Aims The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for... Show moreAims The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.Methods and results Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.Conclusions Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies. Show less
Mysyuk, Y.; Westendorp, R.G.J.; Lindenberg, J. 2016
In this article we explore older persons' definitions of and explanations for elder abuse in the Netherlands by means of interviews with older persons. A qualitative study was conducted based on... Show moreIn this article we explore older persons' definitions of and explanations for elder abuse in the Netherlands by means of interviews with older persons. A qualitative study was conducted based on semistructured interviews with 35 older persons who had no experience with abuse. Our findings show that older persons participating in our study define elder abuse foremost as physical violence that is performed intentionally. The study participants explain elder abuse as a result of the dependency and vulnerability of older persons, of changing norms and values, and of changes in the position of older persons in society, which result in disrespect toward older persons and a lack of social control and responsibility. The older persons' explanations for the occurrence of abuse mainly focus on societal changes; older persons seem to regard elder abuse primarily as a societal problem. This understanding of, and explanation for, elder abuse may influence their detection and reporting behavior, as they may tend to acknowledge only severe cases of intentional physical violence that leave clear and therefore physically detectable evidence. Show less