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BACKGROUND: Identifying patients with COVID-19 disease who will deteriorate can be useful to assess whether they should receive intensive care, or whether they can be treated in a less intensive way or through outpatient care. In clinical care, routine laboratory markers, such as C-reactive protein, are used to assess a person's health status. OBJECTIVES: To assess the accuracy of routine blood-based laboratory tests to predict mortality and deterioration to severe or critical (from mild or moderate) COVID-19 in people with SARS-CoV-2. SEARCH METHODS: On 25 August 2022, we searched the Cochrane COVID-19 Study Register, encompassing searches of various databases such as MEDLINE via PubMed, CENTRAL, Embase, medRxiv, and ClinicalTrials.gov. We did not apply any language restrictions. SELECTION CRITERIA: We included studies of all designs that produced estimates of prognostic accuracy in participants who presented to outpatient services, or were admitted to general hospital wards with confirmed SARS-CoV-2 infection, and studies that were based on serum banks of samples from people. All routine blood-based laboratory tests performed during the first encounter were included. We included any reference standard used to define deterioration to severe or critical disease that was provided by the authors. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from each included study, and independently assessed the methodological quality using the Quality Assessment of Prognostic Accuracy Studies tool. As studies reported different thresholds for the same test, we used the Hierarchical Summary Receiver Operator Curve model for meta-analyses to estimate summary curves in SAS 9.4. We estimated the sensitivity at points on the SROC curves that corresponded to the median and interquartile range boundaries of specificities in the included studies. Direct and indirect comparisons were exclusively conducted for biomarkers with an estimated sensitivity and 95% CI of ≥ 50% at a specificity of ≥ 50%. The relative diagnostic odds ratio was calculated as a summary of the relative accuracy of these biomarkers. MAIN RESULTS: We identified a total of 64 studies, including 71,170 participants, of which 8169 participants died, and 4031 participants deteriorated to severe/critical condition. The studies assessed 53 different laboratory tests. For some tests, both increases and decreases relative to the normal range were included. There was important heterogeneity between tests and their cut-off values. None of the included studies had a low risk of bias or low concern for applicability for all domains. None of the tests included in this review demonstrated high sensitivity or specificity, or both. The five tests with summary sensitivity and specificity above 50% were: C-reactive protein increase, neutrophil-to-lymphocyte ratio increase, lymphocyte count decrease, d-dimer increase, and lactate dehydrogenase increase. Inflammation For mortality, summary sensitivity of a C-reactive protein increase was 76% (95% CI 73% to 79%) at median specificity, 59% (low-certainty evidence). For deterioration, summary sensitivity was 78% (95% CI 67% to 86%) at median specificity, 72% (very low-certainty evidence). For the combined outcome of mortality or deterioration, or both, summary sensitivity was 70% (95% CI 49% to 85%) at median specificity, 60% (very low-certainty evidence). For mortality, summary sensitivity of an increase in neutrophil-to-lymphocyte ratio was 69% (95% CI 66% to 72%) at median specificity, 63% (very low-certainty evidence). For deterioration, summary sensitivity was 75% (95% CI 59% to 87%) at median specificity, 71% (very low-certainty evidence). For mortality, summary sensitivity of a decrease in lymphocyte count was 67% (95% CI 56% to 77%) at median specificity, 61% (very low-certainty evidence). For deterioration, summary sensitivity of a decrease in lymphocyte count was 69% (95% CI 60% to 76%) at median specificity, 67% (very low-certainty evidence). For the combined outcome, summary sensitivity was 83% (95% CI 67% to 92%) at median specificity, 29% (very low-certainty evidence). For mortality, summary sensitivity of a lactate dehydrogenase increase was 82% (95% CI 66% to 91%) at median specificity, 60% (very low-certainty evidence). For deterioration, summary sensitivity of a lactate dehydrogenase increase was 79% (95% CI 76% to 82%) at median specificity, 66% (low-certainty evidence). For the combined outcome, summary sensitivity was 69% (95% CI 51% to 82%) at median specificity, 62% (very low-certainty evidence). Hypercoagulability For mortality, summary sensitivity of a d-dimer increase was 70% (95% CI 64% to 76%) at median specificity of 56% (very low-certainty evidence). For deterioration, summary sensitivity was 65% (95% CI 56% to 74%) at median specificity of 63% (very low-certainty evidence). For the combined outcome, summary sensitivity was 65% (95% CI 52% to 76%) at median specificity of 54% (very low-certainty evidence). To predict mortality, neutrophil-to-lymphocyte ratio increase had higher accuracy compared to d-dimer increase (RDOR (diagnostic Odds Ratio) 2.05, 95% CI 1.30 to 3.24), C-reactive protein increase (RDOR 2.64, 95% CI 2.09 to 3.33), and lymphocyte count decrease (RDOR 2.63, 95% CI 1.55 to 4.46). D-dimer increase had higher accuracy compared to lymphocyte count decrease (RDOR 1.49, 95% CI 1.23 to 1.80), C-reactive protein increase (RDOR 1.31, 95% CI 1.03 to 1.65), and lactate dehydrogenase increase (RDOR 1.42, 95% CI 1.05 to 1.90). Additionally, lactate dehydrogenase increase had higher accuracy compared to lymphocyte count decrease (RDOR 1.30, 95% CI 1.13 to 1.49). To predict deterioration to severe disease, C-reactive protein increase had higher accuracy compared to d-dimer increase (RDOR 1.76, 95% CI 1.25 to 2.50). The neutrophil-to-lymphocyte ratio increase had higher accuracy compared to d-dimer increase (RDOR 2.77, 95% CI 1.58 to 4.84). Lastly, lymphocyte count decrease had higher accuracy compared to d-dimer increase (RDOR 2.10, 95% CI 1.44 to 3.07) and lactate dehydrogenase increase (RDOR 2.22, 95% CI 1.52 to 3.26). AUTHORS' CONCLUSIONS: Laboratory tests, associated with hypercoagulability and hyperinflammatory response, were better at predicting severe disease and mortality in patients with SARS-CoV-2 compared to other laboratory tests. However, to safely rule out severe disease, tests should have high sensitivity (> 90%), and none of the identified laboratory tests met this criterion. In clinical practice, a more comprehensive assessment of a patient's health status is usually required by, for example, incorporating these laboratory tests into clinical prediction rules together with clinical symptoms, radiological findings, and patient's characteristics.
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Proteína C-Reativa , COVID-19 , SARS-CoV-2 , Humanos , COVID-19/mortalidade , COVID-19/sangue , COVID-19/diagnóstico , Proteína C-Reativa/análise , Biomarcadores/sangue , Prognóstico , Deterioração Clínica , Viés , Pandemias , Sensibilidade e Especificidade , Índice de Gravidade de Doença , Teste para COVID-19/métodosRESUMO
BACKGROUND: Critical care transesophageal echocardiography (ccTEE) is an increasingly popular tool used by intensivists to characterize and manage hemodynamics at the bedside. Its usage appears to be driven by expanded diagnostic scope as well as the limitations of transthoracic echocardiography (TTE) - lack of acoustic windows, patient positioning, and competing clinical interests (eg, the need to perform chest compressions). The objectives of this scoping review were to determine the indications, clinical impact, and complications of ccTEE. METHODS: MEDLINE, EMBASE, Cochrane, and six major conferences were searched without a time or language restriction on March 31st, 2021. Studies were included if they assessed TEE performed for adult critically ill patients by intensivists, emergency physicians, or anesthesiologists. Intraoperative or post-cardiac surgical TEE studies were excluded. Study demographics, indication for TEE, main results, and complications were extracted in duplicate. RESULTS: Of the 4403 abstracts screened, 289 studies underwent full-text review, with 108 studies (6739 patients) included. Most studies were retrospective (66%), performed in academic centers (84%), in the intensive care unit (73%), and were observational (55%). The most common indications for ccTEE were hemodynamic instability, trauma, cardiac arrest, respiratory failure, and procedural guidance. Across multiple indications, ccTEE was reported to change the diagnosis in 52% to 78% of patients and change management in 32% to79% patients. During cardiac arrest, ccTEE identified the cause of arrest in 25% to 35% of cases. Complications of ccTEE included two cases of significant gastrointestinal bleeding requiring intervention, but no other major complications (death or esophageal perforation) reported. CONCLUSIONS: The use of ccTEE has been described for the diagnosis and management of a broad range of clinical problems. Overall, ccTEE was commonly reported to offer additional diagnostic yield beyond TTE with a low observed complication rate. Additional high quality ccTEE studies will permit stronger conclusions and a more precise understanding of the trends observed in this scoping review.
