Transfer of virtual reality endoscopy training to live animal colonoscopy: a randomized control trial of proficiency vs. repetition-based training.

BACKGROUND: Low first-time pass rates of the Fundamentals of Endoscopic Surgery (FES) exam stimulated development of virtual reality (VR) simulation curricula for test preparation. This study evaluates the transfer of VR endoscopy training to live porcine endoscopy performance and compares the relative effectiveness of a proficiency-based vs repetition-based VR training curriculum. METHODS: Novice endoscopists completed pretesting including the FES manual skills examination and Global Assessment of GI Endoscopic Skills (GAGES) assessment of porcine upper and lower endoscopy. Participants were randomly assigned one of two curricula: proficiency-based or repetition-based. Following curriculum completion, participants post-tested via repeat FES examination and GAGES porcine endoscopy assessments. The two cohorts pre-to-post-test differences were compared using ANCOVA. RESULTS: Twenty-two residents completed the curricula. There were no differences in demographics or clinical endoscopy experience between the groups. The repetition group spent significantly more time on the simulator (repetition: 242.2 min, SD 48.6) compared to the proficiency group (proficiency: 170.0 min, SD 66.3; p = 0.013). There was a significant improvement in porcine endoscopy (pre: 10.6, SD 2.8, post: 16.6, SD 3.4; p < 0.001) and colonoscopy (pre: 10.4, SD 2.7, post: 16.4, SD 4.2; p < 0.001) GAGES scores as well as FES manual skills performance (pre: 270.9, SD 105.5, post: 477.4, SD 68.9; p < 0.001) for the total cohort. There was no difference in post-test GAGES performance or FES manual skills exam performance between the two groups. Both the proficiency and repetition group had a 100% pass rate on the FES skills exam following VR curriculum completion. CONCLUSION: A VR endoscopy curriculum translates to improved performance in upper and lower endoscopy in a live animal model. VR curricula type did not affect FES manual skills examination or live colonoscopy outcomes; however, a proficiency curriculum is less time-consuming and can provide a structured approach to prepare for both the FES exam and clinical endoscopy.

Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial.

BACKGROUND: The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes. METHODS: We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months. RESULTS: We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference -2.57 mmol/mol; 95% CI -4.5, -0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (-0.55 mmol/mol; 95% CI -2.46, 1.35; p = 0.57), or INT vs CON arms (-2.14 mmol/mol; 95% CI -4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON -4.76 mmol/mol; 95% CI -7.75, -1.78 mmol/mol) than in older participants (-0.46 mmol/mol; 95% CI -2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (-6.01 mmol/mol; 95% CI -9.56, -2.46 age < 65 years old and -0.22 mmol/mol; 95% CI -2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (-7.0 mmol/mol; 95% CI -11.5, -2.5; p = 0.003). CONCLUSION: The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months. TRIAL REGISTRATION: ISRCTN34805606 . Retrospectively registered 14.4.16.

Community-based pre-pregnancy care programme improves pregnancy preparation in women with pregestational diabetes.

