Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction - PubMed (original) (raw)

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Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction

Suresh Vedantham et al. Circ Cardiovasc Interv. 2023 Jul.

Abstract

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.

Keywords: humans; physicians; stents; thrombectomy; thrombosis.

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Conflict of interest statement

Disclosures Dr Vedantham receives nonfinancial research support (donation of compression stockings to study patients) from Medi USA. Dr Zelman Lewis is the President of EBQ Consulting, LLC. Dr Schneider is a consultant for Cagent, Boston Scientific, Limflow, Medtronic, Philips, Silk Road, and Surmodics. Dr Sabri is a consultant for Alucent Biomedical, Boston Scientific, and Medtronic. Dr Kolluri receives honoraria from Medtronic and is a consultant for Abbott Vascular, Auxetics, Avail, Boston Scientific Corporation, Inari Medical, Medtronic, Penumbra Medical, Surmodics, Syntactyx, and Prairie Education and Research Cooperative (PERC). The other authors report no conflicts.

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