ARTICLE
Auteur(s) : Ivana Dunić1, Ljiljana
Medenica2, Branko Bobić3, Olgica
Djurković-Djaković3
1Department for Prevention and Treatment
of Peripheral Vascular Diseases, City Service
for Dermatology and Venereology, Džordža Vašingtona 17,
11000 Belgrade, Serbia
2Institute of Dermatovenereology, School
of Medicine, University of Belgrade, Pasterova 2, 11000
Belgrade, Serbia
3Institute for Medical Research, University
of Belgrade, Dr Subotića 4, Belgrade, Serbia
accepté le 22 Juillet 2009
Chronic venous disease (CVD) is a common chronic disabling
condition. If skin changes have appeared, CVD has progressed to
chronic venous insufficiency (CVI). While CVD affects a significant
proportion of the global population, data on the prevalence vary
considerably, depending on whether studies looked at all CVD signs
or only CVI. The initial signs of visible veins are reported to
occur in up to 80% while leg ulcers, as a terminal stage, occur in
1-2% of the adult population worldwide [1-5].
To allow for objective evaluation of CVD, the CEAP
classification, based on clinical (C), etiological (E), anatomical
(A) and pathophysiological (P) criteria for staging CVD, was
proposed in 1995, and updated and adapted several times thereafter
[6-8]. The C criteria are based upon objective and subjective
clinical signs of CVD (table 1).
CVD has been reported to have a substantial effect on patients’
QoL [9-12]. One instrument to assess the QoL is the Medical
Outcomes Study 36-item short-form (SF-36), constructed for use in
clinical practice and research [13], and currently considered the
generic gold standard measure of QoL [14]. It includes 36 questions
which assess eight health dimensions: physical functioning – PF;
limitations in usual role activities due to physical health
problems – RP; bodily pain – BP; general health – GH; vitality –
VT; social functioning – SF; limitations in usual role activities
due to emotional problems – RE; and mental health – MH.
No study of the QoL of patients with CVD has ever been performed
in Serbia. We thus correlated the SF-36 scores with the CEAP
clinical stage in a series of Serbian CVD patients.
Materials and methods
A cross-sectional study of consecutive patients with CVD at
different stages of the disease who visited the Department for
Prevention and Treatment of Peripheral Vascular Diseases at the
City Service for Dermatology and Venereology in Belgrade was
conducted between 1 October 2007 and 30 June 2008. The exclusion
criteria consisted of concurrent rheumatological and/or
neurological disease impairing mobility or mimicking venous
disease. Evaluation of each patient consisted of socio-demographic
and clinical data, obtained by physical examination and a
standardized interview. In addition, the interview included
CVD-specific information (specified below). Patients who failed to
respond to some question(s) were also excluded from the study
group. Thus, the final patient series involved 570 patients who all
gave written consent to participate, and the study was approved by
the Ethics Committee of the School of Medicine, University of
Belgrade.
Patients underwent a clinical examination of the lower legs to
establish the CEAP C class (C1-C6) (table
1). The etiological (E) criteria were assessed by patient
responses on personal and family clinical history. The anatomical
(A) and pathophysiological (P) criteria were not assessed because
not all patients underwent duplex ultrasound scanning.
After physical examination all patients received the Serbian
translation of SF-36 [15] and were asked to fill it out by
themselves. All responses were scored as recommended [16], with
lower scores indicating poorer QoL.
Disease-specific information included aesthetic concerns and
treatment costs due to CVD. Aesthetic concerns were recorded in
dichotomous form (yes/no); in case of a positive response, whether
they caused covering of legs with clothes (yes/no), and caused
problems with intimacy (yes/no). Since the health insurance system
in Serbia as of the early nineties does not cover the costs of CVD
treatment options (drugs, stockings, surgical procedures for
non-life-threatening conditions), treatment costs were recorded as
unimportant (non-existent or low) or important (high).
Table 1 Clinical classification according to 2004
revised CEAP [8]
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C0: no visible or palpable signs of venous disease
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C1: teleangiectases or reticular veins
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C2: varicose veins
|
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C3: edema without skin changes
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C4a: pigmentation and/or eczema
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C4b: lipodermatosclerosis and/or atrophie blanche
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C5: healed venous ulcer
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C6: active venous ulcer
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Statistics
All data were analyzed using a SPSS 10.0 statistical package.
