Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.

Post hoc analysis of FRAME and ARCH revealed that on-study nonvertebral and vertebral fractures by Month 12 were less common in women initially treated with romosozumab versus placebo or alendronate. Recurrent fracture risk was also lower in romosozumab­treated patients, and there were no fracture­related complications. Results support continuing romosozumab treatment post­fracture. PURPOSE: Post hoc analysis evaluating efficacy and safety of romosozumab, administered in the immediate post­fracture period, in the FRAME and ARCH phase 3 trials. METHODS: In FRAME (NCT01575834) and ARCH (NCT01631214), postmenopausal women with osteoporosis were randomized 1:1 to romosozumab 210 mg monthly or comparator (FRAME, placebo; ARCH, alendronate 70 mg weekly) for 12 months, followed by antiresorptive therapy (FRAME, denosumab; ARCH, alendronate). In patients who experienced on-study nonvertebral or new/worsening vertebral fracture by Month 12, we report the following: fracture and treatment­emergent adverse event (TEAE) incidence through 36 months, bone mineral density changes (BMD), and romosozumab timing. Due to the sample sizes employed, meaningful statistical comparisons between treatments were not possible. RESULTS: Incidence of on-study nonvertebral and vertebral fractures by Month 12 was numerically lower in romosozumab- versus comparator-treated patients (FRAME, 1.6% and 0.5% versus 2.1% and 1.6%; ARCH, 3.4% and 3.3% versus 4.6% and 4.9%, respectively). In those who experienced on-study nonvertebral fracture by Month 12, recurrent nonvertebral and subsequent vertebral fracture incidences were numerically lower in patients initially treated with romosozumab versus comparator (FRAME, 3.6% [2/56] and 1.8% [1/56] versus 9.2% [7/76] and 3.9% [3/76]; ARCH, 10.0% [7/70] and 5.7% [4/70] versus 12.6% [12/95] and 8.4% [8/95], respectively). Among those with on-study vertebral fracture by Month 12, recurrent vertebral and subsequent nonvertebral fracture incidences were numerically lower with romosozumab versus comparator (FRAME, 0.0% [0/17] and 0.0% [0/17] versus 11.9% [7/59] and 8.5% [5/59]; ARCH, 9.0% [6/67] and 7.5% [5/67] versus 15.0% [15/100] and 16.0% [16/100], respectively). In patients with fracture by Month 12, no fracture­related complications were reported in romosozumab-treated patients. BMD gains were numerically greater with romosozumab than comparators. CONCLUSION: Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture. TRIAL REGISTRATIONS: NCT01575834; NCT01631214.

Heavy clinical and economic burden of osteoporotic fracture among elderly female Medicare beneficiaries.

We comprehensively described elderly Medicare women with an outpatient visit in 2011 and fracture within 2 years before. These women were at very high risk for subsequent fracture and high healthcare utilization and cost, especially those with vertebral or multiple fractures. However, rates of fracture prevention treatments were low. INTRODUCTION: Postmenopausal women with osteoporosis are stratified to high and very-high fracture risk categories, and this categorization drives algorithms for osteoporosis management in osteoporosis treatment guidelines. This study comprehensively describes a very-high-risk cohort. METHODS: This retrospective cohort study used the Medicare 20% database; elderly women with an outpatient visit in 2011 and fracture within 2 years before the visit were included. Outcomes included fracture risk, all-cause and fracture-related healthcare resource utilization and cost, and osteoporosis medication use in the 5 years after the visit. RESULTS: Overall, 43,193 patients were included. The 5-year probability was 0.36 for major fracture and 0.11 and 0.17 for hip fracture and vertebral fracture, respectively, much higher than the guidelines' 10-year probability thresholds for very-high-risk (0.3 for major fracture, 0.045 for hip fracture). Rates of hospitalizations, emergency department visits or observation stays, and skilled nursing facility stays in year 1 were 53.7, 57.0, and 18.8 per 100 patient-years, respectively, decreasing slightly in subsequent years. Mean healthcare cost was $23,700 in year 1, decreasing to $18,500 in year 5. About 29.1% of patients received osteoporosis medications in year 1, decreasing to 16.9% by year 5. Rates for all outcomes, especially fractures, were much higher among vertebral and multiple fracture cohorts. CONCLUSION: Elderly women with a fracture within last 2 years were at very-high-risk for subsequent fracture and high healthcare utilization and cost, especially those with vertebral or multiple fractures. However, rates of fracture prevention treatments were low. More effort is needed to identify and treat patients at very-high-risk for fracture.

