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Nupur Greene,1 Keiko Higuchi,1 Katalin Bognar,2 Eunice Chang,2 Michael S Broder2 1Neurology & Immunology (N&I), Sanofi, Cambridge, MA, USA; 2Real World Evidence, PHAR (Partnership for Health Analytic Research), Beverly Hills, CA, USACorrespondence: Nupur Greene, Global HEVA Business Partner, N&I, Sanofi, 450 Water Street, Cambridge, MA, USA, Tel +1 857 259 0037, Email Nupur.Greene@sanofi.comPurpose: Multiple sclerosis (MS) is a costly, immune-mediated disease of the central nervous system. Most patients have relapsing-remitting MS (RRMS) for which disease-modifying therapies (DMTs) provide an effective treatment option by reducing relapse rates. However, adherence to DMTs is suboptimal. This study examines the association between adherence to teriflunomide and clinical and healthcare utilization outcomes.Patients and Methods: Patients with RRMS who started treatment with teriflunomide between 1/1/2018 and 12/31/2019 were analyzed using IQVIA PharMetrics® Plus data. RRMS patients were identified via diagnosis codes and treatment types; the first prescription date for teriflunomide was the index date. Highly and poorly adherent patients were identified based on the proportion of days covered (PDC) post-index (PDC ≥ 0.8 and PDC ≤ 0.5, respectively). Patient demographics, clinical characteristics, healthcare utilization during the year pre- and post-index, and relapse rate post-index were reported descriptively. Outcomes were compared between highly and poorly adherent patients through logistic regression. Models were adjusted for demographics, comorbidities, and utilization measures during the baseline period.Results: Among the 922 RRMS patients identified, 534 (57.9%) were highly adherent to teriflunomide, while 249 (27.0%) had PDC ≤ 0.5. The two groups were not statistically different in terms of demographic characteristics and comorbidities; however, poorly adherent patients were more likely to have emergency department (ED) or inpatient visits during baseline (36.9% versus 26.8%, P=0.004; 17.3% versus 10.9%, P=0.013, respectively). Unadjusted results suggested lower likelihood of both relapses and utilization during follow-up among highly adherent patients compared to poorly adherent patients. Adjusted results confirmed that high adherence was associated with decreased likelihood of post-index relapses, ED utilization, and inpatient utilization (OR [95% CI]: 0.55 [0.39– 0.76], 0.49 [0.34– 0.71], and 0.51 [0.27– 0.97], respectively) even after controlling for baseline utilization.Conclusion: High adherence to teriflunomide was found to be associated with fewer relapses and lower healthcare utilization among patients with RRMS.Keywords: administrative claims analysis, disease modifying therapies, medication compliance, percent of days covered

Background: To estimate the cost of US hospital admissions and outpatient surgeries associated with achondroplasia. Materials & methods: Using 2017 data from nationally representative databases, this study identifies hospital admissions and outpatient encounters with an achondroplasia diagnosis. Descriptive measures are reported. Results: There were 1985 achondroplasia admissions nationwide. The most frequent admissions were neonatal care (33.7%) in children and musculoskeletal (22.7%) in adults. Average hospital length of stay was 6.8 days, 2.2 days longer than the US mean. Total mean inpatient costs were US$19,959, $7789 greater than the US mean. In the outpatient setting, children 5–14 years accounted for 56.9% of procedures. Conclusion: Achondroplasia is a serious condition with a wide range of lifelong complications frequently requiring hospitalization and surgical intervention.

Aim: To compare rates of biologic initiation after commencing treatment with apremilast (APR) versus methotrexate (MTX) in systemic-naive patients with psoriasis (PsO). Methods: This was a retrospective cohort study of systemic-naive patients with PsO who initiated treatment with APR or MTX between 1 January 2015 and 31 March 2018. Outcomes: Adjusted rates of biologic initiation during follow-up were compared by logistic and Cox regressions. Results: APR initiators had 58% lower likelihood of biologic initiation (odds ratio: 0.42; 95% CI: 0.37–0.48; p Conclusion: Systemic-naive patients with PsO have a lower rate of biologic initiation over 1 year following APR initiation.

