TY - JOUR
T1 - Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction
AU - Vedantham, Suresh
AU - Gloviczki, Peter
AU - Carman, Teresa L.
AU - Zelman Lewis, Sandra
AU - Schneider, Peter A.
AU - Sabri, Saher S.
AU - Kolluri, Raghu
N1 - Funding Information:
This project was supported by the Vascular and Interventional Advances Foundation.
Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/7/1
Y1 - 2023/7/1
N2 - Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.
AB - Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.
KW - humans
KW - physicians
KW - stents
KW - thrombectomy
KW - thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85165234427&partnerID=8YFLogxK
U2 - 10.1161/CIRCINTERVENTIONS.123.012894
DO - 10.1161/CIRCINTERVENTIONS.123.012894
M3 - Review article
C2 - 37340977
AN - SCOPUS:85165234427
SN - 1941-7640
VL - 16
SP - E012894
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 7
ER -