S1295 A New, Multifaceted STRIDE II-Based Monitoring Protocol for Advanced Therapy Starts in Inflammatory Bowel Disease
Notice bibliographique
Résumé
Introduction: Outreach monitoring in inflammatory bowel disease (IBD) has been shown to be cost-effective and reduce healthcare utilization. The STRIDE-II guidelines recommend collection of patient-reported outcomes (PRO’s), biomarkers (e.g., fecal calprotectin (FCP), C-reactive protein (CRP)), and endoscopy to determine if patients with IBD are reaching defined therapeutic targets. The optimal way to apply these recommendations to new advanced therapies in IBD Fifty-four remains unclear. We designed a proactive, outreach monitoring protocol for new advanced therapy starts in IBD to assess clinical response and facilitate responsive disease management. Methods: IBD patients complete 24 weeks of outreach monitoring after starting a new advanced therapy. PRO’s are collected on days 0, 3, and 7, and every 2 weeks thereafter. Serum labs are collected at baseline and weeks 4, 8, 12, 16, and 24 and FCP is collected at baseline and weeks 8, 16, and 24. Self-reported medication adherence is assessed at baseline and weeks 12 and 24. Endoscopy is booked 6-12 months from the start date. Granular clinical reports summarizing these results and the dates of last IBD review and last flare are sent to each treating gastroenterologist via our electronic medical record. Results: Sixty-two patients have been monitored with our protocol on the following biologic and small molecule therapies: ustekinumab (n = 30), tofacitinib (n = 14), risankizumab (n = 11), upacitinib (n = 4), vedolizumab (n = 2), and infliximab (n = 1). Forty-one patients (66.1%) had failed 1+ prior advanced therapies and 7 (11.3%) had prior IBD surgery. In 5 cases (8.1%), the patient was switched from their initial agent before 24 weeks due to lack of response. Fifty-four patients (87.0%) complied with all FCP collections and 60 (96.8%) completed 95+% of PRO’s. Per STRIDE-II definitions, 38 patients (61.3%) demonstrated clinical response during the protocol and 20 (35.1%) achieved and maintained remission at 24 weeks. 14 patients (22.6%) received steroid courses, 9 (14.5%) presented to an emergency department, and 5 (8.1%) were hospitalized for their IBD during monitoring. Conclusion: Our STRIDE II based outreach monitoring protocol provided granular detail of clinical response to advanced IBD therapies to treating physicians. Patients were highly compliant with serial collection of PRO’s, FCP, and serum labs. This protocol allows for highly responsive disease management for IBD patients and may lead to treatment-specific monitoring recommendations and reduced healthcare utilization (see Figure 1, Table 1).Figure 1.: An overview of our proactive outreach monitoring protocol for inflammatory bowel disease patients starting on new advanced therapies. Table 1. - Patient outcomes during monitoring for overall sample and by advanced therapy Overall Sample (n = 62) FCP Compliance Yes: 54 (87.0%), No: 8 (12.9%) PRO Compliance Yes: 60 (96.8%), No: 2 (3.2%) MARS-5 Scores Baseline Week 12 Week 24 Mean (SD) 24.1 (1.1) 24.0 (1.5) 24.3 (0.9) Steroid Prescribed Yes: 15 (24.2%), No: 47 (75.8%) ED Presentation Yes: 9 (14.5%), No: 53 (85.5%) Hospitalization Yes: 5 (8.1%), No: 57 (91.9%) Advanced Therapy Clinical Response* Remission at 24 Weeks* Therapy Switched Ustekinumab(n = 30; IBD-U = 1; UC = 29) 18 (60.0%) 10 (33.3%) 1 (3.3%) Tofacitinib(n = 14; UC = 14) 9 (64.3%) 4 (28.6%) 3 (21.4%) Risankizumab(n = 11; CD = 11) 6 (54.5%) 3 (27.3%) 0 (0.0%) Upadacitinib(n = 4; CD = 2, UC = 2) 3 (75.0%) 1 (25.0%) 0 (0.0%) Vedolizumab(n = 2; CD = 1, UC = 1) 2 (100.0%) 1 (50.0%) 0 (0.0%) Infliximab(n = 1; UC = 1) 0 (0.0%) n/a 1 (100.0%) *Definitions per STRIDE-II Guidelines.CD = Crohn's Disease, ED = emergency department, FCP = fecal calprotectin, IBD-U = inflammatory bowel disease unclassified, MARS-5 = 5-item Medication Adherence Report Scale, PRO = patient-reported outcome, UC = ulcerative colitis.
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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 | 0,033 | 0,038 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,002 | 0,001 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,002 | 0,003 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,025 | 0,010 |
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 ».