Search

Acute kidney injury (AKI) is a common and serious complication of cardiac surgical procedures for which unrecognized heterogeneity may underpin poor success in identifying effective therapies. We aimed to identify phenotypically similar groups of patients as defined by their postoperative creatinine trajectories.This was a retrospective, single-center cohort study in an academic tertiary care center including patients undergoing coronary artery bypass graft procedures. AKI phenotypes were evaluated through latent class mixed modeling of serum creatinine patterns (trajectories). To identify trajectory phenotypes, modeling was performed using postoperative creatinine values from 50% of patients (development cohort) and for comparison similarly conducted for the remaining sample (validation cohort). Subsequent assessments included comparisons of classes between development and validation cohorts for consistency and stability, and among classes for patient and procedural characteristics, complications, and long-term survival.We identified 12 AKI trajectories in both the development (n = 2647) and validation cohorts (n = 2647). Discrimination among classes was good (mean posterior class membership probability, 66%-88%), with differences in rate, timing, and degree of serum creatinine rise/fall, and recovery. In matched class comparisons between cohorts, many other phenotypic similarities were present. Notably, 4 high-risk phenotypes had greater long-term risk for death relative to lower risk classes.Latent class mixed modeling identified 12 reproducible AKI classes (serum creatinine trajectory phenotypes), including 4 with higher risk of poor outcome, in patients following coronary artery bypass graft procedures. Such hidden structure offers a novel approach to grouping patients for renoprotection investigations in addition to reanalysis of previously conducted trials.

Background Individuals with chronic kidney disease (CKD), hypertension (HTN), or diabetes mellitus (DM) are at increased risk for cardiovascular disease (CVD). The extent to which psychosocial factors are associated with increased CVD risk within these individuals is unclear. Black individuals experience a high degree of psychosocial stressors due to socioeconomic factors, environment, racism, and discrimination. We examined the association between psychosocial factors and risk of CVD events among Black men and women with CKD and CKD risk factors in the Jackson Heart Study. Methods and Results We identified 1919 participants with prevalent CKD or CKD risk factors at baseline. We used rotated principal component analysis - a form of unsupervised machine learning that may identify constructs not intuitively identified by a person - to describe five groups of psychosocial components (including negative moods, religiosity, discrimination, negative outlooks, and negative coping resources) based on a battery of questionnaires. Multiple imputation by chained equation (MICE) was used to impute missing covariate data. Cox models were used to quantify the association between psychosocial components and incident CVD, defined as a fatal coronary heart disease event, myocardial infarction, cardiac procedure (angiography or revascularization procedure), or stroke. Of the 929 participants in the analysis, 67% were female, 28% were current/former smokers with mean age of 56 years and mean BMI of 33 kg/m2. Over a median follow-up of 8 years, 6% had an incident CVD event. In multivariable models, each standard deviation (SD) increase in the religiosity component was associated with an increased hazard for CVD event (hazard ratio [HR] = 1.52, 95% CI: 1.09–2.13). Conclusions Religiosity was associated with CVD among participants with prevalent CKD or CKD risk factors. Studies to better understand the mechanisms of this relationship are needed.

Background and objectives With multiple medications indicated for mineral metabolism, dialysis providers can apply various strategies to achieve target phosphate and parathyroid hormone (PTH) levels. We describe common prescribing patterns and practice variation in mineral metabolism treatment strategies over the last decade. Design, setting, participants, & measurements In a cohort of adults initiating hemodialysis at Dialysis Clinic, Inc. facilities, we assessed prescriptions of vitamin D sterols, phosphate binders, and cinacalcet longitudinally. To identify the influence of secular trends in clinical practice, we stratified the cohort by dialysis initiation year (2006–2008, 2009–2011, and 2012–2015). To measure practice variation, we estimated the median odds ratio for prescribing different mineral metabolism treatment strategies at 12 months post–dialysis initiation across facilities using mixed effects multinomial logistic regression. Sensitivity analyses evaluated strategies used after detection of first elevated PTH. Results Among 23,549 incident patients on hemodialysis, there was a decline in vitamin D sterol–based strategies and a corresponding increase in strategies without PTH-modifying agents (i.e., phosphate binders alone or no mineral metabolism medications) and cinacalcet-containing treatment strategies between 2006 and 2015. The proportion with active vitamin D sterol–based strategies at dialysis initiation decreased across cohorts: 15% (2006–2008) to 5% (2012–2015). The proportion with active vitamin D sterol–based strategies after 18 months of dialysis decreased across cohorts: 52% (2006–2008) to 34% (2012–2015). The odds of using individual strategies compared with reference (active vitamin D sterol with phosphate binder) varied from 1.5- to two-fold across facilities in 2006–2008 and 2009–2011 cohorts, and increased to two- to three-fold in the 2012–2015 cohort. Findings were similar in sensitivity analyses starting from first elevated PTH measurement. Conclusions Over time, mineral metabolism management involved less use of vitamin D sterol–based strategies, greater use of both more conservative and cinacalcet-containing strategies, and increased practice variation, suggesting growing equipoise.

Exercise is a foundational treatment for nonalcoholic fatty liver disease (NAFLD); however, the majority of patients are unable to initiate and maintain effective exercise habits and remain at increased risk for progressive liver disease. Barriers and limitations to exercise in patients with NAFLD have not been fully identified. We performed a single survey of 94 patients with biopsy‐proven NAFLD to understand baseline physical activity and sedentary behavior, self‐perceived fitness, limitations to exercise, potential solutions to increase physical activity behavior, and perception of exercise as a foundational treatment for NAFLD. For exploratory analyses, we evaluated differences in responses to the survey by grouping severity of hepatic fibrosis as follows: nonalcoholic fatty liver (NAFL); early stage (nonalcoholic steatohepatitis [NASH] F0, NASH F1, NASH F2); and late stage (NASH F3, NASH F4). Zero weekly total physical activity was reported by 29% of patients with NAFLD. Late‐stage NASH had significantly lower vigorous (P = 0.024), walking (P = 0.029), total weekly activity (P = 0.043), and current fitness level (P = 0.022) compared to early stage NASH. Overall, 72% of patients with NAFLD reported limitations to exercise, with the greatest proportion citing lack of energy (62%), fatigue (61%), prior/current Injury (50%), and shortness of breath (49%). A preference for personal training to increase their physical activity was indicated by 66% of patients with NAFLD, and 63% preferred exercise over medication to treat NAFLD. Conclusion: The majority of patients with NAFLD have limitations to exercise but prefer exercise as a treatment option for NAFLD in the form of personal training. Patients with NAFLD may have unique physiologic limitations to exercise that worsen with fibrosis severity. Exercise interventions or services that are personalized and scalable may improve sustainability of exercise habits in the long term., NAFLD patients have physiologic and behavioral limitations to physical activity and exercise that impact their ability to initiate and sustain exercise. These limitations may worsen with disease progression.

