FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study

Por: Ren · T. · Li · Y. · Zhang · X. · Geng · Y. · Shao · Z. · Li · M. · Wu · X. · Wang · X.-A. · Liu · F. · Wu · W. · Shu · Y. · Bao · R. · Gong · W. · Dong · P. · Dang · X. · Liu · C. · Liu · C. · Sun · B. · Liu · J. · Wang · L. · Hong · D. · Qin · R. · Jiang · X. · Zhang · X. · Xu · J. · Jia · J. · Yang · B.
Introduction

Gallbladder cancer (GBC), the sixth most common gastrointestinal tract cancer, poses a significant disease burden in China. However, no national representative data are available on the clinical characteristics, treatment and prognosis of GBC in the Chinese population.

Methods and analysis

The Chinese Research Group of Gallbladder Cancer (CRGGC) study is a multicentre retrospective registry cohort study. Clinically diagnosed patient with GBC will be identified from 1 January 2008 to December, 2019, by reviewing the electronic medical records from 76 tertiary and secondary hospitals across 28 provinces in China. Patients with pathological and radiological diagnoses of malignancy, including cancer in situ, from the gallbladder and cystic duct are eligible, according to the National Comprehensive Cancer Network 2019 guidelines. Patients will be excluded if GBC is the secondary diagnosis in the discharge summary. The demographic characteristics, medical history, physical examination results, surgery information, pathological data, laboratory examination results and radiology reports will be collected in a standardised case report form. By May 2021, approximately 6000 patient with GBC will be included. The clinical follow-up data will be updated until 5 years after the last admission for GBC of each patient. The study aimed (1) to depict the clinical characteristics, including demographics, pathology, treatment and prognosis of patient with GBC in China; (2) to evaluate the adherence to clinical guidelines of GBC and (3) to improve clinical practice for diagnosing and treating GBC and provide references for policy-makers.

Ethics and dissemination

The protocol of the CRGGC has been approved by the Committee for Ethics of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (SHEC-C-2019–085). All results of this study will be published in peer-reviewed journals and presented at relevant conferences.

Trial registration number

NCT04140552, Pre-results.

Impact of team-based community healthcare on preventable hospitalisation: a population-based cohort study in Taiwan

Por: Jan · C.-F. J. · Chang · C.-J. J. · Hwang · S.-J. · Chen · T.-J. · Yang · H.-Y. · Chen · Y.-C. · Huang · C.-K. · Chiu · T.-Y.
Objectives

The objective of this study was to explore the impact of Taiwan’s Family Practice Integrated Care Project (FPICP) on hospitalisation.

Design

A population-based cohort study compared the hospitalisation rates for ambulatory care sensitive conditions (ACSCs) among FPICP participating and non-participating patients during 2011–2015.

Setting

The study accessed the FPICP reimbursement database of Taiwan’s National Health Insurance (NHI) administration containing all NHI administration-selected patients for FPICP enrolment.

Participants

The NHI administration-selected candidates from 2011 to 2015 became FPICP participants if their primary care physicians joined the project, otherwise they became non-participants.

Interventions

The intervention of interest was enrolment in the FPICP or not. The follow-up time interval for calculating the rate of hospitalisation was the year in which the patient was selected for FPICP enrolment or not.

Primary outcome measures

The study’s primary outcome measures were hospitalisation rates for ACSC, including asthma/chronic obstructive pulmonary disease (COPD), diabetes or its complications and heart failure. Logistic regression was used to calculate the ORs concerning the influence of FPICP participation on the rate of hospitalisation for ACSC.

Results

The enrolled population for data analysis was between 3.94 and 5.34 million from 2011 to 2015. Compared to non-participants, FPICP participants had lower hospitalisation for COPD/asthma (28.6–35.9 vs 37.9–42.3) and for diabetes or its complications (10.8–14.9 vs 12.7–18.1) but not for congestive heart failure. After adjusting for age, sex and level of comorbidities by logistic regression, participation in the FPICP was associated with lower hospitalisation for COPD/asthma (OR 0.91, 95% CI 0.87 to 0.94 in 2015) and for diabetes or its complications (OR 0.87, 95% CI 0.83 to 0.92 in 2015).

Conclusion

Participation in the FPICP is an independent protective factor for preventable ACSC hospitalisation. Team-based community healthcare programs such as the FPICP can strengthen primary healthcare capacity.

