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1.  Gender Differences in Cardiovascular Risk Factors in Incident Diabetes 
Cardiovascular disease is a major cause of morbidity and mortality for women and men with diabetes. Previous cross-sectional studies of prevalent diabetes have found that women are less likely to meet ADA and AHA guidelines for control of cardiovascular risk factors (hemoglobin A1c, LDL cholesterol, and blood pressure), but have not studied the critical period immediately after diagnosis.
To assess gender differences in cardiovascular risk factors at the time of diabetes diagnosis (baseline) and one year later (follow-up), we conducted a retrospective cohort study of 6,547 individuals with incident diabetes in an integrated care delivery system. We assessed mean cardiovascular risk factor values by gender and adjusted odds ratios of attaining ADA goals.
Compared with men, at baseline women had lower hemoglobin A1c (7.9% vs. 8.2%, P<0.001), higher LDL cholesterol (118.9 vs. 111.5 mg/dL, P < 0.001), higher systolic blood pressure (131.9 vs. 130.5 mmHg, P<0.001), and lower diastolic blood pressure (79.1 vs. 79.7 mmHg, P=0.006). At follow-up, the hemoglobin A1c gender gap had closed (6.9% vs. 6.9%, P=0.39), and the gender gaps had decreased for blood pressure (129.8/77.0 vs. 128.9/77.6, P=0.009) and LDL cholesterol (104.0 vs 98.2 mg/dL, P<0.001). These associations varied by age. Adjusted odds ratios showed similar relationships.
In this cohort of individuals with incident diabetes, men and women had important differences in risk factor control at the time of diabetes diagnosis. These differences varied by age, and decreased over time.
PMCID: PMC3932744  PMID: 24439948
2.  Unconscious (Implicit) Bias and Health Disparities: Where Do We Go from Here? 
The Permanente Journal  2011;15(2):71-78.
Disparities in health care are of great concern, with much attention focused on the potential for unconscious (implicit) bias to play a role in this problem. Some initial studies have been conducted, but the empirical research has lagged. This article provides a research roadmap that spans investigations of the presence of implicit bias in health care settings, identification of mechanisms through which implicit bias operates, and interventions that may prevent or ameliorate its effects. The goal of the roadmap is to expand and revitalize efforts to understand implicit bias and, ultimately, eliminate health disparities. Concrete suggestions are offered for individuals in different roles, including clinicians, researchers, policymakers, patients, and community members.
PMCID: PMC3140753  PMID: 21841929
3.  Returning to Work after Cancer: Quantitative Studies and Prototypical Narratives 
Psycho-oncology  2010;19(2):115-124.
A combination of quantitative data and illustrative narratives may allow cancer survivorship researchers to disseminate their research findings more broadly. We identified recent, methodologically rigorous quantitative studies on return to work after cancer, summarized the themes from these studies, and illustrated those themes with narratives of individual cancer survivors.
We reviewed English-language studies of return to work for adult cancer survivors through June, 2008, and identified 13 general themes from papers that met methodological criteria (population-based sampling, prospective and longitudinal assessment, detailed assessment of work, evaluation of economic impact, assessment of moderators of work return, and large sample size). We drew survivorship narratives from a prior qualitative research study to illustrate these themes.
Nine quantitative studies met 4 or more of our 6 methodological criteria. These studies suggested that most cancer survivors could return to work without residual disabilities. Cancer site, clinical prognosis, treatment modalities, socioeconomic status, and attributes of the job itself influenced the likelihood of work return. Three narratives - a typical survivor who returned to work after treatment, an individual unable to return to work, and an inspiring survivor who returned to work despite substantial barriers - illustrated many of the themes from the quantitative literature while providing additional contextual details.
Illustrative narratives can complement the findings of cancer survivorship research if researchers are rigorous and transparent in the selection, analysis, and retelling of those stories.
PMCID: PMC2818031  PMID: 19507264
Cancer; oncology; survivorship; work function; quality of life; qualitative research; narrative medidicne; review
4.  Socio-Demographic and Clinical Characteristics are Not Clinically Useful Predictors of Refill Adherence in Patients with Hypertension 
Although many studies have identified patient characteristics or chronic diseases associated with medication adherence, the clinical utility of such predictors has rarely been assessed. We attempted to develop clinical prediction rules for adherence with antihypertensive medications in two health care delivery systems.
