Audit of data from examination image headers collected for quality assurance in the ECOG-ACRIN EA1151 tomosynthesis mammographic imaging screening trial (TMIST).

PURPOSE: A comprehensive, centrally-monitored physics quality control (QC) program was developed for the Tomosynthesis Imaging Screening Trial (TMIST), a randomized controlled trial of digital breast tomosynthesis (TM) versus digital mammography (DM) for cancer screening. As part of the program, in addition to a set of phantom-based tests, de-identified data on image acquisition and processing parameters were captured from the DICOM headers of all individual patient images in the trial. These data were analyzed to assess the potential usefulness of header data from digital mammograms and tomosynthesis images of patients for quality assurance in breast imaging. METHODS: Data were automatically extracted from the headers of all de-identified patient mammograms and tomosynthesis images in the TMIST study. Image acquisition parameters and estimated radiation doses were tracked for individual sites, systems and across system types. These parameters included (among others) kV, target/filter use, number of acquired views per examination, AEC mode, compression thickness and force and detector temperature. Consistency of manually entered study data parameters (subject ID, screening time-point) from TMIST was evaluated. Preliminary observations from the program are presented. RESULTS: We report on data from 812 651 images from 135 525 examinations acquired between October, 2017 and December, 2022. Data came from 6 system models from 3 manufacturers. There was greater variability both in the number of views used and in the estimated (proxy) doses received in DM exams compared to TM. Mean proxy doses per examination varied among manufacturers from 2.76-4.54 mGy for DM and 3-4.84 mGy for the tomosynthesis component in the TM arm with maximum examination proxy doses of 20 and 26 mGy for DM and TM respectively. Mean proxy doses per examination for the combination examination in TM (tomosynthesis plus digital mammography) varied from 6.6 to 7.6 mGy among manufacturers with a maximum of 44.5 mGy. CONCLUSIONS: Overall, modern digital mammography and tomosynthesis systems used in TMIST have operated very reliably. Doses vary considerably due to variation in the number of views per examination, thickness and fibro-glandularity of the breast, and choices in the use of synthesized versus actual 2D mammography in the TM examination. These data may also be useful in predicting equipment problems. Header information is valuable not only for automated QC, but also for cross-checking accuracy and consistency of data in a clinical study.

Quality control for digital tomosynthesis in the ECOG-ACRIN EA1151 TMIST trial.

BACKGROUND: The Tomosynthesis Mammography Imaging Screening Trial (TMIST), EA1151 conducted by the Eastern Cooperative Oncology Group (ECOG)/American College of Radiology Imaging Network (ACRIN) is a randomized clinical trial designed to assess the effectiveness for breast cancer screening of digital breast tomosynthesis (TM) compared to digital mammography (DM). Equipment from multiple vendors is being used in the study. PURPOSE: For the findings of the study to be valid and capture the true capacities of the two technology types, it is important that all equipment is operated within appropriate parameters with regard to image quality and dose. A harmonized QC program was established by a core physics team. Since there are over 120 trial sites, a centralized, automated QC program was chosen as the most practical design. This report presents results of the weekly QC testing program. A companion paper will review quality monitoring based on data from the headers of the patient images. METHODS: Study images are collected centrally after de-identification using the "TRIAD" application developed by ACR. The core physics team devised and implemented a minimal set of quality control (QC) tests to evaluate the tomosynthesis and 2D mammography systems. Weekly, monthly and annual testing is performed by the site mammography technologists with images submitted directly to the physics core. The weekly physics QC tests are described: SDNR of a low-contrast mass object, artifact spread, spatial resolution, tracking of technical factors, and in-slice noise power spectra. RESULTS: As of December 31, 2022 (5 years), 145 sites with 411 machines had submitted QC data. A total of 136 742 TMIST participant screening imaging studies had been performed. The 5th and 95th percentile mean glandular doses for a single tomosynthesis exposure to a 4.0 cm thick PMMA phantom ("standard breast phantom") were 1.24 and 1.68 mGy respectively. The largest sources of QC non-conformance were: operator error, not following the QC protocol exactly, unreported software updates and preventive maintenance activities that affected QC setpoints. Noise power spectra were measured, however, standardization of performance targets across machine types and software revisions was difficult. Nevertheless, for each machine type, test measurement results were very consistent when the protocol was followed. Deviations in test results were mostly related to software and hardware changes. CONCLUSION: Most systems performed very consistently. Although this is a harmonized program using identical phantoms and testing protocols, it is not appropriate to apply universal threshold or target metrics across the machine types because the systems have different non-linear reconstruction algorithms and image display filters. It was found to be more useful to assess pass/fail criteria in terms of relative deviations from baseline values established when a system is first characterized and after equipment is changed. Generally, systems which needed repair failed suddenly, but in retrospect, for a few cases, drops in SDNR and increases in mAs were observed prior to tube failure. TMIST is registered as NCT03233191 by Clinicaltrials.gov.

