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)
Morgano, Gian Paolo (Michael G. DeGroote Cochrane Canada and McMaster GRADE Centres. McMaster University)
Mbuagbaw, Lawrence (Department of Health Research Methods. Evidence and Impact. McMaster University)
Santesso, Nancy (McMaster University (Canadà))
Xie, Feng (McMaster University (Canadà))
Brozek, Jan L (McMaster University (Canadà))
Siebert, Uwe (Center for Health Decision Science/Department of Health Policy and Management. Harvard TH Chan School of Public Health and MGH-ITA. Harvard Medical School. Harvard University)
Bognanni, Antonio (McMaster University (Canadà))
Wiercioch, Wojtek (McMaster University (Canadà))
Piggott, Thomas (McMaster University (Canadà))
Darzi, Andrea J. (Michael G. DeGroote Cochrane Canada and McMaster GRADE Centres. McMaster University)
Akl, Elie A. (Department of Internal Medicine. American University of Beirut)
Verstijnen, Ilse M. (Dutch National Health Care Institute)
Parmelli, Elena (European Commission. Joint Research Centre (JRC))
Saz-Parkinson, Zuleika (European Commission Joint Research Centre)
Alonso-Coello, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Schünemann, Holger J. (Dipartimento di Scienze Biomediche. Humanitas University)

Data:	2022
Resum:	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. PROTOCOL registration number NCT05237635.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	BMJ open, Vol. 12 Núm. 3 (october 2022) , p. e053246, ISSN 2044-6055

DOI: 10.1136/bmjopen-2021-053246
PMID: 35273045

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