Projected outcomes using different nodule sizes to define a positive CT lung cancer screening examination.
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ABSTRACT:
SUBMITTER: Gierada DS
PROVIDER: S-EPMC4207860 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:To characterize the variability in radiologists' interpretations of computed tomography (CT) studies in the National Lung Screening Trial (NLST) (including assessment of false-positive rates [FPRs] and sensitivity), to examine factors that contribute to variability, and to evaluate trade-offs between FPRs and sensitivity among different groups of radiologists.The HIPAA-compliant NLST was approved by the institutional review board at each screening center; all participants provided informed consent. NLST radiologists reported overall screening results, nodule-specific findings, and recommendations for diagnostic follow-up. A noncalcified nodule of 4 mm or larger constituted a positive screening result. The FPR was defined as the rate of positive screening examinations in participants without a cancer diagnosis within 1 year. Descriptive analyses and mixed-effects models were utilized. The average odds ratio (OR) for a false-positive result across all pairs of radiologists was used as a measure of variability.One hundred twelve radiologists at 32 screening centers each interpreted 100 or more NLST CT studies, interpreting 72 160 of 75 126 total NLST CT studies in aggregate. The mean FPR for radiologists was 28.7% ± 13.7 (standard deviation), with a range of 3.8%-69.0%. The model yielded an average OR of 2.49 across all pairs of radiologists and an OR of 1.83 for pairs within the same screening center. Mean FPRs were similar for academic versus nonacademic centers (27.9% and 26.7%, respectively) and for centers inside (25.0%) versus outside (28.7%) the U.S. "histoplasmosis belt." Aggregate sensitivity was 96.5% for radiologists with FPRs higher than the median (27.1%), compared with 91.9% for those with FPRs lower than the median (P = .02).There was substantial variability in radiologists' FPRs. Higher FPRs were associated with modestly higher sensitivity.
| S-EPMC3750416 | biostudies-other
Project description:The objective of this study was to evaluate the cost-effectiveness of newborn screening and treatment for phenylketonuria (PKU) in the context of new data on adherence to recommended diet treatment and a newly available drug treatment (sapropterin dihydrochloride). A computer simulation model was developed to project outcomes for a hypothetical cohort of newborns with PKU. Four strategies were compared: (1) clinical identification (CI) with diet treatment; (2) newborn screening (NBS) with diet treatment; (3) CI with diet and medication (sapropterin dihydrochloride); and (4) NBS with diet and medication. Data sources included published literature, primary data, and expert opinion. From a societal perspective, newborn screening with diet treatment had an incremental cost-effectiveness ratio of $6400/QALY compared to clinical identification with diet treatment. Adding medication to NBS with diet treatment resulted in an incremental cost-effectiveness ratio of more than $16,000,000/QALY. Uncertainty analyses did not substantially alter the cost-effectiveness results. Newborn screening for PKU with diet treatment yields a cost-effectiveness ratio lower than many other recommended childhood prevention programs even if adherence is lower than previously assumed. Adding medication yields cost-effectiveness results unlikely to be considered favorable. Future research should consider conditions under which sapropterin dihydrochloride would be more economically attractive.
