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Rationale: Advanced practice physiotherapy roles (Advanced Physiotherapy Practitioners [APPs] and First Contact Physiotherapists [FCPs]) are pivotal in supporting patients to manage their musculoskeletal (MSK) conditions. Having a greater understanding of how decisions are made by these practitioners will inform competency frameworks and improve the provision of patient-centred care., Aim: To evaluate the current knowledge, views and use of shared decision-making in MSK advanced physiotherapy practice in the United Kingdom., Methods: A cross-sectional survey using an online questionnaire was used to collect demographic information, knowledge, views and self-reported use of shared decision-making (SDM) of APPs and FCPs who work with adults with MSK disorders in the United Kingdom., Results: Responses from 49 participants (25 APPs and 24 FCPs) were included in the study. In total, 80% of participants had received SDM training and overall high levels of knowledge were shown. Only 12% of participants used a communication model to facilitate SDM. In total, 80% of participants reported making decisions together with the patient either always or most of the time. FCPs favoured a more patient-led approach to decision-making compared to APPs who favoured collaborative decision-making. The most commonly reported barriers to SDM included lack of time, lack of patient education resources, lack of access to patient decision aids and treatment pathway restrictions., Conclusions: The responses in this study showed that overall APPs and FCPs have good knowledge of SDM and report routine use of collaborative and patient-led decision-making approaches., (© 2024 The Author(s). Journal of Evaluation in Clinical Practice published by John Wiley & Sons Ltd.)

Purpose: Patient navigation is a recommended practice to improve cancer screenings among underserved populations including those residing in rural areas with care access barriers. We report on patient navigation programme adaptations to increase follow-up colonoscopy rates after abnormal fecal testing in rural primary care practices., Methods: Participating clinics delivered a patient navigation programme to eligible patients from 28 affiliated clinics serving rural communities in Oregon clustered within 3 Medicaid health plans. Patient navigation adaptations were tracked using data sources including patient navigation training programme reflections, qualitative interviews, clinic meetings, and periodic reflections with practice facilitators., Findings: Initial, planned (proactive) adaptations were made to address the rural context; later, unplanned (reactive) adaptations were implemented to address the impact of the COVID-19 global pandemic. Initial planned adaptations to the patient navigation programme were made before the main trial to address the needs of the rural context, including provider shortages and geographic dispersion limiting both patient access to care and training opportunities for providers. Later unplanned adaptations were made primarily in response to COVID-19 care suspension and staff redeployments and shortages that occurred during implementation., Conclusion: While unplanned adaptations were implemented to address the contextual impact of the COVID-19 pandemic on care access patterns and staffing, the changes to training content and context were beneficial to the rural setting overall and should be sustained. Our findings can guide future efforts to optimise the success of such programmes in other rural settings and highlight the important role of adaptations in implementation projects., (© 2024 John Wiley & Sons Ltd.)

The ketogenic diet (KD) is a high-fat, low-carbohydrate diet that results in the elevation of serum ketone bodies, known as ketosis. This metabolic consequence has been suggested as a method for treating neurological conditions, improving exercise performance, and facilitating weight loss for overweight individuals. However, since most research primarily uses male populations, little is known about the potential sex differences during the consumption of the KD. In addition, the effects of the KD on aging are relatively unexplored. Therefore, the purpose of this study was to explore sex- and age-specific differences in mice fed the KD. Male and female C57BL/6N mice at either 12 wks or 24 wks of age were randomly assigned to a KD (90% fat, 1% carbohydrate) or chow (13% fat, 60% carbohydrate) group for 6 wks. KD induced weight gain, increased adiposity, induced hyperlipidemia, caused lipid accumulation in the heart and liver, and led to glycogen depletion in the heart, liver, and muscle with varying degrees of changes depending on age and sex. While younger and older male mice on the KD were prone to glucose intolerance, the KD acutely improved rotarod performance in younger females. Overall, this study highlights potential sex and aging differences in the adaptation to the KD.