Sleep interventions for children with attention deficit hyperactivity disorder (ADHD): A systematic literature review.

OBJECTIVE/BACKGROUND: Healthy sleep is particularly important for children with attention deficit hyperactivity disorder (ADHD), as sleep disturbances might aggravate disease symptoms. This review aims to synthesize and report evidence on the effectiveness of sleep interventions in increasing sleep, quality of life (QoL), and ADHD symptoms among children with ADHD. PATIENTS/METHODS: The systematic literature review follows the Cochrane Collaboration methodology recommendations for literature reviews. Four databases were used based on the population, intervention, control and outcome (PICO) framework. Controlled trials with minimum 20 children in each group, aged 6-18, and published from 2005 and onwards were included. Results from the studies were reported in forest plots and three of the seven review outcomes were synthesized in meta-analyses. RESULTS: The search identified 7710 records; of which 4808 abstracts were screened. After fulltext-screening of 99 papers, eight papers from five studies were included. The studies included behavioral sleep interventions and pharmacological interventions using melatonin and eszopiclone. For six of the seven outcomes, the effect sizes were small to moderate and the certainty of the evidence was low. For one outcome, sleep disturbances, the effect size was a moderate -0.49 standardized mean differences (95% confidence interval -0.65;-0.33), with a moderate certainty of evidence for the behavioral interventions for children aged 5-13 years with ADHD. CONCLUSIONS: This review identified few and heterogeneous studies. A moderate certainty of evidence for a moderate effect size was only obtained for sleep disturbances from the behavioral interventions. A low certainty of the evidence for a moderate effect size was found for the total sleep time from the pharmacological intervention using melatonin and one behavioral intervention, which indicates that these sleep interventions impact sleep quantity and quality among children with ADHD.

Associations between metabolic factors and radiographic knee osteoarthritis in early disease - a cross-sectional study of individuals with knee pain.

OBJECTIVE: Metabolic factors have been shown to be associated to severe radiographic knee osteoarthritis (RKOA). However, more knowledge is needed in early clinical knee osteoarthritis (KOA). The aim was to study associations between metabolic factors and radiographic knee osteoarthritis (OA) in individuals with knee pain. A second aim was to study associations between metabolic factors and RKOA in those with normal BMI and in those overweight/obese, respectively. METHOD: This cross-sectional study included 282 individuals with knee pain (without cruciate ligament injury) and aged 30-67 years, and 70% women. Waist circumference, body mass index (BMI), proportion of fat and visceral fat area (VFA) were assessed. RKOA was defined as Ahlbäck grade 1 in at least one knee. Fasting blood samples were taken and triglycerides, cholesterol (total, low density lipoprotein (LDL) and high density lipoprotein (HDL)), C-reactive protein (CRP), glucose, HbA1C were analysed. Metabolic syndrome was defined in accordance with the International Diabetes Federation (IDF). Associations were analysed by logistic regression. RESULTS: Individuals with RKOA were older, had higher BMI, higher VFA, larger waist circumference and had increased total cholesterol, triglycerides and LDL-cholesterol, but not fasting glucose. There was no difference between the group with RKOA vs. non-radiographic group regarding the presence of metabolic syndrome. In a subgroup analysis of individuals with normal BMI (n = 126), those with RKOA had higher VFA, more central obesity, higher levels of CRP and total cholesterol, compared with individuals without RKOA. In individuals with obesity, age was the only outcome associated to RKOA. CONCLUSION: There were clear associations between metabolic factors and RKOA in individuals with knee pain, also in those with normal BMI. In individuals with obesity age was the only variable associated to RKOA. TRIAL REGISTRATION: clinicalTrials.gov Identifier: NCT04928170.

Technical Note: Volumetric coverage in breast tomosynthesis images - Phantom QC results from the TMIST study.

