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Continuous glucose monitors (CGMs) have become an important tool to aid self-management of blood glucose for many patients with diabetes in the U.S., and the benefits of CGM use are well-documented. However, disparities in CGM use exist, with lower use in certain marginalized racial and ethnic groups. CGM may be an important and underutilized tool to help reduce inequities. Evidence supporting the use of CGMs as a part of virtual care is discussed, with an emphasis on designing virtual diabetes care programs to promote health equity. Recommendations for clinical practice and research are presented. In clinical practice, CGM should be an option for all people with diabetes who qualify based on clinical practice guidelines, regardless of race, ethnicity, or other individual characteristics. Future research should characterize the use of, benefit from, and preferences for CGM among individuals from racial and ethnic groups to guide interventions at the health system, clinic, provider, and patient levels to promote equitable, evidence-based, and guideline-directed CGM use in marginalized racial and ethnic groups with diabetes.

Rationale & Objective: Choosing from multiple kidney failure treatment modalities can create decisional conflict, but little is known about this experience before decision implementation. We explored decisional conflict about treatment for kidney failure and its associated patient characteristics in the context of advanced chronic kidney disease (CKD). Study Design: Cross-sectional study. Setting & Participants: Adults (N = 427) who had advanced CKD, received nephrology care in Pennsylvania-based clinics, and had no history of dialysis or transplantation. Predictors: Participants’ sociodemographic, physical health, nephrology care/knowledge, and psychosocial characteristics. Outcomes: Participants’ results on the Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) screening test for decisional conflict (no decisional conflict vs decisional conflict). Analytical Approach: We used multivariable logistic regression to quantify associations between aforementioned participant characteristics and decisional conflict. We repeated analyses among a subgroup of participants at highest risk of kidney failure within 2 years. Results: Most (76%) participants reported treatment-related decisional conflict. Participant characteristics associated with lower odds of decisional conflict included complete satisfaction with patient–kidney team treatment discussions (OR, 0.16; 95% CI, 0.03-0.88; P = 0.04), attendance of treatment education classes (OR, 0.38; 95% CI, 0.16-0.90; P = 0.03), and greater treatment-related decision self-efficacy (OR, 0.97; 95% CI, 0.94-0.99; P < 0.01). Sensitivity analyses showed a similarly high prevalence of decisional conflict (73%) and again demonstrated associations of class attendance (OR, 0.26; 95% CI, 0.07-0.96; P = 0.04) and decision self-efficacy (OR, 0.95; 95% CI, 0.91-0.99; P = 0.03) with decisional conflict. Limitations: Single-health system study. Conclusions: Decisional conflict was highly prevalent regardless of CKD progression risk. Findings suggest efforts to reduce decisional conflict should focus on minimizing the mismatch between clinical practice guidelines and patient-reported engagement in treatment preparation, facilitating patient–kidney team treatment discussions, and developing treatment education programs and decision support interventions that incorporate decision self-efficacy–enhancing strategies.

Abstract Background and objectives After dialysis initiation, older adults may experience orthostatic or post-dialysis hypotension. Some orthostasis-causing antihypertensives (i.e., central alpha agonists and alpha blockers), are considered potentially inappropriate medications (PIMs) for older adults because they carry more risk than benefit. We sought to (1) describe antihypertensive PIM prescribing patterns before and after dialysis initiation and (2) ascertain the potential risk of adverse outcomes when these medications are continued after dialysis initiation. Design, setting, participants, and measurements Using United States Renal Data System data, we evaluated monthly prevalence of antihypertensive PIM claims in the period before and after dialysis initiation among older adults aged ≥66 years initiating in-center hemodialysis in the US between 2013 and 2014. Patients with an antihypertensive PIM prescription at hemodialysis initiation and who survived for 120 days were classified as ‘continuers’ or ‘discontinuers’ based on presence or absence of a refill within the 120 days after initiation. We compared rates of hospitalization and risk of death across these groups from day 121 through 24 months after dialysis initiation. Results Our study included 30,760 total patients, of whom 5981 (19%) patients had an antihypertensive PIM claim at dialysis initiation and survived ≥120 days. Most [65% (n = 3920)] were continuers. Those who continued (versus discontinued) were more likely to be black race (26% versus 21%), have dual Medicare-Medicaid coverage (31% versus 27%), have more medications on average (12 versus 9) and have no functional limitations (84% versus 80%). Continuers experienced fewer all-cause hospitalizations and deaths, but neither were statistically significant after adjustment (Hospitalization: RR 0.93, 95% CI 0.86, 1.00; Death: HR 0.89, 95% CI: 0.78–1.02). Conclusions Nearly one in five older adults had an antihypertensive PIM at dialysis initiation. Among those who survived ≥120 days, continuation of an antihypertensive PIM was not associated with increased risk of all-cause hospitalization or mortality.

Abstract Background Patients receiving dialysis face a high risk of cardiovascular disease, arrhythmia and sudden cardiac death. Few patients, however, are aware of this risk. Implantable cardiac monitors are currently available for clinical use and can continuously monitor cardiac rhythms without the need for transvenous leads. Our goal was to gauge patients’ and family members’ perceptions of these risks and to identify their concerns about cardiac monitors. Methods Two 90-minute focus groups were conducted: one with patients receiving in-center hemodialysis and one with their family members. Trained moderators assessed: (1) knowledge of cardiovascular disease; (2) cardiovascular disease risk in dialysis; (3) risk of death due to cardiovascular disease; (4) best ways to convey this risk to patients/families; and (5) concerns about cardiac monitors. The sessions were audiotaped, transcribed, and independently analyzed by two reviewers to identify core themes. Emblematic quotations were chosen to illustrate the final themes. Results Nine adult patients and three family members participated. Patients felt education was inadequate and had little knowledge of arrhythmias. Patients’/families’ concerns regarding cardiac monitors were related to adverse effects, the notification process, and cosmetic effects. Patients/families felt that nephrologists, not dialysis staff, would be the best source for education. Conclusions The preliminary data from this small study population suggest that patients/families are not well aware of the high risk of arrhythmia and sudden cardiac death in dialysis. Further investigation is required to gauge this awareness among patients/families and to assess their impressions of implantable cardiac monitors for arrhythmia detection and management.

