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Using the Vitiligo Noticeability Scale in clinical trials: construct validity, interpretability, reliability and

Jonathan M Batchelor1,2, Sonia Gran1, Paul Leighton1

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Summary
This summary is machine-generated.

The Vitiligo Noticeability Scale (VNS) is a reliable and acceptable patient-reported outcome measure for vitiligo trials. A VNS score of 3 indicates treatment success for many patients, regardless of age or skin type.

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Area of Science:

  • Dermatology
  • Clinical Trials
  • Psychometrics

Background:

  • Validated outcome measures are crucial for vitiligo clinical trials.
  • The Vitiligo Noticeability Scale (VNS) is a patient-reported outcome measure (PROM) developed with vitiligo patients.

Purpose of the Study:

  • To assess the construct validity, interpretability, reliability, and acceptability of the VNS.
  • To compare VNS assessments with clinician-reported outcomes and patient perceptions.

Main Methods:

  • Utilized data from the HI-Light Vitiligo trial, including images and outcome data.
  • Compared participant assessments with clinician and independent panel (Patient and Public Involvement) assessments.
  • Employed hypothesis testing for psychometric properties and kappa statistics for agreement.
  • Gathered qualitative insights through focus groups and online discussions.

Main Results:

  • VNS demonstrated a positive association with participant-reported treatment success (κ=0.41 to 0.71).
  • VNS showed higher agreement with participant success than clinician-reported repigmentation (κ=0.41 vs. 0.17).
  • Seventy-five percent of participants considered a VNS score of 3 (partial response) as treatment success.
  • Good test-retest reliability was observed (κ=0.69).
  • VNS interpretation was not influenced by age or skin phototype.

Conclusions:

  • The VNS is a valid, reliable, and acceptable PROM for vitiligo patients across all ages and skin types.
  • A VNS score of 3 or higher is a meaningful indicator of treatment success for patients.
  • Transparency in reporting all VNS levels is recommended for trial interpretation and meta-analysis.
  • Participant and independent observer assessments of VNS may differ, suggesting blinding of participants is beneficial.