BACKGROUND: Additional real-world studies are needed to more fully elucidate the effectiveness of antifibrotic treatment in slowing the progression of idiopathic pulmonary fibrosis (IPF). OBJECTIVE: To compare mortality and hospitalization between Medicare beneficiaries with IPF who initiate antifibrotic therapy and those who did not receive treatment. METHODS: A retrospective observational study of Medicare beneficiaries using the 100% Medicare Research Identifiable File was conducted. We included patients aged 67 years and over diagnosed with IPF (≥ 1 inpatient or ≥ 2 outpatient claims with IPF diagnosis, J84.112]) during the study period (January 1, 2010-December 31, 2017). Patients who initiated antifibrotic treatment (pirfenidone or nintedanib) between October 15, 2014 (FDA approval date) and December 31, 2017 (ie, treated patients) were compared with those who did not receive treatment during a historical period (January 1, 2012-October 14, 2014) before the availability of antifibrotics (ie, untreated historical controls). Patients were matched by propensity score, and the outcomes, mortality, and hospitalization (all cause and respiratory related) were compared using a Cox proportional hazards model. RESULTS: We identified 4,641 treated patients and 4,641 propensity score-matched controls who met all study criteria; 352 treated patients who lacked matches were excluded from the study. Cox regression analysis of treated patients vs matched controls showed a significantly lower risk of mortality (HR = 0.62, 95% CI = 0.57-0.68); lower risk of hospitalization (HR = 0.71, 95% CI = 0.67-0.76; HR = 0.70, 95% CI = 0.64-0.76); and lower rate in number of hospitalizations per month (incident rate ratio [IRR] = 0.65, 95% CI = 0.60-0.71; IRR = 0.65, 95% CI = 0.58-0.73). CONCLUSIONS: This study suggests that treatment with antifibrotics may confer a survival benefit and protection against all-cause and respiratory-related hospitalization for IPF patients. DISCLOSURES: This work was sponsored by F. Hoffmann-La Roche/Genentech, Inc. Corral is employed by Genentech, Inc. Reddy, Chang, Broder, and Gokhale are employed by Partnership for Health Analytic Research LLC, a health services research company, which was hired by Genentech to conduct this research. Mooney has received advisory board/consulting fees and research support from Genentech, unrelated to this work. Mooney also reports advisory board/consulting fees and research support from Boehringer Ingelheim; personal fees from Imvaria; and grants from Celgene and Pliant, unrelated to this work. Through their employment with Partnership for Health Analytic Research, Reddy, Chang, Broder, and Gokhale have been compensated to conduct research for AbbVie, Akcea, ASPC, Amgen, AstraZeneca, BMS, Boston Scientific Corporation, Celgene, Eisai, Ethicon, GRAIL, Helsinn, Illumina, Innovation and Value Initiative, Ionis, Jazz, Kite, Novartis, Otsuka, Pathnostics, PhRMA, Prothena, Sage, Verde Technologies, Genentech, Inc., Greenwich Biosciences, Inc., Mirum Pharmaceuticals, Inc., Sanofi US Services, Inc., Sunovion Pharmaceuticals, Inc., and Dompe US, Inc., unrelated to this work. This research was presented as an abstract at CHEST 2020 Annual Meeting (virtual), October 18-21, 2020, and American Thoracic Society 2020 Virtual Meeting, June 2020.

Aim: Estimate the frequency and costs of diagnostic admissions among hospitalized patients with amyloid light chain (AL) amyloidosis. Materials & methods: This retrospective analysis used nationally representative hospital discharge data from 2017 to 2020 to report resource use and cost for hospitalizations during which AL amyloidosis was diagnosed. Results: Of 1341 admissions, 17.6% were diagnostic. Bone marrow (79.5%) and kidney (44.9%) biopsies were the most common qualifying biopsies. Diagnostic hospitalizations had longer length of stay (14.5 vs 8.4 days; p Conclusion: Diagnostic admissions are more likely to be urgent/emergent, require longer stays and have higher costs compared with hospitalizations in known AL amyloidosis patients. Improved diagnostic pathways toward early diagnosis are needed.

