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Impacts of social support on the treatment outcomes of drug-resistant tuberculosis: a systematic review and meta-analysis

Por: Wen · S. · Yin · J. · Sun · Q.
Objective

To assess the effectiveness of social support on treatment success promotion or lost to follow-up (LTFU) reduction for patients with drug-resistant tuberculosis (DR-TB).

Design

We searched Pubmed, Web of Science, Embase, Scopus and Medline databases until 18 June 2020 for interventional or mixed-method studies which reported social support and treatment outcomes of DR-TB patients. Two independent reviewers extracted data and disagreements were resolved by consensus with a third reviewer. Random-effects meta-analysis was performed to calculate the OR and 95% CI for the effects of social support on the improvement of treatment outcomes and the heterogeneity and risk of bias were assessed.

Setting

Low-income and middle-income countries.

Participants

DR-TB patients.

Outcomes

Treatment success is defined as the combination of the cured and treatment completion, and LTFU is measured as treatment being interrupted for two consecutive months or more.

Results

Among 173 articles selected for full-text review, 162 were excluded through independent review (kappa=0.87) and 10 studies enrolling 1621 DR-TB patients in eight countries were included for qualitative analysis. In these studies, the most frequently introduced social support was material support (10 studies), followed by informational (eight studies), emotional (seven studies) and companionship support (four studies). Seven studies that reported treatment outcomes in both intervention arm and control arm are qualified for meta-analysis. An encouraging improvement on treatment success rate (OR: 2.58; 95% CI: 1.80 to 3.69) was found when material support was integrated into social support packages and no heterogeneity was observed (I1 of 0%, Q test p=0.72). Reduction on LTFU rate (OR: 0.17; 95% CI: 0.05 to 0.55) was also noted when material support was available but substantial heterogeneity was found (I2 of 80%, Q test p=0.002).

Conclusion

Material support appeared feasible and effective to improve treatment success for DR-TB patients combined with other social support interventions.

PROSPERO registration number

CRD42019140824.

Acupuncture for chronic cancer-related pain: a systematic review and network meta-analysis protocol

Por: Yang · J. · Xu · G. · Yin · Z. · Cheng · Y. · Sun · S. M. · Zheng · Q. · Chen · J. · Liang · F.-r. · Zhao · L.
Introduction

Chronic cancer-related pain is one of the most common excruciating symptom that can be caused by the cancer (by the primary tumour or by metastases) or by its treatment (surgery, chemotherapy and radiotherapy). Although multiple clinical trials and systematic reviews have suggested that acupuncture could be effective in treating chronic cancer-related pain, the comparative efficacy and safety of these acupuncture methods remains unclear. We, therefore, performed this study to evaluate and rank the efficacy and safety of different acupuncture methods for chronic cancer-related pain.

Methods and analysis

Seven databases will be searched, including Cochrane Library, MEDLINE, Embase, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, the Chongqing VIP Chinese Science and Technology Periodical Database and Chinese Biomedical Literature Database (CBM) from their inception to March 2020. The primary outcome is the change of pain intensity. Bayesian network meta-analysis will be conducted using software R3.5.1. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation System (GRADE) to assess the quality of evidence.

Ethics and dissemination

Ethical approval is not required for literature-based studies. The results will be disseminated through peer-reviewed publication.

PROSPERO registration number

CRD42020165747

Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial

Por: Lei · C. · Sui · Y. · Ye · J. · Lu · Y. · Xi · J. · Sun · Y. · Jin · L. · Sun · X.
Introduction

Pregnancy loss (PL) is an adverse life event, and there is no proven effective treatment for recurrent PL (RPL). Preimplantation genetic screening (PGS) can be performed to reduce the risks of PL; however, there is still no solid scientific evidence that PGS improves outcomes for couples experiencing RPL. Comprehensive chromosome screening (PGS2.0) has become a routine practice in in vitro fertilisation (IVF) clinics. Previous studies based on PGS1.0 with a focus on RPL couples where the female is of advanced maternal age have reported contradictory results. Hence, a multicentre randomised trial is needed to provide evidence for the clinical benefits of PGS2.0 treatment for RPL couples.