AIMS/HYPOTHESIS: Women with diabetes remain at increased risk of adverse pregnancy outcomes associated with poor pregnancy preparation. However, women with type 2 diabetes are less aware of and less likely to access pre-pregnancy care (PPC) compared with women with type 1 diabetes. We developed and evaluated a community-based PPC programme with the aim of improving pregnancy preparation in all women with pregestational diabetes. METHODS: This was a prospective cohort study comparing pregnancy preparation measures before and during/after the PPC intervention in women with pre-existing diabetes from 1 June 2013 to 28 February 2017. The setting was 422 primary care practices and ten National Health Service specialist antenatal diabetes clinics. A multifaceted approach was taken to engage women with diabetes and community healthcare teams. This included identifying and sending PPC information leaflets to all eligible women, electronic preconception care templates, online education modules and resources, and regional meetings and educational events. Key outcomes were preconception folic acid supplementation, maternal HbA1c level, use of potentially harmful medications at conception and gestational age at first presentation, before and during/after the PPC programme. RESULTS: A total of 306 (73%) primary care practices actively participated in the PPC programme. Primary care databases were used to identify 5075 women with diabetes aged 18-45 years. PPC leaflets were provided to 4558 (89.8%) eligible women. There were 842 consecutive pregnancies in women with diabetes: 502 before and 340 during/after the PPC intervention. During/after the PPC intervention, pregnant women with type 2 diabetes were more likely to achieve target HbA1c levels ≤48 mmol/mol (6.5%) (44.4% of women before vs 58.5% of women during/after PPC intervention; p = 0.016) and to take 5 mg folic acid daily (23.5% and 41.8%; p = 0.001). There was an almost threefold improvement in 'optimal' pregnancy preparation in women with type 2 diabetes (5.8% and 15.1%; p = 0.021). Women with type 1 diabetes presented for earlier antenatal care during/after PPC (54.0% vs 67.3% before 8 weeks' gestation; p = 0.003) with no other changes. CONCLUSIONS/INTERPRETATION: A pragmatic community-based PPC programme was associated with clinically relevant improvements in pregnancy preparation in women with type 2 diabetes. To our knowledge, this is the first community-based PPC intervention to improve pregnancy preparation for women with type 2 diabetes. DATA AVAILABILITY: Further details of the data collection methodology, individual clinic data and the full audit reports for healthcare professionals and service users are available from https://digital.nhs.uk/data-and-information/clinical-audits-and-registries/our-clinical-audits-and-registries/national-pregnancy-in-diabetes-audit .

Electrocardiograms: a guide to rhythm recognition for emergency nurses.

Electrocardiogram (ECG) is one of the most commonly performed investigations in emergency departments (EDs), and is an extremely useful adjunct that guides diagnosis, prognosis and treatment. In most cases nurses are the first healthcare professional to assess patients and record an ECG, yet anecdotal evidence suggests that few emergency nurses review, interpret and act on ECG findings. Research suggests this may be due to lack of confidence in, or knowledge about, interpretation of results, often because of inadequate training. This article aims to help emergency nurses understand and interpret the cardiac rhythms commonly encountered on ECGs in EDs, to enable them to support earlier diagnosis and treatment. It describes a simple, five-step method for evaluating the main components of cardiac rhythm.

Operating Modes and Cooling Capabilities of the 3-Stage ADR Developed for the Soft-X-ray Spectrometer Instrument on Astro-H.

A 3-stage adiabatic demagnetization refrigerator (ADR)[1] is used on the Soft X-ray Spectrometer instrument[2] on Astro-H[3] to cool a 6×6 array of x-ray microcalorimeters to 50 mK. The ADR is supported by a cryogenic system[4] consisting of a superfluid helium tank, a 4.5 K Joule-Thomson (JT) cryocooler, and additional 2-stage Stirling cryocoolers that pre-cool the JT cooler and cool radiation shields within the cryostat. The ADR is configured so that it can use either the liquid helium or the JT cryocooler as its heat sink, giving the instrument an unusual degree of tolerance for component failures or degradation in the cryogenic system. The flight detector assembly, ADR and dewar were integrated into the flight dewar in early 2014, and have since been extensively characterized and calibrated. This paper summarizes the operation and performance of the ADR in all of its operating modes.

Near-surface wetland sediments as a source of arsenic release to ground water in Asia.

Tens of millions of people in south and southeast Asia routinely consume ground water that has unsafe arsenic levels. Arsenic is naturally derived from eroded Himalayan sediments, and is believed to enter solution following reductive release from solid phases under anaerobic conditions. However, the processes governing aqueous concentrations and locations of arsenic release to pore water remain unresolved, limiting our ability to predict arsenic concentrations spatially (between wells) and temporally (future concentrations) and to assess the impact of human activities on the arsenic problem. This uncertainty is partly attributed to a poor understanding of groundwater flow paths altered by extensive irrigation pumping in the Ganges-Brahmaputra delta, where most research has focused. Here, using hydrologic and (bio)geochemical measurements, we show that on the minimally disturbed Mekong delta of Cambodia, arsenic is released from near-surface, river-derived sediments and transported, on a centennial timescale, through the underlying aquifer back to the river. Owing to similarities in geologic deposition, aquifer source rock and regional hydrologic gradients, our results represent a model for understanding pre-disturbance conditions for other major deltas in Asia. Furthermore, the observation of strong hydrologic influence on arsenic behaviour indicates that release and transport of arsenic are sensitive to continuing and impending anthropogenic disturbances. In particular, groundwater pumping for irrigation, changes in agricultural practices, sediment excavation, levee construction and upstream dam installations will alter the hydraulic regime and/or arsenic source material and, by extension, influence groundwater arsenic concentrations and the future of this health problem.

