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

Summary

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.

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