Methods and analysis

Overall, 268 RPL couples undergoing IVF cycles will be enrolled. Couples will be randomised according to a unique grouping number generated by a random digital software into (1) PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation) group. This study aims to investigate whether the live birth rate (LBR) per initiated cycle after PGS2.0 is superior to the LBR per initiated cycle after conventional embryo evaluation (non-PGS group). Live birth will be defined as a live baby born after a gestation period of >28 weeks, with a birth weight of more than 1000 g. A multivariate logistic regression model will be used to adjust for confounding factors.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Obstetrics and Gynecology Hospital, Fudan University and the participating hospitals. Written informed consent will be obtained from each couple before any study procedure is performed. Data from this study will be stored in the Research Electronic Data Capture. The results of this trial will be presented and published via peer-reviewed publications and presentations at international conferences.

Trial registration number

NCT03214185; Pre-results.

Educational needs and disaster response readiness: A cross‐sectional study of clinical nurses

Abstract

Aim

To analyse clinical nurses’ educational needs and disaster response readiness and the factors influencing their disaster response readiness.

Design

This was a cross‐sectional study.

Methods

A convenience sample comprising 260 nurses with more than a year of working experience at a hospital in Korea was selected from 1‐31 August 2019. Data on nurses’ educational needs and disaster response readiness were collected from participants. A multiple regression model was used to examine the factors influencing disaster response readiness among nurses.

Results

Factors influencing personal readiness were number of years of clinical experience, being female, working in a medical ward, and educational needs for disaster response. Factors influencing self‐protection were working in a medical ward and working in the emergency room. Factors influencing the emergency response were working in a medical ward and working in the emergency room. Factors influencing clinical management were a graduate‐level education or higher, working in a medical ward, working in the emergency room, working in the paediatric ward, experience receiving disaster‐related education, and educational needs for disaster response.

Conclusion

It is essential to be aware of the educational needs and disaster readiness of hospital clinical nurses, to develop their capacity to respond such situations. In addition, to improve the disaster competency of nurses, it is necessary to develop an education programme that considers the factors influencing disaster response readiness in this study.

Impact

Nurses must have the knowledge and skills to respond to a disaster. Nurse educators should help nurses strengthen their disaster‐related knowledge, skills, and judgment. Hospital administrators should encourage nurse educators to provide disaster‐related training and simulation‐based education to increase nurses’ disaster competency to act during disasters.

Exploring views and experiences of how infections are detected and managed in practice by nurses, care workers and managers in nursing homes in England and Sweden: a survey protocol

Por: Carey · N. · Alkhamees · N. · Cox · A. · Sund-Levander · M. · Tingström · P. · Mold · F.
Introduction

In order to avoid unnecessary hospital admission and associated complications, there is an urgent need to improve the early detection of infection in nursing home residents. Monitoring signs and symptoms with checklists or aids called decision support tools may help nursing home staff to detect infection in residents, particularly during the current COVID-19 pandemic.

We plan to conduct a survey exploring views and experiences of how infections are detected and managed in practice by nurses, care workers and managers in nursing homes in England and Sweden.

Methods and analysis

An international cross-sectional descriptive survey, using a pretested questionnaire, will be used to explore nurses, care workers and managers views and experiences of how infections are detected and managed in practice in nursing homes. Data will be analysed descriptively and univariate associations between personal and organisational factors explored. This will help identify important factors related to awareness, knowledge, attitudes, belief and skills likely to affect future implementation of a decision support tool for the early detection of infection in nursing home residents.

Ethics and dissemination

This study was approved using the self-certification process at the University of Surrey and Linköping University ethics committee (Approval 2018/514-32) in 2018. Study findings will be disseminated through community/stakeholder/service user engagement events in each country, publication in academic peer-reviewed journals and conference presentations. A LAY summary will be provided to participants who indicate they would like to receive this information.

This is the first stage of a plan of work to revise and evaluate the Early Detection of Infection Scale (EDIS) tool and its effect on managing infections and reducing unplanned hospital admissions in nursing home residents. Implementation of the EDIS tool may have important implications for the healthcare economy; this will be explored in cost–benefit analyses as the work progresses.

