To evaluate health-related quality of life (HRQOL), patient satisfaction, and adherence to treatment in patients with moderate or severe atopic dermatitis on maintenance therapy.
Material and methodsWe performed a national, multicenter, cross-sectional, epidemiological study in adults and children with moderate or severe atopic dermatitis of at least 16 months’ duration who were receiving maintenance therapy. We used the Dermatology Life Quality Index (DLQI), the children's version of this scale (cDLQI), and the Morisky medication adherence scale. Visual analog scales were used to measure treatment satisfaction. We used the Mann-Whitney U test to compare HRQOL between patients with moderate and severe disease and the Wilcoxon test to compare the frequency and duration of flares before and after the start of maintenance therapy.
ResultsWe studied 141 children and 141 adults; the prevalence of moderate AD in these groups was 85.8% and 79.4%, respectively. The impact of AD on HRQOL was mild to moderate. Maintenance therapy led to a significant decrease in the frequency and duration of flares (P < .001). While treatment satisfaction was high in both groups, adherence was poor (18.4%-42.6% in children and 14.9%-27.0% in adults).
ConclusionsPatients with moderate and severe AD receiving maintenance therapy experience a reduction in the number and duration of flares and an improvement in HRQOL. While treatment satisfaction is high, adherence rates could be improved.
Evaluar la calidad de vida relacionada con la salud (CVRS), la satisfacción y cumplimiento en pacientes con dermatitis atópica (DA) moderada-grave en tratamiento farmacológico de mantenimiento.
Material y métodosEstudio epidemiológico, multicéntrico, nacional, transversal con pacientes adultos y pediátricos diagnosticados de DA moderada o grave de al menos 16 meses de evolución y en tratamiento de mantenimiento. Se aplicó el Índice de Calidad de Vida en Dermatología (DLQI), el Cuestionario Dermatológico de Calidad de Vida Infantil (CDLQI), la versión para menores de 4 años (IDQOL), la Escala de Afectación de la Dermatitis Atópica (EADA), el test de Morisky-Green y escalas visuales analógicas de satisfacción. Se comparó la CVRS entre pacientes con afectación moderada y grave (U de Mann-Whitney) y la duración y número de brotes antes y después de la terapia de mantenimiento (prueba de Wilcoxon).
ResultadosParticiparon 141 pacientes pediátricos y 141 adultos con DA moderada en el 85,8% y 79,4% de los casos, respectivamente. El impacto en CVRS fue leve-moderado. La duración y número de los brotes disminuyeron desde la aplicación del tratamiento de mantenimiento (p<0.001). Aunque la satisfacción fue alta en ambos grupos, el cumplimiento fue muy bajo (entre el 18,4%-42,6% en pediátricos y entre el 14,9%-27,0% en adultos).
ConclusionesLos pacientes con DA moderada o grave que siguen tratamiento farmacológico de mantenimiento presentan una reducción en la duración y número de los brotes y menor afectación de su CVRS. Además, los pacientes están satisfechos con el tratamiento aunque su cumplimiento es mejorable.
Atopic dermatitis (AD) is a chronic inflammatory skin disease that appears in early childhood. It is characterized by intense pruritus, dry skin, and skin lesions that appear in flares and have a considerable impact on patients’ lives.1,2 In recent years, the prevalence of AD has increased to between 7% and 20% in children and between 2% and 7% in adults.2,3 The etiology of AD has been linked to genetic, biological, immunological, and environmental factors.4 As a consequence of certain pathophysiological features of AD, such as the persistence of subclinical inflammation and skin barrier dysfunction, there has been a paradigm shift in the approach to treating the disease. It is now possible, after the resolution of a flare, to recommend a proactive treatment strategy aimed at preventing new flares and achieving longer flare-free intervals.5,6
AD can cause various difficulties. Numerous studies have highlighted the physical, psychological, and social impact of the disease on patients’ lives, especially during acute episodes.1,7–9 AD flares can interfere with sleep and rest, disrupt personal performance in school, at work, and in social relationships, and lead to considerable emotional distress associated with symptom severity. We believed it would be interesting to assess how patients with AD on maintenance therapy perceive their health-related quality of life (HRQOL), as there is little evidence on this group of patients in Spain. Previous studies have examined patients’ attitudes toward medical recommendations and treatment for AD flares.10,11 Nevertheless, research on patient satisfaction with maintenance strategies and on adherence to maintenance therapy is needed because these factors have important clinical implications.12–14 The primary objective of this study was to evaluate HRQOL, patient satisfaction, and treatment adherence in patients receiving maintenance therapy to control AD. The secondary objective was to confirm the basic psychometric properties of the Atopic Dermatitis Impact Scale (ADIS).
