- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006017
Do Clinicians Want Recommendations?
August 31, 2017 updated by: McMaster University
Do Clinicians Want Recommendations? A Randomized Trial Comparing Evidence Summaries With and Without Evidence Based Recommendations
The use of the best evidence available for decision-making is nowadays an undisputed goal in health care.
However, this is not always achieved in the context of clinical practice.
Two of the potential solutions to bridge the gap between evidence and the clinical practice are the "evidence summaries" and the "evidence based recommendations".
However, it is not clear, and frequently controversial, to what extent clinicians consider helpful recommendations accompanying evidence summaries.
The investigators will explore this question by conducting a study where clinicians will be randomized to receive a clinical scenario accompanied by an evidence summary plus a recommendation and a second clinical scenario accompanied by only for an evidence summary (group A) or vice versa (Group B).
The outcome will be clinicians' preferences.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
467
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 4K1
- 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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Were trained as Medical Doctors
- Practice primary care or general internal medicine.
Exclusion Criteria: none
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
We will present to participants two general clinical scenarios.
The first scenario will be accompanied by an evidence summary plus a recommendation and a second scenario will be accompanied by an evidence summary alone
|
|
Experimental: Group B
We will present to participants two general clinical scenarios.
The first scenario will be accompanied by an evidence summary alone and a second scenario will be accompanied by an evidence summary plus a recommendation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preferences
Time Frame: Immediately after the intervention (Survey)
|
Preference: for the evidence summary plus the accompanying recommendation or for the evidence summary alone.
We will assess this outcome with a 7-point Lickert scale This outcome will be assessed after the presentation of the two clinical scenarios.
|
Immediately after the intervention (Survey)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding
Time Frame: Immediately after the intervention (Survey)
|
Understanding: Percentage of correct answers regarding the understanding of the evidence: understanding of baseline risk, risk difference, confidence interval and quality of the evidence assessment.
|
Immediately after the intervention (Survey)
|
Interpretation of benefits and harms
Time Frame: Immediately after the intervention (Survey)
|
Interpretation of benefits and harms: Distribution of the interpretation of the magnitude of the benefits in comparison with harms
|
Immediately after the intervention (Survey)
|
Intended course of action
Time Frame: Immediately after the intervention (Survey)
|
Intended course of action: For the clinical questions related with strong recommendations, we will compare the percentage of appropriate decisions (i.e.
decisions that match the strong recommendation).
|
Immediately after the intervention (Survey)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Holger Schunemann, MD, 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.
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
September 30, 2013
Primary Completion (Actual)
August 30, 2017
Study Completion (Actual)
August 30, 2017
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Actual)
September 1, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 13-480
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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