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Long-term total hip arthroplasty rates in patients with acetabular and pelvic fractures after surgery: A population-based cohort study

by Tzu-Chun Chung, Tzu-Shan Chen, Yao-Chun Hsu, Feng-Chen Kao, Yuan-Kun Tu, Pao-Hsin Liu

Background/objective

Osteoarthritis typically develops after surgery for traumatic fractures of the acetabulum and may result in total hip arthroplasty (THA). We conducted a population-based retrospective study to investigate the incidence of THA after treatment of acetabular, pelvic, and combined acetabular and pelvic fractures with open reduction-internal fixation surgery compared with that in the control group.

Design

A retrospective population-based cohort study.

Setting

Data were gathered from the Taiwan National Health Insurance Research Database.

Participants

We enrolled 3041 patients with acetabular fractures, 5618 with pelvic fractures, and 733 with combined pelvic and acetabular fractures between January 1, 1997, and December 31, 2013, totaling 9392 individuals. The control group comprised 664,349 individuals. Study participants were followed up for the occurrence of THA until death or the end of the study period.

Results

The THA rates after surgical intervention were 17.82%, 7.28%, and 18.01% in patients with acetabular, pelvic, and combined acetabular and pelvic fractures, respectively. Moreover, they were significantly higher for the acetabular fracture, pelvic fracture, and combined-fracture groups (adjusted hazard ratios [aHRs] = 58.42, 21.68, and 62.04, respectively) than for the control group (p p Conclusion

The incidence rates of THA after surgical intervention in the pelvic fracture, acetabular fracture, and combined-fracture groups were significantly higher than that of the control group.

You can’t flight, you need to fight – a qualitative study of mothers’ experiences of feeding extremely preterm infants

Abstract

Aim

To describe mother’s experiences of feeding their extremely preterm infant.

Background

When an infant is born extremely preterm, there is a long rocky road for the mother if she wants to breastfeed. Some manage to reach their goals, others do not. Studies of feeding extremely preterm infants in the neonatal intensive care unit (NICU) are scarce.

Design

A qualitative method with an inductive approach.

Methods

Nine mothers giving birth to extremely preterm infants were interviewed by telephone after discharge from the NICU. The interviews were transcribed verbatim and analysed with qualitative content analysis. The COREQ checklist was followed.

Findings

The overall theme was “you can’t flight, you need to fight”. The theme reflects the mothers will to do the best for their infants even if the struggle with milk expression and breastfeeding practice evoked feelings of helplessness, exposure, worry, and disappointment. The categories forming the theme were: The wish to provide own breastmilk; For the infant’s best; Loss of control; Help to reach the goals.

Conclusion

The mothers had a strong will to provide breastmilk to their infants but requested more support in order to be successful.

Relevance to clinical practice

There is a need for evidence based support programs for mothers of extremely preterm infants to encourage them to persevere with milk expression and breastfeeding over time.

The efficacy and safety of cold atmospheric plasma as a novel therapy for diabetic wound in vitro and in vivo

Abstract

Cold atmospheric plasma (CAP) is a group of various chemical active species, such as ozone and nitric oxide, generated by working gas. CAP was demonstrated to have an effect on tissue regeneration and wound healing. We conducted this study to evaluate the efficacy and safety of CAP as a novel therapy for diabetic wounds in vitro and in vivo. The plasma consists of ionised helium gas that is produced by a high‐voltage and high‐frequency power supply. Eight‐week‐old male db/db mice and C57BL mice were treated with helium gas (control group), 90s' CAP (low‐dose group), and 180s' CAP (high‐dose group). Mice were treated and observed for 2 weeks. Skin samples from around the wound and blood samples were collected. Our in vitro analysis included scratch wound‐healing assays by using human HaCaT immortalised human epidermal cells. After 14 days of treatment, CAP could obviously promote diabetic wound healing. Wound closure rates were significantly higher in the low‐dose group and high‐dose groups compared with the control group. Meanwhile, compared with the control group, the protein expression of IL‐6, tumour necrosis factor‐α, inducible nitric oxide synthase, and superoxide dismutase in two CAP groups significantly decreased, while the protein expression of vascular endothelial growth factor and transforming growth factor‐β in two CAP groups significantly increased (all P < .05); these data show good agreement with the change in mRNA level (all P < .05). In vitro, scratch wound‐healing assays showed that plasma treatment could effectively ensure healing within 3 minutes of exposure (all P < .05). In addition, no difference was found in histological observations of normal skin and the level of serum alanine transaminase, aspartate aminotransferase, blood urea nitrogen, creatinine, and white blood cells among the CAP groups and control group. CAP treatment for 3 minutes every day improves wound healing in diabetic mice by suppressing inflammation, reducing oxidative stress, and enhancing angiogenesis, involving several proteins signalling, and it is safe for the liver and kidney.

