title: Stakeholders apply the GRADE evidence-to-decision framework to facilitate coverage decisions.
abstract: OBJECTIVE
  Coverage decisions are complex and require the consideration of many factors. A well-defined, transparent process could improve decision-making and facilitate decision-maker accountability.
  
  
  METHODS
  We surveyed key US-based stakeholders regarding their current approaches for coverage decisions. Then, we held a workshop to test an evidence-to-decision (EtD) framework for coverage based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.
  
  
  RESULTS
  A total of 42 individuals (including 19 US stakeholders as well as international health policymakers and GRADE working group members) attended the workshop. Of the 19 stakeholders, 14 (74%) completed the survey before the workshop. Almost all of their organizations (13 of 14; 93%) used systematic reviews for coverage decision-making; few (2 of 14; 14%) developed their own evidence synthesis; a majority (9 of 14; 64%) rated the certainty of evidence (using various systems); almost all (13 of 14; 93%) denied formal consideration of resource use; and half (7 of 14; 50%) reported explicit criteria for decision-making. At the workshop, stakeholders successfully applied the EtD framework to four case studies and provided narrative feedback, which centered on contextual factors affecting coverage decisions in the United States, the need for reliable data on subgroups of patients, and the challenge of decision-making without formal consideration of resource use.
  
  
  CONCLUSIONS
  Stakeholders successfully applied the EtD framework to four case studies and highlighted contextual factors affecting coverage decisions and affirmed its value. Their input informed the further development of a revised EtD framework, now publicly available (http://gradepro.org/).
authors.affiliation: Minneapolis Veterans Affairs Health Care System, Minneapolis, MN, USA; Department of Urology, University of Minnesota, Minneapolis, MN, USA. Electronic address: pdahm@umn.edu.
authors.forename: Philipp
authors.initials: P
authors.lastname: Dahm
authors.affiliation: Global Health Unit, Norwegian Knowledge Centre for the Health Services, Oslo, Norway.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Oxman
authors.affiliation: Department of Internal Medicine, Division of Evidence-Based Medicine, Program for Comparative Effectiveness Research, University of South Florida, Tampa, FL, USA; Department of Hematology, H Lee Moffitt Cancer Center & Research Institute, Tampa General Hospital, Tampa, FL, USA; Department of Health Outcomes & Behavior, H Lee Moffitt Cancer Center & Research Institute, Tampa General Hospital, Tampa, FL, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Djulbegovic
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Hamilton, Ontario, Canada.
authors.forename: Gordon H
authors.initials: GH
authors.lastname: Guyatt
authors.affiliation: Division of Preventive Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
authors.forename: M Hassan
authors.initials: MH
authors.lastname: Murad
authors.affiliation: Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Amato
authors.affiliation: Department of Oncology, Hematology and Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Parmelli
authors.affiliation: Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Davoli
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Hamilton, Ontario, Canada.
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Morgan
authors.affiliation: Department of Internal Medicine/Nephrology, University of Missouri-Kansas City, Kansas City, MO, USA; Department of Biomedical and Health Informatics, Kansas City, MO, USA.
authors.forename: Reem A
authors.initials: RA
authors.lastname: Mustafa
authors.affiliation: Minneapolis Veterans Affairs Health Care System, Minneapolis, MN, USA; Division of Gastroenterology, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Sultan
authors.affiliation: Veterans Affairs Medical Center, Cleveland, OH, USA; Department of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA.
authors.forename: Yngve
authors.initials: Y
authors.lastname: Falck-Ytter
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Hamilton, Ontario, Canada; Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.
authors.forename: Elie A
authors.initials: EA
authors.lastname: Akl
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Hamilton, Ontario, Canada.
authors.forename: Holger J
authors.initials: HJ
authors.lastname: Schünemann
mesh_terms: D026683:Advisory Committees; D003659:Decision Making, Organizational; D019317:Evidence-Based Medicine; D006291:Health Policy; D006801:Humans; D019458:Insurance Coverage; D011050:Policy Making
keywords: Coverage; Decision-making; Evidence synthesis; Evidence-based medicine; GRADE; Healthcare policy; Resource utilization; Systematic review