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ASSIST Tool and Surgical Randomized Controlled Trial Applicability

NCT01763489 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-12

No results posted yet for this study

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.

Conditions

  • Digestive Cancer

Interventions

BEHAVIORAL

Applicability Assessment

assess the applicability of a trial using the ASSIST tool or the synopsis

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Boutron Isabelle · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01763489 on ClinicalTrials.gov