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Accelerated functional decline is a concern among older cancer survivors that threatens independence and quality of life. Pilot studies suggest that vegetable gardening interventions ameliorate functional decline through improved diet and physical activity.The aim of this article was to describe the rationale, recruitment challenges, and enrollment for the Harvest for Health randomized controlled trial (RCT), which will test the impact of a home-based, vegetable gardening intervention on vegetable and fruit consumption, physical activity, and physical functioning among older cancer survivors. Modifications made to the intervention and assessments to assure safety and continuity of the RCT throughout the COVID-19 pandemic also are reported.Harvest for Health is a 2-year, 2-arm, single-blinded, wait-list controlled RCT with cross-over.Medicare-eligible survivors of cancers with ≥60% 5-year survival were recruited across Alabama from October 1, 2016 to February 8, 2021.Participants were randomly assigned to a wait-list control or a 1-year home-based gardening intervention and individually mentored by extension-certified master gardeners to cultivate spring, summer, and fall vegetable gardens.Although the RCT's primary end point was a composite measure of vegetable and fruit consumption, physical activity, and physical functioning, this article focuses on recruitment and modifications made to the intervention and assessments during COVID-19.χOlder cancer survivors (n = 9,708) were contacted via mail and telephone; 1,460 indicated interest (15% response rate), 473 were screened eligible and consented, and 381 completed baseline assessments and were randomized. Enrollees did not differ from nonrespondents/refusals by race and ethnicity, or rural-urban status, but comprised significantly higher numbers of comparatively younger survivors, those who were female, and survivors of breast cancer (P.001). Although COVID-19 delayed trial completion, protocol modifications overcame this barrier and study completion is anticipated by June 2022.This RCT will provide evidence on the effects of a mentored vegetable gardening program among older cancer survivors. If efficacious, Harvest for Health represents a novel, multifaceted approach to improve lifestyle behaviors and health outcomes among cancer survivors-one with capacity for sustainability and widespread dissemination.

Purpose Relating dose-volume histogram (DVH) information to patient outcomes is critical for outcomes research in radiation oncology, but this is statistically challenging. We performed this focused review of DVH toxicity studies to characterize current statistical approaches and determine the need for updated reporting recommendations. Methods and materials We performed a focused MEDLINE search to identify studies published in 5 radiation oncology specialty journals that associated dosimetry with toxicity outcomes in humans receiving radiotherapy between 2015 and 2021. Elements abstracted from each manuscript included the study outcome, organs-at-risk (OARs) considered, DVH parameters analyzed, summary of the analytic approach, use of multivariable statistics, goodness-of-fit reporting, completeness of model reporting, assessment of multicollinearity, adjustment for multiple comparisons, and methods for dichotomizing variables. Each study was also assessed for sufficient reporting to allow for replication of results. Results The MEDLINE search returned 2,300 studies for review and 325 met the inclusion criteria for the analysis. DVH variables were dichotomized using cut points in 154 (47.4%) studies. Logistic regression (55.4% of studies) was the most common statistical method used to relate DVH to toxicity outcomes, followed by Cox regression (20.6%) and linear regression (12.0%). Multivariable statistical tests were performed in 226 (69.5%) studies; of these, the possibility of multicollinearity was addressed in 47.8% and model goodness-of-fit were reported in 32.6%. The threshold for statistical significance was adjusted to account for multiple comparisons in 41 of 196 (17.1%) studies that included multiple statistical comparisons. Twenty-eight (8.6%) studies were classified as missing details necessary to reproduce the study results. Conclusions Current practices of statistical reporting in DVH outcomes suggest that studies may be vulnerable to threats against internal and external validity. Recommendations for reporting are provided herein to guard against such threats and to promote cohesiveness among radiation oncology outcomes researchers.

(1) Background: A healthful diet, regular physical activity, and weight management are cornerstones for cancer prevention and control. Yet, adherence is low in cancer survivors and others, calling for innovative solutions. Daughters, dUdes, mothers, and othErs fighting cancer Together (DUET) is a 6-month, online, diet-and-exercise, weight-loss intervention to improve health behaviors and outcomes among cancer survivor-partner dyads. (2) Methods: DUET was tested in 56 dyads (survivors of obesity-related cancers and chosen partners) (n = 112), both with overweight/obesity, sedentary behavior, and suboptimal diets. After baseline assessment, dyads were randomized to DUET intervention or waitlist control arms; data were collected at 3- and 6-months and analyzed using chi-square, t-tests, and mixed linear models (α < 0.05). (3) Results: Retention was 89% and 100% in waitlisted and intervention arms, respectively. Dyad weight loss (primary outcome) averaged −1.1 (waitlist) vs. −2.8 kg (intervention) (p = 0.044/time-by-arm interaction p = 0.033). Caloric intake decreased significantly in DUET survivors versus controls (p = 0.027). Evidence of benefit was observed for physical activity and function, blood glucose, and c-reactive protein. Dyadic terms were significant across outcomes, suggesting that the partner-based approach contributed to intervention-associated improvements. (4) Conclusions: DUET represents a pioneering effort in scalable, multi-behavior weight management interventions to promote cancer prevention and control, calling for studies that are larger in size, scope, and duration.

Post-operative analgesic management is challenging in infants and opioids have been the standard of care. However, they are associated with adverse effects which may negatively impact infants. In this retrospective cohort study, we sought to explore the postoperative analgesic efficacy of quadratus lumborum (QL) block in the infant population undergoing dorsal lumbotomy pyeloplasty. Chart review of 34 infants (≤12 months) who underwent dorsal lumbotomy pyeloplasty between 2016–2020 was performed. Post-operative pain was assessed using externally validated pain scales (CRIES &amp, FLACC) and monitored hemodynamics (pulse and blood pressure). Opioid doses were standardized by using morphine milligram equivalency (MME). The Prescription Database Monitoring Program (PDMP) was utilized to determine if discharge opioid prescriptions were filled. Of 34 patients, 13 received the QL block. Mean age at the time of surgery was 6.2 months ± 3.2 months. The QL group received 0.8 MME postoperatively, whereas the non-QL group received 0.9 MME (p = 0.82). The QL group (20%) filled their discharge opioid prescription less frequently compared to non-QL group (100%) (p = 0.002). There were no observed differences between pain scale or hemodynamic variables. Further studies are warranted to explore QL block’s efficacy for post-operative infant pain management.

