Community Practice Settings Research Articles

Association between prevalence of obstructive lung disease and obesity: results from The Vermont Diabetes Information System

BackgroundThe association of obesity with the development of obstructive lung disease, namely asthma and/or chronic obstructive pulmonary disease, has been found to be significant in general population studies, and weight loss in the obese has proven beneficial in disease control. Obese patients seem to present with a specific obstructive lung disease phenotype including a reduced response to corticosteroids. Obesity is increasingly recognized as an important factor to document in obstructive lung disease patients and a critical comorbidity to report in diabetic patients, as it may influence disease management. This report presents data that contributes to establishing the relationship between obstructive lung disease in a diabetic cohort, a population highly susceptible to obesity.MethodsA total of 1003 subjects in community practice settings were interviewed at home at the time of enrolment into the Vermont Diabetes Information System, a clinical decision support program. Patients self-reported their personal and clinical characteristics, including any history of obstructive lung disease. Laboratory data were obtained directly from the clinical laboratory, and current medications were obtained by direct observation of medication containers. We performed a cross-sectional analysis of the interviewed subjects to assess a possible association between obstructive lung disease history and obesity.ResultsIn a multivariate logistic regression model, a history of obstructive lung disease was significantly associated with obesity (body mass index ≥30) even after correcting for potential confounders including gender, low income (<$30,000/year), number of comorbidities, number of prescription medications, cigarette smoking, and alcohol problems (adjusted odds ratio (OR) = 1.58, P = 0.03, 95% confidence interval (CI) = 1.05, 2.37). This association was particularly strong and significant among female patients (OR = 2.18, P = < 0.01, CI = 1.27, 3.72) but not in male patients (OR = 0.97, P = 0.93, CI = 0.51, 1.83).ConclusionThese data suggest an association between obesity and obstructive lung disease prevalence in patients with diabetes, with women exhibiting a stronger association. Future studies are needed to identify the mechanism by which women disproportionately develop obstructive lung disease in this population.

Statewide rates of adjuvant checkpoint inhibitor use after definitive chemoradiation for stage III non-small cell lung cancer.

8523 Background: In the landmark PACIFIC trial, adjuvant durvalumab after definitive chemoradiation for unresectable stage III non-small-cell lung cancer (NSCLC) produced a 11% absolute overall survival benefit at two years compared to placebo, and the US Food and Drug Administration approved durvalumab for this indication in February 2018. We investigated the real-world use of adjuvant durvalumab and other immune checkpoint inhibitors (ICI) in a contemporary cohort of patients. Methods: We identified patients with unresectable stage III (AJCC 8th edition) NSCLC treated with definitive chemoradiation from February 2018 to March 2020 from a statewide radiation oncology quality consortium, representing a mix of community (n=22 centers, 336 patients) and academic practice settings (n=5 centers, 64 patients) across the state of Michigan. Use of adjuvant durvalumab or other ICI (atezolizumab, nivolumab, or pembrolizumab) was ascertained at the time of routine three- or six-month follow-up after completion of chemoradiation. Baseline characteristics of patients treated with or without adjuvant ICI were compared with the Chi-squared test for categorical variables and a two-sided t-test for continuous variables. Results: Of 400 patients with unresectable stage III NSCLC treated with definitive chemoradiation, 268 (67%) received adjuvant ICI. Of these, the majority received durvalumab (86%) followed by pembrolizumab (7.5%) and nivolumab (6.0%). The proportion of patients receiving ICI remained stable throughout the study period with no discernable time trends. Eight-five percent of white patients received ICI compared with 77% of black patients (p=0.04), but there were no differences in gender (54.5% male in ICI vs 52.3% no ICI), current smoking (42.2% ICI vs 37.9% no ICI, p=0.68), number of comorbidities (29.5% with 3 or more comorbidities in ICI vs. 26.5% in no ICI, p=0.86), baseline oxygen use (8.9% ICI vs 10.6% no ICI, p=0.59), age (median 66.4 years [IQR 60.3-73.4] for ICI vs. 66.9 years [IQR 61.1-72.2] no ICI, p=0.89), treatment at an academic center (16.0% ICI vs 15.9% no ICI, p=0.97), or ECOG performance status (59.3% ECOG 0 in ICI vs 62.8% no ICI). Conclusions: In a broad range of academic and community-based practices across a state including 27 sites, only two-thirds of potentially eligible stage III NSCLC patients received adjuvant durvalumab or other ICI agents despite a proven overall survival benefit. Receipt of ICI was not strongly associated with baseline demographic or comorbidity variables. Further work will seek to clarify the patient-level reasons behind non-initiation of adjuvant ICI.