Head trauma (ie, head injury) is a significant public health concern and is a leading cause of morbidity and mortality in children and young adults. Neuroimaging plays an important role in the management of head and brain injury, which can be separated into acute (0-7 days), subacute ( 3 months) phases. Over 75% of acute head trauma is classified as mild, of which over 75% have a normal Glasgow Coma Scale score of 15, therefore clinical practice guidelines universally recommend selective CT scanning in this patient population, which is often based on clinical decision rules. While CT is considered the first-line imaging modality for suspected intracranial injury, MRI is useful when there are persistent neurologic deficits that remain unexplained after CT, especially in the subacute or chronic phase. Regardless of time frame, head trauma with suspected vascular injury or suspected cerebrospinal fluid leak should also be evaluated with CT angiography or thin-section CT imaging of the skull base, respectively. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Background Osilodrostat, a potent cortisol synthesis inhibitor, demonstrated safety and efficacy in the treatment of Cushing's disease (CD). No information is available describing use of osilodrostat in non-pituitary Cushing's syndrome (CS) in US patients. Data from a real-world study in US patients with non-pituitary CS is presented. Methods The ILLUSTRATE study is a real-world characterization of osilodrostat usage in patients with endogenous CS treated May 1, 2020 - October 29, 2021. Forty-two adult patients with a confirmed diagnosis of endogenous CS and a prescription for osilodrostat were included in this real-world study. We report patient characteristics, osilodrostat dose, efficacy, and safety in the subset of patients with non-pituitary CS (n=8,19%). Results The 8 non-pituitary CS patients enrolled comprised 5 with adrenal CS and 3 with ectopic CS. Baseline urinary free cortisol (UFC) was 2.57–75.2×ULN in patients with ectopic CS, and 0.42–27.76×ULN in the 4 adrenal patients with baseline UFC available. In the adrenal CS patients, starting dose ranged from 1–4 mg daily. In adrenal patients with more than one documented clinical encounter (n=4): 2 remained on starting doses of 1 mg BID and 2 mg BID, 1 increased from 1 mg QD to 2 mg BID on day (D) 50, and 1 increased from 2 mg BID to 4 mg BID on D5 and required down-titration on D18 with treatment interruption on D27. The 3 patients with ectopic CS were all initiated at 2 mg BID: 1 patient's dose was unchanged throughout the observation period, and the other 2 patients were up-titrated, both on D91 to 4 mg BID or 5 mg QD. The two ectopic CS patients with available UFC data experienced substantial UFC | reductions (from 57.1×ULN to 2.9×ULN at D91 and 75.2×ULN to 0. 076×ULN at D134). The one adrenal CS patient with available UFC data and prior medical therapy for CS maintained UFC ≤ ULN during osilodrostat treatment. Osilodrostat was generally well tolerated and one ectopic CS patient had treatment interrupted on D214 for adrenal insufficiency (AI). Two of five adrenal CS patients (40%) had symptoms suggestive of glucocorticoid withdrawal (e. g., fatigue, nausea, and headache) and one had an interruption in therapy. Neither had documented AI. Conclusion In this real-world cohort of patients treated with osilodrostat for non-pituitary CS, large UFC reductions were seen in two patients with ectopic CS. All 8 were initiated on ≤2 mg BID, with 3 (38%) remaining on their original dose. In the majority of those up-titrated, there was an extended titration interval. The observed safety profile in this subset (albeit small) of non-pituitary CS patients was consistent with the known osilodrostat safety profile. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.