Abstract Background While catheters are often thought the result of emergency hemodialysis (HD) initiation among patients with little or no pre-dialysis nephrology care, the role of patient level of engagement in care and modality decision-making have not been fully explored. Methods This is a retrospective medical record review of adults (age 18–89 years) who received care in academically affiliated private practice, public hospital, or Veterans Administration settings prior to initiating HD with a catheter between 10/1/2011 and 9/30/2012. Primary predictors were level of patient engagement in nephrology care within 6 months of HD initiation and timing of modality decision-making. Primary outcomes were provider action (referral) and any patient action (evaluation by a vascular surgeon, vein mapping or vascular surgery) toward [arteriovenous fistula or graft, (AVF/AVG)] creation. Results Among 92 incident HD patients, 66% (n = 61) initiated HD via catheter, of whom 34% (n = 21) had ideal engagement in care but 42% (n = 25) had no documented decision. Providers referred 48% (n = 29) of patients for AVF/AVG, of whom 72% (n = 21) took any action. Ideal engagement in care predicted provider action (adjusted OR 13.7 [95% CI 1.08, 175.1], p = 0.04), but no level of engagement in care predicted patient action (p > 0.3). Compared to patients with no documented decision, those with documented decisions within 3, 3–12, or more than 12 months before initiating dialysis were more likely to have provider action toward AVF/AVG (adjusted OR [95% CI]: 9.0 [1.4,55.6], p = 0.2, 37.6 [3.3423.4] p = 0.003, and 4.8 [0.8, 30.6], p = 0.1, respectively); and patient action (adjusted OR [95% CI]: 18.7 [2.3, 149.0], p = 0.006, 20.4 [2.6, 160.0], p = 0.004, and 6.2 [0.9, 44.0], p = 0.07, respectively). Conclusions Timing of patient modality decision-making, but not level of engagement in pre-dialysis nephrology care, was predictive of patient and provider action toward AVF/AVG Interventions addressing patients’ psychological preparation for dialysis are needed.

We respond to a surging interest in science communication training for graduate scientists by advocating for a focus on rhetorically informed approaches to STEM writing and its assessment. We argue that STEM communication initiatives would benefit by shifting from a strategic focus on products to a flexible understanding of writing as a practice worthy of attention and study. To do that, we use our experience across two universities and two distinct programmatic contexts to train STEM graduate students in writing and communication. We draw from cross-disciplinary conversations to identify four facets of “good” STEM writing: (1) connecting to the big picture; (2) explaining science; (3) adhering to genre conventions; and (4) choosing context-appropriate language. We then describe our ongoing conversations across contexts to develop and implement flexible rubrics that capture and foster conversations around “good” writing. In doing so, we argue for a notion of writing rubrics as boundary objects, capable of fostering cross-disciplinary, integrative conversations and collaborations that strengthen student writing, shift STEM students toward a rhetorically informed sense of “good” writing, and offer that kinds of assessment data that make for persuasive evidence of the power of writing-centric approaches for STEM administrators and funders.

Plain English summary We need more research projects that partner and engage with patients and family members as team members. Doing this requires that patients and family members set research priorities and fully participate in research teams. Models for this patient and family member engagement as research partners can help increase patient centered outcomes research. In this article, we describe how we have successfully engaged patients with kidney disease and family members as Co-Investigators on a 5-year research project testing a health system intervention to improve kidney disease care. Abstract Background This article describes a method for successful engagement of patients and family members in all stages of a 5-year comparative effectiveness research trial to improve transitions of care for patients from chronic kidney disease to end-stage kidney disease. Methods This project utilized the Patient-Centered Outcomes Research Institute’s conceptual model for engagement with patients and family members. We conducted a qualitative analysis of grant planning meetings to determine patient and family member Co-Investigators’ priorities for research and to include these engagement efforts in the research design. Patient and family member Co-Investigators partnered in writing this paper. Results Patients and family members were successfully engaged in remote and in-person meetings to contribute actively to research planning and implementation stages. Three patient-centered themes emerged from our data related to engagement that informed our research plan: kidney disease treatment decision-making, care transitions from chronic to end-stage kidney disease, and patient-centered outcomes. Conclusions The model we have employed represents a new paradigm for kidney disease research in the United States, with patients and family members engaged as full research partners. As a result, the study tests an intervention that directly responds to their needs, and it prioritizes the collection of outcomes data most relevant to patient and family member Co-Investigators. Trial registration NCT02722382 .

Rationale & Objective: Chronic kidney disease (CKD) can progress rapidly, and patients are often unprepared to make kidney failure treatment decisions. We aimed to better understand patients’ preferences for and experiences of shared and informed decision making (SDM) regarding kidney replacement therapy before kidney failure. Study Design: Cross-sectional study. Setting & Participants: Adults receiving nephrology care at CKD clinics in rural Pennsylvania. Predictors: Estimated glomerular filtration rate, 2-year risk for kidney failure, duration and frequency of nephrology care, and preference for SDM. Outcomes: Occurrence and extent of kidney replacement therapy discussions and participants’ satisfaction with those discussions. Analytic Approach: Multivariable logistic regression to quantify associations between participants’ characteristics and whether they had discussions. Results: The 447 study participants had a median age of 72 (IQR, 64-80) years and mean estimated glomerular filtration rate of 33 (SD, 12) mL/min/1.73 m2. Most (96%) were White, high school educated (67%), and retired (65%). Most (72%) participants preferred a shared approach to kidney treatment decision making, and only 35% discussed dialysis or transplantation with their kidney teams. Participants who had discussions (n = 158) were often completely satisfied (63%) but infrequently discussed potential treatment-related impacts on their lives. In multivariable analyses, those with a high risk for kidney failure within 2 years (OR, 3.24 [95% CI, 1.72-6.11]; P < 0.01), longer-term nephrology care (OR, 1.12 [95% CI, 1.05-1.20] per 1 additional year; P < 0.01), and more nephrology visits in the prior 2 years (OR, 1.34 [95% CI, 1.20-1.51] per 1 additional visit; P < 0.01) had higher odds of having discussed dialysis or transplantation. Limitations: Single health system study. Conclusions: Most patients preferred sharing CKD treatment decisions with their providers, but treatment discussions were infrequent and often did not address key treatment impacts. Longitudinal nephrology care and frequent visits may help ensure that patients have optimal SDM experiences.