Background The number of exercise trials examining cardiometabolic outcomes in spinal cord injury (SCI) is low, and prescribed exercise is often inconvenient for individuals with SCI to perform within their community. Individuals with SCI experience a myriad of barriers to exercise participation, which can include a lack of time, accessible or usable equipment and facilities, and transportation. Thus, it is imperative to identify effective modes of exercise that provide the greatest overall health benefits but do not require a significant time commitment. Low-volume high intensity interval training (HIIT) has demonstrated the same improvements in cardiometabolic health as moderate intensity exercise training (MIT), despite only requiring 20% of the total time commitment in adults without disabilities and more recently in individuals with SCI. Objectives The primary purpose of this study is to integrate a 16 week home-based telehealth HIIT arm crank exercise training program in individuals with SCI and assess changes in cardiometabolic health. Methods Men and women between the ages of 19 and 60 with a confirmed diagnosis of SCI between C7 and T12 will be recruited for this study. Participants will be randomized to 16 weeks of telehealth HIIT exercise two days per week or a no-exercise control group. Aerobic capacity, muscular strength, blood lipids, glucose tolerance, resting energy expenditure, blood pressure, and body composition will be assessed at baseline and 16 weeks post-training. Discussion Inactivity associated with SCI leads to chronic cardiometabolic health conditions. The majority of exercise interventions to date show that exercise is capable of increasing physical function, aerobic capacity, and muscle mass, and strength. Additionally, we have recently shown the ability of HIIT to improve blood lipid and glucose concentrations. Advances in telehealth exercise approaches have improved the capability to prescribe home-based exercise programs. Therefore, we hypothesize that the utilization of a home-based telehealth HIIT program will improve cardiometabolic health markers, yield high adherence (> 75%), and will be more enjoyable in individuals with SCI. Trial registration Telehealth High-Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury NCT04940598

Purpose Moderate-to-vigorous physical activity (MVPA) can improve quality of life (QoL) for breast cancer survivors (BCS); yet most do not achieve 150 + weekly minutes of MVPA. This study investigated moderators of response to a physical activity (PA) behavior change intervention for BCS. Methods BCS (N = 222) were randomized to the 3-month intervention (BEAT Cancer) or usual care. Measurements occurred at baseline, post-intervention, and 3 months post-intervention. Measures included accelerometry, self-reported MVPA, and Functional Assessment of Cancer Therapy (FACT-General, FACT-Breast, physical well-being [PWB], social well-being [SWB], emotional well-being [EWB], functional well-being [FWB], additional concerns [AC], and Trial Outcome Index (TOI). Results Adjusted linear mixed-model analyses indicated individuals ≤ 24 months post-diagnosis who were single reported smaller increases in weekly MVPA than those > 24 months (44.07 vs 111.93) and partnered (-16.24 vs. 49.16 min), all p’s p’s

PURPOSE: To qualitatively explore exercise barriers and facilitators experienced by rural female cancer survivors from the program interventionist and recipient perspective for the purpose of enhancing exercise program implementation and uptake in rural settings. METHODS: A descriptive qualitative study design was utilized. Focus groups were conducted prior to implementation of an evidence-based exercise program by a rural non-research cancer clinical site. Nineteen rural female cancer survivors (mean age = 61.7 ± 10.9 years) and 11 potential interventionists (mean age = 42.3 ± 15.3 years) completed focus groups (stratified by participant role). Focus groups were audio recorded, transcribed, coded, and analyzed using inductive thematic analysis with NVivo 11. RESULTS: Cancer survivors identified twelve barrier themes (cancer specific adverse effects, lack of support, lack of knowledge, perceived negative aspects of exercise, cost, lack of resources, motivation, inconvenience, lack of program flexibility, time, weather, safety) and eight facilitator themes (knowledge, ease of access, resources, awareness, cost, options, organized, fun) related to exercise. Interventionists identified seven barrier themes (cost, transportation, lack of cancer survivor and interventionist knowledge, fear, motivation, lack of support, lack of resources) and four facilitator themes (resources, support, knowledge, motivation). Narratives revealed differing role-specific perspectives on shared themes between survivors and interventionists as well as potential implementation strategies for enhancing exercise participation and exercise program uptake among rural female cancer survivors. CONCLUSION: Exploring multi-level stakeholder perspectives on cancer survivors’ exercise needs and related strategies yields important information for organizations to consider when implementing exercise programs in rural contexts.

Background Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. Methods Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. Discussion Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. Trial registration ClinicalTrials.gov, NCT04000880. Registered 27 June 2019.

Background: Capsule endoscopy (CE) is an emerging tool in the diagnosis and management of occult bleeding and overt obscure gastrointestinal bleeding (OOGIB). Maximizing efficiency of CE can lead to rapid bleeding localization and shorter time to therapy. We investigated whether a trained registered nurse (RN) can accurately interpret bleeding by CE in real time by measuring inter-observer agreement between RN and physician interpretation. Methods: We conducted a prospective study of patients admitted for OOGIB who underwent live-view capsule endoscopy (LVCE) between 12/2016 and 11/2017. A match control group who underwent standard CE was obtained through retrospective review. An RN received a 2-day training program for CE interpretation. RN bedside interpretation for bleeding was followed by interpretation by 2 GI physicians blinded to LVCE findings. Outcomes were compared between groups using t-tests and chi-square tests. Cohen’s kappa measured agreement between physician and RN. Results: Ten subjects were in the LVCE group, and 12 subjects were in the standard of care group. The agreement between the physicians and RNs was 9/10 (90%) with a kappa of 0.73 (95% CI: 0.26-1.00; p=0.016). Patients in the LVCE group had shorter duration to physician interpretation (0.6 vs 0.7 days (p=0.50), duration to endoscopy (1.8 days vs 3 days (p=0.240) and length of stay (8.1 vs. 11.4 days (p=0.26) compared to the standard of care group. Conclusion: This study utilizing an RN for LVCE interpretation found interobserver agreement between RN and physician findings. Larger studies are needed to assess whether this RN-physician team approach can translate to improved outcomes.

BACKGROUND: Peer support has been shown to improve diabetes self-management and control, but no standard exists to link peer support interventions to clinical care. OBJECTIVE: To compare a community-based diabetes self-management education (DSME) plus mobile health (mHealth)–enhanced peer support intervention to community-based diabetes self-management education (DSME) alone for African American adults with poorly controlled type 2 diabetes. DESIGN: A randomized controlled trial. PARTICIPANTS: African American adults, age > 19 years, receiving care within a safety-net healthcare system in Jefferson County, Alabama, with a diagnosis of type 2 diabetes and a hemoglobin A1c (A1C) ≥ 7.5%. INTERVENTIONS: Participants in the intervention group received community-based diabetes self-management education (DSME) plus 6 months of mHealth-enhanced peer support, including 12 weekly phone calls, then 3 monthly calls from community health workers, who used a novel web application to communicate with participants’ healthcare teams. In the control group, participants received community-based DSME alone. MAIN MEASURES: The primary outcome was A1C; secondary outcomes included diabetes distress, depressive symptoms, self-efficacy or confidence in their ability to manage diabetes, and social support. We used mixed models repeated measures analyses to assess for between-arm differences and baseline to follow-up changes. KEY RESULTS: Of 120 participants randomized, 97 completed the study. Participants in intervention and control groups experienced clinically meaningful reduction in A1C, 10.1 (SD 1.7) to 9.6 (SD 1.9) and 9.8 (SD 1.7) to 9.1 (SD 1.9) respectively, p = 0.004. Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041. CONCLUSIONS: Community-based DSME with and without peer support led to improved glycemic control. Peer support linked to clinical care led to a larger reduction in diabetes distress, which has important implications for the overall wellbeing of adults with type 2 diabetes. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-06011-w) contains supplementary material, which is available to authorized users.

