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Organ donation decision-making in ICU patients: from the perspectives of organ coordinators and physicians in China - a qualitative study

Por: Yang · X. · Chen · C. · Geng · K. · Jia · X. · Si · F. · Lu · X. · Zhang · W. · Du · S. · Zhang · X. · Guo · W. · Yin · Z.
Objectives

Intensive care unit (ICU) dying patients are the most important source of organ donation. This study explores the reasons affecting organ donation in the Chinese sociocultural context from the perspectives of coordinators and physicians, and further seeks countermeasures to alleviate the shortage of organs.

Design and setting

Semistructured interviews conducted in a large tertiary hospital in China.

Participants and method

15 respondents (including 8 organ coordinators and 7 ICU physicians) were interviewed. Participants were invited to describe the factors that influence organ donation and the underlying reasons behind it. Bronfenbrenner’s socioecological system model was used as theoretical support to construct a theoretical model of the factors influencing organ donation. Respondents participated in semistructured qualitative interviews that were audio-recorded and transcribed. The relevant data were analysed using thematic analysis.

Results

Four themes that influenced organ donation were identified including the influence of the deceased person’s attributes, immediate family members, surrounding people and the environment, and the social-level factors. In addition, we obtained four strategies from the interviews to improve the organ shortage to ameliorate the current supply–demand imbalance in organ donation. These include multilevel publicity, relevant policy support, increasing other forms of supply and reducing organ demand.

Conclusions

Factors affecting organ donation after the death of a Chinese citizen include the personal characteristics of the donor, the decisions of family members such as immediate family members and the indirect influence of surrounding people such as collateral family members, in addition to factors related to the humanistic environment, religious beliefs and social opinion.

Correlation between right-to-left shunt and sudden sensorineural hearing loss: protocol for a case-control study

Por: Zheng · J. · Zhan · Y. · Cheng · Y. · Liu · C. · Lu · B. · Yang · W. · Hu · J.
Background and purpose

Sudden sensorineural hearing loss (SSNHL) is a neurological and otolaryngological emergency during which rapid diagnosis and early treatment are of great importance. Clinical experience indicates that a considerable number of patients with SSNHL have concurrent right-to-left shunt (RLS). With limited reports, the association between SSNHL and RLS is yet unclear and there is a need for large observational studies to explore their latent relationship.

Methods and analysis

This proposed study is a prospective, observational case–control study. A total of 194 eligible participants matched in age and sex will be divided equally into two groups: 97 patients with SSNHL included in the case group and 97 individuals without SSNHL in the control group. Medical evaluations, including clinical characteristics, laboratory examination, audiological examination and ultrasonography examination, will be performed in all subjects. The primary outcome of the study is the difference in RLS rates between the groups. Differences in patent foramen ovale rates and other measured variables will be further assessed. A conditional logistic regression as a correlation analysis will be used to evaluate the relationship between RLS and SSNHL.

Discussion

This study may provide evidence on the correlation between RLS and SSNHL in order to enrich the aetiology of SSNHL.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of Peking University Shenzhen Hospital. A written informed consent form will be signed and dated by the participants and the researchers before the study begins. The results will be disseminated in peer-reviewed publications.

Trial registration number

ChiCTR2200064067.

Interventions to treat patients with blood blister-like aneurysms of the internal carotid artery: a protocol for a network meta-analysis

Por: Li · Y. · Yang · X. · Zhou · H. · Li · H. · Zheng · J. · Li · L. · Hui · X.
Introduction

Blood blister-like aneurysm (BBA) is a special type of intracranial aneurysm with relatively low morbidity and high mortality. Various microsurgical techniques and endovascular approaches have been reported, but the optimal management remains controversial. For a better understanding of the treatment of BBA patients, a network meta-analysis that comprehensively compares the effects of different therapies is necessary.

Methods and analysis

This protocol has been reported following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Related studies in the following databases will be searched until November 2022: PubMed, Embase, Scopus, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP and Wanfang. Randomised controlled trials (RCTs) and non-randomised studies comparing at least two different interventions in BBA patients will be included. Quality assessment will be conducted using Cochrane Collaboration’s tool or Newcastle-Ottawa Scale based on their study designs. The primary outcome is the composite of the incidences of intraoperative bleeding, postoperative bleeding and postoperative recurrence. The secondary outcome is an unfavourable functional outcome. Pairwise and network meta-analyses will be conducted using STATA V.14 (StataCorp, College Station, Texas, USA). Mean ranks and the surface under the cumulative ranking curve will be used to evaluate every intervention. Statistical inconsistency assessment, subgroup analysis, sensitivity analysis and publication bias assessment will be performed.

