Decision Support Techniques, GRADE Approach
Conditions
Keywords
Evidence to Decision framework, Clinical practice guidelines, Evidence-based medicine
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.
Interventions
OTHERdescriptive 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).
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Canada
Contacts
Primary ContactHolger J Schunemann, MD, PhD
Backup ContactGian Paolo Morgano, PhD
Outcome results
None listed