Core Descriptor Set for Studies Evaluating Interventions for Chronic Deep Venous Diseases.

Abstract

Objective: Chronic deep venous disease (CDVD) is a common and debilitating disease resulting in significant morbidity and costs. However, inconsistent reporting of patient characteristics in CDVD hinders study comparability and limits opportunities for data synthesis. This study aimed to develop a core descriptor set (CDS) for studies evaluating interventions for CDVD of the lower limbs.

Methods: Candidate descriptors were identified from published literature and stakeholder recommendations. Vascular surgeons, haematologists, interventional radiologists, and nurse specialists took part in two rounds of an international modified Delphi process using a nine point Likert scale to rank descriptor importance. Descriptors not meeting consensus criteria in the first round were re-evaluated in round two. Descriptors meeting the criteria for critical importance were discussed in a final meeting between international specialists to finalise the CDS.

Results: One hundred and thirty-eight Delphi participants were recruited from 29 countries. Ninety-eight descriptors were longlisted from the literature, refined to 84 by the steering group. After round one, 23 descriptors achieved consensus and were removed from subsequent rounds. Seven newly proposed descriptors were then added, resulting in a total of 68 descriptors in round two. Following round two, a further 13 descriptors achieved consensus with eight considered borderline. Following two Delphi survey rounds and a consensus meeting, 84 candidate descriptors were systematically evaluated and narrowed down to a final set of 21 core descriptors across the domains of demographics, thrombotic risk, venous history, anatomy, symptoms, and clinical findings.

Conclusion: This study defined the CDS for CDVD, facilitating more consistent, robust, and meaningful reporting across studies and enabling reliable synthesis.