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
  • [21] Cardioplegia in paediatric cardiac surgery: a systematic review of randomized controlled trials
    Drury, Nigel E.
    Yim, Ivan
    Patel, Akshay J.
    Oswald, Nicola K.
    Chong, Cher-Rin
    Stickley, John
    Jones, Timothy J.
    INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY, 2019, 28 (01) : 144 - 150
  • [22] Outcome reporting in randomized controlled trials and systematic reviews of gastroschisis treatment: a systematic review
    Ross, Andrew R.
    Hall, Nigel J.
    JOURNAL OF PEDIATRIC SURGERY, 2016, 51 (08) : 1385 - 1389
  • [23] Systematic review on the quality of randomized controlled trials from Saudi Arabia
    Rajab, Ahmad Mamoun
    Hamza, Abdulmalik
    Aldairi, Roshdi Kotaiba
    Alaloush, Mohamad Mahmoud
    Saquib, Juliann
    Saquib, Nazmus
    CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, 2019, 16
  • [24] Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials
    Xie, Cheng-long
    Gu, Yong
    Wang, Wen-Wen
    Lu, Lin
    Fu, Deng-lei
    Liu, Ai-ju
    Li, Hui-qin
    Li, Ji-huang
    Lin, Yan
    Tang, Wen-jie
    Zheng, Guo-qing
    BMC COMPLEMENTARY AND ALTERNATIVE MEDICINE, 2013, 13
  • [25] The effect of omentectomy added to bariatric surgery on metabolic outcomes: a systematic review and meta-analysis of randomized controlled trials
    Lee, Yung
    Pedziwiatr, Michal
    Major, Piotr
    Brar, Karanbir
    Doumouras, Aristithes G.
    Hong, Dennis
    SURGERY FOR OBESITY AND RELATED DISEASES, 2018, 14 (11) : 1766 - 1782
  • [26] Enhanced Recovery after Surgery (ERAS): a Systematic Review of Randomised Controlled Trials (RCTs) in Bariatric Surgery
    Amilcare Parisi
    Jacopo Desiderio
    Roberto Cirocchi
    Stefano Trastulli
    Obesity Surgery, 2020, 30 : 5071 - 5085
  • [27] Outcome Measurements Used in Randomized Controlled Trials of Teledermatology: A Systematic Mapping Review
    Chow, Aloysius
    Soon, Charlene
    Smith, Helen Elizabeth
    Apfelbacher, Christian J.
    ACTA DERMATO-VENEREOLOGICA, 2019, 99 (13) : 1210 - 1217
  • [28] Enhanced Recovery after Surgery (ERAS): a Systematic Review of Randomised Controlled Trials (RCTs) in Bariatric Surgery
    Parisi, Amilcare
    Desiderio, Jacopo
    Cirocchi, Roberto
    Trastulli, Stefano
    OBESITY SURGERY, 2020, 30 (12) : 5071 - 5085
  • [29] Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review
    Martin, Enrico
    Muskens, Ivo S.
    Senders, Joeky T.
    DiRisio, Aislyn C.
    Karhade, Aditya V.
    Zaidi, Hasan A.
    Moojen, Wouter A.
    Peul, Wilco C.
    Smith, Timothy R.
    Broekman, Marike L. D.
    ACTA NEUROCHIRURGICA, 2019, 161 (04) : 627 - 634
  • [30] Blinding in randomized controlled trials in general and abdominal surgery: Protocol for a systematic review and empirical study
    Probst P.
    Grummich K.
    Heger P.
    Zaschke S.
    Knebel P.
    Ulrich A.
    Büchler M.W.
    Diener M.K.
    Systematic Reviews, 5 (1)