Academic Medical Community Research Articles

Creating a Community Radiology Division: An Academic Radiology Department’s 3-Year Experience

The US health care system is evolving rapidly with an emphasis on value-based care and management of populations. There is an increased expectation for improved patient outcome and service. As a response to these changes, academic health care systems are seeking care coordination and system integration. For radiology practices, this evolution has resulted in mergers and partnerships between traditional academic radiology departments and community practices [ 1 Fleishon H.B. Itri J.N. Boland G.W. Duszak R. Academic medical centers and community hospitals integration: trends and strategies. J Am Coll Radiol. 2017; 14: 45-51 Abstract Full Text Full Text PDF PubMed Scopus (61) Google Scholar , 2 Natesan R. Yan W.T. Tannir H. Parikh J. Strategic expansion models in academic radiology. J Am Coll Radiol. 2016; 13: 329-334 Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar , 3 Patlas M.N. Farshait N. Duszak R. Academic and community radiology practice integration: the Canadian experience. J Am Coll Radiol. 2017; 14: 1124-1126 Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar , 4 Croft C.R. Dial R. Doyle G. Schaadt J. Merchant L. Integrating a community hospital-based radiology department with an academic medical center. J Am Coll Radiol. 2016; 13: 300-302 Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar ].

Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial

Few options exist for patients with locally advanced or metastatic urothelial carcinoma after progression with platinum-based chemotherapy. We aimed to assess the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1]) versus chemotherapy in this patient population. We conducted this multicentre, open-label, phase 3 randomised controlled trial (IMvigor211) at 217 academic medical centres and community oncology practices mainly in Europe, North America, and the Asia-Pacific region. Patients (aged ≥18 years) with metastatic urothelial carcinoma who had progressed after platinum-based chemotherapy were randomly assigned (1:1), via an interactive voice and web response system with a permuted block design (block size of four), to receive atezolizumab 1200 mg or chemotherapy (physician's choice: vinflunine 320 mg/m2, paclitaxel 175 mg/m2, or 75 mg/m2 docetaxel) intravenously every 3 weeks. Randomisation was stratified by PD-L1 expression (expression on <1% [IC0] or 1% to <5% [IC1] of tumour-infiltrating immune cells vs ≥5% of tumour-infiltrating immune cells [IC2/3]), chemotherapy type (vinflunine vs taxanes), liver metastases (yes vs no), and number of prognostic factors (none vs one, two, or three). Patients and investigators were aware of group allocation. Patients, investigators, and the sponsor were masked to PD-L1 expression status. The primary endpoint of overall survival was tested hierarchically in prespecified populations: IC2/3, followed by IC1/2/3, followed by the intention-to-treat population. This study, which is ongoing but not recruiting participants, is registered with ClinicalTrials.gov, number NCT02302807. Between Jan 13, 2015, and Feb 15, 2016, we randomly assigned 931 patients from 198 sites to receive atezolizumab (n=467) or chemotherapy (n=464). In the IC2/3 population (n=234), overall survival did not differ significantly between patients in the atezolizumab group and those in the chemotherapy group (median 11·1 months [95% CI 8·6-15·5; n=116] vs 10·6 months [8·4-12·2; n=118]; stratified hazard ratio [HR] 0·87, 95% CI 0·63-1·21; p=0·41), thus precluding further formal statistical analysis. Confirmed objective response rates were similar between treatment groups in the IC2/3 population: 26 (23%) of 113 evaluable patients had an objective response in the atezolizumab group compared with 25 (22%) of 116 patients in the chemotherapy group. Duration of response was numerically longer in the atezolizumab group than in the chemotherapy group (median 15·9 months [95% CI 10·4 to not estimable] vs 8·3 months [5·6-13·2]; HR 0·57, 95% CI 0·26-1·26). In the intention-to-treat population, patients receiving atezolizumab had fewer grade 3-4 treatment-related adverse events than did those receiving chemotherapy (91 [20%] of 459 vs 189 [43%] of 443 patients), and fewer adverse events leading to treatment discontinuation (34 [7%] vs 78 [18%] patients). Atezolizumab was not associated with significantly longer overall survival than chemotherapy in patients with platinum-refractory metastatic urothelial carcinoma overexpressing PD-L1 (IC2/3). However, the safety profile for atezolizumab was favourable compared with chemotherapy, Exploratory analysis of the intention-to-treat population showed well-tolerated, durable responses in line with previous phase 2 data for atezolizumab in this setting. F Hoffmann-La Roche, Genentech.

