Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis
Notice bibliographique
Résumé
BACKGROUND: Maintaining accurate medication records in clinical trials is essential to ensure data validity. Traditional methods such as direct observation, self-reporting, and pill counts have shown limitations that make them inaccurate or impractical. Video-based monitoring systems, available as commercial or proprietary mobile applications for smartphones and tablets, offer a promising solution to these traditional limitations. In Korea, a system applicable to the clinical trial context has been developed and used. OBJECTIVE: This study aimed to evaluate the usefulness of an asynchronous video-based self-administration of the investigational medicinal product (SAI) monitoring system (VSMS) in ensuring accurate dosing and validating participant adherence to planned dosing times in repeated-dose clinical trials. METHODS: A retrospective analysis was conducted using data from 17,619 SAI events in repeated-dose clinical trials using the VSMS between February 2020 and March 2023. The SAI events were classified into four categories: (1) Verified on-time dosing, (2) Verified deviated dosing, (3) Unverified dosing, and (4) Missed dosing. Analysis methods included calculating the success rate for verified SAI events and analyzing trends in difference between planned and actual dosing times (PADEV) over the dosing period and by push notification type. The mean PADEV for each subsequent dosing period was compared with the initial period using either a paired t test or a Wilcoxon signed-rank test to assess any differences. RESULTS: A comprehensive analysis of 17,619 scheduled SAI events across 14 cohorts demonstrated a high success rate of 97% (17,151/17,619), with only 3% (468/17,619) unsuccessful due to issues like unclear video recordings or technical difficulties. Of the successful events, 99% (16,975/17,151) were verified as on-time dosing, confirming that the dosing occurred within the designated SAI time window with appropriate recorded behavior. In addition, over 90% (367/407) of participants consistently reported dosing videos on all analyzed SAI days, with most days showing over 90% objective dosing data, underscoring the system's effectiveness in supporting accurate SAI. There were cohort differences in the tendency to dose earlier or later, but no associated cohort characteristics were identified. The initial SAI behaviors were generally sustained during the whole period of participation, with only 16% (13/79) of study days showing significant shifts in actual dosing times. Earlier deviations in SAI times were observed when only dosing notifications were used, compared with using reminders together or no notifications. CONCLUSIONS: VSMS has proven to be an effective tool for obtaining dosing information with accuracy comparable to direct observation, even in remote settings. The use of various alarm features and appropriate intervention by the investigator or observer was identified as a way to minimize adherence deterioration. It is expected that the usage and usefulness of VSMS will be continuously improved through the accumulation of experience in various medical fields.
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 | 0,073 | 0,098 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,004 | 0,005 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 ».