Guideline Development(SOR)NCT07854548
Wording Approaches to Convey the Strength of Recommendations in Health Guidelines
A study testing GRADE approach ("recommends" and "suggest"), New approach ("strongly recommends" and "conditionally recommends") and Alternate approach ("should" and "may") in people with Guideline Development, run by McMaster University at 1 site in Canada.
Trial summary
Recommendations from health organizations rest on a scale. On this scale, some recommendations can be "stronger" than others. This "strength" should be easily understood by everyone, including members in the public and healthcare professionals. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guideline Development
- What is being tested?
- GRADE approach ("recommends" and "suggest"), New approach ("strongly recommends" and "conditionally recommends") and Alternate approach ("should" and "may")
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 741 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 30 Dec 2025
- 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
- Individuals of 16 years or older of age
- Ability to read and understand English
- Previous use of, or intention to use, health guidelines or recommendations (e.g., intention to access clinical or public health guidelines, recommendations, or policy advice)
Who cannot join
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wording Approaches to Convey the Strength of Recommendations in Health Guidelines: Protocol for a Randomized Controlled Trial
Recommendations from health organizations rest on a scale. On this scale, some recommendations can be "stronger" than others. This "strength" should be easily understood by everyone, including members in the public and healthcare professionals. The survey results will help us find a better way to phrase recommendations.
Read the detailed description
This study is a randomized controlled trial with a blinded non-clinical intervention. The three arms of this study are include different wording approaches to phrase health recommendations for the purpose of conveying the strength of a recommendation. Based on the Grading of Recommendations Assessment Development and Evaluation (GRADE) approach, the strength of a recommendation is determined to be either "strong" or "conditional" with a direction that either favours or does not favour an intervention. The wording of health recommendations to reflect this strength is not consistent, and there is no optimal approach that has been identified. Participants will be stratified based on self-identified recommendation user group (e.g., clinician, policymaker, member of public) and view one formatted recommendation intended for that group. Outcome data will be collected via an anonymous survey using multiple choice and 7-point likert scales to capture participant understanding and preference. Comparisons between the results of all participants within each intervention arm will be made, with the goal of clarifying whether there is a better wording approach for conveying the strength of recommendations to all audiences.
- Conditions
- Guideline Development
- Being tested
- GRADE approach ("recommends" and "suggest"), New approach ("strongly recommends" and "conditionally recommends"), Alternate approach ("should" and "may")
- Keywords
- wording, strength, recommendation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRADE approach ("recommends" and "suggest")Other
"recommend" (strong) and "suggest" (conditional) Example: The guideline panel recommend(s)/suggest(s) [against] [the intervention], rather than [the comparator], for [indication].
New approach ("strongly recommends" and "conditionally recommends")Other
"strongly recommend" (strong) and "conditionally recommend" (conditional) Example: The guideline panel strongly recommend(s)/conditionally recommend(s) [against] [the intervention], rather than [the comparator], for [indication].
Alternate approach ("should" and "may")Other
"should" (strong) and "may" (conditional) Example: [The intervention] should/may [not] be [verb], rather than [the comparator], for [indication]
| Study group | Role | What they receive |
|---|---|---|
| GRADE approach ("recommends" and "suggest") | Experimental | Recommendation statements structured as follows:
The guideline panel recommends… The guideline panel suggests… Receives: Other: GRADE approach ("recommends" and "suggest") |
| New approach ("strongly recommends" and "conditionally recommends") | Experimental | Recommendation statements structured as follows:
The guideline panel strongly recommends… The guideline panel conditionally recommends… Receives: Other: New approach ("strongly recommends" and "conditionally recommends") |
| Alternate approach ("should" and "may") | Experimental | Recommendation statements structured as follows:
* should be used
* may be used Receives: Other: Alternate approach ("should" and "may") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of the Strength and Direction of Recommendation
The primary outcome is understanding of the correct interpretation of recommendation strength and direction. This will be assessed with three multiple-choice questions where answer options represent interpretations for strong-for, conditional-for, conditional-against, and strong-against recommendation statements, as indicated by GRADE. Each question has 1 correct answer. Scores will be assessed per-question and aggregate (maximum score of 3/3 suggesting correct understanding versus minimum 0/3 suggesting poor understanding).
Measured: During a single survey session (approximately 10 minutes)
Secondary outcomes (2)
Intended Behaviour
Defined as participants' intention in adopting and following the recommendation they read. Participants are asked how likely it is that they would follow the recommendation if the recommendation hypothetically applied to themselves. The question will be measured using a 7-point Likert-type scale with 1 being 'very unlikely', 4 'neutral', and 7 'very likely'.
Measured: During a single survey session (approximately 10 minutes)
Preference
This outcome aims to assess whether the choice of wording would lead to different decisions by participants. Defined as a greater liking of one wording approach over the others. After the blinded phase for prior questions, participants will be 'unblinded' to the purpose of the wording approaches to convey the strength of recommendation. Subsequently, they will be asked to choose between wording approaches or indicate no preference in a multiple-choice question format.