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.

Rationale & Objective Timely recognition of functional decline in older adults receiving dialysis will allow clinicians to pursue interventions to prevent further disability and/or lead patient-centered goals of care discussions. Annual change in the 12-Item Short Form Health Survey (SF-12) physical component score (PCS) could identify patients with functional decline. Our objectives were to assess SF-12 PCS change over a year, risk factors associated with SF-12 PCS change, and the association of SF-12 PCS change with mortality in a survivor cohort of older adults receiving dialysis. Study Design Retrospective study. Setting & Participants 1,371 adults 65 years or older receiving hemodialysis for 6 or more months who completed SF-12 PCSs 300 or more days apart from 2012 to 2013. Exposures Serum albumin level; hemodialysis access type; SF-12 PCS change (for mortality analyses). Outcomes SF-12 PCS change and mortality. Analytical Approach Multivariable-adjusted linear regression model; Cox proportional hazards model. Results We excluded 24% (n = 801) of our cohort for death before the second SF-12 PCS. Among the 1,371 with sufficient SF-12 PCS data, mean age was 79.9 ± 4.5 years. Average SF-12 PCS change in 1 year was minimal (−0.9 ± 9.6), but 39.3% (n = 539) and 32.2% (n = 442) had clinically relevant SF-12 PCS decline and improvement, respectively. Albumin level and access type were not statistically associated with SF-12 PCS change. SF-12 PCS change was not associated with mortality (adjusted HR, 0.98; 95% CI, 0.96-1.00). Limitations 2 time points to assess SF-12 PCS change; covariate assessment only at baseline; survivor bias. Conclusions In this cohort of older adults receiving hemodialysis, nearly one-fourth died, while among survivors, it was more common for SF-12 PCS to decline than improve in a year. Annual SF-12 PCS change was not associated with traditional risk factors for functional impairment or mortality risk. Additional research is needed to identify appropriate measures and frequency of assessment for functional decline., Graphical abstract

Introduction Poor sleep associates with adverse chronic kidney disease (CKD) outcomes yet the biological mechanisms underlying this relation remain unclear. One proposed mechanism is via allostatic load, a cumulative biologic measure of stress. Methods Using data from 5177 Jackson Heart Study participants with sleep measures available, we examined the association of self-reported sleep duration: very short, short, recommended, and long (≤5, 6, 7–8, or ≥9 hours per 24 hours, respectively) and sleep quality (high, moderate, low) with prevalent baseline CKD, and estimated glomerular filtration rate (eGFR) decline and incident CKD at follow-up. CKD was defined as eGFR, Graphical abstract

BACKGROUND: 25-hydroxyvitamin D [25(OH)D] is lower in black compared with white Americans but is not consistently associated with outcomes in this group, possibly due to genetic and other biological differences. We examined the association of plasma 25(OH)D and renal outcomes in black Americans with a focus on effect modifiers. METHODS: We studied associations between baseline 25(OH)D with (i) annual rate of estimated glomerular filtration rate (eGFR) decline and (ii) incident chronic kidney disease (CKD) in the Jackson Heart Study, a prospective cohort of black Americans. Plasma 25(OH)D levels were corrected for monthly variation in sunlight exposure using the residual method. We used adjusted generalized linear models to evaluate outcomes and assessed potential effect modification by diabetes mellitus, vitamin D binding protein (DBP) genotype, obesity, dietary sodium intake, and use of renin-angiotensin-aldosterone system inhibitors. RESULTS: Among 5164 participants with 25(OH)D available, plasma 25(OH)D was 14.5 ± 6.5 ng/mL (mean ± SD), and eGFR was 94.1 ± 22.0 mL/min/1.73 m(2). Over a median of 8 years, eGFR decline was 1.3 ± 2.0 mL/min/1.73 m(2) per year in 3228 participants with complete data, and 220 out of 1803 eligible participants developed incident CKD. Overall, 25(OH)D was not associated with eGFR decline in fully adjusted models. However, higher 25(OH)D was associated with slower eGFR decline among those with diabetes: each 5 ng/mL higher 25(OH)D was associated with a 0.27 mL/min/1.73 m(2)/y slower eGFR decline (95% CI, 0.13 to 0.41; P < 0.001). Higher 25(OH)D was not associated with incident CKD overall, but it was associated with lower odds of incident CKD among participants with the GG or GT genotype at rs7041 in the gene encoding DBP [OR, 0.69 per 5 ng/mL higher 25(OH)D; 95% CI, 0.51 to 0.93; P-interaction = 0.005]. Other interactions were not significant. CONCLUSION: These findings support a potential benefit of higher 25(OH)D for kidney health in black Americans with diabetes or specific variants in DBP.

The cornerstone of ambulatory care training for internal medicine residents is the continuity clinic, which often serves medically and psychosocially complex patients. We conducted and evaluated a population-oriented redesign to improve care for "high-needs" patients and the resident experience at a hospital-based safety net primary care internal medicine practice in the Southeastern U.S. A Define, Measure, Analyze, Implement, Control (DMAIC) framework was adapted to identify and develop three main interventions to address major unmet needs of patients and trainees: (1) a behavioral health-focused team care model; (2) a formalized hospital discharge transitions workflow; and (3) the creation of larger "firms" of smaller resident practice partnerships. We constructed a financial model to justify investments, with metrics to track progress. Over three years, sustained reductions in hospitalizations and ED visits (mean annual changes of -11.6% and -16.9%, respectively) were achieved. Resident primary care provider (PCP)-to-patient continuity and satisfaction also improved.

BACKGROUND: Guidelines recommend pre-emptive creation of arteriovenous (AV) access. However

Financial incentives could be used to improve adherence to behavioral weight loss interventions, increasing their effectiveness. This Phase IIb randomized pilot study evaluated the feasibility and acceptability of a study protocol for providing financial incentives for dietary self-monitoring and/or weight loss. Community-dwelling adults with obesity were enrolled in a 24 week, group-based weight loss program. Participants were randomized in a 2 × 2 factorial design to receive financial incentives for both dietary self-monitoring and weekly weight loss, just one, or neither. Participants could earn up to $300, evolving from fixed weekly payments to intermittent, variable payments. The notice of reward was provided by text message. The study was conducted in three successive cohorts to evaluate study procedure changes, including dietary approach, recruitment and retention strategies, text messaging, and incentives. Descriptive statistics calculated separately for each cohort described study performance relative to predefined targets for recruitment, including minority representation; retention; adherence; and weight loss. Acceptability was assessed via postintervention qualitative interviews. In Cohort 1 (n = 34), a low-carbohydrate diet was used. Recruitment, retention, adherence, and weight loss were adequate, but minority representation was not. For Cohort 2 (n = 31), employing an additional recruitment method and switching to a reduced-calorie diet yielded adequate recruitment, minority representation, retention, and adherence but less weight loss. Returning to a low-carbohydrate diet in Cohort 3 (n = 28) yielded recruitment, minority representation, retention, adherence, and weight loss similar to Cohort 2. Participant feedback informed changes to text message timing and content and incentive amount. Through successive cohorts, we optimized recruitment and retention strategies and text messaging. An adequately powered trial is warranted to evaluate the efficacy of these incentive structures for reducing weight. The trial registration number is NCT02691260.

