Interdisciplinary care of children with trisomy 13 and 18.

Children with trisomy 13 and 18 (previously deemed "incompatible with life") are living longer, warranting a comprehensive overview of their unique comorbidities and complex care needs. This Review Article provides a summation of the recent literature, informed by the study team's Interdisciplinary Trisomy Translational Program consisting of representatives from: cardiology, cardiothoracic surgery, neonatology, otolaryngology, intensive care, neurology, social work, chaplaincy, nursing, and palliative care. Medical interventions are discussed in the context of decisional-paradigms and whole-family considerations. The communication format, educational endeavors, and lessons learned from the study team's interdisciplinary care processes are shared with recognition of the potential for replication and implementation in other care settings.

Dosimetric impact of breast density in breast tomosynthesis: A comparative study.

A radiation dose survey has been undertaken involving 256 patients to investigate the dosimetric impact of breast tomosynthesis screening by employing different breast densities estimated by the Dance model, 50-50 breast model, and patient-specific density software: Volpara. Mean glandular dose (MGD) based on the Dance model provided the most realistic dose estimate with an average difference of -3.3 ± 4.8% from the patient-specific estimation. Average differences of -8.2 ± 6.5% and -7.3 ± 4.7% were observed for the 50-50 breast model and console MGD, respectively. We conclude that the Dance model should be used for dose calculations in radiation dose surveys and establishing diagnostic reference levels (DRL).

Effect of radiologists' experience on breast cancer detection and localization using digital breast tomosynthesis.

OBJECTIVES: The objectives are To to compare the diagnostic performance of combined digital breast tomosynthesis (DBT) and digital mammography (DM) with that of DM alone, as a function of radiologists' experience with DBT. METHODS: Ethical committee approval was obtained. Fifty cases (27 cancer, 23 normal), each containing both digital mammography (DM) and digital breast tomosynthesis (DBT) images, were reviewed by 26 radiologists, divided into three groups according to level of experience with DBT (none, workshop experience, and clinical experience). The radiologists' diagnostic performance using DM was compared with that using DM + DBT, and evaluated by area under receiver-operating characteristic curve (AUC), jackknife free-response receiver-operator characteristics figure of metric (JAFROC FOM), sensitivity, location sensitivity, and specificity. RESULTS: For all readers combined, performance using DM + DBT was significantly higher than for DM alone by both AUC (0.788 vs 0.681, p < 0.001) and JAFROC FOM (0.745 vs 0.621, p < 0.001). Similar results were obtained for readers with no DBT experience (AUC 0.775 vs 0.682, p = 0.004; JAFROC FOM 0.695 vs 0.603, p = 0.016) and with clinical DBT experience (AUC 0.789 vs 0.681, p = 0.042; and JAFROC FOM 0.764 vs 0.632, p = 0.031). CONCLUSIONS: Addition of DBT to DM significantly improves radiologists' diagnostic performance whether or not they have prior DBT experience. KEY POINTS: • Adding DBT to DM increased the number of detected cancers • DBT + DM led to more accurate localization of breast cancers than DM • Addition of DBT improved radiologists' performance regardless of prior DBT experience • High-volume radiologists with different DBT experience levels performed similarly on DM + DBT.

Perplexing Initial Presentations of MOGAD in Two Children: Intracranial Hypertension and New-Onset Seizure.

We report two distinct challenging initial presentations of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Case 1 describes a 12-year-old boy who developed headaches refractory to pain medication followed by cranial neuropathies and intracranial hypertension, confirmed by lumbar puncture with an opening pressure >36 cm H2O. Case 2 describes a 3-year-old boy who developed new-onset seizures refractory to antiseizure medications, a presentation of FLAIR-hyperintense lesions in MOG-antibody associated encephalitis with seizures (FLAMES). On repeat magnetic resonance imaging, both patients were found to have cortical T2 hyperintensities, leptomeningeal contrast enhancement, and bilateral optic nerve enhancement. In the cerebrospinal fluid, both patients had CSF pleocytosis with neutrophilic predominance. The patients were treated with intravenous immunoglobulins, plasma exchange, and high-dose corticosteroids. The first patient achieved disease remission, whereas the second patient required the addition of rituximab for management of seizures. The two cases highlight the pleomorphic clinical phenotypes of MOGAD.

Effect of x-ray energy on the radiological image quality in propagation-based phase-contrast computed tomography of the breast.