Ethics and dissemination

Ethics approval is not necessary because this study will be based on publications. The results of this study will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42022383699.

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burde

Por: Zhang · Z. · Sheng · Z. · Che · W. · An · S. · Sun · D. · Zhai · Z. · Zhao · X. · Yang · Y. · Meng · Z. · Ye · Z. · Xie · E. · Li · P. · Yu · C. · Gao · Y. · Xiao · Z. · Wu · Y. · Dong · F. · Ren · J. · Zheng · J.
Introduction

ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.

Methods and analysis

The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.

Ethics and dissemination

The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.

Trial registration number

NCT05554588.

The risk factors for and the frequency and outcomes of subsyndromal delirium among patients who have undergone cardiac surgery: a protocol for systematic review and meta-analysis

Por: Gao · Y. · Bai · X. · Zhang · H. · Yang · L. · Wu · T. · Gan · X.
Introduction

Several key symptoms must be present for the accurate diagnosis of patients with postoperative cardiac delirium. Some patients present with symptoms of delirium but do not meet the diagnostic criteria for delirium; such individuals are considered to have having subsyndromal delirium (SSD). SSD is associated with misdiagnosis and poor outcomes. However, to date, no systematic review (SR) has examined the frequency of, risk factors for, and outcomes of SSD among adults who have undergone cardiac surgery.

Methods and analysis

The aim of this SR is to identify those studies that have explored SSD after cardiac surgery. MeSH and free entry terms associated with "subsyndromal delirium" and "subclinical delirium" will be used to search for relevant studies. The PubMed, Web of Science, OVID, Cochrane Library, CINAHL, EMBASE, PsycINFO, China National Knowledge Infrastructure, Wanfang data, VIP database and SinoMed will be searched from inception to the date of retrieval without any restrictions. The primary outcomes will be the frequency of SSD, the risk factors for SSD, and the outcomes of SSD. Analyses will be performed using STATA V.16.0, and descriptive analyses will be performed if the data are not suitable for meta-analysis (ie, data with significant heterogeneity or from different comparisons).

Ethics and dissemination

The SR will examine the frequency of, risk factors for and outcomes of SSD in adults who have undergone cardiac surgery. The results will provide guidance for the identification of knowledge gaps in this field, and areas for further research will be highlighted. The review protocol will be submitted for publication in peer-reviewed journals for dissemination of the findings. Individual patient data will not be included in this protocol, so ethical approval will not be needed.

PROSPERO registration number

CRD42022379211.

Sinus node dysfunction and stroke risk: a systematic review and meta-analysis

Por: Dong · H. · Chen · H. · Hidru · T. H. · Xia · Y. · Yang · X.
Objectives

The role of cardiac arrhythmia in ischaemic stroke is widely studied, but the size of the stroke risk in patients with sinus node dysfunction (SND) with and without atrial fibrillation (AF) is unclear. This systematic review and meta-analysis aimed to compare the risk of stroke and its associated factors in patients with SND with and without AF.

Design

A systematic review and meta-analysis was conducted based on the Grading of Recommendations, Assessment, Development and Evaluation approach.

Data sources

PubMed, EMBASE and Cochrane Database were searched until December 2022.

Eligibility criteria for selecting studies

Studies that investigate stroke in patients with SND diagnosed with or without AF/atrial flutter.

Data extraction and synthesis

Two independent authors screened studies for inclusion and extracted data. Literature quality assessment was performed using the Newcastle-Ottawa Scale and the Cochrane Collaboration Tool. The overall risk of stroke was estimated using the random-effects model. The generic inverse variance method was used to calculate the pooled estimates of stroke-associated factors. We performed a sensitivity analysis using a fixed-effects model.