The History of Sponsoring Institutions, 1982-2017.

The History of Sponsoring Institutions, 1982-2017.

109 Impact of a More Restrictive Overlapping Surgery Policy An Analysis of Complication Rates, Resident Involvement, and Surgical Wait Times at a High-Volume Neurosurgical Department

Abstract INTRODUCTION Recently, overlapping surgery has been a source of controversy both in the popular press and within the academic medical community. There have been no studies examining the possible effects of more stringent overlapping surgery restrictions. The authors examined the impact of a new overlapping surgery policy on complication rates, neurosurgical resident education, and wait times for neurosurgical procedures. METHODS The authors performed a retrospective chart review of nonemergent neurosurgical procedures performed over two periods from June 1, 2014, to October 31, 2014 (pre-policy change) and from June 1, 2016, to October 31, 2016 (post-policy change) by any of 4 senior neurosurgeons at a single institution who were authorized to schedule overlapping cases. Information on preoperative evaluation, patient demographics, premorbid conditions, surgical variables, and postoperative course were collected and analyzed. RESULTS &gt;Six hundred fifty-three patients met inclusion criteria for complications analysis. Of these, 378 (57.9%) underwent surgery before the policy change. On multivariable regression analysis, neither overlapping surgery (OR 1.072, 95% CI 0.710-1.620) nor the overlapping surgery policy change (1.057, OR 0.700 1.596) was associated with overall complication rates. Similarly, neither overlapping surgery (OR 1.472, 95% CI 0.883 2.454) nor the overlapping surgery policy change (OR 1.251, 95% CI 0.748 2.091) was associated with numbers of serious complications. After the policy change, the percentage of procedures in which the senior assistant was a post-residency fellow increased significantly, from 11.9% to 34.2% (P&lt; 0.001). In a multiple linear regression analysis of surgery wait time, patients undergoing surgery post-policy change had significantly longer delays from the decision to operate to the actual neurosurgical procedure (P&lt; 0.001). CONCLUSION At our institution, further restriction of overlapping surgery was not associated with a reduction in overall or serious complications. Resident involvement in neurosurgical procedures decreased significantly after the policy change, and our study suggests that waiting times for neurosurgical procedures also significantly lengthened.

Abstract LB-174: Patient navigation in Appalachia: results from a survey of current practices

Abstract Purpose: The Appalachian region of the US includes 420 counties in 13 states that begin with New York, follow the Appalachian Mountains and extend to Mississippi. The region has a heterogeneous population that shares distinct cultural characteristics, high rates of unemployment, low income, and high rates of chronic disease, including cancer. Patient navigators (PN) provide one-on-one guidance and assistance through the health care continuum from prevention to end-of-life and address barriers and enhance access to healthcare through the use of individual navigators who are sensitive to the needs, interests and values of the community. Although there are numerous PN training programs available, there are no known programs that are designed for the Appalachian population. As a first step in developing such a program, we designed and conducted a survey of PN training needs in Appalachia. Methods: With guidance from formative research involving a variety of stakeholders, we identified key individuals, professional groups, health care systems, and public health agencies serving the Appalachian region. We developed a 26-item survey to collect information on current patient navigation programs, sources of current training, and training needs. After pretesting, the survey was distributed online. Data were collected from June, 2015 through May, 2016. Results: A total of 152 responses were received. The responses were from community based organizations (29.3%), academic medical centers (15.5%), hospitals (35.8%), and community cancer centers (19.5%). PN was currently provided by individuals from a variety of professional backgrounds, chiefly nursing (32.8%) and social work (8.4%), and 15.3% were community navigators. Only 63.8% of respondents reported having received formal PN training. About half (47.3%) indicated that they were interested in attending PN training and suggested specific content and format. Conclusions: Survey respondents identified a need for PN training that focuses on Appalachia. These results supported the development of an Appalachia Patient Navigation Training Program, currently underway. Note: This abstract was not presented at the meeting. Citation Format: Mark B. Dignan, Sharon Dwyer, Carol White, Elizabeth A. Rohan, Dana White, Georgina Castro, Reda Wilson, Mary Boyd, Eric Stockton. Patient navigation in Appalachia: results from a survey of current practices [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr LB-174. doi:10.1158/1538-7445.AM2017-LB-174