Cardiac risk factors and adverse events among patients receiving first-line CLL treatment in a real-world community practice setting.

e24044 Background: First-line (1L) ibrutinib monotherapy (IM) is commonly prescribed for CLL but is associated with cardiovascular adverse events (CVAEs) that may lead to discontinuation. Existing data are largely from clinical trials (both 1L and relapsed/refractory), and real-world evidence is limited. The aim of this study was to compare baseline cardiac risk factors and CVAEs in patients (pts) receiving 1L IM vs intensive therapy (IT; aggressive, less tolerable, majority were bendamustine plus anti-CD20 antibody) or non-intensive therapy (NIT; less aggressive, more tolerable, majority were anti-CD20 antibody alone). Methods: We compared 3 treatment groups (IM, IT, and NIT) in terms of clinical characteristics, baseline CV risk factors, and subsequent CVAEs. Pts were selected from the Flatiron Health database based on the following criteria: aged ≥18 years, CLL/SLL diagnosis, had ≥2 clinic encounters, and initiated 1L treatment between 1/1/2016 and 12/31/2019. Baseline characteristics and subsequent CVAEs were descriptively compared between IM and IT/NIT groups; significance was assumed if p &lt; 0.05. Results: Data on 515 pts were included (IM, 191; IT, 195; NIT, 129). Age at baseline differed significantly between the IM group (mean 71.2 years) and the other 2 groups (IT, 66.2 years; NIT, 74.5 years). The proportion of del(17p) was significantly higher in the IM group vs IT/NIT groups (IM, 26.7%; IT, 3.6%; NIT, 3.1%). Significant differences between IM and IT groups were seen in baseline ECOG (ECOG 0: IM, 28.8%; IT, 43.1%), diabetes mellitus (IM, 56.0%; IT, 44.1%), and hypercholesterolemia (IM, 68.6%; IT, 58.0%). Significant differences between IM and NIT groups were seen in baseline angina/coronary revascularization (2.6% vs 8.5%), atrial fibrillation/atrial flutter (AF; 14.1% vs 26.4%), and cerebrovascular disease (8.9% vs 20.2%). The rate of any CVAE was significantly higher in IM (35.6%) vs IT and NIT groups (IT, 20.0%; NIT, 24.8%) (Table). For IM vs IT treated pts, significant differences were observed in new or worsening (N/W) AF (11.5% vs 5.1%), other arrhythmias (9.4% vs 3.1), and hypertension (HTN; 20.4% vs 8.2%). Conclusions: This is one of the first real-world studies focused specifically on 1L CLL to describe baseline CV risk factors and compare CVAE events in CLL pts treated with IM as compared to IT or NIT. Results show higher CVAE rates of AF, other arrhythmias, and HTN for IM vs IT. [Table: see text]

When Are Treatment Blinding and Treatment Standardization Necessary in Real-World Clinical Trials?

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real‐world evidence in the evaluation of new treatments or products. Real‐world clinical trials or pragmatic trials often differ from traditional clinical trials in the use of open‐label or nonblinded treatments delivered by real‐world clinicians in community practice settings. Blinding and standardization of treatment may sometimes be necessary for internal validity, but they may also obscure or distort meaningful differences between treatments. When investigators consider whether blinding of clinicians, patients, or assessors is necessary, we suggest they consider several specific questions: Will clinicians, patients, and assessors have expectations or preferences regarding benefits or adverse effects? How might those expectations affect treatment uptake, treatment adherence, or assessment of outcomes? Will expectations differ in the settings where trial results will be applied? How would blinding of treatment reduce biases? How would blinding obscure true differences between treatments? How would procedures necessary for blinding reduce acceptability or increase risk of trial participation? When investigators consider how strictly treatments should be standardized, we suggest they consider several specific questions: How would treatment effectiveness or safety vary according to clinician experience or expertise? What level of experience or expertise is available in potential trial settings and settings where trial results would be applied? Is some level of standardization necessary for valid inference? Considering any special vulnerabilities of the study population, is some level of standardization necessary to assure participant safety?

Evolution of pharmacy practice and direct patient care roles for pharmacists in Bangladesh

AbstractThe increasing emphasis on the pharmacists' role as the medication expert has created a global movement towards the implementation of clinical pharmacy practice, defined as any pharmacist in any setting who provides patient care. Although the pharmacy profession in Bangladesh has traditionally been oriented towards the pharmaceutical industry sector, direct patient care roles of pharmacists in both community and hospital practice settings are slowly beginning to emerge. The MEDLINE, Cochrane, Web of Science, and Scopus databases were searched for relevant reference articles for this study. This article presents a narrative review on the current state of pharmacy education and practice in Bangladesh, including a case study highlighting the successful implementation of the country's first clinical pharmacy team‐based care model at a private, tertiary‐care hospital in Dhaka, Bangladesh. Challenges and lessons learned initiating advanced hospital pharmacy practice and a decentralized team‐based care model in Bangladesh may provide insight for institutions in similar settings seeking to expand the role of pharmacists.