Results

Of the 929 records retrieved, 6 papers (106 163 patients) met the inclusion criteria. The average yearly stroke incidence in patients with SND was 1.542% (95% CI: 1.334% to 1.749%). The stroke incidence was similar between the isolated SND (1.587%; 95% CI: 1.510% to 1.664%) and non-isolated (SND+AF) (1.660%; 95% CI: 0.705% to 2.615%) groups. AF (HR, 95% CI: 1.53 (1.01 to 2.33)), stroke/transient ischaemia attack/other thrombotic events (HR, 95% CI: 2.54 (1.14 to 5.69)), hypertension (HR, 95% CI: 1.51 (1.11 to 2.07)) and heart failure (HR, 95% CI: 1.41 (1.01 to 1.97)) were associated with stroke in the SND population.

Conclusion

Our findings suggest that patients with SND carry a similar risk of stroke to those with combined SND and AF. Future studies are needed to investigate whether interventions targeting stroke prevention, such as anticoagulation therapy, can help to prevent stroke in patients with SND.

PROSPERO registration number

CRD42023408436.

Association between dyslipidaemia and dry eye disease: a systematic review and meta-analysis

Por: Li · Y. · Xie · L. · Song · W. · Chen · S. · Cheng · Y. · Gao · Y. · Huang · M. · Yan · X. · Yang · S.
Purpose

To report a systematic review and meta-analysis of the association between dry eye disease (DED) and dyslipidaemia.

Methods

PubMed, Embase, Web of Science and Cochrane Library were systematically searched from January 2000 to December 2021. We included observational studies to assess the correlation of DED with meibomian gland dysfunction and dyslipidaemia without any language restrictions. The pooled OR with 95% CI was calculated in Stata V.15.

Results

Of 6727 identified studies, 18 studies (21 databases) with a total of 2 663 126 patients were analysed in our meta-analysis. The results showed that DED risk was associated with dyslipidaemia (OR=1.53, 95% CI: 1.41 to 1.66, p=0.001), especially elevated total cholesterol levels (OR=1.57, 95% CI: 1.25 to 1.99, p

Conclusions

The findings suggested that dyslipidaemia and lipid-lowering drug use might be associated with an increased risk of DED. More evidence is needed to confirm the findings by prospective studies.

PROSPERO registration number

CRD42022296664.

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial

Por: Hu · X. · Xu · H. · Wang · C. · Wang · Y. · Wang · Y. · Zhou · D. · Zhu · Q. · Xu · K. · Yang · J. · Zhang · H. · Jiang · N. · Zhang · J. · Fang · Z. · Fu · G. · Guo · Y. · Li · Y. · Wang · M. · Feng · D. · Niu · G. · Zhang · E. · Chen · Y. · Ye · Y. · Wu · Y.
Introduction

The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.

Methods and analysis

This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of

Ethics and dissemination

The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.

Trial registration number

NCT05375474.

Association between white blood cell count and adverse pregnancy outcomes: a retrospective cohort study from a tertiary hospital in China

Por: Zhang · Y. · Qian · Y. · Liu · C. · Fan · X. · Li · X. · Song · Y. · Fan · Y. · Hu · Z. · Yang · J.
Objectives

This study aimed to clarify the relationship between white blood cell (WBC) and adverse pregnancy outcomes.

Design

A total of 25 270 pregnant women underwent peripheral blood white blood cell count tests in the first, second and third trimesters. Adverse pregnancy outcomes were gestational hypertension, pre-eclampsia, gestational diabetes mellitus, preterm birth, low birth weight, caesarean delivery, macrosomia and fetal distress. Due to acute infectious disease or other diseases, 1127 were excluded.

Setting

Minhang Hospital, China.

Participants

A total of 24 143 pregnant women were included in this study.

Primary and secondary outcome measures

The primary outcome was the adverse pregnancy outcomes.

