Digital Informed Consent/Assent in Clinical Trials Among Pregnant Women, Minors, and Adults: Multicountry Cross-Sectional Evaluation of Comprehension and Satisfaction
Notice bibliographique
Résumé
Background: Informed consent (IC) is a cornerstone of ethical clinical research, yet comprehension gaps persist. The i-CONSENT guidelines aim to improve IC materials by enhancing clarity, accessibility, and tailoring them to the needs of diverse populations. This study evaluates the effectiveness of electronic IC (eIC) materials developed under these guidelines for 3 target populations-minors, pregnant women, and adults-across Spain, the United Kingdom, and Romania. Objective: The primary aim of this study is to assess participants' comprehension of and satisfaction with eIC materials tailored to their specific needs. The secondary objectives are to identify demographic predictors of comprehension, evaluate the cross-cultural applicability of materials, and explore format preferences. Methods: A cross-sectional study was conducted with 1757 participants (620 minors, 312 pregnant women, and 825 adults), who reviewed eIC materials through a digital platform offering layered web content, narrative videos, printable documents, and infographics. Materials were co-designed using participatory methods, including design thinking sessions with minors and pregnant women, and online surveys with adults. Comprehension was assessed using an adapted version of the Quality of the Informed Consent questionnaire. Objective comprehension (part A) was categorized as low (<70%), moderate (70%-80%), adequate (80%-90%), or high (≥90%). Subjective comprehension (part B) was measured using a 5-point Likert scale. Satisfaction was evaluated through Likert scales and usability questions, with scores ≥80% considered acceptable. Multivariable regression models were applied to identify predictors of comprehension. Results: Objective comprehension exceeded 80% across all groups: minors (mean 83.3, SD 13.5), pregnant women (mean 82.2, SD 11.0), and adults (mean 84.8, SD 10.8). Women/girls outperformed men/boys (β=+.16 to +.36). Generation X adults scored higher than millennials (β=+.26, P<.001), while prior trial participation was associated with lower comprehension scores (β=-.47 to -1.77). Among minors, compared with participants from Spain with no previous clinical trial experience, comprehension was significantly lower in Spain (P=.03), Romania (P<.001), and the United Kingdom (P<.001). Format preferences varied: 382 out of 620 (61.6%) minors and 152 out of 312 (48.7%) pregnant women preferred videos, whereas 452 out of 825 (54.8%) adults favored text (P<.001). Satisfaction rates surpassed 90% in all groups (minors, 604/620, 97.4%; pregnant women, 303/312, 97.1%; and adults, 804/825, 97.5%), with 777 out of 825 (94.2%) adults also indicating that the materials facilitated understanding. While translated materials maintained high efficacy across countries, comprehension scores in Romania were lower among participants with lower educational levels (β=-1.05, P=.001). Materials cocreated in Spain were effective across countries but yielded higher comprehension within the original target population. Conclusions: eIC materials developed following the i-CONSENT guidelines achieved high levels of comprehension and satisfaction across diverse populations, demonstrating scalability for multinational trials. Cocreation and multimodal design effectively addressed participant preferences; however, cultural adaptation remained crucial for optimizing outcomes. The negative impact of prior trial participation highlights the need for tailored engagement strategies for returning participants. Future research should explore regional disparities, evaluate interventions for overconfident returning participants, and validate these tools across broader cultural contexts.
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 | 0,079 | 0,146 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,001 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,002 | 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) | 0,002 | 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 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 ».