Different doses of prucalopride in treating chronic idiopathic constipation: a meta-analysis and Bayesian analysis

Por: Yang · T. · Wang · K. · Cao · Y. · Wen · J. · Wei · S. · Li · H. · Yang · X. · Xiao · T.
Objective

This study aims to explore the incremental benefit of different doses of prucalopride in treating chronic idiopathic constipation (CIC).

Methods

PubMed, EMBASE, MEDLINE, Cochrane Library, Chinese Biomedical Database, China National Knowledge Infrastructure, VIP medicine information and Wanfang databases were comprehensively searched up to March 2020. Prospective trials with different doses of prucalopride versus placebo were selected. The frequency of spontaneous bowel movements (SBMs) per week and the treatment-emergent adverse events (TEAEs), such as headache, arrhythmia, diarrhoea, dizziness, nausea and vomiting, were first synthesised in a meta-analysis. The probability of optimal dose of prucalopride was then ranked by random-effects within Bayesian analysis.

Results

14 high-quality randomised controlled trials with 4328 patients were ultimately included. SBMs per week increased significantly after using 1 mg (OR: 2.40, 95% CI 1.32 to 4.37), 2 mg (OR: 2.55, 95% CI 1.93 to 3.36) and 4 mg (OR: 2.51, 95% CI 1.92 to 3.28) prucalopride. Bayesian analysis demonstrated 1 mg dose obtained the maximum SBMs per week (OR: 3.31, 95% credible interval 1.72 to 6.16, probability rank=0.70) indirectly compared with 2 mg and 4 mg doses. TEAEs were higher significantly in 2 mg (risk ratio (RR): 1.20, 95% CI 1.09 to 1.33) and 4 mg (RR: 1.14, 95% CI 1.07 to 1.22) prucalopride. The 1 mg dose did not reach statistical significance (RR: 1.17, 95% CI 0.94 to 1.44).

Conclusions

The study concludes that 1 mg dose at commencement could be safer in treating CIC and that 2 mg prucalopride could be more efficacious in terms of SBMs per week outcome receiving.

PROSPERO registration number

CRD42019136679.

Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant p

Por: He · B. · Li · R. · Li · D. · Huang · L. · Wen · X. · Yang · G. · Wang · H.
Introduction

The classical pathway for diagnosing prostate cancer is systematic 12-core biopsy under the guidance of transrectal ultrasound, which tends to underdiagnose the clinically significant tumour and overdiagnose the insignificant disease. Another pathway named targeted biopsy is using multiparametric MRI to localise the tumour precisely and then obtain the samples from the suspicious lesions. Targeted biopsy, which is mainly divided into cognitive fusion method and software-based fusion method, is getting prevalent for its good performance in detecting significant cancer. However, the preferred targeted biopsy technique in detecting clinically significant prostate cancer between cognitive fusion and software-based fusion is still beyond consensus.

Methods and analysis

This trial is a prospective, single-centre, randomised controlled and non-inferiority study in which all men suspicious to have clinically significant prostate cancer are included. This study aims to determine whether a novel three-dimensional matrix positioning cognitive fusion-targeted biopsy is non-inferior to software-based fusion-targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy. The main inclusion criteria are men with elevated serum prostate-specific antigen above 4–20 ng/mL or with an abnormal digital rectal examination and have never had a biopsy before. A sample size of 602 participants allowing for a 10% loss will be recruited. All patients will undergo a multiparametric MRI examination, and those who fail to be found with a suspicious lesion, with the anticipation of half of the total number, will be dropped. The remaining participants will be randomly allocated to cognitive fusion-targeted biopsy (n=137) and software-based fusion-targeted biopsy (n=137). The primary outcome is the detection rate of clinically significant prostate cancer for cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy in men without a prior biopsy. The clinically significant prostate cancer will be defined as the International Society of Urological Pathology grade group 2 or higher.

Ethics and dissemination

Ethical approval was obtained from the ethics committee of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. The results of the study will be disseminated and published in international peer-reviewed journals.

Trial registration number

ClinicalTrials.gov Registry (NCT04271527).