Purpose: Breast cancer is the most common cancer in women in developing and developed countries and is responsible for 15% of women's cancer deaths worldwide. Conventional absorption-based breast imaging techniques lack sufficient contrast for comprehensive diagnosis. Propagation-based phase-contrast computed tomography (PB-CT) is a developing technique that exploits a more contrast-sensitive property of x-rays: x-ray refraction. X-ray absorption, refraction, and contrast-to-noise in the corresponding images depend on the x-ray energy used, for the same/fixed radiation dose. The aim of this paper is to explore the relationship between x-ray energy and radiological image quality in PB-CT imaging. Approach: Thirty-nine mastectomy samples were scanned at the imaging and medical beamline at the Australian Synchrotron. Samples were scanned at various x-ray energies of 26, 28, 30, 32, 34, and 60 keV using a Hamamatsu Flat Panel detector at the same object-to-detector distance of 6 m and mean glandular dose of 4 mGy. A total of 132 image sets were produced for analysis. Seven observers rated PB-CT images against absorption-based CT (AB-CT) images of the same samples on a five-point scale. A visual grading characteristics (VGC) study was used to determine the difference in image quality. Results: PB-CT images produced at 28, 30, 32, and 34 keV x-ray energies demonstrated statistically significant higher image quality than reference AB-CT images. The optimum x-ray energy, 30 keV, displayed the largest area under the curve ( AUC VGC ) of 0.754 ( p = 0.009 ). This was followed by 32 keV ( AUC VGC = 0.731 , p ≤ 0.001 ), 34 keV ( AUC VGC = 0.723 , p ≤ 0.001 ), and 28 keV ( AUC VGC = 0.654 , p = 0.015 ). Conclusions: An optimum energy range (around 30 keV) in the PB-CT technique allows for higher image quality at a dose comparable to conventional mammographic techniques. This results in improved radiological image quality compared with conventional techniques, which may ultimately lead to higher diagnostic efficacy and a reduction in breast cancer mortalities.

Breast fine needle aspiration biopsy cytology: the potential impact of the International Academy of Cytology Yokohama System for Reporting Breast Fine Needle Aspiration Biopsy Cytopathology and the use of rapid on-site evaluation.

The present report reviews the current problems associated with the routine use of breast fine needle aspiration biopsy (FNAB) and discusses the potential impact that the new International Academy of Cytology (IAC) Yokohama Reporting System and the use of rapid on-site evaluation (ROSE) should have on reducing these problems to optimize breast care for patients. The recently reported IAC System aims to establish the best practice guidelines for breast FNAB, emphasizing the importance of the FNAB technique and the skillful preparation of direct smears. The IAC System proposes a standardized report and established clear terminology for defined reporting categories, each of which has a risk of malignancy and is linked to management options. The FNAB techniques that will optimize the biopsy specimen and reduce poor quality smears are reviewed and the benefits of ROSE are discussed. FNAB can diagnose accurately the vast majority of breast lesions, and ROSE has been recommended whenever possible to reduce the rate of insufficient/inadequate cases and increase the number of specific benign and malignant diagnoses. ROSE performed by a cytopathologist provides a provisional diagnosis, reducing patient anxiety and facilitating management through cost-effective immediate triage and patient selection for ancillary testing. Thus, patients can be selected for immediate core needle biopsy, as required.

Breast Density Notification: An Australian Perspective.

Breast density, also known as mammographic density, refers to white and bright regions on a mammogram. Breast density can only be assessed by mammogram and is not related to how breasts look or feel. Therefore, women will only know their breast density if they are notified by the radiologist when they have a mammogram. Breast density affects a woman's breast cancer risk and the sensitivity of a screening mammogram to detect cancer. Currently, the position of BreastScreen Australia and the Royal Australian and New Zealand College of Radiologists is to not notify women if they have dense breasts. However, patient advocacy organisations are lobbying for policy change. Whether or not to notify women of their breast density is a complex issue and can be framed within the context of both public health ethics and clinical ethics. Central ethical themes associated with breast density notification are equitable care, patient autonomy in decision-making, trust in health professionals, duty of care by the physician, and uncertainties around evidence relating to measurement and clinical management pathways for women with dense breasts. Legal guidance on this issue must be gained from broad legal principles found in the law of negligence and the test of materiality. We conclude a rigid legal framework for breast density notification in Australia would not be appropriate. Instead, a policy framework should be developed through engagement with all stakeholders to understand and take account of multiple perspectives and the values at stake.

The International Academy of Cytology Yokohama System for Reporting Breast Fine Needle Aspiration Biopsy Cytopathology: A Single Institutional Retrospective Study of the Application of the System Categories and the Impact of Rapid Onsite Evaluation.