Rationale & Objective: Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed. Study Design: Descriptive study of the implementation of digital infrastructure to support a patient-centered health system intervention. Setting & Participants: 4 CKD clinics within a large integrated health system. Exposure: We developed an integrated suite of digital engagement tools to support patients’ shared decision making and preparation for kidney failure treatments. Tools included an automated CKD patient registry and risk prediction algorithm within the electronic health record (EHR) to identify and prioritize patients in need of nurse case management to facilitate shared decision making and preparation for kidney replacement treatments, an electronic patient-facing values clarification tool, a tracking application to document patients’ preparation for treatments, and an EHR work flow to broadcast patients’ treatment preferences to all health care providers. Outcomes: Uptake and acceptability. Analytic Approach: Mixed methods. Results: From July 1, 2017, through June 30, 2018, the CKD registry identified 1,032 patients in 4 nephrology clinics, of whom 243 (24%) were identified as high risk for progressing to kidney failure within 2 years. Kidney Transitions Specialists enrolled 117 (48%) high-risk patients by the end of year 1. The values tool was completed by 30/33 (91%) patients who attended kidney modality education. Nurse case managers used the tracking application for 100% of patients to document 287 planning steps for kidney replacement therapy. Most (87%) high-risk patients had their preferred kidney replacement modality documented and displayed in the EHR. Nurse case managers reported that the tools facilitated their identification of patients needing support and their navigation activities. Limitations: Single institution, short duration. Conclusions: Digital health system tools facilitated rapid identification of patients needing shared and informed decision making and their preparation for kidney replacement treatments. Funding: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (IHS-1409-20967). Trial registration: ClinicalTrials.gov NCT02722382.

Rationale & Objective: Understanding whether family members’ experiences with patients’ treatment for end-stage kidney disease (ESKD) were expected could guide the development of family-centered interventions that enhance the preparedness of patients and their care partners for kidney replacement therapies. We explored unexpected negative experiences with ESKD treatments among family members of dialysis and posttransplantation patients to identify meaningful directions for family-centered research and clinical care. Study Design: Qualitative study. Setting & Participants: 8 focus groups comprising 49 family members of dialysis patients and living donor kidney transplant recipients undergoing medical care in Baltimore, MD. Analytical Approach: Focus groups were stratified by patients’ treatment (in-center hemodialysis, home hemodialysis, peritoneal dialysis, or living donor kidney transplantation) and family members’ self-reported race (African American vs non–African American), resulting in 2 groups per treatment experience. Inductive thematic analysis was used to identify themes in focus group transcripts. Themes shared across different treatment groups were highlighted to provide insight into common experiences. Results: We identified 4 themes that described family members’ unexpected negative treatment experiences: becoming a care partner (unanticipated responsibilities and sleep disruptions), adverse psychological treatment responses in patients (eg, depression) and family members (eg, anxiety), treatment delivery and logistics (insufficient information, medication regimen, and logistical inconveniences), and patient morbidity (dialysis-related health problems and fatigue). All themes were relevant to discussions in the in-center hemodialysis, peritoneal dialysis, and transplantation groups, whereas psychological responses and morbidity themes did not reflect discussions in home hemodialysis groups. Limitations: Data collection occurred from 2008 to 2009; family members were recruited through patients undergoing care in 1 geographic area; 1 family member participant per patient. Conclusions: Family members described a broad range of unexpected negative experiences with ESKD treatments. Efforts to prepare families for ESKD treatments through more family-centered care, early and tailored education, and interventions targeting care partner preparedness, health provider–family member communication, and relationship dynamics in family member–patient dyads are needed. Index Words: End-stage kidney disease treatments, unexpected experiences, families, dialysis, living-donor kidney transplantation

Background: Many patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability. Methods: We conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute LBP were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Trial Registry: ClinicalTrials.gov NCT02647658 Findings: Between May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n = 658) versus 51% of patients in the control arm (35 practices, n = 635; OR=0.83 95% CI 0.64, 1.09; p = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9–0.6; p = 0.12). Opioids and imaging were prescribed in 22%–25% and 23%–26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups. Interpretation: There were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines. Funding: Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402–10867

Rationale & Objective: Chronic kidney disease (CKD) care is often fragmented across multiple health care providers. It is unclear whether patients rely mostly on their nephrologists or non-nephrologist providers for medical care, including CKD treatment and advice. Study Design: Cross-sectional study. Setting & Participants: Adults receiving nephrology care at CKD clinics in Pennsylvania. Predictors: Frequency, duration, and patient-centeredness (range, 1 [least] to 4 [most]) of participants’ nephrology care. Outcome: Participants’ reliance on nephrologists, primary care providers, or other specialists for medical care, including CKD treatment and advice. Analytical Approach: Multivariable logistic regression to quantify associations between participants’ reliance on their nephrologists (vs other providers) and their demographics, comorbid conditions, kidney function, and nephrology care. Results: Among 1,412 patients in clinics targeted for the study, 676 (48%) participated. Among these, 453 (67%) were eligible for this analysis. Mean age was 71 (SD, 12) years, 59% were women, 97% were white, and 65% were retired. Participants were in nephrology care for a median of 3.8 (IQR, 2.0-6.6) years and completed a median of 4 (IQR, 3-5) nephrology appointments in the past 2 years. Half (56%) the participants relied primarily on their nephrologists, while 23% relied on primary care providers, 18% relied on all providers equally, and 3% relied on other specialists. Participants’ adjusted odds of relying on their nephrologists were higher for those in nephrology care for longer (OR, 1.08 [95% CI, 1.02-1.15]; P = 0.02), those who completed more nephrology visits in the previous 2 years (OR, 1.16 [95% CI, 1.05-1.29]; P = 0.005), and those who perceived their last interaction with their nephrologists as more patient-centered (OR, 2.63 [95% CI, 1.70-4.09]; P

