Defining Decision Thresholds for Judgments on Health Benefits and Harms: Study Protocol

Not Applicable

• Conditions: Decision Support Techniques; GRADE Approach
• Interventions: Other: descriptive case-scenarios

• Registration Number: NCT05237635
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study Start: 2020-06-09
• Study First Submitted: 2021-12-08
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1406

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Threshold estimates	descriptive case-scenarios	Descriptive case-scenarios
Alternative threshold estimates	descriptive case-scenarios	Descriptive case-scenarios

Primary Outcome Measures

Name	Time	Method
Moderate effect of an intervention	immediate after completion of study	Questionnaire:Participants will be asked to indicate which decision threshold for discriminating between EtD judgments of 'Small' and 'Moderate' they felt appropriate at the time of participation in the survey.
Small effect of an intervention	immediate after completion of study	Questionnaire: Participants will be asked to indicate which decision threshold for discriminating between EtD judgments of 'Trivial or None' and 'Small' they felt appropriate at the time of participation in the survey.
Large effect of an intervention	immediate after completion of study	Questionnaire:Participants will be asked to indicate which decision threshold for discriminating between EtD judgments of 'Moderate' and Large' they felt appropriate at the time of participation in the survey.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada