Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial.

BACKGROUND: Chronic insomnia is common in patients undergoing in-center hemodialysis, yet there is limited evidence on effective treatments for this population. OBJECTIVE: To compare the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo for insomnia in patients undergoing long-term hemodialysis. DESIGN: Randomized, multicenter, double-blinded, placebo-controlled trial. (ClinicalTrials.gov: NCT03534284). SETTING: 26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington. PARTICIPANTS: Patients with Insomnia Severity Index (ISI) score of 10 or greater, with sleep disturbances on 3 or more nights per week for 3 or more months. INTERVENTION: Participants were randomly assigned to 6 weeks of CBT-I, trazodone, or placebo. MEASUREMENTS: The primary outcome was the ISI score at 7 and 25 weeks from randomization. RESULTS: A total of 923 patients were prescreened, and of the 411 patients with chronic insomnia, 126 were randomly assigned to CBT-I (n = 43), trazodone (n = 42), or placebo (n = 41). The change in ISI scores from baseline to 7 weeks with CBT-I or trazodone was no different from placebo: CBT-I, -3.7 (95% CI, -5.5 to -1.9); trazodone, -4.2 (CI, -5.9 to -2.4); and placebo, -3.1 (CI, -4.9 to -1.3). There was no meaningful change in ISI scores from baseline to 25 weeks: CBT-I, -4.8 (CI, -7.0 to -2.7); trazodone, -4.0 (CI, -6.0 to -1.9); and placebo, -4.3 (CI, -6.4 to -2.2). Serious adverse events (SAEs), particularly serious cardiovascular events, were more frequent with trazodone (annualized cardiovascular SAE incidence rates: CBT-I, 0.05 [CI, 0.00 to 0.29]; trazodone, 0.64 [CI, 0.34 to 1.10]; and placebo, 0.21 [CI, 0.06 to 0.53]). LIMITATION: Modest sample size and most participants had mild or moderate insomnia. CONCLUSION: In patients undergoing hemodialysis with mild or moderate chronic insomnia, there was no difference in the effectiveness of 6 weeks of CBT-I or trazodone compared with placebo. The incidence of SAEs was higher with trazodone. PRIMARY FUNDING SOURCE: National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.

Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis.

BACKGROUND: Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. METHODS: This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. DISCUSSION: This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. TRIAL REGISTRATION: NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).

Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial.

Background: Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective: To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design: Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343). Setting: 41 dialysis facilities in 3 U.S. metropolitan areas. Participants: Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention: Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements: The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms-Clinician-Rated (QIDS-C) at 12 weeks. Results: The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, -12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation: No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion: An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source: Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.

Racial Disparities in Outpatient Mental Health Service Use Among Children Hospitalized for Traumatic Brain Injury.

OBJECTIVE: To examine racial differences in mental health service utilization after hospitalization for traumatic brain injury (TBI) among children with Medicaid insurance. DESIGN AND MAIN MEASURES: Retrospective analysis of the MarketScan Multi-State Medicaid database from 2007 to 2012 was performed. Outpatient mental health service utilization (psychiatric and psychological individual and group services) was compared at TBI hospitalization, from discharge to 3 months and from 4 to 12 months after discharge, between children of non-Hispanic white (NHW), non-Hispanic black (NHB), Hispanic, and "Other" racial groups. Multivariable mixed-effects Poisson regression models with robust standard errors were utilized. RESULTS: A total of 5674 children (aged <21 years) were included in the study. There were no differences by race/ethnicity in mental health service utilization during hospitalization. At 3 months postdischarge, NHB children and children in the "Other" racial category were significantly less likely to receive outpatient mental health services than NHW children (NHB relative risk [RR] = 0.84; 95% confidence interval [CI], 0.72-0.98; Other RR = 0.72; 95% CI, 0.57-0.90). At 12 months, all racial minority children were significantly less likely to receive outpatient mental health services than NHW children (NHB RR = 0.84; 95% CI, 0.75-0.94; Hispanic RR = 0.72; 95% CI, 0.55-0.94; Other RR = 0.71; 95% CI, 0.60-0.84). CONCLUSIONS: Racial disparities in utilization of outpatient mental health services exist for minority children hospitalized for TBI and insured by Medicaid. Future research should focus on improving transitions of care from inpatient to outpatient services for these children.