Methods and Results
Retrospective cohort studies of hypertension registries in an inner-city health care delivery system (N = 17176) and a health maintenance organization (N = 94297) in Denver, Colorado. Adherence was defined by acquisition of 80% or more of antihypertensive medications.
A multivariable model in the inner-city system found that adherent patients (36.3% of the total) were more likely than non-adherent patients to be older, white, married, and acculturated in US society, to have diabetes or cerebrovascular disease, not to abuse alcohol or controlled substances, and to be prescribed less than three antihypertensive medications. Although statistically significant, all multivariate odds ratios were 1.7 or less, and the model did not accurately discriminate adherent from non-adherent patients (C-statistic = 0.606). In the health maintenance organization, where 72.1% of patients were adherent, significant but weak associations existed between adherence and older age, white race, the lack of alcohol abuse, and fewer antihypertensive medications. The multivariate model again failed to accurately discriminate adherent from non-adherent individuals (C-statistic = 0.576).
Although certain socio-demographic characteristics or clinical diagnoses are statistically associated with adherence to refills of antihypertensive medications, a combination of these characteristics is not sufficiently accurate to allow clinicians to predict whether their patients will be adherent with treatment.
PMCID: PMC2768296  PMID: 20031876
drugs; hypertension; prevention
5.  HIV risk after release from prison: a qualitative study of former inmates 
Former prison inmates are at risk for HIV and Hepatitis C (HCV). This study was designed to understand how former inmates perceived their risk of HIV and HCV after release from prison, the behaviors and environmental factors that put patients at risk for new infection and the barriers to accessing health care.
Qualitative study utilizing individual, face-to-face, semi-structured interviews exploring participants’ perceptions and behaviors putting them at risk for HIV and HCV and barriers to engaging in regular medical care after release. Interview transcripts were coded and analyzed utilizing a team-based general inductive approach.
Participants were racially and ethnically diverse and consisted of 20 men and 9 women with an age range of 22–57 years who were interviewed within the first two months after their release from prison to the Denver, Colorado community. Four major themes emerged: 1) risk factors including unprotected sex, transactional sex, and drug use were prevalent in the post-release period; 2) engagement in risky behavior occurred disproportionately in the first few days after release; 3) former inmates had educational needs about HIV and HCV; and 4) former inmates faced major challenges in accessing health care and medications.
Risk factors for HIV and HCV were prevalent among former inmates immediately after release. Prevention efforts should focus on education, promotion of safe sex and needle practices, substance abuse treatment, and drug- free transitional housing. Improved coordination between correctional staff, parole officers and community health care providers may improve continuity of care.
PMCID: PMC3685495  PMID: 21522015
6.  Diabetes care and outcomes for American Indians and Alaska natives in commercial integrated delivery systems: a SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) Study 
To compare cardiovascular disease risk factor testing rates and intermediate outcomes of care between American Indian/Alaska Native (AI/AN) patients with diabetes and non-Hispanic Caucasians enrolled in nine commercial integrated delivery systems in the USA.
Research design and methods
We used modified Poisson regression models to compare the annual testing rates and risk factor control levels for glycated haemoglobin (HbA1c), low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP); number of unique diabetes drug classes; insulin use; and oral diabetes drug medication adherence between insured AI/AN and non-Hispanic white adults with diabetes aged ≥18 in 2011.
5831 AI/AN patients (1.8% of the cohort) met inclusion criteria. After adjusting for age, gender, comorbidities, insulin use, and geocoded socioeconomic status, AI/AN patients had similar rates of annual HbA1c, LDL-C, and SBP testing, and LDL-C and SBP control, compared with non-Hispanic Caucasians. However, AI/AN patients were significantly more likely to have HbA1c >9% (>74.9 mmol/mol; RR=1.47, 95% CI 1.38 to 1.58), and significantly less likely to adhere to their oral diabetes medications (RR=0.90, 95% CI 0.88 to 0.93) compared with non-Hispanic Caucasians.
AI/AN patients in commercial integrated delivery systems have similar blood pressure and cholesterol testing and control, but significantly lower rates of HbA1c control and diabetes medication adherence, compared with non-Hispanic Caucasians. As more AI/ANs move to urban and suburban settings, clinicians and health plans should focus on addressing disparities in diabetes care and outcomes in this population.
