Healthy Individuals (Clinicians)NCT02006017
Do Clinicians Want Recommendations?
A study testing Evidence summary alone plus a recommendation and Evidence summary alone in people with Healthy Individuals (Clinicians), run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals (Clinicians)
- What is being tested?
- Evidence summary alone plus a recommendation and Evidence summary alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2013to 30 Aug 2017
- 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
- Were trained as Medical Doctors
- Practice primary care or general internal medicine.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Individuals (Clinicians)
- Being tested
- Evidence summary alone plus a recommendation, Evidence summary alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence summary alone plus a recommendationOther
Evidence summary aloneOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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 Receives: Other: Evidence summary alone plus a recommendation; Other: Evidence summary alone |
| Group B | Experimental | 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 Receives: Other: Evidence summary alone plus a recommendation; Other: Evidence summary alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferences
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.
Measured: Immediately after the intervention (Survey)
Secondary outcomes (3)
Understanding
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.
Measured: Immediately after the intervention (Survey)
Interpretation of benefits and harms
Interpretation of benefits and harms: Distribution of the interpretation of the magnitude of the benefits in comparison with harms
Measured: Immediately after the intervention (Survey)
Intended course of action
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).
Measured: Immediately after the intervention (Survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study start30 Sep 2013
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Individuals (Clinicians)Studies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holger Schunemann, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006017
- Sponsor's protocol ID
- 13-480
- Status last verified
- Aug 2017
- First submitted
- 19 Nov 2013
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Neumann I, Alonso-Coello P, Vandvik PO, Agoritsas T, Mas G, Akl EA, Brignardello-Petersen R, Emparanza J, McCullagh L, De Sitio C, McGinn T, Almodaimegh H, Almodaimegh K, Rivera S, Rojas L, Stirnemann J, Irani J, Hlais S, Mustafa R, Bdair F, Aly A, Kristiansen A, Izcovich A, Ramirez A, Brozek J, Guyatt G, Schunemann HJ. Do clinicians want recommendations? A multicenter study comparing evidence summaries with and without GRADE recommendations. J Clin Epidemiol. 2018 Jul;99:33-40. doi: 10.1016/j.jclinepi.2018.02.026. Epub 2018 Mar 9.
PubMed 29530644
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Clinicians Want Recommendations? A Randomized Trial Comparing Evidence Summaries With and Without Evidence Based Recommendations
- ClinicalTrials.gov ID
- NCT02006017
- Acronym / sponsor ID
- 13-480
- Conditions
- Healthy Individuals (Clinicians)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Sep 2013
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 9 Dec 2013 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Evidence summary alone plus a recommendation, Other: Evidence summary aloneWe 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 |
| Group B | Experimental | Other: Evidence summary alone plus a recommendation, Other: Evidence summary aloneWe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Were trained as Medical Doctors
- Practice primary care or general internal medicine.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Evidence summary alone plus a recommendation | Other | Group A, Group B |
| Evidence summary alone | Other | Group A, Group B |
Primary outcome
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.
3 secondary outcomes
Understanding
Time frame: Immediately after the intervention (Survey)
Interpretation of benefits and harms
Time frame: Immediately after the intervention (Survey)
Intended course of action
Time frame: Immediately after the intervention (Survey)
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 1 Sep 2017.
- Derived from this study: PubMed 29530644Neumann I, Alonso-Coello P, Vandvik PO, Agoritsas T, Mas G, Akl EA, Brignardello-Petersen R, Emparanza J, McCullagh L, De Sitio C, McGinn T, Almodaimegh H, Almodaimegh K, Rivera S, Rojas L, Stirnemann J, Irani J, Hlais S, Mustafa R, Bdair F, Aly A, Kristiansen A, Izcovich A, Ramirez A, Brozek J, Guyatt G, Schunemann HJ. Do clinicians want recommendations? A multicenter study comparing evidence summaries with and without GRADE recommendations. J Clin Epidemiol. 2018 Jul;99:33-40. doi: 10.1016/j.jclinepi.2018.02.026. Epub 2018 Mar 9.
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.
Holger Schunemann, MD, 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 Evidence summary alone plus a recommendation and Evidence summary alone in people with Healthy Individuals (Clinicians), 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 2 inclusion and 0 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 1 Sep 2017. 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?
Preferences (time frame: Immediately after the intervention (Survey)). 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 NCT02006017, which also lists 1 linked publication.
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 1 Sep 2017.