results

Spectralis OCT demonstrated higher macular thickness but a lower macular volume than Primus 200 OCT (p

Conclusions

Macular thickness and volume assessed by Spectralis and Primus 200 OCT scanners differ. Older age and female sex are associated with lower macular thickness and volume. Macular parameters are associated with education, CVD and spherical equivalent.

Trial registeration number

MIND-China study (ChiCTR1800017758).

Association between perioperative glucose profiles assessed by the continuous glucose monitoring (CGM) system and prognosis in patients with ST-segment elevation myocardial infarction (STEMI): protocol for a cohort study

Por: Shi · J. · Wang · X. · Zhang · H. · Ding · Y. · Wu · J. · Luo · S. · Hu · H. · Zheng · X.
Introduction

ST-segment elevation myocardial infarction (STEMI) presents a serious cardiovascular condition requiring prompt intervention. Dysglycaemia has been identified as a significant risk factor impacting STEMI prognosis. However, limited research has focused on comprehensively examining the association between glucose dynamics during the perioperative period and patient outcomes. This study aims to address this gap by leveraging continuous glucose monitoring (CGM) technology to gain real-time insights into glucose fluctuations and their potential impact on STEMI prognosis.

Methods and analysis

This is a multicentre, prospective, 3-year follow-up cohort study. Between May 2023 and May 2024, 550 eligible STEM patients who underwent percutaneous coronary intervention are expected to be recruited. Using the CGM system, continuous glucose levels will be collected throughout the perioperative phase. Key clinical parameters, including cardiac biomarkers, angiographic findings and major adverse cardiovascular events, will be assessed in relation to glucose profile.

Ethics and dissemination

The study was approved by the Medical Research Ethics Committee of The First Affiliated Hospital of University of Science and Technology of China and will be conducted in accordance with the moral, ethical and scientific principles of the Declaration of Helsinki. Written informed consent will be obtained from all participants before any study-related procedures are implemented. Study results will be disseminated through conferences and peer-reviewed scientific journals.

Trial registration number

ChiCTR2300069662.

Association of Long COVID with mental health disorders: a retrospective cohort study using real-world data from the USA

Por: Zhang · Y. · Chinchilli · V. M. · Ssentongo · P. · Ba · D. M.
Objectives

Mental health disorders (MHD) rank third for US adult hospitalisations. Given the substantial prevalence of ‘Long COVID’ in SARS-CoV-2 survivors, this study aims to assess its association with increased MHD risk using extensive real-world data.

Design

A retrospective cohort study with propensity score matching was conducted. We used the International Classification of Diseases, 10th Revision codes to identify individuals with Long COVID status and COVID-19 histories. Multivariable stratified Cox proportional hazards regression analysis was conducted to determine the association of Long COVID status with MHD.

Setting

Data were sourced from the TriNetX database, spanning records from 1 October 2021 to 16 April 2023.

Participants

Two distinct cohorts were established: one comprising individuals diagnosed with Long COVID and another comprising individuals with no history of Long COVID or COVID-19. At the start of the study, none of the participants had a recorded MHD.

Primary and secondary outcome measures

The main outcome of interest was a composite diagnosis of MHD. Secondary outcomes were individual mental health conditions.

Results

The study included 43 060 control participants without Long COVID and 4306 Long COVID participants, demonstrating well-balanced distribution across all covariates. After adjusting for 4 demographic factors and 10 comorbidities, Long COVID was associated with MHD (adjusted HR, aHR 2.60; 95% CI 2.37 to 2.85). In subgroup analysis, Long COVID was associated with major depression disorder (aHR 3.36; 95% CI 2.82 to 4.00) and generalised anxiety disorder (aHR 3.44; 95% CI 2.99 to 3.96).

Conclusions

In this retrospective large real-world cohort study, Long COVID was associated with an increased risk of incident MHD. The MHD impact is significant considering the vast number of patients with Long COVID. Enhanced MHD screening among COVID-19 survivors should be a priority.

