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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014