Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins

George Hudson; Maia Osborne-Grinter; Aleksandra Staniszewska; Eleanor McNally; Stephen Black; Efthymios Avgerinos; Domenico Baccellieri; Olivier Hartung; Beverley J Hunt; Houman Jalaie; Marie Josee van Rijn; Peter Mezes; Gerry O'Sullivan; Marta Ramírez Ortega; Paolo Prandoni; Robert Hinchliffe; Baris A Ozdemir; European Research Hub (ERH)

doi:10.1016/j.ejvs.2025.04.005

Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins

George Hudson
, Maia Osborne-Grinter
, Aleksandra Staniszewska
, Eleanor McNally
, Stephen Black
, Efthymios Avgerinos
, Domenico Baccellieri
, Olivier Hartung
, Beverley J Hunt
, Houman Jalaie
, Marie Josee van Rijn
, Peter Mezes
, Gerry O'Sullivan
, Marta Ramírez Ortega
, Paolo Prandoni
, Robert Hinchliffe
, Baris A Ozdemir^*
, European Research Hub (ERH)

^*Corresponding author for this work

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

2 Citations (Scopus)

Abstract

Objective
Chronic venous disease (CVD) is a debilitating disease that results in significant morbidity and costs. A lack of standardised outcome reporting has made it difficult to evaluate the impact of interventions for CVD involving the deep veins. This study aimed to develop a core outcome set (COS) for studies evaluating interventions for this subset of CVD.

Methods
The COS was developed using the Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and interviews with 19 patients experiencing post-thrombotic syndrome after deep vein thrombosis generated a longlist of outcomes, which was then refined by a steering group. Each outcome was rated on importance by patients and healthcare practitioners using a 9 point Likert scale within a Delphi survey. Outcomes not meeting consensus criteria in the first round were re-prioritised in a second round. Outcomes meeting the criteria for being critically important were discussed in a final meeting between patients and international experts to develop the COS.

Results
The review and interviews generated 80 outcomes, which entered the Delphi process. In total, 233 stakeholders responded in the first round and 143 in the second round. Consensus was reached on 29 outcomes deemed critically important. These outcomes were discussed in the final meeting to yield seven general outcomes and six procedure specific outcomes, since some outcomes were not relevant to all patients with CVD. The general outcomes were death, lower limb ulceration, venous thromboembolism, bleeding, quality of life, limb pain, and oedema or limb swelling. The procedure specific outcomes were device migration, device mechanical failure, patency, technical and/or procedural success, re-intervention, and vascular complications.

Conclusion
A COS was developed for studies evaluating interventions for CVD involving the deep veins, comprising seven general outcomes and six procedure specific outcomes. Reporting these outcomes will promote comparison of interventions for CVD involving the deep veins.

Original language	English
Pages (from-to)	258-267
Number of pages	10
Journal	European Journal of Vascular and Endovascular Surgery
Volume	70
Issue number	2
Early online date	4 Apr 2025
DOIs	https://doi.org/10.1016/j.ejvs.2025.04.005
Publication status	E-pub ahead of print - 4 Apr 2025

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Publisher Copyright:
© 2025

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Hudson, G., Osborne-Grinter, M., Staniszewska, A., McNally, E., Black, S., Avgerinos, E., Baccellieri, D., Hartung, O., Hunt, B. J., Jalaie, H., van Rijn, M. J., Mezes, P., O'Sullivan, G., Ortega, M. R., Prandoni, P., Hinchliffe, R., Ozdemir, B. A., & European Research Hub (ERH) (2025). Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins. European Journal of Vascular and Endovascular Surgery, 70(2), 258-267. Advance online publication. https://doi.org/10.1016/j.ejvs.2025.04.005

@article{243158f51ec1465fa3b45d96cfacaf12,

title = "Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins",

abstract = "Objective Chronic venous disease (CVD) is a debilitating disease that results in significant morbidity and costs. A lack of standardised outcome reporting has made it difficult to evaluate the impact of interventions for CVD involving the deep veins. This study aimed to develop a core outcome set (COS) for studies evaluating interventions for this subset of CVD. Methods The COS was developed using the Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and interviews with 19 patients experiencing post-thrombotic syndrome after deep vein thrombosis generated a longlist of outcomes, which was then refined by a steering group. Each outcome was rated on importance by patients and healthcare practitioners using a 9 point Likert scale within a Delphi survey. Outcomes not meeting consensus criteria in the first round were re-prioritised in a second round. Outcomes meeting the criteria for being critically important were discussed in a final meeting between patients and international experts to develop the COS. Results The review and interviews generated 80 outcomes, which entered the Delphi process. In total, 233 stakeholders responded in the first round and 143 in the second round. Consensus was reached on 29 outcomes deemed critically important. These outcomes were discussed in the final meeting to yield seven general outcomes and six procedure specific outcomes, since some outcomes were not relevant to all patients with CVD. The general outcomes were death, lower limb ulceration, venous thromboembolism, bleeding, quality of life, limb pain, and oedema or limb swelling. The procedure specific outcomes were device migration, device mechanical failure, patency, technical and/or procedural success, re-intervention, and vascular complications. Conclusion A COS was developed for studies evaluating interventions for CVD involving the deep veins, comprising seven general outcomes and six procedure specific outcomes. Reporting these outcomes will promote comparison of interventions for CVD involving the deep veins.",

author = "George Hudson and Maia Osborne-Grinter and Aleksandra Staniszewska and Eleanor McNally and Stephen Black and Efthymios Avgerinos and Domenico Baccellieri and Olivier Hartung and Hunt, \{Beverley J\} and Houman Jalaie and \{van Rijn\}, \{Marie Josee\} and Peter Mezes and Gerry O'Sullivan and Ortega, \{Marta Ram{\'i}rez\} and Paolo Prandoni and Robert Hinchliffe and Ozdemir, \{Baris A\} and \{European Research Hub (ERH)\}",