Priming transcranial direct current stimulation for improving hemiparetic upper limb in patients with subacute stroke: study protocol for a randomised controlled trial

Por: Zhu · F. · Xu · X. · Jin · M. · Chen · J. · Feng · X. · Wang · J. · Yu · D. · Wang · R. · Lian · Y. · Huai · B. · Lou · X. · Shi · X. · He · T. · Lu · J. · Zhang · J. J. · Bai · Z.
Introduction

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates brain states by applying a weak electrical current to the brain cortex. Several studies have shown that anodal stimulation of the ipsilesional primary motor cortex (M1) may promote motor recovery of the affected upper limb in patients with stroke; however, a high-level clinical recommendation cannot be drawn in view of inconsistent findings. A priming brain stimulation protocol has been proposed to induce stable modulatory effects, in which an inhibitory stimulation is applied prior to excitatory stimulation to a brain area. Our recent work showed that priming theta burst magnetic stimulation demonstrated superior effects in improving upper limb motor function and neurophysiological outcomes. However, it remains unknown whether pairing a session of cathodal tDCS with a session of anodal tDCS will also capitalise on its therapeutic effects.

Methods and analysis

This will be a two-arm double-blind randomised controlled trial involving 134 patients 1–6 months after stroke onset. Eligible participants will be randomly allocated to receive 10 sessions of priming tDCS+robotic training, or 10 sessions of non-priming tDCS+robotic training for 2 weeks. The primary outcome is the Fugl-Meyer Assessment-upper extremity, and the secondary outcomes are the Wolf Motor Function Test and Modified Barthel Index. The motor-evoked potentials, regional oxyhaemoglobin level and resting-state functional connectivity between the bilateral M1 will be acquired and analysed to investigate the effects of priming tDCS on neuroplasticity.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of the Shanghai Yangzhi Rehabilitation Center (reference number: Yangzhi2023-022) and will be conducted in accordance with the Declaration of Helsinki of 1964, as revised in 2013.

Trial registration number

ChiCTR2300074681.

Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C)

Por: Zhang · H. · Li · Y. · Xia · F. · Sun · Y. · Shen · L. · Wan · J. · Chen · Y. · Wang · Y. · Zhou · M. · Wu · R. · Zhou · S. · Wang · Y. · Liu · F. · Cai · S. · Zhang · Z.
Introduction

The preliminary result of the TORCH trial has shown a promising complete response (CR) for managing locally advanced rectal cancer with neoadjuvant short-course radiotherapy (SCRT) combined with chemotherapy and PD-1 inhibitor. For locally advanced colon cancer (LACC) with bulky nodal disease and/or clinically T4, neoadjuvant chemotherapy followed by colectomy with en bloc removal of regional lymph nodes is the suggested treatment. However, the CR rate is less than 5%. TORCH-C will aim to investigate neoadjuvant SCRT combined with chemotherapy and PD-1 inhibitor in LACC.

Methods and analysis

TORCH-C is a randomised, prospective, multicentre, double-arm, open, phase II trial of SCRT combined with chemotherapy and immunotherapy in LACC with microsatellite stable (MSS) patients and cT4 or bulky nodes. Eligible patients will be identified by the multidisciplinary team. 120 patients will be randomised 1:1 to the intervention or control arm. The patients in the control arm will receive four cycles of capecitabine plus oxaliplatin (CAPOX). The patients in the intervention arm will receive SCRT, followed by four cycles of CAPOX and PD-1 inhibitor (serplulimab). Both arms will receive curative surgery, followed by four cycles of CAPOX. The primary endpoint is pathological complete regression.

TORCH-C (TORCH-colon) trial aims to investigate whether the combination of immunotherapy and chemoradiotherapy improves the treatment effect in LACC with MSS. TORCH-C will establish the TORCH platform, a key part of our long-term strategy to develop neoadjuvant treatment for colorectal cancer.

Ethics and dissemination

This study was approved by the Ethics Committee of Fudan University Shanghai Cancer Center (approval number: 2211265-12).

