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BACKGROUND: Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin. SOURCE evaluated the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma. METHODS: We conducted this phase 3, multicentre, randomised, double-blind, placebo-controlled study across 60 sites in seven countries. Participants aged 18-80 years with physician-diagnosed asthma, who had been receiving medium-dose or high-dose inhaled corticosteroids and had at least one asthma exacerbation in the 12 months before screening were eligible. Patients who were receiving medium-dose inhaled corticosteroids must have had their dose increased to a high dose for at least 3 months before screening. After an oral corticosteroid optimisation phase of up to 8 weeks, participants were randomly assigned according to a computer-generated fixed block randomisation sequence to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks during a 48 week treatment period (4 week induction phase, 36 week oral corticosteroid reduction phase, and 8 week maintenance phase). Randomisation was stratified by region. Participants, investigators, and site staff were masked to treatment assignment. The primary endpoint was the categorised percentage reduction from baseline in daily oral corticosteroid dose at week 48 without the loss of asthma control. Efficacy and safety endpoints were assessed in all participants who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03406078. FINDINGS: Between March 5, 2018, and Sept 27, 2019, 150 participants were randomly assigned to receive tezepelumab 210 mg (n=74) or placebo (n=76). The cumulative odds of achieving a category of greater percentage reduction in an oral corticosteroid dose for daily maintenance at week 48 were similar with tezepelumab or placebo in the overall population (odds ratio [OR] 1·28 [95% CI 0·69-2·35], p=0·43; the primary endpoint was not met). The cumulative odds were higher with tezepelumab than with placebo in participants with baseline blood eosinophil counts of at least 150 cells per µL (2·58 [1·16-5·75]), but not in participants with counts below 150 cells per µL (0·40 [0·14-1·13]). Tezepelumab was well tolerated, with no safety concerns identified. 53 (72%) of 74 tezepelumab-assigned participants and 65 (86%) of 76 placebo-assigned participants reported an adverse event. Serious adverse events were reported in 12 (16%) participants in the tezepelumab group and 16 (21%) participants in the placebo group. INTERPRETATION: We did not observe a significant improvement in oral corticosteroid dose reduction with tezepelumab versus placebo in the overall population of this oral corticosteroid-sparing study, although an improvement was observed in participants with baseline blood eosinophil counts of at least 150 cells per µL. FUNDING: AstraZeneca and Amgen.

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BACKGROUND: Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin (TSLP). In the phase IIb PATHWAY study (NCT02054130), tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo in adults with severe, uncontrolled asthma. We evaluated the effects of tezepelumab in reducing type 2 (T2) inflammatory biomarker levels in the PATHWAY population, and the relationship between baseline T2 biomarker levels and AAER. METHODS: Adults with severe, uncontrolled asthma (n = 550) were randomized to tezepelumab (70 mg or 210 mg every 4 weeks, or 280 mg every 2 weeks) or placebo for 52 weeks. Blood eosinophil count, fractional exhaled nitric oxide (FeNO), and serum total immunoglobulin (Ig)E, interleukin (IL)-5, IL-13, periostin, thymus and activation-regulated chemokine (TARC), and TSLP were measured at baseline and over 52 weeks. AAERs were analyzed by baseline threshold (high/low) biomarker levels. RESULTS: Positive correlations were observed between T2 inflammatory biomarkers (blood eosinophil count, FeNO, IL-5, IL-13 and periostin) at baseline. At Week 52, treatment with tezepelumab 210 mg reduced all biomarker levels measured from baseline versus placebo. Exacerbations were reduced by 55-83% in the pooled tezepelumab cohort versus placebo, irrespective of baseline blood eosinophil count, FeNO, or serum total IgE, IL-5, IL-13, periostin, TARC, or TSLP, when these biomarkers were assessed individually. CONCLUSION: At baseline, positive correlations between specific T2 inflammatory biomarkers were observed. Tezepelumab reduced multiple T2 inflammatory biomarkers, which indicates decreased airway inflammation, and reduced exacerbations irrespective of baseline T2 biomarker profiles in patients with severe asthma.

