Difference In Positive Predictive Value Research Articles

Compare nasal endoscopy with Computed Tomography scans for chronic rhinosinusitis detection in adult Iraqi patients

Background: Chronic rhinosinusitis (CRS) is often diagnosed based on clinical features. Assurance in this context is based on the finding of inflammatory features during nasal endoscopy and computed tomography (CT) scans of the paranasal sinuses. While a CT scan is considered the most reliable method, research has shown that nasal endoscopy is also valuable and can sometimes provide additional information to supplement the CT scan in diagnosing CRS. Objective: The study goal was to demonstrate the comparative reliability of nasal endoscopy and computed tomography scans in diagnosing chronic rhinosinusitis in adult patients treated at Baqubah Teaching Hospital. Patients and Methods: The study sample consisted of consecutive adult participants clinically diagnosed with chronic rhinosinusitis. Patients who had a computed tomography scan of the paranasal sinuses and a nasal endoscopy during three months were the subjects of this investigation; the outcomes were linked. Results: Study results exhibit that the most prevalent symptoms seen in the study participants were nasal discharge and nasal obstruction, reported by 95% and 90%, respectively; the most prevailing observation during nasal endoscopy was middle meatus purulent discharge, noticed in 58% of the patients. Maxillary sinus was most often affected, seen in 65% of the patients on a CT scan, and 40% had obstruction of the osteomeatal complex on CT imaging. The nasal endoscopy had a sensitivity of 73.3%, specificity of 85.3%, positive predictive value of 92.7%, and negative predictive value of 55.8%. The research also found no significant differences in positive predictive value (PPV) between nasal endoscopy and CT scan. In contrast, the sensitivity of nasal endoscopy was significantly greater than that of CT scan. Conclusion: The study found that nasal endoscopic findings for patients with positive clinical features were purulent (cream-colored) discharge and middle meatus polyps, which is sufficient for diagnosing chronic rhinosinusitis; the study showed that Nasal endoscopy is almost as accurate as CT scans and CT scan findings are well correlates with sinus endoscopy, due to its precision, cheap cost, and radiation dosage.

Is concurrent LR-5 associated with a higher rate of hepatocellular carcinoma in LR-3 or LR-4 observations? An individual participant data meta-analysis.

The Liver Imaging Reporting and Data System (LI-RADS) does not consider factors extrinsic to the observation of interest, such as concurrent LR-5 observations. To evaluate whether the presence of a concurrent LR-5 observation is associated with a difference in the probability that LR-3 or LR-4 observations represent hepatocellular carcinoma (HCC) through an individual participant data (IPD) meta-analysis. Multiple databases were searched from 1/2014 to 2/2023 for studies evaluating the diagnostic accuracy of CT/MRI for HCC using LI-RADS v2014/2017/2018. The search strategy, study selection, and data collection process can be found at https://osf.io/rpg8x . Using a generalized linear mixed model (GLMM), IPD were pooled across studies and modeled simultaneously with a one-stage meta-analysis approach to estimate positive predictive value (PPV) of LR-3 and LR-4 observations without and with concurrent LR-5 for the diagnosis of HCC. Risk of bias was assessed using a composite reference standard and Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Twenty-nine studies comprising 2591 observations in 1456 patients (mean age 59years, 1083 [74%] male) were included. 587/1960 (29.9%) LR-3 observations in 1009 patients had concurrent LR-5. The PPV for LR-3 observations with concurrent LR-5 was not significantly different from the PPV without LR-5 (45.4% vs 37.1%, p = 0.63). 264/631 (41.8%) LR-4 observations in 447 patients had concurrent LR-5. The PPV for LR-4 observations with concurrent LR-5 was not significantly different from LR-4 observations without concurrent LR-5 (88.6% vs 69.5%, p = 0.08). A sensitivity analysis for low-risk of bias studies (n = 9) did not differ from the primary analysis. The presence of concurrent LR-5 was not significantly associated with differences in PPV for HCC in LR-3 or LR-4 observations, supporting the current LI-RADS paradigm, wherein the presence of synchronous LR-5 may not alter the categorization of LR-3 and LR-4 observations.

Technetium-99m-methylene diphosphonate single photon emission computed tomography/computed tomography combined with prostate-specific antigen/free prostate-specific antigen ratio for bone metastasis of prostate cancer.

