Health and Quality of Life Outcomes

Objective: To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods: Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. Results: There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, selfconsciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. Conclusion: The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures reported elsewhere. Published: 16 October 2008 Health and Quality of Life Outcomes 2008, 6:80 doi:10.1186/1477-7525-6-80 Received: 18 April 2008 Accepted: 16 October 2008 This article is available from: http://www.hqlo. com/content/6/1/80 © 2008 Arbuckle et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Page 1 of 15 (page number not for citation purposes) Health and Quality of Life Outcomes 2008, 6:80 http://www.hqlo. com/content/6/1/80 Introduction Oily skin, or seborrhea (ICD-9 code 706.3), [1-3] is a common condition affecting men and women, typically between puberty and about 60 years of age. It is characterized by the production of a quantity of sebum which is excessive for the age and sex of the individual. Although excessive sebum production has minimal physical impact on body function, chronic oily skin can cause significant concern for people who have the condition. [4] Oily skin appears greasy and shiny, contributes to the development of acne, and is frequently accompanied by large pores on the face. [5] The consequences of excess sebum may be associated with adverse psychological and social effects resulting from associated acne and the appearance of skin oiliness and shine. Various studies have estimated 66% to 75% aged 15–20 years are affected. [5-7] Surveys have also found that sufferers feel ugly, uncomfortable or unkempt and annoyed by the condition. Given that the experience of having oily skin is personal and subjective, validated patient-reported outcome (PRO) measures of severity of oily skin and its impact should be included in any clinical trials seeking to evaluate treatments for the condition. With this in mind, a review of the literature was conducted, but failed to identify any existing PRO measures specific to oily skin. However, since this work was completed, one oily skin specific PRO has been published, the Oily Skin Self Image Questionnaire (OSSIQ). [4] Differences and areas of convergence between the OSSIQ and the measures developed here are examined in the discussion of this article. The literature review identified only one other dermatology instrument which included any oily skin symptom assessment questions (the Acne-Specific Health Related Quality of Life Instrument). [8-10] The health-related quality of life (HRQL) domains that were covered by acne and more general dermatology PROs did suggest a common set of concerns for patients with dermatologic conditions that might also be relevant to those with oily skin (e.g., Symptom Assessment & Impact, Emotional Distress, Coping & Functioning, Negative Image & Appearance, Self-Consciousness, Esteem & Confidence, Social Relationships & Stigma). Due to the absence of validated PRO measures specific to the assessment of oily skin symptoms and its impact, an instrument development program was initiated. The aim was to develop PROs that would meet standards for development and validation recommended by regulatory authorities, and thus be acceptable as endpoints in clinical trials and as the basis of labeling or promotional claims. [11,12] This paper reports on the qualitative methods and findings from preliminary content discovery and validation of items used as the basis for two new PRO measures. Aims and conceptual basis for development of oily skin assessments The following conceptual measurement objectives were developed based on the results of treatment satisfaction focus groups, a review of the research literature, and input from three dermatologists with expertise in oily skin and acne: 1. To identify the characteristics of skin oiliness that are commonly used by patients to know that their skin is oily, 2. To assess the different methods or techniques that individuals' use to self-assess these characteristics or symptoms, 3. To account for the biophysical and environmental conditions which impact or co-vary with self-assessed skin oiliness, 4. To evaluate the impact on patients' daily activities and emotional well-being. These conceptual objectives were used to design a Discussion Guide for the Internet Focus Groups (IFGs). Methods Overview An overview of the study methods is provided in Figure 1. Participants • Initial treatment satisfaction focus groups were conducted with 62 adults with oily skin. In total, seven groups were conducted in the USA: six groups conducted in US English (n = 53); and one in US Spanish (n = 9). • Exploratory IFGs were conducted involving a total of 54 participants with oily skin: 26 in Germany and 28 in the US. • Of the 54 participants from the IFGs, 42 later participated in online cognitive debriefing, 8 in Germany and 24 in the USA. An additional 5 adults with oily skin in the US who had not participated in any of the focus groups participated in face to face cognitive debriefing interviews. Methods for participant recruitment Participants were recruited through newspaper advertisements, the internet, and through GPs and dermatologists. A range of methods of recruitment was used to ensure the sample included both participants who were consulting Page 2 of 15 (page number not for citation purposes) Health and Quality of Life Outcomes 2008, 6:80 http://www.hqlo. com/content/6/1/80 Page 3 of 15 (page number not for citation purposes) Study Overview Figure 1 Study Overview. This is a word file that provides a flow chart providing an overview of the study Figure 1. Study Overview. Review by Expert Clinicians (3 dermatologists) Review of the literature no existing PRO measures of oily skin were identified Initial Treatment Satisfaction Focus Groups (62 subjects) Conceptual basis for development of oily skin PROs Input from Expert Clinicians (3 dermatologists) Development of an IFG Discussion Guide Four Days of IFGs with German (26 subjects) and US (28 subjects) participants (total 54 subjects) to assess perceptions and impact of facial oily skin Item Generation based on qualitative analysis of verbatim transcripts from IFGs Internet Cognitive Debriefing (42 subjects) with German and US participants Face to Face Cognitive Debriefing in US (5 subjects) Revisions to items and instructions Health and Quality of Life Outcomes 2008, 6:80 http://www.hqlo. com/content/6/1/80 with a physician about their oily skin, and others who were not. The screening of candidates for participation specified that: • all participants had to have self-perceived problems with oily skin • all were actively trying to control their symptoms of oily skin, and • all were interested in, or currently seeking, some form of treatment for their oily skin condition In order to help assure the relevance of these content development activities to different gender, ethnic and acne subgroups, the IFG screening criteria was designed to ensure broad demographic representation (age, sex, ethnicity) and included some participants who had been treated by a physician for mild to moderate acne in the last 2 years. Initial face to face treatment satisfaction focus groups Existing findings from face to face focus groups conducted with adults with oily skin to investigate treatment satisfaction with oily skin products were reviewed to identify potential domains that would be important to include in measures of facial oily skin and its impact. Internet focus group methodology Four IFGs (two in Germany and two in the US) were conducted over four days during which participants answered sets of questions on a particular topic each day (based on the conceptual objectives listed above). Within the password-protected IFGs, participants read and answered open-ended questions, responded to focused probes posted by the moderators, and responded to the opinions of other participants. Unlike traditional focus groups, respondents' worked on their own schedul