bluuebunny/crossref_metadata_2025_split huggingface dataset:
Interaction of sleep quality and sleep duration on impaired fasting glucose: a population-based cross-sectional survey in China
Authors: Lou Peian , Chen Peipei , Zhang Lei , Zhang Pan , Chang Guiqiu , Zhang Ning , Li Ting , Qiao Cheng 
Published: March 2014

ObjectivesTo explore the interactions of sleep quality and sleep duration and their effects on impaired fasting glucose (IFG) in Chinese adults.DesignCross-sectional survey.SettingCommunity-based investigation in Xuzhou, China.Participants15 145 Chinese men and women aged 18–75 years old who fulfilled the inclusion criteria.Primary and secondary outcome measuresThe Pittsburgh Sleep Quality Index was used to produce sleep quality categories of good, common and poor. Fasting blood glucose levels were assessed for IFG. Sleep duration was measured by average hours of sleep per night, with categories of <6, 6–8 and >8 h. The products of sleep and family history of diabetes, obesity and age were added to the logistic regression model to evaluate the addictive interaction and relative excess risk of interaction (RERI) on IFG. The attributable proportion (AP) of the interaction and the synergy index (S) were applied to evaluate the additive interaction of two factors. Bootstrap measures were used to calculate 95% CI of RERI, AP and S.ResultsThe prevalence of IFG was greatest in those with poor sleep quality and short sleep duration (OR 6.37, 95% CI 4.66 to 8.67; p<0.001) compared with those who had good sleep quality and 6–8 h sleep duration, after adjusting for confounders. After adjusting for potential confounders RERI, AP and S values (and their 95% CI) were 1.69 (0.31 to 3.76), 0.42 (0.15 to 0.61) and 2.85 (2.14 to 3.92), respectively, for the interaction between poor sleep quality and short sleep duration, and 0.78 (0.12 to 1.43), 0.61 (0.26 to 0.87) and −65 (−0.94 to −0.27) for the interaction between good sleep quality and long sleep duration.ConclusionsThe results suggest that there are additive interactions between poor sleep quality and short sleep duration.
Similarities and Differences in the Oncology Drug Approval Process between FDA and European Union with Emphasis on In Vitro Companion Diagnostics
Authors: Senderowicz Adrian M. , Pfaff Otmar 
Published: March 2014

Abstract
Drug approval [U.S. Food and Drug Administration (FDA), or market authorization for the European Union's European Medicines Agency (EMA)] is the most significant regulatory milestone for any drug, as drugs can only be marketed after marketing approval by a health authority. This article focuses on the main regulatory aspects of the drug approval process in the European Union (EU) and the United States. Although the procedures, requirements, and timelines for drug approvals are different between the EU and the United States, several global harmonization efforts have been developed during the past few years to have more consistent regulatory procedures/outcomes in different parts of the world. One of the most different procedures/requirements among these regions is co-development, also known as in vitro companion diagnostic. In the United States, it is expected that for a drug that requires an in vitro diagnostic test to select the population to be treated, the companion diagnostic should be already/concomitantly approved by the FDA. In the EU, these requirements are not as stringent as in the United States. However, it is anticipated that in the very near future, legislation changes in the EU will lead to similar requirements for the companion diagnostics for EMA. In summary, although the principles, procedures, and requirements for drug approvals may differ between the United States and EMA, novel efforts to harmonize them are being considered and implemented, thereby leading to simpler global drug development. It is of outmost importance that drug developers understand and appreciate differences in regional regulations. Otherwise, lack of understanding may lead to rejection or delays in drug approvals for useful anticancer agents.
See all articles in this CCR Focus section, “The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development.”
Clin Cancer Res; 20(6); 1445–52. ©2014 AACR.
Gender‐Specific Risk Factors for Peripheral Artery Disease in a Voluntary Screening Population
Authors: Hiramoto Jade S. , Katz Ronit , Weisman Steven , Conte Michael 
Published: March 2014

Background

Women have high rates of peripheral artery disease (
PAD
) despite fewer cardiovascular disease (
CVD
) risk factors, compared to men. We sought to determine the gender‐specific prevalence of low ankle brachial index (
ABI
) and the relationship to C‐reactive protein (
CRP
) levels and
CVD
risk factors in the Life Line Screening population.

