ASSIST Tool and Surgical Randomized Controlled Trial Applicability
- Conditions
- Digestive Cancer
- Interventions
- Behavioral: Applicability Assessment
- Registration Number
- NCT01763489
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- No one
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASSIST tool group Applicability Assessment Surgeons will assess the applicability of a trial using the ASSIST Synopsis Group Applicability Assessment Surgeons will assess the applicability of a trial using the synopsis presented in a case vignette
- Primary Outcome Measures
Name Time Method feeling able to judge the applicability of the trial 2 months Participants will indicate on a numeric scale range from 1 to 10 if they feel able to judge the applicability of the trial for patients
- Secondary Outcome Measures
Name Time Method