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The Family Check-Up 4 Health (FCU4Health) is an adaptation of the Family Check-Up (FCU) for delivery in primary care settings. While maintaining the original FCU’s focus on parenting and child behavioral health, we added content targeting health behaviors. This study evaluated whether the adapted FCU maintained positive effects on parenting (positive behavior support, limit setting, parental warmth) and child behavioral health (self-regulation, conduct problems, emotional problems). Pediatric (6–12 years) primary care patients with a BMI ≥ 85th%ile (n = 240) were recruited from primary care clinics in Phoenix. Children were 75% Latino, 49% female, and 73% Medicaid recipients. This type 2 effectiveness-implementation hybrid trial compared families randomized to FCU4Health (n = 141) or usual care (n = 99). FCU4Health was delivered over a period of 6 months. This study focuses on a priori secondary outcomes included parenting and child behavioral health targets of the original FCU, assessed at baseline and 3, 6, and 12 months. Significant improvements were found for the FCU4Health condition, compared to usual care, in parenting from baseline to the 3-month assessment [β = .17 (.01; .32)]. Parenting predicted improvements in child self-regulation at 6-months [β = .17 (.03; .30)], which in turn predicted reductions in conduct problems [β = − .38 (− .51; − .23)] and emotional problems [β = − .24 (− .38; − .09)] at 12 months. Ethnicity and language of delivery (English or Spanish) did not moderate these effects. The FCU4Health can improve parenting and child behavioral health outcomes when delivered in primary care. Trial Registration Trial registration number: NCT03013309 ClinicalTrials.gov

This Viewpoint discusses several shortcomings in patient attribution systems from the perspective of physicians and patients and proposes strategies to improve patient attribution accuracy to better advance the goals of alternative payment models.

Background The American Indian (AI) population experiences significant diet-related health disparities including diabetes and cardiovascular disease (CVD). Owing to the relatively small sample size of AIs, the population is rarely included in large national surveys such as the NHANES. This exclusion hinders efforts to characterize potentially important differences between AI men and women, track the costs of these disparities, and effectively treat and prevent these conditions. Objective We examined the sex differences in diabetes prevalence, comorbidity experience, health care utilization, and treatment costs among AIs within a Northern Plains Indian Health Service (IHS) service unit. Methods We assessed data from a sample of 11,144 persons using an IHS service unit in the Northern Plains region of the United States. Detailed analyses were conducted for adults (n = 7299) on prevalence of diabetes by age and sex. We described sex differences in comorbidities, health care utilization, and treatment costs among the adults with diabetes. Results In our sample, adult men and women had a similar prevalence of diabetes (10.0% and 11.0%, respectively). The prevalence of CVD among men and women with diabetes was 45.7% and 34.0%, respectively. Among adults with diabetes, men had a statistically higher prevalence of hypertension and substance use disorders than women. The men were statistically less likely to have a non–substance use mental health disorder. Although men had higher utilization and costs for hospital inpatient services than women, the differences were not statistically significant. Conclusions In this AI population, there were differences in comorbidity profiles between adult men and women with diabetes, which have differential mortality and cost consequences. Appropriate diabetes management addressing gender-specific comorbidities, such as substance use disorders for men and non–substance use mental health disorders for women, may help reduce additional comorbidities or complications to diabetes.

The Family Check-Up 4 Health (FCU4Health) is an adaptation of the Family Check-Up (FCU) for delivery in primary care settings. While maintaining the original FCU's focus on parenting and child behavioral health, we added content targeting health behaviors. This study evaluated whether the adapted FCU maintained positive effects on parenting (positive behavior support, limit setting, parental warmth) and child behavioral health (self-regulation, conduct problems, emotional problems). Pediatric (6-12 years) primary care patients with a BMI ≥ 85

Originality/Value of Paper – This study fills a major gap in our knowledge of sex differences in diabetes prevalence, comorbidities, healthcare utilization, and treatment costs among AIANs. Differences in the comorbidities that characterized the AIAN adult males and females with diabetes in this sample have important implications for mortality and cost of care. Diabetes management that addresses such gender-specific comorbidities, particularly substance use disorders among men and mental health disorders among women, promises to reduce these comorbidities and related complications.

To describe the variation in asthma quality and costs among children with different Medicaid insurance plans.We used 2013 data from the Center for Health Information and Research, which houses a database that includes individuals who have Medicaid insurance in Arizona. We analyzed children ages 2-17 years-old who lived in Maricopa County, Arizona. Asthma medication ratio (AMR, a measure of appropriate asthma medication use), outpatient follow-up within 2 weeks after asthma-related hospitalization (a measure of continuity of care), asthma-related hospitalizations, and all emergency department (ED) visits were the primary quality metrics. Direct costs were reported in 2013 $US dollars. We used one-way analysis of variance to compare the health plans for AMR and per member cost (total, ER, and hospital), and the chi-squared test for the outpatient follow-up measure. We used coefficient of variation to identify variation of each measure across all individuals in the study.In 2013, 90,652 children in Maricopa County were identified as having asthma. The average patient-weighted AMR for children with persistent asthma was 0.35, well short of the goal of ≥0.70, and only 36% of hospitalized asthma patients had outpatient follow-up within 2 weeks of hospitalization. AMR, total costs, and ED costs varied significantly (p.0001) when comparing health plans while hospital costs and outpatient follow-up showed no significant variation.Targeting appropriate medication use for asthma may help reduce variation, improve outcomes, and increase healthcare value for children with asthma and Medicaid insurance in the US.

