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 reprioritised 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.