Abstract: This study aimed to analyze the quality of life (QOL) of individuals with chronic venous ulcers (VUs). It is a descriptive, exploratory, and cross-sectional study performed through interviews with 89 outpatients with VUs using the generic version of the Ferrans and Powers Quality of Life Index (QLI) adapted for Brazilians and also validated for this study (Cronbach’s alpha = 0.99; concurrent and discriminant validity). The results showed a total QOL mean score of 22.27 ± 5.05, a mean score of 21.01 ± 6.14 for the health/functioning subscale, a mean score of 20.96 ± 5.15 for the social/economic subscale, a mean score of 24.37 ± 5.97 for the psychological/spiritual subscale, and a higher mean score for the family subscale (26.21 ± 5.33). The items not having a job and pain obtained the lowest mean scores (7.33 and 10.10, respectively). There was significant correlation between the psychological/spiritual subscale and the number of VUs (r = -0.19) and between the family subscale and the duration of the present VU (r = -0.19). Other significant and positive correlations were obtained between total QOL and its subscales (except the health/functioning subscale) and Catholic religion and between total QOL and its health/functioning and family subscales and standing position before the first VU. Patients without companions had better QOL in the family subscale, shown in the correlation (r = 0.28, p = 0.004) and comparison (p < 0.006) tests. In conclusion, the authors verified that patients with VUs showed good levels of QOL, mainly in the family and psychological/spiritual subscales.

M

any diseases show a chronic course, and among them, chronic venous insufficiency is considered to be the most common disorder of venous origin.^1,2 Chronic venous insufficiency refers to a set of physical alterations that occur on the skin and in subcutaneous tissue, mainly affecting the lower limbs, and manifest as edema, hyperpigmentation, eczema, and lipodermatosclerosis.³ These manifestations are the result of long-term venous hypertension caused by valvular insufficiency and/or venous obstruction with skin ulceration as a complication.^1,3–6 Ulcers of venous origin are considered to occur most frequently, accounting for about 80 to 90% of all cases of leg ulcers,^7–9 with rates ranging from 0.06 to 1.5% according to Brazilian and international statistics.^6,7,10–14 Unfortunately, the exact etiopathogenic mechanism of venous ulcers is still not completely understood, and some theories have been postulated in an attempt to explain the phenomenon.¹⁵ Classical theory is that venous hypertension is the most common factor in the genesis of ulceration and is complemented by other non-excluding theories implicating “fibrin cuffs,” leukocytes, and growth factors.^8,9,16–19 Some aspects of the clinical condition of these patients—such as the long duration of tissue repair, the high frequency of recurrences, and the high treatment costs—characterize venous ulcers not only as a chronic disease but also as a possible impact factor on the quality of life (QOL) of these individuals.¹⁵
       Although some regard QOL as concepts of satisfaction, happiness, and well-being,²⁰ the present study was based on the concept established by Ferrans and Powers²¹ who understand QOL as “a person’s sense of well-being that stems from satisfaction or dissatisfaction with the areas of life that are important to him/her.”
       While numerous investigations regarding the QOL of patients with chronic diseases exist, studies exclusively related to individuals with chronic venous ulcers (VUs) are rare.¹⁵ These studies include those performed by Walshe²² and Krasner,^23,24 both using a qualitative approach, that of Pieper, Szczepaniak, and Templin25 who applied an instrument adapted for this population, and others.^26–29 These publications report that individuals with VUs have various physical, social, and psychological problems, including altered mobility, depression, pain, low self-esteem, psychosocial suffering, sleep disorders, feelings of frustration, difficulties in body hygiene, social isolation, and difficulties at work, among others. Other studies conducted on patients with chronic ulcers in general, mainly those affecting the lower limbs, have indicated a similar set of problems.^12,30–33
       At the time of this research development, there were only 4 generic QOL instruments adapted for Brazilian culture. Among these, the Ferrans and Powers Quality of Life Index (QLI) was most frequently used at the Nursing College of the University of São Paulo because of its adequate psychometric performance.
       In view of the problems of individuals with VUs reported in the literature, observations in the authors’ clinical practice, and the lack of studies in international and Brazilian literature, especially those using a quantitative approach, the objectives of the present investigation were to analyze the QOL of individuals with VUs and to correlate the QOL scores with demographic (ie, gender, age, number of children, marital status, and religion) and clinical variables (ie, number of ulcers, time since the occurrence of the first ulceration, duration of the present ulcer, position during occupational activities prior to the first VU, current position during occupational activities, new episodes of ulcerations, and ulcerated lower limb).

