Quality of Health Care of Rosacea in Germany from the Patient s Perspective: Results of the National Health Care Study RosaReal 2009

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1 Original Paper DOI: / Received: December 20, 2010 Accepted after revision: June 18, 2011 Published online: September 5, 2011 Quality of Health Care of Rosacea in Germany from the Patient s Perspective: Results of the National Health Care Study RosaReal 2009 A.K. Langenbruch E. Beket M. Augustin German Center for Health Services Research in, CVderm, Institute for Health Services Research in and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Key Words Rosacea Health services research Quality of life Patient advocacy groups Abstract Objectives: To obtain reliable data on quality of care of rosacea and to compare care indicators with those found in atopic dermatitis and psoriasis. Patients and Methods: In this cross-sectional study, clinical history, health-related quality of life (HrQoL), medication and treatment benefit of patients with rosacea were assessed by standardized questionnaires. Data were compared to patients with atopic dermatitis and psoriasis. Results: Almost all 475 participants (96.4%) had received topical therapy. 24% had used cortisone ointments. The mean Life Quality Index (DLQI) was (atopic dermatitis: , psoriasis: ). The Patient Benefit Index (patient-defined therapeutic benefit) was (psoriasis: , atopic dermatitis: ). Conclusions: Only a small proportion of the rosacea patients had substantial impairments in HrQoL. Overall, their burden appears to be lower than in patients with atopic dermatitis or psoriasis. However, the lower therapeutic benefit and the high proportion of topical steroid use indicate a need for optimized therapy. Copyright 2011 S. Karger AG, Basel Introduction Rosacea is a chronic inflammatory disease with a prevalence of about 2.3% in German adults [1]. Although rosacea is not associated with severe pain or other physical discomfort, severe manifestations might cause mental stress due to its high visibility as shown for other visible skin diseases [2, 3]. There is no publication on quality of health care for rosacea. A study of the psychosocial stress of rosacea conducted in Poland in 2007 showed that patients with rosacea had a poorer assessment of their own health-related quality of life (HrQoL) than the healthy control group [1]. Moreover, the patients interviewed stated that they received less social support, had a more pessimistic perception of their state of health, and displayed a higher level of anxiety and greater susceptibility to depression [4, 5]. An increased comorbidity of rosacea and depression was also found in a retrospective study conducted in the USA involving the evaluation of more than 608 dermatological visits between 1995 and 2002 [6]. In the opinion of doctors in German dermatology clinics, however, mental stress as a trigger of rosacea plays a smaller role in rosacea patients than in patients with atopic dermatitis and psoriasis [7]. Not only symptomatic treatments and the avoidance of trigger factors are of importance in the management of Fax karger@karger.ch S. Karger AG, Basel /11/ $38.00/0 Accessible online at: Anna Katharina Langenbruch German Center for Health Services Research in, CVderm Institute for Health Services Research in and Nursing, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, DE Hamburg (Germany) Tel , uke.uni-hamburg.de

2 Table 1. D ata generated in the care study General Health insurance status Case history of rosacea Therapy rosacea, but also cosmetic measures aimed at reducing the visibility of the disease [8]. The management of rosacea in Germany has been standardized by a national guideline published in 2008 [9]. No study has yet been conducted in Germany to determine how these therapies are regarded by the patients themselves and how burdened they feel as a result of their illness and therapy compared to patients with other skin diseases. The following objectives were, therefore, set within the research project: (1) To gather reliable data on the quality of care of patients with rosacea in Germany. (2) To compare care indicators with other skin diseases: atopic dermatitis ( AtopicReal study) and psoriasis ( PsoReal study). Patients and Methods inclusion/exclusion criteria sociodemographic data type of insurance satisfaction with the insurance duration of the disease first-degree relatives with rosacea concomitant diseases inability to work extent of rosacea foci drug history present drug history last 5 years State of health care visits to doctors source of the recommendation for treatment treatment burden satisfaction with care and treatment sources of information Patient-defined PBI therapeutic benefit HrQoL DLQI ( Life Quality