Obesity adversely impacts overall and cancer‐specific survival among breast cancer patients. Preclinical studies demonstrate negative energy balance inhibits cancer progression; however, feasibility and effects in patients are unknown. A two‐arm, single‐blinded, randomized controlled weight‐loss trial was undertaken presurgery among 32 overweight/obese, Stage 0–II breast cancer patients. The attention control arm (AC) received basic nutritional counseling and upper‐body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise to promote 0.68–0.92 kg/week weight loss. Anthropometrics, body composition, blood and survey data were collected at baseline and presurgery ∼30 days later. Tumor markers (e.g., Ki67) and gene expression were assessed on biopsy and surgical specimens; sera were analyzed for cytokines, growth and metabolic factors. Significant WLI vs. AC differences were seen in baseline‐to‐follow‐up changes in weight (−3.62 vs. −0.52 kg), %body fat (−1.3 vs. 0%), moderate‐to‐vigorous physical activity (+224 vs. +115 min/week), caloric density (−0.3 vs. 0 kcal/g), serum leptin (−12.3 vs. −4.0 ng/dl) and upregulation of tumor PI3Kinase signaling and cell cycle‐apoptosis related genes (CC‐ARG; all p‐values, What's new? Obesity adversely impacts survival among breast cancer patients. Preclinical studies demonstrate negative energy balance inhibits cancer progression; however, effects in patients are unknown. This is the first randomized controlled trial to assess the impact of a pre‐surgical weight loss intervention among early‐stage breast cancer patients. Results show the effects of acute negative energy balance on tumor biology, circulating biomarkers, and quality‐of‐life. Short‐term weight loss interventions are feasible; however, mixed effects on tumor biology suggest unclear benefit to pre‐surgical caloric restriction. Such interventions may be better timed after surgical resection, though cell cycle‐apoptosis and DNA damage‐repair scores support increasing physical activity.

BACKGROUND African American or Black young men who have sex with men (BYMSM) are at a disproportionate risk for contracting HIV and have high rates of undiagnosed, and therefore untreated, HIV infection. In the southern United States, BYMSM face region-specific hurdles to HIV prevention, such as limited access to care and high levels of racism and intersectional stigma, necessitating HIV testing and pre-exposure prophylaxis interventions that address sociocultural and structural barriers while motivating BYMSM to engage in prevention. Brothers Saving Brothers (BSB) is a motivational interviewing behavioral intervention that successfully and simultaneously increased community-based HIV testing and prevention counseling and education among BYMSM in the midwestern United States. OBJECTIVE The aim of this protocol is to detail the process for the adaption of the BSB intervention for midwestern BYMSM to the Kings intervention for southern BYMSM. During the adaptation process, the intervention will be modernized to include rapid HIV testing, as opposed to HIV testing that requires BYMSM to return for test results, pre-exposure prophylaxis, and the provision of structural supports, and for relevance in the southern United States. METHODS Aim 1 is to gather qualitative data through focus groups and in-depth interviews with BYMSM aged 18 to 29 years in Alabama and in-depth interviews with prevention and outreach workers who routinely work with BYMSM in Alabama. NVivo qualitative software (QSR International) will be used for the coding and analysis of the transcripts via a thematic analysis approach. For aim 2, intervention mapping will guide the adaptation process, intervention content, components, and design. Both aims 1 and 2 will leverage the Exploration, Preparation, Implementation, Sustainment implementation science framework, with emphasis on the exploration and preparation phases of this model. By applying these frameworks, the original midwestern BSB intervention will be scientifically adapted to the southern BYMSM Kings intervention. RESULTS This study is ongoing as of 2022 and is expected to conclude in 2024, with aims 1 and 2 being completed in 2023. Qualitative data will offer insight into the current real-world experiences and preferences of BYMSM in Alabama. Feedback will be collected through the adaptation process to inform intervention refinement. Institutional review board approvals have been received. CONCLUSIONS The findings will inform next steps, that is, testing the Kings intervention for feasibility, acceptability, and preliminary effectiveness in a pilot hybrid type 1 effective-implementation randomized controlled trial. The study results will provide insights about important considerations for HIV prevention among BYMSM in the southern United States. CLINICALTRIAL ClinicalTrials.gov NCT03680729; https://clinicaltrials.gov/ct2/show/NCT03680729 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/36655

Purpose:Primary Central Nervous System Lymphoma (PCNSL) is an aggressive tumor that is confined to the CNS. Although the provision of high-dose methotrexate (HD-MTX) has remarkably improved outcomes in PCNSL patients, the optimal treatment regimens and standard MTX dose have been largely controversial. Herein, we sought to explore the impact of adjuvant Rituximab and different dosages of HD-MTX on survival outcomes of immunocompetent patients with PCNSL.Methods:In this study, we examined patients with PCNSL treated at a single NCI-designated comprehensive cancer center to evaluate their survival outcomes. We conducted a retrospective analysis of 51 immunocompetent patients with PCNSL who received their induction chemotherapy at the University of Alabama at Birmingham (UAB) between 2001 and 2019. Only adult patients with a confirmed diagnosis of PCNSL who had either HD-MTX alone or in combination with Rituximab were included. Patients’ demographics, clinical characteristics, and survival data were collected and analyzed.Results:There is no significant difference in survival among patients who received MTX alone versus MTX plus Rituximab. Furthermore, lower doses of MTX were associated with worse survival outcomes; however, this difference in survival was not significant when adjusted to age.Conclusion:Our experience challenges the role of Rituximab in PCNSL during induction therapy. Our study also highlights the shorter survival in elderly patients with PCNSL which can be related, to some extent, to the relatively lower doses of HD-MTX. There is an unmet need to establish a consensus on the most effective upfront regimen in PCNSL through prospective studies.

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.

