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1.  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 
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).
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: Unique identifier: NCT01072500.
PMCID: PMC3886743  PMID: 24222666
aging; exercise; peripheral vascular disease
2.  Value of Recruitment Strategies Used in a Primary Care Practice-based Trial 
Contemporary clinical trials  2006;28(3):258-267.
“Physicians-recruiting-physicians” is the preferred recruitment approach for practice-based research. However, yields are variable; and the approach can be costly and lead to biased, unrepresentative samples. We sought to explore the potential efficiency of alternative methods.
We conducted a retrospective analysis of the yield and cost of 10 recruitment strategies used to recruit primary care practices to a randomized trial to improve cardiovascular disease risk factor management. We measured response and recruitment yields and the resources used to estimate the value of each strategy. Providers at recruited practices were surveyed about motivation for participation.
Response to 6 opt-in marketing strategies was 0.40% (53/13290), ranging from 0% to 2.86% by strategy; 33.96% (18/53) of responders were recruited to the study. Of those recruited from opt-out strategies, 8.68% joined the study, ranging from 5.35% to 41.67% per strategy. A strategy that combined both opt-in and opt-out approaches resulted in a 51.14% (90/176) response and a 10.80% (19/90) recruitment rate. Cost of recruitment was $613 per recruited practice. Recruitment approaches based on in-person meetings (41.67%), previous relationships (33.33%), and borrowing an Area Health Education Center’s established networks (10.80%), yielded the most recruited practices per effort and were most cost efficient. Individual providers who chose to participate were motivated by interest in improving their clinical practice (80.5%); contributing to CVD primary prevention (54.4%); and invigorating their practice with new ideas (42.1%).
This analysis provides suggestions for future recruitment efforts and research. Translational studies with limited funds could consider multi-modal recruitment approaches including in-person presentations to practice groups and exploitation of previous relationships, which require the providers to opt-out, and interactive opt-in approaches which rely on borrowed networks. These approaches can be supplemented with non-relationship-based opt-out strategies such as cold calls strategically targeted to underrepresented provider groups.
PMCID: PMC3760001  PMID: 17030154
3.  Intensive Glycemic Control Is Not Associated With Fractures or Falls in the ACCORD Randomized Trial 
Diabetes Care  2012;35(7):1525-1531.
Older adults with type 2 diabetes are at high risk of fractures and falls, but the effect of glycemic control on these outcomes is unknown. To determine the effect of intensive versus standard glycemic control, we assessed fractures and falls as outcomes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) randomized trial.
ACCORD participants were randomized to intensive or standard glycemia strategies, with an achieved median A1C of 6.4 and 7.5%, respectively. In the ACCORD BONE ancillary study, fractures were assessed at 54 of the 77 ACCORD clinical sites that included 7,287 of the 10,251 ACCORD participants. At annual visits, 6,782 participants were asked about falls in the previous year.
During an average follow-up of 3.8 (SD 1.3) years, 198 of 3,655 participants in the intensive glycemia and 189 of 3,632 participants in the standard glycemia group experienced at least one nonspine fracture. The average rate of first nonspine fracture was 13.9 and 13.3 per 1,000 person-years in the intensive and standard groups, respectively (hazard ratio 1.04 [95% CI 0.86–1.27]). During an average follow-up of 2.0 years, 1,122 of 3,364 intensive- and 1,133 of 3,418 standard-therapy participants reported at least one fall. The average rate of falls was 60.8 and 55.3 per 100 person-years in the intensive and standard glycemia groups, respectively (1.10 [0.84–1.43]).
Compared with standard glycemia, intensive glycemia did not increase or decrease fracture or fall risk in ACCORD.
PMCID: PMC3379596  PMID: 22723583
4.  Centers for Cardiovascular Outcomes Research: Defining a Collaborative Vision 
In 2010, recognizing the value of outcomes research to understand and bridge translational gaps, establish evidence in the clinical practice and delivery of medicine, and generate new hypotheses about ongoing questions of treatment and care, the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) established the Centers for Cardiovascular Outcomes Research (CCOR) program.
