Qualification Period Research Articles

Regular whole blood donation and gastrointestinal, breast, colorectal and haematological cancer risk among blood donors in Australia

AbstractBackground and ObjectivesSeveral studies have suggested that blood donors have lower risk of gastrointestinal and breast cancers, whereas some have indicated an increased risk of haematological cancers. We examined these associations by appropriately adjusting the ‘healthy donor effect’ (HDE).Materials and MethodsWe examined the risk of gastrointestinal/colorectal, breast and haematological cancers in regular high‐frequency whole blood (WB) donors using the Sax Institute's 45 and Up Study data linked with blood donation and other health‐related data. We calculated 5‐year cancer risks, risk differences and risk ratios. To mitigate HDE, we used 5‐year qualification period to select the exposure groups, and applied statistical adjustments using inverse probability weighting, along with other advanced doubly robust g‐methods.ResultsWe identified 2867 (42.4%) as regular high‐frequency and 3888 (57.6%) as low‐frequency donors. The inverse probability weighted 5‐year risk difference between high and low‐frequency donors for gastrointestinal/colorectal cancer was 0.2% (95% CI, −0.1% to 0.5%) with a risk ratio of 1.25 (0.83–1.68). For breast cancer, the risk difference was −0.2% (−0.9% to 0.4%), with a risk ratio of 0.87 (0.48–1.26). Regarding haematological cancers, the risk difference was 0.0% (−0.3% to 0.5%) with a risk ratio of 0.97 (0.55–1.40). Our doubly robust estimators targeted minimum loss‐based estimator (TMLE) and sequentially doubly robust (SDR) estimator, yielded similar results, but none of the findings were statistically significant.ConclusionAfter applying methods to mitigate the HDE, we did not find any statistically significant differences in the risk of gastrointestinal/colorectal, breast and haematological cancers between regular high‐frequency and low‐frequency WB donors.

Socio-Cultural and Professional Integration of Foreign-Born and Foreign-Educated Physicians in German Outpatient Care: an Interview-Based Study in Baden-Württemberg and Hessen

Introduction In recent years, it has become increasingly hard to fill outpatient physician vacancies in all parts of Germany. This development is particularly pronounced in general practice. At the same time, the number of doctors trained abroad is increasing, predominantly in the inpatient sector. In the next few years, foreign-born and -trained physicians will presumably be increasingly active also in the field of family medicine. The aim of this study was to explore experiences, support needs and possible improvements from the perspective of such physicians in the outpatient sector with a focus on primary care.Method In this qualitative study, semi-structured interviews were conducted with physicians not raised and trained in Germany and working in the outpatient setting in Germany. The evaluation was carried out by means of qualitative content analysis. Categories were derived in a deductive-inductive manner.Results Thirteen physicians (of which nine were primary care physicians) were interviewed. Next to the deductively derived main categories (departure, des-orientation, adaptation) four subcategories as overarching problems emerged in the interviews: Administrative tasks, communication and professional as well as social adaptation / integration in Germany. Proposed solutions were categorized in structuring measures (official, easily accessible guidelines for physician migration, paid qualification period), specific preparatory courses for the outpatient sector, and personal support such as mentoring and networking of outpatient physicians in training.Conclusions Some of the problem areas mentioned were similar to those known from the inpatient setting. To support sustainable recruitment in the outpatient sector, specific preparatory courses and the promotion of networking among physicians appeared to be additional measures that would benefit physicians applying for positions in the outpatient sector and also easy to implement.