Prostate cancer (PC) is one of the most common malignant tumors in men, and bone metastasis is one of its common complications, which seriously affects the quality of life and prognosis of patients. To investigate the diagnostic value of technetium-99m-methylene diphosphonate (99mTc-MDP) single photon emission computed tomography (SPECT)/CT imaging combined with the serum prostate-specific antigen (PSA)/free PSA ratio for PC bone metastasis (PCBM). One hundred patients with PC who visited the Hospital of Chengdu University of Traditional Chinese Medicine from January 2020 to January 2022 were recruited as the experimental (Exp) group, while 30 patients with benign prostatic lesions (BPLs) were recruited as the control (Ctrl) group. All patients underwent 99mTc-MDP SPECT/CT imaging and serum PSA/fPSA testing. The SPECT/CT imaging results and serum PSA/fPSA ratios of patients were analyzed to evaluate their diagnostic values for PCBM. The difference in general information of the patients was not obvious, showing comparability. The two methods showed no visible differences in negative predictive value and sensitivity for patients with PCBM, but had great differences in positive predictive value and specificity (P < 0.05). The PSA/fPSA ratio of patients with PC in the Exp group was lower than those with BPLs, and patients with PCBM had a much lower PSA/fPSA ratio than those without PC (P < 0.05). The results confirmed that the combined use of 99mTc-MDP SPECT/CT imaging and serum PSA/fPSA ratio achieved a detection rate of 95% for PCBM. The combination of 99mTc-MDP SPECT/CT and PSA/fPSA ratio is accurate and reliable for the diagnosis of PCBM, which provides an important reference for clinical practice.

Comparison of Positive Predictive Values of Biparametric MRI and Multiparametric MRI-directed Transrectal US-guided Targeted Prostate Biopsy.

Background Biparametric MRI (bpMRI) of the prostate is an alternative to multiparametric MRI (mpMRI), with lower cost and increased accessibility. Studies investigating the positive predictive value (PPV) of bpMRI-directed compared with mpMRI-directed targeted biopsy are lacking in the literature. Purpose To compare the PPVs of bpMRI-directed and mpMRI-directed targeted prostate biopsies. Materials and Methods This retrospective cross-sectional study evaluated men who underwent bpMRI-directed or mpMRI-directed transrectal US (TRUS)-guided targeted prostate biopsy at a single institution from January 2015 to December 2022. The PPVs for any prostate cancer (PCa) and clinically significant PCa (International Society of Urological Pathology grade ≥2) were calculated for bpMRI and mpMRI using mixed-effects logistic regression modeling. Results A total of 1538 patients (mean age, 67 years ± 8 [SD]) with 1860 lesions underwent bpMRI-directed (55%, 849 of 1538) or mpMRI-directed (45%, 689 of 1538) prostate biopsy. When adjusted for the number of lesions and Prostate Imaging Reporting and Data System (PI-RADS) score, there was no difference in PPVs for any PCa or clinically significant PCa (P = .61 and .97, respectively) with bpMRI-directed (55% [95% CI: 51, 59] and 34% [95% CI: 30, 38], respectively) or mpMRI-directed (56% [95% CI: 52, 61] and 34% [95% CI: 30, 39], respectively) TRUS-guided targeted biopsy. PPVs for any PCa and clinically significant PCa stratified according to clinical indication were as follows: biopsy-naive men, 64% (95% CI: 59, 69) and 43% (95% CI: 39, 48) for bpMRI, 67% (95% CI: 59, 75) and 51% (95% CI: 43, 59) for mpMRI (P = .65 and .26, respectively); and active surveillance, 59% (95% CI: 49, 69) and 30% (95% CI: 22, 39) for bpMRI, 73% (95% CI: 65, 89) and 38% (95% CI: 31, 47) for mpMRI (P = .04 and .23, respectively). Conclusion There was no evidence of a difference in PPV for clinically significant PCa between bpMRI- and mpMRI-directed TRUS-guided targeted biopsy. © RSNA, 2024 Supplemental material is available for this article.

Validation Study of Cardiovascular International Statistical Classification of Diseases and Related Health Problems, Tenth Edition, Australian Modification (ICD-10-AM) Codes in Administrative Healthcare Databases (ANZACS–QI 77)

Administrative healthcare databases can be utilised for research. The accuracy of the International Statistical Classification of Diseases and Related Health Problems, Tenth Edition, Australian Modification (ICD-10-AM) coding of cardiovascular conditions in New Zealand is not known and requires validation. International Statistical Classification of Diseases and Related Health Problems, Tenth Edition, Australian Modification coded discharges for acute coronary syndrome (ACS), heart failure (HF) and atrial fibrillation (AF), in both primary and secondary diagnostic positions, were identified from four district health boards between 1 January 2019 and 31 June 2019. A sample was randomly selected for retrospective clinician review for evidence of the coded diagnosis according to contemporary diagnostic criteria. Positive predictive values (PPVs) for ICD-10-AM coding vs clinician review were calculated. This study is also known as All of New Zealand, Acute Coronary Syndrome-Quality Improvement (ANZACS-QI) 77. A total of 600 cases (200 for each diagnosis, 5.0% of total identified cases) were reviewed. The PPV of ACS was 93% (95% confidence interval [CI] 89%-96%), HF was 93% (95% CI 89%-96%) and AF was 96% (95% CI 92%-98%). There were no differences in PPV between district health boards. PPV for ACS were lower in Māori vs non-Māori (72% vs 96%; p=0.004), discharge from non-Cardiology vs Cardiology services (89% vs 96%; p=0.048) and ICD-10-AM coding for unstable angina vs myocardial infarction (81% vs 95%; p=0.011). PPV for HF were higher in the primary vs secondary diagnostic position (100% vs 89%; p=0.001). The PPVs of ICD-10-AM coding for ACS, HF, and AF were high in this validation study. ICD-10-AM coding can be used to identify these diagnoses in administrative databases for the purposes of healthcare evaluation and research.

Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan.

The Medical Information Database Network (MID-NET®) in Japan is a vast repository providing an essential pharmacovigilance tool. Gastrointestinal perforation (GIP) is a critical adverse drug event, yet no well-established GIP identification algorithm exists in MID-NET®. This study evaluated 12 identification algorithms by combining ICD-10 codes with GIP therapeutic procedures. Two sites contributed 200 inpatients with GIP-suggestive ICD-10 codes (100 inpatients each), while a third site contributed 165 inpatients with GIP-suggestive ICD-10 codes and antimicrobial prescriptions. The positive predictive values (PPVs) of the algorithms were determined, and the relative sensitivity (rSn) among the 165 inpatients at the third institution was evaluated. A trade-off between PPV and rSn was observed. For instance, ICD-10 code-based definitions yielded PPVs of 59.5%, whereas ICD-10 codes with CT scan and antimicrobial information gave PPVs of 56.0% and an rSn of 97.0%, and ICD-10 codes with CT scan and antimicrobial information as well as three types of operation codes produced PPVs of 84.2% and an rSn of 24.2%. The same algorithms produced statistically significant differences in PPVs among the three institutions. Combining diagnostic and procedure codes improved the PPVs. The algorithm combining ICD-10 codes with CT scan and antimicrobial information and 80 different operation codes offered the optimal balance (PPV: 61.6%, rSn: 92.4%). This study developed valuable GIP identification algorithms for MID-NET®, revealing the trade-offs between accuracy and sensitivity. The algorithm with the most reasonable balance was determined. These findings enhance pharmacovigilance efforts and facilitate further research to optimize adverse event detection algorithms.

314 Long-term Follow-up of Cerebral Aneurysms Completely Occluded at 6 Months After Intervention With the Woven EndoBridge (WEB) Device: A Retrospective Multicenter Observational Study

INTRODUCTION: The Woven EndoBridge (WEB) device has been widely used to treat intracranial wide neck bifurcation aneurysms. Initial studies have demonstrated that approximately 90% of patients have the same or improved long-term aneurysm occlusion after the initial 6-month follow-up. METHODS: This is an analysis of a prospectively maintained database across 13 academic institutions. We included patients with previously untreated cerebral aneurysms embolized using the WEB device who achieved complete occlusion at first follow-up and had available long-term follow-up. RESULTS: A total of 95 patients with a mean age of 61.6 ± 11.9 years were studied. The mean neck diameter and height were 3.9 ± 1.3 mm and 6.0 ± 1.8 mm, respectively. The mean time to the first and last follow-up was 5.4 ± 1.8 and 14.1 ± 12.9 months, respectively. Out of all the aneurysms that were completely occluded at 6 months, 84 (90.3%) showed complete occlusion at the final follow-up, and 11(11.5%) patients did not achieve complete occlusion. The positive predictive value (PPV) of complete occlusion at the first follow was 88.4%. Importantly, this did not differ between Digital Subtraction Device (DSA), Magnetic Resonance Angiography (MRA), or Computed Tomography Angiography (CTA). CONCLUSIONS: This study underlines the importance of repeat imaging in patients treated with the WEB device even if complete occlusion is achieved short term. Follow-up can be performed using DSA, MRA, or CTA with no difference in positive predictive value.

Myelin oligodendrocyte glycoprotein antibody titers by fixed cell-based assay: positive predictive value and impact of sample collection timing.

In January 2023, our laboratory began performing serum myelin oligodendrocyte glycoprotein antibody (anti-MOG) titers by fixed cell-based assay (CBA). As a quality assurance (QA) assessment, we evaluated titer positive predictive value (PPV) as well as impact of sample collection timing on titers. Among patients who underwent antibody titers to distinguish between low-positive (<1:100) and clear-positive (≥1:100) anti-MOG, records were reviewed to classify results as true-positive (TP) or false-positive (FP) and facilitate PPV calculation. Timing of sample collection relative to administration of immunotherapy and symptom onset was determined for TP results. Overall PPV of anti-MOG was 70/85 (82%). The PPV of low-positive anti-MOG was significantly lower than clear-positive anti-MOG (72% vs. 95%, p = 0.009). The difference in PPV between low-positive and clear-positive anti-MOG was significant among adults tested, but not children. Among patients with TP anti-MOG, the proportion who received immunotherapy prior to sample collection was significantly higher and median time from symptom onset to sample collection was significantly longer for low-positive compared to clear-positive results. Overall PPV of anti-MOG testing by fixed CBA was reasonably high. The PPV of low-positive anti-MOG was significantly lower than clear-positive anti-MOG. This was driven by the significantly lower PPV of low-positive anti-MOG in adults, possibly reflecting the lower prevalence of MOG antibody-associated disease among adults tested. Timing of sample collection relative to administration of immunotherapy and symptom onset may substantially impact titers, indicating that testing should ideally be performed prior to immunotherapy and close to time of attack.