Methods and Results
The NHLBI funded three centers and a research coordinating unit. Each center has an individual project focus, including: (1) characterizing care transition and predicting clinical events and quality of life for patients discharged after an acute coronary syndrome; (2) identifying center and regional factors associated with better patient outcomes across several cardiovascular conditions and procedures; and (3) examining the impact of health care reform in Massachusetts on overall and disparate care and outcomes for several cardiovascular conditions and venous thromboembolism. Cross-program collaborations seek to advance the field methodologically and to develop early stage investigators committed to careers in outcomes research.
The CCOR program represents a significant expansion of the NHLBI's investment in cardiovascular outcomes research. The vision of this program is to leverage scientific rigor and cross-program collaboration to advance the science of health care delivery and outcomes beyond what any individual unit could achieve alone.
PMCID: PMC3684990  PMID: 23481526
outcomes research; translation of knowledge; cross-collaboration
5.  Reversibility of Fenofibrate Therapy–Induced Renal Function Impairment in ACCORD Type 2 Diabetic Participants 
Diabetes Care  2012;35(5):1008-1014.
To assess the reversibility of the elevation of serum creatinine levels in patients with diabetes after 5 years of continuous on-trial fenofibrate therapy.
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.
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 m2 (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.
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.
PMCID: PMC3329840  PMID: 22432114
6.  The Impact of Frequent and Unrecognized Hypoglycemia on Mortality in the ACCORD Study 
Diabetes Care  2012;35(2):409-414.
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.
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.
PMCID: PMC3263892  PMID: 22179956
7.  Disparities in HbA1c Levels Between African-American and Non-Hispanic White Adults With Diabetes 
Diabetes care  2006;29(9):2130-2136.
Among individuals with diabetes, a comparison of HbA1c (A1C) levels between African Americans and non-Hispanic whites was evaluated. Data sources included PubMed, Web of Science, the Cumulative Index to Nursing and Allied Health, the Cochrane Library, the Combined Health Information Database, and the Education Resources Information Center.
We executed a search for articles published between 1993 and 2005. Data on sample size, age, sex, A1C, geographical location, and study design were extracted. Cross-sectional data and baseline data from clinical trials and cohort studies for African Americans and non-Hispanic whites with diabetes were included. Diabetic subjects aged <18 years and those with pre-diabetes or gestational diabetes were excluded. We conducted a meta-analysis to estimate the difference in the mean values of A1C for African Americans and non-Hispanic whites.
A total of 391 studies were reviewed, of which 78 contained A1C data. Eleven had data on A1C for African Americans and non-Hispanic whites and met selection criteria. A meta-analysis revealed the standard effect to be 0.31 (95% CI 0.39–0.25). This standard effect correlates to an A1C difference between groups of ~0.65%, indicating a higher A1C across studies for African Americans. Grouping studies by study type (cross-sectional or cohort), method of data collection for A1C (chart review or blood draw), and insurance status (managed care or nonmanaged care) showed similar results.
The higher A1C observed in this meta-analysis among African Americans compared with non-Hispanic whites may contribute to disparity in diabetes morbidity and mortality in this population.
PMCID: PMC3557948  PMID: 16936167
8.  Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data 
Hypoglycemia is a common complication of diabetes treatment. This paper describes symptoms, predecessors, consequences and medications associated with the first episode of severe hypoglycemia among ACCORD participants with type 2 diabetes, and compares these between intensive (Int: goal A1C <6.0%) and standard (Std, goal A1C 7–7.9%) glycemia intervention groups.
Information about symptoms, antecedents, and consequences was collected at the time participants reported an episode of severe hypoglycemia. Data on medications prescribed during the clinical trial was used to determine the association of particular diabetes drug classes and severe hypoglycemia.