Informal dementia caregivers’ experiences and perceptions about mealtime care: A qualitative evidence synthesis

Abstract

Aims

To systematically identify, evaluate and synthesize the available qualitative evidence on the mealtime care experiences of informal caregivers of people with dementia.

Design

A qualitative evidence synthesis using the Thomas and Harden method.

Data Sources

All qualitative and mixed‐method studies in English and Chinese were retrieved from PubMed, Web of Science, Embase, Cochrane, CINAHL, CNKI, WanFang, and Vip from the inception of each database until November 2019.

Review Methods

Two researchers independently selected the studies using qualitative assessment and review instruments for quality evaluation and thematic synthesis for the data analysis.

Results

Ten studies were chosen for this review. The analytical themes identified included injecting a new element, moving forward in the challenge and external supports facilitating better coping.

Conclusion

Community nurses should effectively use resources to provide food‐related information and services to families with dementia. Future research should combine informal caregiver experiences and clinical skills to develop high‐quality interventions to improve the quality of mealtimes.

Impact

The findings established that informal caregivers experienced not only changes in their roles and concerns but also emotional changes. Informal caregivers develop different coping strategies to adapt to feeding issues without professional support. Although informal caregivers attach great importance to mealtimes and nutrition issues, they experience a lack of information and support services. Community nurses can provide more economical, practical, and accessible information resources based on informal caregivers’ perceptions of mealtime care. Future interventions need to be more aware of the importance of dyad or family‐centred support services.

City size and the spreading of COVID-19 in Brazil

by Haroldo V. Ribeiro, Andre S. Sunahara, Jack Sutton, Matjaž Perc, Quentin S. Hanley

The current outbreak of the coronavirus disease 2019 (COVID-19) is an unprecedented example of how fast an infectious disease can spread around the globe (especially in urban areas) and the enormous impact it causes on public health and socio-economic activities. Despite the recent surge of investigations about different aspects of the COVID-19 pandemic, we still know little about the effects of city size on the propagation of this disease in urban areas. Here we investigate how the number of cases and deaths by COVID-19 scale with the population of Brazilian cities. Our results indicate small towns are proportionally more affected by COVID-19 during the initial spread of the disease, such that the cumulative numbers of cases and deaths per capita initially decrease with population size. However, during the long-term course of the pandemic, this urban advantage vanishes and large cities start to exhibit higher incidence of cases and deaths, such that every 1% rise in population is associated with a 0.14% increase in the number of fatalities per capita after about four months since the first two daily deaths. We argue that these patterns may be related to the existence of proportionally more health infrastructure in the largest cities and a lower proportion of older adults in large urban areas. We also find the initial growth rate of cases and deaths to be higher in large cities; however, these growth rates tend to decrease in large cities and to increase in small ones over time.

Cancer Loyalty Card Study (CLOCS): protocol for an observational case-control study focusing on the patient interval in ovarian cancer diagnosis

Por: Brewer · H. R. · Hirst · Y. · Sundar · S. · Chadeau-Hyam · M. · Flanagan · J. M.
Introduction

Ovarian cancer is the eighth most common cancer in women worldwide, and about 1 in 5 women with ovarian cancer do not receive treatment, because they are too unwell by the time they are diagnosed. Symptoms of ovarian cancer are non-specific or can be associated with other common conditions, and women experiencing these symptoms have been shown to self-manage them using over-the-counter medication. Results from a recent proof-of-concept study suggest there may be an increase in the purchases of painkillers and indigestion medication 10–12 months before ovarian cancer diagnosis. We propose a case–control study, as part of a larger project called the Cancer Loyalty Card Study (CLOCS), to investigate whether a significant change in medication purchases could be an indication for early signs of ovarian cancer, using data already collected through store loyalty cards.

Methods and analysis

Using a retrospective case–control design, we aim to recruit 500 women diagnosed with ovarian cancer (cases) and 500 women without ovarian cancer (controls) in the UK who hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. In order to assess ovarian cancer risk in participants and their purchase patterns, we will collect information from participants on ovarian cancer risk factors and clinical data including symptoms experienced before diagnosis from recruited women with ovarian cancer.

