Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

OBJECTIVES The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. BACKGROUND A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND RESULTS Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. CONCLUSIONS This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).

The Impact of Industry Collaboration on Academic Research Output: A Dynamic Panel Data Analysis

The aim of this paper is to analyse the impact of university knowledge and technology transfer activities on academic research output. Specifically, we study whether researchers with collaborative links with the private sector publish less than their peers without such links, once controlling for other sources of heterogeneity. We report findings from a longitudinal dataset on researchers from two engineering departments in the UK between 1985 until 2006. Our results indicate that researchers with industrial links publish significantly more than their peers. Academic productivity, though, is higher for low levels of industry involvement as compared to high levels.

Collaborative information behaviour : a case study of two research groups

The aim of the licentiate thesis is to examine researchers' information practices in research groups. The researchers were involved with study communication and media related issues within Social Sciences and Humanities Faculties. The theoretical framework of the study comprises the new holistic models of information seeking (for example: Meho and Tibbo, 2003; Seldén, 1999) and the collective aspects of information behaviour (Prekop, 2002 ; Talja, 2002; Talja and Hansen, 2006). The research questions are: 1. How do scholars seek information in research groups? 2 What kind of collaborative information behaviour occurs in the research groups? The research data was gathered by interviews and observations. Three meetings of a research group at the University of Tampere were observed during the autumn of 2004. The group members and the group leader of the research group were interviewed in the spring of 2005. The research group members and the group leader of a research group at the University of Jyväskylä were interviewed in the autumn of 2005. Altogether, two research group leaders and eight researchers were interviewed. The significance of the research group for information seeking is more important in closeknit research groups than in rather loose research groups. The significance of the research group for information seeking can be at least threefold. First, research group members can inform the group about relevant information resources and potential library or other information services. Second, the research group can to some extent compensate for the information seeking systems of libraries by distributing material and information resources. Third, information seeking can be carried out in collaboration in research groups. The significance of the research group was found to be most important in informing about new information services and marketing library systems. Recommendations from colleagues were often needed to mobilize researchers into using new library services. The significance of colleagues in informing about library services is in line with earlier studies. The present study showed that sometimes information from colleagues was regarded as more important than information distributed directly by the local library. A culture of information sharing, including mutual trust, seemed mainly to be reflected in collaboration and collaborative information seeking in the research groups studied. The timing of the onset of individual research seemed to be related to the information sharing culture and social networks in research groups. The simultaneous onset of the research work by group members seemed to promote the growth of unbiased collaboration, also in information seeking.

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium

To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health.

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the valve academic research consortium

To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2)

The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

The aim of the current Valvular Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)- clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand understanding of patient risk stratification and case selection.

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions. METHODS AND RESULTS Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern-TAVI-Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870). CONCLUSIONS The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.

Analysis and visualization of the dynamics of research groups in terms of projects and co-authored publications : A case study of library and information science in Argentina

Objective: The present study offers a novel methodological contribution to the study of the configuration and dynamics of research groups, through a comparative perspective of the projects funded (inputs) and publication co-authorships (output). Method: A combination of bibliometric techniques and social network analysis was applied to a case study: the Departmento de Bibliotecología (DHUBI), Universidad Nacional de La Plata, Argentina, for the period 2000-2009. The results were interpreted statistically and staff members of the department, were interviewed. Results: The method makes it possible to distinguish groups, identify their members and reflect group make-up through an analytical strategy that involves the categorization of actors and the interdisciplinary and national or international projection of the networks that they configure. The integration of these two aspects (input and output) at different points in time over the analyzed period leads to inferences about group profiles and the roles of actors. Conclusions: The methodology presented is conducive to micro-level interpretations in a given area of study, regarding individual researchers or research groups. Because the comparative input-output analysis broadens the base of information and makes it possible to follow up, over time, individual and group trends, it may prove very useful for the management, promotion and evaluation of science

Analysis and visualization of the dynamics of research groups in terms of projects and co-authored publications : A case study of library and information science in Argentina

Objective: The present study offers a novel methodological contribution to the study of the configuration and dynamics of research groups, through a comparative perspective of the projects funded (inputs) and publication co-authorships (output). Method: A combination of bibliometric techniques and social network analysis was applied to a case study: the Departmento de Bibliotecología (DHUBI), Universidad Nacional de La Plata, Argentina, for the period 2000-2009. The results were interpreted statistically and staff members of the department, were interviewed. Results: The method makes it possible to distinguish groups, identify their members and reflect group make-up through an analytical strategy that involves the categorization of actors and the interdisciplinary and national or international projection of the networks that they configure. The integration of these two aspects (input and output) at different points in time over the analyzed period leads to inferences about group profiles and the roles of actors. Conclusions: The methodology presented is conducive to micro-level interpretations in a given area of study, regarding individual researchers or research groups. Because the comparative input-output analysis broadens the base of information and makes it possible to follow up, over time, individual and group trends, it may prove very useful for the management, promotion and evaluation of science