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Supplements for cognitive ability in patients with mild cognitive impairment or Alzheimers disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Zhang · X.-Y. · Li · Y.-Q. · Yin · Z.-H. · Bao · Q.-N. · Xia · M.-Z. · Chen · Z.-H. · Zhong · W.-Q. · Wu · K.-X. · Yao · J. · Liang · F.-R.
Introduction

Considering the increasing incidence of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) worldwide, there is an urgent need to identify efficacious, safe and convenient treatments. Numerous investigations have been conducted on the use of supplements in this domain, with oral supplementation emerging as a viable therapeutic approach for AD or MCI. Nevertheless, given the multitude of available supplements, it becomes imperative to identify the optimal treatment regimen.

Methods and analysis

Eight academic databases and three clinical trial registries will be searched from their inception to 1 June 2023. To identify randomised controlled trials investigating the effects of supplements on patients with AD or MCI, two independent reviewers (X-YZ and Y-QL) will extract relevant information from eligible articles, while the risk of bias in the included studies will be assessed using the Rob 2.0 tool developed by the Cochrane Collaboration. The primary outcome of interest is the overall cognitive function. Pair-wise meta-analysis will be conducted using RevMan V.5.3, while network meta-analysis will be carried out using Stata 17.0 and ADDIS 1.16.8. Heterogeneity test, data synthesis and subgroup analysis will be performed if necessary. The GRADE system will be employed to assess the quality of evidence. This study is scheduled to commence on 1 June 2023 and conclude on 1 October 2023.

Ethics and dissemination

Ethics approval is not required for systematic review and network meta-analysis. The results will be submitted to a peer-reviewed journal or at a conference.

Trial registration number

PROSPERO (CRD42023414700).

Protocol for a scoping review of factors associated with disparities in clinical provision of deep brain stimulation

Por: Abramson · T. · Aguero · R. · Arizpe · A. · Frank · A. · Kang · S. · Mason · X.
Introduction

Deep brain stimulation (DBS) can be used to treat several neurological and psychiatric conditions such as Parkinson’s disease, epilepsy and obsessive-compulsive disorder; however, limited work has been done to assess the disparities in DBS access and implementation. The goal of this scoping review is to identify sources of disparity in the clinical provision of DBS.

Methods and analysis

A scoping review will be conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-extension for Scoping Reviews methodology. Relevant studies will be identified from databases including MEDLINE/PubMed, EMBASE and Web of Science, as well as reference lists from retained articles. Initial search dates were in January 2023, with the study still ongoing. An initial screening of the titles and abstracts of potentially eligible studies will be completed, with relevant studies collected for full-text review. The principal investigators and coauthors will then independently review all full-text articles meeting the inclusion criteria. Data will be extracted and collected in table format. Finally, results will be synthesised in a table and narrative report.

Ethics and dissemination

No institutional board review or approval is necessary for the proposed scoping review. The findings will be submitted for publication to relevant peer-reviewed journals and conferences.

Scoping review registration

This protocol has been registered prospectively on the Open Science Framework (https://osf.io/cxvhu).

Development and applications of the Anaesthetists Non-Technical Skills behavioural marker system: a systematic review

Por: Kang · J. · Hu · J. · Yan · C. · Xing · X. · Tu · S. · Zhou · F.
Objectives

To comprehensively synthesise evidence regarding the validity and reliability of the Anaesthetists’ Non-Technical Skills (ANTS) behavioural marker system and its application as a tool for the training and assessment of non-technical skills to improve patient safety.

Design

Systematic review.

Data sources

We employed a citation search strategy. The Scopus and Web of Science databases were searched for articles published from 2002 to May 2022.

Eligibility criteria

English-language publications that applied the ANTS system in a meaningful way, including its use to guide data collection, analysis and reporting.

Data extraction and synthesis

Study screening, data extraction and quality assessment were performed by two independent reviewers. We appraised the quality of included studies using the Joanna Briggs Institute Critical Appraisal Checklists. A framework analysis approach was used to summarise and synthesise the included articles.

