An Abbreviated Protocol for High-Risk Screening Breast MRI Saves Time and Resources.

PURPOSE: To review the ability of an abbreviated, high-risk, screening, breast MRI protocol to detect cancer and save resources. METHODS: High-risk screening breast MR images were reviewed, from both an abbreviated protocol and a full diagnostic protocol. Differences in cancer detection, scanner utilization, interpretation times, and need for additional imaging were recorded in an integrated data form, and reviewed and compared. RESULTS: A total of 568 MRI cases were reviewed, with the abbreviated and full protocols. No difference was found in the number of cancers detected. Scan times were decreased by 18.8 minutes per case, for a total of 10,678 minutes (178 hours). Interpretation time, on average, was 1.55 minutes for the abbreviated protocol, compared with 6.43 minutes for the full protocol. Review of the full protocol led to a significant change in the final BI-RADS® assessment in 12 of 568 (2.1%) cases. CONCLUSIONS: Abbreviated MRI is as effective as full-protocol MRI for demonstration of cancers in the high-risk screening setting, with only 12 (2.1 %) cases recommended for additional MRI evaluation. The efficiency and resource savings of an abbreviated protocol would be significant, and would allow for opportunities to provide MRI for additional patients, as well as improved radiologist time management and workflow, with the potential to add real-time MRI interpretation or double reading.

An Abbreviated Protocol for High-Risk Screening Breast MRI Saves Time and Resources.

PURPOSE: To review the ability of an abbreviated, high-risk, screening, breast MRI protocol to detect cancer and save resources. METHODS: High-risk screening breast MR images were reviewed, from both an abbreviated protocol and a full diagnostic protocol. Differences in cancer detection, scanner utilization, interpretation times, and need for additional imaging were recorded in an integrated data form, and reviewed and compared. RESULTS: A total of 568 MRI cases were reviewed, with the abbreviated and full protocols. No difference was found in the number of cancers detected. Scan times were decreased by 18.8 minutes per case, for a total of 10,678 minutes (178 hours). Interpretation time, on average, was 1.55 minutes for the abbreviated protocol, compared with 6.43 minutes for the full protocol. Review of the full protocol led to a significant change in the final BI-RADS(®) assessment in 12 of 568 (2.1%) cases. CONCLUSIONS: Abbreviated MRI is as effective as full-protocol MRI for demonstration of cancers in the high-risk screening setting, with only 12 (2.1%) cases recommended for additional MRI evaluation. The efficiency and resource savings of an abbreviated protocol would be significant, and would allow for opportunities to provide MRI for additional patients, as well as improved radiologist time management and workflow, with the potential to add real-time MRI interpretation or double reading.

Advanced Breast Imaging Availability by Screening Facility Characteristics.

RATIONALE AND OBJECTIVES: To determine the relationship between screening mammography facility characteristics and on-site availability of advanced breast imaging services required for supplemental screening and the diagnostic evaluation of abnormal screening findings. MATERIALS AND METHODS: We analyzed data from all active imaging facilities across six regional registries of the National Cancer Institute-funded Breast Cancer Surveillance Consortium offering screening mammography in calendar years 2011-2012 (n = 105). We used generalized estimating equations regression models to identify associations between facility characteristics (eg, academic affiliation, practice type) and availability of on-site advanced breast imaging (eg, ultrasound [US], magnetic resonance imaging [MRI]) and image-guided biopsy services. RESULTS: Breast MRI was not available at any nonradiology or breast imaging-only facilities. A combination of breast US, breast MRI, and imaging-guided breast biopsy services was available at 76.0% of multispecialty breast centers compared to 22.2% of full diagnostic radiology practices (P = .0047) and 75.0% of facilities with academic affiliations compared to 29.0% of those without academic affiliations (P = .04). Both supplemental screening breast US and screening breast MRI were available at 28.0% of multispecialty breast centers compared to 4.7% of full diagnostic radiology practices (P < .01) and 25.0% of academic facilities compared to 8.5% of nonacademic facilities (P = .02). CONCLUSIONS: Screening facility characteristics are strongly associated with the availability of on-site advanced breast imaging and image-guided biopsy service. Therefore, the type of imaging facility a woman attends for screening may have important implications on her timely access to supplemental screening and diagnostic breast imaging services.

