Improving Diversity in a Novel Psoriasis Study
Notice bibliographique
Résumé
Importance: Diverse racial and ethnic representation in clinical trials has been limited, not representative of the US population, and the subject of pending US Food and Drug Administration guidance. Psoriasis presentation and disease burden can vary by skin pigmentation, race and ethnicity, and socioeconomic differences. Overall, there are limited primary data on clinical response, genetics, and quality of life in populations with psoriasis and skin of color (SoC). The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety trial (VISIBLE) is underway and uses strategies aimed at addressing this persistent gap. Objective: To assess the innovative strategies used in the VISIBLE trial to recruit and retain diverse participants in a randomized clinical trial of psoriasis in participants with SoC. Design, Setting, and Participants: This was an ad hoc quality improvement assessment of participant recruitment and retention approaches used by the VISIBLE trial. VISIBLE enrolled and randomized 211 participants (mean [SD] age, 43 [13] years; 75 females [36%] and 136 males [64%]) with SoC and moderate to severe plaque psoriasis from August 2022 to March 2023 to evaluate guselkumab treatment. The self-identified race and ethnicity of the participants was: 1 American Indian/Alaska Native (0.5%), 63 Asian (29.9%), 24 Black (11.4%), 94 Hispanic/Latino (44.5%), 13 Middle Eastern (6.2%), 1 Pacific Islander/Native Hawaiian (0.5%), 12 multiracial (5.7%), and 3 of other race and/or ethnicity (1.4%). Using a combination of objective (colorimetry to determine Fitzpatrick skin type) and self-reported (race and ethnicity consistent with SoC) parameters, VISIBLE sought to broaden inclusion of participants from various backgrounds. Results: Observed improvements were that participant enrollment occurred approximately 7 times faster than anticipated (vs historical recruitment data for psoriasis studies); 211 participants (100%) self-identified themselves as a race or ethnicity other than White; and more than 50% had skin tone in the darker half of the Fitzpatrick skin type spectrum (type IV-VI). Innovations implemented by VISIBLE were (1) assessment of the natural history of postinflammatory pigment alteration and improvements over time using combined objective colorimetry and clinician- and patient-reported outcomes; (2) evaluation of genetic and comorbidity biomarkers relevant to participants with SoC; (3) a diverse demographic-driven approach to site selection (emphasizing investigator and staff diversity and experience with populations with SoC); (4) provision of cultural competency training to enhance participant enrollment and retention; (5) collection of patient-reported outcomes data in participants' primary language; and (6) periodic, blinded central review and feedback on investigator efficacy scoring to promote consistency and accuracy in evaluating psoriasis in participants with SoC. Conclusions and Relevance: VISIBLE is a unique study focused on addressing important knowledge and data gaps in populations of patients with psoriasis and SoC, with the goal of generating data to help improve clinical care and inform future best practices in diversity within dermatology research. The rapid study enrollment demonstrates that intentional and strategic approaches to clinical trial design and conduct can speed recruitment and bolster participation and retention of diverse populations in a dermatologic setting. Trial Registration: ClinicalTrials.gov Identifier: NCT05272150.
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 | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 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 ».