Results

54 studies were identified. The ANTS system was applied across a wide variety of study objectives, settings and units of analysis. The methods used in these studies varied and included quantitative (n=42), mixed (n=8) and qualitative (n=4) approaches. Most studies (n=47) used the ANTS system to guide data collection. The most commonly reported reliability statistic was inter-rater reliability (n=35). Validity evidence was reported in 51 (94%) studies. The qualitative application outcomes of the ANTS system provided a reference for the analysis and generation of new theories across disciplines.

Conclusion

Our results suggest that the ANTS system has been used in a wide range of studies. It is an effective tool for assessing non-technical skills. Investigating the methods by which the ANTS system can be evaluated and implemented for training within clinical environments is anticipated to significantly enhance ongoing enhancements in staff performance and patient safety.

PROSPERO registration number

CRD42022297773.

Development of a tool for assessing the clinical competency of Chinese masters nursing students based on the mini-CEX: a Delphi method study

Por: Peng · Q. · Gao · Y. · Liu · N. · Gan · X.
Objective

To construct a scientific and systematic competency evaluation tool for master of nursing specialists (MNS) and to provide a reference for the training, assessment and competency evaluation of MNS.

Methods

A first draft of the indicators for assessing MNS core competencies was developed on the basis of published research and group discussions. Between June and December 2020, the indicators were revised using two rounds of the Delphi expert consultation method, with questionnaires completed by 16 experts from five provinces in China.

Results

The valid retrieval rate of the two questionnaires was 100.00%, and the coefficient of expert authority was 0.931. The Kendall’s concordance coefficients of the two rounds of questionnaires were 0.136 (p

Conclusions

The MNS competency assessment tool constructed in this study is focused and highly credible. The findings can be used as a guide for the training, assessment and competence evaluation of MNS in the future.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

Por: Van Hout · M.-C. · Akugizibwe · M. · Shayo · E. H. · Namulundu · M. · Kasujja · F. X. · Namakoola · I. · Birungi · J. · Okebe · J. · Murdoch · J. · Mfinanga · S. G. · Jaffar · S.
Introduction

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number

ISRCTN15319595.

Implementation of an antibiotic resistance surveillance tool in Madagascar, the TSARA project: a prospective, observational, multicentre, hospital-based study protocol

Por: Elias · C. · Raad · M. · Rasoanandrasana · S. · Raherinandrasana · A. H. · Andriananja · V. · Raberahona · M. · Moore · C. E. · Randria · M. · Raskine · L. · Vanhems · P. · Babin · F.-X.
Introduction

Antimicrobial resistance (AMR) has become a significant public health threat. Without any interventions, it has been modelled that AMR will account for an estimated 10 million deaths annually by 2050, this mainly affects low/middle-income countries. AMR has a systemic negative perspective affecting the overall healthcare system down to the patient’s personal outcome. In response to this issue, the WHO urged countries to provide antimicrobial stewardship programmes (ASPs). ASPs in hospitals are a vital component of national action plans for AMR, and have been shown to significantly reduce AMR, in particular in low-income countries such as Madagascar.

As part of an ASP, AMR surveillance provides essential information needed to guide medical practice. We developed an AMR surveillance tool—Technique de Surveillance Actualisée de la Résistance aux Antimicrobiens (TSARA)—with the support of the Mérieux Foundation. TSARA combines bacteriological and clinical information to provide a better understanding of the scope and the effects of AMR in Madagascar, where no such surveillance tool exists.

Methods and analysis

A prospective, observational, hospital-based study was carried out for data collection using a standardised data collection tool, called TSARA deployed in 2023 in 10 hospitals in Madagascar participating in the national Malagasy laboratory network (Réseau des Laboratoires à Madagascar (RESAMAD)). Any hospitalised patient where the clinician decided to take a bacterial sample is included. As a prospective study, individual isolate-level data and antimicrobial susceptibility information on pathogens were collected routinely from the bacteriology laboratory and compiled with clinical information retrieved from face-to-face interviews with the patient and completed using medical records where necessary. Analysis of the local ecology, resistance rates and antibiotic prescription patterns were collected.

