by Pauline Geuijen, Marlies de Rond, Joanneke Kuppens, Femke Atsma, Aart Schene, Hein de Haan, Cornelis de Jong, Arnt SchellekensIntroduction
Substance use disorders (SUD) in physicians often remain concealed for a long time. Peer monitoring and open discussions with colleagues are essential for identifying SUD. However, physicians often feel uncomfortable discussing substance use with a colleague. We explored physicians’ attitudes and norms about substance use (disorders) and their (intended) approach upon a presumption of substance use in a colleague.Materials and methods
An online cross-sectional survey concerning “Addiction in physicians” was administered by the Royal Dutch Medical Association physician panel. Overall, 1685 physicians (47%) responded. Data were analyzed by logistic regression to explore factors associated with taking action upon a substance use presumption.Results
Most physicians agreed that SUD can happen to anyone (67%), is not a sign of weakness (78%) and that it is a disease that can be treated (83%). Substance use in a working context was perceived as unacceptable (alcohol at work: 99%, alcohol during a standby duty: 91%, alcohol in the eight hours before work: 77%, and illicit drugs in the eight hours before work: 97%). Almost all respondents (97%) intend to act upon a substance use presumption in a colleague. Of the 29% who ever had this presumption, 65% took actual action. Actual action was associated with male gender and older age (OR = 1.81; 95% CI = 1.20–2.74 and OR = 1.03; 95% CI = 1.01–1.05, respectively).Conclusions
About one-third of physicians reported experience with a presumption of substance use in a colleague. Whilst most physicians intend to take action upon such a presumption, two-thirds actually do act upon a presumption. To bridge this intention-behavior gap continued medical education on signs and symptoms of SUD and instructions on how to enter a supportive dialogue with a colleague about personal issues, may enhance physicians’ knowledge, confidence, and ethical responsibility to act upon a presumption of substance use or other concerns in a colleague.
by Tzu-Chun Chung, Tzu-Shan Chen, Yao-Chun Hsu, Feng-Chen Kao, Yuan-Kun Tu, Pao-Hsin LiuBackground/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.
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.
A two‐arm, superiority, assessor‐blinded, cluster randomized trial with randomization at the community level.
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.
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.
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.
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.
by Lin Chen, Kai Fang, Xing-Fan Dong, Ai-Ling Yang, Yu-Xuan Li, Han-Bo ZhangAirborne fungi and their ecological functions have been largely ignored in plant invasions. In this study, high-throughput sequencing technology was used to characterize the airborne fungi in the canopy air of the invasive weed Ageratina adenophora. Then, representative phytopathogenic strains were isolated from A. adenophora leaf spots and their virulence to A.adenophora as well as common native plants in the invaded range was tested. The fungal alpha diversities were not different between the sampling sites or between the high/low part of the canopy air, but fungal co-occurrences were less common in the high than in the low part of the canopy air. Interestingly, we found that the phytopathogenic Didymellaceae fungi co-occurred more frequently with themselves than with other fungi. Disease experiments indicated that all 5 Didymellaceae strains could infect A. adenophora as well as the 16 tested native plants and that there was large variation in the virulence and host range. Our data suggested that the diverse pathogens in the canopy air might be a disease infection source that weakens the competition of invasive weeds, a novel phenomenon that remains to be explored in other invasive plants.
by Yi-Hsuan Lin, Ya-Chi Hsu, Ming-Chih Lin, Chao-Huei Chen, Teh-Ming WangBackground
Breast milk is the optimal choice for feeding premature babies. However, the prevalence rate of extrauterine growth restriction in preterm infants remains high.Objectives
The purpose of this study was to analyze the macronutrients present in human milk and the correlation with the growth of in-hospital preterm infants.Methods
This prospective study is based on data from 99 in-hospital preterm infants younger than 37 weeks of gestational age on an exclusively human milk diet. Infants who had previously received parenteral nutrition were eligible, but they had to have reached full enteral feeding at the time that the samples were taken. A total of 3282 samples of raw human milk or donor pasteurized milk were collected. The levels of lactose, protein, fat, and energy in the samples were measured using a Miris human milk analyzer. The primary outcome was weight growth velocity (g/kg/day) which was obtained using two-point approach.Results
The mean (±standard deviation) macronutrient composition per 100 mL of milk was 7.2 (±0.3) g of lactose, 1.1 (±0.2) g of true protein, 3.5 (±0.9) g of fat, and 66.9 (±6.5) kcal of energy. The protein concentration in human milk had a positive, significant correlation with body weight gain, with a coefficient of 0.41 (p Conclusion
Both the protein concentration in human milk and the daily total protein intake had a positive correlation with the body weight gain of premature infants. Routine analysis of breast milk and individualized fortification might be indicated to optimize the growth of preterm infants.
