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Exploring the Validity of Allostatic Load in Pregnant Women

: The theory of allostatic load has gained momentum in perinatal research to understand the biological pathways of the impact of maternal chronic stress on adverse perinatal outcomes. However, due to physiological changes of pregnancy, including large variations across gestation, the extent to which allostatic load measured in pregnancy is valid has not been queried in depth.

Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial

Por: Yang · J. · Sun · T. · Yuan · Y. · Li · X. · Yu · H. · Guan · J.
Introduction

Cranioplasty is a common surgery in neurosurgery department. However, restoring the integrity of skull brings many challenges to surgeons, and the selection of ideal implant materials is throughout the history of cranioplasty. Although titanium mesh was still preferred by many neurosurgeons in cranial reconstruction, the new polyetheretherketone (PEEK) material, for example, is gaining popularity for craniofacial reconstruction today. There remain limited data that compare the outcome of PEEK cranioplasty and titanium mesh cranioplasty. It is necessary to conduct a study to compare outcome of different materials for cranioplasty.

Methods/design

In this multicentre, assessor-blinded, randomised controlled study, we will randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty. Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on), the defect size is over 25 cm2, and they need to agree to participate in this trial. Instead of standard examinations, the enrolled patients receive neurological, motor, cognitive function and cerebral hemodynamics examinations as well as cosmetic evaluation. The procedures are repeated 3, 6 months after cranioplasty. The primary outcome, defined as infection or implant exposure after surgery, is the implant failure rate within 6 months. Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.

Ethics and dissemination

This trial protocol has been approved by Biomedical Research Ethics Committee of West China Hospital of Sichuan University. All patients will be fully informed the implant materials, potential complications after surgery, responsibilities during the trial, and they will sign the informed consent before joining in this trial. If the patient’s cognitive function is impaired, the patient’s next of kin would be carefully informed. The results will be disseminated through academic conferences, student theses and will be published in a peer-reviewed journal.

Trail registration number

ChiCTR1900024625; Pre-results.

Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study

Por: Lin · J.-Y. · Zhang · C.-H. · Zheng · L. · Li · H.-J. · Zhu · Y.-M. · Fan · X. · Li · F. · Xia · Y. · Huang · M.-Z. · Yang · S.-H. · Qi · X.-L. · Huo · H.-Z. · Chen · H.-S. · Lou · X.-L. · Luo · M.
Introduction

Portal hypertension (PH) is a severe disease with a poor outcome. Hepatic venous pressure gradient (HVPG), the current gold standard to detect PH, is available only in few hospitals due to its invasiveness and technical difficulty. This study aimed to establish and assess a novel model to calculate HVPG based on biofluid mechanics.

Methods and analysis

This is a prospective, randomised, non-controlled, multicentre trial. A total of 248 patients will be recruited in this study, and each patient will undergo CT, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients). The researchers will establish and improve the HVPG using biofluid mechanics (HVPGBFM)model in the original cohort and assess the model in the validation cohort.

Ethics and dissemination

The study was approved by the Scientific Research Projects Approval Determination of Independent Ethics Committee of Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (approval number 2017–430 T326). Study findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT03470389.

Comparative efficacy and safety of probiotics for the treatment of irritable bowel syndrome: a systematic review and network meta-analysis protocol

Por: Yang · M. · Yu · Y. · Lei · P.-G. · Yuan · J.
Introduction

Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder affecting approximately 10% to 25% of the adult population. A large number of clinical trials have been conducted to evaluate the efficacy of probiotics for IBS but the results were inconsistent. Previous meta-analyses have shown that probiotics are effective for IBS, but the comparative efficacy of individual species is unclear. In addition, evidence regarding the superiority of combination over single probiotic is still lacking. We, therefore, perform this study to evaluate the comparative efficacy and safety of various species of probiotics, and combination regimens for the treatment of IBS.

Methods and analysis

This study is a systematic review with network meta-analysis. We will search PubMed, Scopus, The Cochrane Central Register of Controlled Trials and CINAHL for randomised controlled trials comparing probiotics with placebo or comparing different probiotics for IBS, with no language restrictions. The primary outcomes will be treatment response and global IBS-symptom score. We will initially combine included studies with traditional pairwise meta-analysis and then with random-effects network meta-analysis. We will quantify the effect of potential effect modifiers by meta-regression if appropriate. We will check the consistency assumption by testing the absolute difference between direct and indirect estimates for comparisons in closed loops. The quality of evidence will be evaluated according to the GRADE framework.