Benefits of a transtheoretical model‐based program on exercise adherence in older adults with knee osteoarthritis: a cluster randomized controlled trial

Abstract

Aims

Benefits of a transtheoretical model‐based exercise program on exercise adherence (primary outcome) and secondary outcomes (self‐efficacy, decisional balance, knee osteoarthritis symptoms and physical function) were assessed among older adults with knee osteoarthritis.

Design

A two‐arm, superiority, assessor‐blinded, cluster randomized trial with randomization at the community level.

Methods

Participants were recruited from 14 communities in Beijing between April and October 2018 (N = 189). The intervention was a 24‐week transtheoretical model‐based exercise program and the control group underwent a non‐theory‐based exercise program. Exercise adherence was collected every four weeks and secondary outcomes were measured at baseline, 12 and 24 weeks. An independent t‐test and repeated measures ANOVA were the main statistical tests.

Results

Most participants were women (92.5%), married (81.4%), with high‐school education (36.0%), with both knees affected (50.3%) and did not make use of a walker (93.8%). There were no significant differences between groups in any of the outcome measures at baseline. Repeated measures ANOVA indicated that there was a significant difference in the trend of adherence scores between the two groups from 0 to 24 weeks. The independent t‐test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks. Improvements in the intervention group were also significantly greater in all secondary outcomes than in the control group.

Conclusion

A theory‐based exercise program could improve exercise adherence, self‐efficacy, decisional balance, knee osteoarthritis symptoms and physical functioning in older adults with knee osteoarthritis.

Impact

The 24‐week theory‐based exercise program could improve exercise adherence, self‐efficacy, decisional balance, symptoms of knee osteoarthritis and physical functioning in older adults with knee osteoarthritis. The theory‐based exercise program could help older adults with knee osteoarthritis to improve their symptoms and knee function.

Examining and adapting the information-motivation-behavioural skills model of medication adherence among community-dwelling older patients with multimorbidity: protocol for a cross-sectional study

Por: Yang · C. · Hui · Z. · Zeng · D. · Liu · L. · Lee · D. T. F.
Introduction

Multimorbidity is highly prevalent among older patients and has been shown to be associated with poor health outcomes and lower quality of life. Adherence to medication treatments is essential in order to maximise the efficacy of treatments and improve health outcomes. However, nearly half of the older patients with multimorbidity fail to adhere to their medications, which can result in an increased risk of adverse health events, lower quality of life and higher healthcare cost. Only a few studies have explored the underlying mechanism and influencing factors of medication adherence among older patients with multimorbidity, which are inadequate to provide robust evidence for the development and evaluation of the medication adherence interventions. This study aims to examine and adapt the information–motivation–behavioural skills (IMB) model, a widely used social behaviour theory, to explain the medication adherence behaviour among community-dwelling older patients with multimorbidity.

Methods and analysis

A cross-sectional study will be conducted in community settings in China. Around 309 older patients with multimorbidity will be recruited to complete questionnaires on adherence knowledge, adherence motivation, adherence self-efficacy, medication adherence, medication treatment satisfaction, depressive symptoms, treatment burden, disease burden and basic demographic information. Structural equation modelling will be used to analyse and validate the relationships among variables in the IMB model.