Ethics and dissemination

This protocol obtained ethical approval from the Malagasy Ethical Committee n°07-MSANP/SG/AGMED/CNPV/CERBM on 24 January 2023. Findings generated were shared with national health stakeholders, microbiologists, members of the RESAMAD network and the Malagasy academic society of infectious diseases.

Relationship between social isolation and glycaemic control of people previously diagnosed with diabetes: secondary analysis from the CHARLS

Por: Lu · Q. · Qu · L. · Xie · C. · Shu · Y. · Gao · F. · Zou · M. · Fan · X. · Luo · X. · Meng · J. · Xue · Y. · Cao · Y.
Objectives

Social isolation may affect diabetes self-management. This study aimed to explore the relations between social isolation and glycaemic control in patients with diabetes and to explore lifestyle differences among individuals with different levels of social isolation.

Methods

The relevant data of 665 people previously diagnosed with diabetes included in the China Health and Retirement Longitudinal Study from 2011 to 2015 were extracted and analysed. The study included patient general information, blood glucose, lipids, glycosylated haemoglobin, social isolation index, health-related lifestyle factors and diabetes-related factors. Differences in metabolic abnormalities and modifiable lifestyles were compared among patients with varying levels of social isolation.

Results

Multiple linear regression analysis demonstrated that among men aged 45–64 years, the high social isolation group had significantly higher glycosylated haemoglobin levels compared with the low isolation group (7.29±1.81 vs 6.59±1.63, p=0.026). A positive correlation was observed between social isolation and blood glucose (β=14.16; 95% CI 2.75 to 25.57; p=0.015) and glycosylated haemoglobin (β=0.35; 95% CI 0.10 to 0.60; p=0.006), indicating that higher social isolation was associated with higher fasting blood glucose and glycosylated haemoglobin levels. However, no significant associations were observed in other age groups. Notably, men aged 45–65 years with high social isolation had higher depression rates (44.10% vs 24.60%, p=0.024), lower engagement in moderate exercise (5.70% vs 23.50%, p=0.019) and shorter 10-minute walks (17.10% vs 36.80%, p=0.027). Differences in other health-related and diabetes-related factors were not statistically significant.

Conclusion

Middle-aged men with diabetes with higher social isolation tend to have higher blood glucose and glycosylated haemoglobin levels. This subset of patients requires targeted attention to provide social support from family and friends for improved glycaemic control. If necessary, education on diabetes should be made available to family members and friends.

Assessment of the methodological, recommendation and reporting quality of global guidelines for neck pain and synthesis of evidence and recommendations: a systematic review protocol

Por: Li · J. · Ou · J. · Liu · Y. · Shen · C. · Chen · X. · Li · Y. · Zhao · J. · Xu · J. · Zhang · Y. · Wang · L.
Introduction

Neck pain is a global health problem that can cause severe disability and a huge medical burden. Clinical practice guideline (CPG) is an important basis for clinical diagnosis and treatment. A high-quality CPG plays a significant role in clinical practice. However, the quality of the CPGs for neck pain lacks comprehensive assessment. This protocol aims to evaluate the methodological, recommendation, reporting quality of global CPGs for neck pain and identify key recommendations and gaps that limit evidence-based practice.

Method

CPGs from January 2013 to November 2023 will be identified through a systematic search on 13 scientific databases (PubMed, Cochrane Library, Embase, etc) and 7 online guideline repositories. Six reviewers will independently evaluate the quality of CPGs for neck pain by using the Appraisal of Guidelines for Research and Evaluation, the Appraisal of Guidelines Research and Evaluation-Recommendations Excellence and the Reporting Items for Practice Guidelines in Healthcare tools. Intraclass correlation coefficient will be used to test the consistency of the assessment. We will identify the distribution of evidence and recommendations in each evidence-based CPGs for neck pain and regrade the level of evidence and strength of recommendations by adopting the commonly used Grading of Recommendations, Assessment, Development and Evaluations system. The key recommendations based on high-quality evidence will be summarised. In addition, we will categorise CPGs by different characteristics and conduct a subgroup analysis of the results of assessment.

Ethics and dissemination

No subjects will be involved in this systematic review, so there is no need for ethical approval. The finding of this review will be summarised as a paper for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023417717.