Ethics and dissemination

CLOCS was reviewed and approved by the North West-Greater Manchester South Research Ethics Committee (19/NW/0427). Study outcomes will be disseminated through academic publications, the study website, social media and a report to the research sites that support the study once results are published.

Trial registration number

ISRCTN 14897082, CPMS 43323, NCT03994653.

Constipation and risk of cardiovascular diseases: a Danish population-based matched cohort study

Por: Sundboll · J. · Szepligeti · S. K. · Adelborg · K. · Szentkuti · P. · Gregersen · H. · Sorensen · H. T.
Objectives

To assess the risks of myocardial infarction, stroke, peripheral artery disease, venous thromboembolism, atrial fibrillation or atrial flutter and heart failure in patients with constipation compared with a general population cohort.

Design

Population-based matched cohort study.

Setting

All Danish hospitals and hospital outpatient clinics from 2004 to 2013.

Participants

Patients with a constipation diagnosis matched on age, sex and calendar year to 10 individuals without constipation from the general population.

Main outcomes measures

Comorbidity-adjusted and medication-adjusted hazard ratios (aHRs) for cardiovascular outcomes based on Cox regression analysis.

Results

83 239 patients with constipation were matched to 832 384 individuals without constipation. The median age at constipation diagnosis was 46.5% and 41% were men. Constipation was strongly associated with venous thromboembolism (aHR 2.04, 95% CI 1.89 to 2.20), especially splanchnic venous thrombosis (4.23, 95% CI 2.45 to 7.31). Constipation was also associated with arterial events, including myocardial infarction (1.24, 95% CI 1.14 to 1.35), ischaemic stroke (1.50, 95% CI 1.41 to 1.60), haemorrhagic stroke (1.46, 95% CI 1.26 to 1.69), peripheral artery disease (1.34, 95% CI 1.20 to 1.50), atrial fibrillation or atrial flutter (1.27, 95% CI 1.20 to 1.34) and heart failure (1.52, 95% CI 1.42 to 1.62). The associations were strongest during the first year after the constipation diagnosis and strengthened with an increased number of laxative prescriptions.

Conclusions

Constipation was associated with an increased risk of several cardiovascular diseases, in particular venous thromboembolism.

Discursive construction of the patient in online clinical cancer pathways information

Abstract

Aim

To explore how the patient is constructed and socially positioned in discourses of web‐based pathways information available to people with cancer in Norway.

Design

Mixed qualitative and quantitative design, using Corpus‐Assisted Critical Discourse Analysis.

Methods

The study, conducted in January 2020, examined the language of one general and six specific web‐based cancer pathways information brochures. The approach combines analysis of word frequencies and concordance lines using corpus analysis software to identify the ‘linguistic fingerprint’ or ‘aboutness’ of the text prior to further qualitative critical discourse analysis.

Results

The analysis identified three core discourses which constructed the patient differently: (a) a participating active person, in a brief, inclusive discourse; (b) a passive person lacking knowledge or perception of their situation in dominant, medical and interprofessional expert discourse; and (c) reduced to a disease and a code in the pathways discourse.

Conclusion

This study offers insight into the construction of patients in online clinical pathways information for cancer treatment. The analysis revealed how governance systems such as New Public Management and its demands on efficiency and productivity influence the cancer pathways. The World Health Organization has promoted a person‐centred approach, emphasizing the importance of participation and a partnership of equals. A person‐centred approach to care was not evident in the discourse of the online documents. The dominant ideology of these pathways was paternalistic with patients constructed as passive persons who get standardized treatment.

Impact

This study gives new insight that can be valuable for nurses, other healthcare professionals and the government. The lack of a person‐centred focus in the cancer pathway information could have a negative impact on the patient's health outcomes by promoting a culture of inattention to the patients' needs and wishes among practitioners. The results may provide a stimulus for discussion about the role of patients in cancer treatment.