Ethics and dissemination

Ethical approval is not required for literature-based studies. We will disseminate the findings through publications in peer-reviewed journals and relevant conferences.

PROSPERO registration number

CRD42018102101

Carvedilol improves glucose tolerance and insulin sensitivity in treatment of adrenergic overdrive in high fat diet-induced obesity in mice

by Linh V. Nguyen, Quang V. Ta, Thao B. Dang, Phu H. Nguyen, Thach Nguyen, Thi Van Huyen Pham, Trang HT. Nguyen, Stephen Baker, Trung Le Tran, Dong Joo Yang, Ki Woo Kim, Khanh V. Doan

Catecholamine excess reflecting an adrenergic overdrive of the sympathetic nervous system (SNS) has been proposed to link to hyperleptinemia in obesity and may contribute to the development of metabolic disorders. However, relationship between the catecholamine level and plasma leptin in obesity has not yet been investigated. Moreover, whether pharmacological blockade of the adrenergic overdrive in obesity by the third-generation beta-blocker agents such as carvedilol could help to prevent metabolic disorders is controversial and remains to be determined. Using the high fat diet (HFD)-induced obese mouse model, we found that basal plasma norepinephrine, the principal catecholamine as an index of SNS activity, was persistently elevated and highly correlated with plasma leptin concentration during obesity development. Targeting the adrenergic overdrive from this chronic norepinephrine excess in HFD-induced obesity with carvedilol, a third-generation beta-blocker with vasodilating action, blunted the HFD-induced hepatic glucose over-production by suppressing the induction of gluconeogenic enzymes, and enhanced the muscular insulin signaling pathway. Furthermore, carvedilol treatment in HFD-induced obese mice decreased the enlargement of white adipose tissue and improved the glucose tolerance and insulin sensitivity without affecting body weight and blood glucose levels. Our results suggested that catecholamine excess in obesity might directly link to the hyperleptinemic condition and the therapeutic targeting of chronic adrenergic overdrive in obesity with carvedilol might be helpful to attenuate obesity-related metabolic disorders.

Nonalcoholic fatty liver disease is an early predictor of metabolic diseases in a metabolically healthy population

by Seokhun Yang, Soongu Kwak, Jeong-Hoon Lee, Shinae Kang, Seung-Pyo Lee

Aims

The relationship between nonalcoholic fatty liver disease and incident metabolic syndrome in metabolically healthy subjects is unknown. We aimed to investigate whether nonalcoholic fatty liver disease is a predictor of future metabolic syndrome in metabolically healthy subjects.

Materials and methods

Subjects who underwent health evaluation at least twice between 2009 and 2015 from the National Health Insurance Service-National Sample Cohort in South Korea were included. Patients without obesity who had no metabolic syndrome components were finally analyzed (n = 28,880). The definition of nonalcoholic fatty liver disease was based on both the hepatic steatosis and fatty liver indices. The incidence of metabolic syndrome, prediabetes/type 2 diabetes, hypertension, and dyslipidemia was compared between the subjects with and without nonalcoholic fatty liver disease.

Results

The presence of nonalcoholic fatty liver disease was associated with a higher risk of incident metabolic syndrome, prediabetes/type 2 diabetes, hypertension, and dyslipidemia in the entire cohort (metabolic syndrome: adjusted hazard ratio, 2.10; 95% confidence interval, 1.18–3.71; prediabetes/type 2 diabetes: adjusted hazard ratio, 1.42; 95% confidence interval, 1.06–1.90; hypertension: adjusted hazard ratio, 2.36; 95% confidence interval, 1.35–4.12; dyslipidemia: adjusted hazard ratio, 1.49; 95% confidence interval, 1.07–2.06). A similar finding was observed in the age-, sex-, smoking status-, and body mass index-based 1:5 propensity score-matched cohort of 1,092 subjects (metabolic syndrome: adjusted hazard ratio, 3.56; 95% confidence interval, 1.79–7.07; prediabetes/type 2 diabetes: adjusted hazard ratio, 1.97; 95% confidence interval, 1.04–3.73; hypertension: adjusted hazard ratio, 2.57; 95% confidence interval, 1.35–4.88; dyslipidemia: adjusted hazard ratio, 1.61; 95% confidence interval, 1.12–2.32).

