Creating a culture of clinical research in the clinic: Integrating clinical trials into the care of patients with lupus

620 Table 1Clinician-focused opportunities and approaches to cultivate a culture of clinical research in lupus clinical careStrategy Strategies to cultivate a culture of clinical research in clinical care Future directions and opportunities Provide training opportunities for trainees and clinicians • Provide subspecialty fellows/trainees with formal training, practical experience/apprenticeship, and mentorship opportunities to gain experience in clinical trials investigation • Develop and integrate formal training programs throughout medical training and continuing education to develop and strengthen skills and expertise in having effective clinical trial conversations (e.g., verbal and nonverbal skills training, cultural competence and implicit bias training) • Adopt/integrate existing programs such as Materials to Increase Minority Involvement in Clinical Trials (MIMICT), an online accredited CME program through the ACR that focuses on improving clinician knowledge about referring diverse patients to lupus clinical trials21 • Engage diverse stakeholders, including patients, throughout all phases of the development, evaluation, and dissemination of training products Adopt a ‘Universal Precautions' Approach to Educate All Patients About Clinical Trials • Present clinical trial opportunities to all potentially eligible patients (e.g., regardless of beliefs or implicit biases around a patient's willingness to participate or ‘fit' for a trial)• Advocate for consideration of participation, rather than participation11• Offer additional resources for patients to support informed decisions about clinical trial participation• Incorporate teach-back methods to train research personnel as well as to reinforce patient education and understanding• Develop clinical trials materials (including consent forms) in languages other than English • Explore patient preferences for conversations with clinicians about lupus clinical trials• Develop culturally competent, health literate lupus clinical trial-specific information and research materials to support patients in making informed decisions• Diversify clinical research personnel (e.g., bilingual research staff, etc.) Provider Outreach • Engage, exchange information, and build partnerships with rheumatologists, as well as primary care physicians and subspecialists who are closely involved in the care of patients with lupus, as well as health care and research teams • Conduct outreach to create communication and partnerships between academic a d private- practice settings• Encourage outreach to and partnerships with community organizations and stakeholders ReferencesFalasinnu T, Chaichian Y, Bass MB, Simard JF. 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Perceived Impact of the COVID-19 Pandemic on Physical Activity Among Adult Patients With Rheumatologic Disease.

OBJECTIVE: The objective of this cross-sectional study was to investigate the impact of the COVID-19 pandemic on physical activity (PA) levels of patients with rheumatic and musculoskeletal diseases (RMDs) and to examine factors associated with decreased PA. METHODS: A sample of adult patients with RMDs (n = 7,776) was identified through electronic medical records from an academic health care system in North Carolina. Invitations to participate in an online survey were sent between July 2020 and September 2020 to assess self-reported changes in PA during the COVID-19 pandemic. Descriptive statistics, age-adjusted prevalence odds ratios (PORs), and 95% confidence intervals (CIs) were computed to examine patient characteristics associated with decreased PA. RESULTS: A total of 893 eligible participants completed the survey (mean age 57.8 ± 14.9 years, 75.8% female). The most common primary diagnoses reported among participants included rheumatoid arthritis (27.3%), osteoarthritis (16.0%), and systemic lupus erythematosus (SLE) (13.0%). More than half of participants (56.8%) reported engaging in less PA since the pandemic began. Factors associated with engaging in less PA included lower self-reported general health (POR, 2.21; CI, 1.64-2.97) and a diagnosis of SLE (POR, 1.57; CI, 1.03-2.38). Comorbidities associated with decreased PA included chronic pain (POR, 1.38; CI, 1.04-1.82), depression (POR, 1.48; CI, 1.09-2.01), and hypertension (POR, 1.44; CI, 1.10-1.90). CONCLUSION: The COVID-19 pandemic has exacerbated barriers to PA in patients with RMDs. There is a critical need to provide resources, support, and multifaceted programs to encourage PA in patients with RMDs during the COVID-19 pandemic.

EMBRACE: One Small Story in Lupus-One Giant Challenge in Clinical Trials.

