Optimizing external advisory committee meetings of Clinical and Translational Science Awards through focused pre-review.

External advisory committees (EACs) are critical peer-review meetings that drive improvement at Clinical and Translational Science Award Program Hubs. Despite their ubiquity, evaluations of EAC optimization and effective implementation remain scarce. We present a two-tiered approach to optimizing EAC meetings through (1) in-depth, topically focused "pre-review" meetings comprised of external topic experts and at least one standing "full-board" EAC member, followed by (2) a traditional "full-board" EAC meeting.

Methodological Considerations in Evaluating Breast Cancer Screening Studies.

In evidence-based medicine frameworks, the highest level of evidence is derived from quantitative synthesis of double-masked, high-quality, randomly assigned controlled trials. Meta-analyses of randomly assigned controlled trials have demonstrated that screening mammography reduces breast cancer deaths. In the United States, every major guideline-producing organization has recommended screening mammography in average-risk women; however, there are controversies about age and frequency.

The Importance of Outcomes Ascertainment for Accurate Assessment of the Mammography Screening Cancer Detection Rate: A Simulation Study.

Purpose: Cancer detection rate (CDR), an important metric in the mammography screening audit, is designed to ensure adequate sensitivity. Most practices use biopsy results as the reference standard; however, commonly ascertainment of biopsy results is incomplete. We used simulation to determine the relationship between the cancer ascertainment rate of biopsy (AR-biopsy), CDR estimation, and associated error rates in classifying whether practices and radiologists meet the established ACR benchmark of 2.

A leadership model supporting maturation of high-performance translational teams.

Despite understanding its impact on organizational effectiveness, practical guidance on how to train translational team (TT) leaders is lacking. Previously, we developed an evolutionary learning model of TT maturation consisting of three goal-directed phases: (1). team assembly (); (2).

ENIGMA CHEK2gether Project: A Comprehensive Study Identifies Functionally Impaired CHEK2 Germline Missense Variants Associated with Increased Breast Cancer Risk.

Purpose: Germline pathogenic variants in CHEK2 confer moderately elevated breast cancer risk (odds ratio, OR ∼ 2.5), qualifying carriers for enhanced breast cancer screening. Besides pathogenic variants, dozens of missense CHEK2 variants of uncertain significance (VUS) have been identified, hampering the clinical utility of germline genetic testing (GGT).

Temporal development of high-performance translational teams.

Successful translation involves the coupled application of knowledgegenerating research with product development to advance a device, drug, diagnostic, or evidence-based intervention for clinical adoption to improve human health. Critical to the success of the CTSA consortium, translation can be more effectively accomplished by training approaches that focus on improving team-emergent knowledge skills and attitudes (KSAs) linked to performance. We earlier identified 15 specific evidence-informed, team-emergent competencies that facilitate translational team (TT) performance.

Deployment of Real-time Natural Language Processing and Deep Learning Clinical Decision Support in the Electronic Health Record: Pipeline Implementation for an Opioid Misuse Screener in Hospitalized Adults.

Background: The clinical narrative in electronic health records (EHRs) carries valuable information for predictive analytics; however, its free-text form is difficult to mine and analyze for clinical decision support (CDS). Large-scale clinical natural language processing (NLP) pipelines have focused on data warehouse applications for retrospective research efforts. There remains a paucity of evidence for implementing NLP pipelines at the bedside for health care delivery.

Competencies supporting high-performance translational teams: A review of the SciTS evidence base.

A translational team (TT) is a specific type of interdisciplinary team that seeks to improve human health. Because high-performing TTs are critical to accomplishing CTSA goals, a greater understanding of how to promote TT performance is needed. Previous work by a CTSA Workgroup formulated a taxonomy of 5 interrelated team-emergent competency "domains" for successful translation: 1).

A new perspective on breast cancer diagnostic guidelines to reduce overdiagnosis.

Overdiagnosis of breast cancer, defined as diagnosing a cancer that would otherwise not cause symptoms or death in a patient's lifetime, costs U.S. health care system over $1.

Utilization and Cancer Yield of Probably Benign Assessment Category in the National Mammography Database: 2009 to 2018.

Purpose: Data on utilization rate and cancer yield of BI-RADS® category 3 in routine clinical practice in diagnostic mammography are sparse. The aim of this study was to determine utilization rate and cancer yield of BI-RADS 3 in diagnostic mammography in the ACR National Mammography Database (NMD).

