Vidant Health

This Consensus Report is intended to provide clinical professionals with evidencebased guidance about individualizing nutrition therapy for adults with diabetes or prediabetes. Strong evidence supports the efficacy and cost-effectiveness of nutrition therapy as a component of quality diabetes care, including its integration into the medical management of diabetes; therefore, it is important that all members of the health care team know and champion the benefits of nutrition therapy and key nutrition messages. Nutrition counseling that works toward improving or maintaining glycemic targets, achieving weight management goals, and improving cardiovascular risk factors (e.g., blood pressure, lipids, etc.) within individualized treatment goals is recommended for all adults with diabetes and prediabetes.

Purpose: The National Standards for Diabetes Self-Management Education and Support (DSMES) provide guidance and evidence-based, quality practice for all DSMES services. Due to the dynamic nature of health care and diabetes research, the National Standards are reviewed and revised approximately every 5 years by key stakeholders and experts within the diabetes care and education community. For each revision, the Task Force is charged with reviewing the current National Standards for appropriateness, relevance, and scientific basis and making updates based on current evidence and expert consensus. In 2021, the group was tasked with reducing administrative burden related to DSMES implementation across diverse care settings. Conclusion: The evidence supporting the 2022 National Standards clearly identifies the need to provide person-centered services that embrace cultural differences, social determinants of health, and the ever-increasing technological engagement platforms and systems. Payers are invited to review the National Standards as a tool to inform and modernize DSMES reimbursement requirements and to align with the evolving needs of people with diabetes (PWD) and physicians/other qualified health care professionals. The American Diabetes Association and the Association of Diabetes Care & Education Specialists strongly advocate for health equity to ensure all PWD have access to this critical service proven to improve outcomes both related to and beyond diabetes. The 2022 National Standards update is meant to be a universal document that is easy to understand and can be implemented by the entire health care community. DSMES teams in collaboration with primary care have been shown to be the most effective approach to overcome therapeutic inertia.

// Tithi Biswas 1 , Jimmy T. Efird 2 , Shreya Prasad 3 , Charulata Jindal 2 and Paul R. Walker 4 1 Department of Radiation Oncology, University Hospitals, Case Western Reserve University, Cleveland, OH, USA 2 Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia 3 Department of Internal Medicine, North Shore-Long Island Jewish Medical Center, Manhasset, NY, USA 4 Division of Hematology/Oncology, Vidant Health Cancer Care, Greenville, NC, USA Correspondence to: Jimmy T. Efird, email: jimmy.efird@stanfordalumni.org Keywords: adjuvant chemotherapy; disease free survival; neoadjuvant chemotherapy; overall survival; triple negative breast cancer Received: July 07, 2017      Accepted: October 28, 2017      Published: November 20, 2017 ABSTRACT Triple negative breast cancer (TNBC) is an aggressive subtype that accounts for 15-20% of cases, with a higher incidence of relapse/death. Even with adjuvant chemotherapy, the 5 year distant metastasis-free survival rate remains low. A total of 452 tumor registry patients with TNBC and no evidence of metastatic disease were identified over the period of 1996-2011. The median age and follow-up time were 51 (range=21-88) and 3.9 (range=0.14-14) years. Approximately 75% of patients with stage III disease received neoadjuvant chemotherapy (NACT) compared with 47% for stage II. Patients with stage I disease predominantly received adjuvant chemotherapy (ACT). Among those who underwent NACT (n=202), 33% had a pathological complete response (pCR). Overall (OS) and disease-free (DFS) survival were significantly longer among patients achieving pCR (versus residual disease) following NACT (OS: all patients P <0.0001, stage II P <0.0001, stage III P =0.0062; DFS: all patients P <0.0001, stage II P =0.0011, stage III P =0.015). ACT was not associated with improved OS or DFS for stage III disease. Adjustment for age, chemotherapy, health insurance type, lymphovascular invasion, race, radiation, and surgery did not alter our results. These findings suggest that pCR following NACT is associated with improved survival among patients with TNBC, independent of diagnostic stage.