Index) EQ-VAS (EuroQuol Visual Analogue Scale) Compliance self-assessment forgetting about the therapy Study Design In this noninterventional cross-sectional study of rosacea patients, data were generated with the aid of standardized questionnaires. Approval was obtained from the ethics committee of the Hamburg State Chamber of Physicians before the start of the study. R e c r u it m e n t The conception and coordination of the study were developed by the Competence Center for Health Services Research in (CVderm, University Clinics of Hamburg). To create a greater perception of anonymity in the completion of the questionnaires and in order to avoid any possible distortion of the data from responses based on social desirability as can occur in the case of interviews in dermatology centers the present study RosaReal was conducted with persons from the address files of the Deutsche Rosazea Hilfe e.v., the patient organization for rosacea in Germany. A total of 3,000 questionnaires were distributed all over Germany. The participants were informed about background and aims of the survey. They have given their informed consent for the use of their anonymized data for our study purposes by returning the completed questionnaires to CVderm by post. Admitted to the study were patients who, according to their responses, had a medically verified diagnosis of rosacea and were at least 18 years old. O u t c o m e s The data collected included sociodemographics, health insurance status, case history regarding rosacea, past and present treatments, HrQoL, state of health care from the patient s perspective, patient-defined therapeutic benefit and compliance ( table 1 ). Severity of Disease Current severity of rosacea was determined on the basis of four parameters: Size of the rosacea foci, which the patients entered on a box grid of a face and which were calculated by counting the number of points of interception included in the sketch. The intensity of involvement of individual zones of the craniocervical area was assessed separately. Degree of involvement of individual areas of the body, assessed on a five-point scale ( no involvement to extremely involved ). HrQoL ( Life Quality Index (DLQI) [10, 11] and EQ-5D visual analog scale (VAS) [12] ). To measure HrQoL, the DLQI was used. The DLQI assesses patients feelings concerning the impact of skin disease on their HrQoL over the last week. It consists of 10 questions relating to symptoms and feelings, daily activities, leisure, work or school, personal relationships and treatment side effects. Each item is scored on a fourpoint Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much. Scores of individual items (0 3) are added to yield a total score (0 30); higher scores mean greater impairment of the patient s HrQoL [11]. Additionally, we measured the self-rated health status using the EQ-5D VAS which has the end points: best imaginable health state (100) and worst imaginable health state (0). The participants are asked to rate their own health state by drawing a line to that point on the scale that best represents their own health state on that day. Being unfit to work for at least 1 day in the last 12 months because of the rosacea. Patient-Defined Therapeutic Benefit The patient benefit data were collected by means of the Patient Benefit Index (PBI) [13, 14]. The PBI is a variant of goal attainment outcomes measurement where the patients provide a weighting of their individual treatment goals before the therapy in a prestructured questionnaire (Patient Needs Questionnaire, PNQ). The 2 Langenbruch/Beket/Augustin

3 3,000 questionnaires dispatched within Germany 508 forms returned on schedule 11 exclusions wrong address 3 exclusions questionnaire returned empty 494 completed questionnaires returned 19 exclusions inclusion criteria not answered with yes 470 questionnaires included in the evaluation Fig. 1. Flow chart of the inclusions and exclusions. same items are subsequently to be rated again with regards to the extent which the treatment goals have actually been achieved through the current or last therapy (Patient Benefit Questionnaire, PBQ). There were no two time points in this study, so the data on the goals and on the achievement of the goals through the therapy were collected at the same time. A global score was then calculated for all patients by weighting the achievement of the therapeutic goals on the basis of the importance of the individual goals. The procedure used for this ensures that those patients to whom only a few goals were particularly important even at the start of treatment are able to achieve a global score as high as that of patients to whom more goals were important. In the definition of the authors, a minimal patient value can be assumed above a cut-off value of 1 [13]. Indicators of the Quality of Care Quality of care was evaluated in a multidimensional approach: (1) The therapeutic benefit was determined via the PBI. (2) The indicators for quality of care from the national psoriasis studies 2005 [15] and 2007 [16] were adapted to rosacea to determine the global quality of care. (3) Care in compliance with the national guideline was regarded as another indicator of the quality of care [9]. An important aspect is the extent to which the use of topical and systemic corticosteroids was avoided. The Surveys PsoReal and AtopicReal In order to compare the health care quality of patients affected by rosacea with patients affected by atopic dermatitis and patients with psoriasis we used data of the surveys PsoReal and Atopic- Real. These studies had also been conducted with persons from the address files of patient associations for these particular diseases. Due to the similar recruitment and study design of these surveys, the indicators of quality of care from the patient s perspective are reasonably comparable with RosaReal. Statistical Analysis All data were subjected to descriptive evaluation and described with standard statistical parameters (absolute and percentile frequencies for categorical data; mean value and standard deviation for continuous data). Results were checked for significance and supplemented with power and effect size calculations. The evaluation was done with SPSS (Statistical Package for the Social Sciences) 17.0 for Windows. R e s u l t s Study Participants Of the 3,000 questionnaires posted in Germany 111 were excluded because the address given was incorrect. 497 were sent back by the patients within the inclusion time (16.6%). Of these, 3 patients had returned an empty questionnaire. Thus, there were 494 correctly completed questionnaires. Of these, 19 were excluded because the inclusion criteria had not been answered or answered with no. Finally, 475 questionnaires were included in the data evaluation ( fig. 1 ). Quality of Rosacea Care from the Patient s Perspective 3

4 Table 2. S ociodemographic and clinical data (n = 475) Variable n % Missing entries, n Female/Male 370/ / First-degree relatives with rosacea Variable Mean 8 SD Range Missing entries, n Age, years Height, cm Weight, kg Body mass index, kg/m Years since initial diagnosis Table 3. Intensity of rosacea Areas involved n Range Mean SD Nose * Cheeks * Chin * Forehead * Eyes * Neck * Décolleté * Ears * Other parts of the head * * Scale from 0 = not involved to 4 = extremely involved. Sociodemographic and Clinical Variables The mean age of the patients was years. 370 participants (79.9%) were female, 93 (20.1%) were male. The youngest participant was 26 years old, the oldest 90. The largest group of participants (40.3%) had attended secondary school as the highest level of education. 226 (48.5%) of the participants were in paid work, while 172 (36.8%) were retired. 3.9% of respondents were underweight, 51.9% were overweight to markedly obese, and 44.3% were within the normal weight range. On average, the initial diagnosis of rosacea had been made years previously. 106 (22.6%) patients had first-degree relatives who also suffered from rosacea ( table 2 ). Severity of Disease The global score of disease-specific quality of life in skin diseases (DLQI) showed a mean of (0 = Table 4. Visits to the physician because of rosacea in the last 12 months in % (n = 470)* None >10 Dermatologist GP Internal specialist Alternative practitioner * Missing data with regard to a therapist were counted as none in the case of patients who entered any frequency of visits. minimum, 30 = maximum impairment; missing: n = 9) in the rosacea patients. Most patients (71.1%) were in the lower burden range (DLQI 0 5 [15] ). 73.3% of the respondents ticked a value of more than 50 in the visual analogue scale of the EQ-5D, indicating a positive assessment of their state of health (0 = worst possible, 100 = best possible state of health). The size of the rosacea foci sketched onto the facial area of a given box grid showed on average % area involved. In a separate statement about the involvement of individual zones of the craniocervical area, the nose and cheeks were reported as the most intensely involved ( table 3 ). Of the working patients, 17 (7.5%) had been unfit to work for at least one day in the last 12 months because of rosacea. At the time, 4 (1%) were unfit to work. The mean duration of the inability to work was 9.0 days. Treatment Characteristics The overwhelming majority of the patients had received treatment in the last 5 years. Topical therapy was used in 96.4% and systemic therapy in 41%. The doctors most often visited in the last 12 months because of the rosacea were dermatologists (76.7%), general practitioners (27.4%) and alternative practitioners (10.8%) (table 4 ). 41% of the respondents assessed the quality of their rosacea treatment in the recent years as moderate, 31.4% as good or very good, while 27.5% graded it as poor or unsatisfactory. The largest group of respondents (49.6%) were moderately satisfied with the treatment to date, while about a third (33.8%) were fairly or very unsatisfied with it. 16.7% were very satisfied. 4 Langenbruch/Beket/Augustin

