Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial
Notice bibliographique
Résumé
Title: Surveillance AFter Extremity Tumor surgerY International Randomized Controlled Trial Short Title: SAFETY Methodology: Multi-center, 2 x 2 factorial superiority randomized controlled trial (RCT). Coordinating Center: This study will be centrally coordinated by the Methods Center at the Center for Evidence-Based Orthopaedics (CEO) at McMaster University in Hamilton, Ontario Canada. Clinical Sites: We are expecting ten clinical sites to be involved in the pilot phase. Further sites will be recruited for the definitive phase. Primary Objectives: The overall objective is to determine the effect of surveillance strategy on patient survival after surgery for a soft-tissue sarcoma of the extremity by comparing the effectiveness of: A) a surveillance frequency of every three months vs. every six months; and B) CT scans vs. chest radiographs. Secondary Objectives: We will explore: A) the effects of the post-operative surveillance strategies on patient-important outcomes (patient anxiety, overall satisfaction and quality of life), oncologic outcomes (local recurrence- and metastasis-free survival) and treatment-related complications (chemotherapy- and thoracotomy-related complications); and B) the net costs of post-operative surveillance strategies and of metastasis treatment and treatment-related complications. Treatment Groups: This study will compare two surveillance frequencies (every three months vs. every six months) and two imaging modalities (CT scan vs. chest radiograph) for a total of four treatment groups: 1) Surveillance visit and chest CT scan every three months for two years; 2) Surveillance visit and chest CT scan every six months for two years; 3) Surveillance visit and chest radiograph every three months for two years; or 4) Surveillance visit and chest radiograph every six months for two years. Study Outcome: The primary outcome is overall survival at five years post-randomization. Follow-Up: Upon completion of the two-year intervention phase, study participants will be followed every six months for another three years. Sample Size: Pilot - 200 participants | Definitive - 830 participants. Estimated Study Duration: Pilot - September 2019 – January 2023 | Definitive - TBD Significance: Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. The SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity soft-tissue sarcoma patients.
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 | 0,005 | 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 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,307 | 0,086 |
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; les deux têtes enseignantes s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».