Understanding the context of health for persons with multiple chronic conditions: moving from what is the matter to what matters.

PURPOSE: An isolated focus on 1 disease at a time is insufficient to generate the scientific evidence needed to improve the health of persons living with more than 1 chronic condition. This article explores how to bring context into research efforts to improve the health of persons living with multiple chronic conditions (MCC). METHODS: Forty-five experts, including persons with MCC, family and friend caregivers, researchers, policy makers, funders, and clinicians met to critically consider 4 aspects of incorporating context into research on MCC: key contextual factors, needed research, essential research methods for understanding important contextual factors, and necessary partnerships for catalyzing collaborative action in conducting and applying research. RESULTS: Key contextual factors involve complementary perspectives across multiple levels: public policy, community, health care systems, family, and person, as well as the cellular and molecular levels where most research currently is focused. Needed research involves moving from a disease focus toward a person-driven, goal-directed research agenda. Relevant research methods are participatory, flexible, multilevel, quantitative and qualitative, conducive to longitudinal dynamic measurement from diverse data sources, sufficiently detailed to consider what works for whom in which situation, and generative of ongoing communities of learning, living and practice. Important partnerships for collaborative action include cooperation among members of the research enterprise, health care providers, community-based support, persons with MCC and their family and friend caregivers, policy makers, and payers, including government, public health, philanthropic organizations, and the business community. CONCLUSION: Consistent attention to contextual factors is needed to enhance health research for persons with MCC. Rigorous, integrated, participatory, multimethod approaches to generate new knowledge and diverse partnerships can be used to increase the relevance of research to make health care more sustainable, safe, equitable and effective, to reduce suffering, and to improve quality of life.

Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial.

IMPORTANCE: In older adults reduced mobility is common and is an independent risk factor for morbidity, hospitalization, disability, and mortality. Limited evidence suggests that physical activity may help prevent mobility disability; however, there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability. OBJECTIVE: To test the hypothesis that a long-term structured physical activity program is more effective than a health education program (also referred to as a successful aging program) in reducing the risk of major mobility disability. DESIGN, SETTING, AND PARTICIPANTS: The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial that enrolled participants between February 2010 and December 2011, who participated for an average of 2.6 years. Follow-up ended in December 2013. Outcome assessors were blinded to the intervention assignment. Participants were recruited from urban, suburban, and rural communities at 8 centers throughout the United States. We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations, defined as a score on the Short Physical Performance Battery of 9 or below, but were able to walk 400 m. INTERVENTIONS: Participants were randomized to a structured, moderate-intensity physical activity program (n = 818) conducted in a center (twice/wk) and at home (3-4 times/wk) that included aerobic, resistance, and flexibility training activities or to a health education program (n = 817) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises. MAIN OUTCOMES AND MEASURES: The primary outcome was major mobility disability objectively defined by loss of ability to walk 400 m. RESULTS: Incident major mobility disability occurred in 30.1% (246 participants) of the physical activity group and 35.5% (290 participants) of the health education group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.98], P = .03).Persistent mobility disability was experienced by 120 participants (14.7%) in the physical activity group and 162 participants (19.8%) in the health education group (HR, 0.72 [95% CI, 0.57-0.91]; P = .006). Serious adverse events were reported by 404 participants (49.4%) in the physical activity group and 373 participants (45.7%) in the health education group (risk ratio, 1.08 [95% CI, 0.98-1.20]). CONCLUSIONS AND RELEVANCE: A structured, moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability. These findings suggest mobility benefit from such a program in vulnerable older adults. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01072500.

Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Calcium plus vitamin D supplementation and the risk of fractures.

BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal. METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers. RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels. CONCLUSIONS: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

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.).

A multifaceted intervention to improve blood pressure control: The Guideline Adherence for Heart Health (GLAD) study.

BACKGROUND: 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. METHOD: 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. RESULTS: 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%). CONCLUSION: 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.

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.

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.

Does health care provider screening for domestic violence vary by race and income?