M Elaine Husni,1 Eunice Chang,2 Michael S Broder,2 Caleb Paydar,2 Katalin Bognar,2 Pooja Desai,3 Yuri Klyachkin,3 Ibrahim Khilfeh3 1Cleveland Clinic, Cleveland, OH, USA; 2Partnership for Health Analytic Research, LLC, Beverly Hills, CA, USA; 3Amgen Inc., Thousand Oaks, CA, USACorrespondence: Michael S Broder, Partnership for Health Analytic Research, LLC, 280 S. Beverly Drive, Suite 404, Beverly Hills, CA, 90212, USA, Tel +1 310 858 9555, Fax +1 310 858 9552, Email mbroder@pharllc.comPurpose: To compare the rate of biologic initiation after commencing treatment with apremilast (APR) vs methotrexate (MTX), in systemic-naïve patients with psoriatic arthritis (PsA).Patients and Methods: Systemic-naïve patients with PsA who started treatment with either APR or MTX between 01/01/2015 and 12/31/2018 were analyzed using claims data from the IBM® MarketScan® Commercial and Medicare Supplemental databases (2014– 2019). PsA patients were identified via diagnosis codes; the first prescription date for APR or MTX was the index date. Patient demographics, clinical characteristics, healthcare utilization during the year pre-index (baseline) and the year post-index (follow-up), and median time to biologic initiation were reported descriptively. The rates and risk of biologic initiation during follow-up were compared between APR and MTX users by logistic and Cox regressions, respectively. Models were adjusted for demographics, clinical and utilization measures during the baseline period.Results: A total of 2116 patients with PsA newly treated with APR (n = 534) or MTX (n = 1582) were identified. Mean age was similar (50.5 vs 50.4; P = 0.938), and proportion of females was higher for APR vs MTX users (59.4% vs 54.0%; P = 0.031). Mean time to biologic initiation among patients who initiated during follow-up was 194.1 vs 138.7 days between APR vs MTX users (P < 0.001). After adjusting for confounders, the likelihood of biologic initiation was 58% lower (OR, 0.42 [95% CI, 0.32– 0.54]; P < 0.001) with APR, with a significantly lower predicted rate of biologic initiation among APR users when compared to MTX users during follow-up (20.0% [95% CI, 16.6– 23.9%] vs 37.5% [95% CI, 35.0– 40.1%]). Additionally, APR users had a lower risk of biologic initiation than MTX users (HR, 0.46 [95% CI, 0.37– 0.57]; P < 0.001) during the 1-year follow-up.Conclusion: Systemic-naïve patients with PsA have a lower rate of, and longer time to, biologic initiation over one-year following APR initiation, compared to those initiating MTX.Keywords: psoriatic arthritis, oral small molecules, biologics, systemic treatment initiation, administrative claims analysis

Michael S Broder, Sarah N Gibbs, Irina Yermilov Outcomes Research, Partnership for Health Analytic Research (PHAR), LLC, Beverly Hills, CA, USACorrespondence: Michael S Broder, Partnership for Health Analytic Research (PHAR), LLC, 280 S Beverly Drive, Suite 404, Beverly Hills, CA, 90212, USA, Tel +1-310-858-9555, Fax +1-310-858-9550, Email mbroder@pharllc.comAbstract: The RAND/UCLA modified Delphi panel method is a formal group consensus process that systematically and quantitatively combines expert opinion and evidence by asking panelists to rate, discuss, then re-rate items. The method has been used to develop medical society guidelines, other clinical practice guidelines, disease classification systems, research agendas, and quality improvement interventions. Traditionally, a group of experts meet in person to discuss results of a first-round survey. After the meeting, experts complete a second-round survey used to develop areas of consensus. During the COVID-19 pandemic, this aspect of the method was not possible. As such, we have adapted the method to conduct virtual RAND/UCLA modified Delphi panels. In this study, we present a targeted literature review to describe and summarize the existing evidence on the RAND/UCLA modified Delphi panel method and outline our adaptation for conducting these panels virtually. Transitioning from in-person to virtual meetings was not without challenges, but there have also been unexpected advantages. The method we describe here can be a cost-effective and efficient alternative for researchers and clinicians.Keywords: Delphi panel, expert panel, consensus, virtual meeting, COVID-19, pandemic