Gravity-supported exercise with computer gaming improves arm function in chronic stroke.

OBJECTIVE: To investigate the effect of 4 to 6 weeks of exergaming with a computer mouse embedded within an arm skate on upper limb function in survivors of chronic stroke. DESIGN: Intervention study with a 4-week postintervention follow-up. SETTING: In home. PARTICIPANTS: Survivors (N=13) of chronic (≥6 mo) stroke with hemiparesis of the upper limb with stable baseline Fugl-Meyer assessment scores received the intervention. One participant withdrew, and 2 participants were not reassessed at the 4-week follow-up. No participants withdrew as a result of adverse effects. INTERVENTION: Four to 6 weeks of exergaming using the arm skate where participants received either 9 (n=5) or 16 (n=7) hours of game play. MAIN OUTCOME MEASURE: Upper limb component of the Fugl-Meyer assessment. RESULTS: There was an average increase in the Fugl-Meyer upper limb assessment score from the beginning to end of the intervention of 4.9 points. At the end of the 4-week period after the intervention, the increase was 4.4 points. CONCLUSIONS: A 4- to 6-week intervention using the arm skate significantly improved arm function in survivors of chronic stroke by an average of 4.9 Fugl-Meyer upper limb assessment points. This research shows that a larger-scale randomized trial of this device is warranted and highlights the potential value of using virtual reality technology (eg, computer games) in a rehabilitation setting.

Pharmacological management of chronic heart failure.

Chronic heart failure is a progressive and life-limiting syndrome that is caused by a failure of the heart to pump blood around the body effectively. It frequently leads to a range of distressing symptoms, such as breathlessness, fatigue and fluid retention. Chronic heart failure can be caused by a variety of cardiac diseases, but is commonly linked to coronary heart disease and hypertension. In response to these, the body initiates a series of compensatory mechanisms, which ultimately become maladaptive, and the manipulation of these mechanisms is the cornerstone of pharmacological management of the condition. This article explains the compensatory mechanisms that occur in chronic heart failure and outlines the medicines commonly used in its management.

Simulation versus reality: what can interprofessional simulation teach us about team dynamics in the trauma bay?

Purpose: Surgical consultation and the joint management of trauma patients is a common scenario in the emergency department. The goal of this study was to utilize interprofessional trauma team training to understand the role of simulation and its impact on the overall culture of trauma-related care. Methods: Interdisciplinary trauma simulation scenarios were completed by 12 groups of emergency medicine residents, general surgery residents, and emergency medicine nurses across two academic years. Following each simulation, a debriefing session was held to reflect on the scenario, focusing on team interactions. Debriefing sessions were audio-recorded, transcribed, deidentified, and independently, inductively coded by two members of the research team. Using the constant comparative method, a codebook was developed and refined until interrater reliability was confirmed with a kappa of > 0.9. Codes were organized into higher level themes. Results: There were 72 participants, including 23 general surgery residents, 19 emergency medicine residents, and 30 emergency medicine nurses. 214 primary codes were collapsed into 29 coding categories, with 6 emerging themes. Pre-trauma bay impact describes how interactions prior to the trauma scenario can impact how team members communicate, trust one another, and ultimately care for the patient. Role and team identity explores the importance of one knowing their individual role in the trauma bay and how it impacts overall team identity. Resource allocation describes the balance of having appropriate resources to efficiently care for patients while not negatively impacting crowd control or role identity. Impact of the simulation experience highlights the impact of the lower stakes simulation scenario on learning and reflection as well as concerns with simulation fidelity. Trauma leader traits and actions outlines inherent traits and learned actions of trauma leaders that impact how the trauma scenario unfolds. Interprofessional team performance describes the overall performance of the trauma team, including but not limited to the type of communication used, teamwork behaviors, and transition of care of the patient. Conclusions: Interdisciplinary trauma simulations and structured debriefing sessions provide insights into team dynamics and interprofessional relationships. Simulations and debriefing sessions can promote understanding, respect, and familiarity of team members' roles; recognition of key characteristics of high functioning leaders and teams; and discovery of conflict mitigating strategies for future interdisciplinary team improvement. Simulation sessions allow implementation of quality improvement measures and communication and leadership strategy practice in a safe, collaborative learning environment. The lessons learned from these sessions can encourage participants to reexamine how they interact and function as a team within the real-life trauma bay.

