IN A SYSTEMATIC

clinical trials for the product. METHODS: A targeted literature review was conducted in PubMed from 2004 to 2014 for six products (Atopiclair for atopic dermatitis, botulinum toxin type A for hyperhidrosis, calcipotriol plus betametha-sone dipropionate gel for scalp psoriasis, pimecrolimus and tacrolimus for atopic dermatitis, and ustekinumab for psoriasis. Regulatory and health technology agency websites and publications were searched for documentation of PRO label claims and mentions. RESULTS: For patients, inclusion of PROs ensured the full benefit of the was demonstrated, including improvement in symptoms, quality of life, and/or treatment satisfaction. For prescribers, comparative trials reported PRO data information on each benefits and risks and also which was superior from the patient perspective. For regulators, for all except one of the six products, PROs were included in the product label. For payers, utility values based on PROs were used in cost-effectiveness evaluations for three of the six products. For the manufacturer, the PRO data generated label claims and many publications that allowed extensive public dissemination of product benefits. CONCLUSIONS: Patient-reported assessment of the treatment impact on disease during drug devel- opment has many benefits for all stakeholders. A draft patient-reported outcome measure for psoriasis treatment (PROMPT) developed through and comprised 91 items across seven core This study aimed to evaluate the scaling proper- ties and construct validity of the draft measure using the Rasch measurement model. METHODS: Patients with chronic were identified and according to and pso-riasis-specific two Patients completed the draft at two time points, days apart. Respondents of missing data were removed from the final analyses. Data from each sub-scale were analyzed separately using RUMM2030 software to explore Rasch model fit, item difficulty, local dependence, item cat- egory thresholds, and differential item functioning (DIF) by age and gender. Where necessary, items were removed individually and the scale iteratively reassessed for fit and unidimensionality. RESULTS: A sample of n = 209 patients with chronic plaque psoriasis completed the draft measure. Initial fit to the model was poor; disordered category thresholds were identified for items in all scales. Post-hocre-scoring from a 5-point Likert scale to a 3-point Likert scale improved model fit. Items which showed local dependence were removed in context of qualitative findings. Following removal of 11 items, all 7 scales demonstrated acceptable fit with the Rasch model (Chi Sq = 0.09 to 0.2) There was no evidence of DIF by age and gender. CONCLUSIONS: The new measure, PROMPT, comprised 80 items in 6 independent, unidimensional scales, free from age or gender bias, with acceptable fit to the Rasch model. As such, the measure is considered to show initial promise for use with patients with chronic plaque psoriasis in a clinical setting. The psy-chometric properties and scoring of the measure should be explored further and confirmed in future studies. RESULTS: The literature input from a range of Results well. Forty subjects com- pleted the observational study (females = 58%; Caucasian = 65%; and age [mean] = 41 years). The HSIA and HSSA scores were found to perform well psychometrically, with strong evidence of test-retest (ICC = 0.92 and 0.80, respectively) and internal consistency ( α = 0.97 and 0.96, respectively) reliability and known groups (P < 0.001 and P < 0.006, respectively) and construct-related validity (via correlations between the target measures and other, concurrently administered tools). CONCLUSIONS: There is robust evidence supporting the HSIA and HSSA as content valid and psychometrically sound questionnaires for assessing symptoms and impacts in patients with HS. OBJECTIVES: Visual acuity does not fully capture the effect of geographic atrophy (GA), secondary to age-related macular degeneration, on visual function. The Functional Reading Independence (FRI) Index is a 7-item patient-reported measure developed for use in GA trials. This study examined the sensitivity of the FRI Index to change in GA lesion size. METHODS: Post hoc analyses were conducted with data from MAHALO, a phase 2 study of lampalizumab, a complement factor monoclonal antibody fragment, for treatment of GA. For each reading activity performed in the past 7 days (e.g., writing checks or reading medicine labels), patients were asked the extent to which they required vision aids, adjustments in the activity, or translated into universal Spanish according to industry standard methodology. After the translation was completed, five Spanish-speaking patients in the US diag-nosed with chronic idiopathic urticaria completed the translated questionnaire and participated in a cognitive debriefing interview. Interviews were conducted using a standardized guide to assess the relevance, understandability, and appropriateness of the translations. Qualitative analyses were performed to ensure equivalence and that the content validity of the U-AIM was maintained for the Spanish version. RESULTS: Of the five patients (40% male), the mean age of four was 37 years [one patient did not report his age]. All U-AIM items were well understood and proved relevant to the patients in this sample. Of interest, terms such as, “urticaria,” “hives,” “angioedema” and “rapid swelling” were clearly understood as intended. CONCLUSIONS: The results indicate that the Spanish version of the U-AIM translation is conceptually equivalent to the English source version and easily understood by the target population in the US. We consider the translation to be acceptable for PRO assessment in research and clinical practice. Future research could include testing of the questionnaire with patients in other Spanish-speaking countries to confirm its acceptability beyond the US.