Characteristics of Suspicious Breast Lesions Visible Only on MR Imaging: Is It Possible to Classify into Immediate Biopsy and Careful Observation Groups?

To investigate the characteristics of suspicious MRI-only visible lesions and to explore the validity of subcategorizing these lesions into the following two groups: lesions that would require immediate biopsy (4Bi) and lesions for which careful clinical follow-up could be recommended (4Fo). A retrospective review of 108 MRI-only visible lesions in 106 patients who were diagnosed as Breast Imaging Reporting and Data System (BI-RADS) category 4 between June 2018 and June 2022 at our institution was performed by two radiologists. The breast MR images were evaluated according to BI-RADS and additional MRI descriptors (linear ductal, branching, and apparent diffusion coefficient values). The lesions were categorized by previously reported classification systems, and the positive predictive values (PPVs) for the different categories were determined and compared. Subsequently, a new classification system was developed in this study. The total malignancy rate was 31% (34/108). No significant differences between benign and malignant lesions were identified for focus and mass lesions. For non-mass lesions, linear ductal and heterogeneous internal enhancement suggested a benign lesion (P = 0.0013 and P = 0.023, respectively), and branching internal enhancement suggested malignancy (P = 0.0066). Segmental distribution suggested malignancy (P = 0.0097). However, the PPV of segmental distribution with heterogeneous enhancement was significantly lower than that of category 4 segmental lesions with other enhancement patterns (11% vs. 59%; P = 0.0198).As a new classification, the distribution of focal, linear, and segmental was given a score of 0, 1, or 2, and the internal enhancement of heterogeneous, linear-ductal, clumped, branching, and clustered-ring enhancement was given a score of 0, 1, 2, 3, and 4, respectively. When categorized using a scoring system, a statistically significant difference in PPV was observed between 4Fo (n = 27) and 4Bi (n = 33) (7% vs. 61%, P = 0.000029). The new classification system was found to be highly capable of subcategorizing BI-RADS category 4 MRI-only visible non-mass lesions into 4Fo and 4Bi.

Application of non-invasive prenatal testing to 91,280 spontaneous pregnancies and 3477 pregnancies conceived by in vitro fertilization

BackgroundMany clinical studies based on spontaneous pregnancies (SPs) have demonstrated the superiority of non-invasive prenatal testing (NIPT), and the question of whether this technology is suitable for offspring conceived by assisted reproductive technology has attracted attention. This study aimed to evaluate the application value of NIPT in screening for trisomy (T)21, T18, T13 and sex chromosome aneuploidy (SCA) in pregnant women who conceived by in vitro fertilization (IVF).ResultsIn total, there were 804 high-risk cases [0.88% (804/91280), singleton = 795, twin = 9] in the SP group. Among the 558 invasive prenatal diagnosis (IPD) cases (singleton = 556, twin = 2), 343 (singleton = 342, twin = 1) were true positive, including 213 cases of T21, 28 of T18, 5 of T13 and 97 (singleton = 96, twin = 1) of SCA. The positive predictive values (PPVs) of T21, T18, T13, SCA and T21/T18/T13 combined in singleton pregnancy were 89.12% (213/239), 51.85% (28/54), 21.74% (5/23), 40.00% (96/240), and 77.85% (246/316), respectively, and the PPV of SCA in twin pregnancy was 100.00%. In the IVF group, IPD was performed in 19 (singleton = 16, twin = 3) of the 27 high-risk cases [0.78% (27/3477), singleton = 16, twin = 3], of which 9 (singleton = 8, twin = 1) were true positive, including 5 cases (singleton = 4, twin = 1) of T21 and 4 of SCA. The PPVs of singleton T21, SCA and T21/T18/T13 combined were 66.67% (4/6), 50.00% (4/8) and 57.14% (4/7), respectively, and the PPV of twin T21 was 100.00% (1/1). There were no significant differences in PPV among T21, SCA and T21/T18/T13 combined in singletons between the groups (89.12% vs. 66.67%, p = 0.09; 40.00% vs. 50.00%, p = 0.57; 77.85% vs. 57.14%, p = 0.20). The sensitivity and specificity were higher for singleton and twin pregnancies in the two groups. Based on follow-up results, 1 case of false negative T21 was found in the singleton SP group. Additionally, the mean foetal fraction (FF) of the IVF group was lower than that of the SP group (11.23% vs. 10.51%, p < 0.05).ConclusionNIPT has high sensitivity and specificity in screening chromosomal aneuploidies in both IVF pregnancy and spontaneous pregnancy, so it is an ideal screening method for IVF pregnancy.

Prehospital screening of acute stroke with the National Institutes of Health Stroke Scale (ParaNASPP): a stepped-wedge, cluster-randomised controlled trial

Timely treatment of acute stroke depends on early identification and triage. Improved methods for recognition of stroke in the prehospital setting are needed. We aimed to assess whether use of the National Institutes of Health Stroke Scale (NIHSS) by paramedics in the ambulance could improve communication with the hospital, augment triage, and enhance diagnostic accuracy of acute stroke. The Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) was a stepped-wedge, single-blind, cluster-randomised controlled trial. Patients with suspected acute stroke, who were evaluated by paramedics from five ambulance stations in Oslo, Norway, were eligible for inclusion. The five ambulance stations (defined as clusters) all initially managed patients according to a standard stroke protocol (control group), with randomised sequential crossover of each station to the intervention group. The intervention consisted of supervised training on NIHSS scoring, a mobile application to aid scoring, and standardised communication with stroke physicians. Random allocation was done via a simple lottery draw by administrators at Oslo University Hospital, who were independent of the research team. Allocation concealment was not possible due to the nature of the intervention. The primary outcome was the positive predictive value (PPV) for prehospital identification of patients with a final discharge diagnosis of acute stroke, analysed by intention to treat. Prespecified secondary safety outcomes were median prehospital on-scene time and median door-to-needle time. This trial is registered with ClinicalTrials.gov, NCT04137874, and is completed. Between June 3, 2019, and July 1, 2021, 935 patients were evaluated by paramedics for suspected acute stroke. 134 patients met exclusion criteria or did not consent to participate. The primary analysis included 447 patients in the intervention group and 354 in the control group. There was no difference in PPV for prehospital identification of patients with a final discharge diagnosis of acute stroke between the intervention group (48·1%, 95% CI 43·4-52·8) and control group (45·8%, 40·5-51·1), with an estimated percentage points difference between groups of 2·3 (95% CI -4·6 to 9·3; p=0·51). Median prehospital on-scene time increased by 5 min in the intervention group (29 min [IQR 23-36] vs 24 min [19-31]; p<0·0001), whereas median door-to-needle time was similar between groups (26 min [21-36] vs 27 min [20-36]; p=0·90). No prehospital deaths were reported in either group. The intervention did not improve diagnostic accuracy in patients with suspected stroke. A general increase in prehospital time during the pandemic and the identification of smaller strokes that require more deliberation are possible explanations for the increased on-scene time. The ParaNASPP model is to be implemented in Norway from 2023, and will provide real-life data for further research. Norwegian Air Ambulance Foundation and Oslo University Hospital.

Investigation of the diagnostic importance and accuracy of CT in the chest compared to the RT-PCR test for suspected COVID-19 patients in Jordan.

This article aims to synthesize the existing literature on the implementation of public policies to incentivize the development of treatments for rare diseases, (diseases with very low prevalence and therefore with low commercial interest) otherwise known as orphan drugs. The implementation of these incentives in the United States (US), Japan, and in the European Union (EU) seems to be related to a substantial increase in treatments for these diseases, and has influenced the way the pharmaceutical research & development (R&D) system operates beyond this policy area. Despite the success of the Orphan Drug model, the academic literature also highlights the negative implications that these public policies have on affordability and access to orphan drugs, as well as on the prioritization of certain disease rare areas over others. The synthesis focuses mostly on the United States' Orphan Drug Act (ODA) as a model for subsequent policies in other regions and countries. It starts with a historical overview of the creation of the term "rare diseases", continues with a summary of the evidence available on the US ODA's positive and negative impacts, and provides a summary of the different proposals to reform these incentives in light of the negative outcomes described. Finally, it describes some key aspects of the Japanese and European policies, as well as some of the challenges captured in the literature related to their impact in Low- and Middle-Income Countries (LMICs).

Long-Term Follow-Up of Cerebral Aneurysms Completely Occluded at 6Months After Intervention with the Woven EndoBridge (WEB) Device: a Retrospective Multicenter Observational Study.

