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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.

BackgroundPreparedness 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.ObjectiveTo describe unexpected adverse treatment experiences among ESKD patients.MethodThe 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.ResultsThe authors identified 5 themes: (1) psychological reactions, (2) constrained freedom of choice, (3) treatment delivery and logistics, (4) morbidity, and (5) finances.ConclusionPatients 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.

Rationale & objectiveUnderstanding 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 designQualitative study.Setting & participants8 focus groups comprising 49 family members of dialysis patients and living donor kidney transplant recipients undergoing medical care in Baltimore, MD.Analytical approachFocus 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.ResultsWe 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.LimitationsData collection occurred from 2008 to 2009; family members were recruited through patients undergoing care in 1 geographic area; 1 family member participant per patient.ConclusionsFamily 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.

ObjectiveTo determine the impact of policy changes for pulse oximetry oxygen saturation (SpO2) alarm limits on neonatal mortality and morbidity among infants born very preterm.Study designThis was a retrospective cohort study of infants born very preterm in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants were classified based on treatment at a hospital with an SpO2 alarm policy change and study epoch (before vs after policy change). We used a generalized linear mixed model to determine the effect of hospital group and epoch on the primary outcomes of mortality and severe retinopathy of prematurity (ROP) and secondary outcomes of necrotizing enterocolitis, bronchopulmonary dysplasia, and any ROP.ResultsThere were 3809 infants in 10 hospitals with an SpO2 alarm policy change and 3685 infants in 9 hospitals without a policy change. The nature of most policy changes was to narrow the SpO2 alarm settings. Mortality was lower in hospitals without a policy change (aOR 0.63; 95% CI 0.50-0.80) but did not differ between epochs in policy change hospitals. The odds of bronchopulmonary dysplasia were greater for hospitals with a policy change (aOR 1.65; 95% CI 1.36-2.00) but did not differ for hospitals without a policy change. Severe ROP and necrotizing enterocolitis did not differ between epochs for either group. The adjusted odds of any ROP were lower in recent years in both hospital groups.ConclusionsChanging SpO2 alarm policies was not associated with reduced mortality or increased severe ROP among infants born very preterm.

BackgroundAfrican 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.MethodsStudy 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.ResultsOf 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.ConclusionsFindings 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 registrationClinicalTrials.gov [ NCT01439516 ] [August 31, 2011].

BackgroundIntravenous iron use in hemodialysis patients has greatly increased over the last decade, despite limited studies on the safety of iron.MethodsWe studied the association of receipt of intravenous iron with hospitalizations in an incident cohort of hemodialysis patients. We examined 9544 patients from Dialysis Clinic, Inc. (DCI). We ascertained intravenous iron use from DCI electronic medical record and USRDS data files, and hospitalizations through Medicare claims. We examined the association between iron exposure accumulated over 1-, 3- or 6-month time windows and incident hospitalizations in the follow-up period using marginal structural models accounting for time-dependent confounders. We performed sensitivity analyses including recurrent events models for multiple hospitalizations and models for combined outcome of hospitalization and death.ResultsThere were 22 347 hospitalizations during a median follow-up of 23 months. Higher cumulative dose of intravenous iron was not associated with all-cause, cardiovascular or infectious hospitalizations [HR 0.97 (95% CI: 0.77-1.22) for all-cause hospitalizations comparing >2100 mg versus 0-900 mg of iron over 6 months]. Findings were similar in models examining the risk of hospitalizations in 1- and 3-month windows [HR 0.88 (95% CI: 0.79-0.99) and HR 0.88 (95% CI: 0.74-1.03), respectively] or the risk of combined outcome of hospitalization and death in the 6-month window [HR 0.98 (95% CI: 0.78-1.23)].ConclusionsHigher cumulative dose of intravenous iron may not be associated with increased risk of hospitalizations in hemodialysis patients. While clinical trials are needed, employing higher iron doses to reduce erythropoiesis-stimulating agents does not appear to increase morbidity in routine clinical care.

BackgroundMany patients with chronic kidney disease (CKD) have difficulty becoming actively engaged in the pursuit of preemptive living donor kidney transplantation.Study designThe Talking About Live Kidney Donation (TALK) Study was a randomized controlled trial of the effectiveness of educational and social worker interventions designed to encourage early discussions and active pursuit of preemptive living donor kidney transplantation in patients with progressive CKD.Setting & participantsWe recruited participants with progressive CKD from academically affiliated nephrology practices in Baltimore, MD.InterventionParticipants randomly received: (1) usual care (routine care with their nephrologists), the (2) TALK education intervention (video and booklet), or the (3) TALK social worker intervention (video and booklet plus patient and family social worker visits).OutcomesWe followed participants for 6 months to assess their self-reported achievement of behaviors reflecting their discussions about and/or pursuit of living donor kidney transplantation (discussions with family, discussions with physicians, initiating recipient evaluation, completing recipient evaluation, and identifying a potential living donor).MeasurementsWe assessed outcomes through a questionnaire at 1-, 3-, and 6-months follow-up.ResultsParticipants receiving usual care with their nephrologists (n = 44), TALK education (n = 43), and the TALK social worker (n = 43) were similar at baseline. TALK Study interventions improved participants' living donor kidney transplantation discussion and pursuit behaviors, with the social worker leading to greater patient activation (participants' predicted probability of achieving living donor kidney transplantation discussions, evaluations, or donor identification over 6 months): probabilities were 30% (95% CI, 20%-46%), 42% (95% CI, 33%-54%), and 58% (95% CI, 41%-83%), respectively, in the usual care, TALK education, and TALK social worker groups (P = 0.03).LimitationsOur population was well educated and mostly insured, potentially limiting generalizability of our findings.ConclusionsTALK interventions improved discussion and active pursuit of living donor kidney transplantation in patients with progressive CKD and may improve their use of preemptive living donor kidney transplantation.

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 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 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 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

We conducted focus group meetings of African American and non-African American patients with end-stage renal disease (six groups) and their family members (six groups), stratified by race/ethnicity and treatment. We elicited differences in participants' experiences with shared decision making about initiating renal replacement therapy (RRT; that is, hemodialysis, peritoneal dialysis, or a kidney transplant). Patients were often very sick when initiating RRT, and had little, if any, time to make a decision about what type of RRT to initiate. They also lacked sufficient information about alternative treatment options prior to initiation. Family members played supportive roles and shared in decision making when possible. Reports were similar for African American and non-African American participants. Our findings suggest that a greater emphasis on the improved engagement of patients and their families in shared decision making about RRT initiation is needed for both ethnic/racial minorities and nonminorities.

Bacillus thuringiensis is an insect pathogen that is widely used as a biopesticide (3). Here we report the finished, annotated genome sequence of B. thuringiensis Al Hakam, which was collected in Iraq by the United Nations Special Commission (2).