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Survival outcomes following complete mediastinal lymphadenectomy or selective mediastinal lymphadenectomy in patients with stage I-IIIA non-small cell lung cancer: protocol for a systematic review and meta-analysis

Por: Xu · J. · Lai · J. · Huang · X. · Ren · Y. · Chen · Q. · Li · W.
Introduction

Lung cancer remains the largest cause of cancer-related deaths worldwide. Surgical removal of non-small cell lung cancer (NSCLC) has the potential to achieve a cure, although there is ongoing debate regarding the significance of removing mediastinal nodes and the optimal extent of lymph node excision. The purpose of this research is to assess the survival outcomes in patients diagnosed with stage I–IIIA NSCLC who received either complete mediastinal lymphadenectomy (CML) or selective mediastinal lymphadenectomy (SML).

Methods and analysis

The protocol follows the guidelines recommended in Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols, and this meta-analysis will be conducted in accordance with the standard methodology recommended by the Cochrane Collaboration and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidance. We will conduct a comprehensive search for randomised controlled trials and non-randomised studies examining the effectiveness of CML compared with SML in patients with stage I–IIIA NSCLC. Two authors will perform a comprehensive search of the MEDLINE/PubMed, Embase, the Cochrane Library, CNKI, WanFang, Sinomed, VIP and Web of Science databases. There will be no restrictions on language or publication date, and the search will be conducted on 10 April 2024, with ongoing searches for new research. Reference lists will also be checked and pertinent journals will be hand searched. The primary outcomes include overall survival (OS) and disease-free survival (DFS), while the secondary outcomes consist of 1-year, 3-year and 5-year OS rates and 1-year, 3-year and 5-year DFS rates. Two independent reviewers will screen, extract data, assess quality and evaluate the potential for bias in the selected research, with a third acting as arbitrator. Subgroup analyses and sensitivity analyses are planned. The quality of the evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Review Manager V.5.4 will be used for the analysis and synthesis process.

Ethics and dissemination

Ethical review and approval are not necessary for this study because it is based on a secondary analysis of the literature. The results will be submitted for reporting in a peer-reviewed publication.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/PN7UQ).

Immunosuppressant medication behaviours in solid organ transplant recipients: a cross-sectional study from south-central China during COVID-19 reopening period

Por: Zhao · Q. · Dong · L. · Wang · L. · Zhao · H. · Zhu · X. · Zhang · Z. · Liu · J.
Objective

Medication non-adherence to immunosuppressants threatens allograft survival and function maintenance among solid organ transplant (SOT) recipients. This study aimed to investigate the prevalence of immunosuppressant medication non-adherence and associated factors during the COVID-19 reopening period among Chinese SOT recipients.

Design

Cross-sectional study.

Setting

South-central China.

Population

Adult patients who received SOT with functioning graft.

Methods

Sociodemographic questionnaire and scales to measure physical activity, depression and medication non-adherence were used to collect data. Logistic regression analysis was conducted to identify factors associated with medication non-adherence. Mediation and moderated mediation analyses were performed to examine the potential mechanisms influencing medication behaviour during the pandemic reopening period using SPSS PROCESS macro 4.3 software.

Results

A total of 1121 participants were recruited and the prevalence of medication non-adherence was 36.3% in this study. Recipients who were men, had a higher monthly income, lived alone, had received transplantation for a minimum of 3 years, had received COVID-19 vaccination and experienced depressive symptoms exhibited an increased risk of non-adherence. Contrarily, those who engaged in high-intensity physical activity exhibited a decreased risk. Physical activity was negatively associated with medication non-adherence (r=–0.124, p

Conclusion

This study investigated the prevalence of medication non-adherence among SOT recipients during the COVID-19 reopening period in China, its associated factors and a potential mechanism. Depression fully mediated the association between physical activity and medication non-adherence, and COVID-19 vaccination moderated the relationship between physical activity and depression. These findings provide some insights for managing medication behaviour when confronting public health emergencies. However, relationships displayed in the moderated mediation model should be tracked after returning to normal life and other potential relationships should be explored to deeply understand medication non-adherent behaviour.