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BACKGROUND: Tezepelumab is an anti-thymic stromal lymphopoietin mAb. In the PATHWAY phase IIb study (NCT02054130), tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo in adults with severe, uncontrolled asthma. OBJECTIVE: This post hoc analysis assessed the efficacy of tezepelumab in PATHWAY participants with perennial allergy. METHODS: Adults (N = 550) with severe, uncontrolled asthma were randomized to receive tezepelumab (70 mg or 210 mg every 4 weeks or 280 mg every 2 weeks) or placebo, for 52 weeks. The AAER over 52 weeks was analyzed in patients grouped by sensitivity to perennial aeroallergens and by eligibility for omalizumab treatment according to the US or European Union prescribing information. Change from baseline to week 52 in prebronchodilator FEV1 and type 2 biomarkers was assessed in the perennial allergy subgroups. RESULTS: Across doses, tezepelumab reduced the AAER versus placebo by 66% to 78% in patients with perennial allergy (n = 254) and 67% to 71% in patients without perennial allergy (n = 261). Tezepelumab improved prebronchodilator FEV1 and reduced blood eosinophil counts and fractional exhaled nitric oxide levels over 52 weeks, irrespective of perennial allergy status. Tezepelumab reduced the AAER versus placebo by 61% to 82% in omalizumab-eligible patients (US, n = 159; European Union, n = 101) and 63% to 70% in omalizumab-ineligible patients (US, n = 372; European Union, n = 440), respectively. CONCLUSIONS: Treatment with tezepelumab reduced exacerbations, improved lung function, and reduced type 2 biomarkers versus placebo in patients with severe, uncontrolled asthma with or without perennial allergy, further supporting its efficacy in a broad population of patients with severe, uncontrolled asthma.

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BACKGROUND: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis, from binding to its heterodimeric receptor. In the phase 2b PATHWAY study, tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo, irrespective of baseline disease characteristics, and improved lung function and symptom control, in adults with severe, uncontrolled asthma. This post hoc analysis assessed the efficacy of tezepelumab in adults with severe, uncontrolled asthma with and without nasal polyposis (NP). METHODS: In this post hoc analysis of the PATHWAY study (NCT02054130), participants (N=550) were randomized 1:1:1:1 to receive subcutaneous tezepelumab 70 mg every 4 weeks (Q4W), 210 mg Q4W or 280 mg every 2 weeks (Q2W), or placebo Q2W, for 52 weeks. The AAER over 52 weeks and the change from baseline to week 52 in blood eosinophil count, fractional exhaled nitric oxide (FeNO) levels and serum levels of interleukin (IL)-5 and IL-13 with tezepelumab 210 mg (the phase 3 dose) and placebo were analyzed in patients grouped by self-reported presence (NP+) or absence (NP-) of NP at screening. RESULTS: At baseline, NP+ patients had higher blood eosinophil counts, higher FeNO levels and higher serum IL-5 and IL-13 levels than NP- patients. Tezepelumab 210 mg reduced the AAER versus placebo to a similar extent in both NP+ and NP- patients (NP+, 75% [95% confidence interval (CI): 15, 93], n=23; NP-, 73% [95% CI: 47, 86], n=112). Patients treated with tezepelumab 210 mg demonstrated greater reductions in blood eosinophil count and levels of FeNO, IL-5 and IL-13 than placebo-treated patients, irrespective of NP status. DISCUSSION: Tezepelumab reduced exacerbations and reduced type 2 inflammatory biomarkers in patients with and those without NP, supporting its efficacy in a broad population of patients with severe asthma.

