Predictive value of isolated symptoms for diagnosis of SARS-CoV-2 infection in children tested during peak circulation of the delta variant

Background: COVID-19 testing policies for symptomatic children attending U.S. schools or daycare vary, and whether isolated symptoms should prompt testing is unclear. We evaluated children presenting for SARS-CoV-2 testing to determine if the likelihood of having a positive SARS-CoV-2 test differed between participants with one versus ≥ 2 symptoms, and to examine the predictive capability of isolated symptoms. Methods: Participants ≤ 18 years presenting for clinical SARS-CoV-2 molecular testing in six sites in urban/suburban/rural Georgia (July-October, 2021; delta variant predominant) were queried about individual symptoms. Participants were classified into three groups: asymptomatic, one symptom only, or ≥ 2 symptoms. SARS-CoV-2 test results and clinical characteristics of the three groups were compared. Sensitivity, specificity, and positive/negative predictive values (PPV/NPV) for isolated symptoms were calculated by fitting a saturated Poisson model. Results: Of 602 participants, 21.8% tested positive and 48.7% had a known or suspected close contact. Children reporting one symptom (n=82; OR=6.00, 95% CI: 2.70-13.33) and children reporting ≥ 2 symptoms (n=365; OR=5.25: 2.66-10.38) were significantly more likely to have a positive COVID-19 test than asymptomatic children (n=155), but they were not significantly different from each other (OR=0.88: 0.52-1.49). Sensitivity/PPV were highest for isolated fever (33%/57%), cough (25%/32%), and sore throat (21%/45%); headache had low sensitivity (8%) but higher PPV (33%). Sensitivity/PPV of isolated congestion/rhinorrhea were 8%/9%. Conclusions: With high delta variant prevalence, children with isolated symptoms were as likely as those with multiple symptoms to test positive for COVID-19. Isolated fever, cough, sore throat, or headache, but not congestion/rhinorrhea, offered highest predictive value.

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Ambulatory Blood Pressure Monitoring to Predict Response to Renal Denervation

Hypertension ◽

10.1161/hypertensionaha.120.16292 ◽

2020 ◽

Author(s):

Philippe Gosse ◽

Antoine Cremer ◽

Ajay J. Kirtane ◽

Melvin D. Lobo ◽

Manish Saxena ◽

...

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

Predictive Value ◽

Renal Denervation ◽

Blood Pressure Monitoring ◽

Regression To The Mean ◽

Unique Identifier ◽

Predictive Values ◽

Low Sensitivity ◽

Sensitivity Specificity

Renal denervation (RDN) is effective in lowering blood pressure (BP) in patients with hypertension. The issue remains how to best identify potential responders. Ambulatory BP monitoring may be useful. Baseline nighttime systolic BP (SBP) ≥136 mm Hg and its variability (SD) ≥12 mm Hg in DENER-HTN trial or 24-hour heart rate ≥73.5 bpm in SPYRAL HTN-OFF MED Trial were shown to predict the BP response to RDN. We applied these criteria to the patients with hypertension in the sham-controlled RADIANCE-HTN SOLO trial to predict the BP response to ultrasound RDN at 2 months while patients were maintained off medications. BP responders were defined as: clinical with 24-hour SBP <130 mm Hg (RDN: 22/64 versus sham: 7/58); meaningful with 24-hour SBP reduction ≥10 mm Hg (RDN: 24/64, sham: 7/58); and extreme with 24-hour SBP reduction above mean+2 SD of the SBP decrease in the sham group, that is, ≥16.5 mm Hg (RDN: 10/64 versus sham: 2/58). The predictive criteria reported above were tested for sensitivity, specificity, and positive and negative predictive values. The predictive value varied according to the definition of response, with the clinical definition being strongly influenced by regression to the mean. Baseline nighttime SBP and its variability, especially when combined, offered good specificity (>90% irrespective of definition) but low sensitivity (from 9.1% to 30% depending on the definition) to predict responders; the heart rate criterion had insufficient predictive value. This analysis suggests the potential role of nighttime SBP and its variability to predict BP response to RDN in patients with hypertension. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02649426.

