scholarly journals Systematic Reviews of Studies Quantifying the Accuracy of Diagnostic Tests and Markers

2012 ◽  
Vol 58 (11) ◽  
pp. 1534-1545 ◽  
Author(s):  
Johannes B Reitsma ◽  
Karel GM Moons ◽  
Patrick MM Bossuyt ◽  
Kristian Linnet

Abstract Systematic reviews of diagnostic accuracy studies allow calculation of pooled estimates of accuracy with increased precision and examination of differences in accuracy between tests or subgroups of studies. Recently, several advances have been made in the methods used in performing systematic reviews of diagnostic test accuracy studies, most notably in how to assess the methodological quality of primary diagnostic test accuracy studies by use of QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) instrument and how to develop sound statistical models for metaanalysis of the paired measures of test accuracy (bivariate metaregression model of sensitivity and specificity). This article provides an overview of the different steps within a diagnostic systematic review and highlights these advances, illustrated with empirical data. The potential benefits of some recent developments in the areas of network metaanalysis and individual patient data metaanalysis for diagnostic tests are also discussed.

2013 ◽  
Vol 137 (4) ◽  
pp. 566-575 ◽  
Author(s):  
Robert L. Schmidt ◽  
Rachel E. Factor ◽  
Benjamin L. Witt ◽  
Lester J. Layfield

Context.—The quality of diagnostic accuracy studies is determined by 2 key factors: risk of bias and comparability. Bias can distort accuracy estimates and poor reporting impairs comparability. While diagnostic accuracy studies for fine-needle aspiration cytology (FNAC) are frequently published, the methodologic issues associated with this body of literature have never been reviewed. Objective.—To assess the quality of design and reporting of diagnostic test accuracy studies in FNAC. Data Sources.—Diagnostic accuracy studies were identified by a Medline (US National Library of Medicine) search. Sixty-four FNAC diagnostic test accuracy studies were randomly selected for structured review with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) survey. Studies were divided between 2 time periods: 2000-2001 and 2009-2011. Conclusions.—Diagnostic test accuracy studies of FNAC suffer from numerous deficiencies in study design, which negatively affect the reliability of accuracy estimates.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e050296
Author(s):  
Ojiambo Kevin Ouma ◽  
Kisangala Ephraim ◽  
Nakalembe Loyce ◽  
Eve Namisango ◽  
Fred Nalugoda ◽  
...  

IntroductionAccurate and affordable laboratory testing is key to timely diagnosis and appropriate management of patients with COVID-19. New laboratory test protocols are released into the market under emergency use authorisation with limited evidence on diagnostic test accuracy. As such, robust evidence on the diagnostic accuracy and the costs of available tests is urgently needed to inform policy and practice especially in resource-limited settings. We aim to determine the diagnostic test accuracy, cost-effectiveness and utility of laboratory test strategies for COVID-19 in low-income and middle-income countries.Methods and analysisThis will be a multistaged, protocol-driven systematic review conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for diagnostic test accuracy studies. We will search for relevant literature in at least six public health databases, including PubMed, Google Scholar, MEDLINE, Scopus, Web of Science and the WHO Global Index Medicus. In addition, we will search Cochrane Library, COVID-END and grey literature databases to identify additional relevant articles before double-screening and abstraction of data. We will conduct a structured narrative and quantitative synthesis of the results guided by the Fryback and Thornbury framework for assessing a diagnostic test. The primary outcome is COVID-19 diagnostic test accuracy. Using the GRADE approach specific to diagnostic accuracy tests, we will appraise the overall quality of evidence and report the results following the original PRISMA statement. The protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO; https://www.crd.york.ac.uk/prospero/).Ethics and disseminationEthical review was done by the School of Biomedical Sciences Research Ethics Committee and the Uganda National Council for Science and Technology. The published article will be accessible to policy and decision makers. The findings of this review will guide clinical practice and policy decisions and highlight areas for future research.PROSPERO registration number CRD42020209528.


2021 ◽  
Vol 184 (2) ◽  
pp. E5-E9
Author(s):  
Alice J Sitch ◽  
Olaf M Dekkers ◽  
Barnaby R Scholefield ◽  
Yemisi Takwoingi

Diagnostic accuracy studies are fundamental for the assessment of diagnostic tests. Researchers need to understand the implications of their chosen design, opting for comparative designs where possible. Researchers should analyse test accuracy studies using the appropriate methods, acknowledging the uncertainty of results and avoiding overstating conclusions and ignoring the clinical situation which should inform the trade-off between sensitivity and specificity. Test accuracy studies should be reported with transparency using the STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklist.


Diagnosis ◽  
2018 ◽  
Vol 5 (4) ◽  
pp. 205-214 ◽  
Author(s):  
Matthew L. Rubinstein ◽  
Colleen S. Kraft ◽  
J. Scott Parrott

AbstractBackgroundDiagnostic test accuracy (DTA) systematic reviews (SRs) characterize a test’s potential for diagnostic quality and safety. However, interpreting DTA measures in the context of SRs is challenging. Further, some evidence grading methods (e.g. Centers for Disease Control and Prevention, Division of Laboratory Systems Laboratory Medicine Best Practices method) require determination of qualitative effect size ratings as a contributor to practice recommendations. This paper describes a recently developed effect size rating approach for assessing a DTA evidence base.MethodsA likelihood ratio scatter matrix will plot positive and negative likelihood ratio pairings for DTA studies. Pairings are graphed as single point estimates with confidence intervals, positioned in one of four quadrants derived from established thresholds for test clinical validity. These quadrants support defensible judgments on “substantial”, “moderate”, or “minimal” effect size ratings for each plotted study. The approach is flexible in relation to a priori determinations of the relative clinical importance of false positive and false negative test results.Results and conclusionsThis qualitative effect size rating approach was operationalized in a recent SR that assessed effectiveness of test practices for the diagnosis ofClostridium difficile. Relevance of this approach to other methods of grading evidence, and efforts to measure diagnostic quality and safety are described. Limitations of the approach arise from understanding that a diagnostic test is not an isolated element in the diagnostic process, but provides information in clinical context towards diagnostic quality and safety.


Author(s):  
Jared Campbell ◽  
Miloslav Klugar ◽  
Sandrine Ding ◽  
Dennis Carmody ◽  
Sasja Hakonsen ◽  
...  

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.


Author(s):  
Eunhye Jeong ◽  
Jinkyung Park ◽  
Juneyoung Lee

Under-recognition of delirium is an international problem. For the early detection of delirium, a feasible and valid screening tool for healthcare professionals is needed. This study aimed to present a scientific reason for using the 4 ‘A’s Test (4AT) through a systematic review and meta-analysis of studies on the diagnostic test accuracy. We systematically searched articles in the EMBASE, MEDLINE, CINAHL, and PsycINFO databases and selected relevant articles on the basis of the predefined inclusion criteria. The quality of the included articles was evaluated using the Quality Assessment of the Diagnostic Accuracy Studies-2 tool. We estimated the pooled values of diagnostic test accuracy by employing the bivariate model and the hierarchical summary receiver operating characteristic (HSROC) model in data synthesis. A total of 3729 patients of 13 studies were included in the analysis. The pooled estimates of sensitivity and specificity of the 4AT were 81.5% (95% confidence interval: 70.7%, 89.0%) and 87.5% (79.5%, 92.7%), respectively. Given the 4AT’s evidence of accuracy and practicality, we suggest healthcare professionals to utilize this tool for routine screening of delirium. However, for detecting delirium in the dementia population, further work is required to evaluate the 4AT with other cut-off points or scoring methods in order for it to be more sensitive and specific.


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