Artificial intelligence tools for optimising recruitment and retention in clinical trials: a scoping review protocol

Por: Lu · X. · Chen · M. · Lu · Z. · Shi · X. · Liang · L.
Introduction

In recent years, the influence of artificial intelligence technology on clinical trials has been steadily increasing. It has brought about significant improvements in the efficiency and cost reduction of clinical trials. The objective of this scoping review is to systematically map, describe and summarise the current utilisation of artificial intelligence in recruitment and retention process of clinical trials that has been reported in research. Additionally, the review aims to identify benefits and drawbacks, as well as barriers and facilitators associated with the application of artificial intelligence in optimising recruitment and retention in clinical trials. The findings of this review will provide insights and recommendations for future development of artificial intelligence in the context of clinical trials.

Methods and analysis

The review of relevant literature will follow the methodological framework for scoping studies provided by the Joanna Briggs Institute. A comprehensive electronic search will be conducted using the search strategy developed by the authors. Leading medical and computer science databases such as PubMed, Embase, Scopus, IEEE Xplore and Web of Science Core Collection will be searched. The search will encompass analytical observational studies, descriptive observational studies, experimental and quasi-experimental studies published in all languages, without any time limitations, which use artificial intelligence tools in the recruitment and retention process of clinical trials. The review team will screen the identified studies and import them into a dedicated electronic library specifically created for this review. Data extraction will be performed using a data charting table.

Ethics and dissemination

Secondary data will be attained in this scoping review; therefore, no ethical approval is required. The results of the final review will be published in a peer-reviewed journal. It is expected that results will inform future artificial intelligence and clinical trials research.

Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

Por: Stehlik · P. · Dowsett · C. · Camacho · X. · Falster · M. O. · Lim · R. · Nasreen · S. · Pratt · N. L. · Pearson · S.-A. · Henry · D.
Background

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning—specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

Methods and analysis

We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).

Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.

By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

Ethics and dissemination

As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

Registration

https://doi.org/10.17605/OSF.IO/ZHDKR

Latent class analysis of Chinese healthcare providers attitudes towards oocyte cryopreservation: a cross-sectional study

Por: Lu · J. · Tian · X. · Wang · Z.
Objectives

The present study was designed to examine the attitudes towards oocyte cryopreservation among healthcare providers working in hospitals across specialties and potential influencing factors.

Design

A cross-sectional study.

Setting

The questionnaire was distributed among Chinese healthcare providers via the Credamo platform.

Participants

There were 877 respondents recruited from 8 April to 8 May 2022, among whom 160 were identified as unqualified because of inconsistency between the IP and work addresses.

Outcome measures

Individual attitudes towards oocyte cryopreservation under four different settings, familiarity with oocyte cryopreservation and perceived risks about oocyte cryopreservation of healthcare providers were measured using a self-designed questionnaire.

Results

There were 877 respondents recruited, and 717 were identified as qualified respondents. Two latent classes of healthcare providers characterised by different attitudes towards oocyte cryopreservation under four different settings were identified, the supportive and reluctant. Familiarity with oocyte cryopreservation had a significant direct effect on perceived risks, with better familiarity predicting lower perceived risks (β=–0.102, pβ=0.165, p

Conclusions

The majority of healthcare providers held a reluctant attitude towards oocyte cryopreservation of unmarried women for non-medical reasons, which might relate to their worries about the risks to offspring’s health and lack of knowledge about a reproductive technique.

Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: a propensity score-matched retrospective cohort study using the SEER database

Por: Ma · X. · Wu · S. · Zhang · X. · Chen · N. · Yang · C. · Yang · C. · Cao · M. · Du · K. · Liu · Y.
Objectives

This study aimed to investigate the impact of adjuvant chemotherapy (ACT) on survival outcomes in older women with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2–) breast cancer (BC).

Design

A retrospective cohort study using data from the Surveillance, Epidemiology, and End Results database, which contains publicly available information from US cancer registries.

Setting and participants

The study included 45 762 older patients with BC aged over 65 years diagnosed between 2010 and 2015.