Trial registration number

NCT05732493

Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol

Por: Wong · H. · Chi · Y. · Zhang · R. · Yin · C. · Jia · J. · Wang · B. · Liu · Y. · Shang · Y. · Wang · R. · Long · Y. · Zhao · Z. · He · H.
Introduction

Previous studies suggested that electrical impedance tomography (EIT) has the potential to guide positive end-expiratory pressure (PEEP) titration via quantifying the alveolar collapse and overdistension. The aim of this trial is to compare the effect of EIT-guided PEEP and acute respiratory distress syndrome (ARDS) network low PEEP/fraction of inspired oxygen (FiO2) table strategy on mortality and other clinical outcomes in patients with ARDS.

Methods

This is a parallel, two-arm, multicentre, randomised, controlled trial, conducted in China. All patients with ARDS under mechanical ventilation admitted to the intensive care unit will be screened for eligibility. The enrolled patients are stratified by the aetiology (pulmonary/extrapulmonary) and partial pressure of arterial oxygen/FiO2 (≥150 mm Hg or 2 table proposed by the ARDS Network. The primary outcome is 28-day survival.

Analysis

Qualitative data will be analysed using the 2 test or Fisher’s exact test, quantitative data will be analysed using independent samples t-test or Mann-Whitney U test. Kaplan-Meier analysis with log-rank test will be used to evaluate the 28-day survival rate between two groups. All outcomes will be analysed based on the intention-to-treat principle.

Ethics and dissemination

The trial is approved by the Institutional Research and Ethics Committee of the Peking Union Medical College Hospital. Data will be published in peer-reviewed journals.

Trial registration number

NCT05307913.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Priority populations experiences of isolation, quarantine and distancing for COVID-19: protocol for a longitudinal cohort study (Optimise Study)

Por: Pedrana · A. · Bowring · A. · Heath · K. · Thomas · A. J. · Wilkinson · A. · Fletcher-Lartey · S. · Saich · F. · Munari · S. · Oliver · J. · Merner · B. · Altermatt · A. · Nguyen · T. · Nguyen · L. · Young · K. · Kerr · P. · Osborne · D. · Kwong · E. J. L. · Corona · M. V. · Ke · T. · Zhang
Introduction

Longitudinal studies can provide timely and accurate information to evaluate and inform COVID-19 control and mitigation strategies and future pandemic preparedness. The Optimise Study is a multidisciplinary research platform established in the Australian state of Victoria in September 2020 to collect epidemiological, social, psychological and behavioural data from priority populations. It aims to understand changing public attitudes, behaviours and experiences of COVID-19 and inform epidemic modelling and support responsive government policy.

Methods and analysis

This protocol paper describes the data collection procedures for the Optimise Study, an ongoing longitudinal cohort of ~1000 Victorian adults and their social networks. Participants are recruited using snowball sampling with a set of seeds and two waves of snowball recruitment. Seeds are purposively selected from priority groups, including recent COVID-19 cases and close contacts and people at heightened risk of infection and/or adverse outcomes of COVID-19 infection and/or public health measures. Participants complete a schedule of monthly quantitative surveys and daily diaries for up to 24 months, plus additional surveys annually for up to 48 months. Cohort participants are recruited for qualitative interviews at key time points to enable in-depth exploration of people’s lived experiences. Separately, community representatives are invited to participate in community engagement groups, which review and interpret research findings to inform policy and practice recommendations.

Ethics and dissemination

The Optimise longitudinal cohort and qualitative interviews are approved by the Alfred Hospital Human Research Ethics Committee (# 333/20). The Optimise Study CEG is approved by the La Trobe University Human Ethics Committee (# HEC20532). All participants provide informed verbal consent to enter the cohort, with additional consent provided prior to any of the sub studies. Study findings will be disseminated through public website (https://optimisecovid.com.au/study-findings/) and through peer-reviewed publications.

Trial registration number

NCT05323799.