Eğitim Alanında Gelişmiş Ülkelerin Öğretmen Yetiştirme Sistemleri

As we live through the first quarter of the twenty-first century, society's expectation of qualified teachers continues to increase as always. It is a justified and undeniable fact that there is such an expectation in practice. The effort to train and develop teachers is a process that should be considered integrally during the period from the selection of the profession to the termination of the profession, the first dimension of this process is the determination of teacher candidates. There are some basic elements that should be considered in theory and practice in teacher education. When these elements are considered with the system approach; it can be considered in three basic dimensions as inputs, processes and products or outputs. In teacher education, entrance characteristics are very important because the entrance characteristics of teacher candidates and candidates constitute the input. Thanks to the Bologna reforms in education, the minimum qualification period for becoming a teacher has increased. Institutions that train teachers in European Union countries generally conduct education at the undergraduate level. In addition, student selection in European countries is usually carried out with high school graduation exams in Turkey and in some countries with a university entrance exam. In most European countries, three or more criteria are applied when selecting students for teacher training programs. Aptitude tests in which individual and group practice are questioned, interviews in which the candidates' motivations are questioned, language and literacy skills, arithmetic skills are questioned. While education authorities apply these exams in most countries, institutional-level authorities also share responsibility in some countries. The same or similar situation is often applied in other developed countries. Key Words: Education, Education System, Teacher Training Systems, Developed Countries

Psychological preparation of freestyle wrestlers during competitions

The article examines issues related to the construction of a training process in freestyle wrestling, paying attention to psychological preparation during competitions. Organization and formation of loads, use of technical elements and exercises to improve sports form according to sports qualification and training period.
 In sports wrestling (freestyle wrestling), the conditions of competitions differ from the conditions of training classes. Coaches and psychologists must train athletes not only physically and tactically, but also develop in them the ability to resist many pre-competition and competitive factors that have a disorganizing effect and cause inconsistency of functions, that is, reduce reliability in competitive activities.
 Before the responsible start, an attitude related to the expectation of the most likely result of the competition is formed. Often, the setting of tasks is formed on an unconscious level. However, the more complex the future activity is in terms of its structure, the more conscious, volitional components prevail in the formed attitude.
 Overcoming the maximum muscle effort, fatigue in the process of fighting, the wrestler shows volitional efforts, taking into account which willpower qualities develop depending on the difficulty. This is especially significant for juniors, who still have fully developed moral and psychological qualities, which have self-regulation techniques, so necessary in the struggle.
 Tension in sports activities can be not only emotional, but also operational. Operational tension arises as a result of the complexity of the work performed, emotional tension - as a result of the action of negative emotional irritants.
 It has been established that only under the conditions of training load, adequate psychotype of the athlete, the reactivity of the central nervous system increases and the mechanisms of ensuring effective sports activity in extreme conditions, which, in fact, are accompanied by any competitions, are improved.

Regular high-frequency whole blood donation and risk of cardiovascular disease in middle-aged and older blood donors in Australia.

Previous mixed findings on the associations between whole blood (WB) donation and risk of cardiovascular diseases (CVD) may in part reflect inadequate adjustment for the "healthy donor effect" (HDE). We used the Sax Institute's 45 and Up Study linked with blood donation history and other health-related databases to examine the association between regular, high-frequency WB donation and the risk of CVD. To mitigate the impact of HDE, we used a "5-years qualification period," in which donors must donate at least 1 WB donation in the 1st and 5th year of "qualification period." We then compared the risk of CVD in the years following the "qualification period" between the regular high-frequency WB donors (≥2 WB donation in each qualification year) and others using Cox proportional-hazards models. Analyses were adjusted for potential confounders, such as sociodemographic, lifestyle, and health-related variables, and results are reported separately for male and female donors. A total of 2736 male and 2917 female donors were included in the analyses. The median years of follow-up per donor was 5.84 years (Q1-Q3, 5.47-6.23). The rate of CVD hospitalization was 11.20 and 4.50 per 1000 person-years for males and females, respectively. In fully adjusted models, the risk (hazard ratio) of CVD in regular high-frequency donors compared to other donors was 0.93 (95% Confidence Interval (CI), 0.68-1.29) for males and 0.79 (95% CI, 0.49-1.28) for females. We did not observe a statistically significant reduction of CVD risk in regular, high-frequency WB donors when adjusted for potential confounders.

The golden generation of Australian Soccer: understanding the factors which influenced their development

ABSTRACT While sporting research has focussed on the performance factors and activities contributing to elite performance, there is still limited acknowledgement of the athlete’s voice on the specific experiences and milestones that shaped their development into elite athletes. Therefore, the current study, used qualitative first-hand experiences of international level players to understand their developmental stories. In total, 17 players who represented the Australian National Soccer team during the “Golden Generation” Australian soccer (i.e. represented the Australian National Soccer Team during the Qualification period and subsequent 2006 and 2010 FIFA World Cup competitions) participated in the study. Semi-structured interviews were conducted with all participants, with the analysis identifying six key themes which described the developmental story of players. The themes included, Passion; Family; Mentality; Environment; Practice; and Pathway. The findings provide a detailed description of the environmental and socio-cultural factors the players perceived as critical in their journey to representing their nation.