PURPOSE: In the reconstruction of volume breast images from x-ray projections in breast tomosynthesis, some tomographic systems truncate the image data presented to the radiologist such that a non-negligible amount of tissue may be missing from the breast image. QC tests were conducted to determine if this problem existed in imaging in the TMIST study. METHODS: Test tools developed for TMIST containing small objects at known heights were used in routine weekly and annual QC testing of tomosynthesis units to assess the degree to which phantom material that was irradiated in imaging was excluded from the reconstructed image. Results from 318 tests on five system types from three manufacturers are reported. RESULTS: The presence and extent of this problem varied among system types. The cause was most frequently related to machine errors in the determination of breast thickness or to deflection of components during breast compression. In particular, the problem occurred when a compression paddle other than the one calibrated for tomosynthesis was used for the tests. This was also verified to have occurred in some clinical imaging. CONCLUSIONS: Missing volume can be avoided by intentionally reconstructing additional image slices above and below the presumed locations of the breast support and compression plate. A compression paddle which has been calibrated for tomosynthesis should be used both for clinical imaging and testing. The prevalence of this phenomenon suggests that more frequent testing for volume coverage may be advisable.

Technical Note: Robust measurement of the slice-sensitivity profile in breast tomosynthesis.

PURPOSE: The purpose of this work is to improve the repeatability of the measurement of the slice-sensitivity profile (SSP) in reconstructed breast tomosynthesis volumes. METHODS: A grid of aluminum ball-bearings (BBs) within a PMMA phantom was imaged on breast tomosynthesis systems from three different manufacturers. The full-width half-maximum (FWHM) values were measured for the SSPs of the BBs in the reconstructed volumes. The effect of transforming the volumes from a Cartesian coordinate system (CCS) to a cone-beam coordinate system (CBCS) on the variability in the FWHM values was assessed. RESULTS: Transforming the volumes from a CCS to a CBCS before measuring the SSPs reduced the coefficient of variation (COV) in the measurements of FWHM in repeated measurements by 56% and reduced the dependence of the FWHM values on the location of the BBs within the reconstructed volume by 76%. CONCLUSIONS: Measuring the SSP in the volumes in a CBCS improves the robustness of the measurement.

Sleep as a predictive factor for the onset and resolution of multi-site pain: a 5-year prospective study.

BACKGROUND: Disturbed sleep and pain often co-exist and the relationship between the two conditions is complex and likely reciprocal. This 5-year prospective study examines whether disturbed sleep can predict the onset of multi-site pain, and whether non-disturbed sleep can predict the resolution of multi-site pain. METHODS: The cohort (n = 1599) was stratified by the number of self-reported pain sites: no pain, pain from 1-2 sites and multi-site pain (≥3 pain sites). Sleep was categorized by self-reported sleep disturbance: sleep A (best sleep), sleep B and sleep C (worst sleep). In the no-pain and pain-from-1-2 sites strata, the association between sleep (A, B and C) and multi-site pain 5 years later was analysed. Further, the prognostic value of sleep for the resolution of multi-site pain at follow-up was calculated for the stratum with multi-site pain at baseline. In the analyses, gender, age, body mass index, smoking, physical activity and work-related exposures were treated as potential confounders. RESULTS: For individuals with no pain at baseline, a significantly higher odds ratio for multi-site pain 5 years later was seen for the tertile reporting worst sleep [odds ratio (OR) 4.55; 95% confidence interval (CI) 1.28-16.12]. Non-disturbed (or less disturbed) sleep had a significant effect when predicting the resolution of multi-site pain (to no pain) (OR 3.96; 95% CI 1.69-9.31). CONCLUSION: In conclusion, sleep could be relevant for predicting both the onset and the resolution of multi-site pain. It seems to be a significant factor to include in research on multi-site pain and when conducting or evaluating intervention programmes for pain.

Method of measuring NEQ as a quality control metric for digital mammography.

