Wording Approaches to Convey the Strength of Recommendations in Health Guidelines: Protocol for a Randomized Controlled Trial
| Registry | NCT07854548, acronym (SOR) |
|---|---|
| Status | Terminated - 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. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, other |
| Enrollment | 741 (Actual) |
| Sponsor | McMaster University (Other) |
| Conditions | Guideline Development |
| Interventions | GRADE approach ("recommends" and "suggest"), New approach ("strongly recommends" and "conditionally recommends"), Alternate approach ("should" and "may") (Other) |
| Dates | start 2025-08-01, primary completion 2025-12-30, completion 2025-12-30, first posted 2026-10-02, last updated 2026-10-02 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Guideline Development All trials of GRADE approach ("recommends" and "suggest") All trials of New approach ("strongly recommends" and "conditionally recommends")
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 |
Sex: All, ages: 16 Years to any, accepts healthy volunteers
Inclusion Criteria: * 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) Exclusion Criteria: * Previous participation in this study
| Facility | City | Country | Status |
|---|---|---|---|
| McMaster University | Hamilton, Ontario | Canada |