Using PROMIS Methodology to Create Self-Report Measures of Mindfulness and Related Concepts.

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.

Mentoring as a Buffer for the Impact of Social Unrest due to Systemic Racism and Ambient Discrimination.

Mentoring may act as a buffer for the negative impacts of racial trauma. Building Up (conducted 2020-2024) is a cluster-randomized trial at 25 institutions of postdoctoral fellows and early-career faculty from underrepresented backgrounds. Generalized linear mixed models were used to identify mentoring competencies associated with the impact of social unrest due to systemic racism. Eighty-two percent of participants (n=143) identified as female, 33% as non-Hispanic Black, and 36% as Hispanic. Mentoring that aligns expectations and mentoring that assesses understanding were significantly associated with social unrest due to systemic racism impacting ability to work (OR=2.84 and OR=0.52, respectively) and conduct research (OR=4.21 and OR=0.41, respectively). Future research should elucidate specific aspects of mentoring relationships that serve as a buffer during times of social unrest.

Primary care barriers and facilitators to nonpharmacologic treatments for low back pain: A qualitative pilot study.

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.

The impact of inclusive mentoring and identity work on self-efficacy in career advancement and career commitment among underrepresented early-career faculty and post-doctoral fellows.

Objective: Researchers from underrepresented groups leave research positions at a disproportionate rate. We aim to identify factors associated with self-efficacy in career advancement and career commitment among underrepresented post-doctoral fellows and early-career faculty. Methods: Building Up is a cluster-randomized trial with 25 academic health institutions. In September-October 2020, 219 Building Up participants completed the pre-intervention assessment, which included questions on demographics, science identity, mentoring, self-efficacy in career advancement (i.e., advancement is open to me, confidence in career progression, confidence in overcoming professional barriers), and career commitment (i.e., intent to continue research training or studying in a field related to biomedical sciences). Using logistic and multinomial logistic regression, we identified characteristics independently associated with self-efficacy in career advancement and career commitment. Results: The cohort is 80% female, 33% non-Hispanic/Latinx Black, and 34% Hispanic/Latinx. Having mentors that address diversity was significantly associated with the belief that advancement is open to them (OR = 1.7). Higher science identity (OR = 4.0) and having mentors that foster independence (OR = 1.8) were significantly associated with confidence in career progression. Higher science identity was also significantly associated with confidence in overcoming professional barriers (OR = 2.3) and intent to continue studying in a field related to biomedical sciences (OR = 3.3). Higher age (OR = 2.3) and higher science identity (OR = 4.2) were significantly associated with intent to continue research training. Discussion: Science identity and mentoring play key roles in self-efficacy in career advancement and career commitment. These factors may contribute to retention of underrepresented early-career biomedical researchers.

Mobile health intervention to address chronic pain among those who engage in hazardous drinking: A pilot study.

BACKGROUND: Hazardous drinking has been associated with chronic pain in community and medical samples. The purpose of this study was to develop a novel, integrated mobile health intervention that improves pain management and reduces hazardous drinking that may be implemented in primary care settings. METHODS: Forty-eight participants with moderate or greater chronic pain and hazardous drinking were recruited from primary care clinics and through social media sites. Following baseline assessment, participants were randomized to a counselor-supported smartphone app intervention (INTV) or a counselor delivered treatment-as-usual control condition (CTL). RESULTS: Results supported the feasibility and acceptability of the smartphone app intervention. Participants found it easy to use, reported high levels of satisfaction, and showed high levels of engagement with the app. Between-group effect size estimates at follow-up showed small effects for the intervention on pain ratings. However, using clinically meaningful change thresholds of 30% and 50% improvement in pain scores, 38% and 25% respectively of those in the INTV condition showed reductions compared to 20% and 12.5% respectively in the CTL condition. Effect size estimates did not indicate intervention superiority on alcohol outcomes as participants in both conditions showed considerable reductions in drinking over the course of the study. CONCLUSIONS: Results supported the view that a mobile health intervention delivered via smartphone with electronic coaching is a feasible and acceptable method of addressing chronic pain among those who engage in hazardous drinking. Future work should test the efficacy of this approach in a fully powered trial.

Integrating a Community Advisory Board Into a Pragmatic Trial of Mindfulness for Chronic Low Back Pain.

