Contributions of a survey and retrospective cohort study to the planning of a randomised controlled trial of corticosteroids in the treatment of paediatric septic shock
Notice bibliographique
Résumé
BACKGROUND: Randomised controlled trials (RCTs) are challenging to conduct in a paediatric critical-care environment. Background work, including surveys and observational studies, is often used to determine disease estimates, sample sizes and design protocols when planning such RCTs. Our objective was to determine the necessity of performing a survey or a retrospective chart review or both when planning an RCT on corticosteroids in the treatment of paediatric septic shock. METHODS: We compared information on corticosteroid use for moderate to severe paediatric septic shock obtained from a survey of physician beliefs and stated practices with that obtained from a retrospective cohort study. The survey was conducted between February and March 2012 and the retrospective study included children from birth to 17 years of age admitted from January 2010 to June 2011. The survey and the retrospective study were conducted at four academic tertiary care centres in Canada. RESULTS: Survey responses from 23 physicians and retrospective data from 81 septic shock patients were included. The survey identified time to discontinuation of vasoactive infusions as the most feasible and clinically important outcome for an RCT on corticosteroids for paediatric septic shock. The retrospective chart review provided means and standard deviations for the suggested primary outcome, from which we could estimate sample sizes and justify the minimal clinically important difference. The survey found that physicians believe that patients with severe septic shock were most likely to benefit from corticosteroid administration but the majority stated they would be unwilling to randomise such patients, suggesting a lack of individual physician equipoise. The combined information from the survey and retrospective study suggested that enrolment of patients with moderate septic shock would be more feasible but that strategies would still have to be implemented to prevent open-label corticosteroid use. CONCLUSIONS: The survey provided valuable information on the choice of primary outcome, target population and physician equipoise. The retrospective study provided estimates of patient numbers, the minimal clinically important difference, evidence for community equipoise and physician practice patterns. Strong consideration should be given to performing both types of studies prior to conducting RCTs in paediatric critical-care environments.
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 | 0,006 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 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 ».