Toxoplasma gondii seropositivity and cognitive functioning in older adults: an analysis of cross-sectional data of the National Health and Nutrition Examination Survey 2011-2014

Por: Song · G. · Zhao · Q. · Chen · H. · Li · M. · Zhang · Z. · Qu · Z. · Yang · C. · Lin · X. · Ma · W. · Standlee · C. R.
Objectives

This study sought to examine the relationship between Toxoplasma gondii seropositivity and cognitive function in older adults.

Design

An observational cross-sectional study.

Setting

The National Health and Nutrition Examination Survey (NHANES) study took place at participants’ homes and mobile examination centres.

Participants

A total of 2956 older adults aged 60 and above from the NHANES from 2011 to 2014 were included in the study. Exposure of interest: participants had serum Toxoplasma gondii antibody analysed in the laboratory. A value>33 IU/mL was categorised as seropositive for Toxoplasma gondii infection; Toxoplasma gondii infection.

Primary and secondary outcome measures

Cognitive tests included the Consortium to Establish a Registry for Alzheimer’s Disease Word Learning subtest (CERAD-WL) for immediate and delayed memory, the Animal Fluency Test (AFT), and the Digit Symbol Substitution Test (DSST).

Results

About half of the 2956 participants (mean age 70.0) were female (51.0%), non-Hispanic White (48.3%), and completed some college or above (48.3%). A total of 703 participants were positive for Toxoplasma gondii infection (23.8%). Adjusted linear regression showed that compared with participants with negative Toxoplasma gondii infection, those with positive Toxoplasma gondii infection had lower CERAD-WL immediate memory (beta (β) –0.16, 95% CI –0.25 to –0.07), CERAD-WL delayed memory (β –0.15, 95% CI –0.24 to –0.06), AFT (β –0.15, 95% CI –0.24 to –0.06), DSST (β –0.34, 95% CI –0.43 to –0.26), and global cognition (β –0.24, 95% CI –0.32 to –0.16) z-scores after controlling for the covariates.

Conclusions

Toxoplasma gondii seropositivity is associated with worse immediate and delayed verbal learning, language proficiency, executive functioning, processing speed, sustained attention, working memory, as well as global cognition in older adults. Public health measures aiming at preventing Toxoplasma gondii infection may help preserve cognitive functioning in older adults.

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.

Combined MRI-TRUS fusion targeted and systematic biopsy versus systematic biopsy alone for the detection of prostate cancer: protocol for a prospective single-centre trial

Por: Liu · W. · Kadier · A. · Shen · D. · He · Y. · Dong · S. · Zhu · K. · Xu · G. · Zhao · B. · Mao · S. · Guo · C. · Yao · X. · Wei · Q. · Han · D. · Yang · B.
Introduction

The classic way of diagnosing prostate cancer (PCa) is by conducting the 12-core systematic biopsy (SB). However, it has a low detection rate for clinically significant PCa (csPCa) and can lead to the detection of clinically insignificant PCa (cisPCa). Although MRI-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TB) can effectively improve the detection rate of csPCa, it may still miss some cases. Therefore, we propose using a combination of TB and SB methods to enhance the detection rate of csPCa while minimising the detection rate of cisPCa.

Methods and analysis

This study is a prospective, single-centre investigation that aims to assess and compare the detection rate of csPCa using MRI-TRUS fusion TB combined with SB versus TRUS 12-core SB alone. Biopsy-naïve men with suspected PCa will be subjected to multiparametric MRI. Patients with Prostate Imaging Reporting and Data System (V.2.1) score ≥3 will be enrolled in the TB-SB combination group. The sample size is established as 660 participants, considering a 10% drop-out rate. The primary outcome is the detection rate of csPCa in men without prior biopsy using MRI-TRUS fusion TB combined with the standard TRUS-guided 12-core SB method. CsPCa will be defined as International Society of Urological Pathology Grade ≥2.

Ethics and dissemination

This study has been approved by the Ethics Committee at the Shanghai Tenth People’s Hospital, an affiliated hospital of Tongji University School of Medicine. The research results will be published in a peer-reviewed international journal.

Trial registration number

ChiCTR2000036089.

Interventional embolisation for patients with cirrhosis and recurrent or persistent hepatic encephalopathy related to spontaneous portosystemic shunts: protocol for a prospective, non-randomised controlled study

Por: Ke · Q. · Lin · T. · Lei · X. · Weng · X. · He · J. · Huang · X. · Li · L. · Guo · W.-H.
Introduction

The presence of spontaneous portosystemic shunts (SPSS) has been identified to be associated with hepatic encephalopathy (HE) in patients with cirrhosis. Nevertheless, the role of interventional embolisation in managing such patients remains poorly defined. Consequently, this prospective controlled study aims to assess the efficacy and safety of interventional embolisation as a therapeutic approach for patients with cirrhosis and recurrent or persistent HE related to SPSS.