Patient navigation (PN) has been shown to improve participation in cancer screening, including colorectal cancer screening, and is now a recommended practice by the Community Preventive Services Task Force. Despite the effectiveness of PN programs, little is known about the number of contacts needed to successfully reach patients or about the demographic and healthcare utilization factors associated with reach. PRECISE was an individual randomized study of PN versus usual care conducted as a partnership between two large health systems in the Pacific Northwest. The navigation program was a six-topic area telephonic program designed to support patients with an abnormal fecal test result to obtain a follow-up colonoscopy. We report the number of contact attempts needed to successfully reach navigated patients. We used logistic regression to report the demographic and healthcare utilization characteristics associated with patients allocated to PN who were successfully reached. We identified 1,200 patients with an abnormal fecal immunochemical test result, of whom 970 were randomized into the study (45.7% were female, 17.5% were Spanish-speaking, and the mean age was 60.8 years). Of the 479 patients allocated to the PN intervention, 382 (79.7%) were reached within 18 call attempts, and nearly all (n = 356; 93.2%) were reached within six contact attempts. Patient characteristics associated with reach were race, county of residence, and body mass index. Our findings can guide future efforts to optimize the reach of PN programs. Prevention Relevance: The findings from this large study can inform clinic-level implementation of future PN programs in Federally Qualified Health Centers to improve the reach of patients needing cancer screenings, optimize staff resources, and ultimately increase cancer screenings., (©2024 American Association for Cancer Research.)

Background: Physical activity (PA) is essential following an acute cardiac event. Cardiac rehabilitation (CR) is commonly prescribed, and PA after CR is recommended. Because of age-related changes in functional ability and multi-comorbidity, many older cardiac patients struggle to continue performing PA at home after CR. Depressive symptoms and anxiety are prevalent in cardiac patients and associated with poor self-care, including lack of daily PA. Yoga has been demonstrated to improve psychological and physical health outcomes in cardiac patients, but it is unknown whether yoga, modified for older CR patients - Gentle Yoga - is beneficial in managing psychological distress and maintaining PA following phase II CR. Our specific aims are to:1) determine the feasibility and acceptability of a modified gentle yoga intervention delivered via video conferencing for older cardiac patients; 2) compare, at 3-month follow-up, the effects and determine effect sizes of a gentle yoga intervention versus control on psychological health and physical health., Methods: We are conducting a 2-group (intervention versus control) randomized controlled pilot study. The intervention is a 12-week gentle yoga program delivered via video conference. Short-term effects will be evaluated at 3-month., Conclusion: This study is designed to be suited for older cardiac patients who would not have access to supervised PA opportunities after facility-based CR to enhance PA. This study will provide data about the feasibility and acceptability of the protocol for older cardiac patients and will offer effect sizes to determine sample size for a fully powered randomized controlled trial., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Background: Family caregivers are at higher risk for developing cardiovascular disease (CVD) than non-caregivers. This risk is worse for those who live in rural compared to urban areas. Health activation, an indicator of engagement in self-care, is predictive of health outcomes and CVD risk in several populations. However, it is not known whether health activation is associated with CVD risk in rural caregivers of patients with chronic illnesses nor is it clear whether sex moderates any association., Objectives: Our aims were to determine (1) whether health activation independently predicts 10-year CVD risk; and (2) whether sex interacts with health activation in the prediction of 10-year CVD risk among rural family caregivers (N = 247) of patients with chronic illnesses., Methods: Health activation was measured using the Patient Activation Measure. The predicted 10-year risk of CVD was assessed using the Framingham Risk Score. Data were analyzed using nonlinear regression analysis., Results: Higher levels of health activation were significantly associated with decreased risk of developing CVD (p < 0.028). There was no interaction of sex with health activation on future CVD risk. However, male caregivers had greater risk of developing CVD in the next 10 years than female caregivers (p < 0.001)., Conclusions: We demonstrated the importance of health activation to future CVD risk in rural family caregivers of patients with chronic illnesses. We also demonstrated that despite the higher risk of future CVD among male, the degree of association between health activation and CVD risk did not differ by sex., (© 2024 National Rural Health Association.)

