P123 A novel self-referral enrolment pathway in a UK multicentre atopic dermatitis trial (BEACON trial): a single-site prospective observational study to assess feasibility and effectiveness
Notice bibliographique
Résumé
Abstract Recruiting clinical trial participants to time and target can be challenging. Innovative recruitment strategies, such as facilitating participant self-referral, can be beneficial. The BEACON trial is a national multicentre phase IV assessor-blinded randomized controlled trial comparing the effectiveness, tolerability and cost-effectiveness of ciclosporin, methotrexate and dupilumab in adults with moderate-to-severe eczema. The aim of this study was to describe the impact of self-referral at the sponsor (chief investigator) site in the first year of active recruitment. The BEACON trial opened in November 2023. Self-referral was promoted via the BEACON trial and National Eczema Society websites, social media channels and meetings. Interested participants registered their interest via the BEACON website, then were contacted by their nearest trial site. They were subsequently sent a seven-point questionnaire to assess key eligibility criteria and were contacted via telephone by a subinvestigator (with or without photos) once the questionnaires were completed. If deemed suitable they were invited in for formal screening. Data relating to the mechanism of referral and subsequent progress of all potential participants were prospectively collected and analysed. In total, 594 self-referrals have been received through the trial website, of which 127 were forwarded to the sponsor (chief investigator) site. All 127 referrals were contacted, of whom 66 (52%) were screened, 51 (40%) passed screening and 41 (32%) were randomized to study treatment (similar to internal hospital referrals: 46%, 38% and 32%). Among self-referrals, 61 (48%) did not proceed to screening due to disease severity (31%), being unreachable (25%), comorbidities (15%), prior medications (13%) or other reasons. Of the self-referrals screened (66), 15 (23%) did not pass screening. This was due to low disease severity (60%), change of mind (13%) or undisclosed comorbidities (27%). Of those participants who passed screening (51), 53% were of White ethnicity, 24% Asian, 14% mixed and 8% Black. Self-referral participants had an average Eczema Area and Severity Index score of 30.6 (range 19.8–39.1), including one patient with erythroderma. In conclusion, self-referral has proven to be an important, efficient and highly effective mechanism of recruitment into the BEACON trial. It has been as effective as the more traditional site-based identification and has helped increase accessibility and representation of underserved groups. The high level of interest and disease severity may in part reflect the ongoing access challenges within the National Health Service. These data demonstrate that enabling self-referral can significantly aid clinical trial recruitment.
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 | 0,016 | 0,031 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,009 | 0,002 |
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 ».