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381 Role of CT scans of abdomen and pelvis in management of patients with immunotherapy-induced colitis

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0381 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A406-A406

Author(s):

Juan Ibarra Rovira ◽

Raghunandan Vikram ◽

Selvi Thirumurthi ◽

Bulent Yilmaz ◽

Heather Lin ◽

...

Keyword(s):

Negative Predictive Value ◽

Clinical Diagnosis ◽

Predictive Value ◽

Clinical Symptoms ◽

Cytotoxic T Lymphocyte ◽

Checkpoint Inhibitors ◽

Ct Scans ◽

Wall Thickening ◽

Low Sensitivity ◽

Sensitivity Specificity

BackgroundColitis is one of the most common immune-related adverse event in patients who receive immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death-1 (PD-1). Although radiographic changes are reported on computed tomography such as mild diffuse bowel thickening or segmental colitis, the utility of CT in diagnosis of patients with suspected immune-related colitis is not well studied.MethodsCT scans of the abdomen and pelvis of 34 patients on immunotherapy with a clinical diagnosis of immunotherapy induced colitis and 19 patients receiving immunotherapy without clinical symptoms of colitis (control) were enrolled in this retrospective study. Segments of the colon (rectum, sigmoid, descending, transverse, ascending and cecum) were assessed independently by two fellowship trained abdominal imaging specialists with 7 and 13 years‘ experience who were blinded to the clinical diagnosis. Each segment was assessed for mucosal enhancement, wall thickening, distension, peri-serosal fat stranding. Any disagreements were resolved in consensus. The degree of distension and the spurious assignment of wall thickening were the most common causes for disagreement. The presence of any of the signs was considered as radiographic evidence of colitis.ResultsCT evidence of colitis was seen in 16 of 34 patients with symptoms of colitis. 7 of 19 patients who did not have symptoms of colitis showed signs of colitis on CT. The sensitivity, specificity, Positive Predictive Value and Negative Predictive Value for colitis on CT is 47%, 63.2%, 69.5% and 40%, respectively.ConclusionsCT has a low sensitivity, specificity and negative predictive value for the diagnosis of immunotherapy-induced colitis. CT has no role in the diagnosis of patients suspected of having uncomplicated immune-related colitis and should not be used routinely for management.Trial RegistrationThis protocol is not registered on clinicaltrials.gov.Ethics ApprovalThis protocol was IRB approved on: 11/16/2015 - IRB 4 Chair Designee FWA #: 00000363 OHRP IRB Registration Number: IRB 4 IRB00005015ConsentThis protocol utilizes an IRB approved waiver of consent.

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Validity of hearTest Smartphone-Based Audiometry for Hearing Screening in Workers Exposed to Noise

Journal of the American Academy of Audiology ◽

10.1055/s-0040-1718931 ◽

2020 ◽

Author(s):

Luma Cordeiro Rodrigues ◽

Silvia Ferrite ◽

Ana Paula Corona

Keyword(s):