PURPOSE: Current quality control protocols for digital mammography rely on subjective assessments of image quality or simple measures that are not comparable between vendor platforms. The noise-equivalent quanta (NEQ) can be expressed in units of image quanta (fluence) for the spatial frequency range of interest, enabling comparisons between systems and x-ray spectra. The purpose of this work is to explore use of a simple phantom to measure the components of the noise-equivalent quanta of digital mammography systems for use in routine quality control. METHODS: A simple phantom is imaged on six mammography systems from different vendors. The phantom contains uniform regions for measurement of noise power spectrum (NPS), slanted edges for measurement of modulation transfer function (MTF), and objects of various thicknesses for measurement of contrast. Images were acquired at a range of dose levels on each system to examine how measurements scale with dose, and multiple images were taken at a single dose point to examine measurement reproducibility. RESULTS: The phantom and measurement methods show good reproducibility, with average coefficient of variation values of less than or equal to 15% on all systems evaluated. Measured MTF and NPS values are comparable to other published results when the increase in scattered radiation generated by placing the phantom on the breast support is accounted for. CONCLUSIONS: Measurement of the parameters required to calculate NEQ from a single image of a simple phantom is practical, and shows promise as a method of evaluating image quality for routine quality control of digital mammography systems.

Comparative performance of modern digital mammography systems in a large breast screening program.

PURPOSE: To compare physical measures pertaining to image quality among digital mammography systems utilized in a large breast screening program. To examine qualitatively differences in these measures and differences in clinical cancer detection rates between CR and DR among sites within that program. METHODS: As part of the routine quality assurance program for screening, field measurements are made of several variables considered to correlate with the diagnostic quality of medical images including: modulation transfer function, noise equivalent quanta, d' (an index of lesion detectability) and air kerma to allow estimation of mean glandular dose. In addition, images of the mammography accreditation phantom are evaluated. RESULTS: It was found that overall there were marked differences between the performance measures of DR and CR mammography systems. In particular, the modulation transfer functions obtained with the DR systems were found to be higher, even for larger detector element sizes. Similarly, the noise equivalent quanta, d', and the phantom scores were higher, while the failure rates associated with low signal-to-noise ratio and high dose were lower with DR. These results were consistent with previous findings in the authors' program that the breast cancer detection rates at sites employing CR technology were, on average, 30.6% lower than those that used DR mammography. CONCLUSIONS: While the clinical study was not large enough to allow a statistically powered system-by-system assessment of cancer detection accuracy, the physical measures expressing spatial resolution, and signal-to-noise ratio are consistent with the published finding that sites employing CR systems had lower cancer detection rates than those using DR systems for screening mammography.

Resolution at oblique incidence angles of a flat panel imager for breast tomosynthesis.

Oblique incidence of x rays on an imaging detector causes blurring that reduces spatial resolution. For simple projection imaging this effect is small and often ignored. However, for breast tomosynthesis, the incidence angle can be larger (>20 degrees), leading to increased blur for some of the projections. The modulation transfer function (MTF) is measured for a typical phosphor-coupled flat-panel detector versus angular incidence of the x-ray beam for two x-ray spectra: 26 kV Mo/Mo and 40 kV Rh/Al. At an incidence angle of 40 degrees the MTF at 5 mm(-1) falls by 35% and 40% for each spectrum, respectively (and 65%/80% at 8 mm(-1)). Increasing the detector absorber thickness to achieve improved quantum efficiency will cause the blurring effect due to beam obliquity to become greater. The impact of this blur is likely to cause misregistration and increased relative noise in tomosynthesis reconstructed images.

Lag and ghosting in a clinical flat-panel selenium digital mammography system.

We present measurements of lag and ghosting in a FDA-approved digital mammography system that uses a dielectric/selenium based detector structure. Lag is the carryover of signal from a previous image, whereas ghosting is the reduction of sensitivity caused by previous exposure history of the detector. Data from six selenium units were acquired. For the type of selenium detector tested, and under typical clinical usage conditions, the lag was as high as 0.15% of source signal and the ghosting could be as high as 15%. The amount of lag and ghosting varied from unit to unit. Results were compared with data acquired on a phosphor-based full-field digital mammography system. Modifications in the technology of the selenium detectors appear to have resulted in a marked decrease in both lag and ghosting effects in more recent systems.

Quality control for digital mammography in the ACRIN DMIST trial: part I.