Background: Health-related quality of life (HRQoL) is poor in patients with heart failure. Psychological (ie, depressive symptoms [DS], anxiety, and perceived control) and physical (ie, functional status) factors are associated with HRQoL. The dynamic relationships among these variables and their impact on HRQoL remain unclear, limiting the ability to design effective interventions., Purpose: Our aim was to evaluate a moderated mediation model, in which the association between perceived control and HRQoL was hypothesized to be mediated by DS and anxiety in the presence of a moderator, functional status., Methods: Patients (N = 426) with heart failure completed the Control Attitudes Scale-Revised to measure perceived control, Duke Activity Status Index for functional status, Patient Health Questionnaire-9 for DS, Brief Symptom Inventory for anxiety, and Minnesota Living with Heart Failure Questionnaire for HRQoL. We performed a moderated parallel mediation analysis., Results: Higher levels of perceived control were associated with better HRQoL through lower levels of anxiety and DS in the presence of functional status (index of moderated mediation for DS, b = 0.029; 95% confidence interval, 0.016-0.045; for anxiety: b = 0.009, 95% confidence interval, 0.002-0.018). The effect of perceived control on psychological symptoms was stronger at low and moderate functional statuses; however, this effect diminished with increasing functional status., Conclusion: Functional status moderated the indirect effects of perceived control on HRQoL through DS and anxiety in patients with heart failure. Efforts to improve HRQoL by targeting perceived control may be more effective when considering DS and anxiety in patients with low to moderate levels of functional status., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Clinicians and researchers often assume that symptom burden is associated with self-care management (SCM) in patients with heart failure (HF). However, that association is often not borne out in simple regression analyses and may be because another variable mediates the association. Fatalism is an appropriate candidate for mediation and is the belief that circumstances are predetermined without opportunity for control by individuals., Objective: Our objective was to determine whether fatalism mediated the relationship of symptom burden with SCM among adults with HF., Methods: We conducted a secondary analysis (N = 95) from a clinical trial. We used Self-care of HF Index to measure SCM, the Memorial Symptom Assessment Scale-HF for symptom burden, and the Cardiovascular Disease Fatalism Instrument to measure fatalism. We used the PROCESS macro to evaluate mediation., Results: Symptom burden was not directly associated with SCM (effect coefficient [ C '] = 0.0805; 95% confidence interval, -0.048 to 0.209; P = .217). There was, however, an indirect pathway between symptom burden and SCM through fatalism ( ab = -0.040; 95% confidence interval, -0.097 to -0.002). Those with higher symptom burden were more fatalistic ( a = 0.004, P = .015), and greater fatalism was associated with worse SCM ( b = -9.132, P = .007)., Conclusion: Symptom burden, not directly associated with SCM, is associated through the mediator of fatalism. Interventions to improve SCM should include strategies to mitigate fatalistic views. Self-care management interventions should focus on promoting internal locus of control or increasing perceptions of perceived control to decrease fatalism and improve engagement in self-care., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding notifications to mailed FIT programs., Methods: We conducted secondary analyses of a stepped-wedge evaluation of an enhanced mailed FIT program (n = 15 clinics). Patients were stratified by prior FIT completion. Those with prior FIT were sent a text message (Group 1); those without were randomized 1:1 to receive a text message (Group 2) or live phone call (Group 3). All groups were sent automated phone call reminders. In stratified analysis, we measured reach and effectiveness (FIT completion within 6 months) and assessed patient-level associations using generalized estimating equations., Results: Patients (n = 16,934; 83% Latino; 72% completed prior FIT) were reached most often by text messages (78%), followed by live phone calls (71%), then automated phone calls (56%). FIT completion was higher in patients with prior FIT completion versus without [44% (Group 1) vs. 19% (Group 2 + Group 3); P < 0.01]. For patients without prior FIT, effectiveness was higher in those allocated to a live phone call [20% (Group 3) vs. 18% (Group 2) for text message; P = 0.04] and in those who personally answered the live call (28% vs. 9% no call completed; P < 0.01)., Conclusions: Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call., Impact: Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion., (©2024 American Association for Cancer Research.)

Colorectal cancer (CRC) is a leading cause of cancer death in the US. Screening by fecal immunochemical test (FIT) is a strategy to lower CRC rates. Unfortunately, only half of patients with an abnormal FIT result complete the follow-up colonoscopy, an essential component of screening. We used virtual Boot Camp Translation (BCT), to elicit input from partners to develop messaging/materials to motivate patients to complete a follow-up colonoscopy. Participants were Hispanic, ages 50 to 75 years, and Spanish-speaking. All materials were developed in English and Spanish. The first meeting included expert presentations that addressed colorectal health. The two follow-up sessions obtained feedback on messaging/materials developed based on themes from the first meeting. Ten participants attended the first meeting and eight attended the follow-up sessions. The two key barriers to follow-up colonoscopy after abnormal FIT noted by participants were (a) lack of colonoscopy awareness and (b) fear of the colonoscopy procedure. We learned that participants valued simple messaging to increase knowledge and alleviate concerns, patient-friendly outreach materials, and increased access to health information. Using virtual BCT, we included participant feedback to design culturally relevant health messages to promote follow-up colonoscopy after abnormal fecal testing among Hispanic patients served by community clinics., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: From 2020 – present, Dr. Coronado serves as a Scientific Advisor on contracts through the Center for Health Research for Exact Sciences and Guardant Health. All other authors declare no conflicts of interest.