Treatment patterns and outcomes of patients with advanced malignant pleural mesothelioma in a community practice setting.

Aim: To assess real-world treatment patterns and outcomes among patients with advanced malignant pleural mesothelioma. Patients &methods: Retrospective database analysis. Results: In all, 469 patients received first-line systemic anticancer therapy (SACT) at community centers. Median follow-up from diagnosis was 11.6months. Pemetrexed+ platinum was the most common first-line SACT; similar proportions of patients received cisplatin or carboplatin with pemetrexed. Only a small proportion of patients received second- and third-line therapies. Median overall survival for first-line SACT was 12.0months (95% CI: 10.7-14.2). Results were similar with pemetrexed+ cisplatin and pemetrexed+ carboplatin. Median overall survival with second-line SACT was 6.4months (95% CI: 5.1-7.6). Conclusion: There is a need for more effective SACTs for advanced malignant pleural mesothelioma.

An Exploration of Preceptor-Provided Written Feedback on Entrustable Professional Activities During Early Practice Experiences

Objective. To explore and evaluate open-ended feedback on entrustable professional activities (EPAs) provided by preceptors to Doctor of Pharmacy (PharmD) students completing their first practice experience.Methods. A retrospective review was conducted of qualitative data collected from preceptor evaluations of student pharmacists who had completed a two-month practice experience in either community or health-system pharmacy at the end of their first professional year. Preceptors had used a validated EPA framework to assess students. A codebook was developed around the EPA framework and sub-coding was used to indicate positive, negative, or neutral assessment within each EPA. After several rounds of coding, consensus was reached for all codes by two investigators. A dependability audit was implemented to ensure the trustworthiness of the findings.Results. Preceptor evaluations of 153 student pharmacists were included in the study. Eighty students (52.3%) had completed a community experience and 73 (47.7%) had completed a health-system experience between May and August 2018. The preceptors at both practice settings provided overwhelmingly positive feedback on all EPAs. Opportunities to optimize preceptor-provided feedback were identified. The feedback provided by the preceptors in health-system and community practice settings focused on knowledge and behavior, respectively, with both emphasizing students' skill-based performance.Conclusion. This study provides valuable insight into optimizing preceptor-provided written feedback on EPAs. Conducting deeper analysis of preceptor feedback using focus groups or structured interviews is suggested to further explore preceptors' provision of EPA assessment to student pharmacists practicing in real-world settings.

Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and low Karnofsky performance status: Results from the CheckMate 920 trial.

315 Background: Combination therapy with nivolumab + ipilimumab (NIVO+IPI) has demonstrated long-term efficacy and tolerability for patients (pts) with previously untreated advanced renal cell carcinoma (aRCC). Most pivotal clinical trials in pts with aRCC have excluded pts with low Karnofsky performance status (KPS; &lt; 70%). CheckMate 920 is a multi-arm, phase IIIb/IV, open-label clinical trial of NIVO+IPI treatment in pts enrolled in a community practice setting with aRCC and a high unmet medical need. We present safety and efficacy results for the cohort of pts with aRCC of any histology and KPS 50%–60% from CheckMate 920 (NCT02982954). Methods: Pts with previously untreated advanced/metastatic RCC and KPS 50%–60% received NIVO 3 mg/kg + IPI 1 mg/kg Q3W × 4 doses followed by 480 mg NIVO Q4W for ≤ 2 years or until disease progression/unacceptable toxicity. The primary endpoint was incidence of grade ≥ 3 immune-mediated adverse events (imAEs) within 100 days of last dose of study drug. Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 (both per investigator). Exploratory endpoints included overall survival (OS). Results: Of 25 treated pts with KPS 50%–60%, 76% were men; median age was 67 years (range, 34–81). IMDC risk was favorable in 0%, intermediate in 32%, and poor in 68% of pts; 84% had clear cell and 16% had non-clear cell RCC histology. With a minimum follow-up of 25 months, median duration of therapy (95% CI) was 2.3 months (2.1–7.7) for NIVO and 2.1 months (2.1–2.1) for IPI. The median number of doses (range) received was 4 (1–27) for NIVO and 4 (1–4) for IPI; 76% of pts received ≥ 4 NIVO doses and 68% received all 4 IPI doses. The only grade 3–4 imAEs by category were hepatitis (4.0%) and adrenal insufficiency (4.0%). No grade 5 imAEs occurred. Overall, 4 (16%) pts discontinued due to any-grade adverse events (n = 1 each for elevated AST, malignant neoplasm progression, back pain, and acetabulum fracture). Of 18 evaluable pts, ORR was 33.3% (95% CI, 13.3–59.0); no pts had a complete response and 6 had partial response. Median time to objective response was 4.5 months (range, 2.5–24.7). Median duration of objective response was 20.6 months (range, 0.03+–24.2+). Median PFS was 4.6 months (95% CI, 2.5–14.8). Median OS was 15.6 months (95% CI, 5.3–25.1). Conclusions: NIVO+IPI demonstrated an acceptable safety profile and promising antitumor activity in pts with previously untreated aRCC and KPS 50%–60%. The combination was tolerated at a dose intensity similar to that observed in clinical trials conducted in pts with higher KPS (≥ 70%). These data support the value of NIVO+IPI in pts who may not be considered ideal candidates for this therapy and consequently may have limited treatment options. Clinical trial information: NCT02982954 .

