Spots Global Cancer Trial Database for ASSIST Tool and Surgical Randomized Controlled Trial Applicability

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Trial Identification

Brief Title: ASSIST Tool and Surgical Randomized Controlled Trial Applicability

Official Title: Impact of a Graphical Tool on the Reader's Interpretation of Surgical RCT Applicability In the Field of Digestive Cancer

Study ID: NCT01763489

Conditions

Digestive Cancer

Interventions

Applicability Assessment

Study Description

Brief Summary: 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.

Detailed Description: 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.