AdultPLSRCTNCT01939925
Communicating Evidence From Systematic Reviews to the Public
A study testing New plain language summary format and Current plain language summary format in people with Adult, run by Norwegian Knowledge Centre for the Health Services at 5 sites in 5 countries.
Trial summary
The purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult
- What is being tested?
- New plain language summary format and Current plain language summary format
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 5 sitesin 5 countries
- Study dates
- May 2009to Oct 2009
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients or members of the public 16 years or older
Who cannot join
None listed.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Argentina1 site
Argentine Cochrane Centre, Instituto de Efectividad Clínica y Sanitaria (IECS)
Buenos Aires
Spain1 site
Centro Cochrane Iberoamericano - Hospital de la Santa Creu i Sant Pau
Barcelona
About this study
Official title: Communicating Evidence From Systematic Reviews to the Public: A Randomised Controlled Trial
The purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. The study will evaluate if the new presentation improves understanding about the benefits and harms of an intervention, if it improves the accessibility of the information, and if it is preferred over other versions by the public over the current format.
- Conditions
- Adult
- Being tested
- New plain language summary format, Current plain language summary format
- Keywords
- patient education, Health Knowledge, Attitudes, Practice, comprehension, consumer health information
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New plain language summary formatOther
New plain language summary includes qualitative and quantitative description of text (absolute effects and natural frequencies provided); quantitative results provided in a table; quality of the evidence according to GRADE provided in a table; question and answer format; follows principles of linguistic frameworks (e.g. progressive movements from introduction to 'bottom line')
Current plain language summary formatOther
Current plain language summary includes qualitative description of effects only; inconsistent description of the quality of the evidence; paragraph of text; inconsistent flow of information
| Study group | Role | What they receive |
|---|---|---|
| New plain language summary format | Experimental | New plain language summary format of a Cochrane systematic review Receives: Other: New plain language summary format |
| Current plain language summary format | Active comparator | Plain Language Summary format for the public currently in use in Cochrane systematic reviews Receives: Other: Current plain language summary format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of benefits and harms
Average proportion of people who answered 5 multiple choice questions correctly. Each question includes five response options about the number of people who could benefit or be harmed by the intervention and about the quality of evidence
Measured: After reading summary - time 0
Secondary outcomes (1)
Number of questions answered correctly
Total number of questions out of five questions for benefits and harms that were answered correctly
Measured: After reading summary - time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Knowledge Centre for the Health Services
- Sponsor type
- Other government
- Collaborators
- McMaster University, University of Ottawa, Asociacion Colaboracion Cochrane Iberoamericana, University of Milan
- Responsible party
- Principal investigator, Claire Glenton, Norwegian Knowledge Centre for the Health Services
- Investigators
- Claire Glenton, PhD, Principal investigator, Norwegian Knowledge Centre for the Health ServicesHolger J Schunemann, MD PhD, Principal investigator, McMaster UniversityNancy A Santesso, RD PhD cand, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939925
- Sponsor's protocol ID
- PLSRCT1
- Acronym
- PLSRCT
- Status last verified
- Sep 2013
- First submitted
- 27 Aug 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Evidence From Systematic Reviews to the Public: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01939925
- Acronym / sponsor ID
- PLSRCT / PLSRCT1
- Conditions
- Adult
- Keywords
- patient education, Health Knowledge, Attitudes, Practice, comprehension, consumer health information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Norwegian Knowledge Centre for the Health ServicesOther government
- Collaborators
- McMaster University, University of Ottawa, Asociacion Colaboracion Cochrane Iberoamericana, University of Milan
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Sep 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 purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. The study will evaluate if the new presentation improves understanding about the benefits and harms of an intervention, if it improves the accessibility of the information, and if it is preferred over other versions by the public over the current format.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New plain language summary format | Experimental | Other: New plain language summary formatNew plain language summary format of a Cochrane systematic review |
| Current plain language summary format | Active comparator | Other: Current plain language summary formatPlain Language Summary format for the public currently in use in Cochrane systematic reviews |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients or members of the public 16 years or older
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 |
|---|---|---|
| New plain language summary formatNew plain language summary includes qualitative and quantitative description of text (absolute effects and natural frequencies provided); quantitative results provided in a table; quality of the evidence according to GRADE provided in a table; question and answer format; follows principles of linguistic frameworks (e.g. progressive movements from introduction to 'bottom line') | Other | New plain language summary format |
| Current plain language summary formatCurrent plain language summary includes qualitative description of effects only; inconsistent description of the quality of the evidence; paragraph of text; inconsistent flow of information | Other | Current plain language summary format |
Primary outcome
Understanding of benefits and harms
Time frame: After reading summary - time 0
Average proportion of people who answered 5 multiple choice questions correctly. Each question includes five response options about the number of people who could benefit or be harmed by the intervention and about the quality of evidence
1 secondary outcome
Number of questions answered correctly
Time frame: After reading summary - time 0
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 11 Sep 2013.
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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.
Claire Glenton, PhD principal investigator
Norwegian Knowledge Centre for the Health Services
Holger J Schunemann, MD PhD principal investigator
McMaster University
Nancy A Santesso, RD PhD cand principal investigator
McMaster University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New plain language summary format and Current plain language summary format in people with Adult, run by Norwegian Knowledge Centre for the Health Services at 5 sites in 5 countries.
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 1 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 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina, Canada, Italy, Norway, Spain. 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?
Understanding of benefits and harms (time frame: After reading summary - time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2013.