Natalia E Morone’s research while affiliated with Boston University and other places

Background Chronic low back pain is globally prevalent and associated with significant impairment in quality of life. Furthermore, people from historically marginalized communities are less likely to receive treatment, contributing to health inequities. Group mindfulness-based interventions improve pain and function, and virtual delivery has been demonstrated to be feasible. Little is known about how participants experience the virtual delivery of mindfulness-based interventions, especially participants from historically marginalized communities. Objective This study explored participant perspectives of a virtual mindfulness-based group medical visit for people with chronic low back pain. Methods Participants were recruited from the intervention arm of OPTIMUM, a study of virtual medical group visits using an adapted Mindfulness-Based Stress Reduction program for chronic low back pain. Semi-structured exit interviews were examined, and reflexive thematic analysis was used to compose key themes. Results Interviews from 59 participants (mean 56 years, 69.5% women; 45.8% Black or African American) were examined. Two major themes were derived from analysis. The first theme was ‘effects of the external environment,’ ie, the physical location from which the participant engaged with the session. The subthemes were comfort, social demands in the home setting, and sharing personal spaces. The second theme was ‘navigating the virtual platform.’ Subthemes were ease, struggle, and levels of support. Conclusion Patient experiences varied substantially during the virtual mindfulness-based group medical visit intervention and this variation was influenced by social determinants of health. The key themes bring attention to the effects of the external environment and the technology itself on participation for people from historically marginalized communities. Basic tenets of mindfulness, such as present state awareness and equanimit y, can provide a structure within which to navigate virtual participation amid home environments. Future studies are needed to explore differences in virtual and in-person mindfulness programs and to adapt virtual mindfulness programs. Clinicaltrials.gov ID number NCT04129450.

Introduction The purpose of this research was to understand perceptions and experiences of inclusion among underrepresented early-career biomedical researchers (postdoctoral fellows and early-career faculty) enrolled in the Building Up study. Because inclusion is vital to job satisfaction and engagement, our goal was to shed light on aspects of and barriers to inclusion within the academic workforce. Methods We used qualitative interviews to assess workplace experiences of 25 underrepresented postdoctoral fellows and early-career faculty including: their daily work experiences; sense of the workplace culture within the institutions; experiences with microaggressions, racism, and discrimination; and whether the diversity, equity, and inclusion (DEI) policies and practices at their institution enhanced their experiences. Using qualitative methods, we identified themes that highlighted high-level characteristics of inclusion. Results Four distinct themes were identified: (1) participants appreciated the flexibility, versatility, and sense of fulfillment of their positions which enhanced feelings of inclusion; (2) greater psychological safety led to a greater sense of belonging to a research community; (3) participants had varied experiences of inclusion in the presence of microaggressions, racism, and discrimination; and (4) access to opportunities and resources increased feelings of value within the workplace. Discussion Our findings provide new insight into how inclusion is experienced within the institution among underrepresented early-career biomedical researchers. This research points to specific approaches that could be used to enhance experiences of inclusion and to address barriers. More research is needed to understand how to accomplish a balance between the two, so that perceptions of inclusion outweigh negative experiences.

Objective Efficacious modalities are limited in chronic low back pain (cLBP). We determined the efficacy of auricular point acupressure (APA) in older adults with cLBP. Methods Participants, ≥ 60 years with cLBP, were randomized (1:1:1) to APA with ear points targeted to cLBP (T-APA, n = 92), points non-targeted to cLBP (NT-APA, n = 91), or waitlist education control (n = 89), and followed up to 6 months (6M). Participants in the APA groups received 4 weekly APA sessions; the education control group received 4 weekly educational sessions. Primary outcomes were pain and function. Results There were 272 participants (174 women [64%]; mean [SD] age 70.0 [6.95] years; 62% non-White). Compared to control, the T-APA group had significant improvement on pain from baseline to post-intervention and one-month (1M) follow-up by 1.73 and 1.26 points (p ≤ 0.001) respectively. The NT-APA group achieved similar improvements in pain. The improvement in function by T-APA and NT-APA was significant at post-intervention by 1.89 and 2.68 points (p = 0.04 and 0.004) respectively, minimal at 1M follow-up, but significant at 6M in both APA groups. There were no statistically significant differences in treatment responses between the APA groups. Both APA groups had higher responder rates in pain and function at post-intervention and 1M follow-up compared to the control group (odds ratio ranged from 2.11 to 6.32). The APA effects were sustained at 6M follow-up. Conclusions APA treatments significantly improved pain and function compared to control; effects were sustained at 6M. APA should be recommended as a nonpharmacologic therapy for older adults with cLBP.

