bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol for the evaluation of a pilot implementation of essential interventions for the prevention of cardiovascular diseases in primary healthcare in the Republic of Moldova
Authors: Collins Dylan , Ciobanu Angela , Laatikainen Tiina , Curocichin Ghenadie , Salaru Virginia , Zatic Tatiana , Anisei Angela , Farrington Jill 
Published: July 2019

IntroductionNearly 90% of all deaths in the Republic of Moldova are caused by non-communicable diseases, the majority of which (55%) are caused by cardiovascular diseases (CVD). In addition to reducing premature mortality from CVD, it is estimated that strengthening primary healthcare could cut the number of hypertension-related hospital admissions and diabetes-related hospitalisations in half. The aim of this evaluation is to determine the feasibility of implementing and evaluating essential interventions for the prevention of CVD in primary healthcare in the Republic of Moldova, with a view towards national scale-up.Methods and analysisA national steering group including international experts will be convened to adapt WHO Package of Essential NCD Intervention from Primary Healthcare in Low Resource Settings protocols 1 and 2 to the health system of the Republic of Moldova, develop and conduct training of primary healthcare workers and test a core set of indicators to monitor the quality of care and change in clinical practice. To evaluate the impact of this pilot implementation, a pragmatic, sequential mixed methods explanatory design, composed of quantitative and qualitative strands of equal weight, will be used. Twenty primary healthcare centres will be selected and randomised to the training and implementation arm (n=10) and the usual care arm (n=10). At baseline and 12 months follow-up, a standardised data collection form will be piloted to extract data directly from patient paper records in order to estimate the change in clinical practice. Semi-structured interviews and interclinic peer workshops will be conducted at 12 months follow-up, and qualitative data collected from these formats will be analysed thematically for explanatory themes that relate to the quantitative findings.Ethics and disseminationEthical review and approval has been obtained. Findings of the evaluation will be shared in a project report to key stakeholders, presented back to participants and written into a manuscript for an open access peer-reviewed scientific journal.
Exercise duRing Active Surveillance for prostatE cancer—the ERASE trial: a study protocol of a phase II randomised controlled trial
Authors: Kang Dong-Woo , Fairey Adrian S , Boulé Normand G , Field Catherine J , Courneya Kerry S 
Published: July 2019

IntroductionActive surveillance (AS) is the preferred primary treatment strategy for men with low-risk clinically localised prostate cancer (PCa); however, the majority of these men still receive radical treatment within 10 years due to disease progression and/or fear of cancer progression. Interventions designed to suppress tumour growth, mitigate fear of cancer progression and precondition men for impending radical treatments are an unmet clinical need. Exercise has been shown to delay the progression of prostate tumours in animal models, improve physical and functional health and manage psychological outcomes in cancer patients; however, these outcomes have not been demonstrated in PCa patients undergoing AS.Methods and analysisThis phase II randomised controlled trial will randomise 66 men undergoing AS to either an exercise group or a usual care group. The exercise group will perform a 12-week, supervised, high-intensity interval training programme, consisting of 3 sessions/week for 28–40 min/session. The primary outcome will be cardiorespiratory fitness. Secondary outcomes will include immunosurveillance and cancer-related biomarkers, psychosocial outcomes including fear of cancer progression and quality of life and physical function. Exploratory outcomes will include clinical indicators of disease progression. The trial has 80% power to detect a significant between-group difference in VO2peakof 3.5 mL/kg/min with a two-tailed alpha level <0.05 and a 10% dropout rate.Ethics and disseminationThe study has received full ethical approval from the Health Research Ethics Board of Alberta – Cancer Committee (Protocol Number: HREBA.CC-17–0248). The findings of the study will be disseminated through public and scientific channels.Trial registration numberNCT03203460; Pre-results.
Association of fatty liver index with risk of incident type 2 diabetes by metabolic syndrome status in an Eastern Finland male cohort: a prospective study
Authors: Olubamwo Olubunmi Olujimisola , Virtanen Jyrki K , Pihlajamaki Jussi , Tuomainen Tomi-Pekka 
Published: July 2019

