P4‐178: RATER QUALIFICATIONS IN EARLY ALZHEIMER'S DISEASE CLINICAL TRIALS
Notice bibliographique
Résumé
Recent trends have shown a shift in dementia clinical trials as scientific gains have been made in the understanding and development of pharmacologic interventions intended to delay the onset of cognitive impairment caused by Alzheimer's disease (AD). The increased focus upon early-stage therapeutic interventions designed to target precursors to the pathogenesis of Alzheimer's disease has broadened the number of psychometric and functional assessments used in these trials to include those developed for, or found to be sensitive to milder, emergent deficits. In many instances the selection of study raters for trials in Early/Prodromal/MCI trials has assumed that experience with more impaired populations using conventional measures is interchangeable with experience appropriate for Early AD studies. The purpose of the poster is to establish the types of qualifications study raters currently bring to Early AD studies. A total of 698 raters from 23 countries across 3 Early AD studies were included in this survey. Data regarding professional background, experience with the study populations, and familiarity with the study-specific rating scales were gathered as part of formalized rater qualification programs for each study. Mean and standard deviations of years of experience by dementia indication and rating scale experience were calculated. Raters were divided into two groups based on type of assessments performed (psychometric versus global rater role). Raters reported different levels of indication experience by the type of assessments they conducted in the trial, and study scale experience for psychometric scales. Raters' reported experience with early AD and the scales most sensitive to change in early AD call into question the assumption that these qualifications are functionally equivalent across types of clinical trials. Given that increasingly sensitive rating scales are typically the primary outcomes for early AD trials, it is essential that rater experience with this sub-population is carefully assessed. Additionally, consideration should be given to providing these raters with additional indication and scale-specific training to ensure accurate assessment of the emergent symptoms of the early phases of the disease.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 tête enseignante, 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 ».