bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anticoagulation Monitoring Under ECMO Support: A Comparative Study Between the Activated Coagulation Time and the Anti-Xa Activity Assay
Authors: Delmas Clément , Jacquemin Aemilia , Vardon-Bounes Fanny , Georges Bernard , Guerrero Felipe , Hernandez Nicolas , Marcheix Bertrand , Seguin Thierry , Minville Vincent , Conil Jean-Marie , Silva Stein 
Published: May 2018

Purpose: Extra Corporeal Membrane Oxygenation (ECMO) is used in cases of severe respiratory and/or circulatory failure over periods of several days to several weeks. Its circuitry requires a closely monitored anticoagulation therapy that is empirically supported by activated clotting time (ACT)—a method often associated with large inter- and intraindividual variability. We aimed to compare the measurement of heparin activity with ACT and the direct measurement of the heparin activity (anti-Xa) in a large ECMO population. Methods: All patients treated by venoarterial or venovenous ECMO in our intensive care unit between January 2014 and December 2015 were prospectively included. A concomitant measurement of the anti-Xa activity and ACT was performed on the same sample collected twice a day (morning–evening) for unfractionated heparin adaptation with an ACT target range of 180 to 220 seconds. Results: One hundred and nine patients (men 69.7%, median age 54 years) treated with ECMO (70.6% venoarterial) were included. Spearman analysis found no correlation between anti-Xa and ACT (ρ < 0.4) from day 1 and worsened over time. Kappa analysis showed no agreement between the respective target ranges of ACT and anti-Xa. Conclusions: We demonstrate that concomitant measurement of ACT and anti-Xa activity is irrelevant in ECMO patients. Since ACT is poorly correlated with heparin dosage, anti-Xa activity appears to be a more suitable assay for anticoagulation monitoring.
The Influence of Friends and Psychosocial Factors on Physical Activity and Screen Time in Normal and Overweight Adolescents: A Mixed-Methods Analysis
Authors: Garcia Jeanette M. , Sirard John R. , Whaley Diane E. , Rice David J. , Baker Kayla , Weltman Arthur 
Published: May 2018

Background: Understanding factors that influence physical activity (PA) and sedentary behavior is crucial to develop interventions to improve adolescents’ health-related behaviors. Purpose: To compare the influence of friends and psychosocial factors on moderate-to-vigorous physical activity (MVPA) and screen time (ST) between normal weight (NW) and overweight (OW) adolescents. Methods: In all, 21 OW and 21 NW adolescents wore accelerometers and completed questionnaires assessing MVPA, ST, and psychosocial variables. The MVPA and ST were assessed in nominated friends. Adolescents participated in focus groups assessing influence on activity behaviors. Results: There were no differences in MVPA; however, NW adolescents reported less ST than OW adolescents (8.9 vs 13.1 h/wk, P = .04). For OW adolescents, friends’ ST ( P = .002) and psychosocial factors ( P = .05) were associated with ST, while only PA self-efficacy was associated with MVPA. For NW adolescents, only friends’ MVPA ( P = .04) was associated with self-reported PA. Exploratory analyses revealed differences among weight status and gender. Focus group discussions revealed that friends influenced both OW and NW adolescents’ MVPA; however, this appeared to be more apparent for NW males, while psychosocial factors played a role in both OW and NW females. The OW adolescents reported that friends were more of an influence on their ST levels, while NW adolescents indicated that their ST was not affected by their friends’ behaviors. Conclusions: Interventions to increase MVPA and/or decrease ST may need to be tailored for NW and OW adolescents.
Pharmacist Impact on Treatment Intensification and Hemoglobin A1C in Patients With Type 2 Diabetes Mellitus at an Academic Health Center
Authors: Cowart Kevin , Sando Karen 
Published: May 2018

