77 research outputs found

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

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    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.

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    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.

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    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.

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    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

    Interrogating open issues in cancer precision medicine with patient-derived xenografts

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    The construction of a Personal Position Repertoire: Method and practice

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    Abstract In the light of the preceding article Key Words affect, dialogue, meaning, multivoicedness, polyphony, position repertoire Hubert J.M. Hermans University of Nijmegen, The Netherlands The Construction of a Personal Position Repertoire: Method and Practice Whereas the preceding article Second, the method is both quantitative and qualitative. The quantitative part of the method enables the researcher or practitioner to compare, on the basis of particular dimensions, the commonality and differences of the several positions within the same individual and facilitates the comparison of different individuals. The qualitative aspect is based on the consideration that the construction of meaning Culture &amp; Psychology Copyright © 2001 SAGE Publications (London, Thousand Oaks, CA and New Delhi) Vol. 7(3): 323-365 [1354-067X(200109) 7:3; 323-365; 018670] Method and Practice at Universiteitsbibliotheek on March 3, 2009 http://cap.sagepub.com Downloaded from is more than a measurable, quantitative matter. Meaning construction and reconstruction require proper attention to the stories people tell about their lives and to the ways people affectively organize events that are part of their personal and collective histories. The quantitative parts of the method are to be seen not as fixed results but as invitations to a discussion between psychologist and participant. The outcomes of the quantitative analyses require the interpretation of the participants and are taken up as elements in a broader discussion with the psychologist. Third, closely related to the qualitative aspect of the position repertoire, the notion of &apos;voice&apos; will be of central importance to the method presented here. The utterances of people, recounting the events in their everyday life, will be reported as they are spoken by the participants of the investigation themselves. That is, the utterances of people talking about their experiences and reflecting about some relevant aspects of their lives will not be hidden from view or covered by the interpretations and scientific concepts from the psychologist or researcher. Certainly, these psychological interpretations and concepts are a central part of the method to be discussed in this article, but the words, concepts and interpretations from the participants are reported in their original formulations so that their voices can be heard as they want to be heard. Fourth, this is a general method for the investigation of the content, organization and reorganization of people&apos;s position repertoire. Like the theory of the dialogical self, the method is not restricted to any psychological subdiscipline but rather of a more general nature. This implies that research and practice in one psychological subdiscipline may be relevant to research and practice in any other subdiscipline or discipline. This point of view implies that research or applications in developmental psychology, clinical psychology or psychotherapy may contribute to the understanding of cultural processes or cultural positioning. Fifth, it is not suggested that this is the only method for assessing the multivoicedness and dialogicality of the self. One of the purposes of this article is to present an example of a dialogical method with the possibility that other researchers may create other or even better theoryguided alternatives. Moreover, the PPR is not devised as a standardized method. It can be adapted and revised according to the purposes and needs of individual researchers or practitioners in their specific settings and circumstances. Rather than offering a ready-made method for &apos;measuring&apos; the self, the purpose is to offer psychologists and participants a methodological framework that they may reconstruct in view of the theoretical outlines exposed in the preceding article. The method requires, moreover, a commitment of psychologist and participant, and its application may profit from the psychologist&apos;s professional experience with a specific group of participants. In sum, the method functions as a skeleton, and the flesh around the skeleton is the outcome of cooperative enterprise of two parties. The Matrix of Internal and External Positions Imagine a mother who meets her daughter&apos;s friend for the first time. She immediately dislikes him. Later, she tells her husband that her daughter&apos;s friend is &apos;just like Peter&apos;, her brother, who used to exhibit the same behavior (smoking without asking for permission, making deprecating remarks about other people, etc.). After this meeting, the mother discusses this experience with her husband, and finds out that she feels herself to be very vulnerable when she is faced with such a person. Moreover, she is afraid that her daughter will not be able to protect herself against the misbehavior of her new