Methods

Patients were divided into two groups based on age: 65–79 years and ≥80 years. Propensity score matching (PSM) was employed to balance clinicopathological characteristics between patients who received ACT and those who did not. Data analysis used the 2 test and Kaplan-Meier method, with a subgroup analysis conducted to identify potential beneficiaries of ACT.

Outcome measures

Overall survival (OS) and cancer-specific survival (CSS).

Results

Due to clinicopathological characteristic imbalances between patients with BC aged 65–79 years and those aged ≥80 years, PSM was used to categorise the population into two groups for analysis: the 65–79 years age group (n=38 128) and the ≥80 years age group (n=7634). Among patients aged 65–79 years, Kaplan-Meier analysis post-PSM indicated that ACT was effective in improving OS (p

Conclusions

Patients with HR+/HER2– BC ≥80 years of age may be considered exempt from ACT because no benefits were found in terms of OS and CSS.

Prevalence and predictors of depression and anxiety in patients with chronic rhinosinusitis: a systematic review and meta-analysis

Por: Fan · H. · Han · Z. · Gong · X. · Wu · Y. · Fu · Y. · Zhu · T. · Li · H.
Background

Chronic rhinosinusitis (CRS) is a persistent inflammation of the sinuses. As a result of long-term discomfort, patients may experience symptoms of common mental disorders such as anxiety and depression. This may affect the quality of life and disease progression. However, there is still uncertainty about the extent of the problem.

Objective

This meta-analysis aimed to determine the prevalence of depression and anxiety symptoms in patients with CRS.

Search strategy

We searched PubMed, Embase, Web of Science, Cochrane Library, and CBM databases for relevant studies published before 15 July 2022 in patients with CRS with concomitant depression and anxiety symptoms.

Data collection and analysis

Two authors independently performed screening and quality assessment using validated tools. Extraction of data using predefined standardised data collection spreadsheets. Heterogeneity and inconsistency were checked using the I² statistic.

Results

The meta-analysis included 32 articles involving 56 933 patients. The prevalence of depression and anxiety symptoms was estimated at 24.7% (95% CI, 21.3% to 28. 1%) and 29.7% (95% CI, 19.3% to 40.2%). Subgroup analysis revealed the following: (1) CRS without nasal polyps (CRSsNP): 26.2% (95% CI, 21.9% to 30.5%), CRS with nasal polyps(CRSwNP): 20% (95% CI, 15.9% to 24%); (2) Female patients: 36. 1% (95% CI, 25.3% to 46.9%), male patients: 24.3% (95% CI, 12. 1% to 36.6%); and (3) The average age≤50 years patients: 29.8% (95% CI, 21.3% to 38.2%), the average age>50 years patients: 22. 1% (95% CI, 17.1% to 27%).

Conclusion

A significant proportion of people with CRS have symptoms of depression and anxiety, and early screening for depression and anxiety in people with CRS is critical. And, more attention needs to be given to females and patients with CRSsNP during screening.

PROSPERO registration number

CRD42022345959).

Inhaled Nitric Oxide ReDuce postoperatIve pulmoNAry complicaTions in patiEnts with recent COVID-19 infection (INORDINATE): protocol for a randomised controlled trial

Por: Zheng · Z. · Wang · L. · Wang · S. · Fan · Q. · Zhang · H. · Luo · G. · Gao · B. · Yang · X. · Zhao · B. · Wang · X. · Dong · H. · Nie · H. · Lei · C.
Background

A history of SARS-CoV-2 infection has been reported to be associated with an increased risk of postoperative pulmonary complications (PPCs). Even mild PPCs can elevate the rates of early postoperative mortality, intensive care unit (ICU) admission and prolong the length of ICU and/or hospital stays. Consequently, it is crucial to develop perioperative management strategies that can mitigate these increased risks in surgical patients who have recently been infected with SARS-CoV-2. Accumulating evidence suggests that nitric oxide (NO) inhalation might be effective in treating COVID-19. NO functions in COVID-19 by promoting vasodilation, anticoagulation, anti-inflammatory and antiviral effects. Therefore, our study hypothesises that the perioperative use of NO can effectively reduce PPCs in patients with recent SARS-CoV-2 infection.