Post-fracture care programs for prevention of subsequent fragility fractures: a literature assessment of current trends.

Post-fracture care (PFC) programs evaluate and manage patients with a minimal trauma or fragility fracture to prevent subsequent fractures. We conducted a literature review to understand current trends in PFC publications, evaluate key characteristics of PFC programs, and assess their clinical effectiveness, geographic variations, and cost-effectiveness. We performed a search for peer-reviewed articles published between January 2003 and December 2020 listed in PubMed or Google Scholar. We categorized identified articles into 4 non-mutually exclusive PFC subtopics based on keywords and abstract content: PFC Types, PFC Effectiveness/Success, PFC Geography, and PFC Economics. The literature search identified 784 eligible articles. Most articles fit into multiple PFC subtopics (PFC Types, 597; PFC Effectiveness/Success, 579; PFC Geography, 255; and PFC Economics, 98). The number of publications describing how PFC programs can improve osteoporosis treatment rates has markedly increased since 2003; however, publication gaps remain, including low numbers of publications from some countries with reported high rates of osteoporosis and/or hip fractures. Fracture liaison services and geriatric/orthogeriatric services were the most common models of PFC programs, and both were shown to be cost-effective. We identified a need to expand and refine PFC programs and to standardize patient identification and reporting on quality improvement measures. Although there is an increasing awareness of the importance of PFC programs, publication gaps remain in most countries. Improvements in established PFC programs and implementation of new PFC programs are still needed to enhance equitable patient care to prevent occurrence of subsequent fractures.

Medical workforce in the United States.

This section focuses on the professional workforce comprised of the primary medical specialties that utilize ionizing radiation in their practices. Those discussed include the specialties of radiology and radiation oncology, as well as the subspecialties of radiology, namely diagnostic radiology, interventional radiology, nuclear radiology, and nuclear medicine. These professionals provide essential health care services, for example, the interpretation of imaging studies, the provision of interventional procedures, radionuclide therapeutic treatments, and radiation therapy. In addition, they may be called on to function as part of a radiologic emergency response team to care for potentially exposed persons following radiation events, for example, detonation of a nuclear weapon, nuclear power plant accidents, and transportation incidents. For these reasons, maintenance of an adequate workforce in each of these professions is essential to meeting the nation's future needs. Currently, there is a shortage for all physicians in the medical radiology workforce.

U.S. PET/CT and Gamma Camera Diagnostic Reference Levels and Achievable Administered Activities for Noncardiac Nuclear Medicine Studies.

Existing surveys of radiopharmaceutical doses for U.S. nuclear medicine laboratories are of limited scope and size. Dose data are important because they can be used to benchmark individual laboratories, understand geographic variations in practice, and provide source data for societal guidelines and appropriateness criteria. Diagnostic reference levels (DRLs) and achievable administered activities (AAAs) for 13 noncardiac adult gamma camera and PET/CT examinations were derived retrospectively from American College of Radiology accreditation data (January 1, 2015, to December 31, 2017). The calculated DRL and AAA are consistent with previously published surveys. The distributions of radiopharmaceutical doses across facilities are in general consistent but show variation within a particular examination. Analysis of dose distribution suggests this variation results from differences in clinical protocols, educational gaps, and/or equipment factors. The AAA for the surveyed facilities exceeds dose ranges proposed in societal practice guidelines for several common nuclear medicine studies. Compared with similar surveys from Europe and Japan, geographic variation is observed, with some doses greater and others lower than used in the United States. Overall, radiopharmaceutical dose variation within the United States and internationally, and deviation from societal guidelines, imply that these dose-related benchmarks may be used to further standardize and improve clinical practice.