Categorical variables such as gender, or disease-specific
questionnaire components among classes were analyzed by chi square
and Fisher exact test, as appropriate. One way ANOVA and Spearman’s
rank correlation were used to analyze the differences between mean
QoL dimension scores among CEAP classes, and between genders and
mean age per gender in each class. The level of significance was
.05.
Results
The demographic and clinical characteristics of a series of 570
patients are presented in table 2.
Almost 80% of the patients were female. The mean age of all
patients was 61 ± 13.7 years, similar for both genders (p = 0.247);
furthermore, there were no gender differences either in the
duration of CVD (p = 0.111) or time after first treatment (p =
0.302). According to the clinical evaluation results, all patients
were classified into classes C1-C6. Classes C1 and C2 included
patients in the early stages of CVD (11.2%), C3 and C4 those in
advanced stages (74.4%), and C5 and C6 included patients in the
terminal stages of CVD (14.3%). Although women were generally
overrepresented, and predominant in classes C1-4, the number of
male and female patients in the terminal stages was similar.
C1 patients had reticular veins, with or without subjective
symptoms of CVD such as restless or heavy legs, night cramps,
feeling of warmth, etc. In addition to these manifestations, C2
patients all had varicose veins, while one patient reported leg
thrombosis, and three had vascular aesthetic operations. Class 3
patients were characterized by the presence of edema of the legs,
while serious edema of the lymphedema type was noted in 1.4%
patients. Thromboses were reported by 15.2% patients (p = 0.016 vs.
C2). In the C4 patients, characterized by skin changes, lymphedema
was more prevalent (8.1%, p = 0.001 vs. C3), while
dermoliposclerosis occurred in 15.5%. Thromboses were reported by
23.6% patients (p < 0.05 vs. C1, C2 and C3). A similar
proportion of C3 and C4 patients had undergone vascular surgery
(8.3% and 10.1%, respectively). In the C5 and C6 patients,
characterized by the presence of healed and active ulcers,
respectively, the frequency of both thromboses and vascular
operations was significantly (p < 0.05) higher than in C1, C2
and C3, but not (p > 0.05) than in C4 patients.
The mean scores of the SF-36 are presented in table 3. Class 1 patients, as expected, had the
highest SF-36 score in all eight dimensions. Compared with these,
C2 patients had a significant (p = 0.000) reduction in the
dimensions of GH and VT. In C3 patients, all Qol dimensions were
reduced as compared to C1 and C2 patients, with the reductions
reaching significance in the physical dimensions (PF and RP), GH,
VT and MH (p < 0.05). These dimensions were further reduced in
C4 patients (p < 0.05 vs. C1, C2 and C3), which also had a
significantly decreased BP score (p = 0.021 vs. C2, and p = 0.002
vs. C3). As expected, C5 and C6 patients had the highest reduction
of Qol, with C6 scoring lower than C5 patients in all dimensions,
except for BP and SF. QoL items found to be reduced in C3 and C4
vs. C1 and C2 (physical dimensions, GH, VT and MH) were further
significantly (p < 0.05) reduced in both C5 and C6 patients vs.
all classes. However, as compared to C4 patients, the BP score was
increased in the terminal stage patients, but significantly (p =
0.032) only in C6 patients. On the other hand, the SF and RE
dimensions varied among all patient classes only slightly (p >
0.05). Importantly, analysis of all QoL dimension scores according
to gender and age showed virtually no gender or age-related
differences (p > 0.05) in any dimension across classes, except
in C1 where women who scored marginally lower in the BP, SF and RE
dimensions (p = 0.057, p = 0.05 and p = 0.05, respectively) were
significantly younger than men.
The disease-specific questionnaire (table
4) revealed that the frequency of unease due to appearance
was significantly (p = 0.044) higher in C2 than in C1 patients, but
this did not result in increased covering of legs or problems with
intimacy. None of these items differed in C3 in comparison with C1
and C2 patients. In contrast, aesthetic concerns became significant
in parallel with the appearance of skin changes, i.e., more than
half of C4 patients reported unease due to appearance (p < 0.05
vs. C1, C2 and C3) and increased covering of legs with clothes (p
< 0.01 vs. C1, C2 and C3). Also, intimacy problems were first
reported at this stage (p = 0.006 vs. C3). Aesthetic concerns were,
as expected, more prevalent in C6 than in C5 patients. The
treatment costs were perceived by most patients as important in the
early stages of CVD, but became significantly more so after the
appearance of skin changes (in C4-C6 patients). None of these
results were gender-related (p > 0.05).
