跳至主要内容
临床试验/NCT01763489
NCT01763489撤回不适用

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

Assistance Publique - Hôpitaux de Paris0 个研究点开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
feeling able to judge the applicability of the trial

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

研究组 & 干预措施

ASSIST tool group

Experimental

Surgeons will assess the applicability of a trial using the ASSIST

干预措施: Applicability Assessment (Behavioral)

Synopsis Group

Active Comparator

Surgeons will assess the applicability of a trial using the synopsis presented in a case vignette

干预措施: Applicability Assessment (Behavioral)

结局指标

主要结局

feeling able to judge the applicability of the trial

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle BOUTRON

Professor

Assistance Publique - Hôpitaux de Paris

相似试验