Background Thrombopoietin receptor agonists (TPO-RAs) are used to treat primary immune thrombocytopenia (ITP). Some patients have discontinued treatment while maintaining a hemostatic platelet count. Objectives To develop expert consensus on when it is appropriate to consider tapering TPO-RAs in ITP, how to taper patients off therapy, how to monitor patients after discontinuation, and how to restart therapy. Methods We used a RAND/UCLA modified Delphi panel method. Ratings were completed independently by each expert before and after a meeting. Second-round ratings were used to develop the panel's guidance. The panel was double-blinded: The sponsor and nonchair experts did not know each other's identities. Results Guidance on when it is appropriate to taper TPO-RAs in children and adults was developed based on patient platelet count, history of bleeding, intensification of treatment, trauma risk, and use of anticoagulants/platelet inhibitors. For example, it is appropriate to taper TPO-RAs in patients who have normal/above-normal platelet counts, have no history of major bleeding, and have not required an intensification of treatment in the past 6 months; it is inappropriate to taper TPO-RAs in patients with low platelet counts. Duration of ITP, months on TPO-RA, or timing of platelet response to TPO-RA did not have an impact on the panel's guidance on appropriateness to taper. Guidance on how to taper patients off therapy, how to monitor patients after discontinuation, and how to restart therapy is also provided. Conclusion This guidance could support clinical decision making and the development of clinical trials that prospectively test the safety of tapering TPO-RAs.

Introduction Little is known about the burden of hereditary transthyretin (ATTRv) amyloidosis, a genetic, progressive, and fatal disease caused by extracellular deposition of transthyretin amyloid fibrils. The study’s aim was to estimate costs and disease burden associated with ATTRv amyloidosis in a real-world setting. Methods Using IBM® MarketScan® Commercial and Medicare Supplemental data, we identified patients at least 18 years of age with newly diagnosed ATTRv amyloidosis. Diagnosis required at least one medical claim with relevant diagnosis code (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] 277.30–.31, 277.39; ICD-10-CM E85.0–.4, E85.89, E85.9) between January 1, 2014 and December 31, 2016, and at least one additional criterion occurring during study period (2013–2017): at least 15 days diflunisal use without more than a 30-day gap; liver transplant; or claim with codes E85.1 or E85.2. First diagnosis date was study index. Continuous enrollment 1-year pre-index (baseline) and post-index (follow-up) was required. Patients with baseline amyloidosis diagnosis were excluded. Outcomes of interest were comorbidities and 1-year follow-up healthcare utilization and costs (also reported quarterly). Results Among 185 qualifying patients, mean age was 59.2 years (standard deviation 15.2), 54.1% were female, and baseline Charlson comorbidity index was 2.2 (2.5). Neuropathy (30.3%), diabetes (27.0%), and cardiovascular-related comorbidities, including dyspnea (25.9%) and congestive heart failure (21.6%), were common during follow-up. Nearly a quarter of patients (24.9%) were hospitalized during follow-up. Most hospitalizations and emergency department visits occurred in the first quarter post-diagnosis (18.9%, 17.8%, respectively) and dropped in subsequent quarters. The annual mean total cost was $64,066, with inpatient services contributing the majority of the expenses ($34,461), followed by outpatient ($23,853), and then pharmacy ($5752). As with utilization, costs were highest in the first quarter post-diagnosis and dropped in subsequent quarters. Conclusion Patients newly diagnosed with ATTRv amyloidosis have substantial healthcare utilization and costs in the first year, primarily the initial months, post-diagnosis. Further research should examine later costs associated with disease progression and end-of-life care.