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BACKGROUND: Patients with severe, uncontrolled asthma experience frequent exacerbations and hospitalization, leading to poor health-related quality of life. In the phase 2b PATHWAY study (NCT02054130), tezepelumab reduced exacerbations by up to 71% and improved lung function, asthma control, and health-related quality of life vs placebo. OBJECTIVE: This analysis further assessed the impact of tezepelumab on patient-reported outcomes (PROs) in PATHWAY. METHODS: Adults with severe, uncontrolled asthma were randomized to subcutaneous tezepelumab (70 mg every 4 weeks, 210 mg every 4 weeks, or 280 mg every 2 weeks) or placebo for 52 weeks. PROs were assessed using the asthma control questionnaire-6 (ACQ-6) and the asthma quality of life questionnaire (standardized) for patients aged 12 years or older (AQLQ[S]+12). The proportions of responders (defined by improvements of ≥0.5 in ACQ-6 or AQLQ(S)+12 scores) and patients whose asthma was well-controlled, partially-controlled, or uncontrolled in the tezepelumab and placebo groups were identified. The Asthma Daily Diary questionnaire was used to assess changes in overall symptom severity. RESULTS: Overall, 550 patients were randomized. Up to 82% and 77% of tezepelumab-treated patients were ACQ-6 and AQLQ(S)+12 responders, respectively, compared with 70% and 64% of placebo-treated patients, respectively. The proportions of patients with well-controlled or partially-controlled asthma were higher in the tezepelumab-treated group than in the placebo group. In addition, tezepelumab improved the overall symptom severity. CONCLUSION: Tezepelumab treatment improved PROs vs placebo, as indicated by the higher proportion of ACQ-6 and AQLQ(S)+12 responders and improvements in symptom severity in the tezepelumab dose groups. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma.

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Polish women have not been studied in regard to fear, likelihood, or confidence about dangerous situations, nor has there been an instrument to measure those perceptions. The purpose of the study was fourfold: first, to present the Polish translation and validation of the Perception of Dangerous Situations Scale (PDSS-P) and second, to assess Polish women's perceived fear, likelihood, and confidence about dangerous situations using the PDSS-P (41 items). The third purpose was to determine to what degree the General Self-Efficacy Scale (GSES) and/or the Hope for Success Scale (KNS) correlated with any of the three subscales of the PDSS-P. The fourth purpose was to determine the congruence of the PDSS-P to the original PDSS. Two other tools (GSES and KNS) were administered to determine concurrent validity with the PDSS. A sample of 208 women aged 19 to 27 years (M = 21.04, SD = 1.88) participated in the study. Five factors were determined for each subscale, similar to the original version of the PDSS. Women reported they were more afraid of being raped by a stranger than being murdered. Their estimation of the likelihood of some serious events occurring was not congruent with statistical realities. The women thought the least likely events to happen to them in the next year would be being raped or beaten by someone they know, or being held prisoner by someone who wanted to murder them. Confidence to manage dangerous situations was low in cases of being raped by strangers or known people, being kidnapped, or being attacked. The GSES and KNS provided useful information, in that they did not measure the same constructs as the PDSS-P.

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PURPOSE: Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody therapeutic in development for patients with severe, uncontrolled asthma. In ongoing Phase III studies, tezepelumab is administered via subcutaneous (SC) injections using a vial-and-syringe (V-S). This study compared the pharmacokinetic (PK) parameters, safety, and tolerability of tezepelumab administered subcutaneously via V-S versus via an accessorized prefilled syringe (APFS) or autoinjector (AI). METHODS: This single-center, randomized, open-label, parallel-group study was conducted in healthy volunteers aged 18-65 years. Participants, stratified according to weight (50 to <70 kg, 70 to <80 kg, or 80-90 kg), were randomized evenly to 9 groups representing injections to the abdomen, thigh, or upper arm via V-S, APFS, or AI. Tezepelumab PK parameters over 113 days were evaluated after a single 210-mg SC dose. The primary end points were comparison of Cmax and AUC0-∞ between device groups. Further PK parameters, immunogenicity, safety (including injection site reactions [ISRs] and injection site pain [visual analog scale]) were also assessed. FINDINGS: A total of 315 adults were randomized to treatment. Geometric mean ratios for comparisons between device groups of Cmax, AUC0-∞, and AUC0-last were close to 1, with 90% CIs all within the range of 0.8-1.25, meeting bioequivalence criteria. PK variables were also similar between devices across injection sites and weight categories. Across devices, thigh injection resulted in slightly higher exposure than upper arm injection, and abdomen injection resulted in exposure similar to or slightly lower than thigh injection; however, these differences were not clinically meaningful. Treatment-emergent anti-tezepelumab antibodies were present in 3 (2.9%), 1 (1.0%), and 0 participants in the V-S, APFS, and AI groups, respectively. Treatment-related adverse events were reported in 15.0% of participants overall (V-S, 10.7%; APFS, 18.1%; AI, 16.0%), including ISRs in 1 (1.0%), 3 (2.9%), and 3 (2.8%) participants in the V-S, APFS, and AI groups. Median visual analog scale pain score (0-100 mm scale) was 2 mm immediately after injection and was 0 mm at 30 min for all groups. IMPLICATIONS: Tezepelumab PK parameters after a single 210-mg SC dose were comparable when administered via V-S, APFS, or AI. In all groups, immunogenicity rate and injection site pain were low, and ISRs were uncommon. These findings support administration of tezepelumab via APFS or AI, in addition to V-S, providing patients and physicians with greater choice and the potential convenience of at-home use. ClinicalTrials.gov identifier: NCT03989544.

