Latent Class Modeling Approaches for Assessing Diagnostic Error without a Gold Standard: With Applications to p53 Immunohistochemical Assays in Bladder Tumors

Accurate tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been critical in efforts to control its spread. The accuracy of molecular tests for SARS-CoV-2 has been assessed numerous times, usually in reference to a gold standard diagnosis. One major disadvantage of that approach is the possibility of error due to inaccuracy of the gold standard, which is especially problematic for evaluating testing in a real-world surveillance context. We used an alternative approach known as Bayesian latent class modeling (BLCM), which circumvents the need to designate a gold standard by simultaneously estimating the accuracy of multiple tests. We applied this technique to a collection of 1,716 tests of three types applied to 853 individuals on a university campus during a one-week period in October 2020. We found that reverse transcriptase polymerase chain reaction (RT-PCR) testing of saliva samples performed at a campus facility had higher sensitivity (median: 0.923; 95% credible interval: 0.732-0.996) than RT-PCR testing of nasal samples performed at a commercial facility (median: 0.859; 95% CrI: 0.547-0.994). The reverse was true for specificity, although the specificity of saliva testing was still very high (median: 0.993; 95% CrI: 0.983-0.999). An antigen test was less sensitive and specific than both of the RT-PCR tests. These results suggest that RT-PCR testing of saliva samples at a campus facility can be an effective basis for surveillance screening to prevent SARS-CoV-2 transmission in a university setting.

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Estimating Diagnostic Error without a Gold Standard: A Mixed Membership Approach

Handbook of Mixed Membership Models and Their Applications ◽

10.1201/b17520-15 ◽

2014 ◽

pp. 175-192

Keyword(s):

Gold Standard ◽

Diagnostic Error ◽

Without A Gold Standard

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Latent Class Analysis of Noninvasive Methods and Liver Biopsy in Chronic Hepatitis C: An Approach without a Gold Standard

BioMed Research International ◽

10.1155/2017/8252980 ◽

2017 ◽

Vol 2017 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Flavia F. Fernandes ◽

Hugo Perazzo ◽

Luiz E. Andrade ◽

Alessandra Dellavance ◽

Carlos Terra ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis C ◽

Liver Fibrosis ◽

Liver Biopsy ◽

Latent Class Analysis ◽

Chronic Hepatitis C ◽

Gold Standard ◽

Latent Class ◽

Noninvasive Methods ◽

Without A Gold Standard

Aims.To evaluate the applicability of the Latent Class Analysis (LCA) and accuracy of transient elastography (TE), aspartate-to-platelet-ratio-index (APRI), enhanced liver fibrosis (ELF), and liver biopsy (LB) for liver fibrosis assessment in a model without a gold standard.Methods.Significant fibrosis was defined asTE≥7.1 kPa,APRI≥1.5,ELF≥9.37, or LB METAVIRF≥2. Cirrhosis was defined asTE≥12.5 kPa,APRI≥2.0,ELF≥10.31, or LB as METAVIRF=4.Results.117 patients with chronic hepatitis C were included. In the LCA, for significant fibrosis the sensitivities and specificities (95% CI) were 0.92 (0.86–0.98) and 0.79 (0.72–0.86) for TE; 0.47 (0.40–0.54) and 0.99 (0.95–1.00) for APRI; 0.81 (0.74–0.88) and 0.78 (0.71–0.85) for ELF; and 0.86 (0.68–1.00) and 0.91 (0.79–1.00) for LB. For cirrhosis, the sensitivities and specificities were 0.92 (0.76–1.00) and 0.94 (0.91–0.97) for TE; 0.57 (0.37–0.77) and 0.97 (0.93–1.00) for APRI; 0.94 (0.84–1.00) and 0.88 (0.82–0.94) for ELF; and 0.30 (0.12–0.48) and 1.00 for LB.Conclusion.LCA was useful to evaluate accuracy of methods for liver fibrosis staging. Sensitivities and specificities of noninvasive methods were increased in LCA compared to the use of LB as the gold standard.

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Continued controversy in using latent class models for estimating diagnostic accuracy without a gold standard

Statistics in Medicine ◽

10.1002/sim.9085 ◽

2021 ◽

Vol 40 (22) ◽

pp. 4764-4765

Author(s):

Paul S. Albert

Keyword(s):

Diagnostic Accuracy ◽

Gold Standard ◽

Latent Class ◽

Latent Class Models ◽

Class Models ◽

Without A Gold Standard

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Random Effects Modeling Approaches for Estimating ROC Curves from Repeated Ordinal Tests without a Gold Standard

Biometrics ◽

10.1111/j.1541-0420.2006.00712.x ◽

2007 ◽

Vol 63 (2) ◽

pp. 593-602 ◽

Cited By ~ 11

Author(s):

Paul S. Albert

Keyword(s):

Random Effects ◽

Gold Standard ◽

Roc Curves ◽

Modeling Approaches ◽

Random Effects Modeling ◽

Without A Gold Standard

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Comparison of Diagnostic Accuracy of Periprosthetic Tissue Culture in Blood Culture Bottles to That of Prosthesis Sonication Fluid Culture for Diagnosis of Prosthetic Joint Infection (PJI) by Use of Bayesian Latent Class Modeling and IDSA PJI Criteria for Classification

Journal of Clinical Microbiology ◽

10.1128/jcm.00319-18 ◽

2018 ◽

Vol 56 (6) ◽

pp. e00319-18 ◽

Cited By ~ 17

Author(s):

Qun Yan ◽

Melissa J. Karau ◽

Kerryl E. Greenwood-Quaintance ◽

Jayawant N. Mandrekar ◽

Douglas R. Osmon ◽

...