Conclusions

Nonalcoholic fatty liver disease is an early predictor of metabolic dysfunction even in metabolically healthy populations.

Prevalence and service assessment of cataract in Tibetan areas of Sichuan Province, China: population-based study

Por: Jiachu · D. · Jin · L. · Jiang · F. · Luo · L. · Zheng · H. · Ji · D. · Yang · J. · Yongcuo · N. · Huang · W. · Yi · J. · Bright · T. · Yip · J. L. · Xiao · B.
Objectives

To assess the prevalence of visual impairment (VI) and blindness (BL) due to cataract and cataract surgical outcomes in remote dispersed and high-altitude Tibetan areas of China.

Design and setting

A cross-sectional study was conducted among people aged 50 and above in Tibetan Autonomous Prefecture of Kandze (TAPK), China, in 2017. The Rapid Assessment of Avoidable Blindness protocol was followed.

Participants

Of 5000 eligible participants, 4764 were examined (response rate 95.3%).

Primary and secondary outcome measures

Cataract VI was defined as lens opacity at visual acuity (VA) levels of

Results

The estimated prevalence of cataract BL was 0.61% (95% CI 0.42 to 0.87). With best corrected VA, the estimated prevalence of SVI from cataract was 0.86% (95% CI 0.63 to 1.17); MVI was 2.39% (95% CI 2.00 to 2.87) and EVI was 5.21% (95% CI 4.61 to 5.87). Women in TAPK had a significantly higher prevalence of cataract BL (0.82%, 95% CI 0.54 to 2.15) than men (0.34%, 95% CI 0.16 to 0.70). Women had lower cataract surgical coverage (CSC) by eyes (60.8%, 95% CI 55.5 to 65.8) compared with men (70.1%; 95% CI 63.7 to 75.7). The prevalence of cataract BL was higher among Tibetan (2.28%; 95% CI 1.98 to 2.62) than Han Chinese (1.01%%; 95% CI 0.54% to 1.87%). Overall CSC by person with BL (by better eye) was 82.0% (95% CI 75.2 to 87.6). Among cataract-operated participants, 71.2% had VA equal to or better than 6/18.

Conclusions

The study detected a low prevalence of VI and BL due to cataract with high CSC in the study area compared with many other places in China. Further actions should be taken to improve cataract surgical outcome.

Effects of Probiotics, Prebiotics, and Synbiotics on Calcium Homeostasis and Bone Health With Aging: A Systematic Review

Abstract

Background

Calcium homeostasis and bone health are an increasing concern for middle‐aged and older adults. Many studies have explored the positive effects of probiotics, prebiotics, or synbiotics on serum calcium and bone mineral density (BMD) or other parameters related to bone health. However, the participants, the species, doses and duration of interventions, outcomes, and measurements varied among these studies.

Aims

To systematically evaluate the effect of probiotics, prebiotics, or synbiotics on maintaining calcium homeostasis and improving bone health in middle‐aged and older adults.

Methods

We identified studies in Cochrane Library, Embase, PubMed, Web of Science, CINAHL, China National Knowledge Infrastructure, and Wanfang and articles in English and Chinese published from inception up to January 10, 2019. Randomized controlled trials (RCTs) involving probiotics, prebiotics, or synbiotics for middle‐aged or older adults were employed for meta‐analysis by using RevMan 5.3, and heterogeneity and risk of bias assessment were performed.

Results

A total of eight studies, involving 564 participants, were included. Probiotics, prebiotics, or synbiotics supplementation was able to significantly elevate serum calcium levels (0.52 mg/dl, 95% CI [0.38, 0.66]), heterogeneity: p = .13, I 2 = 44%), while the results of meta‐analysis failed to support the effects of this supplementation on the parameters related to bone health in middle‐aged and older adults, including BMD, parathyroid hormone, osteocalcin, and alkaline phosphatase.