Methods and Results

Between April 2005 and August 2011, 133 750 women and 71 996 men had
ABI
and
CRP
measured at a Life Line Screening Center. Women were slightly older than men, whereas men were more likely to be current smokers, have diabetes mellitus (
DM
), and coronary artery disease (
CAD
) (
P
<0.001 for each). Women were more likely to have
ABI
≤1.0, compared to men (26.6% versus 14.4%, respectively;
P
<0.001), as well as
ABI
≤0.9 (4.1% women versus 2.6% men;
P
<0.001). Women had higher median
CRP
levels (1.94 mg/L; interquartile range [
IQR],
0.89, 4.44 mg/L), compared to men (1.35 mg/L;
IQR,
0.73, 2.80 mg/L;
P
<0.001). Men and women shared similar risk factors for
ABI
≤0.9, including older age, black race, smoking,
DM
, hypertension, hypercholesterolemia,
CAD
, and elevated
CRP
levels. In an adjusted model, there were significant interactions between gender and age (
P
<0.001),
CRP
(
P
<0.001),
CAD
(
P
=0.03), and
DM
(
P
=0.06) with
ABI
as the outcome. The associations between age,
CRP
,
CAD
, and
DM
with
ABI
≤0.9 were stronger in men than in women.

Conclusions

Women participating in the Life Line Screening had higher
CRP
levels and a higher prevalence of
PAD,
compared to men. Neither higher
CRP
levels nor conventional
CVD
risk factors explained the excess prevalence of
PAD
in women.
Stroke Thrombolysis
Authors: Meretoja Atte , Keshtkaran Mahsa , Saver Jeffrey L. , Tatlisumak Turgut , Parsons Mark W. , Kaste Markku , Davis Stephen M. , Donnan Geoffrey A. , Churilov Leonid 
Published: March 2014

Background and Purpose—
Stroke thrombolysis is highly time-critical, but data on long-term effects of small reductions in treatment delays have not been available. Our objective was to quantify patient lifetime benefits gained from faster treatment.

Methods—
Observational prospective data of consecutive stroke patients treated with intravenous thrombolysis in Australian and Finnish centers (1998–2011; n=2258) provided distributions of age, sex, stroke severity, onset-to-treatment times, and 3-month modified Rankin Scale in daily clinical practice. Treatment effects derived from a pooled analysis of thrombolysis trials were used to model the shift in 3-month modified Rankin Scale distributions with reducing treatment delays, from which we derived the expected lifetime and level of long-term disability with faster treatment.

Results—
Each minute of onset-to-treatment time saved granted on average 1.8 days of extra healthy life (95% prediction interval, 0.9–2.7). Benefit was observed in all groups: each minute provided 0.6 day in old severe (age, 80 years; National Institutes of Health Stroke Scale [NIHSS] score, 20) patients, 0.9 day in old mild (age, 80 years; NIHSS score, 4) patients, 2.7 days in young mild (age, 50 years; NIHSS score, 4) patients, and 3.5 days in young severe (age, 50 years; NIHSS score, 20) patients. Women gained slightly more than men over their longer lifetimes. In the whole cohort, each 15 minute decrease in treatment delay provided an average equivalent of 1 month of additional disability-free life.

Conclusions—
Realistically achievable small reductions in stroke thrombolysis delays would result in significant and robust average health benefits over patients’ lifetimes. The awareness of concrete importance of speed could promote practice change.
Use of EEG Workload Indices for Diagnostic Monitoring of Vigilance Decrement
Authors: Kamzanova Altyngul T. , Kustubayeva Almira M. , Matthews Gerald 
Published: March 2014

