P-118. Patient Reported Outcomes (PRO) Analysis of the Phase 2 Multi-Center, Prospective, Randomized, Double-Blind Study Assessing Nitazoxanide for the Treatment of Norovirus in Hematopoietic Stem Cell and Solid Organ Transplant Recipients
Notice bibliographique
Résumé
Abstract Background Norovirus (NoV) results in relapsing, remitting diarrhea in immunocompromised hosts (ICH). No prospective studies of existing therapies including nitazoxanide (NTZ) have included evaluation of patient reported outcomes (PRO) or reported impact on patient quality of life (QOL). Methods We conducted a NIH-sponsored multi-center, prospective, randomized, double-blind study of NTZ for the treatment of NoV in adult HSCT and SOT recipients. Subjects with a positive NoV testing and active GI symptoms were randomly assigned (1:1) to NTZ 500 mg twice daily or placebo (P) for 56 consecutives doses and followed for 6 months. PRO diary assessments based on recognized questionnaires were collected: IBSQOL, EuroQOL, PROMIS Emotional, PROMIS GI, PANAS and PROMIS Physical Function Questionnaires.Figure 1.Patient-Reported Quality of Life by EuroQOL-5 Dimension and Study Day – Nitazoxanide vs Placebo, mITT Population Results 31 subjects (16 NTZ, 15 P) were enrolled (Table 1). Early withdrawal was documented in 5 subjects from each group. Thirty (30) had received solid organ transplants. Most had chronic (> = 14d) symptoms (77%). Based on data collected from PRO diaries, there were no significant between-treatment differences for change in diarrhea or nausea from baseline to day 180 (p=0.590 and 0.271). There was no significant difference in median time to 50% reduction in antimotility agents (NTZ 7d vs placebo 5d, p=0.830). However, the EuroQOL-5 questionnaire responses showed that patients seem to report less problems with anxiety/depression (NTZ 29% vs placebo 38%), mobility (21% vs 50%) and usual activities (29 vs 64%) at the end of study drug with NTZ (Fig. 1). There were significant difference in improvement of reported incontinence events between groups over time, which likely impact perceived QOL and activity level. Importantly, analysis of PROs demonstrates the significant and longstanding impact of NoV on ICH with high rates of anxiety/depression and reduced mobility at 180 days. Conclusion PROs from this study provided significant insight into the expected course of NoV infection in ICH, including persistent but intermittent diarrhea, prolonged anxiety and depression, reduced mobility and reduced usual activity even out to 180 days post monitoring. This study provides data to support the use of PROs as primary endpoints in these studies. Disclosures Ajit Limaye, Professor/MD, Memo: Advisor/Consultant|merck: Advisor/Consultant|merck: Grant/Research Support|moderna: Advisor/Consultant|moderna: site investigator|NobelPharma: DSMB member Steven A. Pergam, MD, MPH, Cidara: Advisor/Consultant|F2G: Advisor/Consultant|Global Life Technologies: Grant/Research Support|Symbio: Advisor/Consultant Michael D. Green, MD, MPH, ADMA: Advisor/Consultant|Bristol Myers Squibb: Advisor/Consultant|ITB-MED: Advisor/Consultant|kamada: Honoraria Lara A. Danziger-Isakov, MD, MPH, Aicuris: clinical research contract, paid to institutio|Ansun BioPharma: clinical research contract, paid to institution|Astellas: Advisor/Consultant|Astellas: clinical research contract, paid to institutio|Merck: clinical research contract, paid to institutio|Pfizer: Grant/Research Support|Takeda: clinical research contract, paid to institutio Michael Ison, MD MS, GlaxoSmithKline: Grant/Research Support|UpToDate: Royalties
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 | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 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 ».