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1.  Analysis of start-up, retention, and adherence in ALS clinical trials 
Neurology  2013;81(15):1350-1355.
To investigate predictors of trial start-up times, high attrition, and poor protocol adherence in amyotrophic lateral sclerosis (ALS) trials.
Retrospective analysis of start-up times, retention, and protocol adherence was performed on 5 clinical studies conducted by the Northeast ALS Consortium and 50 ALS clinical trials identified by PubMed search. Predictors of start-up times were estimated by accelerated failure time models with random effects. Predictors of retention and protocol deviations were estimated by mixed-model logistic regression.
Median times for contract execution and institutional review board (IRB) approval were 105 days and 125 days, respectively. Contract execution was faster at sites with more ongoing trials (p = 0.005), and more full-time (p = 0.006) and experienced (p < 0.001) coordinators. IRB approval was faster at sites with more ongoing trials (p = 0.010) and larger ALS clinics (p = 0.038). Site activation after IRB approval was faster at sites with more full-time (p = 0.038) and experienced (p < 0.001) coordinators. Twenty-two percent of surviving participants withdrew before completing the trial. Better participant functional score at baseline was an independent predictor of trial completion (odds ratio 1.29, p = 0.002) and fewer protocol deviations (odds ratio 0.86, p = 0.030).
Delays in IRB review contribute the most to prolonged trial start-up times, and these timelines are faster in sites with more experienced staff. Strategies to improve protocol adherence and participants' retention may include enrolling people at early disease stages.
PMCID: PMC3806927  PMID: 24005339
2.  Consumption of Less Than 10% of Total Energy From Added Sugars is Associated With Increasing HDL in Females During Adolescence: A Longitudinal Analysis 
Atherosclerotic changes associated with dyslipidemia and increased cardiovascular disease risk are believed to begin in childhood. While previous studies have linked added sugars consumption to low high‐density lipoprotein (HDL), little is known about the long‐term impact of this consumption. This study aims to assess the association between added sugars intake and HDL cholesterol levels during adolescence, and whether this association is modified by obesity.
Methods and Results
We used data from the National Heart Lung and Blood Institute's Growth and Health Study, a 10‐year cohort study of non‐Hispanic Caucasian and African‐American girls (N=2379) aged 9 and 10 years at baseline recruited from 3 sites in 1987‐1988 with biennial plasma lipid measurement and annual assessment of diet using a 3‐day food record. Added sugars consumption was dichotomized into low (0% to <10% of total energy) and high (≥10% of total energy). In a mixed model controlling for obesity, race, physical activity, smoking, maturation stage, age, and nutritional factors, low compared with high added sugar consumption was associated with a 0.26 mg/dL greater annual increase in HDL levels (95% CI 0.48 to 0.04; P=0.02). Over the 10‐year study period, the model predicted a mean increase of 2.2 mg/dL (95% CI 0.09 to 4.32; P=0.04) among low consumers, and a 0.4 mg/dL decrease (95% CI −1.32 to 0.52; P=0.4) among high consumers. Weight category did not modify this association (P=0.45).
Low added sugars consumption is associated with increasing HDL cholesterol levels throughout adolescence.
PMCID: PMC3959678  PMID: 24572253
cardiovascular disease risk; diet; dyslipidemia; HDL; lipids; pediatrics
3.  Hybrid aortic arch repair 
Annals of Cardiothoracic Surgery  2013;2(3):300-302.
Innovations in thoracic endovascular aortic repair techniques have enabled its incorporation in open procedures, resulting in a hybrid approach to aortic arch repair. The present study reported our experience with the hybrid technique in managing arch pathologies. Fifty-one patients underwent a hybrid repair of arch pathologies. 10 patients had urgent or emergency surgery, and 8 had previous abdominal aortic aneurysm repair; all were classified as high risk (ASA grade III or IV). Overall 30-day mortality was 9.8% (5/51). Hospital mortality was 30% (3/10) in urgent/emergent surgery and 4.90% (2/41) in elective cases. Ischemic stroke occurred in 11.8% (6/51) of patients, while 5.9% (3/51) experienced paraplegia. Endoleaks occurred in 8 patients, 6 of which were Type 1. Long-term patency rate was 96%. The hybrid technique is a safe, effective and less invasive alternative to open repair of arch pathologies, with comparable outcomes in high-risk patient groups. Patency rates and durability demonstrate the long-term potential of this technique.
PMCID: PMC3741866  PMID: 23977598
Hybrid; endovascular repair; aortic arch surgery
4.  Junior doctor titles following implementation of Modernising Medical Careers in the UK 
JRSM Short Reports  2011;2(3):22.
Recent changes in postgraduate medical training in the UK collectively organized under the auspices of Modernising Medical Careers (MMC) have created new labels for junior doctors in training. It would appear that many nurses and other health workers do not understand the new terminology. We aimed to investigate the knowledge of nursing staff about new junior doctor titles in a district general hospital. As far as we are aware, this is the first survey to determine the views and knowledge of the new terms among staff working in the NHS.
Questionnaire study.
District general hospital, West Midlands, UK.
Fifty-five randomly selected staff nurses working in the surgical directorate.
Main outcome measure
Questions were asked about their views and knowledge of the current nomenclature. To objectively assess knowledge of the new titles respondents were asked to match equivalent positions with those based on the old system.
Only 22% (n = 12) of respondents felt that they fully understand current terms in usage. Seventy-six percent (n = 42) felt that it was ‘very important’ that titles accurately convey role and seniority of the doctor. The most common titles correctly matched were FY1 and House Officer (n = 45, 81%) and FY2 and First Year Senior House Officer (n = 35, 64%). Only 9% (n = 5) of staff nurses correctly matched ST3 to Junior Registrar and 13% (n = 7) correctly matched ST7 to Senior Registrar. Ward-based staff nurses demonstrated greater familiarity with titles when compared to nurses who work mainly in the outpatient clinic and theatre setting (p = 0.017). We did not identify a statistically significant association with demographic characteristics (age, gender, experience) and knowledge of the new terms (p > 0.05). Approximately 98% (n = 54) of the staff surveyed felt that terms are confusing to nurses and need to be simplified.
Our survey revealed that nursing staff lacked knowledge of the current terminology to describe doctors in training. This may have implications for staff expectations regarding specific role of junior doctor in terms of clinical decision-making, working relationships and communication between team members, and ultimately patient care.
PMCID: PMC3086326  PMID: 21541090

Results 1-4 (4)