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1.  An informatics approach to medication adherence assessment and improvement using clinical, billing, and patient-entered data 
The aim of this study was to describe an integrated informatics approach to aggregating and displaying clinically relevant data that can identify problems with medication adherence and facilitate patient–provider communication about strategies to improve medication use. We developed a clinical dashboard within an electronic health record (EHR) system that uses data from three sources: the medical record, pharmacy claims, and a personal health record. The data are integrated to inform clinician–patient discussions about medication adherence. Whereas prior research on assessing patterns of medication adherence focused on a single approach using the EHR, pharmacy data, or patient-entered data, we present an approach that integrates multiple electronic data sources increasingly found in practice. Medication adherence is a complex challenge that requires patient and provider team input, necessitating an integrated approach using advanced EHR, clinical decision support, and patient-controlled technologies. Future research should focus on integrated strategies to provide patients and providers with the right combination of informatics tools to help them adequately address the challenge of adherence to complex medication therapies.
PMCID: PMC3994862  PMID: 24076751
Medication Adherence; Diabetes Mellitus, Type 2; Medical Records Systems, Computerized; Health Records, Personal; Physician-Patient Relations; Patient-Centered Care
2.  Rationale, Design, and Baseline Characteristics of a Community-based Comparative Effectiveness Trial to Prevent Type 2 Diabetes in Economically Disadvantaged Adults: The RAPID Study 
Reaching out And Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA.
RAPID enrolled adult primary care patients, with BMI 24 kg/m2 or higher and abnormal glucose metabolism (HbA1c 5.7-6.9% or fasting plasma glucose 100-125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period.
At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 Ibs, and BMI of 36.9 ± 8.6 kg/m2. 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥130 mmHg, 33.1% had a total blood cholesterol exceeding 200 mg/dl, and 74% reported a household income of <$25,000.
The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.
PMCID: PMC4373538  PMID: 24177413
pre-diabetes; primary prevention; type 2 diabetes mellitus; overweight/obesity; lifestyle intervention; community research
3.  Whale Shark (Rhincodon typus) Seasonal Presence, Residence Time and Habitat Use at Darwin Island, Galapagos Marine Reserve 
PLoS ONE  2014;9(12):e115946.
The life history of the whale shark (Rhincodon typus), including its reproductive ecology, still remains largely unknown. Here, we present results from the first whale shark population study around Darwin Island, Galapagos Marine Reserve. Following a diversified approach we characterized seasonal occurrence, population structure and size, and described habitat use of whale sharks based on fine scale movements around the island. Whale shark presence at Darwin Island was negatively correlated with Sea Surface Temperature (SST), with highest abundance corresponding to a cool season between July and December over six years of monitoring. From 2011 to 2013 we photo-identified 82 whale sharks ranging from 4 to 13.1 m Total Length (TL). Size distribution was bimodal, with a great majority (91.5%) of adult female individuals averaging 11.35 m±0.12 m (TL±SE), all but one showing signs of a potential pregnancy. Population dynamics models for apparently pregnant sharks estimated the presence of 3.76±0.90 (mean ± SE) sharks in the study area per day with an individual residence time of 2.09±0.51 (mean ± SE) days. Movement patterns analysis of four apparently pregnant individuals tracked with acoustic tags at Darwin Island revealed an intense use of Darwin's Arch, where no feeding or specific behavior has been recorded, together with periodic excursions around the island's vicinity. Sharks showed a preference for intermediate depths (20–30 m) with occasional dives mostly to mid-water, remaining the majority of their time at water temperatures between 24–25°C. All of our results point to Darwin Island as an important stopover in a migration, possibly with reproductive purposes, rather than an aggregation site. Current studies carried out in this area to investigate regional scale movement patterns may provide essential information about possible pupping grounds for this enigmatic species.
PMCID: PMC4281130  PMID: 25551553
4.  Correlates of depression among people with diabetes: The Translating Research Into Action for Diabetes (TRIAD) study 
Primary care diabetes  2010;4(4):215-222.
The broad objective of this study was to examine multiple dimensions of depression in a large, diverse population of adults with diabetes. Specific aims were to measure the association of depression with: (1) patient characteristics; (2) outcomes; and (3) diabetes-related quality of care.
Cross-sectional analyses were performed using survey and chart data from the Translating Research Into Action for Diabetes (TRIAD) study, including 8790 adults with diabetes, enrolled in 10 managed care health plans in 7 states. Depression was measured using the Patient Health Questionnaire (PHQ-8). Patient characteristics, outcomes and quality of care were measured using validated survey items and chart data.