| S-EPMC8151371 | biostudies-literature
Project description:ObjectivesThe 2019 Lung CT Screening Reporting & Data System version 1.1 (Lung-RADS v1.1) introduced volumetric categories for nodule management. The aims of this study were to report the distribution of Lung-RADS v1.1 volumetric categories and to analyse lung cancer (LC) outcomes within 3 years for exploring personalized algorithm for lung cancer screening (LCS).MethodsSubjects from the Multicentric Italian Lung Detection (MILD) trial were retrospectively selected by National Lung Screening Trial (NLST) criteria. Baseline characteristics included selected pre-test metrics and nodule characterization according to the volume-based categories of Lung-RADS v1.1. Nodule volume was obtained by segmentation with dedicated semi-automatic software. Primary outcome was diagnosis of LC, tested by univariate and multivariable models. Secondary outcome was stage of LC. Increased interval algorithms were simulated for testing rate of delayed diagnosis (RDD) and reduction of low-dose computed tomography (LDCT) burden.ResultsIn 1248 NLST-eligible subjects, LC frequency was 1.2% at 1 year, 1.8% at 2 years and 2.6% at 3 years. Nodule volume in Lung-RADS v1.1 was a strong predictor of LC: positive LDCT showed an odds ratio (OR) of 75.60 at 1 year (p < 0.0001), and indeterminate LDCT showed an OR of 9.16 at 2 years (p = 0.0068) and an OR of 6.35 at 3 years (p = 0.0042). In the first 2 years after negative LDCT, 100% of resected LC was stage I. The simulations of low-frequency screening showed a RDD of 13.6-21.9% and a potential reduction of LDCT burden of 25.5-41%.ConclusionsNodule volume by semi-automatic software allowed stratification of LC risk across Lung-RADS v1.1 categories. Personalized screening algorithm by increased interval seems feasible in 80% of NLST eligible.Key points• Using semi-automatic segmentation of nodule volume, Lung-RADS v1.1 selected 10.8% of subjects with positive CT and 96.87 relative risk of lung cancer at 1 year, compared to negative CT. • Negative low-dose CT by Lung-RADS v1.1 was found in 80.6% of NLST eligible and yielded 40 times lower relative risk of lung cancer at 2 years, compared to positive low-dose CT; annual screening could be preference sensitive in this group. • Semi-automatic segmentation of nodule volume and increased screening interval by volumetric Lung-RADS v1.1 could retrospectively suggest a 25.5-41% reduction of LDCT burden, at the cost of 13.6-21.9% rate of delayed diagnosis.
| S-EPMC7979670 | biostudies-literature
Project description:We aimed to evaluate radiomic features' stability across different region of interest (ROI) sizes in CT and MR images. We chose a phantom with a homogenous internal structure so no differences for a feature extracted from ROIs of different sizes would be expected. For this, we scanned a plastic cup filled with sodium chloride solution ten times in CT and per MR sequence (T1-weighted-gradient-echo and T2-weighted-turbo-inversion-recovery-magnitude). We placed sphere-shaped ROIs of different diameters (4, 8, and 16 mm, and 4, 8, and 16 pixels) into the phantom's center. Features were extracted using PyRadiomics. We assessed feature stability across ROI sizes with overall concordance correlation coefficients (OCCCs). Differences were tested for significance with the Mann-Whitney U-test. Of 93 features, 87 T1w-derived, 87 TIRM-derived, and 70 CT-derived features were significantly different between ROI sizes. Among MR-derived features, OCCCs showed excellent (>0.90) agreement for mean, median, and root mean squared for ROI sizes between 4 and 16 mm and pixels. We further observed excellent agreement for 10th and 90th percentile in T1w and 10th percentile in T2w TIRM images. There was no excellent agreement among the OCCCs of CT-derived features. In summary, many features indicated significant differences and only few showed excellent agreement across varying ROI sizes, although we examined a homogenous phantom. Since we considered a small phantom in an experimental setting, further studies to investigate this size effect would be necessary for a generalization. Nevertheless, we believe knowledge about this effect is crucial in interpreting radiomics studies, as features that supposedly discriminate disease entities may only indicate a systematic difference in ROI size.
| S-EPMC8293351 | biostudies-literature
Project description:Species' vulnerability to extinction is strongly impacted by their geographical range size. Formulating effective conservation strategies therefore requires a better understanding of how the ranges of the world's species have changed in the past, and how they will change under alternative future scenarios. Here, we use reconstructions of global land use and biomes since 1700, and 16 possible climatic and socio-economic scenarios until the year 2100, to map the habitat ranges of 16,919 mammal, bird, and amphibian species through time. We estimate that species have lost an average of 18% of their natural habitat range sizes thus far, and may lose up to 23% by 2100. Our data reveal that range losses have been increasing disproportionately in relation to the area of destroyed habitat, driven by a long-term increase of land use in tropical biodiversity hotspots. The outcomes of different future climate and land use trajectories for global habitat ranges vary drastically, providing important quantitative evidence for conservation planners and policy makers of the costs and benefits of alternative pathways for the future of global biodiversity.
