P066 Core outcome set implementation in vitiligo clinical trials: barriers and facilitators from a survey of lead researchers
Notice bibliographique
Résumé
Abstract Core outcome sets (COSs) standardize outcome measures across clinical trials, ensuring consistency and comparability of results. In 2015, an internationally agreed COS for vitiligo randomized clinical trials (RCTs) identified three essential outcomes: repigmentation, side-effects/harms, and maintenance of gained repigmentation. Despite its significance, adoption of the COS across vitiligo trials has been inconsistent. This study evaluated COS uptake, barriers to implementation, and facilitators. Eighty-five authors of vitiligo RCTs between 2016 and 2021 were identified through a systematic review evaluating COS uptake, and were contacted via email. Recruitment occurred between July and November 2024, and 36 authors completed the Google Forms survey (response rate 42%). Respondents, predominantly dermatologists worldwide, described awareness and integration of COS domains within their trials. Quantitative results revealed that all respondents incorporated repigmentation as an outcome, and 97% assessed side-effects/harms. However, maintenance of gained repigmentation was measured by only 64% of respondents. Among the four recommended outcomes, 67% of respondents evaluated cosmetic acceptability and quality of life, while tolerability/burden of treatment and cessation of spreading were assessed less frequently (50% and 47%, respectively). Thematic analysis identified barriers to COS implementation. The most cited challenge (44%) concerned long-term follow-up to assess maintenance of gained repigmentation, with many noting cost and resource constraints. Additionally, 28% highlighted the impracticality of assessing maintenance in early-phase trials, where efficacy was the primary focus – despite only late-phase trials being surveyed. Ambiguity in defining certain domains, such as cessation of spreading, was reported by 19%, particularly in trials of stable vitiligo. Some respondents (8%) noted that repetitive data collection burdened patients and trial staff, contributing to incomplete datasets. To enhance uptake, respondents recommended increasing awareness of COS outcomes through public campaigns and academic presentations (53%). Simplifying and validating measurement tools for COS outcomes was suggested by 36%, alongside calls for journal reviewers to require COS adherence during manuscript submission (32%). A tiered outcome collection approach was also proposed, prioritizing repigmentation and side-effects in initial trials, with maintenance in long-term follow-ups. This evaluation underscores the need for flexible COS implementation reflecting practical challenges of vitiligo RCTs. While adoption of repigmentation and side-effects measures reflects COS awareness, gaps in assessing maintenance of repigmentation highlight persistent barriers. Given that most vitiligo RCTs span 52–54 weeks, yet 40% of patients relapse within 3–4 months post-treatment, tracking long-term maintenance is vital. Addressing logistical and definitional challenges, refining outcome frameworks, and fostering collaboration between researchers, industry and journal reviewers will be essential to facilitate COS adherence. These findings will inform ongoing COS refinement and support a planned complementary survey of dermatology journal editors to evaluate COS uptake at the publication level.
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 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 | 0,026 | 0,047 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| 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 | 0,001 |
| 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 ».