Patient-Reported Treatment Satisfaction with Oral Rivaroxaban Versus Standard Therapy in the Treatment of Acute Symptomatic Pulmonary Embolism
Notice bibliographique
Résumé
Abstract Abstract 1163 Background: Rivaroxaban treatment for symptomatic venous thromboembolism does not require routine laboratory monitoring, dose adjustments, or bridging with a parenteral anticoagulant and thus has the potential to reduce patient treatment burden compared with standard of care. It is becoming increasingly important to consider the views of patients in treatment decisions to improve adherence and, consequently, health outcomes. We investigated patient-reported outcomes in the EINSTEIN PE study, a large, open-label, randomized trial of patients with acute symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis. This trial compared oral rivaroxaban with dose-adjusted enoxaparin overlapping with, and followed by, vitamin K antagonist (VKA) treatment. Methods: As part of the EINSTEIN PE study, 2397 patients from 7 countries (Canada, France, Germany, Italy, Netherlands, UK, and USA) were requested to complete a newly developed and validated measure of anticoagulation treatment satisfaction – the Anti-Clot Treatment Scale (ACTS) – at scheduled visits during treatment: Day 15, then at Months 1, 2, 3, 6, and 12. The ACTS consists of 2 scales: ACTS Burdens (12 items, scored on a 12–60 scale) and ACTS Benefits (3 items, scored on a 3–15 scale). The ACTS Burdens scale captures the negative aspects of patients' anticoagulation experience (e.g. hassle/inconvenience, worry/frustration, and activity limitations), whereas the ACTS Benefits scale records the positive aspects (e.g. confidence, reassurance, and satisfaction). For each scale, higher total scores indicate better acceptance. In addition, patients completed the Treatment Satisfaction Questionnaire for Medication version II (TSQM II) at Months 1, 3, 6, and 12, primarily as a validation benchmark for the ACTS scale. There are 4 TSQM II subscales (Effectiveness, Side-Effects, Convenience, and Global Satisfaction), all of which are scored on a 0–100 scale. A pre-specified repeated measures analysis, stratified by intended treatment duration, with time (visit) as the repeated measure factor, was used to compare ACTS Burdens and ACTS Benefits scores between treatment groups in the intention-to-treat population; the analysis was repeated for the 4 TSQM II subscales. Results: Patients reported a lower burden and a higher perceived benefit in the rivaroxaban with higher mean ACTS scores across visits (Table). Mean ACTS Burdens scores were 55.4 versus 51.9 for rivaroxaban and enoxaparin/VKA, respectively (p<0.0001), and mean ACTS Benefits scores were 11.9 versus 11.4, respectively (p<0.001), in favorof rivaroxaban. The ACTS Burdens scores had a consistent treatment effect over time, but the difference in ACTS Benefits scores between the groups was not constant over time and showed a greater difference at Month 2 and later time points. The TSQM II scores confirmed the greater patient-reported treatment satisfaction, with higher scores shown in patients treated with rivaroxaban in all 4 subscales; the Convenience subscale had the largest difference. Conclusions: Patients with acute symptomatic pulmonary embolism reported a lower burden, higher perceived benefits, and improved treatment satisfaction with rivaroxaban compared with enoxaparin/VKA. The improved convenience of treatment, as perceived by patients, may contribute to increased patient acceptance of and adherence to anticoagulant treatment, with consequently improved health outcomes. Disclosures: Prins: Bayer Healthcare: Consultancy, Honoraria. Bamber:Bayer Healthcare: Employment. Cano:Bayer Healthcare: Research Funding. Wang:Bayer Healthcare: Employment. Lensing:Bayer Healthcare: Employment.
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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 | 0,003 | 0,009 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
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 ».