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
相关论文
共 50 条
  • [1] Spin in the Scientific Literature on Bariatric Endoscopy: a Systematic Review of Randomized Controlled Trials
    Shirvani, Sayeh
    Rives-Lange, Claire
    Rassy, Nathalie
    Berger, Arthur
    Carette, Claire
    Poghosyan, Tigran
    Czernichow, Sebastien
    OBESITY SURGERY, 2022, 32 (02) : 503 - 511
  • [2] Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes
    Boutron, Isabelle
    Dutton, Susan
    Ravaud, Philippe
    Altman, Douglas G.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 303 (20): : 2058 - 2064
  • [3] Reporting of Randomized Controlled Trials With Statistically Nonsignificant Primary Outcomes Published in High-impact Surgical Journals
    Arunachalam, Lakshmanan
    Hunter, Iain A.
    Killeen, Shane
    ANNALS OF SURGERY, 2017, 265 (06) : 1141 - 1145
  • [4] Spin in the Scientific Literature on Bariatric Endoscopy: a Systematic Review of Randomized Controlled Trials
    Sayeh Shirvani
    Claire Rives-Lange
    Nathalie Rassy
    Arthur Berger
    Claire Carette
    Tigran Poghosyan
    Sébastien Czernichow
    Obesity Surgery, 2022, 32 : 503 - 511
  • [5] Data Interpretation in Analgesic Clinical Trials With Statistically Nonsignificant Primary Analyses: An ACTTION Systematic Review
    Gewandter, Jennifer S.
    McKeown, Andrew
    McDermott, Michael P.
    Dworkin, Jordan D.
    Smith, Shannon M.
    Gross, Robert A.
    Hunsinger, Matthew
    Lin, Allison H.
    Rappaport, Bob A.
    Rice, Andrew S. C.
    Rowbotham, Michael C.
    Williams, Mark R.
    Turk, Dennis C.
    Dworkin, Robert H.
    JOURNAL OF PAIN, 2015, 16 (01) : 3 - 10
  • [6] Assessment of spin in the abstracts of randomized controlled trials in dental caries with statistically nonsignificant results for primary outcomes: A methodological study
    Su, Naichuan
    van der Linden, Michiel W.
    Faggion, Clovis M.
    van der Heijden, Geert J. M. G.
    CARIES RESEARCH, 2023, 57 (5-6) : 553 - 562
  • [7] Seventy years of bariatric surgery: A systematic mapping review of randomized controlled trials
    Rives-Lange, Claire
    Rassy, Natalie
    Carette, Claire
    Phan, Aurelie
    Barsamian, Charles
    Thereaux, Jeremie
    Moszkowicz, David
    Poghosyan, Tigran
    Czernichow, Sebastien
    OBESITY REVIEWS, 2022, 23 (05)
  • [8] Analyzing Spin in Abstracts of Orthopaedic Randomized Controlled Trials With Statistically Insignificant Primary Endpoints
    Arthur, Wade
    Zaaza, Zachariah
    Checketts, Jake X.
    Johnson, Austin L.
    Middlemist, Kevin
    Basener, Clint
    Jellison, Sam
    Wayant, Cole
    Vassar, Matt
    ARTHROSCOPY-THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, 2020, 36 (05) : 1443 - +
  • [9] Spin in randomized controlled trials of pharmacology in COVID-19: A systematic review
    Oh, Yunkyoung
    Jung, Youn-Joo
    Sujata, Purja
    Kim, Minji
    Yon, Dong Keon
    Lee, Seung Won
    Cho, Kyuyeon
    Koyanagi, Ai
    Dai, Zhaoli
    Lee, Smith
    Shin, Jae Il
    Kim, Eunyoung
    ACCOUNTABILITY IN RESEARCH-ETHICS INTEGRITY AND POLICY, 2025, 32 (03): : 214 - 232
  • [10] Bariatric surgery: a systematic review and network meta-analysis of randomized trials
    Padwal, R.
    Klarenbach, S.
    Wiebe, N.
    Birch, D.
    Karmali, S.
    Manns, B.
    Hazel, M.
    Sharma, A. M.
    Tonelli, M.
    OBESITY REVIEWS, 2011, 12 (08) : 602 - 621