Background: To improve the implementation of clinical trial interventions, there is a need to facilitate communication between key stakeholders and research teams. Community Advisory Boards (CAB) bring together a range of stakeholders not historically included in the research process to inform and work collaboratively with research teams. Objective: To describe our procedures and processes for (1) integration of a CAB into a pragmatic clinical trial of a telehealth-delivered group mindfulness program for persons with chronic low back pain (cLBP) within primary care, and (2) for the rapid uptake and implementation of CAB recommendations. Methods: The CAB we convened includes persons with cLBP who have undergone the mindfulness intervention, health care system leadership, advocacy groups, and mindfulness experts. The CAB members underwent a two hour initial training that introduced the research process and the CAB's role as research partners. The CAB met monthly for 1 hour. We used the Lighting Report method to summarize meetings and share feedback with the research team. Results: The recommendations of the CAB during the first year they met were divided into recruitment, informed consent, and survey recommendations. The study website also was overhauled based on recommendations, including a more engaging first page with rotating images of nature and testimonials. The language on the website was edited to be more concise and participant-friendly. The CAB recommended talking points to discuss with participants during screening or informed consent about the benefits of participating in research. Conclusion: We established a CAB that represented diverse perspectives, organizations, and experience with cLBP and mindfulness. The differing perspectives of the CAB resulted in recommendations that the research team itself would not have decided on their own. The Lightning Reports were also an effective way to efficiently communicate the CAB recommendations to the research team.

A Cluster Analysis of Initial Primary Care Orders for Patients with Acute Low Back Pain.

PURPOSE: Primary care physicians (PCPs) often face a complex intersection of patient expectations, evidence, and policy that influences their care recommendations for acute low back pain (aLBP). The purpose of this study was to elucidate patterns of PCP orders for patients with aLBP, identify the most common patterns, and describe patient clinical and demographic characteristics associated with patterns of aLBP care. METHODS: This prospective cohort study included 9574 aLBP patients presenting to 1 of 77 primary care practices in 4 geographic locations in the United States. We performed a cluster analysis of PCP orders extracted from electronic health records within the first 21 days of an initial visit for aLBP. RESULTS: 1401 (15%) patients did not receive a PCP order related to back pain within the first 21 days of their initial visit. These patients predominantly had aLBP without leg pain, less back-related disability, and were at low-risk for persistent disability. Of the remaining 8146 patients, we found 4 distinct order patterns: combined nonpharmacologic and first-line medication (44%); second-line medication (39%); imaging (10%); and specialty referral (7%). Among all patients, 29% received solely 1 order from their PCP. PCPs more often combined different guideline concordant and discordant orders. Patients with higher self-reported disability and psychological distress were more likely to receive guideline discordant care. CONCLUSION: Guideline discordant orders such as steroids and NSAIDS are often combined with guideline recommended orders such as physical therapy. Further defining patient, clinician, and health care setting characteristics associated with discordant care would inform targeted efforts for deimplementation initiatives.

A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool.

Background: Mindfulness research and clinical programs are widespread, and it is important that mindfulness-based interventions are delivered with fidelity, or as intended, across settings. The MBI:TAC is a comprehensive system for assessing teacher competence, yet it can be complex to implement. A standardized, simple fidelity/engagement tool to address treatment delivery is needed. Objective: We describe the development, evaluation, and outcomes of a brief, practical tool for assessing fidelity and engagement in online mindfulness-based programs. The tool contains questions about session elements such as meditation guidance and group discussion, and questions about participant engagement and technology-based barriers to engagement. Methods: The fidelity rating tool was developed and tested in OPTIMUM, Optimizing Pain Treatment in Medical settings Using Mindfulness. The OPTIMUM study is a 3-site pragmatic randomized trial of group medical visits and adapted mindfulness-based stress reduction for primary care patients with chronic low back pain, delivered online. Two trained study personnel independently rated 26 recorded OPTIMUM sessions to determine inter-rater reliability of the Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI) tool. Trained raters also completed the CoFi-MBI for 105 sessions. Raters provided qualitative data via optional open text fields within the tool. Results: Inter-rater agreement was 77-100% for presence of key session components, and 69-88% for Likert ratings of participant engagement and challenges related to technology, with discrepancies only occurring within 2 categories: 'very much' and 'quite a bit'. Key session components occurred as intended in 94-100% of the 105 sessions, and participant engagement was rated as 'very much' or 'quite a bit' in 95% of the sessions. Qualitative analysis of rater comments revealed themes related to engagement challenges and technology failures. Conclusion: The CoFi-MBI provides a practical way to assess basic adherence to online delivery of mindfulness session elements, participant engagement, and extent of technology obstacles. Optional text can guide strategies to improve engagement and reduce technology barriers.

