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How Much Overtesting Is Needed to Safely Exclude a Diagnosis? A Different Perspective on Triage Testing Using Bayes' Theorem.

ABSTRACT: Ruling out disease often requires expensive or potentially harmful confirmation testing. For such testing, a less invasive triage test is often used. Intuitively, few negative confirmatory tests suggest success of this approach. However, if negative confirmation tests become too rare, too many disease cases could have been missed. It is therefore important to know how many negative tests are needed to safely exclude a diagnosis. We quantified this relationship using Bayes' theorem, and applied this to the example of pulmonary embolism (PE), for which triage is done with a Clinical Decision Rule (CDR) and D-dimer testing, and CT-angiography (CTA) is the confirmation test. For a maximum proportion of missed PEs of 1% in triage-negative patients, we calculate a 67% 'mandatory minimum' proportion of negative CTA scans. To achieve this, the proportion of patients with PE undergoing triage testing should be appropriately low, in this case no higher than 24%. Pre-test probability, triage test characteristics, the proportion of negative confirmation tests, and the number of missed diagnoses are mathematically entangled. The proportion of negative confirmation tests--not too high, but definitely not too low either--could be a quality benchmark for diagnostic processes.

SUBMITTER: Sikkens JJ

PROVIDER: S-EPMC4777363 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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How Much Overtesting Is Needed to Safely Exclude a Diagnosis? A Different Perspective on Triage Testing Using Bayes' Theorem.

Sikkens Jonne J JJ Beekman Djoeke G DG Thijs Abel A Bossuyt Patrick M PM Smulders Yvo M YM

PloS one 20160303 3

Ruling out disease often requires expensive or potentially harmful confirmation testing. For such testing, a less invasive triage test is often used. Intuitively, few negative confirmatory tests suggest success of this approach. However, if negative confirmation tests become too rare, too many disease cases could have been missed. It is therefore important to know how many negative tests are needed to safely exclude a diagnosis. We quantified this relationship using Bayes' theorem, and applied t ...[more]

PMID: 26939066

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Project description:BackgroundWhen a new disease such starts to spread, the commonly asked questions are how deadly is it? and how many people are likely to die of this outbreak? The World Health Organization (WHO) announced in a press conference on January 29, 2020 that the death rate of COVID-19 was 2% on the case fatality rate (CFR). It was underestimated assuming no lag days from symptom onset to deaths while many CFR formulas have been proposed, the estimation on Bays theorem is worthy of interpretation. Hence, it is hypothesized that the over-loaded burdens of treating patients and capacities to contain the outbreak (LSBHRS) may increase the CFR.MethodsWe downloaded COVID-19 outbreak numbers from January 21 to February 14, 2020, in countries/regions on a daily basis from Github that contains information on confirmed cases in >30 Chinese locations and other countries/regions. The pros and cons were compared among the 5 formula of CFR, including [A] deaths/confirmed; [B] deaths/(deaths + recovered); [C] deaths/(cases x days ago); [D] Bayes estimation based on [A] and the outbreak (LSBHRS) in each country/region; and [E] Bayes estimation based on [C] deaths/(cases x days ago). The coefficients of variance (CV = the ratio of the standard deviation to the mean) were applied to measure the relative variability for each CFR. A dashboard was developed for daily display of the CFR across each region.ResultsThe Bayes based on (A)[D] has the lowest CV (=0.10) followed by the deaths/confirmed (=0.11) [A], deaths/(deaths + recoveries) (=0.42) [B], Bayes based on (C) (=0.49) [E], and deaths/(cases x days ago) (=0.59) [C]. All final CFRs will be equal using the formula (from, A to E). A dashboard was developed for the daily reporting of the CFR. The CFR (3.7%) greater than the prior CFR of 2.2% was evident in LSBHRS, increasing the CFR. A dashboard was created to present the CFRs on COVID-19.ConclusionWe suggest examining both trends of the Bayes based on both deaths/(cases 7 days ago) and deaths/confirmed cases as a reference to the final CFR. An app developed for displaying the provisional CFR with the 2 CFR trends can improve the underestimated CFR reported by WHO and media.

Project description:ObjectivesTo identify which level of D-dimer would allow the safe exclusion of pulmonary embolism (PE) in COVID-19 patients presenting to the emergency department (ED).MethodsThis retrospective study was conducted on the COVID database of Assistance Publique - Hôpitaux de Paris (AP-HP). COVID-19 patients who presented at the ED of AP-HP hospitals between March 1 and May 15, 2020, and had CTPA following D-dimer dosage within 48h of presentation were included. The D-dimer sensitivity, specificity, and positive and negative predictive values were calculated for different D-dimer thresholds, as well as the false-negative and failure rates, and the number of CTPAs potentially avoided.ResultsA total of 781 patients (mean age 62.0 years, 53.8% men) with positive RT-PCR for SARS-Cov-2 were included and 60 of them (7.7%) had CTPA-confirmed PE. Their median D-dimer level was significantly higher than that of patients without PE (4,013 vs 1,198 ng·mL-1, p < 0.001). Using 500 ng·mL-1, or an age-adjusted cut-off for patients > 50 years, the sensitivity and the NPV were above 90%. With these thresholds, 17.1% and 31.5% of CTPAs could have been avoided, respectively. Four of the 178 patients who had a D-dimer below the age-adjusted cutoff had PE, leading to an acceptable failure rate of 2.2%. Using higher D-dimer cut-offs could have avoided more CTPAs, but would have lowered the sensitivity and increased the failure rate.ConclusionThe same D-Dimer thresholds as those validated in non-COVID outpatients should be used to safely rule out PE.Key points• The median D-dimer level was significantly higher in COVID-19 patients with PE as compared to those without PE (4,013 ng·mL-1 vs 1,198 ng·mL-1 respectively, p < 0.001). • Using 500 ng·mL-1, or an age-adjusted D-dimer cut-off to exclude pulmonary embolism, the sensitivity and negative predictive value were above 90%. • Higher cut-offs would lead to a reduction in the sensitivity below 85% and an increase in the failure rate, especially for patients under 50 years.

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How Much Overtesting Is Needed to Safely Exclude a Diagnosis? A Different Perspective on Triage Testing Using Bayes' Theorem.

Publications

How Much Overtesting Is Needed to Safely Exclude a Diagnosis? A Different Perspective on Triage Testing Using Bayes' Theorem.

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