Leveraging pharmacists to maintain and extend buprenorphine supply for opioid use disorder amid COVID-19 pandemic.

PurposeStrategies for deploying clinical pharmacists to increase access to buprenorphine in inpatient, outpatient and transitional care, and community practice settings are described.SummaryAccess to medications for opioid use disorder (MOUD) is essential, but patients face many barriers when pursuing treatment and MOUD. The coronavirus disease 2019 (COVID-19) pandemic has compounded the opioid crisis and worsened outcomes by introducing new barriers to MOUD access. Many strategies to ensure continued access to MOUD have been described, but the role of leveraging pharmacists during the opioid/COVID-19 syndemic to improve medication access and outcomes remains underappreciated. Pharmacists, while both qualified and capable of liberalizing access to all forms of MOUD, may have the strongest impact by increasing access to buprenorphine. Herein, we present progressive strategies to maintain and extend buprenorphine access for patients with OUD through deployment of clinical pharmacists, particularly in the context of the COVID-19 pandemic, during which access may be further restricted.ConclusionLeveraging pharmacists to extend access to MOUD, particularly buprenorphine, remains an underutilized strategy that should be implemented, particularly during the concurrent COVID-19 global pandemic.

Treatment patterns and outcomes of hepatocellular carcinoma (HCC) patients (pts) in the CancerLinQ Research Database (CLQ).

283 Background: Treatment and management of pts with HCC is complicated by the presence of underlying chronic liver disease. Clinical trials with unresectable HCC pts are generally limited to Child-Pugh A or pts with good performance status. Therefore there is limited data for less fit HCC pts, particularly those treated in the community practice setting. Methods: The study design was a retrospective cohort study using the US-based CancerLinQ Discovery Database (CLQ). CLQ was launched by the American Society of Clinical Oncology in 2016 and consists of longitudinal, demographically, and geographically diverse data aggregated from oncology practice Electronic Health Record databases. Eligible pts were ≥18 years at time of HCC diagnosis, had a diagnosis of stage IV HCC within the record, and had ≥2 clinical encounters on separate dates during follow-up after the date of diagnosis. The study period and patient identification period was Jan 1997–Aug 2019; follow up continued through May 2020. Patient demographics, clinical characteristics, and general treatment characteristics were summarized using descriptive statistics. Results: 460 pts were eligible for analysis. Of these, 141 pts (31%) had a Child-Pugh score as reported in medical charts or imputed based on structured and curated data. 76 (54%) pts were Child-Pugh class A, 59 (42%) Child-Pugh class B, and 6 (4%) Child-Pugh class C. The proportion of pts with chronic hepatitis C infection and liver cirrhosis was higher in pts with Child-Pugh classes B and C compared to A. Time from diagnosis to first systemic therapy decreased from a median of 126 days for pts with Child-Pugh class A, to 47 and 16 days for class B and C, respectively. Sorafenib was the most common regimen regardless of line of therapy, followed by PD-1 pathway inhibitors and chemotherapy. Median duration of sorafenib therapy decreased from Child-Pugh class A to C (table). There was a similar decrease in duration of therapy for pts receiving PD-1 pathway inhibitors and chemotherapy when moving from class A to class C. Conclusions: This is the first published retrospective study in HCC using the CLQ. Pts with Child-Pugh class B or C, who are typically excluded from clinical trials, represented 48% of the pts with a Child-Pugh score included in this analysis. Duration of therapy was numerically lower for pts with Child-Pugh class B or C compared to Child-Pugh class A. Further research is needed to describe real-world evidence outside the context of a clinical trial for HCC pts. Funding: AstraZeneca. [Table: see text] Avg, average; obs, observed; TKI, tyrosine kinase inhibitor

Quality metrics in the performance of EUS: a population-based observational cohort of the United States