PMCID: PMC4246918  PMID: 25452877
American Indian(s); Health Care Delivery
7.  Health Disparities and the Criminal Justice System: An Agenda for Further Research and Action 
Although racial and ethnic minorities are more likely to be involved with the criminal justice system than whites in the USA, critical scientific gaps exist in our understanding of the relationship between the criminal justice system and the persistence of racial/ethnic health disparities. Individuals engaged with the criminal justice system are at risk for poor health outcomes. Furthermore, criminal justice involvement may have direct or indirect effects on health and health care. Racial/ethnic health disparities may be exacerbated or mitigated at several stages of the criminal justice system. Understanding and addressing the health of individuals involved in the criminal justice system is one component of a comprehensive strategy to reduce population health disparities and improve the health of our urban communities.
PMCID: PMC3284594  PMID: 21915745
Prisons; Health disparities; Health care delivery
8.  Prescription Medication Burden in Patients with Newly-Diagnosed Diabetes: A SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) Study 
To understand the burden of medication use for newly-diagnosed diabetes patients both before and after diabetes diagnosis, and to identify subpopulations of newly-diagnosed diabetes patients who face a relatively high drug burden.
Retrospective cohort.
Eleven U.S. integrated health systems.
196,654 insured adults aged ≥20 diagnosed with newly-diagnosed diabetes from 1/1/2005 – 12/31/2009.
Main Outcome Measure
Number of unique therapeutic classes of drugs dispensed in the 12 months prior to, and 12 months post, the diagnosis of diabetes in 5 categories: overall, antihypertensive, antihyperlipidemic, mental health, and antihyperglycemic (post-period only).
The mean number of drug classes used by newly-diagnosed diabetes patients is high before diagnosis (5.0), and increases significantly afterwards (6.6, p<.001). Eighty-one percent of this increase is due to antihyperglycemic initiation and increased use of medications to control hypertension and lipid levels. Multivariate analyses showed that overall drug burden after diabetes diagnosis was higher in female, older, white, and obese patients, as well as among those with higher A1cs and comorbidity levels (p<.001 for all comparisons). The overall number of drug classes used by newly-diagnosed diabetes patients after diagnosis decreased slightly between 2005 and 2009 (p<.001).
Diabetes patients face significant drug burden to control diabetes and other comorbidities, and our data indicate an increased focus on cardiovascular disease risk factor control after diabetes diagnosis. However, total drug burden may be slightly decreasing over time. This information can be valuable to pharmacists working with newly-diagnosed diabetes patients to address their increasing drug regimen complexity.
PMCID: PMC4161641  PMID: 24860866
diabetes; medication burden; surveillance
9.  Standardizing Terminology and Definitions of Medication Adherence and Persistence in Research employing Electronic Databases 
Medical care  2013;51(8 0 3):S11-S21.
To propose a unifying set of definitions for prescription adherence research utilizing electronic health record prescribing databases, prescription dispensing databases, and pharmacy claims databases and to provide a conceptual framework to operationalize these definitions consistently across studies.
We reviewed recent literature to identify definitions in electronic database studies of prescription-filling patterns for chronic oral medications. We then develop a conceptual model and propose standardized terminology and definitions to describe prescription-filling behavior from electronic databases.
The conceptual model we propose defines two separate constructs: medication adherence and persistence. We define primary and secondary adherence as distinct sub-types of adherence. Metrics for estimating secondary adherence are discussed and critiqued, including a newer metric (New Prescription Medication Gap measure) that enables estimation of both primary and secondary adherence.
Terminology currently used in prescription adherence research employing electronic databases lacks consistency. We propose a clear, consistent, broadly applicable conceptual model and terminology for such studies. The model and definitions facilitate research utilizing electronic medication prescribing, dispensing, and/or claims databases and encompasses the entire continuum of prescription-filling behavior.
Employing conceptually clear and consistent terminology to define medication adherence and persistence will facilitate future comparative effectiveness research and meta-analytic studies that utilize electronic prescription and dispensing records.
PMCID: PMC3727405  PMID: 23774515
medication adherence; medication persistence; medication discontinuation; refill compliance; refill persistence; administrative; database; electronic health record; computerized medical record systems
10.  Return to drug use and overdose after release from prison: a qualitative study of risk and protective factors 
Former inmates are at high risk for death from drug overdose, especially in the immediate post-release period. The purpose of the study is to understand the drug use experiences, perceptions of overdose risk, and experiences with overdose among former prisoners.
This qualitative study included former prison inmates (N = 29) who were recruited within two months after their release. Interviewers conducted in-person, semi-structured interviews which explored participants' experiences and perceptions. Transcripts were analyzed utilizing a team-based method of inductive analysis.
