ABSTRACT
Despite vaccines being instrumental in reducing vaccine-preventable disease, adult vaccination rates in the United States (US) are below optimal levels. To better understand factors affecting vaccination rates, we analyzed trends in adult vaccination coverage using data from the Behavioral Risk Factor Surveillance System (BRFSS) and conducted a targeted literature review (TLR) on interventions to improve adult vaccination rates in the US. Both the BRFSS analysis and the TLR focused on influenza; pneumococcal disease; tetanus and diphtheria or tetanus, diphtheria, and acellular pertussis; herpes zoster; and human papillomavirus vaccination for US adults aged 18-64 years. The TLR additionally included hepatitis A and hepatitis B vaccination. Vaccination coverage rates (VCRs) and changes in VCRs were calculated using the 2011-2019 BRFSS survey data. For the TLR, the MEDLINE and MEDLINE In-Process databases were searched for articles on vaccination interventions published between January 2015 and June 2021. The BRFSS analysis showed that changes in VCRs were generally modest and positive for most states over the study period. The TLR included 32 articles that met the eligibility criteria; intervention strategies that improved adult vaccination outcomes incorporated an educational component, vaccination reminders or reinforcement at the point of care, or authorized non-clinician members of the healthcare team to vaccinate. Furthermore, interventions combining more than one approach appeared to enhance effectiveness. The strategies identified in this TLR will be valuable for policymakers and stakeholders to inform the development and implementation of evidence-based policies and practices to improve adult vaccination coverage.
Subject(s)
Vaccination Coverage , Humans , United States , Vaccination Coverage/statistics & numerical data , Adult , Young Adult , Middle Aged , Adolescent , Behavioral Risk Factor Surveillance System , Vaccination/statistics & numerical data , Female , Male , Immunization Programs/statistics & numerical data , Databases, Factual , Influenza Vaccines/administration & dosage , Vaccine-Preventable Diseases/prevention & controlABSTRACT
BACKGROUND: Patient-reported outcome (PRO) measures provide valuable evidence in clinical trials; however, poor compliance with PRO measures is a notable and long-standing problem, resulting in missing data that potentially impact the interpretation of trial results. Interactive, patient-centric platforms may increase participants' motivation to complete PRO measures over the course of a clinical trial. Thus, the aim of this study was to evaluate and optimize the usability of 3 popular consumer technologies-a traditional app-based interface, a chatbot interface, and a speech-operated interface-that may be used to improve user engagement and compliance with PRO measures. METHODS: Participants aged 18-75 years from the general United States population tested the usability of 3 ePRO platforms: a traditional app-based interface using Datacubed Health Platform (Datacubed), a web-based chatbot interface using the Orbita platform, and a speech-operated Alexa interface using an Alexa Skill called "My Daily Wellness." The usability of these platforms was tested with 2 PRO measures: the EQ-5D-5 L and the SF-12v2 Health Survey (SF-12v2), Daily recall. Using a crossover design, 3 cohorts of participants tested each ePRO platform daily for 1 week. After testing, interviews were conducted regarding the participants' experience with each platform. RESULTS: A total of 24 adults participated in the study. The mean age of participants was 45 years (range, 21-71 years), and half were female (n = 12; 50%). Overall, participants prioritized speed, ease of use, and device portability in selecting their preferred platform. The Datacubed app met these criteria and was the preferred platform among most participants (n = 20; 83%). Participants also suggested various modifications to the platforms, such as programmable notifications, adjustable speed, and additional daily reminders. CONCLUSIONS: These data demonstrate the importance of speed, ease of use, and device portability, features that are currently incorporated in the Datacubed app, in ePRO platforms used in future clinical trials. Additionally, the usability of ePRO platforms may be optimized by adding programmable notifications, adjustable speed, and increased daily reminders. The results of this study may be used to enhance the usability and patient centricity of these platforms to improve user compliance and engagement during clinical trials.
Subject(s)
Patient Reported Outcome Measures , Software , Adult , Humans , Female , United States , Young Adult , Middle Aged , Aged , Male , Motivation , Health Surveys , Patient ComplianceABSTRACT
Objective: To define and contextualize life-threatening gastrointestinal (GI) bleeding in the setting of factor Xa (FXa) inhibitor therapy and to derive a consensus-based, clinically oriented approach to the administration of FXa inhibitor reversal therapy. Methods: We convened an expert panel of clinicians representing specialties in emergency medicine, gastroenterology, vascular medicine, and trauma surgery. Consensus was reached among the clinician panelists using the Delphi technique, which consisted of 2 survey questionnaires followed by virtual, real-time consensus-building exercises. Results: Hypovolemia and hemodynamic instability were considered the most important clinical signs of FXa inhibitor-related, life-threatening GI bleeds. Clinician panelists agreed that potentially life-threatening GI bleeding should be determined on the basis of hemodynamic instability, signs of shock, individual patient characteristics, and clinical judgment. Last, the panel agreed that all patients with life-threatening, FXa inhibitor-associated GI bleeding should be considered for FXa inhibitor reversal therapy; the decision to reverse FXa inhibition should be individualized, weighing the risks and benefits of reversal; and when reversal is elected, therapy should be administered within 1 h after initial emergency department evaluation, when possible. Conclusions: Consensus-based definitions of life-threatening GI bleeding and approaches to FXa inhibitor reversal centered on hemodynamic instability, signs of shock, individual patient characteristics, and clinical judgment. The results from this Delphi panel may inform clinical decision-making for the treatment of patients experiencing GI bleeding associated with FXa inhibitor use in the emergency department setting.
ABSTRACT
The Food and Drug Administration (FDA) encourages the assessment of patient-reported outcomes (PROs) in oncology clinical trials. A 2015 review showed that approximately 26% of industry-sponsored oncology trials included assessment of PROs. However, the proportion of recent trials that supported new oncology drug approvals and assessed PROs is unknown. This review found that assessment of PROs was included in about 75% of registration trials that supported 55 new FDA drug approvals during 2014-2018. Patient-reported outcome assessment was included more in randomized controlled trials than in open-label trials (88% vs. 69%, respectively) and more in phase 3 than in phase 2 trials (89% vs. 66%, respectively).