5 Table 5. Treatments in the last 5 years Treatment Used (% of 475) Used, n 0 = Not at all successful, %* 1 = Fairly unsuccessful, %* 2 = Fairly successful, %* 3 = Very successful, %* Mean 8 SD Missing, n Topical therapy Metronidazol (e.g. Metrogel) Topical antibiotics Cortisone ointments Sunscreens Camouflage (make-up) Laser treatments Systemic therapy Metronidazol Isotretinoin (e.g. Roaccutan) Antibiotics (e.g. Doxycyclin) Cortisone Ichthyol * Percentage of those using the drug. Missing data: n = 4. Patient Benefit The mean patient-defined therapeutic benefit (PBI) was (scores attainable were: 0 = no benefit to 4 = maximum benefit). Furthermore, the patients were asked to grade their satisfaction with individual treatments ( table 5 ). On the basis of the mean values, camouflage was considered to be the most successful measure among the topical treatments. Isotretinoin and antibiotics were reported as the best of the systemic treatments. More than 50% of the patients considered the topical treatments metronidazol, sunscreen agents, camouflage and laser treatment and the systemic treatments isotretinoin and antibiotics to be fairly to very successful. Steroids were reported as being the worst treatment in both topical and systemic form (alongside ichthyol). Table 6. PBI in RosaReal in comparison to other studies Patient Benefit, Satisfaction with Care and Quality of Life in Comparison to Patients with Atopic Dermatitis or Psoriasis In comparison to the two other studies, patient benefit of the participants in RosaReal ( ) was significantly lower than in psoriasis patients in the study Pso- Real ( ). The PBI difference to AtopicReal ( ) was not significant. The percentage of patients who stated no benefit from their therapy (PBI! 1) was highest in the RosaReal study with 23.6% (PsoReal: 16.3%; AtopicReal: 17.1%; table 6 ). The HrQoL of the patients with rosacea was higher than that of those with psoriasis or atopic dermatitis ( table 7 ). The percentage of patients with distinct impairments of HrQoL [17] was lowest in the rosacea patients (RosaReal: 11%, AtopicReal: 31.8%, PsoReal: 23.6%). Similarly, the use of systemic therapeutics differed in that atopic dermatitis patients reported having used systemic preparations most frequently, while rosacea patients reported this least frequently (AtopicReal: 72.4%, RosaReal: 41%, PsoReal: 49.1%). With regard to the mean number of days of absence from the workplace because of the disease, rosacea patients were absent significantly less often than psoriasis patients (p! 0.001) and also less often but not significantly so than patients with atopic dermatitis. Discussion RosaReal (n = 445) AtopicReal (n = 384) PsoReal (n = 2,290) PBI global score, mean 8 SD PBI <1, % of all patients The first aim of the present study was to generate scientific data on the quality of care and on guideline-based care of patients with rosacea in Germany in Quality of Rosacea Care from the Patient s Perspective 5

6 Table 7. Pr ofile of the quality of care: quality indicators in a comparison of PsoReal, AtopicReal and RosaReal Parameter PsoReal AtopicReal RosaReal DLQI Patients with severe impairments of HrQoL (DLQI >10) Patients with previous systemic therapy Days off work PBI Values represent means 8SD or percentages. Questioning people of the address files of a large patient organization should reduce any tendency towards answers based on social desirability existing in a medical practice and result in a broader spectrum of patients. However, it cannot be excluded that a selection effect is present as regards the present study. The members of a patient organization might be well informed about the disease and innovative treatment options available. This could contribute to a better quality of life and to an improved healthcare situation in comparison to other patients with rosacea. Another limitation of this study is the cross-sectional design which does not permit to follow up treatment courses over time. Thus, patient outcomes related to treatment must be interpreted with caution. Moreover, the use of both PBI questionnaires on the treatment goals and treatment benefits at the same time point needs reflection. It can be justified by the fact that the patients were first asked about their treatment preferences, which in such a chronic disease are rather stable