The aim of this study was to examine the relationship between frequent and unrecognized hypoglycemia and mortality in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study cohort.
RESEARCH DESIGN AND METHODS
A total of 10,096 ACCORD study participants with follow-up for both hypoglycemia and mortality were included. Hazard ratios (95% CIs) relating the risk of death to the updated annualized number of hypoglycemic episodes and the updated annualized number of intervals with unrecognized hypoglycemia were obtained using Cox proportional hazards regression models, allowing for these hypoglycemia variables as time-dependent covariates and controlling for the baseline covariates.
Participants in the intensive group reported a mean of 1.06 hypoglycemic episodes (self-monitored blood glucose <70 mg/dL or <3.9 mmol/L) in the 7 days preceding their regular 4-month visit, whereas participants in the standard group reported an average of 0.29 episodes. Unrecognized hypoglycemia was reported, on average, at 5.8% of the intensive group 4-month visits and 2.6% of the standard group visits. Hazard ratios for mortality in models including frequency of hypoglycemic episodes were 0.93 (95% CI 0.9–0.97; P < 0.001) for participants in the intensive group and 0.98 (0.91–1.06; P = 0.615) for participants in the standard group. The hazard ratios for mortality in models, including unrecognized hypoglycemia, were not statistically significant for either group.
Recognized and unrecognized hypoglycemia was more common in the intensive group than in the standard group. In the intensive group of the ACCORD study, a small but statistically significant inverse relationship of uncertain clinical importance was identified between the number of hypoglycemic episodes and the risk of death among participants.
Colorectal cancer (CRC) screening reduces mortality yet remains underutilized. Low health literacy may contribute to this underutilization by interfering with patients’ ability to understand and receive preventive health services.
To determine if a web-based multimedia CRC screening patient decision aid, developed for a mixed-literacy audience, could increase CRC screening.
RCT. Patients aged 50–74 years and overdue for CRC screening were randomized to the web-based decision aid or a control program seen immediately before a scheduled primary care appointment.
A large community-based, university-affiliated internal medicine practice serving a socioeconomically disadvantaged population.
Main Outcome Measures
Patients completed surveys to determine their ability to state a screening test preference and their readiness to receive screening. Charts were abstracted by masked observers to determine if screening tests were ordered and completed.
Between November 2007 and September 2008, a total of 264 patients enrolled in the study. Data collection was completed in 2009, and data analysis was completed in 2010. A majority of participants (mean age 57.8 years) were female (67%), African-American (74%), had annual household incomes of < $20,000 (76%), and had limited health literacy (56%). When compared to control participants, more decision-aid participants had a CRC screening preference (84% vs 55%, p<0.0001), and an increase in readiness to receive screening (52% vs 20%, p=0.0001). More decision-aid participants had CRC screening tests ordered (30% vs 21%) and completed (19% vs 14%), but no statistically significant differences were seen (AORs 1.6 [95% CI 0.97, 2.8] and 1.7 [95% CI 0.88, 3.2] respectively). Similar results were found across literacy levels.
The web-based decision aid increased patients’ ability to form a test preference and their intent to receive screening, regardless of literacy level. Further study should examine ways the decision aid can be combined with additional system changes to increase CRC screening.
The authors studied the incremental value of adding serum cystatin C or creatinine to the Framingham risk score variables (FRSVs) for the prediction of incident cardiovascular disease (CVD) among 6,653 adults without clinical CVD utilizing the Multi-Ethnic Study of Atherosclerosis (2000–2008). CVD events included coronary heart disease, heart failure, stroke, and peripheral arterial disease. Variables were transformed to yield optimal prediction of 6-year CVD events in sex-stratified models with FRSVs alone, FRSVs + cystatin C, and FRSVs + creatinine. Risk prediction in the 3 models was assessed by using the C statistic, and net reclassification improvement was calculated. The mean ages were 61.9 and 64.6 years for individuals with and without diabetes, respectively. After 6 years of follow-up, 447 (7.2%) CVD events occurred. In the total cohort, no significant change in the C statistic was noted with FRSVs + cystatin C and FRSVs + creatinine compared with FRSVs alone, and net reclassification improvement for CVD risk was extremely small and not significant with the addition of cystatin C or creatinine to FRSVs. Similar findings were noted after stratifying by baseline presence of diabetes. In conclusion, the addition of cystatin C or serum creatinine to FRSVs does not improve CVD risk prediction among adults without clinical CVD.
cardiovascular diseases; creatinine; cystatin C; risk model
There are racial and geographic disparities in stroke mortality, with higher rates among African Americans (AAs) and those living in the southeastern US (‘stroke belt’). Racial and geographic differences in dyslipidemia prevalence, awareness, treatment and control may, in part, account for the observed disparities in stroke mortality.
Reasons for Geographic and Racial Differences in Stroke (REGARDS) is a national observational study of community-dwelling black and white participants aged 45 and older, with oversampling from the stroke belt. As of January 15, 2007, 26,122 participants were enrolled and a fasting lipid panel was available of 21,068. Awareness, treatment and control of dyslipidemia were estimated overall and compared across race-sex-region strata.
There were 55% of the participants with dyslipidemia and no racial differences in prevalence. Adjusting for demographic and established stroke risk factors, AAs had a lower prevalence (OR 0.74; 95% CI: 0.66, 0.77) and were less likely to be aware (0.69; 0.61, 0.78), treated (0.77; 0.67, 0.89) and controlled (0.67; 0.58, 0.77) than whites. There was lower control outside of the stroke belt (0.87; 0.76, 0.99).
Racial, but not geographic, differences in dyslipidemia management may play a role in the excess stroke burden in the Southeast.
Cholesterol; Risk factors; Risk factor management; Racial differences; Stroke prevention
Patients with low risk chest pain have high utilization of stress testing and cardiac imaging, but low rates of acute coronary syndrome (ACS). The objective of this study was to determine if the HEART score could safely reduce objective cardiac testing in patients with low risk chest pain.
A cohort of chest pain patients was identified from an Emergency Department-based observation unit registry. HEART scores were determined using registry data elements and blinded chart review. HEART scores were dichotomized into low (0–3) or high risk (>3). The outcome was MACE; a composite endpoint of all cause mortality, myocardial infarction, or coronary revascularization during the index visit or within 30 days. Sensitivity, specificity, and potential reduction of cardiac testing were calculated.
Over 28 months, the registry included 1070 low risk chest pain patients. MACE occurred in 0.6% (5/904) of patients with low-risk HEART scores compared to 4.2% (7/166) with a high-risk HEART scores, OR=7.92, (95%CI 2.48–25.25). A HEART score >3 was 58% sensitive (95% CI 32–81%) and 85% specific (95% CI 83–87%) for MACE. The HEART score missed 5 cases of ACS among 1070 patients (0.5%) and could have reduced cardiac testing by 84.5% (904/1070). Combination of serial troponin > 0.065 ng/ml or HEART score >3 resulted in 100% sensitivity (95% CI 72–100%), specificity of 83% (95%CI 81–85%), and potential reduction in cardiac testing of 82% (879/1070).
If used to guide stress testing and cardiac imaging, the HEART score could substantially reduce cardiac testing in a population with low pre-test probability of ACS.
HEART score; chest pain; cardiac testing; observation; risk stratification
To evaluate independent associations of high density lipoprotein cholesterol (HDL-C) and particle (HDL-P) concentrations with carotid intima-media thickness (cIMT) and incident coronary heart disease (CHD).
HDL-C is inversely related to CHD, but also to triglycerides, LDL particles (LDL-P), and related metabolic risk. HDL-P associations with CHD may be partially independent of these factors.
In a multi-ethnic study of 5598 men and women ages 45-84, without baseline CHD, excluding subjects on lipid-lowering medications, triglycerides >400 mg/dl or missing values, we evaluated associations of HDL-C and NMR-spectroscopy-measured HDL-P with cIMT and incident CHD (myocardial infarction, CHD death, angina, n=227 events, 6.0 years mean follow-up). All models were adjusted for age, sex, ethnicity, hypertension and smoking.
HDL-C and HDL-P correlated with each other (π=0.69) and LDL-P (π = −0.38, −0.25, respectively), p<0.05 for all. For (1-SD) higher HDL-C (15 mg/dl) or HDL-P (6.64 μmol/l), cIMT differences (95%CI) were −26.1(−34.7,−17.4) and −30.1 (−38.8,−21.4) μm, and CHD hazard ratios (HR (95%CI)) were 0.74 (0.63, 0.88) and 0.70 (0.59, 0.82), respectively. Adjusted for each other and LDL-P, HDL-C was no longer associated with cIMT (2.3 (−9.5, 14.2) μm) or CHD (0.97(0.77, 1.22)), but HDL-P remained independently associated with cIMT (−22.2(−33.8,−10.6) μm) and CHD (0.75 (0.61, 0.93)). Interactions by sex, ethnicity, diabetes and high-sensitivity C-reactive protein were not significant.
Adjusting for each other and LDL-P substantially attenuated associations of HDL-C, but not HDL-P, with cIMT and CHD. Potential confounding by related lipids or lipoproteins should be carefully considered when evaluating HDL-related risk.
Lipids; lipoproteins; high-density lipoprotein cholesterol; high-density lipoprotein particles; cardiovascular disease
Health utility (HU) measures are used as overall measures of quality of life and to determine quality adjusted life years (QALYs) in economic analyses. We compared baseline values of three HUs including Short Form 6 Dimensions (SF-6D), and Health Utilities Index, Mark II and Mark III (HUI2 and HUI3) and the feeling thermometer (FT) among type 2 diabetes participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. We assessed relationships between HU and FT values and patient demographics and clinical variables.
