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

NCT01821534 | Completed Results

• 1 other identifier: 191622-128
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

All Participants

Healthy volunteers. No treatment (intervention) was administered.

Other: No Intervention

Interventions

No Intervention OTHER

No treatment (intervention) was administered.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 1, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 30, 2014
• Results First Posted: April 30, 2014

Record last verified: 2014-03

Locations

US (1)