Domestic violence (DV) affects approximately 25% of women in the United States with approximately 5.3 million incidents each year. DV advocates and national medical associations encourage health care providers (HCPs) to screen patients. To determine DV screening rates by race and income, patient race/ethnicity, income, and receipt of and receptiveness toward screening were measured. Patient preference for screening did not vary by race and varied little by income, but experience with screening did. Practices serving predominantly African American and lower income patients screened at higher rates. These findings seem driven by practice factors rather than differential treatment of individuals. Future research should focus on why certain types of practices screen more than others.

Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial aims to test whether a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) plus a fibrate is more efficacious in reducing cardiovascular events than a statin plus placebo in patients with type 2 diabetes mellitus with defined glycemic control. This is a blinded component in a 5,518-patient subset of the ACCORD cohort. These participants were randomized to either be (1) treated with simvastatin (titrated to 40 mg/day if necessary to achieve a goal low-density lipoprotein [LDL] cholesterol level of <2.59 mmol/L [100 mg/dL]) plus placebo or (2) treated to the same goal LDL cholesterol level with the statin plus active fenofibrate 160 mg/day or its bioequivalent (or 54 mg/day if the estimated glomerular filtration rate ranges from 30 to <50 mL/min per 1.73 m2). Setting an upper limit of LDL cholesterol qualifying for randomization excluded patients who would not likely achieve the LDL cholesterol goal. Recruitment for ACCORD began in January 2001, and follow-up is scheduled to end in June 2009. Since recruitment began, several clinical trials and consensus statements have been published that led to changes in the details of the lipid treatment algorithm and protocol. This report describes the design of the lipid protocol and modifications to the protocol during the course of the study in response to and in anticipation of these developments. The current protocol is designed to provide an ethically justifiable test of combined statin plus fibrate treatment consistent with the highest level of safety and lipid treatment standards of care.

Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

Hypoglycemia is a potentially serious side effect of blood glucose lowering in diabetes mellitus. The intensive glycemia treatment arm of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is designed to treat patients with type 2 diabetes with target glycemia within the normal range (ie, glycosylated hemoglobin <6%). Because it is known that treating glycemia to such a low level in patients with diabetes will result in episodes of hypoglycemia, it is necessary to address prevention and treatment of such episodes to ensure patient safety. Thus, several approaches are being taken in the ACCORD trial to prevent initial episodes of severe hypoglycemia, to monitor the frequency of episodes that do occur, and to prevent recurrence. This report describes the processes used in the ACCORD trial, including the definition of severe hypoglycemia, the type of education provided to participants and staff members to prevent initial and subsequent episodes of severe hypoglycemia, and the monitoring systems implemented to identify severe hypoglycemia and prevent its recurrence. The ACCORD trial conducts review and oversight of individual cases of severe hypoglycemia and monitors rates of severe hypoglycemia by clinical site and treatment arm. If the ACCORD intensive glycemia treatment is found to be efficacious in preventing cardiovascular disease events, assessment of the risk and benefit will be essential. In addition, translation of the principles behind the monitoring of severe hypoglycemia in ACCORD into feasible strategies for use in clinical practice will be needed.

Value of recruitment strategies used in a primary care practice-based trial.

PURPOSE: "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. 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. RESULTS: 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%). CONCLUSIONS: 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.

Disparities in HbA1c levels between African-American and non-Hispanic white adults with diabetes: a meta-analysis.

OBJECTIVE: Among individuals with diabetes, a comparison of HbA(1c) (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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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 approximately 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. CONCLUSIONS: 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.

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.

Streamlining cardiovascular clinical trials to improve efficiency and generalisability.

Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease.

Risk of fracture in women with type 2 diabetes: the Women's Health Initiative Observational Study.