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BACKGROUND: The optimal programmed intermittent epidural bolus regimen for labor analgesia remains unknown. Some studies indicate that better drug spread in the epidural space results from greater injection pressure; however, there is a lack of data regarding the maximum pressure generated by epidural bolus injection using different catheters and flow rates. METHODS: We evaluated the flow and pressure characteristics of 11 commonly used epidural catheters combined with 3 different infusion pumps that deliver epidural infusions according to the programmed intermittent epidural bolus regimen. Pressure changes were measured over time at flow rates of 100, 250, and 400 mL·hour and with a bolus volume of 10 mL. To account for repeated measures, linear mixed models were used. Features were selected with a backward stepwise procedure continued until only statistically significant variables were left in the model. RESULTS: We performed 660 measurements. The mean maximal pressure generated during bolus injection ranged from 86 to 863 mm Hg for different flow rates and catheter designs. The interaction between flow rate and catheter gauge resulted in 1.31, 1.65, and 2.00 mm Hg of pressure increase for 18G, 19G, and 20G catheters, respectively, per 1 mL·hour of increased flow rate (P< .001). Analyses including wire-reinforced catheters revealed a 1.16, 1.76, and 2.36 mm Hg pressure increase for 18G, 19G, and 20G catheters, respectively, per 1 mL·hour of increased flow rate (P< .001). In some cases, it triggered the occlusion pump alarm. CONCLUSIONS: Significant differences were observed in the in vitro maximum pressure value among the various catheter and flow rate combinations with a higher pressure value for wire-reinforced catheters used in the study. The optimal flow rate and epidural catheter combination may allow for delivery of the bolus with high flow rate without triggering the occlusion alarm.

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The right ventricle provides systemic circulation in individuals with congenitally corrected transposition of the great arteries (CCTGA) and in those with complete transposition who have had an atrial switch repair (DTGA). The aim of this study was to evaluate how the systemic right ventricle adapts to increased workload and oxygen demand during exercise. From November 2005 through December 2015, 3,358 adult patients with congenital heart disease were treated at our institution; we identified 48 (26 females, 22 males; median age, 25.4 ± 8.1 yr) who met the study criteria; 37 had DTGA and atrial switch repair, and 11 had CCTGA. We studied their echocardiographic and cardiopulmonary exercise test results. A control group consisted of 29 healthy sex- and age-matched volunteers. On exercise testing, oxygen uptake at anaerobic threshold, peak oxygen uptake, peak heart rate, and percentage of maximal heart rate were significantly lower in the group with systemic right ventricle than in the control group (all P <0.001); in contrast, the peak ventilatory equivalent for carbon dioxide was higher in the study group (P=0.013). Impaired systemic right ventricular function reduced peak oxygen uptake. The peak heart rate was lower in the CCTGA group than in the DTGA group. Our results indicate that reduced exercise capacity is related to impaired systemic right ventricular function, severe tricuspid valve regurgitation, and chronotropic incompetence. There was no correlation between cardiopulmonary exercise test results and time after surgery. Chronotropic efficiency is lower in individuals with CCTGA than in those with DTGA.