ACCORD was a randomized clinical trial to test if intensive controls of glucose, blood pressure and lipids can reduce the risk of major cardiovascular disease (CVD) events in type 2 diabetes patients with high risk of CVD. The health-related quality of life (HRQOL) sub-study includes 2,053 randomly selected participants. Interclass correlations (ICCs) and agreement between measures by quartile were used to evaluate relationships between HU’s and the FT. Multivariable regression models specified relationships between patient variables and each HU and the FT.
The ICCs were 0.245 for FT/SF-6D, 0.313 for HUI3/SF-6D, 0.437 for HUI2/SF-6D, 0.338 for FT/HUI2, 0.337 for FT/HUI3 and 0.751 for HUI2/HUI3 (P < 0.001 for all). Common classification by quartile was found for the majority (62%) of values between HUI2 and HUI3, which was significantly (P < 0.001) higher than between other HUs and the FT: SF-6D/HUI3 = 40.8%, SF-6D/HUI2 = 40.9%, FT/HUI3 = 35.0%, FT/HUI2 = 34.9%, and FT/SF-6D = 31.9%. Common classification was higher between SF-6D/HUI2 and SF-6D/HUI3 (P < 0.001) than between FT/SF-6D, FT/HUI2, and FT/HUI3. The mean difference in HU values per patient ranged from −0.024 ± 0.225 for SF-6D/ HUI3 to −0.124 ± 0.133 for SF-6D/HUI2. Regression models were significant; clinical and demographic variables explained 6.1% (SF-6D) to 7.7% (HUI3) of the variance in HUs.
The agreements between the different HUs were poor except for the two HUI measures; therefore HU values derived different measures may not be comparable. The FT had low agreement with HUs. The relationships between HUs and demographic and clinical measures demonstrate how severity of diabetes and other clinical and demographic factors are associated with HUs and FT measures.
ClinicalTrials.gov Identifier: NCT00000620
Diabetes mellitus, Type 2/*complications /physiopathology/psychology; Health status indicators; Randomized controlled clinical trial; Humans; Regression analysis; Glycemic control
Although the Diabetes Prevention Program (DPP) and the Finnish Diabetes Prevention Study (FDPS) demonstrated that weight loss from lifestyle change reduces type 2 diabetes incidence in patients with prediabetes, the translation into community settings has been difficult. The objective of this study is to report the first-year results of a community-based translation of the DPP lifestyle weight loss (LWL) intervention on fasting glucose, insulin resistance, and adiposity.
RESEARCH DESIGN AND METHODS
We randomly assigned 301 overweight and obese volunteers (BMI 25–40 kg/m2) with fasting blood glucose values between 95 and 125 mg/dL to a group-based translation of the DPP LWL intervention administered through a diabetes education program (DEP) and delivered by community health workers (CHWs) or to an enhanced usual-care condition. CHWs were volunteers with well-controlled type 2 diabetes. A total of 42.5% of participants were male, mean age was 57.9 years, 26% were of a race/ethnicity other than white, and 80% reported having an education beyond high school. The primary outcome is mean fasting glucose over 12 months of follow-up, adjusting for baseline glucose.
Compared with usual-care participants, LWL intervention participants experienced significantly greater decreases in blood glucose (−4.3 vs. −0.4 mg/dL; P < 0.001), insulin (−6.5 vs. −2.7 μU/mL; P < 0.001), homeostasis model assessment of insulin resistance (−1.9 vs. −0.8; P < 0.001), weight (−7.1 vs. −1.4 kg; P < 0.001), BMI (−2.1 vs. −0.3 kg/m2; P < 0.001), and waist circumference (−5.9 vs. −0.8 cm; P < 0.001).
This translation of the DPP intervention conducted in community settings, administered through a DEP, and delivered by CHWs holds great promise for the prevention of diabetes by significantly decreasing glucose, insulin, and adiposity.
Pediatric weight management clinics experience significant dropout, and few studies have investigated this problem. The objective of this study was to identify family and clinic characteristics associated with attrition from a tertiary care pediatric weight management clinic.
This was a prospective and retrospective clinical database study of a multidisciplinary clinic for obese children 2–18 years with a weight-related co-morbidity. All patients seen between November, 2007, and July, 2009, were included. Characteristics of Active and Inactive families were compared using chi-squared and t-tests, and logistic regression was used to identify independent correlates of program status. A one-page survey was mailed to all Inactive families.
A total of 133 patients were seen during the study period. Their mean age was 12 years old, mean BMI was 38 kg/m2, 53% were female, 52% represented racial/ethnic minorities, and 50% were Medicaid recipients. In all, 32% dropped out of treatment. Inactive children had significantly lower BMI z-scores, were older, and were more likely to have poor school performance than active children. Similar results were found on regression analysis: Children with higher BMI z-scores, commercial insurance, average school performance, and a major weight-related co-morbidity were less likely to be inactive. The most common parent-reported reasons for dropping out were: Child not wanting to make changes, weight not improving, child desired to leave program, and program not meeting parent or child’s expectations.
