The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study.

BACKGROUND: Little is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement. OBJECTIVE: To answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19? DESIGN: We conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants' experiences with the impact of COVID-19 on research engagement. PARTICIPANTS: Seven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript. APPROACH: We used a content analysis approach and identified the main themes using an inductive process. KEY RESULTS: Respondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity. CONCLUSIONS: COVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement. TRIAL REGISTRATION: Clinicaltrials.gov NCT02722382.

Adherence to inhaled corticosteroids in asthma (ARICA): A randomized controlled pilot study

Background: ARICA (AdheRence to Inhaled Corticosteroids in Asthma) is a comprehensive inhaled corticosteroid (ICS) adherence intervention designed to remediate each patient's unique reason for not taking their ICS as prescribed. Objective: The primary objective was to evaluate the feasibility and acceptability of implementing ARICA in a health system. Methods: 29 Black adults who self-reported ICS nonadherence, had uncontrolled persistent asthma, and a Duke Primary Care provider visit within the past 3 years were randomly assigned to intervention (N=15) or control (N=14) in a waitlist randomized controlled pilot trial. Participants were assigned to 1-3 ARICA components based on adherence barriers selected by participants;including, an asthma selfmanagement program, financial assistance referral program, and/or objective feedback on asthma control. All participants received weekly texts and emails dispelling asthma myths. Activities were delivered virtually due to COVID-19. Primary outcomes were feasibility (e.g., process outcomes) and acceptability (e.g., patient exit interviews) measured at 12 weeks. Secondary asthma (e.g., ACT) and adherence outcomes (e.g., DOSEnonadherence) were measured. Results: Most participants were female (N=27, 93%), nonsmokers (N=26, 70%), poorly controlled with ACT <15 (N=14, 48%), and mean age 49.8. Most (N=14, 93%) completed all assigned intervention components and reported mean 4.8 of 5 on Weiner feasibility, acceptability, and appropriateness of intervention. The intervention group had a greater and statistically significant improvement in ACT (Δ-3.5, CI 6.0,0.96) and Marks AQLQ (Δ 11.5, CI 5.5,17.4) when compared to changes in the control ACT (Δ-2.5, CI-5.2,0.05) and Marks AQLQ (Δ5.7, CI-1.3,12.8), respectively. The improvement in ACT in the intervention group was clinically significant. The intervention group also reported a greater and statistically significant decrease in degree of nonadherence (DOSE Δ 0.74, CI 0.2,1.3) than control (DOSE Δ 0.36, CI-0.04,0.75) and a greater decrease in the number of adherence barriers identified in the intervention group (Δ 2.1, CI 1.2,3.0) versus control group (Δ1.6, CI 0.3,3.0). The study was not powered to assess a statistically significant change between groups. Conclusion: The implementation of ARICA in a cohort of Black adults was feasibly deployed in a health system and acceptable to participants. There was a trend in improvement in asthma control and asthma quality of life and a decrease in nonadherence and barriers to adherence.

Dismantling structural racism as a root cause of racial disparities in COVID-19 and transplantation.

As the United States faces unparalleled challenges due to COVID-19, racial disparities in health and healthcare have once again taken center stage. If effective interventions to address racial disparities in transplantation, including those magnified by COVID-19, are to be designed and implemented at the national level, it is first critical to understand the complex mechanisms by which structural, institutional, interpersonal, and internalized racism influence the presence of racial disparities in healthcare and transplantation. Specifically, we must deeply re-evaluate how scientists and clinicians think about race in the transplant context, and we must actively shift our efforts from merely observing disparities to acknowledging and acting on racism as a root cause underlying the vast majority of these disparities. We must do better to ensure equitable access and outcomes for all transplant patients, including within the current COVID-19 pandemic. We respectfully offer this viewpoint as a call to action to every reader to join us in working together to help dismantle racist influences and advance transplant equity.