Hearing Loss ◽

High Specificity ◽

Hearing Screening ◽

Youden Index ◽

Hearing Level ◽

Predictive Values ◽

Auditory Thresholds ◽

The Mean ◽

Low Sensitivity ◽

Sensitivity Specificity

Abstract Purpose This article investigates the validity of a smartphone-based audiometry for hearing screening to identify hearing loss in workers exposed to noise. Research Design This is a validation study comparing hearing screening with the hearTest to conventional audiometry. The study population included all workers who attended the Brazilian Social Service of Industry to undergo periodic examinations. Sensitivity, specificity, the Youden index, and positive (PPV) and negative predictive values (NPV) for hearing screening obtained by the hearTest were estimated according to three definitions of hearing loss: any threshold greater than 25 dB hearing level (HL), the mean auditory thresholds for 0.5, 1, 2, and 4 kHz greater than 25 dB HL, and the mean thresholds for 3, 4, and 6 kHz greater than 25 dB HL. Note that 95% confidence intervals were calculated for all measurements. Results A total of 232 workers participated in the study. Hearing screening with the hearTest presented good sensitivity (93.8%), specificity (83.9%), and Youden index (77.7%) values, a NPV (97.2%), and a low PPV (69.0%) for the identification of hearing loss defined as any auditory threshold greater than 25 dB HL. For the other definitions of hearing loss, we observed high specificity, PPV and NPV, as well as low sensitivity and Youden index. Conclusion The hearTest is an accurate hearing screening tool to identify hearing loss in workers exposed to noise, including those with noise-induced hearing loss, although it does not replace conventional audiometry.

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Foundational Statistical Principles in Medical Research: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value

Medicina ◽

10.3390/medicina57050503 ◽

2021 ◽

Vol 57 (5) ◽

pp. 503

Author(s):

Thomas F. Monaghan ◽

Syed N. Rahman ◽

Christina W. Agudelo ◽

Alan J. Wein ◽

Jason M. Lazar ◽

...

Keyword(s):

Positive Predictive Value ◽

Negative Predictive Value ◽

Predictive Value ◽

Medical Literature ◽

Disease Prevalence ◽

Positive Test Result ◽

Predictive Values ◽

Sensitivity Specificity ◽

Test Result ◽

Test Probability

Sensitivity, which denotes the proportion of subjects correctly given a positive assignment out of all subjects who are actually positive for the outcome, indicates how well a test can classify subjects who truly have the outcome of interest. Specificity, which denotes the proportion of subjects correctly given a negative assignment out of all subjects who are actually negative for the outcome, indicates how well a test can classify subjects who truly do not have the outcome of interest. Positive predictive value reflects the proportion of subjects with a positive test result who truly have the outcome of interest. Negative predictive value reflects the proportion of subjects with a negative test result who truly do not have the outcome of interest. Sensitivity and specificity are inversely related, wherein one increases as the other decreases, but are generally considered stable for a given test, whereas positive and negative predictive values do inherently vary with pre-test probability (e.g., changes in population disease prevalence). This article will further detail the concepts of sensitivity, specificity, and predictive values using a recent real-world example from the medical literature.

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Drawing the line in the Edinburgh Postnatal Depression Scale (EPDS): a vital decision

International Journal of Adolescent Medicine and Health ◽

10.1515/ijamh.2011.005 ◽

2011 ◽

Vol 23 (1) ◽

Cited By ~ 8

Author(s):

Dagmar Lagerberg ◽

Margaretha Magnusson ◽

Claes Sundelin

Keyword(s):

Positive Predictive Value ◽

Predictive Value ◽

Postnatal Depression ◽

Edinburgh Postnatal Depression Scale ◽

Depression Scale ◽

Child Interaction ◽

Mother Child Interaction ◽

Problem Behaviours ◽

Low Sensitivity ◽

Sensitivity Specificity

Abstract Background: The Edinburgh Postnatal Depression Scale (EPDS) is widely used in early child health care. This study examined the appropriateness of the recommended EPDS cut-off score 11/12. Methods: Two main analyses were performed: 1. Associations between EPDS scores and maternal health behaviour, stress, life events, perceived mother-child interaction quality and child behaviour. 2. Screening parameters of the EPDS, i.e., sensitivity, specificity and positive predictive value. EPDS scores were available for 438 mothers and maternal questionnaires for 361 mothers. Results: Already in the EPDS score intervals 6–8 and 9–11, there were notable adversities, according to maternal questionnaires, in stress, perceived quality of mother-child interaction, perceived child difficultness and child problem behaviours. Using maternal questionnaire reports about sadness/distress postpartum as standard, the recommended EPDS cut-off score 11/12 resulted in a very low sensitivity (24%). The cut-off score 6/7 yielded a sensitivity of 61%, a specificity of 82% and a positive predictive value of 61%. Conclusions: In terms of both clinical relevance and screening qualities, an EPDS cut-off score lower than 11/12 seems recommendable.

