scholarly journals Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Kamil F. Faridi ◽  
Hector Tamez ◽  
Neel M. Butala ◽  
Yang Song ◽  
Changyu Shen ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trials ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Claims Data ◽  
High Specificity ◽  
Kappa Statistics ◽  
Administrative Claims ◽  
Medicare Claims

Background: Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease. Methods: We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with International Classification of Diseases, Ninth Revision codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics. Results: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; P =0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; P <0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively. Conclusions: Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.

scholarly journals Agreement in the diagnosis of dental fluorosis in central incisors performed by a standardized photographic method and clinical examination

2009 ◽  
Vol 25 (5) ◽  
pp. 1017-1024 ◽  
Author(s):  
Carolina Castro Martins ◽  
Loliza Chalub ◽  
Ynara Bosco Lima-Arsati ◽  
Isabela Almeida Pordeus ◽  
Saul Martins Paiva
Keyword(s):  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Clinical Examination ◽  
Predictive Value ◽  
Gold Standard ◽  
Dental Fluorosis ◽  
Digital Camera ◽  
High Specificity ◽  
Photographic Method ◽  
Pediatric Dentists

The aim of this study was to assess agreement in the diagnosis of dental fluorosis performed by a standardized digital photographic method and a clinical examination (gold standard). 49 children (aged 7-9 years) were clinically evaluated by a trained examiner for the assessment of dental fluorosis. Central incisors were evaluated for the presence or absence of dental fluorosis and were photographed with a digital camera. Photographs were presented to three pediatric dentists, who examined the images. Data were analyzed using Cohen's kappa and validity values. Agreement in the diagnosis performed by the photographic method and clinical examination was good (0.67) and accuracy was 83.7%. The prevalence of dental fluorosis was reported to be higher in the clinical examination (49%) compared with the photographic method (36.7%). The photographic method presented higher specificity (96%) than sensitivity (70.8%), a positive predictive value (PPV) of 94.4% and a negative predictive value (NPV) of 77.4%. The diagnosis of dental fluorosis performed using the photographic method presented high specificity and PPV, which indicates that the method is reproducible and reliable for recording dental fluorosis.

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

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
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.

scholarly journals Correlation between ultrasonographic and histopathological findings of hysterectomy specimen in patients with abnormal uterine bleeding

2020 ◽  
Vol 9 (10) ◽  
pp. 4123
Author(s):  
Kaushik Mahajan ◽  
R. K. Praneshwari Devi ◽  
Ajitkumar Singh ◽  
Dipenty Lairenjam ◽  
Leimapokpam Roshan Singh ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Abnormal Uterine Bleeding ◽  
Clinical History ◽  
Uterine Bleeding ◽  
Kappa Statistics ◽  
Cross Sectional ◽  
Common Diagnosis ◽  
Sensitivity Specificity

Background: AUB is a common and debilitating condition and it is one of the main gynaecological reasons for hysterectomy. Ultrasonography can be as good as histopathology (HPE) in the diagnosis of abnormal uterine bleeding. Hence, our study was conducted to validate the ultrasonographic findings with HPE findings in diagnosis of AUB.Methods: A hospital based cross-sectional analytical study was conducted among 86 patients with abnormal uterine bleeding in the department of Obstetrics and Gynaecology in collaboration with department of Pathology, RIMS, Imphal from September 2017 to March 2019. The clinical history and socio demographic profile were collected using a pre-designed proforma. General physical examination, pelvic examination and ultrasonagraphy was carried out and the hysterectomy specimens were subjected to histopathological examination.Results: Fibromyoma was diagnosed by ultrasound in 62.8% of the patients and it was the common diagnosis in this study. The sensitivity, specificity, positive predictive value, negative predictive value and kappa statistics of USG for diagnosing leiomyoma was 92.9%, 93.3%, 96.3%, 87.5% and 84.9% respectively. The sensitivity, specificity, positive predictive value, negative predictive value and kappa statistics of USG for diagnosing adenomyosis was 53.8%, 98.6%, 87.5%, 92.3% and 62.3% respectively.Conclusions: The study provides an evidence that ultrasonography has good diagnostic accuracy as histopathology in the diagnosis of fibroid in patients with abnormal uterine bleeding. However, as with all the diagnostic procedures, the utility of ultrasound in the diagnosis of adenomyosis is questionable, since it has a low sensitivity amidst good specificity.

scholarly journals Clinicoradiological features of intraneural perineuriomas obviate the need for tissue diagnosis

