Preoperative decreased physical activity is associated with greater postoperative pain: the mediating role of preoperative sleep disturbance.

PURPOSE: Engagement in physical activity (PA) is often associated with better sleep quality and less pain severity among patients diagnosed with breast cancer. However, less research has focused on whether patients' PA prior to breast surgery, including their perceived decrease in PA level, is associated with worse preoperative sleep quality, and subsequently, greater postoperative pain. This longitudinal study investigated whether patients' preoperative PA was associated with their postoperative pain. We also explored whether preoperative sleep disturbance partially mediated the relationship between preoperative PA and postoperative pain. METHODS: Prior to breast surgery, patients self-reported both their overall level of PA and whether they perceived a decrease in their PA since the diagnosis/onset of treatment for cancer. Patients also completed a measure of preoperative sleep disturbance. Two weeks after surgery, patients completed a measure of postoperative surgical-area pain severity. RESULTS: Our results showed that preoperatively perceiving a decrease in PA level was significantly associated with greater preoperative sleep disturbance and postoperative pain. A mediation analysis revealed that the association between preoperative decreased PA and postoperative pain was partially mediated by preoperative sleep disturbance. Notably, patients' overall preoperative level of PA was not related to preoperative sleep disturbance or postoperative pain. CONCLUSION: These findings suggest that maintaining, or even increasing, PA after diagnosis/treatment may be more important than the absolute amount of PA that women engage in during the preoperative period. Potentially, some patients with breast cancer may benefit from a preoperative intervention focused on both maintaining PA and bolstering sleep quality.

Implementation of a Clinician-led Medication Adherence Intervention Among Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Medication nonadherence in systemic lupus erythematosus (SLE) leads to poor clinical outcomes. We developed a clinician-led adherence intervention that involves reviewing real-time pharmacy refill data and using effective communication to address nonadherence. Prior pilot testing showed promising effects on medication adherence. Here, we describe further evaluation of how clinicians implemented the intervention and identify areas for improvement. METHODS: We audio recorded encounters of clinicians with patients who were nonadherent (90-day proportion of days covered [PDC] < 80% for SLE medications). We coded recordings for intervention components performed, communication quality, and time spent discussing adherence. We also conducted semistructured interviews with patients and clinicians on their experiences and suggestions for improving the intervention. We assessed change in 90-day PDC post intervention. RESULTS: We included 25 encounters with patients (median age 39, 100% female, 72% Black) delivered by 6 clinicians. Clinicians performed most intervention components consistently and exhibited excellent communication, as coded by objective coders. Adherence discussions took an average of 3.8 minutes, and 44% of patients had ≥ 20% increase in PDC post intervention. In structured interviews, many patients felt heard and valued and described being more honest about nonadherence and more motivated to take SLE medications. Patients emphasized patient-clinician communication and financial and logistical assistance as areas for improvement. Some clinicians wanted additional resources and training to improve adherence conversations. CONCLUSION: We provide further evidence to support the feasibility, acceptability, and fidelity of the adherence intervention. Future work will optimize clinician training and evaluate the intervention's effectiveness in a large, randomized trial.

The Opioid Epidemic and Faith-Based Responses in Southern Appalachia, USA: An Exploration of Factors for Successful Cross-Sector Collaboration.

This study aimed to identify factors for successful cross-sector collaboration with faith-based responses to the opioid epidemic in southern Appalachia. In-depth interviews were conducted with representatives from organizations responding to the opioid epidemic (N = 25) and persons who have experienced opioid dependency (N = 11). Stakeholders perceived that collaboration is hindered by stigma, poor communication, and conflicting medical and spiritual approaches to opioid dependency. Collaborations are facilitated by cultivating compassion and trust, sharing information along relational lines, and discerning shared commitments while respecting different approaches. The study concludes with theoretical and practical implications for both religious leaders and potential cross-sector collaborators.

Sexually Transmitted Infection Prevention Perspectives in Black Men Who Have Sex With Men Taking Preexposure Prophylaxis in New Orleans.

INTRODUCTION: Profound sexual health disparities exist for Black men who have sex with men (MSM) in the US South, including a high prevalence of sexually transmitted infections (STIs). Sexually transmitted infection prevention strategies beyond condoms are needed for Black MSM taking preexposure prophylaxis (PrEP). METHODS: We conducted in-depth interviews with Black MSM taking PrEP in New Orleans, Louisiana. Informed by the Health Belief Model, we asked about participants' perceived susceptibility, severity, and concerns regarding STIs, and perceived benefits of STI prevention. We also asked about willingness to use various STI prevention strategies, including antibiotic prophylaxis. Interviews were audio-recorded and analyzed using applied thematic analysis. RESULTS: We interviewed 24 Black MSM aged 18 to 36 years; half had a recent STI diagnosis. Most participants were concerned about receiving an STI diagnosis, noting shame or disappointment; physical effects were concerning but infrequently considered. Participants described being less likely to use condoms with routine partners or those taking PrEP. Most reported being willing to engage in each of the 6 prevention strategies discussed. CONCLUSIONS: Black MSM taking PrEP voiced concern about STIs, and many noted that they infrequently use condoms. They were willing to engage in methods focused on preventing STIs on an individual or population level.

