Trial Outcomes & Findings for Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale (NCT NCT01636765)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

104 participants

Primary outcome timeframe

Day 1

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Patients with facial erythema associated with rosacea. There was no intervention in this study.
Overall Study STARTED	104
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=104 Participants Patients with facial erythema associated with rosacea. There was no intervention in this study.
Age, Continuous	44.2 Years n=99 Participants
Sex: Female, Male Female	70 Participants n=99 Participants
Sex: Female, Male Male	34 Participants n=99 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	All Participants n=104 Participants Patients with facial erythema associated with rosacea. There was no intervention in this study.
Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale	0.908 Kendall's W Interval 0.703 to 1.0

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	All Participants n=104 Participants Patients with facial erythema associated with rosacea. There was no intervention in this study.
Intra-rater Reliability of the CEA Scale	0.752 Kappa statistics Interval 0.722 to 0.783

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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