Assessing compliance with nonoperative treatments of chronic venous disorders: the VEIN Act Program in Romania



by D. E. Brani s teanu, Romania

Daciana Elena BRANISTEANU,
MD, PhD
Medical and Pharmaceutical
University, Iasi
ROMANIA

Compliance with nonoperative treatments for chronic venous disorders (CVDs) has been poorly studied. The Romanian arm of the VEIN Act Program (VEnous dIsorders maNagement and evaluAtion of Chronic venous disease treatment effecTiveness program), an international, observational, prospective, multicenter study, assessed compliance with and the effects of nonsurgical CVD treatments (lifestyle advice, venoactive drugs and compression therapy) in symptomatic patients. Adult patients complaining of venous pain and/or signs and seeking treatment for a CVD underwent a leg examination during ordinary consultations. Following diagnostic confirmation of CVD, the patient’s clinical presentation and history, symptoms, and prescribed nonsurgical treatment(s) were noted. Compliance with treatment, treatment effect, and patient satisfaction were assessed in a follow-up consultation. Nearly two-thirds (64%) of 2444 Romanian CVD outpatients (1816 female, 608 male) were in CEAP stages C3 to C6, and very few presented with symptoms only (C0s; 3%) or mild signs (C1; 16%). Nearly all patients were prescribed a treatment (99.6%); 42% a combination of lifestyle advice, venoactive drugs, and compression therapy; and 42% venoactive drugs and advice. At the follow- up visit, 99%, 92%, and 30% of patients reported being compliant with venoactive drug prescription, lifestyle advice, and compression therapy, respectively. Most patients prescribed compression therapy did not wear it daily; 24% wore hosiery most days, 27% intermittently, and 19% not at all. At the follow-up visit, 42% were wearing their hosiery incorrectly. The Vein Act Program detected several factors that influence patient compliance with CVD treatment, and this information could help educate physicians and patients about better ways to manage CVD.

Medicographia. 2016;38:175-180 (see French abstract on page 180)

The international VEIN Act program (VEnous dIsorders maNagement and evaluAtion of Chronic venous disease treatment effecTiveness program), carried out under the auspices of the European Venous Forum, was designed to assess compliance with nonoperative treatments (lifestyle advice, venoactive drugs, and compression therapy) for chronic venous disorders (CVDs) in ordinary specialized consultations. The present report focuses on the Romanian arm of the VEIN Act Program, whose primary objective was to assess compliance with nonoperative treatments of CVD in Romania. Its secondary objective was to assess the effects of nonoperative treatments in terms of symptom improvement, improvement in daily activity level, and patient satisfaction.

Methods

The Romanian VEIN Act program is a prospective, multicenter, observational survey. Patients who consulted a doctor for any CVD-related clinical presentation and who complained of pain in the lower limbs were eligible for participation in the study. VEIN Act was conducted in accordance with the principles of the 7th revision of the Declaration of Helsinki (Seoul 2008). Patients were informed and verbal and written consents for participation in the study were obtained. Screening for inclusion in the program was carried out using the following set criteria: age over 18 years (male or female), not currently treated for CVD, not consulting for an emergencyor for the acute episode of an ongoing condition, and free of any concomitant disease that might interfere with venous treatment. Patients who met these criteria were asked about venous signs and symptoms and then underwent a leg examination. If they presented with at least one venous symptom or venous sign, or both, the following information was collected: clinical presentation, clinical history, presence of CVD signs and/or symptoms, and nonoperative treatment prescribed (including all treatment characteristics). They were asked to come back for a follow-up visit during which compliance, treatment effects, and patient satisfaction were assessed. In those patients who were noncompliant the reasons for noncompliance were sought.

Characterization of CVD symptoms and signs
The Vein Consult Program identified four symptoms of CVD (“heavy” legs, leg pain, a swelling sensation, and cramps) and three main circumstances of onset (after prolonged standing, at the end of the day, during the night).1 At least two of these three aggravating factors had to be present to confirm that the symptoms reported by the patients were actually related to CVD. The presence of signs such as those described in the clinical section of the clinical, etiological, anatomical, pathophysiological (CEAP) classification were noted and used to assign patients to the correct CEAP class (C0: no visible signs; C1: telangiectasias, reticular veins; C2: varicose veins/C3: edema/ C4a: Skin changes, angiodermatitis/C4b: Skin changes, atrophie blanche/C5: Healed ulcer/C6: Active ulcer).2

Figure 1. Symptoms reported at inclusion by patients of the Romanian arm of the
VEIN Act Program.

Assessment of chronic venous disorder symptoms
Patients were asked to assess the intensity of their symptoms using a visual analogue scale (VAS) and to report their frequency with a 5-point verbal scale (0=never, 1=rarely; 2=occasionally; 3=regularly; 4=all day and night).