Background: Achievement of treatment goals for patients with type 2 diabetes mellitus (T2DM) is suboptimal. This is in part driven by a lack of treatment intensification when warranted, termed “clinical inertia.” Objectives: To investigate time to treatment intensification and changes in A1C among pharmacist–physician managed (PPM) patients compared to usual medical care (UMC) in patients with T2DM. Methods: Retrospective matched cohort study at 2 academic family medicine clinics. Patients in each cohort were matched 1:1 based on age (±5 years), primary care provider, gender, and race. Results: A total of 50 patients met inclusion criteria. Mean time to treatment intensification was longer in the UMC cohort as compared with the PPM cohort (325 (66) days vs 200 (62) days [ P = .50]). A higher percentage of patients in the PPM cohort achieved ≥0.5% reduction in A1C in comparison to the UMC cohort (60% vs 44%, respectively [ P = .41]). Patients in the PPM cohort experienced a greater mean decrease in A1C from baseline when compared to patients in the UMC cohort (−1% (1.8%) vs −0.4% (2.2%) [ P = .24]). Conclusion: Patients exposed to a pharmacist in this retrospective matched cohort study experienced shorter time to treatment intensification and a greater reduction in A1C than those managed solely by a medical provider, although results were not statistically significant. Additional research is needed to evaluate the role of the pharmacist in improving clinical inertia in the management of T2DM.
Prospective Randomized Trial of Electrolysis for Chronic Plantar Heel Pain
Authors: Fernández-Rodríguez Tomás , Fernández-Rolle Álvaro , Truyols-Domínguez Sebastián , Benítez-Martínez Jose C. , Casaña-Granell Jose 
Published: May 2018

Background: Chronic plantar heel pain (CPHP) is a common condition with high prevalence rates and a projected cost of treatment of US$192 to US$376 million. There are several therapeutic approaches and there is increased interest in treatments aimed at the regeneration of tissues with poor healing potential. Our purpose was to investigate the effectiveness of ultrasound-guided percutaneous needle electrolysis in chronic plantar heel pain. Methods: A total of 73 patients with a clinical and ultrasonographic diagnosis of plantar heel pain unrelated to systemic inflammatory disease who had not received any other treatment in the previous 6 months on the affected foot were randomly allocated to receive either ultrasound-guided percutaneous needle electrolysis of the fascia (experimental group, n = 39) or placebo puncture (control group, n = 34). The primary outcome was pain scored with an 11-point numeric pain rating scale (0 = no pain, 10 = maximum pain). Secondary outcomes were function and disability measured by the 21-item activities of daily living subscale of the Foot and Ankle Ability Measure questionnaire, and fascia thickness measured by ultrasound. Outcomes were measured at 1, 12, and 24 weeks. Results: The mixed-model analysis of covariance observed significant group x time interactions from all variables: pain in numeric pain rating scale ( P < .001), FAAM Activities of Daily Living Subscale scale ( P < .002), and ultrasonographic measures of the plantar heel ( P < .002). Patients in the experimental group had better results posttreatment at 12 and 24 weeks compared with the control group. Conclusion: With chronic plantar heel pain, ultrasound-guided percutaneous needle electrolysis improved pain and function. This treatment may also decrease fascia thickness. Level of Evidence: Level I, randomized controlled trial.
Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals
Authors: Wasserman Scott M. , Sabatine Marc S. , Koren Michael J. , Giugliano Robert P. , Legg Jason C. , Emery Maurice G. , Doshi Sameer , Liu Thomas , Somaratne Ransi , Gibbs John P. 
Published: May 2018

Background: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduces low-density lipoprotein cholesterol (LDL-C) and the risk of cardiovascular events. Objectives: To compare LDL-C reduction using evolocumab 140 mg once every 2 weeks (Q2W) or 420 mg monthly (QM) versus lower doses (70 mg Q2W or 280 mg QM) or placebo. Methods: Patients received evolocumab 70 or 140 mg Q2W, 280 or 420 mg QM, or placebo Q2W or QM in two 12-week phase 2 studies: one with and one without statins. Changes from baseline in LDL-C were compared across Q2W doses and across QM doses. Results: The analysis included 741 patients. Mean (95% confidence interval [CI]) reduction in LDL-C across Q2W visits through week 12 was 63.0% (60.3% to 65.7%) for evolocumab 140 mg Q2W, compared to 41.3% (38.6% to 44.0%) for 70 mg Q2W and 1.9% (4.6% reduction to 0.8% increase) for placebo Q2W (each P < .001 vs 140 mg Q2W), and 62.7% (60.1% to 65.3%) for 420 mg QM, compared to 55.5% (52.9% to 58.0%) for 280 mg QM and 2.5% (5.1% reduction to 0.1% increase) for placebo QM (each P < .001 vs 420 mg QM). Similar results were observed at the mean of weeks 10 and 12. In a subgroup (n = 151) with weekly assessments from weeks 8 to 12, mean (95% CI) peak effect on LDL-C reduction was 72.8% (67.7% to 77.9%) for 140 mg Q2W and 69.0% (63.6% to 74.3%) for 420 mg QM. Trough effect at week 12 underestimated LDL-C reduction. Median peak–trough variability was 20.5%, 21.1%, 31.9%, and 35.1% for evolocumab 140 mg Q2W, 420 mg QM, 70 mg Q2W, and 280 mg QM, respectively. Conclusion: Evolocumab 140 mg Q2W and 420 mg QM yielded similar LDL-C reduction. These doses sustained maximal LDL-C reduction, resulting in greater stability in LDL-C reduction over the dosing interval compared to lower doses. These results support evolocumab doses of either 140 mg Q2W or 420 mg QM.
Cross-modal plasticity among sensory networks in neuromyelitis optica spectrum disorders
Authors: Rocca Maria Assunta , Savoldi Filippo , Valsasina Paola , Radaelli Marta , Preziosa Paolo , Comi Giancarlo , Falini Andrea , Filippi Massimo 
Published: May 2018