Results

For the 24 143 participants, we calculated adjusted ORs for adverse pregnancy outcomes associated with an increased WBC count. For gestational hypertension, the ORs were 1.18 (95% CI, 1.05 to 1.24) in the first trimester and 1.10 (1.06 to 1.13) in the second trimester; for pre-eclampsia, ORs were 1.14 (95% CI, 1.47 to 1.64) in the first trimester and 1.10 (1.05 to 1.16) in the second trimester; for gestational diabetes mellitus, ORs were 1.06 (95% CI, 1.00 to 1.13) in the first trimester and 1.10 (1.04 to 1.16) in the second trimester; for preterm birth, ORs were 1.12 (95% CI, 1.06 to 1.18) in the first trimester, 1.10 (1.06 to 1.13) in the second trimester and 1.12 (1.09 to 1.15) in the third trimester; for low birth weight, ORs were 1.09 (95% CI, 1.02 to 1.17) in the first trimester, 1.03 (0.99 to 1.08) in the second trimester and 1.12 (1.08 to 1.16) in the third trimester. Significant associations were not observed obviously for caesarean delivery, macrosomia and fetal distress.

Conclusions

Our results indicate strong, continuous associations of maternal WBC count with increased risks of adverse pregnancy outcomes.

Prognostic significance of platelet-to-lymphocyte ratio (PLR) in patients with breast cancer treated with neoadjuvant chemotherapy: a meta-analysis

Por: Qi · X. · Chen · J. · Wei · S. · Ni · J. · Song · L. · Jin · C. · Yang · L. · Zhang · X.
Objective

Platelet-to-lymphocyte ratio (PLR), known as a key systemic inflammatory parameter, has been proved to be associated with response to neoadjuvant therapy in breast cancer (BC); however, the results remain controversial. This meta-analysis was carried out to evaluate the prognostic values of PLR in patients with BC treated with neoadjuvant chemotherapy (NACT).

Design

Meta-analysis.

Data sources

Relevant literature published on the following databases: PubMed, Embase, Web of Science databases and the Cochrane Library.

Eligibility criteria

All studies involving patients with BC treated with NACT and peripheral blood pretreatment PLR recorded were included.

Data extraction and synthesis

Two researchers independently extracted and evaluated HR/OR and its 95% CI of survival outcomes, pathological complete response (pCR) rate and clinicopathological parameters.

Results

The last search was updated to 31 December 2022. A total of 22 studies with 5533 patients with BC treated with NACT were enrolled in the final meta-analysis. Our results demonstrate that elevated PLR value appears to correlate with low pCR rate (HR 0.77, 95% CI 0.67 to 0.88, p2=75.80%, Ph2=7.40%, Ph=0.365) and disease-free survival (HR 1.97, 95% CI 1.56 to 2.50, p2=0.0%, Ph=0.460). Furthermore, PLR level was associated with age (OR 0.86, 95% CI 0.79 to 0.93, p2=40.60%, Ph=0.096), menopausal status (OR 0.83, 95% CI 0.76 to 0.90, p2=50.80%, Ph=0.087) and T stage (OR 1.05, 95% CI 1.00 to 1.11, p=0.035; I2=70.30%, Ph=0.005) of patients with BC.

Conclusions

This meta-analysis demonstrated that high PLR was significantly related to the low pCR rate, poor OS and disease-free survival (DFS) of patients with BC treated with NACT. Therefore, PLR can be used as a potential predictor biomarker for the efficacy of NACT in BC.

Combination of computed tomography measurements and flexible video bronchoscope guidance for accurate placement of the right-sided double-lumen tube: a randomised controlled trial

Por: Li · J. · Qian · Y. · Lei · Y. · Huo · W. · Xu · M. · Zhang · Y. · Ji · Q. · Yang · J. · Liu · H. · Hou · Y.
Objective

To compare the modified strategy for the right-sided double-lumen tube (R-DLT) placement using a combination of CT measurements and flexible video bronchoscopy guidance with traditional bronchoscopy technique.

Trial design, setting and participants

Double-blind, parallel randomised control trial at a tertiary care medical centre in China. 100 patients undergoing video-assisted thoracoscopic surgery and requiring R-DLT were randomly allocated to the control group and the intervention group.

Intervention

The control group used the traditional bronchoscopy-guided technique. In the intervention group, the length and anteroposterior diameter of the right main bronchus (RMB) were measured on CT images to select the side and size of the Rüsch tube, and then a black depth marker was placed on the tube according to the difference between the length of the RMB and the bronchial cuff. Under the guidance of bronchoscopy, the depth marker should be placed parallel to the tracheal carina and a characteristic white line on the tube should be parallel to the midline of the tracheal carina.