Ethics and dissemination

This study has been approved by the Survey and Behavioral Research Ethics Committee of the Chinese University of Hong Kong (reference number SBRE-18-675). The study results will be published in peer-reviewed journals and presented in academic conferences and workshops.

Trial registration number

ChiCTR1900024804.

Short-term associations between ambient air pollution and stroke hospitalisations: time-series study in Shenzhen, China

Por: Guo · Y. · Xie · X. · Lei · L. · Zhou · H. · Deng · S. · Xu · Y. · Liu · Z. · Bao · J. · Peng · J. · Huang · C.
Objective

To investigate the association between ambient air pollution and stroke morbidity in different subgroups and seasons.

Methods

We performed a time-series analysis based on generalised linear models to study the short-term exposure–response relationships between air pollution and stroke hospitalisations, and conducted subgroup analyses to identify possible sensitive populations.

Results

For every 10 µg/m3 increase in the concentration of air pollutants, across lag 0–3 days, the relative risk of stroke hospitalisation was 1.029 (95% CI 1.013 to 1.045) for PM2.5, 1.054 (95% CI 1.031 to 1.077) for NO2 and 1.012 (95% CI 1.002 to 1.022) for O3. Subgroup analyses showed that statistically significant associations were found in both men and women, middle-aged and older populations, and both cerebral infarction and intracerebral haemorrhage. The seasonal analyses showed that statistically significant associations were found only in the winter.

Conclusions

Our study indicates that short-term exposure to PM2.5, NO2 and O3 may induce stroke morbidity, and the government should take actions to mitigate air pollution and protect sensitive populations.

Changes to cardiovascular risk factors over 7 years: a prospective cohort study of in situ urbanised residents in the Chaoyang District of Beijing

Por: Li · Z. · Yu · S. · Han · X. · Liu · J. · Yao · H.
Objectives

To examine changes in cardiovascular risk factors of in situ urbanised residents between 2010 and 2017.

Design

Population-based cohort study.

Setting

The Chaoyang District of Beijing, China.

Participants

A total of 942 in situ urbanised rural residents aged 35–64 who participated in the cardiovascular disease (CVD) risk factors study in China between 2010 and 2017.

Main outcome measures

Lifestyles (smoking, drinking and effective exercise) and medical history (diabetes, hypertension, dyslipidaemia, overweight and obesity) were self-reported. New cases of diabetes, hypertension, dyslipidaemia, overweight and obesity were confirmed by physical examination or blood biochemical tests. Multiple linear regression and log-binomial models analyses adjusted for sociodemographic confounders were conducted to evaluate any changes of clinical indexes and to estimate prevalence rate ratios (PRRs), respectively.

Results

During the study period of 2010–2017, diastolic blood pressure elevated by 3.55 mm Hg, central blood pressure increased by 4.39 mm Hg, total cholesterol decreased by 0.29 mmol/L and hypertension increased significantly (PRR=1.25, p>0.05). Prevalence of smoking, drinking, hypertension, overweight and obesity was significantly higher in males than females in both 2010 and 2017. In 2017, the 10-year risk of atherosclerotic CVD increased in 29.8% of participants and decreased in 6.1% of individuals.

Conclusions

CVD risk factors augmented remarkably for in situ urbanised rural residents aged 35–64 in the Chaoyang District of Beijing, especially those indicators related to blood pressure. Awareness of the direction and magnitude of these risk factor changes may be beneficial in informing targeted strategies for preventing CVDs of in situ urbanised populations.

Effect of resting heart rate on the risk of all-cause death in Chinese patients with hypertension: analysis of the Kailuan follow-up study

Por: Zhao · M. X. · Zhao · Q. · Zheng · M. · Liu · T. · Li · Y. · Wang · M. · Yao · S. · Wang · C. · Chen · Y.-M. · Xue · H. · Wu · S.
Objective

Previous studies have shown that an elevated heart rate is associated with a higher risk of cardiovascular events. This study aimed to prospectively examine the relationship between resting heart rate (RHR) and all-cause mortality in Chinese patients with hypertension.