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Ecocardiografia Transesofagiana , Parada Cardíaca , Adulto , Humanos , Ecocardiografia Transesofagiana/efeitos adversos , Estudos Retrospectivos , Ecocardiografia/métodos , Cuidados Críticos , Parada Cardíaca/etiologia , Parada Cardíaca/terapiaRESUMO
INTRODUCTION: This systematic review evaluates the accuracy of the Montreal Cognitive Assessment (MoCA) for detecting mild cognitive impairment (MCI). METHODS: We searched MEDLINE, PSYCInfo, EMBASE, and Cochrane CENTRAL (1995-2021) for studies comparing the MoCA with validated diagnostic criteria to identify MCI in general practice. Screening, data extraction, and risk of bias assessment were performed independently, in duplicate. Pooled sensitivity and specificity for MoCA cutoffs were estimated using bivariate meta-analysis. RESULTS: Thirteen studies [2158 participants, 948(44%) with MCI] were included; 10 used Petersen criteria as the reference standard. Risk of bias of studies were high or unclear for all domains except reference standard. Sensitivity and specificity were 73.5%(95% confidence interval: 56.7-85.5) and 91.3%(84.6-95.3) at cutoff <23; 79.5%(67.1-88.0) and 83.7%(75.4-89.6) at cutoff <24; and 83.8%(75.6-89.6) and 70.8(62.1-78.3) at cutoff <25. DISCUSSION: MoCA cutoffs <23 to <25 maximized the sum of sensitivity and specificity for detecting MCI. The risk of bias of included studies limits confidence in these findings.
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Disfunção Cognitiva , Humanos , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/psicologia , Testes de Estado Mental e Demência , Sensibilidade e Especificidade , Exame Neurológico , Testes NeuropsicológicosRESUMO
Objectives: To investigate intra-specialty citation patterns of radiology articles, compared with another medical specialty: gastroenterology/hepatology. Methods: Four radiology journals (Radiology, European Radiology, Diagnostic and Interventional Imaging, Canadian Association of Radiologists Journal) and four gastroenterology/hepatology journals (Journal of Hepatology, Journal of Gastroenterology, World Journal of Gastroenterology, Journal of Clinical Gastroenterology) with similar Web of Science in-category 2020 IF ranking were selected. The original research, review, letter, and editorial articles published in these journals in 2021 were identified. The average number of intra-specialty citations per article (intra-specialty citation count) and percentage of intra-specialty citations out of total citations per article (intra-specialty citation rate) were compared between radiology and gastroenterology/hepatology articles using Student's t-test. Results: The radiology articles demonstrated a lower total citation count per article (radiology: 29.7 ± .4 (mean ± SEM), n = 2063; gastroenterology/hepatology: 50.1 ± 1.4, n = 1335). The intra-specialty citation count was also lower in radiology articles than gastroenterology/hepatology articles (radiology: 12.9 ± .2, gastroenterology/hepatology: 19.6 ± .7; P < .001), both overall and in all article types. Additionally, the overall intra-specialty citation rate was not significantly different between the two specialties (radiology: 48.8% ± .5%; gastroenterology/hepatology: 47.1 ± .8%; P = .057), although the intra-specialty citation rates were higher in radiology original research and editorial article types. Conclusions: The significantly lower per-article intra-specialty citation counts in all radiology article types, a measurement that directly links to specialty IFs, may contribute to the lower impact factors of radiology journals compared with gastroenterology/hepatology ones.
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Gastroenterologia , Publicações Periódicas como Assunto , Radiologia , Humanos , Canadá , RadiografiaRESUMO
PURPOSE: The aim of the study was to compare diagnostic accuracy of dual-energy computed tomography (DECT) and magnetic resonance imaging (MRI) to detect enhancement in renal masses. METHODS: Adults renal masses of 10 mm or greater with both fast kilovoltage potential switching DECT and contrast-enhanced MRI performed within 12 months were retrospectively included. Two blinded radiologists independently evaluated for enhancement subjectively (5-point Likert scales) and quantitatively (signal intensity ratio ≥15% for MRI, iodine concentration ≥1.2 or ≥2.0 mg/mL for DECT). Per-lesion diagnostic accuracy, with histologic reference standard for solid masses, was expressed as the area under the receiver operator curve (AUC) for each index test. Differences were evaluated for statistical significance using the DeLong test. RESULTS: We included 24 patients with 41 masses: 17 solid renal masses and 24 Bosniak 1 or 2 cysts. There was no significant difference in diagnostic accuracy comparing subjective enhancement by MRI and using iodine overlay DECT for reader 1 (AUC 0.99 vs 0.99, P = 0.38) or reader 2 (AUC 1.00 vs 0.94, P = 0.12) Interobserver agreement was κ = 0.61 for DECT and κ = 0.71 for MRI. There was no significant difference either in accuracy between quantitative assessment using signal intensity ratio or iodine concentration for reader 1 (AUC 0.94 vs 0.94, P = 0.88) or reader 2 (AUC 0.97 vs 0.92, P = 0.16). False-negative results in both subjective and quantitative assessment were nearly exclusively seen in papillary renal cell carcinoma, occurring with both DECT and MRI. CONCLUSIONS: We detected no significant differences in accuracy for detecting enhancement in renal masses comparing MRI and DECT. Our results require further investigation in larger sample sizes, but suggest that DECT may be comparable to MRI for detection of enhancement in renal masses.
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Iodo , Imagem Radiográfica a Partir de Emissão de Duplo Fóton , Humanos , Adulto , Meios de Contraste , Tomografia Computadorizada por Raios X/métodos , Estudos Retrospectivos , Sensibilidade e Especificidade , Imageamento por Ressonância Magnética/métodos , Imagem Radiográfica a Partir de Emissão de Duplo Fóton/métodosRESUMO
BACKGROUND: Accurate rapid diagnostic tests for SARS-CoV-2 infection would be a useful tool to help manage the COVID-19 pandemic. Testing strategies that use rapid antigen tests to detect current infection have the potential to increase access to testing, speed detection of infection, and inform clinical and public health management decisions to reduce transmission. This is the second update of this review, which was first published in 2020. OBJECTIVES: To assess the diagnostic accuracy of rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. We consider accuracy separately in symptomatic and asymptomatic population groups. Sources of heterogeneity investigated included setting and indication for testing, assay format, sample site, viral load, age, timing of test, and study design. SEARCH METHODS: We searched the COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) on 08 March 2021. We included independent evaluations from national reference laboratories, FIND and the Diagnostics Global Health website. We did not apply language restrictions. SELECTION CRITERIA: We included studies of people with either suspected SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included test accuracy studies of any design that evaluated commercially produced, rapid antigen tests. We included evaluations of single applications of a test (one test result reported per person) and evaluations of serial testing (repeated antigen testing over time). Reference standards for presence or absence of infection were any laboratory-based molecular test (primarily reverse transcription polymerase chain reaction (RT-PCR)) or pre-pandemic respiratory sample. DATA COLLECTION AND ANALYSIS: We used standard screening procedures with three people. Two people independently carried out quality assessment (using the QUADAS-2 tool) and extracted study results. Other study characteristics were extracted by one review author and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test, and pooled data using the bivariate model. We investigated heterogeneity by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and compliance with manufacturer instructions for use and according to symptom status. MAIN RESULTS: We included 155 study cohorts (described in 166 study reports, with 24 as preprints). The main results relate to 152 evaluations of single test applications including 100,462 unique samples (16,822 with confirmed SARS-CoV-2). Studies were mainly conducted in Europe (101/152, 66%), and evaluated 49 different commercial antigen assays. Only 23 studies compared two or more brands of test. Risk of bias was high because of participant selection (40, 26%); interpretation of the index test (6, 4%); weaknesses in the reference standard for absence of infection (119, 78%); and participant flow and timing 41 (27%). Characteristics of participants (45, 30%) and index test delivery (47, 31%) differed from the way in which and in whom the test was intended to be used. Nearly all studies (91%) used a single RT-PCR result to define presence or absence of infection. The 152 studies of single test applications reported 228 evaluations of antigen tests. Estimates of sensitivity varied considerably between studies, with consistently high specificities. Average sensitivity was higher in symptomatic (73.0%, 95% CI 69.3% to 76.4%; 109 evaluations; 50,574 samples, 11,662 cases) compared to asymptomatic participants (54.7%, 95% CI 47.7% to 61.6%; 50 evaluations; 40,956 samples, 2641 cases). Average sensitivity was higher in the first week after symptom onset (80.9%, 95% CI 76.9% to 84.4%; 30 evaluations, 2408 cases) than in the second week of symptoms (53.8%, 95% CI 48.0% to 59.6%; 40 evaluations, 1119 cases). For those who were asymptomatic at the time of testing, sensitivity was higher when an epidemiological exposure to SARS-CoV-2 was suspected (64.3%, 95% CI 54.6% to 73.0%; 16 evaluations; 7677 samples, 703 cases) compared to where COVID-19 testing was reported to be widely available to anyone on presentation for testing (49.6%, 95% CI 42.1% to 57.1%; 26 evaluations; 31,904 samples, 1758 cases). Average specificity was similarly high for symptomatic (99.1%) or asymptomatic (99.7%) participants. We observed a steady decline in summary sensitivities as measures of sample viral load decreased. Sensitivity varied between brands. When tests were used according to manufacturer instructions, average sensitivities by brand ranged from 34.3% to 91.3% in symptomatic participants (20 assays with eligible data) and from 28.6% to 77.8% for asymptomatic participants (12 assays). For symptomatic participants, summary sensitivities for seven assays were 80% or more (meeting acceptable criteria set by the World Health Organization (WHO)). The WHO acceptable performance criterion of 97% specificity was met by 17 of 20 assays when tests were used according to manufacturer instructions, 12 of which demonstrated specificities above 99%. For asymptomatic participants the sensitivities of only two assays approached but did not meet WHO acceptable performance standards in one study each; specificities for asymptomatic participants were in a similar range to those observed for symptomatic people. At 5% prevalence using summary data in symptomatic people during the first week after symptom onset, the positive predictive value (PPV) of 89% means that 1 in 10 positive results will be a false positive, and around 1 in 5 cases will be missed. At 0.5% prevalence using summary data for asymptomatic people, where testing was widely available and where epidemiological exposure to COVID-19 was suspected, resulting PPVs would be 38% to 52%, meaning that between 2 in 5 and 1 in 2 positive results will be false positives, and between 1 in 2 and 1 in 3 cases will be missed. AUTHORS' CONCLUSIONS: Antigen tests vary in sensitivity. In people with signs and symptoms of COVID-19, sensitivities are highest in the first week of illness when viral loads are higher. Assays that meet appropriate performance standards, such as those set by WHO, could replace laboratory-based RT-PCR when immediate decisions about patient care must be made, or where RT-PCR cannot be delivered in a timely manner. However, they are more suitable for use as triage to RT-PCR testing. The variable sensitivity of antigen tests means that people who test negative may still be infected. Many commercially available rapid antigen tests have not been evaluated in independent validation studies. Evidence for testing in asymptomatic cohorts has increased, however sensitivity is lower and there is a paucity of evidence for testing in different settings. Questions remain about the use of antigen test-based repeat testing strategies. Further research is needed to evaluate the effectiveness of screening programmes at reducing transmission of infection, whether mass screening or targeted approaches including schools, healthcare setting and traveller screening.