OBJECTIVES: To review the performance and utility of the International Academy of Cytology (IAC) Yokohama System for Reporting Breast Fine Needle Aspiration Biopsy (FNAB) Cytology five category stratification and evaluate the impact of rapid onsite evaluation (ROSE). METHOD: A retrospective analysis of breast FNAB cytology cases with matched histopathological results at a single institution over a 32 months period using a structured reporting system with 5 diagnostic categories ("inadequate/insufficient," "benign," "atypical," "suspicious of malignancy" and "malignant") closely paralleling the proposed IAC System. RESULTS: Of 2,696 breast FNAB cases, there were 579 with matched histopathology and 456 of these had ROSE. ROSE decreased the number in the "insufficient" category (17.1% without ROSE to 4.0% with ROSE) and increased the number in the "malignant" (17.9 to 39.0%) with a lesser impact on the "atypical," "benign" and "suspicious of malignancy" categories. The performance data showed a positive predictive value of 96.4%, negative predictive value of 97.6%, and a risk of malignancy of a FNAB categorized as "insufficient" to be 2.6%, "benign" 1.7%, "atypical" 15.7%, "suspicious of malignancy" 84.6%, and "malignant" 99.5%. CONCLUSION: Breast FNAB is an accurate test enabling effective diagnosis of breast lesions. ROSE improved the performance by decreasing the proportion of "insufficient" and "atypical" and increasing the "suspicious of malignancy" and "malignant" diagnoses and enabling immediate triage for further biopsy where necessary.

Breast screening attendance of Aboriginal and Torres Strait Islander women in the Northern Territory of Australia.

OBJECTIVE: To compare breast screening attendances of Indigenous and non-Indigenous women. METHODS: A total of 4,093 BreastScreen cases were used including 857 self-identified Indigenous women. Chi-squared analysis compared data between Indigenous and non-Indigenous women. Logistic regression was used for groupings based on visits-to-screening frequency. Odds ratios and 95% confidence intervals were calculated for associations with low attendance. RESULTS: Indigenous women were younger and had fewer visits to screening compared with non-Indigenous women. Non-English speaking was mainly associated with fewer visits for Indigenous women only (OR 1.9, 95%CI 1.3-2.9). Living remotely was associated with fewer visits for non-Indigenous women only (OR 1.3, 95%CI 1.1-1.5). Shared predictors were younger age (OR 12.3, 95%CI 8.1-18.8; and OR 11.5, 95%CI 9.6-13.7, respectively) and having no family history of breast cancer (OR 2.1, 95%CI 1.3-3.3; and OR 1.8, 95%CI 1.5-2.1, respectively). CONCLUSIONS: Factors associated with fewer visits to screening were similar for both groups of women, except for language which was significant only for Indigenous women, and remoteness which was significant only for non-Indigenous women. Implications for public health: Health communication in Indigenous languages may be key in encouraging participation and retaining Indigenous women in BreastScreen; improving access for remote-living non-Indigenous women should also be addressed.

Mammographic densities of Aboriginal and non-Aboriginal women living in Australia's Northern Territory.

OBJECTIVES: To compare the mammographic densities and other characteristics of Aboriginal and non-Aboriginal women screened in Australia. METHODS: Population screening programme data of Aboriginal (n = 857) and non-Aboriginal women (n = 3236) were used. Mann-Whitney U test compared ages at screening and Chi-square tests compared personal and clinical information. Logistic regression analysis was used for density groupings. OR and 95% CI were calculated for multivariate association for density. RESULTS: Mammographic density was lower amongst Aboriginal women (P < 0.001). For non-Aboriginal women, higher density was associated with younger age (OR 2.4, 95% CI 2.1-2.8), recall to assessment (OR 2.2, 95% CI 1.6-3.0), family history of breast cancer (OR 1.4, 95% CI 1.2-1.6), English-speaking background (OR 1.4, 95% CI 1.2-1.6), and residence in remote areas (OR 1.2, 95% CI 1.1-1.4). For Aboriginal women, density was associated with younger age (OR 2.7, 95% CI 2.0-3.5; P < 0.001), and recall to assessment (OR 2.3, 95% CI 1.4-3.9; P < 0.05). CONCLUSIONS: Significant differences between Aboriginal and non-Aboriginal women were found. There were more significant associations for dense breasts for non-Aboriginal women than for Aboriginal women.

The International Academy of Cytology Yokohama System for Reporting Breast Fine-Needle Aspiration Biopsy Cytopathology.

