ASTA: ASSIST Tool and Surgical Randomized Controlled Trial Applicability

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01763489

Collaborator

(none)

Enrollment

Arms

13.9

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive Cancer	Behavioral: Applicability Assessment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASSIST tool group Surgeons will assess the applicability of a trial using the ASSIST	Behavioral: Applicability Assessment assess the applicability of a trial using the ASSIST tool or the synopsis
Active Comparator: Synopsis Group Surgeons will assess the applicability of a trial using the synopsis presented in a case vignette	Behavioral: Applicability Assessment assess the applicability of a trial using the ASSIST tool or the synopsis

Arm

Intervention/Treatment

Experimental: ASSIST tool group

Surgeons will assess the applicability of a trial using the ASSIST

Behavioral: Applicability Assessment

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

Active Comparator: Synopsis Group

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

Behavioral: Applicability Assessment

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)