Lack of donors hinders living donor kidney transplantation (LDKT) for African Americans. We studied the effectiveness of a transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance to activate African Americans' potential living kidney donors. African Americans (N = 300) on the transplant waiting list were randomly assigned to usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance. We quantified differences in live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) after 12 months. Participants' mean age was 52 years, 56% were male, and 43% had annual household income less than $40,000. Most previously pursued LDKT. Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance. After 12 months, few (n = 39, 13%) participants had a new donor activation event (35 [12%] new donor inquiries; 17 [6%] new donor evaluations; 4 [1%] LDKT). There were no group differences in donor activation events (subdistribution hazard ratio [95% CI]: 1.09 [0.51-2.30] for TALK SWI and 0.92 [0.42-2.02] for TALK SWI plus Financial Assistance compared to Usual Care, p = 91). Alternative interventions to increase LDKT for African Americans on the waiting list may be needed. Trial registration: ClinicalTrials.gov (NCT02369354).

BACKGROUND: Statins failed to reduce cardiovascular (CV) events in trials of patients on dialysis. However, trial populations used criteria that often excluded those with atherosclerotic heart disease (ASHD), in whom statins have the greatest benefit, and included outcome composites with high rates of non-atherosclerotic CV events that may not be modified by statins. Here, we study whether statin use associates with lower atherosclerotic CV risk among patients with known ASHD on dialysis, including in those likely to receive a kidney transplant, a group excluded within trials, but with lower competing mortality risks. METHODS: Using data from the United States Renal Data System including Medicare claims, we identified adults initiating dialysis with ASHD. We matched statin users 1:1 to statin nonusers with propensity scores incorporating hard matches for age and kidney transplant listing status. Using Cox models, we evaluated associations of statin use with the primary composite of fatal/non-fatal myocardial infarction and stroke (including within pre-specified subgroups of younger age (

RATIONALE & OBJECTIVE: Patients with CKD are at elevated risk of metabolic acidosis due to impaired net acid excretion (NAE). Identifying early markers of acidosis may guide prevention in CKD. This study compared NAE in participants with and without CKD, as well as the NAE, blood pressure (BP), and metabolomic response to bicarbonate supplementation. STUDY DESIGN: randomized-order, cross-over study with controlled feeding. SETTING & PARTICIPANTS: 8 patients with CKD (estimated glomerular filtration rate 30-59 mL/min/1.73 m2 or 60-70 mL/min/1.73 m2 with albuminuria) and 6 patients without CKD. All participants had baseline serum bicarbonate between 20-28 mEq/L, did not have diabetes mellitus, and did not use alkali supplements at baseline. INTERVENTION: Participants were fed a fixed acid-load diet with bicarbonate supplementation (7 days) and with sodium chloride control (7 days) in a randomized-order, cross-over fashion. OUTCOMES: Urine NAE, 24-hour ambulatory BP, and 24-hour urine and plasma metabolomic profiles were measured after each period. RESULTS: During control, mean NAE was 28.3 ± 10.2 mEq/d overall without difference across groups (p=0.5). Urine pH, ammonium, and citrate were significantly lower in CKD versus non-CKD (each p

We studied associations between perceived adequacy of live donor kidney transplant (LDKT) information or knowledge with pursuit of LDKT or receipt of live donor inquiries among 300 African American kidney transplant candidates. Participants reported via questionnaire how informed or knowledgeable they felt regarding LDKT. Participants also reported their pursuit of LDKT, categorized as “low” (no discussion with family or friends about LDKT and no identified donor), “intermediate” (discussed LDKT with family but no identified donor) or “high” (discussed LDKT with family and identified a potential donor). We reviewed participants' electronic health records to identify potential donors' transplant center inquiries on participants' behalves. A minority of participants reported they felt “very” or “extremely” well informed about LDKT (39%) or had “a great deal” of LDKT knowledge (38%). Participants perceiving themselves as “very” or “extremely” (vs “not” or “slightly”) well informed about LDKT had statistically significantly greater odds of intermediate or high (vs low) pursuit of LDKT (odds ratio [95% confidence interval] 2.71 [1.02‐7.17]). Perceived LDKT knowledge was not associated with pursuit of LDKT. Neither perceived information adequacy nor knowledge was associated with living donor inquiries. Efforts to better understand the role of education in the pursuit of LDKT among African American transplant candidates are needed.

Background: Due to marginal efforts to increase living donor kidney transplantation, it is unclear whether interventions to improve African Americans’ interest and pursuit of living donation should be tailored to address patients’ exposure to or familiarity with dialysis or transplant settings. Design, Setting, and Participants: We conducted a cross-sectional secondary analysis of baseline data from 3 separate randomized clinical trials among African Americans with varying degrees of experience with dialysis or transplantation (predialysis, on dialysis but not on transplant list, and on transplant wait-list) settings. Methods: Interest in living donation was described using a 0 to 10 scale and pursuit of living donor kidney transplantation by achievement of at least 1 pursuant behavior. In multivariable logistic regression analyses, we assessed the association of knowledge, health literacy, and trust in health care with interest in or pursuit of living donation. Results: Interest among the 3 study cohorts was high (predialysis, 62.9%; dialysis, 67.4%; and transplant wait-list, 74.2%). The dialysis and transplant wait-list study cohorts pursued living donation more readily than those not on dialysis (73%, 92%, and 45%, respectively). Interest and pursuit were not statistically significantly associated with knowledge, health literacy, or the 3 factors reflecting medical mistrust. Conclusion: Interest and pursuit of living donation were greater among study participants with greater exposure to dialysis or transplant settings. Efforts to promote patients’ early interest and pursuit of living donor transplants may consider novel strategies to educate patients with less experience about the benefits of living donor kidney transplantation.

