Healthy Volunteers
Conditions
Brief summary
This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape Classification for evaluating a patient's lower facial shape.
Interventions
OTHERNo Intervention
No treatment (intervention) was administered.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror
Exclusion criteria
* infection of the mouth or gums, or facial skin infection requiring antibiotics * planned dental or facial procedure * unwillingness to be photographed and have the photos used for research, training, or educational purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS) | 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. |
| Intra-rater Reliability Using a MMPS | 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. |
| Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC) | 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. |
| Intra-rater Reliability Using a LFSC | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Healthy volunteers. No treatment (intervention) was administered. | 201 |
| Total | 201 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 35.5 Years STANDARD_DEVIATION 11.43 |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 201 |
| serious Total, serious adverse events | 0 / 201 |
Outcome results
Primary
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
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.
Time frame: Day 1
Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC) | Assessment 1 | 0.358 Kappa Statistics |
| All Participants | Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC) | Assessment 2 | 0.352 Kappa Statistics |
Primary
Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
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.
Time frame: Day 1
Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS) | Left Side | 0.728 Kendall's W |
| All Participants | Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS) | Right Side | 0.711 Kendall's W |
Primary
Intra-rater Reliability Using a LFSC
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.
Time frame: Day 1
Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Intra-rater Reliability Using a LFSC | 0.658 Kappa statistics |
Primary
Intra-rater Reliability Using a MMPS
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.
Time frame: Day 1
Population: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Intra-rater Reliability Using a MMPS | Left Side | 0.634 Kappa statistics |
| All Participants | Intra-rater Reliability Using a MMPS | Right Side | 0.638 Kappa statistics |