Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01636765
First received: July 9, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Erythema
Rosacea
Drug: No Intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Patients with facial erythema associated with rosacea. There was no intervention in this study.
Drug: No Intervention
No intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with facial erythema related to rosacea

Criteria

Inclusion Criteria:

  • Rosacea

Exclusion Criteria:

  • Unwilling to remove all facial make-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636765

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01636765     History of Changes
Other Study ID Numbers: 199201-003
Study First Received: July 9, 2012
Results First Received: September 12, 2013
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014