Attrition from pediatric weight management treatment is high, with age, weight, school performance, and health associated with dropout. Parents mostly reported child-related issues, including lack of weight loss, as reasons for dropout.
We examined the association between high blood pressure and incident type 2 diabetes in African Americans and whites aged 35–54 years at baseline.
RESEARCH DESIGN AND METHODS
We combined data from the Atherosclerosis Risk in Communities (ARIC) study, the Coronary Artery Risk Development in Young Adults (CARDIA) study, and the Framingham Heart Study offspring cohort. Overall, 10,893 participants (57% women; 23% African American) were categorized by baseline blood pressure (normal, prehypertension, hypertension) and examined for incident diabetes (median follow-up 8.9 years).
Overall, 14.6% of African Americans and 7.9% of whites developed diabetes. Age-adjusted incidence was increasingly higher across increasing blood pressure groups (P values for trend: <0.05 for African American men; <0.001 for other race-sex groups). After adjustment for age, sex, BMI, fasting glucose, HDL cholesterol, and triglycerides, prehypertension or hypertension (compared with normal blood pressure) was associated with greater risks of diabetes in whites (hazard ratio [HR] for prehypertension: 1.32 [95% CI 1.09–1.61]; for hypertension: 1.25 [1.03–1.53]), but not African Americans (HR for prehypertension: 0.86 [0.63–1.17]; for hypertension: 0.92 [0.70–1.21]). HRs for developing diabetes among normotensive, prehypertensive, and hypertensive African Americans versus normotensive whites were: 2.75, 2.28, and 2.36, respectively (P values <0.001).
In African Americans, higher diabetes incidence among hypertensive individuals may be explained by BMI, fasting glucose, triglyceride, and HDL cholesterol. In whites, prehypertension and hypertension are associated with greater risk of diabetes, beyond that explained by other risk factors. African Americans, regardless of blood pressure, have greater risks of developing diabetes than whites.
To investigate the risk of coronary heart disease (CHD) in individuals with spinal cord injury (SCI) according to the National Cholesterol Educational Program (NCEP) guidelines and CT coronary artery calcium scores (CCS).
Cross-sectional study of consecutive sample of males with SCI presenting to a single site for CHD risk assessment.
Males age 45–70 with traumatic SCI (American Spinal Injury Association (ASIA) A, B, and C) injured for at least 10 years with no prior history of clinical CHD. Medical history, blood-pressure, and fasting lipid panel were used to calculate risk for CHD with the use of the Framingham risk score (FRS). Risk and treatment eligibility status was assessed based on NCEP/FRS recommendations and by presence and amount of CCS. Percent agreement (PA) and kappa were calculated between the two algorithms. Spearman correlations were calculated between CCS and FRS and individual risk factors.
A total of 38 men were assessed; 18 (47.4%) had CCS > 0. The PA between NCEP/FRS assessment and CCS was 18% with a kappa of −0.03. 11 (28.9%) had CCS > 100 or >75th percentile for their age, sex, and race, which might qualify them for lipid-lowering treatment. Only 26 were placed into the same treatment category by NCEP/FRS and CCS, for a PA of 68% with a kappa of 0.35. In all, 20 (52.6%) were eligible for lipid-lowering treatment by either NCEP/FRS (n = 9) or CCS (n = 11). Seven subjects were above the treatment threshold based on CCS, but not NCEP/FRS and five subjects were above the NCEP/FRS threshold, but not CCS. Just four subjects were eligible by both algorithms. CCS only correlated with FRS (r = 0.508, P = 0.001) and age (r = 0.679, P < 0.001).
Spinal cord injury; Coronary heart disease; Coronary artery calcium score; Framingham risk score
Healthy Living Partnerships to Prevent Diabetes (HELP PD) is a randomized controlled trial designed to translate the Diabetes Prevention Program (DPP) lifestyle intervention into a community setting using community health workers engaged through an existing Diabetes Care Center (DCC). Overweight and obese (BMI 25-40 kg/m2) individuals with pre-diabetes (fasting blood glucose 95-125 mg/dl) with no medical contraindications to participate in a lifestyle intervention were recruited for participation in this study. Standard recruitment strategies were employed, including mass mailing, direct provider referral, and community events. Participant recruitment and randomization for this trial began in 2007 and was concluded in 2009. 1818 screenings were conducted; of these, 326 (17.9%) qualified and 301 (16.6%) participants were randomized over a 21 month period. 23.8% of potential participants were excluded during the initial telephone screening, primarily for BMI and recent history of CVD. The majority of participants (220, 73.1%) reported mass mailing as their primary source of information about the study. Mass mailing was more effective with participants who identified themselves as white when compared to African Americans. The cost of recruitment per randomized participant was $816, which includes direct costs and staff effort. 41% of the randomized participants were male and approximately 27% reported a race or ethnicity other than white. In comparison to the DPP study cohort, the HELP PD population is older, more educated and predominately white. These differences, reflecting in part the community in which HELP PD was conducted, may have implications for retention and adherence in the lifestyle intervention group.