Design

An observational, prospective and population-based cohort study.

Setting

The Kailuan cohort study was conducted in Tangshan City in northern China.

Participants

We enrolled 46 561 patients who did not receive beta-blocker treatment and were diagnosed with hypertension for the first time during an employee health examination in Kailuan Group in 2006 and 2008.

Outcome

The primary outcome of this study was all-cause mortality.

Methods

The patients in this study were followed for 9.25±1.63 years. All patients were followed up face to face every 2 years. According to the distribution of RHR in the study population, RHR was categorised into five groups on the basis of quintiles: Q1: RHR ≤68 beats per minute (bpm); Q2: RHR >68 and ≤72 bpm; Q3: RHR >72 and ≤76 bpm; Q4: RHR >76 and ≤82 bpm; Q5: RHR >82 bpm. Cox proportional hazards model, which was adjusted for traditional risk factors, was used.

Results

During follow-up, 4751 deaths occurred. After adjustment for potential confounders, restricted cubic spline regression showed that the risk of all-cause mortality increased with heart rate. In multivariate Cox regression analyses adjusted for age, sex and major covariates, the HR for all-cause mortality was 1.31 (95% CI 1.27 to 1.33) in the highest quintile group (Q5) compared with the lowest quintile group (Q1).

Conclusion

An increase in RHR is a long-term risk factor of all-cause mortality in Chinese patients with hypertension.

Trial registration number

ChiCTR-TNC-11001489.

Psychometric properties of the Breast Cancer Awareness Measurement among Chinese women: a cross-sectional study

Por: Liu · N. · Li · P. · Wang · J. · Chen · D.-d. · Sun · W.-j. · Guo · P.-p. · Zhang · X.-h. · Zhang · W.
Objectives

To perform the cross-cultural adaption of the Breast Cancer Awareness Measurement (BCAM) and to test its psychometric properties among Chinese women.

Design

This is a cross-sectional study.

Settings

This study was conducted in communities, schools and institutions in Changchun, Jilin Province, China.

Participants

A total of 328 women voluntarily participated in and completed the Chinese version of the BCAM (C-BCAM), resulting in an effective response rate of 91.1%.

Primary and secondary outcome measures

Psychometric properties, including item analysis (the extreme group comparison and item-total correlations), content validity (item-level content validity index (I-CVI) and scale-level content validity index (S-CVI)), construct validity (exploratory factor analysis (EFA) and confirmatory factor analysis (CFA)) and internal consistency (Cronbach’s α and test–retest reliability), were measured.

Results

The C-BCAM has excellent internal consistency (Cronbach’s α=0.90), with alpha coefficients of 0.88, 0.84 and 0.94 for its three domains. The test–retest reliability coefficient was 0.72. The I-CVI ranged from 0.86 to 1.00, and the S-CVI was 0.92. CFA showed that the three-factor model explained 51.56% of the total variance, with a good model fit (likelihood ratio 2/df=1.86, incremental fit index=0.94, comparative fit index=0.94, goodness-of-fit index=0.84, adjusted goodness-of-fit index=0.80, standardised root mean square error of approximation=0.06 and root mean square residual=0.05).

Conclusions

The C-BCAM has satisfactory validity and reliability and is a culturally appropriate and reliable tool for evaluating breast cancer awareness among Chinese women. This reliable instrument can help researchers and health professionals evaluate women’s knowledge about the symptoms and risk factors of breast cancer and identify their barriers to seeking medical help. It also helps healthcare providers identify women with poor breast cancer awareness and encourage them to perform screening practice.

The intention to undertake physical activity in Pregnant Women using the Theory of Planned Behaviour

Abstract

Aim

To identify the intention of Chinese pregnant women to undertake physical activity (PA) using the theory of planned behavior.

Design

A cross‐sectional survey.

Methods

From April ‐ October in 2017, a cross‐sectional questionnaire was completed by 746 pregnant women from the Health Birth Cohort in Wuhan, China. The theory of planned behavior variables as well as sociodemographic characteristics was recorded, and the Pregnancy PA Questionnaire was together used to assess their PA during pregnancy.