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Value and Diagnostic Efficacy of Fetal Morphology Assessment Using Ultrasound in A Poor-Resource Setting

Diagnostics ◽

10.3390/diagnostics9030109 ◽

2019 ◽

Vol 9 (3) ◽

pp. 109 ◽

Cited By ~ 1

Author(s):

Ukweh ◽

Ugbem ◽

Okeke ◽

Ekpo

Keyword(s):

Predictive Value ◽

Performance Metrics ◽

Area Under The Curve ◽

Youden Index ◽

Likelihood Ratios ◽

Diagnostic Efficacy ◽

Predictive Values ◽

Resource Setting ◽

Post Test ◽

Sensitivity Specificity

Background: Ultrasound is operator-dependent, and its value and efficacy in fetal morphology assessment in a low-resource setting is poorly understood. We assessed the value and efficacy of fetal morphology ultrasound assessment in a Nigerian setting. Materials and Methods: We surveyed fetal morphology ultrasound performed across five facilities and followed-up each fetus to ascertain the outcome. Fetuses were surveyed in the second trimester (18th–22nd weeks) using the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guideline. Clinical and surgical reports were used as references to assess the diagnostic efficacy of ultrasound in livebirths, and autopsy reports to confirm anomalies in terminated pregnancies, spontaneous abortions, intrauterine fetal deaths, and still births. We calculated sensitivity, specificity, positive and negative predictive values, Area under the curve (AUC), Youden index, likelihood ratios, and post-test probabilities. Results: In total, 6520 fetuses of women aged 15–46 years (mean = 31.7 years) were surveyed. The overall sensitivity, specificity, and AUC were 77.1 (95% CI: 68–84.6), 99.5 (95% CI: 99.3–99.7), and 88.3 (95% CI: 83.7–92.2), respectively. Other performance metrics were: positive predictive value, 72.4 (95% CI: 64.7–79.0), negative predictive value, 99.6 (95% CI: 99.5–99.7), and Youden index (77.1%). Abnormality prevalence was 1.67% (95% CI: 1.37–2.01), and the positive and negative likelihood ratios were 254 (95% CI: 107.7–221.4) and 0.23 (95% CI: 0.16–0.33), respectively. The post-test probability for positive test was 72% (95% CI: 65–79). Conclusion: Fetal morphology assessment is valuable in a poor economics setting, however, the variation in the diagnostic efficacy across facilities and the limitations associated with the detection of circulatory system anomalies need to be addressed.

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Development and Evaluation of a Novel Fast Broad-Range ITS/LSU DNA PCR and Sequencing Assay (FBR-PCR/S) for Rapid Diagnosis of Invasive Fungal Diseases: Multi-Year Experience in a Large Canadian Healthcare Zone and a Literature Review

10.21203/rs.3.rs-1009236/v1 ◽

2021 ◽

Author(s):

B Chow ◽

M Groeschel ◽

J Carson ◽

Thomas Griener ◽

Deirdre Church

Keyword(s):