Nearly 18% of patients had major depression, with prevalence 2-3 times higher among patients with low socioeconomic status. Pain and limited mobility were strongly associated with depression, controlling for other patient characteristics. Depression was associated with slightly worse glycemic control, but not other intermediate clinical outcomes. Depressed patients received slightly fewer recommended diabetes-related processes of care.
In a large, diverse cohort of patients with diabetes, depression was most prevalent among patients with low socioeconomic status and those with pain, and was associated with slightly worse glycemic control and quality of care.
PMCID: PMC4269468  PMID: 20832375
5.  Early Response to Preventive Strategies in the Diabetes Prevention Program 
Journal of General Internal Medicine  2013;28(12):1629-1636.
Recommendations for diabetes prevention in patients with prediabetes include lifestyle modification and metformin. However, the significance of early weight loss and glucose measurements when monitoring response to these proven interventions is unknown.
To quantify the relationship between early measures of weight and glucose and subsequent diabetes in patients undergoing diabetes prevention interventions.
Analysis of results from a randomized controlled trial in 27 academic medical centers in the United States.
3,041 adults with hyperglycemia randomized to lifestyle (n = 1,018), metformin (n = 1,036), or placebo (n = 987) with complete follow-up in The Diabetes Prevention Program.
Independent variables were weight loss at 6 and 12 months; fasting glucose (FG) at 6 months; hemoglobin A1c (HbA1c) at 6 months; and post-load glucose at 12 months. The main outcome was time to diabetes diagnosis.
After 6 months, 604 participants developed diabetes in the lifestyle (n = 140), metformin (n = 206), and placebo (n = 258) arms over 2.7 years. In the lifestyle arm, 6-month weight loss predicted decreased diabetes risk in a graded fashion: adjusted HR (95 % CI) 0.65 (0.35–1.22), 0.62 (0.33–1.18), 0.46 (0.24–0.87), 0.34 (0.18–0.64), and 0.15 (0.07–0.30) for 0–<3 %, 3–<5 %, 5–<7 %, 7–<10 %, and ≥10 % weight loss, respectively (reference: weight gain). Attainment of optimal 6-month FG and HbA1c and 12-month post-load glucose predicted >60 % lower diabetes risk across arms. We found a significant interaction between 6-month weight loss and FG in the lifestyle arm (P = 0.038).
Weight and glucose at 6 and 12 months strongly predict lower subsequent diabetes risk with a lifestyle intervention; lower FG predicts lower risk even with substantial weight loss. Early reduction in glycemia is a stronger predictor of future diabetes risk than weight loss for metformin. We offer the first evidence to guide clinicians in making interval management decisions for high-risk patients undertaking measures to prevent diabetes.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-013-2548-4) contains supplementary material, which is available to authorized users.
PMCID: PMC3832727  PMID: 23860722
diabetes prevention; diabetes risk; type 2 diabetes
7.  Promotion and tenure for community engaged research: An examination of promotion and tenure support for community engaged research at three universities collaborating through a Clinical and Translational Science Award 
Clinical and translational science  2013;6(3):10.1111/cts.12061.
Community engaged health research, an approach to research which includes the participation of communities, promotes the translation of research to address and improve social determinants of health. As a way to encourage community engaged research, the National Institutes of Health required applicants to the Clinical and Translational Science Award (CTSA) to include a community engagement component. Although grant-funding may support an increase in community engaged research, faculty also respond to the rewards and demands of university promotion and tenure standards. This paper measures faculty perception of how three institutions funded by a CTSA support community engaged research in the promotion and tenure process.
At three institutions funded by a CTSA, tenure track and non-tenure track faculty responded to a survey regarding perceptions of how promotion and tenure committees value community engaged research.
Faculty view support for community engaged research with some reserve. Only 36% agree that community engaged research is valued in the promotion and tenure process.
Encouraging community engaged scholarship requires changing the culture and values behind promotion and tenure decisions. Institutions will increase community engaged research and more faculty will adopt its principles, when it is rewarded by promotion and tenure committees.
PMCID: PMC3852909  PMID: 23751026
8.  Depression as a Predictor of Weight Regain Among Successful Weight Losers in the Diabetes Prevention Program 
Diabetes Care  2013;36(2):216-221.
To determine whether depression symptoms or antidepressant medication use predicts weight regain in overweight individuals with impaired glucose tolerance (IGT) who are successful with initial weight loss.