Aims To translate evidence-based programs (EBP) for a new setting, attention must be given to the characteristics of the intervention and the local setting, as well as evidence that is compelling to decision-makers. This paper describes the history of a partnership and stakeholder recommendations to inform the adaptation of an EBP for primary care. Methods We established a community advisory board (CAB) consisting of stakeholders with expertize in primary care delivery. A thematic analysis was conducted with fieldnotes and transcriptions from CAB meetings and regular meetings with participating clinics. Results We found that (a) parenting programs with a focus on behavioral and physical health are appropriate for this setting, (b) variability in the structure of primary care means implementation must be tailorable, and (c) financial and organizational outcomes are compelling for decision-makers. Conclusion Factors related to the content and structure of evidence-based programs are uniquely related to distinct implementation outcomes of interest to key stakeholders.

Background The Stop Atherosclerosis in Native Diabetics Study (SANDS) reported cardiovascular benefit of aggressive versus standard treatment targets for both low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in diabetic individuals. Objective In this analysis, we examined within trial cost-effectiveness of aggressive targets of LDL-C ≤70 mg/dL and systolic BP ≤115 mmHg versus standard targets of LDL-C ≤100 mg/dL and systolic BP ≤130 mmHg. Design Randomized, open label blinded-to-endpoint 3-year trial. Data Sources SANDS clinical trial database, Quality of Wellbeing survey, Centers for Medicare and Medicaid Services, Wholesale Drug Prices. Target Population American Indians ≥age 40 years with type 2 diabetes and no previous cardiovascular events. Time Horizon April 2003 to July 2007. Perspective Health payer. Interventions Participants were randomized to aggressive versus standard groups with treatment algorithms defined for both. Outcome Measures Incremental cost-effectiveness. Results of Base-Case Analysis Compared with the standard group, the aggressive group had slightly lower costs of medical services (−$116) but a 54% greater cost for BP medication ($1,242) and a 116% greater cost for lipid-lowering medication ($2,863), resulting in an increased cost of $3,988 over 3 years. Those in the aggressively treated group gained 0.0480 quality-adjusted life-years (QALY) over the standard group. When a 3% discount rate for costs and outcomes was used, the resulting cost per QALY was $82,589. Results of Sensitivity Analysis The use of a 25%, 50%, and 75% reduction in drug costs resulted in a cost per QALY of $61,329, $40,070, and $18,810, respectively. Limitations This study was limited by use of a single ethnic group and by its 3-year duration. Conclusions Within this 3-year study, treatment to lower BP and LDL-C below standard targets was not cost-effective because of the cost of the additional medications required to meet the lower targets. With the anticipated availability of generic versions of the BP and lipid-lowering drugs used in SANDS, the cost-effectiveness of this intervention should improve.

OBJECTIVE American Indians and Alaska Natives are 2.3 times more likely to have diabetes than are individuals in the U.S. general population. The objective of this study was to compare morbidity among American Indian and U.S. adults with diabetes. RESEARCH DESIGN AND METHODS We extracted demographic and health service utilization data for an adult American Indian population aged 18–64 years (n = 30,121) served by the Phoenix Service Unit from the Indian Health Service clinical reporting system. Similar data for a U.S. population (n = 1,500,002) with commercial health insurance, matched by age and sex to the American Indian population, were drawn from the MartketScan Research Database. We used Diagnostic Cost Groups to identify medical conditions for which each individual was treated and to assign a risk score to quantify his or her morbidity burden. We compared the prevalence of comorbidities and morbidity burden of American Indian and U.S. adults with diabetes. RESULTS American Indians with diabetes had significantly higher rates of hypertension, cerebrovascular disease, renal failure, lower-extremity amputations, and liver disease than commercially insured U.S. adults with diabetes (P < 0.05). The American Indian prevalence rates were 61.2, 6.9, 3.9, 1.8, and 7.1%, respectively. The morbidity burden among the American Indian with diabetes exceeded that of the insured U.S. adults with diabetes by 50%. CONCLUSIONS The morbidity burden associated with diabetes among American Indians seen at the Phoenix Service Unit far exceeded that of commercially insured U.S. adults. These findings point to the urgency of enhancing diabetes prevention and treatment services for American Indians/Alaska Natives to reduce diabetes-related disparities.

BACKGROUND: Lowering low-density lipoprotein cholesterol (LDL-C) with statins reduces atherosclerosis. LDL and high-density lipoprotein (HDL) are commonly measured by their cholesterol content, but non-HDL cholesterol, LDL particle number (LDL-P), or total apolipoprotein B (apoB) may better predict cardiovascular risk. Few studies have examined relations among lipoprotein levels and composition before and after interventions to lower LDL-C and non-HDL-C. OBJECTIVE: To measure changes in carotid artery intimal media thickness (CIMT) and lipid concentration and composition during 36 months of statin therapy. METHODS: Analyses were conducted on 418 diabetic individuals, with complete data and no prior cardiovascular events, who were randomized to aggressive (AG) versus standard (STD) treatment for LDL-C, non-HDL-C, and systolic blood pressure (SBP) as part of the Stop Atherosclerosis in Native Diabetics Study (SANDS). RESULTS: The AG group achieved average LDL-C and non-HDL-C of 71mg/dL and 100mg/dL and a decrease in CIMT. No significant interactions were observed between treatment effect and initial levels of LDL-C, non-HDL-C, HDL-C, triglycerides, apoB, or LDL-P. Decreases in LDL-C (p

