IVsight as an Infusion Monitor for Patients Receiving Intravenous Therapy: An Exploratory, Unblinded, Single-Center Trial.

Background: Intravenous (IV) infusion therapy is commonly used in health care settings. However, IV therapy at home can be challenging because it relies on the patient's ability to manage multiple medications correctly, which may lead to decreased treatment adherence. Objective: We aimed to assess the usability and accuracy of the IVsight monitor in capturing IV infusion data compared to manual recording. Methods: A prospective, single-center, usability study involving patients receiving IV infusion therapy at one of the BJC's Home Infusion suites was conducted to evaluate the accuracy, performance, and acceptability of the device IVsight as a monitor for IV infusions. Results: Of the 15 participants, the median (IQR) age was 46 years (36-55), 8 (53%) were female, and 13 (87%) were non-Hispanic white. Each participant received a median (IQR) of 4 (4-5) infusions during the study, and 68 infusions were observed overall. The intraclass correlation coefficient between the IVsight measurement and manual recording of infusion duration in seconds was excellent (ICC 0.97, 95% confidence interval 0.96-0.98). The Bland-Altman plot visually showed an acceptable limit of agreement for the 2 measurements, and the linear regression analysis revealed no significant proportional bias between the 2 methods for measuring the IV infusion time. None of the participants thought that IVsight was difficult to hold, use, clean, or store. Only one participant was concerned that the device could interfere with the IV infusion, and all participants felt comfortable with the device transmitting data to their health care providers. Conclusions: The IVsight infusion monitoring device showed near-perfect agreement on the recorded IV infusion duration compared with manual recording, and good acceptability among the study participants.

Race Does Not Impact Sepsis Outcomes When Considering Socioeconomic Factors in Multilevel Modeling.

OBJECTIVES: To determine whether race is a major determinant of sepsis outcomes when controlling for socioeconomic factors. DESIGN: Retrospective cohort study. SETTING: Barnes-Jewish Hospital a 1,350 bed academic medical center. PATIENTS: Eleven-thousand four-hundred thirty-two patients hospitalized between January 2010 and April 2017 with sepsis and septic shock. INTERVENTIONS: Multilevel random effects modeling was employed whereby patients were nested within ZIP codes. Individual patient characteristics and socioeconomic variables aggregated at the ZIP code level (education, employment status, income, poverty level, access to healthcare) were included in the model. MEASUREMENTS AND MAIN RESULTS: In hospital mortality, length of stay, need for vasopressors, and mechanical ventilation were the main endpoints. Black patients had more comorbidities than White patients except for cirrhosis and malignancy. In unadjusted comparisons, White individuals were more likely to require mechanical ventilation and had higher mortality rates and longer hospital stays for both low- and high-income groups. When nesting within ZIP codes and accounting for socioeconomic variables, race did not have a significant effect on mortality. Non-White races had lower odds ratio for mechanical ventilation. CONCLUSIONS: Our study demonstrates that race is not an independent risk factor for sepsis mortality, as well as sepsis-related length of stay. We should expand our inquiry into determinants of sepsis outcomes by including socioeconomic variables.

Best practices in designing preapproval information engagements for US health care decision makers.

As high-cost and innovative therapies continue to enter the market, health care decision makers (HCDMs) are expressing a need for early information on a product's clinical and economic impacts. Preapproval information exchange (PIE) fulfills these data needs by allowing manufacturers to share drug information with HCDMs prior to US Food and Drug Administration approval. With recent regulatory milestones, such as the Pre-approval Information Exchange Act of 2022, HCDMs look to leverage PIE to forecast budgets and inform reimbursement decisions. However, a lack of stakeholder alignment has challenged the evolving applications of PIE. In addition, manufacturers are still seeking regulatory clarity regarding best practices, and many are developing their own policies for content dissemination. Varying practices have led to heterogeneity of preapproval communications across manufacturers, which may not fully align with HCDM needs and interests. However, recently collected survey data from FormularyDecisions, which focused on HCDM perceptions of both PIE webinars and other formats of PIE (eg, PIE decks and dossiers), indicate that HCDMs have strong preferences regarding the timing and content shared in preapproval engagements. Additionally, product indication and clinical trial information are highly valued, and although desired by HCDMs in other studies, in FormularyDecisions survey data, exact pricing data do not currently appear to be a critical component of PIE. Preapproval communications are expected less than 1 year before anticipated product approval, and PIE webinars, specifically, should prioritize therapeutic areas and products anticipated to have a significant impact on organizational budgets. Although HCDMs prefer nonmanufacturer representatives for PIE webinars and virtual presentations, health outcome liaisons or medical science liaisons are ideal among manufacturer representatives for in-person preapproval engagements. The expectations of HCDMs should be considered as manufacturers establish PIE practices to ensure the exchange of quality and relevant information. DISCLOSURES: This study was funded by Xcenda. Dr Dodda, Dr Bannister, Dr Hydery, Ms Gorey, Ms Dunlap, and Dr Mody report personal fees from Xcenda during the conduct of the study.

Perspectives of Patients on Outpatient Parenteral Antimicrobial Therapy: Experiences and Adherence.

BACKGROUND: Nonadherence to medication is a burden to the US health care system and is associated with poor clinical outcomes. Data on outpatient parenteral antimicrobial therapy (OPAT) treatment plan adherence are lacking. The purpose of this study is to determine the rate of nonadherence and factors associated with it. METHODS: We surveyed patients discharged from a tertiary hospital on OPAT between February and August 2019 about their baseline characteristics, OPAT regimen, adherence, and experience with OPAT. RESULTS: Sixty-five patients responded to the survey. The median age was 62 years, and 56% were male. The rate of reported nonadherence to intravenous (IV) antibiotics was 10%. Factors associated with nonadherence to IV antibiotics included younger age, household income of <$20 000, and lack of time for administering IV antibiotics (30 vs 64 years, P < .01; 83% vs 20%, P < .01, and 33% vs 4%, P = .04, in the nonadherent vs adherent groups, respectively), while less frequent administration (once or twice daily) and having friend or family support during IV antibiotic administration were associated with better adherence (17% vs 76%, P < .01, and 17% vs 66%, P = .03, in the nonadherent vs adherent groups, respectively). Most patients attended their infectious diseases clinic visits (n = 44, 71%), and the most commonly cited reasons for missing an appointment were lacking transportation (n = 12, 60%), not feeling well (n = 8, 40%), and being unaware of the appointment (n = 6, 30%). CONCLUSIONS: Less frequent antibiotic dosing and better social support were associated with improved adherence to OPAT. In contrast, younger age, lower income, and lack of time were associated with nonadherence.