Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale
Study Details
Study Description
Brief Summary
This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema Assessment Scale. There is no treatment (intervention) associated with this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All participants Patients with facial erythema associated with rosacea. There was no intervention in this study. |
Drug: No Intervention
No intervention.
|
Outcome Measures
Primary Outcome Measures
- Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale [Day 1]
Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA 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=slight, 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 the CEA Scale [Day 1]
Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤ 0=poor, 0.00-0.20=slight, 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Rosacea
Exclusion Criteria:
- Unwilling to remove all facial make-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Austin | Texas | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 199201-003
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Patients with facial erythema associated with rosacea. There was no intervention in this study. |
| Period Title: Overall Study | |
| STARTED | 104 |
| COMPLETED | 104 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Patients with facial erythema associated with rosacea. There was no intervention in this study. |
| Overall Participants | 104 |
| Age (Years) [Mean (Full Range) ] | |
| Mean (Full Range) [Years] |
44.2
|
| Sex: Female, Male (Count of Participants) | |
| Female |
70
67.3%
|
| Male |
34
32.7%
|
Outcome Measures
| Title | Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale |
|---|---|
| Description | Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA 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=slight, 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. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Patients with facial erythema associated with rosacea. There was no intervention in this study. |
| Measure Participants | 104 |
| Mean (95% Confidence Interval) [Kendall's W] |
0.908
|
| Title | Intra-rater Reliability of the CEA Scale |
|---|---|
| Description | Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤ 0=poor, 0.00-0.20=slight, 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. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Patients with facial erythema associated with rosacea. There was no intervention in this study. |
| Measure Participants | 104 |
| Mean (95% Confidence Interval) [Kappa statistics] |
0.752
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Participants | |
| Arm/Group Description | Patients with facial erythema associated with rosacea. There was no intervention in this study. | |
All Cause Mortality |
||
| All Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| All Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/104 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/104 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Therapeutic Area Head, |
|---|---|
| Organization | Allergan, Inc |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
- 199201-003