- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05250622
OrthoEvidence Trial Assessing Japanese Knowledge Updates (OTAKU)
July 30, 2022 updated by: McMaster University
OrthoEvidence Trial Assessing Japanese Knowledge Updates : Trial of Knowledge Translation Among Japanese Surgeons
The purpose of this randomized controlled trial is to clarify whether providing translated evidence summary (Advanced Clinical Evidence (ACE) reports from OrthoEvidence) will increase the access to the summary compared to providing the original version of evidence summary among Japanese orthopaedic surgeons
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators will conduct the survey regarding baseline characteristics, barriers and familiality to evidence-based medicine by online.
After the survey, the participants will be randomly assigned to receive either the original version of ACE reports or Japanese version of ACE reports.
The pdf of each ACE report will be provided to the participants through an email link.
Twenty reports will be sent over 4 weeks period.
After that, the investigators will conduct another survey regarding the reports.
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4E8
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Member of Japanese Society for Fracture Repair (JSFR)
- Spend at least 20% of their time in clinical practice
- Non-native speaker of English
- Has regular access to internet
- Prefer to read Japanese-translated material, if there are both translated and English version of the same material.
Exclusion Criteria:
We will exclude surgeons who cannot provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Japanese group
Participants who will receive Japanese-translated version of evidence summaries
|
Other: Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)
Participants will receive emails with the link to Japanese-translated version of evidence summaries.
|
|
Active Comparator: English group
Participants who will receive English version of evidence summaries
|
Participants will receive emails with the link to English version of evidence summaries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of access to evidence summaries
Time Frame: Four weeks (28 days) after the commencement of the trial
|
Total number of access to evidence summaries
|
Four weeks (28 days) after the commencement of the trial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-rated score of understanding the contents of the provided materials
Time Frame: Within four weeks after the end of intervention
|
Five-point Likert scale in understanding the contents of provided materials, evaluated by the participants (higher scores means better outcome)
|
Within four weeks after the end of intervention
|
|
Self-rated score in changing their practice based on the contents of the materials
Time Frame: Within four weeks after the end of intervention
|
Five-point Likert scale in changing their practice based on the contents of the materials evaluated by the participants (higher scores means better outcome)
|
Within four weeks after the end of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kim Madden, PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sprague S, Smith C, Bhandari M. OrthoEvidence: A Clinical Resource for Evidence-Based Orthopedics. Orthop Rev (Pavia). 2015 Jun 3;7(2):5762. doi: 10.4081/or.2015.5762. eCollection 2015 Jun 3.
- Poolman RW, Sierevelt IN, Farrokhyar F, Mazel JA, Blankevoort L, Bhandari M. Perceptions and competence in evidence-based medicine: Are surgeons getting better? A questionnaire survey of members of the Dutch Orthopaedic Association. J Bone Joint Surg Am. 2007 Jan;89(1):206-15. doi: 10.2106/JBJS.F.00633.
- Dahm P, Poolman RW, Bhandari M, Fesperman SF, Baum J, Kosiak B, Carrick T, Preminger GM; American Urological Association Membership. Perceptions and competence in evidence-based medicine: a survey of the American Urological Association Membership. J Urol. 2009 Feb;181(2):767-77. doi: 10.1016/j.juro.2008.10.031. Epub 2008 Dec 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2022
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
July 29, 2022
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
February 10, 2022
First Posted (Actual)
February 22, 2022
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 30, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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