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  • Age and sex differences in the association between sleep duration and general and abdominal obesity at 6-year follow-up: The Rural Chinese Cohort Study
    Sleep Med. (IF 3.360) Pub Date : 2020-01-16
    Qionggui Zhou; Xiaoyan Wu; Dongdong Zhang; Leilei Liu; Jian Wang; Ruirong Cheng; Jinchun Lin; Yu Liu; Xizhuo Sun; Zhaoxia Yin; Honghui Li; Yang Zhao; Yongcheng Ren; Dechen Liu; Xu Chen; Feiyan Liu; Cheng Cheng; Chunmei Guo; Fulan Hu

    Objective The association between sleep duration and general and abdominal obesity in adults, especially in the rural Chinese population, remain unclear. Therefore, we conducted this study to evaluate the association between sleep duration and general and abdominal obesity in rural Chinese adults. Methods We included 12,446 adults aged 18-75 years old who completed a baseline examination during 2007-2008 and follow-up during 2013-2014. We prospectively investigated the sleep–obesity association over a 6-year follow-up, on average. Multivariable logistic regression was performed to assess the probability of new-onset general and abdominal obesity, estimating odds ratios (ORs) and 95% confidence intervals (CIs). Results As compared with sleep duration 6.5-7.5 h, short sleep duration (<6.5 h) was significantly associated with increased probability of abdominal obesity in men (OR=1.60, 95% CI: 1.05-2.45) after controlling for multiple covariates. A similar association was found in men aged >60 years but not in women or in men ≤60 years. We found no significant association between sleep duration and general obesity. The results were consistent when restricting the analysis to participants without cardiovascular disease, type 2 diabetes mellitus or cancer at baseline. Conclusions Short sleep duration was significantly associated with abdominal obesity in rural Chinese adults, and the association varied by sex and age.

    更新日期:2020-01-17
  • Association between genetic variants in CYP2E1 and CTRC genes and susceptibility to alcoholic pancreatitis: a systematic review and meta-analysis
    Drug Alcohol Depen. (IF 3.466) Pub Date : 2020-01-17
    Ricardo Usategui-Martín; Cristina Carbonell; Ignacio Novo-Veleiro; Sara Hernández-Pinchete; José Antonio Mirón-Canelo; Antonio-Javier Chamorro; Miguel Marcos

    Background Genetic predisposition plays an important role in the development of alcoholic pancreatitis (AP), with previous studies suggesting that genetics variants in certain genes, such asCYP2E1 and CTRC, partially explain individual susceptibility to this disease. Therefore, the aim of this work was to conduct a systematic review and meta-analysis of existing studies that analyzed how polymorphisms within CYP2E1 and CTRC genes influence the risk of AP. Material and methods We performed a systematic review of studies that analyzed the genotype distribution of CYP2E1 and CTRC allelic variants among patients with AP and a group of controls. A meta-analysis was conducted using a random effects model. Odds ratios (ORs) and their confidence intervals (CIs) were calculated. Results The T allele of theCTRC 180 C > T variant was significantly more prevalent among patients with AP compared to all controls (OR = 1.79, 95% CI = 1.43–2.24; P < 0.00001) and healthy subjects (OR = 1.84, 95% CI = 1.46–2.31; P < 0.00001). The Trp variant of CTRC Arg254Trp polymorphism was also more prevalent in patients with AP; however, these results were not significant after excluding one study. We found no clear evidence that CYP2E1-DraI or of CYP2E1-RsaI/PstI polymorphisms modulate the risk of developing AP. Conclusions Our meta-analysis supports that the T allele ofCTRC 180C > T polymorphisms modulates the risk of alcoholic pancreatitis. No clear evidence was found for the remaining SNPs being associated with this disease.

    更新日期:2020-01-17
  • Lorcaserin maintenance fails to attenuate heroin vs. food choice in rhesus monkeys
    Drug Alcohol Depen. (IF 3.466) Pub Date : 2020-01-17
    E. Andrew Townsend; S. Stevens Negus; Justin L. Poklis; Matthew L. Banks
    更新日期:2020-01-17
  • Within-treatment frequency of use versus abstinence as a predictor of longitudinal post-treatment follow-up assessments of drug use
    Drug Alcohol Depen. (IF 3.466) Pub Date : 2020-01-17
    Garrett M. Fitzmaurice; Stuart R. Lipsitz; Roger D. Weiss

    Background Abstinence is a widely-used endpoint in clinical trials of stimulant use disorders. A quantitative measure of frequency of use may be a more sensitive endpoint; however, it is important to establish that it is associated with post-treatment drug use. We examine and compare how within-treatment abstinence and frequency of use are related to two post-treatment longitudinal measures of drug use. Methods For each of three existing stimulant use disorder clinical trial datasets, we examined the association between within-treatment frequency of use (based on urine screens), within-treatment abstinence, and post-treatment follow-up assessments of drug use (urine screens and reported days of use). In joint analyses that simultaneously model the effects of within-treatment abstinence and frequency of use, it is possible to discern their relative importance as predictors of post-treatment drug use during the 12 months following the end of treatment. Results Results indicate a quantitative measure of within-treatment frequency of use was associated with longitudinal post-treatment follow-up assessments of drug use. Results from joint analyses of post-treatment follow-up drug use assessed by urine screens suggest that within-treatment frequency of use, rather than abstinence per se, is predictive of post-treatment drug use. However, results from joint analyses of self-report of days of use are equivocal. Conclusion Results lend support to the use of a quantitative measure of within-treatment drug use as an alternative to complete abstinence. They suggest that some within-treatment use that fall short of complete abstinence may potentially represent clinically important improvements given their association with post-treatment drug use.

    更新日期:2020-01-17
  • Effects of lorcaserin on oxycodone self-administration and subjective responses in participants with opioid use disorder
    Drug Alcohol Depen. (IF 3.466) Pub Date : 2020-01-17
    Laura Brandt; Jermaine D. Jones; Suky Martinez; Jeanne M. Manubay; Shanthi Mogali; Tatiana Ramey; Frances R. Levin; Sandra D. Comer

    Background Lorcaserin, a high-affinity 5-HT2C receptor agonist approved for treating obesity, decreased self-administration of oxycodone and cue-induced reinstatement of drug-seeking behavior in preclinical studies. The current investigation is the first clinical trial to evaluate the ability of lorcaserin to alter the reinforcing and subjective effects of oxycodone. Methods In this 7-week inpatient trial, 12 non-treatment-seeking volunteers (11 males) with moderate-to-severe opioid use disorder were detoxified from opioids. In a randomized cross-over fashion, participants were first stabilized on lorcaserin (10 mg BID) or placebo (0 mg BID). Participants underwent a two-week testing period during which the reinforcing and subjective effects of intranasal oxycodone were examined in verbal choice, cue-exposure, and progressive-ratio choice sessions. The two testing weeks were identical with the exception that during the first week, active oxycodone (10 mg) was available during verbal choice (self-administration) sessions, and during the second week placebo oxycodone was available. Subsequently, participants were stabilized on the other medication condition (placebo or lorcaserin) and underwent the same testing procedures again. Results Lorcaserin did not alter oxycodone self-administration. However, lorcaserin had a trend to increase “wanting heroin” when oxycodone was available, and to accentuate oxycodone-induced miosis. Conclusion Under the current experimental conditions, lorcaserin at a dose of 10 mg BID did not reliably decrease the abuse liability of oxycodone, even though the study was sufficiently powered (≥80%) to detect clinically meaningful differences in the main outcome variables between the placebo and active lorcaserin condition. Future research could explore a wider dose range of lorcaserin and oxycodone.

    更新日期:2020-01-17
  • Anabolic androgenic steroid dependence is associated with executive dysfunction
    Drug Alcohol Depen. (IF 3.466) Pub Date : 2020-01-17
    Lisa E. Hauger; Lars T. Westlye; Astrid Bjørnebekk

    Background Anabolic androgenic steroid (AAS) dependence is associated with a high prevalence of intra- and interpersonal problems, hence it is central to identify cognitive factors related to the development and maintenance of dependence. Methods The study explores executive functions (EFs) in a sample of 174 male weightlifters, divided into three groups; 1) AAS dependents; n = 58, 2) AAS non-dependents; n = 38 and 3) AAS non-users; n = 78, using a targeted battery of neuropsychological (NP) tests, and self-report questionnaires assessing EFs in everyday life, ADHD symptoms and psychological distress. Results Multivariate analysis of variance showed significant between-group differences on several EFs, including working memory [F (2, 169) = 13.88, p < .001, ηp² = .14], mental flexibility [F (2, 169) = 4.82, p = .019, ηp² = .05], problem-solving [F (2, 169) = 4.78 p = .010, ηp² = .05] and inhibition [F (2, 150) = 4.15, p = .017, ηp² = .05]. Additionally, significant between-group differences were seen for self-reported problems with EFs [F (2, 124) = 4.38 p = .015, ηp² = .07], ADHD symptoms [F (2, 124) = 7.02 p = .001, ηp² = .10], and psychological distress [F (2, 124) = 4.11 p = .019, ηp² = .06]. Post hoc tests showed that AAS dependents exhibited poorer EFs and reported more psychological distress compared to non-users. Conclusion AAS dependence is associated with executive dysfunction, which might be related to continued abuse despite adverse side-effects and social consequences. Increased awareness of executive dysfunction could have important implications for treatment and rehabilitation.

    更新日期:2020-01-17
  • Do tobacco industry websites target content to specific demographic groups?
    Drug Alcohol Depen. (IF 3.466) Pub Date : 2020-01-17
    Patricia Escobedo; Kai-Ya Tsai; Anuja Majmundar; Jon-Patrick Allem; Daniel W. Soto; Monica Pattarroyo; Jennifer B. Unger; Tess Boley Cruz

    Background Prior research has not examined whether tobacco brand websites vary content based on audience demographics. This study explored whether marketing content on tobacco brand websites varied by user ethnicity, gender or age group. Methods Participants (n = 32) were adult smokers, representing equal numbers of eight demographic groups: user ethnicity (Non-Hispanic White, Hispanic, African American, Asian), gender (women, men) and age (age 21-35, age 36+). This study examined 12 tobacco brand websites representing four tobacco product categories (cigarettes, cigar/cigarillos, smokeless tobacco, and e-cigarettes). From January 2016 to January 2017, participants coded websites for themes, interactive activities, and links to social media sites (n = 874 website visits). Logistic regression was used to analyze observed content by participant ethnicity, age and gender. Results All themes, all interactive activities and all links to social media were observed at least once for each demographic category. Male participants were more likely to observe Harm reduction themes, while female participants were more likely to observe Promotion themes. Older participants were more likely to observe website features allowing them to select music, and request coupons. Compared to Non-Hispanic White participants, African American participants were more likely to observe links to social media sites. Conclusion Tobacco brand website content varied across ethnic, age and gender groups. These findings suggest that other factors, such as tobacco use behaviors, may influence marketing strategies participants recall or find appealing. The findings from this study can inform future regulatory activities and communication strategies aimed at countering pro-tobacco content online.

    更新日期:2020-01-17
  • Thin silk fibroin films as a dried format for temperature stabilization of inactivated polio vaccine
    Vaccine (IF 3.269) Pub Date : 2020-01-17
    Jordan A. Stinson; Carter R. Palmer; David P. Miller; Adrian B. Li; Kandice Lightner; Heather Jost; William C. Weldon; M. Steven Oberste; Jonathan A. Kluge; Kathryn M. Kosuda

    Current inactivated polio vaccine (IPV) products are sensitive to both freezing and elevated temperatures and therefore must be shipped and stored between 2 °C and 8 °C, a requirement that imposes financial and logistical challenges for global distribution. As such, there is a critical need for a robust, thermally stable IPV to support global polio eradication and post-eradication immunization needs. Here, we present the development of air-dried thin films for temperature stabilization of IPV using the biomaterial silk fibroin. Thin-film product compositions were optimized for physical properties as well as poliovirus D-antigen recovery and were tested under accelerated and real-time stability storage conditions. Silk fibroin IPV films maintained 70% D-antigen potency after storage for nearly three years at room temperature, and greater than 50% potency for IPV-2 and IPV-3 serotypes at 45 °C for one year. The immunogenicity of silk fibroin IPV films after 2-week storage at 45 °C was assessed in Wistar rats and the stressed films generated equivalent neutralizing antibody responses to commercial vaccine for IPV-1 and IPV-2. However, the absence of IPV-3 responses warrants further investigation into the specificity of ELISA for intact IPV-3 D-antigen. By demonstrating immunogenicity post-storage, we offer the air-dried silk film format as a means to increase IPV vaccine access through innovative delivery systems such as microneedles.

    更新日期:2020-01-17
  • Development and optimization of OspC chimeritope vaccinogens for Lyme disease
    Vaccine (IF 3.269) Pub Date : 2020-01-17
    Jerilyn R. Izac; Nathaniel S. O'Bier; Lee D. Oliver; Andrew C. Camire; Christopher G. Earnhart; DeLacy V. LeBlanc Rhodes; Brandon F. Young; Stuart R. Parnham; Christopher Davies; Richard T. Marconi

    Experimental Outer surface protein (Osp) C based subunit chimeritope vaccinogens for Lyme disease (LD) were assessed for immunogenicity, structure, ability to elicit antibody (Ab) responses to divergent OspC proteins, and bactericidal activity. Chimeritopes are chimeric epitope based proteins that consist of linear epitopes derived from multiple proteins or multiple variants of a protein. An inherent advantage to chimeritope vaccinogens is that they can be constructed to trigger broadly protective Ab responses. Three OspC chimeritope proteins were comparatively assessed: Chv1, Chv2 and Chv3. The Chv proteins possess the same set of 18 linear epitopes derived from 9 OspC type proteins but differ in the physical ordering of epitopes or by the presence or absence of linkers. All Chv proteins were immunogenic in mice and rats eliciting high titer Ab. Immunoblot and enzyme linked immunosorbent assays demonstrated that the Chv proteins elicit IgG that recognizes a diverse array of OspC type proteins. The panel included OspC proteins produced by N. American and European strains of the LD spirochetes. Rat anti-Chv antisera uniformly labeled intact, non-permeabilized Borreliella burgdorferi demonstrating that vaccinal Ab can bind to targets that are naturally presented on the spirochete cell surface. Vaccinal Ab also displayed potent complement dependent-Ab mediated killing activity. This study highlights the ability of OspC chimeritopes to serve as vaccinogens that trigger potentially broadly protective Ab responses. In addition to the current use of an OspC chimeritope in a canine LD vaccine, chimeritopes can serve as key components of human LD subunit vaccines.