Main outcomes

The primary endpoint was the positioning of right upper lobe (RUL) ventilatory slot and RUL bronchial orifice. The secondary endpoints included intubation data and perioperative adverse events.

Results

Compared with the control group, our modified strategy significantly increased the optimal and acceptable position rate (76% vs 98%, respectively; p

Conclusion

This study demonstrates the superiority of our strategy and provides a new viable method for R-DLT placement.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR1900021676).

Experiences and perspectives of healthcare professionals, patients and caregivers toward the serious illness conversation guide: protocol for a qualitative meta-synthesis

Por: Yang · L. · Zhu · N. · Wang · X. · Tan · J. · Chen · L. · Su · C. · Dong · T. · Long · B. · Qiu · Y. · Deng · R.
Introduction

Exploring the experiences and perspectives of healthcare professionals, patients and caregivers toward serious illness conversations based on the Serious Illness Care Program is vital for improving communication with patients who are seriously ill, as has been shown in previous studies. However, few studies have carried out a systematic review to examine common themes, strengthen conclusions and identify gaps in the literature, the findings of which could help steer further research, policies and practice to improve more timely and person-centred conversations about the values and priorities of patients with serious illnesses. The objective of this qualitative meta-synthesis is to explore how healthcare professionals, patients and caregivers described their own experiences of the processes of serious illness communication through a secondary analysis of published qualitative data.

Methods and analysis

Meta-aggregation will be used to conduct a systematic review of qualitative studies. We conducted an initial search on 10 October 2023; papers published in English will be searched using electronic databases, including PubMed (MEDLINE), Web of Science, Embase, Ovid and CINAHL. Studies that satisfy the eligibility criteria will be evaluated for methodological quality using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research. The meta-aggregative review will consist of the following: (1) extraction of findings of all included studies; (2) categorisation of the findings, with at least two findings per category; and (3) synthesis of one or more findings from at least two categories. Study eligibility screening, data extraction, analysis and JBI Critical Appraisal Checklist and Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research assessments will be undertaken independently by two authors.

Ethics and dissemination

Secondary data analysis of published literature does not require ethical approval. The results will be disseminated in peer-reviewed journals and presented in conference papers and elsewhere.

PROSPERO registration number

CRD42022330859.

Comparison of drug-coated balloon angioplasty versus standard medical therapy on recurrent stroke and mortality rates among patients with symptomatic intracranial atherosclerotic stenosis: protocol for a systematic review and meta-analysis

Por: Sun · Y. · Luo · J. · Gong · H. · Xu · R. · Zhang · X. · Yang · B. · Ma · Y. · Wang · T. · Jiao · L.
Introduction

Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.

Methods and analysis

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.

Ethics and dissemination

This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.

PROSPERO registration number

CRD42022341607.

Preventive strategies for low anterior resection syndrome: a protocol for systematic review and evidence mapping

Por: Zhang · X.-Y. · Yang · K.-L. · Li · Y. · Li · R.-S. · Wang · S.-Q. · Liu · X.-N. · Wang · Q.
Introduction

Rectal cancer is one of the top 10 cancers worldwide. Up to 80% of patients with rectal tumours have had sphincter-saving surgery, mainly due to the large expectation of anal preservation. However, patients tend to experience low anterior resection syndrome (LARS) after rectal resection, which is disordered bowel function that includes faecal incontinence, urgency, frequent defecation, constipation and evacuation difficulties. LARS, with an estimated prevalence of 41%, has been reported to substantially decrease the quality of life of patients. However, no comprehensive preventive strategies are currently available for LARS. This systematic review aims to synthesise evidence on the current LARS preventive strategies.

Methods and analysis

This protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) checklist. Literature in PubMed (via Medline), Embase and the Cochrane Library from inception to July 2023 will be searched to identify articles relevant to preventive effectiveness against LARS. The Cochrane Collaboration’s risk of bias tool for randomised controlled trials and the Newcastle-Ottawa Scale for clinical controlled trials, cohort studies and case–control studies will be used to assess the risk of bias. We will group the included studies by the type of LARS prevention strategy and present an overview of the main findings in the form of evidence mapping. A meta-analysis is planned if there is no substantial clinical heterogeneity between the included studies. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) will be used to evaluate the quality of the evidence.