Perseverance and consistency of interest in underrepresented post-doctoral fellows and early-career faculty.

Introduction: Underrepresented researchers face more challenges than their well-represented counterparts. Perseverance and consistency of interest are associated with career success in well-represented physicians. Therefore, we examined associations of perseverance and consistency of interest with Clinical Research Appraisal Inventory (CRAI), science identity, and other factors related to career success among underrepresented post-doctoral fellows and early-career faculty. Methods: This is a cross-sectional analysis of data collected from September to October 2020 among 224 underrepresented early-career researchers at 25 academic medical centers in the Building Up Trial. We used linear regression to test associations of perseverance and consistency of interest scores with CRAI, science identity, and effort/reward imbalance (ERI) scores. Results: The cohort is 80% female, 33% non-Hispanic Black, and 34% Hispanic. The median perseverance and consistency of interest scores were 3.8 (25th-75th percentile: 3.7,4.2) and 3.7 (25th-75th percentile: 3.2, 4.0), respectively. Higher perseverance was associated with a higher CRAI score (ß = 0.82; 95% CI = 0.30, 1.33, p = 0.002) and science identity (ß = 0.44; 95% CI = 0.19, 0.68, p = 0.001). Higher consistency of interest was associated with a higher CRAI score (ß = 0.60; 95% CI = 0.23, 0.96, p = 0.001) and higher science identity score (ß = 0.20; 95% CI = 0.03, 0.36, p = 0.02), while lower consistency of interest was associated with imbalance favoring effort (ß = -0.22; 95% CI = -0.33, -0.11, p = 0.001). Conclusions: We found that perseverance and consistency of interest are related to CRAI and science identity, indicating that these factors may positively influence one's decision to stay in research.

Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study.

OBJECTIVE: We assessed whether race or ethnicity was associated with the incidence of high-impact chronic low back pain (cLBP) among adults consulting a primary care provider for acute low back pain (aLBP). METHODS: In this secondary analysis of a prospective cohort study, patients with aLBP were identified through screening at seventy-seven primary care practices from four geographic regions. Incidence of high-impact cLBP was defined as the subset of patients with cLBP and at least moderate disability on Oswestry Disability Index [ODI >30]) at 6 months. General linear mixed models provided adjusted estimates of association between race/ethnicity and high-impact cLBP. RESULTS: We identified 9,088 patients with aLBP (81.3% White; 14.3% Black; 4.4% Hispanic). Black/Hispanic patients compared to White patients, were younger and more likely to be female, obese, have Medicaid insurance, worse disability on ODI, and were at higher risk of persistent disability on STarT Back Tool (all P < .0001). At 6 months, more Black and Hispanic patients reported high-impact cLBP (30% and 25%, respectively) compared to White patients (15%, P < .0001, n = 5,035). After adjusting for measured differences in socioeconomic and back-related risk factors, compared to White patients, the increased odds of high-impact cLBP remained statistically significant for Black but not Hispanic patients (adjusted odds ration [aOR] = 1.40, 95% confidence interval [CI]: 1.05-1.87 and aOR = 1.25, 95%CI: 0.83-1.90, respectively). CONCLUSIONS: We observed an increased incidence of high-impact cLBP among Black and Hispanic patients compared to White patients. This disparity was partly explained by racial/ethnic differences in socioeconomic and back-related risk factors. Interventions that target these factors to reduce pain-related disparities should be evaluated. CLINICALTRIALS.GOV IDENTIFIER: NCT02647658.

A Mixed-Methods Analysis of Gender and Career Status Differences in the Impact of the COVID-19 Pandemic on Underrepresented Postdoctoral Fellows and Early-Career Faculty.