Objectives This secondary analysis from the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial examines the effects of lowering low-density lipoprotein cholesterol (LDL-C) with statins alone versus statins plus ezetimibe on common carotid artery intima-media thickness (CIMT) in patients with type 2 diabetes and no prior cardiovascular event. Background It is unknown whether the addition of ezetimibe to statin therapy affects subclinical atherosclerosis. Methods Within an aggressive group (target LDL-C 70 mg/dl; non‐high-density lipoprotein cholesterol 100 mg/dl; systolic blood pressure 115 mm Hg), change in CIMT over 36 months was compared in diabetic individuals 40 years of age receiving statins plus ezetimibe versus statins alone. The CIMT changes in both aggressive subgroups were compared with changes in the standard subgroups (target LDL-C 100 mg/dl; non‐high-density lipoprotein cholesterol 130 mg/dl; systolic blood pressure 130 mm Hg). Results Mean (95% confidence intervals) LDL-C was reduced by 31 (23 to 37) mg/dl and 32 (27 to 38) mg/dl in the aggressive group receiving statins plus ezetimibe and statins alone, respectively, compared with changes of 1 (3 to 6) mg/dl in the standard group (p 0.0001) versus both aggressive subgroups. Within the aggressive group, mean CIMT at 36 months regressed from baseline similarly in the ezetimibe (0.025 [0.05 to 0.003] mm) and nonezetimibe subgroups (0.012 [0.03 to 0.008] mm) but progressed in the standard treatment arm (0.039 [0.02 to 0.06] mm), intergroup p 0.0001. Conclusions Reducing LDL-C to aggressive targets resulted in similar regression of CIMT in patients who attained equivalent LDL-C reductions from a statin alone or statin plus ezetimibe. Common carotid artery IMT increased in those achieving standard targets. (Stop Atherosclerosis in Native Diabetics Study [SANDS]; NCT00047424) (J Am Coll Cardiol 2008;52:000‐000) © 2008 by the American College of Cardiology Foundation Ezetimibe diminishes intestinal cholesterol absorption by inhibiting the Niemann-Pick–like 1 enterocyte receptor, thereby up-regulating low-density lipoprotein cholesterol (LDL-C) receptors and lowering serum levels of LDL-C

Type 2 diabetes is a serious, costly, and increasingly common disease among Native American communities. Increasing evidence suggests that early infant nutrition, particularly breastfeeding, may have a significant impact on the development of diabetes in later life. In this report, the authors describe the scientific basis and development of an innovative program that targets promotion of breastfeeding among Native women as a type 2 diabetes prevention intervention. The program materials, evaluation methods, and outcomes are presented. By developing and sharing strategies that effectively support breastfeeding, the impact of diabetes in Native American communities will be reduced. J Hum Lact. 24(2):193-198.

Few if any Native American/Alaska Native (NA/AN) people have been included in highly active antiretroviral therapy (HAART) treatment trials or epidemiologic studies, leaving little data on which to be assured of the efficacy of HAART in this unique population. This study aims to evaluate the impact of HAART and review determinants of survival in a cohort of NA/AN persons receiving treatment for HIV in a real life clinical setting. A retrospective chart review of 235 HIV-infected Native Americans receiving services at an urban medical center operated by the Indian Health Service from January 1, 1981 through June 30, 2004 was conducted, providing 782.7 person-years of follow-up. The main outcome measures were time from study entry and from incident AIDS diagnosis to death. Death rates fell from 18.4 (13.3-25.4) per 100 person-years in the period prior to 1998 to 6.4 (4.6-8.8) per 100 person-years in the years 1998-2004, (RR 0.35, p0.0001). Factors associated with the greatest reduction in risk of death from time of study entry were current use of HAART, HR 0.13 (0.06-0.30, p0.001), and CD4 count/=200 at entry, HR 0.16 (0.08-0.35, p0.001). Current use of HAART was the strongest predictor of survival from time of AIDS diagnosis, HR 0.11 (0.05-0.25, p0.001). The use of HAART therapy and CD4 count were primary predictors of survival. Earlier diagnosis and access to effective medical treatment will be key factors in reducing disparities in health brought about by HIV infection in Native American/Alaska Native communities.

Objectives. We reviewed changes in blood glucose, blood pressure, and cholesterol levels among American Indians and Alaska Natives between 1995 and 2001 to estimate the quality of diabetes care in the Indian Health Service (IHS) health care delivery system. Methods. We conducted a cross-sectional analysis of data from the Indian Health Service Diabetes Care and Outcomes Audit. Results. Adjusted mean Hemoglobin A1c (HbA1c) levels (7.9% vs 8.9%) and mean diastolic blood pressure levels (76 vs 79 mm Hg) were lower in 2001 than in 1995, respectively. A similar pattern was observed for mean total cholesterol (193 vs 208 mg/dL) and triglyceride (235 vs 257 mg/dL) levels in 2001 and 1995, respectively. Conclusions. We identified changes in intermediate clinical outcomes over the period from 1995 to 2001 that may reflect the global impact of increased resource allocation and improvements in processes on the quality of diabetes care, and we describe the results that may be achieved when community, health program, and congressional initiatives focus on common goals.

Objectives. We examined the costs of treating American Indian adults with diabetes within the Indian Health Service (IHS). Methods. We extracted demographic and health service utilization data from the IHS electronic medical reporting system for 32 052 American Indian adults in central Arizona in 2004 and 2005. We derived treatment cost estimates from an IHS facility–specific cost report. We examined chronic condition prevalence, medical service utilization, and treatment costs for American Indians with and without diabetes. Results. IHS treatment costs for the 10.9% of American Indian adults with diabetes accounted for 37.0% of all adult treatment costs. Persons with diabetes accounted for nearly half of all hospital days (excluding days for obstetrical care). Hospital inpatient service costs for those with diabetes accounted for 32.2% of all costs. Conclusions. In this first study of treatment costs within the IHS, costs for American Indians with diabetes were found to consume a significant proportion of IHS resources. The findings give federal agencies and tribes critical information for resource allocation and policy formulation to reduce and eventually eliminate diabetes-related disparities between American Indians and Alaska Natives and other racial/ethnic populations.