Methods

       Correlation was tested in a cross-sectional, descriptive, exploratory study conducted at the vascular surgery outpatient clinics of 3 public hospitals in the city of São Paulo, Brazil. The sample consisted of 89 patients with VUs who fulfilled the following criteria: age 18 or older, agreement to participate in the study, under outpatient follow-up, and presence of ulcers exclusive to venous etiology.
       Data collection, including the pre-test, was performed after approval from the research ethics committees of 2 of the institutions and authorization by the third institution were received. After selection, written informed consent was obtained from the participants. Demographic and clinical data were then obtained from the records. Additional necessary information was obtained by asking the patients themselves. The QOL data were obtained through interviews performed by the researchers and 3 previously trained nurses.
       The data collection instrument consisted of 2 sections: the first contained the demographic and clinical data of the patients with VUs, and the second consisted of the first generic version of the Ferrans and Powers QLI translated and adapted in Portuguese by Kimura.³⁴ Although specific instruments for the assessment of individuals with chronic VUs have been reported in the literature,^25,35–38 they are not yet available in Brazil. It is the first research to apply the Ferrans and Powers QLI for VU patients.
       The QLI is a generic instrument that is used to assess the QOL of healthy individuals and individuals with any type of disease. The QLI was developed by nurses Ferrans and Powers, professors at the University of Illinois (Chicago, Ill, USA), using different research approaches^21,39,40 with its theoretical framework being satisfaction with life. The QLI consists of 68 items divided into 2 sections and 4 subscales: health/functioning (HF), social/economic (SE), psychological/spiritual (PS), and family (Fa).^21,39,40 The first section is related to the satisfaction the person experiences with various aspects of life, and the second is related to the importance he or she attributes to the same aspects.^21,39,40 Although the instrument contains 68 items, only 66 are answered, because 2 items related to employment are mutually exclusive.^21,39,40 Satisfaction and importance are measured on a 6-point scale ranging from “very dissatisfied” to “very satisfied” and from “very unimportant” to “very important,” respectively.^21,39
       Scores are obtained by first recording all satisfaction items, subtracting 3.5 from each point of the Likert scale (1, 2, 3, 4, 5, 6) and thus obtaining new values (-2.5, -1.5, -0.5, +0.5, +1.5, +2.5). Next, the resulting values are weighted by those obtained for each item in the importance section, and 15 points are added in order to obtain a single positive value for each item. The final total score is the result of the sum and division of all items answered. The same procedure is adopted to obtain the scores for each subscale.³⁹ In addition to the total score of the QLI and a score for each subscale, a score can be obtained for each item of the instrument.¹⁵
       Scores range from zero (poor QOL) to 30 (the best QOL), with no cut-off established by the authors. However, in the present study, the authors used the following categorization based on the proposal of Dunn et al.:⁴¹ 0 to 5 (very poor QOL), 6 to 11 (poor QOL), 12 to 17 (regular QOL), 18 to 23 (good QOL), and 24 to 30 (very good QOL).¹⁵
       The following procedures were adopted for statistical analysis: 95% confidence interval, Kolmogorov-Smirnov normality test, Spearman’s correlation coefficient for ordinal variables, Pearson’s linear correlation coefficient, Mann-Whitney test, Student t-test for independent samples, multiple regression analysis, Bonferroni’s post-hoc test, and analysis of variance.
       The reliability and discriminant and concurrent validity of the QLI were determined in the present investigation. Cronbach’s alpha coefficient ranged from 0.65 to 0.99 for the subscales and total quality of life index (TQLI), indicating a good internal consistency for use with the target population. The discriminative power of the instrument in this population was also confirmed based on the significantly higher mean scores for the HF subscale and TQLI (p = 0.05 and p = 0.029, respectively) obtained for a control group consisting of 50 individuals (52% female; 34.84 ± 14.94 years) from the general population (comprising a random sample selected from a pre-existing data bank) compared to the scores obtained for patients with VUs. Finally, concurrent validity was confirmed based on the significant positive correlation (p < 0.001) between item 32 of the QLI (satisfaction with life) and the TQLI and subscale scores.