The most frequently reported symptoms in both glycemia group were weakness/fatigue (Int 29%; Std 30%) and sweating (Int 26%; Std 27%), followed by confusion/disorientation (Int 22%; Std 29%) and shakiness (Int 21%; Std 19%). Approximately half of all events were preceded by a variation in food intake (Int 48%; Std 58%). The most common consequences were confusion (Int 37%; Std 34%), loss of consciousness (Int 25%; Std 25%), and hospitalization (Int 18%; Std 24%). The highest rates of hypoglycemia were found among those participants treated with insulin only (Int 6.09/100 person yrs; Std 2.64/100 person yrs) while the lowest were among those prescribed oral agents only (Int 1.93/100 person yrs; Std 0.20/100 person yrs).
Severe hypoglycemia episodes were frequently preceded by a change in food intake, making many episodes potentially preventable. Symptoms of confusion/disorientation and loss of consciousness were frequently seen. The highest rates of hypoglycemia were seen with prescription of insulin, either alone or in combination with other medications.
Clinical Trial Registration
Number: NCT00000620
PMCID: PMC3433360  PMID: 22646230
Hypoglycemia; Type 2 diabetes
9.  Effect of Intensive Compared With Standard Glycemia Treatment Strategies on Mortality by Baseline Subgroup Characteristics 
Diabetes Care  2010;33(4):721-727.
To determine if baseline subgroups in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial can be identified for whom intensive compared with standard glycemia treatment had different effects on all-cause mortality.
Exploratory post hoc intention-to-treat comparisons were made between intensive and standard glycemia groups on all-cause mortality by subgroups defined by baseline characteristics.
There were few significant interactions between baseline characteristics and effects of intensive versus standard glycemia treatment on mortality: self-reported history of neuropathy (hazard ratio [HR] 1.95, 95% CI 1.41–2.69) versus no history of neuropathy (0.99, 0.79–1.26; P value for interaction 0.0008), higher A1C (A1C >8.5%: HR 1.64, 95% CI 1.22–2.22; A1C 7.5–8.4%: 1.00, 0.75–1.34; A1C <7.5%: 1.00, 0.67–1.50; P value for interaction 0.04), and aspirin use (HR 1.45, 95% CI 1.13–1.85, compared with 0.96, 0.72–1.27, in nonusers; P value for interaction 0.03).
We found a remarkable similarity of effect from intensive compared with standard glycemia treatment on mortality across most baseline subgroups. No differential effect was found in subgroups defined by variables anticipated to have an interaction: age, duration of diabetes, and previous history of cardiovascular disease. The three baseline characteristics that defined subgroups for which there was a differential effect on mortality may help identify patients with type 2 diabetes at higher risk of mortality from intensive regimens for glycemic control. Further research is warranted.
PMCID: PMC2845012  PMID: 20103550
10.  Appropriateness of Cholesterol Management in Primary Care by Sex and Level of Cardiovascular Risk 
Preventive cardiology  2009;12(2):95-101.
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.
PMCID: PMC2937269  PMID: 19476583
11.  Impact of a Multifaceted Intervention on Cholesterol Management in Primary Care Practices 
Archives of internal medicine  2009;169(7):678-686.
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.
PMCID: PMC2937279  PMID: 19364997
12.  A multifaceted intervention to improve blood pressure control: The Guideline Adherence for Heart Health (GLAD) study 
American heart journal  2008;157(2):278-284.
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.
PMCID: PMC2929708  PMID: 19185634
14.  The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study  
Objective To determine whether there is a link between hypoglycaemia and mortality among participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
Design Retrospective epidemiological analysis of data from the ACCORD trial.
Setting Diabetes clinics, research clinics, and primary care clinics.
Participants Patients were eligible for the ACCORD study if they had type 2 diabetes, a glycated haemoglobin (haemoglobin A1C) concentration of 7.5% or more during screening, and were aged 40-79 years with established cardiovascular disease or 55-79 years with evidence of subclinical disease or two additional cardiovascular risk factors.
Intervention Intensive (haemoglobin A1C <6.0%) or standard (haemoglobin A1C 7.0-7.9%) glucose control.
