NCT05237635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,406

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2.6 years

First QC Date

December 8, 2021

Last Update Submit

February 11, 2022

Conditions

Decision Support TechniquesGRADE Approach

Keywords

Evidence to Decision frameworkClinical practice guidelinesEvidence-based medicine

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Threshold estimates

EXPERIMENTAL

Descriptive case-scenarios

Other: descriptive case-scenarios

Alternative threshold estimates

ACTIVE COMPARATOR

Descriptive case-scenarios

Other: descriptive case-scenarios

Interventions

descriptive case-scenariosOTHER

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).

Alternative threshold estimatesThreshold estimates

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior participation in the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (20)

  • 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/

    PMID: 24983061BACKGROUND

  • 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.

    PMID: 21409613BACKGROUND

  • Atkins D, Eccles M, Flottorp S, Guyatt GH, Henry D, Hill S, Liberati A, O'Connell D, Oxman AD, Phillips B, Schunemann 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. doi: 10.1186/1472-6963-4-38.

    PMID: 15615589BACKGROUND

  • Alonso-Coello P, Schunemann 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. No abstract available.

    PMID: 27353417BACKGROUND

  • Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schunemann 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. No abstract available.

    PMID: 27365494BACKGROUND

  • Marcucci M, Sinclair JC. A generalised model for individualising a treatment recommendation based on group-level evidence from randomised clinical trials. BMJ Open. 2013 Aug 13;3(8):e003143. doi: 10.1136/bmjopen-2013-003143.

    PMID: 23943775BACKGROUND

  • McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: what it is and what that means. Pharmacoeconomics. 2008;26(9):733-44. doi: 10.2165/00019053-200826090-00004.

    PMID: 18767894BACKGROUND

  • Pauker SG, Kassirer JP. Therapeutic decision making: a cost-benefit analysis. N Engl J Med. 1975 Jul 31;293(5):229-34. doi: 10.1056/NEJM197507312930505.

    PMID: 1143303BACKGROUND

  • 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, Schunemann 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.

    PMID: 31112801BACKGROUND

  • Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Ostlund P, Tranaeus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schunemann 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.

    PMID: 28529184BACKGROUND

  • Faraone SV. Interpreting estimates of treatment effects: implications for managed care. P T. 2008 Dec;33(12):700-11. No abstract available.

    PMID: 19750051BACKGROUND

  • 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.

    PMID: 26428330BACKGROUND

  • 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.

    PMID: 23303884BACKGROUND

  • 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.

    PMID: 23116689BACKGROUND

  • 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.

    PMID: 32503619BACKGROUND

  • Abramson JH. WINPEPI updated: computer programs for epidemiologists, and their teaching potential. Epidemiol Perspect Innov. 2011 Feb 2;8(1):1. doi: 10.1186/1742-5573-8-1.

    PMID: 21288353BACKGROUND

  • 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.

    PMID: 31167868BACKGROUND

  • 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.

    PMID: 23163976BACKGROUND

  • Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977 Mar 31;296(13):716-21. doi: 10.1056/NEJM197703312961304.

    PMID: 402576BACKGROUND

  • 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.

    PMID: 35273045DERIVED

Central Study Contacts

Holger J Schunemann, MD, PhD

CONTACT

+19055259140schuneh@mcmaster.ca

Gian Paolo Morgano, PhD

CONTACT

morganog@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

February 14, 2022

Study Start

June 9, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)