Lower-limb venous symptoms: combining physician and patient reporting tools






Michael A. VASQUEZ, MD
Cary MUNSCHAUER, BA
Danielle PANZA, RPA-C
Venous Institute of Buffalo
Buffalo, New York
USA

Lower-limb venous symptoms: combining physician and patient reporting tools


by M. A. Vasquez, C. Munschauer,
and D. Panza,
USA



Recent developments in the number and quality of treatment modalities have increased health provider interest in appropriate outcome assessment. Uniform outcome data are also desirable to establish medical necessity for third party payers. A valuable assessment tool will measure and stratify venous symptoms and elucidate the results of therapy. While general categories of physician-assessed or patient-reported instruments form the framework for evaluation, specific tools have emerged as valid, reproducible methods for the continuum of diagnosis, treatment, and follow-up. Physiciangenerated instruments including the clinical, etiological, anatomical, pathophysiological (CEAP) classification and Venous Clinical Severity Score (VCSS) measure objective data. The revised VCSS is now the most widely used physician- derived assessment tool in chronic venous disease. More subjective patient- reported assessments have also increased in popularity. There are four measurement tools frequently referenced in venous literature and one promising newcomer. The VEnous INsufficiency Epidemiological and economic Study—Quality of Life/Symptoms (VEINES-QoL/Sym), ChronIc Venous Insufficiency quality of life Questionnaire (CIVIQ), Aberdeen Varicose Vein Questionnaire (AVVQ), Charing Cross Venous Ulcer Questionnaire (CXVUQ), and some modifications are reviewed. The Varicose Vein Symptom Questionnaire (VVSymQ®) is introduced. The novel idea of combining physician-generated and patient-reported assessment instruments is being explored. The benefit of a combination approach to following outcomes may be a more accurate evaluation of both symptoms and treatment results in the same patient. A model that combines the elements attributed to symptoms, treatment results, and ultrasound findings may lay the framework for medical necessity and reimbursement in the future.

Medicographia. 2015;37:45-49 (see French abstract on page 49)



The number of available outcome assessment tools has increased dramatically in recent years. There is a genuine interest in following the results of the increasing modalities of treatment available. Arising with this are the demands of an increasingly restrictive payer network. The end result is a tangle of similar, yet different, assessment tools that reflect what is meant to be measured. We will attempt to sift through the currently available, validated tools for the assessment of symptoms and manifestations of chronic venous disease (CVD), focusing on instruments that evaluate the results of therapy. Beyond a systematic review of outcome assessment, we will address the predicted future value of these instruments in light of emerging therapies.


Table I
Table I. The revised Venous Clinical Severity Score (VCSS) is intuitive and easy to follow.

Before endovenous ablation (red): clinical, etiological, anatomical, pathophysiological (CEAP) classification score 4, VCSS score 7, see inset (A). After endovenous ablation (green): CEAP score 4, VCSS score 3, see inset (B).
Adapted from reference 3: Passman et al. J Vasc Surg. 2011;54:2S-9S. © 2011, Society for Vascular Surgery.


Currently available assessment tools

Things have certainly changed in the 6 years since we were first asked to write a review of outcome assessment methods in venous disease. While the two broadest categories of physician-assessed or patient-reported instruments remain, the tools available have increased and undergone further validation. They have been used in numerous studies and have benefited from increased exposure and discussion. We now have a clearer picture of the specific benefits and drawbacks of many of the instruments. We also have models for combining assessment tools to gather as much relevant information as possible from patient and physician perspectives.

With so many instruments available, one important question is how to best choose the tool to provide the desired information without it becoming cumbersome to complete and onerous to evaluate. With this in mind, many clinicians forego the generic quality of life (QoL) instruments, including the Short Form 36 (SF-36). While this survey has been well validated, it yields mainly population-based data and collective treatment results.1,2 With more attention being paid to combining physician- generated tools and patient-reported outcomes (PRO) instruments, the focus seems to have settled on combining instruments that are specific for venous disease symptoms and course of therapy.

