An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology
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48 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY February 2018 • Volume 11 • Number 2 O R I G I N A L R E S E A R C H METHODS Details of the conduct of this study have been described previously. 12 This was a cross-sectional, web-based survey administered over a two-month time period to adults in the United States. Ethical approval for the study was obtained from the Chesapeake Institutional Review Board (Columbia, Maryland) in compliance with regulatory guidelines and in accordance with requirements of studies involving human respondents. Survey respondents provided informed consent via a web-linked opt-in process before starting any study activities. United BioSource Corporation (Bluebell, Pennsylvania) monitored the conduct of the survey, which was administered by Ipsos Observer (Paris, France). The survey was conducted between May 8, 2015, and July 1, 2015. Prospective participants completed an eligibility survey designed to identify those with a prior rosacea diagnosis and current erythema. Participants were asked to rate the severity of their erythema using a scale designed to assess facial redness associated with rosacea. Eligible participants were male or female adults age 18 years or older who self-reported having received a physician's diagnosis of rosacea at any time in the past, were able to read and understand English, and provided informed consent. Exclusion criteria included self-rated facial redness that was less than "mild" at the time of the survey based on the validated Subject Self-Assessment for Rosacea Facial Redness scale with photo guide or any of the following covering more than 25 percent of the face: telangiectases (visible blood vessels), sun-damaged skin (irregular coloring or pigmentation of the skin, with a mottled, wrinkled appearance and liver spots or age spots), or acne. Participants who completed the survey and indicated the presence of at least mild facial redness were classified into an ETR or a PPR cohort, based on the presence of four or more inflammatory bumps or pimples at the time of survey completion (PPR). In the ETR cohort, severity was assessed using the Subject Self-Assessment for Rosacea Facial Redness scale with photo guide, while in the PPR cohort severity was categorized based on the number of facial lesions alone. Participants who indicated having 4 to 9 facial bumps or pimples were classified as having mild PPR, 10 to 20 as moderate PPR, and 21 or more as severe PPR. Participants answered questions about attitudes, self-perception, and satisfaction with appearance as a result of rosacea. Questions on satisfaction with appearance were modeled after the Satisfaction With Appearance Scale (SWAP) questionnaire validated for burn patients 13 and after the modified SWAP questionnaire, adapted and validated for patients with systemic sclerosis. 14 A number of different questionnaires were also administered to the participants to assess the impact of rosacea on QoL. The Impact Assessment for Rosacea Facial Redness (IA-RFR), an instrument developed and validated by Allergan plc (Dublin, Ireland) based on standards recommended by the United States Food and Drug Administration (FDA) to measure patient-reported outcomes, was administered to all participants. 15 The IA-RFR consists of eight individual items within four domains (Self-perception, Emotional, Grooming, and Social) that were rated on a five-point adjectival scale from 0 (no negative impact) to 4 (greatest negative impact). The recall period for each item was seven days. The Impact Assessment for Rosacea Facial Bumps or Pimples (IA-RFB), an instrument adapted from the IA-RFR, was administered to participants in the PPR cohort only. The validated Rosacea-specific Quality-of-Life (RosaQoL) questionnaire, a 21-item instrument based on the 29-item version of the Skindex survey instrument, 16,17 was also administered and includes Emotion, Symptom, and Function domains. 18 The recall period for this scale was four weeks; response options were based on a five-point adjectival scale (1 = never; 5 = all the time), with higher domain scores indicating a greater level of burden. 18 Finally, the RAND 36-Item Short Form Health Survey (SF-36) version 1.0 was used to assess health-related QoL across eight domains: Physical Functioning, Role Limitations Due to Physical Health (which the SF-36 refers to as Physical Role), Role Limitations Due to Emotional Problems (Emotional Role), Energy/Fatigue (Vitality), Emotional Well-being (Mental Health), Social Functioning, Pain (Bodily Pain), and General Health. The recall period for the scale was four weeks. SF-36 domain scores range from 0 to 100, with higher scores indicating better health status. SF-36 scores were compared with published SF-36 data from the general US population. 19 Limited inferential analyses were conducted for key outcomes. Analyses were performed on the population of evaluable participants, which comprised eligible respondents who completed the survey in its entirety. For the IA- RFR and the adapted IA-RFB instruments, all items were transformed to a scale of 0 to 100. The range of scores was set to have the lowest response category set to zero, dividing by the value of the highest response category and then multiplying by 100. Domain scores were calculated as the average of the transformed scores for items within the scale. For the RosaQoL instrument, within each domain, scores were the average of all responses to the items in the domain scale. Similarly, the total score was the average of all responses with individual scale scores weighted equally. RESULTS A total of 600 eligible participants were enrolled and completed the survey, including 409 participants with ETR symptoms and 191 with PPR symptoms. Details of participant screening, disposition, and sociodemographics have been presented in a previous publication. Rosacea was self-rated as mild by 63.6 and 62.8 percent of participants in the ETR and PPR cohorts, respectively; fewer participants self-rated rosacea as moderate (ETR, 32.0% ; PPR, 30.9%). The mean age of participants was 53.1 years in the ETR cohort and 48.7 years in the PPR cohort. Body mass index (BMI) measurements indicated that, overall, 69.0 percent were classified as overweight or obese. Overall, approximately two-thirds of the participants were female; 95.7 percent were Caucasian. More than 99 percent had an education level of a high school diploma or higher, and more than 90 percent had private medical insurance and prescription drug coverage. Participants in the ETR and PPR cohorts expressed dissatisfaction with their appearance and negative feelings about their appearance because of their rosacea symptoms (Table 1). A small proportion of subjects in either cohort agreed or strongly agreed that they were satisfied with their facial appearance due to rosacea (Table 1), and almost half (45%) of the ETR cohort and 53 percent of the PPR cohort disagreed or strongly disagreed that they were satisfied with their facial appearance due to rosacea.