Background: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost., Methods: PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs., Results: The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient., Conclusions: Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost., Impact: Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults., (©2023 American Association for Cancer Research.)

Colorectal cancer (CRC) is a leading cause of cancer death in the USA. Screening programs in federally qualified health centers (FQHCs) are essential to reducing CRC-related mortality and morbidity among underserved populations. Centralized, population-based mailed fecal immunochemical test (FIT) programs can improve CRC screening rates, but barriers to implementation remain. We qualitatively explored barriers and facilitators to implementation of a mailed FIT program at a large, urban FQHC that employed advance notification "primers" (live calls and texts) and automated reminders. We interviewed 25 patients and 45 FQHC staff by telephone about their experience with the program. Interviews were transcribed, coded, and content analyzed using NVivo.12. Patients and staff found advance notifications conveyed through live phone calls or text messages to be acceptable and motivational for FIT completion. Live phone primers were helpful in addressing patients' questions and misconceptions about screening, particularly for patients new to screening. Advance notifications sent by text were considered timely and useful in preparing patients for receipt of the FIT. Barriers to implementation included lack of receipt of primers, reminders, or the mailed FIT itself due to inaccurate patient contact information within the FQHC medical record; lack of systems for documenting mailed FIT outreach to coordinate with clinical care; and lack of local caller identification for primers and reminders. Our findings demonstrate that an enhanced mailed FIT program using primers and reminders was acceptable. Our findings can help other FQHCs implement and optimize their mailed FIT programs., (© Society of Behavioral Medicine 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative., Methods: We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation., Results: ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs., Conclusions: Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice., (© The Author(s) 2023. Published by Oxford University Press.)

Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Through contracts with Kaiser Permanente Center for Health Research, Dr. Coronado served as a scientific advisor for Exact Sciences (2020 – 2023) and as Principal Investigator on a project funded by Guardant Health to assess the adherence to a commercially available blood test for colorectal cancer (2022 – 2024). All other authors have declared that no competing interests exist.

Introduction: In partnership with a federally qualified health center (FQHC), an adapted virtual version of boot camp translation (BCT) was used to elicit input from Spanish-speaking Latino patients and staff to develop messaging and patient education materials for follow-up colonoscopy after abnormal fecal testing. We describe how we adapted an existing in-person BCT process to be delivered virtually and present evaluations from participants on the virtual format., Methods: Three virtual BCT sessions were facilitated by bilingual staff and conducted via Zoom. These sessions included introductions and discussions on colorectal cancer (CRC), CRC screening, and gathered feedback from participants on draft materials. Ten adults were recruited from the FQHC. A research team member from the FQHC served as the point of contact (POC) for all participants and offered Zoom introductory sessions and/or technology support before and during the sessions. Following the third session, participants were invited to complete an evaluation form about their virtual BCT experience. Using a 5-point Likert Scale (where 5 = strongly agree), questions focused on session utility, group comfort level, session pacing, and overall sense of accomplishment., Results: Average scores ranged from 4.3 to 5.0 indicating strong support towards the virtual BCT sessions. Additionally, our study emphasized the importance of a POC to provide technical support to participants throughout the process. Using this approach, we successfully incorporated feedback from participants to design culturally relevant materials to promote follow-up colonoscopy., Conclusion: We recommend ongoing public health emphasis on the use of virtual platforms for community engaged work., (© 2023. The Author(s).)