ObjectiveFatty liver disease (FLD) is increasingly recognised as a predictor of cardiometabolic risk. Our objective was to examine if metabolic syndrome (MS) status affects the association of FLD with incident type 2 diabetes (T2D) in middle-aged men.DesignProspective epidemiological study.SettingUniversity affiliated research centre in Kuopio, Eastern Finland.ParticipantsOur subjects were 1792 Finnish men without diabetes at baseline in the KuopioIschaemicHeart Disease Risk Factor Study cohort.Outcome measureUsing fatty liver index (FLI), the association of baseline FLD with incident T2D was analysed in multivariable-adjusted Cox regression models, considering their MS statuses. The main models were adjusted for constitutional factors, lifestyle factors, biomarkers of inflammation and for high (FLI ≥60) versus low (FLI <30) FLI categories.ResultsDuring a mean follow-up of 19 years, 375 incident cases of T2D were recorded. In the full model, the HR (HR (95% CI)) for T2D was 3.68 (2.80 to 4.82). The association was attenuated, but maintained, with further adjustment for metabolic factors. When MS status was adjusted for in place of metabolic factors, the HRs (95% CIs) were 2.63 (1.92 to 3.59) for FLI ≥60 and 1.77 (1.35 to 2.31) for MS.In MS-stratified analysis, FLI predicted T2D only among persons without MS. In unstratified analysis with subjects categorised by FLI-MS, persons with FLI ≥60 without MS had increased risk for T2D (HR=3.19 (2.26 to 4.52)) compared with persons with FLI <30 without MS. Persons with FLI <30 and MS had greater risk (HR=4.31 (2.15 to 8.61)) and persons with both FLI ≥60 and MS had the greatest risk (HR=4.66 (3.42 to 6.35)).ConclusionGenerally, FLD (FLI ≥60) predicts T2D. It specifically predicted T2D among men without MS but not among men with MS, for whom MS alone already increases the risk. Both FLI and MS can complement each other in screening and surveillance for persons with increased T2D risk.
Association between serum vitamin B6concentration and risk of osteoporosis in the middle-aged and older people in China: a cross-sectional study
Authors: Wang Jing , Chen Lin , Zhang Yan , Li Chen-guang , Zhang Hao , Wang Qiang , Qi Xiaofeng , Qiao Liang , Da Wei-wei , Cui Xue-jun , Lu Sheng , Wang Yong-jun , Shu Bing 
Published: July 2019

ObjectiveTo determine the relationship between serum vitamin B6(Vit B6) concentration and the status of bone mineral density and identify the relationship between serum Vit B6 and bone metabolism parameters in middle-aged and older people in China.DesignThe present study was a cross-sectional study within the framework of an ongoing prospective population-based cohort study.Setting and participantsA total of 1829 residents (men ≥50 years and women ≥45 years) from two subdistricts were recruited from July 2015 to February 2016 in Shanghai, China.MeasuresRecruited residents were grouped (control, osteopenia and osteoporosis) according to their lumbar spine bone mineral density, measured through dual-energy X-ray absorptiometry. Serum Vit B6concentrations, bone turnover marker concentrations and calcium and phosphorus metabolism parameters were assessed.ResultsNo significant linear trend between serum Vit B6concentrations and lumbar bone mass was observed in the men. In the women, the average osteoporosis risk was 61% higher at serum Vit B6concentrations of <19.2 μg/L than at those of >26.9 μg/L (OR 1.61, 95% CI 1.00 to 2.58). However, there was no significance after controlling of serum 25-hydroxy-vitamin D concentration and parathyroid hormone concentration, respectively. In the osteoporotic women, the serum Vit B6concentration was significantly negatively correlated to concentrations of bone turnover marker including N-terminal propeptide of type I collagen, β-C-terminal telopeptide of type I collagen and osteocalcin. It was also positively related to the serum 25-hydroxy-vitamin D concentration and inversely related to the serum parathyroid hormone concentration.ConclusionsA relatively low serum Vit B6concentration, even in the normal range, may be a risk factor for osteoporosis in postmenopausal women, which is dependent on serum 25-hydroxy-vitamin D concentration and parathyroid hormone concentration.Trial registration numberNCT02958020; Post-results.
Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial (NCT03470246)
Authors: Vasankari Ville , Halonen Jari , Husu Pauliina , Vähä-Ypyä Henri , Tokola Kari , Suni Jaana , Sievänen Harri , Anttila Vesa , Airaksinen Juhani , Vasankari Tommi , Hartikainen Juha 
Published: July 2019