Burnout and Its Relationships with Alexithymia, Stress, and Social Support among Romanian Medical Students: A Cross-Sectional Study.

Medical school students often experience emotional difficulties when handling the challenges of their formation, occasionally leading to burnout. In this study, we measured the prevalence of burnout and its relationships with perceived stress, perceived social support, and alexithymia in medical students from the largest academic medical community in Romania. A cross-sectional survey was administered to a randomized sample of 299 preclinical medical students at the University of Medicine in Bucharest. Participants completed four standardized questionnaires. In addition to the assessment of burnout prevalence, stepwise backward regression was used to establish which variables had the highest correlation to burnout components. Further, t-tests were run to assess gender-related differences. Overall, burnout prevalence was 15.05%. Perceived stress was found to be the strongest predictor of emotional exhaustion and lack of accomplishment, while the strongest predictors of depersonalization were low perceived social support (in women) and alexithymia (in men). Women appear to be more vulnerable to two of the components of burnout (emotional exhaustion and low personal accomplishment) and associate higher perceived stress and alexithymia. These results suggest that interventions addressing academic burnout could benefit from being gender-specific, with focus on key elements, such as perceived stress and alexithymia.

Palliative Care and Parkinson's Disease: Caregiver Perspectives.

Palliative care for Parkinson's disease (PD) is an emerging area of interest for clinicians, patients and families. Identifying the palliative care needs of caregivers is central to developing and implementing palliative services for families affected by PD. The objective of this paper was to elicit PD caregiver needs, salient concerns, and preferences for care using a palliative care framework. 11 PD caregivers and one non-overlapping focus group (n = 4) recruited from an academic medical center and community support groups participated in qualitative semi-structured interviews. Interviews and focus group discussion were digitally recorded, transcribed and entered into ATLAS.ti for coding and analysis. We used inductive qualitative data analysis techniques to interpret responses. Caregivers desired access to emotional support and education regarding the course of PD, how to handle emergent situations (e.g. falls and psychosis) and medications. Participants discussed the immediate impact of motor and non-motor symptoms as well as concerns about the future, including: finances, living situation, and caretaking challenges in advanced disease. Caregivers commented on the impact of PD on their social life and communication issues between themselves and patient. All participants expressed interest and openness to multidisciplinary approaches for addressing these needs. Caregivers of PD patients have considerable needs that may be met through a palliative care approach. Caregivers were receptive to the idea of multidisciplinary care in order to meet these needs. Future research efforts are needed to develop and test the clinical and cost effectiveness of palliative services for PD caregivers.

Development of a postgraduate year 2 pharmacy residency in clinical pharmacogenetics.