Objective: A study was run to test which of five electroencephalographic (EEG) indices was most diagnostic of loss of vigilance at two levels of workload. Background: EEG indices of alertness include conventional spectral power measures as well as indices combining measures from multiple frequency bands, such as the Task Load Index (TLI) and the Engagement Index (EI). However, it is unclear which indices are optimal for early detection of loss of vigilance. Method: Ninety-two participants were assigned to one of two experimental conditions, cued (lower workload) and uncued (higher workload), and then performed a 40-min visual vigilance task. Performance on this task is believed to be limited by attentional resource availability. EEG was recorded continuously. Performance, subjective state, and workload were also assessed. Results: The task showed a vigilance decrement in performance; cuing improved performance and reduced subjective workload. Lower-frequency alpha (8 to 10.9 Hz) and TLI were most sensitive to the task parameters. The magnitude of temporal change was larger for lower-frequency alpha. Surprisingly, higher TLI was associated with superior performance. Frontal theta and EI were influenced by task workload only in the final period of work. Correlational data also suggested that the indices are distinct from one another. Conclusions: Lower-frequency alpha appears to be the optimal index for monitoring vigilance on the task used here, but further work is needed to test how diagnosticity of EEG indices varies with task demands. Application: Lower-frequency alpha may be used to diagnose loss of operator alertness on tasks requiring vigilance.
Biomechanical Consequences of Coracoclavicular Reconstruction Techniques on Clavicle Strength
Authors: Spiegl Ulrich J. , Smith Sean D. , Euler Simon A. , Dornan Grant J. , Millett Peter J. , Wijdicks Coen A. 
Published: March 2014

Background: Lateral clavicle fractures have been reported after coracoclavicular (CC) ligament reconstructions with bone tunnels through the clavicle. Purpose: To biomechanically compare clavicle strength following 2 common CC reconstruction techniques with different bone tunnel diameters. Study Design: Controlled laboratory study. Methods: Testing was performed on 2 groups of matched-pair cadaveric clavicles. Clavicles were prepared with either 2.4-mm tunnels and cortical fixation button (CFB) devices or 6.0-mm tunnels with hamstring tendon grafts (TGs) and tenodesis screws; contralateral clavicles were left intact. A 3-point bending load was applied to the distal clavicles at a rate of 15 mm/min until failure. Ultimate failure load and anterior-posterior width of the clavicles 45 mm medial from the lateral border were recorded. Strength reduction was determined as the percentage reduction in ultimate failure load between paired intact and surgically prepared clavicles. Relative tunnel size was determined as the quotient of tunnel diameter and clavicle width, reported as a percentage. Results: The TG technique significantly reduced clavicle strength relative to intact ( P = .011) and caused significantly more strength reduction (mean, −30.7%; range, 8.1% to −62.5%) than the CFB technique (mean, −3.8%; range, 34.2% to −28.1%; P = .031). The CFB technique was not significantly different from intact ( P = .314). There was a significant correlation between clavicle width and strength reduction (τ = −0.36, P = .04) and between relative tunnel size and strength reduction (τ = 0.51, P = .005). Conclusion: The TG reconstruction technique with 6.0-mm tunnels, grafts, and tenodesis screws caused significantly more reduction of clavicle strength compared with the CFB technique with 2.4-mm tunnels and CFB device. Additionally, relative tunnel width correlated highly with the strength reduction. Clinical Relevance: This information can influence intraoperative decision making based on the individual clavicle width and might influence postoperative treatment protocols. Large bone tunnels may predispose patients to clavicle fractures after anatomic CC reconstructions.
Significant Publications About the Medication Use Process in 2012
Authors: Moore Sarah J. , Jenkins Alexander T. , Poppe Lindsey B. , Rowe Erinn C. , Eckel Stephen F. 
Published: March 2014

Purpose: This article identifies, prioritizes, and summarizes the published literature on the medication use process (MUP) from calendar year 2012 that can impact health-system pharmacists’ daily practice. Summary: The MUP is the foundational system that provides the framework for safe patient care within the health care environment. The MUP is defined in this article as having the following components: prescribing/transcribing, dispensing, administration, and monitoring. A PubMed search was conducted in January 2013 for calendar year 2012 using targeted Medical Subject Headings (MeSH) keywords, providing a total of 944 articles. A thorough review identified 46 potentially significant articles: 14 for prescribing/transcribing, 12 for dispensing, 10 for administration, and 10 for monitoring. Peer review led to the selection of key articles from each category. These articles are briefly summarized, with a mention of why this article is important within health-system pharmacy. The other articles are listed for further review and evaluation. Conclusion: It is important to routinely review the published literature and to incorporate significant findings into daily practice. Health-system pharmacists have an active role in improving the MUP in their institution and awareness of the significant published studies can assist in changing practice at the institutional level.
Thoracolumbar Spine Fractures in the Geriatric Fracture Center
Authors: Weerink L. B. M. , Folbert E. C. , Kraai M. , Smit R. S. , Hegeman J. H. , van der Velde D. 
Published: March 2014