Method and analysis

A prospective, double-blind, single-centre, randomised controlled trial is proposed. The trial aims to include participants who are planning to undergo surgery with general anaesthesia and have been recently infected with SARS-CoV-2 (within 7 weeks). Stratified allocation of eligible patients will be performed at a 1:1 ratio based on the predicted risk of PPCs using the Assess Respiratory Risk in Surgical Patients in Catalonia risk index and the time interval between infection and surgery.

The primary outcome of the study will be the presence of PPCs within the first 7 days following surgery, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm and aspiration pneumonitis. The primary outcome will be reported as counts (percentage) and will be compared using a two-proportion 2 test. The common effect across all primary components will be estimated using a multiple generalised linear model.

Ethics and dissemination

The trial is approved by the Institutional Review Board of Xijing Hospital (KY20232058-F1). The findings, including positive, negative and inconclusive results, will be published in scientific journals with peer-review processes.

Trial registration number

NCT05721144.

Deep learning model to predict lupus nephritis renal flare based on dynamic multivariable time-series data

Por: Huang · S. · Chen · Y. · Song · Y. · Wu · K. · Chen · T. · Zhang · Y. · Jia · W. · Zhang · H.-T. · Liang · D.-D. · Yang · J. · Zeng · C.-H. · Li · X. · Liu · Z.-H.
Objectives

To develop an interpretable deep learning model of lupus nephritis (LN) relapse prediction based on dynamic multivariable time-series data.

Design

A single-centre, retrospective cohort study in China.

Setting

A Chinese central tertiary hospital.

Participants

The cohort study consisted of 1694 LN patients who had been registered in the Nanjing Glomerulonephritis Registry at the National Clinical Research Center of Kidney Diseases, Jinling Hospital from January 1985 to December 2010.

Methods

We developed a deep learning algorithm to predict LN relapse that consists of 59 features, including demographic, clinical, immunological, pathological and therapeutic characteristics that were collected for baseline analysis. A total of 32 227 data points were collected by the sliding window method and randomly divided into training (80%), validation (10%) and testing sets (10%). We developed a deep learning algorithm-based interpretable multivariable long short-term memory model for LN relapse risk prediction considering censored time-series data based on a cohort of 1694 LN patients. A mixture attention mechanism was deployed to capture variable interactions at different time points for estimating the temporal importance of the variables. Model performance was assessed according to C-index (concordance index).

Results

The median follow-up time since remission was 4.1 (IQR, 1.7–6.7) years. The interpretable deep learning model based on dynamic multivariable time-series data achieved the best performance, with a C-index of 0.897, among models using only variables at the point of remission or time-variant variables. The importance of urinary protein, serum albumin and serum C3 showed time dependency in the model, that is, their contributions to the risk prediction increased over time.

Conclusions

Deep learning algorithms can effectively learn through time-series data to develop a predictive model for LN relapse. The model provides accurate predictions of LN relapse for different renal disease stages, which could be used in clinical practice to guide physicians on the management of LN patients.

Subphenotypes of self-reported symptoms and outcomes in long COVID: a prospective cohort study with latent class analysis

Por: Kitsios · G. D. · Blacka · S. · Jacobs · J. J. · Mirza · T. · Naqvi · A. · Gentry · H. · Murray · C. · Wang · X. · Golubykh · K. · Qurashi · H. · Dodia · A. · Risbano · M. · Benigno · M. · Emir · B. · Weinstein · E. · Bramson · C. · Jiang · L. · Dai · F. · Szigethy · E. · Mellors · J. W. · Met
Objective

To characterise subphenotypes of self-reported symptoms and outcomes (SRSOs) in postacute sequelae of COVID-19 (PASC).

Design

Prospective, observational cohort study of subjects with PASC.

Setting

Academic tertiary centre from five clinical referral sources.

Participants

Adults with COVID-19 ≥20 days before enrolment and presence of any new self-reported symptoms following COVID-19.

Exposures

We collected data on clinical variables and SRSOs via structured telephone interviews and performed standardised assessments with validated clinical numerical scales to capture psychological symptoms, neurocognitive functioning and cardiopulmonary function. We collected saliva and stool samples for quantification of SARS-CoV-2 RNA via quantitative PCR.

