Optimizing the Performance of the Surrogate Informed Consent Process for Critical Care Research
Notice bibliographique
Résumé
Abstract RATIONALE: Research in intensive care units (ICUs) is essential to improving care for critically ill patients; however, patients are often unable to consent for themselves. Surrogates are often required to participate in the informed consent process for critical care research, though how to best engage surrogates in this process remains unclear. This study seeks to identify best practices for conducting surrogate consent for critical care research. METHODS: We conducted a mixed-methods study including quantitative surveys with open-ended questions, focus groups, and semi-structured interviews with principal investigators (PIs), research coordinators (RCs), surrogate decision makers who had been approached about a critical care research clinical trial, and when possible, the patient who had been critically ill. RESULTS: In total, 230 individuals (105 RC, 90 PI, 27 surrogates, 8 patients) completed surveys, and 61 participated in focus groups or interviews. In both surveys and focus groups/interviews, participants across all groups believed that RCs (as opposed to PIs) should conduct the consent process, as RCs are not considered to be authority figures and have fewer perceived conflicts of interest that could influence surrogates decision-making. Surrogates appreciated it when research staff waited until an optimal time to initiate contact and were given physical space and a defined period to consider their decision before follow up with them. When compared to PI/RCs, surrogates and/or patients attributed more importance to seeing the research team as an additional resource in explaining the progress of the patient's care and were appreciated having additional team members whom they perceived as advocating for adherence to clinical protocols for their loved ones (p<0.0001 and p=0.0016). Compared to PI/RCs, surrogates thought the written consent was more important and were less concerned with its length, (p=0.001 and p<0.0001). In general, all participants felt that phone and electronic consent was less effective than in-person consent, though these modalities could facilitate the process for distant surrogates. Consent timing, respect for surrogate decision-making autonomy, and clear communication of the patient's presumed wishes were additional significant themes. CONCLUSIONS: Our study highlights the need for better guidance for carrying out the surrogate consent process in ICU research and identifies several themes that could serve to develop recommendations including designating trained RCs as primary facilitators, improving consent timing and setting, and for implementing accessible consent documentation. This study supports developing standardized training and guidelines for the surrogate informed consent process that could be consistently applied by ethics review boards in reviewing consent processes for clinical care research.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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 | 0,805 | 0,832 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,002 |
| Méta-épidémiologie (sens large) | 0,003 | 0,004 |
| Bibliométrie | 0,008 | 0,007 |
| Études des sciences et des technologies | 0,006 | 0,015 |
| Communication savante | 0,014 | 0,017 |
| Science ouverte | 0,007 | 0,014 |
| Intégrité de la recherche | 0,008 | 0,009 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,008 | 0,005 |
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; l’étiquette directe de Gemma et le classifieur distillé Codex s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».