Table 2 Demographic and clinical characteristics of a
series of 570 patients with CVD
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No.
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(%)
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P
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Age, years [mean ± SD (range)]
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|
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Female (n = 455)
|
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60.64 ± 13.56 (17-93)
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0.247
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Male (n = 115)
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62.30 ± 14.42 (19-85)
|
|
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Age, years since onset of CVD (mean ± SD)
|
|
|
|
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Female
|
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29.93 ± 12.13
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0.111
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Male
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35.46 ± 17.06
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|
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Age, years at first treatment (mean ± SD)
|
|
|
|
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Female
|
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48.19 ± 16.35
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0.302
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Male
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50.48 ± 18.00
|
|
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CEAP clinical class C1 (n = 17) Female
|
15
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88.2%
|
0.017
|
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C2 (n = 47) Female
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35
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74.5%
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0.015
|
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C3 (n = 276) Female
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248
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89.9%
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0.000
|
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C4 (n=148) Female
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110
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74.3%
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0.000
|
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C5 (n = 38) Female
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22
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57.9%
|
0.490
|
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C6 (n = 44) Female
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25
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56.8%
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0.521
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Vein thromboses of legs
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95
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16.7%
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|
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Female
|
69
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72.6%
|
0.056
|
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Vascular operations
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52
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9.1%
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|
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Female
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38
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73.1%
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0.203
|
Table 3 The eight dimensions of the quality of life as
assessed by SF-36 (mean ± SD) according to CEAP C class
|
Class (No. patients)
|
PF
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RP
|
BP
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GH
|
VT
|
SF
|
RE
|
MH
|
|
C1 (n = 17)
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79.12 ± 22.10
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57.94 ± 30.31
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61.57 ± 36.87
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94.12 ± 17.66
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88.82 ± 18.39
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78.59 ± 31.45
|
69.22 ± 30.10
|
94.41 ± 14.29
|
|
C2 (n = 47)
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77.02 ± 26.43
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48.23 ± 28.32
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58.44 ± 31.01
|
81.72 a ± 14.05
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70.21 a ± 16.74
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72.77 ± 38.84
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58.26 ± 31.27
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94.66 ± 13.27
|
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C3 (n = 276)
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65.68 a,b ± 12.75
|
47.79 a’ ± 19.14
|
54.00 ± 30.42
|
76.69 a, b ± 17.85
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75.48 a, b ± 17.93
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67.19 ± 32.80
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61.75 ± 25.89
|
89.23 a’,b ± 19.83
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C4 (n = 148)
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60.68 a, b, c ± 19.02
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39.63 a, b’, c ± 23.77
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42.77 b’, c ± 33.33
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67.90 a, c ± 14.10
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69.03 a, b, c ± 15.29
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73.75 ± 27.73
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62.59 ± 30.91
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83.41 a, b, c ± 14.02
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C5 (n = 38)
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56.21a, b, c ± 24.44
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40.37 a, c’ ± 15.30
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49.91 ± 29.81
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49.71a, b, c,d ± 13.14
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53.63 a, b, c, d ± 14.88
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61.84 ± 28.41