Background: Perceived control, an indicator of the patient's ability to cope and thrive with a chronic illness, is a common target of nursing interventions. As of 2019, more than 25 000 patients had been implanted with a left ventricular assist device (LVAD) as a treatment of advanced heart failure. Patients with an LVAD experience significant life changes that affect anxiety, depression, health-related quality of life, and, presumably, perceived control. To adequately intervene and improve perceived control, a reliable and valid measure is needed., Objectives: The objectives of this analysis were to (1) assess item discrimination and anticipated range of scores of the Control Attitudes Scale-Revised (CAS-R), (2) assess the internal consistency and validity of the CAS-R, and (3) examine perceived control in a sample of patients with an LVAD., Methods: Two cohorts of patients with an LVAD (n = 113) were combined to evaluate the psychometric qualities of the CAS-R. Correlations among patient-reported outcomes and perceived control were used to evaluate validity. Cronbach α was used to test internal consistency. Item response theory was used to measure item discrimination and anticipated scores. Descriptive statistics describe perceived control in the sample., Results: Overall, the CAS-R demonstrated good internal consistency and convergent validity with other patient-reported outcomes. Using the item response theory, we saw that the CAS-R was a good predictor of lower-moderate scorers but was not good at differentiating high performers. There were several items that were poor discriminators and could be altered or discarded to create a more predictive instrument., Conclusions: The CAS-R is a valid and reliable instrument to measure perceived control in patients who have LVAD implants; however, more work could be done to improve item-level information., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Aims: Dyspnoea is a common symptom of heart failure (HF) that often prompts patients to seek treatment. Implantation of a left ventricular assist device (LVAD) has been associated with reduced dyspnoea but it is unclear if all patients experience similar improvements in dyspnoea over time following LVAD implantation. Our aim was to identify distinct trajectories of dyspnoea symptoms over time following LVAD implantation and predictors of dyspnoea trajectory. We hypothesized that at least two, distinct trajectories of dyspnoea would be observed following LVAD implantation., Methods and Results: This was a secondary analysis of data from the Profiling Biobehavioral Responses to Mechanical Support in Advanced Heart Failure study. In the parent study, sociodemographic and clinical data were collected prior to LVAD implantation and at 1, 3, and 6 months following LVAD implantation from a sample (n = 101) of patients with advanced HF. Latent growth mixture modelling was performed to identify distinct trajectories of dyspnoea symptoms. Backwards stepwise logistic regression was used to identify predictors of dyspnoea trajectory. Two, distinct trajectories of dyspnoea symptoms were identified: sustained improvement and unsustained improvement. Participants who experienced sustained improvement (86.7% of sample) demonstrated large, significant improvement in dyspnoea from pre-implantation to 3 months post-implant followed by smaller, non-significant improvement from 3 to 6 months. Participants who experienced unsustained improvement (13.3% of sample) demonstrated initial improvement from pre-implantation to 3 months post-implantation followed by worsening of dyspnoea from 3 to 6 months. Greater depressive symptoms at baseline and living alone were significant predictors of unsustained improvement., Conclusion: Patients experience different patterns of dyspnoea over time following LVAD implantation. Clinicians should inquire about living arrangements and depressive symptoms at each visit to determine risk of unsustained improvement in dyspnoea., Competing Interests: Conflict of interest: C.V.C. is a consultant for Abbott and is on the Steering Committee for Boston Scientific., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2022. For permissions, please email: journals.permissions@oup.com.)

Although exercise training is an important recommendation for the management of type 1 diabetes (T1D), most of the available research studies predominantly focus on male subjects. Given the importance of sex as a biological variable, additional studies are required to improve the knowledge gap regarding sex differences in T1D research. Therefore, the purpose of this study was to examine the role of exercise training in mediating changes in glucose homeostasis and skeletal muscle metabolism in T1D female mice. Female mice were injected with streptozotocin (STZ) to induce T1D. Two weeks after STZ injection, control (CON) and STZ mice were exercise trained on a treadmill for 4 weeks. Aerobic exercise training failed to improve glucose tolerance, prevent the decrease in body weight and adipose tissue mass, or attenuate muscle atrophy in T1D female mice. However, insulin sensitivity was improved in T1D female mice after exercise training. Aerobic exercise training maintained skeletal muscle triglyceride content but did not prevent depletion of skeletal muscle or liver glycogen in T1D mice. Gene expression analysis suggested that T1D resulted in decreased glucose transport, decreased ketone body oxidation, and increased fatty acid metabolism in the skeletal muscle, which was not altered by exercise training. These data demonstrate that 4 weeks of aerobic exercise training of a moderate intensity is insufficient to counteract the negative effects of T1D in female mice, but does lead to an improvement in insulin sensitivity.