BACKGROUND Higher dietary phosphorus is associated with left ventricular hypertrophy and mortality, which are blood pressure (BP)-related outcomes. For this reason, we hypothesized that dietary phosphorus may be associated with adverse clinic and ambulatory BP patterns. METHODS Our study included 973 African American adults enrolled in the Jackson Heart Study (2000–2004) with 24-hour ambulatory BP monitoring (ABPM) data at baseline. We quantified dietary phosphorus from a validated Food Frequency Questionnaire as follows: (i) absolute daily intake, (ii) ratio of phosphorus-to-protein intake, (iii) phosphorus density, and (iv) energy-adjusted phosphorus intake. Using multivariable linear regression, we determined associations between dietary phosphorus intake and systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure in clinic and over daytime, nighttime, and 24-hour periods from ABPM. Extent of nocturnal BP dipping was also assessed. Using logistic regression, we modeled relationships between dietary phosphorus intake and clinically relevant qualitative BP phenotypes, such as masked, sustained, or white-coat hypertension and normotension. RESULTS There were no statistically significant associations between phosphorus intake and SBP or pulse pressure in adjusted models. Most metrics of higher phosphorus intake were associated with lower daytime, nighttime, and clinic DBP. Higher phosphorus intake was not associated with clinic or ABPM-defined hypertension overall, but most metrics of higher phosphorus intake were associated with lower odds of sustained hypertension compared to sustained normotension, white-coat hypertension, and masked hypertension. There were no associations between dietary phosphorus and nocturnal BP dipping. CONCLUSIONS These data do not support a role for higher phosphorus intake and higher BP in African Americans.

Job related factors have been associated with higher risk for developing depression, but past studies lacked full consideration of individual factors such as personality and coping. We sought to evaluate associations of personality, coping, job characteristics, and burnout with 12-month trajectories of depressive symptoms among nursing workers.Cohort of nursing workers (N = 281) in a private hospital system, with baseline assessments of personality, job characteristics, and coping. Burnout and depression were measured at baseline and during monthly follow-ups. Linear mixed modeling was used to examine contributions to between- and within-individual variation in monthly depressive symptoms.Personality trait of negative affectivity accounted for 36% of between-individual variation in depressive symptoms over 12 months, while job characteristics and coping explained an additional 5% and 8% of this variation, respectively. Exhaustion dimension of burnout was associated with between-individual variation in depressive symptoms (fixed effect β coefficient 2.44, p 0.001), but not with within-individual variation in symptoms. Disengagement dimension of burnout was not associated with between-individual variation in depressive symptoms, but contributed to within-individual variation in depressive symptoms over time (fixed effect β coefficient 0.52, p = 0.01).Participants were nursing workers within a single hospital system. Participants who were excluded due to missing baseline data were more likely of non-white race, which may also limit the generalizability of our results. We used latent variables to represent certain job and coping characteristics, which may make our results less comparable with other studies examining the role of these factors in work-associated depression.Future interventions to prevent depression in healthcare workers should consider multiple job and individual factors. Potential components include strategies to manage negative affectivity and reduce avoidant coping, such as cognitive reframing and mindfulness-based techniques, and organizational approaches to address burnout through augmentation of job resources.

Background and objectives Established risk factors for CKD do not fully account for risk of CKD in black Americans. We studied the association of nondepressive psychosocial factors with risk of CKD in the Jackson Heart Study. Design, setting, participants, & measurements We used principal component analysis to identify underlying constructs from 12 psychosocial baseline variables (perceived daily, lifetime, and burden of lifetime discrimination; stress; anger in; anger out; hostility; pessimism; John Henryism; spirituality; perceived social status; and social support). Using multivariable models adjusted for demographics and comorbidity, we examined the association of psychosocial variables with baseline CKD prevalence, eGFR decline, and incident CKD during follow-up. Results Of 3390 (64%) Jackson Heart Study participants with the required data, 656 (19%) had prevalent CKD. Those with CKD (versus no CKD) had lower perceived daily (mean [SD] score =7.6 [8.5] versus 9.7 [9.0]) and lifetime discrimination (2.5 [2.0] versus 3.1 [2.2]), lower perceived stress (4.2 [4.0] versus 5.2 [4.4]), higher hostility (12.1 [5.2] versus 11.5 [4.8]), higher John Henryism (30.0 [4.8] versus 29.7 [4.4]), and higher pessimism (2.3 [2.2] versus 2.0 [2.1]; all P β =0.08; 95% confidence interval, −0.02 to 0.17; moods: β =0.03; 95% confidence interval, −0.06 to 0.13; coping: β =−0.02; 95% confidence interval, −0.12 to 0.08) or incident CKD (life stressors: odds ratio, 1.07; 95% confidence interval, 0.88 to 1.29; moods: odds ratio, 1.02; 95% confidence interval, 0.84 to 1.24; coping: odds ratio, 0.91; 95% confidence interval, 0.75 to 1.11). Conclusions Greater life stressors were associated with lower prevalence of CKD at baseline in the Jackson Heart Study. However, psychosocial factors were not associated with risk of CKD over a median follow-up of 8 years. Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2018_01_03_CJASNPodcast_18_2_L.mp3

After a stressor, individuals may experience different trajectories of function and recovery. One potential explanation for this variation is differing trajectories may be indicators of differing classes or levels of resilience to the stressor. Latent Class Trajectory (LCTA) and Growth Mixture models (GMM) are two similar approaches used to discover the number and types of trajectories in a study population. Class membership may determine the shape and level of recovery, which may be predicted by individual characteristics. In this talk, we present some insights to using these models to successfully identify the number of classes of trajectories, membership of trajectory classes, and the functional form of the trajectory. We will identify methods for deciding class enumeration, indices for assessing fit quality, and, importantly, the importance of proper model specification. Real life and simulated examples will be shown to compare and contrast differences between GMM and LCTA results. Part of a symposium sponsored by Epidemiology of Aging Interest Group.

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., Graphical abstract

Background There is limited evidence on the relationship between social support and renal outcomes in African Americans. We sought to determine the association of social support with prevalent chronic kidney disease (CKD) and kidney function decline in an African American cohort. We also examined whether age modifies the association between social support and kidney function decline. Methods We identified Jackson Heart Study (JHS) participants with baseline (Exam in 2000–2004) functional and structural social support data via the Interpersonal Support Evaluation List (ISEL) and social network size questions, respectively. With ISEL as our primary exposure variable, we performed multivariable regression models to evaluate the association between social support and prevalent CKD [estimated glomerular filtration rate (eGFR) 30% decrease in eGFR over approximately 10 years). All models were adjusted for baseline sociodemographics, diabetes, hypertension, smoking status, and body mass index; models for eGFR decline and RRFD were additionally adjusted for eGFR and ACR. In models for eGFR decline, we assessed for interaction between age and social support. For secondary analyses, we replaced ISEL with its individual domains (appraisal, belonging, self-esteem, and tangible) and social network size in separate models as exposure variables. Results Of 5301 JHS participants, 4015 (76%) completed the ISEL at baseline. 843 (21%) had low functional social support (ISEL score

BACKGROUND The Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP) more effectively in blacks compared to other US racial subgroups. Considering chronic kidney disease (CKD) raises BP through complex mechanisms, DASH may affect BP differently among blacks with and without CKD. We compared the association of DASH accordance to BP and prevalent hypertension among blacks with and without CKD. METHODS Our study involved 3,135 black Americans enrolled in the Jackson Heart Study (2000–2004) with diet and office BP data. Using linear models adjusted for demographics, health behaviors, and clinical factors, we determined the association of a modified DASH score (excluding sodium intake, ranging from 0 to 8 with increasing DASH accordance) with BP. We performed tests for interaction between DASH score and CKD status. RESULTS Among participants (mean age: 55 years; hypertension: 60%; CKD: 19%), the median DASH score was similar among participants with and without CKD (1.0 [interquartile range (IQR): 0.5–2] and 1.0 [IQR: 0.5–1.5]). CKD status modified the association of the DASH score with systolic BP (SBP) and diastolic BP (DBP; P interactions were 0.06 and CONCLUSIONS Despite low DASH scores overall, better DASH accordance was associated with lower BP among Black Americans with CKD.

