Trial Outcomes & Findings for Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale (NCT NCT01412086)
NCT ID: NCT01412086
Last Updated: 2012-10-29
Results Overview
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.
COMPLETED
112 participants
Day 1
2012-10-29
Participant Flow
Participant milestones
| Measure |
All Participants
Healthy volunteers. No treatment (intervention) was received.
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale
Baseline characteristics by cohort
| Measure |
All Participants
n=112 Participants
Healthy volunteers. No treatment (intervention) was received.
|
|---|---|
|
Age Continuous
|
44.3 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Inter-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.
Outcome measures
| Measure |
All Participants
n=112 Participants
Healthy volunteers. No treatment (intervention) was received.
|
|---|---|
|
Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale
|
0.889 Kendall's W
Interval 0.695 to 1.0
|
PRIMARY outcome
Timeframe: Day 1Population: All enrolled participants.
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.
Outcome measures
| Measure |
All Participants
n=112 Participants
Healthy volunteers. No treatment (intervention) was received.
|
|---|---|
|
Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale
|
0.807 Kappa statistics
Interval 0.78 to 0.834
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER