“Effect of junctional reflux on the Venous Clinical Severity Score in patients with insufficiency of the great saphenous vein (JURY study)”1 used the resources of an academic society (American Venous Forum) and its internal research capabilities to address a "real world" in a new and potentially paradigm-shifting way.
The undertaking of this study was based on the unmet need for data to address the clinical relevance of junctional (saphenofemoral) reflux in patients with symptomatic great saphenous vein insufficiency. This is a well-designed study, with appropriate power to address the clinical question and meticulous statistical analysis and consideration of possible confounding variables. The study includes a broad range of clinical centers (academic and community with varied geography).
The significance of this study is not only in its scientific rigor and accuracy, but also in the manner in which it was conceived and executed. Membership in specialty societies often brings real-world insurance coverage problems to the attention of society leadership and health policy committees, particularly when these problems are perceived to affect the ability to provide good and appropriate clinical care to patients. Often, this is due to inconsistency in carrier policies which may be a result of insufficient high-quality data regarding clinical scenarios.2,3 In this case, the issue was that members of the American Venous Forum noted that treatment for severe, symptomatic great saphenous vein insufficiency was being denied coverage if there was not reflux at the saphenofemoral junction (SFJ) per se. The society evaluated this problem, designed a multicenter study to address it, and obtained industry support for the study. Of note, this industry involvement did not determine the design of the study, the analysis of the data, or the writing of the manuscript.
Indeed, the results show that the Venous Clinical Severity Score in patients with great saphenous vein insufficiency with and without SFJ reflux were found to be equivalent and that SFJ reflux was not a significant predictor of Venous Clinical Severity Score. Based on these results, the treatment of symptomatic great saphenous vein insufficiency without the presence of SFJ reflux may no longer be considered experimental or lacking sufficient data to justify lack of coverage by insurance carriers.
The conception, design, and execution of this study is a new model whereby academic societies can coordinate their expertise and human resources with support from industry partners to assess real-world issues while maintaining unbiased clinical equipoise.
The opinions or views expressed in this commentary are those of the authors and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery: Venous and Lymphatic Disorders or the Society for Vascular Surgery.
Disclosures
None.
Footnotes
The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
References
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