Translational research; randomized controlled trial; recruitment; screening; lifestyle
Describe the management of dyslipidemia and adherence to the National Cholesterol Educational Program (NCEP) guidelines in men with Spinal Cord Injury (SCI)
Cross-sectional study of a consecutive sample of men with SCI presenting to a single site for coronary heart disease (CHD) risk assessment.
Men age 45 to 70 with traumatic SCI (ASIA A, B, and C) at least 10 years prior to participation in the study with no prior history of clinical CHD. Medical history, blood-pressure, and fasting lipid panel were used to calculate risk for CHD using NCEP guidelines and the Framingham Risk Score (FRS). Adherence to treatment recommendations and adequacy of control were assessed based on the NCEP guidelines.
38 men were assessed; 15/38 (39.5%, 95% CI: 24.0–56.6%) had dyslipidemia, defined as an LDL-C above their LDL-C treatment threshold (n = 6) or being on treatment for dyslipidemia (n = 9, for a 60% treatment rate (9/15, 95% CI: 32.3–83.7%)). Of the 9 individuals on treatment, 6 (66.7%) met their treatment goals (for a 40% overall control rate (6/15, 95% CI: 16.3–67.7%)). Dyslipidemia was well controlled in low risk individuals, but control was less common in higher risk individuals.
Dyslipidemia is common in men age 45–70 with chronic SCI and no evidence of clinical cardiovascular disease. Rates of treatment and control of dyslipidemia in this population are far from optimal, especially among the intermediate- and high-risk groups.
Spinal cord injury; Coronary heart disease; Dyslipidemia; National Cholesterol Education Program; Guideline adherence
Randomized treatment comparing an intensive glycemic treatment strategy with a standard strategy in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was ended early because of an unexpected excess of mortality in the intensive arm. As part of ongoing post hoc analyses of potential mechanisms for this finding, we explored whether on-treatment A1C itself had an independent relationship with mortality.
RESEARCH DESIGN AND METHODS
Participants with type 2 diabetes (n = 10,251 with mean age 62 years, median duration of diabetes 10 years, and median A1C 8.1%) were randomly assigned to treatment strategies targeting either A1C <6.0% (intensive) or A1C 7.0–7.9% (standard). Data obtained during 3.4 (median) years of follow-up before cessation of intensive treatment were analyzed using several multivariable models.
Various characteristics of the participants and the study sites at baseline had significant associations with the risk of mortality. Before and after adjustment for these covariates, a higher average on-treatment A1C was a stronger predictor of mortality than the A1C for the last interval of follow-up or the decrease of A1C in the first year. Higher average A1C was associated with greater risk of death. The risk of death with the intensive strategy increased approximately linearly from 6–9% A1C and appeared to be greater with the intensive than with the standard strategy only when average A1C was >7%.
These analyses implicate factors associated with persisting higher A1C levels, rather than low A1C per se, as likely contributors to the increased mortality risk associated with the intensive glycemic treatment strategy in ACCORD.
Carotid intima-media thickness (IMT) is a sub-clinical marker of atherosclerosis and a strong predictor of stroke. Pericardial fat (PF), the fat depot around the heart, has been associated with several atherosclerosis risk factors. We sought to examine the association between carotid IMT and PF, and to examine whether such an association is independent from common atherosclerosis risk factors including measures of overall adiposity.
Unadjusted and multivariable adjusted linear regression analysis was used to examine associations between common (CCA-IMT) and internal (ICA-IMT) carotid IMT with PF in a random sample of 996 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) who underwent carotid ultrasound and chest CT at baseline examination.
A significant positive correlation was observed between PF and CCA-IMT (r =0.27, P<0.0001) and ICA-IMT (r =0.17, P<0.0001). In an unadjusted sex-specific linear regression analysis, there was a significant association between PF (1-SD difference) and CCA-IMT (mm) in both women (β coefficient (95% CI): 0.06 (0.04, 0.08), P<0.0001) and men (0.03 (0.01, 0.05), P<0.0002), an association that persisted after further adjusting for age and ethnicity (0.02 (+0.00, 0.04), P=0.0120 for women, and 0.02 (+0.00, 0.03), P=0.0208 for men). However, after additional adjustment for atherosclerosis risk factors and either BMI or waist circumference, these relations were no longer significant in either sex. In similar analyses, PF was significantly associated with ICA-IMT in both men (0.11 (0.06, 0.15), P<0.0001) and women (0.08 (0.02, 0.13), P=041). These relations were no longer significant in women in multivariable adjusted models, but persisted in men in all models except after adjusting for age, ethnicity and waist circumference.
In the general population PF is associated with carotid IMT, an association that possibly not independent from markers of overall adiposity or common atherosclerosis risk factors.
Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to translate the DPP approach for use in community settings as a cost-effective intervention led by Community Health Workers (CHW's) and administered through a Diabetes Care Center (DCC). Approximately 300 overweight and obese (BMI 25-40 kg/m2) individuals with prediabetes (fasting blood glucose 95-124 mg/dl) were randomly assigned to either a lifestyle weight loss intervention (LW) or an enhanced usual care comparison condition (UC). The goal of LW is ≥7% weight loss achieved through increases in physical activity (180 min/wk) and decreases in caloric intake (approximately 1500 kcal/day). The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months. UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter. The primary outcome is change in fasting blood glucose. Secondary outcomes include cardiovascular risk factors, health-related quality of life, and social cognitive variables. Outcomes are masked and are collected every 6 months. The cost-effectiveness of the program will also be assessed. A community-based program that is administered through local DCC's and that harnesses the experience of community members (CHW's) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals.
translational research; randomized controlled trial; weight loss; prevention; type 2 diabetes; obesity
To assess the cross-sectional association of thiazolidinediones (TZD) with diabetic macular edema (DME).
The cross-sectional association of DME and visual acuity with TZD was examined using baseline fundus photographs and visual acuity measurements from the Eye Substudy of the ACCORD Trial. Visual acuity was assessed in 9,690 participants in ACCORD, 3,473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy.
Among the sub-sample, 695 (20.0%) had TZD use while 217 (6.2%) had DME. TZD use was not associated with DME in unadjusted (OR=1.01, 95% CI: (0.71, 1.44), P=0.95) and adjusted analyses (OR=0.97, (0.67, 1.40), P=0.86). Significant associations with DME were found for retinopathy severity (P<0.0001) and age (OR=0.97, (0.952, 0.997), P=0.0298) but not for HbA1c (P=0.06), duration of diabetes (P=0.65), gender (P=0.72), and race (P=0.20). TZD use was associated with slightly greater visual acuity (0.79 letters, (0.20, 1.38), P=0.0091) of uncertain clinical significance.
In a cross-sectional analysis of data from the largest study to date, no association was observed between TZD exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association.
Type 2 Diabetes; macular edema; visual acuity; thiazolidinediones; Avandia; Actos; retinopathy; visual acuity; rosiglitazone; pioglitazone
Poor prognosis in heart failure (HF) patients with diabetes is often attributed to increased co‐morbidity and advanced disease. Further, this effect may be worse in women.
To determine whether the effect of diabetes on outcomes and the sex‐related variation persisted in a propensity score‐matched HF population, and whether the sex‐related variation was a function of age.
Of the 7788 HF patients in the Digitalis Investigation Group trial, 2218 had a history of diabetes. Propensity score for diabetes was calculated for each patient using a non‐parsimonious logistic regression model incorporating all measured baseline covariates, and was used to match 2056 (93%) diabetic patients with 2056 non‐diabetic patients.
All‐cause mortality occurred in 135 (25%) and 216 (39%) women without and with diabetes (adjusted HR = 1.67; 95% CI = 1.34 to 2.08; p<0.001). Among men, 535 (36%) and 609 (41%) patients without and with diabetes died from all causes (adjusted HR = 1.21; 95% CI = 1.07 to 1.36; p = 0.002). Sex–diabetes interaction (overall adjusted p<0.001) was only significant in patients ⩾65 years (15% absolute risk increase in women; multivariable p for interaction = 0.005), but not in younger patients (2% increase in women; p for interaction = 0.173). Risk‐adjusted HR (95% CI) for all‐cause hospitalisation for women and men were 1.49 (1.28 to 1.72) and 1.21 (1.11 to 1.32), respectively, also with significant sex–diabetes interaction (p = 0.011).
Diabetes‐associated increases in morbidity and mortality in chronic HF were more pronounced in women, and theses sex‐related differences in outcomes were primarily observed in elderly patients.
The aim of this study was to determine the risk factors for conversion from a normal to either a low or high ABI.
Participants in the Multi-Ethnic Study of Atherosclerosis who had two separate measurements of the ABI over a 3-year time period were assessed.
At baseline, the mean age was 62 years and 50% were women, 28% African American, 12% Chinese, 22% Hispanic and 38% non-Hispanic White. Of the 5,514 participants with a baseline ABI between 0.90 and 1.40, 89 (1.6%) had an ABI ≤ 0.90 (“low ABI group”) and 71 (1.3%) had an ABI ≥ 1.40 (“high ABI group”) three years later. On multivariable analysis, the odds for having progressed into the low ABI group were significantly increased for higher baseline age, hypertension, diabetes, greater pack-years of cigarette smoking and homocysteine levels. The odds for progression into the high ABI group were increased for male gender and higher body mass index. Compared to non-Hispanic Whites, African Americans had a significantly higher odds for progression to the low ABI group (OR: 2.24, 95% CI: 1.29 – 3.88) while having a reduced odds for progression to the high ABI group (OR: 0.50, 95% CI: 0.24 – 1.00). Neither Chinese nor Hispanic ethnicity was significantly associated with progression to either ABI group.