Prognostic value of circulating plasma cells detected by flow cytometry in newly diagnosed multiple myeloma patients: a systematic review and meta-analysis

Por: Liu · X. · Wu · F. · Ye · W. · Deng · J. · Zhang · M. · Zhang · C. · Yu · Q. · Cao · L. · Gan · S. · Ma · J.
Objectives

Multiple myeloma (MM) is a malignant plasma cell disorder. The most widely accepted staging system for MM is the revised International Staging System based on cytogenetic and clinical biomarkers. The circulating clonal plasma cells (CPCs) were reported to have potential prognostic impact on MM. Among various diagnostic approaches, multiparametric flow cytometry (FCM) offers heightened sensitivity, minimal invasiveness and reproducibility. We conducted a meta-analysis to evaluate the prognostic value of quantifying CPCs via FCM in newly diagnosed symptomatic MM (NDMM) patients.

Design

Systematic review and meta-analysis.

Data source

PubMed, Web of Science, Embase and references of included studies.

Eligibility criteria for selecting studies

We included observational studies that evaluated the prognostic value of CPCs detected by FCM in NDMM.

Data extraction and synthesis

Data were screened and extracted independently by two investigators. The pooled results originated from random effects models. The primary endpoint was overall survival (OS). The secondary endpoint was progression-free survival (PFS). To evaluate the prognostic value of CPCs in NDMM, HRs and their 95% CI for both OS and PFS were derived using COX multivariable models. These values were then used to compute the pooled estimated effect.

Results

Our meta-analysis encompassed a total of 2704 NDMM patients from 11 studies up to 27 August 2022. The pooled HR for OS and PFS in CPC-positive (CPCs+) group and CPC-negative group were 1.95 (95% CI 1.24 to 3.07) and 2.07 (95% CI 1.79 to 2.39), respectively. The autologous stem cell transplantation (ASCT) failed to eliminate the adverse impact on OS and PFS. The heterogeneity may stem from the use of novel agents or traditional chemotherapy as initial treatment.

Conclusion

This meta-analysis indicates CPCs+ had an adverse impact on the prognosis of NDMM patients in the total population, and the adverse impact could not be eliminated by ASCT.

PROSPERO registration number

CRD42021272381.

Epidemiological characteristics of suspected adenomyosis in the Chinese physical examination population: a nested case-control study

Por: Huang · Y. · Su · X. · Chen · K. · Zhang · L. · Xu · W. · Pu · Y. · Xu · F. · Gong · R. · Zhang · J. · Nie · Y. · Shi · Q.
Objectives

We aimed to explore the epidemiological characteristics of suspected adenomyosis within a physical examination population in China.

Design

A retrospective, nested case-control study; we matched healthy people and those with potential adenomyosis on a 1:2 ratio by age.

Setting

A tertiary hospital health management centre.

Participants

We included 15–60 years old women who underwent at least one uterine examination from October 2017 to December 2020, excluding those who had undergone hysterectomy and menopause.

Primary and secondary outcome measures

We estimated the incidence and prevalence rate of suspected adenomyosis. Conditional logistic regression was used to estimate associations between serum biomarkers and potential adenomyosis. Areas under the receiver-operating characteristic curves (AUC) were used to determine the cut-off point of the cancer antigen 125 (CA125) level for suspected adenomyosis.

Results

A total of 30 629 women had uterus-related imaging examinations; 877 had suspected adenomyosis. The standardised incidence and prevalence of suspected adenomyosis was 1.32% and 2.35%, respectively, for all age groups. The conditional logistic regression analysis results showed that total bilirubin≥18.81 µmol/L (HR: 2.129; 95% CI 1.067 to 4.249; p24 kg/m2 (HR: 1.262; 95% CI 1.055 to 1.511; p

Conclusions

The disease burden of suspected adenomyosis remains huge and can be informed by biomarkers. The disease-specific threshold of CA125 will support further preventive strategy development in population.

Trial registration number

ChiCTR2100049520, 2021/8/2.

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