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Published articles may be misconstrued for trials with nonsignificant primary outcomes
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Some investigators of CV randomized controlled trials with statistically nonsignificant primary outcomes manipulated the language of the published article to minimize the focus on the neutral primary outcomes, according to a systematic review published in JAMA Network Open.
“These observations have significant implications for the integrity of clinical science, the translation of clinical evidence at the bedside, peer review and the rate of medical progress,” Muhammad Shahzeb Khan, MD, of the department of internal medicine at the John H. Stroger Jr. Hospital of Cook County in Chicago, and colleagues wrote. “Manipulation of language to distort findings may also lead to further public distrust in science.”
Researchers reviewed 93 randomized clinical trials with nonsignificant primary outcomes that were published in six high-impact journals from 2015 to 2017. Data extracted from the trials included number of citations in PubMed until August 2018, journal impact factor in 2016, primary clinical outcome, intervention in each group, funding source and the absence or presence of conflict of interest in the first and last authors.
Spin was defined as specific reporting strategies to highlight that an experimental treatment was beneficial even though the primary outcome had a nonsignificant difference. Researchers assessed this in the title, results and conclusions in the abstract, and discussion, results and conclusion from the main article.
Of the trials in the review, spin was seen in 57% of abstracts (95% CI, 47-67) and 67% of main texts (95% CI, 57-75).
In the main text of the published article, spin was observed in 11% of titles (95% CI, 6-19), 38% of results sections (95% CI, 28-48) and 54% of conclusions (95% CI, 44-64).
Within abstracts, 41% of results sections (95% CI, 31-51) and 48% of conclusions sections (95% CI, 38-58) had spin.
“We propose that medical progress might move faster and waste fewer resources if authors were able to publish neutral findings in higher-impact journals,” Khan and colleagues wrote. “Knowing what does not work is also an important part of scientific discovery.”
“Failure to maintain a critical and dispassionate perspective is a disservice to the research community, funding agencies, the practicing physicians who must decide which treatments to use and the lay public,” Stephan D. Fihn, MD, MPH, chief of general internal medicine and professor of general internal medicine and health services at University of Washington in Seattle, wrote in a related editorial. “The last, in particular, may not have the expertise to interpret the important subtleties of statistical testing and are necessarily reliant on authors and editors to convey results in a balanced and accurate manner. Failure to do so can lead to exuberant adoption of marginally effective, useless or even harmful clinical interventions as well as create unfounded anxiety among patients.” – by Darlene Dobkowski
Disclosure s : Khan and Fihn report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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