Methods and analysis

Cirrhotic patients diagnosed with recurrent or persistent HE associated with SPSS will be recruited for this study, and assigned to either the interventional embolisation group or the standard medical treatment group. The efficacy endpoints encompass the evaluation of postoperative alleviation of HE symptoms and the incidence of overt HE recurrence during the follow-up period, as well as the duration and frequency of hospitalisations for HE, alterations in liver function and volume, and overall survival. The safety endpoints encompass both immediate and long-term postoperative complications.

Ethics and dissemination

This study will be conducted in strict adherence to the principles of good clinical practice and the guidelines outlined in the Declaration of Helsinki. Ethical approval for the trial has been obtained from the Ethics Committee of Mengchao Hepatobiliary Hospital of Fujian Medical University (2023_013_02). Written informed consent will be obtained from all the participants by the treating physician for each patient prior to their enrolment. The documented informed consent forms will be retained as part of the clinical trial records for future reference. The study findings will be disseminated through publication in peer-reviewed journals and will be presented at international conferences.

Trial registration number

ChiCTR2300072189.

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol

Por: Wu · L. · Yan · H. · Qin · Y. · Huang · M. · Wang · T. · Jin · Q. · Wei · W.
Introduction

Curing locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib’s low potential for drug–drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ.

Methods and analysis

The FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2–4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate.

Ethics and dissemination

Written informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ.

Trial registration number

NCT05122091.

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

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.

Comparison of industry payments to psychiatrists and psychiatric advanced practice clinicians in the USA, 2021: a cross-sectional study

Por: Havlik · J. · Ososanya · L. · Lee · M. S. · Wahid · S. · Heyang · M. · Sun · Q. W. · Ross · J. S. · Rhee · T. G.
Objectives

To compare industry payment patterns among US psychiatrists and psychiatric advanced practice clinicians (APCs) and determine how scope of practice laws has influenced these patterns.

Design

Cross-sectional study.

Setting

This study used the publicly available US Centers for Medicare and Medicaid Services Sunshine Act Open Payment database and the National Plan and Provider Enumeration System (NPPES) database for the year 2021.

Participants

All psychiatrists and psychiatric APCs (subdivided into nurse practitioners (NPs) and clinical nurse specialists (CNSs)) included in either database.

Primary and secondary outcome measures

Number and percentage of clinicians receiving industry payments and value of payments received. Total payments and number of transactions by type of payment, payment source and clinician type were also evaluated.

Results

A total of 85 053 psychiatric clinicians (61 011 psychiatrists (71.7%), 21 895 NPs (25.7%), 2147 CNSs (2.5%)) were reviewed; 16 240 (26.6%) psychiatrists received non-research payment from industry, compared with 10 802 (49.3%) NPs and 231 (10.7%) CNSs (p United States Dollars (US) $) 100 (33.9% vs 14.6%; IRR, 2.14 (2.08 to 2.20); p US$ 1000 (5.3% vs 4.1%; IRR, 1.29 (1.20 to 1.38); p US$ 10 000 (0.4% vs 1.0%; IRR, 0.39 (0.31 to 0.49); p

Conclusions

Psychiatric NPs were nearly two times as likely to receive industry payments as psychiatrists, while psychiatric CNSs were less than half as likely to receive payment. Stricter scope of practice laws increases the likelihood of psychiatric NPs receiving payment, the opposite of what was found in a recent specialty agnostic study.

How the commercial virtual care industry gathers, uses and values patient data: a Canadian qualitative study

Por: Spithoff · S. · McPhail · B. · Vesely · L. · Rowe · R. K. · Mogic · L. · Grundy · Q.
Objectives

To understand and report on the direct-to-consumer virtual care industry in Canada, focusing on how companies collect, use and value patient data.

Design

Qualitative study using situational analysis methodology.

Setting

Canadian for-profit virtual care industry.

Participants

18 individuals employed by or affiliated with the Canadian virtual care industry.