Dentists Comprehension to Personal Protection Equipment Use Post COVID-19 Pandemic

Background: It has been shown that health care professionals, including dentists, who wear personal protective equipment, reduce the spread of COVID-19, which lowers patient morbidity and mortality as well as illness and absenteeism. Aim: The purpose of the study was to evaluate the impact of dentists' Comprehension of personal infection control and their level of trust in PPE as part of the dental profession's response post COVID-19 pandemic. Material and Method: The sample size was (388) participants distributed as (Specialist, General Dental Practitioners, Dental Branch Practitioners, and Rotators). Google form prepared with specific questions (Demographical, Practice and drawback questions) translated to the mother language (Arabic Language). Structured and distributed online by sharing the link through electronic platforms. Two responses were used in a statistical analysis using the SPSS Package version. Significant p value of 0.05 or less is used. Descriptive statistics were used in the data analysis to analyze the percentage, mean and standard deviation values. All questions employ the spearman test to determine correlations. Kruskal-Wallis H for comparing differences between groups including qualification and experience period between participants. Result: Significant results are shown in both rotators and general practitioners for comparison of different qualification levels between dentists. All dentists are use and practicing well the personal protection equipment. Conclusions: Overall, dentists in the current study are well practice the PPE post COVID-19.

Abstract P065: Excess Weight And Transition To Metabolic Dysregulation Increases Atrial Fibrillation Risk

Background: One in three Americans will have atrial fibrillation (AF) during their lifetime. Obesity and metabolic derangements are key risk factors for AF. It is unclear, however, which subset of patients would benefit most from targeted interventions aimed at weight loss and control of metabolic derangements to prevent incident AF. Methods: A landmark analysis to compare time-to-AF after a three-year run-in period was performed among 95,160 subjects from COMMODORE, a cohort with rich longitudinal data obtained from a de-identified copy of the Vanderbilt University Medical Center Electronic Health Record. Included subjects were required to have four height and weight measures collected during a prespecified three-year qualification (i.e., “landmark”) period, with approximately one year (8 to 16 months) between each measure (t 0 -t 3 ), and did not have AF prior to t 3 . We determined the subject weight during the run-in period and metabolic status according to absence, development, or presence at the start of the landmark period, t 0 , of: hypertension (HTN), diabetes mellitus, low high-density lipoprotein, and elevated triglycerides. Results: From the study population of 95,160 adults, incident AF occurred in 9,094 participants (9.6%), over a median follow-up of 6.35 (IQR: 4.40-9.16) years. Participants who developed AF were more likely to be older, heavier, White, males, and have the four metabolic derangements studied. A cox-proportional hazards model was fit using median population values and varying t3 weight to estimate the 10-year AF risk based on weight alone. We observed a U-shaped pattern of risk where participants with a BMI in the range of 18.5 kg/m 2 to 25 kg/m 2 have the lowest 10-year AF risk. Presence of any of the derangements, either chronic or developed, was associated with a decrease in AF-free probability during the outcome period (p<0.001). For HTN and elevated triglycerides, the presence of the abnormality at t 0 resulted in a significant decrease in AF-free probability compared to those who developed the condition (p<0.001). Burden of metabolicabnormalities influenced AF-risk, with increases in adjusted HR of 1.23 (95%, CI, 1.16-1.30), 1.51 (95%, CI, 1.36-1.68), 1.86 (95%, CI, 1.58-2.19), and 2.29 (95%, CI, 1.84-1.2.84), with accumulation of one to four metabolic derangements, respectively. Conclusions and Relevance: In this analysis of a large real-world clinical cohort, both overweight (BMI > 25 kg/m 2 ) and underweight (BMI < 15 kg/m 2 ) participants are at an increased risk for AF development. The presence of metabolic derangements, regardless of diagnostic time, significantly increases AF risk and metabolic burden corresponds to increments in risk. Our findings suggest that prevention of metabolic derangements is critical to AF risk mitigation and that weight loss for AF management should be targeted to overweight patients regardless of metabolic status.