friend. Gradually, the mother becomes aware that her critical attitude toward her daughter&apos;s friend can be traced back to the relationship with her own brother, who always made her feel very vulnerable. In this example we see at least two external positions in the self of the mother: her daughter&apos;s friend and her brother, who are experienced in similar ways. At the same time, there are two internal positions involved: the mother as a critic and the mother as vulnerable. In this simplified example, the two external positions have in common that they trigger the same set of internal positions. From a theoretical point of view, the two external positions are &apos;functionally equivalent&apos;, which means that they evoke, consciously or unconsciously, the same pattern of internal positions. The two internal positions, in turn, are also functionally equivalent as they are both directed toward the same pattern of external positions. In other words, patterns of internal and external positions emerge from person-world interactions. The above repertoire of two internal and two external positions is highly simplified because usually there are more internal positions and more external positions in a person&apos;s repertoire, resulting in more complex patterns of internal-external relationships. The PPR was devised to assess these more complex patterns with attention to the dialogical relationships that may develop between positions. This can be illustrated with the case of an actual client involved in a process of changing patterns of positions. This case will be used to explain the Hermans Personal Position Repertoire 325 at Universiteitsbibliotheek on March 3, 2009 http://cap.sagepub.com Downloaded from structure of the method and the different steps to be followed in its application in research or practice. Content and Organization of Nancy&apos;s Position Repertoire Nancy, 1 a 47-year-old woman working as a part-time secretary and a mother of two adolescent children, contacted a psychotherapist (Els Hermans-Jansen) in a period in which she was plagued by psychosomatic complaints (e.g. severe headaches and muscular tensions). These complaints were accompanied by problems that she experienced in relation to her social surroundings. She constantly felt forced to defend herself against others and was simultaneously dependent, to a very high degree, on the approval and evaluation of others both at work and in her private life. She felt a persistent urge to be at the center of attention and saw other people as competitors. Her persistent need to be seen and confirmed could never be fulfilled in a world in which almost everybody was felt as an adversary. After about a year and a half of psychotherapy, not much had changed and the problems continued as described. In order to give the therapy a new impulse, the therapist, in collaboration with me as a personality psychologist, decided to suggest that Nancy examine her position repertoire and work further from there. The therapist gave Nancy a list of approximately 50 internal positions and 40 external positions (see Appendix for the most recent list) and asked her to select those positions in which she recognized herself and which played some role in her life. At the same time, she was given the opportunity to add some positions formulated by herself and phrased in her own language. Next, Nancy was invited to estimate the extent to which in her experience a particular internal position is prominent (in a positive or negative way) in relation to a particular external position. Concentrating on the first position, the participant indicates on a 0-5 scale the extent to which the internal position is prominent in relation to the external position (0 = not at all, 1 = very little, 2 = to some extent, 3 = quite a lot, 4 = considerably and 5 = very considerably). The result is a matrix of internal positions (rows) and external positions (columns) with the prominence ratings (extent of prominence) in the entries (see Usually, internal positions differ to the extent in which they are prominent in relation to a variety of external positions. For example, Nancy&apos;s position as a listener received a high prominence rating i

    Bridging traits, story, and self: Prospects and problems

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    Contains fulltext : 29508.pdf (publisher's version ) (Open Access)In his target article, McAdams brings together three domains in the field of psychology in which challenging developments have been observed over the past decades: trait psychology, narrative psychology, and culture. Trait psychology has been rejuvenated by crossnational and cross-cultural research projects on the "Big Five". The narrative approach has cropped up in a great diversity of psychological subdisciplines, including personality psychology, and is on its way to being accepted as a respected development in academic psychology. The notion of culture has also received enormous interest, particularly in discussions around modernity and postmodernity and their implications for psychology as a science. Scientists in and outside psychology are becoming aware that culture is implicit not only in their personal views, but also in the theories and concepts that form the basis of their professional activities. McAdams's contribution has the merit that it provides an intriguing conceptual framework that aims at integrating a diversity of psychological developments that interact in many ways, but that have never been analyzed on their mutual implications from a metatheoretical point of view
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