Methods: Retrospective analysis of NMD mammograms from January 1, 2009, to June 30, 2018, was performed.

Patient and Clinician Characteristics That Predict Breast Cancer Screening Behavior in 40-49-Year-Old Women.

Guidelines recommend that clinicians practice shared decision-making (SDM) with women in their 40s to discuss breast cancer screening. Traditionally, SDM includes discussion of values and preferences to help determine a decision that is congruent with what the patient desires. We analyzed 54 women's breast cancer screening decisions after a SDM conversation with their clinician.

Quantitative breast density analysis to predict interval and node-positive cancers in pursuit of improved screening protocols: a case-control study.

Background: This study investigates whether quantitative breast density (BD) serves as an imaging biomarker for more intensive breast cancer screening by predicting interval, and node-positive cancers.

Methods: This case-control study of 1204 women aged 47-73 includes 599 cancer cases (302 screen-detected, 297 interval; 239 node-positive, 360 node-negative) and 605 controls. Automated BD software calculated fibroglandular volume (FGV), volumetric breast density (VBD) and density grade (DG).

Enhancing reproducibility using interprofessional team best practices.

The pervasive problem of irreproducibility of preclinical research represents a substantial threat to the translation of CTSA-generated health interventions. Key stakeholders in the research process have proposed solutions to this challenge to encourage research practices that improve reproducibility. However, these proposals have had minimal impact, because they either 1.

A Population-Based Study of Genes Previously Implicated in Breast Cancer.

Background: Population-based estimates of the risk of breast cancer associated with germline pathogenic variants in cancer-predisposition genes are critically needed for risk assessment and management in women with inherited pathogenic variants.

Methods: In a population-based case-control study, we performed sequencing using a custom multigene amplicon-based panel to identify germline pathogenic variants in 28 cancer-predisposition genes among 32,247 women with breast cancer (case patients) and 32,544 unaffected women (controls) from population-based studies in the Cancer Risk Estimates Related to Susceptibility (CARRIERS) consortium. Associations between pathogenic variants in each gene and the risk of breast cancer were assessed.

Framing the Clinical Encounter: Shared Decision-Making, Mammography Screening, and Decision Satisfaction.

The study examines whether physicians' framing of clinical interactions is related to patient shared decision-making (SDM) satisfaction when using a clinical decision support tool (CDST) concerning mammographic screening. To answer this question, we combined (a) system log data from a CDST, (b) content coding of the physicians' message framing while using the CDST, and (c) a post-visit patient survey to assess SDM satisfaction concerning screening mammography. Results suggest that two types of message frames - consequence frames and numerical frames - moderated the relationship of the CDST on SDM satisfaction.

Modeling the natural history of ductal carcinoma in situ based on population data.

Background: The incidence of ductal carcinoma in situ (DCIS) has increased substantially since the introduction of mammography screening. Nevertheless, little is known about the natural history of preclinical DCIS in the absence of biopsy or complete excision.

Methods: Two well-established population models evaluated six possible DCIS natural history submodels.

Cancer Yield and Patterns of Follow-up for BI-RADS Category 3 after Screening Mammography Recall in the National Mammography Database.

Background The literature supports the use of short-interval follow-up as an alternative to biopsy for lesions assessed as probably benign, Breast Imaging Reporting and Data System (BI-RADS) category 3, with an expected malignancy rate of less than 2%. Purpose To assess outcomes from 6-, 12-, and 24-month follow-up of probably benign findings first identified at recall from screening mammography in the National Mammography Database (NMD). Materials and Methods This retrospective study included women recalled from screening mammography with BI-RADS category 3 assessment at additional evaluation from January 2009 through March 2018 from 471 NMD facilities.

Core Elements of Shared Decision-making for Women Considering Breast Cancer Screening: Results of a Modified Delphi Survey.

Background: The United States Preventive Services Task Force recommends individualized breast cancer screening for average-risk women before age 50, advised by risk assessment and shared decision-making (SDM). However, the foundational principles of this recommendation that would inform decision support tools for patients and primary care physicians at the point of care have not been codified. Determining the core elements of SDM for breast cancer screening as valued by patients and primary care providers (PCPs) is necessary for implementing effective SDM tools.