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COVID-19 , COVID-19/diagnóstico , Teste para COVID-19 , Humanos , Pandemias , Sistemas Automatizados de Assistência Junto ao Leito , SARS-CoV-2 , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: The diagnostic challenges associated with the COVID-19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS-CoV-2 infection. Serology tests to detect the presence of antibodies to SARS-CoV-2 enable detection of past infection and may detect cases of SARS-CoV-2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS-CoV-2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS-CoV-2 epidemiology. OBJECTIVES: To assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS-CoV-2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS-CoV-2. Sources of heterogeneity investigated included: timing of test, test method, SARS-CoV-2 antigen used, test brand, and reference standard for non-SARS-CoV-2 cases. SEARCH METHODS: The COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) 'COVID-19: Living map of the evidence' and the Norwegian Institute of Public Health 'NIPH systematic and living map on COVID-19 evidence'. We did not apply language restrictions. SELECTION CRITERIA: We included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT-PCR test. Small studies with fewer than 25 SARS-CoV-2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction tests (RT-PCR), clinical diagnostic criteria, and pre-pandemic samples). DATA COLLECTION AND ANALYSIS: We use standard screening procedures with three reviewers. Quality assessment (using the QUADAS-2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta-analysis, we fitted univariate random-effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and summarised results for tests that were evaluated in 200 or more samples and that met a modification of UK Medicines and Healthcare products Regulatory Agency (MHRA) target performance criteria. MAIN RESULTS: We included 178 separate studies (described in 177 study reports, with 45 as pre-prints) providing 527 test evaluations. The studies included 64,688 samples including 25,724 from people with confirmed SARS-CoV-2; most compared the accuracy of two or more assays (102/178, 57%). Participants with confirmed SARS-CoV-2 infection were most commonly hospital inpatients (78/178, 44%), and pre-pandemic samples were used by 45% (81/178) to estimate specificity. Over two-thirds of studies recruited participants based on known SARS-CoV-2 infection status (123/178, 69%). All studies were conducted prior to the introduction of SARS-CoV-2 vaccines and present data for naturally acquired antibody responses. Seventy-nine percent (141/178) of studies reported sensitivity by week after symptom onset and 66% (117/178) for convalescent phase infection. Studies evaluated enzyme-linked immunosorbent assays (ELISA) (165/527; 31%), chemiluminescent assays (CLIA) (167/527; 32%) or lateral flow assays (LFA) (188/527; 36%). Risk of bias was high because of participant selection (172, 97%); application and interpretation of the index test (35, 20%); weaknesses in the reference standard (38, 21%); and issues related to participant flow and timing (148, 82%). We judged that there were high concerns about the applicability of the evidence related to participants in 170 (96%) studies, and about the applicability of the reference standard in 162 (91%) studies. Average sensitivities for current SARS-CoV-2 infection increased by week after onset for all target antibodies. Average sensitivity for the combination of either IgG or IgM was 41.1% in week one (95% CI 38.1 to 44.2; 103 evaluations; 3881 samples, 1593 cases), 74.9% in week two (95% CI 72.4 to 77.3; 96 evaluations, 3948 samples, 2904 cases) and 88.0% by week three after onset of symptoms (95% CI 86.3 to 89.5; 103 evaluations, 2929 samples, 2571 cases). Average sensitivity during the convalescent phase of infection (up to a maximum of 100 days since onset of symptoms, where reported) was 89.8% for IgG (95% CI 88.5 to 90.9; 253 evaluations, 16,846 samples, 14,183 cases), 92.9% for IgG or IgM combined (95% CI 91.0 to 94.4; 108 evaluations, 3571 samples, 3206 cases) and 94.3% for total antibodies (95% CI 92.8 to 95.5; 58 evaluations, 7063 samples, 6652 cases). Average sensitivities for IgM alone followed a similar pattern but were of a lower test accuracy in every time slot. Average specificities were consistently high and precise, particularly for pre-pandemic samples which provide the least biased estimates of specificity (ranging from 98.6% for IgM to 99.8% for total antibodies). Subgroup analyses suggested small differences in sensitivity and specificity by test technology however heterogeneity in study results, timing of sample collection, and smaller sample numbers in some groups made comparisons difficult. For IgG, CLIAs were the most sensitive (convalescent-phase infection) and specific (pre-pandemic samples) compared to both ELISAs and LFAs (P < 0.001 for differences across test methods). The antigen(s) used (whether from the Spike-protein or nucleocapsid) appeared to have some effect on average sensitivity in the first weeks after onset but there was no clear evidence of an effect during convalescent-phase infection. Investigations of test performance by brand showed considerable variation in sensitivity between tests, and in results between studies evaluating the same test. For tests that were evaluated in 200 or more samples, the lower bound of the 95% CI for sensitivity was 90% or more for only a small number of tests (IgG, n = 5; IgG or IgM, n = 1; total antibodies, n = 4). More test brands met the MHRA minimum criteria for specificity of 98% or above (IgG, n = 16; IgG or IgM, n = 5; total antibodies, n = 7). Seven assays met the specified criteria for both sensitivity and specificity. In a low-prevalence (2%) setting, where antibody testing is used to diagnose COVID-19 in people with symptoms but who have had a negative PCR test, we would anticipate that 1 (1 to 2) case would be missed and 8 (5 to 15) would be falsely positive in 1000 people undergoing IgG or IgM testing in week three after onset of SARS-CoV-2 infection. In a seroprevalence survey, where prevalence of prior infection is 50%, we would anticipate that 51 (46 to 58) cases would be missed and 6 (5 to 7) would be falsely positive in 1000 people having IgG tests during the convalescent phase (21 to 100 days post-symptom onset or post-positive PCR) of SARS-CoV-2 infection. AUTHORS' CONCLUSIONS: Some antibody tests could be a useful diagnostic tool for those in whom molecular- or antigen-based tests have failed to detect the SARS-CoV-2 virus, including in those with ongoing symptoms of acute infection (from week three onwards) or those presenting with post-acute sequelae of COVID-19. However, antibody tests have an increasing likelihood of detecting an immune response to infection as time since onset of infection progresses and have demonstrated adequate performance for detection of prior infection for sero-epidemiological purposes. The applicability of results for detection of vaccination-induced antibodies is uncertain.