IntroductionPersonalized intervention to increase physical Activity and reduce sedentary behaviour in rehabilitation after Cardiac Operations (PACO) is a smartphone-based and accelerometer-based eHealth intervention to increase physical activity (PA) and reduce sedentary behaviour (SB) among patients recovering from cardiac surgery.DesignProspective randomised controlled trial.Methods and analysisThe present protocol describes a randomised controlled clinical trial to be conducted in the Heart Centres of Kuopio and Turku university hospitals. The trial comprises 540 patients scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair. The patients will be randomised into two groups. The control group will receive standard postsurgical rehabilitation guidance. The eHealth intervention group will be given the same guidance together with personalised PA guidance during 90 days after discharge. These patients will receive personalised daily goals to increase PA and reduce SB via the ExSedapplication. Triaxial accelerometers will be exploited to record patients’ daily accumulated PA and SB, and transmit them to the application. Using the accelerometer data, the application will provide online guidance to the patients and feedback of accomplishing their activity goals. The data will also be transmitted to the cloud, where a physiotherapist can monitor individual activity profiles and customise the subsequent PA and SB goals online. The postoperative improvement in patients’ step count, PA, exercise capacity, quality of sleep, laboratory markers, transthoracic echocardiography (TTE) parameters and quality of life, and reduction in SB and incidence of major cardiac events are investigated as outcomes.ConclusionsThe PACO intervention aims to build a personalised eHealth tool for the online tutoring of cardiac surgery patients.Trial registration numberNCT03470246.
Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies
Authors: Pappas Gregory , Berlin Jesse , Avila-Tang Erika , Carroll John , Drozda Joseph , Dumont Douglas , Gross Thomas , Hewitt Kathleen , Kirtane Ajay , Kong David , Krucoff Mitchell , Lashinger John , Lew Nellie , Mack Michael , Masoudi Fred , Marinac-Dabic Danica , Mehran Roxanna , Normand Sharon-Lise , Quin Elizabeth , Resnic Fred , Sedrakyan Art , Waksman Ronald , Wood Larry , Wu Changfu , Ziegler Tianay 
Published: July 2019

BackgroundThe Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs.ObjectivesWe aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies.MethodsFor both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers.ResultsWe identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years.ConclusionsThe CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.
Outcome following heart transplant assessment in adults with congenital heart disease
Authors: Crossland David Steven , Jansen Katrijn , Parry Gareth , Harper Andrew , Perri Gianluigi , Davidson Alison , De Rita Fabrizio , Hermuzi Antony , Nassar Mohamed , Seller Neil , MacGowan Guy A , Hasan Asif , O’Sullivan John J , Coats Louise 
Published: July 2019

ObjectivesAdults with congenital heart disease (ACHD) are a growing group with end-stage heart failure. We aim to describe the outcomes of ACHD patients undergoing assessment for orthotopic heart transplant (OHT).MethodsCase notes of consecutive ACHD patients (>16 years) assessed for OHT between 2000 and 2016 at our centre were reviewed. Decision and outcome were reported as of 2017. Data were analysed in three groups: systemic left ventricle (LV), systemic right ventricle (RV) and single ventricle (SV).Results196 patients were assessed (31.8 years, 27% LV, 29% RV, 44% SV). 89 (45%) patients were listed for OHT and 67 (34%) were transplanted. 41 (21%) were unsuitable or too high risk and 36 (18%) were too well for listing. Conventional surgery was undertaken in 13 (7%) and ventricular assist device in 17 (9%) with 7 (4%) bridged to candidacy. Survival from assessment was 84.2% at 1 year and 69.7% at 5 years, with no difference between groups. Patients who were considered unsuitable for OHT (HR 11.199, p<0.001) and listed (HR 3.792, p=0.030) were more likely to die than those who were considered too well. Assessments increased over the study period.ConclusionsThe number of ACHD patients assessed for OHT is increasing. A third are transplanted with a small number receiving conventional surgery. Those who are unsuitable have a poor prognosis.
Socioeconomic inequalities in children’s exposure to tobacco retailing based on individual-level GPS data in Scotland
Authors: Caryl Fiona , Shortt Niamh K , Pearce Jamie , Reid Garth , Mitchell Richard 
Published: July 2019

BackgroundIdentifying factors shaping knowledge of and attitudes towards tobacco products in preadolescence is a key component supporting tobacco control policies aimed at preventing smoking initiation. This study quantified exposure to tobacco retailing environments within the individual-level activity spaces of children across a socioeconomic gradient.MethodsOne week of global positioning system (GPS) tracking data were collected at 10 s intervals from a nationally representative sample of 10–11-year olds (n=692). Proximity of GPS locations (n=~16 M) to the nearest tobacco retailer (n=9030) was measured and exposure defined when a child came within 10 m of a retailer. Duration, frequency, timing and source of exposure were compared across income deprivation quintiles, along with retail density within children’s home neighbourhoods.ResultsOn average, children were exposed to tobacco retailing for 22.7 min (95% CI 16.8 to 28.6) per week in 42.7 (35.2–50.1) independent encounters. However, children from the most deprived areas accumulated six times the duration and seven times the frequency of exposure as children from the least deprived areas. Home neighbourhood retail densities were 2.6 times higher in deprived areas, yet the average number of businesses encountered did not differ. Most exposure came from convenience stores (35%) and newsagents (15%), with temporal peaks before and after school hours.ConclusionsBy accounting for individual mobility, we showed that children in socially disadvantaged areas accumulate higher levels of exposure to tobacco retailing than expected from disparities in home neighbourhood densities. Reducing tobacco outlet availability, particularly in areas frequently used by children, might be crucial to policies aimed at creating ‘tobacco-free’ generations.
Exaggerated cardiovascular responses to muscle contraction and tendon stretch in UCD type-2 diabetes mellitus rats
Authors: Grotle Ann-Katrin , Crawford Charles K. , Huo Yu , Ybarbo Kai M. , Harrison Michelle L. , Graham James , Stanhope Kimber L. , Havel Peter J. , Fadel Paul J. , Stone Audrey J. 
Published: July 2019

