Normal view MARC view ISBD view

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC). [Review]

MedStar author(s):

Citation: Circulation. 148(14):1113-1126, 2023 10 03.PMID: 37782695Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Heart Valve Prosthesis Implantation | *Heart-Assist Devices | Humans | Research Design | Shock, Cardiogenic/su [Surgery] | Shock, Cardiogenic/th [Therapy] | Year: 2023 ISSN:

0009-7322

Name of journal: CirculationAbstract: The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.All authors: Waksman R, Pahuja M, van Diepen S, Proudfoot AG, Morrow D, Spitzer E, Nichol G, Weisfeldt ML, Moscucci M, Lawler PR, Mebazaa A, Fan E, Dickert NW, Samsky M, Kormos R, Pina IL, Zuckerman B, Farb A, Sapirstein JS, Simonton C, West NEJ, Damluji AA, Gilchrist IC, Zeymer U, Thiele H, Cutlip DE, Krucoff M, Abraham WTFiscal year: FY2024 Digital Object Identifier:

https://dx.doi.org/10.1161/CIRCULATIONAHA.123.064527

ORCID:

https://orcid.org/0000-0002-4063-9226

Date added to catalog: 2023-11-22

Holdings ( 1 )
Title notes ( 2 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	37782695	Available		37782695

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

English