Health Care Professionals' Herpes Zoster Awareness and Vaccine Recommendations for Patients with COPD.

Objectives: The objective of this study was to assess health care professionals' (HCPs) knowledge of an increased herpes zoster (HZ) risk and burden for patients with chronic obstructive pulmonary disease (COPD), HCPs' familiarity with the Advisory Committee on Immunization Practices' (ACIP) HZ vaccine recommendations, and the HCPs' current adult vaccine practices. Another objective was to evaluate the impact of a short educational video on knowledge and future vaccine intent. Participants and Methods: An online survey of family physicians (FPs), pulmonologists, nurse practitioners (NPs), and physician assistants (PAs) querying demographics, awareness of ACIP HZ vaccine recommendations, and HZ burdens and risks in patients with COPD and their current recommendations for HZ, influenza, and pneumococcal vaccines was conducted. For those not strongly recommending HZ vaccines concordant with ACIP recommendations, a 5-minute educational video was presented, and post video questions assessed future intended HZ vaccine recommendations. Results: Among 1020 HCP responders, awareness and ACIP concordant HZ vaccine recommendations ranged from 59.0% to 95.2% across HCPs. Lowest recommendation rates were consistently reported by pulmonologists for the 2-dose HZ vaccine beginning at age 50; for the 2-dose vaccine use in those with prior 1-dose HZ vaccinations, and for those with prior HZ. Among all HCPs, HZ vaccine recommendations were lower than for pneumococcal and influenza vaccines. After viewing the educational video, reported vaccine recommendation intent increased significantly in all groups of HCPs, as did awareness of increased HZ risk among patients with COPD. Conclusions: Significant educational opportunities exist for HCPs related to HZ and its vaccine prevention among patients with COPD which may be responsive to brief, targeted interventions.

Knowledge and Attitudes Concerning Herpes Zoster among People with COPD: An Interventional Survey Study.

Herpes zoster (HZ) is common in older adults with conditions such as chronic obstructive pulmonary disease (COPD). Effective prevention is available through vaccination, but HZ vaccine uptake remains incomplete. Using an online survey of people with self-reported COPD, ShiPPS assessed HZ risk awareness, HZ vaccine use and barriers, and the impact of an HZ educational video on vaccine intent. USA members of the COPD Foundation's Patient-Powered Research Network aged >50 years were surveyed in fall 2020. The responses were analyzed using descriptive and comparative statistics. Of the 735 respondents (59.6% female, mean age 68.5 years), 192 (26.1%) reported previous HZ, of whom 49 (25.5%) reported increased COPD symptoms during HZ episodes. Most participants (94.0%) knew of HZ vaccines, but only 33.1% reported receiving the Advisory Committee on Immunization Practices-preferred recombinant HZ vaccination. The recall of receiving HZ vaccine recommendations differed by the site attended: 68.8% primary care, 26.6% pulmonology offices. Most (74.7%) were unaware that COPD increases HZ risk. Among unvaccinated participants, interest in getting the HZ vaccine increased from 32.0% to 73.5% after watching the video. These results highlight the need for people with COPD to receive further HZ education, such as the five-minute video, and HZ vaccine recommendations from healthcare professionals.

A Conceptual Framework for Use of Increased Endurance Time During Constant Work Rate Cycle Ergometry as a Patient-Focused Meaningful Outcome in COPD Clinical Trials.

