Content Validity for the VVSymQ® Instrument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms

Abstract

BackgroundVaricose veins are common and can impact patients’ quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations.ObjectiveThis research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ® instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials.MethodsThe development of the VVSymQ® instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients’ ability to understand and use the VVSymQ® instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument.ResultsFive symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI™]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ® instrument queries patients on the HASTI™ symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from “None of the time” to “All of the time,” and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients’ understanding of and their ability to use the final version of the VVSymQ® instrument.ConclusionContent validity was established for the VVSymQ® instrument, which assesses the five HASTI™ symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice.

Clinical outcomes after varicose vein procedures in octogenarians within the Vascular Quality Initiative Varicose Vein Registry

“…This is important given the overall emphasis on quality of life and patient reported outcomes in modern medicine as quality of life becomes as important of an outcome as the traditional measures of surgical outcomes, recurrence rates and complications. In addition to venous disease quality of life measures in vascular surgery 17–19 , there have been quite a few specialties that have specifically looked at QOL. 20–22 McGirt et al compared effectiveness, morbidity and quality of life following lumbar surgery in the elderly (70 years of age and older) compared to patients younger than 70 years of age.…”

Age is not a barrier to good outcomes after varicose vein procedures

“…12, 14–16 Although many overlook the significant morbidity varicose veins cause, the prevalence increases with age and increases in severity with time. 17 With all of these factors to consider, it is surprising to see such a potential gap in coverage.…”

“…PROs scores are based off of 7 components including: heaviness, achiness, swelling, throbbing, itching, appearance and impact on work. 12, 13 These are assessed on a scale 0–5 via patient survey that is given to the patient during each clinic follow up (early and late). These scores are then combined to create the overall PROs score.…”

Patient-Reported Outcome Measures in the Food and Drug Administration Pilot Compendium: Meeting Today’s Standards for Patient Engagement in Development?

“…A 2008 review by Vasquez and Munschauer [25] identified a number of quality-of-life instruments for use in vein disease; however, none of these measures examined patient satisfaction with treatment. More recently, the VVSymQ® instrument was developed with FDA Guidance serving as a framework for development; however, this measure is not included in the COA Compendium [26][27][28].…”