Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01412086
First received: August 5, 2011
Last updated: September 27, 2012
Last verified: September 2012

August 5, 2011
September 27, 2012
August 2011
September 2011   (final data collection date for primary outcome measure)
  • Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 112 subjects' eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W was provided.
  • Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided.
  • Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale with Photonumeric Guide [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale with Photonumeric Guide [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01412086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale
Not Provided

This study evaluated the inter- and intra-rater reliability of the GEBA Scale with photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment (intervention) associated with this study.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy Volunteers

Healthy Volunteers
Drug: No Intervention
No Intervention.
All Participants
Healthy volunteers. No treatment (intervention) was received.
Intervention: Drug: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing to remove makeup and jewelry at each visit
  • Willing to have photographs taken of the facial area

Exclusion Criteria:

  • Permanent eyebrow makeup (i.e., tattooing) or eyebrow implants of any kind
  • Eyebrow extension application within 3 months of study entry
  • Eyebrow tint or dye application within 2 months of study entry
  • Eyebrow grooming (i.e., tweezing, waxing, or threading) between visits that is not part of the current routine
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01412086
192024-068
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP