Ankle brachial index values, leg symptoms, and functional performance among community-dwelling older men and women in the lifestyle interventions and independence for elders study.

BACKGROUND: The prevalence and significance of low normal and abnormal ankle brachial index (ABI) values in a community-dwelling population of sedentary, older individuals is unknown. We describe the prevalence of categories of definite peripheral artery disease (PAD), borderline ABI, low normal ABI, and no PAD and their association with lower-extremity functional performance in the LIFE Study population. METHODS AND RESULTS: Participants age 70 to 89 in the LIFE Study underwent baseline measurement of the ABI, 400-m walk, and 4-m walking velocity. Participants were classified as follows: definite PAD (ABI <0.90), borderline PAD (ABI 0.90 to 0.99), low normal ABI (ABI 1.00 to 1.09), and no PAD (ABI 1.10 to 1.40). Of 1566 participants, 220 (14%) had definite PAD, 250 (16%) had borderline PAD, 509 (33%) had low normal ABI, and 587 (37%) had no PAD. Among those with definite PAD, 65% were asymptomatic. Adjusting for age, sex, race, body mass index, smoking, and comorbidities, lower ABI was associated with longer mean 400-m walk time: (definite PAD=533 seconds; borderline PAD=514 seconds; low normal ABI=503 seconds; and no PAD=498 seconds [P<0.001]). Among asymptomatic participants with and without PAD, lower ABI values were also associated with longer 400-m walk time (P<0.001) and slower walking velocity (P=0.042). CONCLUSION: Among older community-dwelling men and women, 14% had PAD and 49% had borderline or low normal ABI values. Lower ABI values were associated with greater functional impairment, suggesting that lower extremity atherosclerosis may be a common preventable cause of functional limitations in older people. CLINICAL TRIAL REGISTRATION URL: http://clinicaltrials.gov/ Unique identifier: NCT01072500.

Reversibility of fenofibrate therapy-induced renal function impairment in ACCORD type 2 diabetic participants.

OBJECTIVE: To assess the reversibility of the elevation of serum creatinine levels in patients with diabetes after 5 years of continuous on-trial fenofibrate therapy. RESEARCH DESIGN AND METHODS: An on-drug/off-drug ancillary study to the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial to investigate posttrial changes in serum creatinine and cystatin C. Eligible participants were recruited into a prospective, nested, three-group study based on retrospective on-trial serum creatinine levels: fenofibrate case subjects (n = 321, ≥ 20% increase after 3 months of therapy); fenofibrate control subjects (n = 175, ≤ 2% increase); and placebo control subjects (n = 565). Serum creatinine and cystatin C were measured at trial end and 6-8 weeks after discontinuation of trial therapy. RESULTS At trial end, case subjects had the highest adjusted serum creatinine (± SE) mg/dL (1.11 ± 0.02) and the lowest adjusted estimated glomerular filtration rate (eGFR) (± SE) mL/min/1.73 m(2) (68.4 ± 1.0) versus control subjects (1.01 ± 0.02; 74.8 ± 1.3) and placebo subjects (0.98 ± 0.01; 77.8 ± 0.7). After 51 days off-drug, serum creatinine in case subjects was still higher (0.97 ± 0.02) and eGFR still lower (77.8 ± 1.0) than control subjects (0.90 ± 0.02; 81.8 ± 1.3) but not different from placebo subjects (0.99 ± 0.01; 76.6 ± 0.7). Changes in serum cystatin C recapitulated the serum creatinine changes. CONCLUSIONS: Participants with significant initial on-trial increases in serum creatinine (≥ 20%) returned to the same level of renal function as participants receiving placebo while participants who had ≤ 2% increase in serum creatinine had net preservation of renal function compared with the same unselected placebo reference group. The fenofibrate-associated on-trial increases in serum creatinine were reversible, and the reversal was complete after 51 days off-drug. The similarity of the cystatin C results suggests that the mechanism of this change is not specific for serum creatinine.

Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy.