Linking Evidence to Action

Probiotics, prebiotics, or synbiotics supplementation exerts a facilitating influence on the level of serum calcium, while the present study has not yet supported the beneficial effects of such interventions on bone health. Therefore, further studies with high‐quality RCTs are required to determine the effects of probiotics, prebiotics, or synbiotics supplementation on middle‐aged and older adults.

Association of high-sensitivity C-reactive protein in middle-aged and elderly Chinese people with hyperuricaemia and risk of coronary heart disease: a cross-sectional study

Por: Xie · M. · Xie · D. · Yang · Y. · Zhang · Y. · Li · K. · Zhou · B. · Yang · Z. · Ding · X. · Li · H.
Objectives

Patients with hyperuricaemia are at relatively high risk of developing coronary heart disease (CHD). The purpose of this study was to examine the relationship between high-sensitivity C-reactive protein (hs-CRP) and CHD risk in a middle-aged and elderly population with hyperuricaemia.

Design

A cross-sectional study.

Setting and participants

This study was conducted in a health examination centre of China. Participants were diagnosed with hyperuricaemia based on uric acid concentrations. Specifically, males with a uric acid concentration ≥416 μmol/L were included, as well as females with a concentration ≥360 μmol/L.

Main outcome measures

10-year CHD risk for each individual was evaluated using Framingham risk score based on the Adult Treatment Panel III charts.

Results

A total of 517 patients with hyperuricaemia (438 males and 79 females) aged from 40 to 85 years old were included in the present study. 193 (37.3%) patients were defined with relatively high 10-year CHD risk. Compared with the lowest quintile, the crude ORs of relatively high 10-year CHD risks were 1.43 (95% CI 0.78 to 2.63, p=0.245), 2.05 (95% CI 1.14 to 3.67, p=0.016), 2.77 (95% CI 1.54 to 4.98, p=0.001), 2.12 (95% CI 1.18 to 3.80, p=0.012) in the second, third, fourth and fifth quintiles of serum hs-CRP level, respectively (p for trend=0.057). The multivariable-adjusted ORs of relatively high 10-year CHD risk were 1.40 (95% CI 0.75 to 2.61, p=0.291) in the second, 2.05 (95% CI 1.13 to 3.72, p=0.019) in the third, 2.69 (95% CI 1.47 to 4.89, p=0.001) in the fourth and 2.10 (95% CI 1.15 to 3.84, p=0.016) in the fifth quintile of serum hs-CRP level when compared with the lowest quintile (p for trend=0.068).

Conclusion

This study showed that ORs of relatively high 10-year CHD risk were raised in patients with hyperuricaemia with higher serum hs-CRP level; however, there was a not significant but borderline trend association and that more research is needed.

Preventive strategies and factors associated with surgically treated necrotising enterocolitis in extremely preterm infants: an international unit survey linked with retrospective cohort data analysis

Por: Adams · M. · Bassler · D. · Darlow · B. A. · Lui · K. · Reichman · B. · Hakansson · S. · Norman · M. · Lee · S. K. · Helenius · K. K. · Lehtonen · L. · San Feliciano · L. · Vento · M. · Moroni · M. · Beltempo · M. · Yang · J. · Shah · P. S. · on behalf of the International Network for
Objectives

To compare necrotising enterocolitis (NEC) prevention practices and NEC associated factors between units from eight countries of the International Network for Evaluation of Outcomes of Neonates, and to assess their association with surgical NEC rates.

Design

Prospective unit-level survey combined with retrospective cohort study.

Setting

Neonatal intensive care units in Australia/New Zealand, Canada, Finland, Israel, Spain, Sweden, Switzerland and Tuscany (Italy).

Patients

Extremely preterm infants born between 240 to 286 weeks’ gestation, with birth weights

Exposures

NEC prevention practices (probiotics, feeding, donor milk) using responses of an on-line pre-piloted questionnaire containing 10 questions and factors associated with NEC in literature (antenatal steroids, c-section, indomethacin treated patent ductus arteriosus and sepsis) using cohort data.

Outcome measures

Surgical NEC rates and death following NEC using cohort data.