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The bicuspid aortic valve (BAV) is a congenital heart disease. AIM: The aim of study was to evaluate the assessment of atherosclerosis risk factors in adult patients with bicuspid aortic valve compared against 30 healthy, age and sex matched volunteers. MATERIALS AND METHODS: Thirty patients (22 males, 8 females) at an average age of 27.00 ±10.6 years were compared against thirty healthy, age and sex matched volunteers. The arterial blood pressure, lipid profile, fasting glucose, inflammation markers and the lifestyle factors were analysed. RESULTS: Patients with bicuspid aortic valve have a higher level of glucose (4.95 vs 4.7 mmol / l, p = 0.026) and fibrinogen (2.25 vs. 1.98 g / l, p = 0.001) compared to the control group. In the group of patients with bicuspid aortic valve there was no hypertension, diabetes, tachycardia, stress exposure, alcohol abuse and a positive family history of cardiovascular diseases. CONCLUSIONS: The patients with bicuspid aortic valve have higher glucose and fibrinogen levels and they need systematic checking to reduce cardiovascular risk factors.

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OBJECTIVE: Introduction: Improper initial management of a victim in severe hypothermia is associated with a risk of cardiac arrest. At the same time, an uncontrolled drop in core body temperature in trauma victims is an independent risk factor for mortality. Medical personnel require a thorough understanding of the pathophysiology and treatment of hypothermia. Gaps in this understanding can lead to serious complications for patients. The aim: To compare knowledge concerning hypothermia between medical personnel working in emergency departments (ED) and emergency medical services (EMS). PATIENTS AND METHODS: Materials and methods: A total of 5,362 participants were included in the study. In this study, EMS and ED personnel were encouraged to participate in an e-learning course on hypothermia. Subsequently, the scores of a pre-test, lesson tests and post-test completed by participants of this course were compared. RESULTS: Results: Pre-test scores were significantly higher among personnel working in EMS compared with those working in EDs. Nurses employed in EDs had significantly more failures in completing the course than EMS nurses. The most difficult topics for all practitioners were post-traumatic hypothermia and hypothermia-related clotting disorders. CONCLUSION: Conclusions: EMS personnel have a higher level of knowledge of hypothermia than ED personnel. Moreover, an e-learning course is an effective tool for improving medical personnel's knowledge of hypothermia.

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PURPOSE: Lung ultrasound (LUS) examination is used to evaluate patients with acute respiratory failure. The physiological LUS pattern during labor in healthy parturients has not been well described. The aim of this study was to evaluate the LUS pattern in a cohort of healthy women during uncomplicated labor. METHODS: We used the 8-point LUS assessment protocol and investigated lung sliding, A-lines, B-lines, interstitial syndrome, lung consolidation, and pleural effusion according to the International Consensus Document with two additional supradiaphragmatic projections. All patients were screened twice; once during the first stage of labor and again within 2 hours after delivery. RESULTS: We included 24 patients in this study from February 2014 to August 2015. A total of 480 LUS records were retained for further analysis. Overall, 16 of 24 patients (67%) had at least one positive region (three or more B-lines) during the peridelivery LUS evaluation. Interstitial syndrome was detected in five patients (21%). There were no differences in A-line (P = 0.38) or B-line (P = 0.68) prevalence between LUS examinations before and after delivery. CONCLUSIONS: Women in uncomplicated labor can present abnormal LUS findings, which may affect the interpretation of LUS results in patients with respiratory deterioration. Further studies should address this topic in larger cohort of patients.