Several physician-generated instruments are ideally suited to provide valid, reliable data on the objective criteria of venous disease. The clinical, etiological, anatomical, pathophysiological (CEAP) classification and Venous Clinical Severity Score (VCSS) both provide measurement of clinical parameters in the progression of venous disease (Table I).3 CEAP is foremost only a classification tool and a less responsive periprocedural representation of CVD. The revised VCSS is a more dynamic representation of the course of venous disease through serial reporting.3 Both of these instruments have gained acceptance due to the common descriptive platforms they provide and their ease of use. Both also have strong recommendations for use in the clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. The CEAP classification is not to be used to assess treatment results as a stand-alone tool. CEAP has limited responsiveness to changes in condition with therapy, especially at the C4 and C5 levels. The original VCSS was criticized early on for the precision of language used and the degree of interobserver variability. The VCSS was revised in 2010, and has been widely regarded as improved in specificity of language, nomenclature, and observer variability, especially with regards to pigmentation change. It is intuitive and is now the most widely used physician-derived venous score to date, and has been incorporated into European and American venous registries. It is made readily available on the American Venous Forum Web site. There remains debate about whether the VCSS should include the largely subjective category of compression therapy use, and this may be addressed in future revisions.1,3





Patient-reported, venous disease–specific outcome-reporting tools have gained popularity recently as a subjective measure of the benefits of therapy.2 The five assessments that we encounter most often are the VEnous INsufficiency Epidemiological and Economic Study—Quality of Life/Symptoms (VEINES-QoL/Sym), the ChronIc Venous Insufficiency quality of life Questionnaire (CIVIQ), the Aberdeen Varicose Vein Questionnaire (AVVQ), the Charing Cross Venous Ulceration Questionnaire (CXVUQ)1 and the VVSymQ® Score (Varicose Vein Symptom Questionnaire). All of these PRO instruments are focused primarily on symptoms as opposed to assessing or comparing therapies. As they measure symptoms at a given point in time, they are effective measures for evaluating the effects of treatment.


Table II
Table II. Dimensions and items used in the ChronIc Venous Insufficiency
quality of life Questionnaire (CIVIQ)-20.

After reference 5: Pitsch F. http://www.civiq-20.com/?page_id=45. © 2014,
Les Laboratoires Servier.



CIVIQ has been validated and is used effectively as a global measure of venous disease. Some critics have said that it does not address the specific manifestations of venous disease, but is more valuable in the overall assessment of venous disease.1 However, CIVIQ has been linguistically validated in 17 versions.4 There are two versions of CIVIQ: the CIVIQ-14 and the CIVIQ-20. For CIVIQ-20, patient-generated reports of signs and symptoms of venous disease were specifically used to generate the questionnaire. The final 20-item questionnaire shows a comprehensive collection of relevant parameters: pain, physical, psychological, and social (Table II).5 Patient recall of symptoms was set at 4 weeks.

CIVIQ-20 was felt to be incomplete in assessing social factors in divergent populations, so a new questionnaire, the CIVIQ-14 was developed, which combined social factors with pain to yield three categories: pain, physical, and psychological (Table III, page 48).5 This questionnaire was validated across international lines.


Table III
Table III. Dimensions and items used in the ChronIc Venous Insufficiency
quality of life Questionnaire (CIVIQ)–14.

After reference 5: Pitsch F. http://www.civiq-20.com/?page_id=45. © 2014,
Les Laboratoires Servier.



The issues addressed in the CIVIQ questionnaire assess patients across the spectrum of venous disease, through to C6, although CIVIQ-20 targets C0 to C4. Patients with ulcers are excluded, since factors relevant to patients in the earlier stages of chronic vascular disease may not be relevant to patients with ulceration, including questions relating to participation in sports or limitations on social activities. CIVIQ-20 showed a strong ability to track changes following therapy. This has been validated through its use in comparing treatment methods and conservative therapies.5

VEINES-QoL/Sym is applicable in a wide range of clinical conditions. It focuses on the underlying condition and changes in associated symptoms, not on the therapy itself. It has proven useful in elucidating symptomatic changes in studies utilizing multiple treatments. However, because it focuses on diagnostic elements, it is difficult to assess change in response to a specific therapy. Also, there is less focus on anatomic and physiologic elements, which also might clarify beneficial treatment options.1

AVVQ considers all elements of venous disease, including cosmetic manifestations. Because of this wide-reaching approach, AVVQ is useful in many applications and in consideration of many venous disease findings. However, because of this wide focus, it lacks some sensitivity in elucidating change over time in individual patients, especially those with milder disease.1

CXVUQ is an instrument that considers venous stasis ulcers and their course. Because of its specific focus, it is a consistent measure of QoL factors in patients with venous ulcers, regardless of the treatment option selected. However, largely because of this specificity, in order for CXVUQ to give a complete venous disease assessment in patients with ulcers it probably needs to be combined with a traditional clinical outcome measure or a generic instrument.1