Results

The survey response rate was 91% (153 units). Both probiotic provision and donor milk availability varied between 0%–100% among networks whereas feeding initiation and advancement rates were similar in most networks. The 9792 infants included in the cohort study to link survey results and cohort outcomes, revealed similar baseline characteristics but considerable differences in factors associated with NEC between networks. 397 (4.1%) neonates underwent NEC surgery, ranging from 2.4%–8.4% between networks. Standardised ratios for surgical NEC were lower for Australia/New Zealand, higher for Spain, and comparable for the remaining six networks.

Conclusions

The variation in implementation of NEC prevention practices and in factors associated with NEC in literature could not be associated with the variation in surgical NEC incidence. This corroborates the current lack of consensus surrounding the use of preventive strategies for NEC and emphasises the need for research.

Acupuncture methods for acute migraine attack: a Bayesian network meta-analysis protocol

Por: Zhou · J. · Li · J. · Yang · J. · Li · J. · Wang · C.
Introduction

Migraine is a primary cause of disability worldwide, particularly affecting young adults and middle-aged women. Although multiple clinical trials and systematic reviews have suggested that acupuncture could be effective in treating acute migraine attacks, the methodologies in academic studies and commonly applied practices vary greatly. This study protocol outlines a plan to assess and rank the effectiveness of the different acupuncture methods in order to develop a prioritised acupuncture-based treatment regimen for acute migraine attacks.

Objective

To compare the efficacy of different acupuncture methods and conventional medicinal methods in the treatment of acute migraine attacks.

Methods and analysis

Six databases will be searched, including MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database and Wanfang Database from inception to 31 August 2019. The primary outcomes will be assessed using metrics for intensity and duration (in hours) of pain post-treatment. Bayesian network meta-analysis will be conducted using WinBUGS V.1.4.3. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation System to assess the quality of evidence.

Ethics and dissemination

The results will be disseminated through peer-reviewed publication. Since no private and confidential patient data will be contained in the reporting, there are no ethical considerations associated with this protocol.

PROSPERO registration number

CRD42019126472.

Serum soluble urokinase type plasminogen activated receptor and focal segmental glomerulosclerosis: a systematic review and meta-analysis

Por: Shuai · T. · Pei Jing · Y. · Huang · Q. · Xiong · H. · Liu · J. · Zhu · L. · Yang · K. · Jian · L.
Objectives

Soluble urokinase plasminogen activated receptor (suPAR) is a biomarker that may predict the occurrence of focal segmental glomerulosclerosis (FSGS); however, there is still controversy about whether suPAR can predict FSGS. In this study, we performed a systematic evaluation and meta-analysis to prove whether suPAR can predict FSGS, and to detect a threshold concentration of suPAR that can be used to diagnose FSGS. In addition, a threshold concentration of suPAR for the diagnosis of FSGS was proposed.

Design

Systematic review and meta-analysis.

Data sources

We systematically searched PubMed, Embase, Cochrane Library, Web of Science and China Biology Medicine databases for studies published from the inception dates to 1 December 2018.

Eligibility criteria

(1) Data involving the suPAR level were from blood samples; (2) FSGS was diagnosed by biopsy; and (3) randomised controlled trials, cohort studies, case–control studies and cross-sectional studies.

Data extraction and synthesis

Initially, a total of 364 studies were searched, among which 29 studies were finally included. In addition, seven studies described the cut-off value of suPAR, which ranged from 2992.6 to 5500 pg/mL.

Results

The results showed that the suPAR levels in the primary FSGS group were significantly higher when compared with that in the normal control group (p0.001; standard mean difference (SMD): 2.56; 95% CI 1.85 to 3.28), and significant differences were observed in the secondary FSGS and in the normal control group (p0.001; SMD: 1.68; 95% CI 1.37 to 1.98). A suPAR concentration of 3000 pg/mL may be the best threshold for the diagnosis of primary FSGS (sensitivity=0.72; specificity=0.88; area under the curve=0.85).

Conclusion

Our results suggested that suPAR might be a potential biomarker for predicting primary and secondary FSGS. In addition, our data showed that a suPAR concentration of 3000 pg/mL might be used as a threshold for the diagnosis of FSGS.

Trial registration number

CRD42019120948.