Outcomes measures

Description of PASC SRSOs burden and duration, derivation of distinct PASC subphenotypes via latent class analysis (LCA) and relationship with viral load.

Results

We analysed baseline data for 214 individuals with a study visit at a median of 197.5 days after COVID-19 diagnosis. Participants reported ever having a median of 9/16 symptoms (IQR 6–11) after acute COVID-19, with muscle-aches, dyspnoea and headache being the most common. Fatigue, cognitive impairment and dyspnoea were experienced for a longer time. Participants had a lower burden of active symptoms (median 3 (1–6)) than those ever experienced (p

Conclusions

We identified three distinct PASC subphenotypes. We highlight that although most symptoms progressively resolve, specific PASC subpopulations are impacted by either high burden of constitutional symptoms or persistent olfactory/gustatory dysfunction, requiring prospective identification and targeted preventive or therapeutic interventions.

Early predictors of bacterial pneumonia infection in children with congenital heart disease after cardiopulmonary bypass: a single-centre retrospective study

Por: Wang · Q. · Liu · H. · Zou · L. · Cun · Y. · Shu · Y. · Patel · N. · Yu · D. · Mo · X.
Objectives

The objective of this study was to evaluate the early predictors of bacterial pneumonia infection in children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB).

Design

Retrospective study.

Setting

A freestanding tertiary paediatric hospital in China.

Participants

Patients admitted to the hospital due to CHD who underwent open-heart surgery.

Outcome measures

We retrospectively reviewed and analysed data from 1622 patients with CHD after CPB from June 2018 to December 2020 at the Children’s Hospital of Nanjing Medical University. Enrolled patients were assigned to an infection group or a non-infection group according to the presence of postoperative bacterial pneumonia infection, and the differences in clinical indicators were compared. Potential predictors were analysed by multivariate logistic regression analysis and area under the curve (AUC) analysis.

Results

Among the 376 patients (23.2%) in the infection group, the three most common bacteria were Streptococcus pneumoniae in 67 patients (17.8%), Escherichia coli in 63 patients (16.8%) and Haemophilus influenzae in 53 patients (14.1%). The infection group exhibited a lower weight (8.0 (6.0–11.5) kg vs 11.0 (7.5–14.5) kg, p

Conclusions

In our study, weight, PCT and CRP were found to be independent predictors of pulmonary bacterial infection after CPB. Moreover, PCT was the most specific predictor, and CRP was the most sensitive independent predictor that might be beneficial for the early diagnosis of pulmonary bacterial infection after CPB in patients with CHD.

Exposure to early-life adversity and long-term trajectories of multimorbidity among older adults in China: analysis of longitudinal data from the China Health and Retirement Longitudinal Study

Por: Liu · H. · Zhang · M. · Zhang · X. · Zhao · X.
Objectives

This study aimed to identify long-term distinct trajectories of multimorbidity with ageing from 50 to 85 years among Chinese older adults and examine the relationship between exposure to early-life adversity (ELA; including specific types of adversity and accumulation of different adversities) and these long-term multimorbidity trajectories.

Design

The group-based trajectory models identified long-term multimorbidity trajectories. Multinomial logistic regression models were used to examine the relationship between ELA and the identified multimorbidity trajectories.

Setting

This study used data from the China Health and Retirement Longitudinal Study (CHARLS, 2011–2018) and the 2014 Life History Survey.

Participants

We used data from 9112 respondents (aged 60 and above) of the 2018 wave of CHARLS.

Outcome measures

Each respondent’s history of chronic conditions and experiences of ELA were collected from the 2011–2018 waves of CHARLS and the 2014 Life History Survey.