**Background:** An international study of the epidemiologic characteristics of Creutzfeldt--Jakob disease (CJD) was established in 1993 and included national registries in France, Germany, Italy, the Netherlands, Slovakia, and the United Kingdom. In 1997, the study was extended to Australia, Austria, Canada, Spain, and Switzerland. **Methods:** Data were pooled from all participating countries for the years 1993 to 2002 and included deaths from definite or probable CJD of all etiologic subtypes. **Results:** Four thousand four hundred forty-one cases were available for analysis and included 3,720 cases of sporadic CJD, 455 genetic cases, 138 iatrogenic cases, and 128 variant cases. The overall annual mortality rate between 1999 and 2002 was 1.67 per million for all cases and 1.39 per million for sporadic CJD. Mortality rates were similar in all countries. There was heterogeneity in the distribution of cases by etiologic subtype with an excess of genetic cases in Italy and Slovakia, of iatrogenic cases in France and the UK, and of variant CJD in the UK. **Conclusions:** This study has established overall epidemiologic characteristics for Creutzfeldt--Jakob disease (CJD) of all types in a multinational population--based study. Intercountry comparisons did not suggest any relative change in the characteristics of sporadic CJD in the United Kingdom, and the evidence in this study does not suggest the occurrence of a novel form of human bovine spongiform encephalopathy infection other than variant CJD. However, this remains a possibility, and countries currently unaffected by variant CJD may yet have cases.

In less than twenty years, what began as a concept for the treatment of exsanguinating truncal trauma patients has become the primary treatment model for numerous emergent, life threatening surgical conditions incapable of tolerating traditional methods. Its core concepts are relative straightforward and simple in nature: first, proper identification of the patient who is in need of following this paradigm; second, truncation of the initial surgical procedure to the minimal necessary operation; third, aggressive, focused resuscitation in the intensive care unit; fourth, definitive care only once the patient is optimized to tolerate the procedure. These simple underlying principles can be molded to a variety of emergencies, from its original application in combined major vascular and visceral trauma to the septic abdomen and orthopedics. A host of new resuscitation strategies and technologies have been developed over the past two decades, from permissive hypotension and damage control resuscitation to advanced ventilators and hemostatic agents, which have allowed for a more focused resuscitation, allowing some of the morbidity of this model to be reduced. The combination of the simple, malleable paradigm along with better understanding of resuscitation has proven to be a potent blend. As such, what was once an almost lethal injury (combined vascular and visceral injury) has become a survivable one.

BACKGROUND: The prevalence of obesity and associated metabolic conditions continue to be challenging and costly to address for health care systems; 71% of American adults were overweight, with 35% of men and 40% of women diagnosed with obesity in 2014. Digital health coaching is an innovative approach to decreasing the barriers of cost and accessibility of receiving health coaching for the prevention and management of chronic disease in overweight or obese individuals. OBJECTIVE: To evaluate the early impact of a mobile phone-based health coaching service on weight loss and blood pressure management in a commercially insured population. METHODS: This was a retrospective study using existing registry data from a pilot commercial collaboration between Vida Health and a large national insurance provider, which enrolled adult members who were overweight (body mass index >25 kg/m2) and able to engage in a mobile phone-based coaching intervention. Participants received 4 months of intensive health coaching via live video, phone, and text message through the Vida Health app. Participants were also provided with a wireless scale, pedometer, and blood pressure cuff. Of the 1012 enrolled, 763 (75.40%) participants had an initial weight upon enrollment and final weight between 3 and 5 months from enrollment; they served as our intervention group. There were 73 participants out of the 1012 (7.21%) who had weight data 4 months prior to and after Vida coaching, who served as the matched-pair control group. RESULTS: Participants in the intervention group lost an average of 3.23% total body weight (TBW) at 4 months of coaching and 28.6% (218/763) intervention participants achieved a clinically significant weight loss of 5% or more of TBW, with an average of 9.46% weight loss in this cohort. In the matched-pair control group, participants gained on average 1.81% TBW in 4 months without Vida coaching and lost, on average, 2.47% TBW after 4 months of Vida coaching, demonstrating a statistically significant difference of 4.28% in mean percentage weight change (P<.001). Among 151 intervention participants with blood pressure data, 112 (74.2%) had a baseline blood pressure that was above the goal (systolic blood pressure >120 mmHg); 55 out of 112 (49.1%) participants improved their blood pressure at 4 months by an entire hypertensive stage-as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. CONCLUSIONS: Mobile phone app-based health coaching interventions can be an acceptable and effective means to promote weight loss and improve blood pressure management in overweight or obese individuals. Given the ubiquity of mobile phones, digital health coaching may be an innovative solution to decreasing barriers of access to much-needed weight management interventions for obesity.