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COVID-19 , SARS-CoV-2 , Humanos , COVID-19/diagnóstico , COVID-19/epidemiologia , Anticorpos Antivirais , Imunoglobulina G , Vacinas contra COVID-19 , Pandemias , Estudos Soroepidemiológicos , Imunoglobulina MRESUMO
BACKGROUND: Our March 2021 edition of this review showed thoracic imaging computed tomography (CT) to be sensitive and moderately specific in diagnosing COVID-19 pneumonia. This new edition is an update of the review. OBJECTIVES: Our objectives were to evaluate the diagnostic accuracy of thoracic imaging in people with suspected COVID-19; assess the rate of positive imaging in people who had an initial reverse transcriptase polymerase chain reaction (RT-PCR) negative result and a positive RT-PCR result on follow-up; and evaluate the accuracy of thoracic imaging for screening COVID-19 in asymptomatic individuals. The secondary objective was to assess threshold effects of index test positivity on accuracy. SEARCH METHODS: We searched the COVID-19 Living Evidence Database from the University of Bern, the Cochrane COVID-19 Study Register, The Stephen B. Thacker CDC Library, and repositories of COVID-19 publications through to 17 February 2021. We did not apply any language restrictions. SELECTION CRITERIA: We included diagnostic accuracy studies of all designs, except for case-control, that recruited participants of any age group suspected to have COVID-19. Studies had to assess chest CT, chest X-ray, or ultrasound of the lungs for the diagnosis of COVID-19, use a reference standard that included RT-PCR, and report estimates of test accuracy or provide data from which we could compute estimates. We excluded studies that used imaging as part of the reference standard and studies that excluded participants with normal index test results. DATA COLLECTION AND ANALYSIS: The review authors independently and in duplicate screened articles, extracted data and assessed risk of bias and applicability concerns using QUADAS-2. We presented sensitivity and specificity per study on paired forest plots, and summarized pooled estimates in tables. We used a bivariate meta-analysis model where appropriate. MAIN RESULTS: We included 98 studies in this review. Of these, 94 were included for evaluating the diagnostic accuracy of thoracic imaging in the evaluation of people with suspected COVID-19. Eight studies were included for assessing the rate of positive imaging in individuals with initial RT-PCR negative results and positive RT-PCR results on follow-up, and 10 studies were included for evaluating the accuracy of thoracic imaging for imagining asymptomatic individuals. For all 98 included studies, risk of bias was high or unclear in 52 (53%) studies with respect to participant selection, in 64 (65%) studies with respect to reference standard, in 46 (47%) studies with respect to index test, and in 48 (49%) studies with respect to flow and timing. Concerns about the applicability of the evidence to: participants were high or unclear in eight (8%) studies; index test were high or unclear in seven (7%) studies; and reference standard were high or unclear in seven (7%) studies. Imaging in people with suspected COVID-19 We included 94 studies. Eighty-seven studies evaluated one imaging modality, and seven studies evaluated two imaging modalities. All studies used RT-PCR alone or in combination with other criteria (for example, clinical signs and symptoms, positive contacts) as the reference standard for the diagnosis of COVID-19. For chest CT (69 studies, 28285 participants, 14,342 (51%) cases), sensitivities ranged from 45% to 100%, and specificities from 10% to 99%. The pooled sensitivity of chest CT was 86.9% (95% confidence interval (CI) 83.6 to 89.6), and pooled specificity was 78.3% (95% CI 73.7 to 82.3). Definition for index test positivity was a source of heterogeneity for sensitivity, but not specificity. Reference standard was not a source of heterogeneity. For chest X-ray (17 studies, 8529 participants, 5303 (62%) cases), the sensitivity ranged from 44% to 94% and specificity from 24 to 93%. The pooled sensitivity of chest X-ray was 73.1% (95% CI 64. to -80.5), and pooled specificity was 73.3% (95% CI 61.9 to 82.2). Definition for index test positivity was not found to be a source of heterogeneity. Definition for index test positivity and reference standard were not found to be sources of heterogeneity. For ultrasound of the lungs (15 studies, 2410 participants, 1158 (48%) cases), the sensitivity ranged from 73% to 94% and the specificity ranged from 21% to 98%. The pooled sensitivity of ultrasound was 88.9% (95% CI 84.9 to 92.0), and the pooled specificity was 72.2% (95% CI 58.8 to 82.5). Definition for index test positivity and reference standard were not found to be sources of heterogeneity. Indirect comparisons of modalities evaluated across all 94 studies indicated that chest CT and ultrasound gave higher sensitivity estimates than X-ray (P = 0.0003 and P = 0.001, respectively). Chest CT and ultrasound gave similar sensitivities (P=0.42). All modalities had similar specificities (CT versus X-ray P = 0.36; CT versus ultrasound P = 0.32; X-ray versus ultrasound P = 0.89). Imaging in PCR-negative people who subsequently became positive For rate of positive imaging in individuals with initial RT-PCR negative results, we included 8 studies (7 CT, 1 ultrasound) with a total of 198 participants suspected of having COVID-19, all of whom had a final diagnosis of COVID-19. Most studies (7/8) evaluated CT. Of 177 participants with initially negative RT-PCR who had positive RT-PCR results on follow-up testing, 75.8% (95% CI 45.3 to 92.2) had positive CT findings. Imaging in asymptomatic PCR-positive people For imaging asymptomatic individuals, we included 10 studies (7 CT, 1 X-ray, 2 ultrasound) with a total of 3548 asymptomatic participants, of whom 364 (10%) had a final diagnosis of COVID-19. For chest CT (7 studies, 3134 participants, 315 (10%) cases), the pooled sensitivity was 55.7% (95% CI 35.4 to 74.3) and the pooled specificity was 91.1% (95% CI 82.6 to 95.7). AUTHORS' CONCLUSIONS: Chest CT and ultrasound of the lungs are sensitive and moderately specific in diagnosing COVID-19. Chest X-ray is moderately sensitive and moderately specific in diagnosing COVID-19. Thus, chest CT and ultrasound may have more utility for ruling out COVID-19 than for differentiating SARS-CoV-2 infection from other causes of respiratory illness. The uncertainty resulting from high or unclear risk of bias and the heterogeneity of included studies limit our ability to confidently draw conclusions based on our results.
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COVID-19 , COVID-19/diagnóstico por imagem , Humanos , SARS-CoV-2 , Sensibilidade e Especificidade , Tomografia Computadorizada por Raios X , UltrassonografiaRESUMO
BACKGROUND: The detection of liver metastases is important for pancreatic cancer curative treatment eligibility. The data suggest that magnetic resonance imaging (MRI) is more sensitive than computed tomography (CT) for the diagnosis of pancreatic cancer liver metastases. However, MRI is not currently recommended in multiple published guidelines. PURPOSE: To perform a comparative diagnostic test accuracy systematic review and meta-analysis comparing CT and MRI for pancreatic cancer liver metastases detection. STUDY TYPE: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and multiple radiology society meeting archives were searched until November 2018. Comparative design studies reporting on liver CT and MRI accuracy for detection of pancreatic cancer liver metastases in the same cohort were included. FIELD STRENGTH: 1.5T or 3.0T. ASSESSMENT: Demographic, methodologic, and diagnostic test accuracy data were extracted. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool. STATISTICAL TESTS: Accuracy metrics were obtained using bivariate random-effects meta-analysis. The impact of different covariates on accuracy estimates was assessed using a meta-regression model. Covariates included modality, study design, tumor characteristics, risk of bias, and imaging protocols. RESULTS: Fourteen studies including 987 patients with pancreatic cancer (205 with liver metastases) were included. Sensitivity for CT and MRI was 45% (confidence intervals [95% CI] 21-71%) and 83% (95% CI 74-88%), respectively. Specificity for CT and MRI was 94% (95% CI 84-98%) and 96% (95% CI 93-97%), respectively. The greater observed sensitivity of MRI was preserved in the meta-regression model (P = 0.01), while no difference in specificity was detected (P = 0.16). CT sensitivity was highest for triphasic and quadriphasic examinations compared to single phase or biphasic protocols (P = 0.03). Most studies were at high risk of bias. DATA CONCLUSION: MRI is more sensitive than CT for pancreatic cancer liver metastases detection, accounting for confounding variables. Consideration of this finding in clinical practice guidelines is recommended. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 3.
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Neoplasias Hepáticas , Neoplasias Pancreáticas , Testes Diagnósticos de Rotina , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Imageamento por Ressonância Magnética , Neoplasias Pancreáticas/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Neoplasias PancreáticasRESUMO
BACKGROUND: The edited magnetic resonance spectroscopy (MRS) technique has not yet been formally evaluated for the in vivo detection of 2-hydroxyglutarate (2-HG) in patients with gliomas of various grades. PURPOSE: To evaluate the diagnostic accuracy of edited MRS in the preoperative identification of the isocitrate dehydrogenase (IDH) mutation status in patients with gliomas. STUDY TYPE: Prospective. POPULATION: Fifty-eight subjects (31 glioblastomas, 27 grade II and III gliomas). FIELD STRENGTH/SEQUENCE: Mescher-Garwood (MEGA)-PRESS and routine clinical brain tumor MR sequences were used at 3T. ASSESSMENT: Data were analyzed using an advanced method for accurate, robust, and efficient spectral fitting (AMARES) from jMRUI software. The amplitudes of the 2-HG, N-acetyl-aspartate (NAA), choline (Cho), and creatine/phosphocreatine (Cr) resonances were calculated with their associated Cramer-Rao lower bound (CRLB). The IDH1 R132H mutation status was assessed by immunohistochemistry for all patients. Patients with grades II and III gliomas with negative immunohistochemistry underwent DNA sequencing to further interrogate IDH mutation status. STATISTICAL TEST: The differences in 2-HG amplitudes, 2-HG/NAA, 2-HG/Cho, and 2-HG/Cr between IDH-mutant and IDH-wildtype gliomas were assessed using Mann-Whitney U-tests. Receiver operating characteristic curve analysis was performed to evaluate the diagnostic accuracy of each parameter. RESULTS: The 2-HG amplitudes, 2-HG/NAA, and 2-HG/Cho were higher for IDH-mutant gliomas than IDH-wildtype gliomas (P < 0.007). Using a CRLB threshold <30%, a 2-HG cutoff greater than 0 had a sensitivity of 80% (95% confidence interval [CI]: 52-96%) and a specificity of 81% (95% CI: 54-96%) in identifying IDH-mutant gliomas. In the subset of patients with grades II and III gliomas, the sensitivity was 80% (95% CI: 52-96%) and specificity was 100% (95% CI: 40-100%). Among 2-HG ratios, the highest AUC for the identification of IDH mutant status was achieved using the 2-HG/NAA (AUC = 0.8, 95% CI 0.67-.89). DATA CONCLUSION: Preoperative edited MRS appears to be able to help identify IDH-mutant gliomas with high specificity. Level of Evidence 1 Technical Efficacy Stage 2 J. MAGN. RESON. IMAGING 2021;53:416-426.