There are few data on the quality of EUS in the community setting. We characterized EUS performance at the individual facility level in 3 large American states, using need for repeat biopsy (NRB) as a metric for procedural failure, and the rate of unplanned hospital encounters (UHEs) as a metric for adverse events. We collected data on 76,614 EUS procedures performed at 166 facilities in California, Florida, and New York (2009-2014). The endpoints for the study were 7-day rate of UHEs after EUS, and 30-day rate of NRB after EUS with fine-needle aspiration. Facility-level factors analyzed included annual procedure volume, urban/rural location, and free-standing status (facilities not attached to a larger hospital). Predictors for UHE and NRB were analyzed in both multivariable regression and nonparametric local regression. Facility volume did not predict risk for UHEs. However, high facility volume protected against NRB (P trend<.001) even after adjustment for other facility-level factors. When regressing facility volume against risk for NRB in local regression, a join point (inflection point) was identified at 97 procedures per annum. Once facilities reached this threshold volume, there appeared little additional protective effect of higher volume. Rural facility location (odds ratio, 1.81; 95% confidence interval, 1.36-2.40) and free-standing status (odds ratio, 1.57; 95% confidence interval, 1.16-2.13) were also associated with NRB. Facility volume does not predict risk for adverse events after EUS. However, high facility volume is associated with decreased rates of technical failure (as assessed by NRB). These data provide one of the first descriptions of EUS practice in community settings and highlight opportunities to improve endoscopic quality nationally.

Factors associated with exclusive breastfeeding practices in the commune of Sakété, southern Benin: a cross-sectional study

The purpose of this study was to determine the factors associated with exclusive breastfeeding (EBF) practices in community settings of southern Benin. We conducted a quantitative and qualitative cross-sectional study in Sakété commune. Six midwives and 100 breastfeeding women with at least one child under 6 months of age completed a semi-structured questionnaire. We also conducted focus groups with grandmothers. The quantitative data were analyzed with SPSS 20 using chi-square tests, Student's t-tests, and logistic regression. The data from the focus groups were analyzed thematically. The Information-Education-Communication (IEC) sessions on the EBF were conducted in all the visited maternity care facilities. Nonetheless, only 58% of breastfeeding mothers followed EBF practices, and most grandmothers did not follow EBF practices. Regression analysis identified that mothers who participated in IEC sessions focused on good infant feeding and nutrition practices and those seeking advice from close relatives were more likely to use EBF. The study revealed a low EBF rate and suggested that interventions could educate mothers and other household members on the importance of timely breastfeeding initiation in the study area.

Evaluation of Secure Mobile and Clinical Communication Solution (SMaCCS) across acute and community practice settings

AimsClinicians struggle to provide information to each other that supports safe patient transitions, especially across acute and community care jurisdictions. They need flexible communication tools to improve care coordination. Island...

Factors impeding the supply of over-the-counter medications according to evidence-based practice: A mixed-methods study.

ObjectiveDespite the positive attitudes pharmacists have toward evidence-based practices (EBPs), its application in community pharmacies in Saudi Arabia is lacking. Therefore, this study aimed to explore and assess EBPs by community pharmacists in Saudi Arabia when they dispense over-the-counter (OTC) medications for three minor ailments: diarrhea, cough, and the common cold.Research design and methodsWe used a mixed-methods approach consisting of two study parts. The first was a quantitative investigation that used mystery shoppers. Four researchers, posing as mystery shoppers, visited 214 randomly selected pharmacies in the Riyadh region of Saudi Arabia. They used 14 questions from a standardized checklist to examine EBPs by community pharmacists. The qualitative part of the study entailed three focus-group discussions with 13 pharmacists from different community practice settings and explored factors that affected the application of EBPs when supplying OTC medications from the pharmacists’ point of view.ResultsThe analysis indicated that 40% of pharmacists dispensed OTC medications according to EBPs. Logistic regression analysis showed that one question, "Describe your symptoms", predicted the correct supply of OTC medications (p = 0.021). The qualitative section of the study identified nine factors that affected EBP. Some of these factors facilitated EBP, such as established patient-pharmacist relationships, some acted as barriers such as conflicts between available evidence, while other factors could either facilitate or hinder EBPs, such as the health literacy of the patient.ConclusionGiven that dispensing OTC medication is a core function of pharmacists, this study uncovered low adherence to EBPs by community pharmacists in Saudi Arabia when dispensing OTC medication for three minor ailments: diarrhea, cough, and the common cold. Furthermore, this study identified a number of explanatory factors for this low adherence. Targeting these factors could help change the behavior of pharmacists and decrease undesirable outcomes.

