Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)

Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF.

AIMS: The relationship between outcomes and time after diagnosis for patients with non-valvular atrial fibrillation (NVAF) is poorly defined, especially beyond the first year. METHODS AND RESULTS: GARFIELD-AF is an ongoing, global observational study of adults with newly diagnosed NVAF. Two-year outcomes of 17 162 patients prospectively enrolled in GARFIELD-AF were analysed in light of baseline characteristics, risk profiles for stroke/systemic embolism (SE), and antithrombotic therapy. The mean (standard deviation) age was 69.8 (11.4) years, 43.8% were women, and the mean CHA2DS2-VASc score was 3.3 (1.6); 60.8% of patients were prescribed anticoagulant therapy with/without antiplatelet (AP) therapy, 27.4% AP monotherapy, and 11.8% no antithrombotic therapy. At 2-year follow-up, all-cause mortality, stroke/SE, and major bleeding had occurred at a rate (95% confidence interval) of 3.83 (3.62; 4.05), 1.25 (1.13; 1.38), and 0.70 (0.62; 0.81) per 100 person-years, respectively. Rates for all three major events were highest during the first 4 months. Congestive heart failure, acute coronary syndromes, sudden/unwitnessed death, malignancy, respiratory failure, and infection/sepsis accounted for 65% of all known causes of death and strokes for <10%. Anticoagulant treatment was associated with a 35% lower risk of death. CONCLUSION: The most frequent of the three major outcome measures was death, whose most common causes are not known to be significantly influenced by anticoagulation. This suggests that a more comprehensive approach to the management of NVAF may be needed to improve outcome. This could include, in addition to anticoagulation, interventions targeting modifiable, cause-specific risk factors for death. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Application of film camera in the thrashing process investigations

В статье рассматриваются основные методы фильмования хода прoцесса обмолота применяемые разными авторами. Рассматриваются результаты некоторых исследований проведенных по методу скорых съемок, к тотoрые способствовали лучшему изучению и углублению знаний охватыващих очень сложный процесс обмолота и выделения зерна из общей массы. Уделяется внимание проблемам определения скорости передвижения мaссы, отдельных стеблей соломы и отдельных зерен в рабочем прострaнстве обмолотного механизма, а также ускорению приданному зерне действием обмолотных бичей. Затрагивается также вопрос питания обмою ного механизма зерноуборочного комбайна и возможности использования кинокамеры для улучшения его действия в этой важной стадии работы комбайна.Basic methods of filming the thrashing process applied by various authors are discussed in the work. Results of some investigations carried out by the quickshot technique, which allowed to recognize more precisely and to deepen the knowledge of a very complicated process of thrashing and separation of grain from the cereal mass, are presented. Attention is drawn to problems of determination of the speed of cereal mass, single stables and grains within the working space of the thrashing mechanism and of accelerations given the grain under the effect of thrashing flails. Also the question of feeding the thrashing mechanism of the grain combine harvester as well as of possibility of the film camera use for improvement of the work of this mechanism has been broached

Analiza przyczyn powstawania mechanicznych uszkodzen ziarna w zespolach roboczych maszyn rolniczych

This paper contains an analysis of publications and the author’s own investigations dealing with causes of damage to cereal grains by sowing, threshing and grain shifting assemblies. The causes of mechanical damage of grain in the analyzed processes were determined. The paper concludes by discussing the range of the most favourable settings of the analyzed working assemblies, within which the grain damage is the least.Praca zawiera analizę publikacji i badań własnych dotyczących przyczyn uszkodzenia ziarna zbóż przez zespoły wysiewające, omłotowe i przemieszczające ziarno. Określono przyczyny powstawania mechanicznych uszkodzeń ziarna w analizowanych procesach. Pracę kończą wnioski określające zakres optymalnych parametrów pracy analizowanych zespołów roboczych, przy których występują najmniejsze uszkodzenia ziarna