Results

       Sixty-one (68.5%) of the 89 patients with VUs were female (IC 95%, 68.4% ± 9.84%). Age ranged from 25 to 84 years, with a mean and median of 53.44 ± 13.18 and 54 years, respectively. The predominant age group was 49 to 60 years (29 patients, 32.58%). With respect to schooling, 55 patients (62.5%) had only 8 years of formal education. Eighty-one patients (91.01%) had 2 VUs, with a mean of 1.54 ± 0.99 and a range of 1 to 8 ulcers per individual. The mean duration of VUs was 6.02 ± 8.48 years (range, 2 months to 45 years). The mean number of new VU episodes after the first ulceration was 3.39 ± 6.98.

Table 1

       With respect to the categorization proposed for the analysis of QOL in the present study, 37 (41.57%) and 35 (39.31%) patients with VUs were included in the categories, which considered TQLI as “very good” and “good,” respectively (Table 1). Analysis of variance revealed a significant difference between the TQLI categories (p < 0.05), with normality being confirmed by the Kolmogorov-Smirnov test. Bonferroni’s test showed that the mean TQLI score grew proportionally with increasing category.
       With respect to the mean scores obtained for TQLI and the subscales (Table 2), higher means were observed for the Fa (26.21 ± 5.33) and PS (24.37 ± 5.97) subscales, with a mean and median TQLI score of 22.27 ± 5.05 and 23.4, respectively. The distribution of these scores was asymmetrical, and statistical evidence indicated that the Fa and PS subscales exceeded all other subscales. No difference was observed between TQLI and the HF subscale or between HF and SE scores.

Table 2

       The lowest mean scores were obtained for items 22 (not having a job) and 3 (pain), suggesting greater dissatisfaction of the patients with these items. In contrast, the highest score was reached for item 29 (satisfaction with personal faith in God). Bonferroni’s test confirmed the lowest score for the pain item in the HF subscale, which differed significantly from all other items except for the item related to leisure time activities (item 25). In the SE subscale, a significant difference was observed between the item related to not having a job (item 22) and all other items of the subscale. Correlation analysis showed that although all subscales were positively correlated with TQLI, the highest correlation was observed for the HF subscale (r = 0.94), demonstrating a greater influence on TQLI in this sample. For all subscales, significant positive correlation was also observed between mean scores and the respective items of each subscale. The following items showed the highest correlation with the mean score of the subscale: in the HF subscale, item 17 (amount of stress or worries; r = 0.72); in the SE subscale, item 20 (satisfaction with standard of living; r = 0.75); in the PS subscale, item 32 (satisfaction with life in general; r = 0.88); and in the Fa subscale, the item family’s health (r = 0.76). These results suggest that these items, showing the highest correlation indices, most influenced the composition of the mean scores of each subscale of the instrument.
       Tables 3, 4, and 5 show the results of the statistical analyses between each subscale, TQLI, and the dichotomous quantitative and qualitative variables.
       The data in Table 3 indicate the absence of a significant linear correlation between TQLI, the HF and SE subscales, and the quantitative variables. Multiple regression of TQLI on the same variables detected that only 11.33% of the total variation in the TQLI score are explained by the multiple regression model, ie, none of the independent variables selected seems to have a true effect on TQLI. Analysis of variance applied to Ho regression also confirmed the lack of this effect (p = 0.866), and the same was observed for the HF and SE subscales. In contrast, in the case of the PS and Fa subscales, negative correlation was observed between the number of ulcers and the PS subscale (r = -0.19; p = 0.032) and between the duration of the present VU and the Fa subscale (r = -0.19; p = 0.037).

Table 3

       With respect to the qualitative variables (Table 3), positive correlation was observed between people of Catholic Church, the TQLI (r = 0.26; p = 0.008), and the HF (r = 0.20; p = 0.035), SE (r = 0.28; p = 0.005), PS (r = 0.26; p = 0.008), and Fa subscales (r = 0.22; p = 0.022). The same type of correlation was obtained between to orthostatic position prior to the first VU and TQLI (r = 0.28; p = 0.005) and the HF (r = 0.29; p = 0.003), PS (r = 0.25; p = 0.012), and Fa subscales (r = 0.21; p = 0.001). In addition, a negative correlation was observed between marital status and the Fa subscale (Table 3).
       In order to obtain further evidence regarding the correlation shown in Table 3, the mean scores, their respective standard deviations obtained for TQLI, and the subscales were compared for grouping of dichotomous variables (Tables 4 and 5). The results confirmed that Catholic patients scored higher in terms of TQLI (p = 0.021) and in the SE (p = 0.011), PS (p = 0.021), and Fa subscales (p = 0.036) than Evangelical patients. The same was not observed for the HF subscale. With respect to the item to orthostatic position prior to the first VU, statistical evidence continued to show a better QOL for the HF (p = 0.044) and Fa (p = 0.037) subscales. Regarding marital status, individuals without a partner were confirmed to show a better family QOL (p = 0.006).

