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

Decision Support Techniques Clinical Trial

Official title:

Defining Decision Thresholds for Judgments on Health Benefits and Harms Using the GRADE Evidence to Decision (EtD) Frameworks: Protocol for a Randomized Methodological Study (GRADE-THRESHOLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237635
• Other study ID #: GRADETHRESHLD
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: McMaster University
• Contact: Holger J Schunemann, MD, PhD
• Phone: +19055259140
• Email: schuneh[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1406
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Decision Support Techniques
• GRADE Approach

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. — View Citation

Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. — View Citation

Alper BS, Oettgen P, Kunnamo I, Iorio A, Ansari MT, Murad MH, Meerpohl JJ, Qaseem A, Hultcrantz M, Schünemann 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. Review. — View Citation

Atkins D, Eccles M, Flottorp S, Guyatt GH, Henry D, Hill S, Liberati A, O'Connell D, Oxman AD, Phillips B, Schünemann H, Edejer TT, Vist GE, Williams JW Jr; GRADE Working Group. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res. 2004 Dec 22;4(1):38. — View Citation

Baldeh T, Saz-Parkinson Z, Muti P, Santesso N, Morgano GP, Wiercioch W, Nieuwlaat R, Gräwingholt 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, Schünemann 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. — View Citation

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson 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. — View Citation

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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. Review. Erratum in: J Clin Epidemiol. 2015 Apr;68(4):475. — View Citation

Hultcrantz M, Mustafa RA, Leeflang MMG, Lavergne V, Estrada-Orozco K, Ansari MT, Izcovich A, Singh J, Chong LY, Rutjes A, Steingart K, Stein A, Sekercioglu N, Arevalo-Rodriguez I, Morgan RL, Guyatt G, Bossuyt P, Langendam MW, Schünemann HJ. Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper. J Clin Epidemiol. 2020 Jan;117:138-148. doi: 10.1016/j.jclinepi.2019.05.002. Epub 2019 May 18. — View Citation

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. — View Citation

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. — View Citation

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. Review. — View Citation

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Schünemann 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. Review. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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