The International Academy of Cytology (IAC) gathered together a group of cytopathologists expert in breast cytology who, working with clinicians expert in breast diagnostics and management, have developed the IAC Yokohama System for Reporting Breast Fine-Needle Aspiration Biopsy (FNAB) Cytology. The project was initiated with the first cytopathology group meeting in Yokohama at the 2016 International Congress of Cytology. This IAC Yokohama System defines five categories for reporting breast cytology, each with a clear descriptive term for the category, a definition, a risk of malignancy (ROM) and a suggested management algorithm. The key diagnostic cytopathology features of each of the lesions within each category will be presented more fully in a subsequent atlas. The System emphasizes that the crucial requirements for diagnostic breast FNAB cytology are a high standard for the performance of the FNAB and for the making of direct smears, and well-trained experienced cytopathologists to interpret the material. The performance indicators of breast FNAB, including specificity and sensitivity, negative predictive value, positive predictive value and ROM stated in this article have been derived from the recent literature. The current practice of breast FNAB has evolved with the increasing use of ultrasound guidance and rapid on-site evaluation. Two recent publications have shown a range of ROM for the insufficient/inadequate category of 2.6-4.8%, benign 1.4-2.3%, atypical 13-15.7%, suspicious of malignancy 84.6-97.1%, and malignant 99.0-100%. The management algorithm in the System provides options because there are variations in the management of breast lesions using FNAB and core-needle biopsy in those countries utilizing the "triple test" of clinical, imaging, and FNAB assessment, and also variations in the availability of CNB and imaging in low- and middle-income countries. The System will stimulate further discussion and research, particularly in the cytological diagnostic features of specific lesions within each category and in management recommendations. This will lead to continuing improvements in the care of patients with breast lesions and possible modifications to the IAC Yokohama System.

An investigation into the mammographic appearances of missed breast cancers when recall rates are reduced.

OBJECTIVE: This study investigated whether certain mammographic appearances of breast cancer are missed when radiologists read at lower recall rates. METHODS: 5 radiologists read 1 identical test set of 200 mammographic (180 normal cases and 20 abnormal cases) 3 times and were requested to adhere to 3 different recall rate conditions: free recall, 15% and 10%. The radiologists were asked to mark the locations of suspicious lesions and provide a confidence rating for each decision. An independent expert radiologist identified the various types of cancers in the test set, including the presence of calcifications and the lesion location, including specific mammographic density. RESULTS: Radiologists demonstrated lower sensitivity and receiver operating characteristic area under the curve for non-specific density/asymmetric density (H = 6.27, p = 0.04 and H = 7.35, p = 0.03, respectively) and mixed features (H = 9.97, p = 0.01 and H = 6.50, p = 0.04, respectively) when reading at 15% and 10% recall rates. No significant change was observed on cancer characterized with stellate masses (H = 3.43, p = 0.18 and H = 1.23, p = 0.54, respectively) and architectural distortion (H = 0.00, p = 1.00 and H = 2.00, p = 0.37, respectively). Across all recall conditions, stellate masses were likely to be recalled (90.0%), whereas non-specific densities were likely to be missed (45.6%). CONCLUSION: Cancers with a stellate mass were more easily detected and were more likely to continue to be recalled, even at lower recall rates. Cancers with non-specific density and mixed features were most likely to be missed at reduced recall rates. Advances in knowledge: Internationally, recall rates vary within screening mammography programs considerably, with a range between 1% and 15%, and very little is known about the type of breast cancer appearances found when radiologists interpret screening mammograms at these various recall rates. Therefore, understanding the lesion types and the mammographic appearances of breast cancers that are affected by readers' recall decisions should be investigated.

Breast Cancer in Australian Indigenous Women: Incidence, Mortality, and Risk Factors

The Indigenous people of Australia face significant health gaps compared with the general population, with lower life expectancies, higher rates of death, and chronic illness occurring more often than in non-indigenous Australians. Cancer is the second largest contributor to the burden of disease with breast cancer being the most common invasive cancer diagnosed for females. Despite a lower breast cancer incidence compared with non-indigenous women, fatalities occur at an elevated rate and breast cancers have an earlier age of onset. For indigenous women there are also more advanced and distant tumours at diagnosis, fewer hospitalisations for breast cancer, and lower participation in breast screening. Concomitantly there are demographic, socio-economic and lifestyle factors associated with breast cancer risks that are heavily represented within Indigenous communities. The aim of this two-part narrative review is to examine the available evidence on breast cancer and its risk factors in Australian Indigenous women. Part One presents a summary of the latest incidence, survival and mortality data. Part Two presents the risk factors most strongly associated with breast cancer including age, place of residence, family risk, genetics, reproductive history, tobacco use, alcohol intake, physical activity, participation in screening and breast density. With increasing emphasis on personalized health care, a clear understanding of breast cancer incidence, survival, mortality, and causal agents within the Indigenous population is required if breast cancer prevention and management is to be optimized for Indigenous Australians.