Factors associated with inpatient length of stay among hospitalised patients with chronic obstructive pulmonary disease, China, 2016-2017: a retrospective study

Por: Dong · F. · Huang · K. · Ren · X. · Qumu · S. · Niu · H. · Wang · Y. · Li · Y. · Lu · M. · Lin · X. · Yang · T. · Jiao · J. · Wang · C.
Objectives

To identify factors associated with length of stay (LOS) in chronic obstructive pulmonary disease (COPD) hospitalised patients, which may help shorten LOS and reduce economic burden accrued over hospital stay.

Design

A retrospective cohort study.

Setting

This study was performed in a tertiary hospital in China.

Participants

Patients with COPD who were aged ≥40 years and newly admitted between 2016 and 2017.

Primary and secondary outcome measures

LOS at initial admission was the primary outcome and health expenditures were the secondary outcome. To identify factors associated with LOS, we collected information at index hospitalisation and constructed a conceptual model using directed acyclic graph. Potential factors were classified into five groups: demographic information, disease severity, comorbidities, hospital admission and environmental factors. Negative binomial regression model was fitted for each block of factors and a parsimonious analysis was performed.

Results

In total, we analysed 565 patients with COPD. The mean age was 69±11 years old and 69.4% were men. The median LOS was 10 (interquartile range 8–14) days. LOS was significantly longer in patients with venous thromboembolism (VTE) (16 vs 10 days, p=0.0002) or with osteoporosis (15 vs 10 days, p=0.0228). VTE ((rate ratio) RR 1.38, 95% CI 1.07 to 1.76), hypoxic–hypercarbic encephalopathy (RR 1.53, 95% CI 1.06 to 2.20), respiratory infection (RR 1.12, 95% CI 1.01 to 1.24), osteoporosis (RR 1.45, 95% CI 1.07 to 1.96) and emergence admission (RR 1.08, 95% CI 1.01 to 1.16) were associated with longer LOS. In parsimonious analysis, all these factors remained significant except emergency admission, highlighting the important role of concomitant morbidities in patients’ hospital stay. Total hospitalisation cost and patients’ out-of-pocket cost increased monotonically with LOS (both ptrend

Conclusion

Patients’ concomitant morbidities predicted excessive LOS in patients with COPD. Healthcare cost increased over the LOS. Quality improvement initiatives may need to identify patients at high risk for lengthy stay and implement early interventions to reduce COPD economic burden.

Association between serum uric acid and obesity in Chinese adults: a 9-year longitudinal data analysis

Por: Zeng · J. · Lawrence · W. R. · Yang · J. · Tian · J. · Li · C. · Lian · W. · He · J. · Qu · H. · Wang · X. · Liu · H. · Li · G. · Li · G.
Objectives

Hyperuricaemia has been reported to be significantly associated with risk of obesity. However, previous studies on the association between serum uric acid (SUA) and body mass index (BMI) yielded conflicting results. The present study examined the relationship between SUA and obesity among Chinese adults.

Methods

Data were collected at Guangdong Second Provincial General Hospital in Guangzhou City, China, between January 2010 and December 2018. Participants with ≥2 medical check-up times were included in our analyses. Physical examinations and laboratory measurement variables were obtained from the medical check-up system. The high SUA level group was classified as participants with hyperuricaemia, and obesity was defined as BMI ≥28 kg/m2. Logistic regression model was performed for data at baseline. For all participants, generalised estimation equation (GEE) model was used to assess the association between SUA and obesity, where the data were repeatedly measured over the 9-year study period. Subgroup analyses were performed by gender and age group. We calculated the cut-off values for SUA of obesity using the receiver operating characteristic curves (ROC) technique.

Results

A total of 15 959 participants (10 023 men and 5936 women) were included in this study, with an average age of 37.38 years (SD: 13.27) and average SUA of 367.05 μmol/L (SD: 97.97) at baseline, respectively. Finally, 1078 participants developed obesity over the 9-year period. The prevalence of obesity was approximately 14.2% for high SUA level. In logistic regression analysis at baseline, we observed a positive association between SUA and risk of obesity: OR=1.84 (95% CI: 1.77 to 1.90) for per-SD increase in SUA. Considering repeated measures over 9 year for all participants in the GEE model, the per-SD OR was 1.85 (95% CI: 1.77 to 1.91) for SUA and the increased risk of obesity were greater for men (OR=1.45) and elderly participants (OR=1.01). In subgroup analyses by gender and age, we observed significant associations between SUA and obesity with higher risk in women (OR=2.35) and young participants (OR=1.87) when compared with men (OR=1.70) and elderly participants (OR=1.48). The SUA cut-off points for risk of obesity using ROC curves were approximately consistent with the international standard.