Seizures and epilepsy are a set of conditions that can be challenging to diagnose, treat, and manage. This document summarizes recommendations for imaging in different clinical scenarios for a patient presenting with seizures and epilepsy. MRI of the brain is usually appropriate for each clinical scenario described with the exception of known seizures and unchanged semiology (Variant 3). In this scenario, it is unclear if any imaging would provide a benefit to patients. In the emergent situation, a noncontrast CT of the head is also usually appropriate as it can diagnose or exclude emergent findings quickly and is an alternative to MRI of the brain in these clinical scenarios. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Background Migraine is associated with debilitating symptoms that can affect daily functioning. "My Migraine Voice" was a large, cross-sectional, multi-country online survey aimed at understanding disease burden directly from people with migraine. Objective This study reports on the social and economic impacts of migraine, specifically the impact on activities of daily living and the costs of migraine, from the point of view of people with migraine in the United States. Methods The online survey was administered to adults with a self-reported diagnosis of migraine who experienced 4 or more monthly migraine days each month for the previous 3 months. Prespecified screening quotas were used so that 90% of respondents reported current or past use of preventive migraine medication, 80% of whom switched treatment (ie, changed their prescribed preventive medication at least once). The remaining 10% were preventive treatment naive (ie, never used any prescribed preventive medication). Burden of migraine on activities of daily living and caregivers (eg, functional limitations, fear of next migraine attack, sleep problems) and economic burden (eg, out-of-pocket costs, impact on work productivity using the validated work productivity and activity impairment questionnaire) reported by respondents from the United States are presented. Results are stratified by employment status, migraine frequency (chronic vs episodic migraine), and history of preventive treatment. Results Thousand hundred and one individuals with migraine from the United States responded to the survey. Respondents reported limitations completing daily activities during all migraine phases, including during the premonitory/aura and postdrome phases. Most (761/1101 (69%)) relied on family, friends, or others for help with daily tasks and reported being helped a median of 9 days (25th percentile 5 days, 75th percentile 15 days) within the last 3 months. Respondents with chronic migraine reported being helped for more days (median 10 days, 25th percentile 5 days, 75th percentile 23 days) in the last 3 months. Almost all (962/1101 (87%)) experienced sleep difficulties and 41% (448/1101) (48% (336/697) of those with 2 or more preventive treatment failures) were very or extremely fearful of a next migraine attack. Median (25th percentile, 75th percentile) monthly out-of-pocket costs of $90.00 ($30.00, $144.00) in doctor's fees (n = 504), $124.00 ($60.00, $234.00) in health insurance (n = 450), $40.00 ($20.00, $100.00) for prescriptions (n = 630), and $50.00 ($0.00, $100.00) for complementary therapies (n = 255) were reported. Those with 2 or more preventive treatment failures reported higher monthly out-of-pocket doctor fees (median $99.00 ($30.00, $150.00), n = 388). Among employed respondents (n = 661), migraine resulted in 22% absenteeism, 60% presenteeism, 65% work productivity loss, and 64% activity impairment. Conclusions Migraine impacts individuals' activities of daily living, work-life, and financial status, especially individuals with high needs, namely those with 4 or more monthly migraine days and prior treatment failures. People with migraine are impaired during all migraine phases, experience fear of their next migraine attack and sleep difficulties, and pay substantial monthly out-of-pocket costs for migraine. Burden is even greater among those who have had 2 or more preventive treatment failures. Impacts of migraine extend beyond probands to caregivers who help people with migraine with daily tasks, employers who are affected by employee absenteeism, presenteeism, and reduced productivity, and society which is burdened by lost and reduced economic productivity and healthcare costs.

Background Small-caliber chest tubes are used to treat pneumothorax and pleural fluid collections. Although commonly considered a less invasive alternative to large-caliber thoracostomy tubes, small-caliber tubes have a high complication rate. Emergency physicians must be familiar with common and dangerous procedure complications associated with these devices and have a systematic and rapid approach to identify and solve malfunctions. Structured root cause analysis can facilitate identification of problems. Methods We reviewed the medical literature for complications of small-caliber chest tubes and searched the U.S. Food and Drug Administration (FDA) database for complications of a specific pigtail catheter kit. Using a structured root cause analysis (RCA), we examined two cases of retained pigtail catheter obturators resulting in catheter malfunction and unresolved pneumothorax. Results We identified common complications of pigtail catheters from the medical literature, as well as 28 reports to FDA of complications with the kit used in the analyzed cases; ours were the only reports of the obturator error. RCA identified multiple contributing factors, including unrecognized and novel radiographic clues, human errors, communication breakdown, device design, and opportunities for improved systematic procedural approach. Discussion We discuss factors identified in RCA and regulatory considerations relevant to emergency physicians, including FDA reporting mechanisms. Conclusions A structured review of complications of pigtail catheter insertion revealed opportunities for improved patient safety. We highlight a preventable error in insertion of a percutaneous catheter and describe radiographic features to enhance error detection. Improved design, systematic processes for device insertion and troubleshooting, and enhanced provider education could reduce the risk of medical device errors. An end-of-procedure time-out including instrument counts and systematic assessment of device function is a generalizable patient safety measure for bedside procedures.