O presente estudo teve como objetivo construir com os trabalhadores de enfermagem de Saúde Pública de um Centro Municipal de Saúde (CMS) uma proposta de indicadores de Qualidade de Vida no Trabalho a partir da percepção dos mesmos. Utilizou-se da abordagem qualitativa, tendo como local de estudo um CMS localizado no município do Rio de Janeiro; os sujeitos foram 34 profissionais da equipe de enfermagem, representando 100% do grupo, a saber: 7 enfermeiros, 3 técnicos de enfermagem e 24 auxiliares de enfermagem. Foi utilizado grupo focal para obtenção dos dados. Como resultados, os trabalhadores apontaram como indicadores de Qualidade de Vida no Trabalho (QVT): a inter-relação pessoal, a comunicação interprofissional, as condições de trabalho, a organização e divisão do trabalho, os direitos no trabalho, a motivação e segurança. Neste sentido, conclui-se pela necessidade do desenvolvimento de programas que apóiem a qualidade de vida dos trabalhadores nas unidades de enfermagem em Unidades Básicas, considerando os fatores apontados pelos profissionais como elementos que caracterizam a QVT.

PURPOSE: Lean and Six Sigma are continuous improvement methodologies that have garnered international fame for improving manufacturing and service processes. Increasingly these methodologies are demonstrating their power to also improve healthcare processes. The purpose of this paper is to discuss a case study for the application of Lean and Six Sigma tools in the reduction of turnaround time (TAT) for Emergency Department (ED) specimens. This application of the scientific methodologies uncovered opportunities to improve the entire ED to lab system for the specimens. DESIGN/METHODOLOGY/APPROACH: This case study provides details on the completion of a Lean Six Sigma project in a 1,000 bed tertiary care teaching hospital. Six Sigma's Define, Measure, Analyze, Improve, and Control methodology is very similar to good medical practice: first, relevant information is obtained and assembled; second, a careful and thorough diagnosis is completed; third, a treatment is proposed and implemented; and fourth, checks are made to determine if the treatment was effective. Lean's primary goal is to do more with less work and waste. The Lean methodology was used to identify and eliminate waste through rapid implementation of change. FINDINGS: The initial focus of this project was the reduction of turn-around-times for ED specimens. However, the results led to better processes for both the internal and external customers of this and other processes. The project results included: a 50 percent decrease in vials used for testing, a 50 percent decrease in unused or extra specimens, a 90 percent decrease in ED specimens without orders, a 30 percent decrease in complete blood count analysis (CBCA) Median TAT, a 50 percent decrease in CBCA TAT Variation, a 10 percent decrease in Troponin TAT Variation, a 18.2 percent decrease in URPN TAT Variation, and a 2-5 minute decrease in ED registered nurses rainbow draw time. PRACTICAL IMPLICATIONS: This case study demonstrated how the quantitative power of Six Sigma and the speed of Lean worked in harmony to improve the blood draw process for a 1,000 bed tertiary care teaching hospital. The blood draw process is a standard process used in hospitals to collect blood chemistry and hematology information for clinicians. The methods used in this case study demonstrated valuable and practical applications of process improvement methodologies that can be used for any hospital process and/or service environment. ORIGINALITY/VALUE: While this is not the first case study that has demonstrated the use of continuous process improvement methodologies to improve a hospital process, it is unique in the way in which it utilizes the strength of the project focussed approach that adheres more to the structure and rigor of Six Sigma and relied less on the speed of lean. Additionally, the application of these methodologies in healthcare is emerging research.

Process evaluations provide multiple opportunities to improve prevention and intervention programs that benefit communities experiencing oppression and marginalization. In order to thwart the negative effects of power and privilege, it is essential that collaborative partnerships with community-based organizations (CBOs) incorporate the voices, experiences, and skills of community members. This article presents a process evaluation that was collaboratively developed and implemented by a team consisting of members from an HIV/AIDS-related CBO and a university. The process evaluation was guided by an empowerment evaluation theoretical framework and utilized elements of narrative ethnography. The methods for the evaluation were developed to ensure cultural appropriateness, community sensitivity, and scientific rigor. Modifications made to the CBO's HIV prevention programs for Latina female adolescents and gay/bisexual/questioning Latino and African-American male adolescents incorporated specific social, cultural, and environmental factors that impact HIV risk. The multiple benefits gained by those involved in the evaluation are detailed and emphasize the importance of conducting collaborative process evaluations when developing interventions for oppressed and marginalized communities.