Addressing Needs of Women Radiologists: Opportunities for Practice Leaders to Facilitate Change.

Women are, and have always been, underrepresented in radiology. This gender disparity must be addressed. Women bring a different perspective to the workplace; and their collaborative, empathetic, and compassionate approach to patient care and education is an asset that the radiology community should embrace and leverage. Radiologic organizations should focus on removing barriers to the entry of women physicians into radiology as a specialty and to their career advancement. Organizations should address bias, promote physician well-being, and cultivate a safe and positive work environment. Radiology leaders committed to increasing gender diversity and fostering an inclusive workplace have the opportunity to strengthen their organizations. This article outlines the key steps that practice leaders can take to address the needs of women in radiology: (a) marketing radiology to talented women medical students, (b) addressing recruitment and bias, (c) understanding and accommodating the provisions of the Family and Medical Leave Act of 1993 and the Fair Labor Standards Act for both trainees and radiologists in practice, (d) preventing burnout and promoting well-being, (e) offering flexible work opportunities, (f) providing mentorship and career advancement opportunities, and (g) ensuring equity. ©RSNA, 2018.

State of Academic Radiology: Current Challenges, Future Adaptations.

There are approximately 200 academic radiology departments in the United States. While academic medical centers vary widely depending on their size, complexity, medical school affiliation, research portfolio, and geographic location, they are united by their 3 core missions: patient care, education and training, and scholarship. Despite inherent differences, the current challenges faced by all academic radiology departments have common threads; potential solutions and future adaptations will need to be tailored and individualized-one size will not fit all. In this article, we provide an overview based on our experiences at 4 academic centers across the United States, from relatively small to very large size, and discuss creative and innovative ways to adapt, including community expansion, hybrid models of faculty in-person vs teleradiology (traditional vs non-traditional schedule), work-life integration, recruitment and retention, mentorship, among others.

Celebrating a legacy, reflecting on the present, and safeguarding our future.

OBJECTIVE: During the 20th century, radiologists enjoyed relationships with clinicians and patients through daily face-to-face communication. As specialist consultants, radiologists were naturally integral members of the care team. CONCLUSION: The widespread availability of information technology, notably PACS, has disrupted the fundamental radiologist-clinician axis. New generations of radiologists must respond to this disturbing trend by (re)learning how to "add value" by rekindling personal professional relationships, developing global leadership skills, and becoming involved in health care system design and implementation.

Invited commentary: fracture follow-up program in an open healthcare system.

The basis of the Fracture Liaison Service is to identify and treat those patients at highest risk of suffering a second fracture. The execution of this type of program poses unique challenges in open healthcare settings that lack a central coordination of patient care. This invited editorial reviews the establishment and operation of The Marian Osteoporosis Center at Marian Medical Center in Santa Maria, California.

Leveraging Radiopharmaceutical Programmatic Collaboration for Management of Pretherapy and On-treatment Urinary Incontinence.

ABSTRACT: Many parenteral radiopharmaceuticals available as anticancer therapy are filtered by the kidneys and excreted in the urine. Here, physician leaders of radiation medicine, nuclear medicine/molecular imaging, and the radiotheranostics programs as well as radiation safety officers, collaborated to develop a decision-making guideline for the administration of therapeutic radiopharmaceuticals in patients with pretherapy or day-of-treatment incontinence. We discussed challenges and opportunities in the screening of patients in urine collection strategies according to grade of urinary incontinence and in subsequent coordination of care. Lutetium-177 ( 177 Lu)-based radiopharmaceutical therapies provided clinical examples of how our procedures were operationalized. Our key management issues of urinary incontinence were cutaneous radiation injury and redness, infection, or pain. In response, we developed clinical practice guidelines for the recognition and management of incontinence-related adverse events. Common adverse events of urinary incontinence were noted in this study. Our how-to guideline for the safe administration of therapeutic radiopharmaceuticals for patients with urinary incontinence warrants further investigation and should continue to be evaluated across all radiopharmaceutical therapy agents.