Results

Enrollment in the VEIN Act program
The Romanian arm of the VEIN Act program took place between December 2013 and September 2014 and involved 248 investigators from the Romanian health care system. These physicians came from a wide range of medical specialties and included general practitioners, dermatologists, internists, vascular surgeons, rheumatologists, rehabilitation physicians, and gastroenterologists. A total of 2496 patients were enrolled at V0, and 2444 patients returned for the followup visit (V1). The mean time between inclusion visits (V0) and follow-up visits (V1) was 88 days, ie, approximately 3 months. There was no statistical difference between men and women regarding the interval between visits (P=0.97).

Patient characteristics at V0
Participants were predominantly female (74.9%), had a mean age of 56.1±14.1 years, and were overweight (BMI 27.67± 5.13 kg/m2). Most of them were in the 50-59 years age group (29% of women and 29% of men).

Symptoms of CVD
Symptoms were present in 96.1% of patients, and at least 91.2% of them reported having symptoms over the previous 4 weeks. In order of decreasing frequency the symptoms re- ported were: heaviness (91.2%), sensation of swelling (81.6%), leg pain (75.2%), and cramps (52.7%). Patients complained of 3±1 symptoms on average. Average symptom intensity was 5.4 cm on the VAS. Women reported symptoms more frequently than men (97% in women, vs 95% in men, P=0.028), in particular “heaviness,” albeit at a lower intensity (5.3 cm in women vs 5.4 cm in men) (Figure 1). Symptoms were experienced “regularly” in 70% of patients and “occasionally, rarely or never” in 30% of cases, and were more intense at the end of the day (83%) and after prolonged standing (82%). The prevalence of local pain and cramps over the previous 4 weeks increased with age in females, but not in males. Symptom intensity increased with both increasing BMI and increasing CEAP class in both sexes. The frequency of symptoms also increased with age.

Figure 2. Self-reported signs at inclusion in the Romanian arm of the VEIN Act
Program.

Self-reported signs of CVD
Telangiectasias were reported in 80% of cases, edema in 62%, and varicose veins in 61%. There was no difference according to sex for edema (P=0.0084) and telangiectasias (P=0.0028), but more men than women sought treatment for varicose veins (72% in men vs 57% in women; P<0.0001); this was also the case for skin changes (35% in men vs 17% in women, P<0.0001) and venous leg ulcers (12% in men vs 2% in women, P<0.0001) (Figure 2).

Physician-reported signs (CEAP classification)
Most patients seeking treatment had chronic venous insufficiency and were assigned to high CEAP classes: C3, 38.6%; C4 (skin changes), 21%, and C5-C6 (venous leg ulcer, 4%), while there were fewer patients in mild stages: C0s, 3%; C1, 16.2%; and C2, 15.3% (Figure 3). In the C1 and C2 classes, most patients were under 34 years old, while patients in the C3 to C6 classes were older and had a higher BMI.

Treatment for CVD
A total of 551 patients (22.7%) reported that they had previously consulted a physician for venous leg problems (68.4% women and 31.6% men), but only 328 patients (13.5%) had received a treatment (69.5% women and 30.5% men). These figures significantly increased with older age, and increasing BMI, symptom intensity, and CEAP class, regardless of sex (<0.0001). Nearly all patients (99.6%) who consulted for leg problems at V0 were prescribed a treatment, irrespective of their CEAP clinical class, including those in C0s (P=NS). Approximately 40% of them (42.4%) were prescribed a treatment combining lifestyle advice, venoactive drugs, and compression therapy, and another 41.9% were prescribed a combination of venoactive drugs and advice. A few patients were prescribed a single treatment (<1%). The type and combination of treatments did not vary according to the patient profile.

Most of the 51.4% of patients who were prescribed compression therapy were prescribed “mild” compression (15-22 mm Hg; 34.0%) and “moderate” compression (23-32 mm Hg; 38.6%). Stockings (85.3%), particularly at thigh level (52%), were preferred to bandages. Most patients were prescribed compression therapy for more than 12 weeks.

Figure 3. Distribution by CEAP class at inclusion (V0) in the Romanian arm of the
VEIN Act Program.
Abbreviations: CEAP, clinical, etiological, anatomical, pathophysiological [classification].

Figure 4.
Reasons for
noncompliance
to compression
therapy stratified
by sex.

Assessment of compliance to treatment at V1
♦ Venoactive drugs and lifestyle advice

Analysis of treatment compliance revealed that 99% of patients followed their prescription for venoactive drugs in terms of trade name, posology, and treatment duration, and that 92% followed the lifestyle advice they were given. The reasons evoked by patients for not taking the recommended venoactive drugs were “I forgot” or “I took another drug.” In general, older patients were more likely to switch to another drug (P<0.0001). The reasons given by patients for not following lifestyle advice were “lack of time” (49%), “too difficult to follow” (47%), and “ineffective” (4%). There were no differences according to sex, age, BMI, CEAP class, or symptom intensity.