The Woven EndoBridge (WEB) device has been widely used to treat intracranial wide neck bifurcation aneurysms. Initial studies have demonstrated that approximately 90% of patients have same or improved long-term aneurysm occlusion after the initial 6-month follow up. The aim of this study is to assess the long-term follow-up in aneurysms that have achieved complete occlusion at 6months. We also compared the predictive value of different imaging modalities used. This is an analysis of a prospectively maintained database across 13 academic institutions. We included patients with previously untreated cerebral aneurysms embolized using the WEB device who achieved complete occlusion at first follow-up and had available long-term follow-up. A total of 95 patients with a mean age of 61.6 ± 11.9years were studied. The mean neck diameter and height were 3.9 ± 1.3mm and 6.0 ± 1.8mm, respectively. The mean time to first and last follow-up was 5.4 ± 1.8 and 14.1 ± 12.9months, respectively. Out of all the aneurysms that were completely occluded at 6months, 84 (90.3%) showed complete occlusion at the final follow-up, and 11(11.5%) patients did not achieve complete occlusion. The positive predictive value (PPV) of complete occlusion at first follow was 88.4%. Importantly, this did not differ between digital subtraction angiography (DSA), magnetic resonance angiography (MRA), or computed tomography angiography (CTA). This study underlines the importance of repeat imaging in patients treated with the WEB device even if complete occlusion is achieved short term. Follow-up can be performed using DSA, MRA or CTA with no difference in positive predictive value.

Multitarget Stool DNA Testing Has High Positive Predictive Value for Colorectal Neoplasia on the Second Round of Testing

Multitarget stool DNA (mt-sDNA) testing is a stool-based screening test for colorectal cancer (CRC). In a single instance of testing, the pivotal Food and Drug Administration-approval study (NCT01397747) found that 16% of mt-sDNA tests were positive, and the positive predictive value (PPV) for CRC or advanced precursor lesions (APL) was 27.3%. We aimed to examine real-world longitudinal performance by determining the test-positive rate and PPV of mt-sDNA on the second round of testing. Colonoscopy and pathology reports were reviewed retrospectively for patients with a negative mt-sDNA on the first round of screening and a positive mt-sDNA on the second round. The test-positivity rate and PPV for CRC, APL, and any colorectal neoplasia were calculated for the second mt-sDNA and compared with baseline PPVs from a previously published cohort of patients from our institution who tested positive on the first round of screening. A total of 2758 patients completed a second test at a median of 3.2 years after the first test. Of these, 422 (15%) had a positive second mt-sDNA. The PPV was 0.25% for CRC, 24% for APL, and 67% for any colorectal neoplasia. There was no significant difference in PPV on the second mt-sDNA test compared with the first round (24% vs 28% for APL; P= .12). mt-sDNA test positive rate and PPV were similar between the first and second rounds of screening. These observations confirm the utility of a second round of mt-sDNA screening and may inform estimates of mt-sDNA effectiveness for CRC screening.

Analysis of the factors influencing positive predictive value of noninvasive prenatal testing for chromosome aneuploidies

Objective: To investigate the influence of Z-score and different risk factors on positive predictive value (PPV) of noninvasive prenatal testing (NIPT) for chromosome aneuploidies. Methods: A total of 81 838 NIPT samples from January 1, 2016 to May 31, 2021 in the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed. Invasive prenatal diagnosis was applied to verify the diagnosis of NIPT-positive results and the corresponding PPV was calculated. The PPV of the samples with different Z-score were compared. The women were divided into high-risk group and non-high-risk group: high-risk group (n=39 114) included those with ultrasound soft index abnormalities, advanced maternal age or high risk for maternal serum screening, while non-high-risk group (n=42 724) included those with intermediate risk for maternal serum screening or no indications. The differences of the PPV between these two groups were compared. Finally, the comprehensive influence of Z-score and different risk factors on PPV were analyzed. Results: A total of 471 high-risk cases were detected by NIPT results, including 362 cases of trisomy 21, 77 cases of trisomy 18 and 32 cases of trisomy 13. For trisomy 21, trisomy 18 and trisomy 13, there were 226 cases, 46 cases and 6 cases which were confirmed via invasive prenatal diagnosis respectively. The corresponding PPV were 79.3% (226/285), 82.1% (46/56) and 27.3% (6/22), respectively. PPV of trisomy 21 and trisomy 18 were positively correlated with the corresponding Z-score (r=0.92, 0.62, all P<0.05), while trisomy 13 could not be analyzed due to the small sample size. The PPV of high-risk group was 85.2% (207/243), which was higher than that of the non-high-risk group with PPV of 59.2%(71/120, χ2=30.30, P<0.01). When the Z-score was between 3-<4 and 4-<5, the PPV of the high-risk group were 46.2%(12/26)and 62.5%(15/24) respectively, which were higher than those of the non-high-risk group [16.0%(4/25) and 14.3%(3/21), χ2=4.10, 8.90, all P<0.05]. With the increase of Z-score, there was no significant difference in PPV between the two groups (all P>0.05). Conclusions: The PPV of trisomy 21 and trisomy 18 are positively correlated with Z-score. The PPV of high-risk group is higher than that of non-high-risk group. The combination of Z-score and other risk factors may provide more accurate genetic counseling for those with NIPT positive results.