Use of Self-management Interventions for Chronic Pain Management: A Comparison between Rural and Nonrural Residents.

Individuals with chronic pain who live in rural communities often lack access to pain specialists and rely on primary care providers who may be less prepared. Research has indicated that rural residents with chronic pain are more likely to receive an opioid prescription than nonrural residents. Although self-management approaches are available for chronic pain management, it is unclear to what extent rural residents use these interventions. This study compares usage of self-management interventions and opioid-based analgesics for chronic pain management between rural and nonrural residents. This study is a secondary analysis of baseline data from a randomized controlled trial evaluating a telehealth intervention for chronic pain management. Participants, recruited from primary care clinics, were 65 rural residents and 144 nonrural residents with similar demographic characteristics. Differences in the use of self-management interventions, pain intensity, and opioid dose were evaluated between rural and nonrural residents. Rural residents (n = 50, 77%) were less likely to use self-management interventions compared with nonrural residents (n = 133, 92%) (p = .019). Opioids were taken for pain relief by 76% of the rural residents compared with 52% of the nonrural residents. A disparity exists in the use of self-management interventions for chronic pain management by rural residents compared with nonrural residents. Further study is needed to determine if this is related to the lack of access to specialists and/or pain management training of primary care providers. Nurses can play an essential role in addressing this disparity by educating patients about self-management interventions.

Feeding Neonates by Cup: A Systematic Review of the Literature.

Objective WHO and UNICEF recommend cup feeding for neonates unable to breastfeed in low-resource settings. In developed countries, cup feeding in lieu of bottle feeding in the neonatal period is hypothesized to improve breastfeeding outcomes for those initially unable to breastfeed. Our aim was to synthesize the entire body of evidence on cup feeding. Methods We searched domestic and international databases for original research. Our search criteria required original data on cup feeding in neonates published in English between January 1990 and December 2014. Results We identified 28 original research papers. Ten were randomized clinical trials, 7 non-randomized intervention studies, and 11 observational studies; 11 were conducted in developing country. Outcomes evaluated included physiologic stability, safety, intake, duration, spillage, weight gain, any and exclusive breastfeeding, length of hospital stay, compliance, and acceptability. Cup feeding appears to be safe though intake may be less and spillage greater relative to bottle or tube feeding. Overall, slightly higher proportions of cup fed versus bottle fed infants report any breastfeeding; a greater proportion of cup fed infants reported exclusive breastfeeding at discharge and beyond. Cup feeding increases breastfeeding in subgroups (e.g. those who intend to breastfeed or women who had a Caesarean section). Compliance and acceptability is problematic in certain settings. Conclusions Further research on long-term breastfeeding outcomes and in low-resource settings would be helpful. Research data on high risk infants (e.g. those with cleft palates) would be informative. Innovative cup feeding approaches to minimize spillage, optimize compliance, and increase breastfeeding feeding are needed.

Renal outcomes in patients with type 1 diabetes and macroalbuminuria.

Macroalbuminuria, defined as urine albumin excretion rate (AER)≥300 mg/d, has long been considered a stage of irreversible kidney damage that leads reliably to GFR loss. We examined the long-term renal outcomes of persons with type 1 diabetes who developed incident macroalbuminuria during the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) study. One hundred fifty-nine participants developed incident macroalbuminuria and were subsequently followed for a median duration of 9 years (maximum of 25 years). At the time of macroalbuminuria diagnosis, mean (SD) age was 37 (9) years, mean (SD) duration of diabetes was 17 (5) years, median AER was 524 mg/d, and mean (SD) eGFR was 108 (20) ml/min per 1.73 m(2). Ten years after macroalbuminuria diagnosis, the cumulative incidence of a sustained reduction in AER to <300 mg/d was 52%, mostly but not entirely under treatment with renin-angiotensin system inhibitors. The cumulative incidence of impaired GFR (sustained eGFR<60 ml/min per 1.73 m(2)) 10 years after macroalbuminuria diagnosis was 32%, including 16% who developed ESRD. Lower hemoglobin A1c and BP and regression to AER<300 mg/d were associated with reduced risk of developing impaired GFR. In conclusion, people with type 1 diabetes who develop macroalbuminuria are at high risk of progressive kidney disease. However, through at least 10 years of follow-up, AER could often be controlled, and GFR frequently remained in the normal range.