Clinical trials of novel therapeutics in the United States have not been adequately representative of diverse populations, particularly racial and ethnic minorities. The challenges and consequences of underrepresentation in clinical trial recruitment are exemplified by the case of belimumab, a biologic treatment for systemic lupus erythematosus (SLE), a disease that is more prevalent in patients of Black African ancestry and of Hispanic/Latino ethnicity than in other patient populations. Although belimumab was found to be effective in phase 2 and 3 clinical trials in the general population, post hoc analyses of efficacy data in patients of Black African ancestry showed inconsistent results. Consequently, a cautionary statement regarding belimumab use in this population was added to the product label. To alleviate concerns that belimumab may not be safe and effective for patients of Black African ancestry, the Efficacy and Safety of Belimumab in Black Race Patients with SLE (EMBRACE) study was conducted in a post-marketing commitment to the Food and Drug Administration. The study recruited only patients who self-identified as being of Black race; its findings led to the removal of the cautionary labeling of belimumab use in patients of Black African ancestry. Our manuscript highlights the critical lessons learned from the successes and failures of the EMBRACE study. It also provides suggestions for overcoming health disparities, highlighting strategies for conducting well-designed clinical trials to overcome systematic barriers to diversity in recruitment, with a focus on enacting long-term support to ensure equity in the process, products, and benefits from drug development and clinical trials.

ACT for Lupus: Pilot Feasibility and Acceptability Study of a Novel Web-Based Acceptance and Commitment Therapy Program for Patients With Lupus.

OBJECTIVE: Acceptance and commitment therapy (ACT) has demonstrated effectiveness in addressing symptoms of anxiety and depression, frequently experienced by patients with systemic lupus erythematosus (SLE). The goal of this pilot study was to develop and assess the feasibility and acceptability of a novel web-based ACT skills training program tailored for patients with lupus: ACT for Lupus. The program served as a complementary approach to support the management of symptoms and stressors during the COVID-19 pandemic. METHODS: This study employed a single-group pretest-posttest design. Participants with a diagnosis of SLE were primarily recruited through an institutional healthcare system between November 25, 2020 and December 17, 2020 and through an online national lupus organization listserv. Participants were invited to attend two 1-hour webinars delivered over a 2-week period. Educational ACT-based content was tailored for patients with lupus and delivered by an experienced clinical psychologist specializing in ACT. Surveys assessed patient-reported outcomes of anxiety, depression, and quality of life and evaluated program feedback, usability, and satisfaction. RESULTS: A total of 83 participants submitted the baseline survey, with 21 participants designated as study completers. The program was well received by participants, who reported feasibility and acceptability of the intervention, as reflected by high usability ratings. Participants reported favorable experiences with the program. Feedback included suggestions to include additional lupus-tailored content, increase the range and scope of sessions and activities, and improve program flexibility and availability to avoid scheduling conflicts. CONCLUSION: This study provides preliminary evidence for an adapted, ACT-based virtual skills training program as a feasible and acceptable intervention to support the well-being of patients with lupus.

Rise and Fall: Hydroxychloroquine and COVID-19 Global Trends: Interest, Political Influence, and Potential Implications.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic has led to rapid research and reporting on potential preventatives and treatments for the disease, including the drug hydroxychloroquine (HCQ). Despite a lack of robust evidence to support the use of HCQ for treatment of COVID-19, it was publicly endorsed and received widespread media coverage and public interest. The purpose of this report is to describe and contextualize the surges in public interest, demand, and adoption of HCQ for treatment of COVID-19 and outline implications for future public health policy and practice. METHODS: Using national and global events and Google Trends data as a measure of public interest, we describe the timeline and trends in the emergence of, interest in, and adoption of HCQ as a treatment of COVID-19. We additionally review reports on public demand for HCQ for treatment of COVID-19 and impacts on medication access among patients with indicated uses. RESULTS: Public interest and demand for HCQ surged in the United States and globally following endorsements from public officials and enaction of policies to facilitate off-label use of HCQ for treatment of COVID-19. Surges in demand for HCQ led to multiple documented shortages and barriers to accessing HCQ treatment for patients with indicated uses for HCQ. Although there have been reversals in policies to support HCQ use for treatment of COVID-19 in some regions, others have continued or expanded recommended uses. CONCLUSION: Insights from the global response to HCQ and COVID-19 can be used to inform prudent decision-making in the future to prevent premature action and promote informed and equitable responses to promote public health.