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Neoplasias Encefálicas , Glioma , Neoplasias Encefálicas/diagnóstico por imagem , Neoplasias Encefálicas/genética , Glioma/diagnóstico por imagem , Glioma/genética , Humanos , Isocitrato Desidrogenase/genética , Mutação , Estudos ProspectivosRESUMO
BACKGROUND: Accurate rapid diagnostic tests for SARS-CoV-2 infection could contribute to clinical and public health strategies to manage the COVID-19 pandemic. Point-of-care antigen and molecular tests to detect current infection could increase access to testing and early confirmation of cases, and expediate clinical and public health management decisions that may reduce transmission. OBJECTIVES: To assess the diagnostic accuracy of point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. We consider accuracy separately in symptomatic and asymptomatic population groups. SEARCH METHODS: Electronic searches of the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) were undertaken on 30 Sept 2020. We checked repositories of COVID-19 publications and included independent evaluations from national reference laboratories, the Foundation for Innovative New Diagnostics and the Diagnostics Global Health website to 16 Nov 2020. We did not apply language restrictions. SELECTION CRITERIA: We included studies of people with either suspected SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included test accuracy studies of any design that evaluated commercially produced, rapid antigen or molecular tests suitable for a point-of-care setting (minimal equipment, sample preparation, and biosafety requirements, with results within two hours of sample collection). We included all reference standards that define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction (RT-PCR) tests and established diagnostic criteria). DATA COLLECTION AND ANALYSIS: Studies were screened independently in duplicate with disagreements resolved by discussion with a third author. Study characteristics were extracted by one author and checked by a second; extraction of study results and assessments of risk of bias and applicability (made using the QUADAS-2 tool) were undertaken independently in duplicate. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and pooled data using the bivariate model separately for antigen and molecular-based tests. We tabulated results by test manufacturer and compliance with manufacturer instructions for use and according to symptom status. MAIN RESULTS: Seventy-eight study cohorts were included (described in 64 study reports, including 20 pre-prints), reporting results for 24,087 samples (7,415 with confirmed SARS-CoV-2). Studies were mainly from Europe (n = 39) or North America (n = 20), and evaluated 16 antigen and five molecular assays. We considered risk of bias to be high in 29 (50%) studies because of participant selection; in 66 (85%) because of weaknesses in the reference standard for absence of infection; and in 29 (45%) for participant flow and timing. Studies of antigen tests were of a higher methodological quality compared to studies of molecular tests, particularly regarding the risk of bias for participant selection and the index test. Characteristics of participants in 35 (45%) studies differed from those in whom the test was intended to be used and the delivery of the index test in 39 (50%) studies differed from the way in which the test was intended to be used. Nearly all studies (97%) defined the presence or absence of SARS-CoV-2 based on a single RT-PCR result, and none included participants meeting case definitions for probable COVID-19. Antigen tests Forty-eight studies reported 58 evaluations of antigen tests. Estimates of sensitivity varied considerably between studies. There were differences between symptomatic (72.0%, 95% CI 63.7% to 79.0%; 37 evaluations; 15530 samples, 4410 cases) and asymptomatic participants (58.1%, 95% CI 40.2% to 74.1%; 12 evaluations; 1581 samples, 295 cases). Average sensitivity was higher in the first week after symptom onset (78.3%, 95% CI 71.1% to 84.1%; 26 evaluations; 5769 samples, 2320 cases) than in the second week of symptoms (51.0%, 95% CI 40.8% to 61.0%; 22 evaluations; 935 samples, 692 cases). Sensitivity was high in those with cycle threshold (Ct) values on PCR ≤25 (94.5%, 95% CI 91.0% to 96.7%; 36 evaluations; 2613 cases) compared to those with Ct values >25 (40.7%, 95% CI 31.8% to 50.3%; 36 evaluations; 2632 cases). Sensitivity varied between brands. Using data from instructions for use (IFU) compliant evaluations in symptomatic participants, summary sensitivities ranged from 34.1% (95% CI 29.7% to 38.8%; Coris Bioconcept) to 88.1% (95% CI 84.2% to 91.1%; SD Biosensor STANDARD Q). Average specificities were high in symptomatic and asymptomatic participants, and for most brands (overall summary specificity 99.6%, 95% CI 99.0% to 99.8%). At 5% prevalence using data for the most sensitive assays in symptomatic people (SD Biosensor STANDARD Q and Abbott Panbio), positive predictive values (PPVs) of 84% to 90% mean that between 1 in 10 and 1 in 6 positive results will be a false positive, and between 1 in 4 and 1 in 8 cases will be missed. At 0.5% prevalence applying the same tests in asymptomatic people would result in PPVs of 11% to 28% meaning that between 7 in 10 and 9 in 10 positive results will be false positives, and between 1 in 2 and 1 in 3 cases will be missed. No studies assessed the accuracy of repeated lateral flow testing or self-testing. Rapid molecular assays Thirty studies reported 33 evaluations of five different rapid molecular tests. Sensitivities varied according to test brand. Most of the data relate to the ID NOW and Xpert Xpress assays. Using data from evaluations following the manufacturer's instructions for use, the average sensitivity of ID NOW was 73.0% (95% CI 66.8% to 78.4%) and average specificity 99.7% (95% CI 98.7% to 99.9%; 4 evaluations; 812 samples, 222 cases). For Xpert Xpress, the average sensitivity was 100% (95% CI 88.1% to 100%) and average specificity 97.2% (95% CI 89.4% to 99.3%; 2 evaluations; 100 samples, 29 cases). Insufficient data were available to investigate the effect of symptom status or time after symptom onset. AUTHORS' CONCLUSIONS: Antigen tests vary in sensitivity. In people with signs and symptoms of COVID-19, sensitivities are highest in the first week of illness when viral loads are higher. The assays shown to meet appropriate criteria, such as WHO's priority target product profiles for COVID-19 diagnostics ('acceptable' sensitivity ≥ 80% and specificity ≥ 97%), can be considered as a replacement for laboratory-based RT-PCR when immediate decisions about patient care must be made, or where RT-PCR cannot be delivered in a timely manner. Positive predictive values suggest that confirmatory testing of those with positive results may be considered in low prevalence settings. Due to the variable sensitivity of antigen tests, people who test negative may still be infected. Evidence for testing in asymptomatic cohorts was limited. Test accuracy studies cannot adequately assess the ability of antigen tests to differentiate those who are infectious and require isolation from those who pose no risk, as there is no reference standard for infectiousness. A small number of molecular tests showed high accuracy and may be suitable alternatives to RT-PCR. However, further evaluations of the tests in settings as they are intended to be used are required to fully establish performance in practice. Several important studies in asymptomatic individuals have been reported since the close of our search and will be incorporated at the next update of this review. Comparative studies of antigen tests in their intended use settings and according to test operator (including self-testing) are required.