Weight-loss interventions generally improve lipid profiles and reduce cardiovascular disease risk, but effects are variable and may depend on genetic factors. We performed a genetic association analysis of data from 2,993 participants in the Diabetes Prevention Program to test the hypotheses that a genetic risk score (GRS) based on deleterious alleles at 32 lipid-associated single-nucleotide polymorphisms modifies the effects of lifestyle and/or metformin interventions on lipid levels and nuclear magnetic resonance (NMR) lipoprotein subfraction size and number. Twenty-three loci previously associated with fasting LDL-C, HDL-C, or triglycerides replicated (P = 0.04–1×10−17). Except for total HDL particles (r = −0.03, P = 0.26), all components of the lipid profile correlated with the GRS (partial |r| = 0.07–0.17, P = 5×10−5–1×10−19). The GRS was associated with higher baseline-adjusted 1-year LDL cholesterol levels (β = +0.87, SEE±0.22 mg/dl/allele, P = 8×10−5, P interaction = 0.02) in the lifestyle intervention group, but not in the placebo (β = +0.20, SEE±0.22 mg/dl/allele, P = 0.35) or metformin (β = −0.03, SEE±0.22 mg/dl/allele, P = 0.90; P interaction = 0.64) groups. Similarly, a higher GRS predicted a greater number of baseline-adjusted small LDL particles at 1 year in the lifestyle intervention arm (β = +0.30, SEE±0.012 ln nmol/L/allele, P = 0.01, P interaction = 0.01) but not in the placebo (β = −0.002, SEE±0.008 ln nmol/L/allele, P = 0.74) or metformin (β = +0.013, SEE±0.008 nmol/L/allele, P = 0.12; P interaction = 0.24) groups. Our findings suggest that a high genetic burden confers an adverse lipid profile and predicts attenuated response in LDL-C levels and small LDL particle number to dietary and physical activity interventions aimed at weight loss., Author Summary The study included 2,993 participants from the Diabetes Prevention Program, a randomized clinical trial of intensive lifestyle intervention, metformin treatment, and placebo control. We examined associations between 32 gene variants that have been reproducibly associated with dyslipidemia and concentrations of lipids and NMR lipoprotein particle sizes and numbers. We also examined whether genetic background influences a person's response to cardioprotective interventions on lipid levels. Our analysis, which focused on determining whether common genetic variants impact the effects of cardioprotective interventions on lipid and lipoprotein particle size, shows that in persons with a high genetic risk score the benefit of intensive lifestyle intervention on LDL and small LDL particle levels is substantially diminished; this information may be informative for the targeted prevention of dyslipidemia, as it suggests that genetics might help identify persons in whom lifestyle intervention is likely to be an effective treatment for elevated lipids and lipoproteins. The NMR subfraction analyses provide novel insight into the biology of dyslipidemia by illustrating how numerous genetic variants that have previously been associated with lipid levels also modulate NMR lipoprotein particle sizes and number. This information may be informative for the targeted prevention of cardiovascular disease.

Background Although lipid management in diabetes is standard practice, goals often are neither met nor maintained. Strategies for achieving lower targets have not been explored. The Stop Atherosclerosis in Native Diabetics Study randomized patients with diabetes to standard versus aggressive lipid and blood pressure goals for 36 months. Objective To report strategies used to achieve and maintain lipid goals and to report adverse events (AEs). Methods Adults with type 2 diabetes and no history of cardiovascular disease (N = 499) were randomized to standard (low-density lipoprotein cholesterol [LDL-C] ≤ 100 mg/dL, non-high-density lipoprotein cholesterol [non-HDL-C] ≤ 130 mg/dL) or aggressive (LDL-C ≤ 70 mg/dL, non-HDL-C ≤ 100 mg/dL) targets. An algorithm was started with statin monotherapy, with intestinally acting agents added as required to reach LDL-C targets. Triglyceride [TG]-lowering agents were next used to reach non-HDL-C goals. Lipid management was performed by mid-level practitioners, with physician consultation, by the use of point-of-care lipid determinations. Results On average, both groups achieved the LDL-C and non-HDL-C goals within 12 months and maintained them throughout the study. At 36 months, mean (SD) LDL-C and non-HDL-C were 72 (24) and 102 (29) mg/dL in the aggressive group (AGG) and 104 (20) and 138 (26) mg/dL, respectively, in the standard group (STD); systolic blood pressure targets were 115 and 130 mmHg, respectively. A total of 68% of participants reached target LDL-C for greater than 50% of the visits and 46% for greater than 75% of visits. At 36 months, the AGG averaged 1.5 lipid lowering medications and the STD 1.2. Statins were used in 91% and 68% of the AGG and STD; ezetimibe by 31% and 10%; fibrates by 8% and 18%. No serious AEs were observed; AEs occurred in 18% of the AGG and 14% of the STD. Conclusion Standard and aggressive lipid targets can be safely maintained in diabetic patients. Standardized algorithms, point-of-care lipid testing, and nonphysician providers facilitate care delivery.

Objectives Cardiovascular disease prevention for patients with type 2 diabetes is accomplished through hypertension and dyslipidemia management. Although studies have established strategies for lowering low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP), none have examined whether glycemia influences ability to achieve lipid and BP targets. This post hoc analysis from the Stop Atherosclerosis in Native Diabetics Study examines the role of baseline glycemia in achieving standard and aggressive targets and outcomes after 36 months. Methods Diabetic individuals aged >40 years with no cardiovascular events ( n =499) were randomized to aggressive versus standard targets for LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and systolic BP (SBP). Management algorithms were used for both groups. Carotid ultrasound and echocardiography were performed at baseline and after 36 months. Results No differences were observed in baseline hemoglobin A1c between treatment groups nor any significant change in A1c after 36 months in either group. Baseline A1c, however, was significantly and negatively related to achieving LDL-C ( P =.007), non-HDL-C ( P =.03) and SBP targets ( P =.007) and to changes in LDL-C ( P =.007), non-HDL-C ( P =.03) and SBP ( P =.001) in both groups. Baseline A1c failed to predict progression of carotid intima medial thickness (CIMT) ( P =.42) or left ventricular mass index (LVMI) ( P =.10), nor was it related to the effects of lipid and BP lowering on CIMT and LVMI over 36 months. Conclusions In diabetic adults with no cardiovascular disease events, A1c was negatively associated with ability to achieve LDL-C, non-HDL-C and SBP goals but was not independently related to treatment-associated changes in CIMT or LVMI over 36 months.