The OPTIMUM trial is a multisite pragmatic randomized clinical trial of an adapted Mindfulness Based Stress Reduction (MBSR) program for people with chronic low back pain in primary care settings provided via telehealth group medical visits. Researchers conducted fifty-nine exit interviews at the end of the intervention to inform the ongoing conduct of the trial and to better understand patients’ experiences. This manuscript describes a pragmatic approach to the qualitative analysis of exit interviews within a pragmatic clinical trial. The analysis included three important pivots. First, researchers conducted a process evaluation using a rapid approach called the Lightning Report method. Second, team-based approaches to qualitative analysis were utilized to pair experienced and inexperienced qualitative researchers. Third, based upon principles from Big Qual methodology, a codebook was developed and applied to provide an aerial overview of the data in preparation for more in-depth exploration. Based upon these pivots, the process evaluation provided actionable results in a timely fashion, team members increased analytical skills, and multiple analyses are being applied to the data set. By describing the pragmatic decisions to pivot approaches to qualitative analysis, this manuscript contributes to existing literature regarding rapid qualitative analysis methods for process evaluation in pragmatic clinical trials, team-based mentorship in large trials, and applications from Big Qual for large data sets.

Introduction Limited adoption of first line treatments for low back pain (LBP) in primary care settings may contribute to an overreliance on pain medications by primary care providers (PCPs). While chiropractic care typically includes recommended nonpharmacologic approaches (e.g., manual therapy, exercise instruction, advice on self-care), implementation strategies to increase adoption of chiropractic care for LBP in primary care clinics are understudied, particularly in underserved communities. Methods We will use a stepped-wedge cluster randomized controlled pilot trial design to evaluate the feasibility of a multi-level implementation strategy to increase adoption of chiropractic care for LBP in primary care clinics at community health centers. Key barriers and facilitators identified by site champions and other key stakeholders will help us to develop and tailor implementation strategies including educational materials and meetings, developing a network of local chiropractors, and modifying the electronic health record to facilitate referrals. Three primary care clinics will be randomized to receive the implementation strategy first, second, or third over a fourteen-month study period. At our first clinic, we will have a four-month pre-implementation period, a two-month implementation deployment period, and a subsequent eight-month follow-up period. We will stagger the start of our implementation strategy, beginning in a new clinic every two months. We will evaluate the proportion of patients with LBP who receive a referral to chiropractic care in the first 21 days after their index visit with PCP. We will also evaluate adoption of other guideline concordant care (e.g., other nonpharmacologic treatments) and non-guideline concordant care (e.g., opioids, imaging) over the study period. Discussion LBP is currently the leading cause of disability worldwide. While there are several treatment options available for individuals with LBP, patients in underserved populations do not often access recommended nonpharmacologic treatment options such as chiropractic care. The results from this study will inform the development of practical implementation strategies that may improve access to chiropractic care for LBP in the primary care context. Furthermore, results may also inform policy changes needed to expand access to chiropractic care in underserved communities. Clintrials.gov NCT# NCT06104605.

Scientists from diverse backgrounds are underrepresented (UR) in academia. This lack of diversity impedes scientific discovery and innovation. UR scientists tend to conduct research on issues relevant to UR populations, including chronic disease prevention and management, and health disparities. Difficulty in attaining grant funding is a major barrier preventing UR scientists from remaining in academia. Programs designed to provide UR scientists with career development training can help increase the number of UR scientists who obtain grant funding. These programs have shown some level of success, yet none have been specifically designed to target scientists conducting research pertaining to the interests of the National Institute for Diabetes, Digestive, and Kidney Disorders (NIDDK). Here, the Bringing Resources to Increase Diversity, Growth, Equity, and Scholarship for Obesity, Nutrition, and Diabetes Research (BRIDGES) consortium is described. BRIDGES is the first program to be funded by the NIDDK designed to increase the success rate of UR scientists competing for and obtaining funding related to nutrition, obesity, and diabetes. Four programs across the country, located in California, Massachusetts, North Carolina, and Louisiana, were funded in 2022. By design, some programmatic elements are shared across each of the funded programs, including mentoring and a pilot and feasibility funding program. Some elements are specific to each program. The BRIDGES program is expected to impact a substantial number of UR scientists who are then likely to have an influence on nutrition, obesity, diabetes, and health disparities research, shaping NIH priorities, and future scientists conducting NIDDK-related research.

Background The NIH Pragmatic Trials Collaboratory supports the design and conduct of 31 embedded pragmatic clinical trials, and many of these trials use patient-reported outcome measures (PROMs) to provide valuable information about the patients' health and wellness. Often these trials enroll medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnic minority groups, or rural or frontier communities. Objectives In this series of trial case reports, we provide lessons learned about collecting PROMs in these populations. Unbiased collection of PROM data is critical to increase the generalizability of trial outcomes and to address health inequities. Use of electronic health records (EHRs) and other digital modes of PROM administration has gained traction. However, engagement with these modes is often low among populations prone to disparity due to lower digital proficiency, device access, and uptake of EHR portals and web interfaces. Methods To maximize the completeness and representativeness of their trial outcome data, study teams tested a range of strategies to improve PROM response rates with emphasis on disparities prone and underserved patient groups. This manuscript describes the approaches, their implementation, and the targeted populations. Conclusion Optimized PROM collection required hybrid approaches with multiple outreach modes, high-touch methods, creativity in promoting digital uptake, multimodal participant engagement, and text messaging.