Ethics and dissemination

Ethical approval is not needed for systematic review of published data. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences.

PROSPERO registration number

CRD42023402886.

Understanding the patterns and health impact of indoor air pollutant exposures in Bradford, UK: a study protocol

Por: Ikeda · E. · Hamilton · J. · Wood · C. · Chatzidiakou · L. · Warburton · T. · Ruangkanit · A. · Shao · Y. · Genes · D. · Waiblinger · D. · Yang · T. C. · Giorio · C. · McFiggans · G. · O'Meara · S. P. · Edwards · P. · Bates · E. · Shaw · D. R. · Jones · R. L. · Carslaw · N. · McEachan · R.
Introduction

Relative to outdoor air pollution, there is little evidence examining the composition and concentrations of indoor air pollution and its associated health impacts. The INGENIOUS project aims to provide the comprehensive understanding of indoor air pollution in UK homes.

Methods and analysis

‘Real Home Assessment’ is a cross-sectional, multimethod study within INGENIOUS. This study monitors indoor air pollutants over 2 weeks using low-cost sensors placed in three rooms in 300 Born in Bradford (BiB) households. Building audits are completed by researchers, and participants are asked to complete a home survey and a health and behaviour questionnaire, in addition to recording household activities and health symptoms on at least 1 weekday and 1 weekend day. A subsample of 150 households will receive more intensive measurements of volatile organic compound and particulate matter for 3 days. Qualitative interviews conducted with 30 participants will identify key barriers and enablers of effective ventilation practices. Outdoor air pollution is measured in 14 locations across Bradford to explore relationships between indoor and outdoor air quality. Data will be analysed to explore total concentrations of indoor air pollutants, how these vary with building characteristics, and whether they are related to health symptoms. Interviews will be analysed through content and thematic analysis.

Ethics and dissemination

Ethical approval has been obtained from the NHS Health Research Authority Yorkshire and the Humber (Bradford Leeds) Research Ethics Committee (22/YH/0288). We will disseminate findings using our websites, social media, publications and conferences. Data will be open access through the BiB, the Open Science Framework and the UK Data Service.

Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial

Por: Lu · Y.-Q. · Yang · G. · Li · M.-Y. · Hong · J. · Yang · Y.-T. · Wang · X.-J. · Kong · X.-H. · Zhao · Y. · Ma · Z. · Huang · X.-Y. · Zou · Y.-L. · Zhou · X.-T. · Ma · X.-P.
Introduction

Dry eye (DE) is a multifactorial ocular surface disease causing considerable medical, social and financial implications. Currently, there is no recognised long-term, effective treatment to alleviate DE. Clinical evidence shows that electroacupuncture (EA) can improve DE symptoms, tear secretion and tear film stability, but it remains controversial whether it is just a placebo effect. We aim to provide solid clinical evidence for the EA treatment of DE.

Methods and analysis

This is a multicentre, randomised, sham-controlled trial. A total of 168 patients with DE will be enrolled and randomly assigned to EA or sham EA groups to receive 4-week consecutive treatments and follow-up for 24 weeks. The primary outcome is the change in the non-invasive tear break-up time (NIBUT) from baseline to week 4. The secondary outcomes include tear meniscus height, the Schirmer I test, corneal and conjunctival sensation, the ocular surface disease index, corneal fluorescein staining, the numerical rating scale and the Chinese DE-related quality of life scale.

Ethics and dissemination

The trial protocol and informed consent were approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (identifier: 2021–119), Shanghai Eye Disease Prevention and Treatment Center (identifier: 2022SQ003) and Eye and ENT Hospital of Fudan University (identifier: 2022014).

Trial registration number

NCT05552820.

Effect of preinitiated glucose-insulin-potassium strategy for patients with undergoing planned percutaneous coronary intervention: a systematic review and meta-analysis

Por: Liu · H. · Liu · R. · Yang · Z. · Xu · F. · Li · C.
Objectives

Whether the glucose-insulin-potassium (GIK) should be used as an adjuvant therapy for ischaemic myocardial disease remains controversial nowadays reperfusion era. This meta-analysis aimed to assess the effects of preinitiated GIK for patients undergoing planned percutaneous coronary intervention (PCI).

Design

Systematic review and meta-analysis.