The following themes emerged: 1) Relapse to drugs and alcohol occurred in a context of poor social support, medical co-morbidity and inadequate economic resources; 2) former inmates experienced ubiquitous exposure to drugs in their living environments; 3) intentional overdose was considered "a way out" given situational stressors, and accidental overdose was perceived as related to decreased tolerance; and 4) protective factors included structured drug treatment programs, spirituality/religion, community-based resources (including self-help groups), and family.
Former inmates return to environments that strongly trigger relapse to drug use and put them at risk for overdose. Interventions to prevent overdose after release from prison may benefit from including structured treatment with gradual transition to the community, enhanced protective factors, and reductions of environmental triggers to use drugs.
PMCID: PMC3414824  PMID: 22966409
Drug use; Overdose; Prisoners; Relapse; Prison re-entry
11.  Construction of a Multisite DataLink Using Electronic Health Records for the Identification, Surveillance, Prevention, and Management of Diabetes Mellitus: The SUPREME-DM Project 
Electronic health record (EHR) data enhance opportunities for conducting surveillance of diabetes. The objective of this study was to identify the number of people with diabetes from a diabetes DataLink developed as part of the SUPREME-DM (SUrveillance, PREvention, and ManagEment of Diabetes Mellitus) project, a consortium of 11 integrated health systems that use comprehensive EHR data for research.
We identified all members of 11 health care systems who had any enrollment from January 2005 through December 2009. For these members, we searched inpatient and outpatient diagnosis codes, laboratory test results, and pharmaceutical dispensings from January 2000 through December 2009 to create indicator variables that could potentially identify a person with diabetes. Using this information, we estimated the number of people with diabetes and among them, the number of incident cases, defined as indication of diabetes after at least 2 years of continuous health system enrollment.
The 11 health systems contributed 15,765,529 unique members, of whom 1,085,947 (6.9%) met 1 or more study criteria for diabetes. The nonstandardized proportion meeting study criteria for diabetes ranged from 4.2% to 12.4% across sites. Most members with diabetes (88%) met multiple criteria. Of the members with diabetes, 428,349 (39.4%) were incident cases.
The SUPREME-DM DataLink is a unique resource that provides an opportunity to conduct comparative effectiveness research, epidemiologic surveillance including longitudinal analyses, and population-based care management studies of people with diabetes. It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions.
PMCID: PMC3457753  PMID: 22677160
12.  Statin Prescribing Patterns in a Cohort of Cancer Patients with Poor Prognosis 
Journal of Palliative Medicine  2013;16(4):412-418.
There are no evidence-based recommendations for statin continuation or discontinuation near the end of life. However, some expert opinion recommends continuing statins prescribed for secondary versus primary prevention of cardiovascular disease.
Our aim was to explore statin prescribing patterns in a longitudinal cohort of individuals with life-limiting illness, and to evaluate differences in these patterns based on secondary versus primary prevention of cardiovascular disease.
Design and setting
This study was a retrospective cohort analysis of 539 persons in an integrated, not-for-profit health maintenance organization (HMO) setting who were receiving statins at diagnosis of a cancer with 0% to 25% predicted 5-year survival. Of the cohort patients, 343 were taking statins for secondary prevention and 196 for primary prevention of cardiovascular disease. Measurements included number and timing of statin refills between diagnosis and date of death, disenrollment, or the end of the observation period.
Four hundred and ninety-six cohort members died within the observation period. Fifty-eight percent of the secondary prevention and 62% of the primary prevention group had at least one statin refill after diagnosis. There were no significant differences between groups for number of days between diagnosis and last refill, or between last refill and death. Two deaths were attributable to cardiovascular causes in each group.
Our retrospective cohort analysis of persons with incident poor-prognosis cancer describes diminished, but persistent statin refills after diagnosis. Neither timing of statin discontinuation nor cardiovascular mortality differed by prescribing indication. There may be an opportunity to reevaluate medication burden in persons taking statins for primary prevention, and it is unclear whether continuing statins prescribed for secondary prevention affects cardiovascular outcomes.