Methods

Semistructured interviews were conducted between October 2021 and January 2022 and publicly available documents on websites of commercial virtual care platforms were retrieved. Analysis was informed by situational analysis, a constructivist grounded theory methodology, with a continuous and iterative process of data collection and analysis; theoretical sampling and creation of theoretical concepts to explain findings.

Results

Participants described how companies in the virtual care industry highly valued patient data. Companies used data collected as patients accessed virtual care platforms and registered for services to generate revenue, often by marketing other products and services. In some cases, virtual care companies were funded by pharmaceutical companies to analyse data collected when patients interacted with a healthcare provider and adjust care pathways with the goal of increasing uptake of a drug or vaccine. Participants described these business practices as expected and appropriate, but some were concerned about patient privacy, industry influence over care and risks to marginalised communities. They described how patients may have agreed to these uses of their data because of high levels of trust in the Canadian health system, problematic consent processes and a lack of other options for care.

Conclusions

Patients, healthcare providers and policy-makers should be aware that the direct-to-consumer virtual care industry in Canada highly values patient data and appears to view data as a revenue stream. The industry’s data handling practices of this sensitive information, in the context of providing a health service, have implications for patient privacy, autonomy and quality of care.

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).

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.

Risk factors and glycaemic control in small-for-gestational-age infants born to mothers with gestational diabetes mellitus: a case-control study using propensity score matching based on a large population

Por: Li · J. · Pan · Y. · Zheng · Q. · Chen · X. · Jiang · X. · Liu · R. · Zhu · Y. · Huang · L.
Background

Small for gestational age (SGA) poses a significant concern for newborns, being linked to neonatal complications and potential metabolic disorders in adulthood, especially when born to mothers with gestational diabetes mellitus (GDM), elevating their risk of complications and mortality. However, the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM remain unclear.

Aim

To identify the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM.

Method

This case–control study was conducted among 1910 women with GDM in China. Data were collected by the integrated electronic medical record system. Using 1:4 propensity score matching analysis, we adjusted for gestational age as confounder. Univariate and multivariate analyses were performed to identify risk factors.

Results

Risk factors for SGA born to mothers with GDM included a history of low birth weight, gestational hypertension, oligohydramnios, short maternal height, underweight pre-pregnancy body mass index and inadequate weight growth. While SGA was protected by weakly positive ketonuria levels in the first trimester, multiparous, anaemia and previous uterine scar were protective factors for SGA. Moreover, 2-hour postprandial glucose and haemoglobin A1c in the second trimester, as well as the 0-hour and 2-hour 75 g oral glucose tolerance test (OGTT) were linked to risk of SGA.

Conclusions

SGA infants are the result of multifactorial interactions among GDM pregnant women. Notably, glycaemic control levels were associated with SGA. There is a need for enhanced perinatal monitoring and antenatal care to reduce SGA.

Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)

Por: Lu · C. · Kang · Y. · Luo · Q. · Zhong · F. · Cai · Y. · Zhang · G. · Guo · Z. · Zhang · S. · Ma · J. · Shu · H.
Introduction

It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.

Methods and analysis

This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.

Ethics and dissemination

This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.

Trial registration number

ChiCTR2200062520

Incidence of community-acquired pneumonia among children under 5 years in Suzhou, China: a hospital-based cohort study

Por: Qian · C. · Chen · Q. · Lin · W. · Li · Z. · Zhu · J. · Zhang · J. · Luan · L. · Zheng · B. · Zhao · G. · Tian · J. · Zhang · T.
Objectives

To depict the seasonality and age variations of community-acquired pneumonia (CAP) incidence in the context of the COVID-19 impact.

Design

Retrospective cohort study.

Participants

The observational cohort study was conducted at Soochow University Affiliated Children’s Hospital from January 2017 to June 2021 and involved 132 797 children born in 2017 or 2018. They were followed and identified CAP episodes by screening on the Health Information Systems of outpatients and inpatients in the same hospital.

Outcome

The CAP episodes were defined when the diagnoses coded as J09–J18 or J20–J22. The incidence of CAP was estimated stratified by age, sex, birth year, health status group, season and month, and the rate ratio was calculated and adjusted by a quasi-Poisson regression model. Stratified analysis of incidence of CAP by birth month was conducted to understand the age and seasonal variation.