Patients and MethodsA total of 156 dermatologists throughout Spain participated in this multicenter, cross-sectional, epidemiological study. The enrollment period lasted from November 2009 to June 2010. During this period, each dermatologist consecutively interviewed 2 patients—1 adult (aged > 16 years) and 1 child (aged 2-15 years)—who had been clinically diagnosed with moderate or severe AD in accordance with the diagnostic criteria described by Hanifin and Rajka.15 Patients enrolled in the study had a disease duration of at least 16 months and had been receiving topical pharmacologic maintenance therapy for at least 4 months as a proactive strategy to prevent flares and control the disease. Topical pharmacologic maintenance therapy was defined as the prescription of topical calcineurin inhibitors, topical corticosteroids, or alternatives, with or without emollients, once the dermatologist had determined that the AD flare for which the patient had previously been treated was under control (stable or inactive AD lesions in the dermatologist's judgment). This topical therapy was prescribed according to the dermatologist's criteria, following the routine clinical practice of each hospital. All patients (or their parents, in the case of children) gave their written informed consent to participate in the study, which was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.
Study Variables and Measurement ToolsThe dermatologists recorded the following sociodemographic and clinical variables for each participating patient: age, sex, duration of AD, clinical assessment of disease severity (moderate or severe) at the time of diagnosis, number of flares in the previous year, duration of flares before the start of maintenance therapy, topical maintenance therapy prescribed for flare-free intervals (topical calcineurin inhibitors, topical corticosteroids, or alternatives), and number and duration of flares after at least 4 months of maintenance therapy. They also indicated their clinical impression of each patient's adherence to maintenance therapy and the treatment of flares.
Specific HRQOL Questionnaires (Completed by Patients or Their Parents)Dermatology Life Quality Index (DLQI).16,17 This 10-item questionnaire was used to evaluate patients’ symptoms and feelings as well as problems related to daily activities, leisure, work and school, personal relationships (including sexual difficulties), and treatment.
Children's Dermatology Life Quality Index (cDLQI).18 This version of the DLQI scale was used for patients between the ages of 5 and 16 years.
Infants’ Dermatitis Quality of Life Index (IDQOL).19 This scale was used for patients under the age of 5.
On the basis of these 3 specific questionnaires, patients were given a total aggregate score of between 0 (minimum impact, better HRQOL) and 30 (maximum impact, worse HRQOL). In addition, on the basis of their overall scores on the DLQI or cDLQI, patients were classified in 5 categories according to the impact of AD on HRQOL: no effect (0-1 points), small effect (2-5 points), moderate effect (6-10 points), very large effect (11-20 points), and extremely large effect (21-30 points). In addition, the IDQOL questionnaire included an item that evaluated the severity of the eczema on a scale of 1 (extremely severe) to 5 (fairly good or none).
Atopic Dermatitis Impact Scale (ADIS).11 This questionnaire has 9 items in the adult version and 8 items in the children's version. Respondents chose from 4 possible answers on a Likert-type scale and their overall scores were linearly transformed into a scale of 0 (minimum impact on HRQOL) to 10 (maximum impact).
Adherence and SatisfactionMorisky Medication Adherence Scale.20 This indirect measure was included in order to take into account self-reported adherence to the prescribed treatment regimen, thereby complementing our assessment from another relevant perspective. In the case of pediatric patients