Issa J. Dahabreh, MD, MS; Thomas A. Trikalinos, MD; Ethan M. Balk, MD, MPH; John B. Wong, MD
Disclaimer: The findings and conclusions in this paper are those of the authors, who are responsible for its content, and do not necessarily represent the views of the Agency for Healthcare Research and Quality (AHRQ). The final recommendations reflect the authors' best judgment and should not be taken to represent the views of persons involved in the guidance development process, including the technical expert panel members, stakeholder meeting attendees, and external reviewers. No statement in this paper should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.
Acknowledgment: The authors thank the clinical and advisory policy team, technical expert panel members, stakeholder meeting attendees, and reviewers of the chapter of the Methods Guide for Comparative Effectiveness Reviews (11) on which this paper is based for their help during various stages of the project. They also thank Ms. Esther Avendano, Mr. Jeffrey Chan, and Ms. Amy Earley; and Drs. Denish Moorthy, Jeroen Jansen, and Natasha Stout for their contributions to a companion methods research report that was used as input for the development of these recommendations.
Grant Support: This paper is based on a chapter of the Methods Guide for Comparative Effectiveness Reviews (11), which was prepared under funding by AHRQ (contract HHSA 290 200 710 055 I).
Disclosures: Dr. Balk reports grants from the Agency for Healthcare Research and Quality during the conduct of the study. Dr. Wong reports grants from the Agency for Healthcare Research and Quality during the conduct of the study and personal fees from American College of Physicians, Cambridge University Press, and Wolters Kluwer outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0161.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Issa J. Dahabreh, MD, MS, Department of Health Services, Policy & Practice, Center for Evidence-based Medicine, Brown University, 121 South Main Street, Box G-S121-8, Providence, RI 02912; e-mail, issa_dahabreh@brown.edu.
Current Author Addresses: Drs. Dahabreh, Trikalinos, and Balk: Department of Health Services, Policy & Practice, Center for Evidence-based Medicine, Brown University, 121 South Main Street, Box G-S121-8, Providence, RI 02912.
Dr. Wong: Tufts Medical Center, 800 Washington Street, Box TMC #302, Boston, MA 02111.
Author Contributions: Conception and design: I.J. Dahabreh, T.A. Trikalinos, E.M. Balk, J.B. Wong.
Analysis and interpretation of the data: I.J. Dahabreh, E.M. Balk, J.B. Wong.
Drafting of the article: I.J. Dahabreh, E.M. Balk, J.B. Wong.
Critical revision of the article for important intellectual content: I.J. Dahabreh, T.A. Trikalinos, E.M. Balk, J.B. Wong.
Final approval of the article: I.J. Dahabreh, E.M. Balk, J.B. Wong.
Provision of study materials or patients: I.J. Dahabreh, J.B. Wong.
Statistical expertise: I.J. Dahabreh, T.A. Trikalinos, J.B. Wong.
Obtaining of funding: E.M. Balk, J.B. Wong.
Administrative, technical, or logistic support: J.B. Wong.
Collection and assembly of data: I.J. Dahabreh, E.M. Balk, J.B. Wong.
Models and simulations are valuable tools for addressing the uncertainty, tradeoffs, and heterogeneous preferences that complicate research questions in health technology assessment. This article presents recommendations for the conduct and reporting of modeling and simulation studies based on a systematic review of published recommendation statements, a survey of Web sites of international health technology assessment organizations, and input from experts and other stakeholders. The recommendations apply to mathematical models that represent structural relationships among model components and integrate information from multiple sources; they address model identification, estimation, verification, and validation, as well as the conduct of sensitivity, stability, and uncertainty analyses. They are organized into model conceptualization and structure, data, model assessment and consistency, and interpreting and reporting results. They should contribute to increased use and better conduct and reporting of modeling and simulation studies in health technology assessment.
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Dahabreh IJ, Trikalinos TA, Balk EM, Wong JB. Recommendations for the Conduct and Reporting of Modeling and Simulation Studies in Health Technology Assessment. Ann Intern Med. 2016;165:575-581. doi: 10.7326/M16-0161
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© 2017
Published: Ann Intern Med. 2016;165(8):575-581.
DOI: 10.7326/M16-0161
Published at www.annals.org on 20 September 2016
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