Background: Preparedness regarding prognosis and treatment options enables patients to cope with uncertainties, make value-based treatment decisions, and set treatment goals. Yet, little is known about the expectedness of end-stage kidney disease (ESKD) patients’ treatment experiences beyond their desire for better treatment education. Objective: To describe unexpected adverse treatment experiences among ESKD patients. Method: The authors conducted 7 focus groups with 55 dialysis patients and living-donor kidney transplantation recipients receiving medical care in Baltimore, Maryland. Data were analyzed thematically. Themes present in different treatment groups were highlighted to provide insight into common experiences. Results: The authors identified 5 themes: (1) psychological reactions, (2) constrained freedom of choice, (3) treatment delivery and logistics, (4) morbidity, and (5) finances. Conclusion: Patients were unprepared for nonclinical, logistical, and clinical aspects of ESKD treatment. The need for providers’ use of tailored preparatory techniques and the development of pretreatment interventions to help patients know what to expect from and feel psychologically prepared for treatment, particularly with respect to nonclinical implications, is critical. These efforts have great potential to improve patients’ treatment experiences.

Abstract Background African Americans have persistently poor access to living donor kidney transplants (LDKT). We conducted a small randomized trial to provide preliminary evidence of the effect of informational decision support and donor financial assistance interventions on African American hemodialysis patients’ pursuit of LDKT. Methods Study participants were randomly assigned to receive (1) Usual Care; (2) the Providing Resources to Enhance African American Patients’ Readiness to Make Decisions about Kidney Disease (PREPARED); or (3) PREPARED plus a living kidney donor financial assistance program. Our primary outcome was patients’ actions to pursue LDKT (discussions with family, friends, or doctor; initiation or completion of the recipient LDKT medical evaluation; or identification of a donor). We also measured participants’ attitudes, concerns, and perceptions of interventions’ usefulness. Results Of 329 screened, 92 patients were eligible and randomized to Usual Care (n = 31), PREPARED (n = 30), or PREPARED plus financial assistance (n = 31). Most participants reported interventions helped their decision making about renal replacement treatments (62%). However there were no statistically significant improvements in LDKT actions among groups over 6 months. Further, no participants utilized the living donor financial assistance benefit. Conclusions Findings suggest these interventions may need to be paired with personal support or navigation services to overcome key communication, logistical, and financial barriers to LDKT. Trial registration ClinicalTrials.gov [NCT01439516] [August 31, 2011].

Abstract Background Reverse Innovation has been endorsed as a vehicle for promoting bidirectional learning and information flow between low- and middle-income countries and high-income countries, with the aim of tackling common unmet needs. One such need, which traverses international boundaries, is the development of strategies to initiate and sustain community engagement in health care delivery systems. Objective In this commentary, we discuss the Baltimore “Community-based Organizations Neighborhood Network: Enhancing Capacity Together” Study. This randomized controlled trial evaluated whether or not a community engagement strategy, developed to address patient safety in low- and middle-income countries throughout sub-Saharan Africa, could be successfully applied to create and implement strategies that would link community-based organizations to a local health care system in Baltimore, a city in the United States. Specifically, we explore the trial’s activation of community knowledge brokers as the conduit through which community engagement, and innovation production, was achieved. Summary Cultivating community knowledge brokers holds promise as a vehicle for advancing global innovation in the context of health care delivery systems. As such, further efforts to discern the ways in which they may promote the development and dissemination of innovations in health care systems is warranted. Trial registration Trial Registration Number: NCT02222909. Trial Register Name: Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes (CONNECT). Date of Trial’s Registration: August 22, 2014.

Background: Despite improvements in cardiovascular disease (CVD) prevention and treatment, low-income African Americans experience disparities in CVD-related morbidity and mortality. Childhood obesity disparities and poor diet and physical activity behaviors contribute to CVD disparities throughout the life course. Given the potential for intergenerational transmission of CVD risk, it is important to determine whether adult disease management interventions could be modified to achieve family-level benefits and improve primary prevention among high-risk youth.Objective: To explore mechanisms by which African-American adults' (referred to as index patients) participation in a hypertension disease management trial influences adolescent family members' (referred to as adolescents) lifestyle behaviors.Design/Methods: The study recruited index patients from the Achieving blood pressure Control Together (ACT) study who reported living with an adolescent ages 12–17 years old. Index patients and adolescents were recruited for in-depth interviews and were asked about any family-level changes to diet and physical activity behaviors during or after participation in the ACT study. If family-level changes were described, index patients and adolescents were asked whether role modeling, changes in the home food environment, meal preparation, and family functioning contributed to these changes. These mechanisms were hypothesize to be important based on existing research suggesting that parental involvement in childhood obesity interventions influences child and adolescent weight status. Thematic content analysis of transcribed interviews identified both a priori and emergent themes.Results: Eleven index patients and their adolescents participated in in-depth interviews. Index patients and adolescents both described changes to the home food environment and meal preparation. Role modeling was salient to index patients, particularly regarding healthy eating behaviors. Changes in family functioning due to study participation were not endorsed by index patients or adolescents. Emergent themes included adolescent care-taking of index patients and varying perceptions by index patients of their influence on adolescents' health behaviors.Conclusions: Our findings suggest that disease management interventions directed at high-risk adult populations may influence adolescent family members' health behaviors. We find support for the hypotheses that role modeling and changes to the home food environment are mechanisms by which family-level health behavior change occurs. Adolescents' roles as caretakers for index patients emerged as another potential mechanism. Future research should explore these mechanisms and ways to leverage disease management to support both adult and adolescent health behavior change.