Multicentre, randomised controlled trial of adjuvant chemotherapy in cervical cancer with residual human papilloma virus DNA following primary radiotherapy or chemoradiotherapy: a study protocol

Por: Wang · Y. · Ouyang · Y. · Su · J. · Liu · J. · Cai · Q. · Xu · Q. · Bai · Z. · Cao · X.
Introduction

The role of adjuvant chemotherapy after radical radiotherapy (RT) or chemoradiotherapy (CRT) in cervical cancer awaits further confirmation. Evidences have shown that persistent human papilloma virus (HPV) DNA in exfoliated cell post-RT is a potential biomarker of subclinical residual disease and thus increases the risk of recurrence. In this prospective, multicentre, randomised controlled trial, we will use HPV DNA in exfoliated cell to identify patients with cervical cancer who received definitive RT or CRT with higher risk of relapse for adjuvant chemotherapy.

Methods and analysis

Eligible patients with histologically confirmed cervical cancer stage IIA2 to IVA of the International Federation of Gynaecology and Obstetrics, adequate organ function and no locoregional disease or distant metastasis after completion of primary treatment will be screened for HPV DNA in exfoliated cell at 1 month post-RT. Patients with undetectable HPV DNA will undergo standard surveillance. Patients with detectable HPV DNA will be randomly assigned to either adjuvant chemotherapy with docetaxel and nedaplatin for four cycles (arm 1) or observation (arm 2). Patients will be stratified for primary treatment (RT vs CRT). The primary endpoint is relapse-free survival.

Ethics and dissemination

This protocol received a favourable ethical opinion from the Ethics Committee of the Second Affiliated Hospital of Fujian Medical University on 6 February, 2018, (No. 28). The trial results will be published in peer-reviewed journals and presented in conferences. A summary of the findings will be made available to participants.

Trial registration number

ChiCTR-IIR-17012655; Pre-results.

Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF) in couples with non-severe male infertility (NSMI-ICSI): protocol for a multicentre randomised controlled trial

Por: Zheng · D. · Zeng · L. · Yang · R. · Lian · Y. · Zhu · Y.-M. · Liang · X. · Tang · L. · Wang · H. · Cao · Y. · Hao · G. · Liu · J. · Zhao · J. · Wang · R. · Mol · B. W. · Li · R. · Huang · H.-F. · Qiao · J.
Introduction

Intracytoplasmic sperm injection (ICSI), originally introduced as add-on to in vitro fertilisation (IVF) for couples with severe male infertility, is in current clinical practice also used in couples with mild male or even unexplained infertility. However, ICSI has involved unresolved concerns regarding the selection and damage to gametes and the health conditions of the offspring, and it is also labour intensive and therefore more expensive than conventional IVF. High-quality well-powered randomised clinical trials (RCTs) comparing ICSI and IVF are lacking.

Methods and analysis

We propose a multicentre, open-label RCT in 10 reproductive medical centres across China. We will study couples with non-severe male infertility (defined as a semen concentrate 5–15x106/mL or sperm with a progressive motility 10%–32%) scheduled for their first or second ICSI or IVF cycle, as low fertility rate after fertilisation are more frequent in this population, which could lead to controversy about ICSI or conventional IVF for fertilisation. On the day of oocyte retrieval, eligible participants are after informed consent be randomised to undergo either ICSI or conventional IVF in a 1:1 treatment ratio. Other standard assisted reproductive treatments are similar and parallel between two groups. Our primary outcome is ongoing pregnancy leading to live birth after the first cycle with embryo transfer. To demonstrate or refute a difference of 7% between ICSI and conventional IVF, we need to include 2346 women (1173 in each intervention arm). In addition, we will follow-up neonatal outcomes after delivery to identify the influence of ICSI on offspring.

Ethics and dissemination

Ethical approval was obtained from Peking University Third Hospital medical science research ethics committee. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.

Trial registration number

ClinicalTrials.gov registry (NCT03298633).