PMCID: PMC3612279  PMID: 23305190
13.  Circulating adiponectin levels are lower in Latino versus non-Latino white patients at risk for cardiovascular disease, independent of adiposity measures 
Latinos in the United States have a higher prevalence of type 2 diabetes than non-Latino whites, even after controlling for adiposity. Decreased adiponectin is associated with insulin resistance and predicts T2DM, and therefore may mediate this ethnic difference. We compared total and high-molecular-weight (HMW) adiponectin in Latino versus white individuals, identified factors associated with adiponectin in each ethnic group, and measured the contribution of adiponectin to ethnic differences in insulin resistance.
We utilized cross-sectional data from subjects in the Latinos Using Cardio Health Actions to reduce Risk study. Participants were Latino (n = 119) and non-Latino white (n = 60) men and women with hypertension and at least one other risk factor for CVD (age 61 ± 10 yrs, 49% with T2DM), seen at an integrated community health and hospital system in Denver, Colorado. Total and HMW adiponectin was measured by RIA and ELISA respectively. Fasting glucose and insulin were used to calculate the homeostasis model insulin resistance index (HOMA-IR). Variables independently associated with adiponectin levels were identified by linear regression analyses. Adiponectin's contribution to ethnic differences in insulin resistance was assessed in multivariate linear regression models of Latino ethnicity, with logHOMA-IR as a dependent variable, adjusting for possible confounders including age, gender, adiposity, and renal function.
Mean adiponectin levels were lower in Latino than white patients (beta estimates: -4.5 (-6.4, -2.5), p < 0.001 and -1.6 (-2.7, -0.5), p < 0.005 for total and HMW adiponectin), independent of age, gender, BMI/waist circumference, thiazolidinedione use, diabetes status, and renal function. An expected negative association between adiponectin and waist circumference was seen among women and non-Latino white men, but no relationship between these two variables was observed among Latino men. Ethnic differences in logHOMA-IR were no longer observed after controlling for adiponectin levels.
Among patients with CVD risk, total and HMW adiponectin is lower in Latinos, independent of adiposity and other known regulators of adiponectin. Ethnic differences in adiponectin regulation may exist and future research in this area is warranted. Adiponectin levels accounted for the observed variability in insulin resistance, suggesting a contribution of decreased adiponectin to insulin resistance in Latino populations.
PMCID: PMC3141565  PMID: 21736747
14.  Using Community Data to Test the Discriminate Validity of Ethnic/Racial Group IATs 
Zeitschrift fur Psychologie  2010;218(1):10.1027/0044-3409/a000006.
The present study used a multi-method, multi-measure, multi-group approach to investigate the discriminant validity of prejudice-related IATs. Community members from three ethnic/racial groups in the U.S. completed IATs and explicit measures of attitudes toward African Americans and Latinos, with Whites used as the comparison group. The results of this study provided strong support for the discriminant validity of the IATs by showing, (a) expected patterns of variation among the three participant groups that were unique to each IAT, (b) unique relations between responses on each IAT and corresponding (same-group) explicit measures of prejudice, and (c) invariance across the three participant groups in the degree to which the attitude measures loaded on two latent factors, indicating distinct attitudes toward African Americans and Latinos.
PMCID: PMC3882026  PMID: 24404433
15.  An Assessment of Biases Against Latinos and African Americans Among Primary Care Providers and Community Members 
American journal of public health  2012;103(1):10.2105/AJPH.2012.300812.
This study assessed implicit and explicit bias against both Latinos and African Americans, among experienced primary care providers (PCPs) and community members (CMs) in the same geographic area.
210 PCPs and 190 CMs from three health care organizations in the Denver metro area completed Implicit Association Tests and self-report measures of implicit and explicit bias, respectively.
With a 60% participation rate, the PCPs demonstrated substantial implicit bias against both Latinos and African Americans, but this was no different from CMs. Explicit bias was largely absent in both groups. Adjustment for background characteristics showed the PCPs to have slightly weaker ethnic/racial bias than CMs.
This research provides the first evidence of implicit bias against Latinos in health care, as well as confirming prior findings of implicit bias against African Americans. The lack of substantive differences in bias between the experienced PCPs and CMs suggests a wider societal problem. At the same time, the wide range of implicit bias suggests that bias in healthcare is neither uniform nor inevitable, and important lessons may be learned from providers who do not exhibit bias.
PMCID: PMC3518332  PMID: 23153155
16.  A Pragmatic Framework for Single-site and Multisite Data Quality Assessment in Electronic Health Record-based Clinical Research 
Medical care  2012;50(0):10.1097/MLR.0b013e318257dd67.
