Open Access Highly Accessed Study protocol

The efficacy of a health-related quality-of-life intervention during 48 weeks of biologic treatment of patients with moderate to severe psoriasis: study protocol for a multicenter randomized controlled trial

Cecilia AC Prinsen13*, Phyllis I Spuls1, Mirjam AG Sprangers2, Menno A de Rie1, Catharina M Legierse1 and John de Korte1

Author Affiliations

1 Academic Medical Center, Department of Dermatology, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

2 Academic Medical Center, Department of Medical Psychology, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

3 Academic Medical Center, Department of Dermatology, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands

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Trials 2012, 13:236  doi:10.1186/1745-6215-13-236

Published: 8 December 2012

Abstract

Background

Interest in health-related quality of life (HRQoL) outcome research in dermatology is increasing, especially in the systemic treatment of psoriasis with biologic agents. In other specialties, such as oncology, the application of a HRQoL intervention is considered to be an aid for monitoring disease and treatment over time, for the communication with the patient, and for improving treatment outcome. However, in dermatology practice, the application of this intervention is relatively new. Moreover, evidence on the effectiveness of a HRQoL intervention in dermatology is missing. It is hypothesized that the application of a HRQoL intervention in dermatology practice will have a positive impact on patients’ HRQoL as well as on doctor-patient communication.

Methods/design

In a prospective multicenter cluster randomized controlled trial, patients diagnosed with moderate to severe psoriasis who receive biologic treatment, will be followed for 48 weeks. The study sites, and not the patients, will be randomly allocated via a computer-based randomization system to either the intervention (treatment with etanercept and standardized HRQoL assessment and communication) or the control group (treatment with etanercept alone). The HRQoL intervention will include 1) the electronic assessment of the Skindex-29, a well-studied dermatology-specific HRQoL questionnaire, and 2) the communication of the resulting Skindex-29 data with the patient. Prior to study start, dermatologists in the intervention group will be educated and trained in standardized HRQoL assessment and communication using the Skindex-29. At six consecutive visits, patients at study sites in the intervention group will be asked to complete the Skindex-29 on a desk-top pc at the clinic, just before their consultation with the dermatologist. A print-out of the completed questionnaire will be made and, guided by this print-out, feedback on the HRQoL scores will be given during the consultation. Primary outcome parameters are the impact of the HRQoL intervention on patients’ HRQoL, and the effect of the HRQoL intervention on doctor-patient communication. Secondary outcomes include health status and disease severity.

Trial registration

The Netherlands National Trial Register (NTR): NTR1364.

Keywords:
Dermatology; Randomized controlled trial; Patient-reported outcomes; Health-related quality of life; Intervention; Skindex-29; Psoriasis; Biologic; Etanercept