From strategy to action: a qualitative study on salient factors influencing knowledge transfer in project-based experiential learning in healthcare organisations in Kenya

Por: Chelagat · T. · Onyango · J. · Kokwaro · G. · Rice · J.
Objectives

Knowledge transfer is recognised as a key determinant of organisational competitiveness. Existing literature on the transfer of knowledge and skills imply diminutive return on investment in training and development due to the low application of learnt knowledge. Following devolution of health services provision to new counties in Kenya in 2013, Strathmore Business School designed an experiential facility improvement project-based leadership training programme for healthcare managers in the new counties. Selected healthcare management teams participated in the leadership training to improve health systems performance in the devolved counties in Kenya. Despite similar training, the projects implementation contexts were different, leading to different implementation completion rates. The aim of this study was to investigate the reasons for this disparity and then recommend solutions.

Design

A qualitative study using semi-structured interviews. A thematic framework approach was used in data analysis.

Setting and participants

Thirty-nine projects teams constituting; 33 successful and 6 unsuccessful project teams, were purposively selected based on their project implementation success rates at the end of the leadership training. The managers had undertaken a team-based institutional improvement project. The prioritised projects were housed within; 23 public, 10 faith-based and 6 private health facilities in 19 counties in Kenya.

Results

Our findings indicate projects completion rates were influenced by (training design, work environment climate, trainee characteristics, team-based coaching and leveraging on occurring opportunities). Transfer barriers were (inadequate management support, inadequate team and staff support, high staff turnover, misalignment of board’s verses manager’s priorities, missing technical expertise, endemic strikes, negative politics and poor communication). Recommendations were (need-driven curriculum, effective allocation and efficient utilisation of resources, proper prioritisation, effective communication, longitudinal coaching and work-teams recruitment).

Conclusion

The findings reveal that unless training interventions are informed by a need-driven curriculum customised to real-world work teams, the potential knowledge and skill transfer can be thwarted.

Prevalence of overweight and obesity and associated risk factors among adult residents of northwest China: a cross-sectional study

Por: Song · N. · Liu · F. · Han · M. · Zhao · Q. · Zhao · Q. · Zhai · H. · Li · X.-M. · Du · G.-L. · Li · X.-M. · Yang · Y.-N.
Objective

Overweight and obesity have been shown to be related to multiple chronic conditions, leading to a heavy economic burden on society throughout the world. This study aims to estimate the prevalence of overweight and obesity and determine potential influencing factors among adults in Xinjiang, northwest China.

Design

A community-based observational study.

Setting

The First Affiliated Hospital of Xinjiang Medical University.

Methods

In total, 14 618 adult participants (7799 males; 6819 females) aged over 35 years were recruited from the Cardiovascular Risk Survey conducted in 2010. Data were obtained from face-to-face interviews and physical examinations. The sample was used to estimate the prevalence of overweight (body mass index (BMI) 24–28 kg/m2) and obesity (BMI ≥28 kg/m2) in Xinjiang Province. Influencing factors were analysed based on statistical methods.

Results

In Xinjiang Province, the overall prevalence of overweight was 36.5% (male 40.1%; female 33.4%), and the prevalence of obesity was 26.5% (male 27.2%; female 25.8%). The prevalence of both overweight and obesity were higher in women than in men (p

Conclusions

This study estimated that the prevalence of overweight and obesity among adult residents of Xinjiang Province, northwest China, was high. These data suggest that efforts related to the prevention and control of overweight and obesity should be a public health priority in northwest China.

Critical appraisal of clinical practice guidelines for the diagnosis and treatment of stress urinary incontinence using AGREE II instrument: a systematic review protocol

Por: Yang · X. · Zhang · A. · Tan · Y. · Zhang · Z. · Zhang · J.
Introduction

Stress urinary incontinence is a major health problem, and several clinical guidelines have been formulated and released regarding this in different countries. However, the recommendations in these guidelines formulated by different organisations and countries are inconsistent. This review aims to conduct a critical appraisal of clinical practice guidelines for the diagnosis and treatment of stress urinary incontinence.

Methods and analysis

We will conduct a comprehensive search in the following databases: PubMed, Embase, Medline, Cochrane Library, three Chinese databases and six guideline databases. The databases will be searched from January 2003, and the comprehensive search will be done again to include all the qualified guidelines before making conclusions. The quality of clinical practice guidelines will be assessed by three appraisers using the Appraisal of Guidelines Research and Evaluation II instrument, and this will be scored. The recommendation available in the guidance will also be summarised in different domains including the diagnosis standard, recommended examination and questionnaire for assessment, conservative treatment and surgical treatment.