Outcome measures Symptomatic, severe hypoglycaemia, manifest as either blood glucose concentration of less than 2.8 mmol/l (<50 mg/dl) or symptoms that resolved with treatment and that required either the assistance of another person or medical assistance, and all cause and cause specific mortality, including a specific assessment for involvement of hypoglycaemia.
Results 10 194 of the 10 251 participants enrolled in the ACCORD study who had at least one assessment for hypoglycaemia during regular follow-up for vital status were included in this analysis. Unadjusted annual mortality among patients in the intensive glucose control arm was 2.8% in those who had one or more episodes of hypoglycaemia requiring any assistance compared with 1.2% for those with no episodes (53 deaths per 1924 person years and 201 deaths per 16 315 person years, respectively; adjusted hazard ratio (HR) 1.41, 95% CI 1.03 to 1.93). A similar pattern was seen among participants in the standard glucose control arm (3.7% (21 deaths per 564 person years) v 1.0% (176 deaths per 17 297 person years); adjusted HR 2.30, 95% CI 1.46 to 3.65). On the other hand, among participants with at least one hypoglycaemic episode requiring any assistance, a non-significantly lower risk of death was seen in those in the intensive arm compared with those in the standard arm (adjusted HR 0.74, 95% 0.46 to 1.23). A significantly lower risk was observed in the intensive arm compared with the standard arm in participants who had experienced at least one hypoglycaemic episode requiring medical assistance (adjusted HR 0.55, 95% CI 0.31 to 0.99). Of the 451 deaths that occurred in ACCORD up to the time when the intensive treatment arm was closed, one death was adjudicated as definitely related to hypoglycaemia.
Conclusion Symptomatic, severe hypoglycaemia was associated with an increased risk of death within each study arm. However, among participants who experienced at least one episode of hypoglycaemia, the risk of death was lower in such participants in the intensive arm than in the standard arm. Symptomatic, severe hypoglycaemia does not appear to account for the difference in mortality between the two study arms up to the time when the ACCORD intensive glycaemia arm was discontinued.
Trial registration NCT00000620.
PMCID: PMC2803744  PMID: 20061358
15.  The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study 
Objectives To investigate potential determinants of severe hypoglycaemia, including baseline characteristics, in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and the association of severe hypoglycaemia with levels of glycated haemoglobin (haemoglobin A1C) achieved during therapy.
Design Post hoc epidemiological analysis of a double 2×2 factorial, randomised, controlled trial.
Setting Diabetes clinics, research clinics, and primary care clinics.
Participants 10 209 of the 10 251 participants enrolled in the ACCORD study with type 2 diabetes, a haemoglobin A1C concentration of 7.5% or more during screening, and aged 40-79 years with established cardiovascular disease or 55-79 years with evidence of significant atherosclerosis, albuminuria, left ventricular hypertrophy, or two or more additional risk factors for cardiovascular disease (dyslipidaemia, hypertension, current smoker, or obese).
Interventions Intensive (haemoglobin A1C <6.0%) or standard (haemoglobin A1C 7.0-7.9%) glucose control.
Main outcome measures Severe hypoglycaemia was defined as episodes of “low blood glucose” requiring the assistance of another person and documentation of either a plasma glucose less than 2.8 mmol/l (<50 mg/dl) or symptoms that promptly resolved with oral carbohydrate, intravenous glucose, or glucagon.
Results The annual incidence of hypoglycaemia was 3.14% in the intensive treatment group and 1.03% in the standard glycaemia group. We found significantly increased risks for hypoglycaemia among women (P=0.0300), African-Americans (P<0.0001 compared with non-Hispanic whites), those with less than a high school education (P<0.0500 compared with college graduates), aged participants (P<0.0001 per 1 year increase), and those who used insulin at trial entry (P<0.0001). For every 1% unit decline in the haemoglobin A1C concentration from baseline to 4 month visit, there was a 28% (95% CI 19% to 37%) and 14% (4% to 23%) reduced risk of hypoglycaemia requiring medical assistance in the standard and intensive groups, respectively. In both treatment groups, the risk of hypoglycaemia requiring medical assistance increased with each 1% unit increment in the average updated haemoglobin A1C concentration (standard arm: hazard ratio 1.76, 95% CI 1.50 to 2.06; intensive arm: hazard ratio 1.15, 95% CI 1.02 to 1.21).
