Patient and Caregiver Perspectives on the Design and Execution of ACT-GLOBAL, a Stroke Adaptive Platform Trial: A Focus Group Study
Notice bibliographique
Résumé
INTRODUCTION: Adaptive platform trials represent a paradigm shift in stroke research. We examined how patient-partners perceived the design and execution of an international platform trial in acute stroke, ACT-GLOBAL (A multi-faCtorial, mulTi-arm, multi-staGe, randomized, gLOBal Adaptive pLatform trial for stroke), through a series of focus groups with process evaluation methodology. METHODS: Participants were recruited from two comprehensive stroke centers one in Calgary, Canada and one in Sydney, Australia. Four virtual focus groups were attended by a total of 21 patient-partners and 11 clinician-researchers. One focus group had repeat attendees to review a draft consent form and patient information sheet, and one presented a video describing platform trials. Physician facilitators presented the platform trial concept followed by a facilitated discussion. Audio recordings were transcribed and combined with field notes. Exemplar quotes and themes were identified separately for each group and subsequently across groups. RESULTS: Patients/caregivers perceived acute stroke-focused adaptive platform trials such as ACT-GLOBAL as providing potentially beneficial opportunities to be randomized to multiple treatments, with efficiencies and richer data to improve patient care. Emphasis was given to the importance of gatekeeper processes for the addition of future questions posed by the platform to ensure examined questions would not interfere with routine care, and that safety decisions were ultimately made by nonconflicted parties. They appreciated that deferral of consent would be ideal to allow timely randomization/treatment within the adaptive stroke platform, and for patient safety to be prioritized in enrolment-related decisions with family input whenever feasible. The need to have trial information accessible in digestible chunks, multiple languages, and modalities was emphasized. To facilitate engagement, transparency, trust, and two-way communication was deemed critical to the informed consent process. CONCLUSION: Patient-partners were supportive of an adaptive platform trial design. However, they expressed important priorities in their execution while safeguarding patient autonomy and safety. Oversight, multiple modes of delivering patient information, and having feedback evaluation and transparency with ongoing participation were identified as valued components. Deferral of consent was recognized as a pragmatic way to enroll patients. Similar considerations may apply to adaptive platform trials in other neurological/medical emergencies.
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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 | 0,001 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| 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) | 0,000 | 0,000 |
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 ».