Conclusions

Our study observed higher SUA level was associated with increased risk of obesity. More high-quality research is needed to further support these findings.

Cost-effectiveness analysis of renal replacement therapy strategies in Guangzhou city, southern China

Por: Yang · F. · Liao · M. · Wang · P. · Liu · Y.
Objectives

This study aims to assess the cost-effectiveness of three renal replacement therapy (RRT) modalities as well as proposed changes of scheduled policies in RRT composition in Guangzhou city.

Methods

From a payer perspective, we designed Markov model-based cost-effectiveness analyses to compare the cost-effectiveness of three RRT modalities and four different scheduled policies to RRT modalities in Guangzhou over three time horizons (5, 10 and 15 years). The current situation (scenario 1: haemodialysis (HD), 73%; peritoneal dialysis (PD), 14%; kidney transplantation (TX), 13%) was compared with three different scenarios: an increased proportion of incident RRT patients on PD (scenario 2: HD, 47%; PD, 40%; TX, 13%); on TX (scenario 3: HD, 52%; PD, 14%; TX, 34%); on both PD and TX (Scenario 4: HD, 26%; PD, 40%; TX, 34%).

Results

Over 5-year time horizon, HD was dominated by PD. At a willingness-to-pay (WTP) threshold of US$44 300, TX was cost-effective compared with PD with an incremental cost-effectiveness ratio of US$35 518 per quality-adjusted life year (QALY) gained. The scenario 2 held a dominant position over the scenario 1, with a net saving of US$ 5.92 million and an additional gain of 6.24 QALYs. The scenarios 3 and 4 were cost-effective compared with scenario 1 at a WTP threshold of US$44 300. The above results were consistent across the three time horizons.

Conclusions

TX is the most cost-effective RRT modality, followed in order by PD and HD. The strategy with an increased proportion of incident patients on PD and TX is cost-effective compared with the current practice pattern at the given WTP threshold. The planning for RRT service delivery should incorporate efforts to increase the utilisation of PD and TX in China.

A new surgical approach of direct perineal wound full‐thick closure for perineal wound of abdominoperineal resection for rectal carcinoma: A prospective cohort trial

Abstract

Perineal wound complications after APR have high morbidity in the colorectal surgical department. Although some approaches have been figured out to solve this clinical focus, the outcomes are still not satisfied. Herein, this prospective comparative clinical trial has been designed to evaluate a new surgical procedure of direct perineal wound full‐thick closure (DPWC), compared with conventional perineal wound closure (CPWC), with hopes of making wound healing with less complications. In addition, an evaluation of an incision negative wound pressure therapy, as another focus in this field, was also analysed in the DPWC group. A total of 44 participants in our department were recruited from March 2018 to March 2020, divided into two groups randomly, CPWC group and DPWC group. The patients' characteristics, such as age, gender, BMI, smoking, alcohol consumption, comorbidities, CEA level, and high‐risk of invasion, were recorded without statistical significance between the CPWC group and DPWC group. After the same standard abdominal phase, these two groups were performed in different perineal phases. And then, operative and postoperative outcomes were analysed with different statistical methods. Data on wound healing time and length of stay in the DPWC group were shorter than those in the CPWC group (P < .05). Furthermore, cases of wound infection within 30 days in the DPWC group were also less than that in the CPWC group (P < .05). However, no difference was found between the incisional negative pressure wound therapy assisted group (NPA group) and non‐ incisional negative pressure wound therapy assisted group (non‐NPA group). During this study, hypoalbuminemia, as an independent high‐risk factor, impacted perineal wound healing. (P = .0271) In conclusion, DPWC is a new surgical approach, which can lead to a better outcome than DPWC, and it can be another surgical procedure for clinicians. In addition, hypoalbuminemia should be interfered for avoiding perineal wound complications.

Physical activity reduces symptoms of anxiety, but further research is needed to determine a preventative effect

Por: Singh · S. · Yang · L.

