Partial verification bias and incorporation bias affected accuracy estimates of diagnostic studies for biomarkers that were part of an existing composite gold standard

Karch, Annika; Koch, Armin; Zapf, Antonia; Zerr, Inga; Karch, André

doi:10.1016/j.jclinepi.2016.03.022

Cited by 18 publications

(10 citation statements)

References 28 publications

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“…This is pertinent to COVID-19 because most early studies incorporate rRT-PCR into the criterion standard. 9,112 Differential verification bias is possible when patients with a positive or concerning index test (e.g., CT findings associated with COVID-19) are more likely to receive an immediate invasive criterion standard such as repeat rRT-PCR testing or bronchoalveolar lavage specimens. 82,97 Differential verification bias raises specificity in diseases that resolve spontaneously or lowers specificity for diseases that only become detectable during follow-up.…”

Section: Potential Diagnostic Biases Skew Observed Accuracymentioning

confidence: 99%

Diagnosing COVID‐19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases

Carpenter

Mudd

West

et al. 2020

Academic Emergency Medicine

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Objective Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) emerged as a global pandemic in early 2020 with rapidly evolving approaches to diagnosing the clinical illness called coronavirus disease (COVID‐19). The primary objective of this scoping review is to synthesize current research of the diagnostic accuracy of history, physical examination, routine laboratory tests, real‐time reverse transcription–polymerase chain reaction (rRT‐PCR), immunology tests, and computed tomography (CT) for the emergency department (ED) diagnosis of COVID‐19. Secondary objectives included a synopsis of diagnostic biases likely with current COVID‐19 research as well as corresponding implications of false‐negative and false‐positive results for clinicians and investigators. Methods A Preferred Reporting Items for Systematic Reviews and Meta‐Analyses–Scoping Review (PRISMA‐ScR)–adherent synthesis of COVID‐19 diagnostic accuracy through May 5, 2020, was conducted. The search strategy was designed by a medical librarian and included studies indexed by PubMed and Embase since January 2020. Results A total of 1,907 citations were screened for relevance. Patients without COVID‐19 are rarely reported, so specificity and likelihood ratios were generally unavailable. Fever is the most common finding, while hyposmia and hypogeusia appear useful to rule in COVID‐19. Cough is not consistently present. Lymphopenia is the mostly commonly reported laboratory abnormality and occurs in over 50% of COVID‐19 patients. rRT‐PCR is currently considered the COVID‐19 criterion standard for most diagnostic studies, but a single test sensitivity ranges from 60% to 78%. Multiple reasons for false‐negatives rRT‐PCR exist, including sample site tested and disease stage during which sample was obtained. CT may increase COVID‐19 sensitivity in conjunction with rRT‐PCR, but guidelines for imaging patients most likely to benefit are emerging. IgM and IgG serology levels are undetectable in the first week of COVID‐19, but sensitivity (range = 82% to 100%) and specificity (range = 87% to 100%) are promising. Whether detectable COVID‐19 antibodies correspond to immunity remains unanswered. Current studies do not adhere to accepted diagnostic accuracy reporting standards and likely report significantly biased results if the same tests were to be applied to general ED populations with suspected COVID‐19. Conclusions With the exception of fever and disorders of smell/taste, history and physical examination findings are unhelpful to distinguish COVID‐19 from other infectious conditions that mimic SARS‐CoV‐2 like influenza. Routine laboratory tests are also nondiagnostic, although lymphopenia is a common finding and other abnormalities may predict severe disease. Although rRT‐PCR is the current criterion standard, more inclusive consensus‐based criteria will likely emerge because of the high false‐negative rate of PCR tests. The role of serology and CT in ED assessments remains undefined.

