Healthy VolunteerOTAKUNCT05250622
OrthoEvidence Trial Assessing Japanese Knowledge Updates
A study testing Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) and English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) in people with Healthy Volunteer, run by McMaster University at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) and English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2022to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- We will exclude surgeons who cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence), English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)
- Keywords
- Surveys and Questionnaires, Clinical Competence, Orthopedics, Attitude of Health Personnel, Evidence-based medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)Other
Participants will receive emails with the link to Japanese-translated version of evidence summaries.
English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)Other
Participants will receive emails with the link to English version of evidence summaries.
| Study group | Role | What they receive |
|---|---|---|
| Japanese group | Experimental | Participants who will receive Japanese-translated version of evidence summaries Receives: Other: Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) |
| English group | Active comparator | Participants who will receive English version of evidence summaries Receives: Other: English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of access to evidence summaries
Total number of access to evidence summaries
Measured: Four weeks (28 days) after the commencement of the trial
Secondary outcomes (2)
Self-rated score of understanding the contents of the provided materials
Five-point Likert scale in understanding the contents of provided materials, evaluated by the participants (higher scores means better outcome)
Measured: Within four weeks after the end of intervention
Self-rated score in changing their practice based on the contents of the materials
Five-point Likert scale in changing their practice based on the contents of the materials evaluated by the participants (higher scores means better outcome)
Measured: Within four weeks after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start8 Apr 2022
- Primary completion1 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Japanese Society for Fracture Repair, OrthoEvidence
- Responsible party
- Sponsor
- Investigators
- Kim Madden, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250622
- Sponsor's protocol ID
- 13493
- Acronym
- OTAKU
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26330990Poolman 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.
PubMed 17200328Dahm 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.
PubMed 19091333
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OrthoEvidence Trial Assessing Japanese Knowledge Updates : Trial of Knowledge Translation Among Japanese Surgeons
- ClinicalTrials.gov ID
- NCT05250622
- Acronym / sponsor ID
- OTAKU / 13493
- Conditions
- Healthy Volunteer
- Keywords
- Surveys and Questionnaires, Clinical Competence, Orthopedics, Attitude of Health Personnel, Evidence-based medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Japanese Society for Fracture Repair, OrthoEvidence
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Japanese group | Experimental | Other: Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)Participants who will receive Japanese-translated version of evidence summaries |
| English group | Active comparator | Other: English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)Participants who will receive English version of evidence summaries |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- We will exclude surgeons who cannot provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)Participants will receive emails with the link to Japanese-translated version of evidence summaries. | Other | Japanese group |
| English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence)Participants will receive emails with the link to English version of evidence summaries. | Other | English group |
Primary outcome
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
2 secondary outcomes
Self-rated score of understanding the contents of the provided materials
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 26330990Sprague 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.
- Background: PubMed 17200328Poolman 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.
- Background: PubMed 19091333Dahm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Madden, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Japanese-translated evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) and English evidence summaries (Advanced Clinical Evidence report from OrthoEvidence) in people with Healthy Volunteer, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of access to evidence summaries (time frame: Four weeks (28 days) after the commencement of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250622, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.