Introduction: Statistical literacy is essential in clinical and translational science (CTS). Statistical competencies have been published to guide coursework design and selection for graduate students in CTS. Here, we describe common elements of graduate curricula for CTS and identify gaps in the statistical competencies. Methods: We surveyed statistics educators using e-mail solicitation sent through four professional organizations. Respondents rated the degree to which 24 educational statistical competencies were included in required and elective coursework in doctoral-level and master’s-level programs for CTS learners. We report competency results from institutions with Clinical and Translational Science Awards (CTSAs), reflecting institutions that have invested in CTS training. Results: There were 24 CTSA-funded respondents representing 13 doctoral-level programs and 23 master’s-level programs. For doctoral-level programs, competencies covered extensively in required coursework for all doctoral-level programs were basic principles of probability and hypothesis testing, understanding the implications of selecting appropriate statistical methods, and computing appropriate descriptive statistics. The only competency extensively covered in required coursework for all master’s-level programs was understanding the implications of selecting appropriate statistical methods. The least covered competencies included understanding the purpose of meta-analysis and the uses of early stopping rules in clinical trials. Competencies considered to be less fundamental and more specialized tended to be covered less frequently in graduate courses. Conclusion: While graduate courses in CTS tend to cover many statistical fundamentals, learning gaps exist, particularly for more specialized competencies. Educational material to fill these gaps is necessary for learners pursuing these activities.

To evaluate the adherence and effectiveness of a home-based exergame program for patients with idiopathic pulmonary fibrosis (IPF).Patients with IPF were randomly assigned to a relatively unsupervised Wii Fit exergame intervention group or Wii video game control group (with no active whole-body movement involved). Participants in both groups were instructed to play their respective games 30 min/d, 3 d/wk for 12 wk. In addition, they were asked to perform their usual exercise/physical activities. Outcome measures were 6-min walk distance (6MWD), exercise-related dyspnea, and St George's Respiratory Questionnaire (SGRQ).The 20 participants differed significantly between intervention and control groups in baseline characteristics (forced vital capacity = 2.0 ± 0.5 vs 3.1 ± 0.7 L; forced expiratory volume in 1 sec = 1.7 ± 0.4 vs 2.5 ± 0.6 L, respectively). Participant adherence rate to the exergame program was very low (20%). There was no significant improvement in the outcome measures in either group. In fact, both the intervention and control groups had a deterioration in 6MWD (-22 ± 56 m vs -60 ± 111 m), respectively and SGRQ scores (3 ± 9 vs 1 ± 11), respectively.The home-based exergame intervention for patients with IPF did not show improvement in functional performance, dyspnea, or health-related quality of life at the completion of the 12-wk program in our 2 heterogeneous groups. In addition to the low adherence rate, insufficient frequencies and durations of exergaming may contribute to the lack of improvement. A lack of effectiveness of home-based pulmonary rehabilitation using exergaming for patients with IPF appears consistent with prior observational studies that used more traditional modes of home-based exercise.

Background: Metabolic disorders (e.g., impaired glucose tolerance, insulin resistance, and type 2 diabetes) are more prevalent in people with spinal cord injury (SCI) vs. able-bodied individuals. Dietary modification is a more cost-effective treatment option than pharmacological therapies for reducing the risk of metabolic dysfunction. Lowering carbohydrate, increasing protein, and maintaining a proper dietary fat intake are expected to induce favorable adaptations in glucose control, body fat distribution, and the composition of gut microbiome. However, dietary modification has not been rigorously investigated in people with SCI. The purpose of this study is to determine if an 8-week low-carbohydrate/high-protein (LC/HP) dietary intervention will show improvements in clinically important metrics of metabolic function, body composition, the composition of gut bacteria, and quality of life. Methods: We intend to recruit 100 participants with chronic traumatic SCI (3 years post-injury, C5-L2, AIS A-D, and 18-65 yr) and insulin resistance, impaired glucose tolerance or untreated type 2 diabetes and randomly assign them into an 8-week LC/HP dietary intervention group or a control group. The daily LC/HP dietary intervention includes ~30% total energy as protein (1.6 g/kg per day) with a carbohydrate-to-protein ratio Discussion: New and impactful information to be derived from this project will result in the development of a low-cost, simple, self-administered LC/HP dietary intervention for improving metabolic function in individuals with chronic SCI, improved understanding of the composition of gut bacteria in SCI, and how an LC/HP dietary intervention alters gut bacteria composition. In addition, this project will improve our understanding of the relationship between metabolic function and quality of life in individuals with long-standing SCI. Trial Registration: ClinicalTrials.gov, NCT03207841. Registered 5 June 2017, https://clinicaltrials.gov/ct2/show/NCT03207841. Keywords: Spinal cord injury, high-protein diet, low-carbohydrate diet, metabolic disease, insulin sensitivity, diabetes, gut microbiome.

To identify constructs relevant to implementation of evidence-based physical activity (PA) behavior change interventions for rural women cancer survivors from an organizational perspective. During the development of a PA intervention implementation toolkit, 11 potential interventionists and 19 community and organizational stakeholders completed focus groups stratified by role. Narratives were audio recorded, transcribed, and coded for Consolidated Framework for Implementation Research (CFIR) constructs. Multiple CFIR constructs were identified: Implementation Process (i.e., Engaging, Reflecting and Evaluating), Intervention Characteristics (i.e., Design Quality and Packaging, Cost, Evidence Strength and Quality, Adaptability, Complexity), Inner Setting (i.e., Implementation Readiness, Implementation Climate, Structural Characteristics), Outer Setting (i.e., Patient Needs and Resources, Cosmopolitanism), and Characteristics of Individuals (i.e., Knowledge and Beliefs, Stage of Change). Narratives identified rural implementation barriers (e.g., transportation) and facilitators (e.g., community-oriented). Unique needs of the cancer survivor (e.g., coping during cancer treatment and long-term effects on physical abilities) were emphasized as important barriers potentially addressed through Adaptability and Readiness implementation strategies. Narratives identified multi-level (i.e., individual-, organizational-, and community-level) strategies for targeting the identified constructs. Fourteen CFIR constructs emerged as potentially important for organizations to consider when implementing PA interventions. Constructs were integrated into our implementation toolkit and research testing their potential mechanisms of action when implementing PA interventions in rural settings is warranted. Strategies that target the identified constructs may enhance the implementation of PA programs for rural cancer survivors. Cancer survivors can facilitate these efforts by partnering with their health care providers and community organizations. Organizations promoting physical activity programs for cancer survivors must overcome implementation barriers including but not limited to cost, necessary expertise, and lack of awareness. Cancer survivors can facilitate these efforts by partnering with their health care providers, cancer center, and local community organizations to raise awareness and champion these efforts. It will “take a village”, with cancer survivors being their own best advocate, to bring physical activity promotion to a broad range of cancer survivors.

Introduction:Compliance with 24-hour urine collections for assessing kidney stone risk is important in assigning preventive therapy. We determined factors associated with compliance and the...