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Section: Potential Diagnostic Biases Skew Observed Accuracymentioning

confidence: 99%

Diagnosing COVID‐19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases

Carpenter

Mudd

West

et al. 2020

Academic Emergency Medicine

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“…Scenarios where the gold standard is not applied to all participants in the study (i.e. there is a missing gold standard) because it is expensive, or invasive, or patients do not consent to it, or the clinicians decided not to give the gold test to some patients for medical reasons [19, 20]. Evaluating the new test using data only from participants whose disease status was confirmed with the gold standard can produce work-up or verification bias [21].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic test evaluation methodology: A systematic review of methods employed to evaluate diagnostic tests in the absence of gold standard – An update

Chikere¹,

Wilson²,

Graziadio³

et al. 2019

PLoS ONE

144

122

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ObjectiveTo systematically review methods developed and employed to evaluate the diagnostic accuracy of medical test when there is a missing or no gold standard.Study design and settingsArticles that proposed or applied any methods to evaluate the diagnostic accuracy of medical test(s) in the absence of gold standard were reviewed. The protocol for this review was registered in PROSPERO (CRD42018089349).ResultsIdentified methods were classified into four main groups: methods employed when there is a missing gold standard; correction methods (which make adjustment for an imperfect reference standard with known diagnostic accuracy measures); methods employed to evaluate a medical test using multiple imperfect reference standards; and other methods, like agreement studies, and a mixed group of alternative study designs. Fifty-one statistical methods were identified from the review that were developed to evaluate medical test(s) when the true disease status of some participants is unverified with the gold standard. Seven correction methods were identified and four methods were identified to evaluate medical test(s) using multiple imperfect reference standards. Flow-diagrams were developed to guide the selection of appropriate methods.ConclusionVarious methods have been proposed to evaluate medical test(s) in the absence of a gold standard for some or all participants in a diagnostic accuracy study. These methods depend on the availability of the gold standard, its’ application to the participants in the study and the availability of alternative reference standard(s). The clinical application of some of these methods, especially methods developed when there is missing gold standard is however limited. This may be due to the complexity of these methods and/or a disconnection between the fields of expertise of those who develop (e.g. mathematicians) and those who employ the methods (e.g. clinical researchers). This review aims to help close this gap with our classification and guidance tools.

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“…Among them, 14-3-3 and tau proteins, 2 surrogate disease markers considered to reflect the degree of neuronal damage, present increased levels in the CSF of sCJD and are currently used in the diagnostic routine [2,3]. 14-3-3 is part of the diagnostic criteria for sCJD; however, there is a debate about if the diagnostic accuracy of 14-3-3 is lower [4,5], similar to that of the tau protein [6,7], or even higher [8]. Although elevated tau levels can also be detected in other neurological and neurodegenerative conditions [9,10], an optimum cutoff for the diagnosis of sCJD has been defined in the range of 1,200-1,300 pg/mL [6,11,12,13].…”

Section: Introductionmentioning

confidence: 99%

Cerebrospinal Fluid Biomarker-Based Diagnosis of Sporadic Creutzfeldt-Jakob Disease: A Validation Study for Previously Established Cutoffs

Llorens

Karch

Golanska

et al. 2017

Dement Geriatr Cogn Disord

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Background: Several biomarkers have been proposed to discriminate sporadic Creutzfeldt-Jakob disease (sCJD) from other dementias and control cases. However, their clinical accuracy depends on the PRNP codon 129 genotype, leaving it unclear how well established markers behave in untested conditions. Methods: We analyzed 14-3-3, tau, p-tau levels, and the p-tau/tau ratio in a population sample collected from Polish hospitals including nondementia, dementia, and definite sCJD cases and validated their parameters according to previously established cutoffs. Additionally, the correlation between biomarkers and disease duration as well as the influence of the PRNP129 polymorphism are reported. Results: The tau levels and p-tau/tau ratios differed considerably between sCJD and clinically characterized non-CJD cases (p < 0.001). p-tau was only elevated in sCJD when compared to cases without dementia (p < 0.05). Tau and the p-tau/tau ratio showed a sensitivity of 95 and 100%, respectively, in detecting sCJD cases. A negative correlation between tau levels and disease duration, but not the timing of lumbar puncture was observed. Conclusion: The present findings confirmed the value of the p-tau/tau ratio as a robust sCJD biomarker and suggest a role for tau as prognostic marker.

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Partial verification bias and incorporation bias affected accuracy estimates of diagnostic studies for biomarkers that were part of an existing composite gold standard

Cited by 18 publications

References 28 publications

Diagnosing COVID‐19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases

Diagnosing COVID‐19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases

Diagnostic test evaluation methodology: A systematic review of methods employed to evaluate diagnostic tests in the absence of gold standard – An update

Cerebrospinal Fluid Biomarker-Based Diagnosis of Sporadic Creutzfeldt-Jakob Disease: A Validation Study for Previously Established Cutoffs

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