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

被引:9
|
作者
Rassy, Nathalie [1 ]
Rives-Lange, Claire [1 ,2 ,3 ]
Carette, Claire [1 ,2 ]
Barsamian, Charles [1 ]
Moszkowicz, David [4 ]
Thereauxe, Jeremie [5 ,6 ]
Poghosyan, Tigran [7 ]
Czernichow, Sebastien [1 ,2 ,3 ]
机构
[1] Hop Europeen Georges Pompidou, AP HP, Serv Nutr, Ctr Specialise Obesite, Paris, France
[2] Univ Paris, F-75015 Paris, France
[3] METHODS Team, Epidemiol & Biostat Sorbonne Paris Cite Ctr CRESS, INSERM, UMR1153, Paris, France
[4] Nord Univ Paris, Univ Paris, Hop Louis Mourier,GHU, AP HP,DMU ESPRIT,UFR Med Paris Diderot,Fac Sante, Paris, France
[5] La Cavale Blanche Univ Hosp, Dept Gen Digest & Metab Surg, Blvd Tanguy Prigent, F-29200 Brest, France
[6] Univ Bretagne Occidentale UBO, EA 3878, GETBO, 22 Ave Camille Desmoulins,CS 93837, F-29238 Brest, France
[7] Hop Europeen Georges Pompidou, AP HP, Serv Chirurg Digest, Paris, France
关键词
Spin; Bariatric surgery; Randomized controlled trial; PUBLISHED PRIMARY OUTCOMES; CLINICAL-TRIALS; IMPACT; BIAS;
D O I
10.1016/j.jclinepi.2021.05.004
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objectives: To systematically identify the strategy and frequency of spin in reports of bariatric surgery randomized controlled trials (RCTs) with statistically nonsignificant primary endpoint. Study design and Setting: 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. Results: 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. Conclusion: Spin occurred in a high proportion of bariatric surgery RCTs with a statistically nonsignificant primary endpoint. (c) 2021 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/ licenses/ by/ 4.0/ )
引用
收藏
页码:87 / 95
页数:9
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