Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 201
- 主要终点
- Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror
排除标准
- •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
结局指标
主要结局
Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
时间窗: 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.
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
时间窗: 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 MMPS
时间窗: 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.
Intra-rater Reliability Using a LFSC
时间窗: 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.
次要结局
未报告次要终点