Usability of a perioperative medication-related clinical decision support software application: a randomized controlled trial.

OBJECTIVE: We developed a comprehensive, medication-related clinical decision support (CDS) software prototype for use in the operating room. The purpose of this study was to compare the usability of the CDS software to the current standard electronic health record (EHR) medication administration and documentation workflow. MATERIALS AND METHODS: The primary outcome was the time taken to complete all simulation tasks. Secondary outcomes were the total number of mouse clicks and the total distance traveled on the screen in pixels. Forty participants were randomized and assigned to complete 7 simulation tasks in 1 of 2 groups: (1) the CDS group (n = 20), who completed tasks using the CDS and (2) the Control group (n = 20), who completed tasks using the standard medication workflow with retrospective manual documentation in our anesthesia information management system. Blinding was not possible. We video- and audio-recorded the participants to capture quantitative data (time on task, mouse clicks, and pixels traveled on the screen) and qualitative data (think-aloud verbalization). RESULTS: The CDS group mean total task time (402.2 ± 85.9 s) was less than the Control group (509.8 ± 103.6 s), with a mean difference of 107.6 s (95% confidence interval [CI], 60.5-179.5 s, P < .001). The CDS group used fewer mouse clicks (26.4 ± 4.5 clicks) than the Control group (56.0 ± 15.0 clicks) with a mean difference of 29.6 clicks (95% CI, 23.2-37.6, P < .001). The CDS group had fewer pixels traveled on the computer monitor (59.5 ± 20.0 thousand pixels) than the Control group (109.3 ± 40.8 thousand pixels) with a mean difference of 49.8 thousand pixels (95% CI, 33.0-73.7, P < .001). CONCLUSIONS: The perioperative medication-related CDS software prototype substantially outperformed standard EHR workflow by decreasing task time and improving efficiency and quality of care in a simulation setting.

Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia: A Randomized Clinical Trial.