PURPOSE/OBJECTIVE(S) The addition of cisplatin to radiation therapy (RT) results in improved outcomes in oropharyngeal head and neck cancer (OHNC) patients. This comes at the cost of increased toxicities over RT alone and often results in the inability to complete the initially prescribed chemotherapy regimen. In this study, potential predictors of chemotherapy completion and their effect on outcomes were investigated in OHNC patients treated at two different institutions. MATERIALS/METHODS We conducted a retrospective chart review of patients with OHNC at two different institutions. Patients were staged according to AJCC 8th Ed and separated into two groups: Completers (able to complete initially prescribed concurrent cisplatin regimen) and Non-Completers (unable to complete all prescribed cycles and/or required change to a different systemic therapy agent). Age, sex, race, ECOG, smoking status, HPV status, and stage were analyzed for ability to predict completion of chemotherapy regimen and for prognostic implication on outcomes. Overall survival (OS) and local control (LC) were calculated from start of RT. Chi-squared was used for associations, Kaplan-Meier estimates were compared using log-rank test, odds ratios (OR) and hazard ratios (HR) were generated from logistic and Cox regression analyses, respectively. RESULTS Between 2007 and 2019, 271 patients with OHNC were reviewed and included in the study. Most patients were Stage II (60%) and HPV positive (83%). More patients were Completers (61%) than Non-Completers (39%). Mean age was 56.6 years in Completers and 58.0 years in Non-Completers. Comparing Stage I to IV was the only significant predictor of chemotherapy completion (OR 6.139, 95% CI 1.43-26.35). HPV negative status trended towards significance for non-completion (OR 0.520 P = 0.061). Predictors of inferior OS were race (Non-White vs White) HR 2.520 P = 0.001; ECOG (2-3 vs 0-1) HR 2.324 P = 0.018; ever smoker (Yes vs No) HR 2.582 P = 0.001; HPV status (Negative vs Positive) HR 3.584 P < 0.001; and Stage (IV vs I) HR 5.983, 95% CI 1.38, 25.97. Inability to complete chemotherapy was not found to be a predictor of inferior survival (HR 0.737 P = 0.173). OS at 3 years was not statistically different between Completers (81%) and Non-Completers (77%), P = 0.404. LC at 3 years was not statistically different between Completers (93%) and Non-Completers (92%), P = 0.755. CONCLUSION In our study of OHNC patients who were mostly HPV positive and early stage, cancer stage was found to be the only significant predictor of chemotherapy completion. Chemotherapy completion was not found to be a predictor of outcome. Provided the Non-Completer group included those who had a change in systemic agent but may have completed the same total number of planned chemotherapy cycles, this study suggests the need for further multivariate analysis and potentially more upfront individualized chemotherapy regimens.

Background The rates of physical inactivity and related cancer incidence and mortality are disproportionately high in the Deep South region in the United States, a rural, medically underserved region with a large African American population compared with the rest of the nation. Given this region’s lower rates of literacy and internet access, interactive voice response (IVR) system–automated telephone-based interventions have the potential to help overcome physical activity intervention barriers (literacy, internet access, costs, and transportation) but have yet to be extended to rural, underserved populations, such as in the Deep South. Thus, extensive formative research is being conducted to develop and beta test the Deep South IVR System–Supported Active Lifestyle intervention in preparation for dissemination in rural Alabama counties. Objective This paper aims to describe the design and rationale of an ongoing efficacy trial of the Deep South IVR System–Supported Active Lifestyle intervention. Methods A two-arm randomized controlled trial will be conducted to compare a 12-month physical activity intervention versus a wait-list control condition in 240 underactive adults from 6 rural Alabama counties. The Deep South IVR System–Supported Active Lifestyle intervention is based on the Social Cognitive Theory and includes IVR-automated physical activity–related phone counseling (daily in months 0-3, twice weekly in months 4-6, and weekly in months 7-12) and support from local rural county coordinators with the University of Alabama O’Neal Comprehensive Cancer Center Community Outreach and Engagement Office. The primary outcome is weekly minutes of moderate- to vigorous-intensity physical activity (7-day physical activity recall; accelerometry) at baseline, 6 months, 12 months, and 18 months. Rural Active Living Assessments will be conducted in each rural county to assess walkability, assess recreational amenities, and inform future environment and policy efforts. Results This study was funded in March 2019 and approved by the institutional review board of the University of Alabama at Birmingham in April 2019. As of February 2020, start-up activities (hiring and training staff and purchasing supplies) were completed. Study recruitment and assessments began in September 2020 and are ongoing. As of February 2021, a total of 43 participants have been enrolled in Dallas County, 42 in Sumter County, and 51 in Greene County. Conclusions IVR-supported phone counseling has great potential for addressing physical activity barriers (eg, culture, literacy, cost, or transportation) and reducing related rural health disparities in this region. Trial Registration ClinicalTrials.gov NCT03903874; https://clinicaltrials.gov/ct2/show/NCT03903874. International Registered Report Identifier (IRRID) DERR1-10.2196/29245

Diet has been associated with several metabolic diseases and may impact immunity. Increased consumption of meals with high oxalate content may stimulate urinary calcium oxalate (CaOx) crystals, which are precursors to CaOx kidney stones. We previously reported that CaOx stone formers have decreased monocyte cellular bioenergetics compared to healthy participants and oxalate reduces monocyte metabolism and redox status in vitro. The purpose of this study was to investigate whether dietary oxalate loading impacts monocyte cellular bioenergetics, mitochondrial complex activity, and inflammatory signaling in humans. Healthy participants (n = 40; 31.1 ± 1.3 years) with a BMI of 24.9 ± 0.6 kg/m2 consumed a controlled low oxalate diet for 3 days before drinking a blended preparation of fruits and vegetables containing a large amount of oxalate. Blood and urine were collected before (pre-oxalate) and for 5 h after the oxalate load to assess urinary oxalate levels, monocyte cellular bioenergetics and mitochondrial complex activity, and plasma cytokine/chemokine levels. Urinary oxalate levels significantly increased in post-oxalate samples compared to pre-oxalate samples. Monocyte cellular bioenergetics, mitochondrial complex I activity, and plasma cytokine and chemokine levels were altered to varying degrees within the study cohort. We demonstrate for the first time that dietary oxalate loading may impact monocyte metabolism and immune response in a cohort of healthy adults, but these response are variable. Further studies are warranted to understand oxalate mediated mechanisms on circulating monocytes and how this potentially influences CaOx kidney stone formation.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT03877276.