Eye diseases and visual impairment more commonly affect elderly adults, thus, the majority of ophthalmic cohort studies have focused on older adults. Cohort studies on the ocular health of younger adults, on the other hand, have been few. The Raine Study is a longitudinal study that has been following a cohort since their birth in 1989–1991. As part of the 20-year follow-up of the Raine Study, participants underwent a comprehensive eye examination. As part of the 27- and 28-year follow-ups, eye assessments are being conducted and the data collected will be compared with those of the 20-year follow-up. This will provide an estimate of population incidence and updated prevalence of ocular conditions such as myopia and keratoconus, as well as longitudinal change in ocular parameters in young Australian adults. Additionally, the data will allow exploration of the environmental, health and genetic factors underlying inter-subject differential long-term ocular changes.
Participants are being contacted via telephone, email and/or social media and invited to participate in the eye examination. At the 27-year follow-up, participants completed a follow-up eye screening, which assessed visual acuity, autorefraction, ocular biometry and ocular sun exposure. Currently, at the 28-year follow-up, a comprehensive eye examination is being conducted which, in addition to all the eye tests performed at the 27-year follow-up visit, includes tonometry, optical coherence tomography, funduscopy and anterior segment topography, among others. Outcome measures include the incidence of refractive error and pterygium, an updated prevalence of these conditions, and the 8-year change in ocular parameters.
The Raine Study is registered in the Australian New Zealand Clinical Trials Registry. The Gen2 20-year, 27-year and 28-year follow-ups are approved by the Human Research Ethics Committee of the University of Western Australia. Findings resulting from the study will be published in health or medical journals and presented at conferences.
ACTRN12617001599369; Active, not recruiting.
The administration of androgen deprivation therapy (ADT) to patients with metastatic prostate cancer might be associated with some adverse effects such as anaemia; however, few studies have been performed in East Asian populations. This study aimed to investigate the association between ADT and iron-deficiency anaemia (IDA) among patients with prostate cancer in a population-based nationwide cohort.
Data for the cohort study were retrieved from the Taiwan National Health Insurance Research Database. Propensity score matching was used to select 7262 patients with prostate cancer who received ADT as the study group and 3631 patients who did not receive ADT as the control group.
This study individually tracked patients over a 3-year study period and identified those who were subsequently diagnosed with IDA following the index date.
The incidence rates of IDA in the study and control groups were 1.66 (95% CI CI 1.45 to 1.86) and 1.01 per 100 person-years (95% CI 0.78 to 1.25), respectively. Furthermore, proportional Cox regression revealed an HR of 1.62 (95% CI 1.24 to 2.12) for IDA in the study group after adjusting for patients’ age, monthly income, geographic location, residential urbanisation level and incidence of hyperlipidaemia, diabetes, hypertension, coronary heart disease, inflammatory bowel disease, other cancers and gastrointestinal bleeding.
Compared with its non-use among patients with prostate cancer, ADT use was associated with a higher risk of IDA.
The prevalence of haemorrhoidal diseases was high in general population, and many treatments are proposed for the management of haemorrhoids. The treatments include conservative and surgical interventions; the credibility and strength of current evidence of their effectiveness are not comprehensively evaluated. We aim to evaluate the credibility of systematic reviews and meta-analyses that assess the effectiveness of the treatments for haemorrhoidal diseases through an umbrella review.
We will search Ovid Medline, Embase, Cochrane library and Web of Science from inception to March 2020 without any language restriction. We will include meta-analyses that examine the effectiveness of treatments in the management of haemorrhoids. Two reviewers will independently screen the titles and abstracts of retrieved articles, and they will extract data from the included meta-analyses. For each meta-analysis, we will estimate the effect size of a treatment through the random-effect model and the fixed-effect model, and we will evaluate between-study heterogeneity (Cochrane’s Q and I2 statistics) and small-study effect (Egger’s test); we will also estimate the evidence of excess significance bias. Evidence of each treatment will be graded according to prespecified criteria. Methodological quality of each meta-analysis will be evaluated by using Assessment of Multiple Systematic Reviews 2. The corrected cover area method will be used to assess the impact of overlap in reviews on the findings of the umbrella review.
We will present the results of the umbrella review at conferences and publish the final report in a peer-reviewed journal. The umbrella review does not require ethical approval.
Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.
In this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention ‘StudiCare Mindfulness’ will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.