Importance: Nearly half of the older adult population has diabetes or a high-risk intermediate glycemic category, but we still lack trial evidence for effective type 2 diabetes prevention interventions in most of the current high-risk glycemic categories. Objective: To determine whether a group-based lifestyle intervention (with or without trained volunteers with type 2 diabetes) reduced the risk of progression to type 2 diabetes in populations with a high-risk glycemic category. Design, Setting, and Participants: The Norfolk Diabetes Prevention Study was a parallel, 3-arm, group-based, randomized clinical trial conducted with up to 46 months of follow-up from August 2011 to January 2019 at 135 primary care practices and 8 intervention sites in the East of England. We identified 141 973 people at increased risk of type 2 diabetes, screened 12 778 (9.0%), and randomized those with a high-risk glycemic category, which was either an elevated fasting plasma glucose level alone (≥110 and <126 mg/dL [to convert to millimoles per liter, multiply by 0.0555]) or an elevated glycated hemoglobin level (≥6.0% to <6.5%; nondiabetic hyperglycemia) with an elevated fasting plasma glucose level (≥100 to <110 mg/dL). Interventions: A control arm receiving usual care (CON), a theory-based lifestyle intervention arm of 6 core and up to 15 maintenance sessions (INT), or the same intervention with support from diabetes prevention mentors, trained volunteers with type 2 diabetes (INT-DPM). Main Outcomes and Measures: Type 2 diabetes incidence between arms. Results: In this study, 1028 participants were randomized (INT, 424 [41.2%] [166 women (39.2%)]; INT-DPM, 426 [41.4%] [147 women (34.5%)]; CON, 178 [17.3%] [70 women (%39.3)]) between January 1, 2011, and February 24, 2017. The mean (SD) age was 65.3 (10.0) years, mean (SD) body mass index 31.2 (5) (calculated as weight in kilograms divided by height in meters squared), and mean (SD) follow-up 24.7 (13.4) months. A total of 156 participants progressed to type 2 diabetes, which comprised 39 of 171 receiving CON (22.8%), 55 of 403 receiving INT (13.7%), and 62 of 414 receiving INT-DPM (15.0%). There was no significant difference between the intervention arms in the primary outcome (odds ratio [OR], 1.14; 95% CI, 0.77-1.7; P = .51), but each intervention arm had significantly lower odds of type 2 diabetes (INT: OR, 0.54; 95% CI, 0.34-0.85; P = .01; INT-DPM: OR, 0.61; 95% CI, 0.39-0.96; P = .033; combined: OR, 0.57; 95% CI, 0.38-0.87; P = .01). The effect size was similar in all glycemic, age, and social deprivation groups, and intervention costs per participant were low at $153 (£122). Conclusions and Relevance: The Norfolk Diabetes Prevention lifestyle intervention reduced the risk of type 2 diabetes in current high-risk glycemic categories. Enhancing the intervention with DPM did not further reduce diabetes risk. These translatable results are relevant for current diabetes prevention efforts. Trial Registration: ISRCTN Registry Identifier: ISRCTN34805606.

Experience of point-of-care HbA1c testing in the English National Health Service Diabetes Prevention Programme: an observational study.

INTRODUCTION: To report the observations of point-of-care (POC) glycated hemoglobin (HbA1c) testing in people with non-diabetic hyperglycemia (NDH; HbA1c 42-47 mmol/mol (6.0%-6.4%)), applied in community settings, within the English National Health Service Diabetes Prevention Programme (NHS DPP). RESEARCH DESIGN AND METHODS: A service evaluation assessing prospectively collected national service-level data from the NHS DPP, using data from the first referral received in June 2016-October 2018. Individuals were referred to the NHS DPP with a laboratory-measured HbA1c in the NDH range and had a repeat HbA1c measured at first attendance of the program using one of three POC devices: DCA Vantage, Afinion or A1C Now+. Differences between the referral and POC HbA1c and the SD of the POC HbA1c were calculated. The factors associated with the difference in HbA1c and the association between POC HbA1c result and subsequent attendance of the NHS DPP were also evaluated. RESULTS: Data from 73 703 participants demonstrated a significant mean difference between the referral and POC HbA1c of -2.48 mmol/mol (-0.23%) (t=157, p<0.001) with significant differences in the mean difference between devices (F(2, 73 700)=738, p<0.001). The SD of POC HbA1c was 4.46 mmol/mol (0.41%) with significant differences in SDs between devices (F(2, 73 700)=1542, p<0.001). Participants who were older, from more deprived areas and from Asian, black and mixed ethnic groups were associated with smaller HbA1c differences. Normoglycemic POC HbA1c versus NDH POC HbA1c values were associated with lower subsequent attendance at behavioral interventions (58% vs 67%, p<0.001). CONCLUSION: POC HbA1c testing in community settings was associated with significantly lower HbA1c values when compared with laboratory-measured referrals. Acknowledging effects of regression to the mean, we found that these differences were also associated with POC method, location, individual patient factors and time between measurements. Compared with POC HbA1c values in the NDH range, normoglycemic POC HbA1c values were associated with lower subsequent intervention attendance.

Modern Medical Consequences of the Ancient Evolution of a Long, Flexible Lumbar Spine.