The Chronic Lung Disease Biomarker and Clinical Outcome Assessment Qualification Consortium (CBQC) evaluates the potential of biomarkers and outcome measures as drug development tools. Exercise endurance is an objective indicator of treatment benefit, closely related to daily physical function. Therefore, it is an ideal candidate for an outcome for drug development trials. Unfortunately, no exercise endurance measure is qualified by regulatory authorities for use in trials of chronic obstructive pulmonary disease (COPD) and no approved COPD therapies have claims of improving exercise endurance. Consequently, it has been challenging for developers to consider this outcome when designing clinical trials for new therapies. Endurance time during constant work rate cycle ergometry (CWRCE), performed on an electronically braked stationary cycle ergometer, provides an exercise endurance measure under standardized conditions. Baseline individualized work rate for each participant is set using an incremental test. During CWRCE the patient is encouraged to continue exercising for as long as possible. Although not required, physiological and sensory responses (e.g., pulmonary ventilation, heart rate, dyspnea ratings) are frequently collected to support interpretation of endurance time changes. Exercise tolerance limit is reached when the individual is limited by symptoms, unable to maintain pedaling cadence or unable to continue safely. At exercise cessation, exercise duration is recorded. An CWRCE endurance time increase from the pre-treatment baseline is proposed as a key efficacy endpoint in clinical trials. In COPD, improved exercise endurance has a direct relationship to the experience of physical functioning in daily life, which is a patient-centered, meaningful benefit.

Objectively Measured Physical Activity in Patients with COPD: Recommendations from an International Task Force on Physical Activity.

Physical activity (PA) is of key importance for health among healthy persons and individuals with chronic obstructive pulmonary disease (COPD). PA has multiple dimensions that can be assessed and quantified objectively using activity monitors. Moreover, as shown in the published literature, variable methodologies have been used to date to quantify PA among individuals with COPD, precluding clear comparisons of outcomes across studies. The present paper aims to provide a summary of the available literature for the rationale behind using objectively measured PA and proposes a standardized methodology for assessment, including standard operating procedures for future research. The present paper, therefore, describes the concept of PA, reports on the importance of PA, summarizes the dimensions of PA, provides a standard operating procedure on how to monitor PA using objective assessments, and describes the psychometric properties of objectively measured PA. The present international task force recommends implementation of the standard operating procedure for PA data collection and reporting in the future. This should further clarify the relationship between PA and clinical outcomes, test the impact of treatment interventions on PA in individuals with COPD, and successfully propose a PA endpoint for regulatory qualification in the future.

Objectively Measured Physical Activity as a COPD Clinical Trial Outcome.

BACKGROUND: Reduced physical activity is common in COPD and is associated with poor outcomes. Physical activity is therefore a worthy target for intervention in clinical trials; however, trials evaluating physical activity have used heterogeneous methods. RESEARCH QUESTION: What is the available evidence on the efficacy and/or effectiveness of various interventions to enhance objectively measured physical activity in patients with COPD, taking into account the minimal preferred methodologic quality of physical activity assessment? STUDY DESIGN AND METHODS: In this narrative review, the COPD Biomarker Qualification Consortium (CBQC) task force searched three scientific databases for articles that reported the effect of an intervention on objectively measured physical activity in COPD. Based on scientific literature and expert consensus, only studies with ≥ 7 measurement days and ≥ 4 valid days of ≥ 8 h of monitoring were included in the primary analysis. RESULTS: Thirty-seven of 110 (34%) identified studies fulfilled the criteria, investigating the efficacy and/or effectiveness of physical activity behavior change programs (n = 7), mobile or electronic-health interventions (n = 9), rehabilitative exercise (n = 9), bronchodilation (n = 6), lung volume reduction procedures (n = 3), and other interventions (n = 3). Results are generally variable, reflecting the large differences in study characteristics and outcomes. Few studies show an increase beyond the proposed minimal important change of 600 to 1100 daily steps, indicating that enhancing physical activity levels is a challenge. INTERPRETATION: Only one-third of clinical trials measuring objective physical activity in people with COPD fulfilled the preset criteria regarding physical activity assessment. Studies showed variable effects on physical activity even when investigating similar interventions.

Plasma Fibrinogen Qualification as a Drug Development Tool in Chronic Obstructive Pulmonary Disease. Perspective of the Chronic Obstructive Pulmonary Disease Biomarker Qualification Consortium.

The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on qualification of drug development tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support qualification of several tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the qualification. This led to the FDA qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development tool qualified for use in COPD under the FDA's drug development tool qualification program. This perspective summarizes the FDA's qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker qualification efforts.