RESUMO
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, 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. 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.
Assuntos
Acne Vulgar/psicologia , Dermatite Seborreica/psicologia , Psicometria/instrumentação , Qualidade de Vida , Autoimagem , Perfil de Impacto da Doença , Inquéritos e Questionários , Acne Vulgar/fisiopatologia , Acne Vulgar/terapia , Atividades Cotidianas , Adulto , Comparação Transcultural , Dermatite Seborreica/fisiopatologia , Dermatite Seborreica/terapia , Face/fisiopatologia , Feminino , Grupos Focais , Alemanha , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
OBJECTIVES: This proof of concept (POC) study was designed to evaluate the use of an Internet-based bulletin board technology to aid parallel cross-cultural development of thematic content for a new set of patient-reported outcome measures (PROs). METHODS: The POC study, conducted in Germany and the United States, utilized Internet Focus Groups (IFGs) to assure the validity of new PRO items across the two cultures--all items were designed to assess the impact of excess facial oil on individuals' lives. The on-line IFG activities were modeled after traditional face-to-face focus groups and organized by a common 'Topic' Guide designed with input from thought leaders in dermatology and health outcomes research. The two sets of IFGs were professionally moderated in the native language of each country. IFG moderators coded the thematic content of transcripts, and a frequency analysis of code endorsement was used to identify areas of content similarity and difference between the two countries. Based on this information, draft PRO items were designed and a majority (80%) of the original participants returned to rate the relative importance of the newly designed questions. FINDINGS: The use of parallel cross-cultural content analysis of IFG transcripts permitted identification of the major content themes in each country as well as exploration of the possible reasons for any observed differences between the countries. Results from coded frequency counts and transcript reviews informed the design and wording of the test questions for the future PRO instrument(s). Subsequent ratings of item importance also deepened our understanding of potential areas of cross-cultural difference, differences that would be explored over the course of future validation studies involving these PROs. CONCLUSION: The use of IFGs for cross-cultural content development received positive reviews from participants and was found to be both cost and time effective. The novel thematic coding methodology provided an empirical platform on which to develop culturally sensitive questionnaire content using the natural language of participants. Overall, the IFG responses and thematic analyses provided a thorough evaluation of similarities and differences in cross-cultural themes, which in turn acted as a sound base for the development of new PRO questionnaires.
Assuntos
Atitude Frente a Saúde , Comparação Transcultural , Dermatologia/instrumentação , Avaliação de Resultados em Cuidados de Saúde/métodos , Psicometria/métodos , Dermatopatias/psicologia , Face/patologia , Grupos Focais , Alemanha , Humanos , Internet , Couro Cabeludo/patologia , Sebo , Dermatopatias/etnologia , Estados UnidosRESUMO
PURPOSE: To validate the treatment-specific Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP). METHODS: Item content was developed by 4 heterogeneous patient focus groups (n = 32). Instrument validation involved 250 patients on ocular hypotensive medications recruited from ophthalmology practices in the Southern USA. Participants responded to demographic and test questions during a clinic visit. Standard psychometric analyses were performed on the resulting data. SAMPLE: Of the 412 patients screened, 253 consented to participate, and 250 provided complete datasets. The sample included 44% male (n = 109), 44% Black (n = 109) and 57% brown eyed (n = 142) participants, with a mean age of 64.6 years (SD 13.1) and a history of elevated IOP for an average of 8.4 yrs (SD 7.8). A majority was receiving monotherapy (60%, n = 151). RESULTS: A PC Factor analysis (w/ varimax rotation) of the 31 items yielded 5 factors (Eigenvalues > 1.0) explaining 70% of the total variance. Weaker and conceptually redundant items were removed and the remaining 15 items reanalyzed. The satisfaction factors were; Eye Irritation (EI; 4 items), Convenience of Use (CofU; 3 items), Ease of Use (EofU; 3 items), Hyperemia (HYP; 3 items), and Medication Effectiveness (EFF; 2 items). Chronbach's Alphas ranged from.80 to.86. Greater distributional skew was found for less common experiences (i.e., HYP & EI with 65% & 48.4% ceilings) than for more common experiences (i.e., EofU, CofU, EFF with 10.8%, 20.8% & 15.9% ceilings). TSS-IOP scales converged with conceptually related scales on a previously validated measure of treatment satisfaction, the TSQM (r =.36 to.77). Evidence of concurrent criterion-related validity was found. Patients' symptomatic ratings of eye irritation, hyperemia and difficulties using the medication correlated with satisfaction on these dimensions (r =.30-.56, all p <.001). Clinicians' ratings of IOP control, severity of side effects and problematic medication use correlated with patients' satisfaction scores on these dimensions (r =.13-.26, all p <.01). CONCLUSIONS: This study provides initial evidence that the TSS-IOP is a reliable and valid measure, assessing patients' satisfaction with ocular hypotensive medications.