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Inconsistency between abstract and main text reporting is common in pilot randomized controlled trials of surgical interventions: A methodological survey - 12/04/25

Doi : 10.1016/j.amjsurg.2025.116250 
Tyler McKechnie a, b, , Tania Kazi c, Victoria Shi c, Austine Wang c, Sophia Zhang c, Alex Thabane b, Keean Nanji b, d, Phillip Staibano b, e, Lily J. Park a, b, Aristithes Doumouras a, b, c, Cagla Eskicioglu a, c, Lehana Thabane b, f, g, Sameer Parpia b, h, Mohit Bhandari b, i
a Division of General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada 
b Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, ON, Canada 
c Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada 
d Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, ON, Canada 
e Division of Otolaryngology Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada 
f Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada 
g Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa 
h Department of Oncology, McMaster University, Hamilton, ON, Canada 
i Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada 

Corresponding author. Department of Surgery, Division of General Surgery. McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada. Department of Surgery Division of General Surgery McMaster University 1280 Main Street West Hamilton Ontario L8S 4L8 Canada

Abstract

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.

Il testo completo di questo articolo è disponibile in PDF.

Highlights

This is the first study to evaluate inconsistent reporting in pilot studies.
70 ​% of pilot studies in surgery have inconsistencies between abstract and full text.
The most common inconsistency was omission of negative results from the abstracts.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Pilot and feasibility trials, Pilot projects, Feasibility studies, Surgery, Methodological survey


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  Requests for Reprints (∗): Tyler McKechnie MD MSc. McMaster University, Department of Surgery, Division of General Surgery. McMaster University, 1280 Main Street West, Hamilton, Ontario, Canada, L8S 4L8. Email: tyler.mckechnie@medportal.ca . Phone: (613) 868–9442.


© 2025  The Authors. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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