Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Healthy volunteers. No treatment (intervention) was administered. | Other: No Intervention<br>* No treatment (intervention) was administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 |