Comparing two health literacy measurements used for assessing older adults’ medication adherence

Abstract

Aims and objectives

To compare two health literacy measurements’ ability to assess older adults’ medication adherence by using the Korean Health Literacy Screening Questions (KHLSQ) and the Modified Korean Functional Health Literacy Test (M‐KFHLT), and to identify an appropriate health literacy measurement.

Background

Lower health literacy has been associated with poorer medication adherence. Thus, health professionals should evaluate the available health literacy assessment instruments they are using and choose an appropriate instrument to assess health literacy to increase older adults’ medication adherence.

Design

Following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist, a descriptive, cross‐sectional study was conducted.

Methods

From November 2017–May 2018, 116 community‐dwelling older adults were recruited in South Korea. Questionnaires were completed during a face‐to‐face interview with each participant in a private room; health literacy was assessed using the KHLSQ and the M‐KFHLT and medication adherence using the Morisky Medication Adherence Scale.

Results

Health literacy assessed using the KHLSQ was found to be a predictor of medication adherence, but was not a predictor when measured by the M‐KFHLT. Having low income, multiple chronic diseases and vision problems were also significant factors related to medication adherence.

Conclusions

This study suggests that health literacy was negatively associated with medication adherence. Furthermore, KHLSQ is an appropriate tool for healthcare providers to use when assessing health literacy to predict older adults’ medication adherence.

Relevance to clinical practice

This finding indicated that healthcare providers should select an appropriate health literacy measurement that suits their purposes and the population they serve, particularly for older adults.

Relationship between cancer stigma, social support, coping strategies and psychosocial adjustment among breast cancer survivors

Abstract

Aims and objectives

The purpose of this study was to examine the magnitude of cancer stigma, social support, coping strategies and psychosocial adjustment among breast cancer survivors and to identify the factors associated with patients’ psychosocial adjustment.

Background

Few studies have examined the association between cancer stigma and adaptation outcomes, which are considered interpersonal stressors for breast cancer survivors.

Design

A correlational, cross‐sectional research design was used.

Methods

This study was designed based on the stress‐coping theory of Lazarus and Folkman. This descriptive cross‐sectional study included 158 breast cancer survivors who visited a Korean tertiary hospital. Data collection was performed using a structured questionnaire and electronic medical records between March–May 2018. Data analyses included descriptive statistics, independent t test, one‐way ANOVA, Kruskal–Wallis test, partial correlation analysis and hierarchical regression analysis and were performed with the SPSS WIN 25.0 program. This study adheres to STROBE guidelines.

Results

Cancer stigma had the strongest association with psychosocial adjustment among Korean breast cancer survivors, followed by social support and coping strategies. These variables accounted for approximately 44% of the variance in psychosocial adjustment.

Conclusion

Cancer stigma had the strongest association with psychosocial adjustment. Healthcare professionals should assess patients’ cancer stigma to develop patient‐tailored stigma management programmes.

Relevance to clinical practice

Interventions to alleviate cancer stigma should be developed, and social support and coping strategies for breast cancer survivors should be considered in clinical oncology settings.

Plasma proteome atlas for differentiating tumor stage and post-surgical prognosis of hepatocellular carcinoma and cholangiocarcinoma

by Ting-Tsung Chang, Cheng-Hsun Ho

Although mass spectrometry-based plasma proteomics enables sensitive and large-scale discovery and validation of biomarkers for various diseases, its integrative application to hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA) is not well investigated. Therefore, we analyzed albumin- and immunoglobulin G-depleted plasma samples from 148 and 60 patients with HCC and CCA, respectively, using liquid chromatography-tandem mass spectrometry. The algorithm used to measure the content of each protein was the percentage of exponentially modified protein abundance index. From 5320 proteins assayed in plasma, 53 and 25 biomarker candidates were identified for HCC and CCA, respectively. The abundance of six and two HCC markers particularly protruded in stage II and III, respectively, whereas plasma serine protease inhibitor was the sole marker the level of which steadily decreased with CCA progression. From a prognostic facet, we showed candidate markers and their cutoff levels for evaluating probability of tumor recurrence and patient survival period. Combination Kaplan-Meier models showed that HCC stage III or IV and both the content of alpha-2-HS-glycoprotein and apolipoprotein CIII

Cost-utility of sofosbuvir/velpatasvir versus other direct-acting antivirals for chronic hepatitis C genotype 1b infection in China

Por: Yun · H. · Zhao · G. · Sun · X. · Shi · L.
Objective

This study aimed to estimate the cost–utility of sofosbuvir/velpatasvir (SOF/VEL) compared with other direct-acting antivirals (DAAs) in Chinese patients with hepatitis C virus (HCV).

