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Patients’ reported quality of life in chronic venous disease in an outpatient service in Belgrade, Serbia

European Journal of Dermatology. Volume 19, Number 6, 616-20, November-December 2009, Clinical report

DOI : 10.1684/ejd.2009.0795

Summary

Author(s) : Ivana Dunić, Ljiljana Medenica, Branko Bobić, Olgica Djurković-Djaković , Department for Prevention and Treatment of Peripheral Vascular Diseases, City Service for Dermatology and Venereology, Džordža Vašingtona 17, 11000 Belgrade, Serbia, Institute of Dermatovenereology, School of Medicine, University of Belgrade, Pasterova 2, 11000 Belgrade, Serbia, Institute for Medical Research, University of Belgrade, Dr Subotića 4, Belgrade, Serbia.

Summary : Chronic venous disease (CVD) has been reported to substantially affect patients’ quality of life (QoL). To evaluate the impact of CVD on patient-reported QoL in a patient series in Serbia, a cross-sectional study of 570 CVD patients, classified according to the CEAP clinical classification into classes (C) 1-6, was performed in a Belgrade outpatient clinic. QoL was assessed by the general short-form (SF)-36 questionnaire, and additionally by a brief CVD-specific questionnaire. The SF-36 scores for all QoL dimensions showed a progressive reduction from C1 to C6. Class 5 and 6 patients scored the lowest across all dimensions, with significant (p <\; 0.05) reductions in physical functioning, role-physical, general health, vitality and mental health. The score for bodily pain decreased from C1 to C4, but increased in C5 and C6 as compared to C4 patients. Interestingly, despite an increasing rate of aesthetic concerns as the disease progresses, no variations were found in the social functioning and emotional role scores across the groups. There were no age or gender differences in any QoL item across the classes. The data presented show that QoL of CVD patients decreases, particularly after the appearance of skin changes, and suggest that even patients in the early stages consider CVD a disease and not merely a cosmetic problem.

Keywords : CEAP classification, chronic venous disease, quality of life, SF-36 questionnaire, skin changes

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]

C0: no visible or palpable signs of venous disease

C1: teleangiectases or reticular veins

C2: varicose veins

C3: edema without skin changes

C4a: pigmentation and/or eczema

C4b: lipodermatosclerosis and/or atrophie blanche

C5: healed venous ulcer

C6: active venous ulcer

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

	No.	(%)	P
Age, years [mean ± SD (range)]
Female (n = 455)		60.64 ± 13.56 (17-93)	0.247
Male (n = 115)		62.30 ± 14.42 (19-85)
Age, years since onset of CVD (mean ± SD)
Female		29.93 ± 12.13	0.111
Male		35.46 ± 17.06
Age, years at first treatment (mean ± SD)
Female		48.19 ± 16.35	0.302
Male		50.48 ± 18.00
CEAP clinical class C1 (n = 17) Female	15	88.2%	0.017
C2 (n = 47) Female	35	74.5%	0.015
C3 (n = 276) Female	248	89.9%	0.000
C4 (n=148) Female	110	74.3%	0.000
C5 (n = 38) Female	22	57.9%	0.490
C6 (n = 44) Female	25	56.8%	0.521
Vein thromboses of legs	95	16.7%
Female	69	72.6%	0.056
Vascular operations	52	9.1%
Female	38	73.1%	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	RP	BP	GH	VT	SF	RE	MH
C1 (n = 17)	79.12 ± 22.10	57.94 ± 30.31	61.57 ± 36.87	94.12 ± 17.66	88.82 ± 18.39	78.59 ± 31.45	69.22 ± 30.10	94.41 ± 14.29
C2 (n = 47)	77.02 ± 26.43	48.23 ± 28.32	58.44 ± 31.01	81.72 ^a ± 14.05	70.21 ^a ± 16.74	72.77 ± 38.84	58.26 ± 31.27	94.66 ± 13.27
C3 (n = 276)	65.68 ^a,b ± 12.75	47.79 ^a’ ± 19.14	54.00 ± 30.42	76.69 ^{a, b} ± 17.85	75.48 ^{a, b} ± 17.93	67.19 ± 32.80	61.75 ± 25.89	89.23 ^a’,b ± 19.83
C4 (n = 148)	60.68 ^{a, b, c} ± 19.02	39.63 ^{a, b’, c} ± 23.77	42.77 ^{b’, c} ± 33.33	67.90 ^{a, c} ± 14.10	69.03 ^{a, b, c} ± 15.29	73.75 ± 27.73	62.59 ± 30.91	83.41 ^{a, b, c} ± 14.02
C5 (n = 38)	56.21^{a, b, c} ± 24.44	40.37 ^{a, c’} ± 15.30	49.91 ± 29.81	49.71^{a, b, c,d} ± 13.14	53.63 ^{a, b, c, d} ± 14.88	61.84 ± 28.41	60.83 ± 30.91	61.49 ^{a, b, c, d} ± 14.98
C6 (n = 44)	54.55 ^{a, b,c, d’} ± 28.07	26.91 ^{a, b, c, d, e} ± 14.98	57.67 ^d’ ± 28.60	43.11 ^{a,b, c, d, e} ± 14.90	45.73 ^{a, b, c, d, e} ± 11.73	68.32 ± 29.98	57.71 ± 28.62	59.36 ^{a, b, c, d} ± 15.46

Table 4 CVD-specific items according to CEAP C class

	Aesthetic concerns No. (%)			Treatment costs No. (%)
Class (No. patients)	Unease due to appearance	Covering legs	Intimacy problems	Important
C1 (n = 17) C2 (n = 47)	2 (11.8%) 18 (38.3%) ^a’	3 (17.6%) 13 (27.7%)	0 (0%) 0 (0%)	12 (70.6%) 33 (70.2%)
C3 (n = 276) C4 (n = 148)	77 (27.9%) 86 (58.1%) ^{a, b’, c}	76 (27.5%) 98 (66.2%) ^{a, b, c}	0 (0%) 4 (2.7%) ^c	216 (78.3%) 145 (98%) ^{a, b, c}
C5 (n = 38) C6 (n = 44)	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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