ASSIST Tool and Surgical Randomized Controlled Trial Applicability (ASTA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01763489
First received: January 3, 2013
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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 Intervention
Digestive Cancer
Behavioral: Applicability Assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • feeling able to judge the applicability of the trial [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 130
Study Start Date: January 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763489

Contacts
Contact: Boutron Isabelle, PHD 0033142347833 isabelle.boutron@htd.aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Boutron Isabelle Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Isabelle BOUTRON, Professor, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01763489     History of Changes
Other Study ID Numbers: RAV004
Study First Received: January 3, 2013
Last Updated: March 15, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
randomized controlled trial
applicability
ASSIST tool
surgery
digestive cancer

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 16, 2014