Commentary on: McDowell, C, Dishman, RK, Gordon, BR, et al. Physical activity and anxiety: a systematic review and meta-analysis of prospective cohort studies. Am J Prev Med 2019;574:545–56.

Implications for practice and research

  • The burden of anxiety disorders and symptoms can potentially be reduced by increasing physical activity at the population level.

  • More studies require using prospective designs and rigorous measures for assessing anxiety and dosing of physical activity.

  • Context

    Anxiety is a debilitating1 and costly chronic illness.2 Pharmacological treatment of anxiety disorders and symptoms can be challenging with side effects and expensive for many,3 which makes prevention strategies critical. Physical activity has been previously shown to reduce the symptoms of anxiety and depression.4 Whether physical activity may be effective in preventing anxiety has not yet been previously investigated, presenting a knowledge gap and an opportunity...

    Development and validation of a prognostic nomogram for myocardial infarction patients in intensive care units: a retrospective cohort study

    Por: Guo · Q. · Wu · M. · Li · H. · Ouyang · H. · Sun · R. · Wang · J. · Liu · Z. · Wang · J. · Zhang · Y.
    Objectives

    We aimed to develop and validate a prognostic nomogram and evaluate the discrimination of the nomogram model in order to improve the prediction of 30-day survival of critically ill myocardial infarction (MI) patients.

    Design

    A retrospective cohort study.

    Setting

    Data were collected from the Medical Information Mart for Intensive Care (MIMIC)-III database, consisting of critically ill participants between 2001 and 2012 in the USA.

    Participants

    A total of 2031 adult critically ill patients with MI were enrolled from the MIMIC-III database.

    Primary and secondary outcome

    Thirty-day survival.

    Results

    Independent prognostic factors, including age, heart rate, white blood cell count, blood urea nitrogen and bicarbonate, were identified by Cox regression model and used in the nomogram. Good agreement between the prediction and observation was indicated by the calibration curve for 30-day survival. The nomogram exhibited reasonably accurate discrimination (area under the receiver operating characteristic curve, 0.765, 95% CI, 0.716 to 0.814) and calibration (C-index, 0.758, 95% CI, 0.712 to 0.804) in the validation cohort. Decision curve analysis demonstrated that the nomogram was clinically beneficial. Additionally, participants could be classified into two risk groups by the nomogram, and the 30-day survival probability was significantly different between them (p

    Conclusion

    This five-factor nomogram can achieve a reasonable degree of accuracy to predict 30-day survival in critically ill MI patients and might be helpful for risk stratification and decision-making for MI patients.

    Relationship between parental overweight and obesity and childhood metabolic syndrome in their offspring: result from a cross-sectional analysis of parent-offspring trios in China

    Por: Yang · Z. · Li · Y. · Dong · B. · Gao · D. · Wen · B. · Ma · J.
    Objective

    Metabolic syndrome (MS) and its components are observed to emerge in childhood and may continue into adulthood. The study aimed to investigate the association between parental overweight and risk of childhood MS and its components in their offspring.

    Methods

    Data were obtained from a cross-sectional survey conducted in Chinese children and adolescents; a total of 11 784 children aged 7–18 years were included in this study; child outcomes were obtained from objective measurements and parental data were obtained from questionnaires; MS was defined according to the modified criteria of Adult Treatment Panel ; correlation between parental overweight and offspring MS was assessed via multivariate logistic regression models adjusted for potential covariates.

    Results

    3476 (29.5%) children were found to have overweight fathers, 1041 (8.8%) had overweight mothers and 852 (7.2%) had both overweight parents. The prevalence of MS was 7.1% in total, 8.2% in boys and 5.9% in girls; children with overweight parents had a higher prevalence of MS and its components (except for elevated glucose) compared with children with normal-weight parents. Children with overweight fathers, mothers and both parents had 2.17 times (95% CI: 1.65–2.85), 2.89 times (95% CI: 2.03–4.11) and 2.81 times (95% CI: 1.91–4.15) higher risk of MS, respectively. Children with overweight mothers were likely to have a higher risk of MS compared with children with overweight fathers. Parental overweight was positively correlated with higher risk of MS, abdominal obesity and low HDL-C both in boys and girls.

    Conclusion

    Parental overweight was strongly associated with increased risk of MS in their offspring, the risk was highest in children with both parents to be overweight. Maternal overweight seems to have a stronger correlation with offspring MS than paternal overweight. Parental overweight is one of the factors for identifying metabolic dysfunction risk in their offspring and other factors need to be considered as well.