Results

Only 11.3% of the women met the international guideline. The intention to undertake PA was found it to be positive in 63.9% of pregnant women. Structural equation modeling analysis revealed that behavioral attitudes, subjective norms and perceived behavioral control (PBC) influenced PA by directly influencing the behavior intention. Both behavioral attitude and subjective norms influenced PA by indirectly affecting the behavior. Overall, the model described 60% variance of the behavioral intention to undertake PA during pregnancy.

Conclusion

PBC was confirmed to be a prominent factor in determining behavioral intention to undertake PA during pregnancy. Pregnant women should be helped and appropriately guided by health providers to overcome barriers to PA.

Effect

This study investigates the effect of perceived behavioral control (PBC) on the intention to undertake physical activity (PA). The findings suggest that nurses’ and midwives’ attention should be focused on how to promote the improvement of perceived behavioral control ability of pregnant women to improve pregnant women’s PA intention. The attitude of pregnant women on taking up PA and their ability to control behaviors can be improved with support from family or healthcare providers.

Development of screening tools to predict the risk of recurrence and related complications following anal fistula surgery: protocol for a prospective cohort study

Por: Mei · Z. · Li · Y. · Zhang · Z. · Zhou · H. · Liu · S. · Han · Y. · Du · P. · Qin · X. · Shao · Z. · Ge · M. · Wang · Q. · Yang · W.
Introduction

Postoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.

Methods and analysis

This is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.

Ethics and dissemination

The study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.

Trial registration number

ChiCTR1900025069; Pre-results.

Factors influencing health behaviour, blood pressure control, and disability in hypertensive ischaemic stroke patients after a comprehensive reminder intervention

Abstract

Aims

To test prospective pathways of a Comprehensive Reminder System based on the Health Belief Model (CRS‐HBM), stroke knowledge, health belief in health behaviour, blood pressure (BP) control, and disability in hypertensive ischaemic stroke patients at 6‐month postdischarge.

Design

A nested cohort study design.

Methods

Data were derived from a randomized controlled trial evaluating the effects of the intervention (N = 174, performed during February 2015 ‐ March 2016). Data were collected by questionnaires and analysed in structural equation modelling in Mplus software.

Results

The proposed model provided a good fit to the data. This model accounted for 51.5% of the variance in health behaviour, 34.1% in BP control, and 5.7% in modified Rankin Scale score at 6‐month postdischarge. The CRS‐HBM had: (a) direct positive effect (β = .391, p < .001) and indirect positive effects (β = .186, p = .002) on health behaviour; (b) direct positive effect (β = .356, p < .001) and indirect positive effects (β = .183, p = .009) on BP control; and (c) indirect negative effect (β = −.146, p = .008) on disability. Being female was linked to better health behaviour. Higher education predicted higher level of stroke knowledge and health belief.

Conclusions

The CRS‐HBM can not only directly but also indirectly improve patients' health behaviours by improving their health knowledge or health belief. Better health behaviour can improve patients' BP control and reduce disability. Therefore, nurses need to pay more attention to not only patients' health knowledge but also their health belief when providing education.

Impact

The CRS‐HBM intervention accounted for 51.5% of variance in health behaviour, 34.1% in BP control, and 5.7% in modified Rankin Scale score at 6‐month postdischarge. This research can help nurses improve health education strategies in postdischarge and community contexts to achieve better health results.

Changes in pregnancy-related serum biomarkers early in gestation are associated with later development of preeclampsia

by Shiying Hao, Jin You, Lin Chen, Hui Zhao, Yujuan Huang, Le Zheng, Lu Tian, Ivana Maric, Xin Liu, Tian Li, Ylayaly K. Bianco, Virginia D. Winn, Nima Aghaeepour, Brice Gaudilliere, Martin S. Angst, Xin Zhou, Yu-Ming Li, Lihong Mo, Ronald J. Wong, Gary M. Shaw, David K. Stevenson, Harvey J. Cohen, Doff B. Mcelhinney, Karl G. Sylvester, Xuefeng B. Ling

Background

Placental protein expression plays a crucial role during pregnancy. We hypothesized that: (1) circulating levels of pregnancy-associated, placenta-related proteins throughout gestation reflect the temporal progression of the uncomplicated, full-term pregnancy, and can effectively estimate gestational ages (GAs); and (2) preeclampsia (PE) is associated with disruptions in these protein levels early in gestation; and can identify impending PE. We also compared gestational profiles of proteins in the human and mouse, using pregnant heme oxygenase-1 (HO-1) heterozygote (Het) mice, a mouse model reflecting PE-like symptoms.

