Atopic dermatitis: impact on quality of life and patients’ attitudes toward its management

ARTICLE

ejd.2011.1560

Auteur(s) : Antonio Torrelo¹ atorrelo@aedv.es, Javier Ortiz², Agustín Alomar³, Sandra Ros³, Marta Prieto⁴, Jesús Cuervo⁵

¹ Hospital Niño Jesús, Avda. de Menéndez Pelayo 65, 28009, Madrid, Spain

² Hospital 12 de Octubre, Avda. de Córdoba s/n, 28041, Madrid, Spain

³ Hospital de la Santa Creu i Sant Pau, C/ Sant Antoni María Claret 167, 08025, Barcelona, Spain

⁴ Medical Department, Astellas Pharma, Parque Empresarial La Finca, Paseo del Club Deportivo 1, bloque 14, 28223, Pozuelo de Alarcón, Madrid, Spain

⁵ BAP Health Outcomes, C/ Azcárraga 12 A, 33010, Oviedo, Spain

Reprints: A. Torrelo Fernández

Atopic Dermatitis (AD) is a chronic inflammatory skin disease characterized by itch and eczema which appears in episodic exacerbations (flares) and remissions. In some cases, skin involvement may be continuous [1]. In recent years, epidemiological studies have shown higher rates of AD prevalence, ranging from 7-20% in children and 2-7% in adults [2, 3]. The aetiology of AD still remains unclear; however, a genetic predisposition is involved [1]. The risk of suffering AD is 30% if one parent is diagnosed with AD and rises up to 70% if both parents are affected. Environmental factors may contribute to trigger flares and influence its severity [4]. Due to this complex aetiology, pharmacological treatments are recommended not only for acute episodes but also for preventing the flares and reducing their intensity [5-7].

AD can result in a significant and negative impact on a patient's health related quality of life, (HRQoL) [3, 7]. Its recurrent exacerbations and their severity may disturb the quality of sleep of patients, and performance at school, at work or during social activities [8, 9]. In consequence, daily activities and emotional balance are frequently disturbed, not only in these patients [8, 10, 11] but also in their families [12]. Several scoring systems have been created and validated [13] during recent years in order to provide both an objective clinical evaluation of AD [14, 15] and the subjective impact associated to AD [16-19]. Only a few studies have focused on analyzing both the impact of AD on a wide range of patients’ HRQoL domains and patients’ attitudes toward pharmacological treatment and medical recommendations related to AD management and AD long term control [20]. Moreover, to our knowledge, no similar studies have been carried out in Spain.

The present work aimed to investigate the impressions of AD severity of both professionals and patients and to point out if there were discrepancies between their criteria regarding the intensity of AD episodes. Furthermore, the study also focused on the impact of AD on patients’ HRQoL and their attitudes toward the strategies applied to control AD (topical pharmacological treatment for flares and medical recommendations about hygienic and preventive strategies). In consequence, it should be possible to better understand AD patients’ suffering, and also to gain knowledge with the purpose of improving patients’ adherence and compliance with pharmacological treatment and medical recommendations for the short- and long-term management of AD. Significant rates of non-compliance with treatment have been shown in previous studies [21, 22]. It is common that patients only use treatment in restricted areas of their body or apply the treatment less frequently than advised, so the effectiveness of pharmacological approaches is compromised.

Material and methods

An epidemiological, multicentre cross-sectional study was carried out from October 2008 to March 2009. Dermatologists from public and private health services in Spain (n=191) participated in the present study. Each specialist recruited, consecutively, the first 2 patients (1 adult, 1 child) who fulfilled the selection criteria: patients aged 2 to 16 (children) or patients aged over 16 years old (adults) with a diagnosis of AD according to Hanifin and Rajka criteria [23] with moderate or severe involvement. All patients were enrolled after they (or their caregivers in patients under 16 years old) provided their written informed consent to participate in the study, which was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethical Committee of the University Hospital Niño Jesus (Madrid).

