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Validity and sensitivity to change of laser Doppler imaging as a novel objective outcome measure for cutaneous lupus erythematosus.

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  • معلومة اضافية
    • المصدر:
      Publisher: SAGE Publications Country of Publication: England NLM ID: 9204265 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-0962 (Electronic) Linking ISSN: 09612033 NLM ISO Abbreviation: Lupus Subsets: MEDLINE
    • بيانات النشر:
      Publication: London : SAGE Publications
      Original Publication: Houndmills, Basingstoke, Hampshire, UK : Scientific & Medical Division, Macmillan Press Ltd., c1991-
    • الموضوع:
      Laser-Doppler Flowmetry* ; Outcome Assessment, Health Care*; Lupus Erythematosus, Cutaneous/*diagnostic imaging ; Lupus Erythematosus, Systemic/*diagnostic imaging; Adult ; Biopsy ; Cohort Studies ; Female ; Humans ; Male ; Middle Aged ; Observer Variation ; Prospective Studies ; Reproducibility of Results ; Sensitivity and Specificity
    • نبذة مختصرة :
      Objectives: The objectives of this study were to assess the reliability of a novel objective outcome measure, laser Doppler imaging (LDI), its validity against skin biopsy histology and other clinical instruments, including localized cutaneous lupus disease area and severity index (L-CLASI) and visual analogue scale (VAS) score of photographs, and its responsiveness to clinical change with therapy.
      Methods: A prospective observational cohort study was conducted in 30 patients with active cutaneous lupus erythematosus (CLE). At baseline and 3 months, disease activity was assessed using L-CLASI and a high resolution LDI system by two assessors. Skin biopsy was scored as 0 = non-active, 1 = mild activity and 2 = active. Photographs were assessed by two clinicians using 100 mm VAS. Inter-rater reliability was analyzed using Bland-Altman limits of agreement. Correlation between histology and LDI, L-CLASI and VAS and sensitivity to change of LDI with physician subjective assessment of change (PSAC) at 3 months were analyzed using Kendall's tau-a.
      Results: Of 30 patients with CLE, 28 (93%) were female, mean (SD) age 48.4 (11.5) y, 25 (83%) were Caucasians, 25 (83%) had concurrent systemic lupus erythematosus and 16 (53%) were smokers. CLE subtypes were acute = 9, subacute = 8 and chronic = 13. Inter-rater agreement for LDI was fair but for VAS score of photographs was poor. In 20 patients with biopsy, correlation with histology was better for LDI (tau-a = 0.53) than L-CLASI (tau-a = 0.26) (difference = 0.27; 90% CI 0.05-0.49) or VAS score of photographs (tau-a = 0.17) (difference = 0.36; 90% CI 0.04-0.68). There was a moderate correlation between PSAC score and change in LDI (tau-a = 0.56; 90% CI 0.38-0.74; p  < 0.001, n  = 15).
      Conclusion: LDI provides a reliable, valid and responsive quantitative measure of inflammation in CLE. It has a better correlation with histology compared to clinical instruments. LDI provides an objective outcome measure for clinical trials.
    • Grant Information:
      DRF-2014-07-155 United Kingdom DH_ Department of Health; MR/M01665X/1 United Kingdom MRC_ Medical Research Council; MRF_MRF-159-0003-ELP-VITAL United Kingdom MRF MRF; CS-2013-13-032 United Kingdom DH_ Department of Health; RTF/01/097 United Kingdom DH_ Department of Health
    • Contributed Indexing:
      Keywords: Cutaneous lupus; Doppler; imaging; outcome measure; systemic lupus erythematosus
    • الموضوع:
      Date Created: 20190917 Date Completed: 20200220 Latest Revision: 20220720
    • الموضوع:
      20240829
    • الرقم المعرف:
      10.1177/0961203319873977
    • الرقم المعرف:
      31522626