Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection

Research output: Contribution to journalArticlepeer-review

Standard

Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection. / Doust, Jenny A; Bell, Katy JL ; Leeflang, Mariska M G; Dinnes, Jacqueline; Lord, Sally J ; Mallett, Sue; van de Wijgert, Janneke HHM ; Sandberg, Sverre ; Adeli, Khosrow ; Deeks, Jon; Bossuyt, Patrick M.; Horvath, Andrea R .

In: BMJ, Vol. 372, n568, 29.03.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

Doust, JA, Bell, KJL, Leeflang, MMG, Dinnes, J, Lord, SJ, Mallett, S, van de Wijgert, JHHM, Sandberg, S, Adeli, K, Deeks, J, Bossuyt, PM & Horvath, AR 2021, 'Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection', BMJ, vol. 372, n568. https://doi.org/10.1136/bmj.n568

APA

Doust, J. A., Bell, K. JL., Leeflang, M. M. G., Dinnes, J., Lord, S. J., Mallett, S., van de Wijgert, J. HHM., Sandberg, S., Adeli, K., Deeks, J., Bossuyt, P. M., & Horvath, A. R. (2021). Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection. BMJ, 372, [n568]. https://doi.org/10.1136/bmj.n568

Vancouver

Author

Doust, Jenny A ; Bell, Katy JL ; Leeflang, Mariska M G ; Dinnes, Jacqueline ; Lord, Sally J ; Mallett, Sue ; van de Wijgert, Janneke HHM ; Sandberg, Sverre ; Adeli, Khosrow ; Deeks, Jon ; Bossuyt, Patrick M. ; Horvath, Andrea R . / Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection. In: BMJ. 2021 ; Vol. 372.

Bibtex

@article{0c922d3674eb4327abb57bf5633384a9,
title = "Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection",
abstract = "Testing for SARS-CoV-2 infection is key in managing the current pandemic. More than 1700 preprints and peer reviewed journal articles evaluating tests for SARS-CoV-2 infection have been published as of January 2021. However, evaluations of these studies have identified many methodological issues, leading to a high risk of bias and difficulties applying the results in practice. Better guidance is urgently needed on the conduct and interpretation of these studies. This article outlines the principles for defining the intended purpose of the test; study population selection; reference standard, test timing; and other critical considerations for the design, reporting, and interpretation of diagnostic accuracy studies. The implementation and accuracy of SARS-CoV-2 tests have major implications for individuals and communities, balancing the potential consequences of continued infection against the need for public health measures, such as the restriction of movements and social activities. Decision making in the current pandemic requires a clear understanding of the clinical performance and limitations of testing. This article provides guidance to assist researchers design robust diagnostic accuracy studies, assist publishers and peer reviewers to assess such studies, and support clinicians and policy makers in their evaluation of the evidence on SARS-CoV-2 testing for clinical and public health decisions. The guidance aims to ensure that studies evaluating the diagnostic accuracy of SARS-CoV-2 tests are conducted as rigorously as possible, in an efficient and timely way.",
author = "Doust, {Jenny A} and Bell, {Katy JL} and Leeflang, {Mariska M G} and Jacqueline Dinnes and Lord, {Sally J} and Sue Mallett and {van de Wijgert}, {Janneke HHM} and Sverre Sandberg and Khosrow Adeli and Jon Deeks and Bossuyt, {Patrick M.} and Horvath, {Andrea R}",
year = "2021",
month = mar,
day = "29",
doi = "10.1136/bmj.n568",
language = "English",
volume = "372",
journal = "BMJ",
issn = "1756-1833",
publisher = "BMJ Publishing Group",

}

RIS

TY - JOUR

T1 - Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection

AU - Doust, Jenny A

AU - Bell, Katy JL

AU - Leeflang, Mariska M G

AU - Dinnes, Jacqueline

AU - Lord, Sally J

AU - Mallett, Sue

AU - van de Wijgert, Janneke HHM

AU - Sandberg, Sverre

AU - Adeli, Khosrow

AU - Deeks, Jon

AU - Bossuyt, Patrick M.

AU - Horvath, Andrea R

PY - 2021/3/29

Y1 - 2021/3/29

N2 - Testing for SARS-CoV-2 infection is key in managing the current pandemic. More than 1700 preprints and peer reviewed journal articles evaluating tests for SARS-CoV-2 infection have been published as of January 2021. However, evaluations of these studies have identified many methodological issues, leading to a high risk of bias and difficulties applying the results in practice. Better guidance is urgently needed on the conduct and interpretation of these studies. This article outlines the principles for defining the intended purpose of the test; study population selection; reference standard, test timing; and other critical considerations for the design, reporting, and interpretation of diagnostic accuracy studies. The implementation and accuracy of SARS-CoV-2 tests have major implications for individuals and communities, balancing the potential consequences of continued infection against the need for public health measures, such as the restriction of movements and social activities. Decision making in the current pandemic requires a clear understanding of the clinical performance and limitations of testing. This article provides guidance to assist researchers design robust diagnostic accuracy studies, assist publishers and peer reviewers to assess such studies, and support clinicians and policy makers in their evaluation of the evidence on SARS-CoV-2 testing for clinical and public health decisions. The guidance aims to ensure that studies evaluating the diagnostic accuracy of SARS-CoV-2 tests are conducted as rigorously as possible, in an efficient and timely way.

AB - Testing for SARS-CoV-2 infection is key in managing the current pandemic. More than 1700 preprints and peer reviewed journal articles evaluating tests for SARS-CoV-2 infection have been published as of January 2021. However, evaluations of these studies have identified many methodological issues, leading to a high risk of bias and difficulties applying the results in practice. Better guidance is urgently needed on the conduct and interpretation of these studies. This article outlines the principles for defining the intended purpose of the test; study population selection; reference standard, test timing; and other critical considerations for the design, reporting, and interpretation of diagnostic accuracy studies. The implementation and accuracy of SARS-CoV-2 tests have major implications for individuals and communities, balancing the potential consequences of continued infection against the need for public health measures, such as the restriction of movements and social activities. Decision making in the current pandemic requires a clear understanding of the clinical performance and limitations of testing. This article provides guidance to assist researchers design robust diagnostic accuracy studies, assist publishers and peer reviewers to assess such studies, and support clinicians and policy makers in their evaluation of the evidence on SARS-CoV-2 testing for clinical and public health decisions. The guidance aims to ensure that studies evaluating the diagnostic accuracy of SARS-CoV-2 tests are conducted as rigorously as possible, in an efficient and timely way.

UR - http://www.scopus.com/inward/record.url?scp=85103452247&partnerID=8YFLogxK

U2 - 10.1136/bmj.n568

DO - 10.1136/bmj.n568

M3 - Article

VL - 372

JO - BMJ

JF - BMJ

SN - 1756-1833

M1 - n568

ER -