MIRO study: Do the results of a randomized controlled trial apply in a real population?

Adult Humans Esophagectomy / methods Cohort Studies Postoperative Complications / epidemiology Esophageal Neoplasms / surgery Randomized Controlled Trials as Topic

Journal

Surgery
ISSN: 1532-7361
Titre abrégé: Surgery
Pays: United States
ID NLM: 0417347

Informations de publication

Date de publication:
Apr 2024
Historique:
received: 04 09 2023
revised: 04 10 2023
accepted: 26 11 2023
medline: 18 3 2024
pubmed: 16 3 2024
entrez: 15 3 2024
Statut: ppublish

Résumé

The aim of our study was to evaluate the external validity of the MIRO randomized controlled trial findings in a similar nationwide setting "real life" population, especially the benefit of a hybrid approach in esophageal resection for pulmonary complication. The external validity of randomized controlled trial findings to the general population with the same condition remains problematic because of the inherent selection bias and rigid inclusion criteria. This study was a cohort study from a National Health Database (Programme de Medicalisation des Systemes d'Informations) between 2010 and 2022. All adult patients operated on using Ivor Lewis resection for esophageal cancer were included. We first validated the detection algorithm of postoperative complications in the health database. Then, we assessed the primary outcome, which was the comparison of postoperative severe pulmonary complications, leak rate, and 30-day mortality between the 2 surgical approaches (hybrid versus open) over a decade. Between 2010 and 2012, 162 of 205 patients in the MIRO trial were anonymously identified in the health care database. No difference between randomized controlled trials and healthcare database measurements was found within severe respiratory complications (24% vs 22%, respectively) nor within leak rate (10% vs 9%, respectively). After application of selection criteria according to the MIRO trial, 3,852 patients were included between 2013 and 2022. The hybrid approach was a protective factor against respiratory complications after adjustment for confounding variables (odds ratio = 0.83; 95% confidence interval = 0.71-0.98, P = .025). No significant difference in the 30-day mortality rate or 30-day leakage rate between the types of approach was reported. This national cohort study demonstrates the external validity of the MIRO randomized controlled trial findings in a real-life population within France.

Sections du résumé

BACKGROUND BACKGROUND
The aim of our study was to evaluate the external validity of the MIRO randomized controlled trial findings in a similar nationwide setting "real life" population, especially the benefit of a hybrid approach in esophageal resection for pulmonary complication. The external validity of randomized controlled trial findings to the general population with the same condition remains problematic because of the inherent selection bias and rigid inclusion criteria.
METHODS METHODS
This study was a cohort study from a National Health Database (Programme de Medicalisation des Systemes d'Informations) between 2010 and 2022. All adult patients operated on using Ivor Lewis resection for esophageal cancer were included. We first validated the detection algorithm of postoperative complications in the health database. Then, we assessed the primary outcome, which was the comparison of postoperative severe pulmonary complications, leak rate, and 30-day mortality between the 2 surgical approaches (hybrid versus open) over a decade.
RESULTS RESULTS
Between 2010 and 2012, 162 of 205 patients in the MIRO trial were anonymously identified in the health care database. No difference between randomized controlled trials and healthcare database measurements was found within severe respiratory complications (24% vs 22%, respectively) nor within leak rate (10% vs 9%, respectively). After application of selection criteria according to the MIRO trial, 3,852 patients were included between 2013 and 2022. The hybrid approach was a protective factor against respiratory complications after adjustment for confounding variables (odds ratio = 0.83; 95% confidence interval = 0.71-0.98, P = .025). No significant difference in the 30-day mortality rate or 30-day leakage rate between the types of approach was reported.
CONCLUSION CONCLUSIONS
This national cohort study demonstrates the external validity of the MIRO randomized controlled trial findings in a real-life population within France.

Identifiants

DOI: 10.1016/j.surg.2023.11.026 PMID: 38490752
pubmed: 38490752
pii: S0039-6060(23)00892-9
doi: 10.1016/j.surg.2023.11.026
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1055-1062

Informations de copyright

Copyright © 2023 Elsevier Inc. All rights reserved.

Auteurs

Alexandre Challine (A)

Sorbonne Université, Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Paris, France; HeKA, Inria, Paris, France; Service de Chirurgie Viscérale, Cancérologique et Endocrinienne, Hôpital Saint Louis, Assistance Publique des Hôpitaux de Paris, Université de Paris, Paris, France. Electronic address: alexandre.challline@aphp.fr.

Mehdi Kirouani (M)

Service de Chirurgie Viscérale, Cancérologique et Endocrinienne, Hôpital Saint Louis, Assistance Publique des Hôpitaux de Paris, Université de Paris, Paris, France.

Sheraz R Markar (SR)

Nuffield Department of Surgery, University of Oxford, Oxford, United Kingdom.

Stylianos Tzedakis (S)

HeKA, Inria, Paris, France.

Romain Jaquet (R)

HeKA, Inria, Paris, France.

Guillaume Piessen (G)

CHU Lille, Department of Digestive and Oncological Surgery, F-59000 Lille, France; Univ. Lille, CNRS, Inserm, CHU Lille, UMR9020-U1277 - CANTHER - Cancer Heterogeneity Plasticity and Resistance to Therapies, F-59000 Lille, France.

Tienhan Sandrine Dabakoyo-Yonli (TS)

The Epidemiology and Quality of Life Unit, INSERM Unité 1231, Centre Georges François Leclerc, Dijon (T.S.D.-Y.).

Jérémie H Lefèvre (JH)

Sorbonne Université, Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Paris, France.

Andrea Lazzati (A)

HeKA, Inria, Paris, France; Service de chirurgie digestive et bariatrique, Centre intercommunal de Créteil, Créteil, France.

Thibault Voron (T)

Sorbonne Université, Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Paris, France.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › MIRO study: Do the results of a randomized...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › MIRO study: Do the results of a randomized...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie digestive › Oesophagectomie › MIRO study: Do the results of a randomized...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › MIRO study: Do the results of a randomized...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Complications postopératoires › MIRO study: Do the results of a randomized...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies gastro-intestinales › Tumeurs gastro-intestinales › Tumeurs de l'oesophage › MIRO study: Do the results of a randomized...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › MIRO study: Do the results of a randomized...