Objective: To characterize and explain variation in the comparative effectiveness of self-care interventions on relevant outcomes of chronic illness compared with controls., Design: Meta-analysis and meta-regression., Methods: Data extraction was framed within the context of a previously-published scoping review of randomized trials designed to enhance self-care in type 2 diabetes mellitus, heart failure, hypertension, asthma, coronary artery disease, and chronic obstructive pulmonary disease (published between 2008 and 2019). Data were pooled using random-effects meta-analyses. Meta-regression was used to test the effect of potential moderators on trial effectiveness., Results: 145 trials involving 36,853 participants were included. Overall, the effect size of self-care interventions on improving outcomes was small (Hedges' g = 0.29 (95% CI = 0.25-0.33), p < 0.001) with statistically significant heterogeneity across trials (Q = 514.85, p < 0.001, I 2  = 72.0%). A majority of trials (n = 83, 57.2%) were rated as having a high risk of bias. There was no statistically significant difference in trial effectiveness based on the use of theory, specific components of self-care addressed, the number of modes of delivery, the number of behavioral change techniques, specific modes of delivery, specific behavioral change techniques, intervention duration, total number of hours of intervention, or either participant age or gender., Conclusions: Self-care interventions are modestly effective in improving outcomes. Poor trial quality limits the strength of conclusions in this area of science. There is much to be done to enhance the design, conduct and reporting of self-care trials in order to gain more insight into the effectiveness of self-care interventions., Tweetable Abstract: New review highlights poor trial design as major impediment to understanding the contribution of self -care to outcomes in chronic illness., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Screening reduces incidence and mortality from colorectal cancer (CRC), yet US screening rates are low, particularly among Medicaid enrollees in rural communities. We describe a two-phase project, SMARTER CRC, designed to achieve the National Cancer Institute Cancer Moonshot SM objectives by reducing the burden of CRC on the US population. Specifically, SMARTER CRC aims to test the implementation, effectiveness, and maintenance of a mailed fecal test and patient navigation program to improve rates of CRC screening, follow-up colonoscopy, and referral to care in clinics serving rural Medicaid enrollees., Methods: Phase I activities in SMARTER CRC include a two-arm cluster-randomized controlled trial of a mailed fecal test and patient navigation program involving three Medicaid health plans and 30 rural primary care practices in Oregon and Idaho; the implementation of the program is supported by training and practice facilitation. Participating clinic units were randomized 1:1 into the intervention or usual care. The intervention combines (1) mailed fecal testing outreach supported by clinics, health plans, and vendors and (2) patient navigation for colonoscopy following an abnormal fecal test result. We will evaluate the effectiveness, implementation, and maintenance of the intervention and track adaptations to the intervention and to implementation strategies, using quantitative and qualitative methods. Our primary effectiveness outcome is receipt of any CRC screening within 6 months of enrollee identification. Our primary implementation outcome is health plan- and clinic-level rates of program delivery, by component (mailed FIT and patient navigation). Trial results will inform phase II activities to scale up the program through partnerships with health plans, primary care clinics, and regional and national organizations that serve rural primary care clinics; scale-up will include webinars, train-the-trainer workshops, and collaborative learning activities., Discussion: This study will test the implementation, effectiveness, and scale-up of a multi-component mailed fecal testing and patient navigation program to improve CRC screening rates in rural Medicaid enrollees. Our findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings., Trial Registration: Registered at clinicaltrial.gov ( NCT04890054 ) and at the NCI's Clinical Trials Reporting Program (CTRP #: NCI-2021-01032) on May 11, 2021., (© 2022. The Author(s).)

Aims: Left ventricular assist devices (LVAD) are used to treat advanced heart failure, and the use of these devices in ever increasing, with over 19 000 people having had a device. However, during device therapy over 50% of patients will have some type of major adverse event. The aim of this study was to examine whether having a major adverse event, including major infection and major bleed, would alter patient-reported outcomes over time, including depressive symptoms and health-related quality of life., Methods and Results: T-tests and χ2 analyses were used to determine significant differences between patients who had an adverse event and those who did not. Latent curve growth modelling was used to evaluate change over time in those patients with and without and adverse event. The only difference between those with and without an adverse event was pre-implant depressive symptoms and health-related quality of life. The trajectories of both groups were also similar, with only differences at the pre-implant time point., Conclusion: In response to an adverse event occurring post-LVAD implantation, we found that patient-reported outcomes, including depressive symptoms and health-related quality of life were not significantly impacted., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