Background Mindfulness meditation is ubiquitous in health care, education, and communities at large. Mindfulness-Based Interventions (MBIs) are the focus of hundreds of NIH-funded trials given the myriad health benefits associated with this practice across multiple populations. Notwithstanding, significant gaps exist in how mindfulness concepts are measured using currently available self-report instruments. Due to the number of available mindfulness measurement tools, each measuring different aspects, it is difficult to determine the extent to which individuals develop comparable mindfulness skills and attitudes and which health benefits can be attributed to which gains in mindfulness. The Patient-Reported Outcomes Measurement Information System (Puerto RicoOMIS®) has established a rigorous instrument development methodology to create brief, precise, and clinically relevant outcomes tools. Objective This is the first of 4 papers representing an NCCIH-funded initiative ( R01AT009539 ), which has applied Puerto RicoOMIS® instrument development methodologies to mindfulness measurement to improve the rigor, relevance, and reproducibility of MBI research results. Methods/Results This introductory paper sets the stage for why improved mindfulness measurement tools are needed and briefly describes the Puerto RicoOMIS® development approach. The second 2 papers highlight results from a national survey, focus groups, and expert interviews to identify and organize relevant mindfulness concepts, domains, and items for eventual item bank creation. The fourth paper reviews the item writing and development process of these new instruments, including results from stakeholder cognitive interviews and a translatability review. Conclusion Together these papers feature the rigorous development approach, rationale, logic, and significance that supports the development, calibration, and validation of new Puerto RicoOMIS® measures of mindfulness and related concepts.

Objective Negative psychological beliefs like fear avoidance and catastrophizing can interfere with exercise engagement in people with knee osteoarthritis (OA). Mindfulness, when integrated with exercise, could potentially address both psychological and physical impairments. Our objectives were to optimize and assess the feasibility of a novel telehealth, group-based mindful exercise intervention for people with knee OA. Methods We conducted a decentralized randomized controlled trial where participants (n = 40) with symptomatic knee OA were randomized into mindful exercise (n = 21) or exercise-only (n = 19) groups. Both groups received supervised group-based interventions weekly for 8-weeks via Zoom. Primary outcomes were safety, fidelity, and feasibility of the mindful exercise intervention. Participants completed patient-reported outcomes (PRO) for pain, function, and psychological measures at baseline, week-8, and week-14. Results Participants were from 21 US states; >90% identified as having White race, 16% were from rural areas, and approximately 40% had an annual income < $50,000. At 8-weeks, mindful exercise and exercise groups had retention rates of 86% (18/21) and 100% (19/19), and attendance was 54% (11.4/21) and 68% (13/19) respectively. There were no adverse events in the mindful exercise group and four in the exercise group related to exacerbation of knee pain. Preliminary findings showed numerically larger improvements in several PROs for the mindful exercise group. Conclusion An 8-week telehealth, group-based, mindful exercise intervention was safe for people with knee OA. Our decentralized approach was feasible in terms of recruitment and retention. Further refinement is needed to improve intervention attendance and participant diversity.

Background Clinical practice guidelines encourage primary care providers (PCPs) to recommend nonpharmacologic treatment as first‐line therapy for low back pain (LBP). However, the determinants of nonpharmacologic treatment use for LBP in primary care remain unclear, particularly in low‐income settings. Objective To pilot a framework‐informed interview guide and codebook to explore determinants of nonpharmacologic treatment use in primary care. Methods In this qualitative interview study, we enrolled PCPs and community health workers (CHWs) from four primary care clinics at a safety net hospital. A semistructured interview guide informed by the Consolidated Framework for Implementation Research (CFIR) guided inquiry on barriers/facilitators to nonpharmacologic treatments for LBP (eg, acupuncture, chiropractic care, physical therapy). We included questions on whether current CHW roles may address barriers to nonpharmacologic treatment use. Interviews were audio‐recorded, transcribed verbatim, and independently coded by four investigators. An a priori codebook composed of CFIR determinants and known CHW roles guided deductive content analysis to identify major themes. Results Eight individuals (six PCPs, two CHWs; age range: 32–51 years, five female) participated in hour‐long interviews. Half had worked at the hospital for ≥15 years and all reported seeing patients with LBP (range: 2–20 patients per week). All participants identified the following CFIR factors as barriers/facilitators: nonpharmacologic treatment characteristics (perceived cost, relative advantage compared to other treatments); outer setting (patient needs/resources, limited connections with community‐based nonpharmacologic treatment) and PCP characteristics (attitudes/beliefs about nonpharmacologic treatments). Although participants indicated several CHW roles could be adapted to address barriers (eg, care coordination, resource linking, case management), other roles seemed less feasible (eg, targeted health education) in our health care system. Conclusions Preliminary insight on key determinants of nonpharmacologic treatments for LBP should be further examined in large multisite studies. Future studies may also determine whether a CHW‐led strategy can improve nonpharmacologic treatment access and clinical outcomes in primary care.