Objective: To explore resting-state (RS) functional connectivity (FC) of the main sensory/motor networks of patients with neuromyelitis optica spectrum disorders (NMOSDs), clinically isolated optic neuritis (ON), and myelitis. Methods: Clinical evaluation and RS fMRI were obtained from 28 NMOSD, 11 recurrent ON, and 12 recurrent myelitis patients and 30 healthy controls. Between-group RS FC comparisons and correlations with motor performance were assessed (SPM12) on the main sensory/motor RS networks (RSNs) identified by independent component analysis. Functional network connectivity analysis estimated inter-network connectivity. Results: Intra- and inter-network RS FCs were reduced in RSNs associated to somatosensory modalities affected by pathology: regions of the primary visual network in ON patients, of the sensorimotor networks in myelitis patients, and of the sensorimotor and secondary visual networks in NMOSD patients. The opposite trend was observed in regions of RSNs spared by pathology: the auditory and part of visual networks in NMOSD, the secondary visual and sensorimotor networks in ON, and the primary visual network in myelitis patients. Better motor performance correlated with higher RS FC of spared RSNs. Conclusion: Sensory and motor RSN abnormalities occur in NMOSD. Loss of function within disease–target networks may elicit cross-modal plasticity across sensory networks potentially preserving clinical function.
Dosing challenges with direct oral anticoagulants in the elderly: a retrospective analysis
Authors: Fava Joseph P. , Starr Katelyn M. , Ratz David , Clemente Jennifer L. 
Published: May 2018

Background: Direct oral anticoagulants (DOACs) provide patients with attractive options for anticoagulation in atrial fibrillation (AF). However, dosing these agents in the elderly can be challenging due to factors such as drug interactions, reduced renal function, and less frequent monitoring. This study addressed this challenge by reviewing the dosing of three commonly used DOACs (i.e. apixaban, dabigatran, and rivaroxaban) in elderly patients managed at a pharmacist-run anticoagulation clinic. Methods: This was a single-center, retrospective cohort study. A total of 98 cases of DOAC therapy in patients with AF aged 75 years or older receiving care at a large urban healthcare center were identified via chart review. Dosing of each DOAC was assessed at therapy initiation and throughout treatment whenever a serum creatinine was reported, using the Cockcroft–Gault equation to estimate creatinine clearance (CrCl). Dose excursions (defined as instances where patients were exposed to non-Food and Drug Administration (FDA)-approved doses) were documented in each case. Rationales for dose excursions were determined by study investigators via review of progress notes and categorized using clinical judgement. Results: Upon therapy initiation apixaban was dosed in accordance with FDA recommendations in 92.9% of patient cases, dabigatran in 91.2% of cases, and rivaroxaban in 86.1% of cases ( p = 0.70). FDA-recommended dosing was maintained throughout treatment at the highest rates with dabigatran (88.2% versus 78.6% with apixaban and 58.3% with rivaroxaban; p = 0.01, p = 0.005 for dabigatran versus rivaroxaban). The most common rationales for dose excursion were fluctuation in estimated CrCl near the dosing cutoff, and recommendations from nonpharmacist providers co-managing the patient. Conclusions: Prescribing and maintaining FDA-recommended doses of DOAC agents in the elderly is more challenging than initially perceived. Fluctuations in renal function, comorbidities, and concomitant antiplatelet use may necessitate more individualized dosing strategies with these agents.
Cardiac events within one year after a subarachnoid haemorrhage: The predictive value of troponin elevation after aneurysm occlusion
Authors: Akkermans Annemarie , Peelen Linda M , van Waes Judith A , Rinkel Gabriël J , van Klei Wilton A 
Published: May 2018

