Impact of clinical symptoms and diagnosis: the electronic Person-Specific Outcome Measure (ePSOM) development programme
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Résumé
INTRODUCTION: Regulatory bodies recommend that outcome measures used in Alzheimer's disease (AD) clinical trials capture clinically meaningful changes for the trial participant. However, commonly used outcome measures do not reflect the individual's views on what matters to them individually. The aim of the electronic Person-Specific Outcome Measure (ePSOM) programme is to better understand what outcomes matter to patients in early Alzheimer's disease. METHODS: As part of the ePSOM programme, we designed and ran an online study to understand what matters to individuals when developing new treatments for AD. The ePSOM survey ran Aug 2019-Dec 2019 (UK) and collected primarily free text responses which were analysed using Natural Language Processing (NLP) techniques. In this paper, we focus our analyses on individuals who reported having a neurodegenerative disease diagnosis (primarily Mild Cognitive Impairment (MCI) or AD), reporting the most frequent and most important brain health priorities for this group. Due to a small sample size, the Diagnosis group was analysed as a whole. Finally, we compared the Diagnosis group to an age and gender matched control group using chi-squared tests to look for any differences between the Diagnosis and control groups' priorities. RESULTS: The survey was completed by 5808 respondents, of whom 167 (2.9%) (women n = 91, men n = 69, other n = 7) had received one of our pre-defined neurodegenerative disease diagnosis: most commonly MCI n = 52, 1.1% (mean age 69.42, SD = 10.8); or Alzheimer's disease n = 48, 1.0% (mean age 71.24, SD = 9.79). Several thematic clusters were significantly more important for the target diagnostic group, e.g.: Expressing opinions; and less important, e.g., Cognitive Games. CONCLUSION: We conclude there are a range of outcomes which individuals consider important and what potential new treatments should help maintain or improve, suggesting that outcomes that matter shift along the preclinical, prodromal and overt dementia continuum. This has important implications for the development of outcome measures in long term prevention studies that last several years where participants may pass through different stages of disease. In the final stage of our project, we will design an electronic outcomes app which will employ the methodology tested in the large-scale survey to capture what matters to individuals about their brain health at an individual level.
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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 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| 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 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
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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 découle