The risk factors for progression to a low or high ABI were distinct and African Americans were at increased risk for progression to a low ABI but at decreased risk for progression into the high ABI group.
In general, adherence to blood pressure guidelines is low. We assessed whether hypertension recognition and control in North Carolina was consistent with the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) in primary care practices participating in a quality improvement study regarding the implementation of the ATP3 cholesterol management guideline in primary care in North Carolina (GLAD Heart).
Demographic and clinical data were abstracted from 5,073 charts (patients aged 21–84 years, seen from June 1, 2001 to May 31, 2003) at 60 practices. Sites were non-university based primary care practices from 22 North Carolina counties. A dyslipidemia screening was defined as a lipid profile performed when not on lipid-lowering therapy. Among patients receiving a lipid profile, the proportion with diagnosed, undiagnosed, and controlled hypertension, was calculated according to JNC 7 guidelines. Practice level hypertension control was examined using the median and interquartile range across practices.
Among 1,763 patients screened for dyslipidemia, 49.4% had diagnosed hypertension. Only 67 individuals (3.8%) had undiagnosed hypertension. Although 85.8% of hypertensive patients were treated, the median proportions of patients with blood pressure below goal (<140/90, <130/80 with diabetes) was 33.3% (21.8% – 43.7%), with women more likely to be controlled and individuals treated by a solo provider less likely to be controlled.
These data were abstracted from the charts of patients who received a lipid profile; therefore, they are only generalizable to individuals who are screened for hyperlipidemia.
There remains a need to improve hypertension management in North Carolina primary care among patients screened for hyperlipidemia.
blood pressure; primary health care; risk factors
A study was undertaken to ascertain the appropriateness of lipid screening and management per the Third Report of the Adult Treatment Panel National Cholesterol Education Program (ATP III) guideline in a sample of North Carolina primary care practices. Demographics, cholesterol values, and comorbid conditions were abstracted from the medical records from 60 community practices participating in a randomized practice-based trial (Guideline Adherence for Heart Health). Eligible patients were aged 21 to 84 years, seen during the baseline period of June 1, 2001, through May 31, 2003, and who were not taking lipid-lowering therapy. Multivariable logistic regression was utilized to assess whether age, sex, race/ethnicity, diabetes, cardiovascular disease, ATP III risk category, or pretreatment low-density lipoprotein (LDL) influenced treatment. Among 5031 eligible patients, 1711 (34.5%) received screening lipid profiles. Screening rates were higher with older age, diabetes, and cardiovascular disease. No large differences were seen by sex. Among patients screened (mean age, 51.6 years; 57.9% female), 76.6% were appropriately managed within 4 months. In adjusted analyses, older age was associated with less appropriate treatment (odds ratio [OR] per 5 years, 0.91; P=.01), and patients with LDL cholesterol ≤130 mg/dL (OR, 18.8; P<.001) and the low-risk group (OR, 27.5; P<.001) were more likely to be managed appropriately compared with patients with LDL ≥190 mg/dL and those at high risk. Among 375 patients eligible for drug treatment, those with LDL levels between 131 and 159 mg/dL were much less likely to be treated (OR, 0.15; P<.001) compared with those with LDL >190 mg/dL, whereas risk category did not influence treatment. The challenge facing implementation of ATP III guidelines is much greater for intermediate- and high-risk patients than for low-risk patients.
Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor.
We recruited 68 primary care family and internal medicine practices; 66 were randomly allocated to a study arm; 5 practices withdrew, resulting in 29 receiving the Third Adult Treatment Panel (ATP III) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7). The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III–recommended treatment. All practices received copies of each clinical practice guideline, an introductory lecture, 1 performance feedback report, and 4 visits for intervention-specific academic detailing. Data were abstracted at 61 practices from random samples of medical records of patients treated from June 1, 2001, through May 31, 2003 (baseline), and from May 1, 2004, through April 30, 2006 (follow-up). The proportion screened with subsequent appropriate decision making (primary outcome) was calculated. Generalized estimating equations were used to compare results by arm, accounting for clustering of patients within practices.
We examined 5057 baseline and 3821 follow-up medical records. The screening rate for lipid levels increased from 43.6% to 49.0% (ATP III practices) and from 40.1% to 50.8% (control practices) (net difference, −5.3% [P=.22]). Appropriate management of lipid levels decreased slightly (73.4% to 72.3%) in ATP III practices and more markedly (79.7% to 68.9%) in control practices. The net change in appropriate management favored the intervention (+9.7%; 95% confidence interval [CI], 2.8%-16.6% [P<.01]). Appropriate drug prescription within 4 months decreased in both arms (38.8% to 24.8% in ATP III practices and 45.3% to 24.1% in control practices; net change, +7.2% [P=.37]) Overtreat-ment declined from 6.6% to 3.9% in ATP III and rose from 4.2% to 6.4% in control practices (net change, −4.9% [P=.01]).