Ethics and dissemination

This review will be disseminated through peer-reviewed publications. The results will help inform the health practitioners about the recommendations in clinical practice guidelines.

PROSPERO registration number

CRD42018115743.

Workplace violence and its aftermath in Chinas health sector: implications from a cross-sectional survey across three tiers of the health system

Por: Yang · S. Z. · Wu · D. · Wang · N. · Hesketh · T. · Sun · K. S. · Li · L. · Zhou · X.
Objectives

To determine the prevalence of physical violence and threats against health workers and the aftermath in tertiary, secondary and primary care facilities in China.

Design

A cross-sectional questionnaire study.

Setting

5 tertiary hospitals, 8 secondary hospitals and 32 primary care facilities located in both urban and rural areas of Zhejiang Province, China, were chosen as the study sites.

Participants

A total of 4862 health workers who have contact with patients completed a survey from July 2016 to July 2017.

Outcome measures

The prevalence of physical violence, threats and Yi Nao, specific forms of physical violence and their aftermath were measured by a self-designed and verified questionnaire. Multivariable logistic regression models were used to examine the association between perceived organisational encouragement of reporting workplace violence (WPV) and physical violence, threats and Yi Nao after controlling for age, sex, level of facility, professional ranking and type of health worker.

Results

Among all respondents, 224 (4.6%) were physically attacked and 848 (17.4%) experienced threats in the past year. Respondents in secondary hospitals were more likely to experience physical violence (AOR=3.29, 95% CI 2.21 to 4.89), threats (AOR=1.61, 95% CI 1.32 to 1.98) and Yi Nao (AOR=2.47, 95% CI 2.10 to 2.91), compared with primary care providers. Lack of organisational policies to report WPV was associated with higher likelihood of physical violence (AOR=3.64, 95% CI 2.57 to 5.18) and threats (AOR=2.21, 95% CI 1.76 to 2.78). Among physical violence cases, only 29.1% reported the attack to police mainly because most felt it useless to do so (58.8%). Only 25.7% were investigated and 72.4% of attackers received no punishment. Of all those attacked or threatened, 59.4% wanted to quit current post and 76.0% were fearful of dealing with urgent or severe cases.

Conclusions

Proper management of the aftermath of violence against health workers is inadequate. Formal guidelines for reporting and managing WPV are urgently needed.

Effectiveness and safety of oral Chinese patent medicines as adjuvant treatment for unstable angina pectoris on the national essential drugs list of China: a protocol for a systematic review and network meta-analysis

Por: Hua · Z. · Zhai · F.-T. · Tian · J. · Gao · C.-F. · Xu · P. · Zhang · F. · Liu · S.-j. · Dong · K. · Du · X.-F. · Zhang · Z. · Yang · G.
Introduction

Achieving efficacious and safe treatments for unstable angina pectoris (UAP) is still a challenging clinical problem. The availability of different oral Chinese patent medicines frequently poses a practical challenge to clinicians, namely, which one to choose as first-line regimen for treatment. This study aims to examine the comparative effectiveness and safety of oral Chinese patent medicines for UAP on the national essential drugs list of China.

Methods and analysis

We will conduct a network meta-analysis (NMA) of all randomised controlled trials to evaluate the use of oral Chinese patent medicines as adjuvant for the treatment of UAP. We will explore eight electronic databases from their inception to June 2018 and search for grey literature. Primary outcomes include mortality and the cardiovascular events. Secondary outcomes include: (1) symptom improvement; (2) ECG improvement; (3) frequency of acute angina attack; (4) duration of angina; (5) adverse effects. Two independent authors will screen titles and abstracts, review full texts, extract data, assess the risk of bias using the Cochrane risk of bias tool and assess the quality of evidence and strength of the recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). If adequate data are available, NMA will be performed with Bayesian analysis methods.

Ethics and dissemination

The NMA will help us to reduce the uncertainty of interventions and help clinicians to make optimal and more accurate therapeutic decisions for adults with UAP. Therefore, we will publish the findings of this study in a peer-reviewed journal. No ethics approval is necessary for this study based on the nature of its design.

Trial registration number

CRD42018092822.

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