Nonalcoholic fatty liver disease (NAFLD) is associated with obesity, insulin resistance, and impaired glucose tolerance. We investigated whether metformin or changes in metabolic measurements (weight, fasting plasma glucose (FPG), or fasting insulin (FI)) improved serum alanine aminotransferase (ALT) activity, as a marker for NAFLD, in the Diabetes Prevention Program (DPP). From 1996 to 1999, 2,153 participants without marked elevations of serum ALT at baseline were randomized (1,081 to placebo, 1,072 to metformin) and treated for an average of 3.2 years. ALT increased during the first 2 years of the study, and was slightly but significantly lower in the participants randomized to metformin. In regression models adjusted for sex, baseline age, FPG, and FI, these differences remained significant, but disappeared after adjustment for weight, FPG, and FI changes at each examination. The 3-year cumulative incidence for development of abnormal ALT concentrations was not significantly different ((mean +/- s.e.) 21.4 +/- 1.4% and 24.6 +/- 1.4%, P = 0.11) in the metformin vs. placebo groups but was lower in individuals in both groups that lost more weight by the end of year 1 (metformin: 19.4 +/- 2.4% vs. 27.5 +/- 3.7%, for highest vs. lowest quartile of weight loss; placebo: 18.7 +/- 3.4% vs. 28.8 +/- 2.6%). Over 3 years of follow-up in persons at high risk for development of diabetes, serum ALT was consistently lower in those treated with metformin compared with placebo. This effect was mediated by weight loss, indicating that the effects of metformin therapy on ALT is via its effects on weight.

BACKGROUND: Lowering low-density lipoprotein cholesterol (LDL-C) with statins reduces atherosclerosis. LDL and high-density lipoprotein (HDL) are commonly measured by their cholesterol content, but non-HDL cholesterol, LDL particle number (LDL-P), or total apolipoprotein B (apoB) may better predict cardiovascular risk. Few studies have examined relations among lipoprotein levels and composition before and after interventions to lower LDL-C and non-HDL-C. OBJECTIVE: To measure changes in carotid artery intimal media thickness (CIMT) and lipid concentration and composition during 36 months of statin therapy. METHODS: Analyses were conducted on 418 diabetic individuals, with complete data and no prior cardiovascular events, who were randomized to aggressive (AG) versus standard (STD) treatment for LDL-C, non-HDL-C, and systolic blood pressure (SBP) as part of the Stop Atherosclerosis in Native Diabetics Study (SANDS). RESULTS: The AG group achieved average LDL-C and non-HDL-C of 71mg/dL and 100mg/dL and a decrease in CIMT. No significant interactions were observed between treatment effect and initial levels of LDL-C, non-HDL-C, HDL-C, triglycerides, apoB, or LDL-P. Decreases in LDL-C (p.005) and non-HDL-C (p.001) were independently correlated with CIMT regression in the AG group. Changes in apoB and LDL-P showed borderline correlations with CIMT regression (p=.07 and p=.09). CONCLUSIONS: In diabetic adults with no prior cardiovascular events, treatment to current targets for lipids and SBP reduces atherosclerosis progression and when more aggressive targets are met, atherosclerosis regresses. The aggressive targets for LDL-C and non-HDL-C appeared to be the main determinants of CIMT regression and were more predictive of this outcome than changes in LDL-P or apoB.

The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (< or =115/75 mm Hg vs < or =130/80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/dL, aggressive systolic blood pressure-lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus.

Purpose The purpose of this study was to determine the safety and effectiveness of implementing standing orders for nurse case managers to adjust antihyperglycemic medications. Methods A retrospective cohort design was used to assess outcomes in American Indian and Alaska Native people who received case management and medication adjustment and those who received only standard primary care. Patients with diabetes and evidence of keeping regular follow-up appointments for diabetes care (N = 2345) who all had baseline A1C ≥ 7.0% were divided into 3 mutually exclusive groups for analysis: (1) those seen only by primary care providers (PCP; n = 1574); (2) those seen by nurse case managers (NCM; in addition to primary care) for diabetes education services only (n = 711); and (3) those who, in addition to a PCP and NCM visit, had medications adjusted by the nurse case managers (MA; n = 60). Outcome variables were number of visits with documentation of hypoglycemia (safety) and rate of A1C change (effectiveness). Results Documented hypoglycemia occurred more frequently with more intensive treatment. The MA group experienced the greatest rate of hypoglycemic events. The difference in hypoglycemia incidence between the groups was significant, but the number of events was small. Glycemic control improved most rapidly in the MA group, even after adjusting for potentially confounding variables. Conclusions In this setting, hypoglycemia occurs infrequently in all groups, but at higher rates with more intensive treatment. Nurse case management, whether with or without medication adjustment, is effective in improving short-term glucose control.

To determine the etiologies of chronic liver disease among American Indians.American Indians are disproportionately affected by chronic liver disease, yet little is known about its underlying etiologies in this group.We conducted a cross-sectional prevalence study at medical centers serving American Indian populations in Arizona and California. Patients' records were reviewed to identify those with chronic liver disease (ICD-9 code for chronic liver disease or 2 abnormal liver testsor = 6 mo apart). ICD-9 codes and laboratory findings were abstracted to determine etiologies.Of the 30,698 American Indian patients seen at the Arizona center during 2000 to 2002, 1496 (4.9%) had chronic liver disease, including 268/1496 (17.9%) with decompensated cirrhosis. Etiologies included alcohol (621; 41.5%), hepatitis C (103; 6.9%), both (136; 9.1%), or nonalcoholic fatty liver disease (191; 12.8%). Among alcohol-related liver disease patients tested for hepatitis C, 32.2% were positive. Of the 6074 American Indian patients seen at the California center during 2002 to 2003, 344 (5.7%) had chronic liver disease, including 45/344 (13.1%) with decompensated cirrhosis. Etiologies included alcohol (57; 16.6%) hepatitis C (83; 24.1%), and both (42; 12.2%). In one-third of chronic liver disease patient at the 2 centers, no etiology could be identified; 30% to 45% had not been tested for hepatitis C.Alcohol-related liver disease and hepatitis C were the most commonly identified etiologies among these American Indian patients with chronic liver disease in clinical care. Identifying American Indian and Alaska Native patients with chronic liver disease and providing treatment are critical for reducing disease burden.

Individuals with diabetes are at increased risk for cardiovascular disease (CVD), but more aggressive targets for risk factor control have not been tested.To compare progression of subclinical atherosclerosis in adults with type 2 diabetes treated to reach aggressive targets of low-density lipoprotein cholesterol (LDL-C) of 70 mg/dL or lower and systolic blood pressure (SBP) of 115 mm Hg or lower vs standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower.A randomized, open-label, blinded-to-end point, 3-year trial from April 2003-July 2007 at 4 clinical centers in Oklahoma, Arizona, and South Dakota. Participants were 499 American Indian men and women aged 40 years or older with type 2 diabetes and no prior CVD events.Participants were randomized to aggressive (n=252) vs standard (n=247) treatment groups with stepped treatment algorithms defined for both.Primary end point was progression of atherosclerosis measured by common carotid artery intimal medial thickness (IMT). Secondary end points were other carotid and cardiac ultrasonographic measures and clinical events.Mean target LDL-C and SBP levels for both groups were reached and maintained. Mean (95% confidence interval) levels for LDL-C in the last 12 months were 72 (69-75) and 104 (101-106) mg/dL and SBP levels were 117 (115-118) and 129 (128-130) mm Hg in the aggressive vs standard groups, respectively. Compared with baseline, IMT regressed in the aggressive group and progressed in the standard group (-0.012 mm vs 0.038 mm; P.001); carotid arterial cross-sectional area also regressed (-0.02 mm(2) vs 1.05 mm(2); P.001); and there was greater decrease in left ventricular mass index (-2.4 g/m(2.7) vs -1.2 g/m(2.7); P = .03) in the aggressive group. Rates of adverse events (38.5% and 26.7%; P = .005) and serious adverse events (n = 4 vs 1; P = .18) related to blood pressure medications were higher in the aggressive group. Clinical CVD events (1.6/100 and 1.5/100 person-years; P = .87) did not differ significantly between groups.Reducing LDL-C and SBP to lower targets resulted in regression of carotid IMT and greater decrease in left ventricular mass in individuals with type 2 diabetes. Clinical events were lower than expected and did not differ significantly between groups. Further follow-up is needed to determine whether these improvements will result in lower long-term CVD event rates and costs and favorable risk-benefit outcomes.clinicaltrials.gov Identifier: NCT00047424.

This paper describes the development of the American Indian Oncology Program (AIOP) and presents the accomplishments of a participatory research approach that involved an integrated network for cancer care and research. AIOP used a participatory process to develop infrastructure, identify research questions, develop methodologies, write supplemental grants, and evaluate accomplishments based on community defined measures of success. Partnerships between University and Indian Health Service, private, and state institutions led to improved collaboration. Health services delivery improved by increasing provider involvement at multiple institutions via a Tumor Board. Community awareness improved through workshops addressing community-specific cancer concerns. Collectively, these resulted in an environment receptive to the development of research activities. The AIOP team, through a participatory process, developed infrastructure at each institution that facilitated interaction, community-based education, and improved patient care; identified new partners; raised community-level knowledge and awareness about cancer; encouraged a research-friendly environment and building research capacity; and increased the cultural competency of researchers wishing to work in American Indian communities and created a cadre of future American Indian cancer researchers. As evidenced by successful pilot project development and formation of ongoing research and funding applications, the authors created a research-receptive environment and promoted potentially sustainable research capacity in the community. Much of their success is the result of utilizing a participatory model for capacity building that included not only communities but institutions. Cancer 2006. Published 2006 by the American Cancer Society.

A Native American-Indian female presenting with anemia and thrombocytosis was diagnosed with myelodysplastic syndrome (MDS, refractory anemia). Over the course of 5 years she developed cytopenias and periods of leukocytosis with normal bone marrow (BM) blast counts, features of an unclassifiable MDS/MPS syndrome. The patient ultimately progressed to acute myelogenous leukemia (AML, FAB M2) and had a normal karyotype throughout her course. The episodes of leukocytosis were associated with infectious complications. Transformation to AML was characterized by a BM blast percentage of 49%. Peripheral blood and BM samples were obtained for serum protein analysis and gene expression profiling (GEP) to elucidate her disease process. An ELISA assay of the serum analyzed approximately 80 cytokines, which demonstrated that hepatocyte growth factor/scatter factor and insulin-like growth factor binding protein 1 were markedly elevated compared to normal. GEP demonstrated a unique "tumor molecular profile," which included overexpression of oncogenes (HOXA9, N-MYC, KOC1), proliferative genes (PAWR, DLG5, AKR1C3), invasion/metastatic genes (FN1, N-CAM-1, ITGB5), pro-angiogenesis genes (c-Kit), and down regulation of tumor suppressor genes (SUI1, BARD1) and anti-apoptotic genes (PGLYRP, SERPINB2, MPO). Hence, a biomics approach has provided insight into elucidating disease mechanisms, molecular prognostic factors, and discovery of novel targets for therapeutic intervention.

