Format

Send to

Choose Destination
See comment in PubMed Commons below
Eur J Clin Microbiol Infect Dis. 2012 Sep;31(9):2111-6. doi: 10.1007/s10096-012-1602-1. Epub 2012 Mar 29.

Methods and recommendations for evaluating and reporting a new diagnostic test.

Author information

1
University of Maryland School of Medicine, Baltimore, MD, USA. ahess@epi.umaryland.edu

Abstract

No standardized guidelines exist for the biostatistical methods appropriate for studies evaluating diagnostic tests. Publication recommendations such as the STARD statement provide guidance for the analysis of data, but biostatistical advice is minimal and application is inconsistent. This article aims to provide a self-contained, accessible resource on the biostatistical aspects of study design and reporting for investigators. For all dichotomous diagnostic tests, estimates of sensitivity and specificity should be reported with confidence intervals. Power calculations are strongly recommended to ensure that investigators achieve desired levels of precision. In the absence of a gold standard reference test, the composite reference standard method is recommended for improving estimates of the sensitivity and specificity of the test under evaluation.

PMID:
22476385
PMCID:
PMC3661219
DOI:
10.1007/s10096-012-1602-1
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Springer Icon for PubMed Central
    Loading ...
    Support Center