- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01821534
Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification
28 mars 2014 uppdaterad av: Allergan
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.
Studieöversikt
Studietyp
Observationell
Inskrivning (Faktisk)
201
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Newport Beach, California, Förenta staterna
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Healthy Volunteers
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
All Participants
Healthy volunteers.
No treatment (intervention) was administered.
|
Ingen behandling (intervention) administrerades.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
Tidsram: 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.
|
Day 1
|
Intra-rater Reliability Using a MMPS
Tidsram: 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.
|
Day 1
|
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
Tidsram: 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.
|
Day 1
|
Intra-rater Reliability Using a LFSC
Tidsram: 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.
|
Day 1
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2013
Primärt slutförande (Faktisk)
1 maj 2013
Avslutad studie (Faktisk)
1 maj 2013
Studieregistreringsdatum
Först inskickad
25 mars 2013
Först inskickad som uppfyllde QC-kriterierna
25 mars 2013
Första postat (Uppskatta)
1 april 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 191622-128
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Friska volontärer
-
University of MiamiJames and Esther King Biomedical Research ProgramAvslutadHealthy Lifetime Icke-rökareFörenta staterna
-
University of LeicesterNational Institute for Health Research, United KingdomAvslutadPatienter med hjärtsvikt och konserverad ejektionsfraktion - HFpEF | Patienter med hjärtsvikt med reducerad ejektionsfraktion - HFrEF | Healthy Controls Group - ålders- och könsmatchad
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvslutadParkinsons sjukdom | Healthy Controls Group - ålders- och könsmatchadFrankrike
Kliniska prövningar på Inget ingripande
-
Case Western Reserve UniversityAmerican University; Purdue UniversityRekrytering
-
Otsuka Pharmaceutical Factory, Inc.CelerionAvslutad
-
Seoul National University HospitalSamsung Medical Center; Chosun University HospitalAvslutadRadiofrekvensablation | MikrovågsablationKorea, Republiken av
-
Federal University of São PauloOkändHjärtkirurgi | Aorta No-touchBrasilien
-
University of MinnesotaAvslutad
-
Catharina Ziekenhuis EindhovenAvslutadVaskulära infektionerNederländerna
-
University of British ColumbiaAvslutadCentral Line komplikationKanada
-
Swiss Federal Institute of TechnologyInstituto de Investigação em ImunologiaAvslutadStörningar i järnmetabolism | Överbelastning av järn | PolyfenolerPortugal, Schweiz
-
Assistance Publique - Hôpitaux de ParisAvslutadSicklecellanemiFrankrike