PURPOSE: The lack of racial and ethnic diversity in the biomedical workforce is pronounced and those from underrepresented backgrounds encounter more challenges than their majority counterparts. The extent of the impact of the COVID-19 pandemic on early-career investigators from underrepresented backgrounds is not yet fully understood. To examine the impact of the pandemic on underrepresented early-career biomedical researchers, this study evaluated differences in productivity, research, and psychological well-being by gender and career status. METHOD: This was a cross-sectional analysis of preintervention data, collected in September-October 2020, from 220 participants enrolled in the Building Up a Diverse Biomedical Research Workforce study. Participants were from 25 academic medical centers in the United States and were underrepresented early-career researchers. The primary outcomes were agreement on a 5-point Likert scale with pandemic impact statements (e.g., "The COVID-19 pandemic has impacted my ability to conduct research"). Thematic analysis was conducted on responses to 2 open-ended questions assessing the pandemic's impact. RESULTS: Most participants were female (79.9%), of non-Hispanic/Latinx/Spanish origin Black/African American (33.2%) or Hispanic/Latinx/Spanish origin (34.1%), and early-career faculty (53.4%). Over half of participants agreed or strongly agreed that the COVID-19 pandemic impacted their ability to work (55.7%) and conduct research (70.7%). Themes from qualitative analysis suggested lower research productivity, concerns about the academic job market and funding, and psychological distress due to the pandemic. Women were more likely to attribute lost productivity and psychological distress to homeschooling and childcare responsibilities. Postdoctoral fellows were concerned about more competition for fewer academic positions. CONCLUSIONS: In this study of early-career underrepresented biomedical researchers, the impact of the COVID-19 pandemic was widely felt by participants, varying by gender and career status. For those postdoctoral fellows and early-career faculty who are underrepresented, it is critical for institutions to offer flexibility in their positions.

The impact of social unrest due to systemic racism on underrepresented post-doctoral fellows and early-career faculty.

Introduction: Social unrest tied to racism negatively impacted half of NIH-funded extramural researchers underrepresented (UR) in science. UR early-career scientists encounter more challenges in their research careers, but the impact of social unrest due to systemic racism in this group is unclear. We used mixed methods to describe the impact of social unrest due to systemic racism on mentoring relationships, research, and psychological well-being in UR post-doctoral fellows and early-career faculty. Methods: This is a cross-sectional analysis of data collected in September 2021-January 2022 from 144 UR early-career researchers from 25 academic medical centers in the Building Up Trial. The primary outcomes were agreement on five-point Likert scales with social unrest impact statements (e.g., "I experienced psychological distress due to events of social unrest regarding systemic racism"). Thematic analysis was conducted on responses to one open-ended question assessing how social unrest regarding systemic racism affected participants. Results: Most participants were female (80%), non-Hispanic Black (35%), or Hispanic (40%). Over half of participants (57%) experienced psychological distress as a result of social unrest due to systemic racism. Participants described direct and indirect discrimination and isolation from other persons of color at their institutions. Twice as many participants felt their mentoring relationships were positively (21%) versus negatively (11%) impacted by social unrest due to systemic racism. Conclusions: Experiences with racial bias and discrimination impact the career and well-being of UR early-career researchers. Mentoring relationships and institutional support play an important role in buffering the negative impact of racial injustice for this population.

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs.

Background: In 2017, the American College of Physicians (ACP) designated Mindfulness-Based Stress Reduction (MBSR), an eight-week group program, as first-line non-pharmacological treatment for chronic low back pain. However, interprofessional collaboration between mindfulness instructors and Primary Care Providers (PCP) remains largely unknown. Objective: We developed a survey to assess communication between mindfulness instructors and PCPs, identify predictors of referral to MBSR, and determine areas where interventions could increase patient access to MBSR. Methods: The 25-question survey was sent via email to PCPs at the Division of General Internal Medicine, University of Pittsburgh, PA, the Piedmont Health Services Family Medicine Section, Chapel Hill, NC, the Boston Medical Center General Internal Medicine and Family Medicine Sections, Boston, MA, and the UMass Memorial Medical Center Family Medicine Section, Worcester, MA. We used descriptive statistics and logistic regression to analyze the data. Results: Among 118 eligible respondents, 85 (72.0%) were female PCPs, mean age was approximately 41.5±10.1, and the majority (65.2%) had been in medical practice ≤10 years. Of these PCPs, 83 (70.1%) reported familiarity with MBSR (95% CI: 62.1, 78.5), and 49 (59.0%) of them referred patients at least yearly. Of those who referred, 8 (16.3%) reported collaboration with mindfulness instructors. PCPs who were quite a bit or very much familiar with MBSR had 5.10 (1.10, 22.50) times the odds (P=.03), and those who were 50 years or younger had 3.30 times the odds (P=.04) of referring patients to MBSR. Frequency of PCPs' personal practice of mindfulness was not significantly associated with referrals (P=.30). Conclusion: This is the first study to assess interprofessional collaboration between mindfulness instructors and PCPs. Suggestions for a potential integrative health care model are included; further studies on methods to augment communication and education are warranted to improve the referral process and ultimately increase accessibility and utilization of mindfulness-based programs.

What Are Adverse Events in Mindfulness Meditation?