Changes in Diagnostic Performance of Thyroid Cancer Screening before and after the Korean Thyroid Imaging Reporting and Data System Revision.

BackgroundSince the era of “thyroid cancer epidemic,” many Korean academic societies discouraged the use of ultrasonography in healthy individuals and revised the Korean Thyroid Imaging Reporting and Data System to address the overscreening and overdiagnosis issues. This study aimed to evaluate the change in the diagnostic effectiveness of thyroid cancer screening over the last decade.MethodsThis single-center, retrospective observational study analyzed the data of 125,962 thyroid nodules obtained during cancer screening at the health promotion center of Seoul National University Bundang Hospital from 2010 to 2019. Only 327 thyroid cancer cases pathologically confirmed by fine-needle aspiration (FNA) were included in the study. The strength of the association between the number of FNA and (1) the number of thyroid cancer diagnoses, (2) the positive predictive values (PPVs), and (3) the difference in PPV from the previous year were evaluated using Pearson’s correlation analysis.ResultsThe number of thyroid FNA biopsies as well as the thyroid cancer diagnoses decreased from 2010 to 2019 (166 to 48 [-71.1%] vs. 43 to 22 [-48.8%]). The PPV of FNA biopsies increased from 25.9% to 45.8% (+76.8%) and was negatively correlated with the number of FNA biopsies performed (R=-0.87, P<0.001). The difference in PPV from the previous year increased similarly but without statistical significance (R=-0.59, P=0.09).ConclusionThe diagnostic efficiency of thyroid cancer screening has increased over the last decade, as evidenced by the increasing PPV of FNA biopsies.

How Well Do ICD-9-CM Codes Predict True Congenital Heart Defects? A Centers for Disease Control and Prevention-Based Multisite Validation Project.

BackgroundThe Centers for Disease Control and Prevention's Surveillance of Congenital Heart Defects Across the Lifespan project uses large clinical and administrative databases at sites throughout the United States to understand population‐based congenital heart defect (CHD) epidemiology and outcomes. These individual databases are also relied upon for accurate coding of CHD to estimate population prevalence.Methods and ResultsThis validation project assessed a sample of 774 cases from 4 surveillance sites to determine the positive predictive value (PPV) for identifying a true CHD case and classifying CHD anatomic group accurately based on 57 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes. Chi‐square tests assessed differences in PPV by CHD severity and age. Overall, PPV was 76.36% (591/774 [95% CI, 73.20–79.31]) for all sites and all CHD‐related ICD‐9‐CM codes. Of patients with a code for complex CHD, 89.85% (177/197 [95% CI, 84.76–93.69]) had CHD; corresponding PPV estimates were 86.73% (170/196 [95% CI, 81.17–91.15]) for shunt, 82.99% (161/194 [95% CI, 76.95–87.99]) for valve, and 44.39% (83/187 [95% CI, 84.76–93.69]) for “Other” CHD anatomic group (X 2=142.16, P<0.0001). ICD‐9‐CM codes had higher PPVs for having CHD in the 3 younger age groups compared with those >64 years of age, (X 2=4.23, P<0.0001).ConclusionsWhile CHD ICD‐9‐CM codes had acceptable PPV (86.54%) (508/587 [95% CI, 83.51–89.20]) for identifying whether a patient has CHD when excluding patients with ICD‐9‐CM codes for “Other” CHD and code 745.5, further evaluation and algorithm development may help inform and improve accurate identification of CHD in data sets across the CHD ICD‐9‐CM code groups.

Clinical application of a prefabricated interocclusal recording cap for making interocclusal records of implant-supported fixed prostheses

Objective: To use a self-developed, prefabricated cap for making interocclusal records in implant-supported fixed prosthetic treatment, and to evaluate its effect of clinical application and accuracy of transferring intra-oral intercuspal position. Methods: Series of prefabricated caps for occlusal recording of implant-supported fixed prostheses were designed based on the healing abutments, and fabricated with three-dimensional (3D) printing. According to the inclusion and exclusion criteria, 12 partially edentulous patients who visited the Department of Prosthodontics, Peking University School and Hospital of Stomatology between November 2020 and September 2021, had lost no fewer than 2 contiguous teeth in distal extension (Kennedy Class Ⅰ or Ⅱ), and had received implant placement 3 months ago were enrolled. Self-control study design was used. Two occlusal records of each included case were obtained by the following 2 methods: for the test group, appropriate prefabricated caps were used; and for the control group, polyvinyl siloxane occlusal record was directly set on the healing abutments. The working casts were mounted on the mechanical articulator using the 2 groups of occlusal records successively. Accuracy of occlusal relationship of the mounted casts was evaluated. Diagnostics test was performed to obtain the sensitivity and positive predictive value, which were determined in photographs by comparing the intra-oral occlusal contact points with those in the mounted casts, point-by-point. Virtual casts were taken by intraoral and extraoral scans in intercuspal position and imported to Geomagic Studio 2014. Then the root mean square values of occlusal clearance space between the upper and lower occlusal surfaces of remaining posterior teeth, and the deviations of the interocclusal position of the occlusal surfaces of the remaining teeth in the mandibular arches when superimposing the maxillary arches of the intraoral and extraoral scans were calculated. As a self-control design, paired t test was used. Results: Twelve participants were enrolled, including 3 men and 9 women aged (52.6±12.1) years, and 36 missing teeth. The prefabricated caps could fit on the healing abutments with good retention and stability. The sensitivity of the test group (0.73±0.14) was significantly better than that of control group (0.63±0.12,P<0.01), with no significant difference in positive predictive value between the 2 groups (P>0.05). The deviations of the interocclusal position of the occlusal surfaces of the remaining teeth were (357.0±140.2) μm for the test group, and (399.4±206.3) μm for the control group, with no significant difference between them (P>0.05). Conclusions: Interocclusal position record based on prefabricated cap in this study for implant-supported fixed prosthetic treatment can improve the consistency between the intra-oral occlusion and the occlusion in dental casts. This technique has good accuracy, clinical convenience and usability.