Artificial intelligence and colonoscopy experience: lessons from two randomised trials

Background and aimsArtificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related...

태권도장 수련생 학부모들의 구매의사결정과정 분석

The purpose of study was to analyze the purchasing decision making process focused on students‘ parents of Taekwondo gym. The 270 questionnaires were distributed to students’ parents of Taekwondo gym through convenience sampling and 247 samples were included in the actual analysis. Data were analyzed for Frequency analysis, descriptive statistics, cluster analysis and chi-square by using SPSS Ver. 24.0. The Chi-square results shows significant (p＜.05) difference according to academic qualification, age group, residence and participation period. And there is not significant (p＜.05) difference according to gender and profession. In purchasing decision-making process of the Taekwondo trainees’parents physical fitness training is the major factors of recognizing problems, mostly internet(moble)was used to search the informations, registeration was done by personally visiting and mostly recommendation was done after satisfaction of Taekwondo program.

An elite athlete’s storying of injuries and non-qualification for an Olympic Games: a socio-narratological case study

ABSTRACTIn this article, we present and examine the case of one elite athlete – 28-year old Mark (pseudonym), who during a 10-month lead-up to the 2016 Rio OG qualification deadline, aimed to achieve his NGB/NOC’s qualification standards, but sustained several injuries and was forced to give up his qualification attempt. Adopting a socio-narratological framework, we aim to understand how Mark storied the qualification period; how socio-cultural, organisational, and biographical contexts complicated his qualification and how he handled these complications; and how he made sense of not qualifying. Based on data produced through a longitudinal prospective study that included a background questionnaire, three semi-structured interviews, a weekly web survey, a training observation, and a compilation of competition results, our socio-narratological interpretations evidence that Mark aligned his athletic life to the ‘sport performance investment narrative’, but that this narrative provided limited resources to story poor competitive results and injuries. Instead, as Mark faced unexpected disruptions, he adopted a number of restitution strategies (e.g. alternative training/competition plans; positive thinking; rehabilitation) to re-align to the performance narrative. In so doing, Mark compromised injury recovery to worsen his performance and further injure his body, which eventually stopped his qualification process. After a directionless period and personal suffering, Mark again intended to follow the performance investment narrative. We propose that coaches, support staff and sport organisations recognise the pressurised nature of a qualification phase and provide support strategies to moderate instability and possible non-qualification.

Satisfaction analysis of patients with single implant treatments based on a questionnaire survey.

Background: The factors influencing satisfaction of the patients with implant treatments are still unclear. This study aims to evaluate the patients’ satisfaction and to identify influencing factors, which will improve the medical quality of oral implantology.Materials and methods: Patients who lost single teeth and received implant treatments were enrolled in Nanjing Stomatological Hospital between February 2016 and March 2018. A questionnaire survey was performed to assess patient satisfaction and data were collected at four time points. Information included gender, age, educational level, application of bone augmentation, type of prosthetic restoration, period of teeth loss, dentist qualification, and tooth position. Meanwhile, the satisfaction of the patients was evaluated by visual analog scale.Results: A total of 373 patients completed the questionnaires. The mean of overall satisfaction score was 69.05±7.10. Lower overall satisfaction score was found in patients who received bone augmentation (P<0.001) and those with a longer period of teeth loss (P<0.05). In the bone augmentation group, the elements of pain and complication were significantly associated with a decrease in the median satisfaction score (P<0.001), and a similar result was obtained form the duration of operative time and healing response (P<0.001). On the other hand, the satisfaction scores for elements including the duration of operative time and healing response (P<0.05), aesthetics and psychology (P<0.05), and chewing function (P<0.05) decreased with an extended period of teeth loss. Meanwhile, over half of respondents were more concerned about the survival time (40.70%) and success rate (20.49%) of implants.Conclusion: Bone augmentation and the period of teeth loss are negative factors affecting patient satisfaction, and the success rate and survival time of implants are considerable aspects for patients. It is essential to raise general awareness of oral hygiene and optimize the dental implant therapeutic process.