BACKGROUND: Digital mental health interventions offer a scalable solution that reduces barriers to seeking care for clinical depression and anxiety. OBJECTIVE: We aimed to examine the effectiveness of a 12-week therapist supported, app-based cognitive behavioral therapy program in improving symptoms of depression and anxiety within 9 months. METHODS: A total of 323 participants with mild to moderately severe depression or anxiety were enrolled in a 12-week digital cognitive behavior therapy program. The analysis was restricted to participants who provided at least one follow-up assessment after baseline. As a result, 146 participants (45.2%) were included in the analysis-74 (50.7%) participants completed assessments at 3 months, 31 participants (21.2%) completed assessments at 6 months, and 21 participants (14.4%) completed assessments at 9 months. The program included structured lessons and tools (ie, exercises and practices) as well as one-on-one weekly video counseling sessions with a licensed therapist for 12 weeks and monthly check-in sessions for 1 year. The clinically validated Patient Health Questionnaire (PHQ-8) and Generalized Anxiety Disorder Scale (GAD-7) were used to assess depression and anxiety, respectively. Linear mixed-effects modeling was employed to examine changes in depression and anxiety over time. RESULTS: We observed a significant positive effect of program time on improvement in depression (β=-0.12, P<.001) and anxiety scores (β=-0.10, P<.001). At the end of the 12-week intervention, we observed an average reduction of 3.76 points (95% CI -4.76 to -2.76) in PHQ-8 scores. Further reductions in depression were seen at program month 6 (4.75-point reduction, 95% CI -6.61 to -2.88) and program month 9 (6.42-point reduction, 95% CI -8.66 to -6.55, P<.001). A similar pattern of improvement emerged for anxiety, with a 3.17-point reduction at the end of the 12-week intervention (95% CI -4.21 to -2.13). These improvements were maintained at program month 6 (4.87-point reduction, 95% CI -6.85 to -2.87) and program month 9 (5.19-point, 95% -6.85 to 4.81). In addition, greater program engagement during the first 12 weeks predicted a greater reduction in depression (β=-0.29, P<.001). CONCLUSIONS: The results suggest that digital interventions can support sustained and clinically meaningful improvements in depression and anxiety. Furthermore, it appears that strong initial digital mental health intervention engagement may facilitate this effect. However, the study was limited by postintervention participant attrition as well as the retrospective observational study design.

Endothelial dysfunction increases cardiovascular disease risk in chronic kidney disease (CKD). This study investigates whether VDR activation affects endothelial function in CKD. The 5/6 nephrectomized (NX) rats with experimental chronic renal insufficiency were treated with or without paricalcitol, a VDR activator. Thoracic aortic rings were precontracted with phenylephrine and then treated with acetylcholine or sodium nitroprusside. Uremia significantly affected aortic relaxation (-50.0 +/- 7.4% in NX rats versus -96.2 +/- 5.3% in SHAM at 30 muM acetylcholine). The endothelial-dependent relaxation was improved to -58.2 +/- 6.0%, -77.5 +/- 7.3%, and -90.5 +/- 4.0% in NX rats treated with paricalcitol at 0.021, 0.042, and 0.083 mug/kg for two weeks, respectively, while paricalcitol at 0.042 mug/kg did not affect blood pressure and heart rate. Parathyroid hormone (PTH) suppression alone did not improve endothelial function since cinacalcet suppressed PTH without affecting endothelial-dependent vasorelaxation. N-omega-nitro-L-arginine methyl ester completely abolished the effect of paricalcitol on improving endothelial function. These results demonstrate that VDR activation improves endothelial function in CKD.

AIMS: Examine the presence and various sources of incivility among nursing staff working within an academic medical centre utilizing the Nurse Incivility Scale (NIS). BACKGROUND: Evidence suggests various forms of negative behaviour including incivility exist among nurses. Established consequences of these behaviours include increased employee turnover rates, decreased job satisfaction, decreased productivity and increased absenteeism. METHODS: A descriptive survey design was used which included the NIS instrument to measure the presence of incivility within the nursing workforce and specific sources of these behaviours among 414 nurses in an academic medical centre. RESULTS: Hospital nurses working within the intensive and intermediate care unit experienced significantly greater incivility from patients and families than other participants within the study [F (3, 413) 8.62, p = .001]. No other significant differences existed in sources of incivility between various levels of direct care. CONCLUSIONS: Nursing staff working within high-risk areas for incivility such as the intensive care and intermediate care units may require additional interventions to reduce perceptions of incivility from patients/families. IMPLICATIONS FOR NURSING MANAGEMENT: Findings suggest further research is necessary to develop targeted interventions for nurses practicing within intensive care and intermediate units to alleviate the perceived burden of incivility from patients/families.