Correlation between plasma, intracellular, and cervical tissue levels of raltegravir at steady-state dosing in healthy women.

Raltegravir is an antiretroviral with potential value for preexposure prophylaxis (PrEP) against HIV, but the intracellular pharmacokinetics in genital tissue have not been described. In this study, healthy, HIV-uninfected nonpregnant women took 400 mg of raltegravir twice daily for 22 days. On day 8, 15, and 22, blood was collected 0, 4, 6, 8, and 12 h and cervical biopsy specimens taken 0, 6, and 12 h after raltegravir dosing. Plasma and intracellular raltegravir concentrations in peripheral blood mononuclear cells (PBMC) and cervical tissue were measured by tandem mass spectrometry. Linear mixed effects models evaluated correlations between different sample types, as well as differences in concentration between phases of the menstrual cycle. Ten women were enrolled: 9 completed all three visits and 1 completed two visits. The age (mean ± standard deviation) of participants was 30 ± 8 years. Trough plasma concentrations of raltegravir 12 h after a directly observed dose were above the HIV 95% inhibitory concentration (IC95) of 33 nM (14.6 ng/ml) in 96% of measurements, compared to 67% of PBMC and 89% of cervical tissue trough values. Across all measurements, only 2% (3/135) of plasma values fell below the IC95, compared to 10% (13/135) for PBMC and 6% (5/81) for cervical tissue. There was no impact of menstrual phase on raltegravir concentrations. In conclusion, cervical tissue raltegravir concentrations were no greater than plasma concentrations, and ∼10% of all cervical tissue trough values were below the IC95, making the current twice-daily formulation of raltegravir impractical for PrEP.

The burden of influenza-associated critical illness hospitalizations.

OBJECTIVE: Influenza is the most common vaccine-preventable disease in the United States; however, little is known about the burden of critical illness due to influenza virus infection. Our primary objective was to estimate the proportion of all critical illness hospitalizations that are attributable to seasonal influenza. DESIGN: Retrospective cohort study. SETTING: Arizona, California, and Washington from January 2003 to March 2009. PATIENTS: All adults hospitalized with critical illness, defined by International Classification of Diseases, 9th Edition, Clinical Modification diagnosis and procedure codes for acute respiratory failure, severe sepsis, or in-hospital death. MEASUREMENTS AND MAIN RESULTS: We combined the complete hospitalization discharge databases for three U.S. states, regional influenza virus surveillance, and state census data. Using negative binomial regression models, we estimated the incidence rates of adult influenza-associated critical illness hospitalizations and compared them with all-cause event rates. We also compared modeled outcomes to International Classification of Diseases, 9th Edition, Clinical Modification-coded influenza hospitalizations to assess potential underrecognition of severe influenza disease. During the study period, we estimated that 26,760 influenza-associated critical illness hospitalizations (95% CI, 14,541, 47,464) occurred. The population-based incidence estimate for influenza-associated critical illness was 12.0 per 100,000 person-years (95% CI, 6.6, 21.6) or 1.3% of all critical illness hospitalizations (95% CI, 0.7%, 2.3%). During the influenza season, 3.4% of all critical illness hospitalizations (95% CI, 1.9%, 5.8%) were attributable to influenza. There were only 2,612 critical illness hospitalizations with International Classification of Diseases, 9th Edition, Clinical Modification-coded influenza diagnoses, suggesting influenza is either undiagnosed or undercoded in a substantial proportion of critical illness. CONCLUSIONS: Extrapolating our data to the 2010 U.S. population, we estimate that about 28,000 adults are hospitalized for influenza-associated critical illness annually. Influenza in many of these critically ill patients may be undiagnosed. Critical care physicians should have a high index of suspicion for influenza in the ICU, particularly when influenza is known to be circulating in their communities.

Population-based incidence estimates of influenza-associated respiratory failure hospitalizations, 2003 to 2009.