Conclusions A greater drop in haemoglobin A1C concentration from baseline to the 4 month visit was not associated with an increased risk for hypoglycaemia. Patients with poorer glycaemic control had a greater risk of hypoglycaemia, irrespective of treatment group. Identification of baseline subgroups with increased risk for severe hypoglycaemia can provide guidance to clinicians attempting to modify patient therapy on the basis of individual risk.
Trial registration number NCT00000620.
PMCID: PMC2803743  PMID: 20061360
16.  Validity of diabetes self-reports in the Women's Health Initiative: comparison with medication inventories and fasting glucose measurements 
Although diabetes is conveniently assessed by self-report, few validation studies have been performed. Therefore, we studied whether self-report of prevalent and incident diabetes in Women's Health Initiative (WHI) participants was concordant with other diagnostic evidence of diabetes.
Study Design and Setting
A total of 161 808 postmenopausal women aged 50–79 were enrolled at 40 clinical centers in the U.S. in 1993–1998 and followed prospectively. At baseline, prevalent medication treated diabetes was defined as a self-report of physician diagnosis and treatment with insulin or oral antidiabetic drugs. During followup, incident treated diabetes was defined as a self-report of a new physician diagnosis of diabetes treated with insulin or oral drugs. Diabetes self-reports were compared with medication inventories and fasting glucose levels at baseline and during follow-up.
At baseline, self-reported treated diabetes was concordant with the medication inventory in 79% of clinical trial, and 77% of observational study participants. Self-reported incident treated diabetes was concordant with the medication inventory in 78% between baseline and Year 1 in the clinical trials, in 62% between Year 1 and Year 3 in the clinical trials, and in 72% between baseline and Year 3 in the observational study. Over similar periods, 99.9% of those who did not report treated diabetes had no oral antidiabetic drugs or insulin in the medication inventory. At baseline, about 3% not reporting diabetes had fasting glucose >126 mg/dl, and 88% of these subjects subsequently reported treated diabetes during 6.9 years of follow-up.
Incident self-reported diabetes treated by lifestyle alone was not determined in WHI. Medication inventories may have been incomplete and fasting glucose may have been lowered by treatment; therefore, concordance with self-reported treatment or fasting glucose ≥ 126 may have been underestimated.
In the WHI, self-reported prevalent and incident diabetes was consistent with medication inventories, and a high proportion of those with undiagnosed diabetes subsequently reported diabetes treatment. Self-reports of ‘treated diabetes’ are sufficiently accurate to allow use in epidemiologic studies.
PMCID: PMC2757268  PMID: 18559413
17.  A practice-centered intervention to increase screening for domestic violence in primary care practices 
BMC Family Practice  2006;7:63.
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.
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.
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).
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.
PMCID: PMC1637109  PMID: 17064413
18.  Prevalence of Nutrition and Exercise Counseling for Patients with Hypertension 
To evaluate the prevalence of nutrition and exercise counseling for patients with hypertension.
Cross-sectional survey data from the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) for 1999 and 2000.
Office-based physician practices and hospital outpatient departments.
Patients age 18 or older with a diagnosis of hypertension.
In 1999 and 2000, over 137 million patient encounters had a diagnosis of hypertension. Nutrition and exercise counseling were provided at 35% and 26% of visits, respectively. Patients older than 74 received the least nutrition (28%) and exercise (18%) counseling. Asians and Hispanics were more likely to undergo any lifestyle counseling, while non-Hispanic whites received the least exercise and nutrition counseling. Patients with 2 cardiovascular comorbidities were counseled for diet (53%) and exercise (32%) more than those with 1 (44% and 31%) or none (30% and 23%; P≤ .001 and P≤ .001). The encounters in the NAMCS had higher rates of counseling than those in the NHAMCS. There were no significant differences in counseling rates with respect to gender, geographic region, severity of hypertension, or physician specialty.