Assessing the effects of reemployment bonuses on job search: A regression discontinuity approach

This study examines the impacts of reemployment bonuses, that is, the incentive payments to unemployment insurance (UI) recipients who find a job within a specified period, using Korean data. A sharp discontinuity in treatment assignment at age 55 identifies the effect of increased reemployment bonuses on unemployment duration and on subsequent job duration. The results indicate that increases in the reemployment bonus boost the job-finding hazards of UI claimants early in their unemployment spells during the bonus qualification period and significantly shorten the duration of UI spells by 0.16 to 0.42 months (0.68 to 1.82 weeks). In addition, employment stability is not significantly affected by an increased bonus, which implies no negative influence of the bonus on subsequent job match quality. The simulated estimates show that the increase in tax revenue and the decrease in UI benefit payment caused by the behavioral response of UI recipients are large enough to offset the increased cost of the reemployment bonus.

Anaerobic Capacity Changes of the National Freestyle Wrestlers during the Olympic Qualification Competition Period

This study aimed to evaluate the national level wrestlers’ anaerobic capacity through the preparation and qualification periods for Rio 2016 summer Olympic Games. For this manner, 10 national level freestyle wrestlers’(age 22,10 ± 3,21; weight 64,75 ±6,34; height 164,31 ± 4,75) anaerobic outputs measured 3 times in three month intervals with Bosco repeated jump test. Peak Jump(cm), Flight time, average power, average power/weight, first 15sec average jump height, last 15sec average jump height, fatigue index scores analyzed with repeated measures Anova. Mean power/weight output of the wrestlers increased from 20,42 W/kg to 21,28 W/kg(4,21 %) and fatigue index is decreased from 1,185 to 1,142 (3,62 %). However, this increase was not statistically significant (p&lt;0,05). In six months of qualification and preparation period wrestlers’ anaerobic capacity did not changed and it is thought to have been caused by some reasons such as having already reached a certain anaerobic peak level or athletes’ competition level and frequency which might made it difficult for them to have a proper periodization during the year.

Module production of the one-arm AFP 3D pixel tracker

The ATLAS Forward Proton (AFP) detector is designed to identify events in which one or two protons emerge intact from the LHC collisions. AFP will consist of a tracking detector, to measure the momentum of the protons, and a time of flight system to reduce the background from multiple proton-proton interactions. Following an extensive qualification period, 3D silicon pixel sensors were selected for the AFP tracker. The sensors were produced at CNM (Barcelona) during 2014. The tracker module assembly and quality control was performed at IFAE during 2015. The assembly of the first AFP arm and the following installation in the LHC tunnel took place in February 2016. This paper reviews the fabrication process of the AFP tracker focusing on the pixel modules.

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice

ObjectiveTo determine the clinical effectiveness of ultrasound tailored treatment in patients with acute subacromial disorders.DesignPragmatic randomised controlled trial.SettingDutch general practice.ParticipantsPatients aged 18–65 years with acute (duration <3 months) unilateral shoulder...

1466P - Treatment of opioid-induced constipation with naldemedine in patients with cancer: onset of action in a randomized phase 3 trial