OBJECTIVE: To assess the cross-sectional association of thiazolidinediones with diabetic macular edema (DME). METHODS: The cross-sectional association of DME and visual acuity with thiazolidinediones was examined by means of baseline fundus photographs and visual acuity measurements from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Visual acuity was assessed in 9690 participants in the ACCORD trial, and 3473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy from October 23, 2003, to March 10, 2006. RESULTS: Among the subsample, 695 (20.0%) people had used thiazolidinediones, whereas 217 (6.2%) people had DME. Thiazolidinedione use was not associated with DME in unadjusted (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.71-1.44; P = .95) and adjusted (OR, 0.97; 95% CI, 0.67-1.40; P = .86) analyses. Significant associations with DME were found for retinopathy severity (P < .001) and age (OR, 0.97; 95% CI, 0.952-0.997; P = .03) but not for hemoglobin A(1c) (P = .06), duration of diabetes (P = .65), sex (P = .72), and ethnicity (P = .20). Thiazolidinedione use was associated with slightly greater visual acuity (0.79 letter; 95% CI, 0.20-1.38; P = .009) of uncertain clinical significance. CONCLUSIONS: In a cross-sectional analysis of data from the largest study to date, no association was observed between thiazolidinedione exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association. Trial Registration clinicaltrials.gov Identifier: NCT00542178.

Appropriateness of cholesterol management in primary care by sex and level of cardiovascular risk.

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 or=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.

Are depressive symptoms associated with cancer screening and cancer stage at diagnosis among postmenopausal women? The Women's Health Initiative observational cohort.

BACKGROUND: Women with depressive symptoms may use preventive services less frequently and experience poorer health outcomes. We investigated the association of depressive symptoms with breast and colorectal cancer screening rates and stage of cancer among a cohort of postmenopausal women. METHODS: In The Women's Health Initiative Observational Study, 93,676 women were followed on average for 7.6 years. Depressive symptoms were measured at baseline and at 3 years using the 6-item scale from the Center for Epidemiological Studies Depression scale (CES-D). We calculated a cancer screening rate expressed as a proportion of the years that women were current with recommended cancer screening over the number of follow-up visits in the study. Breast and colorectal cancers were staged based on Surveillance, Epidemiology and End Results (SEER) classification. RESULTS: At baseline, 15.8% (12,621) women were positive for depressive symptoms, and 6.9% (4,777) were positive at both baseline screening and at 3 years. The overall average screening rate was 71% for breast cancer and 53% for colorectal cancer. The breast cancer screening rate was 1.5% (CI 0.9%-2.0%) lower among women who reported depressive symptoms at baseline than among those who did not. Depressive symptoms were not a predictor for colorectal cancer screening. Stage of breast and colorectal cancer was not found to be associated with depressive symptoms after adjusting for covariates. CONCLUSIONS: Among a healthy and self-motivated cohort of women, self-reported depressive symptoms were associated with lower rates of screening mammography but not with colorectal cancer screening.

A prospective study of inflammatory cytokines and diabetes mellitus in a multiethnic cohort of postmenopausal women.

BACKGROUND: Inflammatory cytokines, including tumor necrosis factor alpha, IL-6 (interleukin 6), and high-sensitivity C-reactive protein (hsCRP), have been related to both insulin resistance and type 2 diabetes mellitus. However, prospective studies that comprehensively assess their roles in the development of type 2 diabetes are few, especially in minority populations. METHODS: Among 82,069 postmenopausal women aged 50 to 79 years without cardiovascular disease or diabetes mellitus who participated in the Women's Health Initiative Observational Study, we prospectively examined the relationships of plasma levels of tumor necrosis factor alpha receptor 2, IL-6, and hsCRP to diabetes risk. During a median follow-up period of 5.9 years, 1584 women who had clinical diabetes were matched by age, ethnicity, clinical center, time of blood draw, and duration of follow-up to 2198 study participants who were free of the disease. RESULTS: After adjustment for matching factors and known diabetes risk factors, all 3 markers were significantly associated with increased diabetes risk; the estimated relative risks comparing the highest with the lowest quartiles were 1.47 (95% confidence interval [CI], 1.10-1.97) for tumor necrosis factor alpha receptor 2, 3.08 (95% CI, 2.25-4.23) for IL-6, and 3.46 (95% CI, 2.50-4.80) for hsCRP (P for trend, <.01 for all biomarkers). When mutually adjusted, IL-6 and hsCRP remained significant in each ethnic group. While no statistically significant interactions were observed between ethnicity and these biomarkers on diabetes risk, there were consistent trends for the associations of hsCRP and IL-6 with increased diabetes risk in all ethnic groups. CONCLUSION: These prospective data showed that elevated levels of IL-6 and hsCRP were consistently and significantly associated with an increased risk of clinical diabetes in postmenopausal women.

