Fig 1.
PRISMA flow diagram showing the study selection and exclusion process.
In total, 85 prospective studies with a clinical outcome measure published since 2005 were included. Abbreviations: PWS, port wine stain.
Fig 2.
Stratification of the study designs used in the included studies.
Studies with a control group (controlled studies) allocated different treatments to different treatment sites within individual patients (within-patient controlled) or to different patients (between-patients controlled).
Fig 3.
Stratification of all outcome measures.
Note that the secondary percentages are relative to the primary variable and that their sum can exceed 100% as single studies assessed multiple outcomes (e.g., some studies used both a relative and static measure of treatment efficacy). Abbreviations: DMV, depth measuring videomicroscopy; FS, fluorescence spectrometry; HFUS, high-frequency ultrasound; LDI, laser Doppler imaging; LSCI, laser speckle contrast imaging, NS, not specified; PWS, port wine stain; RCM, reflectance confocal microscopy.
Table 1.
Measures and scoring systems used for observer/clinician-reported efficacy assessments in prospective PWS trials from 2005 to May 2020.
Fig 4.
Scoring systems used to classify observer/clinician-reported percentage ‘improvement’, ‘lightening’, ‘clearance’ or ‘blanching’ for global assessment of port wine stain improvement.
The percentage-based scoring systems in Table 1 were stratified according to their categories.
Table 2.
Patient- and parent-reported outcome measures and scoring systems in prospective trials from 2005 to May 2020.
Table 3.
Outcomes of objective instruments.
Fig 5.
Mean Downs and Black checklist scores per item for controlled and uncontrolled studies.
Item numbers are indicated within the outer ring. For uncontrolled studies, items 14, 15, 21–25, and 27 were considered irrelevant and were therefore omitted. All scores are normalized to 1 inasmuch as one item (#5) has a maximum score of 2 instead of 1.
Fig 6.
Trends in quality of published studies.
The stacked columns show the absolute annual number of published studies stratified by Downs and Black checklist scores. The year 2020 (N = 1 ‘good’ quality study) was omitted because it is incomplete. No studies of ‘excellent’ quality were found.
Fig 7.
The professional background of the evaluator who performed the primary efficacy assessment.
Three studies used a panel of evaluators with different professional backgrounds (compositions were: a physician and a dermatologist; a plastic surgeon and a dermatologist, and a plastic surgeon, medical student, and investigator). Studies with ‘experts’ did not specify the experts’ background. Abbreviations: NL, not listed.