Core Outcome Measures in Effectiveness Trials

Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease

General Information

Abstract:
Peripheral arterial disease (PAD) represents a spectrum from asymptomatic stenosis to limb-threatening ischemia. The last decade has seen a tremendous increase in the variety of endovascular devices and techniques to treat occlusive disease. Like many evolving technologies, the literature surrounding therapy for endovascular arterial disease consists of mixed-quality manuscripts without clear standardization. Accordingly, critical evaluation of the reported results may be problematic. As such, providers and their patients make treatment decisions without the full benefit of a comparative effectiveness framework. The purpose of this document is to provide a summary for the reporting of endovascular revascularization techniques in the setting of chronic disease. Much of the work in this document is based on prior publications and standards proposed by the Society for Vascular Surgery. We have also made recommendations based on current literature and have attempted to acknowledge shortcomings and areas for future research. The various sections contain summaries of required reporting standards and should serve as a guide for the design of clinical trials and as reference for journal editors and reviewers when considering scientific work pertaining to endovascular therapy for chronic lower extremity arterial disease. An Appendix is provided with commonly used abbreviations in this document.

Authors:
Stoner, M. C. Calligaro, K. D. Chaer, R. A. Dietzek, A. M. Farber, A. Guzman, R. J. Hamdan, A. D. Landry, G. J. Yamaguchi, D. J. Society for Vascular, Surgery

Publication

Journal:
J Vasc Surg
Volume:
64
Issue:
1
Pages:
e1 - e21
Year:
2016
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Heart & circulation

Disease Name
Chronic lower extremity peripheral artery disease

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Procedure

Method(s)

Unknown

Stakeholders Involved

Clinical experts
Researchers

Study Type

COS for clinical trials or clinical research

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