Venous appropriate use criteria are an important step in improving the quality of chronic venous disease care

Abstract

Maximizing quality of care relies on a physician using his or her expertise in combination with best available evidence to determine the right management for an individual patient. However, the explosion of knowledge through print and online journals has made it virtually impossible to read all of the published literature related to a particular topic or procedure. The solution to the enviable problem of too much literature is to synthesize the evidence to make it useful for physicians. In an ideal world, synthesizing the evidence would involve four steps: reporting standards, systematic reviews, practice guidelines, and appropriate use criteria (AUC). Reporting standards are essentially dictionaries that ensure that investigators use the same definitions when reporting their results, so that comparisons across studies are precise and valid, that is, comparing apples to apples. For example, in studies of chronic venous disease, it would make little sense to compare the outcomes of procedures on patients with varicose veins and no tissue loss with patients with venous ulcers. So reporting standards, which establish definitions and classifications of disease, like the CEAP classification for chronic venous disorders, are the first step in quality assessment. If all authors adhered to reporting standards, systematic reviews of the literature by those trained in the process could be conducted easily and result in a meaningful compilation of the existing data. Reporting standards and systematic reviews have been used in venous disease management for more than 20 years and are among the most highly valued and quoted publications in the venous disease literature. In conjunction with systematic reviews, meta-analyses, which combine data from multiple studies, can be used to achieve greater power. Meta-analyses, like systematic reviews, are more effective when authors adhere to the same reporting standards. In addition, reporting standards can also be incorporated into multi-institutional databases such as the Vascular Quality Initiative. This process enables standardized data collection, which can be used to determine the comparative effectiveness of treatment options, allowing physicians to make evidence-based treatment recommendations. When a large number of prospective and retrospective studies, meta-analyses, and systematic reviews exist on a topic, interpretation by experts are often required to provide the best recommendations. Practice guidelines are developed by a team of experts who collate and interpret the literature, providing recommendations on prevention, diagnosis, and management. But because the quality of studies reported in the literature vary greatly, a system for evaluating the quality of papers, called GRADE, is used in all Society for Vascular Surgery and American Venous Forum (AVF) practice guidelines. It classifies the evidence from grade 1A for strong recommendations based on the highest level of evidence, such as multiple prospective randomized trials with similar conclusions, to grade 2C, which are those with the weakest evidence. Practice guidelines give recommendations that are intended to optimize patient care, and they are created through a consensus process, based on scientific evidence. AUCs are additionally intended to help determine if a given patient should receive a certain diagnostic test or treatment. AUCs use a combination of the best available evidence and expert opinion, but differ from practice guidelines in two main ways. First, AUC do not require that the expert panel reach consensus. Second, AUCs have the ability to address as many permutations of patient characteristics as desired. The only validated, scientific method of determining appropriateness is the RAND/UCLA Appropriateness Method,1Fitch K. Bernstein S.J. Aguilar M.D. Burnand B. LaCalle J.R. Lazaro P. et al.The RAND/UCLA appropriateness method user's manual. RAND Corporation, Santa Monica, CA2001Google Scholar which was used by Masuda et al2Masuda E. Ozsvath K. Vossler J. Woo K. Kistner R. Lurie F. et al.The 2020 appropriate use criteria for chronic lower extremity venous disease of the American Venous Forum, the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional Radiology.J Vasc Surg Venous Lymphat Disord. 