Results

The overall incidence of CAP among children aged ≤5 years was 130.08 per 1000 person years. Children aged ≤24 months have a higher CAP incidence than those aged >24 months (176.84 vs 72.04 per 1000 person years, p

Conclusions

The burden of CAP among children is considerable. The incidence of CAP among children ≤5 years varied by age and season and decreased during COVID-19 lockdown.

Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol

Por: Wang · Z. · Li · T. · Zhang · Z. · Yuan · M. · Shi · M. · Wang · F.-S. · Linghu · E.-Q. · Shi · L.
Introduction

There are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.

Methods and analysis

This study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0x107, 1.0x108, 1.5x108 or 2.0x108 cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.

Ethics and dissemination

The study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.

Trial registration number

NCT05227846.

Changing epidemiology, microbiology and mortality of bloodstream infections in patients with haematological malignancies before and during SARS-CoV-2 pandemic: a retrospective cohort study

Por: Cai · L. · Chen · H. · Wei · Y. · Guo · X. · Zheng · H. · Jiang · X. · Zhang · Y. · Yu · G. · Dai · M. · Ye · J. · Zhou · H. · Xu · D. · Huang · F. · Fan · Z. · Xu · N. · Shi · P. · Xuan · L. · Feng · R. · Liu · X. · Sun · J. · Liu · Q. · Wei · X.
Objective

This study was to explore the changes in bacterial bloodstream infection (BSI) in patients with haematological malignancies (HMs) before and during SARS-CoV-2 pandemic.

Design

Retrospective cohort study between 2018 and 2021.

Setting

The largest haematological centre in southern China.

Results

A total of 599 episodes of BSI occurring in 22 717 inpatients from January 2018 to December 2021 were analysed. The frequencies of the total, Gram-negative and Gram-positive BSI before and during the pandemic were 2.90% versus 2.35% (p=0.011), 2.49% versus 1.77% (p

Conclusion

Our data showed that the incidence of total and Gram-negative organisms BSI decreased, but Gram-positive BSI incidence increased in patients with HMs during the pandemic along with the changes of main isolates and susceptibility profiles. Although the 30-day mortality due to BSI was lower during the pandemic, the new infection prevention strategy should be considered for any future pandemics.

Avoidance of healthcare service use and correlates among HIV-positive patients in Vietnam: a cross-sectional study

Por: Nguyen · H. L. T. · Bui · T. M. · Dam · V. A. T. · Nguyen · T. T. · Nguyen · H. T. · Zeng · G. M. · Bradley · D. · Nguyen · Q. N. · Ngo · T. V. · Latkin · C. A. · Ho · R. C. · Ho · C. S.
Objective

The prevention of HIV/AIDS is not making sufficient progress. The slow reduction of HIV/AIDS infections needs to prioritise hesitancy towards service utilisation, including treatment duration, social support and social stigma. This study investigates HIV-positive patients’ avoidance of healthcare services and its correlates.

Design

A cross-sectional study.

Setting

The secondary data analysis used cross-sectional data from a randomised controlled intervention, examining the effectiveness of HIV-assisted smartphone applications in the treatment of HIV/AIDS patients in the Bach Mai and Ha Dong clinics in Hanoi.

Methods

Simple random sampling was used to identify 495 eligible patients. Two-tailed 2, Mann-Whitney, multivariate logistic and ordered logistic regression models were performed.

Primary and secondary outcome measures

The main study outcome was the patients’ healthcare avoidance and frequency of healthcare avoidance. The association of individual characteristics, social and behavioural determinants of HIV patients’ usage of health services was also determined based on the collected data using structured questionnaires.

Results

Nearly half of the participants avoid health service use (47.3%), while 30.7% rarely avoid health service use. Duration of antiretroviral therapy and initial CD4 cell count were negatively associated with avoidance of health services and frequency of health service avoidance. Similarly, those with the middle and highest income were more likely to avoid health services compared with those with the lowest income. People having health problems avoided health service use more frequently (OR 1.47, 95% CI 1.35 to 1.61).

Conclusions

Our study’s findings identify characteristics of significance in relation to health service avoidance and utilisation among HIV-positive patients. The results highlighted the need to improve satisfaction, adherence and utilisation of treatment. Moreover, identifying ways to address or incorporate those social determinants in new policy may also help the treatment of HIV/AIDS and strategically allocate funding in the changing financial and political climate of Vietnam.

Trial registration number

Thai Clinical Trials Registry TCTR20220928003.

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