Variables of the study

Dermatologists were asked about the diagnosis of AD and their clinical impression/diagnosis of AD severity in each case. Socio-demographic variables were also recorded. Patients (or caregivers in case of children between 2-12 years old) answered a questionnaire addressing AD impact, patients’ HRQoL and their attitudes with respect to AD flare management: compliance rate with topical pharmacological treatment and medical recommendations, the level of importance of those measures and finally, patients’ satisfaction. Regarding pharmacological therapy, the study focused on the most frequently prescribed topical medications to control AD flares (corticosteroids or calcineurin inhibitors). However, since the aims of this research did not include establishing comparisons between these topical alternatives, both treatments were referred as topical pharmacological treatment. Furthermore, medical recommendations comprised both hygienic and preventive measures to control AD (i.e. use of special soaps or oils, moisturizing creams or emollients and avoiding extreme temperatures).

This questionnaire was specifically developed for this study. To this end, experts’ and patients’ panels were conducted. At first, 3 dermatologists were interviewed about the most important issues associated to the medical management of flares. As a result, the following ones were identified (tables 2, 3):

• –. severity of AD symptoms (3 items);
• –. AD affectation: sleep disturbances (2 items), school /professional fulfillment (4 items), and emotional disturbances (10 items);
• –. attitude toward AD flares and topical pharmacological treatment (4 items);
• –. overall satisfaction with topical pharmacological treatment (1 item, visual analogical scale-VAS-);
• –. perceived benefits of topical pharmacological treatment for flares (6 items).

Next, specialists were asked to report those areas related to AD preventive strategies and the patient's compliance with these measures. In this case, the following were identified:

• –. attitude toward medical recommendations (hygienic and preventive strategies, 4 items);
• –. satisfaction with medical recommendations for AD management and control (1 item, VAS);
• –. satisfaction with the information given by their specialist (1 item, VAS);
• –. feelings before the next flare (5 items).

Finally, one clinical psychologist interviewed 7 adult patients and 5 caregivers of paediatric patients to ensure the comprehension and point out the importance of the selected areas and items regarding treatment management for AD control. Once the importance of the items was confirmed and the patients’ (or caregivers’) comprehension of the interview was ensured, the present study was carried out.

Statistical analysis

The sample size was estimated according to the relative frequency of severe and moderate AD patients. Taking into account previous studies [20], a higher frequency of moderate AD patients was considered in a 2:1 proportion with respect to severe cases. Therefore, a minimum of 320 patients were needed (160 adults and 160 paediatrics) to enable investigators to analyze mean differences (one tailed) of medium size (d=0.33) between moderate and severe patients in VAS scales with a confidence interval of 95% and 80% of power (1-β). Firstly, clinical and socio-demographic variables were described along with the variables reflecting AD impact and patients’ attitudes toward AD management (frequencies and percentages in nominal values and mean and standard deviation [SD] in case of continuous values). Secondly, patients’ and clinicians’ impressions of severity were compared by using Cohen's kappa coefficient.

Furthermore, considering AD impact, it was analyzed whether a global score could be extracted for both paediatric and adult patients. To this end, item-total correlations (ITC) were checked following the criterion of removing items with a score lower than 0.3 in the discrimination rates. Besides, to assess the one-dimensional structure of AD affectation in both paediatric and adult patients, an exploratory factorial analysis (extraction criterion of eigenvalue > 1; varimax rotation) was also conducted. Finally, the internal consistency of those measures was calculated by using the Cronbach's α. Once the one-dimensional structure was confirmed, a global score for each group was obtained by summarizing the levels of the included items (“Total AD disturbance”) and was linearly transformed into 2 different scales ranging from a minimum of 0 (no disturbance at all) and a maximum of 10 (heavy impact on the patient's HRQoL). Mann-Whitney's U test was applied to study the differences between moderate and severe patients in AD affectation, attitudes toward treatment and medical recommendations and finally, overall satisfaction with respect to treatment and the information they received from the specialists. This statistic was also applied to test if there were differences in AD affectation depending on patients’ sex. Finally, Spearman's rank correlation coefficients (rho) were calculated to study the relationship between the severity of AD and disturbances in the patient's life.

Results

In total, 191 dermatologists participated in the present study, 47.64% of them were male and mean age was 43.68 years old. They collected data from 386 patients (adult and paediatric). Once the selection criteria were reviewed, 64 cases had to be removed because the selection criteria were not completely fulfilled (30 children and 34 adults). As a consequence, the final sample included for the analysis comprised 322 patients (163 children and 159 adults). The description of their clinical and socio-demographic variables is shown in table 1. In addition, descriptive analyses of the patients’ affectation and reported attitudes toward AD management are detailed in tables 2 and 3, respectively.

