跳至主要内容
临床试验/NCT01821534
NCT01821534已完成不适用

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

Allergan0 个研究点目标入组 201 人开始时间: 2013年3月最近更新:
适应症

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

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

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

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