UK Prescribing Safety Assessment (PSA): The development, implementation and outcomes of a national online prescribing assessment.

AIMS: The United Kingdom (UK) Prescribing Safety Assessment (PSA) is a 2-h online assessment of basic competence to prescribe and supervise the use of medicines. It has been undertaken by students and doctors in UK medical and foundation schools for the past decade. This study describes the academic characteristics and performance of the assessment; longitudinal performance of candidates and schools; stakeholder feedback; and surrogate markers of prescribing safety in UK healthcare practice. METHODS: We reviewed the performance data generated by over 70 000 medical students and 3700 foundation doctors who have participated in the PSA since its inception in 2013. These data were supplemented by Likert scale and free text feedback from candidates and a variety of stakeholder groups. Further data on medication incidents, collected by national reporting systems and the regulatory body, are reported, with permission. RESULTS: We demonstrate the feasibility, high quality and reliability of an online prescribing assessment, uniquely providing a measure of prescribing competence against a national standard. Over 90% of candidates pass the PSA on their first attempt, while a minority are identified for further training and assessment. The pass rate shows some variation between different institutions and between undergraduate and foundation cohorts. Most responders to a national survey agreed that the PSA is a useful instrument for assessing prescribing competence, and an independent review has recommended adding the PSA to the Medical Licensing Assessment. Surrogate markers suggest there has been improvement in prescribing safety in practice, temporally associated with the introduction of the PSA but other factors could be influential too. CONCLUSIONS: The PSA is a practical and cost-effective way of delivering a reliable national assessment of prescribing competence that has educational impact and is supported by the majority of stakeholders. There is a need to develop national systems to identify and report prescribing errors and the harm they cause, enabling the impact of educational interventions to be measured.

Environmental effects of ambient temperature and relative humidity on insulin pharmacodynamics in adults with type 1 diabetes mellitus.

OBJECTIVE: This study aimed to explore the effects of ambient temperature and relative humidity on insulin pharmacodynamics in adults with type 1 diabetes. MATERIALS AND METHODS: A three-way, cross-over, randomised study was performed in adults with type 1 diabetes mellitus (n = 10). The pharmacodynamics profile of a single dose of short-acting insulin (insulin lispro) was investigated, using a controlled environmental chamber, under three environmental conditions: (a) temperature: 15°C and humidity: 10%; (b) temperature: 30°C and humidity: 10%; and (c) temperature: 30°C and humidity: 60%. A euglycaemic glucose clamp technique ensured constant blood glucose of 100 mg/dL (5.5 mmol/L). The following pharmacodynamic endpoints were calculated: maximum glucose infusion rate (GIRmax ), time to GIRmax (tGIRmax ), total area under the curve (AUC) for GIR from 0-6 hours (AUCGIR.0-6h ), and partial AUCs (AUCGIR.0-1h , AUCGIR.0-2h and AUCGIR.2-6h ). RESULTS: Higher temperature (30°C) under 10% fixed humidity conditions resulted in greater GIRmax (P = 0.04) and a later tGIR.max (P = 0.049) compared to lower temperature (15°C). Humidity did not affect any pharmacodynamic parameter. When the combined effects of temperature and humidity were explored, tGIR.max (P = 0.008) occurred earlier, with a lower late insulin pharmacodynamic effect (AUCGIR.2-6h ; P = 0.017) at a temperature of 15°C and humidity of 10% compared to a temperature of 30°C and humidity of 60%. CONCLUSIONS: High ambient temperature resulted in a greater insulin peak effect compared to low ambient temperature, with the contribution of high relative humidity apparent only at high ambient temperature. This suggests that patients with type 1 diabetes mellitus who are entering higher environmental temperatures, with or without high humidity, could experience more hypoglycaemic events.

The obesity paradox in type 2 diabetes mellitus: relationship of body mass index to prognosis: a cohort study.

BACKGROUND: Whether obesity is associated with a better prognosis in patients with type 2 diabetes mellitus is controversial. OBJECTIVE: To investigate the association between body weight and prognosis in a large cohort of patients with type 2 diabetes followed for a prolonged period. DESIGN: Prospective cohort. SETTING: National Health Service, England. PATIENTS: Patients with diabetes. MEASUREMENTS: The relationship between body mass index (BMI) and prognosis in patients with type 2 diabetes without known cardiovascular disease at baseline was investigated. Information on all-cause mortality and cardiovascular morbidity (such as the acute coronary syndrome, cerebrovascular accidents, and heart failure) was collected. Cox regression survival analysis, corrected for potential modifiers, including cardiovascular risk factors and comorbid conditions (such as cancer, chronic kidney disease, and lung disease), was done. RESULTS: 10,568 patients were followed for a median of 10.6 years (interquartile range, 7.8 to 13.4). Median age was 63 years (interquartile range, 55 to 71), and 54% of patients were men. Overweight or obese patients (BMI >25 kg/m²) had a higher rate of cardiac events (such as the acute coronary syndrome and heart failure) than those of normal weight (BMI, 18.5 to 24.9 kg/m²). However, being overweight (BMI, 25 to 29.9 kg/m²) was associated with a lower mortality risk, whereas obese patients (BMI >30 kg/m²) had a mortality risk similar to that of normal-weight persons. Patients with low body weight had the worst prognosis. LIMITATION: Data about cause of death were not available. CONCLUSION: In this cohort, patients with type 2 diabetes who were overweight or obese were more likely to be hospitalized for cardiovascular reasons. Being overweight was associated with a lower mortality risk, but being obese was not. PRIMARY FUNDING SOURCE: National Institute for Health Research and University of Hull.