2020; 8: 505-525Abstract Full Text Full Text PDF Scopus (34) Google Scholar in the AUC published in this issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders. Multiple scenarios addressing various permutations of patient characteristics were evaluated in an iterative process by a panel of experts, in combination with the best available evidence. The result is a set of AUC that provide guidance for physicians regarding the best management for an individual patient with chronic venous disease. Congratulations to Dr Masuda, her coauthors, and the vascular societies who took the high road and addressed both appropriate and inappropriate chronic venous care by producing these AUC. Although the definition of appropriateness can vary from one AUC to the next, Masuda et al used the RAND definition of appropriateness: “An appropriate procedure is one in which the expected health benefit exceeds the expected negative consequences by a sufficiently wide margin that the procedure is worth doing, exclusive of cost."1Fitch K. Bernstein S.J. Aguilar M.D. Burnand B. LaCalle J.R. Lazaro P. et al.The RAND/UCLA appropriateness method user's manual. RAND Corporation, Santa Monica, CA2001Google Scholar Therefore, these AUCs should be used to guide treatment by well-intentioned physicians whose goal is to improve the health of their patients with chronic venous disease. Some clinicians have not been trained in the management of venous disease, so the AUC can educate them, whereas others claim that there are no AUC, so all treatments are indicated. They can no longer say that! Although AUC can address a number of permutations of patient characteristics, it remains impossible to address every possible extenuating circumstance. Thus, when evaluating whether a physician provides appropriate care, the entire physician's practice must be examined,3Crawford J.M. Gasparis A. Almeida J. Elias S. Wakefield T. Lal B.K. et al.A review of United States endovenous ablation practice trends from the Medicare Data Utilization and Payment Database.J Vasc Surg Venous Lymphat Disord. 2019; 7: 471-479Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar,4Mann M. Wang P. Schul M. Khilnani N. Park A. Makary M.A. et al.Significant physician practice variability in the utilization of endovenous thermal ablation in the 2017 Medicare population.J Vasc Surg Venous Lymphat Disord. 2019; 7: 808-816.e1Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar rather than individual cases. There will always be exceptions to guidelines and AUC based on unusual characteristics of a given patient, but these exceptions should constitute the small minority of a physician's practice. What should be the next steps, now that AUC for chronic venous disease have been developed? First, the AUC should be widely disseminated among venous specialists, insurers, and professional societies whose members treat chronic venous disease, so they get incorporated into everyone's core knowledge. Second, it is incumbent upon Medicare Evidence Development & Coverage Advisory Committee, the Centers for Medicare and Medicaid Services, insurers, and the companies who manufacture venous devices and drugs to identify physicians who are routinely using devices and drugs inappropriately and deny access to them, as well as denying reimbursement. In addition, now that there are AUCs for chronic venous disease, unethical physicians who put patients at risk by performing inappropriate procedures should be prosecuted when they repeatedly perform procedures that are inappropriate and provide no health benefit, while creating patient risk and unnecessary costs. Next, professional societies, including the American Society of Venous and Lymphatic Medicine, AVF, Society of Interventional Radiology, and Society for Vascular Surgery, who supported the development of these AUCs, should use them to evaluate the ethics of their members and ostracize those who repeatedly do inappropriate procedures. Also, these AUC can be incorporated into Vascular Quality Initiative and other venous databases to determine the degree of appropriate and inappropriate care being delivered, and provide feedback through appropriateness5Lawrence P.F. “Better” (sometimes) in vascular disease management.J Vasc Surg. 2016; 63: 260-269Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar reports. For example, what percent of superficial venous ablations done by a physician are for appropriate indications and anatomy? Finally, I would encourage the AVF ethics committee and the vascular societies involved in this AUC project to regularly update the reporting standards such as CEAP classification, practice guidelines, systematic reviews, and ultimately these AUC to keep them contemporary and relevant as our knowledge of the best devices and treatments evolves. The 2020 appropriate use criteria for chronic lower extremity venous disease of the American Venous Forum, the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional RadiologyJournal of Vascular Surgery: Venous and Lymphatic DisordersVol. 8Issue 4PreviewStimulated by published reports of potentially inappropriate application of venous procedures, the American Venous Forum and its Ethics Task Force in collaboration with multiple other professional societies including the Society for Vascular Surgery (SVS), American Vein and Lymphatic Society (AVLS), and the Society of Interventional Radiology (SIR) developed the appropriate use criteria (AUC) for chronic lower extremity venous disease to provide clarity to the application of venous procedures, duplex ultrasound imaging, timing, and reimbursements. Full-Text PDF