Problemy uszkodzen ziarna w trzybebnowym zespole mlocaco-wydzielajacym

Przeprowadzano stanowiskowe badania trzybębnowego zespołu wydzielającego współpracującego z cepowym zespołem młócącym kombajnu zbożowego. Omłotowi poddano pszenicę, żyto, jęczmień i owies. Określono ilość makro- i mikrouszkodzeń ziarna w zależności od parametrów roboczych badanego zespołu i wilgotności młóconego zboża.Changing the construction of the threshing-separating unit can help to receive higher efficiency of cereal harvester work. Research has shown that constructors of agricultural machines, especially cereal harvesters, payed much attention to multi-drum threshing-separating systems, which allowed to obtain higher efficiency of those machines. Therefore, at the Institute of Agricultural Engeeniering of the Agricultural University of Lublin such a system has been constructed, which later underwent stand-mode testing. The aim of the study was to estimate the influence of separator's construction and technical and technological factors of threshing on quality of grains. The number of micro- and macro-damages in grains (of the four basic cereal species) occurring during threshing and separating was the criterion of estimation. The results obtained were elaborated statistically. The following values have been proved to have an important influence on grain damages: peripheral velocity of separating and threshing drums, feed value, and grain moisture in threshed cereal mass. Amounts of grain damages caused by the tested unit were compared with damages made in other devices (separators). That comparison allowed us to estimate the usefulness and efficiency of the investigated unit as a standard separator of future cereal harvesters

Ocena technologii zbioru pasz objetosciowych w postaci wielkowymiarowych bel

Przedstawiono podstawowe wskaźniki i współczynniki eksploatacyjne dla technologii zbioru słomy i siana (podsuszonej zielonki), w której główną maszyną była prasa formująca duże bele prostopadłościenne.The results of exploatation tests of machines for harvesting, transporting, and storing bulky feed in the shape of big, rectangular bales, have shown that the amount of human work in that technology had been equal to 0.56-0.82 man-hour per ton for the distance of feed transport of about 3 km. Technologies basing on traditional presses with high degree of compression require the amount of work of up to 6 man-hour per ton

Vlijanie izbrannykh tekhnologicheskikh proccesov na kachestvo zerna

The paper presents a theoretical analysis and experimental investigations gn the effect of the processes of cereal grain sowing, the combine harvesting and threshing, and its transport, on mechanical damage sustained by the grain during the processes and on its germination capacity. The paper is an effect of five years studies carried out by the authors at the request of the Institute of Agrophysics, Polish Academy of Sciences, Lublin. The studies involved the utilization of such new methods of investigation as the rapid-sequence photography technique and the colorimetric evaluation of grain damage state. The causes of grain damage were determined as well as the effect of the damage sustained by grain on its germination capacity. The authors provide also information on optimum parameters of machines operation, at which the least damage is sustained by the grain involved. The paper is concluded with recommendations and conclusions of value for both agricultural science and practice.Praca zawiera teoretyczną analizę oraz badania eksperymentalne dotyczące wpływu procesu wysiewu ziarna zbóż, kombajnowego zbioru i omłotu oraz przemieszczania ziarna na jego mechaniczne uszkodzenia i zdolność kiełkowania. Praca jest efektem pięcioletnich badań przeprowadzonych przez autorów na zlecenie Zakładu Agrofizyki PAN w Lublinie. W badaniach stosowano nowe metody badawcze jak technika szybkich zdjęć oraz kolometryczna ocena ilości uszkodzeń ziarna. Przeprowadzone badania pozwoliły na określenie głównych przyczyn uszkadzania ziarna oraz wpływu tych uszkodzeń na zdolność kiełkowahia. Podano też zakresy optymalnych parametrów pracy maszyn, przy których uzyskuje się najmniejsze uszkodzenia ziarna. Pracę zakończono zaleceniami i wnioskami przydatnymi dla nauki jak również dla praktyki rolniczej.Работа содержит теоретический анализ и экспериментальные исследования влияния процесса высева зерен зерновых, комбайнового сбора и обмолота, а также перемещения зерна на его механические повреждения и всхожесть. Работа является эффектом 5-летних исследований,проведенных авторами по поручению Агрофизического института ПАН в Люблине. В исследованиях применялись новые исследовательские методы, как техника быстрых съемок и колориметрическая оценка количества повреждений зерна. Проведенные исследования позволили определить главные причины повреждения зерна и влияние этих повреждений на всхожесть. Привели также диапазоны оптимальных параметров работы машин, при которых получаются наименьшие повреждения зерна. Работа заканчивается рекомендациями и выводами, пригодными для науки как для сельскохозяйственной практики