Design

A Markov model was developed to estimate the disease progression of patients with HCV over a lifetime horizon from the healthcare system perspective. Efficacy, clinical inputs and utilities were derived from the published literature. Drug costs were from the market price survey, and health costs for Markov health states were sourced from a Chinese study. Costs and utilities were discounted at an annual rate of 5%. One-way and probabilistic sensitivity analyses were conducted to test the impact of input parameters on the results.

Interventions

SOF/VEL was compared with sofosbuvir+ribavirin (SR), sofosbuvir+dasabuvir (SD), daclatasvir+asunaprevir (DCV/ASV), ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) and elbasvir/grazoprevir (EBR/GZR).

Primary and secondary outcomes

Costs, quality-adjusted life years (QALYs) and incremental cost–utility ratios (ICURs).

Results

SOF/VEL was economically dominant over SR and SD. However, 3D was economically dominant compared with SOF/VEL. Compared with DCV/ASV, SOF/VEL was cost-effective with the ICUR of US$1522 per QALY. Compared with EBR/GZR, it was not cost-effective with the ICUR of US$369 627 per QALY. One-way sensitivity analysis demonstrated that reducing the cost of SOF/VEL to the lower value of CI resulted in dominance over EBR/GZR and 3D. Probabilistic sensitivity analysis demonstrated that 3D was cost-effective in 100% of iterations in patients with genotype (GT) 1b and SOF/VEL was not cost-effective.

Conclusions

Compared with other oral DAA agents, SOF/VEL treatment was not the most cost-effectiveness option for patients with chronic HCV GT1b in China. Lower the price of SOF/VEL will make it cost-effective while simplifying treatment and achieving the goal of HCV elimination.

Impact of a mass media campaign on breast cancer symptoms awareness and screening uptake in Malaysia: findings from a quasi-experimental study

Por: Schliemann · D. · Htay · M. N. N. · Dahlui · M. · Paramasivam · D. · Cardwell · C. R. · Ibrahim Tamin · N. S. B. · Somasundaram · S. · Donnelly · C. · Su · T. T. · Donnelly · M.
Objective

To evaluate the impact of a mass media campaign in terms of improving breast cancer (BC) symptoms awareness and screening uptake.

Design

Before—and after—study with comparator groups.

Setting

Selangor State, Malaysia.

Participants

Malaysian women aged >40 years (n=676) from randomly selected households.

Intervention

A culturally adapted mass media campaign (TV, radio, print media and social media).

Primary and secondary outcome measures

The primary endpoint was BC symptoms awareness, which was assessed with the Breast Cancer Awareness Measure precampaign and postcampaign. Secondary outcomes included campaign reach, self-efficacy to notice BC symptoms and clinical outcomes. Clinical breast examination and mammogram screening data were collected from hospitals and clinics.

Results

Most participants recognised at least one of the campaign materials (65.2%). The odds of seeing the campaign were lowest for Chinese women (adjusted OR 0.25, 95% CI 0.15 to 0.40) compared with Malays and for women aged >70 years (adjusted OR 0.47, 95% CI 0.23 to 0.94) compared with younger women. Participants who recognised the campaign were significantly more likely to have improved awareness postcampaign compared with non-recognisers particularly for key symptoms such as ‘a lump or thickening in your breast’ (88.9% vs 62.1%) and ‘discharge or bleeding from nipple’ (79.7% vs 55.3%). Improvement in symptoms awareness scores was not associated with sociodemographic variables.

Conclusions

Implementation in Malaysia of an evidence-based mass media campaign from the UK that was culturally adapted appeared to lead to improved awareness about some BC symptoms, though various modes of media communication and perhaps other health education approaches may be required to extend the reach to diverse, multiethnic populations and all age groups.