Accuracy of the International Classification of Diseases, 9th Revision for Identifying Infantile Eye Disease

ABSTRACT Purpose To determine the predictive value of International Classification of Diseases, 9th Revision (ICD-9) codes for identifying infantile eye diagnoses. Methods Population-based retrospective cohort study of all residents of Olmsted County, Minnesota diagnosed at ≤1 year of age with an ocular disorder. The medical records of all infants diagnosed with any ocular disorder from January 1, 2005, through December 31, 2014, were identified. To assess ICD-9 code accuracy, the medical records of all diagnoses with ≥20 cases were individually reviewed and compared to their corresponding ICD-9 codes. Main outcome measures included positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity of ICD-9 codes. Results In a cohort of 5,109 infants with ≥1 eye-related ICD-9 code, 10 ocular diagnoses met study criteria. The most frequent diagnoses were conjunctivitis (N = 1,695) and congenital nasolacrimal duct obstruction (N = 1,250), while the least common was physiologic anisocoria (N = 23). The PPVs ranged from 8.3% to 88.0%, NPVs from 96.3% to 100%, sensitivity from 3.0% to 98.7%, and specificity from 72.6% to 99.9%. ICD-9 codes were most accurate at identifying physiologic anisocoria (PPV: 88.0%) and least accurate at identifying preseptal cellulitis (PPV: 8.3%). In eye specialists versus non-eye specialists, there was a significant difference in PPV of ICD-9 codes for conjunctivitis (26.8% vs. 63.9%, p < .001), pseudostrabismus (85.9% vs. 25.0%, p < .001), and physiologic anisocoria (95.5% vs. 33.3%, p = .002). Conclusion The predictive value of ICD-9 codes for capturing infantile ocular diagnoses varied widely in this cohort. These findings emphasize the limitations of database research methodologies that solely utilize claims data to identify pediatric eye diseases.Abbreviations/Acronyms PPV: positive predictive value; NPV: negative predictive value; CNLDO: congenital nasolacrimal duct obstruction

CT-guided percutaneous lung biopsy: Correlation between diagnostic yield, lung lesion size, and lobar distribution

Objectives: The aim of this retrospective study was to investigate the relationship between lung lesion lobar distribution, lesion size, and lung biopsy diagnostic yield. Material and Methods: This retrospective study was performed between January 1, 2013, and April 30, 2019, on CT-guided percutaneous transthoracic needle biopsies of 1522 lung lesions, median size 3.65 cm (range: 0.5– 15.5 cm). Lung lesions were localized as follows: upper lobes, right middle lobe and lingual, lower lobes superior segments, and lower lobes basal segments. Biopsies were classified as either diagnostic or non-diagnostic based on final cytology and/or pathology reports. Results were considered diagnostic if malignancy or a specific benign diagnosis was established, whereas atypical cells, non-specific benignity, or insufficient specimen were considered non-diagnostic. Results: The positive predictive value (PPV) of a diagnostic yield was 85%, regardless of lobar distribution. Because all PPVs were relatively high across locations (84–87%), we failed to find statistically significant difference in PPV between locations (P = 0.79). Furthermore, for every 1 cm increase in target size, the odds of a diagnostic yield increased by 1.42-fold or 42% above 85%. Although target size increased the diagnostic yield differently by location (between 1.4- and 1.8-fold across locations), these differences failed to be statistically significant, P = 0.55. Conclusion: Percutaneous transthoracic needle biopsy of lung lesions achieved high diagnostic yield (PPV: 84– 87%) across all lobes. A 42% odds increase in yield was achieved for every 1 cm increase in target size. However, this increase in size failed to be statistically significant between lobes.