Table 5

Table 4

Discussion

       The term QOL has been frequently mentioned in different publications regarding VUs, but these studies are generally limited to an approach to the set of problems of this patient group. Although limited, the most important studies are the reports of Walshe²² and Krasner^23,24 who used qualitative methods. In addition, QOL measurement scales specifically directed at this population are scarce, and although they include tested psychometric properties,^25,37,38 they are not adapted to the Brazilian culture. Thus, in the present study, the authors used the first generic version of the QLI translated and adapted in Portuguese.
       Once the psychometric properties of the instrument were found to be adequate for the target population, the scores obtained for TQLI, the subscales, and most items showed values higher than 20 points, demonstrating positive tendencies for QOL (ie, good and very good), although both the TQLI and HF scores were significantly lower than those observed for the control group. It should be emphasized that the score obtained for the HF subscale was 1 of the scores that most influenced TQLI, showing its importance in the QOL of individuals with VUs.
       As previously noted, the lack of studies regarding QOL of patients with VUs measured by the QLI impairs comparisons between results. Since this scale has been employed in some national and international studies involving groups of patients with other chronic diseases and individuals of the general population, the results obtained here are discussed in view of the findings reported in these investigations (Table 6).

Table 6

       Comparison of the mean scores reported in the studies developed by Brazilian researchers^3,42 and the present results show that all mean scores obtained for both TQLI and the subscales were lower in patients with heart disease, indicating a worse QOL when compared to patients discharged from the intensive care unit (ICU) and those with VUs. In contrast, patients with VUs scored lower than those discharged from the ICU, except for the HF subscale in which indices were practically the same. Interestingly, in the 3 studies, the highest mean scores were obtained for the Fa and PS subscales, suggesting that the highest degree of satisfaction is related to family and the psychological/spiritual area, irrespective of the type of disease.
       In other investigations involving groups of the general population,^43,44 all mean scores were generally higher than those obtained for patients with VUs, except for the PS subscale in 1 study.⁴³ In contrast, in the present study, significant differences were only observed in mean HF and TQLI scores between individuals of the general population—used as the control group in the analysis of discriminant validity—and patients with VUs.
       Analysis of the previously discussed studies showed that although the groups of healthy individuals demonstrated better general QOL than sick patients, in 2 of these investigations, family-related QOL presented worse indices.
       Among the international studies assessing the QOL of sick individuals using the QLI are studies performed by the authors of the instrument themselves using versions of the QLI specific to dialysis and cardiac patients.^45,46 For patients under hemodialysis,⁴⁵ the authors verified lower scores than those observed in the present study. In a study of cardiac patients,⁴⁶ all scores before angioplasty were lower than those observed for patients with VUs, except for the SE subscale in which patients with heart disease scored slightly higher. After surgery when the data reported by the authors suggested improvement in TQLI and health, the scores reported for both TQLI and the HF subscale were higher than those obtained in the present study, although only a slightly higher TQLI score was observed. These scores, although much higher than those reported by Meneguin,⁴² suggest that patients with heart disease show a poorer QOL than patients with VUs. It should be noted that the authors used QLI versions specific for those populations, a fact that might have improved the specificity of the results.
       Mellors et al.⁴⁷ studied HIV-infected patients in different stages—asymptomatic, symptomatic, and with AIDS—and observed a decline in scores with progression of the disease, especially during the more severe phase. No differences in mean TQL scores were observed between asymptomatic patients and those of the present study.
       Based on the comparative analysis of the results obtained in Brazilian and international studies and on the categorization adopted in the present investigation, most patients were found to show a good QOL level, except for patients with valvular diseases,⁴² and a very good level among the general population.
       In addition to a more general view of QOL, investigation of the components of the subscales indicated dissatisfaction with 2 important phenomena, not having a job and pain, in addition to others, such as standard of living, amount of stress and worries, life in general, and family’s health.
       With respect to the work item, one may infer that morbidity resulting from chronic venous insufficiency and VUs and the difficulties resulting from the limitations imposed by the disease, eg, physical (in)dependence, undoubtedly not only increase amount of stress and worries but also have repercussions on the execution of work and on the reduction in leisure time activities item, although both are also influenced by the standard of living. In their first publication on the recently constructed FPQOL, Ferrans and Powers²¹ concluded that higher QOL indices are associated with the group of dialysis patients with a higher annual per capita income.