An Alternative to Traditional Bedside Teaching During COVID-19: High-Fidelity Simulation-Based Study.

BACKGROUND: Bedside teaching is integral to medical education and has been highlighted to improve clinical and communication skills, as well as clinical reasoning. Despite the significant advantages of bedside teaching, its usage within medical education has been declining, and COVID-19 has added additional challenges. The pandemic has resulted in a significant reduction in opportunities to deliver bedside teaching due to risk of viral exposure, patients declining student interactions, and ward closures. Educators have therefore been required to be innovative in their teaching methods, leading to the use of online learning, social media platforms, and simulation. Simulation-based education allows for learning in a low-risk environment and affords the opportunity for deliberated repeated practice with case standardization. The results demonstrate that simulation-based training can increase students' confidence, increase the rates of correct clinical diagnoses, and improve retention of skills and knowledge when compared with traditional teaching methods. OBJECTIVE: To mitigate the impact of COVID-19 upon bedside teaching for third year students at Hull York Medical School amid closure of the cardiorespiratory wards, a high-fidelity simulation-based model of traditional bedside teaching was designed and implemented. The objectives of the teaching session were to enable students to perform history taking and a focused cardiorespiratory clinical examination in a COVID-19-safe environment using SimMan 3G. METHODS: Four clinical teaching fellows with experience of simulation-based medical education scripted histories for 2 common cardiorespiratory cases, which were asthma and aortic stenosis. The simulation sessions were designed for students to take a focused cardiorespiratory history and clinical examination using SimMan 3G. All cases involved dynamic vital signs, and the simulator allowed for auscultation of an ejection systolic murmur and wheezing in accordance with the cases chosen. Key aspects of the pathologies, including epidemiology, differential diagnoses, investigations, and management, were summarized using an interactive PowerPoint presentation, followed by a debriefing session. RESULTS: In total, 12 third year medical students undertook the sessions, and overall feedback was highly positive. Of the 10 students who completed the feedback questionnaires, 90% (n=9) felt more confident in their clinical examination skills following the teaching; 100% (n=10) of the students responded that they would recommend the session to a colleague; and implementation of regular simulation was frequently requested on feedback. These results are in keeping with the current literature. CONCLUSIONS: Bedside teaching continues to face ongoing challenges from the COVID-19 pandemic as well as declining patient recruitment and fluctuations in clinical findings. The support for simulation-based medical education is derived from high-quality studies; however, studies describing the use of this technology for bedside teaching in the undergraduate curriculum are limited. The authors describe a highly effective teaching session amid the pandemic, which allowed for maintenance of staff and student safety alongside continued education during a challenging time for educators globally.

High-fidelity simulation and virtual reality: an evaluation of medical students' experiences.

Background: Simulation technology is widely used in medical education, providing an environment in which students can develop and practise a multitude of skills that are relevant to clinical practice, without the risk of harm to patients. Methods: We conducted a mixed methods cross-over study with quantitative and qualitative outcomes. This analysed students' perceptions of two simulation technologies: a high-fidelity patient simulator and virtual reality. Twenty final year medical students completed a questionnaire after having experienced both simulation modalities. Results: Students scored the patient simulator higher in domains such as developing team working and 'ABCDE assessment skills', whereas the virtual reality simulation was more immersive and fun. Participants found the patient simulator more useful in preparing them for clinical practice. Conclusion: Medical students in this study expressed that a high-fidelity patient simulator, in a simulated clinical environment, was of greater value to their preparation for clinical practice than virtual reality simulation of a similar environment. However, the virtual reality simulation offered a near comparable experience, and was found to be was enjoyable, immersive and easily portable.

Usefulness of low-dose combined spinal epidural anesthesia for a woman with systemic lupus erythematosus, mechanical prosthesis in the mitral valve position, and worsening heart failure presenting for cesarean delivery.

A 31-year-old woman, gravida one, para zero, at 32 weeks, 4 days gestation, with a history of antiphospholipid antibody syndrome, mitral valve replacement requiring anticoagulation, chronic diastolic heart failure, and systemic lupus erythematous was admitted to the hospital for worsening cardiac decompensation with superimposed pneumonia. She was on warfarin for anticoagulation at the time of hospital admission and eventually started on an intravenous heparin infusion. Cesarean delivery was planned due to comorbidities and anticoagulation status. After administration of betamethasone for fetal lung maturity, the patient's heparin infusion was discontinued approximately 16 hours prior to cesarean delivery. Upon obtaining laboratory testing that confirmed appropriate coagulation status, a low-dose combined spinal epidural anesthetic technique was used for cesarean delivery and the expected hemodynamic shifts due to spinal anesthesia were mitigated with a prophylactic norepinephrine infusion.