    更新日期:2020-01-17
  • Women who received varicella vaccine versus natural infection have different long-term T cell immunity but similar antibody levels
    Vaccine (IF 3.269) Pub Date : 2020-01-17
    Ellen Tourtelot; Sally Quataert; J. Christopher Glantz; Lauren Perlis; Gowrishankar Muthukrishnan; Tim Mosmann

    Background Varicella-zoster virus (VZV) infection during pregnancy is associated with serious fetal anomalies. The live-attenuated VZV vaccine was approved in 1995, so many vaccinated women are now of childbearing age. The question of long-term immunity to varicella is critical because breakthrough chickenpox can occur after vaccination. Objective To compare humoral and T cell immunity between women of childbearing age who were immunized by vaccination or chickenpox disease. Study design Non-pregnant females between 18 and 36 years old with a history of VZV immunization (n = 20) or prior chickenpox disease (n = 20) were recruited. IgG antibody titers and T cell responses were measured by flow cytometry-based methods in serum and peripheral blood, respectively. Results There were no significant differences in median antibody titers between vaccinated and chickenpox groups (p = 0.34). The chickenpox group had significantly higher levels of VZV antigen-specific CD4 T cells (p = 0.004). Conclusion Natural infection induced higher VZV-specific T cell immune responses than vaccination.

    更新日期:2020-01-17
  • Activity of human serum antibodies in an influenza virus hemagglutinin stalk-based ADCC reporter assay correlates with activity in a CD107a degranulation assay
    Vaccine (IF 3.269) Pub Date : 2020-01-17
    Veronika Chromikova; Jessica Tan; Sadaf Aslam; Arvind Rajabhathor; Maria Bermudez-Gonzalez; Juan Ayllon; Viviana Simon; Adolfo García-Sastre; Bruno Salaun; Raffael Nachbagauer; Florian Krammer

    The stalk of the influenza virus hemagglutinin (HA) is an attractive target for antibody-based universal influenza virus vaccine development. While antibodies that target this part of the virus can be neutralizing, it has been shown in recent years that Fc receptor-mediated effector functions are of significant importance for the protective effect of anti-stalk antibodies. Several assays to measure Fc-Fc receptor interaction-based effector functions like antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis exist, but they suffer from limitations such as low throughput and high run-to-run variability. Reporter assays for antibody-dependent cellular cytotoxicity based on reporter cells that express luciferase upon engagement of human FcγRIIIa with the Fc of antigen-bound antibodies have been developed as well. These reporter assays can be used in a higher throughput setting with limited run-to-run assay variability but since they express only one Fc receptor, their biological relevance is unclear. Here we optimized an antibody-dependent cellular cytotoxicity reporter assay to measure the activity of antibodies to the conserved stalk domain of H1 hemagglutinin. The assay was then correlated to a CD107a-based degranulation assay, and a strong and significant correlation could be observed. This data suggests that the FcγRIIIa-based reporter assay is a good substitute for functional assays, especially in settings where larger sample numbers need to be analyzed.

    更新日期:2020-01-17
  • A randomised double-blind dose–response study of weight-adjusted infusions of norepinephrine for preventing hypotension during combined spinal–epidural anaesthesia for Caesarean delivery
    Br. J. Anaesth. (IF 6.199) Pub Date : 2020-01-17
    Feng Fu; Fei Xiao; Wending Chen; Meijuan Yang; Yanhong Zhou; Warwick D. Ngan Kee; Xinzhong Chen

    Background Norepinephrine infusion has been suggested as an effective method for preventing hypotension during spinal anaesthesia for Caesarean delivery. However, optimal dosing regimens for norepinephrine have not been well established. This study aimed to determine the dose–response characteristics of a weight-adjusted fixed-rate infusion of norepinephrine to prevent hypotension during neuraxial anaesthesia for Caesarean delivery. Methods In a double-blind, randomised controlled trial, 80 parturients having elective Caesarean delivery received a prophylactic norepinephrine infusion at 0.025 μg kg−1 min−1 (Group N1), 0.05 μg kg−1 min−1 (Group N2), 0.075 μg kg−1 min−1 (Group N3), or 0.10 μg kg−1 min−1 (Group N4), starting immediately after induction of combined spinal–epidural anaesthesia. The primary outcome was non-occurrence of hypotension, defined as a decrease in systolic arterial pressure ≥20% below baseline value or to ≤90 mm Hg, before delivery. Values for 50% effective dose (ED50) and ED90 were calculated using probit regression. Results The incidence of hypotension was 11/20 (55%), 6/20 (30%), 2/20 (10%), and 1/20 (5%) in Groups N1, N2, N3, and N4, respectively (P<0.0001). The ED50 and ED90 (95% confidence interval) of norepinephrine infusions for preventing hypotension were 0.029 (–0.002 to 0.043) and 0.080 (0.065–0.116) μg kg−1 min−1, respectively. The incidence of reactive hypertension increased with increasing norepinephrine dose (P=0.002). Other adverse effects were similar among groups. Conclusions Under the conditions of this study, an infusion of norepinephrine 0.08 μg kg−1 min−1 was effective for preventing hypotension in 90% of patients. This information should provide a guide for initiating norepinephrine infusions. Clinical trial registration ChiCTR1900022322 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/enindex.aspx).

    更新日期:2020-01-17
  • Factors associated with persistent pain after childbirth: a narrative review
    Br. J. Anaesth. (IF 6.199) Pub Date : 2020-01-17
    Ryu Komatsu; Kazuo Ando; Pamela D. Flood

    A systematic literature search was performed to identify studies that reported risk factors for persistent pain after childbirth. Many studies have sought to identify risk factors for post-delivery pain in different populations, using different methodologies and different outcome variables. Studies of several different but interrelated post-partum pain syndromes have been conducted. Factors strongly and specifically associated with persistent incisional scar pain after Caesarean delivery include a coexisting persistent pain problem in another part of the body and severe acute postoperative pain. For persistent vaginal and perineal pain, operative vaginal delivery and the magnitude of perineal trauma have been consistently linked. History of pregnancy-related and pre-pregnancy back pain and heavier body weight are robust risk factors for persistent back pain after pregnancy. Unfortunately, limitations, particularly small samples and lack of a priori sample size calculation designed to detect specific effect sizes for risk of persistent pain outcomes, preclude definitive conclusions about many other predictors and the strength of outcome associations. In future studies, assessments of specific phenotypes using a rigorous analysis with appropriate predetermined sample sizes and validated instruments are needed to allow elucidation of stronger and reliable associations. Interventional studies targeting the most robustly associated, modifiable risk factors, such as acute post-partum pain, may lead to solutions for the prevention and treatment of these common problems that impact a large population.

    更新日期:2020-01-17
  • Improving Evidence-Based Oral Health of Nursing Home Residents Through Coaching by Dental Hygienists
    J. Am. Med. Dir. Assoc. (IF 4.899) Pub Date : 2019-11-25
    Lisa Volk; Melony Spock; Philip D. Sloane; Sheryl Zimmerman

    Good oral hygiene has an impact on the overall health of residents in long-term care; however, significant improvement is needed in nursing homes. A “boots on the ground” project was developed that incorporates Mouth Care without a Battle, an evidence-based approach to person-centered daily mouth care, into 22 New York State nursing homes using a coaching model with part-time dental hygienists. This report discusses implementation of the quality improvement project, which improved the quality of daily mouth care provided to nursing home residents, as well as changed the knowledge and attitudes of the staff providing their care, all supported by regional dental hygienist coaches.

    更新日期:2020-01-17
  • The lipid composition of platelets and the impact of storage: an overview
    Transfus. Med. Rev. (IF 3.610) Pub Date : 2020-01-08
    Sarah M. Green; Matthew P. Padula; Denese C. Marks; Lacey Johnson

    Lipids and bioactive lipid mediators are essential for platelet function. The lipid profile of platelets is highly dynamic due to free exchange of lipids with the plasma, release of extracellular vesicles, and both enzymatic and non-enzymatic lipid conversion. The lipidome of platelets changes in response to activation to accommodate the functional requirements of platelets, particularly for maintenance of hemostasis. Further, when stored at room temperature as a component for transfusion, the lipid profile of platelets is altered. While there is a growing interest in alternate storage conditions, such as refrigeration and cryopreservation, few contemporary studies have examined the impact of these storage modes on the lipid profile. However, evidence exists that bioactive lipid mediators produced over the storage of blood products may have functional implications once these products are transfused. As such, there is a need to determine the changes occurring to the lipid profile of these products over storage. This review outlines the role of lipids in platelets and discusses the current state of lipidomics for studying platelet components for transfusion, in an effort to highlight the necessity for additional transfusion-focused investigations.

    更新日期:2020-01-17
  • A systematically derived exposure assessment instrument for Chronic Hypersensitivity Pneumonitis
    Chest (IF 9.657) Pub Date : 2020-01-17
    Hayley Barnes; Julie Morisset; Philip Molyneaux; Glen Westall; Ian Glaspole; Harold R. Collard

    Background Chronic hypersensitivity pneumonitis (CHP) is an immune mediated interstitial lung disease, caused by inhalational exposure to environmental antigens, resulting in parenchymal fibrosis. By definition, a diagnosis of CHP assumes a history of antigen exposure, but only half of all patients eventually diagnosed with CHP will have a causative antigen identified. Individual clinician variation in eliciting a history of antigen exposure may affect the frequency and confidence of CHP diagnosis. Methods A list of potential causative exposures were derived from a systematic review of the literature. A Delphi method was applied to an international panel of ILD experts, to obtain consensus regarding technique for the elicitation of exposure to antigens relevant to a diagnosis of CHP. The consensus threshold was set at 80% agreement, and median ≤ 2, IQR = 0 on a five-point Likert scale (1: strongly agree, 2: tend to agree, 3: neither agree nor disagree, 4: disagree, 5: strongly disagree). Results In two rounds, 36/40 experts participated. Experts agreed on 18 exposure items to ask every patient with suspected CHP. Themes included CHP inducing exposures, features that contribute to an exposure’s relevance, and quantification of a relevant exposure. Based on the results from the literature review and Delphi process, a CHP exposure assessment instrument was derived. Using cognitive interviews, the instrument was revised by ILD patients for readability and usability. Conclusions This Delphi survey provides items that ILD experts agree are important to ask in all patients presenting with suspected CHP and provides basis for a systematically derived CHP exposure assessment instrument. Clinical utility of this exposure assessment instrument may be affected by different local prevalence patterns of exposures. Ongoing research is required to clinically validate these items and consider their impact in more geographically diverse settings.

    更新日期:2020-01-17
  • Eosinophilic Granulomatosis with Polyangiitis: clinical predictors of long-term asthma severity.
    Chest (IF 9.657) Pub Date : 2020-01-17
    Alvise Berti; Divi Cornec; Marta Casal Moura; Robert J. Smyth; Lorenzo Dagna; Ulrich Specks; Karina A. Keogh

    Background The long-term clinical course of asthma in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) remains unclear. We aimed to characterize long-term asthma in EGPA and to identify baseline predictors of long-term asthma severity. Methods Retrospective cohort study of patients who fulfilled standardized criteria for EGPA that were followed in a single referral center between 1990-2017. Baseline and 3 (±1) years of follow-up clinical, laboratory and pulmonary function data were analyzed. Results Eighty-nine patients with EGPA, and a documented asthma assessment at baseline and at 3 years from diagnosis were included. Severe/uncontrolled asthma was observed in 42.7% of patients at diagnosis and was associated with previous history of respiratory allergy (p<0.01), elevated serum total IgE levels (p<0.05), increased use of high dose inhaled (ICS; p<0.05) and oral corticosteroids (OCS; p<0.001) for respiratory symptoms the year before the diagnosis of EGPA. During follow-up, an improvement or worsening in asthma severity was noted in 12.3% and 10.1% of patients, respectively. Severe/uncontrolled asthma was present in 40.5% of patients at 3 years, and was associated with increased airway resistance on pulmonary function testing (p<0.05). Long-term PFTs did not improve during long-term follow-up regardless of ICS or OCS therapy. Using multivariate binary logistic regressions, severe rhinosinusitis (p=0.038), pulmonary infiltrates (p=0.011), overweight (BMI>25kg/m2; p=0.041) and severe/uncontrolled asthma at vasculitis diagnosis (p<0.001) independently predicted severe/uncontrolled asthma at the 3-year endpoint. Conclusion In asthmatic patients with EGPA, long-term severe/uncontrolled asthma is associated with baseline pulmonary and ENT manifestations, but not with clear-cut vasculitic features.