BackgroundProviding financial incentives has gained popularity as a strategy to promote weight loss, but questions remain about how best to utilize them. A promising mobile health strategy provides users with near-real-time financial incentives based on both the process of weight loss (behavioral modification) and actual weight loss. To maximize the impact of this strategy, a methodology is needed to close the gap between the desired behavior and the financial incentive. Leveraging mobile health tools—such as mobile phone apps, cellular body weight scales that transmit data to physicians and researchers, and text messaging for instructions and encouragement—has the potential to close this gap. ObjectiveThis study aimed to describe the development of an innovative technology-based solution and lessons learned from a feasibility trial—Log2Lose—that encouraged individuals to lose weight by providing near-real-time financial incentives for weight loss and/or dietary self-monitoring. MethodsWe recruited participants (N=96) with a body mass index greater than or equal to 30 kg/m2 for a 24-week weight loss trial. Participants received a behavioral intervention of biweekly, in-person group sessions and were instructed to log a minimum number of daily calories in MyFitnessPal and to step on the BodyTrace cellular scale at least twice per week. In a 2×2 design, participants were randomized into 4 groups to receive financial incentives for the following: (group 1) weekly weight loss and dietary self-monitoring, (group 2) dietary self-monitoring only, (group 3) weekly weight loss only, or (group 4) no financial incentives. Diet and weight data from the devices were obtained through application programming interfaces. Each week, we applied algorithms to participants’ data to determine whether they qualified for a monetary incentive (groups 1-3). A text message notified these participants of whether they met weight loss and/or self-monitoring requirements to earn an incentive and the amount they earned or would have earned. The money was uploaded to a debit card. ResultsOur custom-engineered software platform analyzed data from multiple sources, collated and processed the data to send appropriate text messages automatically, and informed study staff of the appropriate incentives. We present lessons learned from the development of the software system and challenges encountered with technology, data transmission, and participants (eg, lost connections or delayed communication). ConclusionsWith consistent and constant validation checks and a robust beta test run, the process of analyzing data and determining eligibility for weekly incentives can be mostly automated. We were able to accomplish this project within an academic health system, which required significant security and privacy safeguards. Our success demonstrates how this methodology of automated feedback loops can provide health interventions via mobile technology. Trial RegistrationClinicalTrials.gov NCT02691260; https://clinicaltrials.gov/ct2/show/NCT02691260

Correlated binary data may arise in longitudinal or spatial studies or through some other form of clustering of sampling units. The simplest setting, with clusters of size two and no covariates, leads to familiar methods of analysis. Models with covariates include response feature models, conditionally specified models, transitional models, marginal models, and cluster-specific models. These may lead to different interpretations of the regression parameters. Keywords: longitudinal; matched pairs; response feature; conditional; transitional; marginal; cluster-specific; missing data; generalized estimating equations; generalized linear model

BACKGROUND: Effective hypertension self-management interventions are needed for socially disadvantaged African Americans, who have poorer blood pressure (BP) control compared to others. OBJECTIVE: We studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans. DESIGN: Randomized comparative effectiveness trial. PARTICIPANTS: One hundred fifty-nine African Americans at an urban primary care clinic. INTERVENTIONS: Participants were randomly assigned to receive (1) a community health worker (“CHW”) intervention, including the provision of a home BP monitor; (2) the CHW plus additional training in shared decision-making skills (“DoMyPART”); or (3) the CHW plus additional training in self-management problem-solving (“Problem Solving”). MAIN MEASURES: We assessed group differences in BP control (systolic BP (SBP) < 140 mm Hg and diastolic BP (DBP) < 90 mmHg), over 12 months using generalized linear mixed models. We also assessed changes in SBP and DBP and participants’ BP self-monitoring frequency, clinic visit patient-centeredness (i.e., extent of patient-physician discussions focused on patient emotional and psychosocial concerns), hypertension self-management behaviors, and self-efficacy. KEY RESULTS: BP control improved in all groups from baseline (36%) to 12 months (52%) with significant declines in SBP (estimated mean [95% CI] − 9.1 [− 15.1, − 3.1], − 7.4 [− 13.4, − 1.4], and − 11.3 [− 17.2, − 5.3] mmHg) and DBP (− 4.8 [− 8.3, − 1.3], − 4.0 [− 7.5, − 0.5], and − 5.4 [− 8.8, − 1.9] mmHg) for CHW, DoMyPART, and Problem Solving, respectively). There were no group differences in BP outcomes, BP self-monitor use, or clinic visit patient-centeredness. The Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 18.7 [4.0, 87.3]) and self-efficacy scores (OR [95% CI] 4.7 [1.5, 14.9]) at 12 months compared to baseline, while other groups did not. Compared to DoMyPART, the Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 5.7 [1.3, 25.5]) at 12 months. CONCLUSION: A context-adapted CHW intervention was correlated with improvements in BP control among socially disadvantaged African Americans. However, it is not clear whether improvements were the result of this intervention. Neither the addition of shared decision-making nor problem-solving self-management training to the CHW intervention further improved BP control. TRIAL REGISTRY: ClinicalTrials.gov Identifier: NCT01902719 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-019-05396-7) contains supplementary material, which is available to authorized users.

