Recruiting

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

Sponsor:

McMaster University

Code:

NCT05237635

Conditions

Decision Support Techniques

GRADE Approach

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

descriptive case-scenarios

Study Details

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.

Conditions

Decision Support Techniques

GRADE Approach

Study ID

NCT05237635

Start date

Jun 9, 2020

Status verified date

Feb, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

1406 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Threshold estimates

Descriptive case-scenarios

active comparator: Alternative threshold estimates

Descriptive case-scenarios

Interventions

descriptive case-scenarios

Each case-scenario will include: (1) a GRADE Summary of Finding (SoF) table providing information about the Population, Intervention, Comparator, Outcome (PICO), the relative and absolute anticipated effects of the intervention, and the certainty in the evidence; (2) a Health Outcome Descriptor describing key attributes of the outcome under consideration including symptoms, time horizon, testing and treatment, and consequences; a measure of the impact on health of the outcome (also known as 'value' of the outcome or 'health utility' in health economics).

Primary outcome measure

Small effect of an intervention [ Time Frame: immediate after completion of study ]
Moderate effect of an intervention [ Time Frame: immediate after completion of study ]
Large effect of an intervention [ Time Frame: immediate after completion of study ]

Central Contacts and Locations

Central contacts

Holger J Schunemann, MD, PhD

+19055259140 schuneh@mcmaster.ca

Gian Paolo Morgano, PhD

morganog@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Holger J Schunemann, MD, PhD

+19055259140 schuneh@mcmaster.ca

Gian Paolo Morgano, PhD

+393498125719 morganog@mcmaster.ca

Principal Investigator:

Holger J Schunemann, MD, PhD

More Information

Sponsor

McMaster University

Last update posted

Feb 14, 2022

Last verified

Feb, 2022

Keywords

Evidence to Decision framework
Clinical practice guidelines
Evidence-based medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2022-02-14.