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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Threshold estimates | Experimental | Descriptive case-scenarios |
|
| Alternative threshold estimates | Active Comparator | Descriptive case-scenarios |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| descriptive case-scenarios | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Small effect of an intervention | 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. | immediate after completion of study |
| Moderate effect of an intervention | 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. | immediate after completion of study |
| Large effect of an intervention | 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. | immediate after completion of study |
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Inclusion Criteria:
The target population of the survey will include:
Exclusion Criteria:
• Prior participation in the survey
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holger J Schunemann, MD, PhD | Contact | +19055259140 | 24699 | schuneh@mcmaster.ca |
| Gian Paolo Morgano, PhD | Contact | morganog@mcmaster.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Recruiting | Hamilton | Ontario | L8S 4K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24983061 | Background | Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines; Graham R, Mancher M, Miller Wolman D, Greenfield S, Steinberg E, editors. Clinical Practice Guidelines We Can Trust. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209539/ | |
| 21409613 |
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| Schunemann HJ. Guidelines 2.0: do no net harm-the future of practice guideline development in asthma and other diseases. Curr Allergy Asthma Rep. 2011 Jun;11(3):261-8. doi: 10.1007/s11882-011-0185-8. |
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| 26428330 | Background | Johnston BC, Ebrahim S, Carrasco-Labra A, Furukawa TA, Patrick DL, Crawford MW, Hemmelgarn BR, Schunemann HJ, Guyatt GH, Nesrallah G. Minimally important difference estimates and methods: a protocol. BMJ Open. 2015 Oct 1;5(10):e007953. doi: 10.1136/bmjopen-2015-007953. |
| 23303884 | Background | Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. |
| 23116689 | Background | Guyatt GH, Thorlund K, Oxman AD, Walter SD, Patrick D, Furukawa TA, Johnston BC, Karanicolas P, Akl EA, Vist G, Kunz R, Brozek J, Kupper LL, Martin SL, Meerpohl JJ, Alonso-Coello P, Christensen R, Schunemann HJ. GRADE guidelines: 13. Preparing summary of findings tables and evidence profiles-continuous outcomes. J Clin Epidemiol. 2013 Feb;66(2):173-83. doi: 10.1016/j.jclinepi.2012.08.001. Epub 2012 Oct 30. |
| 32503619 | Background | Baldeh T, Saz-Parkinson Z, Muti P, Santesso N, Morgano GP, Wiercioch W, Nieuwlaat R, Grawingholt A, Broeders M, Duffy S, Hofvind S, Nystrom L, Ioannidou-Mouzaka L, Warman S, McGarrigle H, Knox S, Fitzpatrick P, Rossi PG, Quinn C, Borisch B, Lebeau A, de Wolf C, Langendam M, Piggott T, Giordano L, van Landsveld-Verhoeven C, Bernier J, Rabe P, Schunemann HJ. Development and use of health outcome descriptors: a guideline development case study. Health Qual Life Outcomes. 2020 Jun 5;18(1):167. doi: 10.1186/s12955-020-01338-8. |
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| 31167868 | Background | Alper BS, Oettgen P, Kunnamo I, Iorio A, Ansari MT, Murad MH, Meerpohl JJ, Qaseem A, Hultcrantz M, Schunemann HJ, Guyatt G; GRADE Working Group. Defining certainty of net benefit: a GRADE concept paper. BMJ Open. 2019 Jun 4;9(6):e027445. doi: 10.1136/bmjopen-2018-027445. |
| 23163976 | Background | Puhan MA, Singh S, Weiss CO, Varadhan R, Boyd CM. A framework for organizing and selecting quantitative approaches for benefit-harm assessment. BMC Med Res Methodol. 2012 Nov 19;12:173. doi: 10.1186/1471-2288-12-173. |
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| 35273045 | Derived | Morgano GP, Mbuagbaw L, Santesso N, Xie F, Brozek JL, Siebert U, Bognanni A, Wiercioch W, Piggott T, Darzi AJ, Akl EA, Verstijnen IM, Parmelli E, Saz-Parkinson Z, Alonso-Coello P, Schunemann HJ. Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD). BMJ Open. 2022 Mar 10;12(3):e053246. doi: 10.1136/bmjopen-2021-053246. |