Patients with type-2 diabetes mellitus (T2DM) have exaggerated sympathetic activity and blood pressure responses to exercise. However, the underlying mechanisms for these responses, as well as how these responses change throughout disease progression, are not completely understood. For this study, we examined the effect of the progression of T2DM on the exercise pressor reflex, a critical neurocardiovascular mechanism that functions to increase sympathetic activity and blood pressure during exercise. We also aimed to examine the effect of T2DM on reflexive cardiovascular responses to static contraction, as well as those responses to tendon stretch when an exaggerated exercise pressor reflex was present. We evoked the exercise pressor reflex and mechanoreflex by statically contracting the hindlimb muscles and stretching the Achilles tendon, respectively, for 30 s. We then compared pressor and cardioaccelerator responses in unanesthetized, decerebrated University of California Davis (UCD)-T2DM rats at 21 and 31 wk following the onset of T2DM to responses in healthy nondiabetic rats. We found that the pressor response to static contraction was greater in the 31-wk T2DM [change in mean arterial pressure (∆MAP) = 39 ± 5 mmHg] but not in the 21-wk T2DM (∆MAP = 24 ± 5 mmHg) rats compared with nondiabetic rats (∆MAP = 18 ± 2 mmHg; P < 0.05). Similarly, the pressor and the cardioaccelerator responses to tendon stretch were significantly greater in the 31-wk T2DM rats [∆MAP = 69 ± 6 mmHg; change in heart rate (∆HR) = 28 ± 4 beats/min] compared with nondiabetic rats (∆MAP = 14 ± 2 mmHg; ∆HR = 5 ± 3 beats/min; P < 0.05). These findings suggest that the exercise pressor reflex changes as T2DM progresses and that a sensitized mechanoreflex may play a role in exaggerating these cardiovascular responses. NEW & NOTEWORTHY This is the first study to provide evidence that as type-2 diabetes mellitus (T2DM) progresses, the exercise pressor reflex becomes exaggerated, an effect that may be due to a sensitized mechanoreflex. Moreover, these findings provide compelling evidence suggesting that impairments in the reflexive control of circulation contribute to exaggerated blood pressure responses to exercise in T2DM.
Sex and age differences in the association between sympathetic outflow and central elastic artery wall thickness in humans
Authors: Holwerda Seth W. , Luehrs Rachel E. , DuBose Lyndsey E. , Majee Rumbidzai , Pierce Gary L. 
Published: July 2019

Aging is characterized by increased wall thickness of the central elastic arteries (i.e., aorta and carotid arteries), although the mechanisms involved are unclear. Evidence suggests that age-related increases in muscle sympathetic nerve activity (MSNA) may be a contributing factor. However, studies in humans have been lacking. Therefore, we tested the hypothesis that age-related increases in MSNA would be independently associated with carotid artery intima-media thickness (IMT) but not in young women given the reduced influence of MSNA on the vasculature in this group. In 93 young and middle-age/older (MA/O) adults (19–73 yr, 41 women), we performed assessments of MSNA (microneurography) and common carotid IMT and lumen diameter (ultrasonography). Multiple regression that included MSNA and other cardiovascular disease risk factors indicated that MSNA ( P = 0.002) and 24-h systolic blood pressure (BP) ( P = 0.024) were independent determinants of carotid IMT-to-lumen ratio (model R2 = 0.38, P < 0.001). However, when examining only young women (<45 yr), no correlation was observed between MSNA and carotid IMT-to-lumen ratio ( R = −0.01, P = 0.963). MSNA was significantly correlated with IMT-to-lumen ratio while controlling for 24-h systolic BP among young men ( R = 0.49, P < 0.001) and MA/O women ( R = 0.59, P = 0.022). However, among MA/O men, controlling for 24-h systolic BP attenuated the association between MSNA and carotid IMT-to-lumen ratio ( R = 0.50, P = 0.115). Significant age differences in IMT-to-lumen ratio between young and MA/O men ( P = 0.047) and young and MA/O women ( P = 0.023) were removed when adjusting for MSNA (men: P = 0.970; women: P = 0.152). These findings demonstrate an association between higher sympathetic outflow and carotid artery wall thickness with a particular exception to young women. NEW & NOTEWORTHY Increased wall thickness of the large elastic arteries serves as a graded marker for cardiovascular disease risk and progression of atherosclerosis. Findings from the present study establish an independent association between higher sympathetic outflow and carotid artery wall thickness in adults with an exception to young women and extend findings from animal models that demonstrate hypertrophy of vascular smooth muscle following chronic sympathetic-adrenergic stimulation.