As the health care policy in the U.S. shifts from a quantitative-based system to a more qualitative one, reliance on reporting becomes utterly essential to this change in environment. Both objective and subjective reporting are important, and this is especially true for the specialty of phlebology. As such, quality of life measures stand out as pivotal components to this effort, but why?
First, given the vast array of clinical presentation in venous disease, it is crucial that reporting methods not only capture most, if not all, of the various symptoms patients are experiencing, but make sense of them as well. This allows for the results to be compared so that practice standards can be established.1 Second, compared to peripheral arterial disease, where objective tools are available for the measurement of disease severity and disease change (such as ankle-brachial pressure indexes), the assessment and classification of venous disease is less clear. Third, prior studies on the efficacy of endovenous ablation techniques and traditional surgery have concentrated primarily on occlusion rates, clinical recurrence and hemodynamic function because these outcomes can be objectively measured. However, these surrogate endpoints do not necessarily reflect the patient’s experience, or the clinical or functional outcome. Moreover, with increasing amount of clinical, scientific and third-party attention b ing paid to quality of life (QOL) measures, the importance of patient-reported QOL outcomes cannot be underestimated.2 Fourth, unlike other vascular diseases, clinical hard endpoints such as death, myocardial infarction, stroke, amputation rate, critical limb ischemia, etc., typically are not applicable to phlebology. However, lifestyle limitation and functional deterioration are at the heart of venous insufficiency. As an example, a tremendous amount of sick time is spent on venous ulcer care, limb pain and/or edema, and other venous-related disabilities. These can all lead to a decrease in work productivity, and even permanent disability. Based on recent estimations, venous ulcer care alone costs approximately $3 billion annually in the U.S.3 Given such extraordinary amount of healthcare burden and economic impact, the care of patients with phlebological issues cannot be undervalued.
As patient preference becomes increasingly important in the management of venous diseases, patient-reported outcomes are poised to provide the most accurate assessment of disease severity. The reported outcomes can also change following intervention and are becoming increasingly popular in the hopes that a patient-centered approach will lead to improvements in quality of healthcare. Key concepts of these measures include paying attention to the patient’s perspective, coming to a realistic assessment of the disease’s impact on the patient’s daily life, and consideration of the patient’s physical, social and psychological status. In fact, quality of life questionnaires have already been introduced in the U.K. since the early 2000s for the assessment of outcomes following elective procedures, including varicose vein treatment.4 Then the question becomes, which of the quality of life measures are important? Generally speaking, there are two categories of quality of life surveys: generic and disease-specific. Generic instruments assess the global state of well-being and provide subjective measures of treatment efficacy, which are appropriate for use across a wide spectrum of disease states. Disease-specific instruments focus on features associated with specific disease process and treatment outcomes. This, in turn, increases the sensitivity to detect trends and effects of the studied condition. For the remainder of this article, more focus will be placed on disease-specific questionnaires.
Currently, there are a number of these questionnaires in use. Most of the studies on disease-specific quality of life questionnaires have demonstrated a strong correction between them. First, Chronic Venous Insufficiency Questionnaires (CIVIQ) were first published by Launois5 in 1996, and have since been validated in many outcome studies that are specifically related to chronic venous insufficiency. There were two versions available. The first version consisted of four areas of quality of life effects—physical, psychological, social and pain. Due to the various numbers of questions in each group, generating a composite score was deemed difficult. As a result, a revised version, CIVIQ 2, was created and all the categories were weighed equally across 20 questions to provide a generalized score. Second, the Venous Insufficiency Epidemiological and Economical Study (VEINES) consisted of 36 questions in two categories to generate two scores.6 The first questionnaire, VEINES quality-of-life (VEINES-QOL), estimated the effect of the disease process on quality of life thru 26 inquiries; and the second, VEINES symptoms (VEINES-Sym), proposed 10 items to measure the extent of symptoms. Higher scores were associated with better quality of life. Both VEINES-QOL and VEINES-Sym have been proven valid and specifically detect morbidity directly attributable to chronic venous disease, not to other comorbid conditions or patient characteristics.7 Third, Aberdeen Varicose Vein Questionnaire (AVVQ) consisted of 13 questions assessing all elements of varicose vein disease. It is scored from 0 to 100, with a higher score suggesting increased severity. This has been validated against generic health surveys, such as short-form 36 (SF-36); and physician-generated measuring tools, such as the clinical-etiology-anatomy-pathology classification (CEAP) and venous clinical severity scoring (VCSS) in various treatment trials.8 Overall, it has proven specific for varicose vein-related quality of life changes.8 Fourth, the Specific Quality of Life Outcome Response – Venous (SQOR-V)9 consists of 45 items focusing on clinical features related to chronic venous insufficiency, and is completely patient-driven. It is unique in its consideration of symptoms, impairment of activities, appearance of the legs and health risk concerns. Moreover, particular attention is given to quality of life concerns in those with CEAP C0 to C3 categories. One last benefit of SQOR-V is that it’s free of charge as opposed to other questionnaires that may have fee schedules associated with their usage. Lastly, Charing Cross Venous Ulceration Questionnaire (CXVUQ) is a tool specifically used for patients with venous ulceration and has been validated in a number of trials.10,11
As the focus shifts from objective hemodynamic improvement and/or occlusion rate to one that relies on patient-reported outcomes in recent years, the American Venous Forum in 2007 published a recommended reporting standard that advocates the use of disease-specific, patientreported outcome assessments in addition to measurement of generic quality of life and clinical assessments in clinical trials.12 Moreover, in 2011, consensus documentation on clinical practice guidelines published in the Journal of Vascular Surgery gave patient–reported, disease-specific quality of life instruments a 1B recommendation.13 Overall, patient-reported outcomes have become a practice standard in the care of patients with superficial venous diseases.
Quality of Life Questionnaires (QOL) and electronic health record (EHR)
As healthcare in the U.S. transitions itself from a paperto electronic-based system, advances in information technology are the primary mechanisms in making this change a reality. The goal of any digital transfer is to promote process automation. This limits the amount of manual input, thus avoiding human error, data inconsistency and/or poor data quality. Needless to say, any form of QOL data captured is best serve with minimal manual input. Nonetheless, manual input is still required to some extent. Traditionally, completion of QOL questionnaires was recommended before treatment, at 1 month, 3 month and yearly follow-up. This timeline will truly assess the longitudinal success and QOL improvement of any form of phlebological intervention. This can be accomplished in various ways during office visits: 1) Patients report the QOL questionnaire via an EHR-linked portal and the data is then interfaced automatically with one’s EHR record using XML transmission standard such as HL7 or comma separated values (csv). 2) Patients can complete the questionnaire via kiosks, such as a desktop or laptop computer with web connection, or electronic portable devices (i.e. tablets or smart phones). After completion, the data is spontaneously uploaded to a cloud-based database and can be retrieved and analyzed on command. 3) Paper-based input by way of PDF document and scanned electronically and converted into electronic format to be digitally archived.
Once the data is archived and stored, it’s then processed, analyzed and presented in an easy-to-understand format such as a graph, table or chart to relevant users. Embedded within is the true essence of data conversion from a traditionally paper-based system into one that is digitally focused.
Conclusion
As the field of phlebology advances and moves toward standardization, adherence and anticipation of policy shift are essential to its prosperity. At this time, the focus should be shifted from one that depends solely on surrogate measures to one that emphasizes quality of life input, including patientreported outcomes. Process conversion from a paper-based system to digital data capture is the primary mechanism to ensure its overall success.
References
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