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

Tracking Information

First Received Date ^ICMJE

August 5, 2011

Last Updated Date

September 27, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01412086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: No Intervention

No Intervention.

Study Group/Cohort (s)

All Participants

Healthy volunteers. No treatment (intervention) was received.

Intervention: Drug: No Intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

112

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01412086

Other Study ID Numbers ^ICMJE

192024-068

Has Data Monitoring Committee

Responsible Party

Allergan

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

September 2012

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

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