Stakeholder Reflections on Implementing the National Institutes of Health's Policy on Single Institutional Review Boards.

The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads. CTTI used these findings to propose a new framework for evaluating the NIH sIRB policy.

Evidence2Practice (E2P): Leveraging Implementation Science to Promote Careers in HIV Research Among Students From Historically Black Colleges and Universities.

BACKGROUND: The HIV research workforce is not representative of populations most affected by the epidemic. Innovative educational programs are needed to motivate diverse student populations to pursue careers in HIV research. METHODS: The Duke University Center for AIDS Research Evidence2Practice (E2P) program is a 3-day interactive workshop that introduces students from Historically Black Colleges and Universities (HBCU) to HIV pre-exposure prophylaxis, implementation science, and human-centered design. Participants develop 1-page action plans to increase awareness and uptake of pre-exposure prophylaxis on their campus. The program was evaluated using a partially mixed-method concurrent equal status study design with pre-program and post-program surveys and in-depth interviews. RESULTS: Among the 52 participating students, 44 completed the preworkshop survey, 45 completed the postworkshop survey, and 10 participated in an in-depth interview. Most participants identified as Black or African American and cisgender female. Participating in the E2P program was associated with: (1) an increase in median interest in pursuing a career in HIV research (P < 0.01) and (2) a decrease in median perceived difficulty in starting a career in HIV research (P < 0.01). Several students described that a lack of knowledge about initiating an HIV research career, a perceived lack of qualifications and knowledge about HIV science, and limited experience were major barriers to considering careers in HIV research. CONCLUSIONS: The E2P program enhanced HBCU students' interest in careers related to HIV research and improved their self-efficacy to pursue such careers. On-campus educational enrichment initiatives, led by active HIV researchers and clinicians, should be a critical part of diversifying the HIV workforce.

Enhancing Diversity and Inclusion in Clinical Trials.

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study-level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas-commitment, partnerships, accountability, and resources-on sustaining organizational-level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational-level approaches to improve equitable access and diverse patient participation in clinical trials.

Identification of Determinants and Implementation Strategies to Increase PrEP Uptake Among Black Same Gender-Loving Men in Mecklenburg County, North Carolina: The PrEP-MECK Study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) use is low among Black same gender-loving men (BSGLM) in Mecklenburg County, NC, an Ending the HIV Epidemic priority jurisdiction. We created PrEP-MECK-an investigator partnership among a community-based organization representative, a PrEP provider, and researchers-and conducted iterative preparation research to identify determinants of PrEP uptake and implementation strategies to address them. METHODS: We first established the PrEP-MECK Coalition of community stakeholders. Next, informed by PrEP-MECK Coalition input and PRECEDE-PROCEED's educational/ecological assessment phase, we conducted focus group discussions with BSGLM not using PrEP and in-depth interviews with BSGLM who were currently or had previously taken PrEP to describe determinants and suggest implementation strategies. Based on interim findings, we partnered with clinics participating in the Mecklenburg County PrEP Initiative, which offers free PrEP services to uninsured individuals. We also conducted Consolidated Framework for Implementation Research-informed organizational assessments with community-based organizations and clinics to assess readiness to pilot the implementation strategies. RESULTS: We conducted 4 focus group discussions, 17 in-depth interviews, and 6 assessments. BSGLM were aware of PrEP yet perceived that costs made it unattainable. Awareness of how to access PrEP and the Mecklenburg County PrEP Initiative was lacking, and clinic scheduling barriers and provider mistrust limited access. We identified client-level implementation strategies, primarily focusing on engaging the consumer, to increase comfort with and awareness of how to access PrEP, and clinic-level implementation strategies focusing on changing clinic infrastructure, to make PrEP access easier. CONCLUSION: We plan to evaluate implementation of these strategies once fully developed to determine their acceptability and other outcomes in future research.

Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.

INTRODUCTION: Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as well as to refine and expand guidance on participant and family engagement in Pediatric Trials Network's (PTN) pragmatic paediatric clinical research. METHODS: Informed by draft PTN guidance, we conducted in-depth qualitative interviews with adolescent clinical trial participants and caregivers of paediatric participants in four trials conducted by PTN across eight sites. Participants were shown multiple versions of mock lay summaries and thank you notes and asked questions on their preferences for content and layout, and on trial communications. We used applied thematic analysis to analyse the data. RESULTS: We interviewed 27 individuals engaged in PTN research: 24 caregivers and 3 adolescents. During a trial, participants want regular updates on study progress, reminders of the study purpose and reassurances of data confidentiality. After the trial, participants want to learn the aggregated results, particularly medication effectiveness. Participants reported that lay summaries should include a review of the study's purpose, methods and length, and that they expect to learn individual-level results. Participants stated that thank you notes must be of sufficient length to be meaningful. CONCLUSIONS: This is the first study to describe stakeholder preferences for thank you note content and layout. Using these findings, we finalized PTN's trial communication guidance for use in future PTN trials. Research is needed to determine the effect of lay summaries and thank you notes on improving public transparency regarding clinical trials and paediatric trial recruitment and completion. PATIENT OR PUBLIC CONTRIBUTION: By design, stakeholders (adolescent trial participants and caregivers of pediatric trial participants) contributed to PTN's guidance on the content and layout of lay summaries and thank you notes through their participation in the in-depth interviews.