RATIONALE: The incidence of influenza-associated acute respiratory failure is unknown. OBJECTIVES: To estimate the population-based incidence of influenza-associated acute respiratory failure hospitalizations. METHODS: This is a cohort study from January 2003 through March 2009 using hospitalization databases for Arizona, California, and Washington from the Healthcare Cost and Utilization Project and influenza surveillance data for regions encompassing these states. Acute respiratory failure requiring mechanical ventilation was defined by International Classification of Diseases-9-CM code. We used negative-binomial regression modeling to estimate the incidence of influenza-associated events. MEASUREMENTS AND MAIN RESULTS: The incidence of influenza-associated acute respiratory failure was 2.7 per 100,000 person-years (95% confidence interval, 0.2-23.5), and during the influenza season, 3.8% of all respiratory failure hospitalizations were attributable to influenza. Compared with adults aged 18-49 years, the incidence rate ratio for influenza-associated acute respiratory failure was lower among children aged 1-4 (0.9) and 5-17 years (0.3); however, it was higher among adults aged 50-64 (4.8), 65-74 (10.4), 75-84 (19.9), and 85 years and older (33.7). Results were similar with more sensitive and specific outcome definitions and in a sensitivity analysis using only Arizona-specific outcome and surveillance data. CONCLUSIONS: Our data indicate that influenza was an important contributor to respiratory failure hospitalizations during 2003-2009. Clinicians should maintain a high index of suspicion for influenza among hospitalized patients with acute respiratory illness when influenza is circulating in a community. Influenza has a greater effect on respiratory failure in the elderly, for whom better prevention measures are needed.

Rhombencephalosynapsis: a hindbrain malformation associated with incomplete separation of midbrain and forebrain, hydrocephalus and a broad spectrum of severity.

Rhombencephalosynapsis is a midline brain malformation characterized by missing cerebellar vermis with apparent fusion of the cerebellar hemispheres. Rhombencephalosynapsis can be seen in isolation or together with other central nervous system and extra-central nervous system malformations. Gómez-López-Hernández syndrome combines rhombencephalosynapsis with parietal/temporal alopecia and sometimes trigeminal anaesthesia, towering skull shape and dysmorphic features. Rhombencephalosynapsis can also be seen in patients with features of vertebral anomalies, anal atresia, cardiovascular anomalies, trachea-oesophageal fistula, renal anomalies, limb defects (VACTERL) association. Based on a comprehensive evaluation of neuroimaging findings in 42 patients with rhombencephalosynapsis, we propose a spectrum of severity, ranging from mild (the partial absence of nodulus, anterior and posterior vermis), to moderate (the absence of posterior vermis with some anterior vermis and nodulus present), to severe (the absence of posterior and anterior vermis with some nodulus present), to complete (the absence of the entire vermis including nodulus). We demonstrate that the severity of rhombencephalosynapsis correlates with fusion of the tonsils, as well as midbrain abnormalities including aqueductal stenosis and midline fusion of the tectum. Rhombencephalosynapsis is also associated with multiple forebrain abnormalities including absent olfactory bulbs, dysgenesis of the corpus callosum, absent septum pellucidum and, in rare patients, atypical forms of holoprosencephaly. The frequent association between rhombencephalosynapsis and aqueductal stenosis prompted us to evaluate brain magnetic resonance images in other patients with aqueductal stenosis at our institution, and remarkably, we identified rhombencephalosynapsis in 9%. Strikingly, subjects with more severe rhombencephalosynapsis have more severely abnormal neurodevelopmental outcome, as do subjects with holoprosencephaly and patients with VACTERL features. In summary, our data provide improved diagnostic and prognostic information, and support disruption of dorsal-ventral patterning as a mechanism underlying rhombencephalosynapsis.

Association of socio-demographic factors and parental education with depressive symptoms among older African Americans and Caribbean Blacks.

OBJECTIVE: The purpose of this study was to examine ethnic variation in the relationship between individual socio-demographic factors, parental educational level, and late-life depressive symptoms in older African Americans and Caribbean Blacks. METHOD: This cross-sectional study used data from the National Survey of American Life. A subsample of older African Americans (N = 837) and Caribbean Blacks (N = 271) was analyzed using multiple regression analysis. RESULTS: Findings suggest differences in predictors of depressive symptoms for the two ethnic groups. Among older African Americans, lower educational attainment and lower income were predictive risk factors for higher depressive symptoms. Findings among older Caribbean Blacks suggest that nativity and income were significantly associated with depressive symptoms. This study did not find support for any association between parental education and late-life depressive symptoms. CONCLUSION: This study adds new information by considering ethnic variation in an examination of depressive symptoms in older Black Americans. The results contribute to the growing awareness of the older Caribbean Black population in the United States.