Background: Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. Objective: This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. Methods: Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. Results: Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. Conclusion: We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. Trial Registration: ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU)

Background Live donor kidney transplantation (LDKT) is underutilized by patients with end-stage kidney disease due to knowledge, communication, and logistical barriers. Material and Methods The Talking About Live Kidney Donation Social Worker Intervention (TALK-SWI) is a previously validated intervention demonstrated to improve patients' access to and pursuit of LDKT through in-person delivery of education and social support. To help overcome logistical barriers to LDKT, we adapted TALK-SWI into a telehealth intervention employing digital (ie, tablet, smartphone) and telephone technologies. We studied the usability and acceptability of both the mobile device and telephone counseling portions of the intervention among people with kidney disease. For the digital portion, we assessed critical (ie, inability to complete a task) and non-critical (ie, ability to complete a task utilizing an alternative method) errors participants encountered when using the program and their preferences regarding digital materials. Simultaneously, we assessed participants' satisfaction with telephone-adapted counseling compared to the original, in-person counseling. Results The 15 participants testing the digital technology made 25 critical errors and 29 non-critical errors, while they easily completed 156 tasks (out of 210). A majority of participants (73%) preferred the tablet/smart phone education application over traditional materials, and most (80%) indicated they would be more likely to utilize the mobile platform over traditional materials. Participants testing the telephone-adapted (n = 45) and in-person (n = 125) social worker counseling all reported high satisfaction with the intervention. Conclusion We successfully adapted a validated educational and behavioral intervention to improve access to LDKT into a usable and acceptable telehealth intervention.

Care for patients transitioning from chronic kidney disease to kidney failure often falls short of meeting patients' needs. The PREPARE NOW study is a cluster randomized controlled trial studying the effectiveness of a pragmatic health system intervention, ‘Patient Centered Kidney Transition Care,’ a multi-component health system intervention designed to improve patients' preparation for kidney failure treatment. Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and risk prediction tools) to help providers recognize patients in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences. Patient-Centered Kidney Transition Care also adds a ‘Kidney Transitions Specialist’ to the nephrology health care team to facilitate patients' self-management empowerment, shared-decision making, psychosocial support, care navigation, and health care team communication. The PREPARE NOW study is conducted among eight [8] outpatient nephrology clinics at Geisinger, a large integrated health system in rural Pennsylvania. Four randomly selected nephrology clinics employ the Patient Centered Kidney Transitions Care intervention while four clinics employ usual nephrology care. To assess intervention effectiveness, patient reported, biomedical, and health system outcomes are collected annually over a period of 36 months via telephone questionnaires and electronic health records. The PREPARE NOW Study may provide needed evidence on the effectiveness of patient-centered health system interventions to improve nephrology patients' experiences, capabilities, and clinical outcomes, and it will guide the implementation of similar interventions elsewhere. Trial registration: NCT02722382

This article resulted from our participation in the session on the “role of expert opinion and judgment in statistical inference” at the October 2017 ASA Symposium on Statistical Inference. We present a strong, unified statement on roles of expert judgment in statistics with processes for obtaining input, whether from a Bayesian or frequentist perspective. Topics include the role of subjectivity in the cycle of scientific inference and decisions, followed by a clinical trial and a greenhouse gas emissions case study that illustrate the role of judgments and the importance of basing them on objective information and a comprehensive uncertainty assessment. We close with a call for increased proactivity and involvement of statisticians in study conceptualization, design, conduct, analysis, and communication.

The obesity epidemic has negative physical, psychological, and financial consequences. Despite the existence of effective behavioral weight loss interventions, many individuals do not achieve adequate weight loss, and most regain lost weight in the year following intervention. We report the rationale and design for a 2×2 factorial study that involves financial incentives for dietary self-monitoring (yes vs. no) and/or interim weight loss (yes vs. no). Outpatients with obesity participate in a 24-week, group-based weight loss intervention. All participants are asked to record their daily dietary and liquid intake on a smartphone application (app) and to weigh themselves daily at home on a study-provided cellular scale. An innovative information technology (IT) solution collates dietary data from the app and weight from the scale. Using these data, an algorithm classifies participants weekly according to whether they met their group's criteria to receive a cash reward ranging from $0 to $30 for dietary self-monitoring and/or interim weight loss. Notice of the reward is provided via text message, and credit is uploaded to a gift card. This pilot study will provide information on the feasibility of using this novel IT solution to provide variable-ratio financial incentives in real time via its effects on recruitment, intervention adherence, retention, and cost. This study will provide the foundation for a comprehensive, adequately-powered, randomized controlled trial to promote short-term weight loss and long-term weight maintenance. If efficacious, this approach could reduce the prevalence, adverse outcomes, and costs of obesity for millions of Americans. Clinicaltrials.gov registration: NCT02691260.

BACKGROUND: African Americans are at high risk for chronic kidney disease (CKD). Obesity may increase the risk for CKD by exacerbating features of the metabolic syndrome and promoting glomerular hyperfiltration. Whether other factors also affecting these pathways may amplify or mitigate obesity–CKD associations has not been investigated. METHODS: We studied interactions between obesity and these candidate factors in 2043 African Americans without baseline kidney disease enrolled in the Jackson Heart Study. We quantified obesity as body mass index (BMI), sex-normalized waist circumference and visceral adipose volume measured by abdominal computed tomography at an interim study visit. Interactions were hypothesized with (i) metabolic risk factors (dietary quality and physical activity, both quantified by concordance with American Heart Association guidelines) and (ii) factors exacerbating or mitigating hyperfiltration (dietary protein intake, APOL1 risk status and use of renin–angiotensin system blocking medications). Using multivariable regression, we evaluated associations between obesity measures and incident CKD over the follow-up period, as well as interactions with metabolic and hyperfiltration factors. RESULTS: Assessed after a median of 8 years (range 6–11 years), baseline BMI and waist circumference were not associated with incident CKD. Higher visceral adipose volume was independently associated with incident CKD (P = 0.008) in a nonlinear fashion, but this effect was limited to those with lower dietary quality (P = 0.001; P-interaction = 0.04). In additional interaction models, higher waist circumference was associated with greater risk of incident CKD among those with the low-risk APOL1 genotype (P = 0.04) but not those with a high-risk genotype (P-interaction = 0.02). Other proposed factors did not modify obesity–CKD associations. Conclusions. Higher risks associated with metabolically active visceral adipose volume and interactions with dietary quality suggest that metabolic factors may be key determinants of obesity-associated CKD risk. Interactions between obesity and APOL1 genotype should be considered in studies of African Americans.

While racial variation in ambulatory blood pressure (BP) is known, patterns of diurnal dipping in the context of diabetic kidney disease have not been well defined. The authors sought to determine the association of race with nocturnal dipping status among participants with diabetic kidney disease enrolled in the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) trial. The primary outcome was nocturnal dipping—percent decrease in average systolic BP from wake to sleep—with categories defined as reverse dippers (decrease

This study aims to evaluate the relationship between survivorship care planning (SCP) and survivorship care and health outcomes reported by long-term lung and colorectal cancer survivors. Participants (n = 832) were diagnosed and enrolled during 2003–2005. In 2012, patient-reported outcomes (survivorship care and health outcomes) and two patient-reported SCP measures (receipt of written summary of cancer treatment and receipt of instructions on who to see for routine cancer follow-up) were collected. Analyses controlled for SCP predictors collected from medical records and an interview 1 year after diagnosis. One in four survivors reported receiving both SCP elements. Those receiving both were more certain which doctor was in charge (odds ratio (OR) 7.0; 95 % confidence intervals (95 % CI) 3.9–12.5), more likely to report follow-up checkup (OR 5.1; 95 % CI 3.3–8.0), and had an MRI/PET/CT scan in the past 2 years (OR 2.8; 95 % CI 1.7–4.7) compared to those receiving neither. Physician communication experiences were significantly more positive and having physical exams (OR 2.0; 95 % CI 1.2–3.4) and meeting exercise guidelines (OR 1.6; 95 % CI 1.004–2.4) more likely. Physical health (p = 0.012) and good-to-excellent self-perceived health status (OR 2.2; 95 % CI 1.3–3.9) were better for those receiving both elements. SCP may lead to better cancer follow-up care, long-term physical health, and physician-patient communication experiences. The positive association between outcomes and SCP suggests that efforts to implement SCP should be fruitful.