Mindfulness meditation has become a successful treatment of both physical and psychosocial ailments over the past decade. Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) are now implemented in various clinical and hospital settings for the treatment of stress, depression, substance abuse, and chronic pain. However, given mindfulness meditation's exponential rise in popularity, scientific and media reports have called for the evaluation of mindfulness meditation's safety for those who participate in its programs. Studies have described adverse events, such as anxiety and pain, and more severe events like psychosis, that have been associated with mindfulness meditation. However, there has not been a consistent, systematic way to define and report adverse events in meditation randomized control trials. The objective of our viewpoint was to dispel the notion that these emotive feelings and sensations are adverse events due to mindfulness meditation. Instead, they are actually expected reactions involved in the process of achieving the true benefits of mindfulness meditation. For the more severe outcomes of meditation, for example, psychosis and mania, these events are confounded by other factors, such as the intensity and length of the meditative practices as well as psychological stressors and the psychiatric histories of those affected. Comparatively, mindfulness-based programs like MBSR and MBCT are shorter in duration and less intense. They are designed to be adapted to their participants' needs as to not induce pain or panic. Mindfulness meditation teaches its students to learn how to deal with their minds and bodies instead of using maladaptive coping techniques. Thus, we urge that further research in mindfulness meditation consistently use the definition of adverse events as those which lead to severe outcomes or hospitalization.

Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial.

INTRODUCTION: US military veterans have disproportionately high rates of diabetes and diabetes-related morbidity in addition to being at risk of comorbid stress-related conditions. This study aimed to examine the effects of a technology-supported mindfulness intervention integrated into usual diabetes care and education on psychological and biobehavioral outcomes. RESEARCH DESIGN AND METHODS: Veterans (N=132) with type 1 or 2 diabetes participated in this two-arm randomized controlled efficacy trial. The intervention arm received a one-session mindfulness intervention integrated into a pre-existing program of diabetes self-management education and support (DSMES) plus one booster session and 24 weeks of home practice supported by a mobile application. The control arm received one 3-hour comprehensive DSMES group session. The primary outcome was change in diabetes distress (DD). The secondary outcomes were diabetes self-care behaviors, diabetes self-efficacy, post-traumatic stress disorder (PTSD), depression, mindfulness, hemoglobin A1C (HbA1C), body weight, and blood pressure. Assessments were conducted at baseline, 12 weeks, and 24 weeks. Participant satisfaction and engagement in home practice were assessed in the intervention group at 12 and 24 weeks. RESULTS: Intention-to-treat group by time analyses showed a statistically significant improvement in DD in both arms without significant intervention effect from baseline to 24 weeks. Examination of distal effects on DD between weeks 12 and 24 showed significantly greater improvement in the intervention arm. Improvement in DD was greater when baseline HbA1C was <8.5%. A significant intervention effect was also shown for general dietary behaviors. The secondary outcomes diabetes self-efficacy, PTSD, depression, and HbA1C significantly improved in both arms without significant intervention effects. Mindfulness and body weight were unchanged in either group. CONCLUSIONS: A technology-supported mindfulness intervention integrated with DSMES showed stronger distal effects on DD compared with DSMES control. Examination of longer-term outcomes, underlying mechanisms, and the feasibility of virtual delivery is warranted. TRIAL REGISTRATION NUMBER: NCT02928952.

Recruiting underrepresented individuals in a double pandemic: Lessons learned in a randomized control trial.

The Building Up Trial is a cluster-randomized trial that aims to address the issue of the leaky career pathway for underrepresented (UR) faculty in biomedical fields. Regulatory approval and recruitment for the Building Up Trial took place during the COVID-19 pandemic and the anti-racism movement. The pandemic and anti-racism movement personally and professionally impacted the target population and made recruitment challenging at both the institution and participant level. The target sample size for this study was 208 postdoctoral fellows or early-career faculty across 26 predominately white institutions. Challenges and adaptations are described. The Building Up Trial was delayed by 3 months. In total, 225 participants from 26 institutions were enrolled. Participants are predominately female (80%), Hispanic/Latinx (34%) or non-Hispanic/Latinx Black (33%), and early-career faculty (53%). At the institution level, obtaining Institutional Review Board (IRB) approval through a single Institutional Review Board (sIRB) posed the biggest challenge. We adapted to COVID-19-related challenges through simplifying sIRB forms, modifying study practices, and increasing communication with institutions. Recruiting UR postdoctoral fellows and faculty during the COVID-19 pandemic and anti-racism movement was challenging but not impossible. Studies should be prepared to modify study and recruitment policies to overcome additional barriers posed by the pandemics.