Answers to clinical and public health research questions increasingly require aggregated data from multiple sites. Data from electronic health records and other clinical sources are useful for such studies, but require stringent quality assessment. Data quality assessment is particularly important in multisite studies to distinguish true variations in care from data quality problems.
We propose a “fit-for-use” conceptual model for data quality assessment and a process model for planning and conducting single-site and multisite data quality assessments. These approaches are illustrated using examples from prior multisite studies.
Critical components of multisite data quality assessment include: thoughtful prioritization of variables and data quality dimensions for assessment; development and use of standardized approaches to data quality assessment that can improve data utility over time; iterative cycles of assessment within and between sites; targeting assessment toward data domains known to be vulnerable to quality problems; and detailed documentation of the rationale and outcomes of data quality assessments to inform data users. The assessment process requires constant communication between site-level data providers, data coordinating centers, and principal investigators.
A conceptually based and systematically executed approach to data quality assessment is essential to achieve the potential of the electronic revolution in health care. High-quality data allow “learning health care organizations” to analyze and act on their own information, to compare their outcomes to peers, and to address critical scientific questions from the population perspective.
PMCID: PMC3833692  PMID: 22692254
data quality; data quality assessment; single-site studies; multisite studies
17.  Acculturation and Outcomes among Patients with Heart Failure 
Circulation. Heart failure  2012;5(2):160-166.
Acculturation to U.S. society among minority patients may influence health outcomes beyond race and ethnicity alone. In particular, those who are foreign-born and who do not speak English as their primary language may have greater challenges interacting with the health care system and thus be at greater risk for adverse outcomes.
Methods and Results
We studied patients hospitalized with a principal discharge diagnosis of HF between January 2000 and December 2007 in an integrated delivery system that cares for minority patients. Individuals were defined as having low acculturation if their primary language was not English and their country of birth was outside of the U.S. Multivariable logistic regression and Cox proportional hazards regression were used to determine the independent risk of 30-day rehospitalization and 1-year mortality, respectively. Candidate adjustment variables included demographics (age, gender, race/ethnicity), coexisting illnesses, laboratory values, left ventricular systolic function, and characteristics of the index admission. Of 1,268 patients, 30% (n=379) were Black, 39% (n=498) Hispanic, and 27% (n= 348) White. Eighteen percent (n=228) had low acculturation. After adjustment, low acculturation was associated with a higher risk of readmission at 30 days (OR 1.70; 95% CI 1.07-2.68) but not 1-year all-cause mortality (HR 0.69; 95% CI 0.42-1.14).
Patients with HF who are foreign-born and do not speak English as their primary language have a greater risk of rehospitalization, independent of clinical factors and race/ethnicity. Future studies should evaluate whether culturally concordant interventions focusing on such patients may improve outcomes for this patient population.
PMCID: PMC3786352  PMID: 22247483
heart failure; readmission; survival; risk factors; health disparities
18.  Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials 
Journal of Oncology Practice  2008;4(4):162-168.
To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate.
Participants and Methods:
In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks.
Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%).
Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.
Potential strategies to overcome barriers to enrollment of seniors into early-phase trials.
PMCID: PMC2793956  PMID: 20856765
19.  Simultaneous Control of Diabetes, Hypertension, and Hyperlipidemia in Two Health Systems 
Many individuals with diabetes, hypertension and hyperlipidemia have difficulty achieving control of all three conditions. We assessed the incidence and duration of simultaneous control of hyperglycemia, blood pressure, and low-density lipoprotein (LDL) cholesterol in patients from two health care systems in Colorado.
Methods and Results
Retrospective cohort study of adults at Denver Health (DH) and Kaiser Permanente Colorado (KP) with diabetes, hypertension, and hyperlipidemia from 2000 through 2008. Over a median of 4.0 and 4.4 years, 16% and 30% of individuals at DH and KP achieved the primary outcome (simultaneous control with a glycosylated hemoglobin (HbA1c) < 7.0%, blood pressure < 130/80 mmHg and LDL cholesterol < 100 mg/dL), respectively. With less strict goals (HbA1c < 8.0%, BP < 140/90 mmHg, and LDL cholesterol < 130 mg/dL), 44% and 70% of individuals at DH and KP achieved simultaneous control. Socio-demographic characteristics (increasing age, white ethnicity), and the presence of cardiovascular disease or other comorbidities were significantly but not strongly predictive of achieving simultaneous control in multivariable models. Simultaneous control was less likely as severity of the underlying conditions increased, and more likely as medication adherence increased.