Based on in vitro data, the U.S. Food and Drug Administration recommends chemical disinfection of raw sprout seeds to reduce enteric pathogens contaminating the seed coats. However, little is known about the effectiveness of decontamination at preventing human disease. In 1999, an outbreak of Salmonella enterica serotype Mbandaka occurred in Oregon, Washington, Idaho, and California. Based on epidemiologic and pulsed-field gel electrophoresis evidence from 87 confirmed cases, the outbreak was linked to contaminated alfalfa seeds grown in California’s Imperial Valley. Trace-back and trace-forward investigations identified a single lot of seeds used by five sprout growers during the outbreak period. Cases of salmonellosis were linked with two sprout growers who had not employed chemical disinfection; no cases were linked to three sprout growers who used disinfection. This natural experiment provides empiric evidence that chemical disinfection can reduce the human risk for disease posed by contaminated seed sprouts.

Objective We aimed to understand how, why and in what context upskilling programmes for unregulated care providers (UCPs) to provide foot screening for systematically marginalised groups living with diabetes were implemented.Design We used realist synthesis based on Realist And Meta-narrative Evidence Syntheses: Evolving Standards guidance.Data sources We searched the Medline, Embase, PsycINFO, CINAHL, ERIC, Web of Science Core Collection, and Scopus databases and the grey literature (Google Scholar, ProQuest Dissertations and Theses) up to November 2022.Eligibility criteria We included experimental and non-experimental articles in English that either described mechanisms or discussed expected outcomes for educational interventions for patients and family caregivers or healthcare providers, both regulated and unregulated. We also included articles that evaluated the impact of foot care programmes if the UCPs’ training was described.Data extraction and synthesis The lead author extracted, annotated and coded uploaded relevant data to identify contexts, mechanisms and outcome configurations using MAXQDA (a qualitative data analysis software). We used deductive and inductive coding to structure the process. Our team members double-reviewed and appraised a random sample of 20% of articles at all stages to ensure consistency.Results Our search identified 52 articles. Evidence suggested the necessity of developing upskilling foot screening programmes within the context of preventive care programmes that also provide education in diabetes, and early referrals for appropriate interventions. Multidisciplinary programmes created an ideal context facilitating coordination between UCPs and their regulated counterparts. Engaging patients and community partners, using a competency-based model, and incorporating cultural competencies were determinants of success for these programmes.Conclusion This review provides a realistic programme theory for the mechanisms used, the context in which these programmes were developed, and the expected outcomes to train UCPs to provide preventive foot care for systematically marginalised populations.PROSPERO registration number CRD42022369208.

Introduction Foot ulcers are one of the most devastating complications of diabetes mellitus leading to leg amputations. In Canada, systematically marginalised and racialised populations are more prone to developing foot ulcers and at higher risk of limb amputations. Shortages of regulated healthcare have hindered efforts to provide foot care. Upskilling unregulated care providers (UCPs) to deliver foot screening seems a reasonable solution to reduce limb loss. UCPs can advocate for health equity and deliver appropriate care. There is a need, however, to understand how and why an educational intervention for UCPs providing foot screening for these high-risk groups may or may not work.Methods and analysis This realist review will follow the Realist And Meta-narrative Evidence Syntheses: Evolving Standards standards. First, we will develop an initial programme theory (PrT) based on exploratory searches and discussions with experts and stakeholders. Then, we will search MEDLINE, Embase, PsycINFO, ERIC, CINAHL and Scopus databases along with relevant sources of grey literature. The retrieved articles will be screened for studies focusing on planned educational interventions for UCPs related to diabetic foot assessment. Data regarding contexts, mechanisms and outcomes will be extracted and analysed using a realist analysis through an iterative process that includes data reviewing and consultation with our team. Finally, we will use these results to modify the initial PrT.Ethics and dissemination Ethical approval is not required for this review. The main output of this research will be an evidence-based PrT for upskilling programmes for UCPs. We will share our final PrT using text, tables and infographics to summarise our results and draw insights across papers/reports. For academic, clinical, social care and educational audiences, we will produce peer-reviewed journal articles, including those detailing the process and findings of the realist review and establishing our suggestions for effective upskilling programmes.PROSPERO registration number CRD42022369208.

Physical activity benefits the health of older adults (e.g., lowering risk of cardiovascular disease, depression, dementia, and falls). However, less than one in four Americans meets guidelines for physical activity and inactivity increases with age. Masters athletes are exemplary because of their remarkable physical functioning. Swimming is a global, fast-growing sport in Masters athletics. This qualitative study explored motivations and barriers of 18 older adult members of a Masters swim club in Southern California. Guided by a primary research question: Why do Masters swimmers choose swim late in life, when most of their age cohort are becoming less physically active, semi-structured interviews delved into the lived experiences of the participants, and solicited peer feedback. Four main themes emerged: (1) I Just Love the Sensation of Being in the Water, (2) Tell Your Body What to Do Instead of the Other Way Around, (3) Make a Commitment to Your Friends That You’re Going to be There, and (4) I’ve Never Gone This Long in My Life Without Swimming. Participants expressed longing and regret that they could not swim due to COVID risk and safety guidelines. These findings can be used to design community programs to promote lifelong physical activity participation.