2018 ◽  
Vol 129 (4) ◽  
pp. 1034-1040 ◽  
Author(s):  
Thomas J. Wilson ◽  
B. Matthew Howe ◽  
Shelby A. Stewart ◽  
Robert J. Spinner ◽  
Kimberly K. Amrami
Keyword(s):  
Positive Predictive Value ◽  
Contrast Enhancement ◽  
Negative Predictive Value ◽  
Diagnostic Criteria ◽  
Predictive Value ◽  
High Specificity ◽  
Mr Images ◽  
Cancer History ◽  
Tissue Diagnosis ◽  
Intraneural Perineurioma

OBJECTIVEThis study aimed to define a set of clinicoradiological parameters with a high specificity for the diagnosis of intraneural perineurioma, obviating the need for operative tissue diagnosis.METHODSThe authors retrospectively reviewed MR images obtained in a large cohort of patients who underwent targeted fascicular biopsy and included only those patients for whom the biopsy yielded a diagnosis. Clinical and radiological findings were then tested for their ability to predict a tissue diagnosis of intraneural perineurioma. The authors propose a new set of diagnostic criteria, referred to as the Perineurioma Diagnostic Criteria. The sensitivity, specificity, positive predictive value, and negative predictive value of several clinicoradiological methods of diagnosis were compared.RESULTSA total of 195 patients who underwent targeted fascicular biopsy were included in the cohort, of whom 51 had a tissue diagnosis of intraneural perineurioma. When the clinicoradiological methods used in this study were compared, the highest sensitivity (0.86), negative predictive value (0.95), and F1 score (0.88) were observed for the decision trees generated in C5.0 and rPart, whereas the highest specificity (1.0) and positive predictive value (1.0) were observed for the Perineurioma Diagnostic Criteria.CONCLUSIONSThis study identified clinical and radiological features that are associated with a diagnosis of perineurioma. The Perineurioma Diagnostic Criteria were determined to be the following: 1) no cancer history, 2) unifocal disease, 3) moderate to severe hyperintensity on T2-weighted MR images, 4) moderate to severe contrast enhancement, 5) homogeneous contrast enhancement, 6) fusiform shape, 7) enlargement of the involved nerves, and 8) age ≤ 40 years. Use of the Perineurioma Diagnostic Criteria obviates the need for tissue diagnosis when all of the criteria are satisfied.

scholarly journals A highly predictive signature of cognition and brain atrophy for progression to Alzheimer’s dementia

2018 ◽  
Author(s):  
Angela Tam ◽  
Christian Dansereau ◽  
Yasser Itturia-Medina ◽  
Sebastian Urchs ◽  
Pierre Orban ◽  
...  
Keyword(s):  
Machine Learning ◽  
Clinical Trials ◽  
High Risk ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
High Specificity ◽  
Alzheimer’S Dementia ◽  
Learning Tools ◽  
Operating Characteristics ◽  
Alzheimer's Dementia

AbstractClinical trials in Alzheimer’s disease need to enroll patients whose cognition will decline over time, if left untreated, in order to demonstrate the efficacy of an intervention. Machine learning models used to screen for patients at risk of progression to dementia should therefore favor specificity (detecting only progressors) over sensitivity (detecting all progressors), especially when the prevalence of progressors is low. Here, we explore whether such high-risk patients can be identified using cognitive assessments and structural neuroimaging, by training machine learning tools in a high specificity regime. A multimodal signature of Alzheimer’s dementia was first extracted from ADNI1. We then validated the predictive value of this signature on ADNI1 patients with mild cognitive impairment (N=235). The signature was optimized to predict progression to dementia over three years with low sensitivity (55.1%) but high specificity (95.6%), resulting in only moderate accuracy (69.3%) but high positive predictive value (80.4%, adjusted for a “typical” 33% prevalence rate of true progressors). These results were replicated in ADNI2 (N=235), with 87.8% adjusted positive predictive value (96.7% specificity, 47.3% sensitivity, 85.1% accuracy). We found that cognitive measures alone could identify high-risk individuals, with structural measurements providing a slight improvement. The signature had comparable receiver operating characteristics to standard machine learning tools, yet a marked improvement in positive predictive value was achieved over the literature by selecting a high specificity operating point. The multimodal signature can be readily applied for the enrichment of clinical trials.

scholarly journals Drain Tip Culture: Would It Help Us Predict and Prevent Surgical Site Infection After Spinal Surgery?