Predictive Value ◽

Patient Characteristics ◽

Invasive Fungal Disease ◽

Molecular Testing ◽

Fungal Culture ◽

Diagnostic Efficiency ◽

Molecular Assay ◽

Risk Patients ◽

Sensitivity Specificity ◽

Canadian Healthcare

Abstract BackgroundThis study evaluated the performance of a novel fast broad range PCR and sequencing (FBR-PCR/S) assay for the improved diagnosis of invasive fungal disease (IFD) in high-risk patients in a large Canadian healthcare region.MethodsA total of 114 clinical specimens (CS) including bronchoalveolar lavages (BALs) were prospectively tested from 107 patients over a 2-year period. Contrived BALs (n=33) inoculated with known fungi pathogens were also tested to increase diversity. Patient characteristics, fungal stain and culture results were collected from the laboratory information system. Dual-priming oligonucleotide (DPO) primers targeted to the ITS (~350 bp) and LSU (~550 bp) gene regions were used to perform FBR-PCR/S assays on extracted BALs/CS. The performance of the molecular test was evaluated against results of fungal stains and culture, and where available, histopathology, and clinical review for the presence of IFD.ResultsThe 107 patients were predominantly male (67, 62.6%%) with a mean age of 59 yrs. (range = 0 to 85 yrs.): 74 (69.2%) patients had at least one underlying comorbidity: 19 (34.5%) had confirmed and 12 (21.8%) had probable IFD. Culture recovered 66 fungal isolates from 55 BALs/CS with Candida spp. and Aspergillus spp. being most common. For BALs, the molecular assay vs. fungal culture had sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), and efficiency of 88.5% vs.100%, 100% vs. 61.1%, 100% vs. 88.5%, 61.1% vs. 100%, and 90.2% for both. For other CS, the molecular assay had similar performance to fungal culture with sensitivity, specificity, PPV, NPV and efficiency of 66.7%, 87.0%, 66.7%, 87.0% and 81.3% for both methods. Both methods also performed similarly, regardless of whether CS stain/microscopy showed yeast/fungal elements. FBR-PCR/S assays results were reported in ~8h compared to fungal cultures that took between 4 to 6 weeks.ConclusionsRapid molecular testing compared to culture has equivalent diagnostic efficiency but improves clinical utility by reporting a rapid species-level identification the same dayshift (~8h).

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Prediction of preeclampsia using a combination of serum micro RNA-210 and uterine artery Doppler ultrasound

Science Progress ◽

10.1177/00368504211036856 ◽

2021 ◽

Vol 104 (3) ◽

pp. 003685042110368

Author(s):

Ananya Trongpisutsak ◽

Vorapong Phupong

Keyword(s):

Pregnant Women ◽

Doppler Ultrasound ◽

Predictive Value ◽

Early Onset ◽

Uterine Artery ◽

Micro Rna ◽

Predictive Values ◽

Uterine Artery Doppler ◽

Early Onset Preeclampsia ◽

Sensitivity Specificity

The objective was to determine whether a combination of serum micro RNA-210 level and uterine artery Doppler can predict preeclampsia in pregnant women at 16–24 weeks gestation. A prospective observational study conducted in singleton pregnant women at 16–24 weeks of gestation who had prenatal care at the King Chulalongkorn Memorial Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand between 2017 and 2018. Uterine artery Doppler ultrasound and blood testing for serum micro RNA-210 were performed. Pregnancy outcomes were recorded. Optimal cut-off for uterine artery pulsatility index (PI) and serum micro RNA-210 were obtained to calculate the predictive values for preeclampsia. Data from 443 participants were analyzed. Twenty-two cases developed preeclampsia (5.0%) and seven of these preeclamptic cases had early-onset preeclampsia (1.6%). Pregnant women with preeclampsia had higher mean PI of the uterine artery (1.34 ± 0.52 vs 0.98 ± 0.28, p = 0.004), higher detection rates of diastolic notching (45.5% vs 11.2%, p < 0.001), and lower median serum micro RNA-210 level (22.86 vs 795.78, p < 0.001) than pregnant women without preeclampsia. Using abnormal serum micro RNA-210 level, abnormal mean PI or uterine artery diastolic notches to predict for preeclampsia, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 95.5%, 54.9%, 10.0%, and 99.6%, respectively. For early-onset preeclampsia prediction, the sensitivity, specificity, PPV, and NPV were 100.0%, 53.2%, 3.3%, and 100.0%, respectively. This study demonstrated that a combination of serum micro RNA-210 and uterine artery Doppler is effective in predicting preeclampsia in the second trimester.

