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

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ClinicalTrials.gov Identifier: NCT01636765
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment
Erythema Rosacea Drug: No Intervention

Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : May 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Group/Cohort Intervention/treatment
All participants
Patients with facial erythema associated with rosacea. There was no intervention in this study.
Drug: No Intervention
No intervention.




Primary Outcome Measures :
  1. Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale [ Time Frame: 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.

  2. Intra-rater Reliability of the CEA Scale [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636765


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01636765     History of Changes
Other Study ID Numbers: 199201-003
First Posted: July 10, 2012    Key Record Dates
Results First Posted: November 15, 2013
Last Update Posted: November 15, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases