[To evaluate the quality of life and peristomal skin ostomy patient with the new device Sensura].
Notice bibliographique
Résumé
UNLABELLED: In 2006, Coloplast launched in several European countries a new device for ostomy care called Sensura. This clinical research report includes only the results of the subpopulation included in Spain as a part of an international study involving many countries such as Denmark, United States, Canada, Australia, Poland, Netherlands, France, Slovakia, Germany, UK, Italy, Iceland, Japan, Czech Republic, Portugal, South Korea and Argentina. OBJECTIVES AND STUDY VARIABLES: The main purpose of the study is to evaluate the experience with Sensura, under normal conditions of use, with special attention to skin condition and quality of life. The main objective of the study is to evaluate the quality of life, through Quality of Life Questionnaire called "Stoma QoL". A secondary objective, is to study the correlation between quality of life and the peristomal skin condition. Other Secondary objectives include the evaluation of the patient's current device at the time of entering the study and by the other hand, the device Sensura and safety evaluation throughout the study. DESIGN STUDY: The study was designed as an open label non-comparative, multi-national Post Market study. The study period for each patient is 6 to 8 weeks +/- 4 days, which includes an initial visit and a final visit. The study population included people who carry a colostomy or ileostomy. METHODOLOGY: Regarding Spain, a total of 10 sites participated and included a total of 131 patients. This report only presents results for nine sites and a total of 123 patients. The reason is that the last participating site began the study with a considerable delay The remaining subjects included in this site together with the other centers in Spain and the other participating countries will be included in the final international report, that will present the overall results. MEASUREMENT TOOLS. Stoma-QoL (Quality of Life Questionnaire for people with an ostomy). OST (Ostomy Skin Tool) instrument for the assessment of peristomal skin. RESULTS: As for the quality of life, at baseline we found a mean of 59 out of 100 (SD = 8.8), while the final study visit, mean score was 59.6 out of 100 (SD = 9.3), although the final results on this variable will be presented in the global report, since it has not reached sufficient population in Spain for the analysis of this variable. The study revealed a significant improvement in the peristomal skin condition at the end of the study, measured by the tool OST (Ostomy Skin Tool). Regarding the evaluation of the SenSura device, there was a significant improvement related to the appearance of leakage of effluent, as well as other items evaluated in relation with the device.
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 | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».