Introduction: Thoracolumbar spine fractures are common osteoporotic fractures among elderly patients. Several studies suggest that these fractures can be treated successfully with a nonoperative management. The aim of this study is to evaluate the conservative treatment of elderly patients with a vertebral fracture. Methods: This study is a retrospective cohort study, which included all patients with an age of 65 years and older, who were diagnosed with a vertebral fracture and where therefore admitted to the Geriatric Fracture Center over a period of 2 years. Primary outcome was the level of functioning 6 weeks and 3 months after admission. Results: We included 106 patients with 143 vertebral fractures, of which 61 patients were evaluated after 3 months. In our population, 53% of the patients had a fracture involving both middle and anterior columns. The majority of the patients functioned sufficiently 6 weeks and 3 months after admission. Analysis showed that age <80 years is an independent predictor of a sufficient level of functioning after 6 weeks. Discussion: The nonoperative treatment of elderly patients with a vertebral fracture leads to a sufficient level of functioning 6 weeks and 3 months after admission. In our population, only age <80 years is an independent predictor for a sufficient level of functioning 6 weeks after admission. The level of functioning at 6 weeks predicts the level of functioning 3 months after admission. On comparison, the level of functioning after early ambulation is equal to the level of functioning after immobilization. Where immobilization may lead to complications, early ambulation was not associated with new complications or neurological damage. Based on these advantages, the treatment of elderly patients with a fracture involving both middle and anterior columns may be altered from immobilization to mobilization in the future.
Do Elderly Patients Fare Worse Following Operative Treatment of Distal Femur Fractures Using Modern Techniques?
Authors: Shulman Brandon S. , Patsalos-Fox Bianka , Lopez Nicole , Konda Sanjit R. , Tejwani Nirmal C. , Egol Kenneth A. 
Published: March 2014

Background: The purpose of this study was to compare the functional outcomes and quality of life of older and younger patients with similarly treated distal femur fractures. Methods: We conducted an assessment of 57 patients who sustained distal femur fractures (Orthopaedic Trauma Association Type 33B, C) and underwent surgical treatment at our academic medical center. Patients were divided into 2 groups for analysis: an elderly cohort of patients aged 65 or older and a comparison cohort of patients younger than age of 65. A retrospective review of demographics, preoperative ambulatory status, radiographic data, and physical examination data was collected from the medical records. Follow-up functional data were collected via telephone at a mean of 2.5 years (range 6 months-8 years) using a Short Musculoskeletal Functional Assessment (SMFA). All patients underwent standard operative treatment of either nail or plate fixation. Results: There was no statistical difference in gender, fracture type, surgical technique, surgeon, or institution where the surgery was performed. The percentage of patients with healed fractures at 6-months follow-up was not significantly different between the cohorts. The elderly cohort had slightly worse knee range of motion at 3, 6, and 12 months postoperatively but there was not a statistically significant difference between the groups. The SMFA Daily Activity, Functional, and Bother indices were significantly worse in the older cohort ( P < .01, P = .01, P = .02, respectively). However, there was no significant difference in the SMFA Emotional or Mobility indices. Conclusion: Despite lower quality of life and functional scores, this study suggests that relatively good clinical outcomes can be achieved with surgical fixation of distal femoral fractures in the elderly patients. Age should not be used as a determinate in deciding against operative treatment of distal femur fractures in the elderly patients.
Right ventricular reverse remodelling after balloon pulmonary angioplasty
Authors: Fukui Shigefumi , Ogo Takeshi , Morita Yoshiaki , Tsuji Akihiro , Tateishi Emi , Ozaki Kumi , Sanda Yoshihiro , Fukuda Tetsuya , Yasuda Satoshi , Ogawa Hisao , Nakanishi Norifumi 
Published: March 2014

