Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool
Notice bibliographique
Résumé
Background: The Outcomes of Babies With Opioid Exposure (OBOE) study is an observational cohort study examining the impact of antenatal opioid exposure on outcomes from birth to 2 years of age. COVID-19 social distancing measures presented challenges to research coordinators discussing the study at length with potential participants during the birth hospitalization, which impacted recruitment, particularly among caregivers of unexposed (control) infants. In response, the OBOE study developed a digital tool (consenter video) to supplement the informed consent process, make it more engaging, and foster greater identification with the research procedures among potential participants. Objective: We aim to examine knowledge of the study, experiences with the consent process, and perceptions of the consenter video among potential participants of the OBOE study. Methods: Analyses included 129 caregivers who were given the option to view the consenter video as a supplement to the consent process. Participants selected from 3 racially and ethnically diverse avatars to guide them through the 11-minute video with recorded voice-overs. After viewing the consenter video, participants completed a short survey to assess their knowledge of the study, experiences with the consent process, and perceptions of the tool, regardless of their decision to enroll in the main study. Chi-square tests were used to assess differences between caregivers of opioid-exposed and unexposed infants in survey responses and whether caregivers who selected avatars consistent with their racial or ethnic background were more likely to enroll in the study than those who selected avatars that were not consistent with their background. Results: Participants demonstrated good understanding of the information presented, with 95% (n=123) correctly identifying the study purpose and 88% (n=112) correctly indicating that their infant would not be exposed to radiation during the magnetic resonance imaging. Nearly all indicated they were provided "just the right amount of information" (n=123, 98%) and that they understood the consent information well enough to decide whether to enroll (n=125, 97%). Survey responses were similar between caregivers of opioid-exposed infants and unexposed infants on all items except the decision to enroll. Those in the opioid-exposed group were more likely to enroll in the main study compared to the unexposed group (n=49, 89% vs n=38, 51%; P<.001). Of 81 caregivers with known race or ethnicity, 35 (43%) chose avatars to guide them through the video that matched their background. Caregivers selecting avatars consistent with their racial or ethnic background were more likely to enroll in the main study (n=29, 83% vs n=43, 57%; P=.01). Conclusions: This interactive digital tool was helpful in informing prospective participants about the study. The consenter tool enhanced the informed consent process, reinforced why caregivers of unexposed infants were being approached, and was particularly helpful as a resource for families to understand magnetic resonance imaging procedures.
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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 | 0,066 | 0,090 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,002 | 0,001 |
| Études des sciences et des technologies | 0,002 | 0,001 |
| Communication savante | 0,001 | 0,002 |
| Science ouverte | 0,001 | 0,002 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 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 ».