Background: Blood group incompatibility (ABOi) is the most common barrier to living donor kidney transplantation. Options for such recipients include kidney paired donation (KPD) or desensitization methodology to reduce blood antibody response. Objective: The objective of this study is to report on the first North America experience in ABOi living donor kidney transplantation using Glycosorb ABO immunoadsorption columns. Design: Retrospective observational cohort study. Setting: Renal transplant program at St. Michael’s Hospital, Unity Health Toronto, University of Toronto. Patients: Twenty-six ABOi living donor transplants from August 2011 through February 2020 were undertaken at our center. Measurements: Renal allograft and patient survival postdesensitization for ABOi living donor transplants and isohemagglutinin titer reduction. Methods: Preoperative immunosuppressive regimen consisted of a single dose of Rituximab 375 mg/m 2 IV on day −28; tacrolimus, mycophenolic acid, and prednisone to start on day −7. Immunoadsorption treatments with Glycosorb A or B columns were performed on day −7 through day −1 based on anti-A or anti-B titers on Spectra Optia Apheresis System. Immunosuppression included basiliximab, solumedrol followed by oral prednisone, once-daily tacrolimus, and mycophenolic acid. The mean follow-up was 53 months (3-96 months). Results: A total of 26 individuals underwent an attempt at desensitization of whom 24 patients underwent immediate transplant. One patient had a rebound in titers and subsequently was transplanted from a blood group compatible living donor. A second patient had an unrelated medical issue and desensitization was discontinued. Five-year patient survival was 96% and death censored allograft survival was 92%. Posttransplant anti-A or anti-B titers were monitored daily for the first 7 days posttransplant and every 2 days from days 7 to 14. There were no acute rejections seen in this cohort of transplant recipients. Limitations: As our protocol was first initiated as proof of concept, a few recipients had low initial isohemagglutinin titers. This may have contributed to improved clinical outcomes. Conclusions: ABO column immunoadsorption with specific columns is a safe and effective method for ABOi living donor kidney transplantation, and an option when KPD is less than ideal. Trial not registered as this was a retrospective cohort review.

Dengue viruses (DENVs) are mosquito-borne flaviviruses and the causative agents of dengue fever and dengue hemorrhagic fever. As there are four serotypes of DENV (DENV1-4), people can be infected multiple times, each time with a new serotype. Primary infections stimulate antibodies that mainly neutralize the serotype of infection (type-specific), whereas secondary infections stimulate responses that cross-neutralize 2 or more serotypes. Previous studies have demonstrated that neutralizing antibodies induced by primary infections recognize tertiary and quaternary structure epitopes on the viral envelope (E) protein that are unique to each serotype. The goal of the current study was to determine the properties of neutralizing antibodies induced after secondary infection with a different (heterotypic) DENV serotypes. We evaluated whether polyclonal neutralizing antibody responses after secondary infections consist of distinct populations of type-specific antibodies to each serotype encountered or a new population of broadly cross-neutralizing antibodies. We observed two types of responses: in some individuals exposed to secondary infections, DENV neutralization was dominated by cross-reactive antibodies, whereas in other individuals both type-specific and cross-reactive antibodies contributed to neutralization. To better understand the origins of type-specific and cross-reactive neutralizing antibodies, we analyzed sera from individuals with well-documented sequential infections with two DENV serotypes only. These individuals had both type-specific and cross-reactive neutralizing antibodies to the 2 serotypes responsible for infection and only cross-reactive neutralizing antibodies to other serotypes. Collectively, the results demonstrate that the quality of neutralizing (and presumably protective) antibodies are different in individuals depending on the number of previous exposures to different DENV serotypes. We propose a model in which low affinity, cross-reactive antibody secreting B-cell clones induced by primary exposure evolve during each secondary infection to secrete higher affinity and more broadly neutralizing antibodies.

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In 2009, we started a project to support the teaching and learning of university-level plant sciences, called Teaching Tools in Plant Biology. Articles in this series are published by the plant science journal, The Plant Cell (published by the American Society of Plant Biologists). Five years on, we investigated how the published materials are being used through an analysis of the Google Analytics pageviews distribution and through a user survey. Our results suggest that this project has had a broad, global impact in supporting higher education, and also that the materials are used differently by individuals in terms of their role (instructor, independent learner, student) and geographical location. We also report on our ongoing efforts to develop a global learning community that encourages discussion and resource sharing.

In 2009, we started a project to support the teaching and learning of university-level plant sciences, called Teaching Tools in Plant Biology. Articles in this series are published by the plant science journal, The Plant Cell (published by the American Society of Plant Biologists). Five years on, we investigated how the published materials are being used through an analysis of the Google Analytics pageviews distribution and through a user survey. Our results suggest that this project has had a broad, global impact in supporting higher education, and also that the materials are used differently by individuals in terms of their role (instructor, independent learner, student) and geographical location. We also report on our ongoing efforts to develop a global learning community that encourages discussion and resource sharing.

This article explores the “afterward” for qualitative research in the ruins of NCLB and its failure to deliver. In the space opened up “after” the dominance of the gold standard bullying and “metric mania” of neo-positivism, I articulate a post-retirement project on the weight of sports in U.S. secondary schools out of a re-engagement with the work of Walter Benjamin. Here my interest is to imagine forward out of troubling the narrow scientism of the recent past of educational research toward a post-qualitative future.

Background: This study explored the key physical and social factors within the home environment that influence the participation of children with an ASD in home activities. Method: Step 1 used a correlational research design to identify relationships between the home environment and participation patterns of children with ASD. Twenty-two children, ages 3 to 6 years, with a diagnosis of ASD participated. Data were collected using the Preschool Activity Card Sort (PACS), Home Observation for Measurement of the Environment Inventory (HOME), Parenting Stress Index (PSI), Social Responsiveness Scale (SRS), and Hollingshead Four Factor Index of Social Status (ISS). In Step 2, an electronic survey gathered information from 20 occupational therapists, attempting to identify their perceptions related to factors within the home environment that influence the participation of children with ASD. Results: Significant correlations were found among parenting stress, the availability of learning materials, and parent responsiveness toward the child and the participation patterns of children in home activities. Themes relating to designated play areas for children at home, parents’ awareness of the needs of the child, and parents’ responsiveness toward their child emerged from the occupational therapists’ qualitative survey data. Conclusion: The results indicated that home environments do contribute to a child’s ability to participate in home activities.

This paper asks what it is to claim empathy, voice and authenticity as the grounds of feminist research. It explores representational practices that refuse such grounds by residing in both situated and constantly changing intersections of interpretation, interruption and mutuality. The typical investments and categories of ethnography are challenged so as to put under theoretic pressure the claims of scientificity. Grounded in a study of women living with HIV/AIDS, also challenged is the ethnographer as "the one who knows" whose task is to produce the persuasive text the elicits reader empathy. Finally, the paper probes what is at work in the concepts of "voice" and "authenticity" in ethnographic work.