RELATIONSHIP BETWEEN RADIATION DOSE AND IMAGE QUALITY IN DIGITAL BREAST TOMOSYNTHESIS.

This phantom-based study aimed to examine radiation dose from digital breast tomosynthesis (DBT) and digital mammography (DM) and to assess the potential for dose reductions for each modality. Images were acquired at 10-60 mm thicknesses and four dose levels and mean glandular dose was determined using a solid-state dosemeter. Eleven readers assessed image quality and compared simulated lesions with those on a reference image, and the data produced was analysed with the Friedman and Wilcoxon signed-rank tests. For a phantom thickness of 50 mm (typical breast thickness), DBT dose was 13 % higher than DM, but this differential is highly dependent on thickness. Visibility of masses was equal to a reference image (produced at 100 % dose) when dose was reduced by 75 and 50 % for DBT and DM. For microcalcifications, visibility was comparable with the reference image for both modalities at 50 % dose. This study highlighted the potential for reducing dose with DBT.

Cancer detection and mammogram volume of radiologists in a population-based screening programme.

This study investigates the relationship between the number of screening mammograms read by radiologists and the screening breast cancer detection rate. Cancer detection rates for incident screens (all women aged 40 years) were compared by increasing categories of reader volume using Poisson regression. Data from New South Wales (NSW) for a 2 year period (2000-2001) were obtained from the BreastScreen NSW programme. Cancer detection rates increased with the number of mammograms read in the programme, reaching a plateau of approximately 40 per 10,000 after 1375 mammograms per year. No significant differences in cancer detection were evident above 875 mammograms (compared to below 875 mammograms) per year (RR=0.79, 95% CI 0.63-0.99).

Breast density (BD) assessment with digital breast tomosynthesis (DBT): Agreement between Quantra™ and 5th edition BI-RADS®.

PURPOSE: To assess the agreement between digital breast tomosynthesis (DBT) breast density (BD) assessment made using Quantra™ and fifth edition BI-RADS®. MATERIALS AND METHODS: This board approved study involved BD assessment of 234 women undergoing DBT investigation. BD estimation was performed from the raw DBT images using Quantra™ 3 (v.2.1.1, Hologic, Bedford MA). BI-RADS® assessment was performed using prior digital mammograms displayed simultaneously with 2D images synthesized from DBT by three radiologists using the fifth edition BI-RADS® (A, B, C, D). Kappa (к) was used to assess inter-reader agreement, agreement between Quantra™ and each reader, as well as the majority report of all readers. Receiver Operating Characteristic (ROC) analysis was used to assess the performance of Quantra™ in reproducing the majority BI-RADS® assessment. Data was then grouped into a two-category scale [almost entirely fatty and scattered fibroglandular tissue (A-B) versus heterogeneously dense and extremely dense (C-D)], and a further analysis performed. RESULTS: Inter-reader agreement varied from fair [0.38 (95%CI: 0.30-0.46)] to substantial [0.68 (95%CI: 0.61-0.75)] on a four-category scale and substantial [0.70 (95%CI: 0.61-0.78)] to almost perfect [0.85 (95%CI: 0.78-0.92)] on a two-category scale. Using the majority report, the agreement between BI-RADS® and Quantra™ was 0.68 (95%CI: 0.59-0.75) on a four-category scale and 0.86 (95%CI: 0.79-0.93) on a two-category scale. Quantra™ distinguished BI-RADS® A-B from C-D with 97.1% sensitivity and 83.1% specificity. CONCLUSION: Data demonstrate moderate to substantial agreement in BD assessment between fifth edition BI-RADS® and Quantra™.

Quantra™ should be considered a tool for two-grade scale mammographic breast density classification.

