Abstract

ObjectiveTo 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.MethodsUsing 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.ResultsThere 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, self-consciousness, 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.ConclusionThe 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.

Highlights

  • Skin, or seborrhea (ICD-9 code 706.3), [1,2,3] is a common condition affecting men and women, typically between puberty and about 60 years of age

  • The health-related quality of life (HRQL) domains that were covered by acne and more general dermatology patient-reported outcome (PRO) did suggest a common set of concerns for patients with dermatologic conditions that might 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)

  • The aim was to develop PROs that would meet standards for development and validation recommended by regulatory authorities, and be acceptable as endpoints in clinical trials and as the basis of labeling or promotional claims. [11,12] This paper reports on the qualitative meth

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Summary

Introduction

Seborrhea (ICD-9 code 706.3), [1,2,3] 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. Various studies have estimated 66% to 75% aged 15–20 years are affected.[5,6,7] Surveys have found that sufferers feel ugly, uncomfortable or unkempt and annoyed by the condition

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