    Quality appraisal of clinical guidelines for venous thromboembolism prophylaxis in patients undergoing hip and knee arthroplasty: a systematic review

    Por: Wang · Y. · Zhu · L.-Y. · Deng · H.-B. · Yang · X. · Wang · L. · Xu · Y. · Wang · X.-J. · Pang · D. · Sun · J.-H. · Cao · J. · Liu · G. · Liu · Y. · Ma · Y.-F. · Wu · X.-J.
    Introduction

    Venous thromboembolism (VTE) occurs in up to 40%–80% of patients after hip and knee arthroplasty. Clinical decision-making aided by guidelines is the most effective strategy to reduce the burden of VTE. However, the quality of guidelines is dependent on the strength of their evidence base. The objective of this article is to critically evaluate the quality of VTE prevention guidelines and the strength of their recommendations in VTE prophylaxis in patients undergoing hip and knee arthroplasty.

    Methods

    Relevant literature up to 16 March 2020 was systematically searched. We searched databases such as Web of Science, PubMed, EMBASE, Cumulative Index of Nursing and Allied Health Literature, China National Knowledge Infrastructure and WanFang and nine guidelines repositories. The identified guidelines were appraised by two reviewers using the Appraisal of Guidelines for Research and Evaluation II and appraised the strength of their recommendations independently. Following quality assessment, a predesigned data collection form was used to extract the characteristics of the included guideline.

    Results

    We finally included 15 guidelines. Ten of the included guidelines were rated as ‘recommended’ or ‘recommended with modifications’. The standardised scores were relatively high in the domains of Clarity of Presentation, and Scope and Purpose. The lowest average standardised scores were observed in the domains of Applicability and Stakeholder Involvement. In reference to the domains of Rigour of Development and Editorial Independence, the standardised scores varied greatly between the guidelines. The agreement between the two appraisers is almost perfect (intraclass correlation coefficients higher than 0.80). A considerable proportion of the recommendations is based on low-quality or very-low-quality evidence or is even based on working group expert opinion.

    Conclusions

    In summary, the majority of the recommendations are based on low-quality evidence, and further confirmation is needed. Furthermore, guideline developers should pay more attention to methodological quality, especially in the Stakeholder Involvement domain and the Applicability domain.

    Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial

    Por: Hu · K.-L. · Gan · K. · Wang · R. · Li · W. · Wu · Q. · Zheng · B. · Zou · L. · Zhang · S. · Liu · Y. · Wu · Y. · Chen · R. · Cao · W. · Yang · S. · Liu · F.-T. · Tian · L. · Zeng · H. · Xu · H. · Qiu · S. · Yang · L. · Chen · X. · Pan · X. · Wu · X. · Mol · B. W. · Li · R. · Zhang · D.
    Introduction

    Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women of childbearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates. However, evidence regarding the effectiveness of vitamin D supplementation in women with PCOS is inconclusive. This multicentre randomised, double-blinded, placebo-controlled trial aims to evaluate the effectiveness of vitamin D supplementation prior to in vitro fertilisation (IVF) on the live birth rate in women with PCOS.

    Methods and analysis

    We plan to enrol women with PCOS scheduled for IVF. After informed consent, eligible participants will be randomised in a 1:1 ratio to receive oral capsules of 4000 IU vitamin D per day or placebo for around 12 weeks until the day of triggering. All IVF procedures will be carried out routinely in each centre. The primary outcome is live birth after the first embryo transfer. The primary analysis will be by intention-to-treat analysis. To demonstrate or refute that treatment with vitamin D results in a 10% higher live birth rate than treatment with placebo, we need to recruit 860 women (48% vs 38% difference, anticipating 10% loss to follow-up and non-compliance, significance level 0.05 and power 80%).

    Ethics and dissemination

    This study has been approved by the Ethics Committee in Women’s Hospital of Zhejiang University on 2 March 2020 (reference number: IRB-20200035-R). All participants will provide written informed consent before randomisation. The results of the study will be submitted to scientific conferences and a peer-reviewed journal.

    Trial registration number

    NCT04082650.

