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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
History of Changes
  Purpose

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.


Condition Intervention
Healthy Volunteers
 Drug: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Enrollment: 112
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All Participants
Healthy volunteers. No treatment (intervention) was received.
 Drug: No Intervention
No Intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Volunteers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412086

Locations
United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01412086     History of Changes
Other Study ID Numbers: 192024-068
Study First Received: August 5, 2011
Results First Received: September 27, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013