Methods

Serum levels of placenta-related proteins–leptin (LEP), chorionic somatomammotropin hormone like 1 (CSHL1), elabela (ELA), activin A, soluble fms-like tyrosine kinase 1 (sFlt-1), and placental growth factor (PlGF)–were quantified by ELISA in blood serially collected throughout human pregnancies (20 normal subjects with 66 samples, and 20 subjects who developed PE with 61 samples). Multivariate analysis was performed to estimate the GA in normal pregnancy. Mean-squared errors of GA estimations were used to identify impending PE. The human protein profiles were then compared with those in the pregnant HO-1 Het mice.

Results

An elastic net-based gestational dating model was developed (R2 = 0.76) and validated (R2 = 0.61) using serum levels of the 6 proteins measured at various GAs from women with normal uncomplicated pregnancies. In women who developed PE, the model was not (R2 = -0.17) associated with GA. Deviations from the model estimations were observed in women who developed PE (P = 0.01). The model developed with 5 proteins (ELA excluded) performed similarly from sera from normal human (R2 = 0.68) and WT mouse (R2 = 0.85) pregnancies. Disruptions of this model were observed in both human PE-associated (R2 = 0.27) and mouse HO-1 Het (R2 = 0.30) pregnancies. LEP outperformed sFlt-1 and PlGF in differentiating impending PE at early human and late mouse GAs.

Conclusions

Serum placenta-related protein profiles are temporally regulated throughout normal pregnancies and significantly disrupted in women who develop PE. LEP changes earlier than the well-established biomarkers (sFlt-1 and PlGF). There may be evidence of a causative action of HO-1 deficiency in LEP upregulation in a PE-like murine model.

Performance evaluation of a laboratory developed PCR test for quantitation of HIV-2 viral RNA

by Linda L. Jagodzinski, Mark M. Manak, Holly R. Hack, Ying Liu, Sheila A. Peel

Management of Human Immunodeficiency Virus Type 2 (HIV-2) infections present unique challenges due to low viral titers, slow disease progression, and poor response to standard antiviral therapies. The need for a nucleic acid assay to detect and quantify HIV-2 virus has led to the development of a number of molecular-based assays for detection and/or quantification of HIV-2 viral RNA in plasma in order to provide laboratory evidence of HIV-2 infection and viral loads for use in treatment decisions. As HIV-2 is less pathogenic and transmissible than HIV-1 and has resistance to several of the antiretroviral drugs, delay of treatment is common. Cross sero-reactivity between HIV-1 and HIV-2 makes it difficult to distinguish between the two viruses based upon serological tests. As such we developed a quantitative reverse transcription PCR (qRT-PCR) assay targeting the 5’ long terminal repeat of HIV-2 for detection and quantification of HIV-2 viral RNA in plasma to identify HIV-2 infection and for use in viral load monitoring. Serial dilutions of cultured HIV-2 virus demonstrated a wide dynamic range (10 to 100,000 copies/ml) with excellent reproducibility (standard deviation from 0.12–0.19), linearity (R2 = 0.9994), and a lower limit of detection at 79 copies/ml (NIH-Z). The assay is highly specific for HIV-2 Groups A and B and exhibits no cross reactivity to HIV-1, HBV or HCV. Precision of the assay was demonstrated for the High (Mean = 6.41; SD = 0.12) and Medium (Mean = 4.46; SD = 0.13) HIV-2 positive controls. Replicate testing of clinical specimens showed good reproducibility above 1,000 copies/ml, with higher variability under 1,000 copies/ml. Analysis of 220 plasma samples from HIV-2 infected West African individuals demonstrated significantly lower viral loads than those observed in HIV-1 infections, consistent with results of previous studies. Slightly more than seven percent of clinical samples (7.3%) demonstrated viral loads above 100,000 copies/ml, while 37.3% of samples were undetectable. The high sensitivity, specificity, precision, and linearity of the WRAIR qRT-PCR assay makes it well suited for detection and monitoring of HIV-2 RNA levels in plasma of infected individuals.