Modern human bipedality is unique and requires lumbar lordosis, whereas chimpanzees, our closest relatives, have short lumbar spines rendering them incapable of lordosis. To facilitate lordosis, humans have longer lumbar spines, greater lumbosacral angle, dorsally wedged lumbar vertebral bodies, and lumbar zygapophyseal joints with both increasingly coronal orientation and further caudal interfacet distances. These features limit modern lower lumbar spine and lumbosacral joint ailments, albeit imperfectly. The more coronal zygapophyseal orientation limits spondylolisthesis, while increasing interfacet distance may limit spondylolysis. Common back pain, particularly in people who are obese or pregnant, may result from increased lumbar lordosis, causing additional mass transfer through the zygapophyseal joints rather than vertebral bodies. Reduction in lumbar lordosis, such as in flatback syndrome from decreased lumbosacral angle, can also cause back pain. Human lumbar lordosis is necessary for placing the trunk atop the pelvis and presents a balancing act not required of our closest primate relatives.

Recruitment, retention, and training of people with type 2 diabetes as diabetes prevention mentors (DPM) to support a healthcare professional-delivered diabetes prevention program: the Norfolk Diabetes Prevention Study (NDPS).

Objective: Intensive lifestyle interventions reduce the risk of type 2 diabetes in populations at highest risk, but staffing levels are usually unable to meet the challenge of delivering effective prevention strategies to a very large at-risk population. Training volunteers with existing type 2 diabetes to support healthcare professionals deliver lifestyle interventions is an attractive option. Methods: We identified 141 973 people at highest risk of diabetes in the East of England, screened 12 778, and randomized 1764 into a suite of type 2 diabetes prevention and screen detected type 2 diabetes management trials. A key element of the program tested the value of volunteers with type 2 diabetes, trained to act as diabetes prevention mentors (DPM) when added to an intervention arm delivered by healthcare professionals trained to support participant lifestyle change. Results: We invited 9951 people with type 2 diabetes to become DPM and 427 responded (4.3%). Of these, 356 (83.3%) were interviewed by phone, and of these 131 (36.8%) were interviewed in person. We then appointed 104 of these 131 interviewed applicants (79%) to the role (mean age 62 years, 55% (n=57) male). All DPMs volunteered for a total of 2895 months, and made 6879 telephone calls to 461 randomized participants. Seventy-six (73%) DPMs volunteered for at least 6 months and 66 (73%) for at least 1 year. Discussion: Individuals with type 2 diabetes can be recruited, trained and retained as DPM in large numbers to support a group-based diabetes prevention program delivered by healthcare professionals. This volunteer model is low cost, and accesses the large type 2 diabetes population that shares a lifestyle experience with the target population. This is an attractive model for supporting diabetes prevention efforts.

Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial.

OBJECTIVE: This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in adults with type 2 diabetes receiving basal insulin and oral antidiabetic agents. RESEARCH DESIGN AND METHODS: The primary end point was HbA1c change from baseline after 26 weeks' treatment. After an 8-week run-in to optimize basal insulin, subjects were randomized (1:1) to mealtime faster aspart (n = 345) or IAsp (n = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin. RESULTS: HbA1c change was -1.38% (faster aspart) and -1.36% (IAsp); mean HbA1c was 6.6% for both groups. Faster aspart demonstrated noninferiority versus IAsp in reducing HbA1c (estimated treatment difference [ETD] [95% CI] -0.02% [-0.15; 0.10]). Both treatments improved postprandial plasma glucose (PPG) control; the PPG increment (liquid meal test) was statistically significant in favor of faster aspart after 1 h (ETD [95% CI] -0.59 mmol/L [-1.09; -0.09]; -10.63 mg/dL [-19.56; -1.69]; P = 0.0198), but not after 2-4 h. Change from baseline in fasting plasma glucose, body weight, and overall severe/blood glucose-confirmed hypoglycemia rates (rate ratio [RR] [95% CI] 1.09 [0.88; 1.36]) were similar between treatments. Postmeal hypoglycemia (0-2 h) rates were 2.27 (faster aspart) and 1.49 (IAsp) per patient-year of exposure (RR [95% CI] 1.60 [1.13; 2.27]). CONCLUSIONS: Faster aspart and IAsp were confirmed noninferior in a basal-bolus regimen regarding change from baseline in HbA1c. Faster aspart improved 1-h PPG with no differences in 2-4-h PPG versus IAsp. Overall hypoglycemia rates were similar except for an increase in 0-2-h postmeal hypoglycemia with faster aspart.