Relationship between a single measurement at baseline of body mass index, glycated hemoglobin, and the risk of mortality and cardiovascular morbidity in type 2 diabetes mellitus.

OBJECTIVE: This study aims to evaluate the relationship between a single measurement at baseline of body mass index (BMI), glycated hemoglobin (HbA1c) and subsequent clinical outcomes in patients with type 2 diabetes mellitus (T2DM). METHOD: Patients with T2DM were recruited from an outpatient diabetes clinic in a single large teaching hospital in Kingston upon Hull, UK. At baseline, demographics and HbA1c were recorded. Patients were categorized by BMI: normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obese (>30 kg/m2). Multivariable Cox regression models that included demographic, risk factors, and comorbidities were separately constructed for all-cause, cardiovascular, cancer and sepsis-related mortality, using four groups of HbA1c (<6%, 6.0-6.9%, 7.0-7.9%, and >8%). RESULTS: In total, 6220 patients with T2DM (median age 62 years, 54% male) were followed for a median of 10.6 years. HbA1c levels >8.0% were associated with increased risk of all-cause mortality and cardiovascular death. However, this increased risk was not consistent across the weight categories and reached statistical significance only in overweight patients (BMI 25-29.9 kg/m2). CONCLUSIONS: In a large cohort of patients with T2DM elevated HbA1c levels at baseline did not consistently predict increased risk of all-cause and cardiovascular mortality across the different BMI categories.

Biological variation of homeostasis model assessment-derived insulin resistance in type 2 diabetes.

OBJECTIVE: Individuals with type 2 diabetes are particularly vulnerable to cardiovascular disease. Insulin resistance is a major determinant of this increased risk and is a potential therapeutic target. This study was undertaken to establish the natural biological variation of insulin resistance in individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: The biological variation of insulin resistance was assessed by measuring insulin resistance at 4-day intervals on 10 consecutive occasions in 12 postmenopausal women with diet-controlled type 2 diabetes and in 11 weight- and age-matched postmenopausal women without type 2 diabetes. Insulin resistance was derived using the homeostasis model assessment for insulin resistance (HOMA-IR) method. RESULTS: The distribution of HOMA-IR was log Gaussian in the type 2 diabetic study group and Gaussian in the control group. The HOMA-IR in the type 2 diabetic group was significantly greater than that of the control group (mean +/- SD: 4.33 +/- 2.3 vs. 2.11 +/- 0.79 units, P = 0.001). After accounting for analytical variation, the mean intraindividual variation was also substantially greater in the type 2 diabetic group than in the control group (mean 1.05 vs. 0.15, P = 0.001). Consequently, at any level of HOMA-IR, a subsequent sample must increase by >90% or decrease by >47% to be considered significantly different from the first. CONCLUSIONS: HOMA-IR is significantly greater and more variable for individuals with type 2 diabetes. Therefore, this inherent variability needs to be accounted for in studies evaluating therapeutic reduction of HOMA-IR in this group.

Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes.

OBJECTIVE: Phytoestrogen consumption has been shown to reduce risk factors for cardiovascular disease. Type 2 diabetes confers an adverse cardiovascular risk profile particularly in women after menopause. The aim of this study was to determine whether a dietary supplement with soy protein and isoflavones affected insulin resistance, glycemic control, and cardiovascular risk markers in postmenopausal women with type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 32 postmenopausal women with diet-controlled type 2 diabetes completed a randomized, double blind, cross-over trial of dietary supplementation with phytoestrogens (soy protein 30 g/day, isoflavones 132 mg/day) versus placebo (cellulose 30 g/day) for 12 weeks, separated by a 2-week washout period. RESULTS: Compliance with the dietary supplementation was >90% for both treatment phases. When compared with the mean percentage change from baseline seen after 12 weeks of placebo, phytoestrogen supplementation demonstrated significantly lower mean values for fasting insulin (mean +/- SD 8.09 +/- 21.9%, P = 0.006), insulin resistance (6.47 +/- 27.7%, P = 0.003), HbA(1c) (0.64 +/- 3.19%, P = 0.048), total cholesterol (4.07 +/- 8.13%, P = 0.004), LDL cholesterol (7.09 +/- 12.7%, P = 0.001), cholesterol/HDL cholesterol ratio (3.89 +/- 11.7%, P = 0.015), and free thyroxine (2.50 +/- 8.47%, P = 0.004). No significant change occurred in HDL cholesterol, triglycerides, weight, blood pressure, creatinine, dehydroepiandrosterone sulfate, androstenedione, and the hypothalamic-pituitary-ovarian axis hormones. CONCLUSIONS: These results show that dietary supplementation with soy phytoestrogens favorably alters insulin resistance, glycemic control, and serum lipoproteins in postmenopausal women with type 2 diabetes, thereby improving their cardiovascular risk profile.