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J Clin Epidemiol. 2019 May 28;114:38-48. doi: 10.1016/j.jclinepi.2019.05.018. [Epub ahead of print]

Development of practical recommendations for diagnostic accuracy studies in low-prevalence situations.

Author information

1
Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford OX2 6GG, UK; Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, PO Box 196, 9700 AD Groningen, the Netherlands. Electronic address: g.a.holtman@umcg.nl.
2
Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, PO Box 196, 9700 AD Groningen, the Netherlands.
3
Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK; NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, University of Birmingham, Birmingham B15 2TT, UK.
4
Department of General Practice and Family Medicine, Faculty of Medicine, Philipps University of Marburg, Karl-von-Str. 4, Marburg 35037, Germany.
5
Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford OX2 6GG, UK.
6
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands.
7
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA Utrecht, the Netherlands.
8
Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford OX2 6GG, UK; Academic Centre of General Practice, University of Leuven, Kapucijnenvoer 33 blok J, Bus 7001, 3000 Leuven, Belgium.

Abstract

OBJECTIVE:

Low disease prevalence poses challenges for diagnostic accuracy studies because of the large sample sizes that are required to obtain sufficient precision. The aim is to collate and discuss designs of diagnostic accuracy studies suited for use in low-prevalence situations.

STUDY DESIGN AND SETTING:

We conducted a literature search including backward citation tracking and expert consultation. Two reviewers independently selected studies on designs for estimating diagnostic accuracy in a low-prevalence situation. During a 1-day expert meeting, all designs were discussed and recommendations were formulated.

RESULTS:

We identified six designs for diagnostic accuracy studies that are suitable in low-prevalence situations because they reduced the total sample size or the number of patients undergoing the index test or reference standard depending on which poses the highest burden. We described the advantages and limitations of these designs and evaluated efficiencies in sample sizes, risk of bias, and alignment with the clinical pathway for applicability in routine care.

CONCLUSION:

Choosing a study design for diagnostic accuracy studies in low-prevalence situations should depend on whether the aim is to limit the number of patients undergoing the index test or reference standard, and the risk of bias associated with a particular design type.

KEYWORDS:

Diagnostic accuracy studies; Low prevalence; Primary care

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