Literature DB >> 20501928

Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes.

Isabelle Boutron1, Susan Dutton, Philippe Ravaud, Douglas G Altman.   

Abstract

CONTEXT: Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.
OBJECTIVE: To identify the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes. DATA SOURCES: March 2007 search of MEDLINE via PubMed using the Cochrane Highly Sensitive Search Strategy to identify reports of RCTs published in December 2006. STUDY SELECTION: Articles were included if they were parallel-group RCTs with a clearly identified primary outcome showing statistically nonsignificant results (ie, P > or = .05). DATA EXTRACTION: Two readers appraised each selected article using a pretested, standardized data abstraction form developed in a pilot test.
RESULTS: From the 616 published reports of RCTs examined, 72 were eligible and appraised. The title was reported with spin in 13 articles (18.0%; 95% confidence interval [CI], 10.0%-28.9%). Spin was identified in the Results and Conclusions sections of the abstracts of 27 (37.5%; 95% CI, 26.4%-49.7%) and 42 (58.3%; 95% CI, 46.1%-69.8%) reports, respectively, with the conclusions of 17 (23.6%; 95% CI, 14.4%-35.1%) focusing only on treatment effectiveness. Spin was identified in the main-text Results, Discussion, and Conclusions sections of 21 (29.2%; 95% CI, 19.0%-41.1%), 31 (43.1%; 95% CI, 31.4%-55.3%), and 36 (50.0%; 95% CI, 38.0%-62.0%) reports, respectively. More than 40% of the reports had spin in at least 2 of these sections in the main text.
CONCLUSION: In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results.

Mesh:

Year:  2010        PMID: 20501928     DOI: 10.1001/jama.2010.651

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


  176 in total

1.  Efficacy, effectiveness, and behavior change trials in exercise research.

Authors:  Kerry S Courneya
Journal:  Int J Behav Nutr Phys Act       Date:  2010-11-12       Impact factor: 6.457

2.  Clinical trials: subgroup analyses in randomized trials--more rigour needed.

Authors:  Douglas G Altman
Journal:  Nat Rev Clin Oncol       Date:  2015-07-28       Impact factor: 66.675

3.  Principles for the ethical analysis of clinical and translational research.

Authors:  Jonathan A L Gelfond; Elizabeth Heitman; Brad H Pollock; Craig M Klugman
Journal:  Stat Med       Date:  2011-07-12       Impact factor: 2.373

Review 4.  Quality of reporting of randomized controlled trials published in Intensive Care Medicine from 2001 to 2010.

Authors:  Nicola Latronico; Marta Metelli; Maddalena Turin; Simone Piva; Frank A Rasulo; Cosetta Minelli
Journal:  Intensive Care Med       Date:  2013-06-07       Impact factor: 17.440

5.  Belief beyond the evidence: using the proposed effect of breakfast on obesity to show 2 practices that distort scientific evidence.

Authors:  Andrew W Brown; Michelle M Bohan Brown; David B Allison
Journal:  Am J Clin Nutr       Date:  2013-09-04       Impact factor: 7.045

6.  The Drug Facts Box: Improving the communication of prescription drug information.

Authors:  Lisa M Schwartz; Steven Woloshin
Journal:  Proc Natl Acad Sci U S A       Date:  2013-08-13       Impact factor: 11.205

Review 7.  Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions.

Authors:  Mario Gaudino; Irbaz Hameed; Mohamed Rahouma; Faiza M Khan; Derrick Y Tam; Giuseppe Biondi-Zoccai; Michelle Demetres; Mary E Charlson; Marc Ruel; Filippo Crea; Volkmar Falk; Leonard N Girardi; Stephen Fremes; Joanna Chikwe
Journal:  JAMA Intern Med       Date:  2020-07-01       Impact factor: 21.873

8.  Communication of randomized controlled trial results must match the study focus.

Authors:  Andrew W Brown; John L Sievenpiper; Theodore A Kyle; Kathryn A Kaiser
Journal:  J Nutr       Date:  2015-05       Impact factor: 4.798

9.  Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group.

Authors:  Steven P Cohen; Arun Bhaskar; Anuj Bhatia; Asokumar Buvanendran; Tim Deer; Shuchita Garg; W Michael Hooten; Robert W Hurley; David J Kennedy; Brian C McLean; Jee Youn Moon; Samer Narouze; Sanjog Pangarkar; David Anthony Provenzano; Richard Rauck; B Todd Sitzman; Matthew Smuck; Jan van Zundert; Kevin Vorenkamp; Mark S Wallace; Zirong Zhao
Journal:  Reg Anesth Pain Med       Date:  2020-04-03       Impact factor: 6.288

10.  Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

Authors:  Andreas Lundh; Marija Barbateskovic; Asbjørn Hróbjartsson; Peter C Gøtzsche
Journal:  PLoS Med       Date:  2010-10-26       Impact factor: 11.069

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.