    更新日期:2020-01-17
  • A geographic analysis of racial disparities in use of pulmonary rehabilitation after hospitalization for COPD exacerbation
    Chest (IF 9.657) Pub Date : 2020-01-17
    Kerry A. Spitzer; Mihaela S. Stefan; Aruna Priya; Quinn R. Pack; Penelope S. Pekow; Tara Lagu; Kathy Mazor; Victor M. Pinto-Plata; Richard L. ZuWallack; Peter K. Lindenauer

    Rationale Guidelines recommend pulmonary rehabilitation (PR) after hospitalization for an exacerbation of COPD, but few patients enroll in PR. We explored whether density of PR programs explained regional variation and racial disparities in receipt of PR. Methods We used CMS data from 223,832 Medicare beneficiaries hospitalized for COPD during 2012 who were eligible for PR post-discharge. We used Hospital-Referral Regions (HRR) as the unit of analysis. For each HRR, we calculated the density of PR programs as a measure of program access, and estimated risk-standardized rates of PR within 6 months of discharge overall, and for non-Hispanic, white and black beneficiaries. We used linear regression to examine the relationship between access to PR and HRR PR rates. We tested for racial disparity in PR rates among non-Hispanic white and black beneficiaries living in the same HRRs. Results Across 306 HRRs the median number of PR programs per 1,000 Medicare beneficiaries was 0.06 (IQR: 0.04-0.10). Risk-standardized rates of PR ranged from 0.53% to 6.67% (median 1.93%). Density of PR programs was positively associated with PR rates overall and among non-Hispanic white beneficiaries (p <0.001), but this relationship was not observed among black beneficiaries. Rates were higher among non-Hispanic white beneficiaries (median 2.08%: IQR 1.54%-2.87%) compared to black beneficiaries (median 1.19%: IQR 1.15%-1.20%). Conclusions Greater PR program density was associated with higher rates of PR for non-Hispanic white but not black beneficiaries. Further research is needed to identify reasons for this discrepancy and strategies to increase receipt of PR for black patients.

    更新日期:2020-01-17
  • Update on Apneas of Heart Failure with Reduced Ejection Fraction: Emphasis on the Physiology of Treatment Part 2: Central Sleep Apnea
    Chest (IF 9.657) Pub Date : 2020-01-17
    Shahrokh Javaheri; Lee K. Brown; Rami N. Khayat

    Central sleep apnea/Hunter-Cheyne-Stokes Breathing (CSA/HCSB), is prevalent in patients with heart failure with reduced ejection fraction (HFrEF). The acute pathobiological consequences of CSA/HSCB eventually lead to sustained sympathetic over-activity, repeated hospitalization, and premature mortality. Few small randomized controlled trials (RCTs) have shown statistically significant and clinically important reduction in sympathetic activity when CSA/HCSB is attenuated by oxygen or positive airway pressure (PAP) therapy, both continuous PAP (CPAP) and Adaptive servo ventilation (ASV) devices. Yet, the two largest PAP trials in patients with HFrEF, one with CPAP and the other with an ASV, were negative with respect to their primary outcomes, and both associated with excess mortality. However, both trials suffered from significant deficiencies casting doubt on their results. A second RCT evaluating an ASV device with advanced algorithm is ongoing. A new modality of therapy, unilateral phrenic nerve stimulation, has undergone an RCT that demonstrated an improvement in CSA that was associated with a reduction in arousals, improvement in sleepiness and quality of life. However, a long-term mortality trial has not been performed with this modality. Most recently, the NIH funded a long-term, phase-III RCT of low flow oxygen vs. sham for the treatment of CSA/HCSB in HFrEF. The composite primary outcome includes all-cause mortality and hospitalization for worsening HF. In this article, we focus on various therapeutic options for the treatment of CSA/HCSB and, when appropriate, emphasize the importance of identifying CSA/HCSB phenotypes to tailor treatment.

    更新日期:2020-01-17
  • Associations between 25-hydroxy-vitamin D levels, lung function, and exacerbation outcomes in COPD: An analysis of the SPIROMICS cohort
    Chest (IF 9.657) Pub Date : 2020-01-17
    Robert M. Burkes; Agathe S. Ceppe; Claire M. Doerschuk; David Couper; Eric A. Hoffman; Alejandro P. Comellas; R. Graham Barr; Jerry A. Krishnan; Christopher Cooper; Wassim W. Labaki; Victor E. Ortega; J. Michael Wells; Gerard J. Criner; Prescott G. Woodruff; Russell P. Bowler; Cheryl S. Pirozzi; Nadia N. Hansel; Robert Wise; M. Bradley Drummond

    Introduction The relationship between 25-hydroxy-vitamin D (25-OH-vitamin D) and COPD outcomes remains unclear. Using the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS), we determined associations between baseline 25-OH-vitamin D and cross-sectional and longitudinal lung function and COPD exacerbations. Methods Serum 25-OH-vitamin D level was measured in stored samples from 1609 SPIROMICS participants with COPD. 25-OH-vitamin D levels were modeled continuously and dichotomized as deficient (<20 ng/ml) vs. not deficient (≥20 ng/ml). Outcomes of interest included %-predicted FEV1 (current and one-year longitudinal decline) and COPD exacerbations (separately any and severe, occurring in prior year and first year of follow-up). Results Vitamin D deficiency was present in 21% of the cohort and was more prevalent in the younger-aged, active smokers, and African-Americans. Vitamin D deficiency was independently associated with 4.11 lower FEV1 %-predicted at enrollment (95% CI -6.90 to -1.34 %-predicted, P=0.004), 1.27 %-predicted greater rate-of-FEV1-decline after one year (95% CI -2.32 to -0.22 %-predicted/yr; P=0.02), and higher odds of any COPD exacerbation in the prior year (OR 1.32; 95% CI 1.00-1.74; P=0.049). Each 10 ng/ml decrease in 25-OH-vitamin D was associated with lower baseline lung function [-1.27 %-predicted (95% CI -2.32 to -0.22 %-predicted); P=0.02] and increased odds of any exacerbation in the year prior to enrollment [OR 1.11 (95% CI 1.01-1.22); P=0.04]. Interpretation Vitamin D deficiency is associated with worse cross-sectional and longitudinal lung function and increased odds of prior COPD exacerbations. These findings identify 25-OH-vitamin D levels as a potentially useful marker of adverse COPD-related outcomes.

    更新日期:2020-01-17
  • Genetic risk factors for spontaneous pneumothorax in Birt-Hogg-Dubé syndrome
    Chest (IF 9.657) Pub Date : 2020-01-17
    Elke C. Sattler; Zulfiya Syunyaeva; Ulrich Mansmann; Ortrud K. Steinlein

    Background Birt-Hogg-Dubé syndrome (BHDS) is a genetic tumor syndrome characterized by lung cysts, spontaneous pneumothorax, fibrofolliculoma and renal cell cancer. Due to its rarity and clinical heterogeneity, much is still unknown regarding the course of the disease and individual risk assessment. Therefore, we studied non-environmental risk factors for pneumothorax in a large sample of BHDS patients. Methods Clinical data were available from 197 BHDS patients (male 103, female 94) belonging to 63 unrelated families. The FLCN coding region including adjacent intronic sequences was analysed by PCR and subsequent Sanger sequencing as well as MLPA. Statistical analyses were performed using adequate methods to account for familial clustering. Results Patients who had only a single spontaneous pneumothorax were significantly older at the time of occurrence than those with multiple ones (mean 38.93 versus 29.74 years, p-value 0.010). The risk for three or more pneumothoraces drastically increased after the second event. Significantly increased pneumothorax risks were found for mutations c.1300G>C (59%) and c.250-2A>G (77%), compared to FLCN hotspot mutation c.1285dup (37% risk) (p-value 0.02). Conclusions We observed significant differences for the spontaneous pneumothorax risk regarding both age and gender in BHDS patients. Furthermore, two FLCN mutations were identified that are associated with significantly increased pneumothorax risk. Thus, formerly unknown individual predictors have been identified that provide improved risk stratification for BHDS patients.

    更新日期:2020-01-17
  • UNDERWEIGHT PATIENTS WITH CYSTIC FIBROSIS HAVE ACCEPTABLE SURVIVAL AFTER LUNG TRANSPLANTATION: A UNOS REGISTRY STUDY
    Chest (IF 9.657) Pub Date : 2020-01-17
    Kathleen J. Ramos; Siddhartha G. Kapnadak; Miranda C. Bradford; Ranjani Somayaji; Eric D. Morrell; Joseph M. Pilewski; Erika D. Lease; Michael S. Mulligan; Moira L. Aitken; Cynthia J. Gries; Christopher H. Goss

    Background Reduced body mass index (BMI) is an absolute contraindication for lung transplantation (LTx) at most centers in the United States (US). Our objective was to quantify post-LTx survival of moderate-to-severely underweight cystic fibrosis (CF) patients (BMI <17 kg/m2) in the US relative to normal-weight CF recipients and other frequently transplanted patient cohorts. Methods Using United Network for Organ Sharing (UNOS) data (transplanted June 2005-November 2015), Kaplan-Meier estimates of median post-transplant survival were calculated for all CF, chronic obstructive pulmonary disease (COPD), and idiopathic pulmonary fibrosis (IPF) patients, as well as low and normal-weight CF subgroups. Cox regression modeling stratified by transplant center assessed risk of post-transplant mortality in CF recipients with BMI <17 kg/m2 compared to COPD recipients (reference). Results Median post-transplant survival [95% CI] for CF, COPD, and IPF was 7.9 [7.2, 8.6], 5.9 [5.6, 6.2], and 5.5 [5.2, 5.8] years, respectively. While an absolute decrease was noted in post-transplant survival for CF recipients with BMI < 17 kg/m2, compared to those with BMI ≥17 kg/m2 (7.0 years [4.5, 7.9] vs. 8.2 years [7.3, 9.0]), Cox modeling found no increased mortality risk (adjusted HR 1.09 [0.90, 1.32], p=0.38). There was no difference in post-transplant mortality between CF with BMI <17 kg/m2 and COPD recipients of all BMIs (adjusted HR 1.04 [0.86, 1.25], p=0.71). Conclusions CF recipients with BMI <17 kg/m2 had post-transplant survival comparable to other frequently transplanted groups. BMI <17 kg/m2 as a single risk factor in the CF population should not be treated as an absolute contraindication to LTx.

    更新日期:2020-01-17
  • Impact of preoperative right heart chambers measurement in the evaluation of pulmonary hypertension after aortic valve replacement.
    Chest (IF 9.657) Pub Date : 2020-01-17
    Mercè Cladellas; Cora Garcia-Ribas; Mirea Ble; Miquel Gómez; Núria Farré; Aleksandra Mas-Stachurska; Consol Ivern; Joan Vila; Julio Martí-Almor

    Background Severe pulmonary hypertension (PH) in patients with aortic stenosis is related to poor prognosis after aortic valve replacement (AVR). Current European PH guidelines recommend adding two different echocardiographic signs to tricuspid regurgitation velocity (TRV) in PH estimation, classifying its probability as “low” (TRV≤2.8m/s), “intermediate” (TRV 2.9-3.4m/s) and “high” (TRV>3.4m/s). Right ventricle (RV) is an important determinant of prognosis in PH. Our aim was to analyze the value of right atrial area>18cm2 and RV/left ventricle ratio>1 in the long-term prognosis after AVR, mainly in the “intermediate” group. Methods We included 429 consecutive patients (mean age 73±8 years, 55% males) with median follow-up of 4.25 years (completed in 98%). Patients were divided into “low” (n=247), “intermediate” (n=117) and “high” groups (n=65). The “intermediate” group was divided into 2 subgroups: “subgroup 2a” (n=27, TRV non-measurable or ≤2.8m/s and two signs present) and “subgroup 2b” (n=90, TRV 2.9-3.4m/s and none or only one sign present). Results Overall mortality rates during follow-up of the “low”, “intermediate” and “high” were 24%, 32% and 42%, respectively. “High” PH probability was an independent predictor of all-cause mortality (HR 1.82; 95% CI:1.11-3.00), but the "intermediate" group did not reach significance after multivariate analysis (HR 1.40; 95% CI: 0.91-2.16). When the "intermediate" group was divided into subgroups, “subgroup 2a” mortality rate (56%) was higher than that of both “subgroup 2b” (24%, p=0.002) and the "low" group (24%, p<0.001). After multivariate analysis, “subgroup 2a” showed a significantly higher mortality (HR 2.13; 95% CI: 1.11-4.10) in contrast to “subgroup 2b” (HR 1.24, 95% CI: 0.75-2.05), both compared to the low group. Conclusions Incorporating right cavities measures to the PH probability model in the assessment of long-term prognosis after AVR, allows better risk discrimination, especially in the “intermediate” group.

    更新日期:2020-01-17
  • A Systematic Review of Digital Versus Analog Drainage for Air Leak Following Surgical Resection or Spontaneous Pneumothorax
    Chest (IF 9.657) Pub Date : 2020-01-17
    Fadi Aldaghlawi; Jonathan S. Kurman; Jason A. Lilly; D. Kyle Hogarth; Jessica Donington; Mark K. Ferguson; Septimiu D. Murgu

    Background The concerns regarding air leak following lung surgery or spontaneous pneumothorax include detection and duration. Prior studies have suggested that digital drainage systems permit a shorter chest tube duration and hospital length of stay (LOS) by earlier detection of air leak cessation. We conducted a systematic review to assess the impact of digital drainage on chest tube duration and hospital LOS following pulmonary surgery and spontaneous pneumothorax. Methods Ovid MEDLINE, PubMed, Embase, the Cochrane Library, Scopus, and Google Scholar were searched from inception through January 2019. We included randomized controlled trials, cohort studies, and case series of adult patients using digital or traditional drainage devices for air leaks of either post-surgical or spontaneous pneumothorax origin. Results Of 1,272 references reviewed, 23 articles were included. Nineteen articles addressed post-operative air leak, while 4 articles pertained to air leak after spontaneous pneumothorax. Thirteen studies were randomized controlled trials. Digital drainage resulted in significantly shorter chest tube duration in 8 of 18 studies and shorter hospital LOS in 6 of 14 studies for post-operative air leak. For post-pneumothorax air leak, digital drainage resulted in a significantly shorter chest tube duration in 2 of 3 studies and hospital LOS in 1 of 2 studies with an analog control group. Conclusions Most studies show no significant differences in chest tube duration and hospital LOS with digital versus analog drainage systems for patients with air leak after pulmonary resection. For post spontaneous pneumothorax air leak, the limited published evidence suggests a shorter chest tube duration and hospital LOS with analog drainage systems.