Data sources

PubMed, Web of science, MEDLINE, Embase, Cochrane Library and ClinicalTrials.gov were searched through 27 November 2022.

Eligibility criteria

Only randomised controlled trials involving participants preinitiated with GIK or placebo before planned PCI were included.

Data extraction and synthesis

Two independent reviewers used standardised methods to search, screen and code included trials. Risk of bias was assessed with the Cochrane tool. Pooled analysis was conducted using random or effects models according to the heterogeneity. Subgroup analyses were carried out for dosage of GIK and if with ongoing myocardial ischaemia.

Results

13 randomised controlled trials (RCTs) including 3754 participants were evaluated. We found patients preconditioned with GIK before PCI showed a significant increase in Thrombolysis in Myocardial Infarction 3 flow events after angioplasty (OR 1.59, 95% CI 1.03 to 2.46, p=0.04), also revealed improved in-hospital left ventricular ejection fraction (weighed mean difference, WMD 1.62, 95% CI 0.21 to 3.03, p=0.02) and myocardial salvage index (WMD 0.09, 95% CI 0.01 to 0.16, p=0.03). Nevertheless, no benefit was observed in all-cause mortality neither on 30-day (OR 0.81, 95% CI 0.59 to 1.11, p=0.18) nor 6 months (OR 1.02, 95% CI 0.42 to 2.46, p=0.97). Furthermore, GIK intervention was associated with higher occurrences of complications such as phlebitis (OR 10.13, 95% CI 1.74 to 59.00, p=0.01) and hypoglycaemia (OR 10.43, 95% CI 1.32 to 82.29, p=0.03), but not hyperkalaemia (OR 9.36, 95% CI 0.50 to 175.27, p=0.13), liquid overload (OR 1.02, 95% CI 0.25 to 4.13, p=0.98) or in-hospital heart failure (OR 0.42, 95% CI 0.06 to 2.96, p=0.39).

Conclusions

Our study shows preconditioning GIK exhibits myocardial reperfusion and cardiac function benefits for patients planning to receive PCI intervention, while also some complications such as phlebitis and hypoglycaemia accompany.

PROSPERO registration number

CRD42022326334.

Economic evaluation of serplulimab plus chemotherapy as the first-line treatment of oesophageal squamous cell carcinoma in China

Por: Chen · F. · Long · Y. · Yang · J. · Zhong · K. · Liu · B.
Objective

The ASTRUM-007 study confirmed the significant efficacy and safety of serplulimab plus chemotherapy for patients with locally advanced/metastatic, programmed cell death-ligand 1 positive oesophageal squamous cell carcinoma (OSCC). The economics of this regimen, however, is unclear. Therefore, this study aimed to evaluate the cost-effectiveness of adding serplulimab to chemotherapy for the treatment of advanced OSCC from the perspective of the Chinese healthcare system.

Design

A partitioned survival model was established to simulate the costs and outcomes of chemotherapy versus serplulimab plus chemotherapy. The survival data came from the ASTRUM-007 study. Only direct medical costs were considered, and utility values were referred to the literature. Sensitivity analysis was performed to assess the effect of parameter uncertainty on the model.

Outcome measures

Total costs, incremental costs, life years, quality-adjusted life years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER).

Results

The base case analysis showed that the cost of serplulimab plus chemotherapy (US$69 356) was US$41 607 higher than that of chemotherapy (US$27 749), but it also gained 0.38 QALYs more (1.38 vs 1 QALYs), with an ICER of US$110 744.36/QALY, which was higher than the willingness to pay. The factors that most influenced the ICER were the price of serplulimab, weight and utility value of the progression-free survival stage. The subgroup analysis and scenario analysis also demonstrated that serplulimab plus chemotherapy was not economical.

Conclusions

Compared with chemotherapy, serplulimab coupled with chemotherapy was not cost-effective for the treatment of advanced OSCC in China.