over time, and after that about the outcomes of the current treatment. Regarding the retrospective character of the questions in this study, there exists the possibility of inaccurate recall. This can result in inaccurate answers but it does not necessarily translate into bias. The extent of inaccurate recall in retrospective studies is determined by characteristics of the exposure of interest including the degree of detail, significance to the respondent, social acceptance and time period involved [18]. Taking into account that the participation in the present study was anonymous (and therefore the pressure for a socially desirable answer lower) and the questions dealing with the past referred to close periods of time, the possibility that something was remembered inaccurately is low. The question about the therapies undergone within the last five years is an exception because it refers to a broader time frame. Due to the low complexity of the question and the important role of medications in the treatment of rosacea there is a high probability of accurate recall. With regard to the sociodemographic variables of the study patients, the mean age was relatively high but the duration of the disease is short in comparison to studies of patients with other diseases. This corresponds to the fact that this disease often does not start until middle age. For the greater part, the treatment of the patients was not inconsistent with guideline-based therapy. Almost all patients with rosacea (96.4%) had used topical therapy at least once in the past 5 years. Almost half the study participants (41%) had received systemic therapy in the course of the last 5 years. Around a quarter (24%) of the patients had used cortisone in the treatment of rosacea in the course of the last 5 years, and as many as 4.8% of them had also used the preparation systemically. The fact that the patients considered cortisone to be the least successful treatment both as topical and systemic therapy is a clear indication that this preparation is unsuitable for the treatment of rosacea, not only from a medical point of view [19]. Furthermore, the fact that camouflage was considered to be the best form of topical treatment suggests that according to patients, drugs are not much superior in the treatment of rosacea. This can also be seen as an indication of just how much the burden of rosacea is determined by its visibility. The second aim of the study was the comparison of care indicators with atopic dermatitis and psoriasis. A small percentage of the rosacea patients had substantial impairments of their HrQoL as measured by the DLQI (11%). Overall, the burden was quite small in comparison to the studies AtopicReal and PsoReal. However, the DLQI may be too insensitive for assessing specific QoL problems in rosacea as it could be shown for the Skindex-29 [20]. On the other hand the problem that specific 6 Langenbruch/Beket/Augustin

7 QoL issues are not evaluated may also occur with other skin diseases. The advantage of using the DLQI is its comparability between studies with different skin diseases because the DLQI is one of the most widely used dermatology-specific quality-of-life instruments [11]. With regard to the areas the DLQI deals with one can assume that rosacea patients are less impaired than other skin diseases. Additionally, the low number of days absent from the workplace because of rosacea suggests that the disease rarely impedes everyday life. Nevertheless, the better QoL in rosacea does not mean that patient-defined outcomes are better. By contrast, there is a larger proportion of patients with rosacea showing an insufficient benefit in the PBI, compared to psoriasis and atopic eczema. This is supported by the observation that satisfaction with care is mostly described by the rosacea patients as only moderate. It is worth noting that a large number about a third of the patients were fairly or very dissatisfied with their treatment. This might indicate that the need for improved care is particularly great in rosacea patients. Conclusion The patients who took part in this study perceived only a relatively small reduction of their quality of life. A need to improve the treatment does, nevertheless, appear to exist both in the view of the patients and on the basis of verifiable parameters (e.g. the high proportion of cortisone preparations used). Disclosure Statement The authors declare that there is no conflict of interest. References 1 Augustin M, Herberger K, Hintzen S, Heigel H, Franzke N, Schäfer I: Prevalence of skin lesions and need for treatment in a cohort of 90,880 workers. Br J Dermatol 2011 DOI: /j x. 2 Shuster S, Fisher GH, Harris E, Binnell D: The effect of skin disease on self image. 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