A new integrated care pathway for ambulance attended severe hypoglycaemia in the East of England: The Eastern Academic Health Science Network (EAHSN) model.

AIMS: We developed a new clinical integrated pathway linking a regional Ambulance Trust with a severe hypoglycaemia (SH) prevention team. We present clinical data from the first 2000 emergency calls taken through this new clinical pathway in the East of England. METHODS: SH patients attended by Ambulance crew receive written information on SH avoidance, and are contacted for further education through a new regional SH prevention team. All patients are contacted unless they actively decline. RESULTS: Median age (IQR) was 67 (50-80) years, 23.6% of calls were for patients over 80years old, and patients more than 90years old were more common than 20-25year olds in this population. Most calls were for patients (84.9%) who were insulin treated, even those over 80years (75%). One - third of patients attended after a call were unconscious on attendance. 5.6% of patients in this call population had 3 or more ambulance call outs, and they generated 17.6% of all calls. In total, 728 episodes (36.4%) were repeat calls. Insulin related events were clinically more severe than oral hypoglycaemic related events. Patients conveyed to hospitals (13.8%) were significantly older, with poorer recovery in biochemical hypoglycaemia after ambulance crew attendance. Only 19 (1%) opted out of further contact. Patients were contacted by the SH prevention team after a median 3 (0-6) days. The most common patient self - reported cause for their SH episode was related to perceived errors in insulin management (31.4%). CONCLUSIONS: This new clinical service is simple, acceptable to patients, and a translatable model for prevention of recurrent SH in this largely elderly insulin treated SH population.

Evaluation of the Achieve Mapping Catheter in cryoablation for atrial fibrillation: a prospective randomized trial.

PURPOSE: The purpose of this study is to establish the role of Achieve Mapping Catheter in cryoablation for paroxysmal atrial fibrillation (PAF) in a randomized trial. METHODS: A total of 102 patients undergoing their first ablation for PAF were randomized at 2:1 to an Achieve- or Lasso-guided procedure. Study patients were systematically followed up for 12 months with Holter monitoring. Primary study endpoint was acute procedure success. Secondary endpoint was clinical outcomes assessed by AF free at 6 and 12 months after the procedure. RESULTS: Of 102 participants, 99 % of acute procedure success was achieved. Significantly shorter procedure duration with the Achieve-guided group than with the Lasso-guided group (118 ± 18 vs. 129 ± 21 min, p < 0.05) was observed as was the duration of fluoroscopy (17 ± 5 vs. 20 ± 7 min, p < 0.05) by subgroup analysis focused on procedures performed by experienced operators. In the whole study patients, procedure and fluoroscopic durations were similar in the Achieve- (n = 68) and Lasso-guided groups (n = 34). Transient phrenic nerve weakening was equally prevalent with the Achieve and Lasso. No association was found between clinical outcomes and the mapping catheter used. The use of second-generation cryoballoon (n = 68) reduced procedure time significantly compared to the first-generation balloon (n = 34); more patients were free of AF in the former than the latter group during follow-up. CONCLUSIONS: The use of the Achieve Mapping Catheter can reduce procedure and fluoroscopic durations compared with Lasso catheters in cryoablation for PAF after operators gained sufficient experience. The type of mapping catheter used does not affect procedure efficiency and safety by models of cryoballoon.

Plasma F2 isoprostanes: direct evidence of increased free radical damage during acute hyperglycemia in type 2 diabetes.

