Back to resultsASSIST Tool and Surgical Randomized Controlled Trial Applicability (ASTA)
Primary Purpose
Digestive Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Applicability Assessment
Sponsored by
About this trial
This is an interventional health services research trial for Digestive Cancer focused on measuring randomized controlled trial, applicability, ASSIST tool, surgery, digestive cancer
Eligibility Criteria
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)
Exclusion Criteria:
- No one
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ASSIST tool group
Synopsis Group
Arm Description
Surgeons will assess the applicability of a trial using the ASSIST
Surgeons will assess the applicability of a trial using the synopsis presented in a case vignette
Outcomes
Primary Outcome Measures
feeling able to judge the applicability of the trial
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
Full Information
NCT ID
NCT01763489
First Posted
January 3, 2013
Last Updated
September 10, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01763489
Brief Title
ASSIST Tool and Surgical Randomized Controlled Trial Applicability
Acronym
ASTA
Official Title
Impact of a Graphical Tool on the Reader's Interpretation of Surgical RCT Applicability In the Field of Digestive Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
lack of recruitment
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Cancer
Keywords
randomized controlled trial, applicability, ASSIST tool, surgery, digestive cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASSIST tool group
Arm Type
Experimental
Arm Description
Surgeons will assess the applicability of a trial using the ASSIST
Arm Title
Synopsis Group
Arm Type
Active Comparator
Arm Description
Surgeons will assess the applicability of a trial using the synopsis presented in a case vignette
Intervention Type
Behavioral
Intervention Name(s)
Applicability Assessment
Intervention Description
assess the applicability of a trial using the ASSIST tool or the synopsis
Primary Outcome Measure Information:
Title
feeling able to judge the applicability of the trial
Description
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
Time Frame
2 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Exclusion Criteria:
No one
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boutron Isabelle
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
ASSIST Tool and Surgical Randomized Controlled Trial Applicability
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