    更新日期:2020-01-17
  • Engineered skin graft with stromal vascular fraction cells encapsulated in fibrin–collagen hydrogel: A clinical study for diabetic wound healing
    J. Tissue Eng. Regen. Med. (IF 3.319) Pub Date : 2020-01-17
    Mohammad Ali Nilforoushzadeh; Mahsa Mollapour Sisakht; Mohammad Amir Amirkhani; Alexander M. Seifalian; Hamid Reza Banafshe; Javad Verdi; Mehdi Nouradini

    Despite the abundance of skin substitutes in the worldwide market, major hurdles in developing more complex tissues include the addition of skin appendages and vascular networks as the most important structure. The aim of this research was a clinical feasibility study of a novel prevascularized skin grafts containing the dermal and epidermal layer using the adipose stromal vascular fraction (SVF)‐derived endothelial cell population for vascular network regeneration. Herein, we characterized hydrogel with emphasis on biological compatibility and cell proliferation, migration, and vitality. The therapeutic potential of the prevascularized hydrogel transplanted on five human subjects as an intervention group with diabetic wounds was compared with nonvascularized skin grafts as the control on five patients. Wound planimetric and biometric analysis was performed using a Mann–Whitney nonparametric t‐test (p ≤ .05). The fibrin–collagen hydrogel was suitable for skin organotypic cell culture. There was a significant (p ≤ .05) increased in skin thickness and density in the vascular beds of the hypodermis measured with skin scanner compared with that in the control group. No significant macroscopic differences were observed between the intervention and control groups (p ≤ .05). In summary, we report for the first time the use of autologous dermal–epidermal skin grafts with intrinsic vascular plexus in a clinical feasibility study. The preliminary data showed that SVF‐based full‐thickness skin grafts are safe and accelerate the wound healing process. The next stage of the study is a full‐scale randomized clinical trial for the treatment of patients with chronic wounds.

    更新日期:2020-01-17
  • Education and information needs for physicians about rare diseases in Spain
    Orphanet J. Rare Dis. (IF 3.687) Pub Date : 2020-01-17
    Enrique Ramalle-Gómara; Elena Domínguez-Garrido; María Gómez-Eguílaz; María Eugenia Marzo-Sola; José Luis Ramón-Trapero; Josefa Gil-de-Gómez

    Rare diseases are a priority objective for public health systems. Given its complexity, late and misdiagnoses occur very often which causes mental and physical burden for patients and family. This would be caused, in part, for unprepared clinicians in this field. The aim of this study was to report the training needs and the perceived shortcomings of Spanish physicians of the public health system in the diagnosis, treatment and monitoring of patients with rare diseases. We used a descriptive cross-sectional study through an “ad hoc” survey of 26 questions was completed by 132 primary care physicians and 37 specialists during April and May 2018. Less than a third of the physicians had received training in rare disease during their undergraduate or postgraduate years, and for hospital professionals, they received more training in the postgraduate period. Primary care physicians and specialists showed low training level in rare diseases. An academical and continuous program on rare disease, as well as, multidisciplinary units and high quality practice guidelines are necessary to help to prevention and support clinical decisions and improve quality of care of patients and families.

    更新日期:2020-01-17
  • Finnish gelsolin amyloidosis causes significant disease burden but does not affect survival: FIN-GAR phase II study
    Orphanet J. Rare Dis. (IF 3.687) Pub Date : 2020-01-17
    Eeva-Kaisa Schmidt; Tuuli Mustonen; Sari Kiuru-Enari; Tero T. Kivelä; Sari Atula

    Hereditary gelsolin (AGel) amyloidosis is an autosomal dominantly inherited systemic amyloidosis that manifests with the characteristic triad of progressive ophthalmological, neurological and dermatological signs and symptoms. The National Finnish Gelsolin Amyloidosis Registry (FIN-GAR) was founded in 2013 to collect clinical data on patients with AGel amyloidosis, including altogether approximately one third of the Finnish patients. We aim to deepen knowledge on the disease burden and life span of the patients using data from the updated FIN-GAR registry. We sent an updated questionnaire concerning the symptoms and signs, symptomatic treatments and subjective perception on disease progression to 240 members of the Finnish Amyloidosis Association (SAMY). We analyzed the lifespan of 478 patients using the relative survival (RS) framework. The updated FIN-GAR registry includes 261 patients. Symptoms and signs corresponding to the classical triad of ophthalmological (dry eyes in 93%; corneal lattice amyloidosis in 89%), neurological (numbness, tingling and other paresthesias in 75%; facial paresis in 67%), and dermatological (drooping eyelids in 86%; cutis laxa in 84%) manifestations were highly prevalent. Cardiac arrhythmias were reported by 15% of the patients and 5% had a cardiac pacemaker installed. Proteinuria was reported by 13% and renal failure by 5% of the patients. A total of 65% of the patients had undergone a skin or soft tissue surgery, 26% carpal tunnel surgery and 24% at least unilateral cataract surgery. As regards life span, relative survival estimates exceeded 1 for males and females until the age group of 70–74 years, for which it was 0.96. AGel amyloidosis causes a wide variety of ophthalmological, neurological, cutaneous, and oral symptoms that together with repeated surgeries cause a clinically significant disease burden. Severe renal and cardiac manifestations are rare as compared to other systemic amyloidoses, explaining in part the finding that AGel amyloidosis does not shorten the life span of the patients at least for the first 75 years.

    更新日期:2020-01-17
  • Evaluation of retinal microvascular perfusion in hereditary angioedema: a case-control study
    Orphanet J. Rare Dis. (IF 3.687) Pub Date : 2020-01-17
    Paola Triggianese; Massimo Cesareo; Maria Domenica Guarino; Paola Conigliaro; Maria Sole Chimenti; Francesca Cedola; Caterina Mazzeo; Carlo Nucci; Roberto Perricone

    Evidence supports that hereditary angioedema (HAE) may be considered as a paroxysmal permeability disorder with defective but self-limiting endothelial barrier dysfunction. A potential subclinical abnormal vascular permeability at retinal capillaries could induce damage resulting in retinopathy. We aimed at exploring for the first time the presence of microangiopathy at retinal level from a highly selective cohort of patients with HAE due to C1 esterase inhibitor protein (C1INH) deficiency (type I). We conducted a pilot, prospective, case-control study including 20 type I HAE patients and 20 age−/sex-matched healthy controls (HC). All participants underwent standard ophthalmological examination including visual fields. Superficial and deep capillary plexi in the retina were analyzed by using new optical coherence tomography angiography (OCT-A). A total of 40 eyes from 20 HAE patients and 20 eyes from HC were evaluated. Perimetric indices of visual field were slightly worse in HAE than in controls. OCT-angiograms documented in HAE patients a lower retinal capillary density in both superficial and deep scans and a higher retinal thickness compared to healthy eyes. Our findings firstly documented subclinical abnormalities in retinal microvascular network in type I HAE patients that might be associated with early subtle functional changes. This preliminary evidence supports the hypothesis of a recurrent endothelial barrier failure at retinal level in HAE patients potentially resulting in chronic damage.

    更新日期:2020-01-17
  • ‘Jump start’ childcare-based intervention to promote physical activity in pre-schoolers: six-month findings from a cluster randomised trial
    Int. J. Behav. Nutr. Phys. Act. (IF 6.037) Pub Date : 2020-01-16
    Anthony D. Okely; Rebecca M. Stanley; Rachel A. Jones; Dylan P. Cliff; Stewart G. Trost; Donna Berthelsen; Jo Salmon; Marijka Batterham; Simon Eckermann; John J. Reilly; Ngiare Brown; Karen J. Mickle; Steven J. Howard; Trina Hinkley; Xanne Janssen; Paul Chandler; Penny Cross; Fay Gowers

    Participation in adequate levels of physical activity during the early years is important for health and development. We report the 6-month effects of an 18-month multicomponent intervention on physical activity in early childhood education and care (ECEC) settings in low-income communities. A cluster randomised controlled trial was conducted in 43 ECEC settings in disadvantaged areas of New South Wales, Australia. Three-year-old children were recruited and assessed in the first half of 2015 with follow-up 6 months later. The intervention was guided by Social Cognitive Theory and included five components. The primary outcome was minutes per hour in total physical activity during ECEC hours measured using Actigraph accelerometers. Intention-to-treat analysis of the primary outcome was conducted using a generalized linear mixed model. A total of 658 children were assessed at baseline. Of these, 558 (85%) had valid accelerometer data (mean age 3.38y, 52% boys) and 508 (77%) had valid accelerometry data at 6-month follow-up. Implementation of the intervention components ranged from 38 to 72%. There were no significant intervention effects on mins/hr. spent in physical activity (adjusted difference = − 0.17 mins/hr., 95% CI (− 1.30 to 0.97), p = 0.78). A priori sub-group analyses showed a greater effect among overweight/obese children in the control group compared with the intervention group for mins/hr. of physical activity (2.35mins/hr., [0.28 to 4.43], p = 0.036). After six-months the Jump Start intervention had no effect on physical activity levels during ECEC. This was largely due to low levels of implementation. Increasing fidelity may result in higher levels of physical activity when outcomes are assessed at 18-months. Australian New Zealand Clinical Trials Registry ACTRN12614000597695.

    更新日期:2020-01-17
  • What hinders and helps academics to conduct Dissemination and Implementation (D&I) research in the field of nutrition and physical activity? An international perspective
    Int. J. Behav. Nutr. Phys. Act. (IF 6.037) Pub Date : 2020-01-16
    Harriet Koorts; Patti-Jean Naylor; Rachel Laws; Penelope Love; Jaimie-Lee Maple; Femke van Nassau

    Ineffective research-practice translation is a major challenge to population health improvement. This paper presents an international perspective on the barriers and facilitators associated with the uptake of and engagement in Dissemination and Implementation (D&I) research in the fields of physical activity and nutrition. A mixed methods study involving participants from the International Society for Behavioral Nutrition and Physical Activity (ISBNPA) network. Participants completed an online survey (May–July 2018) and/or participated in a focus group during the annual ISBNPA conference (June 2018). Descriptive statistics were generated for quantitative online and pre-focus group survey data. Fisher’s exact tests investigated associations of (i) length of time in academia, (ii) career stage and (iii) country of work, and agreement with ‘perceptions of D&I’. Qualitative data were analysed thematically. In total, 141 participants responded to the survey (76% female, 21% aged 35–39 years, 14 countries represented) and 25 participated in focus groups (n = 3). Participants self-identified as having knowledge (48%), skills (53%) and experience supporting others (40%) to conduct D&I research. The majority (96%) perceived D&I was important, with 66% having organizational support for D&I, yet only 52% reported prioritizing D&I research. Perceptions of D&I differed by length of time in academia, career stage and country of work. Barriers included: (i) lack of D&I expertise; (ii) lack of organisational support/value for D&I; (iii) embedded scientific beliefs/culture; (iv) methodological challenges with D&I research; (v) funding/publishing priorities and; (vi) academic performance structures. Facilitators included: (i) increased presence/value of D&I; (ii) collective advocacy; (iii) organisational support for D&I; (iv) recruitment of D&I scientists and; (v) restructure of academic performance models, funding/publishing criteria. Individual, organisational and system-wide factors hindered academics’ engagement with and support for D&I research, which was perceived to reduce opportunities for research-practice translation. Factors were mostly consistent across countries and individual career stages/time spent in academia. Embedding D&I early within academic training, and system-wide reorientation of academic performance and funding structures to promote and facilitate D&I research, are some of the necessary actions to reduce the research-practice gap. Consistent with public health more broadly, these changes are long overdue in the fields of physical activity and nutrition.

    更新日期:2020-01-17
  • Neighbourhood drivability: environmental and individual characteristics associated with car use across Europe
    Int. J. Behav. Nutr. Phys. Act. (IF 6.037) Pub Date : 2020-01-17
    Nicolette R. den Braver; Julia G. Kok; Joreintje D. Mackenbach; Harry Rutter; Jean-Michel Oppert; Sofie Compernolle; Jos W. R. Twisk; Johannes Brug; Joline W. J. Beulens; Jeroen Lakerveld

    Car driving is a form of passive transportation associated with higher sedentary behaviour, which is associated with morbidity. The decision to drive a car is likely to be influenced by the ‘drivability’ of the built environment, but there is lack of scientific evidence regarding the relative contribution of environmental characteristics of car driving in Europe, compared to individual characteristics. This study aimed to determine which neighbourhood- and individual-level characteristics were associated with car driving in adults of five urban areas across Europe. Second, the study aimed to determine the percentage of variance in car driving explained by individual- and neighbourhood-level characteristics. Neighbourhood environment characteristics potentially related to car use were identified from the literature. These characteristics were subsequently assessed using a Google Street View audit and available GIS databases, in 59 administrative residential neighbourhoods in five European urban areas. Car driving (min/week) and individual level characteristics were self-reported by study participants (analytic sample n = 4258). We used linear multilevel regression analyses to assess cross-sectional associations of individual and neighbourhood-level characteristics with weekly minutes of car driving, and assessed explained variance at each level and for the total model. Higher residential density (β:-2.61, 95%CI: − 4.99; -0.22) and higher land-use mix (β:-3.73, 95%CI: − 5.61; -1.86) were significantly associated with fewer weekly minutes of car driving. At the individual level, higher age (β: 1.47, 95%CI: 0.60; 2.33), male sex (β: 43.2, 95%CI:24.7; 61.7), being employed (β:80.1, 95%CI: 53.6; 106.5) and ≥ 3 person household composition (β: 47.4, 95%CI: 20.6; 74.2) were associated with higher weekly minutes of car driving. Individual and neighbourhood characteristics contributed about equally to explained variance in minutes of weekly car driving, with 2 and 3% respectively, but total explained variance remained low. Residential density and land-use mix were neighbourhood characteristics consistently associated with minutes of weekly car driving, besides age, sex, employment and household composition. Although total explained variance was low, both individual- and neighbourhood-level characteristics were similarly important in their associations with car use in five European urban areas. This study suggests that more, higher quality, and longitudinal data are needed to increase our understanding of car use and its effects on determinants of health.