Balloon pulmonary angioplasty (BPA) has been reported to improve haemodynamics and functional capacity, with an acceptable risk, in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for pulmonary endarterectomy. However, right ventricular (RV) function, an important predictor in CTEPH, remains to be elucidated. We aimed to examine the impact of BPA on RV remodelling and dysfunction relative to haemodynamic improvements in patients with inoperable CTEPH.20 consecutive patients with inoperable CTEPH who underwent BPA with cardiovascular magnetic resonance before and after BPA were retrospectively studied.BPA led to significant amelioration of the mean pulmonary arterial pressure, cardiac index and pulmonary vascular resistance (PVR), without death or major complications. Furthermore, BPA significantly ameliorated right-sided heart failure symptoms and signs, and exercise capacity. Cardiovascular magnetic resonance revealed a marked improvement in RV end-diastolic and end-systolic volume index, with concomitant improvements in RV ejection fraction, mass and interventricular septal bowing after BPA. Changes in RV volumes strongly correlated with changes in cardiac index and PVR.BPA induced RV reverse remodelling and improved systolic dysfunction safely by ameliorating haemodynamics in patients with inoperable CTEPH. Evaluating RV function with cardiovascular magnetic resonance may be effective for noninvasively monitoring BPA efficacy.
Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study
Authors: Sitbon Olivier , Jaïs Xavier , Savale Laurent , Cottin Vincent , Bergot Emmanuel , Macari Elise Artaud , Bouvaist Hélène , Dauphin Claire , Picard François , Bulifon Sophie , Montani David , Humbert Marc , Simonneau Gérald 
Published: March 2014

Patients with severe pulmonary arterial hypertension (PAH) in New York Heart Association (NYHA) functional class (FC) III/IV have a poor prognosis, despite survival benefits being demonstrated with intravenous epoprostenol. In this pilot study, the efficacy and safety of a triple combination therapy regimen in patients with severe PAH was investigated.Data from newly diagnosed NYHA FC III/IV PAH patients (n=19) initiated on upfront triple combination therapy (intravenous epoprostenol, bosentan and sildenafil) were collected retrospectively from a prospective registry.Significant improvements in 6-min walk distance and haemodynamics were observed after 4 months’ triple combination therapy in 18 patients (p<0.01); 17 patients had improved to NYHA FC I or II. One patient was not included in the month 4 assessment (due to an emergency lung transplant in month 3). At the final evaluation (mean±sd32±19 months), all 18 patients had sustained clinical and haemodynamic improvement. Overall survival estimates for the triple combination cohort were 100% at 1, 2 and 3 years. Expected survival calculated from the French equation was 75% (95% CI 68–82%), 60% (95% CI 50–70%) and 49% (95% CI 38–60%) at 1, 2 and 3 years, respectively.This pilot study provides preliminary evidence of the long-term benefits of upfront triple combination therapy in patients with severe PAH.
Validation of N-terminal pro-brain natriuretic peptide cut-off values for risk stratification of pulmonary embolism
Authors: Lankeit Mareike , Jiménez David , Kostrubiec Maciej , Dellas Claudia , Kuhnert Katherina , Hasenfuß Gerd , Pruszczyk Piotr , Konstantinides Stavros 
Published: March 2014

The optimal N-terminal pro-brain natriuretic peptide (NT-proBNP) cut-off value for risk stratification of pulmonary embolism remains controversial.In this study we validated and compared different proposed NT-proBNP cut-off values in 688 normotensive patients with pulmonary embolism.During the first 30 days, 28 (4.1%) patients reached the primary outcome (pulmonary embolism-related death or complications) and 29 (4.2%) patients died. Receiver operating characteristic analysis yielded an area under the curve of 0.70 (0.60–0.80) for NT-proBNP. A cut-off value of 600 pg·mL−1was associated with the best prognostic performance (sensitivity 86% and specificity 50%) and the highest odds ratio (6.04 (95% CI 2.07–17.59), p=0.001) compared to the cut-off values of 1000, 500 or 300 pg·mL−1. Using multivariable logistic regression analysis, NT-proBNP ≥600 pg·mL−1had a prognostic impact on top of that of the simplified Pulmonary Embolism Severity Index and right ventricular dysfunction on echocardiography (OR 4.27 (95% CI 1.22–15.01); p=0.024, c-index 0.741). The use of a stepwise approach based on the simplified Pulmonary Embolism Severity Index, NT-proBNP ≥600 pg·mL−1and echocardiography helped optimise risk assessment.Our findings confirm the prognostic value of NT-proBNP and suggest that a cut-off value of 600 pg·mL−1is most appropriate for risk stratification of normotensive patients with pulmonary embolism. NT-proBNP should be used in combination with a clinical score and an imaging procedure for detecting right ventricular dysfunction.