Clinical trial NCT05237635: Defining Decision Thresholds for Judgments on Health Benefits and Harms: Study Protocol
Official title: Defining Decision Thresholds for Judgments on Health Benefits and Harms Using the GRADE Evidence to Decision (EtD) Frameworks: Protocol for a Randomized Methodological Study (GRADE-THRESHOLD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decision Support Techniques
GRADE Approach
Keywords: Evidence to Decision framework
Clinical practice guidelines
Evidence-based medicine
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 1406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is an approach to derive and use decision-thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks.

Detailed description: The objective of this study is to derive decision-thresholds (DTs) for Evidence to Decision (EtD) judgments on the magnitude of health benefits and harms. The study hypothesis is that DTs could discriminate between the four categories for EtD judgments. Explicit DTs, providing an indication for which could be the appropriate judgment for a given scenario, might have the potential to support panels of decision-makers in their work, facilitate a common understanding, and promote consistency and transparency in judgments.

Study investigators will conduct a methodological randomized controlled trial to collect the data that allow deriving the decision-thresholds. They will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, investigators will investigate the validity of decision-threshold by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that the DTs approach would suggest if applied on the same guideline data.

Eligibility criteria: Inclusion Criteria:

The target population of the survey will include:

* clinicians
* epidemiologist
* decision scientists
* health research methodologists
* experts in health technology assessment (HTA)
* and members of guideline working groups
* members from the general public

Exclusion Criteria:

• Prior participation in the survey

Primary outcomes:
measure: Small effect of an intervention
timeFrame: immediate after completion of study
measure: Moderate effect of an intervention
timeFrame: immediate after completion of study
measure: Large effect of an intervention
timeFrame: immediate after completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
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