The Digital Mammography Imaging Screening Trial, conducted by the American College of Radiology Imaging Network, is a clinical trial designed to compare the accuracy of full-field digital mammography (FFDM) versus screen-film mammography in a screening population. Five FFDM systems from four manufacturers (Fischer, Fuji, General Electric, and Lorad) were employed in the study at 35 clinical sites. A core physics team devised and implemented tests to evaluate these systems. A detailed description of physics and quality control tests is presented, including estimates of: mean glandular dose, modulation transfer function (MTF), 2D noise power spectra, and signal-to-noise ratio (SNR). The mean glandular doses for the standard breast ranged from 0.79 to 2.98 mGy, with 1.62 mGy being the average across all units and machine types. For the five systems evaluated, the MTF dropped to 50% at markedly different percentages (22% to 87%) of the Nyquist limit, indicating that factors other than detector element (del) size have an important effect on spatial resolution. Noise power spectra and SNR were measured; however, we found that it was difficult to standardize and compare these between units. For each machine type, the performance as measured by the tests was very consistent, and no predictive benefit was seen for many of the tests during the 2-year period of the trial. It was found that, after verification of proper operation during acceptance testing, if systems failed they generally did so suddenly rather than through gradual deterioration of performance. Because of the relatively short duration of this study further, investigation of the long-term failure characteristics of these systems is advisable.

Quality control for digital mammography: part II. Recommendations from the ACRIN DMIST trial.

The Digital Mammography Imaging Screening Trial (DMIST), conducted under the auspices of the American College of Radiology Imaging Network (ACRIN), is a clinical trial designed to compare the accuracy of digital versus screen-film mammography in a screening population [E. Pisano et al., ACRIN 6652-Digital vs. Screen-Film Mammography, ACRIN (2001)]. Part I of this work described the Quality Control program developed to ensure consistency and optimal operation of the digital equipment. For many of the tests, there were no failures during the 24 months imaging was performed in DMIST. When systems failed, they generally did so suddenly rather than through gradual deterioration of performance. In this part, the utility and effectiveness of those tests are considered. This suggests that after verification of proper operation, routine extensive testing would be of minimal value. A recommended set of tests is presented including additional and improved tests, which we believe meet the intent and spirit of the Mammography Quality Standards Act regulations to ensure that full-field digital mammography systems are functioning correctly, and consistently producing mammograms of excellent image quality.

Effect of scatter and an antiscatter grid on the performance of a slot-scanning digital mammography system.

The use of a grid increases perceptibility of low contrast objects in mammography. Slot-scan mammography provides a more dose efficient reduction of the scattered radiation reaching the detector than obtained with an antiscatter grid in screen-film or flat-panel digital mammography. In this paper, the potential of using a grid in a slot-scan system to provide a further reduction of scattered radiation is investigated. The components of the digital signal: primary radiation, off-focus radiation, scattered radiation, and optical fluorescence glare in a CsI(Tl) detector were quantified. Based on these measurements, the primary and scatter transmission factors (Tp, Ts), scatter-to-primary ratio (SPR), signal-difference-to-noise ratio (SDNR), and the SDNR improvement factor (K(SDNR)) were obtained. Our results showed that the SPR ranged from 0.05 to 0.19 for breast thicknesses between 2 and 8 cm, respectively. The values of K(SDNR) ranged from 0.85 to 0.94. Because the slot-scanning system has an inherently low SPR, the increase in dose required when the grid is used outweighs the benefit of the small increase in SDNR. It is possible that greater benefit could be achieved by using a grid with a higher Tp, such as obtained using air-core technology.

Development of contrast digital mammography.

Development of breast tumors is often accompanied by angiogenesis--the formation of new blood vessels. It is possible to image the effects of this process by tracking the uptake and washout of contrast agents in the vicinity of a lesion. In this article, a method for carrying out contrast subtraction mammography on a full-field digital mammography unit is described. Spectral measurements and modeling were performed to optimize the choice of x-ray target, kilovoltage and x-ray beam filtration for contrast digital mammography (CDM) on an available digital mammography system. Phantom studies were carried out to determine the sensitivity of CDM to iodine. Detection of iodine area densities of 0.3 mg/cm2 is possible for a circular object with a radius of 1.3 mm, which allows detection of uptake levels in the breast typically seen with cancer and some benign breast conditions. It was found that with a molybdenum anode x-ray tube, copper filtration could be used to effectively shape the x-ray spectrum to maximize the proportion of x rays with energies above the k edge of iodine. Simple logarithmic subtraction was found to be adequate in suppressing background signals dependent on the x-ray beam intensity and background thickness of the breast. The total x-ray dose from the procedure ranges between 1 and 3 mGy, similar to that from a conventional single view film mammogram. A clinical pilot study is currently being carried out to evaluate this technique.