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Inconsistency between abstract and main text reporting is common in pilot randomized controlled trials of surgical
Tyler McKechnie1, Tania Kazi2, Victoria Shi2
1Division of General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Background:
There is often inconsistency between abstract and main text reporting. While extensively demonstrated in randomized controlled trials, this inconsistency has never been explored in the setting of pilot and feasibility trials. We designed this methodological survey to assess the inconsistency between abstract and main text reporting in pilot and feasibility trials in surgery.
Methods:
Medline, Embase, and CENTRAL databases were searched from January 1, 2011 to December 31, 2011, and January 1, 2021 to December 31, 2021. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was the proportion of pilot and feasibility trials with inconsistency between abstract and main text reporting. Secondary outcomes included the association between research characteristics and inconsistent reporting. Inconsistent abstract reporting was defined as any of the following: (1) conclusions stronger than the main text; (2) omission of negative results found in the main text; (3) different outcomes than in the main text; (4) presence of outcomes/findings/claims not in the main text.
Results:
After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. Fifty of the included pilot and feasibility trials (69.4 %, 95 % confidence interval [CI] 58.0-78.9 %) had inconsistencies between abstract and main text reporting. Fourteen trials (19.4 %, 95%CI 11.8-30.2 %) had stronger conclusions in their abstract than main text, 19 trials (26.4 %, 95%CI 17.5-37.6 %) omitted negative results from their abstracts, 27 trials (37.5 %, 95%CI 27.2-49.1 %) had different primary outcomes in their abstract and main text, and 35 trials (48.6 %, 95%CI 37.4-59.9 %) had outcomes, findings, and/or claims in their abstract that were not present in the main text.
Conclusion:
(s): The majority of surgical pilot and feasibility trials have inconsistent reporting between their abstract and main text. Efforts from both authors and journals are required to improve the consistency of abstract reporting.
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