The structure and development of an innovative, ASHP-accredited postgraduate year 2 (PGY2) clinical pharmacogenetics residency program are described. A 12-month PGY2 clinical pharmacogenetics residency was created at St. Jude Children's Research Hospital in accordance with the ASHP standards for advanced practice residencies. The purpose of this 12-month residency program is to prepare pharmacy residents to implement pharmacogenetics in clinical practice. The program helps residents develop expertise in the science of pharmacogenetics as well as an understanding of translational research, innovative pharmacy practice model development, and clinical informatics. The resident learns to optimize patient outcomes through the expert provision of evidence-based, patient-centered precision medicine as an integral part of an interprofessional team. After completing the program, residents are expected to have the clinical skills necessary to practice in the field of clinical pharmacogenetics and independently implement pharmacogenetic testing in other health-system settings. Because implementation of pharmacogenetics requires collaboration across many disciplines, residents works within an interprofessional team of physicians, nurses, informatics specialists, pharmacists, and clinical laboratory personnel to achieve program goals. Since the first resident graduated in 2012, the program has graduated 1 resident each year. Graduated residents have accepted pharmacogenetics positions at major academic medical centers and community hospitals, as well as academic and research positions with a pharmacogenetics emphasis. A PGY2 clinical pharmacogenetics residency was successfully developed at St. Jude in 2013. After completion of the program, residents are equipped with the clinical skills and necessary experience to drive precision medicine forward and lead the implementation of pharmacogenetic testing in other healthcare settings.

Risk Factors for Colistin Resistance; A 10 Year Experience at a Tertiary Medical Center

Colistin is an antibiotic of last resort for treatment of Carbapenem-resistant Enterobacteraceae (CRE) infections. Resistance to colistin is associated with increased mortality and has been observed with increasing frequency in Klebsiella spp.(K) Risk factors for colistin-resistant infection have been incompletely studied. All patients admitted to academic tertiary medical center and community hospital from 2006-2016, where routine microbiology susceptibility testing includes gold standard broth micro-dilution. From 2006 to 2011, colistin testing was done by request. Starting in 2012, all Gram-negative organisms underwent colistin testing, except urine isolates where only CRE undergo colistin testing. We searched the clinical data warehouse for patients in whom K was isolated from any source. Logistic regression models were used to create univariate and multivariable predictive models for colistin resistance. Data were analyzed for complete cases only and were analyzed once per hospital admission. From 2006-2016, there were 3,837 admissions with K isolated and 1360 with complete data. There were 93 admissions with colistin-resistant K and 80/93 demonstrated meropenem resistance. Univariate predictors are shown. Table 1 On unadjusted analysis, days in hospital, male gender, skilled nursing residence, black race, increased age, Elixhauser score, and end-stage renal disease were each significantly associated with increased risk of colistin-resistance. On multivariable analysis, the best model included days hospitalized, gender, skilled nursing residence, and Elixhauser score, with an AUROC of 0.81. Table 2 Colistin resistance among patients with Klebsiella is significantly associated with skilled nursing facility residence, male gender, prolonged hospitalization, and increased comorbidity. Further studies will look at events within a hospitalization, including patient location, antibiotic exposure to determine modifiable factors associated. L. G. Miller, Sage Products: Study coordination, Conducting studies in healthcare facilities that are receiving contributed product. Xttrium: Study coordination, Conducting studies in healthcare facilities that are receiving contributed product. Clorox: Study coordination, Conducting studies in healthcare facilities that are receiving contributed product. 3M: Study coordination, Conducting studies in healthcare facilities that are receiving contributed product.

Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial

First-line chemotherapy for patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma is associated with short response duration, poor survival, and high toxicity. This study assessed atezolizumab (anti-programmed death-ligand 1 [PD-L1]) as treatment for metastatic urothelial cancer in cisplatin-ineligible patients. For this single-arm, multicentre, phase 2 study, in 47 academic medical centres and community oncology practices in seven countries in North America and Europe, we recruited previously untreated patients with locally advanced or metastatic urothelial cancer who were cisplatin ineligible. Patients were given 1200 mg intravenous atezolizumab every 21 days until progression. The primary endpoint was independently confirmed objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 (central review), assessed in prespecified subgroups based on PD-L1 expression and in all patients. All participants who received one or more doses of atezolizumab were included in the primary and safety analyses. This study was registered with ClinicalTrials.gov, number NCT02108652. Between June 9, 2014, and March 30, 2015, we enrolled 123 patients, of whom 119 received one or more doses of atezolizumab. At 17·2 months' median follow-up, the objective response rate was 23% (95% CI 16 to 31), the complete response rate was 9% (n=11), and 19 of 27 responses were ongoing. Median response duration was not reached. Responses occurred across all PD-L1 and poor prognostic factor subgroups. Median progression-free survival was 2·7 months (2·1 to 4·2). Median overall survival was 15·9 months (10·4 to not estimable). Tumour mutation load was associated with response. Treatment-related adverse events that occurred in 10% or more of patients were fatigue (36 [30%] patients), diarrhoea (14 [12%] patients), and pruritus (13 [11%] patients). One treatment-related death (sepsis) occurred. Nine (8%) patients had an adverse event leading to treatment discontinuation. Immune-mediated events occurred in 14 (12%) patients. Atezolizumab showed encouraging durable response rates, survival, and tolerability, supporting its therapeutic use in untreated metastatic urothelial cancer. F Hoffmann-La Roche, Genentech.

Can Academic Medicine Lead the Way in the Refugee Crisis?

The world is currently in the midst of the largest refugee crisis since World War II, with the highest interval of mass displacement in recorded history according to the United Nations. The United States has pledged to maintain its position as one of the world's top resettlement countries in response to this crisis. These new immigrants will arrive with exceptional chronic and acute medical needs, including higher rates of behavioral health disorders. The author describes the health care challenges experienced by refugees seeking asylum in the United States and outlines the ways in which our health care system is currently deficient in helping refugee patients to overcome these challenges. He argues that the academic medical community can change this dynamic by standardizing and expanding instruction in cross-cultural competence and behavioral health screenings throughout the spectrum of medical education. Ensuring the long-term well-being of refugees in the United States, including meeting their mental health needs, will be the best inoculation against the risks of violent extremism which so many fear. With the absence of national leadership on this issue, academic medicine can and should lead the way.

Academic Medical Centers and Community Hospitals Integration: Trends and Strategies

Academic medical centers are widely recognized as vital components of the American health care system, generally differentiated from their community hospital peers by their tripartite mission of clinical care, education, and research. Community hospitals fill a critical and complementary role, serving as the primary sites for health care in most communities. Health care reform initiatives and economic pressures have created incentives for hospitals and health systems to integrate, resulting in a nationwide trend toward consolidation with academic medical centers leveraging their substantial assets to merge, acquire, or establish partnerships with their community peers. As these alliances accelerate, they have and will continue to affect the radiology groups providing services at these institutions. A deeper understanding of these new marketplace dynamics, changing relationships and potential strategies will help both academic and private practice radiologists adapt to this ongoing change.

Philanthropy for Science: Is It a Viable Option?

Philanthropy is frequently viewed as an alternative way for supporting innovative research, but how to ideally approach this in Academic Medical Centers is rarely discussed. There are several ethical principles that should be adhered to, while recognizing that philanthropy should also be regarded as a partnership between donors and physician-scientists. Training of physician leaders, incorporating the institution’s d evelopment officers will allow philanthropy to fill potential funding gaps and successfully be used to support promising research in an ethical manner. The past decade has seen a substantial fall in medical research funding from government resources and international outsourcing of clinical research, creating a difficult environment for US medical schools and Academic Medical Centers. Although some of the increased competitiveness to obtain National Institutes of Health funding was driven by a substantial growth in funding during the 1990s, it was later corrected by reduced funding and sequestration, leading to an unprecedented low funding rate for grants after the recession in 2008. It has been estimated that there has been a crippling 20% reduction in National Institutes of Health funding since 2004, with a minor recent uptick.1 This reduction has led to a risk-averse funding environment where truly innovative projects or investigators get triaged and overlooked in the review process. Therefore, it has become attractive for Academic Medical Centers to seek alternative methods of support for innovative projects. It has been estimated that in 2009 $4.8 billion was donated through philanthropic support to US Academic Medical Centers, healthcare systems, or community hospitals, making this an attractive source for funding projects and scientists.2 However, although this process is vastly different from competitive grant writing, it requires similar rigor of attention to detail, strategic thinking and planning, infrastructure and due process, which is rarely discussed in the medical literature. The word philanthropy …