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Clinical Performance of the Spot Vision Photo Screener before and after Induction of Cycloplegia in Children

Journal of Ophthalmology ◽

10.1155/2019/5329121 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Konuralp Yakar

Keyword(s):

Positive Predictive Value ◽

Negative Predictive Value ◽

Predictive Value ◽

Clinical Performance ◽

High Specificity ◽

Screening Criteria ◽

Predictive Values ◽

Before And After ◽

Sensitivity Specificity ◽

Vision Screener

Aim. To compare the clinical performance of the Spot Vision Screener used to detect amblyopia risk factors (ARFs) in children before and after induction of cycloplegia; the children were referred because they met the screening criteria of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS). Methods. The Spot Vision Screener and a standard autorefractometer were used to examine 200 eyes of 100 children aged 3–10 years, before and after cycloplegia induction, in terms of ARFs. Sensitivity, specificity, and positive and negative predictive values for the detection of significant refractive errors were measured using the AAPOS referral criteria. It was explored that Spot Screener data were affected by cycloplegia. The extent of agreement between cycloplegic/noncycloplegic photoscreening data and cycloplegic autorefraction measurements was assessed using Wilcoxon and Spearman correlation analyses. Results. The Spot’s sensitivity was improved from 60.9% to 85.3% and specificity from 94.9% to 87.4% with cycloplegia compared to cycloplegic standard autorefractometer results. The positive predictive value of Spot was 75.7%, and the negative predictive value was 90.4% without cycloplegia. With cycloplegia, the positive predictive value of Spot was 63.6% and the negative predictive value was 95.8%. Conclusions. The Spot Screener afforded moderate sensitivity and high specificity prior to cycloplegia. The sensitivity and negative predictive value improved after induction of cycloplegia. Examiners should be aware of the effects of cycloplegia on their findings.

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An assessment of chromosomal alterations detected by fluorescence in situ hybridisation in pancreatobiliary tract malignancy

BMC Gastroenterology ◽

10.1186/s12876-020-01439-0 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Xiaohong Pu ◽

Hongwei Zheng ◽

Xin Yang ◽

Qing Ye ◽

Zhiwen Fan ◽

...

Keyword(s):

Predictive Value ◽

In Situ Hybridisation ◽

False Negative ◽

Chinese Patients ◽

Fluorescence In Situ Hybridisation ◽

Predictive Values ◽

Formalin Fixed Paraffin Embedded ◽

9P21 Locus ◽

Sensitivity Specificity

Abstract Background Using fluorescence in situ hybridisation (FISH) to detect any gain of chromosomes 3, 7, or 17 and loss of the 9p21 locus has been proven to be sensitive in the diagnosis of pancreatobiliary tumors. However, both genetic and environmental factors contribute to the pathogenesis of pancreatobiliary tumors. Therefore, it is unknown whether this method is suitable for Chinese patients with pancreatobiliary tumors. This study aims to compare the sensitivity, specificity, predictive values and accuracy of cytology, ERCP/MRCP and FISH based on Chinese patients with pancreatobiliary tumors,and to analyze differences between brushing-based and formalin-fixed paraffin-embedded (FFPE)-based FISH. Methods A total of 66 brush cytology specimens obtained during ERCP were detected by FISH and cytology test respectively to compare the sensitivity, specificity, predictive values and accuracy. Besides, FFPE-based FISH was performed on 46 corresponding paraffin sections of pancreatobiliary tumors obtained by surgical resection. Results Our findings demonstrate that FISH greatly improves diagnostic sensitivity and negative predictive value compared to ERCP/MRCP and cytology without much reduction in specificity and positive predictive value. However, our results also indicate that FFPE-based FISH could not effectively identify the false-negative of brushing-based FISH. Conclusions We believe that FISH can effectively distinguish true positive and false positive results of cytological or radiological suspicions of malignancy. However, FFPE-based FISH still does not precisely recognize the false-negative of brushing-based FISH. Both cytology-based and PPFE-based FISH had limitation in some specimens.

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