A total of 1,442 participants who successfully lost at least 3% of their baseline body weight after 12 months of participation in the randomized controlled Diabetes Prevention Program (DPP) continued in their assigned treatment group (metformin, intensive lifestyle, or placebo) and were followed into the Diabetes Prevention Program Outcome Study (DPPOS). Weight regain was defined as a return to baseline DPP body weight. Participant weight and antidepressant medication use were assessed every 6 months. Depression symptoms (Beck Depression Inventory [BDI] score ≥11) were assessed every 12 months.
Only 2.7% of the overall cohort had moderate to severe depression symptoms at baseline; most of the participants with BDI score ≥11 had only mild symptoms during the period of observation. In unadjusted analyses, both depression symptoms (hazard ratio 1.31 [95% CI 1.03–1.67], P = 0.03) and antidepressant medication use at either the previous visit (1.72 [1.37–2.15], P < 0.0001) or cumulatively as percent of visits (1.005 [1.002–1.008], P = 0.0003) were predictors of subsequent weight regain. After adjustment for multiple covariates, antidepressant use remained a significant predictor of weight regain (P < 0.0001 for the previous study visit; P = 0.0005 for the cumulative measure), while depression symptoms did not.
In individuals with IGT who do not have severe depression and who initially lose weight, antidepressant use may increase the risk of weight regain.
PMCID: PMC3554307  PMID: 23002085
10.  Impact of Lifestyle Intervention and Metformin on Health-Related Quality of Life: the Diabetes Prevention Program Randomized Trial 
Journal of General Internal Medicine  2012;27(12):1594-1601.
Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL).
To assess changes in HRQoL after interventions aimed at diabetes risk reduction.
A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m²; 68 % women, and 45 % members of minority groups.
Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB).
HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %.
After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p = 0.04) and PCS (+1.57, p < 0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p = 0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p < 0.001), physical function (+3.6, p < 0.001), bodily pain (+1.9, p = 0.01), and vitality (+2.1, p = 0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score.
Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-012-2122-5) contains supplementary material, which is available to authorized users.
PMCID: PMC3509296  PMID: 22692637
quality of life; lifestyle; metformin; diabetes risk; weight loss
11.  Predictors of Mortality Over 8 Years in Type 2 Diabetic Patients 
Diabetes Care  2012;35(6):1301-1309.
To examine demographic, socioeconomic, and biological risk factors for all-cause, cardiovascular, and noncardiovascular mortality in patients with type 2 diabetes over 8 years and to construct mortality prediction equations.
Beginning in 2000, survey and medical record information was obtained from 8,334 participants in Translating Research Into Action for Diabetes (TRIAD), a multicenter prospective observational study of diabetes care in managed care. The National Death Index was searched annually to obtain data on deaths over an 8-year follow-up period (2000–2007). Predictors examined included age, sex, race, education, income, smoking, age at diagnosis of diabetes, duration and treatment of diabetes, BMI, complications, comorbidities, and medication use.
There were 1,616 (19%) deaths over the 8-year period. In the most parsimonious equation, the predictors of all-cause mortality included older age, male sex, white race, lower income, smoking, insulin treatment, nephropathy, history of dyslipidemia, higher LDL cholesterol, angina/myocardial infarction/other coronary disease/coronary angioplasty/bypass, congestive heart failure, aspirin, β-blocker, and diuretic use, and higher Charlson Index.
Risk of death can be predicted in people with type 2 diabetes using simple demographic, socioeconomic, and biological risk factors with fair reliability. Such prediction equations are essential for computer simulation models of diabetes progression and may, with further validation, be useful for patient management.
PMCID: PMC3357242  PMID: 22432119
13.  Getting Under the Skin of Clinical Inertia in Insulin Initiation: The Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project 
The Diabetes educator  2012;38(1):94-100.
The purpose of this cross-sectional study is to explore primary care providers’ (PCPs) perceptions about barriers to initiating insulin among patients. Studies suggest that many patients with poorly controlled type 2 diabetes do not receive insulin initiation by PCPs.
As part of the TRIAD study, we conducted structured interviews in health systems in Indiana, New Jersey, and California, asking PCPs about the importance of insulin initiation and factors affecting this decision. We calculated proportions choosing each multiple-choice response option and listed the most frequently offered open-ended response categories.
