A Core Outcome Set for Patients with Chronic Symptomatic Peripheral Arterial Disease

VASCUL-AID collaborators and expert consensus meeting collaborators; Henk A. Marquering

doi:10.1016/j.ejvs.2025.09.022

A Core Outcome Set for Patients with Chronic Symptomatic Peripheral Arterial Disease

VASCUL-AID collaborators and expert consensus meeting collaborators
, Henk A. Marquering

Department of Surgery
Vrije Universiteit Amsterdam
Amsterdam UMC
University of Belgrade
Clinic for Vascular and Endovascular Surgery
Clinical Center of Serbia
Department of Angiology and Vascular Surgery
Centro Hospitalar Universitário de São João
RISE-Health
University of Porto
University of Oxford
Department of Vascular Surgery
Helsinki University Hospital
University of Helsinki
Department of Vascular and Endovascular Surgery
Asklepios Medical School
Asklepios Medical School
Université Côte d'Azur
Department of Vascular Surgery
Hospital of Antibes Juan-les-Pins
Laboratoire de PhysioMédecine Moléculaire
Hospital of Antibes Juan-les-Pins
Department of Informatics
University of Bergen
MMIV
Vascular Surgery
Department of Applied Mathematics
University of Twente
Department of Biomedical Engineering and Physics
Amsterdam UMC - University of Amsterdam
University of Amsterdam
Department of Ethics
Chief Medical Information Officer
Brightfish B.V.
Brightfish B.V.
Clinical Chemistry Laboratory
CHU de Nice
Université Côte d'Azur
Centre Hospitalier Universitaire de Nice
ALLAI
Stichting allai Nederland
Laboratory for Radiobiology and Molecular Genetics
Epidemiology Section
Amsterdam Gastroenterology and Metabolism
Department of Public and Occupational Health & Department of Vascular Medicine
Department of Cardiology
Markus-Krankenhaus Frankfurt
Center of Thrombosis and Hemostasis
Johannes Gutenberg University Mainz
Department of Vascular Surgery
Department of Biomedicine
CINTESIS@RISE – Centre for Health Technology and Services Research
Department of Vascular Surgery
Spaarne Gasthuis
Department of Surgery
Radboud University Nijmegen
Department of Surgery
Dijklander Hospital
Department of Vascular and Endovascular Surgery
Hôpital de la Cavale Blanche

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Objective: Current literature on patients with peripheral arterial disease (PAD) is heterogeneous and characterised by selective outcome reporting. A core outcome set (COS) is a list of essential outcomes based on expert consensus used to standardise clinical research, reflecting the needs of all stakeholders, including patients. This is especially important in research involving artificial intelligence (AI), such as the VASCUL-AID project, a European collaboration aimed at creating predictive models for cardiovascular disease progression in patients with chronic symptomatic PAD. This study aimed to create a COS for patients with chronic symptomatic PAD for use in clinical and AI research. Methods: This COS was pre-registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and was developed in line with the COMET Initiative recommendations. A longlist of PAD outcomes was formed based on outcomes identified from a systematic literature review and focus groups with patients and healthcare professionals (HCPs). Next, a Delphi study with patients and HCPs was conducted. The COS was finalised in an expert consensus meeting with key opinion leaders, patients, and patient representatives. Results: The longlist comprised 67 outcomes: 36 outcomes identified from a systematic literature review and 31 patient centred outcomes from the focus groups. In total, 153 HCPs and 92 patients participated in the Delphi study, with an overall participation rate of 85%. The Delphi study's 20 highest rated outcomes were discussed in the expert consensus meeting, attended by 21 HCPs, three patients, and two patient representatives. The final COS consists of 11 outcomes: death, myocardial infarction, major amputation, acute limb ischaemia, thromboembolic complications, disease progression, pain free walking distance, physical activity, health related quality of life, smoking cessation, and good communication by healthcare provider. Conclusion: This is the first COS for patients with chronic symptomatic PAD recommended for adoption in clinical and AI research.