Purpose Implementing efficacious physical activity interventions in real-world rural settings is needed because rural cancer survivors are more physically inactive and experience poorer health. To address this gap, this study evaluated effectiveness of an evidenced-based physical activity program (Better Exercise Adherence after Treatment for Cancer [BEAT Cancer]) for rural women cancer survivors when implemented by community-based, non-research staff. Methods 16 rural women cancer survivors received BEAT Cancer implemented by a rural, community organization and non-research staff; physical activity, patient-reported outcomes, and social cognitive constructs were measured at baseline and post-program. Cancer survivors and interventionists completed program evaluations post-program. Results Cancer survivor mean age was 58±12 years; 62% were White. Mean months since diagnosis was 54±72; 69% had breast cancer. Significant improvements from pre- to post-program occurred for self-report weekly minutes of moderate-to-vigorous physical activity (mean change [M] = 146±186, p = 0.009), anxiety (M = -1.3±1.8, p = 0.016), depression (M = -2.1±2.0, p = 0.001), self-efficacy (M = 20.9±30.5, p = 0.019), barriers interference (M = -15.0±14.1, p = 0.001), and social support (M = 5.0±7.4, p = 0.02). Cancer survivors ranked the program highly, identified strategies that were helpful (e.g., group activities, personalized exercise plan, etc.), and suggested additional implementation strategies (e.g., guide for home-based phase, etc.). Interventionists identified strategies (e.g., logistics, staff training and certification, cost, etc.) for enhancing organizational readiness for program delivery. Conclusion Evidence-based physical activity programs can be effective when implemented by non-research staff in rural settings. Further research testing strategies that improve implementation is needed. Practical implications Effectiveness and identified strategies supporting delivery when implemented by a rural organization can improve physical activity promotion for rural, at-risk populations.

BACKGROUND With the increasing number of older cancer survivors, it is imperative to optimize the reach of interventions that promote healthy lifestyles. Web-based delivery holds promise for increasing the reach of such interventions with the rapid increase in internet use among older adults. However, few studies have explored the views of middle-aged and older cancer survivors on this approach and potential variations in these views by gender or rural and urban residence. OBJECTIVE The aim of this study was to explore the views of middle-aged and older cancer survivors regarding the features of web-based healthy lifestyle programs to inform the development of a web-based diet and exercise intervention. METHODS Using a qualitative descriptive approach, we conducted 10 focus groups with 57 cancer survivors recruited from hospital cancer registries in 1 southeastern US state. Data were analyzed using inductive thematic and content analyses with NVivo (version 12.5, QSR International). RESULTS A total of 29 male and 28 female urban and rural dwelling Black and White survivors, with a mean age of 65 (SD 8.27) years, shared their views about a web-based healthy lifestyle program for cancer survivors. Five themes emerged related to program content, design, delivery, participation, technology training, and receiving feedback. Cancer survivors felt that web-based healthy lifestyle programs for cancer survivors must deliver credible, high-quality, and individually tailored information, as recommended by health care professionals or content experts. Urban survivors were more concerned about information reliability, whereas women were more likely to trust physicians’ recommendations. Male and rural survivors wanted information to be tailored to the cancer type and age group. Privacy, usability, interaction frequency, and session length were important factors for engaging cancer survivors with a web-based program. Female and rural participants liked the interactive nature and visual appeal of the e-learning sessions. Learning from experts, an attractive design, flexible schedule, and opportunity to interact with other cancer survivors in Facebook closed groups emerged as factors promoting program participation. Low computer literacy, lack of experience with web program features, and concerns about Facebook group privacy were important concerns influencing cancer survivors’ potential participation. Participants noted the importance of technology training, preferring individualized help to standardized computer classes. More rural cancer survivors acknowledged the need to learn how to use computers. The receipt of regular feedback about progress was noted as encouragement toward goal achievement, whereas women were particularly interested in receiving immediate feedback to stay motivated. CONCLUSIONS Important considerations for designing web-based healthy lifestyle interventions for middle-aged and older cancer survivors include program quality, participants’ privacy, ease of use, attractive design, and the prominent role of health care providers and content experts. Cancer survivors’ preferences based on gender and residence should be considered to promote program participation. CLINICALTRIAL

Background Although evidence-based interventions for increasing exercise among cancer survivors (CSs) exist, little is known about factors (e.g., implementation facilitators) that increase effectiveness and reach of such interventions, especially in rural settings. Such factors can be used to design implementation strategies. Hence, our study purpose was to (1) obtain multilevel perspectives on improving participation in and implementation of a multicomponent exercise behavior change intervention for rural women CSs and (2) identify factors important for understanding the context using the Consolidated Framework for Implementation Research (CFIR) for comparison across three levels (CSs, potential interventionists, community/organizational stakeholders). Methods We conducted three nominal group technique meetings with rural women CSs, three with community/organizational stakeholders, and one with potential interventionists. During each meeting, participants were asked to respond silently to one question asking what would make a multicomponent exercise intervention doable from intervention participation (CSs) or implementation (potential interventionists, stakeholders) perspectives. Responses were shared, discussed to clarify meaning, and prioritized by group vote. Data was deductively coded using CFIR. Results Mean age of CSs (n = 19) was 61.8 ± 11.1 years, community stakeholders (n = 16) was 45.9 ± 8.1 years, and potential interventionists (n = 7) was 41.7 ± 15.2 years. There was considerable consensus among CSs, potential interventionists, and stakeholders in terms of CFIR domains and constructs, e.g., “Design quality and packaging” (Innovation Characteristics), “Patients needs and resources” (Outer Setting), “Available resources” (Inner Setting), and “Engaging” (Process). However, participant-specific CFIR domains and constructs were also observed, e.g., CSs endorsed “Knowledge and beliefs about the intervention,” “Individual stage of change,” and “Self-efficacy” (Characteristics of Individuals); potential interventionists valued “Tension for change” (Inner Setting) and “Innovation participants” and “Key stakeholder” (Process); stakeholders emphasized “Goals and feedback” and “Network and communication” (Inner Setting), and “Planning” (Process). How the three participant levels conceptualized the CFIR constructs demonstrated both similarities and differences. Conclusions Multilevel input yielded diversity in type, relative priority, and conceptualization of implementation facilitators suggesting foci for future implementation strategy development and testing. Findings also reinforced the importance of multilevel implementation strategies for increasing exercise in an underserved, at-risk population.

(1) Background: Anthropometric and physical performance testing is commonly done in lifestyle research and is traditionally performed in-person. To expand the scalability of lifestyle interventions among cancer survivors, in-person assessments were adapted to remote means and evaluated for feasibility, safety, validity, and reliability. (2) Methods: Cancer survivors and supportive partners were approached to participate in three anthropometric and physical performance testing sessions (two remote/one in-person). Correlations, concordance, and differences between testing modes were evaluated. (3) Results: 110-of-112 individuals approached for testing participated (98% uptake); the sample was 78% female, 64% non-Hispanic White, of mean age 58 years and body mass index = 32.4 kg/m2. ICCs for remote assessments ranged from moderate (8’ walk = 0.47), to strong (8’ get-up-and-go = 0.74), to very strong (30 s chair stand = 0.80; sit-and-reach = 0.86; 2 min step test = 0.87; back scratch = 0.90; weight = 0.93; waist circumference = 0.98) (p-values < 0.001). Perfect concordance (100%) was found for side-by-side and semi-tandem balance, and 87.5–90.3% for tandem balance. No significant differences between remote and in-person assessments were found for weight, 8’ walk, and 8’ get-up-and-go. No adverse events occurred and 75% indicated no preference or preferred virtual testing to in-person. (4) Conclusions: Remote anthropometric and physical performance assessments are reliable, valid, acceptable, and safe among cancer survivors and supportive partners.