Results

Four heterogeneous long-term trajectories of multimorbidity development were identified: ‘maintaining-low’ (19.1%), ‘low onset-rapidly increasing’ (23.3%), ‘middle onset-moderately increasing’ (41.5%) and ‘chronically-high’ (16.2%). Our findings indicated that the heterogeneity can be explained by ELA experiences. Across various types of different ELA experiences, exposure to food insufficiency (relative risk ratios from 1.372 (95% CI 1.190 to 1.582) to 1.780 (95% CI 1.472 to 2.152)) and parental quarrel/divorce (relative risk ratios from 1.181 (95% CI 1.000 to 1.394) to 1.262 (95% CI 1.038 to 1.536)) had the most prominent associations with health deterioration. The accumulation of more different ELA experiences was associated with a higher relative risk of developing more severe multimorbidity trajectories (relative risk ratio for five to seven ELAs and chronically high trajectory: 7.555, 95% CI 4.993 to 11.431).

Conclusions

There are heterogeneous long-term trajectories of multimorbidity in Chinese older adults, and the risk of multimorbidity associated with ELA accumulates over the lifespan. Our findings highlight the role of a supportive early-life family environment in promoting health development across the lifespan, advocating for the integration of life-course approaches to implementing health disparity interventions.

Association between socioeconomic status and hypertension among adults in Fujian province and the mediating effect of BMI and cooking salt intake: a cross-sectional study

Por: Li · Y. · Ge · W. · Wu · M. · Gao · M. · Peng · Z. · Han · Y. · Hu · X. · Li · L.
Objectives

This study aimed to investigate the association between socioeconomic status (SES) and the prevalence of hypertension in Fujian province, China, and to evaluate the mediating effect of body mass index (BMI) and cooking salt intake between SES and hypertension.

Design

Community-based cross-sectional survey was conducted between June 2018 and December 2019.

Setting

Fujian province, China.

Participants

A total of 26 500 participants aged >18 years completed the survey.

Outcome measures

The primary outcome was the prevalence of hypertension. Education, income and occupation were used as SES indicators. Meanwhile, certain health behaviours and metabolic risk factors were used as secondary indicators of SES.

Results

The prevalence of hypertension was relatively high among participants who finished primary education (34.8%), had the lowest annual income (46.0%), were unemployed or retired (34.7%). Education and income levels were negatively associated with the prevalence of hypertension (p

Conclusions

SES was associated with the prevalence of hypertension among adults in Fujian province, China. BMI and cooking salt intake were partial mediators of the association between SES and hypertension.

Predictive value of the Trauma Rating Index in Age, Glasgow Coma Scale, Respiratory rate and Systolic blood pressure score (TRIAGES) for the short-term mortality of older patients with isolated traumatic brain injury: a retrospective cohort study

Por: Jiang · D. · Chen · T. · Yuan · X. · Yang · Y. · Shen · Y. · Huang · Z.
Objectives

This study aimed to evaluate the effectiveness of the Trauma Rating Index in Age, Glasgow Coma Scale, Respiratory rate and Systolic blood pressure score (TRIAGES) in predicting 24-hour in-hospital mortality among patients aged 65 years and older with isolated traumatic brain injury (TBI).

Design

A retrospective, single-centre cohort study.

Setting

This study was conducted at a government-run tertiary comprehensive hospital.

Participants

This study included 982 patients aged 65 years or older with isolated TBI, who were admitted to the emergency department between 1 January 2020 and 31 December 2021.

Interventions

None.

Primary outcome

24-hour in-hospital mortality was the primary outcome.

Results

Among the 982 patients, 8.75% died within 24 hours of admission. The non-survivors typically had higher TRIAGES and lower GCS scores. Logistic regression showed significant associations of both TRIAGES and GCS with mortality; the adjusted ORs were 1.98 (95% CI 1.74 to 2.25) for TRIAGES and 0.72 (95% CI 0.68 to 0.77) for GCS. Receiver operating characteristic (ROC) analysis indicated an area under the ROC curve of 0.86 for GCS and 0.88 for TRIAGES, with a significant difference (p=0.012). However, precision–recall curve (PRC) analysis revealed an area under the PRC of 0.38 for GCS and 0.47 for TRIAGES, without a significant difference (p=0.107).

Conclusions

The TRIAGES system is a promising tool for predicting 24-hour in-hospital mortality in older patients with TBI, demonstrating comparable or slightly superior efficacy to the GCS. Further multicentre studies are recommended for validation.

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