A Guide to Writing Academic Portfolios for Radiologists

The academic educator's portfolio is a collection of materials that document academic performance and achievements, supplementing the curriculum vitae, in order to showcase a faculty member's most significant accomplishments. A decade ago, a survey of medical schools revealed frustration in the nonuniform methods of measuring faculty's medical education productivity. A proposed solution was the use of an academic educator's portfolio. In the academic medical community, compiling an academic portfolio is always a challenge because teaching has never been confined to the traditional classroom setting and often involves active participation of the medical student, resident, or fellow in the ongoing care of the patient. Diagnostic radiology in addition requires a knowledge base that encompasses basic sciences, imaging physics, technology, and traditional and molecular medicine. Teaching and performing research that involves this complex mix, while providing patient care that is often behind the scenes, provides unique challenges in the documentation of teaching, research, and clinical service for diagnostic radiology faculty. An academic portfolio is seen as a way to explain why relevant academic activities are significant to promotions committee members who may have backgrounds in unrelated academic areas and may not be familiar with a faculty member's work. The academic portfolio consists of teaching, research, and service portfolios. The teaching portfolio is a collection of materials that document teaching performance and documents the educator's transition to a more effective educator. A research portfolio showcases the most significant research accomplishments. The service portfolio documents service responsibilities and highlight any service excellence. All portfolios should briefly discuss the educator's philosophy, activities, methods used to implement activities, leadership, mentoring, or committee roles in these respective areas. Recognizing that academic programs have differing needs, this article will attempt to provide some basic guidelines that may help junior faculty in diagnostic radiology develop their teaching, research, and service portfolios.

Current trends in the practice of endoscopy among surgeons in the USA.

The diagnostic and therapeutic roles for endoscopic intervention are expanding. To continue emphasis on endoscopy in surgical training, The Society of American Gastrointestinal and Endoscopic Surgeons has developed the Fundamentals of Endoscopic Surgery (FES) course to standardize and assess endoscopy training. However, little demographic information exists about the current practice of endoscopy by general surgeons and how to best integrate endoscopic skills into surgical training. A survey to collect data regarding the current practice patterns of endoscopy was sent to surgeons with a valid email address in the American Medical Association masterfile. Information regarding the type of training (academic vs. community general surgery residency) and current practice environment (academic medical center vs. community hospital) was collected. The respondents' current practice volume of upper endoscopy and colonoscopy over the prior year was stratified into three groups: rare (<1 per month), moderate (1-10 per month), and frequent (>10 per month). Pearson's Chi-squared test was used to analyze the data. The survey was sent to 9902 general surgeons. There were 767 who provided answers regarding their current practice of endoscopy. Mean time in practice was 18±10years, 87% were male, and 83% practiced in a metropolitan area. Respondents who trained at academic general surgery programs were less likely than those at community programs to frequently perform colonoscopy (17.3 vs. 27.9%, p<0.05) and upper endoscopy (11.8 vs. 17.1%, p<0.05). Those who currently practice in academic medical centers were also less likely to be frequent performers of colonoscopy (5.6 vs. 24.7%, p<0.05) and upper endoscopy (9.8 vs. 14.8%, p<0.05) than those who practice at community hospitals. The type of residency training and current practice setting of general surgeons has a significant influence on the volume of endoscopic procedures performed. This study identifies areas where more emphasis on endoscopic skills training is needed, such as FES.