Keyword(s):

Tissue Culture ◽

Blood Culture ◽

Gold Standard ◽

Latent Class ◽

Joint Infection ◽

Periprosthetic Tissue ◽

Prosthetic Joint ◽

Latent Class Modeling ◽

Sonication Culture ◽

Fluid Culture

ABSTRACT We have previously demonstrated that culturing periprosthetic tissue in blood culture bottles (BCBs) improves sensitivity compared to conventional agar and broth culture methods for diagnosis of prosthetic joint infection (PJI). We have also shown that prosthesis sonication culture improves sensitivity compared to periprosthetic tissue culture using conventional agar and broth methods. The purpose of this study was to compare the diagnostic accuracy of tissue culture in BCBs (subsequently referred to as tissue culture) to prosthesis sonication culture (subsequently referred to as sonicate fluid culture). We studied 229 subjects who underwent arthroplasty revision or resection surgery between March 2016 and October 2017 at Mayo Clinic in Rochester, Minnesota. Using the Infectious Diseases Society of America (IDSA) PJI diagnostic criteria (omitting culture criteria) as the gold standard, the sensitivity of tissue culture was similar to that of the sonicate fluid culture (66.4% versus 73.1%, P = 0.07) but was significantly lower than that of the two tests combined (66.4% versus 76.9%, P < 0.001). Using Bayesian latent class modeling, which assumes no gold standard for PJI diagnosis, the sensitivity of tissue culture was slightly lower than that of sonicate fluid culture (86.3% versus 88.7%) and much lower than that of the two tests combined (86.3% versus 99.1%). In conclusion, tissue culture in BCBs reached sensitivity similar to that of prosthesis sonicate fluid culture for diagnosis of PJI, but the two tests combined had the highest sensitivity without compromising specificity. The combination of tissue culture in BCBs and sonicate fluid culture is recommended to achieve the highest level of microbiological diagnosis of PJI.

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Diagnosing REM sleep behavior disorder in Parkinson’s disease without a gold standard: a latent-class model study

SLEEP ◽

10.1093/sleep/zsz323 ◽

2020 ◽

Vol 43 (7) ◽

Author(s):

Michela Figorilli ◽

Ana R Marques ◽

Mario Meloni ◽

Maurizio Zibetti ◽

Bruno Pereira ◽

...

Keyword(s):

Diagnostic Criteria ◽

Rem Sleep ◽

Gold Standard ◽

Latent Class ◽

Rem Sleep Behavior Disorder ◽

Behavior Disorder ◽

Scoring Methods ◽

Sleep Behavior ◽

Screening Questionnaires ◽

Without A Gold Standard

Abstract Study Objectives To ascertain whether current diagnostic criteria for REM sleep behavior disorder (RBD) are appropriate in patients with Parkinson’s disease (PD) consulting a movement disorder center, to evaluate the accuracy of REM sleep without atonia (RSWA) thresholds and determine the value of screening questionnaires to discriminate PD patients with RBD. Methods One hundred twenty-eight consecutive PD patients (M = 80; mean age: 65.6 ± 8.3 years) underwent screening questionnaires, followed by a sleep-focused interview and a full-night video-polysomnography (vPSG). Without a gold standard, latent class models (LCMs) were applied to create an unobserved (“latent”) variable. Sensitivity analysis was performed using RSWA cutoff derived from two visual scoring methods. Finally, we assessed the respective diagnostic performance of each diagnostic criterion for RBD and of the screening questionnaires. Results According to the best LCM-derived model, patients having either “history” or “video” with RSWA or alternatively showing both “history” and “video” without RSWA were classified as having RBD. Using both SINBAR and Montreal scoring methods, RSWA criterion showed the highest sensitivity while concomitant history of RBD and vPSG-documented behaviors, regardless to presence of RSWA, displayed the highest specificity. Currently recommended diagnostic threshold of RSWA was found to be optimal in our large cohort of PD patients. Both the RBD screening questionnaire (RBDSQ) and the RBD single question (RBD1Q) showed poor sensitivity and specificity. Conclusions Results of the best LCM for diagnosis of RBD in PD were consistent with the current diagnostic criteria. Moreover, RBD might be considered in those PD patients with both history and vPSG-documented dream enactment behaviors, but with RSWA values within the normal range.

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