PLoS ONE (Jan 2020)

Clinical outcome measures and scoring systems used in prospective studies of port wine stains: A systematic review.

  • M Ingmar van Raath,
  • Sandeep Chohan,
  • Albert Wolkerstorfer,
  • Chantal M A M van der Horst,
  • Jacqueline Limpens,
  • Xuan Huang,
  • Baoyue Ding,
  • Gert Storm,
  • René R W J van der Hulst,
  • Michal Heger

DOI
https://doi.org/10.1371/journal.pone.0235657
Journal volume & issue
Vol. 15, no. 7
p. e0235657

Abstract

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BACKGROUND:Valid and reliable outcome measures are needed to determine and compare treatment results of port wine stain (PWS) studies. Besides, uniformity in outcome measures is crucial to enable inter-study comparisons and meta-analyses. This study aimed to assess the heterogeneity in reported PWS outcome measures by mapping the (clinical) outcome measures currently used in prospective PWS studies. METHODS:OVID MEDLINE, OVID Embase, and CENTRAL were searched for prospective PWS studies published from 2005 to May 2020. Interventional studies with a clinical efficacy assessment were included. Two reviewers independently evaluated methodological quality using a modified Downs and Black checklist. RESULTS:In total, 85 studies comprising 3,310 patients were included in which 94 clinician/observer-reported clinical efficacy assessments had been performed using 46 different scoring systems. Eighty-one- studies employed a global assessment of PWS appearance/improvement, of which -82% was expressed as percentage improvement and categorized in 26 different scoring systems. A wide variety of other global and multi-item scoring systems was identified. As a result of outcome heterogeneity and insufficient data reporting, only 44% of studies could be directly compared. A minority of studies included patient-reported or objective outcomes. Thirteen studies of good quality were found. CONCLUSION:Clinical PWS outcomes are highly heterogeneous, which hampers study comparisons and meta-analyses. Consensus-based development of a core outcome-set would benefit future research and clinical practice, especially considering the lack of high-quality trials.