Background Patients who survive after an aneurysmal subarachnoid haemorrhage (ASAH) have an increased incidence of cardiovascular events compared with the general population. We assessed whether troponin elevation after aneurysm occlusion, as marker of myocardial injury, can predict long-term cardiac events. Methods We analysed a prospectively collected cohort of 159 patients with ASAH and early aneurysm occlusion, in whom routine post-intervention troponin I (TnI) measurements were performed. With competing risk regression modelling we estimated the association between TnI elevation after aneurysm occlusion and major adverse cardiac events within one year. Secondary outcome measures were all-cause mortality and neurological condition within one year. The predictive value of post-intervention TnI was compared with the predictive value of pre-intervention characteristics using c-statistics and the integrated discrimination improvement index. Results Subdistribution hazard ratios for TnI elevation and major adverse cardiac events at one year were 1.05 (95% confidence interval (CI) 1.03–1.07) per 10 ng/l increase in TnI and 7.91 (95% CI 1.46–43.0) for any TnI elevation. After adjustment for pre-intervention variables, the subdistribution hazard ratios were 1.47 (95% CI 0.81–2.67) per 10 ng/l and 9.00 (95% CI 1.62–50.1) for any elevation. The c-statistic was 0.71 for TnI elevation as a continuous measure and 0.69 for any TnI elevation. The integrated discrimination improvement index showed a minimum improvement in prediction of 0.08 (interquartile range 0.06 to 0.09) for TnI as a continuous measure and 0.003 (interquartile range −0.004 to 0.01) for any TnI elevation, when compared with pre-intervention characteristics. Conclusion TnI elevation after occlusion of a ruptured intracranial aneurysm predicts the occurrence of a major adverse cardiac event within one year after ASAH.
Optimal duration for continuation of statin therapy in bacteremic patients
Authors: Pawar Ajinkya M. , LaPlante Kerry L. , Timbrook Tristan T. , Caffrey Aisling R. 
Published: May 2018

Background: Evidence suggests statins may improve survival in patients with bloodstream infections. However, there is no consensus on optimal timing and duration of exposure. Objectives: To quantify statin therapy duration associated with decreased mortality in bacteremic statin users. Methods: We conducted a case-control study using OptumClinformatics™ with matched Premier hospital data (1 October 2009–31 March 2013). Cases who died during the hospitalization were matched 1:1 to survivors on disease risk scores (DRSs). Post-admission statin therapy duration was evaluated in patients with at least 90 days of pre-admission continuous statin use. Classification and regression tree (CART) analysis was conducted to identify the optimal duration of statin continuation which provided the lowest inpatient mortality. Logistic regression was used to calculate the odds of mortality. Results: We included 58 DRS matched pairs of cases and controls: 47 patients (41%) continued statin therapy during the hospital admission, 15 (32%) cases and 32 (68%) controls. The CART analysis partitioned the continuation of statin therapy at ⩾2 days, representing lower mortality for patients who continued statins for 2 days or more and higher mortality for patients who did not continue or remained on statins for only 1 day. Inpatient mortality was 76% lower among those with at least 2 days of continued statin use (odds ratio 0.24, 95% confidence interval 0.11–0.55). Conclusion: Among matched cases and controls with at least 90 days of baseline statin use prior to the admission, the continuation of statins for at least 2 days after admission demonstrated a survival benefit among bacteremic patients.
Apps and wearables for monitoring physical activity and sedentary behaviour: A qualitative systematic review protocol on barriers and facilitators
Authors: Wilde Laura J , Ward Gillian , Sewell Louise , Müller Andre M , Wark Petra A 
Published: May 2018