Factors Associated with Burnout Among Hematology & Oncology Physicians

Background The American Society of Hematology and researchers at the Fitzhugh Mullan Institute for Health Workforce Equity at the George Washington University are conducting a 3-year study of the hematology workforce to understand factors that influence the supply of hematology services in the U.S. The Survey of Practicing Hematologists and Oncologists focuses on practicing hematology/oncology physicians' practice activities and experiences, compensation, job satisfaction and burnout. While the prevalence and predictors of burnout in the oncology workforce have been studied in detail previously, less is known about factors associated with burnout in the hematology or combined hematology/oncology workforce--or whether these differ across academic and community practice settings. This study seeks to examine factors associated with severe burnout for hematology/oncology physicians in academic and community practice settings using data from a large-scale, comprehensive survey of hematology/oncology physicians. Methods We collected survey data via mail and online survey (using Qualtrics, an online survey tool) in April through June 2019. The survey included questions about hematology/oncology physicians' work hours, practice activities, compensation, job satisfaction and burnout. This analysis uses data from a single validated question examining respondents' level of burnout: "Overall, based on your definition of burnout, how would you rate your level of burnout?" The question asks respondents to rank their burnout on a 5-point Likert scale. We collapsed responses into a dichotomous variable indicating severe burnout (=4 or 5 on the Likert scale). We used two weighted multiple logistic regression models to examine associations between severe burnout and work hours, practice characteristics and activities, and type of compensation for respondents in academic and community practice in Stata 15, controlling for demographics and type of practice (p&amp;lt;0.05=statistically significant). Results A total of 675 hematologists/oncologists completed the survey (27% response rate). Of these, 427 respondents reported working in academic or community practice and had complete data to be included in the analysis: 162 (38%) in academic practice settings and 265 (62%) in community practice settings. Respondents in academic practice settings were slightly less likely to report experiencing severe burnout than those in community practice settings (9% [15/162] vs. 12% [34/265], p=0.26). In the logistic regression models, we found statistically significant and positive association between severe burnout and Relative Value Unit or RVU-based compensation (vs. salaried or other compensation models) for both academic (OR=18.42, p&amp;lt;0.01) and community practice respondents (OR=3.05, p&amp;lt;0.01). We also found a significant and positive association between severe burnout and being female for respondents in academic practice only (OR=6.07, p&amp;lt;0.01). We found a significant and negative association between severe burnout and often working with advanced practice providers (nurse practitioners and/or physician assistants) for respondents in community practice only (OR=0.32, p&amp;lt;0.01). Conclusions Study findings suggest that severe burnout rates are similar for hematology/oncology physicians in academic and community practice settings. Severe burnout appears to be related to use of RVU-based compensation systems in both academic and community practices, suggesting that these models may require major revision to reduce burnout and support the health and longevity in practice of hematology/oncology physicians. Improving access to advanced practice providers may mitigate severe burnout, especially in community practice settings. Higher levels of burnout among women in academic hematology/oncology practices suggest an area for further research into possible explanations and solutions. These findings merit further exploration, particularly given the increased pressures on physicians in the era of COVID-19. Disclosures No relevant conflicts of interest to declare.

Progression Free Survival of Relapsed or Refractory Multiple Myeloma (RRMM) after Failure of Three Prior Lines of Therapy in United States (US) Real-World Practice