Compression therapy
Just over three-quarters of patients (77%) purchased the strength of compression hosiery they were prescribed. The remaining 23%, who did not buy the prescribed strength, gave the following reasons: “unavailability at the place of purchase” (14%), and “switched to a different strength by the pharmacist” (5%), but most patients gave no reason (83%).

Only 58% of the patients who had been prescribed compression therapy attended the follow-up appointment wearing the compression hosiery correctly, and 30% reported that they had worn the hosiery as prescribed. A majority of patients (70%) wore hosiery either most days (24%), or intermittently (27%), or did not wear it at all (19%). A significant percentage of patients (42%) did not use the recommended compression therapy. Their reasons for not wearing compression hosiery were that they found it “uncomfortable” (48%), “too difficult to put on” (35%), “too hot” (22%), “itchy” (21%), “unattractive” (13%), or “ineffective” (2%) (Figure 4).

Compliance with compression therapy differed according to sex, age, BMI, and symptom intensity. Most women preferred mild compression (37% of women vs 20% of men), while men preferred moderate and strong compression (80% of men vs 63% of women). Women felt that the stockings were unattractive, while men found them too hot. Young patients preferentially bought mild-strength stockings (P<0.0001). In young people noncompliance was related to the perceived unattractiveness or discomfort of wearing stockings, while older patients and those with advanced CVD (CEAP classes C3-C6) complained of having difficulty in putting the hosiery on. Patients with mild symptoms bought light-compression stockings, and those with advanced symptoms purchased moderate- and strong-compression stockings (P<0.0001), which they found difficult to put on (P=0.03).

Discussion

CVD is often underdiagnosed by doctors and neglected by patients, which is why the cost of care for patients with CVD is very high (particularly in severe stages), accounting for at least 2% to 3% of community health care budgets.3,4 CVD is a chronic, progressive, and debilitating disease; greater patient compliance with prescribed treatments and early diagnosis are key in controlling its progression and improving the quality of life for patients.5,6 Findings from the VEIN Act program have confirmed that although CVD affects millions of people worldwide, it is still underdiagnosed and dismissed by some patients despite its negative impact on the quality of life.7-10

The Russian arm of the VEIN Act program found that a very small percentage of patients diagnosed with CVD prior to enrollment had been prescribed a treatment.11 Similarly, in our study, 551 patients (22.7%) reported having made at least one visit to a doctor for CVD-related problems prior to entering the study, though only 328 patients (13.5%) had received a treatment. This was also the case in the RELIEF study (Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids), which found that a very low percentage (21.8%) of the intention-to-treat (ITT) population had previously been treated, despite showing obvious symptoms of chronic venous disorders.12 These findings confirm the fact that some patients underestimate CVD and that their compliance with treatment is poor.13 Therefore, more efforts are required to increase public awareness about the chronic, progressive, and potentially disabling nature of CVD, and patients should be reminded that only a correct diagnosis and prompt treatment initiation can control the disease and prevent its progression to more severe stages.2,14,15

Findings from the VEIN Act program show that very few CVD patients (3.3%) are diagnosed in CEAP class C0s, and that most patients are diagnosed in stage C3 (38.6%).16 Similarly, the Vein Consult Program has showed that CVD is most often diagnosed when patients are in the advanced stages of the disease.17 These findings emphasize the need for a sustained effort to actively detect CVD and—why not—provide additional training for both GPs and specialists, so that therapeutic decisions can be made in the early stages of CVD. One of the risk factors for CVD is obesity. The Romanian arm of the VEIN Act Program has identified a significant positive correlation between BMI and incidence of CVD, especially for severe stages of the disease. Multiple studies have shown that patients with a high BMI tend to have a higher risk of CVD and leg ulcers.1,18 The VEIN Act program has also identified a strong correlation between BMI and the time needed to obtain symptom relief with venoactive drugs.19 Little is known about how obesity affects the management of CVD. A recently published study carried out in obese patients concluded that the treatment of CVD is affected by BMI and class II obesity (ie, BMI between 35.0 and 39.9), and that morbidly obese CVD patients are less compliant with compression therapy but are willing to undergo surgical procedures and use topical agents.19,20 Another question is whether the usual doses of venoactive drugs are sufficient for CVD patients with a very high BMI. It is important to emphasize that in obese CVD patients, lifestyle changes and weight loss are imperatively recommended in addition to long-term venoactive treatment.18

Short-term treatment with venoactive drugs may be responsible for their low therapeutic efficacy and the occurrence of CVD complications.13,14 Thus, incomplete control of the signs and symptoms of CVD could be responsible for both the progression to severe stages and a decrease in quality of life and, consequently, poor patient compliance with the recommended treatments.5 Therefore, it may prove useful to promote awareness among physicians of the potentially detrimental effects of prescribing venoactive drugs for too short a period of time.

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Keywords: chronic venous disorders; compliance; compression therapy; venoactive drugs