2021 ◽  
Vol 2 (1) ◽  
Keyword(s):  
Positive Predictive Value ◽  
Surgical Site Infection ◽  
Negative Predictive Value ◽  
Spine Surgery ◽  
Predictive Value ◽  
Spinal Surgery ◽  
Statistical Significance ◽  
High Specificity ◽  
Site Infection ◽  
Low Sensitivity

Background: Systematic cultures of drain tips or drainage fluids are commonly used by surgical teams for the early detection of Surgical Site Infection (SSI), even in the absence of clinical suspicion of infection. However, their prognostic values are controversial. Method: This was a prospective study of patients undergoing spine surgery at our institute during the study period. Patients already diagnosed with spine infection were excluded from the study. At the time of drain removal, the drain tip was cut and sent to microbiology laboratory for bacterial culture. All patients were treated with antimicrobial prophylaxis based on evidence-based guidelines and were monitored for at least 6 months after surgery for the development of Surgical Site Infection (SSI). SSI was defined according to Centers for Disease Control and Prevention criteria. Results: The study comprised of 183 patients including 85 males and 98 females. The rate of Surgical Site Infection in our study was 2.73 % (5 patients). Drain Tip Culture (DTC) was positive in 4 patients (2.18 %). Association of DTC with SSI was found to have high Specificity (98.31 %) and Negative Predictive Value (97.76 %) but low Sensitivity (20 %) and Positive Predictive Value (25 %). Conclusion: Culture of drain tip after spine surgery does not conclusively predict the presence or absence of surgical site infection. However, statistical significance was observed between drain tip culture and surgical site infection with high specificity, high negative predictive value, low sensitivity and low positive predictive value. Keywords: Drain tip culture; Spinal Surgery; Surgical site infection.

scholarly journals Early diagnosis of myocardial infarction in patients presenting late after chest pain onset

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Boeddinghaus ◽  
T Nestelberger ◽  
P Lopez-Ayala ◽  
P.D Ratmann ◽  
D Wussler ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Chest Pain ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Funding Source ◽  
Late Presenters ◽  
Coronary Syndrome ◽  
Rule Out

Abstract Background The European Society of Cardiology (ESC) recommends the clinical use of the 0/1h-algorithms in patients with suspected acute coronary syndrome (ACS) to rule-out or rule-in non-ST elevation myocardial infarction (NSTEMI). However, the diagnostic performance of the ESC 0/1h-algorithms was only validated in patients presenting within 12 hours after chest pain onset (=early presenters) to the emergency department (ED). To this date, evidence regarding their performance in patients with chest pain onset &gt;12h (=late presenters) is lacking. Purpose To evaluate the diagnostic performance of the ESC 0/1h-algorithms in late presenters. Methods We prospectively enrolled patients presenting to the ED with symptoms suggestive of ACS such as acute chest discomfort. Two independent cardiologists adjudicated the final diagnoses based on all available clinical information including serial hs-cTn concentrations, follow-up information and cardiac imaging. Hs-cTnT/I concentrations at 0h and 1h were measured in a blinded fashion. The primary diagnostic endpoint was the diagnostic performance of the hs-cTnT/I ESC 0/1h-algorithms in patients presenting late after chest pain onset compared to those presenting early. Diagnostic performance was quantified by safety of rule-out (sensitivity and negative predictive value), accuracy of rule-in (specificity and positive predictive value), and efficacy (proportion of patients) classified as rule-out or rule-in within 1 hour after presentation to the ED. The primary prognostic endpoint was all-cause mortality after 30-days and two-years in patients in whom NSTEMI was ruled-out by the ESC 0/1h-algorithms. Results Among 4733 patients, 308/4733 (7%) presented late to the ED. The ESC hs-cTnT 0/1h-algorithm ruled-out 185/308 (60%) of late presenters with a sensitivity of 100% (95% CI, 93.7–100) and a negative predictive value (NPV) of 100% (95% CI, 98.0–100). Sixty-one of 308 (20%) were ruled-in with a specificity of 95.2 (95% CI, 91.8–97.2) and a positive predictive value (PPV) of 80.3% (95% CI, 68.7–88.4). The remaining 62/308 (20%) were classified as observe with a NSTEMI prevalence of 13%. In comparison, 59% of early presenters were ruled-out (sensitivity 99.3% [95% CI, 98.4–99.7]; NPV 99.8 [99.5–99.9]), 17% were ruled-in (specificity 96.2 [95% CI, 95.5–96.8]; PPV 81.4 [95% CI, 78.4–84.0]), and 45% were classified as observe. Late presenters in whom NSTEMI was ruled-out had 30-day and two-year survival rates of 100% and 98.2%, respectively. Similar findings were made for the ESC hs-cTnI 0/1h-algorithm. Conclusion The ESC hs-cTnT/I algorithms also provide excellent diagnostic performance for early triage and specifically safe rule-out of NSTEMI in patients presenting late after chest pain onset to the ED. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Swiss Heart Foundation, Swiss National Science Foundation

scholarly journals The Use of Active Melioidosis Detect TM in Early Diagnosis of Melioidosis in Hospital Tengku Ampuan Afzan and Hospital Sultanah Nur Zahirah