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Objectives: The coarctation of aorta is commonly related to bicuspid aortic valve. The aim of the study was to assess arterial stiffness in adults after aortic coarctation repair and to evaluate an impact of bicuspid aortic valve concomitance on arterial stiffness results.Methods: Fifty-eight patients after coarctation of aorta repair, 36 male, median age of 27.46 ± 10.57, were compared to 30 with bicuspid aortic valve and to 30 healthy, sex, age and BMI matched volunteers. Physical examination, laboratory analysis and non-invasive assessment of arterial stiffness were performed.Results: CoA patients and BAV patients have higher central arterial stiffness parameters in comparison to healthy controls: AP (7.86 ± 6.56 vs 7.68 ± 5.96 vs 1.41 ± 3.82 mmHg, p < 0.001, p = 0.011, respectively) and AIx (18.81 ± 14.94 vs 18.06 ± 13.38 vs 4.41 ± 10.82%, p < 0.001, p = 0.006, respectively). There were no differences of PWV between CoA patients, BAV patients and healthy controls (6.07 ± 1.20 vs 5.95 ± 1.20 vs 5.67 ± 0.73 m/s, p = 0.099, p = 0.278, respectively). In CoA group, there was correlation of PWV with age (r = 0.55 p < 0.001), BMI (r = 0.29, p = 0.025), fibrinogen (r = 0.31, p = 0.039), glucose (r = 0.58, p < 0.001), ascending aorta diameter (r = 0.29, p = 0.026) and age at operation (r = 0.27, p = 0.041). Among group of BAV, there was a correlation of PWV with age (r = 0.58, p < 0.001), central AP with total cholesterol (r = 0.38, p = 0.036) and fibrinogen (r = 0.41, p = 0.024).Conclusions: The increased arterial stiffness occurs in both groups: patients after aortic coarctation repair and patients with bicuspid aortic valve. Concomitance of coarctation of the aorta and bicuspid aortic valve has no influence on arterial stiffness augmentation.

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Podsiadlo, Pawel, Sylweriusz Kosinski, Tomasz Darocha, Kinga Salapa, Tomasz Sanak, and Hermann Brugger. The use of e-learning in medical education for mountain rescuers concerning hypothermia. High Alt Med Biol 19:272-277, 2018. OBJECTIVE: Victims of mountain accidents are often exposed to wet and cold environments which may increase the risk of hypothermia. Mountain rescuers should be able to recognize and manage hypothermia. We aimed to assess relevant knowledge in professional and volunteer mountain rescuers, as well as to evaluate the efficacy of an e-learning platform for continuing medical education. METHODS: An e-learning platform was developed to provide access to updated information about hypothermia. Volunteer and professional mountain rescuers participated in an e-learning course. Pretest, post-test, and specific lesson test scores were compared. After 1 year, a follow-up course was performed. RESULTS: In total, 187 rescuers, comprising 136 (72.7%) volunteers and 51 (27.3%) professionals, were enrolled. Ahead of the course, no difference in knowledge was found between professionals and volunteers. After the course, one's knowledge of hypothermia increased significantly (p < 0.001). The scores achieved in the field management of hypothermia were better among professional rescuers than among volunteer rescuers (p = 0.003), whereas in post-traumatic hypothermia half of the results were insufficient in both groups. Moreover, 57 rescuers repeated the course after 12 months. While professionals partially retained the achieved level of knowledge, the volunteers had dropped back to their initial level. CONCLUSIONS: The e-learning course increased the knowledge of hypothermia among mountain rescuers. The poor retention after 1 year indicates that the interval between lectures should be reduced. An e-learning platform is an effective tool for the medical education of mountain rescuers.

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The coarctation of the aorta (CoA) is a congenital condition of the thoracic aorta. AIM: The aim of the study was assessment of atherosclerosis risk factors in adult patients after surgical treatment of aortic coarctation. MATERIALS AND METHODS: 58 patients (36 male, 22 female) at median age of 27.46 ±10.57 were compared with 30 healthy, age and sex matched volunteers. The arterial blood pressure, lipid profile, fasting glucose, inflammation markers and the lifestyle factors were analyzed. RESULTS: CoA patients have higher systolic blood pressure 136.55±16.27 vs 123.47±10.34 mmHg, p<0.001, fasting glucose 4.95±0.5 vs 4.65±0.46 mmol/l p=0.002, hsCRP 1.03±0.12 vs 0.89±0.14 mg/l p=0.025 and fibrinogen 2.55±0.34 vs 1.98±0.28 g/l p<0.001. Hyperlipidemia is more common 44.8% vs 23.3% p=0.048, treated with statin. When comparing hypertensive patients (N=28) with normotensive ones (N=30), the patients with arterial hypertension are older 33.5±12.23 vs 25.73±7.12 p=0.004, have higher body weight 78.03±14.58 vs 68.7±14.29 p=0.017, in this group more common are: hypoplastic aortic arch 28.6% vs 6.7% p=0.027, recoarctation 39.3% vs 13.3% p=0.024, cardiovascular disease 14.3% vs 0% p=0.032 and family history 21.4% vs 3.3% p=0.034. CONCLUSIONS: The coarctation of aorta is related to higher cardiovascular risk due to arterial hypertension, hyperlipidemia, higher glucose and inflammation markers levels when comparing with healthy population.