A multifactor intervention including personal digital assistant–based decision support may improve primary care physician adherence to the ATP III guidelines.
To test the hypothesis that A1C is associated with subclinical cardiovascular disease (CVD) in a population without evident diabetes, after adjusting for traditional CVD risk factors and BMI.
RESEARCH DESIGN AND METHODS
This was a cross-sectional study of 5,121 participants without clinically evident CVD or diabetes (fasting glucose ≥7.0 mmol/l or use of diabetes medication), aged 47–86 years, enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA). Measurements included carotid intimal-medial wall thickness (CIMT) and coronary artery calcification (CAC). Results were adjusted for age, sex, ethnicity, smoking, systolic blood pressure, LDL cholesterol, HDL cholesterol, antihypertensive medication use, lipid-lowering medication use, and BMI.
Compared with those in the lowest quartile for A1C ([mean ± SD] 5.0 ± 0.2%), participants in the highest quartile (6.0 ± 0.3%) had higher adjusted mean values for common CIMT (0.85 vs. 0.87 mm, P = 0.003) and internal CIMT (1.01 vs. 1.08 mm, P = 0.003). A1C quartile was not associated with prevalence of CAC in the entire cohort (P = 0.27); however, the association was statistically significant in women (adjusted prevalence of CAC in lowest and highest A1C quartiles 37.5 vs. 43.0%, P = 0.01). Among those with some CAC, higher A1C quartile tended to be associated with higher CAC score, but the results were not statistically significant (adjusted P = 0.11).
In this multiethnic cohort, there were small, positive associations between A1C, common CIMT, and internal CIMT in the absence of clinically evident diabetes. An association between higher A1C and CAC prevalence was evident only in women.
Although high blood pressure is associated with significant morbidity and mortality, the proportion reaching the goal blood pressures as outlined in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, Treatment of High Blood Pressure (JNC 7) is low. We conducted a randomized trial in primary care practices of a multifactorial intervention targeted to improve providers' adherence to hypertension guidelines.
A total of 61 primary care practices in North Carolina were randomized to receive either a multifactorial intervention (guideline dissemination via a continuing medical education session, academic detailing sessions, audit and feedback on preintervention rates of adherence, and automated blood pressure machines) or an attention control of similar magnitude but targeted at a different guideline. Outcomes were determined through review of patient charts conducted by an independent masked quality assurance organization.
We found no difference between the 2 groups in any of the adherence measures including no difference in the percentage of patients at goal (intervention 49.2%, control 50.6%), with undiagnosed hypertension (18.1% vs 13.6%), average systolic (126 vs 125.1 mm Hg), or diastolic blood pressure (73.1 vs 73.4 mm Hg). Similarly, there was no difference in provider adherence to treatment recommendations (use of thiazide-type diuretic as first-line therapy: 32% vs 29.5%; use of 2-drug therapy in stage 2 hypertension: 11.3% vs 10.4%).
An intensive, multifactorial intervention did not improve adherence to national hypertension guidelines among community-based primary care. Efforts should be focused on other types of interventions to improve rates of control of hypertension.
Hypertension (HTN) is a risk factor for dementia and animal studies suggest that centrally active (cross the blood brain barrier) angiotensin converting enzyme (ACE) inhibitors may protect against dementia beyond HTN control.
Participants in the Cardiovascular Health Study cognition substudy (mean age 75 yrs) with treated HTN and no diagnosis of heart failure (n= 1054) were followed for a median of 6 years to determine whether cumulative exposure to ACE inhibitors (as a class and by central activity), compared to other antihypertensive agents, was associated with lower risk of incident dementia, cognitive decline (by the modified mini mental state exam, 3MSE), or incident disability in instrumental activities of daily living (IADL).
Among 414 participants exposed to ACE inhibitors and 640 not, there were 158 cases of incident dementia. Compared to other anti-HTN drugs, there was no association between exposure to all ACE inhibitors and risk of dementia (HR 1.01, 95% CI 0.88–1.15), difference in 3MSE scores (−0.32 points/yr, p=0.15), or odds of IADL disability (OR (95% CI) 1.06 (0.99–1.14). Adjusted results were similar. However, centrally active ACE inhibitors were associated with 65% less decline in 3MSE scores per year of exposure (p= 0.01) and non-centrally active ACE inhibitors were associated with greater risk of incident dementia (adjusted HR 1.20 (1.00–1.43) per year of exposure) and greater odds of IADL disability (adjusted OR 1.16 (1.03–1.30) per year of exposure) compared to other anti-HTN drugs.
While ACE inhibitors as a class do not appear to be independently associated with dementia risk or cognitive decline in older hypertensive adults, there may be within class differences in regards to these outcomes. These results should be confirmed with an RCT of a centrally active ACE inhibitor in the prevention of cognitive decline and dementia.