The new kid on the block is the VVSymQ® Score. It is a symptom- focused PRO instrument that was designed to evaluate the symptom burden of varicose veins before and after treatment of the great saphenous vein in the BTG Varithena® (polidocanol injectable foam) randomized controlled trials. In fact, it is the only PRO instrument that meets the exacting standards set out in the US Food and Drug Administration (FDA) guidance document titled Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.6 The VVSymQ® score is based on daily patient assessment of the varicose vein symptoms determined through research to be most important to patients: heaviness, achiness, swelling, throbbing, and itching (Table IV).7

There is a demonstrated intercorrelation with known instruments such as the VCSS, VEINES-QoL, and CIVIQ-20. In the Varithena® trials, VVSymQ®, VCSS, and VEINES-QoL were highly sensitive to change.7 The moderate correlation with VCSS seems to indicate that both instruments measure different aspects of the same disease. This falls in line with our understanding of the complementary nature of physician-generated and patient-reported tools.

The VVSymQ® Score is captured via a 7-day electronic daily diary. This proved valuable in allowing proper completion of the questionnaire without outside influence. However, the 7-day coverage period may be problematic for patients without electronic skills or for physicians with busy practices. Additionally, the VVSymQ® is proprietary to BTG and not as yet available for broader use.

With regards to venoactive drug use in a patient with CVD, key assessment tools have been used to assess efficacy. The most commonly used include CIVIQ-14, CIVIQ-20, and the 10-point Visual Analog Scale (VAS) which assesses pain intensity. CEAP has been used to classify patients in these studies. The revised VCSS has not been directly used with venoactive drugs to date. The investigators of the studies found that the use of valid, reliable assessment tools was very useful in determining both the clinical effect of venoactive drug therapy and to measure the QoL of a venous disease patient using venoactive drug therapy.8,9


Table IV
Table IV. Dimensions
and items used in the
Varicose Vein Symptom
Questionnaire
(VVSymQ®).

Data from reference 7.



One thought-provoking combined study, the DECISION study, evaluated whether the addition of micronized purified flavonoid fraction (MPFF) to patients undergoing endovenous treatment for varicose veins of the lower extremities improves postoperative symptoms and signs of CVD and patient QoL.10 They found that the “reduction inVCSS score during the first2weeks after the endovenous procedure was significantly greater in the MPFF group compared with the control group.” The reason for this is not entirely clear and elicits further questions. What changes would be seen if MPFF were used along with medical compression? A valid alternative may be offered for those patients with symptomatic deep reflux or postthrombotic syndrome.

Conclusion

There are a range of valid, reliable assessment instruments to measure CVD symptoms and results of treatment. New modalities of treatment are ever present. Comparison of ablation outcomes is best performed when the same outcome measures are used no matter what the mode of treatment. Physician assessment and patient self-assessment serve complementary functions and should be combined to provide a more accurate clinical scenario. We will even go so far as to profess that a combined scoring system, inclusive of duplex findings, would be a preferred manner to establish medical necessity for those considering treatment and insurance reimbursement.


References
1. Vasquez MA, Munschauer CE. Venous Clinical Severity Score and quality-oflife assessment tools: application to vein practice. Phlebology. 2008;23(6):259.
2. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53:2S-48S.
3. Passman MA, McLafferty RB, Lentz MF, et al. Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American Venous Forum, National Venous Screening Program. J Vasc Surg. 2011;54: 2S-9S.
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5. Pitsch F. CIVIQ Domains. The CIVIQ-20 Users’ Guide. http://www.civiq-20.com/ ?page_id=45. Accessed June 2, 2014.
6. United States Food and Drug Administration. Guidance for Industry. Patient- Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM193282.pdf. Accessed August 25, 2014.
7. Paty J. VVSymQ and patient profiles: interpreting a new patient-reported outcome (PRO) instrument for great saphenous vein incompetence (GSVI). J Vasc Interv Radiol. 2014;25(3 suppl):S101.
8. Yanushko VA, Bayeshko AA, Sushkov SA, Nebylitsyn YS, Nazaruk AM. Benefits of MPFF on primary chronic venous disease-related symptoms and quality of life: the DELTA study. Phlebolymphology. 2014;21(3):146-151.
9. Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assessment and quality of life improvement with micronized flavonoids. Angiology. 2002;53:245-256.
10. Bogachev VY, Golovanova OV, Kuznetsov AN, Sheokyan AO; DECISION Investigators group. Can micronized purified flavonoid fraction (MPFF) improve outcomes of lower extremity varicose vein endovenous treatment? First results from the DECISION study. Phlebolymphology. 2013;20(4):181-187.


Keywords: CEAP; chronic venous disease; CIVIQ; CXVUQ; lower limb; VCSS; venous symptom