Multiple-dose tranexamic acid for perioperative blood loss in total knee arthroplasty in patients with rheumatoid arthritis:a single-blinded, randomised, parallel-controlled study protocol in China

Por: Kang · B.-X. · Xu · H. · Gao · C.-X. · Zhong · S. · Zhang · J. · Xie · J. · Sun · S.-T. · Ma · Y.-H. · Zhai · W.-T. · Xiao · L.-B.
Introduction

This clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).

Methods and analysis

A randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50–75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.

Ethics and dissemination

The Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.

Trial registration number

ChiCTR1900025013.

Identifying the effects of an upgraded 'fever clinic on COVID-19 control and the workload of emergency department: retrospective study in a tertiary hospital in China

Por: Wang · J. · Zong · L. · Zhang · J. · Sun · H. · Harold Walline · J. · Sun · P. · Xu · S. · Li · Y. · Wang · C. · Liu · J. · Li · F. · Xu · J. · Li · Y. · Yu · X. · Zhu · H.
Objective

COVID-19 started spreading widely in China in January 2020. Outpatient fever clinics (FCs), instituted during the SARS epidemic in 2003, were upgraded to serve for COVID-19 screening and prevention of disease transmission in large tertiary hospitals in China. FCs were hoped to relieve some of the healthcare burden from emergency departments (EDs). We aimed to evaluate the effect of upgrading the FC system on rates of nosocomial COVID-19 infection and ED patient attendance at Peking Union Medical College Hospital (PUMCH).

Design

A retrospective cohort study.

Participants

A total of 6365 patients were screened in the FC.

Methods

The FC of PUMCH was upgraded on 20 January 2020. We performed a retrospective study of patients presenting to the FC between 12 December 2019 and 29 February 2020. The date when COVID-19 was declared an outbreak in Beijing was 20 January 2020. Two groups of data were collected and subsequently compared with each other: the first group of data was collected within 40 days before 20 January 2020; the second group of data was collected within 40 days after 20 January 2020. All necessary data, including patient baseline information, diagnosis, follow-up conditions and the transfer records between the FC and ED, were collected and analysed.

Results

6365 patients were screened in the FC, among whom 2912 patients were screened before 21 January 2020, while 3453 were screened afterward. Screening results showed that upper respiratory infection was the major disease associated with fever. After the outbreak of COVID-19, the number of patients who were transferred from the FC to the ED decreased significantly (39.21% vs 15.75%, p

Conclusion

The workload of the FC increased significantly after the COVID-19 outbreak. New protocols regarding the use of FC likely helped prevent the spread of COVID-19 within the hospital. The upgraded FC also reduced the burden on the ED.

Protocol of a multicenter, single-blind, randomised, parallel controlled feeding trial evaluating the effect of a Chinese Healthy Heart (CHH) diet in lowering blood pressure and other cardiovascular risk factors

Por: Xie · W. · Wang · Y. · Sun · J. · Zeng · G. · Zhu · H. · Yang · Z. · Gao · P. · Yang · J. · Feng · L. · Lin · P.-H. · Li · M. · Xu · J. · Chen · J. · Wu · Y.
Introduction

Unhealthy diet has been identified as the number one attributor of total mortality in China, accounting for more than 20% of total deaths. Although the Dietary Approach to Stop Hypertension (DASH) and Mediterranean diets have been proven beneficial in managing cardiovascular risk factors in Western countries, whether healthy diets with similar cardiovascular benefits can be developed that are consistent with Chinese food culture remains unknown.

Methods/design

The Diet, ExerCIse and CarDiovascular hEalth (DECIDE)-Diet trial is a multicentre, single-blind, randomised controlled feeding trial to evaluate the effect of the Chinese Healthy Heart (CHH) diet, in comparison with the Chinese usual diet, in lowering cardiovascular risk factors among community residents with the increased cardiovascular risk. A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu. After 1 week of run-in period with local usual diet, the compliant participants will be randomised to the intervention group with the CHH diet or the control group with the usual local diet, on a 1:1 ratio, for 4 weeks. Body weight of study participants will be maintained during the entire study period. The primary outcome is the change in SBP from the baseline to the end of the study. DECIDE-Diet trial will be the first randomised controlled feeding trial to evaluate the effect of a CHH diet in lowering cardiovascular risk factors. This trial will provide compelling evidence on the CHH diet in effect of improving cardiovascular health among Chinese food consumers all around the world.