The purpose of this discussion is to describe the worldview and sacred relationship of the Cree people in Alberta, as well as how colonial policy has created despair (pomewin) in Aboriginal communities and a state of disconnectedness from the water. It concludes with the presentation of a framework for the development of policies that seek to repair the relationship between Aboriginal people and mainstream society – with the potential to create the good life, broadly defined (pimatisiwin) for all Albertans (Aboriginal and non-Aboriginal). This discussion is based upon the findings of a three-year research project entitled “The Sacred Relationship”. The goals of the project were three-fold: to describe the Aboriginal People of Alberta’s sacred relationship with water, to articulate the Indigenous science practices of Aboriginal people, and to find common ground between Western and Indigenous science.

Abstract Background The endocannabinoids, anandamide and 2-AG, are produced by adipocytes, where they stimulate lipogenesis via cannabinoid CB1 receptors and are under the negative control of leptin and insulin. Endocannabinoid levels are elevated in the blood of obese individuals and nonobese type 2 diabetes patients. To date, no study has evaluated endocannabinoid levels in subcutaneous adipose tissue (SAT) of subjects with both obesity and type 2 diabetes (OBT2D), characterised by similar adiposity and whole body insulin resistance and lower plasma leptin levels as compared to non-diabetic obese subjects (OB). Design and Methods The levels of anandamide and 2-AG, and of the anandamide-related PPARα ligands, oleoylethanolamide (OEA) and palmitoylethanolamide (PEA), in the SAT obtained by abdominal needle biopsy in 10 OBT2D, 11 OB, and 8 non-diabetic normal-weight (NW) subjects, were measured by liquid chromatography-mass spectrometry. All subjects underwent a hyperinsulinaemic euglycaemic clamp. Results As compared to NW, anandamide, OEA and PEA levels in the SAT were 2-4.4-fold elevated (p < 0.05), and 2-AG levels 2.3-fold reduced (p < .05), in OBT2D but not in OB subjects. Anandamide, OEA and PEA correlated positively (p < .05) with SAT leptin mRNA and free fatty acid during hyperinsulinaemic clamp, and negatively with SAT LPL activity and plasma HDL-cholesterol, which were all specifically altered in OBT2D subjects. Conclusions The observed alterations emphasize, for the first time in humans, the potential different role and regulation of adipose tissue anandamide (and its congeners) and 2-AG in obesity and type 2 diabetes.

Background: The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a “call to action” to develop bone-health plans incorporating components of (1) improved nutrition, (2) increased health literacy, and (3) increased physical activity.Objective: To conduct a Comparative Effectiveness Research (CER) study comparing changes in bone mineral density in healthy women over-40 with above-average compliance when following one of three bone health Plans incorporating the SG's three components.Methods: Using an open-label sequential design, 414 females over 40 years of age were tested, 176 of whom agreed to participate and follow one of three different bone-health programs. One Plan contained a bone-health supplement with 1,000 IUs of vitamin D3 and 750 mg of a plant-sourced form of calcium for one year. The other two Plans contained the same plant form of calcium, but with differing amounts of vitamin D3 and other added bone health ingredients along with components designed to increase physical activity and health literacy. Each group completed the same baseline and ending DXA bone density scans, 43-chemistry blood test panels, and 84-item Quality of Life Inventory (QOL). Changes for all subjects were annualized as percent change in BMD from baseline. Using self-reports of adherence, subjects were rank-ordered and dichotomized as “compliant” or “partially compliant” based on the median rating. Comparisons were also made between the treatment groups and two theoretical age-adjusted expected groups: a non-intervention group and a group derived from a review of previously published studies on non-plant sources of calcium.Results: There were no significant differences in baseline BMD between those who volunteered versus those who did not and between those who completed per protocol (PP) and those who were lost to attrition. Among subjects completing per protocol, there were no significant differences between the three groups on baseline measurements of BMD, weight, age, body fat and fat-free mass suggesting that the treatment groups were statistically similar at baseline. In all three treatment groups subjects with above average compliance had significantly greater increases in BMD as compared to the two expected-change reference groups. The group following the most nutritionally comprehensive Plan outperformed the other two groups. For all three groups, there were no statistically significant differences between baseline and ending blood chemistry tests or the QOL self-reports.Conclusions: The increases in BMD found in all three treatment groups in this CER stand in marked contrast to previous studies reporting that interventions with calcium and vitamin D3 reduce age-related losses of BMD, but do not increase BMD. Increased compliance resulted in increased BMD levels. No adverse effects were found in the blood chemistry tests, self-reported quality of life and daily tracking reports. The Plans tested suggest a significant improvement over the traditional calcium and vitamin D3 standard of care.

Bitter orange (Citrus aurantium) extract is widely used in dietary supplements for weight management and sports performance. Its primary protoalkaloid is p-synephrine. Most studies involving bitter orange extract and p-synephrine have used products with multiple ingredients. The current study assessed the thermogenic effects of p-synephrine alone and in conjunction with the flavonoids naringin and hesperidin in a double-blinded, randomized, placebo-controlled protocol with 10 subjects per treatment group. Resting metabolic rates (RMR), blood pressure, heart rates and a self-reported rating scale were determined at baseline and 75 min after oral ingestion of the test products in V-8 juice. A decrease of 30 kcal occurred in the placebo control relative to baseline. The group receiving p-synephrine (50 mg) alone exhibited a 65 kcal increase in RMR as compared to the placebo group. The consumption of 600 mg naringin with 50 mg p-synephrine resulted in a 129 kcal increase in RMR relative to the placebo group. In the group receiving 100 mg hesperidin in addition to the 50 mg p-synephrine plus 600 mg naringin, the RMR increased by 183 kcal, an increase that was statistically significant with respect to the placebo control (pp-synephrine plus 600 mg naringin resulted in a RMR that was only 79 kcal greater than the placebo group. None of the treatment groups exhibited changes in heart rate or blood pressure relative to the control group, nor there were no differences in self-reported ratings of 10 symptoms between the treatment groups and the control group. This unusual finding of a thermogenic combination of ingredients that elevated metabolic rates without corresponding elevations in blood pressure and heart-rates warrants longer term studies to assess its value as a weight control agent.