Original language	English
Journal	European journal of vascular and endovascular surgery
Early online date	2025
DOIs	https://doi.org/10.1016/j.ejvs.2025.09.022
Publication status	E-pub ahead of print - 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Artificial intelligence
Core outcome set
Peripheral arterial disease

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@article{7cd8028f01a649f6b005ac8830f1b143,

title = "A Core Outcome Set for Patients with Chronic Symptomatic Peripheral Arterial Disease",

abstract = "Objective: Current literature on patients with peripheral arterial disease (PAD) is heterogeneous and characterised by selective outcome reporting. A core outcome set (COS) is a list of essential outcomes based on expert consensus used to standardise clinical research, reflecting the needs of all stakeholders, including patients. This is especially important in research involving artificial intelligence (AI), such as the VASCUL-AID project, a European collaboration aimed at creating predictive models for cardiovascular disease progression in patients with chronic symptomatic PAD. This study aimed to create a COS for patients with chronic symptomatic PAD for use in clinical and AI research. Methods: This COS was pre-registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and was developed in line with the COMET Initiative recommendations. A longlist of PAD outcomes was formed based on outcomes identified from a systematic literature review and focus groups with patients and healthcare professionals (HCPs). Next, a Delphi study with patients and HCPs was conducted. The COS was finalised in an expert consensus meeting with key opinion leaders, patients, and patient representatives. Results: The longlist comprised 67 outcomes: 36 outcomes identified from a systematic literature review and 31 patient centred outcomes from the focus groups. In total, 153 HCPs and 92 patients participated in the Delphi study, with an overall participation rate of 85\%. The Delphi study's 20 highest rated outcomes were discussed in the expert consensus meeting, attended by 21 HCPs, three patients, and two patient representatives. The final COS consists of 11 outcomes: death, myocardial infarction, major amputation, acute limb ischaemia, thromboembolic complications, disease progression, pain free walking distance, physical activity, health related quality of life, smoking cessation, and good communication by healthcare provider. Conclusion: This is the first COS for patients with chronic symptomatic PAD recommended for adoption in clinical and AI research.",

keywords = "Artificial intelligence, Core outcome set, Peripheral arterial disease",

author = "\{VASCUL-AID collaborators and expert consensus meeting collaborators\} and Zwetsloot, \{Sabrina L.M.\} and Lotte Rijken and Igor Koncar and Ivan Tomic and Marina Dias-Neto and Regent Lee and Riikka Tulamo and Behrendt, \{Christian Alexander\} and Fabien Lareyre and Smit, \{Noeska N.\} and Vincent Jongkind and Yeung, \{Kak Khee\} and Wolterink, \{Jelter M.\} and Ivana I{\v s}gum and Marquering, \{Henk A.\} and Ploem, \{M. Corrette\} and Fabio Catarinella and Bera, \{Kasia D.\} and Jenny Buisan and Ping Zhang and Juliette Raffort and Catelijne Muller and Igor Koncar and David Matejevic and Maja {\v Z}ivkovi{\'c} and Tamara Djuric and Aleksandra Stankovic and Maarit Venermo and Mirjami Laivuori and Schijven, \{Marlies P.\} and \{van den Born\}, \{Bert J.H.\} and Ronak Delewi and Smorenburg, \{Stefan P.M.\} and Venkat Ayyalasomayajula and Rupert Bauersachs and Petteri Kauhanen and Katariina Noronen and Neves, \{Jo{\~a}o Rocha\} and Barbosa, \{C{\'a}tia Martins\} and Dias, \{Dinis Pereira\} and \{Dias da Silva\}, Carlos and Barbosa, \{Jo{\~a}o Silva\} and Miroslav Markovic and Denise Nio and Michiel Warl{\'e} and Anna Teeuw and Bahaa Nasr",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s)",

year = "2025",

doi = "10.1016/j.ejvs.2025.09.022",

language = "English",

journal = "European journal of vascular and endovascular surgery",

issn = "1078-5884",

publisher = "W.B. Saunders Ltd",

}

TY - JOUR

T1 - A Core Outcome Set for Patients with Chronic Symptomatic Peripheral Arterial Disease

AU - VASCUL-AID collaborators and expert consensus meeting collaborators

AU - Zwetsloot, Sabrina L.M.

AU - Rijken, Lotte

AU - Koncar, Igor

AU - Tomic, Ivan

AU - Dias-Neto, Marina

AU - Lee, Regent

AU - Tulamo, Riikka

AU - Behrendt, Christian Alexander

AU - Lareyre, Fabien

AU - Smit, Noeska N.

AU - Jongkind, Vincent

AU - Yeung, Kak Khee

AU - Wolterink, Jelter M.

AU - Išgum, Ivana

AU - Marquering, Henk A.

AU - Ploem, M. Corrette

AU - Catarinella, Fabio

AU - Bera, Kasia D.

AU - Buisan, Jenny

AU - Zhang, Ping

AU - Raffort, Juliette

AU - Muller, Catelijne

AU - Koncar, Igor

AU - Matejevic, David

AU - Živković, Maja

AU - Djuric, Tamara

AU - Stankovic, Aleksandra

AU - Venermo, Maarit

AU - Laivuori, Mirjami

AU - Schijven, Marlies P.