    更新日期:2020-01-17
  • Overcoming barriers to evidence-based patient blood management: a restricted review
    Implement. Sci. (IF 4.525) Pub Date : 2020-01-17
    Alana Delaforce; Jed Duff; Judy Munday; Janet Hardy

    Blood transfusions are associated with a range of adverse patient outcomes, including coagulopathy, immunomodulation and haemolysis, which increase the risk of morbidity and mortality. Consideration of these risks and potential benefits are necessary when deciding to transfuse. Patient blood management (PBM) guidelines exist to assist in clinical decision-making, but they are underutilised. Exploration of barriers to the implementation and utilisation of the PBM guidelines is required. This study aimed to identify common barriers and implementation strategies used to implement PBM guidelines, with a comparison against current expert opinion. A restricted review approach was used to identify the barriers to PBM guideline implementation as reported by health professionals and to review which implementation strategies have been used. Searches were undertaken in MEDLINE/PubMed, CINAHL, Embase, Scopus and the Cochrane library. The Consolidated Framework for Implementation Research (CFIR) was used to code barriers. The Expert Recommendations for Implementing Change (ERIC) tool was used to code implementation strategies, and subsequently, develop recommendations based on expert opinion. We identified 14 studies suitable for inclusion. There was a cluster of barriers commonly reported: access to knowledge and information (n = 7), knowledge and beliefs about the intervention ( = 7) and tension for change (n = 6). Implementation strategies used varied widely (n = 25). Only one study reported the use of an implementation theory, model or framework. Most studies (n = 11) had at least 50% agreement with the ERIC recommendations. There are common barriers experienced by health professionals when trying to implement PBM guidelines. There is currently no conclusive evidence to suggest which implementation strategies are most effective. Further research using validated implementation approaches and improved reporting is required.

    更新日期:2020-01-17
  • Temporal and anatomical distribution of 18F-flutemetamol uptake in canine brain using positron emission tomography
    BMC Vet. Res. (IF 1.792) Pub Date : 2020-01-17
    Taesik Yun; Wonguk Lee; Ji-Houn Kang; Mhan-Pyo Yang; Byeong-Teck Kang

    Positron emission tomography (PET) is increasingly being used as an imaging modality for clinical and research applications in veterinary medicine. Amyloid PET has become a useful tool for diagnosing Alzheimer’s disease (AD) in humans, by accurately identifying amyloid-beta (Aβ) plaques. Cognitive dysfunction syndrome in dogs shows cognitive and pathophysiologic characteristics similar to AD. Therefore, we assessed the physiologic characteristics of uptake of 18F-flutemetamol, an Aβ protein-binding PET tracer in clinical development, in normal dog brains, for distinguishing an abnormal state. Static and dynamic PET images of six adult healthy dogs were acquired after 18F-flutemetamol was administered intravenously at approximately 3.083 MBq/kg. For static images, PET data were acquired at 30, 60, and 90 min after injection. One week later, dynamic images were acquired for 120 min, from the time of tracer injection. PET data were reconstructed using an iterative technique, and corrections for attenuation and scatter were applied. Regions of interest were manually drawn over the frontal, parietal, temporal, occipital, anterior cingulate, posterior cingulate, and cerebellar cortices, cerebral white matter, midbrain, pons, and medulla oblongata. After calculating standardized uptake values with an established formula, standardized uptake value ratios (SUVRs) were obtained, using the cerebellar cortex as a reference region. Among the six cerebral cortical regions, the cingulate cortices and frontal lobe showed the highest SUVRs. The lowest SUVR was observed in the occipital lobe. The average values of the cortical SUVRs were 1.25, 1.26, and 1.27 at 30, 60, and 90 min post-injection, respectively. Tracer uptake on dynamic scans was rapid, peaking within 4 min post-injection. After reaching this early maximum, cerebral cortical regions showed a curve with a steep descent, whereas cerebral white matter demonstrated a curve with a slow decline, resulting in a large gap between cerebral cortical regions and white matter. This study provides normal baseline data of 18F-flutemetamol PET that can facilitate an objective diagnosis of cognitive dysfunction syndrome in dogs in future.

    更新日期:2020-01-17
  • Variation in the implementation of PaTz: a method to improve palliative care in general practice - a prospective observational study
    BMC Palliat. Care (IF 2.922) Pub Date : 2020-01-16
    Ian Koper; H. Roeline W. Pasman; Bart P. M. Schweitzer; Greet van der Zweep; Gon Uyttewaal; Bregje D. Onwuteaka-Philipsen

    PaTz (palliative care at home) is a method to improve palliative care in the primary care setting in the Netherlands. PaTz has three basic principles: (1) local GPs and DNs meet at least six times per year to identify and discuss their patients with a life-threatening illness; (2) these meetings are supervised by a specialist palliative care professional; (3) groups use a palliative care register on which all identified patients are listed. Since the start in 2010, the number of PaTz-groups in the Netherlands has been growing consistently. Although the theory of all PaTz-groups is the same, the practical functioning of PaTz-groups may vary substantially, which may complicate further implementation of PaTz as well as interpretation of effect studies. This study aims to describe the variation in practice of PaTz-groups in the Netherlands. In this prospective observational study, ten PaTz-groups logged and described the activities in their meetings as well as the registered and discussed patients and topics of discussions in registration forms for a 1 year follow-up period. In addition, non-participatory observations were performed in all participating groups. Meeting and patient characteristics were analysed using descriptive statistics. Conventional content analysis was performed in the analysis of topic discussions. While the basic principles of PaTz are found in almost every PaTz-group, there is considerable variation in the practice and content of the meetings of different PaTz-groups. Most groups spend little time on other topics than their patients, although the number of patients discussed in a single meeting varies considerably, as well as the time spent on an individual patient. Most registered patients were diagnosed with cancer and patient discussions mainly concerned current affairs and rarely concerned future issues. The basic principles are the cornerstone of any PaTz-group. At the same time, the observed variation between PaTz-groups indicates that tailoring a PaTz-group to the needs of its participants is important and may enhance its sustainability. The flexibility of PaTz-groups may also provide opportunity to modify the content and tools used, and improve identification of palliative patients and advance care planning.

    更新日期:2020-01-17
  • Management of constipation in long-term care hospitals and its ward manager and organization factors
    BMC Nurs. (IF 0) Pub Date : 2020-01-16
    Manami Takaoka; Ayumi Igarashi; Asako Futami; Noriko Yamamoto-Mitani

    Studies examining organizational factors that may influence constipation management in long-term care (LTC) hospitals are lacking. This study aimed to clarify the practice of constipation management in LTC hospitals and to explore its factors, including ward manager’s perception, organizational climate, and constipation assessment. In this cross-sectional questionnaire survey of ward managers and staff nurses working in LTC wards, we determined daily assessment and practices regarding constipation management. We also conducted multivariate analyses to examine factors related to constipation management. There was a 20% response rate to the questionnaire. Nearly all LTC wards routinely assessed bowel movement frequency; other assessments were infrequent. Laxatives were used, but the use of dietary fiber and probiotic products was implemented in only 20–30% of wards. The implementation of non-pharmacological management and adequate use of stimulant laxatives were positively associated with the ward manager’s belief and knowledge, organizational climate, the existence of nursing records for constipation assessment, planned nursing care for constipation, and organized conferences and in-hospital study sessions on constipation management. Areas to improve constipation management in LTC hospitals include altering the ward manager’s perception, improving hospital’s organizational climate, and introducing standardized assessment/care planning systems.

    更新日期:2020-01-17
  • A systematic survey of randomised trials that stopped early for reasons of futility
    BMC Med. Res. Methodol. (IF 2.509) Pub Date : 2020-01-16
    S. D. Walter; H. Han; G. H. Guyatt; D. Bassler; N. Bhatnagar; V. Gloy; S. Schandelmaier; M. Briel

    Randomised trial protocols may incorporate interim analyses, with the potential to stop the study for futility if early data show insufficient promise of a treatment benefit. Previously, we have shown that this approach will theoretically lead to mis-estimation of the treatment effect. We now wished to ascertain the importance of this phenomenon in practice. We reviewed the methods and results in a set of trials that had stopped for futility, identified through an extensive literature search. We recorded clinical areas, interventions, study design, outcomes, trial setting, sponsorship, planned and actual treatment effects, sample sizes; power; and if there was a data safety monitoring board, or a published protocol. We identified: if interim analyses were pre-specified, and how many analyses actually occurred; what pre-specified criteria might define futility; if a futility analysis formed the basis for stopping; who made the decision to stop; and the conditional power of each study, i.e. the probability of statistically significant results if the study were to continue to its complete sample size. We identified 52 eligible trials, covering many clinical areas. Most trials had multiple centres, tested drugs, and 40% were industry sponsored. There were 75% where at least one interim analysis was planned a priori; a majority had only one interim analysis, typically with about half the target total sample size. A majority of trials did not pre-define a stopping rule, and a variety of reasons were given for stopping. Few studies calculated and reported low conditional power to justify the early stop. When conditional power could be calculated, it was typically low, especially under the current trend hypothesis. However, under the original design hypothesis, a few studies had relatively high conditional power. Data collection often continued after the interim analysis. Although other factors will typically be involved, we conclude that, from the perspective of conditional power, stopping early for futility was probably reasonable in most cases, but documentation of the basis for stopping was often missing or vague. Interpretation of truncated trials would be enhanced by improved reporting of stopping protocols, and of their actual execution.

    更新日期:2020-01-17
  • The TRANSFER Approach for assessing the transferability of systematic review findings
    BMC Med. Res. Methodol. (IF 2.509) Pub Date : 2020-01-17
    Heather Munthe-Kaas; Heid Nøkleby; Simon Lewin; Claire Glenton

    Systematic reviews are a key input to health and social welfare decisions. Studies included in systematic reviews often vary with respect to contextual factors that may impact on how transferable review findings are to the review context. However, many review authors do not consider the transferability of review findings until the end of the review process, for example when assessing confidence in the evidence using GRADE or GRADE-CERQual. This paper describes the TRANSFER Approach, a novel approach for supporting collaboration between review authors and stakeholders from the beginning of the review process to systematically and transparently consider factors that may influence the transferability of systematic review findings. We developed the TRANSFER Approach in three stages: (1) discussions with stakeholders to identify current practices and needs regarding the use of methods to consider transferability, (2) systematic search for and mapping of 25 existing checklists related to transferability, and (3) using the results of stage two to develop a structured conversation format which was applied in three systematic review processes. None of the identified existing checklists related to transferability provided detailed guidance for review authors on how to assess transferability in systematic reviews, in collaboration with decision makers. The content analysis uncovered seven categories of factors to consider when discussing transferability. We used these to develop a structured conversation guide for discussing potential transferability factors with stakeholders at the beginning of the review process. In response to feedback and trial and error, the TRANSFER Approach has developed, expanding beyond the initial conversation guide, and is now made up of seven stages which are described in this article. The TRANSFER Approach supports review authors in collaborating with decision makers to ensure an informed consideration, from the beginning of the review process, of the transferability of the review findings to the review context. Further testing of TRANSFER is needed.

    更新日期:2020-01-17
  • Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-16
    Christoph Schickhardt; Henrike Fleischer; Eva C. Winkler

    As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

    更新日期:2020-01-17
  • Identifying and addressing social determinants of health in outpatient practice: results of a program-wide survey of internal and family medicine residents
    BMC Med. Educ. (IF 1.87) Pub Date : 2020-01-16
    Lauren A. Gard; Andrew J. Cooper; Quentin Youmans; Aashish Didwania; Stephen D. Persell; Muriel Jean-Jacques; Paul Ravenna; Mita Sanghavi Goel; Matthew J. O’Brien

    Up to 60% of preventable mortality is attributable to social determinants of health (SDOH), yet training on SDOH competencies is not widely implemented in residency. The objective of this study was to assess internal and family medicine residents’ competence at identifying and addressing SDOH. Residents’ perceived competence at identifying, discussing, and addressing SDOH in outpatient settings was assessed using a single questionnaire administered in March 2017. In this cross-sectional analysis, bivariate associations of resident characteristics with the following outcomes were examined: identifying, discussing, and addressing patients’ challenges related to SDOH through referrals. The survey was completed by 129 (84%) residents. Twenty residents (16%) reported an annual income of less than $50,000 during childhood. Overall, 108 residents (84%) reported previous SDOH training. Two-thirds had outpatient practices in Veterans Affairs or safety-net clinics. Thirty-nine (30%) intended to pursue a career in primary care. The following numbers of residents reported high levels of competence for performing these outcomes: identifying patients’ challenges related to SDOH: 37 (29%); discussing them with patients: 18 (14%); and addressing these challenges through referrals to internal and external resources: 13 (10%) and 11 (9%), respectively. Factors associated with higher competence included older age, lower childhood household income, prior education about SDOH, primary practice site and intention to practice primary care. Most residents had previous SDOH training, yet only a small proportion of residents reported being highly competent at identifying or addressing SDOH. Providing opportunities for practical training may be a key component in preparing medical residents to identify and address SDOH effectively in outpatient practice.