OBJECTIVE: To assess the agreement between Quantra™ (Hologic Inc., Bedford, MA) and Breast Imaging Reporting and Data Systems (BI-RADS(®)) and the performance of Quantra at reproducing BI-RADS mammographic breast density (MBD) assessment. METHODS: MBD assessment was performed using Quantra and BI-RADS. BI-RADS assessment was performed in two phases (1314 and 292 cases, respectively). Kappa was used to assess the interreader agreement and the agreement between Quantra and BI-RADS, and receiver-operating characteristics analysis was used to assess the performance of Quantra at reproducing BI-RADS rating. RESULTS: Agreement (weighted kappa) between BI-RADS and Quantra in Phase 1 was 0.75 [95% confidence interval (CI): 0.73-0.78] and 0.85 (95% CI: 0.80-0.90) on four- and two-grade scales, respectively. The corresponding agreement in Phase 2 was 0.79 (95% CI: 0.75-0.84) and 0.84 (95% CI: 0.79-0.87) using the majority report. In Phase 1, Quantra demonstrated 93.2% sensitivity and 86.1% specificity for BI-RADS on a two-grade scale (1-2 vs 3-4). In Phase 2, it demonstrated 91.3% sensitivity and 83.6% specificity on a two-grade scale. CONCLUSION: Quantra is limited in reproducing BI-RADS rating on a four-grade scale; however, it highly reproduces BI-RADS assessment on a two-grade scale. ADVANCES IN KNOWLEDGE: Quantra (v. 2.0) is a poor predictor of BI-RADS assessment on a four-grade scale, but well reproduces BI-RADS rating on a two-grade scale. Therefore, it should be considered a tool for two-grade scale MBD classification.

Comparison of the validity and reliability of two image classification systems for the assessment of mammogram quality.

OBJECTIVE: To compare the reliability and validity of two classification systems used to evaluate the quality of mammograms: PGMI ('perfect', 'good', 'moderate' and 'inadequate') and EAR ('excellent', 'acceptable' and 'repeat'). SETTING: New South Wales (Australia) population-based mammography screening programme (BreastScreen NSW). METHODS: Thirty sets of mammograms were rated by 21 radiographers and an expert panel. PGMI and EAR criteria were used to assign ratings to the medio-lateral oblique (MLO) and cranio-caudal (CC) views for each set of films. Inter-observer reliability and criterion validity (compared with expert panel ratings) were assessed using mean weighted observed agreement and kappa statistics. RESULTS: Reliability: Kappa values for both classification systems were low (0.01-0.17). PGMI produced significantly higher values than EAR. Agreement between raters was higher using PGMI than EAR for the MLO view (77% versus 74%, P < 0.05), but was similar for the CC view. Dichotomized ratings ('acceptable' or 'needs repeating') did not improve reliability estimates. VALIDITY: Kappa values between raters and the reference standard were low for both classification systems (0.05-0.15). Agreement between raters and the reference standard was higher using PGMI than EAR for the MLO view (74% versus 63%), but was similar for the CC view. Dichotomized ratings of the MLO view showed slightly higher observer agreement. CONCLUSIONS: Both PGMI and EAR have poor reliability and validity in evaluating mammogram quality. EAR is not a suitable alternative to PGMI, which must be improved if it is to be useful.

Precision imaging-its impact on image quality and diagnostic confidence in breast ultrasound examinations.

OBJECTIVE: To determine the effect of noise-reducing innovation-precision imaging (PI)-on image quality and diagnostic efficacy in breast ultrasound. METHODS: The study, which assessed four levels of PI from zero to three, consisted of two parts: image quality assessment and diagnostic efficacy evaluation. For the first part, 247 sets of ultrasound images displayed at each PI level were evaluated by 6 experienced breast imaging observers, by rating image quality using visual grading analysis on a 1-4 scale. For the diagnostic efficacy part 51 breast lesions were displayed at each PI level and scored 1-6 to generate a receiver operating characteristic (ROC) curve. These images were evaluated by radiologists and sonographers. Analyses were performed using non-parametric Friedman and Wilcoxon signed rank tests and a multireader multicase methodology. RESULTS: Statistically, higher scores of image quality were observed with increased levels of PI than with the zero setting (p < 0.001). The ROC analysis did not demonstrate any significant change in diagnostic efficacy, with mean scores for all observers being 0.79, 0.80, 0.81 and 0.81 for settings zero, one, two and three, respectively. CONCLUSION: This study suggested a perceived improvement in image quality with increasing levels of PI; however, no changes in diagnostic efficacy were noted. The importance of looking at the impact of new imaging technologies in a multifaceted way is emphasized. ADVANCES IN KNOWLEDGE: To our knowledge, this is the first article investigating the impact of the PI algorithm on ultrasound image quality and breast lesion characterization.