Newport Beach, California, United States
NCT Number: NCT01821534
Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
No intervention
OtherNo treatment (intervention) was administered.
Primary outcomes
-
Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Allergan
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Apr 1, 2013
- Registry last updated
- Apr 30, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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