| S-EPMC7648644 | biostudies-literature
Project description:Pragmatic clinical trials are commonly used in patient-centered outcomes research to assess heterogeneity of treatment effects. Patient-Centered Outcomes Research Institute (PCORI) methodology standards for assessing heterogeneity of treatment effects are extremely rigorous, but their implementation in real-world settings can be difficult. Predicting recruitment effectiveness and subgroup characteristics is often challenging and may require mid-stream revision of projected group and subgroup sizes. Yet, little real-world data are available to demonstrate methodologically valid approaches to address situations where such revisions are necessary. These data were used for mid-stream revision of group and subgroup sizes in the Management of Diabetes in Everyday Life (MODEL) clinical trial. The planned number of randomized participants retained over the one-year study period was reduced from 800 to 581 due to recruitment difficulties among potential participants residing in rural areas. Prospective power analyses are based on the revised target of 581 participants retained and the proportions of 167 participants with various key baseline characteristics, who had been randomized in MODEL by January 2018, as reported to the Patient Center Outcomes Research Institute (PCORI) and the MODEL Data Safety and Monitoring Committee. Power calculations are based on two-sided t-tests with type-I error rates of 0.05 and the assumption that effect sizes will range from small (standardized difference = 0.36) to medium (= 0.50). The primary outcome variables are how many days in the previous week participants 1) ate healthy meals, 2) participated in at least 30 minutes of physical activity, and 3) took medications as prescribed. The POWER procedure of SAS 9.4 was used for all analyses. These data, along with the approach, can assist statisticians as they plan future pragmatic clinical trials evaluating heterogeneity of treatment effects. These data can help inform investigators, conducting patient-centered outcomes research, as they define subgroups for either confirmatory analyses for testing heterogeneity of treatment effects or for exploratory analyses where estimation of confidence bounds may be useful for generating future hypotheses. (This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (SC15-1503-28336), www.ClinicalTrials.gov and Identifier: NCT02957513 [1].).
| S-EPMC7708786 | biostudies-literature
Project description:We aimed to evaluate the added value of positive intraluminal contrast computed tomography (CT) over fluoroscopy in detecting anastomotic leakage after gastrointestinal (GI) surgery. A total of 141 GI surgery patients who underwent fluoroscopic examination and CT were included. Two radiologists reviewed the fluoroscopic images with and without CT to determine anastomotic leakage on a 5-point confidence scale and graded the leakage on a 4-point grading system. The hospital stay duration and treatment type were recorded. The radiologists' diagnostic performance in determining leakage was compared using the receiver operating characteristics analysis, and interobserver agreement was analyzed. Fifty-three patients developed GI leakage. When CT was added to the fluoroscopic images, the area under the curve (AUC) values significantly increased for both reviewers. The interobserver agreement for leakage between the two reviewers was excellent and improved with the addition of CT (weighted kappa value, 0.869 versus 0.805). Postoperative intervention was more frequently performed (P < 0.001), and patients with leakage had a significantly longer mean postoperative hospital stay (45 days vs. 27 days) (P = 0.003). Thus, positive intraluminal contrast CT provides added value over fluoroscopic examination for detecting GI leakage in patients undergoing GI tract surgery, increasing AUC values, and improving interobserver agreement.
| S-EPMC10781980 | biostudies-literature
Project description:Background Highly sensitive digital total-body PET/CT scanners (uEXPLORER) have great potential for clinical applications and fundamental research. Given their increasing sensitivity, low-dose scanning or snapshot imaging is now possible in clinics. However, a standardized total-body 18F-FDG PET/CT protocol is still lacking. Establishing a standard clinical protocol for total-body 18F-FDG PET/CT examination under different activity administration plans can help provide a theoretical reference for nuclear radiologists. Methods The NEMA image quality (IQ) phantom was used to evaluate the biases of various total-body 18F-FDG PET/CT protocols related to the administered activity, scan duration, and iterations. Several objective metrics, including contrast recovery (CR), background variability (BV), and contrast-to-noise ratio (CNR), were measured from different protocols. In line with the European Association of Nuclear Medicine Research Ltd. (EARL) guidelines, optimized protocols were suggested and evaluated for total-body 18F-FDG PET/CT imaging for three different injected activities. Results Our NEMA IQ phantom evaluation resulted in total-body PET/CT images with excellent contrast and low noise, suggesting great potential for reducing administered activity or shortening the scan duration. Different to the iteration number, prolonging the scan duration was the first choice for achieving higher image quality regardless of the activity administered. In light of image quality, tolerance of oncological patients, and the risk of ionizing radiation damage, the 3-min acquisition and 2-iteration (CNR = 7.54), 10-min acquisition and 3-iteration (CNR = 7.01), and 10-min acquisition and 2-iteration (CNR = 5.49) protocols were recommended for full-dose (3.70 MBq/kg), half-dose (1.95 MBq/kg), and quarter-dose (0.98 MBq/kg) activity injection schemes, respectively. Those protocols were applied in clinical practices, and no significant differences were observed for the SUVmax of large/small lesions or the SUVmean of different healthy organs/tissues. Conclusion These findings support that digital total-body PET/CT scanners can generate PET images with a high CNR and low-noise background, even with a short acquisition time and low administered activity. The proposed protocols for different administered activities were determined to be valid for clinical examination and can maximize the value of this imaging type. Supplementary Information The online version contains supplementary material available at 10.1186/s40658-023-00533-y.