Simultaneous control of diabetes, hypertension, and hyperlipidemia was uncommon and generally transient. Less stringent goals had a relatively large effect on the proportion achieving simultaneous control. Individuals who simultaneously achieve multiple treatment goals may provide insight into self-care strategies for individuals with comorbid health conditions.
PMCID: PMC3590111  PMID: 22851534
Diabetes mellitus; hypertension; hypercholesterolemia; epidemiology
20.  Characteristics of Patients with Primary Non-adherence to Medications for Hypertension, Diabetes, and Lipid Disorders 
Information comparing characteristics of patients who do and do not pick up their prescriptions is sparse, in part because adherence measured using pharmacy claims databases does not include information on patients who never pick up their first prescription, that is, patients with primary non-adherence. Electronic health record medication order entry enhances the potential to identify patients with primary non-adherence, and in organizations with medication order entry and pharmacy information systems, orders can be linked to dispensings to identify primarily non-adherent patients.
This study aims to use database information from an integrated system to compare patient, prescriber, and payment characteristics of patients with primary non-adherence and patients with ongoing dispensings of newly initiated medications for hypertension, diabetes, and/or hyperlipidemia.
This is a retrospective observational cohort study.
Participants of this study include patients with a newly initiated order for an antihypertensive, antidiabetic, and/or antihyperlipidemic within an 18-month period.
Proportion of patients with primary non-adherence overall and by therapeutic class subgroup. Multivariable logistic regression modeling was used to investigate characteristics associated with primary non-adherence relative to ongoing dispensings.
The proportion of primarily non-adherent patients varied by therapeutic class, including 7% of patients ordered an antihypertensive, 11% ordered an antidiabetic, 13% ordered an antihyperlipidemic, and 5% ordered medications from more than one of these therapeutic classes within the study period. Characteristics of patients with primary non-adherence varied across therapeutic classes, but these characteristics had poor ability to explain or predict primary non-adherence (models c-statistics = 0.61–0.63).
Primary non-adherence varies by therapeutic class. Healthcare delivery systems should pursue linking medication orders with dispensings to identify primarily non-adherent patients. We encourage conduct of research to determine interventions successful at decreasing primary non-adherence, as characteristics available from databases provide little assistance in predicting primary non-adherence.
PMCID: PMC3250550  PMID: 21879374
medication adherence; primary non-adherence; antihypertensive adherence; antidiabetic adherence; antihyperlipidemic adherence
22.  The Effect of Incident Cancer, Depression and Pulmonary Disease Exacerbations on Type 2 Diabetes Control 
Little is known about how the development of a new chronic health condition affects management of existing chronic conditions over time. New conditions might worsen management of existing conditions because of competing demands or improve management of existing conditions because of increased engagement with heath care. We assessed the effect of incident stage 0, 1, 2 or 3 breast, colon or prostate cancer; incident depression; or an exacerbation of chronic pulmonary disease on control of type 2 diabetes (DM2).
We conducted a longitudinal, historical cohort study within an integrated, not-for-profit HMO. Of a cohort of persons with diagnoses of DM2 between 1998 and 2008, 582, 2,959 and 2,332 developed incident cancer, depression or pulmonary disease exacerbation, respectively. We assessed change in hemoglobin A1c (A1c) as a function of the occurrence of the incident comorbidity in each subcohort for a period of 1 to 5 years after the occurrence of the incident comorbidity. Secondary outcomes were systolic blood pressure (SBP) and low density lipoprotein (LDL) levels. Multivariate linear regression was adjusted for demographics, morbidity level, BMI, numbers of primary and specialty visits, and continuity of primary care. Latent class analyses assessed post-comorbidity outcome trajectories. All time-varying covariates were calculated for a 24-month pre-diagnosis period and 0 to 24- and 24 to 60-month post-diagnosis periods.
For each condition, A1c did not change significantly from before to after the incident comorbidity. This was confirmed by latent class growth curve analyses that grouped patients by their A1c trajectories. SBP and LDL were also not significantly changed pre- and post-diagnosis of the incident comorbidities.
Although incident comorbidities inevitably will affect patients’ and clinicians’ care priorities, we did not observe changes in these particular outcomes. Additional investigation of interactions between diseases will inform changes in care that benefit complex patient populations.