Background: Ordering and delivering chemotherapy is complex, impacting patient and caregiver quality of life. Metastatic breast cancer (mBC) patients receive intravenous chemotherapy with variable administration times and patient satisfaction may differ by session length. We investigated common chemotherapy agents for mBC through a time and motion analysis. Methods: We conducted a prospective, observational time-and-motion study of adult females with mBC receiving ≥ 2nd-line eribulin, vinorelbine (VI), or gemcitabine (GC) at a large community oncology clinic. An observer documented times events occurred (Table). Patients completed a satisfaction survey adapted from Agency for Healthcare Research and Quality’s cancer care survey and the Cancer Therapy Satisfaction Questionnaire. Event times were compared using t-test. Spearman’s rank correlation was used to test correlations between time and satisfaction. Results: 17 patients (11 eribulin, 6 VI/GC) comprising 31 observations (20 eribulin, 11 VI/GC) were included in the preliminary analysis. Patients were 65 years on average, 71% white, and 94% post-menopausal; all were HER-2-. Mean years since mBC diagnosis was lower for eribulin than VI/GC patients (1.7 vs 5.0, p All observationsEribulin Vinorelbine/ GemcitabineP value * Citation Format: Lee Schwartzberg, Debanjana Chatterjee, Russel Knoth, Sarah N Gibbs, K Hamzah Ahmed, Michael S Broder, Irina Yermilov. A time-and-motion study of chemotherapy administration in metastatic breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-13.

Introduction Patients with major depressive disorder (MDD) incur high costs, despite established treatment options. Adding an atypical antipsychotic (AAP) to antidepressant therapy has shown to reduce depressive symptoms in MDD, but it remains unclear with which adjunctive AAP to initiate. As economic burden is one factor that can influence treatment selection, this study's objective was to evaluate the impact of adjunctive AAP choice on psychiatric costs and healthcare utilization in MDD. Materials and methods This retrospective cohort study analyzed de-identified data from: (1) IBM® MarketScan® Commercial (C), Medicare Supplemental (MS), and MarketScan Multi-State Medicaid (M) Databases, and (2) Optum® Clinformatics® Datamart. Adult MDD patients were included if they had: initiated adjunctive AAPs during study identification period (7/1/15-9/30/16 MarketScan C/MS, and Optum; 7/1/15-6/30/16 MarketScan M), and ≥12 months of continuous enrollment before (baseline) and after (follow-up) first treatment date. Models included generalized linear models (GLMs) for psychiatric costs (total inpatient and outpatient services, excluding outpatient pharmacy costs), and a two-part model (logistic regression for psychiatric hospitalizations, GLM for psychiatric hospitalization costs among hospitalized patients); models were adjusted for baseline characteristics. Results The final study sample consisted of 10,325 patients (7657 aripiprazole, 1219 brexpiprazole, 827 lurasidone, 622 quetiapine). Using brexpiprazole as reference, lurasidone and quetiapine users had $1662 and $3894 higher psychiatric costs, respectively. Psychiatric costs were not statistically significantly different between aripiprazole and brexpiprazole (p>0.05). Quetiapine users had $15,159 (p 0.05). Conclusion In MDD, brexpiprazole users had significantly lower psychiatric costs than lurasidone and quetiapine users, and significantly lower psychiatric hospitalization risk than quetiapine users. Adjunctive AAP choice may impact subsequent healthcare costs and utilization in MDD.

This study analyzed a privately insured pediatric population with and without narcolepsy to determine the impact of pediatric narcolepsy on comorbidities, health care utilization, and cost. Additional analyses compared narcolepsy type 1 and type 2.This retrospective cross-sectional study identified US patients with narcolepsy18 years of age with ≥2 claims with a diagnosis code of narcolepsy using Truven MarketScan® data 2011 to 2015. Patients were matched to controls without narcolepsy. Comorbid conditions, health care utilization, and costs were measured by calendar year. P values are nominal, and no adjustments for multiplicity or multiple comparisons were made.A total of 1427 pediatric patients with narcolepsy were identified and matched with 4281 controls from 2011 to 2015. Patients with narcolepsy had more comorbid conditions (mean 5.8 vs 2.4, nominal P 0.001). Respiratory diseases and mood disorders were more common in patients with narcolepsy than controls (57% vs 32% and 56% vs 14%, respectively; both nominal P 0.001). Compared to controls, patients with narcolepsy underwent more diagnostic tests (electroencephalogram, EEG [0.13 vs 0.0053]) and brain computed tomography, CT/magnetic resonance imaging, MRI (0.26 vs 0.022; both nominal P 0.001). Mean annual inpatient days (0.71 vs 0.15), emergency department visits (0.51 vs 0.15), and outpatient office visits (8.6 vs 2.3) were higher for patients with narcolepsy than controls (all nominal P 0.001). Annual mean health care costs were higher for patients with narcolepsy versus controls ($15,797 vs $2449, nominal P 0.001).Pediatric patients with narcolepsy had greater comorbidity, higher health care utilization, and higher costs than patients without narcolepsy.

