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Guide to Statistics and Methods
Reporting Guidelines
April 7, 2021

ISPOR Reporting Guidelines for Comparative Effectiveness Research

Author Affiliations
  • 1Houston Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas
  • 2Division of Surgical Oncology, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
  • 3Department of Emergency Medicine, Denver Health Medical Center, University of Colorado School of Medicine, Denver
  • 4Department of Epidemiology, Colorado School of Public Health, Aurora
  • 5Statistical Editor, JAMA Surgery
  • 6Department of Surgery, University of Michigan, Ann Arbor
  • 7Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor
JAMA Surg. Published online April 7, 2021. doi:10.1001/jamasurg.2021.0534

Randomized clinical trials (RCTs) are considered the main source of data driving evidence-based practice and the primary method for establishing the efficacy of an intervention. However, for a variety of reasons, the universe of research questions that can be definitively addressed by traditional RCTs is limited.1 At the heart of comparative effectiveness research (CER) is a desire to generate real-world evidence demonstrating the effectiveness (rather than the efficacy) of an intervention using real-world data (obtained outside the often-ideal conditions of a traditional RCT). As value-based reimbursement models are better integrated into the US health care system and patient-centered care is increasingly emphasized, there will be a greater need for high-quality CER studies to inform the most clinically effective and cost-effective treatments and to help identify the right type of treatment for patients being treated in specific clinical contexts.

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