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

McMaster University

Status: Unknown

Conditions: Decision Support Techniques; GRADE Approach

Treatments: Other: descriptive case-scenarios

Study type: Interventional

Funder types: Other

Identifiers

NCT05237635

GRADETHRESHLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,406 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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1,406 participants in 2 patient groups

Threshold estimates

Experimental group

Description:

Descriptive case-scenarios

Treatment:

Other: descriptive case-scenarios

Alternative threshold estimates

Active Comparator group

Description:

Descriptive case-scenarios

Treatment:

Other: descriptive case-scenarios