Diabetes incidence is increasing rapidly in the United States. Diabetes increases the risk for cardiovascular disease, the major cause of death in diabetic individuals. The conventional cardiovascular risk factors of hyperlipidemia and hypertension worsen diabetic vascular disease. Treatment targets for low-density lipoprotein cholesterol (LDL-C) and blood pressure in diabetic individuals are being debated. The SANDS is a randomized, open-label, 3-year trial to examine the effects of aggressive LDL-C (goal b70 mg/dL) and blood pressure (BP) (goal b115/75 mm Hg) reduction versus the standard goals of b100 mg/dL for LDL-C and b130/85 mm Hg for BP. Five hundred forty-nine American-Indian men and women N40 years old with type 2 diabetes were randomized to 1 of 2 groups. Lipids and BP are managed using Food and Drug Administration–approved medications in an algorithmic approach. The presence and progression of atherosclerosis are evaluated by carotid ultrasonography; echocardiography assesses cardiac function. The primary end point is the composite outcome of change in carotid artery intimal medial thickness and fatal/nonfatal cardiovascular events. These outcomes are combined by using a ranked analysis for carotid thickness and assigning a bworst rankQ for a cardiovascular event. Secondary end points include carotid plaque score, left ventricular geometry and function, serum C-reactive protein, and safety measures. Unique aspects of the study design and analysis plan involve the use of a composite outcome and changes during the trial of LDL-C treatment goals for participants with baseline or incident cardiovascular disease in the conventional group because of changes in the standard of care. Study results will further understanding of the effects of aggressive risk factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in US populations and will help determine optimal LDL-C and BP treatment goals for diabetic patients. (Am Heart J 2006;152:867275.)

Type 2 diabetes is a serious, costly, and increasingly common disease. Several conditions commonly seen in family medicine settings confer increased risk of developing diabetes. Among these conditions are impaired glucose tolerance, impaired fasting glucose, obesity, gestational diabetes, hypertension, hyperlipidemia, and menopause. We here present the results of a systematic review of the literature examining the evidence for different strategies aimed at preventing type 2 diabetes in patients with these conditions. The strongest evidence supports an intensive lifestyle intervention designed to induce modest weight loss. The greatest degree of prevention, based on lesser quality evidence, may be imparted by bariatric surgery. Metformin and troglitazone have appreciable evidence in specific populations, and orlistat and acarbose have slightly less evidence among obese patients, for preventing diabetes. Ramipril, captopril, losartan, pravastatin, and estrogens show some very preliminary promise for preventing diabetes in patients treated for hypertension, hyperlipidemia, and menopause, but each needs a more rigorous evaluation. Although more questions remain to be answered, family physicians now have tools available to help our patients lead lives free of diabetes.

OBJECTIVE—Digital retinal imaging is a relatively new technology that can be used to assess patients for diabetic retinopathy. We evaluated the impact of adding a primary care–based retinal imaging technology to an existing eye care professional referral process on the rate of surveillance and treatment of diabetic retinopathy in a large, well-defined patient population over a 5-year period. RESEARCH DESIGN AND METHODS—We performed systematic performance evaluations using a computerized patient information system and a comprehensive procedure log to describe annually the patient population, the number of patients with diabetes, and the proportion of patients with diabetes who received appropriate eye care services, including surveillance and laser treatment for diabetic retinopathy before and after implementation of a digital retinal imaging system at the Phoenix Indian Medical Center Primary Care Medical Clinic. RESULTS—The rate of annual retinal examinations increased from 50% (95% CI 44–56%) to 75% (70–80%; P < 0.000001), representing a 50% increase in the retinal examination rate. The rate of laser therapy increased from 19.6 per 1,000 patients with diabetes in 1999 to 29.5 per 1,000 in 2003 for a 51% increase in the laser treatment rate. CONCLUSIONS—Implementing retinal imaging technology in a primary care setting resulted in a significant increase in the rate of diabetic retinopathy surveillance and a proportional increase in the rate of laser treatment for diabetic retinopathy for a large patient population. Application of this technology in primary care settings holds the potential to extend sight-preserving care by increasing access to appropriate retinal care.

Little is known about the breast cancer risk factors or mammogram characteristics among Native-American women. Southwestern Native-American women have a low risk of breast cancer and a high risk of diabetes. Our purpose was to determine the prevalence of known clinical risk factors for breast cancer and their association with mammogram density in a sample of Southwestern Native-American women undergoing breast cancer screening. A retrospective review was performed of screening mammogram examinations in 455 women. Density was classified by American College of Radiology Breast Imaging Reporting and Data System (BIRADS) density patterns 1 to 4 (fat to dense). Clinical data including patient age, weight, body mass index, parity, lactation, age at first birth, menopause status, hormone replacement therapy, diabetes status, and family history of breast cancer were obtained. Multivariate analyses were performed. Among the entire group, 152 women (33.4%) had diabetes. Patient age (P = 0.0012), weight (P0.0001), menopause status (P = 0.0134), estrogen use (P = 0.0311), age at first birth (P = 0.0035), and diabetes (P = 0.0015) were associated with mammogram density. Diabetes was associated with mammogram density in premenopausal women (P = 0.0032) but not in postmenopausal women (P = 0.3178) in stratified analyses. Diabetes, hormone replacement therapy, age, weight, menopause status, parity, and age at first birth were significantly associated with mammogram density. The association of mammogram density with diabetes varied by menopause status and was significant only for premenopausal women.