The impact of the COVID-19 pandemic on underrepresented early-career PhD and physician scientists.

Underrepresented minorities have higher attrition from the professoriate and have experienced greater negative impacts of the COVID-19 pandemic. The purpose of this study was to compare the impact of COVID-19 on the lives of 196 early-career physician-scientists versus PhD researchers who are underrepresented in biomedical research. Participants in the Building Up study answered questions on the impact of the COVID-19 pandemic on their personal and professional lives, and a mixed-methods approach was used to conduct the analysis. While most participants experienced increases in overall stress (72% of PhD researchers vs 76% of physician-scientists), physician-scientists reported that increased clinical demands, research delays, and the potential to expose family members to SARS-CoV-2 caused psychological distress, specifically. PhD researchers, more than physician-scientists, reported increased productivity (27% vs 9%), schedule flexibilities (49% vs 25%), and more quality time with friends and family (40% vs 24%). Future studies should consider assessing the effectiveness of programs addressing COVID-19-related challenges experienced by PhD researchers and physician-scientists, particularly those from underrepresented backgrounds.

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.

The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms.

OBJECTIVE: This study aimed to explore a) if high pain interference has a negative effect on response to computerized cognitive behavioral therapy (cCBT) for anxiety and depression and b) whether high optimism can buffer the negative effects of pain interference on cCBT outcomes. METHODS: We performed a secondary analysis of data on 403 participants from the randomized controlled clinical trial "Online Treatment for Mood and Anxiety Disorders in Primary Care." It examined the impact of cCBT, with and without access to an Internet support group, on health-related quality of life (HRQoL), mood, and anxiety symptoms. RESULTS: High versus low pain interference had a negative effect on response to cCBT for physical HRQoL regardless of high or low optimism level (between group difference = -3.46 [-5.89 to -1.03], p = .005, or -4.06 [-6.28 to -1.85], p < .001, respectively). However, in the context of low optimism/high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 [0.63 to 6.73], p = .018) and anxiety symptoms (-2.61 [-4.87 to -0.35], p = .024). Although the pattern of effects was similar for depressive symptoms, the between-group differences were not significant. CONCLUSIONS: High optimism may buffer against the negative effects of pain interference on treatment response from cCBT. Primary care patients who report high pain interference yet also lack optimism may not receive as much benefit from cCBT as other groups. Furthermore, this study found an unexpected positive effect of low optimism on treatment response. For depressed and anxious patients with low pain interference, low optimism enhanced the impact of cCBT on mental HRQoL.Trial Registration:ClinicalTrials.gov Identifier: NCT01482806.

Integrating patient perspectives in the development of a mobile health intervention to address chronic pain and heavy drinking in primary care: a qualitative study of patients in an urban, safety-net hospital setting.

BACKGROUND: Chronic pain and heavy drinking are conditions that commonly co-occur among primary care patients. Despite the availability of behavioral interventions that target these conditions individually, engagement and adherence to treatment remain a challenge, and there have been no interventions designed to address both of these conditions together for patients presenting to primary care. This study seeks to incorporate the perspectives of patients regarding symptoms, treatment experiences, views on behavior change, and technology use to develop a tailored, integrated mobile health intervention that addresses both pain and heavy drinking among patients in primary care. METHODS: Twelve participants with moderate or greater chronic pain intensity and heavy drinking were recruited from primary care clinics in a large urban safety-net hospital. One-on-one interviews were recorded and transcribed. Codes were developed from interview transcripts, followed by thematic analysis in which specific meanings were assigned to codes. Participants also completed a series of Likert-based rating scales to evaluate components of the proposed intervention to supplement qualitative interviews. RESULTS: A number of themes were identified that had implications for intervention tailoring including: ambivalence about changing drinking, low expectations about pain treatment success, desire for contact with a designated provider, common use of smartphones but lack of familiarity with functions as a potential barrier to use, and strategies to maintain engagement and adherence. Evaluative ratings indicated that the proposed intervention content was perceived as helpful and the proposed structure, layout and design of the mobile intervention was acceptable to patients. CONCLUSIONS: Results supported the view that a mobile health intervention delivered via smartphone with electronic coaching is an acceptable method of addressing chronic pain and heavy drinking among patients in primary care. The interviews highlight the need to utilize an intervention approach that addresses motivation to change drinking, sets realistic expectations for change, provides careful attention to training/education of the use of technology components, and fosters engagement through the use of reminders, feedback, and personalized activities.