Table 1 Sample description.

^a Atopic dermatitis.

Table 2 Atopic dermatitis impact on patients’ health-related quality of life.

^a Atopic dermatitis; ^b Health-related quality of life.

Table 3 Patients’ attitudes toward flare control.

^a Atopic dermatitis.

Regarding frequency of flares, these were slightly higher in case of adults (a mean of 7.08 in adults during the last year and 4.76 flares in case of children) whereas the duration of the last flare was similar (17.87 days in adults and 18.34 days in children, table 2). Moreover, when comparing clinicians’ and patients’ impressions of severity, poor rates of agreement were found (Cohen's kappa coefficient=0.44, p<0.001, in the case of paediatric patients and kappa coefficient=0.52, p<0.001, in the case of adult patients). Patients’ impressions of severity were significantly higher than physicians’ clinical impressions. A total score for AD disturbances (Total AD disturbance) was calculated for both adults and children. To this end, ITC analyses (table 4) and exploratory factorial analyses (table 5) led, firstly, to eliminate in both samples the items referring to indifference and resignation (ITC < 0.3) and, secondly, to confirm the appropriateness of calculating one total score (table 5). Moreover, the internal consistencies of those scales were high in paediatric and adult samples (Cronbach's α=0.75 and 0.87, respectively). Once properties were tested, the Total AD disturbance score was estimated. Despite the similar affectation of flares in both samples, differences in terms of the impact on patients’ lives were found. Adult patients reported higher levels of AD disturbance (table 2). However, in both samples, the higher the AD severity, the higher the level of AD disturbance. In paediatric patients, differences according to AD severity were significant, especially, in sleep/rest and school fulfillment. In adult patients, the affected areas most related to AD severity were also sleep/rest, work fulfillment and even more, disturbances on their daily lives and on their emotional well-being (table 6). In fact, 51% of these patients lost work days during last year due to AD (mean of work days lost=8.29), 70% declared having work limitations and 84% had sleep/rest disruptions (table 2). Nevertheless, no differences in AD affectation were found with respect to patients’ sex, neither in children (males=2.873±0.198, females=2.976±0.2687, p=0.935) nor in adults (males=3.972±0.317, females=4.444±0.285, p=0.234).

Table 4 Atopic dermatitis impact scale: Item-total correlation.

^a Atopic dermatitis.

Table 5 Atopic dermatitis impact scale: Component matrix (exploratory factor analyses).

Table 6 Differences in patients’ attitudes and atopic dermatitis disturbance according to severity.

^a U Mann Whitney- non parametric test-; ^b Atopic dermatitis.

The present study also tried to highlight patients’ attitudes toward topical pharmacological treatment and medical recommendations regarding hygienic and preventive strategies against AD flares. The importance of compliance with pharmacological treatment referred by patients was high in both groups (table 3) and in the case of adults it was associated with the intensity of AD disturbances (table 7). A majority of caregivers and patients declared not delaying the application of pharmacological treatment for flares and always applying the topical treatment on affected areas (table 3). However, a significant proportion of patients delayed treatment application or had concerns about its use (table 3). The benefits of the pharmacological treatment reported by patients were, mainly, the reduction of skin irritation and itch, the clearance of skin lesions and the reduction of flare duration. In contrast, lower percentages of patients or caregivers reported the benefits of a reduction in school/work fulfillment affectation or the prevention of new flares (table 3).

Table 7 Associations between patient's satisfaction, atopic dermatitis impact on patient's life, and patient's beliefs with respect to the measures for preventing and controlling atopic dermatitis flares.

Spearman correlation coefficient –rho-: * p<0.05; ** p<0.001.

^a Atopic dermatitis; ^b Medical recommendations.

With respect to the importance of the medical recommendations for AD control, high values were also found in both groups (table 3) and in the case of children, it was associated with AD disturbances (table 7). The strategies more frequently followed were the use of special soaps, oils, moisturizing creams and special creams and emollients for AD in both groups (table 3). Patients’ satisfaction with pharmacological treatment for flares and with the information given by dermatologists was high in paediatric and adult patients. In spite of this, satisfaction with medical recommendations about preventive measures was lower than satisfaction with pharmacological treatment or with the information given by the specialist. Patients’ satisfaction with treatment and preventive/skin care strategies was negatively associated with AD impact (table 7): the higher the impact on their life, the lower the satisfaction with treatment for AD control.