Androgen deprivation therapy for prostate cancer and the risk of hematologic disorders

by Jui-Ming Liu, Yueh-Ping Liu, Heng-Chang Chuang, Chun-Te Wu, Yu-Li Su, Ren-Jun Hsu

Purpose

This study aimed to investigate the association between androgen deprivation therapy (ADT) and the risk of subsequently developing hematologic disorders in patients with prostate cancer.

Materials and methods

This population-based nationwide cohort study utilized data from the Taiwan National Health Insurance Research Database between 1997 and 2013. The patients were divided into three groups—those who received ADT only (ADT-only group), those who had radiotherapy (RT) only (RT-only group), and those treated with radical prostatectomy (RP) only (RP-only group). The study outcome was newly diagnosed hematologic disorder, including anemia and hematologic malignancy. Propensity score-matched, Cox regression, and Kaplan–Meier curve analyses were performed to investigate the risk of subsequently developing hematologic disorders after ADT.

Results

Of the 17,168 patients with prostate cancer who were included in the study, 13,318 met the inclusion and exclusion criteria. After propensity score matching, 1,797, 1,797, and 1,797 patients treated with ADT only, RT only, and RP only, respectively, who had a median follow-up period of 4.32 years were included in the study cohort. Compared with the patients treated with RP only, those who received ADT and RT were significantly at increased risk of subsequently developing hematologic disorders (ADT: adjusted hazard ratio [aHR]: 1.60, 95% confidence interval [CI]: 1.29–1.97; RT: aHR, 1.98, 95% CI: 1.62–2.42) according to the Cox regression analysis. Based on the Kaplan–Meier curve analysis, patients with bone metastasis who received ADT only had the lowest cumulative probabilities of not developing hematologic disorders. Moreover, a significantly increased risk of hematologic disorders was observed with the increasing duration of ADT (P for trend Conclusions

The use of ADT in patients with prostate cancer may increase the risk of subsequently developing hematologic disorders.

Predicting value of white cell count and total bilirubin on clinical outcomes in patients with ST-elevation myocardial infarction following percutaneous coronary intervention: a cohort study

Por: Tuxun · M. · Zhao · Q. · Xiang · Y. · Liu · F. · Shan · C.-F. · Zhou · X.-R. · Song · N. · Waisiding · A. · Zhang · X.-H. · Aihemaiti · G. · Yang · Y.-N. · Li · X.-M.
Objectives

A combined equation based on white cell count (WCC) and total bilirubin (TB) was assessed for its ability to predict adverse clinical outcomes in patients with acute ST-segment elevation myocardial infarction (STEMI) with primary percutaneous coronary intervention (PCI).

Design

A single-centre, prospective cohort study.

Setting

The First Affiliated Hospital of Xinjiang Medical University.

Method

A total of 615 patients with STEMI postprimary PCI were enrolled. WCC and TB were collected at admission. Logistic regression was used to determine the combined equation. The primary endpoints were in-hospital mortality and major adverse cardiovascular events (MACE), which composed of cardiac death, cardiac shock, malignant arrhythmia (ventricular tachycardia, ventricular fibrillation), severe cardiac insufficiency, non-fatal myocardial infarction, angina pectoris readmission, severe cardiac insufficiency (cardiac III–IV level), stent restenosis and target vessels revascularisation during the hospitalisation and 36 months follow-up period.