All study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.
Pain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.
This will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.
This trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.
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.
An observational, prospective and population-based cohort study.
The Kailuan cohort study was conducted in Tangshan City in northern China.
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.
The primary outcome of this study was all-cause mortality.
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.
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).
An increase in RHR is a long-term risk factor of all-cause mortality in Chinese patients with hypertension.
To perform the cross-cultural adaption of the Breast Cancer Awareness Measurement (BCAM) and to test its psychometric properties among Chinese women.
This is a cross-sectional study.
This study was conducted in communities, schools and institutions in Changchun, Jilin Province, China.
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%.
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.
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).
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.
Many bowel problems following low anterior resection (LAR) for rectal cancer considerably impair the quality of life (QoL) of patients. The LAR syndrome (LARS) scale is a self-report questionnaire to identify and assess bowel dysfunction after rectal cancer surgery. It has been translated and validated in several languages but not in French (metropolitan French). The primary objective is to adapt the LARS scale to the French language (called French-LARS score) and to assess its psychometric properties. Secondary objectives are to assess both the prevalence and severity of LARS and to measure their impact on QoL.
A French multicentre observational cohort study has been designed. The validation study will include translation of the LARS scale following the current international recommendations, assessment of its reliability, convergent and discriminant validities, sensitivity, internal consistency, internal validity and confirmatory analyses. One thousand patients will be enrolled for the analyses. The questionnaire will be initially administered to the first 100 patients to verify the adequacy and degree of comprehension of the questions. Then reproducibility will be investigated by a test–retest procedure in the following 400 patients.
An analysis will be conducted to determine the correlation between the LARS score and the Quality of Life Questionnaire (QLQ; European Organization for Treatment and Research of Cancer’s QLQ-C30, QLQ-CR29). Risk factors linked to QoL deterioration will be identified and their impact will be measured. This study will meet the need for a validated tool to improve patient care and QoL.
The institutional review board of the University Hospital of Caen and the ethics committee (CPP Nord Ouest I, 25 January 2019) approved the study.
Despite the positive effect of physical activity on reducing depressive symptoms among patients with coronary heart disease (CHD), the effect of physical activity on depressive symptoms is poorly understood.
To examine the mediating role of physical activity self‐efficacy in the relationship between leisure‐time physical activity and depressive symptoms in CHD patients.
This was a secondary data analysis study. A total of 593 CHD patients were included. Data on leisure‐time physical activity, physical activity self‐efficacy, and depressive symptoms were collected by validated questionnaires. Sociodemographic and clinical data were collected via patient interviews and medical records reviewing. The approach of Baron and Kenny was adopted to examine the mediating effect of physical activity self‐efficacy on the association between leisure‐time physical activity and depressive symptoms.
On average, participants aged 56.9 (± 12.5) years old, with 66% male. Statistical analyses showed that leisure‐time physical activity was significantly associated with depressive symptoms (β = −0.041, p = .040) and physical activity self‐efficacy (β = 0.197, p = .001), and physical activity self‐efficacy was significantly associated with depressive symptoms (β = −0.223, p = .001) after adjusting for leisure‐time physical activity. The indirect effect of leisure‐time physical activity on depressive symptoms through physical activity self‐efficacy was also significant (β = −0.044, 95% confidence interval: −0.064, −0.027), suggesting a mediating role of physical activity self‐efficacy on the relationship between leisure‐time physical activity and depressive symptoms.
Leisure‐time physical activity is associated with reduced depressive symptoms among CHD patients, and this association is mediated by physical activity self‐efficacy. This mediating model has important clinical implications, where integrating physical activity that is enjoyable and pleasant, and self‐efficacy building elements in physical activity regimens should be considered, so as to improve psychological outcomes among CHD patients.
by Matthew R. Allen, Joseph Wallace, Erin McNerney, Jeffry Nyman, Keith Avin, Neal Chen, Sharon MoeIndividuals with chronic kidney disease have elevated levels of oxidative stress and are at a significantly higher risk of skeletal fracture. Advanced glycation end products (AGEs), which accumulate in bone and compromise mechanical properties, are known to be driven in part by oxidative stress. The goal of this study was to study effects of N-acetylcysteine (NAC) on reducing oxidative stress and improving various bone parameters, most specifically mechanical properties, in an animal model of progressive CKD. Male Cy/+ (CKD) rats and unaffected littermates were untreated (controls) or treated with NAC (80 mg/kg, IP) from 30 to 35 weeks of age. Endpoint measures included serum biochemistries, assessments of systemic oxidative stress, bone morphology, and mechanical properties, and AGE levels in the bone. CKD rats had the expected phenotype that included low kidney function, elevated parathyroid hormone, higher cortical porosity, and compromised mechanical properties. NAC treatment had mixed effects on oxidative stress markers, significantly reducing TBARS (a measure of lipid peroxidation) while not affecting 8-OHdG (a marker of DNA oxidation) levels. AGE levels in the bone were elevated in CKD animals and were reduced with NAC although this did not translate to a benefit in bone mechanical properties. In conclusion, NAC failed to significantly improve bone architecture/geometry/mechanical properties in our rat model of progressive CKD.