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Antígenos Virais/análise , Teste Sorológico para COVID-19/métodos , COVID-19/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Sistemas Automatizados de Assistência Junto ao Leito , SARS-CoV-2/imunologia , Adulto , Infecções Assintomáticas , Viés , Teste de Ácido Nucleico para COVID-19 , Teste Sorológico para COVID-19/normas , Criança , Estudos de Coortes , Reações Falso-Negativas , Reações Falso-Positivas , Humanos , Técnicas de Diagnóstico Molecular/normas , Valor Preditivo dos Testes , Padrões de Referência , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: The respiratory illness caused by SARS-CoV-2 infection continues to present diagnostic challenges. Our 2020 edition of this review showed thoracic (chest) imaging to be sensitive and moderately specific in the diagnosis of coronavirus disease 2019 (COVID-19). In this update, we include new relevant studies, and have removed studies with case-control designs, and those not intended to be diagnostic test accuracy studies. OBJECTIVES: To evaluate the diagnostic accuracy of thoracic imaging (computed tomography (CT), X-ray and ultrasound) in people with suspected COVID-19. SEARCH METHODS: We searched the COVID-19 Living Evidence Database from the University of Bern, the Cochrane COVID-19 Study Register, The Stephen B. Thacker CDC Library, and repositories of COVID-19 publications through to 30 September 2020. We did not apply any language restrictions. SELECTION CRITERIA: We included studies of all designs, except for case-control, that recruited participants of any age group suspected to have COVID-19 and that reported estimates of test accuracy or provided data from which we could compute estimates. DATA COLLECTION AND ANALYSIS: The review authors independently and in duplicate screened articles, extracted data and assessed risk of bias and applicability concerns using the QUADAS-2 domain-list. We presented the results of estimated sensitivity and specificity using paired forest plots, and we summarised pooled estimates in tables. We used a bivariate meta-analysis model where appropriate. We presented the uncertainty of accuracy estimates using 95% confidence intervals (CIs). MAIN RESULTS: We included 51 studies with 19,775 participants suspected of having COVID-19, of whom 10,155 (51%) had a final diagnosis of COVID-19. Forty-seven studies evaluated one imaging modality each, and four studies evaluated two imaging modalities each. All studies used RT-PCR as the reference standard for the diagnosis of COVID-19, with 47 studies using only RT-PCR and four studies using a combination of RT-PCR and other criteria (such as clinical signs, imaging tests, positive contacts, and follow-up phone calls) as the reference standard. Studies were conducted in Europe (33), Asia (13), North America (3) and South America (2); including only adults (26), all ages (21), children only (1), adults over 70 years (1), and unclear (2); in inpatients (2), outpatients (32), and setting unclear (17). Risk of bias was high or unclear in thirty-two (63%) studies with respect to participant selection, 40 (78%) studies with respect to reference standard, 30 (59%) studies with respect to index test, and 24 (47%) studies with respect to participant flow. For chest CT (41 studies, 16,133 participants, 8110 (50%) cases), the sensitivity ranged from 56.3% to 100%, and specificity ranged from 25.4% to 97.4%. The pooled sensitivity of chest CT was 87.9% (95% CI 84.6 to 90.6) and the pooled specificity was 80.0% (95% CI 74.9 to 84.3). There was no statistical evidence indicating that reference standard conduct and definition for index test positivity were sources of heterogeneity for CT studies. Nine chest CT studies (2807 participants, 1139 (41%) cases) used the COVID-19 Reporting and Data System (CO-RADS) scoring system, which has five thresholds to define index test positivity. At a CO-RADS threshold of 5 (7 studies), the sensitivity ranged from 41.5% to 77.9% and the pooled sensitivity was 67.0% (95% CI 56.4 to 76.2); the specificity ranged from 83.5% to 96.2%; and the pooled specificity was 91.3% (95% CI 87.6 to 94.0). At a CO-RADS threshold of 4 (7 studies), the sensitivity ranged from 56.3% to 92.9% and the pooled sensitivity was 83.5% (95% CI 74.4 to 89.7); the specificity ranged from 77.2% to 90.4% and the pooled specificity was 83.6% (95% CI 80.5 to 86.4). For chest X-ray (9 studies, 3694 participants, 2111 (57%) cases) the sensitivity ranged from 51.9% to 94.4% and specificity ranged from 40.4% to 88.9%. The pooled sensitivity of chest X-ray was 80.6% (95% CI 69.1 to 88.6) and the pooled specificity was 71.5% (95% CI 59.8 to 80.8). For ultrasound of the lungs (5 studies, 446 participants, 211 (47%) cases) the sensitivity ranged from 68.2% to 96.8% and specificity ranged from 21.3% to 78.9%. The pooled sensitivity of ultrasound was 86.4% (95% CI 72.7 to 93.9) and the pooled specificity was 54.6% (95% CI 35.3 to 72.6). Based on an indirect comparison using all included studies, chest CT had a higher specificity than ultrasound. For indirect comparisons of chest CT and chest X-ray, or chest X-ray and ultrasound, the data did not show differences in specificity or sensitivity. AUTHORS' CONCLUSIONS: Our findings indicate that chest CT is sensitive and moderately specific for the diagnosis of COVID-19. Chest X-ray is moderately sensitive and moderately specific for the diagnosis of COVID-19. Ultrasound is sensitive but not specific for the diagnosis of COVID-19. Thus, chest CT and ultrasound may have more utility for excluding COVID-19 than for differentiating SARS-CoV-2 infection from other causes of respiratory illness. Future diagnostic accuracy studies should pre-define positive imaging findings, include direct comparisons of the various modalities of interest in the same participant population, and implement improved reporting practices.
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COVID-19/diagnóstico por imagem , Radiografia Torácica , Tomografia Computadorizada por Raios X , Ultrassonografia , Adolescente , Adulto , Idoso , Viés , Teste de Ácido Nucleico para COVID-19/normas , Criança , Intervalos de Confiança , Humanos , Pulmão/diagnóstico por imagem , Pessoa de Meia-Idade , Radiografia Torácica/normas , Radiografia Torácica/estatística & dados numéricos , Padrões de Referência , Sensibilidade e Especificidade , Tomografia Computadorizada por Raios X/normas , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Ultrassonografia/normas , Ultrassonografia/estatística & dados numéricos , Adulto JovemRESUMO
LEVEL OF EVIDENCE: 5. TECHNICAL EFFICACY: Stage 2 J. Magn. Reson. Imaging 2020;52:821-822.
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Colangiopancreatografia por Ressonância Magnética , Imageamento por Ressonância Magnética , Estudos de Coortes , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: This study aimed to assess material-specific iodine and fat images for diagnosis of clear cell renal cell carcinoma (cc-RCC) compared to papillary RCC (p-RCC) and other renal masses. MATERIALS AND METHODS: With IRB approval, we identified histologically confirmed solid renal masses that underwent rapid-kVp-switch DECT between 2016 and 2018: 25 cc-RCC (7 low grade versus 18 high grade), 11 p-RCC, and 6 other tumors (2 clear cell papillary RCC, 2 chromophobe RCC, 1 oncocytoma, 1 renal angiomyomatous tumor). A blinded radiologist measured iodine and fat concentration on material-specific iodine-water and fat-water basis pair images. Comparisons were performed between groups using univariate analysis and diagnostic accuracy calculated by ROC. RESULTS: Iodine concentration was higher in cc-RCC (6.14 ± 1.79 mg/mL) compared to p-RCC (1.40 ± 0.54 mg/mL, p < 0.001), but not compared to other tumors (5.0 ± 2.2 mg/mL, p = 0.370). Intratumoral fat was seen in 36.0% (9/25) cc-RCC (309.6 ± 234.3 mg/mL [71.1-762.3 ng/mL]), 9.1% (1/11) papillary RCC (97.11 mg/mL), and no other tumors (p = 0.036). Iodine concentration ≥ 3.99 mg/mL achieved AUC and sensitivity/specificity of 0.88 (CI 0.76-1.00) and 92.31%/82.40% to diagnose cc-RCC. To diagnose p-RCC, iodine concentration ≤ 2.5 mg/mL achieved AUC and sensitivity/specificity of 0.99 (0.98-1.00) and 100%/100%. The presence of intratumoral fat had AUC 0.64 (CI 0.53-0.75) and sensitivity/specificity of 34.6%/93.8% to diagnose cc-RCC. A logistic regression model combining iodine concentration and presence of fat increased AUC to 0.91 (CI 0.81-1.0) with sensitivity/specificity of 80.8%/93.8% to diagnose cc-RCC. CONCLUSION: Iodine concentration values are highly accurate to differentiate clear cell RCC from papillary RCC; however, they overlap with other tumors. Fat-specific images may improve differentiation of clear cell RCC from other avidly enhancing tumors. KEY POINTS: ⢠Clear cell renal cell carcinoma (RCC) has significantly higher iodine concentration than papillary RCC, but there is an overlap in values comparing clear cell RCC to other renal tumors. ⢠Iodine concentration ≤ 2.5 mg/mL is highly accurate to differentiate papillary RCC from clear cell RCC and other renal tumors. ⢠The presence of microscopic fat on material-specific fat images was specific for clear cell RCC, helping to differentiate clear cell RCC from other avidly enhancing renal tumors.