Perceived discrimination and social networks among older African Americans and Caribbean blacks.

The relationship between perceived discrimination and depressive symptoms among older black American populations is poorly understood. Although a small number of studies have examined the relationship between stress and social support, few have examined the association between perceived discrimination, social networks, and depressive symptoms among a representative sample of older racial and ethnic groups. This study examines (a) the relationship between sociodemographic factors, perceived discrimination and depressive symptoms and (b) social networks as a potential moderator in the perceived discrimination and depressive symptom relationship between 2 groups of older black Americans. This was a cross-sectional study using data from the National Survey of American Life with a sample of older African Americans (N = 837) and Caribbean blacks (N = 271). Depressive symptoms were assessed using the 12-item Center for Epidemiological Studies Depression scale. Linear regression analyses were used to predict depressive symptoms. The relationship between perceived discrimination and depressive symptoms was significant in both groups. Social networks contributed as a protective factor for depressive symptoms for both groups. However, there was no significant moderation effect. Results suggest that regardless of ethnic affiliation, the experience of perceived discrimination is similar in both groups and is a risk factor for depressive symptoms. Future research is needed in this area to better understand the associations between sociodemographic factors, perceived discrimination, social networks, and their impact on depressive symptoms.

Maternal early life risk factors for offspring birth weight: findings from the add health study.

The aim of this study was to examine the pathways that link mothers' early life socio economic status (SES) and mothers' experience of childhood maltreatment with birth weight among their later born offspring. Data were drawn from a nationally representative longitudinal survey of school-aged respondents, initially enrolled during adolescence in Wave I (1994-1995) and Wave II (1996) of the National Longitudinal Study of Adolescent Health and followed-up in adulthood in Wave III (2001-2002). Data on offspring birth weight were obtained from nulliparous females (N = 1,897) who had given birth between Waves II and III. Analyses used structural equation modeling to examine the extent to which early life maternal risk predicted offspring birth weight, and demonstrated that maternal childhood SES and maternal childhood maltreatment predicted offspring birth weight through several mediated pathways. First, maternal adolescent substance use and prenatal cigarette use partially mediated the association between maternal childhood SES and offspring birth weight. Second, maternal adolescent depressive symptoms and adult SES partially mediated the association between maternal childhood SES and offspring birth weight. Third, adult SES partially mediated the association between maternal childhood SES and offspring birth weight. Fourth, maternal adolescent substance use and prenatal cigarette use partially mediated the association between maternal childhood maltreatment and offspring birth weight. Finally, maternal adolescent depressive symptoms and adult SES partially mediated the association between maternal childhood maltreatment and offspring birth weight. To our knowledge, this is the first study to identify maternal childhood maltreatment as an early life risk factor for offspring birth weight among a nationally representative sample of young women, and to demonstrate the mechanisms that link childhood SES and maltreatment to offspring birth weight. These findings suggest the importance of designing and implementing prevention and intervention strategies to address early life maternal social conditions in an effort to improve inter generational child health at birth.

Temporal trends in the prevalence of diabetic kidney disease in the United States.

CONTEXT: Diabetes is the leading cause of kidney disease in the developed world. Over time, the prevalence of diabetic kidney disease (DKD) may increase due to the expanding size of the diabetes population or decrease due to the implementation of diabetes therapies. OBJECTIVE: To define temporal changes in DKD prevalence in the United States. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional analyses of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988-1994 (N = 15,073), NHANES 1999-2004 (N = 13,045), and NHANES 2005-2008 (N = 9588). Participants with diabetes were defined by levels of hemoglobin A(1c) of 6.5% or greater, use of glucose-lowering medications, or both (n = 1431 in NHANES III; n = 1443 in NHANES 1999-2004; n = 1280 in NHANES 2005-2008). MAIN OUTCOME MEASURES: Diabetic kidney disease was defined as diabetes with albuminuria (ratio of urine albumin to creatinine ≥30 mg/g), impaired glomerular filtration rate (<60 mL/min/1.73 m(2) estimated using the Chronic Kidney Disease Epidemiology Collaboration formula), or both. Prevalence of albuminuria was adjusted to estimate persistent albuminuria. RESULTS: The prevalence of DKD in the US population was 2.2% (95% confidence interval [CI], 1.8%-2.6%) in NHANES III, 2.8% (95% CI, 2.4%-3.1%) in NHANES 1999-2004, and 3.3% (95% CI, 2.8%-3.7%) in NHANES 2005-2008 (P <.001 for trend). The prevalence of DKD increased in direct proportion to the prevalence of diabetes, without a change in the prevalence of DKD among those with diabetes. Among persons with diabetes, use of glucose-lowering medications increased from 56.2% (95% CI, 52.1%-60.4%) in NHANES III to 74.2% (95% CI, 70.4%-78.0%) in NHANES 2005-2008 (P <.001); use of renin-angiotensin-aldosterone system inhibitors increased from 11.2% (95% CI, 9.0%-13.4%) to 40.6% (95% CI, 37.2%-43.9%), respectively (P <.001); the prevalence of impaired glomerular filtration rate increased from 14.9% (95% CI, 12.1%-17.8%) to 17.7% (95% CI, 15.2%-20.2%), respectively (P = .03); and the prevalence of albuminuria decreased from 27.3% (95% CI, 22.0%-32.7%) to 23.7% (95% CI, 19.3%-28.0%), respectively, but this was not statistically significant (P = .07). CONCLUSIONS: Prevalence of DKD in the United States increased from 1988 to 2008 in proportion to the prevalence of diabetes. Among persons with diabetes, prevalence of DKD was stable despite increased use of glucose-lowering medications and renin-angiotensin-aldosterone system inhibitors.

A Holistic approach to assess older adults' wellness using e-health technologies.

OBJECTIVES: To date, methodologies are lacking that address a holistic assessment of wellness in older adults. Technology applications may provide a platform for such an assessment, but have not been validated. We set out to demonstrate whether e-health applications could support the assessment of older adults' wellness in community-dwelling older adults. MATERIALS AND METHODS: Twenty-seven residents of independent retirement community were followed over 8 weeks. Subjects engaged in the use of diverse technologies to assess cognitive performance, physiological and functional variables, as well as psychometric components of wellness. Data were integrated from various e-health sources into one study database. Correlations were assessed between different parameters, and hierarchical cluster analysis was used to explore the validity of the wellness model. RESULTS: We found strong associations across multiple parameters of wellness within the conceptual model, including cognitive, functional, and physical. However, spirituality did not correlate with any other parameter studied in contrast to prior studies of older adults. Participants expressed overall positive attitudes toward the e-health tools and the holistic approach to the assessment of wellness, without expressing any privacy concerns. CONCLUSIONS: Parameters were highly correlated across multiple domains of wellness. Important clusters were noted to be formed across cognitive and physiological domains, giving further evidence of need for an integrated approach to the assessment of wellness. This finding warrants further replication in larger and more diverse samples of older adults to standardize and deploy these technologies across population groups.

Nursing interventions to promote dignified dying in South Korea.

PURPOSE: This descriptive study aimed to assess the appropriateness of the International Classification for Nursing Practice (ICNP) catalogue Palliative Care for Dignified Dying for palliative care nursing interventions in South Korea. METHODS: The study surveyed 213 South Korean nurses who might regularly care for dying patients. Nurses were recruited to complete a survey that included interventions from the ICNP catalogue listed with Likert response sets. FINDINGS: All of the interventions were scored as being at least 'slightly important' on average. The following three nursing interventions were ranked as most important when caring for dying patients: establish trust, establish rapport, and administer pain medication. CONCLUSIONS: The study provides new insights into the palliative care provided in South Korea by documenting nurses' views of what are the most important palliative care nursing interventions. It also suggests that the palliative care interventions listed in the ICNP catalogue Palliative Care for Dignified Dying are in congruence with the interventions that nurses in South Korea use.

Supporting dignified dying in the Philippines.