Background: Given the approval of a vast array of potent therapies and treatment combinations in multiple myeloma, it is important to understand outcomes of patients who relapse and/or become refractory to these commonly used drugs such as proteasome inhibitors (PI), immunomodulatory agents (IMiD), and CD38 targeting monoclonal antibodies (MoAB; ie. daratumumab). This study aims to describe clinical characteristics and progression free survival (PFS) after failure of at least 1 PI and IMiD +/- daratumumab in US community practice to provide context for the outcomes of RRMM patients after exposure to at least three lines of anti-myeloma therapies. Methods: Data analyzed were from electronic health record (EHR) generated by Flatiron Health (New York, NY). These data represent over 280 cancer clinics representing over 2 million active patients treated at primarily community-based hematology/oncology practices in the US. Inclusion criteria included adult patients ≥18 years with a diagnosis of MM, at least two clinic visits after 2015, failure of a PI and IMiD, ECOG ≤2, adequate hematologic/renal/hepatic function, and no stem cell transplant within three months of study entry. Study eligibility began as early as treatment initiation in ≥ fourth line (4L+) from January 2015 through March 2020. Progression free survival was measured from treatment until death, progression, or start of new line of therapy, and PFS was estimated for patients who were eligible for study inclusion (index date) between 2015-2018. Last follow-up occurred at March 2020. Results: In total, 141 patients had prior daratumumab exposure (64 included in time-to-event analysis) and 294 patients were daratumumab naïve (56 of these 294 had daratumumab exposure in a later line of therapy, at which point they were counted in the 141 daratumumab exposed patients group; 230 included in time-to-event analysis) once meeting the inclusion criteria for this study. Of patients exposed to daratumumab, 50% qualified for the study after 3-4 lines versus 87% of daratumumab naive patients. The median age at study entry was 69-70 years (Table 1). Approximately 36% of daratumumab exposed patients and 33% of non-previously daratumumab exposed patients presented with either intermediate or high-risk cytogenetics at study entry for patients with available cytogenetics. About half (48%) of daratumumab-exposed patients and over a quarter (29%) of non-previously daratumumab-exposed patients had a prior transplant. Median time from diagnosis until study entry was 49 months for the daratumumab exposed and 39 months for the non-previously daratumumab exposed groups. Median follow-up for the daratumumab exposed group was 8 months and 15 months for the non-previously daratumumab exposed group. At study entry for the daratumumab exposed patients, 4% received monotherapy, 18% received a doublet (5% carfilzomib/dexamethasone and 4% daratumumab/dexamethasone), 56% received a triplet (11% daratumumab/pomalidomide/dexamethasone, 7% carfilzomib/pomalidomide/dexamethasone), and 12% a quadruplet. In total, 56 (40%) patients received re-treatment with a daratumumab combination. Among the non-previously daratumumab exposed patients, 12% received monotherapy, 29% received a doublet (8% carfilzomib/dexamethasone, 7% daratumumab/dexamethasone), 48% received a triplet (12% daratumumab/pomalidomide/dexamethasone, 5% bortezomib/daratumumab/dexamethasone), and 8% received a quadruplet. PFS was short in both groups (Figure 1). In the daratumumab exposed group, the median PFS was 3.3 months (95% CI: 2.1-5.8) and the in the non-previously daratumumab exposed group, the median PFS was 4.4 months (95% CI: 3.6-5.9). Discussion: In this study with majority of patients having 3-4 prior lines of treatment, short PFS was observed for RRMM patients regardless of prior daratumumab exposure. Strikingly, many patients received re-treatment with a drug they had previously failed, suggesting many patients may have run out of effective therapies to utilize. Additionally, the daratumumab exposed group had a higher proportion with prior transplant which may also lead to differential outcome between these groups. Overall, these data suggest that these patients have poor outcomes and the need for effective novel classes of therapies remains high within the US community practice setting. Disclosures Kim: Amgen: Current Employment. Braunlin:Amgen: Current Employment. Belani:Amgen: Current Employment. Wheeling:Amgen: Consultancy.

Measuring health care quality: Implications, threats, and opportunities for clinical pharmacists

AbstractThe Patient Protection and Affordable Care Act of 2010 has helped usher in an era of focus on health care quality and quality improvement. Since then, a variety of programs has driven quality improvement throughout the health care system using a combination of incentives and penalties. Many studies have demonstrated the value of integrating clinical pharmacist services into interdisciplinary models of care for the purpose of moving the needle on performance measures. The implementation of quality‐linked reimbursement programs has the greatest potential to meaningfully improve quality of care and reduce costs. However, the benefits of quality measures are dependent on their implementation into measurement systems and their application into clinical practice. Common threats to quality measurement in pharmacy practice may arise due to misapplication of health plan‐related measures to evaluate pharmacy services. Additionally, the core concepts related to novel reimbursement models have not adequately percolated into the formal education of practicing pharmacists. Therefore, the goal of this article is to help educate and raise awareness about the current quality landscape and present opportunities and directions for pharmacists to demonstrate their value in interdisciplinary health care teams. This article is broadly divided into four sections—first, we provide an introduction to quality measurement and its application to clinical pharmacists. Second, we elaborate on the development and endorsement of quality measures and measurement systems. Third, we present clinical scenarios of patient care—set in inpatient, ambulatory care, and community practice settings—that engage pharmacists in the context of quality measurement and evaluate the implications, threats, and opportunities for clinical pharmacists in each of these scenarios. Finally, we present recommendations for future advocacy, measurement, and leadership for pharmacist involvement in the quality landscape.

Treatment Sequencing Patterns in Patients with Metastatic Urothelial Cancer Treated in the Community Practice Setting in the United States: SPEAR-Bladder (Study informing treatment Pathway dEcision in bladder cAnceR).