This paper explores the potential of rAAV2-retro to deliver gene modifying cargoes to the cells of origin of multiple pathways that are interrupted by spinal cord injury (SCI), summarizing data from previous studies and new data from additional experiments. rAAV-retro exhibits uniquely robust and reliable long-distance retrograde transport from pre-terminal axons and synapses back to neuronal bodies. Previous studies have documented that various AAV-based genetic modifications can enable axon regeneration after SCI, but these have targeted the cells of origin of one pathway at a time. In contrast, rAAV-retro can simultaneously transduce large numbers of neurons of origin of multiple spinal pathways with single injections into the spinal cord. Our initial studies use Rosa tdTomato and double transgenic PTEN f/f ; Rosa tdTomato mice in which transfection with rAAV-retro/Cre deletes PTEN and activates tdT expression in the same neurons. Injections of rAAV-retro/Cre into the cervical, thoracic and lumbar spinal cord led to topographically specific retrograde transduction in cortical motoneurons and neurons in subcortical regions that give rise to different spinal pathways. Our results confirm and extend previous studies indicating selective transduction of neurons that terminate at the level of the injection with minimal retrograde transduction of axons in transit to lower levels. We document feasibility of using rAAV-retro expressing shRNA against PTEN along with a GFP reporter (rAAV-retro-shPTEN/GFP) to effectively knock down PTEN in multiple populations of neurons, which can be used in any species. Some limitations and caveats of currently available rAAV-retros are discussed. Together, our results support the potential applications of rAAV-retro for AAV-based gene-modifications for SCI., (Copyright © 2021. Published by Elsevier Inc.)

Purpose: Mailed fecal immunochemical test (FIT) programs can facilitate colorectal cancer (CRC) screening. We sought to identify modifiable, clinic-level factors that distinguish primary care clinics with higher vs lower FIT completion rates in response to a centralized mailed FIT program., Methods: We used baseline observational data from 15 clinics within a single urban federally qualified health center participating in a pragmatic trial to optimize a mailed FIT program. Clinic-level data included interviews with leadership using a guide informed by the Consolidated Framework for Implementation Research (CFIR) and FIT completion rates. We used template analysis to identify explanatory factors and configurational comparative methods to identify specific combinations of clinic-level conditions that uniquely distinguished clinics with higher and lower FIT completion rates., Results: We interviewed 39 clinic leaders and identified 58 potential explanatory factors representing clinic workflows and the CFIR inner setting domain. Clinic-level FIT completion rates ranged from 30% to 56%. The configurational model for clinics with higher rates (≥37%) featured any 1 of the following 3 factors related to support staff: (1) adding back- or front-office staff in past 12 months, (2) having staff help patients resolve barriers to CRC screening, and (3) having staff hand out FITs/educate patients. The model for clinics with lower rates involved the combined absence of these same 3 factors., Conclusions: Three factors related to support staff differentiated clinics with higher and lower FIT completion rates. Adding nonphysician support staff and having those staff provide enabling services might help clinics optimize mailed FIT screening programs., (© 2022 Annals of Family Medicine, Inc.)

Background: Biomarker science in heart failure (HF) is advancing quickly in our ability to diagnosis and treat patients with this complex syndrome. Researchers are urged to not use single-marker strategies, but instead evaluate biomarkers in patterns to better understand their relationship to one another, as well as disease progression. Latent class mixture modeling allows researchers to determine novel associations between biomarkers., Objective: The objectives of this study were to identify and compare latent classes of cardiovascular biomarkers among patients with moderate to advanced HF., Methods: This was a cross-sectional study of 96 participants with moderate to advanced HF. Latent class mixture modeling was used to identify unique classes of biomarkers and their associations to sociodemographic and clinical variables., Results: The average age of the sample was 54 years, with most of the sample being men (77%) and having an average ejection fraction of 23%. Two unique classes of biomarkers were identified. Latent class 1 had higher levels of all biomarkers, whereas latent class 2 had lower levels. The higher biomarker class had, on average, more neurohormonal activation and fluid retention; however, the higher levels of biomarker class were not more likely to be diagnosed with advanced HF or have more comorbidities., Conclusion: By identifying classes of biomarkers, providers may be better able to identify patients who are at risk of progressing into advanced HF quicker or those who are more likely to have more severe complications, such as fluid overload or renal disease., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Individuals with an abnormal fecal immunochemical test (FIT) result have an elevated risk of colorectal cancer, and the risk increases if the follow-up colonoscopy is delayed. Of note, rates of follow-up colonoscopy are alarmingly low in federally qualified health centers (FQHCs), US health care settings that serve a majority racial and ethnic minority patient population. We assessed factors associated with colonoscopy after an abnormal FIT result and used chart-abstracted data to assess reasons (including process measures) for lack of follow-up as part of an annual, mailed-FIT outreach program within a large, Latino-serving FQHC., Methods: As part of the National Institutes of Health-funded PROMPT study, we identified patients with an abnormal FIT result and used logistic regression to assess associations between patient demographics and receipt of follow-up colonoscopy, controlling for patients' preferred language. We report on time (days) to referral and time to colonoscopy. For charts with an abnormal FIT result but no evidence of colonoscopy, we performed a manual abstraction and obtained the reason for the absence of colonoscopy. When there was no evidence of colonoscopy in a patient's electronic health record (EHR), we performed an automated query of the administrative claims database to identify colonoscopy outcomes., Results: We identified 324 patients with abnormal FIT results from July to October 2018. These patients were mostly publicly insured (Medicaid 53.1%, Medicare 14.5%), 81.8% were aged 50 to 64 years, 55.3% were female, 80.3% were Hispanic/Latino, and 67.3% preferred to speak Spanish. We found that 108/324 (33.3%) patients completed colonoscopy within 12 months, and the median time to colonoscopy was 94 days (IQR: 68-176). Common barriers to colonoscopy completion, obtained from chart-abstracted data, were: no documentation following referral to gastrointestinal (GI) specialist or GI consultation (41.6%), no referral to GI specialist following abnormal fecal test (34.2%), and absence of a valid insurance authorization (6.5%)., Conclusions: Multi-level strategies are needed to provide optimal care across the cancer continuum for FQHC patients. In order to reduce the risk of CRC and realize the return on fecal testing investment, concerted system-level efforts are urgently needed to improve rates of follow-up colonoscopy among FQHC patients and redress racial and ethnic disparities in CRC screening outcomes.