Result

77 patients occurred in MACE during the hospitalisation (17 in-hospital mortality). WCC and TB were taken as an independent variables to make a category of logistic regression analysis of in-hospital MACE, the logistic regression model was: logit (P)=–8.00+0.265 WCC+0.077 TB, the combination of WCC and TB was more valuable on evaluating the in-hospital mortality (area under the curve 0.804, 95% CI 0.678 to 0.929, p

Conclusion

The combination of WCC and TB is an independent predictor for in-hospital outcomes in patients with STEMI than single detection.

Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)

Por: Liu · X. · Robbins · S. · Eyles · J. · Fedorova · T. · Virk · S. · Deveza · L. A. · McLachlan · A. · Hunter · D.
Introduction

Hand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo.

Methods and analysis

The RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containing Boswellia serrata extract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study.

Ethics and dissemination

This protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results

Experiences of pregnant women with gestational diabetes mellitus: a systematic review of qualitative evidence protocol

Por: He · J. · Wang · Y. · Liu · Y. · Chen · X. · Bai · J.
Introduction

The incidence of gestational diabetes mellitus (GDM) is increasing and an issue of global concern. GDM can cause severe adverse effects for pregnant women and their fetuses. This systematic review is proposed to explore women’s experiences during the pregnancy with GDM. This review will provide insights into the physical, psychological and social adaptation experiences of women with GDM that can help to identify challenges of glycaemic control and provide targeted care and interventions to improve maternal and child health.

Methods and analysis

The databases we will search include English databases (ie, PubMed, CINAHL, Embase, the Cochrane Library, Web of Science, Joanna Briggs Institute (JBI) Database of Systematic Reviews, PsycINFO, OpenGrey and Deep Blue) and Chinese databases (ie, China Biology Medicine disc, China National Knowledge Infrastructure, and VIP Database for Chinese Technical Periodicals). Published qualitative evidence of life changes or experiences of the women with GDM will be searched. There will be no limits on publication year. Two reviewers will independently use the JBI Critical Appraisal Checklist for Qualitative Research for methodological validity prior to inclusion in this review. Any disagreements regarding article evaluation will be resolved through discussion or with a third reviewer. Data will be extracted using the standardised data extraction tool from JBI System for the Unified Management, Assessment and Review of Information. Synthesis will include in-depth reading of the original text and the discovery of the results, and then summarising similar categories for more advanced synthesised findings. The final synthesised findings will be graded according to the ConQual approach for establishing confidence.

Ethics and dissemination

This study does not require ethical approval as primary data will not be collected. Results of this systematic review will be submitted to peer-reviewed international journals for publication and be presented in relevant international conferences.

PROSPERO registration number

CRD42019132065.

Laparoendoscopic single-site surgery compared with conventional laparoscopic surgery for benign ovarian masses: a systematic review and meta-analysis

Por: Lin · Y. · Liu · M. · Ye · H. · He · J. · Chen · J.
Objective

We aimed to evaluate the safety, efficiency and preferred indication for laparoendoscopic single-site surgery (LESS) compared with conventional laparoscopic (CL) surgery for benign ovarian masses.

Design

A systemic review and cumulative meta-analysis were performed in line with the criteria of Grading of Recommendations Assessment, Development and Evaluation: levels of evidence and grades of recommendation.

Data sources

We comprehensively searched the electronic databases including PubMed, Medline, Embase and the Cochrane Library in November 2018.

Eligibility criteria for selecting studies

We included all randomised controlled trials (RCTs) and retrospective studies published in recent 10 years, which investigated the performance of LESS versus CL in patients at all ages with benign ovarian masses.

Results

Four RCTs and nine retrospective studies published in recent decade including 1542 cases (744 cases for LESS and 798 cases for CL) were identified. Perioperative complication was consisted of intraoperative and postoperative complications, including ileus, wound infection or dehiscence and incisional hernia. Although LESS has less postoperative analgesic consumption (46.78% and 79.25%; OR: 0.49; 95% CI: 0.33 to 0.74, p

Conclusions

The indications of LESS for benign ovarian masses are similar to CL and it has better postoperative recovery. However, with less perioperative complications, CL surgery is safer than LESS.

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