Using an Annual Diversity, Equity and Inclusion Dashboard to Accelerate Change in Academic Radiology Departments.

Despite widespread interest in creating a more equitable and inclusive culture, a lack of workforce diversity persists in Radiology, in part due to a lack of universal and longitudinal metrics across institutions. In an attempt to establish benchmarks, a subset of the Society of Chairs of Academic Radiology Departments (SCARD) Diversity, Equity and Inclusion (DEI) Committee volunteered to design a DEI dashboard as a potential tool for academic radiology programs to use to document and track their progress. This freely-available, modular dashboard includes suggested (plus optional department-defined) DEI activities/parameters and suggested assessment criteria across three domains: faculty, residents & fellows, and medical students; it can be completed, in whole or in part, by departmental leaders annually. The suggested metrics and their associated rubrics were derived from the collective experiences of the five working group members, all of whom are chairs of academic radiology departments. The resulting dashboard was unanimously approved by the remaining 14 DEI committee members and endorsed by the SCARD board of directors.

68Ga-DOTATATE PET/CT: The Optimum Standardized Uptake Value (SUV) Internal Reference.

RATIONALE AND OBJECTIVES: Standardized Uptake Value (SUV) is an important semiquantitative measurement used in the clinical and research domains to assess radiopharmaceutical concentration in tumors versus normal organs, but is susceptible to many factors beyond the tumor biological environment. So, the aim of this study is to identify the optimum internal reference among organs with physiological uptake in 68Ga-DOTATATE PET/CT (DOTA PET/CT) scans. MATERIALS AND METHODS: This HIPAA-compliant, IRB-approved study with waiver of consent included retrospective imaging review of 180 consecutive patients with neuroendocrine tumors presenting for DOTA PET/CT image acquisition: Ga-68 DOTATATE dose was reported as (0.054 mCi/Kg) scans between September 2018 and May 2019. Mean value of body weight normalized SUV (SUVbw) and lean body mass normalized SUV (SUL) of liver and spleen were measured. Information about the patients and scan characteristics were collected. The paired Grambsch test was used to compare variance among the measured SUVs. Spearman's rank correlation coefficient was used to assess correlation between SUVs and potential patient- and scan-specific confounding factors. RESULTS: Variance of SUL was significantly lower than variance of SUVbw in both liver and spleen (p-value < 0.0001). Variances of liver SUVbw and SUL were significantly lower than the corresponding spleen SUVs. Liver SUL showed the lowest variance (3.69% ± 1.25%) among all measured SUVs. CONCLUSION: SUL is a more reproducible, less variable, and therefore more reliable quantitative measure in DOTA PET/CT scans, compared SUVbw. Among the available organs with physiological uptake, liver SUL is the optimum internal reference given the liver's larger size and uniform SUL values resulting in lower variability and better reproducibility.

Authentic gold: Celebrating the life and career of Cheri L. Canon, MD, FACR, FAAWR.

Since 1927, the American College of Radiology (ACR) has awarded Gold Medals to up to four individuals each year in recognition of their distinguished and extraordinary service to the ACR or to the discipline of radiology (American College of Radiology, n.d. [1]). As of 2019, only 10 of 194 Gold Medalists have been women. In May 2021, Dr. Cheri L. Canon will become the eleventh woman in ACR history to receive this prestigious award. Contemporaneously, in November 2020, she received the highest honor bestowed by the American Association for Women in Radiology (AAWR), the Marie Sklodowska-Curie Award, presented annually to an individual who has made outstanding contributions to the advancement of women in radiology or radiation oncology (American Association for Women in Radiology, n.d. [2]). Herein we celebrate Dr. Canon's remarkable life and impressive career achievements, and learn important lessons from her shared wisdom.

The Current State of Nuclear Medicine and Nuclear Radiology: Workforce Trends, Training Pathways, and Training Program Websites.