    Association between the occurrence of albuminuria and the risk of early dementia among older people upon health examination: a community-based cohort study in Taiwan

    Por: Tseng · T.-J. · Yen · Y.-T. · Yang · Y.-H. · Chen · Y.-H. · Chan · T.-C.
    Objectives

    This study aimed to investigate the associations between biochemical markers, renal function, health behaviours and dementia among older people.

    Design

    A retrospective cohort study.

    Setting

    Community-based health examination database from Taipei city.

    Participants

    In total, 35 434 older people were included from February 2005 to December 2012. To assess changes in renal function, we selected participants who attended health examinations at least twice and responded to the AD8 questionnaire in 2012. We excluded those with dementia at baseline.

    Primary outcome measures

    Early dementia was assessed using the AD8 questionnaire in 2012. Explanatory variables included demographic factors, health behaviours, biochemical markers and renal function. We used a Cox proportional hazard model to estimate the HR for early dementia onset.

    Results

    Individuals with mild albuminuria (HR 1.228; 95% CI 1.066 to 1.414), lower eGFR (HR 1.549; 95% CI 1.319 to 1.820) and higher age (HR 1.022; 95% CI 1.015 to 1.028) were associated with a high risk of early dementia. Older people with no alcohol intake (HR 0.872; 95% CI 0.794 to 0.958), and higher education levels (HR 0.647; 95% CI 0.589 to 0.710) were at a low risk of early dementia.

    Conclusions

    Elevated mild albuminuria and low eGFR were associated with a high risk of early dementia in this community-based cohort. Routine health examinations for older people can help screen out the high-risk population, and clinical management might reduce or delay the risk of early dementia.

    Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial

    Por: Zhou · Y. · Deng · H. · Liu · H. · Yang · D. · Xu · W. · Yao · B. · Yan · J. · Weng · J.
    Introduction

    Optimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited. This study aims to evaluate the effect of FGM in suboptimally controlled adult patients with T1DM .

    Methods and analysis

    This open-label, multicentre, randomised trial will be conducted at eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1 year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0%). After a run-in period (baseline, 0–2 weeks), eligible participants will be randomised 1:1 to either use FGM or self-monitoring of blood glucose alone consequently for the next 24 weeks. At baseline, 12–14 weeks and 24–26 weeks, retrospective continuous glucose monitoring (CGM) systems will be used in both groups for device-related data collection. Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events, will be assessed at baseline, week 14 and week 26. All analyses will be conducted on the intent-to-treat population. Efficacy endpoint analyses will also be repeated on the per-protocol population. The primary outcome is the change of HbA1c from baseline to week 26. The secondary outcomes are the changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (

    Ethics and dissemination

    This study was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University in January 2017. Ethical approval has been obtained at all centres. All participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.

    Trial registration number

    NCT03522870.

    Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial

    Por: Njuguna · I. N. · Beima-Sofie · K. · Mburu · C. W. · Mugo · C. · Neary · J. · Itindi · J. · Onyango · A. · Richardson · B. A. · Rubin Means · A. · Sharma · M. · Weiner · B. J. · Wagner · A. D. · Oyiengo · L. · Wamalwa · D. · John-Stewart · G.
    Introduction

    Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes.

    Methods and analysis

    In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ≥100 adolescents and young adults age 10–24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1 year. The primary outcome is transition readiness among ALWHIV ages 15–24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided α=0.05.

    Ethics and dissemination

    The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers.

    Trials registration number

    NCT03574129; Pre-results.

    Family Functioning Mediates the Relationship Between Activities of Daily Living and Poststroke Depression

    imageBackground Poststroke depression is common and includes depressive and somatic symptoms. However, few studies have confirmed the influence of family functioning on poststroke depression or explored the association among daily activities, family functioning, and poststroke depression. Objectives We examined the independent risk factors of daily activities and family functioning for poststroke depression and identified the mediating effect of family functioning on the association between daily activities and poststroke depression. Methods This cross-sectional study design used convenience sampling to recruit 422 stroke survivors from the neurology department of a hospital in Harbin, China, from February to July 2018. We assessed participants’ demographic and clinical variables, including depression, daily activities, and family functioning. Pearson’s correlations and multiple linear regression analyses were conducted, and a path analysis with bootstrapping was utilized to define direct/indirect effects. Results Daily activities and family functioning had a significant and direct negative effect on participants’ depression. The indirect effect of 1,000 bootstrap samples after bias correction with a 95% confidence interval was below zero, indicating that family function had a significant mediating effect on the association between depression and daily activities. Discussion This study revealed the importance of family functioning in the association between depression and daily activities in stroke survivors. To the best of our knowledge, this study was the first to explore the mediating role of family functioning in poststroke depression, emphasizing the importance of family for the mental health of stroke patients. To reduce the incidence of poststroke depression, interventions that enhance daily activities and family functioning may include nurses, family therapists, rehabilitation physicians, and community workers.