OBJECTIVES: Acute hyperglycemia in type 2 diabetes increases the generation of plasma 8-epi-prostaglandin F2 (8-epi-PGF2alpha) isoprostane, a sensitive direct marker of in vivo free radical oxidative damage to membrane phospholipids. RESEARCH DESIGN AND METHODS: A total of 21 patients with type 2 diabetes underwent an oral 75-g glucose tolerance test. Plasma 8-epi-PGF2alpha isoprostane concentrations (by gas chromatography [GC]/mass spectrometry [MS]), intralymphocyte reduced-to-oxidized glutathione ratios, and plasma total antioxidant capacity were measured at baseline and 90 min after glucose loading. RESULTS: Plasma 8-epi-PGF2alpha isoprostane concentrations rose significantly (P=0. 010) from 0.241 +/- 0.1 to 0.326 +/- 0.17 ng/l after 90 min. Intracellular oxidative balance and plasma antioxidant capacity did not change in either group. CONCLUSIONS: Plasma concentrations of 8-epi-PGF2alpha isoprostane increase during acute hyperglycemia in type 2 diabetes, providing direct evidence of free radical-mediated oxidative damage and demonstrating a pathway for an association between acute rather than fasting hyperglycemia and macrovascular risk in type 2 diabetes.

Increased expression of a scavenger receptor (CD36) in monocytes from subjects with Type 2 diabetes.

Uptake of modified low density lipoprotein (LDL) by monocyte-macrophages is mediated by the scavenger receptor CD36, which is upregulated in vitro by high glucose concentrations and oxidatively modified LDL. We hypothesised that monocyte CD36 expression would be higher in Type 2 diabetes, and would increase during acute hyperglycaemia. Sixteen subjects with Type 2 diabetes and 11 controls underwent a 75 g oral glucose load. Monocyte CD36 expression (by laser flow cytometry), plasma LDL diene conjugates, plasma LDL hydroxyoctadecadienoic acid-13 (a peroxisome proliferator activator receptor gamma agonist) were measured at 0, 2 and 4 h. Mean monocyte CD36 expression at baseline was 34% higher in the diabetes group (P=0.01), did not change during acute hyperglycaemia and plasma LDL conjugated diene concentration was the only variable directly related to CD36 expression (F=4.53; P=0.05; r=0.51). Higher baseline CD36 expression in Type 2 diabetes could reflect increased post-transcriptional efficiency of CD36 mRNA in response to chronic hyperglycaemia and could be a proatherogenic mechanism in Type 2 diabetes.

Outcomes after anterior cervical discectomy and fusion in professional athletes.

BACKGROUND: Significant controversy exists regarding when an athlete may return to contact sports after anterior cervical discectomy and fusion (ACDF). Return-to-play (RTP) recommendations are complicated due to a mix of medical factors, social pressures, and limited outcome data. OBJECTIVE: The aim of this study was to characterize our diagnostic and surgical criteria, intervention, postoperative imaging results, and rehabilitation and report RTP decisions and outcomes for professional athletes with cervical spine injuries. METHODS: Fifteen professional athletes who had undergone a 1-level ACDF by a single neurosurgeon were identified after a retrospective chart and radiographic review from 2003 to 2012. Patient records and imaging studies were recorded. RESULTS: Seven of the 15 athletes presented with neurapraxia, 8 with cervical radiculopathy, and 2 with hyperintensity of the spinal cord. Cervical stenosis with effacement of the cerebrospinal fluid signal was noted in 14 subjects. The operative level included C3-4 (4 patients), C4-5 (1 patient), C5-6 (8 patients), and C6-7 (2 patients). All athletes were cleared for RTP after a neurological examination with normal findings, and radiographic criteria for early fusion were confirmed. Thirteen of the 15 players returned to their sport between 2 and 12 months postoperatively (mean, 6 months), with 8 still participating. The RTP duration of the 5 who retired after full participation ranged from 1 to 3 years. All athletes remain asymptomatic for radicular or myelopathic symptoms or signs. CONCLUSION: After a single-level ACDF, an athlete may return to contact sports if there are normal findings on a neurological examination, full range of neck movement, and solid arthrodesis. There may be an increased risk of the development of adjacent segment disease above or below the level of fusion. Cord hyperintensity may not necessarily preclude RTP.