OBJECTIVE: The computerized patient registration databases maintained by the Indian Health Service (IHS) represent a potentially important source of data about the epidemic of diabetes among American Indian and Alaskan Native people. The purpose of this study is to determine the accuracy of this data source, and to identify the optimal search criteria to identify patients with a diagnosis of diabetes in an IHS patient registration database. METHODS: The authors compared the results of a series of computerized searches to a "gold standard" sample of 465 manually reviewed charts from a large IHS facility. RESULTS: Among patients ages 15 years and older, the best criterion for identifying patients diagnosed with diabetes was the presence of at least one purpose of visit narrative identified by a 250.00 to 250.93 ICD-9 code. The presence of a single computerized code for diabetes identified patients with diagnosed diabetes with a sensitivity of 92% (95% confidence interval [CI] 81, 97), a specificity of 99% (95% CI 98, 99), and a calculated positive predictive value of 94% (95% CI 85, 99). In a separate chart review of 462 charts of patients who had at least one 250.00 to 250.93 ICD-9 code recorded in the database, 435 had a diagnosis of diabetes for an observed positive predictive value of 94%. Because the prevalence of diabetes varies by age of the patient, the positive predictive value of the ability to identify patients with diabetes also varies by age. CONCLUSION: A computerized search of an IHS patient database can identify patients with a diagnosis of diabetes with an accuracy that is similar to the reported accuracy from other health care system databases.

The offspring of Pima Indians with early onset type 2 diabetes are at high risk for developing diabetes at an early age. This risk is greater among those whose mothers were diabetic during pregnancy. To define the metabolic abnormalities predisposing individuals in these high-risk groups to diabetes, we conducted a series of studies to measure insulin secretion and insulin action in healthy adult Pima Indians. In 104 normal glucose-tolerant subjects, acute insulin secretory response (AIR) to a 25-g intravenous glucose challenge correlated with the age at onset of diabetes in the mother (r = 0.23, P = 0.03) and, in multiple regression analyses, the age at onset of diabetes in the father (P = 0.02), after adjusting for maternal age at onset and after allowing for an interaction between these terms. In contrast, insulin action (hyperinsulinemic glucose clamp) did not correlate with the age at onset of diabetes in the parents. To determine whether early onset diabetes in the parents affected insulin secretion in the offspring across a range of glucose concentrations, responses to a stepped glucose infusion were measured in 23 subjects. Insulin secretion rates were lower in individuals whose mothers had developed diabetes before 35 years of age (n = 8) compared with those whose parents remained nondiabetic until at least 49 years of age (n = 15) (average insulin secretory rates: geometric mean [95% CI] 369 [209–652] vs. 571 [418–780] pmol/min, P = 0.007). Finally, the AIR was lower in individuals whose mothers were diabetic during pregnancy (n = 8) than in those whose mothers developed diabetes at an early age but after the birth of the subject (n = 41) (740 [510–1,310] vs. 1,255 [1,045–1,505] pmol/l, P < 0.02). Thus, insulin secretion is lower in normal glucose tolerant offspring of people with early onset type 2 diabetes. This impairment may be worsened by exposure to a diabetic environment in utero.

Recent reports suggest that the white blood cell (WBC) count is related to plasma insulin concentrations and insulin resistance in healthy individuals. The present study examines whether these relations are independent of obesity and the pattern of body fat distribution and tests whether race and gender affect these relations. WBC counts, insulin responses to a 75 gram oral glucose tolerance test (OGTT) and glucose disposal during a two-step hyperinsulinemic euglycemic clamp were measured in 300 men and women (149 Pima Indians, 100 whites, and 51 blacks) with a wide range of obesity. WBC counts were lower in blacks than Pima Indians or whites and tended to be higher in women than men. The subgroups were comparable in age and body weight, but percent body fat and plasma insulin concentrations were higher and glucose disposal during the glucose clamp was lower in Pima Indians than in blacks or whites. In the group as a whole, the WBC count correlated with obesity (body mass index and percent body fat), the waist to thigh ratio (an index of the pattern of body fat distribution), and plasma insulin concentrations and was negatively related to age and glucose disposal during the clamp. In multiple regression analyses, only age, race and obesity were significantly associated with the WBC count. When the analyses were restricted to Pima men, in whom correlations between the WBC count and the metabolic variables appeared the strongest, the WBC count remained significantly associated with plasma insulin concentrations, but not glucose disposal, after controlling for age and obesity. The results of this study indicate that age, race, and obesity are significantly associated with the WBC count in healthy individuals. Plasma insulin concentrations, but not insulin resistance per se, may also be weakly associated with the WBC count, but this may be population specific.

Background: Although more classically associated with insulin-dependent diabetes mellitus, diabetic ketoacidosis (DKA) can occur in some patients with non—insulindependent diabetes mellitus (NIDDM). To better define the clinical features that may be associated with ketoacidosis in patients with NIDDM, we reviewed the medical histories of Apache Indians with NIDDM who had been treated for an episode of DKA. Methods: Cases of ketoacidosis among patients with NIDDM were identified at 2 separate Apache Indian reservations. Chart data were used to confirm and characterize the diagnosis of NIDDM, the metabolic disturbances associated with DKA, and the historical features of the patients. Results: Among 724 patients with NIDDM, 17 patients experiencing at least 1 episode of DKA were identified. The mean (±SD) age at the time of the episode was 40.8± 13.9 years. The patients were predominantly male (15[88%]), with a mean (±SD) body mass index (calculated as the weight in kilograms divided by the square of the height in meters) of 24.9±4.4 kg/m 2 . Causes of DKA included infections (8[47%]) and omission of treatment (3/15[20%]). Concurrent abuse of alcohol was noted in 4 (27%) of the patients. In addition, a lifetime history of alcohol abuse was noted in 15 (94%) of 16 patients. Conclusions: This report confirms the growing recognition that DKA occurs in some patients with NIDDM. The present study also adds male sex, alcohol abuse, and relatively low body mass index as clinical factors that may play a role in the development of DKA in this setting. Arch Intern Med. 1997;157:2098-2100