P242 Universal exclusion of patients with Permanent Ileostomy in Crohn’s disease clinical trials: A systematic review
Notice bibliographique
Résumé
Abstract Background Crohn’s disease (CD) can be progressive leading to complications such as strictures and fistula requiring surgery in up to 50% of patients within 10 years of diagnosis and increased risk of permanent ileostomy (PI) formation. Approximately one third of patients with PI experience clinical recurrence within the small bowel which may need medical therapy and 16% significant recurrence requiring further surgery. Despite the physical and psychological morbidity associated with PI formation, there is a paucity of research in patients with CD and PI. We performed a systematic review to investigate whether patients with CD and PI were eligible to take part in pharmaceutical clinical trials. Methods MEDLINE, Embase, and the Cochrane library (CENTRAL) databases were searched from inception to April 2022 for randomized, placebo-controlled induction and maintenance trials of biologics and small molecules in adult patients with active CD. Eligibility criteria of included studies were screened by two authors independently. The primary outcome was to determine the proportion of trials that included patients with CD and a PI. Trial characteristics such as number of participants, mean age, sex, trial phase, class of drug, inclusion, or exclusion of patients with ostomy were collected. Results After excluding duplicates 11693 records from databases and additional sources were selected for screening. In total,144 records were assessed for full text assessment and 81 studies (induction: 58 and maintenance: 23) which enrolled 22000 participants were considered eligible (Table 1). The majority were phase 2 trials (n=41, 50.6%), 86.4% (n=70) evaluated efficacy and safety of biologics and the remaining studies (n=11, 13.6%) evaluated oral small molecules. Amongst the induction trials, 39 (67.2%) specifically stated that they excluded patients with an ostomy and the remaining studies (n=19, 32.8%) did not comment. For maintenance trials, 16 (69.6%) stated that they excluded patients with an ostomy and the remaining seven (30.4%) studies did not comment. Twenty-one induction studies and thirteen maintenance studies reported the proportion of patients with prior intestinal resection which ranged from 2.4% to 51%. No clinical trial included patients with a PI. Conclusion Patients with CD and PI have been excluded from pharmaceutical trials of biologics and small molecules to date. This group represents a high-risk patient population that have developed penetrating disease and may require medical therapy to prevent and treat recurrence. There is an urgent need to identify barriers to enrolment and develop eligibility and outcome measures that enable inclusion of patients with CD and PI into clinical trials.
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 | 0,031 | 0,111 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,018 | 0,012 |
| Bibliométrie | 0,011 | 0,013 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,005 | 0,005 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,003 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,008 | 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 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 ».