    更新日期:2020-01-17
  • Evidence-based medicine self-assessment, knowledge, and integration into daily practice: a survey among Romanian physicians and comparison between trainees and specialists
    BMC Med. Educ. (IF 1.87) Pub Date : 2020-01-16
    Roxana-Denisa Capraş; Adriana Elena Bulboacă; Sorana D. Bolboacă

    A gap between the attitude towards evidence-based medicine (EBM), knowledge and awareness has been reported among physicians from different parts of the world. However, no investigation on Romanian physicians is available in the scientific literature. Our study aimed, firstly, to assess EBM awareness and the knowledge used by Romanian physicians, and, secondly, to compare resident trainees with specialists. Romanian trainee and specialist physicians were invited to participate in this cross-sectional study. The study tool was an online questionnaire designed to explore their awareness, knowledge, usefulness, the attitude in medical documentation, and the use of professional EBM resources. Data were collected by Google Form from January 1st to April 30th, 2017, respecting the responders’ anonymity. Two groups of physicians were investigated as trainees and specialists, respectively. Descriptive statistics (number, percentage, median and interquartile range) was used to describe the survey-related variables. Statistical significance on qualitative data was calculated with the Chi-square test, Fisher’s exact test, or the Z-test for proportions. Two hundred and 50 physicians participated in this study (68% trainees vs. 32% specialists). In both groups, a significantly high percentage was represented by women as compared to men (trainees 72.4%, specialists 70%). The correct definition of EBM was identified by most respondents (75.6%). Affirmatively, both trainees and specialists always looked at levels of evidence when reading scientific literature, but a small percentage (6.5% trainees and 3% specialists) adequately identified the uppermost types of evidence in the hierarchy. Almost a quarter of the respondents shared the name of mobile EBM resources that they used to support the daily practice. Only six out of the 49 listed mobile resources met the EBM criteria. The participants proved to have limited knowledge of EBM and a positive attitude towards the concept. They made use of mobile medical resources without understanding which of these were evidence-based.

    更新日期:2020-01-17
  • Curricular changes: the impact on medical students knowledge of neuroanatomy
    BMC Med. Educ. (IF 1.87) Pub Date : 2020-01-17
    Mavilde Arantes; José Paulo Andrade; Joselina Barbosa; Maria Amélia Ferreira

    Although neuroanatomy is considered an essential requirement in medical curriculum, its teaching has undergone many changes in recent years, with most medical schools starting to implement an integrated approach. The current paper describes the comparative evaluation of the neuroanatomy knowledge scores of medical students who attended two different pedagogic approaches of neuroanatomy in the Faculty of Medicine of the University of Porto. Forty fourth-year medical students who attended a traditional stand-alone approach and 42 third-year medical students who attended an integrated approach completed a written test of knowledge. Although there were some significant differences, the results globally revealed no statistically significant difference between the neuroanatomy knowledge scores of the integrated and traditional education groups, with most students obtaining a passing score in both curricula. Our study is the first attempt to compare the knowledge acquired by medical students from two different pedagogical approaches to neuroanatomy. Although the integrated curricula were only implemented in the Faculty of Medicine of the University of Porto a few years ago, the students who attended these curricula obtained similar scores as those obtained by the students of the traditional curriculum. This finding suggests that an integrated curriculum can be, in light of curricular reform, an efficient approach to teaching neuroanatomy to medical students.

    更新日期:2020-01-17
  • Establishing content validity for a conceptualized instrument to measure barriers to eating a healthful diet in adults: a consensus approach
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-16
    Enia Zigbuo-Wenzler; Gayenell S. Magwood; Martina Mueller; Angela Fraser

    A poor quality diet is a well-known risk factor for many chronic diseases. However, eating a healthful diet is not always simple as many underlying factors can impede adherence. Individuals with fewer barriers are more likely to eat a healthful diet than those who have more barriers. Accurately measuring barriers to eating a healthful diet could inform personalized interventions, particularly those aiming to prevent chronic diseases. The aim of this study was to establish content validity for selected items obtained from the National Health and Nutrition Examination Survey (NHANES) database to be considered for inclusion as items on the conceptualized Dietary Health Status (DHS) instrument, which is designed to measure barriers to eating a healthful diet in adults. The Behavioral Change Wheel hub COM-B and the Theoretical Domains Framework (TDF) were the two theoretical frameworks underpinning the development of the DHS instrument. Seven steps were conducted to create the instrument: 1) development of operational definitions for each TDF domain; 2) identification of items from the NHANES database 2011–2012; 3) screening of items to ensure inclusion of all relevant items; 4) assigning items to a theory-based domain; 5) evaluation of the items against inclusion/exclusion criteria; 6) solicitation of feedback from expert reviewers to reach consensus on inclusion into a domain; and 7) validation of items. A total of 170 items representing twelve domains were identified as potential barriers to eating a healthful diet-- knowledge, optimism, beliefs about consequences, beliefs about capabilities, reinforcement, memory, attention and decision processes, environmental context and resources, social influences, emotion, behavioral regulation, health identity, and functional status. Expert review consultation and a consensus approach established content validity for 12 theory-based domains comprised of 170 items identified as potential barriers to eating a healthful diet. The use of these explanatory domains may: assist researchers to better understand barriers to adult dietary practices; inform the development of a screening tool that could be used in a community setting to measure barriers to eating a healthful diet; and inform individualized interventions.

    更新日期:2020-01-17
  • Acceptability of youth clubs focusing on comprehensive sexual and reproductive health education in rural Zambian schools: a case of Central Province
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-16
    Eunice Chirwa-Kambole; Joar Svanemyr; Ingvild Sandøy; Peter Hangoma; Joseph Mumba Zulu

    The youths in Zambia have limited access to information concerning Sexual Reproductive Health (SRH) and this puts them at risk of unwanted pregnancies. Talking about other methods of preventing pregnancy or sexually transmitted infections than abstinence is regarded as culturally unacceptable. The Research Initiative to Support the Empowerment of Girls (RISE) is a cluster randomised controlled trial testing the effectiveness of different support packages on teenage pregnancies, early marriages and school drop-out rates. One of the support packages included youth clubs focusing on Comprehensive Sexual and Reproductive Health Education (CSRHE). Although similar interventions have been implemented in other settings, their integration process has been complex and comprehensive assessments of factors shaping acceptability of CSRHE are lacking. This article qualitatively aimed at identifying factors that shaped the acceptability of CSRHE youth clubs in rural schools in Central Province. A qualitative case study was conducted after the youth clubs had been running for a year. Data were gathered through eight focus group discussions with grade eight pupils and eight individual interviews with teachers. Data were analysed using thematic analysis. The perceived advantage and simplicity of the clubs related to the use of participatory learning methods, films and role plays to communicate sensitive reproductive health information made the learners like the youth clubs. Further, the perceived compatibility of the content of the sessions with the science curriculum increased the learners’ interest in the youth clubs as the meetings also helped them to prepare for the school examinations. However, cultural and religious beliefs among teachers and parents regarding the use of contraceptives complicated the delivery of reproductive health messages and the acceptability of youth clubs’ information among the learners. The study indicated that CSRHE youth clubs may be acceptable in rural schools if participatory learning methods are used and head-teachers, teachers as well as parents appreciate and support the clubs.

    更新日期:2020-01-17
  • Patients’ and healthcare workers’ recommendations for a surgical patient safety checklist – a qualitative study
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-16
    Kristin Harris; Eirik Søfteland; Asgjerd Litleré Moi; Stig Harthug; Anette Storesund; Sebastius Jesuthasan; Nick Sevdalis; Arvid Steinar Haugen

    Patients’ involvement in patient safety has increased in healthcare. Use of checklists may improve patient outcome in surgery, though few have attempted to engage patients’ use of surgical checklist. To identify risk elements of complications based on patients’ and healthcare workers’ experiences is warranted. This study aims to identify what the patients and healthcare workers find to be the risk elements that should be included in a patient-driven surgical patient safety checklist. A qualitative study design where post-operative patients, surgeons, ward physicians, ward nurses, and secretaries from five surgical specialties took part in focus group interviews. Eleven focus groups were conducted including 25 post-operative patients and 27 healthcare workers at one tertiary teaching hospital and one community hospital in Norway. Based on their experiences, participants were asked to identify perceived risks before and after surgery. The interviews were analysed using content analysis. Safety risk factors were categorised as pre-operative information: pre-operative preparations, post-operative information, post-operative plans and follow-up. The subcategories under pre-operative information and preparations were: contact information, medication safety, health status, optimising health, dental status, read information, preparation two weeks before surgery, inform your surgical ward, planning your own discharge, preparation on admission and just before surgery. The subcategories under post-operative information, further plans and follow-up were: prevention and complications, restriction and activity, medication safety, pain relief, stomach functions, further care and appointments. Both healthcare workers and patients express the need for a surgical patient safety checklist. A broad spectre of risk elements for a patient safety checklist were identified. Developing a surgical safety checklist based on these risk elements might reduce complications and unwanted errors. The study is registered as part of a clinical trial in ClinicalTrials.gov: NCT03105713.

    更新日期:2020-01-17
  • Development of a percutaneous coronary intervention patient level composite measure for a clinical quality registry
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-17
    Darshini Ayton; Sze-Ee Soh; Renata Morello; Susannah Ahern; Arul Earnest; Angela Brennan; Jeffrey Lefkovits; Susan Evans; Christopher Reid; Rasa Ruseckaite; John McNeil

    Composite measures combine data to provide a comprehensive view of patient outcomes. Despite composite measures being a valuable tool to assess post-intervention outcomes, the patient perspective is often missing. The purpose of this study was to develop a composite measure for an established cardiac outcome registry, by combining clinical outcomes following percutaneous coronary interventions (PCI) with a patient-reported outcome measure (PROM) developed specifically for this population (MC-PROM). Two studies were undertaken. Study 1: Patients who had undergone a PCI at one of the three participating registry hospital sites completed the 5-item MC-PROM. Clinical outcome data for the patients (e.g. death, myocardial infarction, repeat vascularisation, new bleeding event) were collected 30 days post-intervention as part of routine data collection for the cardiac registry. Exploratory factor analysis of clinical outcomes and MC-PROM data was conducted to determine the minimum number of constructs to be included in a composite measure. Study 2: Clinical experts participated in a Delphi technique, consisting of three rounds of online surveys, to determine the clinical outcomes to be included and the weighting of the clinical outcomes and MC-PROM score for the composite measure. Study 1: Routine clinical outcomes and the MC-PROM data were collected from 266 patients 30 days post PCI. The MC-PROM score was not significantly correlated with any clinical outcomes. Study 2: There was a relatively consistent approach to the weighting of the clinical outcomes and MC-PROM items by the expert panel (n = 18) across the three surveys with the exception of the clinical outcome of ‘deceased at 30 days’. The final composite measure included five clinical outcomes within 30 days weighted at 90% (new heart failure, new myocardial infarction, new stent thrombosis, major bleeding event, new stroke, unplanned cardiac rehospitalisation) and the MC-PROM score (comprising 10% of the total weighting). A single patient level composite score, which incorporates weighted clinical outcomes and a PROM was developed. This composite score provides a more comprehensive reported measure of individual patient wellbeing at 30 days post their PCI-procedure, and may assist clinicians to further assess and address patient level factors that potentially impact on clinical recovery.

    更新日期:2020-01-17
  • Does insurance protect individuals from catastrophic payments for surgical care? An analysis of Ghana’s National Health Insurance Scheme at Korle-Bu teaching Hospital
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-17
    Juliet Okoroh; Doris Ottie-Boakye Sarpong; Samuel Essoun; Robert Riviello; Hobart Harris; Joel S. Weissman

    According to the World Health Organization, essential surgery should be recognized as an essential component of universal health coverage. In Ghana, insurance is associated with a reduction in maternal mortality and improved access to essential medications, but whether it eliminates financial barriers to surgery is unknown. This study tested the hypothesis that insurance protects surgical patients against financial catastrophe. We interviewed patients admitted to the general surgery wards of Korle-Bu Teaching Hospital (KBTH) between February 1, 2017 – October 1, 2017 to obtain demographic data, income, occupation, household expenditures, and insurance status. Surgical diagnoses and procedures, procedural fees, and anesthesia fees incurred were collected through chart review. The data were collected on a Qualtrics platform and analyzed in STATA version 14.1. Fisher exact and Student T-tests were used to compare the insured and uninsured groups. Threshold for financial catastrophe was defined as health costs that exceeded 10% of household expenditures, 40% of non-food expenditures, or 20% of the individual’s income. Among 196 enrolled patients, insured patients were slightly older [mean 49 years vs 40 years P < 0.05] and more of them were female [65% vs 41% p < 0.05]. Laparotomy (22.2%) was the most common surgical procedure for both groups. Depending on the definition, 58–87% of insured patients would face financial catastrophe, versus 83–98% of uninsured patients (all comparisons by definition were significant, p < .05). This study—the first to evaluate the impact of insurance on financial risk protection for surgical patients in Ghana—found that although insured patients were less likely than uninsured to face financial catastrophe as a result of their surgery, more than half of insured surgical patients treated at KBTH were not protected from financial catastrophe under the Ghana’s national health insurance scheme due to out-of-pocket payments. Government-specific strategies to increase the proportion of cost covered and to enroll the uninsured is crucial to achieving universal health coverage inclusive of surgical care. Registered at www.clinical trials.gov identifier NCT03604458.