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The aims of this study were to translate the Michigan Hand Outcomes Questionnaire into the Polish language and to test the measurement properties of its quality criteria. A total of 120 patients with hand complaints completed the Polish Michigan Hand Outcomes Questionnaire and the Disabilities of the Arm, Shoulder, and Hand questionnaire on the first assessment, along with the grip test, pinch test, and pain sore assessed using a visual analogue scale during activity. After 7 days, 76 patients completed the Michigan Hand Outcomes Questionnaire the second time. The Cronbach alpha of the Michigan Hand Outcomes Questionnaire subscales ranged from 0.79 to 0.96. The intraclass correlation coefficient varied from 0.82-0.97, and the Bland-Altman method indicated the Michigan Hand Outcomes Questionnaire total score limit of agreement was -13.2-12.3 and -9.18-9.62 for the right and left hand, respectively. The construct validity revealed a moderate to strong correlation between every subscale of the Polish Michigan Hand Outcomes Questionnaire and Disabilities of the Arm, Shoulder, and Hand, but they only correlated with the grip test and the visual analogue scale, and neither correlated with the pinch test. The study demonstrated properties similar to the original version, validating the belief that the use of this questionnaire in medical practice in Poland is justified.

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Polish Medical Air Rescue is tasked to deal with the most serious incidents associated with life threatening situations, in multiple circumstances. As a consequence, medical personnel have to meet high standards of education and show a continuous theoretical and practical development of the skills which are necessary during medical treatment. Thanks to the introduction of ECMO treatment for accidental hypothermia patients, new clinical and operational possibilities have arisen, so more patients can be saved with a very good neurological outcome. AIM: To analyze the data on hypothermia collected by the personnel of Polish Medical Air Rescue and to assess the e-learning platform as an educational tool. MATERIALS AND METHODS: 123 persons were involved. The subject of analysis were the e-learning platform results of the Polish Medical Air Rescue medical personnel. The e-learning consisted of a pre-test, 8 lessons followed by MCQ's (multi choice questions) and a post-test. RESULTS AND CONCLUSIONS: We could not prove a statistically significant difference in the knowledge about hypothermia between doctors and other medical professionals. Post-traumatic hypothermia and associated coagulation disturbances are two important topics requiring particular focus during the design of further educational and training projects. As a consequence of the training, both groups significantly improved their knowledge: i.e. a statistically significant improvement of knowledge about hypothermia between pre-test and post-test results in both groups was shown. The hypothermia e-learning platform for medical personnel is an effective educational tool.

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INTRODUCTION    Insulin­like growth factor 1 (IGF­1) is involved in the modulation of immunity and inflammation. It also plays a role in regulating the migration of endothelial cells and production of vasoactive agents. OBJECTIVES    This study assessed the concentrations of IGF­1 and insulin­like growth factor-binding protein 3 (IGFBP­3) and their relationships to disease activity in patients with inflammatory bowel disease (IBD). PATIENTS AND METHODS    A total of 129 adult patients with IBD (69 with Crohn disease [CD] and 60 with ulcerative colitis [UC]) were involved in the study. The control group consisted of 31 healthy volunteers. Biochemical serum analyses were performed and the associations of IGF­1 and IGFBP­3 with inflammatory markers and disease activity were assessed. RESULTS    IGF­1 levels were decreased in patients with active UC compared with those with nonactive UC (mean [SD], 78.3 [22.7] ng/ml and 96.2 [24.5] ng/ml, respectively; P = 0.02) and controls (94.5 [26.5] ng/ml; P = 0.03). The IGF­1 level was lower in patients with active CD compared with those with nonactive CD (mean [SD], 79.2 [24.9] ng/ml and 110.1 [43.4] ng/ml, respectively; P <0.001). The IGFBP­3 level was lower in patients with active UC compared with those with nonactive UC (P = 0.04) and controls (P = 0.04). IGF­1 correlated negatively with C­reactive protein (CRP) levels (P <0.01), disease activity (P <0.05), and disease duration (P <0.05). IGFBP­3 levels correlated negatively with CRP levels (P <0.05). CONCLUSIONS    The IGF system is disrupted in patients with IBD. Systemic levels of the IGF axis components are related to disease activity and duration.

