Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-13 @ 1:13 PM
Study NCT ID:
NCT01821534
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2013-03-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification
Sponsor:
Organization:
Raw JSON
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No treatment (intervention) was administered.', 'otherNumAtRisk': 201, 'otherNumAffected': 0, 'seriousNumAtRisk': 201, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Healthy volunteers. No treatment (intervention) was administered.'}], 'classes': [{'title': 'Left Side', 'categories': [{'measurements': [{'value': '0.728', 'groupId': 'OG000', 'lowerLimit': '0.677', 'upperLimit': '0.786'}]}]}, {'title': 'Right Side', 'categories': [{'measurements': [{'value': '0.711', 'groupId': 'OG000', 'lowerLimit': '0.661', 'upperLimit': '0.767'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "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. 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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.', 'unitOfMeasure': 'Kappa statistics', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1'}, {'type': 'PRIMARY', 'title': 'Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Healthy volunteers. No treatment (intervention) was administered.'}], 'classes': [{'title': 'Assessment 1', 'categories': [{'measurements': [{'value': '0.358', 'groupId': 'OG000', 'lowerLimit': '0.343', 'upperLimit': '0.372'}]}]}, {'title': 'Assessment 2', 'categories': [{'measurements': [{'value': '0.352', 'groupId': 'OG000', 'lowerLimit': '0.337', 'upperLimit': '0.367'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': '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.', 'unitOfMeasure': 'Kappa Statistics', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1'}, {'type': 'PRIMARY', 'title': 'Intra-rater Reliability Using a LFSC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Healthy volunteers. No treatment (intervention) was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.658', 'groupId': 'OG000', 'lowerLimit': '0.629', 'upperLimit': '0.686'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': '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. 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No treatment (intervention) was administered.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Healthy volunteers. No treatment (intervention) was administered.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '11.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-28', 'studyFirstSubmitDate': '2013-03-25', 'resultsFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-28', 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)', 'timeFrame': 'Day 1', 'description': "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."}, {'measure': 'Intra-rater Reliability Using a MMPS', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Intra-rater Reliability Using a LFSC', 'timeFrame': 'Day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror\n\nExclusion Criteria:\n\n* infection of the mouth or gums, or facial skin infection requiring antibiotics\n* planned dental or facial procedure\n* unwillingness to be photographed and have the photos used for research, training, or educational purposes'}, 'identificationModule': {'nctId': 'NCT01821534', 'briefTitle': 'Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191622-128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Healthy volunteers. No treatment (intervention) was administered.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No treatment (intervention) was administered.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}