    更新日期:2020-01-17
  • Negotiating bodily sensations between patients and GPs in the context of standardized cancer patient pathways – an observational study in primary care
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-17
    Cecilia Hultstrand; Anna-Britt Coe; Mikael Lilja; Senada Hajdarevic

    How interactions during patient-provider encounters in Swedish primary care construct access to further care is rarely explored. This is especially relevant nowadays since Standardized Cancer Patient Pathways have been implemented as an organizational tool for standardizing the diagnostic process and increase equity in access. Most patients with symptoms indicating serious illness as cancer initially start their diagnostic trajectory in primary care. Furthermore, cancer symptoms are diverse and puts high demands on general practitioners (GPs). Hence, we aim to explore how presentation of bodily sensations were constructed and legitimized in primary care encounters within the context of Standardized Cancer Patient Pathways (CPPs). Participant observations of patient-provider encounters (n = 18, on 18 unique patients and 13 GPs) were carried out at primary healthcare centres in one county in northern Sweden. Participants were consecutively sampled and inclusion criteria were i) patients (≥18 years) seeking care for sensations/symptoms that could indicate cancer, or had worries about cancer, Swedish speaking and with no cognitive disabilities, and ii) GPs who met with these patients during the encounter. A constructivist approach of grounded theory method guided the data collection and was used as a method for analysis, and the COREQ-checklist for qualitative studies (Equator guidelines) were employed. One conceptual model emerged from the analysis, consisting of one core category Negotiating bodily sensations to legitimize access, and four categories i) Justifying care-seeking, ii) Transmitting credibility, iii) Seeking and giving recognition, and iv) Balancing expectations with needs. We interpret the four categories as social processes that the patient and GP constructed interactively using different strategies to negotiate. Combined, these four processes illuminate how access was legitimized by negotiating bodily sensations. Patients and GPs seem to be mutually dependent on each other and both patients’ expertise and GPs’ medical expertise need to be reconciled during the encounter. The four social processes reported in this study acknowledge the challenging task which both patients and primary healthcare face. Namely, negotiating sensations signaling possible cancer and further identifying and matching them with the best pathway for investigations corresponding as well to patients’ needs as to standardized routines as CPPs.

    更新日期:2020-01-17
  • Examining health care providers’ and middle-level managers’ readiness for change: a qualitative study
    BMC Health Serv. Res. (IF 1.932) Pub Date : 2020-01-17
    Tujuanna Austin; Samia Chreim; Agnes Grudniewicz

    Readiness is a critical precursor of successful change; it denotes whether those involved in the change are motivated and empowered to participate in the change. Research on readiness tends to focus on frontline providers or individuals in non-managerial positions and offers limited attention to individuals in middle management positions who are expected to lead frontline providers in change implementation. Yet middle-level managers are also recipients of changes that are planned and decreed by those in higher positions. This study sought to examine both frontline provider and middle manager readiness for change in the context of primary care program integration. Using a qualitative case study approach, we examined how frontline providers and middle managers experienced six readiness factors: discrepancy, appropriateness, valence, efficacy, fairness and trust in management. Data were collected through documents, meeting observation and semi-structured interviews with frontline providers and middle managers involved in the change. The findings highlighted similarities and differences in readiness experiences of frontline providers and middle managers. Across both types of participants, we found that the notion of valence should be expanded to consider individuals’ evaluation of benefits to patients and the health system; efficacy applies to both content and process of change; fairness and trust in management findings require further exploration to determine their appropriateness to be incorporated in models of readiness for change; and trust in management (or lack of trust) has a cascading influence across the levels in the organization. Our study makes a contribution by nuancing and extending conceptualizations of individual readiness factors, and by highlighting the central role of middle manager readiness for change. Implications of the study include the need to consider readiness factors prior to the implementation of change and the importance of fostering readiness throughout all levels of the organization.

    更新日期:2020-01-17
  • Cordyceps militaris induces apoptosis in ovarian cancer cells through TNF-α/TNFR1-mediated inhibition of NF-κB phosphorylation
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-13
    Eunbi Jo; Hyun-Jin Jang; Kyeong Eun Yang; Min Su Jang; Yang Hoon Huh; Hwa-Seung Yoo; Jun Soo Park; Ik-Soon Jang; Soo Jung Park

    Cordyceps militaris (L.) Fr. (C. militaris) exhibits pharmacological activities, including antitumor properties, through the regulation of the nuclear factor kappa B (NF-κB) signaling. Tumor Necrosis Factor (TNF) and TNF-α modulates cell survival and apoptosis through NF- κB signaling. However, the mechanism underlying its mode of action on the NF-κB pathway is unclear. Here, we analyzed the effect of C. militaris extract (CME) on the proliferation of ovarian cancer cells by confirming viability, morphological changes, migration assay. Additionally, CME induced apoptosis was determined by apoptosis assay and apoptotic body formation under TEM. The mechanisms of CME were determined through microarray, immunoblotting and immunocytochemistry. CME reduced the viability of cells in a dose-dependent manner and induced morphological changes. We confirmed the decrease in the migration activity of SKOV-3 cells after treatment with CME and the consequent induction of apoptosis. Immunoblotting results showed that the CME-mediated upregulation of tumor necrosis factor receptor 1 (TNFR1) expression induced apoptosis of SKOV-3 cells via the serial activation of caspases. Moreover, CME negatively modulated NF-κB activation via TNFR expression, suggestive of the activation of the extrinsic apoptotic pathway. The binding of TNF-α to TNFR results in the disassociation of IκB from NF-κB and the subsequent translocation of the active NF-κB to the nucleus. CME clearly suppressed NF-κB translocation induced by interleukin (IL-1β) from the cytosol into the nucleus. The decrease in the expression levels of B cell lymphoma (Bcl)-xL and Bcl-2 led to a marked increase in cell apoptosis. These results suggest that C. militaris inhibited ovarian cancer cell proliferation, survival, and migration, possibly through the coordination between TNF-α/TNFR1 signaling and NF-κB activation. Taken together, our findings provide a new insight into a novel treatment strategy for ovarian cancer using C. militaris.

    更新日期:2020-01-17
  • Acute and sub-acute toxicity of Echinops kebericho decoction in rats
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-13
    Serawit Deyno; Abiy Abebe; Mesfin Asefa Tola; Ariya Hymete; Joel Bazira; Eyasu Makonnen; Paul E. Alele

    Echinops kebericho is widely used for treatment of a variety of diseases including infectious, non-infectious disease and fumigation during child birth. Antibacterial, antimalarial, anti-leshimania, anti-diarrheal and insect repellent activities have been elucidated. Its toxicity profile is not yet investigated and thus this study was to investigate acute and sub-acute toxicity of E. kebericho decoctions. Acute toxicity study was performed in female Wistar albino rats with single oral dose and followed up to 14 days. The sub-acute oral dose toxicity studies were conducted in rats of both sexes in accordance with the repeated dose 28-day oral toxicity study in rodent OECD guidelines. Physical observations were made regularly during the study period while body weight was measured weekly. Organ weight, histopathology, clinical chemistry and hematology data were collected on the 29th day. Results were presented as mean ± standard deviation. One-way analysis of variance (ANOVA) was performed if assumptions were met; otherwise Kruskal-Wallis analysis was performed. Oral administration of E. kebericho decoction showed no treatment-related mortality in female rats up to the dose of 5000 mg/kg. In sub-acute toxicity studies, no significant treatment-related abnormalities were observed compared to negative controls. Food consumption, body weight, organ weight, hematology, clinical chemistry, and histopathology did not show significant variation between controls and treatment groups. However, creatinine, relative lung weight, triglycerides, and monocytes were lower in treated compared to control groups. Significant variations between male and female groups in food consumption, relative organ weight, hematology, clinical chemistry were observed. Histolo-pathology of high-dose treated groups showed fatty liver. Echinops kebericho showed LD50 of greater than 5000 mg/kg in acute toxicity study and is well tolerated up to the dose of 600 mg/kg body weight in sub-acute toxicity study.

    更新日期:2020-01-17
  • Xiao-ai-ping injection adjunct with platinum-based chemotherapy for advanced non-small-cell lung cancer: a systematic review and meta-analysis
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-13
    Fanchao Feng; Jingyi Huang; Zhichao Wang; Jiarui Zhang; Di Han; Qi Wu; Hailang He; Xianmei Zhou

    Xiao-ai-ping injection (XAPI), as patented Chinese medicine, has shown promising outcomes in non-small-cell lung cancer (NSCLC) patients. This meta-analysis investigated the efficacy and safety of XAPI in combination with platinum-based chemotherapy. A comprehensive literature search was conducted to identify relevant studies in Pubmed, EMBASE, the Cochrane Library, Chinese National Knowledge Infrastructure, Wangfang Database, VIP Database, and Chinese Biology Medical Database from the date of their inception to September 2018. The RevMan 5.3 software was applied to calculate the risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI). We included and analyzed 24 randomized controlled trials. The meta-analysis showed that XAPI adjunctive to platinum-based chemotherapy had better outcomes in objective tumor response rate (ORR) (RR: 1.27, 95% CI, 1.14–1.40); improved Karnofsky performance scores (KPS) (RR: 1.70, 95% CI, 1.48–1.95); reduction in occurrence of grade 3/4 leukopenia (RR: 0.49, 95% CI, 0.38–0.64), anemia (RR: 0.63, 95% CI, 0.46–0.87) and thrombocytopenia (RR: 0.53, 95% CI, 0.38–0.73), nausea and vomiting (RR: 0.57, 95% CI, 0.36–0.90); and enhanced immune function (CD8+ [MD: 4.96, 95% CI, 1.16–8.76] and CD4+/CD8+ [MD: 2.58, 95% CI, 1.69–3.47]). However, it did not increase dysregulated liver and kidney function, diarrhea, constipation, and fatigue. Subgroup analysis of ORR and KPS revealed that dosage, treatment duration, and methodological quality did not affect the outcome significantly. Our meta-analyses demonstrated that XAPI in combination with platinum-based chemotherapy had a better tumor response, improved the quality of life, attenuated adverse side effects, and enhanced immune function, which suggests that it might be used for advanced NSCLC. Moreover, low dosage (< 60 ml/d) and long-term treatment of XAPI might be a choice for advanced NSCLC patients.

    更新日期:2020-01-17
  • Parents’ experiences of information-seeking and decision-making regarding complementary medicine for children with autism spectrum disorder: a qualitative study
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-13
    Caroline A. Smith; Chloe Parton; Marlee King; Gisselle Gallego

    Complementary and alternative medicine and therapies (CAM) are widely used by parents of children with autism spectrum disorder (ASD). However, there is a gap in our understanding of how and why parents of children with ASD make decisions about CAM treatment, and how “evidence” influences their decision-making. The aim of this study was to explore views and perspectives on CAM decision-making among parents of children with ASD in Australia. Semi-structured interviews were conducted with parents of children with ASD (18 years and under) who were living in Australia. The interviews were digitally recorded, transcribed and then analysed using thematic analysis. Twenty-one parents were interviewed (20 women and one man). The mean age of participants was 43 years, (SD = 5.12 years), the majority of whom were born in Australia (71%), and almost half (43%) had a bachelor degree or higher. Three main themes were identifiedin the thematic analysis. First theme was ‘Parents’ experiences of researching CAM treatments, the second theme was, “Navigating CAM information and practices”, which comprises of the subthemes: Assessing information on CAM treatments’ What counts as ‘evidence’? and Assessing the impact of CAM treatments on the child - What counts as effective?, and the final theme was, “Creating a central and trustworthy source about CAM”. Across themes parents’ CAM decision-making was described as pragmatic, influenced by time, cost, and feasibility. Parents also reported that information on CAM was complex and often conflicting, and the creation of a centralised and reliable source of information on CAM was identified as a potential solution to these challenges. The development of evidence-based information resources for parents and supporting CAM health literacy may assist with navigating CAM decision-making for children’s with ASD.

    更新日期:2020-01-17
  • Antiproliferative and apoptotic effects of proteins from black seeds (Nigella sativa) on human breast MCF-7 cancer cell line
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-13
    Yamna Khurshid; Basir Syed; Shabana U. Simjee; Obaid Beg; Aftab Ahmed

    Nigella sativa (NS), a member of family Ranunculaceae is commonly known as black seed or kalonji. It has been well studied for its therapeutic role in various diseases, particularly cancer. Literature is full of bioactive compounds from NS seed. However, fewer studies have been reported on the pharmacological activity of proteins. The current study was designed to evaluate the anticancer property of NS seed proteins on the MCF-7 cell line. NS seed extract was prepared in phosphate-buffered saline (PBS), and proteins were precipitated using 80% ammonium sulfate. The crude seed proteins were partially purified using gel filtration chromatography, and peaks were resolved by SDS-PAGE. MTT assay was used to screen the crude proteins and peaks for their cytotoxic effects on MCF-7 cell line. Active Peaks (P1 and P4) were further studied for their role in modulating the expression of genes associated with apoptosis by real-time reverse transcription PCR. For protein identification, proteins were digested, separated, and analyzed with LC-MS/MS. Data analysis was performed using online Mascot, ExPASy ProtParam, and UniProt Knowledgebase (UniProtKB) gene ontology (GO) bioinformatics tools. Gel filtration chromatography separated seed proteins into seven peaks, and SDS-PAGE profile revealed the presence of multiple protein bands. Among all test samples, P1 and P4 depicted potent dose-dependent inhibitory effect on MCF-7 cells exhibiting IC50 values of 14.25 ± 0.84 and 8.05 ± 0.22 μg/ml, respectively. Gene expression analysis demonstrated apoptosis as a possible cell killing mechanism. A total of 11 and 24 proteins were identified in P1 and P4, respectively. The majority of the proteins identified are located in the cytosol, associate with biological metabolic processes, and their molecular functions are binding and catalysis. Hydropathicity values were mostly in the hydrophilic range. Our findings suggest NS seed proteins as a potential therapeutic agent for cancer. To our knowledge, it is the first study to report the anticancer property of NS seed proteins.