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Podsiadlo, Pawel, Tomasz Darocha, Sylweriusz Kosinski, Kinga Salapa, Miroslaw Zietkiewicz, Tomasz Sanak, Rachel Turner, and Hermann Brugger. Severe hypothermia management in mountain rescue: A survey study. High Alt Med Biol 18:411-416, 2017. INTRODUCTION: Severe hypothermia is a rare but demanding medical emergency. Although mortality is high, if well managed, the neurological outcome of survivors can be excellent. The aim of the study was to assess whether mountain rescue teams (MRTs) are able to meet the guidelines in the management of severe hypothermia, regarding their equipment and procedures. METHODS: Between August and December 2016, an online questionnaire, with 24 questions to be completed using Google Forms, was sent to 123 MRTs in 27 countries. RESULTS: Twenty-eight MRTs from 10 countries returned the completed questionnaire. Seventy-five percent of MRTs reportedly provide advanced life support (ALS) on-site and 89% are regularly trained in hypothermia management. Thirty-two percent of MRTs transport hypothermic patients in cardiac arrest to the nearest hospital instead of an Extracorporeal Life Support facility; 39% are equipped with mechanical chest compression devices; 36% measure core body temperature on-site and no MRT is equipped with a device to measure serum potassium concentration on-site in avalanche victims. CONCLUSIONS: Most MRTs are regularly trained in the treatment of severe hypothermia and provide ALS. The majority are not equipped to follow standard procedural guidelines for the treatment of severely hypothermic patients, especially with cardiac arrest. However, the low response rate-23% (28/123)-could have induced a bias.

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AIM: To evaluate the levels of von Willebrand factor (VWF) and metalloproteinase with thrombospondin type-1 motif, number 13 (ADAMTS13) in inflammatory bowel disease (IBD) and correlate them with the disease activity. METHODS: Consecutive patients with IBD aged 18 years or older were enrolled in the study. Forty-seven patients with ulcerative colitis (UC), 38 with Crohn's disease (CD), and 50 healthy controls were included. The white blood cell count, haematocrit, platelet count, fibrinogen, partial activated thromboplastin time, C-reactive protein, albumin, VWF antigen level (VWF:Ag), VWF ristocetin cofactor activity (VWF:RCo), VWF collagen-binding activity (VWF:CB), and ADAMTS13 antigen level (ADAMTS13:Ag) and activity (ADAMTS13act) were measured. The following ratios were assessed: VWF:RCo/VWF:Ag, VWF:CB/VWF:Ag, VWF:Ag/ADAMTS13act, and ADAMTS13act/ADAMTS13:Ag. RESULTS: Compared to controls, the odds ratio (OR) of an elevated VWF: Ag > 150% was 8.7 (95%CI: 2.7-28.1) in the UC group and 16.2 (95%CI: 4.8-54.0) in the CD group. VWF:CB was lower in UC patients, and active CD was associated with a higher VWF: RCo (+38%). The ORs of VWF:CB/VWF:Ag < 0.7 (a marker of acquired von Willebrand syndrome) in the UC and CD groups were 11.9 (95%CI: 4.4-32.4) and 13.3 (95%CI: 4.6-38.1), respectively. Active UC was associated with lower ADAMTS13:Ag (-23%) and ADAMTS13act (-20%) compared to UC in remission. Patients with active CD had a 15% lower ADAMTS13act than controls. The activity of UC, but not that of CD, was inversely correlated with ADAMTS13:Ag (r = -0.76) and ADAMTS13act (r = -0.81). CONCLUSION: Complex VWF-ADAMTS13-mediated mechanisms disturb haemostasis in IBD. A reduced WVF:CB is a risk factor for bleeding, while a lower ADAMTS13 level combined with an elevated VWF:Ag could predispose one to thrombosis.

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