Spin occurs in bariatric surgery randomized controlled trials with a statistically nonsignificant primary outcome: A systematic review.


Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
11 2021
Historique:
received: 08 12 2020
revised: 22 04 2021
accepted: 05 05 2021
pubmed: 19 5 2021
medline: 21 12 2021
entrez: 18 5 2021
Statut: ppublish

Résumé

To systematically identify the strategy and frequency of spin in reports of bariatric surgery randomized controlled trials (RCTs) with statistically nonsignificant primary endpoint. The use of specific reporting strategies to highlight the beneficial effect of an experimental treatment can affect the reader interpretation of trial results, particularly when the primary endpoint is not statistically significant. A literature search was performed to identify RCTs publications assessing the impact of bariatric surgery on obesity-related comorbidities published over the past 10 years (from January 2020 till December 2020) in MEDLINE and EMBASE. RCTs publications with statistically non-significant primary outcomes were included. Of 46 576 reports screened for title and abstract inclusion, 29 RCT reports met the inclusion criteria for spin analysis. In total, 16 abstracts (55%) and 18 main texts (62%) were classified as having a spin. In abstract results and conclusion sections, the spin was identified in 69% of reports. In main text results, discussion, and conclusion sections, the spin was recognized in 37%, 72%, and 76% of reports respectively. The spin consisted mainly of focusing on within-group improvements and the interpretation of statistically nonsignificant results as showing treatment equivalence. Spin occurred in a high proportion of bariatric surgery RCTs with a statistically nonsignificant primary endpoint.

Identifiants

pubmed: 34004338
pii: S0895-4356(21)00147-5
doi: 10.1016/j.jclinepi.2021.05.004
pii:
doi:

Types de publication

Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

87-95

Informations de copyright

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Auteurs

Nathalie Rassy (N)

Assistance Publique-Hôpitaux de Paris (AP-HP), Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Paris, France.

Claire Rives-Lange (C)

Assistance Publique-Hôpitaux de Paris (AP-HP), Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Paris, France; Université de Paris, F-75015 Paris, France; INSERM, UMR1153, Epidemiology and Biostatistics Sorbonne Paris Cité Center (CRESS), METHODS team, Paris, France.

Claire Carette (C)

Assistance Publique-Hôpitaux de Paris (AP-HP), Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Paris, France; Université de Paris, F-75015 Paris, France.

Charles Barsamian (C)

Assistance Publique-Hôpitaux de Paris (AP-HP), Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Paris, France.

David Moszkowicz (D)

Hôpital Louis Mourier, UFR de Médecine Paris Diderot - Faculté de santé de l'Université de Paris, DMU ESPRIT - GHU AP-HP. Nord - Université de Paris.

Jérémie Thereaux (J)

Department of General, Digestive and Metabolic Surgery, La Cavale Blanche University Hospital, Boulevard Tanguy Prigent, 29200 Brest, France; University of Bretagne Occidentale (UBO), EA 3878 (GETBO), 22 avenue Camille Desmoulins CS 93837, 29238 Brest, France.

Tigran Poghosyan (T)

Assistance Publique-Hôpitaux de Paris (AP-HP), Service de chirurgie digestive, Hôpital Européen Georges Pompidou, Paris, France.

Sébastien Czernichow (S)

Assistance Publique-Hôpitaux de Paris (AP-HP), Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Paris, France; Université de Paris, F-75015 Paris, France; INSERM, UMR1153, Epidemiology and Biostatistics Sorbonne Paris Cité Center (CRESS), METHODS team, Paris, France. Electronic address: sebastien.czernichow@aphp.fr.

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