wetenschapsdag 2023 | 67 Sessie 2b: Classificaties: van Chaos naar Categorie x5 Auteurs S.L.M. Zwetsloot, V. Jongkind, K.K. Yeung Abstract titel Protocol for the development of a core outcome set for intermittent claudication: a systematic review and Delphi study Background Currently, it is unknown which patients suffering from peripheral arterial disease (PAD) and an abdominal aortic aneurysm (AAA) will experience disease progression or develop adverse cardiovascular events. VASCUL-AID is an European Horizonsponsored research project that aims to build an AI-driven user interface to adequately predict PAD and AAA progression. This tool will help patients alter their own disease course by offering tailored feedback. As a first step in this multi-year project, clinically relevant and patient-reported outcomes need to be identified. Literature on PAD is heterogeneous and lacks standardization. Therefore, the main objective of the current study is to create consensus among patients, clinical specialists and researchers on a list of core outcomes that should be applied to all future research on intermittent claudication (IC). Methods The study will be conducted in three phases; the first being a systematic review identifying all outcomes related to conservative, endovascular, and operative treatment of IC (Fontaine classification II and III); the second a three-step Delphi study stakeholders to create a list of outcomes regarded as most important; the third an expert panel meeting finalizing the definitive core outcome set (COS). Stakeholders will include patients (n=40) and vascular specialists (n=40) from each of our European participating centers. In developing this COS, we adhere to the Core Outcome Set-STAndards for Development (COS-STAD) recommendations and the Core Outcome Measures in Effectiveness Trials (COMET) Handbook. The COS will be published in accordance with the COS-STAndards for Reporting statement. For the Delphi study, recommendations as reported by Sinha et al. will be complied with. The final COS will consist of a maximum of ten outcomes. These outcomes will be utilized for the consecutive retrospective and prospective studies.
RkJQdWJsaXNoZXIy MTk4NDMw