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April 4, 2018

Tips for Analyzing Large Data Sets From the JAMA Surgery Statistical Editors

Author Affiliations
  • 1Harbor–University of California Los Angeles Medical Center, Torrance, California
  • 2Northwestern University, Chicago, Illinois
  • 3Duke University, Durham, North Carolina
  • 4Statistical Editor, JAMA Surgery
JAMA Surg. Published online April 4, 2018. doi:10.1001/jamasurg.2018.0647

With the advent of administrative databases and patient registries, big data is increasingly accessible to researchers. The large sample size of these data sets make the study of rare outcomes easier and provide the potential to determine national estimates and regional variations. As such, the JAMA Surgery editors and reviewers have seen more submissions using big data to answer clinical and policy-related questions. However, no database is completely free of bias and measurement error. With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals. While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.

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    1 Comment for this article
    IRB approval or determination exemption usually does not apply
    Mark Schreiner, MD. | The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania
    The authors state that "There should be some statement that the study was performed after institutional review board approval or exemption was obtained." However, for many if not most research involving national database registries, IRB review would not required nor would a determination of exemption.

    The definition of human subjects research at 45 CFR 46.102(f) requires that the investigator obtain private information such that the subjects would be readily identifiable.

    "Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in
    order for obtaining the information to constitute research involving human subjects."

    Most of the time, the data provided to investigators by national registries will not be individually identifiable. When this is the case, the research would not meet the definition of human subjects research and IRB review of the proposed research would be required nor would the research require a determination of exemption. Only when the research meets the definition of human subjects research is IRB review or a determination of exemption required.