Development and validation of patient-reported outcome measures for platysma prominence
Notice bibliographique
Résumé
Background Platysma prominence (PP) is characterized by vertical bands along the length of the neck and blunting of the jawline, impacting aesthetic appearance. No validated patient-reported outcome (PRO) measures are available to assess patient experiences specific to PP.Objective Develop and validate fit-for-purpose PRO measures that capture patient experiences with PP and treatment outcomes.Methods PRO measures were developed and validated in alignment with the FDA’s patient-focused drug development guidance. Three interviews (concept elicitation [CE], N = 30; cognitive debriefing [CD] round 1, N = 20; round 2, N = 5) were conducted with treatment-naive and previously treated adults with PP. Instruments were drafted based on concepts emerging from CE interviews. Psychometric testing for reliability and validity was conducted using phase 2 PP treatment study (ClinicalTrials.gov; NCT03915067) data (N = 164). While there were no available gold standard measures, convergent and known-groups validity were assessed using multiple FACE-Q modules, the Participant Global Impression of Severity (PGIS)-Jawline, and the Participant Global Impression of Treatment Satisfaction (PGI-TS). The 2-way random intraclass correlation coefficient ICC (2,1) and Rλ were calculated to evaluate test-retest reliability. Values of ≥0.70 were considered success for both the ICC(2,1) and Rλ. Spearman correlations (𝜌) between scores from draft instruments and co-validators were used to assess convergent validity (|𝜌|≥0.40). Additionally, internal consistency reliability was examined for multi-item measures where Cronbach’s α ≥ 0.70 was considered success.Results “Bands” or a variation (eg, cords, ridges, lines) were the most common terms used to describe PP, reported by 50% of participants. The most frequently reported psychosocial impacts were looking older than desired (n = 28, 93.3%), feeling self-conscious (n = 24, 80.0%), feeling less attractive (n = 20, 66.7%), and looking less attractive and dressing differently (both: n = 19, 63.3%). Reduced platysma band prominence was the most cited change that would increase satisfaction (n = 15, 50.0%). Following CE interviews, 3 PRO measures were drafted: Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts, ANLFQ: Satisfaction (Baseline/Follow-up), and the BAS-PP. CD interviews indicated that participants found the questionnaires understandable and relevant. In psychometric testing, established criteria for reliability and validity were predominantly met, with some exceptions. Three correlations were under the 0.40 threshold, and while these correlations were all in the expected direction, their smaller magnitudes were not unexpected given the restricted conceptual alignment between the PP PROs and co-validating measures.Conclusion These PRO measures demonstrated content and psychometric validity and are ready for use in research and practice to better understand the impact of PP from the patient perspective.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,057 | 0,073 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,002 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,002 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».