Measured: During a single survey session (approximately 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Aug 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: Participant responses to primary outcome -assessing questions were abnormal. Out of 3 multiple choice Qs, #1 was \~70% correct, #2 and #3 were 50%. Review of question structure suggested confusing wording that confounded outcome assessment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guideline DevelopmentStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Schunemann, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854548
- Sponsor's protocol ID
- 18107
- Acronym
- (SOR)
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be used for purposes of analyses in this study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wording Approaches to Convey the Strength of Recommendations in Health Guidelines: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07854548
- Acronym / sponsor ID
- (SOR) / 18107
- Conditions
- Guideline Development
- Keywords
- wording, strength, recommendation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant responses to primary outcome -assessing questions were abnormal. Out of 3 multiple choice Qs, #1 was \~70% correct, #2 and #3 were 50%. Review of question structure suggested confusing wording that confounded outcome assessment.
- Enrolment
- 741 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 2 Oct 2026 (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.
Recommendations from health organizations rest on a scale. On this scale, some recommendations can be "stronger" than others. This "strength" should be easily understood by everyone, including members in the public and healthcare professionals. The survey results will help us find a better way to phrase recommendations.
Detailed description
This study is a randomized controlled trial with a blinded non-clinical intervention. The three arms of this study are include different wording approaches to phrase health recommendations for the purpose of conveying the strength of a recommendation. Based on the Grading of Recommendations Assessment Development and Evaluation (GRADE) approach, the strength of a recommendation is determined to be either "strong" or "conditional" with a direction that either favours or does not favour an intervention. The wording of health recommendations to reflect this strength is not consistent, and there is no optimal approach that has been identified. Participants will be stratified based on self-identified recommendation user group (e.g., clinician, policymaker, member of public) and view one formatted recommendation intended for that group. Outcome data will be collected via an anonymous survey using multiple choice and 7-point likert scales to capture participant understanding and preference. Comparisons between the results of all participants within each intervention arm will be made, with the goal of clarifying whether there is a better wording approach for conveying the strength of recommendations to all audiences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GRADE approach ("recommends" and "suggest") | Experimental | Other: GRADE approach ("recommends" and "suggest")Recommendation statements structured as follows: The guideline panel recommends… The guideline panel suggests… |
| New approach ("strongly recommends" and "conditionally recommends") | Experimental | Other: New approach ("strongly recommends" and "conditionally recommends")Recommendation statements structured as follows: The guideline panel strongly recommends… The guideline panel conditionally recommends… |
| Alternate approach ("should" and "may") | Experimental | Other: Alternate approach ("should" and "may")Recommendation statements structured as follows: * should be used * may be used |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals of 16 years or older of age
- Ability to read and understand English
- Previous use of, or intention to use, health guidelines or recommendations (e.g., intention to access clinical or public health guidelines, recommendations, or policy advice)
Key exclusion criteria (1 listed)
- Previous participation in this study
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 |
|---|---|---|
| GRADE approach ("recommends" and "suggest")"recommend" (strong) and "suggest" (conditional) Example: The guideline panel recommend(s)/suggest(s) [against] [the intervention], rather than [the comparator], for [indication]. | Other | GRADE approach ("recommends" and "suggest") |
| New approach ("strongly recommends" and "conditionally recommends")"strongly recommend" (strong) and "conditionally recommend" (conditional) Example: The guideline panel strongly recommend(s)/conditionally recommend(s) [against] [the intervention], rather than [the comparator], for [indication]. | Other | New approach ("strongly recommends" and "conditionally recommends") |
| Alternate approach ("should" and "may")"should" (strong) and "may" (conditional) Example: [The intervention] should/may [not] be [verb], rather than [the comparator], for [indication] | Other | Alternate approach ("should" and "may") |
Primary outcome
Understanding of the Strength and Direction of Recommendation
Time frame: During a single survey session (approximately 10 minutes)
The primary outcome is understanding of the correct interpretation of recommendation strength and direction. This will be assessed with three multiple-choice questions where answer options represent interpretations for strong-for, conditional-for, conditional-against, and strong-against recommendation statements, as indicated by GRADE. Each question has 1 correct answer. Scores will be assessed per-question and aggregate (maximum score of 3/3 suggesting correct understanding versus minimum 0/3 suggesting poor understanding).
2 secondary outcomes
Intended Behaviour
Time frame: During a single survey session (approximately 10 minutes)
Preference
Time frame: During a single survey session (approximately 10 minutes)
Results and safety
The study was stopped early (reason given: Participant responses to primary outcome -assessing questions were abnormal. Out of 3 multiple choice Qs, #1 was \~70% correct, #2 and #3 were 50%. Review of question structure suggested confusing wording that confounded outcome assessment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will only be used for purposes of analyses in this study.
Related trials for Guideline Development
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Not yet recruiting
Development of Training Protocol and Application for Speech Language Pathologists on Teletherapy: A Contemporary Approach to Speech Language Therapy
Practice Guideline
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Not yet recruiting
Developing Pilot Postoperative Guidelines for Improved Functional Outcomes After High-Risk Cancer Surgery
Cancer, Abdominal Cancer Surgery
Recruiting
A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines
Chronic Kidney Disease, Proteinuria
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRADE approach ("recommends" and "suggest"), New approach ("strongly recommends" and "conditionally recommends") and Alternate approach ("should" and "may") in people with Guideline Development, 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 3 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: stopped early, as of the sponsor's last update on 2 Oct 2026. 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 was stopped early (reason given: Participant responses to primary outcome -assessing questions were abnormal. Out of 3 multiple choice Qs, #1 was \~70% correct, #2 and #3 were 50%. Review of question structure suggested confusing wording that confounded outcome assessment.). Results are not available in the source record.
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 the Strength and Direction of Recommendation (time frame: During a single survey session (approximately 10 minutes)). 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 2 Oct 2026.