PURPOSE Preoperative (preop) chemoradiation therapy (CRT) improves local control and reduces toxicity more than postoperative (postop) CRT for the treatment of stages II/III rectal cancer, but studies suggest that many patients still receive postop CRT. We examined patient beliefs and clinical and provider characteristics associated with receipt of recommended therapy. METHODS We identified stages II/III rectal cancer patients who had primary site resection and CRT among subjects in the Cancer Care Outcomes Research and Surveillance Consortium, a population-based and health system-based prospective cohort of newly diagnosed colorectal cancer patients from 2003 to 2005. Patient surveys and abstracted medical records were used to construct variables and determine sequence of CRT and surgery. Logistic regression was used to model the association between predictors and receipt of preop CRT. RESULTS Of the 201 patients, 66% received preop and 34% received postop CRT. Those visiting a medical oncologist and/or radiation oncologist before a surgeon had a 96% (95% confidence interval, 92%-100%) predicted probability of receiving preop CRT, compared with 48% (95% confidence interval, 41%-55%) for those visiting a surgeon first. Among those visiting a surgeon first, documentation of recommended staging procedures was associated with receiving preop CRT. CONCLUSIONS Sequence of provider visits and documentation of recommended staging procedures were important predictors of receiving preop CRT. Initial multidisciplinary evaluation led to better adherence to CRT guidelines. Further evaluation of provider characteristics, referral patterns, and related health system processes should be undertaken to inform targeted interventions to reduce variation from recommended care.

Comprehensive medication reviews (CMRs) consist of in-depth reviews of patients' medications to identify effectiveness or safety problems and often generate cost savings for individuals. Despite their advantages, CMRs are not widely obtained. Previous studies found that older age, female sex, and experience of side effects were associated with obtaining a medication review.To quantify the association between attitudinal and clinical factors with intention and predict future behavior to obtain a CMR among Medicare Part D beneficiaries.A sample of Medicare Part D beneficiaries from 1 health care plan (n = 660) completed a 14-item survey over the telephone assessing factors that were hypothesized to affect their intention and behavior to obtain a CMR. The survey collected medication use history and health care information with the medication user self-evaluation tool, health status, adherence, intention to obtain a CMR, and demographic characteristics. Subjects subsequently were informed that they could obtain a CMR from their pharmacies. Claims data were obtained that indicated which subjects received a CMR. Two dependent variables were predicted: intention to schedule a CMR using a multivariate linear regression model and receipt of a CMR using a logistic regression and including intention as a predictor variable.The mean age of participants was 76.6 (SD = 7.61) years; 71% were female; and participants took an average of 5.2 (SD = 3.18) medications. The intention to have a CMR was 2.85 (SD = 1.41) on a 5-point scale, and 5.6% of the participants actually had a CMR. Worrying about medications doing more harm than good, number of pharmacies where participants obtained their medications from, number of medications, and number of medical conditions predicted intention to obtain a CMR. Patients who perceived their health status to be poorer compared with others their age were more likely to have a CMR. Intention to obtain a CMR was not associated with receipt of a CMR.Stakeholders should target patients who perceive their health to be poor for a CMR, hence expanding the scope of CMRs and increasing the number of older adults benefiting from this service.This study was funded by a grant from the Agency for Healthcare Research and Quality (1R18HS018353). Frank is an employee of Outcomes MTM. Pendergast has received grants from the NIH, NIA, and PICORI. Farris has received grants from NIH and speaker fees from Chulalongkorn University, Bangkok, Thailand, and the American College of Clinical Pharmacy. All other authors declare that they have no conflicts of interest. Study concept was developed by Farris, Pendergast, Chrischilles, and Doucette. Pendergast, Frank, Farris, and Aneese collected the data, with assistance from Chrischilles and Doucette. Data interpretation was performed by Farris, Marshall, Salgado, and Aneese, with assistance from the other authors. The manuscript was written by Farris, Salgado, and Aneese, with assistance from the other authors, and revised by Salgado and Marshall, assisted by the other authors.

Introduction: African Americans (AA) suffer disproportionately from chronic kidney disease (CKD) and its sequelae. Persons with prevalent CKD or those at risk (i.e., those with diabetes and/or hypertension [HTN]) are at markedly greater risk for incident cardiovascular disease (CVD) compared to patients without these conditions. This association is independent of traditional demographic and clinical risk factors. A growing body of evidence suggests that social determinants, such as socioeconomic and psychosocial factors, impact health. Little data exists on the impact of these factors in the development of CVD among individuals with CKD. Objective: Quantify the association between socioeconomic and psychosocial factors and risk of CVD events among individuals with or at risk for CKD in the Jackson Heart Study (JHS), a prospective study of AA men and women from Jackson, Mississippi. Methods: We identified participants with prevalent diabetes, HTN and/or CKD (i.e., presence of albuminuria or glomerular filtration rate Results: Of the 5301 participants, 3468 (65%) had diabetes, HTN and/or CKD at baseline. Of these, 536 were excluded for history of CVD at baseline and 1357 people were excluded for incomplete covariate/outcome information. Of the 1,575 participants in the analysis, 68% were female, 58% were obese, and 29% were current/former smokers with a mean age of 58 years. Over a median follow-up of 8 years, 128 (8%) had an incident CVD event. In models adjusted for baseline demographic and clinical covariates, socioeconomic and most psychosocial factors were not associated with incident CVD. Individuals with lower self-reported participation in organized religion had a lower risk of CVD events compared to individuals with greater participation in organized religion (HR=0.74, 95% CI: 0.57-0.97). Individuals with lower levels of spirituality had a marginally lower risk of incident CVD compared to those with greater spirituality (HR=0.95, 95% CI: 0.90-1.01). Conclusions: Many social and psychosocial factors were not associated with CVD. Our findings contrast with prior studies that report religious participation is associated with reduced adverse health outcomes, suggesting further study of the impact of these factors among African Americans is needed.

Objectives To characterize factors contributing to physical resilience in older cancer survivors, as demonstrated by resistance to decline or recovery (resilience). Materials and Methods We conducted a secondary analysis of data from a randomized controlled trial of cancer survivors ≥ 65 years old and ≥ 5 years from cancer diagnoses. Physical function was assessed quarterly over 2 years, with Short-Form 36 physical function subscale. Participants with ≥ 2 follow-up assessments (n = 594) were evaluated for physical resilience: 1) Resistance was defined as lack of any decline, where decline was a drop of ≥ 13 points, and 2) resilience (i.e., recovery) was defined as regaining ≥ 50% of lost function, subsequent to decline. Results Mean age was 73.1 years and 89.1% were Caucasian. Forty-nine percent (n = 289) were resistant to decline in function; these individuals were younger, had higher education and income, were more likely to be Caucasian, and had higher baseline physical function (mean difference [MD] 7.8 points, 95% CI 5.0–10.8) and general health (MD 7.5 points, 95% CI 4.9–10.1). Fifty-seven percent (n = 137 of 239) demonstrated resilience, with 91.2% (n = 125) recovering within 6 months of declines; these participants had higher baseline physical function (MD 6.6 points, 95% CI 1.8–11.4), but similar pre-decline function. More participants who were resistant, and more who showed resilience, reported high self-efficacy and social support. Conclusions The majority of older cancer survivors exhibited physical resilience; this was associated with high baseline health, physical function, self-efficacy, and social support. Assessing and targeting psychosocial factors may be important for interventions seeking to promote physical resilience.

When continuous predictors are present, classical Pearson and deviance goodness-of-fit tests to assess logistic model fit break down. The Hosmer-Lemeshow test can be used in these situations. While simple to perform and widely used, it does not have desirable power in many cases and provides no further information on the source of any detectable lack of fit. Tsiatis proposed a score statistic to test for covariate regional effects. While conceptually elegant, its lack of a general rule for how to partition the covariate space has, to a certain degree, limited its popularity. We propose a new method for goodness-of-fit testing that uses a very general partitioning strategy (clustering) in the covariate space and either a Pearson statistic or a score statistic. Properties of the proposed statistics are discussed, and a simulation study demonstrates increased power to detect model misspecification in a variety of settings. An application of these different methods on data from a clinical trial illustrates their use. Discussions on further improvement of the proposed tests and extending this new method to other data situations, such as ordinal response regression models are also included.

To assess the impact of a patient engagement intervention utilizing the Medication User Self-Evaluation (MUSE) tool on the completion percentage of comprehensive medication reviews (CMRs) among Medicare Part D beneficiaries.A case-control study.Beneficiaries from 2 Medicare Part D plans were randomly assigned to 3 study arms (1 control arm plus 2 intervention arms for 2011 and 2012, respectively). Each beneficiary who participated in the MUSE intervention met 3 inclusion criteria and was matched with a single control group beneficiary based on: gender; age (within 5-year interval); plan type (ie, Medicare Prescription Drug Plan, Medicare Advantage Prescription Drug Plan); number of unique prescriptions; pharmacy medication therapy management (MTM) training status; and time period (2011, 2012). The outcome of interest was whether or not the beneficiary received a CMR in the 6 months following the index date. Generalized estimating equation (GEE) models were used to compare CMR percentages over time and between MUSE intervention groups. This study used MTM service claims data.The final sample of 1015 beneficiaries received MUSE intervention, of which 1007 were successfully matched to a control beneficiary. The estimated odds of having a CMR among those who received the MUSE intervention were 2 times that of their counterparts (P = .0048) across both study years.Given the strong evidence found for a positive association between participation in a CMR and the MUSE intervention, Part D plans could use the MUSE to engage targeted beneficiaries in using pharmacist-provided MTM services.

Many patients do not receive guideline-recommended neoadjuvant chemoradiotherapy for resectable rectal cancer. Little is known regarding long-term quality of life (QOL) associated with various treatment approaches. Our objective was to determine patient characteristics and subsequent QOL associated with treatment approach.Our study was a geographically diverse population- and health system-based cohort study that included adults age 21 years or older with newly diagnosed stage II/III rectal cancer who were recruited from 2003 to 2005. Eligible patients were contacted 1 to 4 months after diagnosis and asked to participate in a telephone survey and to consent to medical record review, with separate follow-up QOL surveys conducted 1 and 7 years after diagnosis.Two hundred thirty-nine patients with stage II/III rectal cancer were included in this analysis. Younger age (65 v ≥ 65 years: odds ratio, 2.49; 95% CI, 1.33 to 4.65) was significantly associated with increased odds of receiving neoadjuvant or adjuvant chemoradiotherapy. The adjuvant chemoradiotherapy group had significantly worse mean EuroQol-5D (range, 0 to 1) and Short Form-12 physical health component scores (standardized mean, 50) at 1-year follow-up than the neoadjuvant chemoradiotherapy group (0.75 v 0.85; P = .002; 37.2 v 43.3; P = .01, respectively) and the group that received only one or neither form of treatment (0.75 v 0.85; P = .02; 37.2 v 45.1; P = .008, respectively).Neoadjuvant treatment may result in better QOL and functional status 1 year after diagnosis. Further evaluation of patient and provider reasons for not pursuing neoadjuvant therapy is necessary to determine how and where to target process improvement and/or education efforts to ensure that patients have access to recommended treatment options.

Background: Optimal diabetes management relies on providers adhering to evidence-based practice guidelines in the processes of care delivery and patients adhering to self-management recommendations to maximize patient outcomes. Purpose: To explore: (1) the degree to which providers adhere to the guidelines; (2) the extent of glycemic, lipid, and blood pressure control in patients with diabetes; and (3) the roles of organizational and patient population characteristics in affecting both provider adherence and patient outcome measures for diabetes. Design: Secondary data analysis of provider adherence and patient outcome measures from chart reviews, along with surveys of facility quality managers. Sample: We sampled 109 Veterans Affairs medical centers (VAMCs). Results: Analyses indicated that provider adherence to diabetes guidelines (ie, hemoglobin A1c, foot, eye, renal, and lipid screens) and patient outcome measures (ie, glycemic, lipid, and hypertension control plus nonsmoking status) are comparable or better in VAMCs than reported elsewhere. VAMCs with higher levels of provider adherence to diabetes guidelines had distinguishing organizational characteristics, including more frequent feedback on diabetes quality of care, designation of a guideline champion, timely implementation of quality-of-care changes, and greater acceptance of guideline applicability. VAMCs with better patient outcome measures for diabetes had more effective communication between physicians and nurses, used educational programs and Grand Rounds presentations to implement the diabetes guidelines, and had an overall patient population that was older and with a smaller percentage of black patients. Conclusions: Healthcare organizations can adopt many of the identified organizational characteristics to enhance the delivery of care in their settings.