PMCID: PMC3101974  PMID: 21203859
23.  The Spectrum of Engagement in HIV Care and its Relevance to Test-and-Treat Strategies for Prevention of HIV Infection 
Poor engagement in HIV care is common in the United States and worsens HIV treatment outcomes. In addition, poor engagement in care is likely to drastically reduce the effectiveness of “test and treat” HIV prevention strategies.
(See the editorial commentary by Lange, on pages 801–802.)
For individuals with human immunodeficiency virus (HIV) infection to fully benefit from potent combination antiretroviral therapy, they need to know that they are HIV infected, be engaged in regular HIV care, and receive and adhere to effective antiretroviral therapy. Test-and-treat strategies for HIV prevention posit that expanded testing and earlier treatment of HIV infection could markedly decrease ongoing HIV transmission, stemming the HIV epidemic. However, poor engagement in care for HIV-infected individuals will substantially limit the effectiveness of test-and-treat strategies. We review the spectrum of engagement in care for HIV-infected individuals in the United States and apply this information to help understand the magnitude of the challenges that poor engagement in care will pose to test-and-treat strategies for HIV prevention.
PMCID: PMC3106261  PMID: 21367734
24.  Prediction of cardiovascular death in racial/ethnic minorities using Framingham risk factors 
Risk factors for cardiovascular disease (CVD) derived from the Framingham study are widely used to guide preventive efforts. It remains unclear whether these risk factors predict CVD death in racial/ethnic minorities as well as they do in the predominately white Framingham cohorts.
Methods and Results
Using linked data from the National Health and Nutrition Examination Survey III (1988-1994) and the National Death Index, we developed Cox proportional-hazard models that predicted time to cardiovascular death separately for non-Hispanic white (NHW), non-Hispanic black (NHB) and Mexican American (MA) participants aged 40-80 with no previous CVD. We compared calibration and discrimination for the three racial/ethnic models. We also plotted predicted 10-year CVD mortality by age for the three racial/ethnic groups while holding other risk factors constant. 3437 NHW, 1854 NHB and 1834 MA subjects met inclusion criteria. Goodness of fit chi-square tests demonstrated adequate calibration for the three models (NHW, p=0.49; NHB, p=0.47; MA, p=0.55 and areas under the receiver operating characteristic curves demonstrated similar discrimination (c-statistics-NHW=0.8126; NHB=0.7679; and MA=0.7854). Older age was more strongly associated with CVD mortality in NHWs (HR-3.37, 95%CI-2.80, 4.05) than NHBs (HR-2.29, 95%CI-1.91, 2.75) and was intermediate in MAs (HR-2.46, 95%CI-1.95, 3.11). Predicted 10-year mortality was highest for NHBs across all age ranges and was higher for MAs than NHWs until late in the seventh decade.
Framingham risk factors predict CVD mortality equally well in NHWs, NHBs and MAs, but the strength of the association between individual risk factors and CVD mortality differs by race and ethnicity. When other risk factors are held constant, minority individuals are at higher risk of CVD mortality at younger ages than NHWs.
PMCID: PMC2853913  PMID: 20124526
Risk factors; cardiovascular diseases; prevention; epidemiology
25.  Antiretroviral medication adherence and the development of class-specific antiretroviral resistance 
AIDS (London, England)  2009;23(9):1035-1046.
To assess the association between antiretroviral adherence and the development of class-specific antiretroviral medication resistance.
Design and methods:
Literature and conference abstract review of studies assessing the association between adherence to antiretroviral therapy and the development of antiretroviral medication resistance.
Factors that determine class-specific adherence–resistance relationships include antiretroviral regimen potency, viral fitness or more specifically the interplay between the fold-change in resistance and fold-change in fitness caused by drug resistance mutations, and the genetic barrier to antiretroviral resistance. During multidrug therapy, differential drug exposure increases the likelihood of developing resistance. In addition, antiretroviral medications with higher potency and higher genetic barriers to resistance decrease the incidence of resistance for companion antiretroviral medications at all adherence levels.
Knowledge of class-specific adherence–resistance relationships may help clinicians and patients tailor therapy to match individual patterns of adherence in order to minimize the development of resistance at failure. In addition, this information may guide the selection of optimal drug combinations and regimen sequences to improve the durability of antiretroviral therapy.
PMCID: PMC2704206  PMID: 19381075
adherence; antiretroviral resistance; antiretroviral therapy; genetic barrier to resistance; HIV; potency; replication capacity

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