BACKGROUND: Nuclear medicine (NM) is a multidisciplinary field. Its overlap with nuclear radiology (NR) creates unique training considerations, opportunities, and challenges. Various factors impact the workforce, training needs, and training pathways. This state of flux may be perplexing to prospective NM/NR trainees. PURPOSE: To evaluate the state of NM/NR training by assessing the (1) workforce trends and job prospects for NM/NR trainees, (2) NM and NR training pathways, and (3) applicant-accessible online presence of training programs. METHODS: Workforce trends were analyzed using data collected from the 2017 American College of Radiology Commission on Human Resources Workforce Survey. Information regarding the training pathways leading to board certification(s) for NM and NR physicians were obtained through the American Board of Nuclear Medicine, the American Board of Radiology (ABR), and the Society of Nuclear Medicine and Medical Imaging. Each Accreditation Council for Graduate Medical Education-accredited NM residency or NR fellowship training program's website was reviewed for 20 content items to assess its comprehensiveness for those seeking information regarding eligibility, applications, training curriculum, and program characteristics. RESULTS: Number of hires for NM/NR physicians has exceeded the projected number of hires from 2014 to 2017. In the last decade, there has been a greater than 25% decrease in the combined number of traditional NM residencies and NR fellowships (79-58 programs) and a greater than 50% decrease in the combined number of NM and NR trainees (173-82 trainees). In 2017, the ABR redesigned its 16-month pathway leading to specialty certification in diagnostic radiology and subspecialty certification in NR. As of March 24, 2019, there are 36 diagnostic radiology or IR residency programs with 64 trainees participating in this redesigned NR pathway. Of the 93.1% (54/58) of traditional Accreditation Council for Graduate Medical Education-accredited NM and NR training programs having websites in the 2017-2018 academic year, the mean number of online criteria met per program was 7.74 ± 3.2 of 20 (38.7%). CONCLUSION: Recruitment into the traditional NM/NR training pathways has been steadily declining, but there has been a renewed interest with the redesigned ABR 16-month pathway. There is a paucity of online information available to prospective NM/NR applicants. In this rapidly evolving and unique field, it is important to streamline NM/NR training and bolster the information accessible to potential NM/NR applicants as they weigh career options.

Microcolumn separations and the analysis of single cells.

Capillary zone electrophoresis and open tubular liquid chromatography are two examples of an emerging area of analytical instrumentation known as microcolumn separations. The high resolution and small sample requirements of these methods make them suitable for the quantitative, multicomponent chemical analysis of single cells. Appropriate instrumentation for the analysis of nanoliter and subnanoliter samples is discussed. Data from the analysis of individual neurons are presented, including amino acid and neurotransmitter content.

Influence of 99mTc-tetrofosmin SPECT myocardial perfusion imaging on the prediction of future adverse cardiac events.

BACKGROUND: The impact of myocardial perfusion imaging (MPI) on prediction of risk for future cardiac events was examined by comparing predictions based on clinical information alone and in combination with MPI findings. METHODS AND RESULTS: A 3-cardiologist Cardiac Event Prediction Panel (CEPP) estimated three-year cardiac event (non-fatal MI; aborted sudden cardiac death; cardiac death) risk based on clinical data (C) for 371 subjects. CEPP repeated this estimation after receiving Summed Stress Scores (SSS) and Summed Rest Scores (SRS) from blinded reading of rest-stress (99m)Tc-tetrofosmin MPI SPECT studies (C + MPI). The C and C + MPI estimates were then compared with three-year and total event rates. MPI was normal (SSS 13) in 77 (21%). Eighteen cardiac events occurred within 3 years and 33 occurred during a mean follow-up of 3.9 years. C + MPI estimates of low risk (<1-1.5%/year) identified significantly more patients who did not have events than C. C + MPI three-year event-rate predictions were more accurate than those made with C (P < .01). C + MPI categorization also provided better delineation of incremental risk on time-to-event analyses. CONCLUSIONS: (99m)Tc-tetrofosmin MPI single photon emission computed tomography (SPECT) findings significantly improve accuracy of cardiac event rate prediction compared to those based on clinical information alone.