The impact of chronic urticaria on the quality of life in Indian patients.

BACKGROUND: Besides the relief of symptoms, the main purpose of any treatment must be to ensure a better quality of life (QOL). Mere recording of symptoms reveals their severity and frequency, but gives scant information on its effect on QOL. AIM: The study was designed to assess QOL in Indian patients with chronic urticaia (CU). SUBJECTS AND METHODS: We used the validated CU-QOL by Bairadani et al., consisting of five domains and each domain consisting of several items. Each item was scored from 1 to 5 (score 5 = most affected, score 1 = not affected). CRITERIA FOR INCLUSION: Patients having symptoms of rash and pruritis on most of the days for at least 6 weeks were enrolled. CRITERIA FOR EXCLUSION: If the individuals had CU secondary to any other disease, they were excluded.
RESULTS: We enrolled 48 patients. The means of the domains, the items, and the frequency of occurrence of an item were tabulated. The highest mean scores were in the domains of symptoms, followed by sleep disturbances, life activities, looks, and limits. The highest mean scores for the items were for pruritis and wheals followed by sleep disturbances, mood changes, nervousness, embarrassment, fatigue, loss of concentration, reduced work, and social relationships. We also observed a significant relationship among individual items. It is possible that they may have an additive effect.
CONCLUSIONS: Even though CU significantly affected many items, patients were rarely aware of them. There was a significant inter-item correlation, suggesting that items might be aggravating each other. It is important to address the issues regarding QOL along with symptoms for better management of CU.

Introduction

The aim of any therapy, besides relief of symptoms, must be to ensure the well-being of patients and improve their quality of life (QOL). Recording of symptoms reveals the severity and the frequency of the symptoms, but is unable to capture the involvement of QsOL (social, occupational, and emotional functions). In patients having different personalities, leading a wide range of life styles and abilities, QOL is differently disturbed in individuals. Therefore, to understand the total burden of the disease, evaluation of both the symptoms and the QOL[12] are necessary.

Often chronic urticaia (CU) is considered to be a disease of annoyance, with scant attention paid to QOL.[3] A number of generic questionnaires are available for many skin conditions, but there is only one study available with generic and none with the CU-specific QOL[45] in Indian patients.

Objective

The primary objective was to measure QOL in Indian patients with a validated CU-QOL. The secondary objective was to observe its adaptation by the Indian population.

Subjects and Methods

Patients attending the Allergy clinic of the Hinduja Hospital from July to October 2008 were enrolled, if they had symptoms of rash and itching on most of the days of the week for at least 6 weeks, with or without angioedema. Only those who could read and understand English language were included. Patients were excluded if their urticaria was secondary to an underlying disease.

The CU-QOL questionnaire consists of five domains (symptoms, impact on life activities, sleep problems, limits, and looks). Each domain contains several items: symptoms (pruritus, wheals), impact on life activities (work, physical activities, sleep, spare time, social relationship and eating behavior), sleep problems (falling asleep, waking up, tired, concentration, and nervousness), limits (bad mood, choosing food, and sport activities), and looks (side effects, embarrassed, public places, cosmetics, and clothing material). Each of these items was scored from 1 to 5 (score 5=most affected, score 1=not affected). The highest possible score for an item was five and the lowest was one. A product score was obtained by multiplying the score of an item with its frequency.

Statistical analysis used

The CU-QOL has been reported to have a six-dimensional structure. The internal consistency for its reliability for the items exceeded the minimum reliability standard of 0.50–0.70 recommended for group comparison. It showed satisfactory Chronbach's alpha values: Pruritus (0.79), swelling (0.65), impact on life activities (0.83), sleep problems (0.77), limits (0.74), and looks (0.83). Its reliability was good for inter class coefficients (>0.40 and <0.75) for the following items: “physical activity”, “social relationship”, sleep-associated problem and mood changes. It was responsive to expected changes in severity of symptoms.

Results

We enrolled 48 patients (22 males=52.1%, 26 females= 47.9%, mean age=38. SD=±10.2). The means and the medians of all the domains and items were close, indicating that the data followed a Gaussian distribution. Table 1 shows the means of the domains, items, and the percentage of patients bothered by individual items. Table 2 gives the correlation between various items.

Table 1

Means of the domains and the individual items

Table 2

Correlation between items with QOL parameters

Table 1 shows that the highest score were seen in the domain of symptom. Also affected, but to a lower extent, were the domains of sleep disturbances, effect on life activities, limits, and looks, in that order.

Product score (PS) was also the highest for the domain of symptoms, followed by sleep disturbances, effect on life activities, limits, and looks, in that order. PS is important because it is the product of an item and its frequency and indicates group characteristic. A high frequency in the study population increases the PS, indicating the importance of an item. A lower PS does not decrease the importance, because its particular item may be relevant to a few individuals and bringing the score down. The percentage of individuals identifying for the items varied between 12% and 99%.

As seen in Table 1, the highest scores were for the items of pruritis and wheals, but there was involvement that disturbed the QOL: sleep disturbances, mood changes, nervousness, embarrassment, fatigue, loss of concentration and reduced social reactions, and work. Studies conducted in patients with allergic rhinitis show that the effect on QOL could be equal to those with a heart or lung disease.[6] The lowest scores were for cosmetics, clothing, sports activities, and side effects of drugs. The remaining items had moderate scores.

Table 2 shows a positive correlation (P=>0.005) between the items themselves. Pruritis correlated with sleep disturbances and feeling of embarrassment. Sleep disturbances correlated with bad mood, fatigue, loss of concentration, feeling of nervousness, embarrassment, and avoidance of public places. Fatigue correlated with poor concentration, disinterest for spare time activity, social relationships, and waking up at night. Bad mood correlated with avoiding public places. Poor concentration by itself was associated with nervousness. Also noted were significant diminished work and physical activities, change in diets, discontinuation of the use of cosmetics, and change of fabrics used for clothing. Probably, the items had an additive effect on each other.

Discussion

The CU-QOL was well validated in the Indian patients. Most of our patients suffered from severe symptoms (mean score = 4.3), yet they seldom complained about the effect on their QOL. Significantly, CU-QOL could reveal the involvement of a number of items never realised by the patients themselves. Also seen was a significant inter-item correlation, which might be aggravating each other. We suggest that CU-QOL should be routinely used during every initial and follow-up visit to document the full extent of the burden of CU, its treatment and for research purposes.

We accept that there may be a selection bias in selection of English understanding population in this study as the relative importance of the various CU-QOL indices may be different in this group as compared to the general population in our country.