Trial Outcomes & Findings for Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification (NCT NCT01821534)
NCT ID: NCT01821534
Last Updated: 2014-04-30
Results Overview
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall's coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. 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 to ≤0.2: slight, \>0.2 to ≤0.4: fair, \>0.4 to ≤0.6: moderate, \>0.6 to ≤0.8: substantial, and \>0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.
COMPLETED
201 participants
Day 1
2014-04-30
Participant Flow
Participant milestones
| Measure |
All Participants
Healthy volunteers. No treatment (intervention) was administered.
|
|---|---|
|
Overall Study
STARTED
|
201
|
|
Overall Study
COMPLETED
|
201
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification
Baseline characteristics by cohort
| Measure |
All Participants
n=201 Participants
Healthy volunteers. No treatment (intervention) was administered.
|
|---|---|
|
Age, Continuous
|
35.5 Years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall's coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. 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 to ≤0.2: slight, \>0.2 to ≤0.4: fair, \>0.4 to ≤0.6: moderate, \>0.6 to ≤0.8: substantial, and \>0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.
Outcome measures
| Measure |
All Participants
n=201 Participants
Healthy volunteers. No treatment (intervention) was administered.
|
|---|---|
|
Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
Left Side
|
0.728 Kendall's W
Interval 0.677 to 0.786
|
|
Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
Right Side
|
0.711 Kendall's W
Interval 0.661 to 0.767
|
PRIMARY outcome
Timeframe: Day 1Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. 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 pre-defined as: ≤0: poor, \>0 to ≤0.2: slight, \>0.2 to ≤0.4: fair, \>0.4 to ≤0.6: moderate, \>0.6 to ≤0.8: substantial, and \>0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Outcome measures
| Measure |
All Participants
n=201 Participants
Healthy volunteers. No treatment (intervention) was administered.
|
|---|---|
|
Intra-rater Reliability Using a MMPS
Left Side
|
0.634 Kappa statistics
Interval 0.607 to 0.66
|
|
Intra-rater Reliability Using a MMPS
Right Side
|
0.638 Kappa statistics
Interval 0.611 to 0.665
|
PRIMARY outcome
Timeframe: Day 1Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category 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 pre-defined as: ≤0: poor, \>0 to ≤0.2: slight, \>0.2 to ≤0.4: fair, \>0.4 to ≤0.6: moderate, \>0.6 to ≤0.8: substantial, and \>0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Outcome measures
| Measure |
All Participants
n=201 Participants
Healthy volunteers. No treatment (intervention) was administered.
|
|---|---|
|
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
Assessment 1
|
0.358 Kappa Statistics
Interval 0.343 to 0.372
|
|
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
Assessment 2
|
0.352 Kappa Statistics
Interval 0.337 to 0.367
|
PRIMARY outcome
Timeframe: Day 1Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. 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 pre-defined as: ≤0: poor, \>0 to ≤0.2: slight, \>0.2 to ≤0.4: fair, \>0.4 to ≤0.6: moderate, \>0.6 to ≤0.8: substantial, and \>0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Outcome measures
| Measure |
All Participants
n=201 Participants
Healthy volunteers. No treatment (intervention) was administered.
|
|---|---|
|
Intra-rater Reliability Using a LFSC
|
0.658 Kappa statistics
Interval 0.629 to 0.686
|
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