Predictive factors of poor outcome and mortality among anterior ischaemic stroke patients despite successful recanalisation in China: a secondary analysis of the CAPTURE trial

Por: Li · G. · Sun · Y. · Liu · T. · Yang · P. · Peng · Y. · Chen · W. · Zhang · L. · Chu · J. · Kuai · D. · Wang · Z. · Wu · W. · Xu · Y. · Zhou · B. · Geng · Y. · Yin · C. · Li · J. · Wang · M. · Peng · X. · Xiao · Y. · Li · M. · Zhang · X. · Liu · P. · Wang · N. · Zhang · Y.
Objectives

This work aimed to analyse the risk factors for poor outcomes and mortality among patients with anterior large vessel occlusion (LVO) ischaemic stroke, despite successful recanalisation.

Setting and participants

This study conducted a secondary analysis among patients who underwent successful recanalisation in the CAPTURE trial. The trial took place between March 2018 and September 2020 at 21 sites in China. The CAPTURE trial enrolled patients who had an acute ischaemic stroke aged 18–80 years with LVO in anterior circulation.

Interventions

Thrombectomy was immediately performed using Neurohawk or the Solitaire FR after randomisation in CAPTURE trial. Rescue treatment was available for patients with severe residual stenosis caused by atherosclerosis.

Primary and secondary outcome measures

The primary goal was to predict poor 90-day survival or mortality within 90 days post-thrombectomy. Univariate analysis, using the 2 test or Fisher’s exact test, was conducted for each selected factor. Subsequently, a multivariable analysis was performed on significant factors (p≤0.10) identified through univariate analysis using the backward selection logistic regression approach.

Results

Among the 207 recruited patients, 79 (38.2%) exhibited poor clinical outcomes, and 26 (12.6%) died within 90 days post-thrombectomy. Multivariate analysis revealed that the following factors were significantly associated with poor 90-day survival: age ≥67 years, internal carotid artery (ICA) occlusion (compared with middle cerebral artery (MCA) occlusion), initial National Institutes of Health Stroke Scale (NIHSS) score ≥17 and final modified Thrombolysis in Cerebral Infarction (mTICI) score 2b (compared with mTICI 3). Additionally, the following factors were significantly associated with mortality 90 days post-thrombectomy: initial NIHSS score ≥17, ICA occlusion (compared with MCA occlusion) and recanalisation with more than one pass.

Conclusions

Age, NIHSS score, occlusion site, mTICI score and the number of passes can be independently used to predict poor 90-day survival or mortality within 90 days post-thrombectomy.

Trial registration number

NCT04995757.

Effects of repetitive transcranial magnetic stimulation over the contralesional dorsal premotor cortex on upper limb function in severe ischaemic stroke: study protocol for a randomised controlled trial

Por: Dai · W. · Yang · X. · Liu · C. · Ding · H. · Guo · C. · Zhu · Y. · Dong · M. · Qian · Y. · Fang · L. · Wang · T. · Shen · Y.
Introduction

Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment widely recommended to promote hand motor recovery after ischaemic stroke. However, the therapeutic efficacy of rTMS over the motor cortex in stroke patients is currently restricted and heterogeneous. This study aimed to determine whether excitatory rTMS over the contralesional dorsal premotor cortex (cPMd) facilitates the functional recovery of the upper limbs during the postacute stage of severe ischaemic stroke.

Methods and analysis

This study will be conducted as a single-blind, controlled, randomised study, in which 44 patients with poststroke hemiplegia with a course of disease ranging from 1 week to 3 months and Fugl-Meyer upper limb score ≤22 will be enrolled. The study participants will be randomly assigned to groups A (n=22) and B (n=22). The two groups are based on routine rehabilitation training and drug treatment; group A will be treated with low-frequency (1 Hz) rTMS over the contralesional primary motor cortex (cM1), and group B will be treated with high-frequency (10 Hz) rTMS over cPMd. For 2 weeks, rTMS will be administered once a day, 5 days a week. The primary outcome is the Fugl-Meyer assessment of the upper limb. The secondary outcomes include the Arm Subscore of the Motricity Index, Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity, Modified Barthel Index and Modified Ashworth Scale score of the paralysed pectoralis major and biceps brachii. Furthermore, data of diffusion tensor imaging and functional MRI will be collected. These outcomes will be assessed before and after the completion of the intervention.

Ethics and dissemination

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2020 SR-266). The findings of this study will be spread through networks of scientists, professionals and the general public as well as peer-reviewed scientific papers and presentations at pertinent conferences.

Trial registration number

ChiCTR2000038049

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