We investigated the molecular mechanism of paraoxonase‐2 (PON‐2) in regulating blood coagulation activation in rats with haemorrhagic shock through endothelial tissue factor (TF). Thirty adult Sprague Dawley rats were randomly divided into three groups: healthy control group (group A), the haemorrhagic shock PON‐2 treatment group (group B), and the haemorrhagic shock group (group C). After the model was established, blood was withdrawn from the inferior vena cava of all rats. The difference in plasma thrombomodulin (TM) levels of the three groups was determined by Western blotting. The expression of transcription factors Egr‐1 and Sp1 was detected by Western blotting assays. reverse transcription‐polymerase chain Reaction (RT‐PCR) was used to determine the mRNA expression of t‐PA, PAI‐1, TM, and PON‐2 in the serum of three groups of rats. Endothelial TF was measured by enzyme linked immunosorbent assay (ELISA), and coagulation assay was used to detect the activity of coagulation factor VIII. Histopathological examination of the arteries of the rats was performed. The molecular mechanism of PON‐2 in regulating blood coagulation activation in haemorrhagic shock model rats by endothelial tissue factor was analysed. The expression of thrombin was determined by electrophoresis. Compared with the healthy control group, the expression of TM in groups B and C decreased, both 188.64 ± 12.47 and 137.48 ± 9.72, respectively, with a significant difference. The mRNA expression of TM and PON was determined by RT‐PCR. The mRNA expression of TM and PON in group B was 0.97 ± 0.07 and 1.14 ± 0.09, compared with the control group, and the mRNA expression of TM and PON in group C was 0.86 ± 0.38 and 1.12 ± 0.41, both of which increased, and there were significant differences. By measuring the expression of endothelial TF, the expression of TF in groups B and C was elevated to 12.69 ± 1.07 and 11.59 ± 0.87, with significant differences. The enzyme activities of PON‐2 in groups B and C, which were 110.34 ± 14.37 and 52.37 ± 8.06, respectively, were increased compared with the healthy control group and there were significant differences. PON‐2 regulates the activation of coagulation in rats with haemorrhagic shock by regulating the expression of endothelial tissue‐related genes such as plasma TM and endothelial TF under hypoxic and ischaemic conditions.
Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.
This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.
This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.
by Sheng Feng Lin, Shui-Yi Tung, Kuo-Liang Wei, Chien-Hung Chen, Tsung-Hui Hu, Chien Heng Shen, Te-Sheng Chang, Wei-Ming Chen, Chih-Wei Yen, Jing-Houng Wang, Chao-Hung Hung, Sheng-Nan LuBackground
Hepatitis C virus core antigen (HCV Ag) assay has been proposed as a more economical alternative to HCV RNA detection. This study aimed to investigate the clinical utility of HCV Ag assay in the monitoring of direct-acting antivirals (DAAs) for chronic hepatitis C patients.Methods
We analyzed serum samples from 110 patients treated with paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) with or without ribavirin. The levels for both HCV Ag and HCV RNA assessed by COBAS TaqMan HCV (CTM) Test or Abbott RealTime HCV (ART) assay were evaluated at baseline, week 2, 4, and 12 during treatment and 12 weeks after completion.Results
Baseline HCV Ag levels showed good correlations with HCV viral load (r = 0.879; pp = 0.074). The concordance of HCV Ag and HCV RNA undetectability was significantly better in CTM test than in ART assay at week 2 (p = 0.003) and week 4 (p = 0.003). A sustained viral response 12 weeks off therapy (SVR12) was achieved in 108 patients (98%); the HCV Ag assay identified 99% of these patients. Both undetectability of serum HCV Ag and HCV RNA had high positive predictive value at week 2 (98% vs. 100%) and at week 4 (97% vs. 99%) in predicting SVR12.Conclusions
HCV Ag assay may be a feasible alternative to HCV RNA for the determination of SVR12 in patients treated with DAAs.
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. LingBackground
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.