PurposeClinical trial evidence has affirmed the role for immuno-oncology (IO) treatment for locally advanced or metastatic urothelial carcinoma (la/mUC). This Study informing treatment Pathway dEcision in bladder cAnceR (SPEAR-Bladder) aimed to provide insight into the optimal sequencing of IO treatments among la/mUC patients treated in the US Oncology Network.Patients and MethodsThis was a retrospective analysis of adult patients with la/mUC who initiated first-line chemotherapy followed by either IO therapy (C-IO subgroup) or chemotherapy (C-C subgroup) between 01/01/2015 and 04/30/2017 and included a potential follow-up period through 06/30/2017. Data were sourced from iKnowMed electronic health records. Patient and treatment characteristics were assessed descriptively, with Kaplan–Meier methods used to evaluate time-to-event outcomes, including overall survival (OS).ResultsA total of 117 patients were included in this analysis (median age 69 years, 74.4% male, 88.0% Caucasian): 79 and 38 patients were in the C-IO and C-C subgroups, respectively. The median OS was 19.2 months among patients who received the C-IO sequence and 11.9 months among those who received the C-C treatment sequence.ConclusionThese results suggest that patients who received the C-IO treatment sequence had notable improvement in OS compared with those who received the C-C sequence. In light of the rapidly evolving therapeutic landscape, further investigation will be required to determine how best to select the optimal therapeutic regimen and sequencing for patients with la/mUC.

Examining the Effect of Utilizing a Surgical First Assist Versus Physician on Gynecologic Robotic Operative Variables

Study Objective To examine whether utilizing a salaried surgical first assistant or a physician as an assistant during gynecologic robotic cases affects surgical variables. Design Retrospective chart review. Setting Community Practice Setting in Las Vegas, Nevada. Patients or Participants Female patients undergoing robotic surgical intervention for any gynecologic reason from 2005-2018 by a single gynecologic oncologist(n=1,690). Interventions N/A Measurements and Main Results A high volume gynecologic oncologist's robotic case data spanning fourteen years (2005-2018) was analyzed. We separated the cases based on the type of assistant used, either an employed surgical first assist or another physician. The assisting physicians were either members of the same practice or general gynecologists in the community. The two groups were compared for operative time and estimated blood loss. We controlled for patient Body Mass Index, uterine weight, use of the fourth robotic arm, benign versus cancer pathology, and a subjective estimate of the difficulty of the case using a conventional laparoscopic versus robotic approach. Cases with an employed surgical assist had a mean adjusted robotic console time that was 0.32hrs(19.2min) faster than cases with a physician as the assist (95% CI 0.26hrs to 0.37hrs faster, p Conclusion The use of an employed surgical assist was associated with a faster console time and lower blood loss compared to using an available physician even adjusting for confounding factors. This deserves further exploration, particularly in regards to complication rates, operating room efficiency, utilization of health care personnel, and cost.

Knowledge and evaluation of geriatric assessment (GA) domains among U.S. community oncologists/hematologists (cOH).

206 Background: GA is a multidisciplinary assessment consisting of the following domains: physical function, comorbidity, cognition, mood, social support, nutrition and medication review. Conducting a GA with validated instruments to assess these domains has been shown to improve outcomes in older adults with cancer [Soo, et al ASCO 2020]. The utilization of validated GA tools and its domains versus use of other surrogates from history and physical exam (HPE) for risk-stratification in older adults in the community practice setting is unclear. In this survey-based study, we assessed the knowledge of GA and the methods used to evaluate GA domains among cOH. Methods: Questions pertaining to GA and the care of older adults with cancer were developed by two medical oncologists (AG and BAF) and presented to cOH with diverse US geographic representation at live meetings and via web-based questionnaire between September 2019 and March 2020. Results were analyzed using descriptive statistics. Results: Of the 173 participants surveyed, 59% reported performing no GA, while 13% and 28% reported performing GA on all and selected older adults, respectively. When presented with a list of daily living activities, over half of cOH were unable to correctly identify all activities of daily living (ADLs) and instrumental ADLs (56% and 70%, respectively). The top 2 methods used by cOH to assess physical functional were the ECOG performance status (82%) and HPE (42%). For assessment of cognition, most cOH used HPE (78%) or the Mini Mental State Exam (MMSE; 12%). Social support was assessed via HPE (44%) or GA (27%). cOH reported that medication review is performed by an office staff (medical assistant 31%, nurse 12%, pharmacist 5%), with the physician signing off on the information reported in the chart irrespective of who entered the medication information (50%). Regarding chemotherapy dosing in older adults with cancer, only 7% utilized GA to inform chemotherapy dose; 48% reported starting at a lower chemotherapy dose with intent to escalate, while 33% reported starting at the standard dose with intent to de-escalate if toxicity is encountered. Lastly, 27% stated that oncologists are not adequately equipped to care for older adults with cancer given the complexity involved. Conclusions: Many cOH do not utilize validated instruments to assess the domains of GA. There also appear to be knowledge gaps regarding individual domains of GA. There is a need to further the education of cOH regarding the components and value of GA in older adults with cancer.