The pain item, as a complaint and factor of dissatisfaction, was frequently observed in the assessments (65.9% of patients) and being completely free of pain was considered very important. A similar percentage (64%) was reported in another investigation on pain associated with chronic ulcers.⁴⁸ The occurrence of pain is an aspect observed in the authors’ clinical experience and has been widely explored in the literature regarding the problems of patients with VUs.^{12,22–25,31,35,48–50} Pain is described as something that suffocates the individual, consumes each aspect of life, and has a marked negative influence on general QOL,^32,51 thus deserving increasing consideration in investigations.
       Clinically, only the number of ulcers and the longer duration of the present ulcer were correlated with a poorer QOL of patients with VUs in the PS and Fa subscales, respectively. However, it should be emphasized that although statistically significant, the indices were very low. In a study on the QOL of patients with chronic vasculogenic ulcers, Lindholm et al.¹² observed that ulcer duration did not influence the QOL of the population studied, and patients with long-term ulcers reported fewer problems than those with ulcers of short duration, a finding that suggests the presence of adaptive mechanisms.
       On the other hand, feelings of rage and resentment and the time spent with the care of ulcers have been positively correlated to the QOL of individuals with leg ulcers³¹ and in a certain way confirm the psychospiritual problems that compromise the QOL in this subscale. In the present study, sadness, rebellion, discouragement, disgust, shame, complexes, limitation in choice of clothes and shoes, and limitation in mobility and leisure were verbalized by the patients during interviews, demonstrating the degree to which VUs compromise their psychological and spiritual life.¹⁵ The chronic character of the lesions that involves long healing periods and the high rate of recurrence reported in the international literature may also result in dependence on family members for different aspects of life, although at a lower intensity. Care might require the participation of caregivers for manipulation of the lesions, cleaning, walking, and other activities. Social isolation, specifically from work and leisure, represents another important aspect of dependence that may also interfere with economical aspects. It should be emphasized that the PS subscale was the second subscale that most influenced TQLI, again showing its importance for the assessment of QOL.
       Possible impairment of body image and self-esteem associated with the aspects described, in addition to the fear and insecurity related to the physical trauma of ulcers, exudation and unpleasant odor, and repulsion and rejection of the partner, may have contributed to the significant perception of a poorer family QOL among individuals with partners, although the literature^43,52 indicates family as an important source of social support that contributes to QOL improvement of individuals.
       In contrast to the presence of a partner in the marital status item, religion was found to contribute to a better QOL, being positively correlated with all subscales and TQLI, except for the HF subscale.
       An atypical result of inferential analysis was the fact that the group of individuals whose occupational activities required long periods of orthostatic position prior to the first VU presented better TQLI related to the HF and Fa subscales, indicating the need for further corroborative studies. It is important to emphasize that orthostatic position is a factor that causes discomfort due to pain in the limbs affected by chronic venous insufficiency. In this respect, Lindholm et al.¹² observed that individuals whose occupations require standing up suffer from long-term ulcers. This evidence indicates the existence of certain occupations that, in fact, may contribute to the formation and maintenance of VUs because of the persistence of venous hypertension.
       Despite the limitations of having employed a generic instrument, the weak correlation obtained for most of the clinical variables and QOL scores (although under statistical significance), and the lack of a control group, which was only used for validation of the instrument, the present study will contribute information for investigators in the area of wound care. Further investigations regarding the measurement of QOL in this population using specific instruments need to be performed in order to determine the specific impact that VUs and the level of adaptation to a chronic condition have on the QOL of affected individuals. Additionally, QOL population norms must be contoured to the Brazilian culture.

Conclusions

       This study of the QOL of individuals with VUs demonstrates that the general QOL indices obtained are indicative of good and very good QOL according to the perception of patients with VUs. Significant negative correlation was observed between the PS subscale and the number of ulcers, between the Fa subscale and the duration of the present ulcer, and between the Fa subscale and individuals with a partner, suggesting poorer QOL indices for these variables. A significant positive correlation was observed between religion, TQLI, and the SE, PS, and Fa subscales, as well as the standing position prior to the first VU and the HF and Fa subscales.

Acknowledgements

       The authors acknowledge Irmandade da Santa Casa de Misericórdia de São Paulo, Hospital Santa Marcelina, and Hospital Regional Sul for allowing their patients to be interviewed, as well as the nurses Ceres Machado de Oliveira, Shirlei Ribeiro Medeiros, and Marilucia Rodrigues de Freitas for help with data collection.