AU - van den Born, Bert J.H.

AU - Delewi, Ronak

AU - Smorenburg, Stefan P.M.

AU - Ayyalasomayajula, Venkat

AU - Bauersachs, Rupert

AU - Kauhanen, Petteri

AU - Noronen, Katariina

AU - Neves, João Rocha

AU - Barbosa, Cátia Martins

AU - Dias, Dinis Pereira

AU - Dias da Silva, Carlos

AU - Barbosa, João Silva

AU - Markovic, Miroslav

AU - Nio, Denise

AU - Warlé, Michiel

AU - Teeuw, Anna

AU - Nasr, Bahaa

PY - 2025

Y1 - 2025

N2 - Objective: Current literature on patients with peripheral arterial disease (PAD) is heterogeneous and characterised by selective outcome reporting. A core outcome set (COS) is a list of essential outcomes based on expert consensus used to standardise clinical research, reflecting the needs of all stakeholders, including patients. This is especially important in research involving artificial intelligence (AI), such as the VASCUL-AID project, a European collaboration aimed at creating predictive models for cardiovascular disease progression in patients with chronic symptomatic PAD. This study aimed to create a COS for patients with chronic symptomatic PAD for use in clinical and AI research. Methods: This COS was pre-registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and was developed in line with the COMET Initiative recommendations. A longlist of PAD outcomes was formed based on outcomes identified from a systematic literature review and focus groups with patients and healthcare professionals (HCPs). Next, a Delphi study with patients and HCPs was conducted. The COS was finalised in an expert consensus meeting with key opinion leaders, patients, and patient representatives. Results: The longlist comprised 67 outcomes: 36 outcomes identified from a systematic literature review and 31 patient centred outcomes from the focus groups. In total, 153 HCPs and 92 patients participated in the Delphi study, with an overall participation rate of 85%. The Delphi study's 20 highest rated outcomes were discussed in the expert consensus meeting, attended by 21 HCPs, three patients, and two patient representatives. The final COS consists of 11 outcomes: death, myocardial infarction, major amputation, acute limb ischaemia, thromboembolic complications, disease progression, pain free walking distance, physical activity, health related quality of life, smoking cessation, and good communication by healthcare provider. Conclusion: This is the first COS for patients with chronic symptomatic PAD recommended for adoption in clinical and AI research.

AB - Objective: Current literature on patients with peripheral arterial disease (PAD) is heterogeneous and characterised by selective outcome reporting. A core outcome set (COS) is a list of essential outcomes based on expert consensus used to standardise clinical research, reflecting the needs of all stakeholders, including patients. This is especially important in research involving artificial intelligence (AI), such as the VASCUL-AID project, a European collaboration aimed at creating predictive models for cardiovascular disease progression in patients with chronic symptomatic PAD. This study aimed to create a COS for patients with chronic symptomatic PAD for use in clinical and AI research. Methods: This COS was pre-registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and was developed in line with the COMET Initiative recommendations. A longlist of PAD outcomes was formed based on outcomes identified from a systematic literature review and focus groups with patients and healthcare professionals (HCPs). Next, a Delphi study with patients and HCPs was conducted. The COS was finalised in an expert consensus meeting with key opinion leaders, patients, and patient representatives. Results: The longlist comprised 67 outcomes: 36 outcomes identified from a systematic literature review and 31 patient centred outcomes from the focus groups. In total, 153 HCPs and 92 patients participated in the Delphi study, with an overall participation rate of 85%. The Delphi study's 20 highest rated outcomes were discussed in the expert consensus meeting, attended by 21 HCPs, three patients, and two patient representatives. The final COS consists of 11 outcomes: death, myocardial infarction, major amputation, acute limb ischaemia, thromboembolic complications, disease progression, pain free walking distance, physical activity, health related quality of life, smoking cessation, and good communication by healthcare provider. Conclusion: This is the first COS for patients with chronic symptomatic PAD recommended for adoption in clinical and AI research.

KW - Artificial intelligence

KW - Core outcome set

KW - Peripheral arterial disease

UR - https://www.scopus.com/pages/publications/105023672579

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=105023672579&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/40992592

U2 - 10.1016/j.ejvs.2025.09.022

DO - 10.1016/j.ejvs.2025.09.022

M3 - Article

C2 - 40992592

AN - SCOPUS:105023672579

SN - 1078-5884

JO - European journal of vascular and endovascular surgery

JF - European journal of vascular and endovascular surgery

ER -

A Core Outcome Set for Patients with Chronic Symptomatic Peripheral Arterial Disease

Abstract

UN SDGs

Keywords

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