2020 ◽  
Vol 18 (2) ◽  
Author(s):  
Wan Nurliyana Wan Ramli
Keyword(s):  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Sensitivity And Specificity ◽  
Predictive Value ◽  
Point Of Care ◽  
Rapid Test ◽  
High Specificity ◽  
Culture Method ◽  
Lower Sensitivity ◽  
Spot Urine

Introduction: Melioidosis is endemic in Malaysia and an important cause of sepsis. Current gold standard for diagnosis is by culture method,but its long procedure will delay the treatment leading to hospital-related mortality.Thus,a good rapid test is needed to reduce its mortality burden. Recently, Active Melioidosis Detect (AMD) have been shown to be useful. Objectives: (1)To measure the sensitivity and specificity of AMD. (2)To study the sensitivity and specificity of early morning urine AMD compared to spot urine AMD. Materials and method: A prospective crosssectional study of clinically suspected melioidosis patients in HTAA and HSNZ from April until December 2018. Blood and urine samples were tested with AMD. Test results were analysed for sensitivity, specificity,positive predictive value and negative predictive value. Results: A total of 89 patients were included in this study.The mean age is 52 years old, and 56.3% were male gender.64% of patients have diabetes mellitus.11 patients have positive blood culture for Bukholderia pseudomallei, 4 of them were tested positive for AMD.3 of them presented with septic shock (3.4%), however none died.The sensitivity of the AMD was 36.4% ([95% CI 12.4 to 68.4]) and the specificity was 66.7% ( [95% CI 46.0 to 82.8]) in all samples, with positive predictive value of 30.7% and negative predictive value of 72%.Blood samples have lower sensitivity of 9.1% ([95% CI 4.8 to 42.9]) with high specificity of 100% ([95% CI 84.5 to 100]). Urine spot samples have higher sensitivity compared to serum and morning urine, with 36.4% ([95%CI 12.4 to 68.4]) and specificity of 88.9% ([95% CI 69.7 to 97.1]). Conclusion: From this pilot study, this test requires further evaluation before incorporating as point of care assay.

scholarly journals Point of Care Tests VerifyNow P2Y12 and INNOVANCE PFA P2Y Compared to Light Transmittance Aggregometry After Fibrinolysis

2018 ◽  
Vol 24 (7) ◽  
pp. 1109-1116 ◽  
Author(s):  
Vincent Roule ◽  
Pierre Ardouin ◽  
Yohan Repessé ◽  
Agnès Le Querrec ◽  
Katrien Blanchart ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Platelet Reactivity ◽  
Point Of Care ◽  
Light Transmittance ◽  
Light Transmittance Aggregometry ◽  
St Elevation ◽  
Point Of Care Tests

Detection of high on-treatment platelet reactivity (HPR) by point-of-care tests has not been validated after successful fibrinolysis for ST-elevation myocardial infarction. We assessed the validity of the point-of-care VerifyNow P2Y12 (VN) and INNOVANCE PFA P2Y (PFA) tests on HPR compared to light transmittance aggregometry (LTA) in these patients. The HPR was identified in 10 (34.5%) patients, 15 (51.7%) patients, and 14 (50%) patients using LTA, VN, and PFA, respectively. Discrepancies were observed between the tests despite significant correlations between platelet reactivity measures by LTA and VN ( r = 0.74; P < .0001) and LTA and PFA ( r = .75; P < .0001). Compared to LTA, VN and PFA were associated with a 92% and 53% and 92% and 64% positive predictive value (PPV) and negative predictive value (NPV), respectively, in detecting HPR. When combined, VN and PFA results yielded 90% and 100% PPV and NPV values if discrepancies between the 2 tests were considered as non-HPR. The VN or PFA identify patients without HPR correctly but overestimate the proportion of HPR patients. The association of the 2 tests, in case of HPR, improves the accuracy of the detection of HPR.

Sign in / Sign up

Export Citation Format

Share Document