The Priority of Intersectionality in Academic Medicine.

Recent societal events highlight inequities experienced by underrepresented and marginalized communities. These inequities are the impetus for ongoing efforts in academic medicine to create inclusive educational and patient care environments for diverse stakeholders. Frequently, approaches focus on singular populations or broad macroscopic concepts and do not always elucidate the complexities that arise at the intersection between multiple identities and life experiences. Intersectionality acknowledges multidimensional aspects of identity inclusive of historical, structural, and cultural factors. Understanding how multiple identity experiences impact different individuals, from patients to trainees to providers, is critical for improving health care education and delivery. Building on existing work within academic medicine, this Commentary outlines six key recommendations to advance intersectionality in academic medicine: embrace personal and collective loci of responsibility; examine and rectify unbalanced power dynamics; celebrate visibility and intersectional innovation; engage all stakeholders in the process of change; select and analyze meaningful metrics; and sustain the commitment to achieving health equity over time. Members of the academic medical community committed to advancing health equity can use these recommendations to promote and maintain meaningful changes that recognize and respond to the multidimensional voices and expressed needs of all individuals engaged in providing and receiving health care.

Development and significance of automated history-taking software for clinical medicine, clinical research and basic medical science.

Development and significance of automated history-taking software for clinical medicine, clinical research and basic medical science.

Abstract P5-09-02: Impact of therapeutic complexity on practice patterns for metastatic breast cancer (MBC) in the United States: Results of a 2-phase national study

Abstract Background: The rapidly changing clinical management of MBC has challenged the ability of clinicians to understand and integrate new data, which relates directly to the quality of clinical care and is a key determinant of patient outcomes. This study was designed to determine the potential impact of the increased clinical complexity of decision making in MBC on optimal patient care by quantifying professional practice gaps and barriers among oncology specialists at academic medical centers and community clinic settings in the United States. Methods: From October 2014 to February 2015, 216 actively practicing US oncology specialists with a caseload of ≥1 patient/year with MBC were recruited to participate in a 2-phase national needs assessment study. In the first, qualitative phase, 35 participants consented to a 45-minute telephone interview focused on the personal, contextual, and behavioral factors that influence their clinical reasoning process in diagnosis and treatment of MBC. Findings from this initial phase informed the second phase of the study. This quantitative phase included an online survey comprising specific multiple choice questions, semantic differential rating scales, and case vignettes. Respondents' (N = 181) answers to these questions were compared with optimal answers, as identified by treatment guidelines and MBC experts. Results: Eight core practice gaps were identified through combined analysis of data from the in-depth interviews and online surveys. Of note, only 15% of respondents agreed with the experts' choice of letrozole + palbociclib as initial treatment for a postmenopausal patient with HR+ MBC with bone and visceral lesions after a prolonged response to adjuvant endocrine therapy. Survey respondents indicated that they use chemotherapy substantially more frequently than experts when treating patients with HR+ MBC. Only 36% of respondents' current practice matched expert recommendations regarding management of toxicity associated with exemestane + everolimus and 32% opted for management strategies with a risk of worsening treatment-related toxicity. Just over 30% of respondents agreed with the expert choice of ado-trastuzumab emtansine as second-line therapy for HER2+ MBC after progression on trastuzumab/paclitaxel. In addition, a minority of respondents knew the mechanisms of action of newly approved (palbociclib [45%]) and investigational agents, including dovitinib (19%), neratinib (30%), pembrolizumab (49%), and pictilisib (28%). Conclusions: A significant percentage of US oncology specialists are not applying optimal care in patients with MBC. Most notably, this study indicated that participants overuse chemotherapy in patients with HR+ MBC, suboptimally manage treatment-related toxicities, and are challenged to select optimal therapy for HER2+ MBC patients who progress on previous therapy. Finally, a lack of familiarity with mechanisms of action of approved and promising investigational agents in MBC may lead to delays in the appropriate integration of new agents or indications into clinical practice. A full review of the study results and recommendations will be presented. Citation Format: Quill TA, Jahanzeb M, Obholz KL, Brady E, Howson A, Rasulina M, Willis C, Hurvitz S. Impact of therapeutic complexity on practice patterns for metastatic breast cancer (MBC) in the United States: Results of a 2-phase national study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-09-02.