Patient attitudes toward screening.

BACKGROUND: Physician organizations recommend screening for health care behaviors. Despite these recommendations, health care providers worry that questions on sensitive topics may not be accepted by their patients. To determine if there is a relationship between health care screening by providers and acceptance of that screening by patients, a survey of female patients was analyzed. METHOD: Two telephone surveys were conducted two years apart. Each was a cross-sectional sample of female patients over the age of 18 years who had been seen by their primary care provider (PCP) in the previous 12 months. Patients were asked if they had been screened for eight different health behaviors (exercise, smoking, use of alcohol or drugs, excessive stress, sexual functioning concerns, safety or violence in the home, guns in the home) in the past year. They were also asked about their attitudes toward screening for those behaviors by health care providers. Odds ratios were calculated for patients who both agreed that screening should occur and reported having been screened in the last year. RESULTS: 3,175 women were surveyed. There was high acceptance of routine screening for exercise (75%), smoking (72%), alcohol/drugs (68%), and stress (62%), but less for sexual functioning (40%), safety/violence (40%), or guns (23%). There was a higher likelihood of agreeing with routine screening if the patient reported having been screened in the past year: exercise (OR 2.3, 95% CI 1.8-2.9), smoking (OR 1.6, 95% CI 1.3-1.9), alcohol/drugs (OR 2.3, 95% CI 1.9-2.7), stress (OR 1.7, 95% CI 1.4-1.9), sexual functioning (OR 2.7, 95% CI 2.2-3.4), safety/violence (OR 3.4, 95% CI 2.8-4.2), and guns (OR 4.4, 95% CI 3.4-5.8). LIMITATIONS: Only women in established relationships with primary care providers were surveyed. The cross-sectional nature of the survey prevents determination of the causality of the relationship. CONCLUSION: Women who had been screened for a health behavior had greater acceptance of routine screening for that behavior. Although further research is needed to determine the casual relationship, providers should not worry about offending their patients when screening for sensitive health behaviors.

A practice-centered intervention to increase screening for domestic violence in primary care practices.

BACKGROUND: Interventions to change practice patterns among health care professionals have had mixed success. We tested the effectiveness of a practice centered intervention to increase screening for domestic violence in primary care practices. METHODS: A multifaceted intervention was conducted among primary care practice in North Carolina. All practices designated two individuals to serve as domestic violence resources persons, underwent initial training on screening for domestic violence, and participated in 3 lunch and learn sessions. Within this framework, practices selected the screening instrument, patient educational material, and content best suited for their environment. Effectiveness was evaluated using a pre/post cross-sectional telephone survey of a random selection of female patients from each practice. RESULTS: Seventeen practices were recruited and fifteen completed the study. Baseline screening for domestic violence was 16% with a range of 2% to 49%. An absolute increase in screening of 10% was achieved (range of increase 0 to 22%). After controlling for clustering by practice and other patient characteristics, female patients were 79% more likely to have been screened after the intervention (OR 1.79, 95% CI 1.43-2.23). CONCLUSION: An intervention that allowed practices to tailor certain aspects to fit their needs increased screening for domestic violence. Further studies testing this technique using other outcomes are needed.

Quality of cholesterol screening and management with respect to the National Cholesterol Education's Third Adult Treatment Panel (ATPIII) guideline in primary care practices in North Carolina.

BACKGROUND: Adherence to previous national cholesterol guidelines has been low. We assessed whether lipid screening and management was consistent with the National Cholesterol Education's ATPIII in a sample of primary care practices participating in a quality improvement study. METHODS: Demographic and clinical data were abstracted from charts of 5071 patients aged 21 to 84 years, which were seen between June 1, 2001, and May 31, 2003, at 60 practices. Clinical sites were non-university-based primary care practices from 22 North Carolina counties. A dyslipidemia screening test was defined as a lipid profile performed on persons when not on a lipid-lowering drug. Among patients receiving a lipid profile, the proportion of patients appropriately treated, per ATPIII, was calculated. Practice level variation in screening and management was examined using the 50th (20th and 80th) percentile values across practices. RESULTS: The median practice level dyslipidemia screening rate during the 2 years was 40.1% (25.8%, 53.7%) of their age-eligible patients. The appropriate decision regarding lipid-lowering therapy was documented within 4 months of the lipid profile for 79.3% (69.0%, 86.0%) of practices' patients. Within 4 months, among the drug-ineligible patients, 100% (94%, 100%) were not prescribed drugs; 33.3% (6.3%, 50.0%) of the drug-eligible patients were prescribed lipid-lowering agents. CONCLUSIONS: The median dyslipidemia screening rate met the recommendations. There remains a need to improve the management of dyslipidemia; in particular, there was a significant underprescription of lipid-lowering drugs.

