ASSIST Tool and Surgical Randomized Controlled Trial Applicability (ASTA)
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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 |
- 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 |
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| Contact: Boutron Isabelle, PHD | 0033142347833 | isabelle.boutron@htd.aphp.fr |
| 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 May 22, 2013