    The psychological symptoms of patients with mild symptoms of coronavirus disease (2019) in China: A cross‐sectional study

    Abstract

    Aims

    To determine psychological symptoms of patients with mild symptoms of coronavirus disease 2019 in China and to explore the influencing factors.

    Design

    A cross‐sectional study.

    Methods

    A convenience sample of 296 mild coronavirus disease 2019 patients were recruited from a Fangcang hospital in Wuhan, Hubei Province, from 3–5 March, 2020. Participants were assessed using a sociodemographic and clinical characteristics questionnaire, and Symptom Check List 90. The binary logistic regression was utilized to explore the influencing factors of psychological symptoms of patients with mild symptoms of coronavirus disease 2019.

    Results

    In total, 296 of 299 patients with mild symptoms of coronavirus disease 2019 participated in the study (response rate: 99.0%). The findings revealed that 12.8% patients with mild symptoms have mental health problems; the most common psychological symptoms are phobic anxiety (58.4%), paranoid ideation (50.7%) and psychoticism (40.2%). Female patients [OR = 3.587, 95% CI (1.694–7.598)] and those having physical symptoms currently [OR = 2.813, 95% CI (1.210–6.539)] are at higher risk, while those in the middle duration of hospitalization [OR = 0.278, 95% CI (0.121–0.639)] protect against mental‐health problems.

    Conclusions

    The minority of patients with mild symptoms of coronavirus disease 2019 were still suffering from psychological symptoms. Healthcare providers are recommended to pay particular attention to screening these high‐risk groups (women, those in the initial stages of hospitalization and those with physical symptoms currently) and implement targeted psychological care as required.

    Impact

    This study found that most patients of coronavirus disease 2019 in Fangcang hospital exhibited normal mental health at par with the general Chinese norm and the minority of them were suffering from psychological symptoms. The findings can provide a reference for healthcare providers to screen high‐risk psychological symptoms groups and implement targeted psychological intervention for patients with coronavirus disease 2019.

    Knowledge, attitude and practice of residents in the prevention and control of COVID‐19: An online questionnaire survey

    Abstract

    Aims

    To explore the status quo and the influencing factors of residents’ knowledge, attitude and practice (KAP) in the prevention and control of coronavirus disease 2019 (COVID‐19), and the difficulties or challenges perceived by residents in their preventive practice.

    Design

    An online questionnaire survey.

    Methods

    The self‐designed questionnaire was distributed among residents online in February 2020. Descriptive statistics, two independent samples t‐tests, one‐way analysis of variance, Pearson's correlation analysis, multivariate linear regression and content analysis were performed.

    Results

    A total of 919 valid questionnaires were collected. The scoring rates of residents’ KAP were 85.2%, 92.9% and 84.4% respectively. Main factors influencing residents’ knowledge included gender and occupation; while those influencing attitude were occupation, family economic level and knowledge; and those influencing practice included place of residence, occupation, with or without chronic disease, knowledge and attitude. Mass media was the primary approach for people to learn the knowledge and information of COVID‐19. Difficulties or challenges faced were mainly lack of protective equipments, concerns about the risk of prevention and control, impact on daily life, work and study, lack of knowledge and consensus, psychological problems and information problems.

    Conclusion

    The attitude of residents towards COVID‐19 prevention and control is generally positive. The knowledge and practice have been popularized to a certain extent, but there are still deviations or deficiencies in residents’ understanding of certain important knowledge and the adoption of relevant preventive measures. Evidence‐based tailored public education initiatives are indicated.

    Impact

    Findings of this study add important knowledge about residents’ understanding, attitude, practice and the influencing factors on COVID‐19 prevention and control, which serves as a scientific foundation for optimizing the pandemic public education and decision‐making.

    ❌