Calcium plus vitamin D supplementation and the risk of colorectal cancer.

BACKGROUND: Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials. However, randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 36,282 postmenopausal women from 40 Women's Health Initiative centers: 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [corrected] twice daily (1000 mg of elemental calcium and 400 IU of vitamin D3) and 18,106 received a matching placebo for an average of 7.0 years. The incidence of pathologically confirmed colorectal cancer was the designated secondary outcome. Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study. RESULTS: The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo (168 and 154 cases; hazard ratio, 1.08; 95 percent confidence interval, 0.86 to 1.34; P=0.51), and the tumor characteristics were similar in the two groups. The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups. There were no significant treatment interactions with baseline characteristics. CONCLUSIONS: Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women. The long latency associated with the development of colorectal cancer, along with the seven-year duration of the trial, may have contributed to this null finding. Ongoing follow-up will assess the longer-term effect of this intervention. (ClinicalTrials.gov number, NCT00000611.).

Improving diabetes care among low-income North Carolinians: Project IDEAL.

OBJECTIVES: Many barriers exist in implementing evidence-based guidelines for diabetes care, particularlyfor low-income patients. To address this, the North Carolina Project IDEAL (Improving Diabetes Education, Access to Care, and Living) Diabetes Initiative was created STUDY DESIGN/SETTING: Fourteen programs representing different types of agencies and intervention strategies across the state participated in the initiative. DATA COLLECTION: Separate random samples of medical charts of participating patients were reviewed at baseline (n=429) and three-year follow-up (n=656) to assess changes in six process (assessment of hemoglobin A1c, cholesterol blood pressure, and urinary protein; conduction of foot and retina examination) and three outcome (glycemia, blood pressure, and lipid control) measures. Four national guidelines (DQIP, HEDIS, NCEP and ADA) were used as benchmarks. RESULTS: Large increases were observed for some measures (hemoglobin A1c control and testing, LDL-cholesterol testing), while modest increases were observed for others (dilated eye exam, blood pressure testing, and control). CONCLUSIONS/RELEVANCE: Project IDEAL was successful in improving access to high-quality diabetes care for low-income patients. Additional effort is needed to address specific areas of concern, particularly retinopathy screening.

Sex disparities in procedure use for acute myocardial infarction in the United States, 1995 to 2001.

BACKGROUND: Sex disparities in procedure use for acute myocardial infarction (AMI) have been well documented in selected populations in the 1980s and early 1990s. As little is known about more recent trends in sex disparities in the general population, we analyzed more recent rates of catheterization, angioplasty, and coronary artery bypass grafting (CABG) performed before discharge for acute myocardial infarction. METHODS: Data from representative civilian hospitals in 33 US states in the Nationwide Inpatient Sample from 1995 to 2001 were used to identify men and women discharged with a primary diagnosis of acute myocardial infarction. Receipt of cardiac catheterization, angioplasty, stent placement, or CABG was determined. Multivariate Poisson modeling was used to determine the likelihood of procedure receipt by sex, adjusting for demographic, comorbidity, and hospital characteristics. RESULTS: From 1995 to 2001, the adjusted proportion receiving catheterization, angioplasty, and stents increased in women as well as men, whereas the adjusted proportion receiving CABG declined slightly. Women were nearly as likely as men to undergo catheterization (adjusted prevalence ratio [PR], 0.96; 95% CI, 0.95 to 0.97), angioplasty (adjusted PR, 0.98; 95% CI, 0.97 to 0.99), or stent placement (adjusted PR, 0.96; 95% CI, 0.95 to 0.97). Women remained less likely to undergo CABG (adjusted PR, 0.78; 95% CI, 0.77 to 0.79). CONCLUSIONS: These recent nationwide data suggest that compared with men, women are nearly as likely to undergo catheterization-based procedures but remain less likely to undergo CABG.