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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2003

Open Access 01-12-2003 | Research

Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

Authors: Richard Shikiar, Brian W Bresnahan, Stephen P Stone, Christine Thompson, John Koo, Dennis A Revicki

Published in: Health and Quality of Life Outcomes | Issue 1/2003

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Abstract

Background

Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials.

Objective

To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI), the Psoriasis Symptom Assessment (PSA) Scale, and two itch measures, a Visual Analog Scale (VAS) and the National Psoriasis Foundation (NPF) itch measure.

Methods

Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095). Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change) assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial.

Results

Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes.

Conclusions

The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology-related limitations of functional ability and the frequency, severity and impact of psoriasis symptoms on patients' lives and psoriasis-related quality of life.
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Metadata
Title
Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials
Authors
Richard Shikiar
Brian W Bresnahan
Stephen P Stone
Christine Thompson
John Koo
Dennis A Revicki
Publication date
01-12-2003
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2003
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-1-53

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