Ethics and dissemination

This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-18094). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.

Trail registration number

ClinicalTrials.gov Registry (NCT03882645); Pre-results.

Efficacy of deep learning methods for predicting under-five mortality in 34 low-income and middle-income countries

Por: Adegbosin · A. E. · Stantic · B. · Sun · J.
Objectives

To explore the efficacy of machine learning (ML) techniques in predicting under-five mortality (U5M) in low-income and middle-income countries (LMICs) and to identify significant predictors of U5M.

Design

This is a cross-sectional, proof-of-concept study.

Settings and participants

We analysed data from the Demographic and Health Survey. The data were drawn from 34 LMICs, comprising a total of n=1 520 018 children drawn from 956 995 unique households.

Primary and secondary outcome measures

The primary outcome measure was U5M; secondary outcome was comparing the efficacy of deep learning algorithms: deep neural network (DNN); convolution neural network (CNN); hybrid CNN-DNN with logistic regression (LR) for the prediction of child’s survival.

Results

We found that duration of breast feeding, number of antenatal visits, household wealth index, postnatal care and the level of maternal education are some of the most important predictors of U5M. We found that deep learning techniques are superior to LR for the classification of child survival: LR sensitivity=0.47, specificity=0.53; DNN sensitivity=0.69, specificity=0.83; CNN sensitivity=0.68, specificity=0.83; CNN-DNN sensitivity=0.71, specificity=0.83.

Conclusion

Our findings provide an understanding of determinants of U5M in LMICs. It also demonstrates that deep learning models are more efficacious than traditional analytical approach.

Association between plasma exosome neurogranin and brain structure in patients with Alzheimers disease: a protocol study

Por: He · M. · Sun · L. · Cao · W. · Yin · C. · Sun · W. · Liu · P. · Tan · L. · Xu · Z. · Zhao · W.
Introduction

Neurogranin is known to be significantly elevated in patients with Alzheimer’s disease (AD) and may be an effective clinical predictor of cognitive decline and neurodegeneration. Amnestic mild cognitive impairment (aMCI) is an intermediate disease state between normal cognitive ageing and dementia, the latter of which can easily revert to AD. There remains significant uncertainty regarding the conversion of aMCI to AD, and therefore, elucidating such progression is paramount to the field of cognitive neuroscience. In this protocol study, we therefore aim to investigate the changes in plasma neurogranin in the early stage of AD and the mechanism thereof regarding the cognitive progression towards AD.

Methods and analysis

In this study, patients with aMCI and AD patients (n=70 each) will be recruited at the memory clinic of the Department of Neurology of Hongqi Hospital affiliated with the Mudanjiang Medical University of China. Healthy older controls (n=70) will also be recruited from the community. All subjects will undergo neuroimaging and neuropsychological evaluations in addition to blood collection at the first year and the third year. We hope to identify a new biomarker of cognitive decline associated with AD and characterise its behaviour throughout the progression of aMCI to AD. This work will reveal novel targets for the therapeutic prevention, diagnosis and treatment of AD. The primary outcome measures will be (1) neuropsychological evaluation, including Mini-Mental State Examination, Montreal Cognitive Assessment, Clinical Dementia Rating scale, Shape Trail Test-A&B, Auditory Verbal Learning Test-HuaShan version; (2) microstructural alterations and hippocampal features from MRI scans; and (3) neurogranin levels in the neuronal-derived exosomes from peripheral blood samples.

Ethics and dissemination

The ethics committee of the Hongqi Hospital affiliated with the Mudanjiang Medical University of China has approved this study protocol. The results will be published in peer-reviewed journals and presented at national or international scientific conferences.

Trial registration number

ChiCTR2000029055.

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