Core Outcome Measures in Effectiveness Trials

Reporting of outcomes in randomised controlled trials on nail psoriasis; a Systematic Review.

General Information

Abstract:
Harmonization of outcome measures is needed to increase the value of clinical trials on nail psoriasis. To provide the first step in core outcome set (COS) development, a systematic review was conducted to identify outcome domains and instruments reported in (ongoing) randomised controlled trials (RCTs) on nail psoriasis. Identified outcome domains included clinical signs, quality of life, symptoms and delivery of care. A NAPSI was most commonly used to assess clinical signs (73.8% of studies). Other outcome instruments used included the NAS, composite fingernail score, a physician global assessment, individual nail features or a combination of these. Heterogeneity in type and reporting (e.g. NAPSI 50, NAPSI 75) of outcome instruments was high and characteristics were often insufficient reported. 43.1% of studies assessed quality of life, with 3.1% of studies using a nail psoriasis specific tool. Assessment of symptoms and delivery of care was limited. In conclusion, heterogeneity in type and reporting of nail psoriasis outcome instruments needs to be addressed in the process towards COS development. Sufficient reporting of instrument characteristics should be encouraged. As nail psoriasis is generally assessed secondary to psoriasis of the skin or joints, collaboration between different research groups in COS development is needed. This article is protected by copyright. All rights reserved.

Aim:
A systematic review was conducted to identify outcome domains and instruments reported in (ongoing) randomised controlled trials (RCTs) on nail psoriasis.

Authors:
Busard CIM, Nolte JYC, Pasch MC, Spuls PI

Publication

Journal:
British Journal of Dermatology
Volume:
Issue:
Pages:
-
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):
Not supported by funding

Health Area

Disease Category
Skin

Disease Name
Nail psoriasis

Target Population

Age Range
0 - 110

Sex
Either


Nature / type of Intervention
Any

Method(s)

Systematic review

Stakeholders Involved

Researchers

Study Type

Systematic review of outcomes measured in trials

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