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  1. Food and Drug Administration (.gov)
    https://www.fda.gov › regulatory-information › search-fda-guidance-documents › statistical...

    Statistical Guidance on Reporting Results from Studies Evaluating ...

    • This guidance is intended to describe some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identify some common inappropriate practices. The reco… See more

    Scope

    This document provides guidance for the submission of premarket notification (510(k)) and … See more

    Food and Drug Admini…
    Introduction

    This section provides an explanation of the concepts relevant to this guidance. We note at the outset that evaluation of a new diagnostic test should compare a new product’s o… See more

    Food and Drug Administration (.gov)
    Benchmark and Study Population Recommendations

    FDA recommends you carefully plan your study before collecting the first specimen or taking the first measurement. This includes determining whether you want to report diagnostic … See more

    Food and Drug Administration (.gov)
    Reporting Recommendations

    Similar reporting principles apply to any study evaluating a diagnostic test, regardless of whether the comparative benchmark is a reference standard. Reporting t… See more

    Food and Drug Administration (.gov)
    Statistically Inappropriate Practices

    Some common practices for reporting results are statistically inappropriate because they are misleading or can lead to inaccurate estimates of test performance. These prac… See more

    Food and Drug Administration (.gov)
    What does “apparent” mean in a 2x2 table?
    the “apparent” overall percent agreement calculated from the revised table will always be greater than or equal to percent agreement calculated from the original 2x2 table. The third consequence needs further explanation. The agreement calculated from the revised results is called “apparent” because agreement with “what” is not clear.
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    Table of Contents
    Scope
    Introduction
    Benchmark and Study Population Recommendations
    Reporting Recommendations
    Statistically Inappropriate Practices
    What does “apparent” mean in a 2x2 table?
     

  1. Images of 2x2 table PPA NPA

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  2. Westgard Web
    https://westgard.com › lessons › basic-method...

    Estimating Clinical Agreement for a Qualitative Test: A Web …

  3. westgard.com
    https://tools.westgard.com › two-by-two-contingency.shtml

    2x2 Contingency Calculator - Westgard

  4. Analyse-it
    https://analyse-it.com › docs › user-guide › method...

    Agreement measures for binary and semi-quantitative data

  5. Analyse-it
    https://analyse-it.com › blog › diagnostic...

    Diagnostic accuracy (sensitivity/specificity) versus …

    Apr 22, 2020 · CLSI EP12: User Protocol for Evaluation of Qualitative Test Performance protocol describes the terms positive percent agreement (PPA) and negative percent agreement (NPA). When you have two binary diagnostic …

  6. Open Educational Resources
    https://open.oregonstate.education › epi…

    4 Introduction to 2 x 2 Tables, Epidemiologic Study …

    Learning Objectives. After reading this chapter, you will be able to do the following: Interpret data found in a 2 x 2 table. Compare and contrast the 4 most common types of epidemiologic studies: cohort studies, randomized controlled …

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    • PPA

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  7. National Center for Biotechnology Information
    https://www.ncbi.nlm.nih.gov › pmc › articles

    Observer agreement paradoxes in 2x2 tables: comparison of …

  8. libretexts.org
    https://med.libretexts.org › Bookshelves › Medicine...

    1.4: Introduction to 2 x 2 Tables, Epidemiologic Study Design, and ...

  9. National Center for Biotechnology Information
    https://www.ncbi.nlm.nih.gov › books › table

    Appendix Table, 2×2 table used in the calculation of test …

  10. SAGE Journals
    https://journals.sagepub.com › doi › pdf
    [PDF]

    Measures of Diagnostic Accuracy: Sensitivity, Specificity, PPV …