This second Guideline for Reasonable and Appropriate Care in the Emergency Department (GRACE-2) from the Society for Academic Emergency Medicine is on the topic "low-risk, recurrent abdominal pain in the emergency department." The multidisciplinary guideline panel applied the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of evidence and strength of recommendations regarding four priority questions for adult emergency department patients with low-risk, recurrent, undifferentiated abdominal pain. The intended population includes adults with multiple similar presentations of abdominal signs and symptoms recurring over a period of months or years. The panel reached the following recommendations: (1) if a prior negative computed tomography of the abdomen and pelvis (CTAP) has been performed within 12 months, there is insufficient evidence to accurately identify populations in whom repeat CTAP imaging can be safely avoided or routinely recommended; (2) if CTAP with IV contrast is negative, we suggest against ultrasound unless there is concern for pelvic or biliary pathology; (3) we suggest that screening for depression and/or anxiety may be performed during the ED evaluation; and (4) we suggest an opioid-minimizing strategy for pain control. EXECUTIVE SUMMARY: The GRACE-2 writing group developed clinically relevant questions to address the care of adult patients with low-risk, recurrent, previously undifferentiated abdominal pain in the emergency department (ED). Four patient-intervention-comparison-outcome-time (PICOT) questions were developed by consensus of the writing group, who performed a systematic review of the literature and then synthesized direct and indirect evidence to formulate recommendations, following GRADE methodology. The writing group found that despite the commonality and relevance of these questions in emergency care, the quantity and quality of evidence were very limited, and even fundamental definitions of the population and outcomes of interest are lacking. Future research opportunities include developing precise and clinically relevant definitions of low-risk, recurrent, undifferentiated abdominal pain and determining the scope of the existing populations in terms of annual national ED visits for this complaint, costs of care, and patient and provider preferences.

Estimate the annual cost of care in the 5 years following a cancer diagnosis for 17 invasive cancer types, by stage at diagnosis. We used 2012–2016 data from the Surveillance, Epidemiology, and End Results (SEER) registry-Medicare claims database to examine cost of care among Medicare beneficiaries with a confirmed cancer diagnosis based on International Classification of Diseases for Oncology, Third Edition histology codes reported in SEER. Beneficiaries contributed to the annual cost calculations (Years 1–5) using their observed time after diagnosis. Beneficiaries were continuously enrolled in fee-for-service Medicare Parts A/B and Part D during follow-up. Total, inpatient, outpatient, and pharmacy cancer-related service costs were calculated. From 2012 to 2016, we identified 597,778 Medicare beneficiaries with incident cancer diagnosis within 5 years (Stage I, II, III, and IV: 32.6%, 33.4%, 15.9%, and 18.0%, respectively). In Year 1, mean (standard deviation) total costs for Stage I diagnoses varied from $7640 ($17,378) (prostate) to $94,636 ($117,636) (pancreas). Total costs increased by stage and reached $58,783 ($92,344) (prostate) to $156,982 ($175,009) (stomach) for Stage IV diagnoses in Year 1. Costs in Year 1 were significantly higher for Stage IV diagnoses than for earlier stages across all cancer types. In Years 2–5, total costs were lower than in Year 1 but continued to increase by stage. Beneficiaries diagnosed at later stages of cancer have higher costs of care (up to 7 times as much) than those diagnosed at earlier stages. Earlier cancer diagnosis may lead to more efficient treatment and decreased management cost.