Background Traditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control. Objective In this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program. Methods The study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A1c (HbA1c) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up). Results We observed a significant reduction in HbA1c of –0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t257=7.71; P&lt;.001). Among participants considered high risk (baseline HbA1c≥8), there was an average reduction of –1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t139=9.14; P&lt;.001). Additionally, average follow-up HbA1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA1c (mean 8.12, SD 1.46; F2, 210=22.90; P&lt;.001) There was also significant effect of program usage on HbA1c change (β=–.60; P&lt;.001) such that high usage was associated with a greater decrease in HbA1c (mean –1.02, SD 1.60) compared to low usage (mean –.61, SD 1.72). Conclusions The present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA1c. The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data.

OBJECTIVE: The aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2-12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury. METHODS: This was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments. RESULTS: Nineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators. CONCLUSIONS: In this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial. Clinical trial registration no.: NCT02138110 (clinicaltrials.gov).

BACKGROUND: Some guidelines state that in-person weight management interventions are more efficacious than those delivered digitally. However, digital programs are more scalable and accessible. We hypothesized that one-on-one health coaching via app-based video chat would simulate an in-person experience and help achieve outcomes comparable to those of in-person interventions. METHODS: A 12-month digital weight management intervention was provided to overweight or obese adults recruited from a large technology company. One-on-one health coaching sessions were offered during a 24-week intensive phase as well as subsequent maintenance phase. Focused on sustainable changes in activity and diet, the intervention incorporates SMART goals, in-app food and activity logs, Fitbit integration, as well as optional sleep and stress modules. Self-Determination Theory and the Transtheoretical Model are incorporated to drive behavior change. Multilevel mixed-effects models were used to analyze weight changes retrospectively. RESULTS: Six hundred eighty-three participants reported 29,051 weights. At 12 months, mean percent changes in body weight were -7.2% and -7.6% for overweight and obese groups, respectively. A weight change of -5% is commonly targeted for in-person weight management interventions. Observed weight loss exceeded this target by 2.2% (95% CI, 0.7% to 3.8%; P < .01) for the overweight group and 2.6% (95% CI, 1.4% to 3.9%; P < .01) for the obese group. CONCLUSIONS: Further research is needed with randomization to in-person or digital interventions. Though limited by an observational, retrospective design, preliminary results suggest that some digital weight management programs with one-on-one coaching may achieve outcomes comparable to those of robust, in-person interventions.

Although alliances between community-based organizations (CBOs) and university-based evaluators provide opportunities to enhance community-based interventions, such partnerships may be fraught with challenges and obstacles. This paper focuses on the "story" behind a collaborative partnership between a Latino-focused CBO and a team of university-based evaluators that was formed to evaluate HIV prevention interventions for Mexican American female adolescents and gay/bisexual/questioning (GBQ) Latino male adolescents. A developmental trajectory of the partnership is detailed, with a focus on the creation and enhancement of a reciprocal and mutually beneficial relationship. In tracing this history, the paper explores challenges that were faced and presents ways in which the partnership attempted to overcome obstacles. Recommendations are offered to assist in the formation and maintenance of collaborative partnerships between CBOs and university-based evaluators/researchers.

PURPOSE: Rural low-income African American patients with diabetes have traditionally poorer clinical outcomes and limited access to state-of-the-art diabetes care. We determined the effectiveness of a redesigned primary care model on patients' glycemic, blood pressure, and lipid level control. METHODS: In 3 purposively selected, rural, fee-for-service, primary care practices, African American patients with type 2 diabetes received point-of-care education, coaching, and medication intensification from a diabetes care management team made up of a nurse, pharmacist, and dietitian. In 5 randomly selected control practices matched for practice and patient characteristics, African American patients received usual care. Using univariate and multivariate adjusted models, we evaluated the effects of the intervention on intermediate (median 18 months) and long-term (median 36 months) changes in glycated hemoglobin (hemoglobin A1c) levels, blood pressure, and lipid levels, as well as the proportion of patients meeting target values. RESULTS: Among 727 randomly selected rural African American diabetic patients (368 intervention, 359 control), intervention patients had a significantly greater reduction in mean hemoglobin A1c levels at intermediate (-0.5 % vs -0.2%; P <.05) and long-term (-0.5% vs -0.10%; P <.005) follow-up in univariate and multivariate models. The proportion of patients achieving a hemoglobin A1c level of less than 7.5% (68% vs 59%, P <.01) and/or a systolic blood pressure of less than 140 mm Hg (69% vs 57%, P <.01) was also significantly greater in intervention practices in multivariate models. CONCLUSION: Redesigning care strategies in rural fee-for-service primary care practices for African American patients with established diabetes results in significantly improved glycemic control relative to usual care.