Online support: Impact on anxiety in women who experience an abnormal screening mammogram.

OBJECTIVES: To determine whether an online support tool can impact anxiety in women experiencing an abnormal mammogram. MATERIALS AND METHODS: We developed an online support system using the Comprehensive Health Enhancement Support System (CHESS) designed for women experiencing an abnormal mammogram as a model. Our trial randomized 130 of these women to online support (the intervention group) or to a list of five commonly used Internet sites (the comparison group). Surveys assessed anxiety and breast cancer worry, and patient satisfaction at three important clinical time points: when women were notified of their abnormal mammogram, at the time of diagnostic imaging, and at the time of biopsy (if biopsy was recommended). RESULTS: Study participants in the intervention group showed a significant decrease in anxiety at the time of biopsy compared to the comparison group (p = 0.017). However, there was no significant difference in anxiety between the intervention group and the comparison group at the time of diagnostic work-up. We discontinued assessment of patient satisfaction after finding that many women had substantial difficulty answering the questions that referenced their physician, because they did not understand who their physician was for this process of care. CONCLUSION: The combination of the inability to identify the physician providing care during the mammography work-up and anxiety effects seen only after an interaction with the breast imaging team may indicate that online support only decreases the anxiety of women in concert with direct interpersonal support from the healthcare team.

Fear of causing harm: use of mannequin-based simulation to decrease student anxiety prior to interacting with female teaching associates.

BACKGROUND: There is a paucity of research assessing the potential benefits of mannequin trainers when preparing students to interact with teaching associates. PURPOSE: The goal of this study was to better understand the effects of mannequin-based simulators on student comfort toward learning specific aspects of the clinical female pelvic exam. METHODS: First-year medical students (N = 344) were surveyed before and after a mannequin-based simulation curriculum to assess their comfort levels toward learning the female pelvic exam. RESULTS: Causing harm was the top cause of student anxiety toward learning the pelvic exam. Although the mannequin-based simulation curriculum was effective in significantly increasing (p < .001) student comfort levels toward learning the pelvic exam, the majority of students progressed from being "very uncomfortable" with the exam to being "somewhat comfortable." CONCLUSION: We suggest that mannequin-based simulators be used prior to students' learning experience with pelvic exam teaching associates.

Hepatotoxicity associated with long- versus short-course HIV-prophylactic nevirapine use: a systematic review and meta-analysis from the Research on Adverse Drug events And Reports (RADAR) project.

BACKGROUND AND OBJECTIVE: The antiretroviral nevirapine can cause severe hepatotoxicity when used 'off-label' for preventing mother-to-child HIV transmission (PMTCT), newborn post-exposure prophylaxis and for pre- and post-exposure prophylaxis among non-HIV-infected individuals. We describe the incidence of hepatotoxicity with short- versus long-course nevirapine-containing regimens in these groups. METHODS: We reviewed hepatotoxicity cases among non-HIV-infected individuals and HIV-infected pregnant women and their offspring receiving short- (or=5 days) nevirapine prophylaxis. Sources included adverse event reports from pharmaceutical manufacturers and the US FDA, reports from peer-reviewed journals/scientific meetings and the Research on Adverse Drug events And Reports (RADAR) project. Hepatotoxicity was scored using the AIDS Clinical Trial Group criteria. RESULTS: Toxicity data for 8216 patients treated with nevirapine-containing regimens were reviewed. Among 402 non-HIV-infected individuals receiving short- (n=251) or long-course (n=151) nevirapine, rates of grade 1-2 hepatotoxicity were 1.99% versus 5.30%, respectively, and rates of grade 3-4 hepatotoxicity were 0.00% versus 13.25%, respectively (p<0.001 for both comparisons). Among 4740 HIV-infected pregnant women receiving short- (n=3031) versus long-course (n=1709) nevirapine, rates of grade 1-2 hepatotoxicity were 0.62% and 7.04%, respectively, and rates of grade 3-4 hepatotoxicity were 0.23% versus 4.39%, respectively (p<0.001 for both comparisons). The rates of grade 3-4 hepatotoxicity among 3074 neonates of nevirapine-exposed HIV-infected pregnant women were 0.8% for those receiving short-course (n=2801) versus 1.1% for those receiving long-course (n=273) therapy (p<0.72). CONCLUSIONS: Therapy duration appears to significantly predict nevirapine hepatotoxicity. Short-course nevirapine for HIV prophylaxis is associated with fewer hepatotoxic reactions for non-HIV-infected individuals or pregnant HIV-infected women and their offspring, but administration of prophylactic nevirapine for >or=2 weeks appears to be associated with high rates of hepatotoxicity among non-HIV-infected individuals and HIV-infected pregnant mothers. When full highly active antiretroviral therapy (HAART) regimens are not available, single-dose nevirapine plus short-course nucleoside reverse transcriptase inhibitors to decrease the development of HIV viral resistance is an essential therapeutic option for PMTCT and these data support the safety of single-dose nevirapine in this setting.

Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw.

More than half of all serious adverse reactions are identified 7 or more years after a drug receives approval from the US Food and Drug Administration (FDA). In 2002, 9 months after the intravenous bisphosphonate zoledronic acid received regulatory approval for marketing, the FDA received reports of nine patients with cancer, who were treated with zoledronic acid, who unexpectedly developed osteonecrosis of the jaw. During the next 2 years, three oral surgeons described 104 patients with cancer with osteonecrosis of the jaw in the medical literature and identified intravenous bisphosphonate therapy as being common to the care of these patients. In subspecialty medical, radiology, and dental journals, case reports and case series described clinical features of osteonecrosis of the jaw in patients with cancer who were treated with bisphosphonates. Manufacturer-sponsored epidemiological studies reported the first estimates of the incidence of this toxic effect, ranging from 0.1% to 1.8%. By contrast, independent epidemiological efforts from clinicians and the International Myeloma Foundation reported incidence estimates between 5% and 10%. Between 2003 and 2005, warnings about the risks of bisphosphonate-associated osteonecrosis were disseminated by national regulatory agencies, the manufacturers of bisphosphonates, and the International Myeloma Foundation. From 2006, independent clinical recommendations for diagnosis, prevention, and treatment of this toxic effect have been disseminated by manufacturers, national regulatory authorities, the International Myeloma Foundation, and medical specialty organisations. Furthermore, independent efforts by pharmaceutical manufacturers, dental and medical professionals, a non-profit organisation (the International Myeloma Foundation), patients, and regulatory authorities has led to the rapid identification and dissemination of safety information for this serious adverse reaction. Better coordination of safety-related pharmacovigilance initiatives is now needed.

Gadolinium-associated nephrogenic systemic fibrosis.

The authors explain why physicians should refrain from ordering MRIs for patients with renal dysfunction unless the test is essential to provide diagnostic information. A possibly class-wide toxicity from the contrast agent gadolinium has been reported.

Caveat medicus: consequences of federal investigations of marketing activities of pharmaceutical suppliers of prostate cancer drugs.

In the course of recent health care fraud investigations against TAP Pharmaceuticals (Lake Forest, IL) and AstraZeneca International (London, United Kingdom), each pled guilty to one violation of the Prescription Drug Marketing Act, settled claims related to alleged violations of the False Claims Act without admitting guilt, and paid fines, settlements for liabilities, and reimbursements of dollar 850 million and dollar 355 million, respectively. In a unique aspect of these cases, federal investigators brought criminal charges against 14 TAP employees and investigated the billing practices of several urologists. These investigations resulted in guilty pleas from both urologists and industry employees relative to the Prescription Drug Marketing Act or the False Claims Act and probationary sentences with payments of fines and restitution to the government for urologists who cooperated with federal investigations. One uncooperative urologist was found guilty of violating the Federal False Claims Act and sentenced to 6 months of home arrest, excluded from Medicare for 5 years, required to provide 600 hours of free medical care to indigent patients and patients covered by Medicare or Medicaid, and paid fines and restitution to the government. The cases against TAP and AstraZeneca have been followed by federal and state investigations of allegedly illegal marketing practices of other pharmaceutical firms and have resulted in negotiated settlements of dollar 3.8 billion and dollar 71.5 million, respectively. Believing that an Average Wholesale Price-based reimbursement system was an important driving factor for these marketing activities, Medicare has shifted to an Average Sales Price-based reimbursement system. This is expected to greatly impact the practice of outpatient oncology nationwide.