Publications by authors named "Dina Chau"
Background: Patient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process.
View Article and Find Full Text PDFObjectives: The study sought to review the characteristics of existing patient-reported outcome (PRO) instruments used with chronic heart failure (HF) patients and evaluate their potential to support an approved U.S. Food and Drug Administration (FDA) product label claim.
View Article and Find Full Text PDFObjective: To evaluate the effect of brodalumab on psoriasis signs and symptoms assessed by the Psoriasis Symptom Inventory (PSI) in patients with psoriatic arthritis (PsA).
Methods: This prespecified analysis of a phase II study (NCT01516957) evaluated patients with active PsA and psoriasis-affected body surface area ≥ 3%, randomized to brodalumab (140 or 280 mg) or placebo every 2 weeks (Q2W) for 12 weeks with loading dose at Week 1. At Week 12, patients entering an open-label extension received brodalumab 280 mg Q2W.
Introduction: The Psoriasis Symptom Inventory is a patient-reported outcome instrument that assesses severity of psoriasis signs and symptoms. In early qualitative research, patients reported pain related to psoriasis skin lesions and redness of affected areas of skin as key symptoms.
Methods: Individual concept elicitation interviews and cognitive interviews were conducted in adults with moderate to severe plaque psoriasis.
Background: Newer therapies provide high levels of skin clearance in patients with moderate to severe psoriasis. However, insufficient evidence exists on the impact of total skin clearance from the patient's perspective.
Objectives: To examine effects of total skin clearance on health-related quality of life (HRQoL) and psoriasis symptom severity in subjects with moderate to severe psoriasis.
Purpose: To evaluate the equivalence of electronic and paper versions of the Psoriasis Symptom Inventory and to examine measurement properties of the electronic version.
Methods: In a prospective, randomized, crossover, non-interventional study in adult subjects (age ≥18 years) with plaque psoriasis conducted over a period of 15 days, subjects were randomized to two groups, completing either the paper or electronic Psoriasis Symptom Inventory daily for 7 consecutive days followed by the alternate version. Equivalence was assessed by the intraclass correlation coefficient (ICC) between both administration modes.
Background: In the UK, referrals to specialists are initiated by general practitioners (GPs). Study objectives were to estimate the incidence of diagnosed psoriasis in the UK and identify factors associated with GP referrals to dermatologists.
Methods: Newly diagnosed patients with psoriasis were identified in The Health Improvement Network (THIN) database between 01 July 2007-31 Oct 2009.
Objectives: The psoriasis symptom inventory (PSI) is a patient-reported outcome measure for assessing symptom severity in patients with moderate-to-severe psoriasis. The primary objective of this study was to evaluate the measurement properties of the PSI.
Materials And Methods: Analyses of psychometric characteristics (reliability, convergent and known-groups validity,responsiveness, item performance, and dimensionality) were conducted using data from a Phase II trail to evaluate efficacy of brodalumab in subjects with moderate-to-severe psoriasis.
Objective: To describe biologic treatment patterns and effectiveness among patients with psoriasis who initiated biologic therapy.
Methods: A chart review was conducted for 169 patients with psoriasis initiating biologic treatment between 1 July 2005 and 30 June 2009 from six dermatology clinics. Severity was measured by the Psoriasis Area and Severity Index (PASI) at baseline and time of treatment change.
Objective: To develop and assess content validity of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome (PRO) measure of psoriasis symptoms.
Methods: Following initial literature exploration and input from experts, concept elicitation was conducted in two rounds (focus groups and individual interviews) with 59 subjects with mild to severe psoriasis. Transcripts were coded to identify symptom concepts and develop a conceptual framework using ATLAS.
Background: Data investigating the effect of etanercept on work productivity and healthcare resource utilization in Canadian patients in a clinical setting is limited.
Objective: The aim of the study was to describe work productivity and healthcare resource utilization in patients with psoriasis prescribed etanercept.
Methods: A 12-month, phase IV, non-randomized, multicentre, open-label, single-arm prospective trial of patients with moderate-to-severe plaque psoriasis was conducted between March 2006 and July 2009 in 37 community dermatology practice sites across Canada.