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Carcinoma de Células Renais/diagnóstico , Iodo/farmacologia , Neoplasias Renais/diagnóstico , Estadiamento de Neoplasias/métodos , Tomografia Computadorizada por Raios X/métodos , Tecido Adiposo , Idoso , Meios de Contraste/farmacologia , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Estudos RetrospectivosRESUMO
BACKGROUND: The respiratory illness caused by SARS-CoV-2 infection continues to present diagnostic challenges. Early research showed thoracic (chest) imaging to be sensitive but not specific in the diagnosis of coronavirus disease 2019 (COVID-19). However, this is a rapidly developing field and these findings need to be re-evaluated in the light of new research. This is the first update of this 'living systematic review'. This update focuses on people suspected of having COVID-19 and excludes studies with only confirmed COVID-19 participants. OBJECTIVES: To evaluate the diagnostic accuracy of thoracic imaging (computed tomography (CT), X-ray and ultrasound) in people with suspected COVID-19. SEARCH METHODS: We searched the COVID-19 Living Evidence Database from the University of Bern, the Cochrane COVID-19 Study Register, The Stephen B. Thacker CDC Library, and repositories of COVID-19 publications through to 22 June 2020. We did not apply any language restrictions. SELECTION CRITERIA: We included studies of all designs that recruited participants of any age group suspected to have COVID-19, and which reported estimates of test accuracy, or provided data from which estimates could be computed. When studies used a variety of reference standards, we retained the classification of participants as COVID-19 positive or negative as used in the study. DATA COLLECTION AND ANALYSIS: We screened studies, extracted data, and assessed the risk of bias and applicability concerns using the QUADAS-2 domain-list independently, in duplicate. We categorised included studies into three groups based on classification of index test results: studies that reported specific criteria for index test positivity (group 1); studies that did not report specific criteria, but had the test reader(s) explicitly classify the imaging test result as either COVID-19 positive or negative (group 2); and studies that reported an overview of index test findings, without explicitly classifying the imaging test as either COVID-19 positive or negative (group 3). We presented the results of estimated sensitivity and specificity using paired forest plots, and summarised in tables. We used a bivariate meta-analysis model where appropriate. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs). MAIN RESULTS: We included 34 studies: 30 were cross-sectional studies with 8491 participants suspected of COVID-19, of which 4575 (54%) had a final diagnosis of COVID-19; four were case-control studies with 848 cases and controls in total, of which 464 (55%) had a final diagnosis of COVID-19. Chest CT was evaluated in 31 studies (8014 participants, 4224 (53%) cases), chest X-ray in three studies (1243 participants, 784 (63%) cases), and ultrasound of the lungs in one study (100 participants, 31 (31%) cases). Twenty-six per cent (9/34) of all studies were available only as preprints. Nineteen studies were conducted in Asia, 10 in Europe, four in North America and one in Australia. Sixteen studies included only adults, 15 studies included both adults and children and one included only children. Two studies did not report the ages of participants. Twenty-four studies included inpatients, four studies included outpatients, while the remaining six studies were conducted in unclear settings. The majority of included studies had a high or unclear risk of bias with respect to participant selection, index test, reference standard, and participant flow. For chest CT in suspected COVID-19 participants (31 studies, 8014 participants, 4224 (53%) cases) the sensitivity ranged from 57.4% to 100%, and specificity ranged from 0% to 96.0%. The pooled sensitivity of chest CT in suspected COVID-19 participants was 89.9% (95% CI 85.7 to 92.9) and the pooled specificity was 61.1% (95% CI 42.3 to 77.1). Sensitivity analyses showed that when the studies from China were excluded, the studies from other countries demonstrated higher specificity compared to the overall included studies. When studies that did not classify index tests as positive or negative for COVID-19 (group 3) were excluded, the remaining studies (groups 1 and 2) demonstrated higher specificity compared to the overall included studies. Sensitivity analyses limited to cross-sectional studies, or studies where at least two reverse transcriptase polymerase chain reaction (RT-PCR) tests were conducted if the first was negative, did not substantively alter the accuracy estimates. We did not identify publication status as a source of heterogeneity. For chest X-ray in suspected COVID-19 participants (3 studies, 1243 participants, 784 (63%) cases) the sensitivity ranged from 56.9% to 89.0% and specificity from 11.1% to 88.9%. The sensitivity and specificity of ultrasound of the lungs in suspected COVID-19 participants (1 study, 100 participants, 31 (31%) cases) were 96.8% and 62.3%, respectively. We could not perform a meta-analysis for chest X-ray or ultrasound due to the limited number of included studies. AUTHORS' CONCLUSIONS: Our findings indicate that chest CT is sensitive and moderately specific for the diagnosis of COVID-19 in suspected patients, meaning that CT may have limited capability in differentiating SARS-CoV-2 infection from other causes of respiratory illness. However, we are limited in our confidence in these results due to the poor study quality and the heterogeneity of included studies. Because of limited data, accuracy estimates of chest X-ray and ultrasound of the lungs for the diagnosis of suspected COVID-19 cases should be carefully interpreted. Future diagnostic accuracy studies should pre-define positive imaging findings, include direct comparisons of the various modalities of interest on the same participant population, and implement improved reporting practices. Planned updates of this review will aim to: increase precision around the accuracy estimates for chest CT (ideally with low risk of bias studies); obtain further data to inform accuracy of chest X-rays and ultrasound; and obtain data to further fulfil secondary objectives (e.g. 'threshold' effects, comparing accuracy estimates across different imaging modalities) to inform the utility of imaging along different diagnostic pathways.
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COVID-19/diagnóstico por imagem , Radiografia Torácica , SARS-CoV-2 , Tomografia Computadorizada por Raios X , Ultrassonografia , Adulto , Viés , Estudos de Casos e Controles , Criança , Estudos Transversais/estatística & dados numéricos , Erros de Diagnóstico/estatística & dados numéricos , Humanos , Pulmão/diagnóstico por imagem , Radiografia Torácica/estatística & dados numéricos , Reação em Cadeia da Polimerase Via Transcriptase Reversa/estatística & dados numéricos , Sensibilidade e Especificidade , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Ultrassonografia/estatística & dados numéricosRESUMO
BACKGROUND: The diagnosis of infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents major challenges. Reverse transcriptase polymerase chain reaction (RT-PCR) testing is used to diagnose a current infection, but its utility as a reference standard is constrained by sampling errors, limited sensitivity (71% to 98%), and dependence on the timing of specimen collection. Chest imaging tests are being used in the diagnosis of COVID-19 disease, or when RT-PCR testing is unavailable. OBJECTIVES: To determine the diagnostic accuracy of chest imaging (computed tomography (CT), X-ray and ultrasound) in people with suspected or confirmed COVID-19. SEARCH METHODS: We searched the COVID-19 Living Evidence Database from the University of Bern, the Cochrane COVID-19 Study Register, and The Stephen B. Thacker CDC Library. In addition, we checked repositories of COVID-19 publications. We did not apply any language restrictions. We conducted searches for this review iteration up to 5 May 2020. SELECTION CRITERIA: We included studies of all designs that produce estimates of test accuracy or provide data from which estimates can be computed. We included two types of cross-sectional designs: a) where all patients suspected of the target condition enter the study through the same route and b) where it is not clear up front who has and who does not have the target condition, or where the patients with the target condition are recruited in a different way or from a different population from the patients without the target condition. When studies used a variety of reference standards, we included all of them. DATA COLLECTION AND ANALYSIS: We screened studies and extracted data independently, in duplicate. We also assessed the risk of bias and applicability concerns independently, in duplicate, using the QUADAS-2 checklist and presented the results of estimated sensitivity and specificity, using paired forest plots, and summarised in tables. We used a hierarchical meta-analysis model where appropriate. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs). MAIN RESULTS: We included 84 studies, falling into two categories: studies with participants with confirmed diagnoses of COVID-19 at the time of recruitment (71 studies with 6331 participants) and studies with participants suspected of COVID-19 (13 studies with 1948 participants, including three case-control studies with 549 cases and controls). Chest CT was evaluated in 78 studies (8105 participants), chest X-ray in nine studies (682 COVID-19 cases), and chest ultrasound in two studies (32 COVID-19 cases). All evaluations of chest X-ray and ultrasound were conducted in studies with confirmed diagnoses only. Twenty-five per cent (21/84) of all studies were available only as preprints, 15/71 studies in the confirmed cases group and 6/13 of the studies in the suspected group. Among 71 studies that included confirmed cases, 41 studies had included symptomatic cases only, 25 studies had included cases regardless of their symptoms, five studies had included asymptomatic cases only, three of which included a combination of confirmed and suspected cases. Seventy studies were conducted in Asia, 2 in Europe, 2 in North America and one in South America. Fifty-one studies included inpatients while the remaining 24 studies were conducted in mixed or unclear settings. Risk of bias was high in most studies, mainly due to concerns about selection of participants and applicability. Among the 13 studies that included suspected cases, nine studies were conducted in Asia, and one in Europe. Seven studies included inpatients while the remaining three studies were conducted in mixed or unclear settings. In studies that included confirmed cases the pooled sensitivity of chest CT was 93.1% (95%CI: 90.2 - 95.0 (65 studies, 5759 cases); and for X-ray 82.1% (95%CI: 62.5 to 92.7 (9 studies, 682 cases). Heterogeneity judged by visual assessment of the ROC plots was considerable. Two studies evaluated the diagnostic accuracy of point-of-care ultrasound and both reported zero false negatives (with 10 and 22 participants having undergone ultrasound, respectively). These studies only reported True Positive and False Negative data, therefore it was not possible to pool and derive estimates of specificity. In studies that included suspected cases, the pooled sensitivity of CT was 86.2% (95%CI: 71.9 to 93.8 (13 studies, 2346 participants) and specificity was 18.1% (95%CI: 3.71 to 55.8). Heterogeneity judged by visual assessment of the forest plots was high. Chest CT may give approximately the same proportion of positive results for patients with and without a SARS-CoV-2 infection: the chances of getting a positive CT result are 86% (95% CI: 72 to 94) in patient with a SARS-CoV-2 infection and 82% (95% CI: 44 to 96) in patients without. AUTHORS' CONCLUSIONS: The uncertainty resulting from the poor study quality and the heterogeneity of included studies limit our ability to confidently draw conclusions based on our results. Our findings indicate that chest CT is sensitive but not specific for the diagnosis of COVID-19 in suspected patients, meaning that CT may not be capable of differentiating SARS-CoV-2 infection from other causes of respiratory illness. This low specificity could also be the result of the poor sensitivity of the reference standard (RT-PCR), as CT could potentially be more sensitive than RT-PCR in some cases. Because of limited data, accuracy estimates of chest X-ray and ultrasound of the lungs for the diagnosis of COVID-19 should be carefully interpreted. Future diagnostic accuracy studies should avoid cases-only studies and pre-define positive imaging findings. Planned updates of this review will aim to: increase precision around the accuracy estimates for CT (ideally with low risk of bias studies); obtain further data to inform accuracy of chest X rays and ultrasound; and continue to search for studies that fulfil secondary objectives to inform the utility of imaging along different diagnostic pathways.