Purpose: Our objective was to calculate the positive predictive value (PPV) of the ICD-9 diagnosis code for angioedema when physicians adjudicate the events by electronic health record review. Our secondary objective was to evaluate the inter-rater reliability of physician adjudication., Methods: Patients from the Cardiovascular Research Network previously diagnosed with heart failure who were started on angiotensin-converting enzyme inhibitors (ACEI) during the study period (July 1, 2006 through September 30, 2015) were included. A team of two physicians per participating site adjudicated possible events using electronic health records for all patients coded for angioedema for a total of five sites. The PPV was calculated as the number of physician-adjudicated cases divided by all cases with the diagnosis code of angioedema (ICD-9-CM code 995.1) meeting the inclusion criteria. The inter-rater reliability of physician teams, or kappa statistic, was also calculated., Results: There were 38 061 adults with heart failure initiating ACEI in the study (21 489 patient-years). Of 114 coded events that were adjudicated by physicians, 98 angioedema events were confirmed for a PPV of 86% (95% CI: 80%, 92%). The kappa statistic based on physician inter-rater reliability was 0.65 (95% CI: 0.47, 0.82)., Conclusions: ICD-9 diagnosis code of 995.1 (angioneurotic edema, not elsewhere classified) is highly predictive of angioedema in adults with heart failure exposed to ACEI., (© 2021 John Wiley & Sons Ltd.)

Background & Aims: Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of mailed FIT outreach programs., Methods: We performed a prospective study of patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group., Results: Participants had a FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%-11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%-20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call., Conclusions: In a randomized trial, advance notification live phone calls outperformed text messages in prompting health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Delays in receiving follow-up colonoscopy after an abnormal fecal immunochemical test (FIT) result are associated with increased colorectal cancer incidence and mortality. Little is known about patterns of follow-up colonoscopy completion in federally qualified health centers., Methods: We abstracted the medical records of health center patients, aged 50-75 years, who had an abnormal FIT result between August 5, 2017 and August 4, 2018 (N = 711). We assessed one-year rates of colonoscopy referral, pre-procedure visit completion, colonoscopy completion, and time to colonoscopy; associations between these outcomes and patient characteristics; and reasons for non-completion found in the medical record., Results: Of the 711 patients with an abnormal FIT result, 90% were referred to colonoscopy, but only 52% completed a pre-procedure visit, and 43% completed a colonoscopy within 1 year. Median time to colonoscopy was 83 days (interquartile range: 52-131 days). Pre-procedure visit and colonoscopy completion rates were relatively low in patients aged 65-75 (vs. 50-64), who were uninsured (vs. insured) or had no clinic visit in the prior year (vs. ≥ 1 clinic visit). Common reasons listed for non-completion were that the patient declined, or the provider could not reach the patient., Discussion: Efforts to improve follow-up colonoscopy rates in health centers might focus on supporting the care transition from primary to specialty gastroenterology care and emphasize care for older uninsured patients and those having no recent clinic visits. Our findings can inform efforts to improve follow-up colonoscopy uptake, reduce time to colonoscopy receipt, and save lives from colorectal cancer., Trial Registration: National Clinical Trial (NCT) Identifier: NCT03925883., (© 2021. The Author(s).)