"An Extra Variable to Consider"-Vaccine-Induced Seropositivity and Adolescent HIV Vaccine Clinical Trials.

Our study explores the understanding of vaccine-induced seropositivity (VISP) and its potential impact on US adolescents' and caregivers' willingness to participate in adolescent HIV vaccine clinical trials. Findings from in-depth interviews suggest that addressing concerns about VISP will be essential for future pediatric HIV vaccine trials in the United States.

Outcomes of a Weight Loss Intervention to Prevent Diabetes Among Low-Income Residents of East Harlem, New York.

There is a need for diabetes prevention efforts targeting vulnerable populations. Our community-academic partnership, the East Harlem Partnership for Diabetes Prevention, conducted a randomized controlled trial to study the impact of peer led diabetes prevention workshops on weight and diabetes risk among an economically and racially diverse population in East Harlem, New York. We recruited overweight/obese adults from more than 50 community sites and conducted oral glucose tolerance testing and completed other clinical assessments and a health and lifestyle survey. We randomized prediabetic participants to intervention or delayed intervention groups. Intervention participants attended eight 90-minute peer-led workshop sessions at community sites. Participants in both groups returned for follow-up assessments 6 months after randomization. The main outcomes were the proportion of participants who achieved 5% weight loss, percentage weight loss, and change in the probability of developing diabetes over the next 7.5 years according to the San Antonio Diabetes Prediction Model. We enrolled 402 participants who were mainly female (85%), Latino (73%) or Black (23%), foreign born (64%), and non-English speaking (58%). At 6 months, the intervention group lost a greater percentage of their baseline weight, had significantly lower rise in HbA1c (glycated hemoglobin), decreased risk of diabetes, larger decreases in fat and fiber intake, improved confidence in nutrition label reading, and decrease in sedentary behavior as compared with the control group. Thus, in partnership with community stakeholders, we created an effective low-resource program that was less intensive than previously studied programs by incorporating strategies to engage and affect our priority population.

Smartphone ownership and perspectives on health apps among a vulnerable population in East Harlem, New York.

BACKGROUND: Individuals from low-income and racial/ethnic minority backgrounds have traditionally had less access to mobile health (mHealth) technologies, but there is evidence that this gap has been rapidly narrowing. Given the increase in access to mobile technologies recently seen in vulnerable populations, mHealth has been championed as a strategy for improving population health and reducing health disparities. However, members of low-income and racial/ethnic minority populations have had a limited role in the development and implementation of mHealth interventions designed to impact them. METHODS: We used community-based participatory research (CBPR), a research approach that is frequently employed to help reach communities that are disproportionately affected by illness but are difficult to engage. Our community-academic collaboration, the East Harlem Partnership for Diabetes Prevention, sought to create a mobile technology platform that would allow adults in East Harlem, New York to improve their own health and promote the health of the broader community. As a first step, we developed and conducted a survey of community residents to better understand access to, usage of, and attitudes towards mobile technologies among diverse, low-income adults. We administered the cross-sectional survey to a convenience sample of adults who utilized a variety of community-based organizations in East Harlem. We examined frequencies for each survey item and then used chi-square tests (or Fisher's exact tests) and multivariate logistic regression to evaluate relationships between these outcomes and sociodemographic factors. RESULTS: We approached 154 people, of whom 104 (68%) agreed to participate. The majority of respondents were of Black and/or Hispanic/Latino descent with a mean age of 37 years. Our sample displayed a high percentage of smartphone ownership (82% of the participants reported that they owned a cell phone, and 88% of owners reported that their cell phone was a smartphone). We found lower rates of ownership among individuals who were older, self-identified as Latino, insured by Medicare, and had a household income of less than $30,000 per year. Multivariate logistic regression showed that after adjusting for age, gender and race, those with at least a high school education were seven times more likely to use health apps than those with less than a high school education (OR 6.8, 95% CI: 1.7-27.1). Participants expressed interest in health promoting apps that provide interactive, individualized diet, exercise and weight loss tools and offer information about local health resources and events. CONCLUSIONS: Despite some notable disparities, our study results suggest that the digital divide is narrowing in the East Harlem community with relatively high rates of smartphone ownership and use, even among individuals from low-income, low education backgrounds and those without health insurance. Based on study results, our partnership developed an app supporting healthy lifestyle and diabetes prevention tailored to the East Harlem community.