Background: Optimal treatment of nonoperative patients with large, node-negative non–small cell lung cancer (NSCLC) is poorly defined. Current NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) recommend definitive radiotherapy (RT) with or without sequential chemotherapy and do not include concurrent chemoradiotherapy (chemoRT) as a treatment option. In this study, we identified factors that predict nonadherence to NCCN Guidelines. Patients and Methods: Patients who received definitive RT for nonmetastatic, node-negative NSCLC with tumor size of 5 to 7 cm were identified in the National Cancer Database from 2004 through 2016. Patients were evaluated by RT type (stereotactic body RT [SBRT], hypofractionated RT [HFRT], or conventionally fractionated RT [CFRT]) and chemotherapy use (none, sequential, or concurrent with RT). Patients were classified as receiving NCCN-adherent (RT with or without sequential chemotherapy) or NCCN-nonadherent (concurrent chemoRT) treatment. Demographic and clinical factors were assessed with logistic regression modeling. Overall survival was evaluated with Kaplan-Meier, log-rank, and univariable/multivariable Cox proportional hazards regression analyses. Results: Among 2,020 patients in our cohort, 32% received NCCN-nonadherent concurrent chemoRT, whereas others received NCCN-adherent RT alone (51%) or sequential RT and chemotherapy (17%). CFRT was most widely used (64% CFRT vs 22% SBRT vs 14% HFRT). Multivariable analysis revealed multiple factors to be associated with NCCN-nonadherent chemoRT: age ≤70 versus >70 years (odds ratio [OR] , 2.72; PPP=.026). Survival was similar between the NCCN-nonadherent chemoRT and NCCN-adherent groups (hazard ratio, 1.00; P=.992) in multivariable analysis. Conclusions: A substantial proportion of inoperable patients with large, node-negative NSCLC are not treated according to NCCN Guidelines and receive concurrent chemoRT. Younger patients with larger tumors receiving treatment at nonacademic medical centers were more likely to receive NCCN-nonadherent therapy, but adherence to NCCN Guidelines was not associated with differences in overall survival.

The emphasis on team science in clinical and translational research increases the importance of collaborative biostatisticians (CBs) in healthcare. Adequate training and development of CBs ensure appropriate conduct of robust and meaningful research and, therefore, should be considered as a high-priority focus for biostatistics groups. Comprehensive training enhances clinical and translational research by facilitating more productive and efficient collaborations. While many graduate programs in Biostatistics and Epidemiology include training in research collaboration, it is often limited in scope and duration. Therefore, additional training is often required once a CB is hired into a full-time position. This article presents a comprehensive CB training strategy that can be adapted to any collaborative biostatistics group. This strategy follows a roadmap of the biostatistics collaboration process, which is also presented. A TIE approach (Teach the necessary skills, monitor the Implementation of these skills, and Evaluate the proficiency of these skills) was developed to support the adoption of key principles. The training strategy also incorporates a “train the trainer” approach to enable CBs who have successfully completed training to train new staff or faculty.

FMRI Montreal Imaging Stress Tasks (MIST) have been shown to activate endocrine and autonomic stress responses that are mediated by a prefrontal cortex (PFC)-hippocampus-amygdala circuit. However, the stability of the neurobehavioral responses over time and the ability to monitor response to clinical interventions has yet to be validated. The objective of this study was to compare the fMRI and physiologic responses to acute psychosocial stress in healthy volunteers during initial and follow-up visits approximately 13 weeks later, simulating a typical duration of clinical intervention. We hypothesized that responses to stress would remain highly conserved across the 2 visits in the absence of an intervention. 15 healthy volunteers completed a variant of control math task (CMT) and stress math task (SMT) conditions based on MIST. Neural responses were modeled using an event-related design with estimates for math performance and auditory feedback for each task condition. For each visit, measures of stress reactivity included differential fMRI and heart rate (SMT-CMT), as well as salivary alpha-amylase before and after scanning sessions. The results revealed that differential fMRI, as well as increased heart rate and salivary alpha-amylase from before and after scanning remained similar between visits. Intraclass correlation coefficient (ICC) values revealed areas of reliable task-dependent BOLD fMRI signal response across visits for peaks of clusters for the main effect of condition (SMT vs CMT) within dorsal anterior cingulate cortex (ACC), insula, and hippocampus regions during math performance and within subgenual ACC, posterior cingulate cortex, dorsolateral PFC regions during auditory feedback. Given that the neurobehavioral response to acute stress remained highly conserved across visits in the absence of an intervention, this study confirms the utility for MIST for assessing longitudinal changes in controlled trials that can identify underlying neurobiological mechanisms involved in mediating the efficacy of stress-reduction interventions.

It is very important for medical professionals and medical researchers to be literate in statistics. However, we have found that the degree of literacy that is required should not be identical for every statistical competency or even for every learner. We first begin by describing why the development, teaching, and assessment of statistical competencies for medical professionals and medical researchers are critical tasks. We next review our three substantial efforts at developing a comprehensive list of statistical competencies that can be used as a guide for what medical research learners should know about statistics, for curricular development, and for assessment of statistical education. We then summarize the origin and the inclusion of the statistical competency items. We follow this with a description of potential uses and applications of the statistical competencies to improve targeted learning for medical research learners. Finally, we discuss implications of the statistical competencies for undergraduate statistics education.