Disparate access to treatment regimens in chronic hepatitis C patients: data from the TRIO network.

Despite the clinical success in the real-world of all oral hepatitis C virus (HCV) therapy with response rates approaching that seen in the clinical trials, access has been limited by many payers with discussion of prioritization of treatment based upon AASLD guidelines. We evaluated patients in the TRIO network who were prescribed sofosbuvir (SOF)-based regimens to determine reasons for not starting treatment. Trio Health is a disease management company that works in partnership with academic medical centres, community physicians and specialty pharmacies in the United States to optimize care for HCV. Data for 3841 patients prescribed a sofosbuvir-containing regimen between December 2013 and September 2014 were obtained through this programme. Of the entire group, 315 (8%) patients did not start the prescribed sofosbuvir-containing therapy. A total of 141 (45%) of the nonstart patients had a commercial plan as their primary insurance, 137 (44%) were primarily covered by Medicaid, 17 (5%) were primarily covered by Medicare, and 20 (6%) were either without coverage or coverage was not specified. Reasons for nonstarts were varied and overlapping. Only 15 patients (5% of nonstarts) did not start because they were unreachable or failed to complete required testing. Another 39 patients who did not start (12%) were following their physicians' direction to either wait for new treatment options or to hold treatment for an unspecified reason. Insurance-related processes and financial reasons accounted for 254 (81%) of the 315 nonstarts. The remaining 7 (2%) patients did not have a specified reason for not starting treatment. Nonstart rates were highest in the Medicaid-covered population at 35%. Medicare and Commercial nonstart rates were 2% and 6%, respectively. In a matched comparison, patients with commercial coverage were 6.5 times as likely to start SOF-based therapy compared to patients with Medicaid. Despite high SVR rates of SOF-based regimens in clinical practice, there are still barriers to access to care. In fact, almost half of the nonstart patients had advanced fibrosis scores (F3 or F4) and should have been prioritized to start treatment. As better treatment for HCV with high efficacy and low side effect rates become available, the disparity in access to treatment, as evidenced by the high nonstart rate in the Medicaid-covered group, must be resolved.

Provision of Services in Perinatal Palliative Care: A Multicenter Survey in the United States.

Congenital anomalies account for 20% of neonatal and infant deaths in the United States. Perinatal palliative care is a recent addition to palliative care and is meant to meet the needs of families who choose to continue a pregnancy affected by a life-limiting diagnosis. To examine characteristics of programs and services provided, assess alignment with the National Consensus Project domains of care, and identify providers and disciplines involved in programs. A cross-sectional survey design included 48 items addressing funding and domains of quality care. Program representatives from 30 states (n = 75). Perinatal palliative care programs are housed in academic medical centers, regional or community hospitals, local hospices, or community-based organizations. Significant differences by program setting were observed for type of fetal diagnoses seen, formal training in communicating bad news to parents, mechanisms to ensure continuity of care, and reimbursement mechanisms. One hundred percent of programs provided attention to spiritual needs and bereavement services; 70% of programs are less than 10 years old. Follow-up with parents to assess whether goals were met occurs at 43% of the perinatal palliative care programs. Formal measures of quality assessment were articulated in 38% of programs. This study dramatically adds to the literature available on perinatal palliative care program settings, types, and domains of care. It is clear that there are a variety of types of programs and that the field is still developing. More work is needed to determine which quality measures are needed to address perinatal care needs in this population.