Literature DB >> 27257737

Reporting of Randomized Controlled Trials With Statistically Nonsignificant Primary Outcomes Published in High-impact Surgical Journals.

Lakshmanan Arunachalam1, Iain A Hunter, Shane Killeen.   

Abstract

OBJECTIVE: To determine the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies which highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes in surgical journals.
BACKGROUND: Multiple reports have suggested that interpretation of RCT results in medical journals can be distorted by authors of published reports.
METHODS: Using a defined search strategy, RCTs with clearly nonsignificant results for the primary outcome (P > 0.05) form 10 high-impact factor surgical journals (Annals of Surgery, Journal of Neurology, Neurosurgery and Psychiatry, Journal of Heart and Lung Transplantation, American Journal of Transplantation, British Journal of Surgery, Journal of Bone and Joint Surgery, Journal of the American College of Surgeons, Endoscopy, Archives of Surgery, and Liver transplantation), published between July 2013 to July 2015, were identified. Two reviewers independently appraised each selected article using a validated, standardized data abstraction form.
RESULTS: In all, 110 eligible RCTs with nonsignificant primary outcomes were appraised. The title was reported with spin in 8 (7%) articles. Forty-four (40%) included abstracts and 39 (35%) main texts were classified as having spin in at least 1 section. The level of spin was high in 16 (14%) abstract and 19 (19%) main-text "Conclusions" sections. Twenty-five articles (23%) recommended the intervention of interest despite a nonsignificant primary outcome. There was no relationship between trial funding source, use of statistician and article section, and the presence of spin.
CONCLUSIONS: In RCTs with statistically nonsignificant primary outcomes published in surgical journals, the reporting and interpretation of findings was frequently inconsistent with the results.

Entities:  

Mesh:

Year:  2017        PMID: 27257737     DOI: 10.1097/SLA.0000000000001795

Source DB:  PubMed          Journal:  Ann Surg        ISSN: 0003-4932            Impact factor:   12.969


  11 in total

1.  Evidence of spin in clinical trials in the surgical literature.

Authors:  Padhraig S Fleming
Journal:  Ann Transl Med       Date:  2016-10

2.  Misrepresentation and distortion of research in biomedical literature.

Authors:  Isabelle Boutron; Philippe Ravaud
Journal:  Proc Natl Acad Sci U S A       Date:  2018-03-13       Impact factor: 11.205

3.  Acetyl-L-carnitine for patients with hepatic encephalopathy.

Authors:  Arturo J Martí-Carvajal; Christian Gluud; Ingrid Arevalo-Rodriguez; Cristina Elena Martí-Amarista
Journal:  Cochrane Database Syst Rev       Date:  2019-01-05

4.  A systematic search and qualitative review of reporting bias of lifestyle interventions in randomized controlled trials of diabetes prevention and management.

Authors:  Natalie D Riediger; Andrea E Bombak; Adriana Mudryj; Jackson Bensley; Samuel Ankomah
Journal:  Nutr J       Date:  2018-09-07       Impact factor: 3.271

5.  Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020: A Systematic Review.

Authors:  N Bryce Robinson; Stephen Fremes; Irbaz Hameed; Mohamed Rahouma; Viola Weidenmann; Michelle Demetres; Mahmoud Morsi; Giovanni Soletti; Antonino Di Franco; Marco A Zenati; Shahzad G Raja; David Moher; Faisal Bakaeen; Joanna Chikwe; Deepak L Bhatt; Paul Kurlansky; Leonard N Girardi; Mario Gaudino
Journal:  JAMA Netw Open       Date:  2021-06-01

6.  Influence of overstated abstract conclusions on clinicians: a web-based randomised controlled trial.

Authors:  Kiyomi Shinohara; Takuya Aoki; Ryuhei So; Yasushi Tsujimoto; Aya M Suganuma; Morito Kise; Toshi A Furukawa
Journal:  BMJ Open       Date:  2017-12-14       Impact factor: 2.692

7.  The reporting of outcomes in randomised controlled trials: The switch and the spin.

Authors:  M Ghert
Journal:  Bone Joint Res       Date:  2017-10       Impact factor: 5.853

8.  Overstatements in abstract conclusions claiming effectiveness of interventions in psychiatry: A meta-epidemiological investigation.

Authors:  Kiyomi Shinohara; Aya M Suganuma; Hissei Imai; Nozomi Takeshima; Yu Hayasaka; Toshi A Furukawa
Journal:  PLoS One       Date:  2017-09-13       Impact factor: 3.240

Review 9.  'Spin' in published biomedical literature: A methodological systematic review.

Authors:  Kellia Chiu; Quinn Grundy; Lisa Bero
Journal:  PLoS Biol       Date:  2017-09-11       Impact factor: 8.029

10.  Abstracts for reports of randomised trials of COVID-19 interventions had low quality and high spin.

Authors:  Dongguang Wang; Lingmin Chen; Lian Wang; Fang Hua; Juan Li; Yuxi Li; Yonggang Zhang; Hong Fan; Weimin Li; Mike Clarke
Journal:  J Clin Epidemiol       Date:  2021-07-02       Impact factor: 6.437

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