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Septic arthritis of the shoulder girdle remains relatively uncommon, with Staphylococcus aureus and β-hemolytic streptococci the typical offending organisms in adult patients. Rare cases of Streptococcus viridans, an oral bacterium with low virulence, have been reported in the setting of septic arthritis, mostly involving the knee joint or the sternoclavicular joint. In this article, we report a case of Streptococcus mitis infection of the glenohumeral joint that likely resulted from hematogenous spread after oral trauma in a patient with poor underlying dentition. Prompt diagnosis followed by arthroscopic irrigation and débridement of the glenohumeral joint resulted in a satisfactory clinical outcome.

Background Non-adherence to antipsychotic therapy among patients with schizophrenia is a key driver of relapse, which can lead to costly inpatient stays. Long-acting injectables (LAIs) may improve adherence, thus reducing hospitalizations, but inpatient cost reductions need to be balanced against higher drug acquisition costs of LAIs. Real-world evidence is needed to help quantify the economic value of oral atypical antipsychotics compared with LAIs. Objective The objective of this study was to compare healthcare costs and resource utilization between once-monthly paliperidone palmitate (PP) and oral antipsychotic therapy (OAT) in a population of Medicaid beneficiaries with schizophrenia. Methods A retrospective, observational study was performed using Truven Health MarketScan Medicaid claims data from 2009 to 2012. Marginal structural modeling, a form of weighted repeated measures analysis to control for differences between cohorts and time-varying confounding, was used to estimate monthly costs of care in 2012 US dollars and resource utilization over a 12-month period for patients in each cohort. Results While per-month mental-health prescription costs were US$1019 higher in the PP cohort, approximately 55 % of this premium was offset by lower inpatient and outpatient care costs, producing a mean monthly total cost differential of US$434 (95 % CI 298–569, p

e18138 Background: Little is known of the changes pts experience in day-to-day function as a consequence of cancer and/or treatment. With ongoing and future oncology drug development, gaining a greater understanding of the functional impact of these agents could help complement assessments of survival and quality of life. We set out to understand “function,” the performance of (and changes in) tasks and roles required for everyday living, and which aspects of function are most meaningful from the pts’ perspective to inform future assessment. Methods: We reviewed literature related to functional assessments used in oncology and conducted 20 1:1 semi-structured interviews to explore how pts describe their daily functioning. Results: There was no consensus on the definition of “function” (N = 40 publications). Interview participants represented a broad spectrum of clinical (e.g. eight cancer types, ECOG status 0–3 [n = 4, 7, 6, and 2, respectively], prior treatment exposure [7/20 received taxanes]) and demographic characteristics. Interview participants had difficulty defining “function;” 7/20 did not provide a definition. Pts referred to 60 unique concepts that were organized into four overarching categories: mobility, cognition, activities (basic activities of daily living, domestic life, social context, and exercise), and roles (e.g. caregiver/parent, employee, spouse/partner) within the research. Functional impairments were described as limitations in mobility and/or cognitive abilities. Interviews also revealed 47 stimuli (e.g. signs/symptoms) that were associated with changes in the aforementioned functional categories as well as 20 different adaptations (e.g. frequency, intensity, precaution/prevention, external aids, proactive behavioral changes) that were used to overcome functional impairment. Conclusions: “Function” is a complex concept; impact on mobility, cognition, and the activities and roles that comprise function are unique and depend on the type of cancer, treatment, and life situation. Results point to the assessment of mobility, cognition, activities, and roles as individual concepts for measuring function comprehensively.

88 Background: FDA released draft Guidance on Patient-Reported Outcomes (PROs) in 2006 and finalized it in 2009. The Guidance applies equally to clinician and observer outcomes (ClinROs, ObsROs; collectively, clinical outcome assessments - COAs), and defines regulatory expectations for COA instruments in pivotal clinical trials and the inclusion of COA data in approved labeling. The purpose of this review was to survey labels for oncologic drugs approved in the three years since the “PRO Guidance” was finalized and to characterize any COAs in these labels. Methods: CenterWatch maintains a list of FDA approved drugs following definitions established by the Tufts Center for the Study of Drug Development, including only drugs or NMEs newly approved by the FDA Center for Drug Evaluation and Research. From 2010 through 2013, 45 oncologic drugs were approved by the FDA. The labels and other information from the Drugs@FDA website were reviewed. Results: Few of the approved labels included any reference to COAs or data collected using PROs, ClinROs, or ObsROs. Several (e.g., carfilzomib) had clear statements indicating approval for the product was based on a predefined response rate rather than “improvement in survival or symptoms.” The exceptions are fentanyl tablets and spray, and abiraterone, all with PRO data on pain. The number of PROs in the labels reviewed was low, but the trend suggests that products reviewed by Divisions outside the Office of Hematology and Oncology Products were more likely to have a PRO. Abiraterone was an exception as it was reviewed by Oncology Products I and included patient reported pain. Conclusions: There are several explanations for the low rate of COAs in oncology labels, e.g., oncology trials tend to be unblinded. The FDA has stated that open label designs cannot support PRO claims. Yet there is still a heavy reliance on outcomes such as progression free and overall survival. Three labels were identified with PRO data on pain, two of which were specifically indicated for pain rather than tumor control. This review suggests there are opportunities for sponsors and the FDA to increase the degree to which the patient’s voice is heard during the regulatory decision process, particularly, in programs reviewed by the oncology divisions.