| S-EPMC9938848 | biostudies-literature
Project description:BackgroundEpidemiological evidence suggests that HIV-infected individuals are at increased risk of lung cancer, but no data exist because large computed tomography (CT) screening trials routinely exclude HIV-infected participants.MethodsFrom 2006 to 2013, we conducted the world's first lung cancer screening trial of 224 HIV-infected current/former smokers to assess the CT detection rates of lung cancer. We also used 130 HIV-infected patients with known lung cancer to determine radiographic markers of lung cancer risk using multivariate analysis.ResultsMedian age was 48 years with 34 pack-years smoked. During 678 person-years, one lung cancer was found on incident screening. Besides this lung cancer case, 18 deaths (8%) occurred, but none were cancer related. There were no interim diagnoses of lung or extrapulmonary cancers. None of the pulmonary nodules detected in 48 participants at baseline were diagnosed as cancer by study end. The heterogeneity of emphysema across the entire lung as measured by CT densitometry was significantly higher in HIV-infected subjects with lung cancer compared with the heterogeneity of emphysema in those without HIV (p ≤ 0.01). On multivariate regression analysis, increased age, higher smoking pack-years, low CD4 nadir, and increased heterogeneity of emphysema on quantitative CT imaging were all significantly associated with lung cancer.ConclusionsDespite a high rate of active smoking among HIV-infected participants, only one lung cancer was detected in 678 patient-years. This was probably because of the young age of participants suggesting that CT screening of high-risk populations should strongly consider advanced age as a critical inclusion criterion. Future screening trials in urban American must also incorporate robust measures to ensure HIV patient compliance, adherence, and smoking cessation.
| S-EPMC4023914 | biostudies-literature
Project description:BackgroundPrevious studies with a limited number of patients have reported divergent findings on whether screening can detect small cell lung cancer (SCLC) at an earlier stage and whether there might be a survival benefit.MethodsThis study examined the characteristics of SCLC detected by using low-dose CT (LDCT) screening in the National Lung Screening Trial, a randomized study of individuals at high risk for developing lung cancer comparing LDCT imaging vs chest radiography. SCLC was denoted as screen detected if diagnosed ? 1 year of a positive screen or after a longer period but with no time gap between diagnostic procedures of > 1 year; interval detected if diagnosed ? 1 year of a negative screen; and nonscreen detected if the subject did not receive any screens or otherwise as postscreening.ResultsA total of 143 cases of SCLC were diagnosed, including 49 (34.2%) screen detected, 15 (10.5%) interval detected, and 79 (55.2%) nonscreened/postscreening. Of the screening phase-diagnosed cases (ie, screen or interval detected), a higher proportion of SCLC cases compared with NSCLC cases were interval detected (23% vs 5%; P < .0001). A higher proportion of all SCLC cases compared with NSCLC cases were advanced stage (III/IV: 86% vs 36%; P < .0001). The unfavorable SCLC stage distribution extended across screen-detected (80% stage III/IV), interval-detected (86%), and nonscreened/postscreening (90%) cancers. Among screen-detected SCLC, only 63.3% had ? 1 noncalcified nodule in the cancer lobe compared with 85.4% of NSCLC cases (P < .0001). Even with very small LDCT screen-detected nodules, a high proportion of SCLC cases were late stage. There was no significant difference in survival between screen- and interval-detected or postscreening SCLC.Conclusions"Early detection" with the use of LDCT imaging had no impact on SCLC outcomes. A successful screening modality should ideally detect SCLC earlier than when it can be detected on LDCT scans.
| S-EPMC6335258 | biostudies-literature