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Betacoronavirus , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico por imagem , Pneumonia Viral/diagnóstico por imagem , Adulto , COVID-19 , Teste para COVID-19 , Criança , Infecções por Coronavirus/diagnóstico , Humanos , Pulmão/diagnóstico por imagem , Pandemias , Radiografia Torácica/estatística & dados numéricos , SARS-CoV-2 , Sensibilidade e Especificidade , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Ultrassonografia/estatística & dados numéricosRESUMO
PURPOSE: To assess T2-weighted (T2W) MRI to differentiate transition zone (TZ) prostate cancer (PCa) from benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: With IRB approval, 22 consecutive TZ PCa were retrospectively compared with 30 consecutive BPH (15 stromal, 15 glandular) nodules diagnosed using radical prostatectomy MRI maps. Two blinded radiologists (R1/R2) subjectively assessed the shape (round/oval vs. lenticular) and margin (circumscribed vs. blurred/indistinct) and for a T2W hypointense rim. Both radiologists segmented lesions extracting quantitative shape features (circularity, convexity and topology/skeletal branching). Statistical tests were performed using chi-square (subjective features), Mann-Whitney U (quantitative features), Cohen's kappa/Bland-Altman and receiver-operator characteristic analysis. RESULTS: There were differences in the subjective analysis of the shape, margin and absence of a T2W-rim comparing TZ PCa with BPH (p < 0.0001) with moderate to almost perfect agreement [kappa = 0.56 (shape), 0.72 (margin), 0.97 (T2W-rim)]. Area under the curve (AUC ± standard error) for diagnosis of TZ PCas was shape = 0.88 ± 0.05, margin = 0.89 ± 0.04, and T2W-rim = 0.91 ± 0.04. Shape, judged subjectively, was specific (100%/94% R1/R2) with low-to-moderate sensitivity (55%/88% R1/R2). Circularity and convexity differed between groups (p < 0.001) with no difference in topology/skeletal branches (p = 0.31). Agreement in measurements was substantial for significant quantitative variables and AUC ± SE, sensitivity and specificity for diagnosis of TZ PCa were: circularity = 0.98 ± 0.01, 90%/96%; convexity = 0.85 ± 0.06, 68%/97%. AUCs for circularity were higher than for subjective analysis (p = 0.01 and 0.26). CONCLUSION: Subjective analysis of T2W-MRI accurately diagnoses TZ PCa with high accuracy also demonstrated for quantitative shape analysis, which may be useful for future radiogenomic analysis of transition zone tumors. KEY POINTS: ⢠Presence of a complete T2-weighted hypointense circumscribed rim accurately diagnoses BPH. ⢠Round shape accurately diagnoses BPH and can be assessed quantitatively using circularity. ⢠Lenticular shape accurately diagnoses TZ PCa and can be assessed quantitatively using convexity.
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Imageamento por Ressonância Magnética/métodos , Margens de Excisão , Neoplasias da Próstata/patologia , Idoso , Área Sob a Curva , Humanos , Masculino , Pessoa de Meia-Idade , Período Pré-Operatório , Prostatectomia , Neoplasias da Próstata/cirurgia , Curva ROC , Estudos RetrospectivosRESUMO
INTRODUCTION: To assess the association between the impact of the completeness of pre-operative spine tumour embolisation and clinical outcomes, including estimated blood loss (EBL), neurological status and complications. METHODS: Retrospective chart review of all preoperative spine tumour embolisation procedures performed over 11 years by a single operator (2007-2018) at Vancouver General Hospital on 44 consecutive patients (mean age 57; 77% males) with 46 embolisation procedures, of which surgery was done en bloc in 26 cases and intralesional in the remaining 20. A multivariable negative binomial regression model was fit to examine the association between EBL and surgery type, tumour characteristics, embolisation completeness and operative duration. RESULTS: Among intralesional surgeries, complete versus incomplete embolisation was associated with reduced blood loss (772 vs 1428 mL, P < 0.01). There was no statistically significant difference in neurological outcomes or complications between groups. Highly vascular tumours correlated with greater blood loss than their less vascular counterparts, but tumour location did not have a statistically significant effect. CONCLUSION: This study provides evidence in support of our hypothesis that complete as opposed to incomplete tumour embolisation correlates with reduced blood loss in intralesional surgeries. Randomised control trials with larger samples are necessary to confirm this benefit and to ascertain other potential clinical benefits.
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Perda Sanguínea Cirúrgica , Embolização Terapêutica , Cuidados Pré-Operatórios , Neoplasias da Coluna Vertebral , Humanos , Embolização Terapêutica/métodos , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Neoplasias da Coluna Vertebral/terapia , Neoplasias da Coluna Vertebral/diagnóstico por imagem , Cuidados Pré-Operatórios/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Resultado do Tratamento , Idoso , AdultoRESUMO
OBJECTIVES: Systematic reviews are often considered among the highest quality of evidence. Completely reported systematic reviews, however, are required so readers can assess for generalisability of the research to practice and risk of bias. The objective of this study was to assess the completeness of reporting for systematic reviews assessing the diagnostic accuracy of point-of-care ultrasound (POCUS) using the Preferred Reporting Items for Systematic Reviews and Meta-analyses for Diagnostic Test Accuracy (PRISMA-DTA) checklist that was published in 2018. DESIGN AND SETTING: In this meta-research study, MEDLINE, EMBASE and Cochrane Library databases were searched, with no date restriction, on March 1st, 2020 for systematic reviews assessing the diagnostic accuracy of POCUS. Adherence to PRISMA-DTA for the main text and abstract was scored independently and in duplicate using a modified checklist. Prespecified subgroup analyses were performed. MAIN OUTCOME MEASURES: The primary outcome was the mean PRISMA-DTA checklist adherence for the full-text and abstract. RESULTS: A total of 71 studies published from 2008 to 2020 met the inclusion criteria. The overall adherence for the full-text was moderate: 19.8 out of 26.0 items (76%) and for the abstract was 7.0 out of 11.0 items (64%). Although many items in the PRISMA-DTA checklist were frequently reported, several were r infrequently reported (<33% of studies), including item 5 (protocol registration), item D2 (minimally acceptable test accuracy) and item 14 (variability in target condition, index test and reference standards). Subgroup analyses showed a higher PRISMA-DTA mean adherence (SD) for high impact journals (20.9 (2.52) vs 18.9 (1.95); p<0.001), studies including supplemental materials (20.6 (2.48) vs 18.9 (2.28); p=0.004), studies citing adherence to PRISMA reporting guidelines (20.4 (1.95) vs 19.0 (3.00); p=0.038) and studies published in journals endorsing PRISMA guidelines (20.2 (2.47) vs 18.6 (2.37); p=0.025). There was variable adherence based on journal of publication (p=0.006), but not for study population (adult vs paediatric vs mixed) (p=0.62), year of publication (p=0.94), body region (p=0.78) or country (p=0.40). There was no variability in abstract adherence based on whether the abstract was structured with subheadings or not (p=0.25). A Spearman's correlation found moderate correlation between higher word counts and abstractand full-text adherence (R=0.45, p<0.001 and R=0.38, p=0.001), respectively. CONCLUSIONS: Overall, the reporting of POCUS diagnostic accuracy systematic reviews and meta-analyses was moderate. We identified deficits in several key areas including the preregistration of systematic reviews in an online repository, handling of multiple definitions of target conditions, index tests and reference standards and specifying minimally acceptable test accuracy. Prospective registration of reviews and detailed reporting as per PRISMA-DTA during the research process could improve reporting completeness. At an editorial level, word count and supplemental material limitations may impede reporting completeness, whereas endorsement of reporting guidelines on journal websites could improve reporting.
RESUMO
OBJECTIVE: To evaluate Prostate Imaging Reporting and Data System (PI-RADS) category 3 lesions' impact on the diagnostic test accuracy (DTA) of MRI for prostate cancer (PC) and to derive the prevalence of PC within each PI-RADS category. METHODS: MEDLINE and Embase were searched until April 10, 2020 for studies reporting on the DTA of MRI by PI-RADS category. Accuracy metrics were calculated using a bivariate random-effects meta-analysis with PI-RADS three lesions treated as a positive test, negative test, and excluded from the analysis. Differences in DTA were assessed utilizing meta-regression. PC prevalence within each PI-RADS category was estimated with a proportional meta-analysis. RESULTS: In total, 26 studies reporting on 12,913 patients (4,853 with PC) were included. Sensitivities for PC in the positive, negative, and excluded test groups were 96% (95% confidence interval [CI] 92-98), 82% (CI 75-87), and 95% (CI 91-97), respectively. Specificities for the positive, negative, and excluded test groups were 33% (CI 23-44), 71% (CI 62-79), and 52% (CI 37-66), respectively. Meta-regression demonstrated higher sensitivity (p < 0.001) and lower specificity (p < 0.001) in the positive test group compared to the negative group. Clinically significant PC prevalences were 5.9% (CI 0-17.1), 11.4% (CI 6.5-17.3), 24.9% (CI 18.4-32.0), 55.7% (CI 47.8-63.5), and 81.4% (CI 75.9-86.4) for PI-RADS categories 1, 2, 3, 4 and 5, respectively. CONCLUSION: PI-RADS category 3 lesions can significantly impact the DTA of MRI for PC detection. A low prevalence of clinically significant PC is noted in PI-RADS category 1 and 2 cases. ADVANCES IN KNOWLEDGE: Inclusion or exclusion of PI-RADS category 3 lesions impacts the DTA of MRI for PC detection.