Opioid analgesics are widely administered to treat patients with cancer pain; however, many patients suffer from opioid-induced constipation (OIC) as a side effect. Naldemedine (NAL), a peripherally-acting &mgr;-opioid receptor antagonist (PAMORA), is being developed for the treatment of patients with OIC. The aim of this analysis was to assess the onset of action of NAL in the context of primary efficacy and safety results previously reported. The study was a double-blind, randomized, placebo-controlled phase 3 trial in Japan. Cancer patients with OIC, defined as having ≤ 5 spontaneous bowel movements (SBMs) during the 2-week qualification period, were evenly assigned to either oral NAL 0.2 mg QD or placebo (PBO). The primary efficacy endpoint was SBM responder rate (percentage of patients with ≥ 3 SBMs/week and an increase from baseline of ≥ 1 SBM/week) during the 2-week treatment period. To assess the onset of action, 1) time to the first SBM, 2) proportion of patients with at least 1 SBM at several time points after initial dose and 3) change in frequency of SBMs/week from baseline to first week were evaluated. A total of 193 patients were randomized (NAL: 97, PBO: 96). The SBM responder rate of NAL was significantly larger than that of PBO (71.1% vs 34.4%, respectively; P < 0.0001). Besides, the time to onset of action of NAL was shorter than that of PBO with a shorter median time to the first SBM after the initial dose (NAL: 4.67, PBO: 26.58 hrs). The differences between the two groups in the proportion of patients with at least one SBM were statistically significant at all assessed time points (up to 4 hrs: 48.5% vs 7.3%, 8 hrs: 60.8% vs 14.6%, 12 hrs: 71.1% vs 25.0%, 24 hrs: 77.3% vs 47.9%, P < 0.0001 for all). The change in the frequency of SBMs per week from baseline to the first week with NAL was significantly greater than that with PBO (5.70 vs 1.73, P < 0.0001). The overall incidences of adverse events reported during the treatment period were 44.3% and 26.0% for NAL and PBO, respectively. Only diarrhea was reported for ≥ 5% of patients (19.6% vs 7.3%). However, the most cases were reported as mild and recovered. Treatment with NAL led to timely improvement of OIC in patients with cancer and was generally well tolerated.

Determination of Labeled Fatty Acids Content in Milk Products, Infant Formula, and Adult/Pediatric Nutritional Formula by Capillary Gas Chromatography: Collaborative Study, Final Action 2012.13.

A collaborative study was conducted on AOAC First Action Method 2012.13 "Determination of Labeled Fatty Acids Content in Milk Products and Infant Formula by Capillary Gas Chromatography," which is based on an initial International Organization for Standardization (ISO)-International Dairy Federation (IDF) New Work Item that has been moved forward to ISO 16958:2015|IDF 231:2015 in November 2015. It was decided to merge the two activities after the agreement signed between ISO and AOAC in June 2012 to develop common standards and to avoid duplicate work. The collaborative study was performed after having provided highly satisfactory single-laboratory validation results [Golay, P.A., & Dong, Y. (2015) J. AOAC Int. 98, 1679-1696] that exceeded the performance criteria defined in AOAC Standard Method Performance Requirement (SMPR(®)) 2012.011 (September 29, 2012) on 12 products selected by the AOAC Stakeholder Panel on Infant Formula (SPIFAN). After a qualification period of 1 month, 18 laboratories participated in the fatty acids analysis of 12 different samples in duplicate. Six samples were selected to meet AOAC SPIFAN requirements (i.e., infant formula and adult nutritionals in powder and liquid formats), and the other Six samples were selected to meet ISO-IDF requirements (i.e., dairy products such as milk powder, liquid milk, cream, butter, infant formula with milk, and cheese). The fatty acids were analyzed directly in all samples without preliminary fat extraction, except in one sample (cheese). Powdered samples were analyzed after dissolution (i.e., reconstitution) in water, whereas liquid samples (or extracted fat) were analyzed directly. After addition of the internal standards solution [C11:0 fatty acid methyl ester (FAME) and C13:0 triacylglycerols (TAG)] to the samples, fatty acids attached to lipids were transformed into FAMEs by direct transesterification using methanolic sodium methoxide. FAMEs were separated using highly polar capillary GLC and were identified by comparison with the retention times of pure analytical standards. Quantification of fatty acids was done relative to C11:0 FAME as internal standard and to instrument response factors (determined separately using calibration standards mixture). The performance of the method (i.e., transesterification) was monitored in all samples using the second internal standard, C13:0 TAG. RSDR values were summarized separately for labeled fatty acids in SPIFAN materials and ISO-IDF materials due to different expression of results. This method was applied to representative dairy, infant formula, and adult/pediatric nutritional products and demonstrated global acceptable reproducibility precision for all fatty acids analyzed (i.e., 46 individuals and/or groups) for these categories of products.