note = "Publisher Copyright: {\textcopyright} 2025",

year = "2025",

month = apr,

day = "4",

doi = "10.1016/j.ejvs.2025.04.005",

language = "English",

volume = "70",

pages = "258--267",

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Hudson, G, Osborne-Grinter, M, Staniszewska, A, McNally, E, Black, S, Avgerinos, E, Baccellieri, D, Hartung, O, Hunt, BJ, Jalaie, H, van Rijn, MJ, Mezes, P, O'Sullivan, G, Ortega, MR, Prandoni, P, Hinchliffe, R, Ozdemir, BA & European Research Hub (ERH) 2025, 'Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins', European Journal of Vascular and Endovascular Surgery, vol. 70, no. 2, pp. 258-267. https://doi.org/10.1016/j.ejvs.2025.04.005

Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins. / Hudson, George; Osborne-Grinter, Maia; Staniszewska, Aleksandra et al.
In: European Journal of Vascular and Endovascular Surgery, Vol. 70, No. 2, 04.04.2025, p. 258-267.

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

TY - JOUR

T1 - Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins

AU - Hudson, George

AU - Osborne-Grinter, Maia

AU - Staniszewska, Aleksandra

AU - McNally, Eleanor

AU - Black, Stephen

AU - Avgerinos, Efthymios

AU - Baccellieri, Domenico

AU - Hartung, Olivier

AU - Hunt, Beverley J

AU - Jalaie, Houman

AU - van Rijn, Marie Josee

AU - Mezes, Peter

AU - O'Sullivan, Gerry

AU - Ortega, Marta Ramírez

AU - Prandoni, Paolo

AU - Hinchliffe, Robert

AU - Ozdemir, Baris A

AU - European Research Hub (ERH)

PY - 2025/4/4

Y1 - 2025/4/4

N2 - Objective Chronic venous disease (CVD) is a debilitating disease that results in significant morbidity and costs. A lack of standardised outcome reporting has made it difficult to evaluate the impact of interventions for CVD involving the deep veins. This study aimed to develop a core outcome set (COS) for studies evaluating interventions for this subset of CVD. Methods The COS was developed using the Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and interviews with 19 patients experiencing post-thrombotic syndrome after deep vein thrombosis generated a longlist of outcomes, which was then refined by a steering group. Each outcome was rated on importance by patients and healthcare practitioners using a 9 point Likert scale within a Delphi survey. Outcomes not meeting consensus criteria in the first round were re-prioritised in a second round. Outcomes meeting the criteria for being critically important were discussed in a final meeting between patients and international experts to develop the COS. Results The review and interviews generated 80 outcomes, which entered the Delphi process. In total, 233 stakeholders responded in the first round and 143 in the second round. Consensus was reached on 29 outcomes deemed critically important. These outcomes were discussed in the final meeting to yield seven general outcomes and six procedure specific outcomes, since some outcomes were not relevant to all patients with CVD. The general outcomes were death, lower limb ulceration, venous thromboembolism, bleeding, quality of life, limb pain, and oedema or limb swelling. The procedure specific outcomes were device migration, device mechanical failure, patency, technical and/or procedural success, re-intervention, and vascular complications. Conclusion A COS was developed for studies evaluating interventions for CVD involving the deep veins, comprising seven general outcomes and six procedure specific outcomes. Reporting these outcomes will promote comparison of interventions for CVD involving the deep veins.

AB - Objective Chronic venous disease (CVD) is a debilitating disease that results in significant morbidity and costs. A lack of standardised outcome reporting has made it difficult to evaluate the impact of interventions for CVD involving the deep veins. This study aimed to develop a core outcome set (COS) for studies evaluating interventions for this subset of CVD. Methods The COS was developed using the Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and interviews with 19 patients experiencing post-thrombotic syndrome after deep vein thrombosis generated a longlist of outcomes, which was then refined by a steering group. Each outcome was rated on importance by patients and healthcare practitioners using a 9 point Likert scale within a Delphi survey. Outcomes not meeting consensus criteria in the first round were re-prioritised in a second round. Outcomes meeting the criteria for being critically important were discussed in a final meeting between patients and international experts to develop the COS. Results The review and interviews generated 80 outcomes, which entered the Delphi process. In total, 233 stakeholders responded in the first round and 143 in the second round. Consensus was reached on 29 outcomes deemed critically important. These outcomes were discussed in the final meeting to yield seven general outcomes and six procedure specific outcomes, since some outcomes were not relevant to all patients with CVD. The general outcomes were death, lower limb ulceration, venous thromboembolism, bleeding, quality of life, limb pain, and oedema or limb swelling. The procedure specific outcomes were device migration, device mechanical failure, patency, technical and/or procedural success, re-intervention, and vascular complications. Conclusion A COS was developed for studies evaluating interventions for CVD involving the deep veins, comprising seven general outcomes and six procedure specific outcomes. Reporting these outcomes will promote comparison of interventions for CVD involving the deep veins.

U2 - 10.1016/j.ejvs.2025.04.005

DO - 10.1016/j.ejvs.2025.04.005

M3 - Article (Academic Journal)

C2 - 40188862

SN - 1078-5884

VL - 70

SP - 258

EP - 267

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

IS - 2

ER -

Editor's Choice – A Core Outcome Set for Clinical Studies on Chronic Venous Disease Involving the Deep Veins

Abstract

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