Objective Monitoring of physical activity and sedentary behaviours by mobile phone applications (apps) and wearable technology (wearables) may improve these health behaviours. This systematic review aims to synthesise the qualitative literature on the barriers and facilitators of using apps and wearables for monitoring physical activity and/or sedentary behaviour in adults. Methods This review protocol is registered in PROSPERO (CRD42017070194). Scientific databases including CINAHL Complete, MEDLINE, PsycINFO, SPORTDiscus, Cochrane Library and Scopus will be searched for relevant studies published from 1 January 2012 to the date the searches are conducted. Studies will be included if they incorporated adults who used an app or wearable for monitoring physical activity and/or sedentary behaviour; explored the barriers and/or facilitators of using an app and/or wearable; and were published in English. Following duplicate screening of titles and abstracts, full texts of potentially eligible papers will be screened to identify studies using qualitative approaches to explore barriers and facilitators of using apps and/or wearables for monitoring physical activity and/or sedentary behaviour. Discrepancies will be resolved through consensus or by consulting a third screener. Relevant excerpts (quotes and text) from the included papers will be extracted and analysed thematically. The Critical Appraisal Skills Programme Qualitative Research Checklist will be used to appraise included studies. Conclusion The results of this work will be useful for those intending to monitor physical activity and/or sedentary behaviour using these technologies.
Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data
Authors: Tapuria Archana , Bruland Philipp , Delaney Brendan , Kalra Dipak , Curcin Vasa 
Published: May 2018

Objectives Integrating Electronic Health Record (EHR) systems into the field of clinical trials still contains several challenges and obstacles. Heterogeneous standards and specifications are used to represent healthcare and clinical trial information. Therefore, this work investigates the mapping and data interoperability between healthcare and research standards: EN13606 used for the EHRs and the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used for clinical research. Methods Based on the specifications of CDISC ODM 1.3.2 and EN13606, a mapping between the structure and components of both standards has been performed. Archetype Definition Language (ADL) forms built with the EN13606 editor were transformed to ODM XML and reviewed. As a proof of concept, clinical sample data has been transformed into ODM and imported into an electronic data capture system. Reverse transformation from ODM to ADL has also been performed and finally reviewed concerning map-ability. Results The mapping between EN13606 and CDISC ODM shows the similarities and differences between the components and overall record structure of the two standards. An EN13606 archetype corresponds with a group of items within CDISC ODM. Transformations of element names, descriptions, different languages, datatypes, cardinality, optionality, units, value range and terminology codes are possible from EN13606 to CDISC ODM and vice versa. Conclusion It is feasible to map data elements between EN13606 and CDISC ODM and transformation of forms between ADL and ODM XML format is possible with only minor limitations. EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies. It is feasible to transform EHR data in the EN13606 form to ODM to transfer it into research database. The attempt to use EN13606 to build a study protocol (that was already built with CDISC ODM) also suggests the possibility of using EN13606 standard in place of CDISC ODM if needed to avoid transformations.
Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study
Authors: Freedman Mark S , Morawski Julia , Thangavelu Karthinathan 
Published: May 2018

Patients enrolled in the phase 3 TOWER study (NCT00751881) of teriflunomide had variable treatment durations (48–173 weeks). This has led to challenges when interpreting results in the context of other phase 3 trials of disease-modifying therapies for multiple sclerosis, which typically have a fixed 2-year duration. This communication reports clinical outcomes in TOWER over a fixed 2-year period. Reductions in annualised relapse rates and 12-week confirmed disability worsening associated with teriflunomide were comparable between overall intent-to-treat and fixed 2-year study populations in TOWER. Consistency in outcomes supports the inclusion of TOWER data in comparative analyses with other disease-modifying therapies. ClinicalTrials.gov: NCT00751881.
Drivers of Patient Costs in Accessing HIV/AIDS Services in Tanzania
Authors: Mnzava Thomas , Mmari Eunice , Berruti Andres 
Published: May 2018

Background: Patient costs pose a challenge in accessing antiretroviral therapy for people living with HIV in sub-Saharan Africa. The study aimed at identifying drivers for out-of-pocket (OOP) costs in Tanzania. Methods: In 2009, 500 adult patients who attended 10 HIV clinics across 7 regions of Tanzania were asked about time and resources consumed to access HIV services. Bivariate and multivariate median regression models were used to determine the main drivers for OOP costs. Results: Male and female patients have a median OOP costs of $40.37 and $28.01 per year, respectively ( P = .01). Males spend significantly more on travel ($26.51) than females ($19.68; P = .02). Living in rural areas and poor social economic status (SES) are associated with greater OOP costs ( P = .001) for both sexes. Conclusion: Poor SES and rural residence are main drivers of OOP costs. Patients are less likely to seek health care unless they are in dire need, leading to expensive services.