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)
Por:
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
Publicada:
10 mar 2022
Ahead of Print:
10 mar 2022
Resumen:
Introduction The Grading of Recommendations Assessment, Development and Evaluation (GRADE) and similar Evidence to Decision (EtD) frameworks require its users to judge how substantial the effects of interventions are on desirable and undesirable people-important health outcomes. However, decision thresholds (DTs) that could help understand the magnitude of intervention effects and serve as reference for interpretation of findings are not yet available.
The objective of this study is an approach to derive and use DTs for EtD judgments about the magnitude of health benefits and harms. We hypothesise that approximate DTs could have the ability to discriminate between the existing four categories of EtD judgments (Trivial, Small, Moderate, Large), support panels of decision-makers in their work, and promote consistency and transparency in judgments.
Methods and analysis We will conduct a methodological randomised controlled trial to collect the data that allow deriving the DTs. We 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, we will investigate the validity of our DTs by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that our DTs approach would suggest if applied on the same guideline data.
Ethics and dissemination The Hamilton Integrated Research Ethics Board reviewed this study as a quality improvement study and determined that it requires no further consent. Survey participants will be required to read a consent statement in order to participate in this study at the beginning of the trial. This statement reads: You are being invited to participate in a research project which aims to identify indicative DTs that could assist users of the GRADE EtD frameworks in making judgments. Your input will be used in determining these indicative thresholds. By completing this survey, you provide consent that the anonymised data collected will be used for the research study and to be summarised in aggregate in publication and electronic tools.
Filiaciones:
Morgano, GP:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
Mbuagbaw, L:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
Santesso, N:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
Xie, F:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
Brozek, JL:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
Siebert, U:
UMIT Univ Hlth Sci Med Informat & Technol, Inst Publ Hlth Med Decis Making & Hlth Technol As, Dept Publ Hlth Hlth Serv Res & Technol Assessment, Hall In Tirol, Austria
ONCOTYROL Ctr Personalized Canc Med, Div Hlth Technol Assessment & Bioinformat, Innsbruck, Austria
Harvard Univ, Harvard Med Sch, Harvard TH Chan Sch Publ Hlth, Ctr Hlth Decis Sci,Dept Hlth Policy & Management, Boston, MA 02115 USA
Harvard Univ, Harvard Med Sch, MGH ITA Dept Radiol, Boston, MA 02115 USA
Bognanni, A:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
Wiercioch, W:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
Piggott, T:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
Darzi, AJ:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
Akl, EA:
Amer Univ Beirut, Dept Internal Med, Beirut, Lebanon
Verstijnen, IM:
Dutch Natl Hlth Care Inst, Diemen, Netherlands
Parmelli, E:
European Commiss Joint Res Ctr, Ispra, Italy
Saz-Parkinson, Z:
European Commiss Joint Res Ctr, Ispra, Italy
Alonso-Coello, P:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
Schunemann, HJ:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
McMaster Univ, Michael G DeGroote Cochrane Canada, Hamilton, ON, Canada
McMaster Univ, McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
Humanitas Univ, Dipartimento Sci Biomed, Milan, Italy
gold, Green Published, Gold, Green
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