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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412086
• Other study ID #: 192024-068
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: September 27, 2012
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• No Intervention
No Intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale	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.	Day 1	No
Primary	Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale	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.	Day 1	No