PURPOSE: This study aimed to assess the appropriateness of the International Classification for Nursing Practice (ICNP) Palliative Care for Dignified Dying catalogue for palliative nursing in the Philippines. METHODS: The study recruited 230 nurses to complete the ICNP Dignified Dying survey. Participants rated ICNP nursing intervention items and identified additional interventions for promoting dignified dying. RESULTS: All of the intervention items were scored on average as being at least 'slightly important'. The three top-ranked nursing intervention categories were providing social support, maintaining privacy boundaries, and relieving psychological distress. CONCLUSIONS: The ICNP Palliative Care for Dignified Dying catalogue lists nursing interventions that are appropriate to promoting dignity at the end of life in the Philippines.

Integrative analysis of DNA copy number and gene expression in metastatic oral squamous cell carcinoma identifies genes associated with poor survival.

BACKGROUND: Lymphotropism in oral squamous cell carcinoma (OSCC) is one of the most important prognostic factors of 5-year survival. In an effort to identify genes that may be responsible for the initiation of OSCC lymphotropism, we examined DNA copy number gains and losses and corresponding gene expression changes from tumor cells in metastatic lymph nodes of patients with OSCC. RESULTS: We performed integrative analysis of DNA copy number alterations (CNA) and corresponding mRNA expression from OSCC cells isolated from metastatic lymph nodes of 20 patients using Affymetrix 250 K Nsp I SNP and U133 Plus 2.0 arrays, respectively. Overall, genome CNA accounted for expression changes in 31% of the transcripts studied. Genome region 11q13.2-11q13.3 shows the highest correlation between DNA CNA and expression. With a false discovery rate < 1%, 530 transcripts (461 genes) demonstrated a correlation between CNA and expression. Among these, we found two subsets that were significantly associated with OSCC (n = 122) when compared to controls, and with survival (n = 27), as tested using an independent dataset with genome-wide expression profiles for 148 primary OSCC and 45 normal oral mucosa. We fit Cox models to calculate a principal component analysis-derived risk-score for these two gene sets ('122-' or '27-transcript PC'). The models combining the 122- or 27-transcript PC with stage outperformed the model using stage alone in terms of the Area Under the Curve (AUC = 0.82 or 0.86 vs. 0.72, with p = 0.044 or 0.011, respectively). CONCLUSIONS: Genes exhibiting CNA-correlated expression may have biological impact on carcinogenesis and cancer progression in OSCC. Determination of copy number-associated transcripts associated with clinical outcomes in tumor cells with an aggressive phenotype (i.e., cells metastasized to the lymph nodes) can help prioritize candidate transcripts from high-throughput data for further studies.

A genetic expression profile associated with oral cancer identifies a group of patients at high risk of poor survival.

PURPOSE: To determine if gene expression signature of invasive oral squamous cell carcinoma (OSCC) can subclassify OSCC based on survival. EXPERIMENTAL DESIGN: We analyzed the expression of 131 genes in 119 OSCC, 35 normal, and 17 dysplastic mucosa to identify cluster-defined subgroups. Multivariate Cox regression was used to estimate the association between gene expression and survival. By stepwise Cox regression, the top predictive models of OSCC-specific survival were determined and compared by receiver operating characteristic analysis. RESULTS: The 3-year overall mean+/-SE survival for a cluster of 45 OSCC patients was 38.7+/-0.09% compared with 69.1+/-0.08% for the remaining patients. Multivariate analysis adjusted for age, sex, and stage showed that the 45 OSCC patient cluster had worse overall and OSCC-specific survival (hazard ratio, 3.31; 95% confidence interval, 1.66-6.58 and hazard ratio, 5.43; 95% confidence interval, 2.32-12.73, respectively). Stepwise Cox regression on the 131 probe sets revealed that a model with a term for LAMC2 (laminin gamma2) gene expression best identified patients with worst OSCC-specific survival. We fit a Cox model with a term for a principal component analysis-derived risk score marker and two other models that combined stage with either LAMC2 or PCA. The area under the curve for models combining stage with either LAMC2 or PCA was 0.80 or 0.82, respectively, compared with 0.70 for stage alone (P=0.013 and 0.008, respectively). CONCLUSIONS: Gene expression and stage combined predict survival of OSCC patients better than stage alone.