    更新日期:2020-01-17
  • Study on the mechanisms of compound Kushen injection for the treatment of gastric cancer based on network pharmacology
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Wei Zhou; Jiarui Wu; Yingli Zhu; Ziqi Meng; Xinkui Liu; Shuyu Liu; Mengwei Ni; Shanshan Jia; Jingyuan Zhang; Siyu Guo

    As an effective prescription for gastric cancer (GC), Compound Kushen Injection (CKI) has been widely used even though few molecular mechanism analyses have been carried out. In this study, we identified 16 active ingredients and 60 GC target proteins. Then, we established a compound-predicted target network and a GC target protein-protein interaction (PPI) network by Cytoscape 3.5.1 and systematically analyzed the potential targets of CKI for the treatment of GC. Finally, molecular docking was applied to verify the key targets. In addition, we analyzed the mechanism of action of the predicted targets by Kyoto Encyclopedia of Genes and Genomes (KEGG) and Gene Ontology (GO) analyses. The results showed that the potential targets, including CCND1, PIK3CA, AKT1, MAPK1, ERBB2, and MMP2, are the therapeutic targets of CKI for the treatment of GC. Functional enrichment analysis indicated that CKI has a therapeutic effect on GC by synergistically regulating some biological pathways, such as the cell cycle, pathways in cancer, the PI3K-AKT signaling pathway, the mTOR signaling pathway, and the FoxO signaling pathway. Moreover, molecular docking simulation indicated that the compounds had good binding activity to PIK3CA, AKT1, MAPK1, ERBB2, and MMP2 in vivo. This research partially highlighted the molecular mechanism of CKI for the treatment of GC, which has great potential in the identification of the effective compounds in CKI and biomarkers to treat GC.

    更新日期:2020-01-17
  • Comparison of the acute toxicity, analgesic and anti-inflammatory activities and chemical composition changes in Rhizoma anemones Raddeanae caused by vinegar processing
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Sha-Sha Wang; Shao-Yan Zhou; Xiao-Yan Xie; Ling Zhao; Yao Fu; Guang-Zhi Cai; Ji-Yu Gong

    As the dry rhizome of Anemone raddeana Regel, Rhizoma Anemones Raddeanae (RAR), which belongs to Ranunculaceae, is usually used to treat wind and cold symptoms, hand-foot disease and spasms, joint pain and ulcer pain in China. It is well known that the efficacy of RAR can be distinctly enhanced by processing with vinegar due to the reduced toxicity and side effects. However, the entry of vinegar into liver channels can cause a series of problems. In this paper, the differences in the acute toxicity, anti-inflammatory and analgesic effects between RAR and vinegar-processed RAR were compared in detail. The changes in the chemical compositions between RAR and vinegar-processed RAR were investigated, and the mechanism of vinegar processing was also explored. Acute toxicity experiments were used to examine the toxicity of vinegar-processed RAR. A series of studies, such as the writhing reaction, ear swelling experiment, complete Freund’s adjuvant-induced rat foot swelling experiment and cotton granuloma, in experimental mice was conducted to observe the anti-inflammatory effect of vinegar-processed RAR. The inflammatory cytokines of model rats were determined by enzyme-linked immunosorbent assay (ELISA). Liquid Chromatography-Quadrupole-Time of Flight mass spectrometer Detector (LC-Q-TOF) was used to analyse the chemical compositions of the RARs before and after vinegar processing. Neither obvious changes in mice nor death phenomena were observed as the amount of vinegar-processed RAR in crude drug was set at 2.1 g/kg. Vinegar-processed RAR could significantly prolong the latency, reduce the writhing reaction time to reduce the severity of ear swelling and foot swelling, and remarkably inhibit the secretion of Interleukin-1β(IL-1β), Interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) proinflammatory cytokines. The content of twelve saponins (e.g., Eleutheroside K) in RAR was decreased after vinegar processing, but six other types (e.g., RDA) were increased. These results revealed that vinegar processing could not only improve the analgesic and anti-inflammatory effects of RAR but also reduce its own toxicity. Not applicable.

    更新日期:2020-01-17
  • Cytotoxycity and antiplasmodial activity of phenolic derivatives from Albizia zygia (DC.) J.F. Macbr. (Mimosaceae)
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Romeol Romain Koagne; Frederick Annang; Bastien Cautain; Jesús Martín; Guiomar Pérez-Moreno; Gabin Thierry M. Bitchagno; Dolores González-Pacanowska; Francisca Vicente; Ingrid Konga Simo; Fernando Reyes; Pierre Tane

    The proliferation and resistance of microorganisms area serious threat against humankind and the search for new therapeutics is needed. The present report describes the antiplasmodial and anticancer activities of samples isolated from the methanol extract of Albizia zygia (Mimosaseae). The plant extract was prepared by maceration in methanol. Standard chromatographic, HPLC and spectroscopic methods were used to isolate and identify six compounds (1–6). The acetylated derivatives (7–10) were prepared by modifying 2-O-β-D-glucopyranosyl-4-hydroxyphenylacetic acid and quercetin 3-O-α-L-rhamnopyranoside, previously isolated from A. zygia (Mimosaceae). A two-fold serial micro-dilution method was used to determine the IC50s against five tumor cell lines and Plasmodium falciparum. In general, compounds showed moderate activity against the human pancreatic carcinoma cell line MiaPaca-2 (10 < IC50 < 20 μM) and weak activity against other tumor cell lines such as lung (A-549), hepatocarcinoma (HepG2) and human breast adenocarcinoma (MCF-7and A2058) (IC50 > 20 μM). Additionally, the two semi-synthetic derivatives of quercetin 3-O-α-L-rhamnopyranoside exhibited significant activity against P. falciparum with IC50 of 7.47 ± 0.25 μM for compound 9 and 6.77 ± 0.25 μM for compound 10, higher than that of their natural precursor (IC50 25.1 ± 0.25 μM). The results of this study clearly suggest that, the appropriate introduction of acetyl groups into some flavonoids could lead to more useful derivatives for the development of an antiplasmodial agent.

    更新日期:2020-01-17
  • Toxicology studies of aqueous-alcohol extracts of Harpagophytum procumbens subsp. procumbens (Burch.) DC.Ex Meisn. (Pedaliaceae) in female and male rats
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Kirtan Joshi; Alan Parrish; Elizabeth A. Grunz-Borgmann; Mary Gerkovich; William R. Folk

    A variety of medicinal products prepared from secondary tubers of Harpagophytum procumbens subsp. procumbens (Burch.) DC.ex Meisn. (Devil’s Claw) and H. zeyheri are marketed in Africa, Europe, the United States, South America and elsewhere, where they are used for inflammatory and musculoskeletal conditions such as arthritis, lower back pain, rheumatism and neuralgia, etc. While clinical studies conducted over the last twenty years support the general safety of such products, infrequent gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal pain), headache, vertigo and hypersensitivity (allergic) reactions (rash, hives and face swelling) have been documented. Sex-related differences occur in the health conditions for which Devil’s Claw products are used, so it is likely that usage is similarly sex-related and so might be side effects and potential toxicities. However toxicologic studies of Devil’s Claw products have been conducted primarily with male animals. To address this deficit, we report toxicological studies in female and male rats of several H. procumbens (HP) aqueous-alcohol extracts chemically analyzed by UPLC-MS. Female and male Sprague Dawley rats were studied for one and three months in groups differing by consumption of diets without and with HP extracts at a 7–10-fold human equivalent dose (HED). Sera were analyzed for blood chemistry, and heart, liver, lung, kidney, stomach, and small and large intestine tissues were examined for histopathology. Treatment group differences for blood chemistry were analyzed by ANOVA with Dunnett’s test and significant group differences for endpoints with marginal distributional properties were verified using the Kruskal-Wallis test. Group differences for histopathology were tested using Chi Square analysis. Significant group by sex-related differences in blood chemistry were detected in both studies. Additionally, several sex-related differences occurred between the studies. However, significant histopathology effects associated with the consumption of the extracts were not detected. Toxicologic analysis of Devil’s Claw extracts cause significant sex-related effects in blood chemistry. However, in our judgement, none of the observed effects suggest serious toxicity at these doses and durations. Subsequent toxicologic and clinical studies of H. procumbens and other medicines with similar properties should explore in greater detail the basis and consequences of potential sex-related effects.

    更新日期:2020-01-17
  • Expert consensus on the development of a health-related questionnaire for the pediatric field of Korean medicine: a Delphi study
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Jihong Lee; Sun Haeng Lee; Gyu Tae Chang

    Although a variety of patient-reported outcome measures (PROMs) for children have been developed, there is no pediatric PROM specific to Korean medicine (KM) that is validated by experts in the field. The aim of this study was to collate the opinions of specialists in KM pediatrics on the development of a generic PROM that can be used by Korean medical doctors to assess the health status of children. A three-round Delphi survey was conducted to determine the level of consensus on the development of a new PROM. Delphi questionnaires were sent by e-mail to 91 KM pediatricians on January 24, 2018. The Delphi questionnaire was composed of four sections: conceptualization, construction, items, and sources of content for a PROM. A nine-point Likert scale was used, and if more than two-thirds of the panels agreed or disagreed with a given sentence, they were considered to have reached a consensus. A draft of a PROM for the pediatric field of KM was developed in accordance with the preliminary conceptual framework. Out of 91 experts, 18 finished three rounds of the Delphi survey. The experts reached a consensus on the necessity of a KM pediatric PROM for measuring various areas including child health, and using Likert scales with a recall period of 3 months. They also agreed on specific items and sources of content. A new draft of a health questionnaire for KM pediatrics was developed based on the Delphi consensus. It contains 44 items covering 7 domains: i) functions of the digestive system, ii) functions of the respiratory system, iii) mental functions, iv) skin functions, v) pain, vi) functions of the metabolic and endocrine systems, and vii) demographic details. This research represents the first step in developing a health questionnaire for the pediatric field of KM. The questionnaire can be used in clinical and research settings after verifying several types of validity and reliability.

    更新日期:2020-01-17
  • Ginsenoside Rb1 can ameliorate the key inflammatory cytokines TNF-α and IL-6 in a cancer cachexia mouse model
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Shuai Lu; Yubo Zhang; Huajun Li; Jing Zhang; Yingqian Ci; Mei Han

    Cancer cachexia is a severe condition that leads to the death of advanced cancer patients, and approximately 50~80% of cancer patients have cancer cachexia. Ginseng extract has been reported to have substantial anticancer and immune-enhancing effects; however, no study has reported the use of ginseng alone to treat cancer cachexia. Our study’s purpose was to investigate the therapeutic effects of ginseng-related monomers or mixtures on a cancer cachexia mouse model. We selected BALB/c mice and injected the mice subcutaneously with C26 colon cancer cells to construct a cancer cachexia experimental animal model. The water extract of ginseng (WEG), two types of ginseng extracts (ginsenosides at doses of 5 mg/kg (GE5) and 50 mg/kg (GE50)) and ginsenoside Rb1 (Rb1) were used to treat cancer cachexia mice. Enzyme-linked immunosorbent assays (ELISAs) were used to analyze the inhibitory effects on two key inflammatory cytokines, tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). Our experimental results show that GE5, GE50 and Rb1 significantly reduced the levels of TNF-α (P < 0.01) and IL-6 (P < 0.01), which are closely related to cancer cachexia; however, WEG, GE5, GE50 and Rb1 did not significantly improve the gastrocnemius muscle weight or the epididymal fat weight of mice with cancer cachexia. These results indicate that GE5, GE50 and Rb1 may be useful for reducing symptoms due to inflammation by reducing the TNF-α and IL-6 cytokine levels in cancer cachexia mice, thereby ameliorating the symptoms of cancer cachexia. Our results may be beneficial for future studies on the use of Chinese herbal medicines to treat cancer cachexia.

    更新日期:2020-01-17
  • Therapeutic use of cannabis and cannabinoids: an evidence mapping and appraisal of systematic reviews
    BMC Complement. Altern. Med. (IF 2.479) Pub Date : 2020-01-15
    Nadia Montero-Oleas; Ingrid Arevalo-Rodriguez; Solange Nuñez-González; Andrés Viteri-García; Daniel Simancas-Racines

    Although cannabis and cannabinoids are widely used with therapeutic purposes, their claimed efficacy is highly controversial. For this reason, medical cannabis use is a broad field of research that is rapidly expanding. Our objectives are to identify, characterize, appraise, and organize the current available evidence surrounding therapeutic use of cannabis and cannabinoids, using evidence maps. We searched PubMed, EMBASE, The Cochrane Library and CINAHL, to identify systematic reviews (SRs) published from their inception up to December 2017. Two authors assessed eligibility and extracted data independently. We assessed methodological quality of the included SRs using the AMSTAR tool. To illustrate the extent of use of medical cannabis, we organized the results according to identified PICO questions using bubble plots corresponding to different clinical scenarios. A total of 44 SRs published between 2001 and 2017 were included in this evidence mapping with data from 158 individual studies. We extracted 96 PICO questions in the following medical conditions: multiple sclerosis, movement disorders (e.g. Tourette Syndrome, Parkinson Disease), psychiatry conditions, Alzheimer disease, epilepsy, acute and chronic pain, cancer, neuropathic pain, symptoms related to cancer (e.g. emesis and anorexia related with chemotherapy), rheumatic disorders, HIV-related symptoms, glaucoma, and COPD. The evidence about these conditions is heterogeneous regarding the conclusions and the quality of the individual primary studies. The quality of the SRs was moderate to high according to AMSTAR scores. Evidence on medical uses of cannabis is broad. However, due to methodological limitations, conclusions were weak in most of the assessed comparisons. Evidence mapping methodology is useful to perform an overview of available research, since it is possible to systematically describe the extent and distribution of evidence, and to organize scattered data.

    更新日期:2020-01-17
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