CONTEXT: Some but not all studies have shown higher rates of fracture in individuals with type 2 diabetes. OBJECTIVE: The objective of the study was to determine the risk of fracture in postmenopausal women with type 2 diabetes and determine whether risk varies by fracture site, ethnicity, and baseline bone density. DESIGN, SETTING, AND PARTICIPANTS: Women with clinically diagnosed type 2 diabetes at baseline in the Women's Health Initiative Observational Cohort, a prospective study of postmenopausal women (n = 93,676), were compared with women without diagnosed diabetes and risk of fracture overall and at specific sites determined. MAIN OUTCOME MEASURES: All fractures and specific sites separately (hip/pelvis/upper leg; lower leg/ankle/knee; foot; upper arm/shoulder/elbow; lower arm/wrist/hand; spine/tailbone) were measured. Bone mineral density (BMD) in a subset also was measured. RESULTS: The overall risk of fracture after 7 yr of follow-up was higher in women with diabetes at baseline after controlling for multiple risk factors including frequency of falls [adjusted relative risk (RR) 1.20, 95% confidence interval (CI) 1.11-1.30]. In a subsample of women with baseline BMD scores, women with diabetes had greater hip and spine BMD. The elevated fracture risk was found at multiple sites (hip/pelvis/upper leg; foot; spine/tailbone) among black women (RR 1.33, 95% CI 1.00-1.75) and women with increased baseline bone density (RR 1.26, 95% CI 0.96-1.66). CONCLUSION: Women with type 2 diabetes are at increased risk for fractures. This risk is also seen among black and non-Hispanic white women after adjustment for multiple risk factors including frequent falls and increased BMD (in a subset).

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.

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.

Estrogen plus progestin and the risk of peripheral arterial disease: the Women's Health Initiative.

BACKGROUND: Observational studies have reported less frequent carotid atherosclerosis in healthy women taking postmenopausal hormone therapy. Estrogen with progestin did not reduce peripheral arterial events among women with preexisting coronary heart disease. This analysis evaluates clinical peripheral arterial disease among generally healthy women in the Women's Health Initiative randomized trial of estrogen plus progestin. METHODS AND RESULTS: The Estrogen Plus Progestin trial assigned 16 608 postmenopausal women, mean age 63.3+/-7.1 years, to daily conjugated estrogens (0.625 mg) with medroxyprogesterone acetate (2.5 mg) or placebo and documented health outcomes over an average of 5.6 years of follow-up. Hospitalization for peripheral arterial disease was infrequent, with annualized rates of 0.08%, 0.06%, and 0.02% for carotid disease, lower extremity arterial disease, and abdominal aortic aneurysm, respectively. The incidence of peripheral arterial events did not differ between treatment groups (hazard ratio [HR] 0.89, 95% confidence interval 0.63, 1.25). The risk was slightly greater among women assigned to active estrogen with progestin in years 1 (HR 1.33) and 2 (HR 1.27), and was slightly lower in later years (HR 0.85 and 0.87 in years 5 and > or =6). Among adherent participants, the hazard ratio for peripheral arterial events was 1.23 (95% confidence interval 0.79, 1.91) over the 5.6 years of follow up. Subgroup analysis identified no significant interactions between estrogen with progestin and baseline characteristics with regard to peripheral arterial disease risk. CONCLUSIONS: Among generally healthy postmenopausal women, conjugated estrogens with progestin did not confer protection against peripheral arterial disease.

Acute coronary syndrome national statistics: challenges in definitions.

BACKGROUND: Increasing convergence in the management of acute myocardial infarction (AMI) and unstable angina (UA) has led some to consider whether these 2 diagnoses should be consolidated into acute coronary syndrome (ACS) for the purpose of coronary heart disease surveillance. METHODS: We used the 1988-2001 Nationwide Inpatient Sample, which has demographic and diagnosis data on 6 to 7 million discharges per year from a sample of US nonfederal hospitals. We identified discharges with a first- or all-listed diagnosis of AMI ( International Classification of Diseases, Ninth Revision, Clinical Modification 410) or UA (International Classification of Diseases, Ninth Revision, Clinical Modification 411) and defined ACS-first as a primary diagnosis of either condition and all-listed ACS as codes 410 or 411 among any diagnoses. Sampling weights were applied to produce yearly national discharge estimates; annual population estimates were used to calculate yearly hospital discharge rates; rates were then adjusted to the 2000 standard population. RESULTS: Rates of first- and all-listed AMIs changed little. Rates of first-listed UA fell 87% from 29.7/10,000 in 1988 to 3.9/10,000 in 2001. This sharp decline was seen among all age and sex groups. Consequently, rates of ACS as a primary diagnosis declined 44%. In contrast, discharge rates for all-listed UA and ACS declined only modestly. CONCLUSIONS: As a primary diagnosis, UA is disappearing. Rates of first-listed ACS are quite sensitive to the decline in UA. Although discharge data based on first-listed diagnoses have been used to estimate the national incidence of AMI, they may not provide accurate data regarding current trends for ACS.