BACKGROUND: Based on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls. OBJECTIVE: To evaluate outcomes through 24 months postimplantation. METHODS: INSPIRE was a prospective, open-label, multicenter, single-arm study. Eligible patients had traumatic nonpenetrating SCI with a visible contusion on MRI, AIS A classification, neurological level of injury at T2-T12, and requirement for open spine surgery ≤96 hours postinjury. RESULTS: Nineteen patients underwent NSS implantation. Three patients had early death determined by investigators to be unrelated to the NSS or its implantation procedure. Seven of 16 evaluable patients (44%) had improvement of ≥1 AIS grade at 6 months (primary end point) to AIS B (n = 5) or AIS C (n = 2). Three patients with AIS B at 6 months had further neurological improvement to AIS C by 12 (n = 2) and 24 (n = 1) months, respectively; none have deteriorated per latest available follow-up. No unanticipated or serious adverse device effects were reported. CONCLUSION: In this small group of patients with complete thoracic SCI, acute NSS implantation within the spinal cord appeared to be safe with no long-term neurological issues identified during the 24-month follow-up. Patients remain stable, with additional AIS conversions observed in some patients at 12 months and beyond. These data further support the safety and probable benefit of NSS implantation in this patient population.

Metabolic detoxification (detox)-or biotransformation-is a physiological function that removes toxic substances from our body. Genetic variability and dietary factors may affect the function of detox enzymes, thus impacting the body's sensitivity to toxic substances of endogenous and exogenous origin. From a genetic perspective, most of the current knowledge relies on observational studies in humans or experimental models in vivo and in vitro, with very limited proof of causality and clinical value. This review provides health practitioners with a list of single nucleotide polymorphisms (SNPs) located within genes involved in Phase I and Phase II detoxification reactions, for which evidence of clinical utility does exist. We have selected these SNPs based on their association with interindividual variability of detox metabolism in response to certain nutrients in the context of human clinical trials. In order to facilitate clinical interpretation and usage of these SNPs, we provide, for each of them, a strength of evidence score based on recent guidelines for genotype-based dietary advice. We also present the association of these SNPs with functional biomarkers of detox metabolism in a pragmatic clinical trial, the LIFEHOUSE study.

PURPOSE: Patients with cancer are at heightened risk of experiencing financial hardship. Financial navigation (FN) is an evidence-based approach for identifying and addressing patient and caregiver financial needs. In preparation for the implementation of a multisite FN intervention, we describe existing processes (ie, events and actions) and mechanisms (ie, how events work together) connecting patients to financial assistance, comparing rural and nonrural practices. METHODS: We conducted in-depth, semistructured interviews with stakeholders (ie, administrators, providers, and staff) at each of the 10 oncology care sites across a single state (five rural and five nonrural practices). We developed process maps for each site and analyzed stakeholder perspectives using thematic analysis. After reporting findings back to stakeholders, we synthesized themes and process maps across rural and nonrural sites separately. RESULTS: Eighty-three stakeholders were interviewed. We identified six core elements of existing financial assistance processes across all sites: distress screening (including financial concerns), referrals, resource connection points, and pharmaceutical, insurance, and community/foundation resources. Processes differed by rurality; however, facilitators and barriers to identifying and addressing patient financial needs were consistent. Open communication between staff, providers, patients, and caregivers was a primary facilitator. Barriers included insufficient staff resources, challenges in routinely identifying needs, inadequate preparation of patients for anticipated medical costs, and limited tracking of resource availability and eligibility. CONCLUSION: This study identified a clear need for systematic implementation of oncology FN to equitably address patient and caregiver financial hardship. Results have informed our current efforts to implement a multisite FN intervention, which involves comprehensive financial toxicity screening and systematization of intake and referrals.