While there were significant differences in counseling rates with respect to age, race, comorbidity, and survey cohort, counseling for therapeutic lifestyle changes for patients with hypertension was uniformly suboptimal. Physicians need to recognize the importance of nonpharmacologic treatment in hypertension.
PMCID: PMC1492516  PMID: 15333055
hypertension; lifestyle counseling; national survey
19.  Racial and ethnic disparities in cardiac catheterization for acute myocardial infarction in the United States, 1995--2001. 
OBJECTIVE: To examine recent trends in racial and ethnic disparities in cardiac catheterization for acute myocardial infarction (AMI) to determine whether disparities documented from the 1980s through mid-1990s persist, and evaluate whether patient and hospital characteristics are associated with any observed disparities METHODS: Cross-sectional analyses of 585,710 white, 51,369 black and 31,923 Hispanic discharges from hospitals in the Nationwide Inpatient Sample (which includes data on all discharges from 951 representative hospitals in 23 states) that had performed cardiac catheterization from 1995--2001 with a primary diagnosis of AMI. Adjusted procedure rates and prevalence ratios (PR) were computed to compare catheterization rates by race and ethnicity. MEASUREMENTS AND MAIN RESULTS: Catheterization rates were higher for whites than blacks for all years examined; rates among Hispanics increased during this period and approached the rate among whites. After adjustment for age, demographics, comorbidity, year and hospital characteristics, rates (per 100 discharges) were 58.4 for whites, 50.1 for blacks (PR 0.87; 95% CI 0.84-0.91) and 55.2 for Hispanics (PR 0.95; 95% CI 0.90-0.99). CONCLUSIONS: These nationwide data suggest blacks remain less likely than whites and Hispanics to undergo catheterization during a hospitalization for AMI. Whether this disparity stems from patient or provider factors remains to be determined.
PMCID: PMC2568623  PMID: 15779495
20.  The association of patient trust and self-care among patients with diabetes mellitus 
BMC Family Practice  2004;5:26.
Diabetes requires significant alterations to lifestyle and completion of self management tasks to obtain good control of disease. The objective of this study was to determine if patient trust is associated with reduced difficulty and hassles in altering lifestyle and completing self care tasks.
A cross-sectional telephone survey and medical record review was performed to measure patient trust and difficulty in completing diabetes tasks among 320 medically underserved patients attending diabetes programs in rural North Carolina, USA. Diabetes tasks were measured three ways: perceived hassles of diabetic care activities, difficulty in completing diabetes-related care activities, and a global assessment of overall ability to complete diabetes care activities. The association of patient trust with self-management was examined after controlling for patient demographics, physical functioning, mental health and co-morbidities.
Level of patient trust was high (median 22, possible max 25). Higher trust levels were associated with lower levels of hassles (p = 0.006) and lower difficulty in completing care activities (p = 0.001). Patients with higher trust had better global assessments of overall ability to complete diabetes care activities (p < 0.0001).
Higher patient trust in physicians is associated with reduced difficulty in completing disease specific tasks by patients. Further studies are needed to determine the causal relationship of this association, the effect of trust on other outcomes, and the potential modifiability of trust
PMCID: PMC535564  PMID: 15546482
21.  Lack of Association between Thiazolidinediones and Macular Edema in Type 2 Diabetes: The ACCORD Eye Study 
Archives of ophthalmology  2010;128(3):312-318.
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.
PMCID: PMC3010554  PMID: 20212201
Type 2 Diabetes; macular edema; visual acuity; thiazolidinediones; Avandia; Actos; retinopathy; visual acuity; rosiglitazone; pioglitazone
22.  Are Depressive Symptoms Associated with Cancer Screening and Cancer Stage at Diagnosis among Postmenopausal Women? The Women's Health Initiative Observational Cohort 
Journal of Women's Health  2008;17(8):1353-1361.
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.
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.
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.
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.
PMCID: PMC2944436  PMID: 18788983

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