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60.83 ± 30.91
|
61.49 a, b, c, d ± 14.98
|
|
C6 (n = 44)
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54.55 a, b,c, d’ ± 28.07
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26.91 a, b, c, d, e ± 14.98
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57.67 d’ ± 28.60
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43.11 a,b, c, d, e ± 14.90
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45.73 a, b, c, d, e ± 11.73
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68.32 ± 29.98
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57.71 ± 28.62
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59.36 a, b, c, d ± 15.46
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Table 4 CVD-specific items according to CEAP C class
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Aesthetic concerns No. (%)
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Treatment costs No. (%)
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Class (No. patients)
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Unease due to appearance
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Covering legs
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Intimacy problems
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Important
|
|
C1 (n = 17) C2 (n = 47)
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2 (11.8%) 18 (38.3%) a’
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3 (17.6%) 13 (27.7%)
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0 (0%) 0 (0%)
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12 (70.6%) 33 (70.2%)
|
|
C3 (n = 276) C4 (n = 148)
|
77 (27.9%) 86 (58.1%) a, b’, c
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76 (27.5%) 98 (66.2%) a, b, c
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0 (0%) 4 (2.7%) c
|
216 (78.3%) 145 (98%) a, b, c
|
|
C5 (n = 38) C6 (n = 44)
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12 (31.6%) d 26 (59.1%) a, b’, c,
e’
|
9 (23.7%) d 32 (72.2%) a, b, c,
e
|
1 (2.6%) c 1 (2.3%) c’
|
30 (78.9%) d 43 (97.7%) a, b, c,
e
|
Discussion
The relationship between QoL dimension scores assessed by SF-36 and
the clinical CEAP class shown in several studies performed in the
past decade reflects the progressive nature of CVD [17-21]. This
first study of the QoL in CVD patients in Serbia also showed a
gradual reduction of QoL with the advancement of the disease,
irrespective of gender and age. Significant reductions were found
in the physical dimensions (PF, RP), GH, VT and MH. However, the BP
score gradually decreased from C1 to C4, but increased thereafter
(in C5 and C6). The highest perception of pain in C4 patients may
be attributed to the occurrence of dermatoliposclerosis and
atrophie blanche. The subsequent increase in the BP score in C5 and
C6 patients reflects the appearance of venous ulcers which are
seldom associated with pain, but may also be attributed to a
certain level of adaptation to physical sensations including pain
during the long course of CVD. In contrast, the finding of little
variation in the RE and SF scores across groups is interesting in
view of a clear reduction in the MH score. Since both SF and RE
already had (comparatively) lower values in early stage patients,
this finding may suggest that CVD patients at all stages have a
secret fear for their health progression.
Interestingly, in an Italian pilot study [19], the RE was
dominant, while in the San Diego population study [10], no
significance for the mental components was found. In our patient
series, however, MH was significantly reduced; differences in the
mental component scores among studies performed in different
geographical areas may reflect differences in the perception of
disease among populations with different cultural, ethnic and
environmental backgrounds [19].
The results obtained by the disease-specific questionnaire may
help interpret the above results. While the patients in our series
increasingly acknowledged aesthetic concerns with the advance of
the disease, aesthetic aspects did not appear to be dominant, given
the small variation demonstrated in the SF-36 RE and SF dimensions.
Quite the contrary, the early involvement of the physical
dimensions, also shown in the Italian pilot study [19], was
interpreted to suggest that patients perceive CVD as a disease and
not merely a cosmetic problem.
On the other hand, treatment costs did represent a major
concern. Although treatment costs were assessed as particularly
high after the appearance of skin changes, no less than 70%
patients in any group assessed the cost of their treatment as
important. A relative overrepresentation of male patients in
the advanced stages indicates that men tend to see a physician due
to CVD less frequently and do so later during the course of the
disease; that women react to CVD earlier than men is also suggested
by the finding of younger women scoring marginally lower in the SF
and RE dimensions at the very beginning of the disease (C1 stage).
However, given the overall similar reductions in QoL observed in
both genders, men perceive their disease similarly to women.
In summary, the results of this study show a gradual impairment
of QoL during CVD, which becomes significant as CVD progresses to
CVI (as at C4). This finding is in agreement with previous reports,
showing that impaired QoL begins from class C3-4 [17-20]. However,
our results may represent an underestimate; i.e. many of the
subjective symptoms such as burning, pain, itching, restless legs
or other sensations in the lower legs which are noted from the
early stages of CVD may also have a negative impact on QoL [22]. It
is therefore possible that the patient-reported QoL was already
decreased in the early stage patients in our series, but we could
not verify this since QoL data for the general population are not
yet available in Serbia [23].
To conclude, our study shows that patients do not consider CVD
as merely an esthetic problem but rather as a disease. Adequate
therapy can improve the condition and consequently, the QoL
[24-26]. Thus, in view of the findings that the QoL of CVD patients
decreases, particularly after the appearance of skin changes, it is
up to the dermatologist to educate patients on the chronic nature
of the illness, and also to focus on prevention to decrease health
costs.
Acknowledgements
The study was supported by grant No. 145002 from the Ministry of
Science and Technological Development of Serbia. The authors
declare no conflict of interest whatsoever. We are grateful to Mr
Nikola Kocev for help with the SF-36 scores analysis.
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