Validity of studies suggesting preoperative chemotherapy for resectable thoracic esophageal cancer: A critical appraisal of randomized trials.

Assessment of validity CONSORT Esophageal cancer Meta-analysis Overall survival

Journal

World journal of gastrointestinal oncology
ISSN: 1948-5204
Titre abrégé: World J Gastrointest Oncol
Pays: China
ID NLM: 101532470

Informations de publication

Date de publication:
15 Jan 2020
Historique:
received: 22 03 2019
revised: 20 09 2019
accepted: 14 10 2019
entrez: 23 1 2020
pubmed: 23 1 2020
medline: 23 1 2020
Statut: ppublish

Résumé

In 2015, Kidane published a Cochrane review and meta-analysis to summarise the impact of preoperative chemotherapy versus surgery alone on survival for resectable thoracic esophageal cancer. The authors concluded that preoperative chemotherapy improved overall survival (OS). The aim of this article was to assess the validity of the three most powerful studies included in the Cochrane review and the meta-analysis supporting the advantage of preoperative chemotherapy and to investigate the impact of an exclusion of these three studies on the result of the meta-analysis. OS was selected as the endpoint of interest. Among the ten included papers which analysed this endpoint, we identified the three publications with the highest weights influencing the final result. The validity of these papers was analysed using the CONSORT checklist for randomized controlled trials. We performed a new meta-analysis without the three studies to assess their impact on the general result of the original meta-analysis. The three analysed studies revealed several inconsistencies. Inappropriate answers were found in up to one third of the items of the CONSORT checklist. Missing information about sample-size calculation and power, unclear or inadequate randomisation, and missing blinded set-up were the most common findings. When the three criticized studies were excluded in the meta-analysis, preoperative chemotherapy showed no benefit in OS. The three most powerful publications in the Cochrane review show substantial deficits. After the exclusion of these studies from the meta-analysis, preoperative chemotherapy does not seem to result in an advantage in survival. We suggest a more critical appraisal regarding the validity of single studies.

Sections du résumé

BACKGROUND BACKGROUND
In 2015, Kidane published a Cochrane review and meta-analysis to summarise the impact of preoperative chemotherapy versus surgery alone on survival for resectable thoracic esophageal cancer. The authors concluded that preoperative chemotherapy improved overall survival (OS).
AIM OBJECTIVE
The aim of this article was to assess the validity of the three most powerful studies included in the Cochrane review and the meta-analysis supporting the advantage of preoperative chemotherapy and to investigate the impact of an exclusion of these three studies on the result of the meta-analysis.
METHODS METHODS
OS was selected as the endpoint of interest. Among the ten included papers which analysed this endpoint, we identified the three publications with the highest weights influencing the final result. The validity of these papers was analysed using the CONSORT checklist for randomized controlled trials. We performed a new meta-analysis without the three studies to assess their impact on the general result of the original meta-analysis.
RESULTS RESULTS
The three analysed studies revealed several inconsistencies. Inappropriate answers were found in up to one third of the items of the CONSORT checklist. Missing information about sample-size calculation and power, unclear or inadequate randomisation, and missing blinded set-up were the most common findings. When the three criticized studies were excluded in the meta-analysis, preoperative chemotherapy showed no benefit in OS.
CONCLUSION CONCLUSIONS
The three most powerful publications in the Cochrane review show substantial deficits. After the exclusion of these studies from the meta-analysis, preoperative chemotherapy does not seem to result in an advantage in survival. We suggest a more critical appraisal regarding the validity of single studies.

Identifiants

pubmed: 31966919
doi: 10.4251/wjgo.v12.i1.113
pmc: PMC6960071
doi:

Types de publication

Journal Article

Langues

eng

Pagination

113-123

Informations de copyright

©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.

Déclaration de conflit d'intérêts

Conflict-of-interest statement: The authors have no conflicts of interest to declare.

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Auteurs

Giulia Manzini (G)

Department of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany.

Ursula Klotz (U)

Department of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany.

Doris Henne-Bruns (D)

Department of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany. doris.henne-bruns@uniklinik-ulm.de.

Michael Kremer (M)

Department of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany.

Classifications MeSH