Finally, when patients were asked to report how they feel when they think about a new flare, it is remarkable that 68.1%, 59.9% and 58.6% of adult patients feel helpless, distressed/anxious and irritable respectively. In children, the feelings reported were irritability and distress/anxiety (59.8% and 37.3%, respectively).

Discussion

The present study investigated patients’ and dermatologists’ impressions of AD severity to test whether there was any discrepancy in their criteria. Moreover, how AD affects patients’ lives was analyzed, how they apply topical pharmacological treatment and medical recommendations, their perception about the treatment benefits and possible causes for non-compliance. Finally, patients were interviewed about their satisfaction with these measures to control AD.

A low agreement between patients’/caregivers’ and clinicians’ impression of AD severity was found. In general, patients and caregivers tended to report higher AD severity than their clinicians. Taking into account the impairment suffered by patients, the average number of flare episodes during the last 12 months was higher in adults than in children, as was found in a previous multicentre study [20]. The mean duration of the last acute episode as referred by patients was 18 days (18.34 and 17.87 in paediatric and adult patients, respectively) which means almost 3 days more than the flare duration published before [20]. In contrast, sleep disturbances and days of school/work lost during the last year were in concordance with results from the ISOLATE study [20]. In terms of AD impact, findings from this study evidenced the emotional impact and disturbance in daily activities caused by AD [8, 10, 11]. Those disturbances were different depending on age. For instance, in paediatric patients, irritation was more frequent, whereas in the case of adult patients, tiredness, depression, sadness or worries about their appearance were more common. Limitations in social and daily activities were also more frequent in adults [8]. In this population, the number of work days reported lost is especially important, as has been shown before. Besides, in both groups, patients’ HRQoL was associated with the severity of flares [7, 20]. A limitation of the study is that AD severity was graded according to the dermatologists’ criterion during clinical practice, as it is commonly evaluated in Spain. It should be recognized that the application of objective measures to assess AD severity would have provided a more precise classification of this variable [14, 15] enabling comparisons with data from other research. In fact, it was planned to include the SCORing Atopic Dermatitis Index [SCORAD] [14] along with dermatologists’ and patients’ impressions of severity in order to compare the latter with a “gold standard” and also to study the impact on patients’ HRQoL according to the SCORAD outputs. To this end, all dermatologists involved in the study had been previously interviewed about the objective instruments they used in their clinical practice to assess the severity of the disease. Unfortunately, it was found that only 35.6 % of them used the SCORAD in their clinical practice, so collection of these data from clinical records was not feasible.

The analysis performed on patients’ attitudes toward topical pharmacological treatment pointed out a significant proportion of both paediatric and adult patients who delay the application of treatment. Therefore, although patients and caregivers perceived the relevance of the pharmacological treatment during flares, it appears that, unfortunately, there are still some concerns about the use of topical treatments [20, 22]. Thus, although nowadays there are a wide range of effective topical treatments for AD, previous research has shown similar results addressing the lack of patients’ compliance, compromising AD control [21, 22]. In consequence, these results may suggest the appropriateness of new efforts [24, 25] focused on improving patients’ information about their disease, triggers, non-pharmacological and pharmacological approaches to manage AD (in the short and the long term) and also to foster compliance and adherence with treatment in order to get a better control of AD. Besides, regarding generic recommendations about hygienic and preventive strategies, a large majority of patients in both groups declared following these measures (with the exception of “avoiding extreme temperatures” in case of adults).

Finally, the anticipatory feelings of anxiety, irritation, helpless or downheartedness were found both in paediatric an adult patients (but especially in the case of adults). This fact is related to the disturbance in daily activities and to the evidenced impact of AD on different aspects of the patients’ life (sleep/rest, professional/scholar life, social activities and emotional disturbance). These findings support the importance of assessing AD impact on patients’ HRQoL and the clinical importance of reducing the number of flares suffered by patients as well as increasing the time free of flares for better management and AD control. Considering the positive motivation of patients to medical advice, integral interventions could be feasible and pertinent to improve treatment outcomes.

Disclosure

Acknowledgments: The authors would like to acknowledge the collaboration of all the investigators who participated in the CONDA study. Financial support: This research project has been possible thanks to the support of Astellas Pharma, S.A. Conflicts of interest: none.

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