Highlights
- •We investigated spin in RCTs with nonsignificant primary analyses.
- •Authors and editors should prioritize transparent reporting of RCTs.
- •Transparent reporting includes unbiased interpretation and recognizing limitations.
Abstract
Peer-reviewed publications of randomized clinical trials (RCTs) are the primary means
of disseminating research findings. “Spin” in RCT publications is misrepresentation
of statistically nonsignificant research findings to suggest treatment benefit. Spin
can influence the way readers interpret clinical trials and use the information to
make decisions about treatments and medical policies. The objective of this study
was to determine the frequency with which 4 types of spin were used in publications
of analgesic RCTs with nonsignificant primary analyses in 6 major pain journals. In
the 76 articles included in our sample, 28% of the abstracts and 29% of the main texts
emphasized secondary analyses with P values <.05; 22% of abstracts and 29% of texts emphasized treatment benefit based
on nonsignificant primary results; 14% of abstracts and 18% of texts emphasized within-group
improvements over time, rather than primary between-group comparisons; and 13% of
abstracts and 10% of texts interpreted a nonsignificant difference between groups
in a superiority study as comparable effectiveness. When considering the article conclusion
sections, 21% did not mention the nonsignificant primary result, 22% were presented
with no uncertainty or qualification, 30% did not acknowledge that future research
was required, and 8% recommended the intervention for clinical use.
Perspective
This article identifies relatively frequent “spin” in analgesic RCTs. These findings
highlight a need for authors, reviewers, and editors to be more cognizant of how analgesic
RCT results are presented and attempt to minimize spin in future clinical trial publications.
Key words
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Article info
Publication history
Published online: October 22, 2014
Footnotes
The work was performed at the University of Rochester, Rochester, New York.
The manuscript was reviewed and approved by the Executive Committee of the ACTTION public-private partnership with the United States Food and Drug Administration.
The views expressed in this article are those of the authors and no official endorsement by the Food and Drug Administration (FDA) or the pharmaceutical companies that provided unrestricted grants to support the activities of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership should be inferred. Financial support for this project was provided by the ACTTION public-private partnership, which has received research contracts, grants, or other revenue from the FDA (U01 FD004187), Annovation, Astellas, Collegium, Depomed, Jazz, Johnson & Johnson, Lilly, Olatec, Pfizer, Purdue, Spinifex, and Teva. None of the authors have financial disclosures that are relevant to this article.
Supplementary data accompanying this article are available online at www.jpain.org and www.sciencedirect.com.
Identification
Copyright
© 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.