Long-term variability of exhaled nitric oxide measurements

Measurement of fractional exhaled nitric oxide (FENO) is recommended as an adjunct in the diagnosis of eosinophilic airway inflammation, to determine the likelihood of corticosteroid responsiveness, to monitor therapy, and to assess adherence to inhaled corticosteroid therapy. The American Thoracic Society Guidelines for the interpretation of FENO concentrations identify cut points in children of greater than 35 parts per billion (ppb) for eosinophilic airway inflammation and less than 20 ppb for no inflammation. For adults, the guidelines recommend greater than 50 ppb and less than 25 ppb, respectively. The NIOX MINO (Aerocrine AB, Solna, Sweden) is a commonly used portable method of analyzing FENO that does not require calibration. The accuracy and precision of this device were largely determined by extensive in vitro testing for US Food and Drug Administration clearance. The same is true for its successor, the NIOX VERO. The clinical study in the MINO FDA submission was a single measurement before and after beginning inhaled corticosteroids, which demonstrated a decrease in FENO. Other published clinical studies are single visit comparisons with other methods or multiple technicians. Only one study compared 2 measurements on different days. Because there are no published reports on the long-term reproducibility of devices used to measure FENO, we undertook the following study. We analyzed 451 quality control measurements obtained over a 2-year period from 5 devices. There were 5 nonasthmatic technicians (quality control subjects) who performed these measurements on each day that the device was used for a clinical study or patient care (see Table E1 in this article’s Online Repository at www.jaci-inpractice.org for more details). All control subjects met the manufacturer’s criteria, which included >18 years old, no ongoing cold or known airway disorder, nonsmoker, expected stable exhaled nitric oxide values between 5 and 40 ppb during the qualification period, and preferably no allergies (except seasonal) or asthma. To obtain a control FENO measurement, each technician was required to empty his or her lungs by slowly exhaling and then forming a tight seal around the mouthpiece, making sure not to let the air leak out. Then, they inhaled to total lung capacity and exhaled forcefully for approximately 10 seconds through the mouthpiece while responding to sound and light cues on the LCD to guide the rate of exhalation. The general linear model procedure was used to determine whether there was a device*subject interaction. Because the interaction was significant (P .05). Measurements for subjects 3-5 who used device 5 were 31.79 (7.2), 11.51 (4.2), and 15.0 (4.1) ppb, respectively (Figure 2). Measurements for subject 3 were significantly higher than those for subjects 4 and 5 (P < .0001). Eighty-two percent of her values were above 25 ppb. The NIOX MINO portable device employing an electrochemical methodology was cleared by FDA as “substantially equivalent” to the chemiluminescence stationary method (NIOX), largely based on extensive in vitro testing using certified nitric oxide in nitrogen calibration gas. Similarly, the new NIOX VERO was cleared in the same way as “substantially

Percutaneous closure of the left atrial appendage for secondary prevention of stroke in patients with atrial fibrillation and contraindications to chronic anticoagulant therapy

IntroductionStroke accounts for approx. 90% of thromboembolic complications associated with atrial fibrillation. The use of oral anticoagulants is the most effective therapy but is associated with risk of haemorrhagic complications.AimIn this article, we describe a series of patients with atrial fibrillation, cardiogenic stroke history, and contraindications for long-term anticoagulant therapy, in whom an alternative method – percutaneous closure of the left atrial appendage – was performed.Material and methodsNine patients with atrial fibrillation and previous stroke were qualified for percutaneous closure of the left atrial appendage (5 men and 4 women, aged 45–78 years). Physical and neurological examinations were conducted in the qualification period, 1–3 days before the intervention, and 1–3 days and 1, 3, 6, 12, and 24 months following percutaneous closure of the left atrial appendage. Transoesophageal echocardiography was carried out in the qualification period, 1–3 days before the intervention, and at 1–3 days and 3 and 6 months following the procedure.ResultsNo complications were observed in the perioperative period and during the follow-up period of 16–31 months. Echocardiographic examinations showed that occluders were present in the appropriate positions.ConclusionsPercutaneous closure of the left atrial appendage can be an alternative form of secondary prevention of stroke in patients with atrial fibrillation and contraindications for long-term anticoagulant therapy or those who have problems managing drug treatment. Complex clinical assessment performed by a neuro-cardiac team allows safe and efficient invasive treatment.