Abstract Background Little is known regarding the types of information African American and non-African American patients with chronic kidney disease (CKD) and their families need to inform renal replacement therapy (RRT) decisions. Methods In 20 structured group interviews, we elicited views of African American and non-African American patients with CKD and their families about factors that should be addressed in educational materials informing patients’ RRT selection decisions. We asked participants to select factors from a list and obtained their open-ended feedback. Results Ten groups of patients (5 African American, 5 non-African American; total 68 individuals) and ten groups of family members (5 African American, 5 non-African American; total 62 individuals) participated. Patients and families had a range (none to extensive) of experiences with various RRTs. Patients identified morbidity or mortality, autonomy, treatment delivery, and symptoms as important factors to address. Family members identified similar factors but also cited the effects of RRT decisions on patients’ psychological well-being and finances. Views of African American and non-African American participants were largely similar. Conclusions Educational resources addressing the influence of RRT selection on patients’ morbidity and mortality, autonomy, treatment delivery, and symptoms could help patients and their families select RRT options closely aligned with their values. Including information about the influence of RRT selection on patients’ personal relationships and finances could enhance resources’ cultural relevance for African Americans.

Abstract Background Few educational resources have been developed to inform patients’ renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients’ treatment and support patients’ decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. Methods We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in “stages.” For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. Results The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals’ testimonials regarding various considerations that might influence patients’ and families’ treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. Conclusions This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.

Abstract Background Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD). Methods/design The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community. Discussion The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies’ impact on clinical care and patients’ outcomes.

Abstract Background Living related kidney transplantation (LRT) is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD) and improve rates of LRT is unknown. Methods/design We report the protocol of the Providing Resources to Enhance African American Patients’ Readiness to Make Decisions about Kidney Disease (PREPARED) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making) and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients’ and families’ proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1) usual dialysis care by their nephrologists, 2) the informational intervention (educational video and handbook), or 3) the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients’ self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor). Discussion Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD. Trial registration ClinicalTrials.gov NCT01439516

Abstract Background A growing body of research suggests that elevated circulating levels of glucose and insulin accelerate risk factors for a wide range of disorders. Low-risk interventions that could suppress glucose without raising insulin levels could offer significant long-term health benefits. Methods To address this issue, we conducted two sequential studies, the first with two phases. In the first phase of Study 1, baseline fasting blood glucose was measured in 20 subjects who consumed 70 grams of sucrose in water and subsequently completed capillary glucose measurements at 30, 45, 60 and 90 minutes (Control). On day-2 the same procedure was followed, but with subjects simultaneously consuming a novel formula containing l-arabinose and a trivalent patented food source of chromium (LA-Cr) (Treatment). The presence or absence of the LA-Cr was blinded to the subjects and testing technician. Comparisons of changes from baseline were made between Control and Treatment periods. In the second phase of Study 1, 10 subjects selected from the original 20 competed baseline measures of body composition (DXA), a 43-blood chemistry panel and a Quality of Life Inventory. These subjects subsequently took LA-Cr daily for 4 weeks completing daily tracking forms and repeating the baseline capillary tests at the end of each of the four weeks. In Study 2, the same procedures used in the first phase were repeated for 50 subjects, but with added circulating insulin measurements at 30 and 60 minutes from baseline. Results In both studies, as compared to Control, the Treatment group had significantly lower glucose responses for all four testing times (AUC = P < 0.0001). Additionally, the Treatment was significantly more effective in lowering circulating insulin after 60 minutes from baseline (AUC = P = < 0.01). No adverse effects were found after acute sucrose challenge or in those who consumed LA-Cr daily for four weeks. Conclusions As compared to a placebo control, consumption of a LA-Cr formula after a 70-gram sucrose challenge was effective in safely lowering both circulating glucose and insulin levels. Trial Registration Clinical Trials.gov, NCT0110743

Abstract Background The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that: (1) improve nutrition, (2) increase health literacy and, (3) increase physical activity. This study is a response to this call to action. Methods After signing an informed consent, 158 adults agreed to follow an open-label bone-health plan for six months after taking a DXA test of bone density, a 43-chemistry blood test panel and a quality of life inventory (AlgaeCal 1). Two weeks after the last subject completed, a second group of 58 was enrolled and followed the identical plan, but with a different bone-health supplement (AlgaeCal 2). Results There were no significant differences between the two groups in baseline bone mineral density (BMD) or in variables related to BMD (age, sex, weight, percent body fat, fat mass, or fat-free mass). In both groups, no significant differences in BMD or related variables were found between volunteers and non-volunteers or between those who completed per protocol and those who were lost to attrition. Both groups experienced a significant positive mean annualized percent change (MAPC) in BMD compared to expectation [AlgaeCal 1: 1.15%, p = 0.001; AlgaeCal 2: 2.79%, p = 0.001]. Both groups experienced a positive MAPC compared to baseline, but only AlgaeCal 2 experienced a significant change [AlgaeCal 1: 0.48%, p = 0.14; AlgaeCal 2: 2.18%, p < 0.001]. The MAPC in AlgaeCal 2 was significantly greater than that in AlgaeCal 1 (p = 0.005). The MAPC contrast between compliant and partially compliant subjects was significant for both plans (p = 0.001 and p = 0.003 respectively). No clinically significant changes in a 43-panel blood chemistry test were found nor were there any changes in self-reported quality of life in either group. Conclusions Following The Plan for six months with either version of the bone health supplement was associated with significant increases in BMD as compared to expected and, in AlgaeCal 2, the increase from baseline was significantly greater than the increase from baseline in AlgaeCal 1. Increased compliance was associated with greater increases in BMD in both groups. No adverse effects were reported in either group. Trial Registration ClinicalTrials.gov NCT01114685