GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

Holger J Schünemann; Reem Mustafa; Jan Brozek; Nancy Santesso; Pablo Alonso-Coello; Gordon Guyatt; Rob Scholten; Miranda Langendam; Mariska M Leeflang; Elie A Akl; Jasvinder A Singh; Joerg Meerpohl; Monica Hultcrantz; Patrick Bossuyt; Andrew D Oxman; GRADE Working Group

doi:10.1016/j.jclinepi.2016.01.032

GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

J Clin Epidemiol. 2016 Aug:76:89-98. doi: 10.1016/j.jclinepi.2016.01.032. Epub 2016 Feb 27.

Authors

Affiliations

¹ Department of Clinical Epidemiology and Biostatistics & McGRADE Center, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada. Electronic address: schuneh@mcmaster.ca.
² Department of Clinical Epidemiology and Biostatistics & McGRADE Center, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, School of Medicine, University of Missouri-Kansas City, M4-303, 2411 Holmes Street, Kansas City, MO 64108-2792, USA.
³ Department of Clinical Epidemiology and Biostatistics & McGRADE Center, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada.
⁴ Department of Clinical Epidemiology and Biostatistics & McGRADE Center, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada.
⁵ Department of Clinical Epidemiology and Biostatistics & McGRADE Center, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Centro Cochrane Iberoamericano, Instituto de Investigación Biomédica (IIB Sant Pau-CIBERESP), Sant Antoni Maria Claret 167, 08025 Barcelona, Spain.
⁶ Cochrane Netherlands/Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
⁷ Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Clinical Epidemiology and Biostatistics and Bioinformatics Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room J1b-209, P.O. Box 227001100 DE, Amsterdam, The Netherlands.
⁸ Clinical Epidemiology and Biostatistics and Bioinformatics Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room J1b-209, P.O. Box 227001100 DE, Amsterdam, The Netherlands.
⁹ Department of Clinical Epidemiology and Biostatistics & McGRADE Center, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Department of Internal Medicine, American University of Beirut Medical Center, P.O. Box 11-0236, Riad-El-Solh Beirut 1107 2020, Lebanon.
¹⁰ Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Medicine Service and Center for Surgical Medical Acute care Research and Transitions, Department of Medicine, VA Medical Center, 510, 20th Street South, FOT 805B, Birmingham, AL, USA.
¹¹ Cochrane GRADEing (Applicability and Recommendations) Methods Group, 1280 Main Street West McMaster University, Hamilton, Ontario L8S 4K1, Canada; Cochrane Germany, Medical Center, University of Freiburg, Berliner Allee 29, 79110 Freiburg, Germany.
¹² Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), S:t Eriksgatan 117, SE-102 33, Stockholm, Sweden & Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Tomtebodav. 18 A, SE-171 77, Stockholm, Sweden.
¹³ Norwegian Knowledge Centre for the Health Services, Boks 7004 Street Olavsplass, N-0130 Oslo, Norway.

PMID: 26931285
DOI: 10.1016/j.jclinepi.2016.01.032

Abstract

Objectives: To describe the grading of recommendations assessment, development and evaluation (GRADE) interactive evidence to decision (EtD) frameworks for tests and test strategies for clinical, public health, or coverage decisions.

Study design and setting: As part of the GRADE Working Group's DECIDE project, we conducted workshops, user testing with systematic review authors, guideline developers and other decision makers, and piloted versions of the EtD framework.

Results: EtD frameworks for tests share the structure, explicitness, and transparency of other EtD frameworks. They require specifying the purpose of the test, linked or related management, and the key outcomes of concern for different test results and subsequent management. The EtD criteria address test accuracy and assessments of the certainty of the additional evidence necessary for decision making. When there is no direct evidence of test effects on patient-important outcomes, formal or informal modeling is needed to estimate effects. We describe the EtD criteria based on examples developed with GRADEpro (www.gradepro.org), GRADE's software that also allows development and dissemination of interactive summary of findings tables.

Conclusion: EtD frameworks for developing recommendations and making decisions about tests lay out the sequential steps in reviewing and assessing the different types of evidence that need to be linked.

Keywords: Decision-making; GRADE; GRADEpro; Guidelines; Recommendations; Summary of findings; Tests.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Clinical Competence / standards*
Education, Medical / standards*
Educational Measurement / standards*
Evidence-Based Medicine / standards*
Guidelines as Topic*
Humans
Public Health / education*