This study compares the effects of an 8-wk isocaloric high-protein (HP) diet versus a combination exercise (Comb-Ex) regimen on paralytic vastus lateralis (VL) and nonparalytic deltoid muscle in individuals with long-standing spinal cord injury (SCI). Fiber-type distribution, cross-sectional area (CSA), levels of translation initiation signaling proteins (Erk-1/2, Akt, p70S6K1, 4EBP1, RPS6, and FAK), and lean thigh mass were analyzed at baseline and after the 8-wk interventions. A total of 11 participants (C5-T12 levels, 21.8 ± 6.3 yr postinjury; 6 Comb-Ex and 5 HP diet) completed the study. Comb-Ex training occurred 3 days/wk and consisted of upper body resistance training (RT) in addition to neuromuscular electrical stimulation (NMES)-induced-RT for paralytic VL muscle. Strength training was combined with high-intensity arm-cranking exercises (1-min intervals at 85–90%, V̇o2peak) for improving cardiovascular endurance. For the HP diet intervention, protein and fat each comprised 30%, and carbohydrate comprised 40% of total energy. Clinical tests and muscle biopsies were performed 24 h before and after the last exercise or diet session. The Comb-Ex intervention increased Type IIa myofiber distribution and CSA in VL muscle and Type I and IIa myofiber CSA in deltoid muscle. In addition, Comb-Ex increased lean thigh mass, V̇o2peak, and upper body strength ( P < 0.05). These results suggest that exercise training is required to promote favorable changes in paralytic and nonparalytic muscles in individuals with long-standing SCI, and adequate dietary protein consumption alone may not be sufficient to ameliorate debilitating effects of paralysis. NEW & NOTEWORTHY This study is the first to directly compare the effects of an isocaloric high-protein diet and combination exercise training on clinical and molecular changes in paralytic and nonparalytic muscles of individuals with long-standing spinal cord injury. Our results demonstrated that muscle growth and fiber-type alterations can best be achieved when the paralyzed muscle is sufficiently loaded via neuromuscular electrical stimulation-induced resistance training.

This abstract was withdrawn by the authors.

Background During the COVID-19 pandemic, in-person research assessments needed to be adapted to ensure safety of participants and staff. Participants' willingness to participate in research activities, how to prepare assessors to ensure data integrity, and the feasibility of modified protocols, were unknown. Within the AMPLIFI randomized clinical trial (RCT) for cancer survivors, we elicited participants' preferences and willingness to participate in Clinic, Home, or Virtual assessments, prepared assessors for, and implemented virtual assessments. Methods 1) We conducted phone surveys of potential AMPLIFI participants; 2) Based on survey results, we modified assessments from in-person to virtual visits (VV) by videoconference. Assessors were trained and certified, i.e., assessors recorded 3 assessments that were reviewed and scored by 2 investigators. The modified protocol was proposed to 62 participants: we report numbers of those who agreed to attend VV. Results 1) Survey results: Among 74 survey respondents, 44.6% preferred, 75.7% were willing to attend Clinic Visits; 32.4% preferred, 83.8% were willing to do VV; 23% preferred, 77% were willing to do Home Visits. Survivors 70+ were less likely than 50-69 years old to be willing to do VV: no other differences were noted by gender, race, rural status or education. 2) Assessment uptake: 66.1% agreed to attend VV, and of them 75.6% completed them. Conclusion Diverse research participants adapted to protocols that prioritize their safety, although older participants may be reluctant to do virtual assessments. Virtual assessments are feasible and research teams can rigorously prepare to collect quality data through them.

Background With the increasing number of older cancer survivors, it is imperative to optimize the reach of interventions that promote healthy lifestyles. Web-based delivery holds promise for increasing the reach of such interventions with the rapid increase in internet use among older adults. However, few studies have explored the views of middle-aged and older cancer survivors on this approach and potential variations in these views by gender or rural and urban residence. Objective The aim of this study was to explore the views of middle-aged and older cancer survivors regarding the features of web-based healthy lifestyle programs to inform the development of a web-based diet and exercise intervention. Methods Using a qualitative descriptive approach, we conducted 10 focus groups with 57 cancer survivors recruited from hospital cancer registries in 1 southeastern US state. Data were analyzed using inductive thematic and content analyses with NVivo (version 12.5, QSR International). Results A total of 29 male and 28 female urban and rural dwelling Black and White survivors, with a mean age of 65 (SD 8.27) years, shared their views about a web-based healthy lifestyle program for cancer survivors. Five themes emerged related to program content, design, delivery, participation, technology training, and receiving feedback. Cancer survivors felt that web-based healthy lifestyle programs for cancer survivors must deliver credible, high-quality, and individually tailored information, as recommended by health care professionals or content experts. Urban survivors were more concerned about information reliability, whereas women were more likely to trust physicians’ recommendations. Male and rural survivors wanted information to be tailored to the cancer type and age group. Privacy, usability, interaction frequency, and session length were important factors for engaging cancer survivors with a web-based program. Female and rural participants liked the interactive nature and visual appeal of the e-learning sessions. Learning from experts, an attractive design, flexible schedule, and opportunity to interact with other cancer survivors in Facebook closed groups emerged as factors promoting program participation. Low computer literacy, lack of experience with web program features, and concerns about Facebook group privacy were important concerns influencing cancer survivors’ potential participation. Participants noted the importance of technology training, preferring individualized help to standardized computer classes. More rural cancer survivors acknowledged the need to learn how to use computers. The receipt of regular feedback about progress was noted as encouragement toward goal achievement, whereas women were particularly interested in receiving immediate feedback to stay motivated. Conclusions Important considerations for designing web-based healthy lifestyle interventions for middle-aged and older cancer survivors include program quality, participants’ privacy, ease of use, attractive design, and the prominent role of health care providers and content experts. Cancer survivors’ preferences based on gender and residence should be considered to promote program participation.

Summary Introduction The incidence of pediatric urolithiasis has been increasing over the years; however, the etiology of this increase is not well understood. Age, body mass index, and gender have been examined as possible risk factors for stone disease, but with inconsistent and variable associations. Objective We aim to investigate the urine chemistry factors, as assessed by 24-h urinary parameters, in pediatric stone formers at a large volume tertiary referral center in the highest areas in the United States, the Southeast, based on age, body mass index, and gender. Study design We retrospectively reviewed all pediatric stone formers who completed a 24-h study between 2005 and 2016. Patients were stratified by age (3–10 versus 11–18 years of age), overweight status (above versus below the 85th percentile for body mass index), and gender (male versus female) (Summary Figure). Statistical analysis included analysis of variance and logistic regression. Results 243 patients were included in our analysis. Patients in the first decade of life were found to have greater numbers of urinary risk factors than those in the second decade. Non-overweight patients were more likely to have hyperoxaluria and hyperuricosuria, while overweight patients were more likely to have hypocitraturia. Female patients were more likely to have higher hyperoxaluria, while male patients were more likely to have hypercalciuria. Discussion In contrast to prior publications, obesity is not linked to increased risk of urolithiasis with non-overweight individuals having a greater number of risk factors than the overweight cohort. Despite stone disease being more prevalent in adolescents, the greatest number of risk factors were present in the first decade of life. Lastly, female children had more urinary risk factors than males. Further understanding of the underlying causes of stone disease in various pediatric populations is warranted. Conclusion While more urinary risk factors were identified in younger, non-overweight, and female patients, there remains no consensus on the urinary risk factors for pediatric urolithiasis. Further study is needed to elucidate the risk factors and pathophysiology of pediatric stone disease.