Evidence-Based MedicineNCT02414360
Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial
A study testing Shortened Format and Full Length in people with Evidence-Based Medicine, run by University of Toronto.
Trial summary
The purpose of this pilot study is to determine the feasibility of running a full-scale trial that compares two formats of a shortened systematic review to a full-length systematic review to be used in clinical decision-making. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Evidence-Based Medicine
- What is being tested?
- Shortened Format and Full Length
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Aug 2014
- 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
- Physicians who were in practice full- or part-time at study enrollment were recruited for participation
- Participants had to have access to the Internet as the study was conducted online.
Who cannot join
- The systematic reviews in all formats were only available in English, thus any participants who were not able to read and understand English were not eligible to participate.
- Anyone who had taken part in any phase of the development of the shortened versions of the systematic reviews (cased-based or evidence-expertise formats) were not eligible for recruitment.
About this study
The purpose of this pilot study is to determine the feasibility of running a full-scale trial that compares two formats of a shortened systematic review to a full-length systematic review to be used in clinical decision-making.
Read the detailed description
Two shortened systematic review formats were developed to enhance their use in clinical decision making. An online randomized controlled trial is planned to make comparisons of the shortened formats to a full-length systematic review. To prepare for the full-scale trial, a pilot study will be conducted to test methods and procedures in order to refine the processes.
- Conditions
- Evidence-Based Medicine
- Being tested
- Shortened Format, Full Length
- Keywords
- Review Literature as Topic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortened FormatOther
Shortened format of a systematic review
Full LengthOther
Full length systematic review
| Study group | Role | What they receive |
|---|---|---|
| Shortened Format | Experimental | Shortened format of a systematic review Receives: Other: Shortened Format |
| Control | Active comparator | Full length systematic review Receives: Other: Full Length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of participant's answers measured using a kappa statistic
Feasibility of assessing participants' answers
Measured: 6 months
Rate of recruitment
Feasibility of recruiting participants in a timely manner
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Evidence-Based MedicineStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laure Perrier, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414360
- Sponsor's protocol ID
- 487776
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrier L, Persaud N, Ko A, Kastner M, Grimshaw J, McKibbon KA, Straus SE. Development of two shortened systematic review formats for clinicians. Implement Sci. 2013 Jun 14;8:68. doi: 10.1186/1748-5908-8-68.
PubMed 23767771Perrier L, Kealey MR, Straus SE. An iterative evaluation of two shortened systematic review formats for clinicians: a focus group study. J Am Med Inform Assoc. 2014 Oct;21(e2):e341-6. doi: 10.1136/amiajnl-2014-002660. Epub 2014 May 1.
PubMed 24786378Perrier L, Kealey MR, Straus SE. A usability study of two formats of a shortened systematic review for clinicians. BMJ Open. 2014 Dec 23;4(12):e005919. doi: 10.1136/bmjopen-2014-005919.
PubMed 25537782Perrier L, Persaud N, Thorpe KE, Straus SE. Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial. Implement Sci. 2015 Aug 15;10:118. doi: 10.1186/s13012-015-0303-4.
PubMed 26276278
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02414360
- Acronym / sponsor ID
- 487776
- Conditions
- Evidence-Based Medicine
- Keywords
- Review Literature as Topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Apr 2015 (estimated)
- 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 pilot study is to determine the feasibility of running a full-scale trial that compares two formats of a shortened systematic review to a full-length systematic review to be used in clinical decision-making.
Detailed description
Two shortened systematic review formats were developed to enhance their use in clinical decision making. An online randomized controlled trial is planned to make comparisons of the shortened formats to a full-length systematic review. To prepare for the full-scale trial, a pilot study will be conducted to test methods and procedures in order to refine the processes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shortened Format | Experimental | Other: Shortened FormatShortened format of a systematic review |
| Control | Active comparator | Other: Full LengthFull length systematic review |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Physicians who were in practice full- or part-time at study enrollment were recruited for participation
- Participants had to have access to the Internet as the study was conducted online.
Key exclusion criteria (2 listed)
- The systematic reviews in all formats were only available in English, thus any participants who were not able to read and understand English were not eligible to participate.
- Anyone who had taken part in any phase of the development of the shortened versions of the systematic reviews (cased-based or evidence-expertise formats) were not eligible for recruitment.
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 |
|---|---|---|
| Shortened FormatShortened format of a systematic review | Other | Shortened Format |
| Full LengthFull length systematic review | Other | Control |
Primary outcome
Assessment of participant's answers measured using a kappa statistic
Time frame: 6 months
Feasibility of assessing participants' answers
Rate of recruitment
Time frame: 6 months
Feasibility of recruiting participants in a timely manner
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 10 Apr 2015.
- Background: PubMed 23767771Perrier L, Persaud N, Ko A, Kastner M, Grimshaw J, McKibbon KA, Straus SE. Development of two shortened systematic review formats for clinicians. Implement Sci. 2013 Jun 14;8:68. doi: 10.1186/1748-5908-8-68.
- Background: PubMed 24786378Perrier L, Kealey MR, Straus SE. An iterative evaluation of two shortened systematic review formats for clinicians: a focus group study. J Am Med Inform Assoc. 2014 Oct;21(e2):e341-6. doi: 10.1136/amiajnl-2014-002660. Epub 2014 May 1.
- Background: PubMed 25537782Perrier L, Kealey MR, Straus SE. A usability study of two formats of a shortened systematic review for clinicians. BMJ Open. 2014 Dec 23;4(12):e005919. doi: 10.1136/bmjopen-2014-005919.
- Derived from this study: PubMed 26276278Perrier L, Persaud N, Thorpe KE, Straus SE. Using a systematic review in clinical decision making: a pilot parallel, randomized controlled trial. Implement Sci. 2015 Aug 15;10:118. doi: 10.1186/s13012-015-0303-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shortened Format and Full Length in people with Evidence-Based Medicine, run by University of Toronto.
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 2 inclusion and 2 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of participant's answers measured using a kappa statistic (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02414360, which also lists 4 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 10 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.