Digestive Cancer Clinical Trial
Official title:
Impact of a Graphical Tool on the Reader's Interpretation of Surgical RCT Applicability In the Field of Digestive Cancer
Background: The ASSIST tool is a graphical tool to represent and evaluate the applicability
of a surgery trial to improve the translation of research to practice.
Objective: To evaluate the impact of the ASSIST tool on the interpretation of the
applicability of randomized controlled trials (RCTs) in the field of digestive cancer
surgery.
Design: This study is a randomized controlled trial with two parallel arms. Participants:
Surgeons who contribute to the assessment of manuscripts as experts (peer-reviewer) for
international scientific journals of surgery (Annals of Surgery, Archives of Surgery,
Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology).
Intervention: Surgeons will be randomized into 2 groups. A group that will evaluate a case
vignette (synopsis) of a randomized trial in surgery, and the other group that will evaluate
the same case vignette with the representation of the external validity of the trial with
ASSIST tool.
Outcome measures: Participants will indicate on a numeric scale range from 1 to 10 if they
feel able to judge the applicability of the trial for 1) patients, 2) centers, 3) surgeons
and 4) intervention.
Sample Size: 28 case vignettes with randomized trials and their ASSIST tool have been
developed and evaluated. The inclusion of 130 participants (65 per arm) is required.
The study will be conducted in 2 steps:
In a first step, investigators will develop cases vignettes of published RCTs evaluating
surgical interventions in the field of digestive cancer with its representations of external
validity according to ASSIST.
In a second step, investigators will invite a panel of peer reviewers to appraise the
external validity (applicability) of selected RCTs without and with the graphical tool
(ASSIST), on a security web site.
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