Among 83 PCPs, 45% were women, 60% were Caucasian, and they averaged 13.4 years in practice. Four-fifths of PCPs endorsed guideline-concordant glycemic targets, but 54% individualized targets based on patient age, life expectancy, medical co-morbidities, self-management capacity, and willingness. Most (64%) reported that many patients were resistant to new oral or insulin therapies due to fears about the therapy and what it meant about their disease progression. Two-thirds (64%) cited patient resistance as a barrier to insulin initiation, and 43% cited problems with patient self-management, including cognitive or mental health issues, dexterity, or ability to adhere.† Eighty percent felt that patient non-adherence would dissuade them from initiating insulin at least some of the time.
PCPs perceived that patient resistance and poor self-management skills were significant barriers to initiating insulin. Future studies should investigate whether systems-level interventions to improve patient-provider communication about insulin and enhance providers’ perceptions of patient self-management capacity can increase guideline-concordant, patient-centered insulin initiation.
PMCID: PMC3557962  PMID: 22222513
diabetes; insulin therapy; clinical inertia; clinical decision-making
14.  Thiazolidinediones, Cardiovascular Disease and Cardiovascular Mortality: Translating Research Into Action For Diabetes (TRIAD) 
Studies have associated thiazolidinedione (TZD) treatment with cardiovascular disease (CVD) and questioned whether the two available TZDs, rosiglitazone and pioglitazone, have different CVD risks. We compared CVD incidence, cardiovascular (CV) and all-cause mortality in type 2 diabetic patients treated with rosiglitazone or pioglitazone as their only TZD.
We analyzed survey, medical record, administrative, and National Death Index (NDI) data from 1999 through 2003 from Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Medications, CV procedures, and CVD were determined from health plan (HP) administrative data, and mortality was from NDI. Adjusted hazard rates (AHR) were derived from Cox proportional hazard models adjusted for age, sex, race/ethnicity, income, history of diabetic nephropathy, history of CVD, insulin use, and HP.
Across TRIAD’s ten HPs, 1,815 patients (24%) filled prescriptions for a TZD, 773 (10%) for only rosiglitazone, 711 (10%) for only pioglitazone, and 331 (4%) for multiple TZDs. In the seven HPs using both TZDs, 1,159 patients (33%) filled a prescription for a TZD, 564 (16%) for only rosiglitazone, 334 (10%) for only pioglitazone, and 261 (7%) for multiple TZDs. For all CV events, CV and all-cause mortality, we found no significant difference between rosiglitazone and pioglitazone.
In this relatively small, prospective, observational study, we found no statistically significant differences in CV outcomes for rosiglitazone- compared to pioglitazone-treated patients. There does not appear to be a pattern of clinically meaningful differences in CV outcomes for rosiglitazone- versus pioglitazone-treated patients.
PMCID: PMC3548906  PMID: 20583206
Thiazolidinediones; rosiglitazone; pioglitazone; diabetes
15.  Evaluation of risk equations for prediction of short-term coronary heart disease events in patients with long-standing type 2 diabetes: the Translating Research into Action for Diabetes (TRIAD) study 
To evaluate the U.K. Prospective Diabetes Study (UKPDS) and Framingham risk equations for predicting short-term risk of coronary heart disease (CHD) events among adults with long-standing type 2 diabetes, including those with and without preexisting CHD.
Prospective cohort of U.S. managed care enrollees aged ≥ 18 years and mean diabetes duration of more than 10 years, participating in the Translating Research into Action for Diabetes (TRIAD) study, was followed for the first occurrence of CHD events from 2000 to 2003. The UKPDS and Framingham risk equations were evaluated for discriminating power and calibration.
A total of 8303 TRIAD participants, were identified to evaluate the UKPDS (n = 5914, 120 events), Framingham-initial (n = 5914, 218 events) and Framingham-secondary (n = 2389, 374 events) risk equations, according to their prior CHD history. All of these equations exhibited low discriminating power with Harrell’s c-index <0.65. All except the Framingham-initial equation for women and the Framingham-secondary equation for men had low levels of calibration. After adjsusting for the average values of predictors and event rates in the TRIAD population, the calibration of these equations greatly improved.
The UKPDS and Framingham risk equations may be inappropriate for predicting the short-term risk of CHD events in patients with long-standing type 2 diabetes, partly due to changes in medications used by patients with diabetes and other improvements in clinical care since the Frmaingham and UKPDS studies were conducted. Refinement of these equations to reflect contemporary CHD profiles, diagnostics and therapies are needed to provide reliable risk estimates to inform effective treatment.
PMCID: PMC3433369  PMID: 22776317
16.  Temporal Trends in Recording of Diabetes on Death Certificates 
Diabetes Care  2011;34(7):1529-1533.
To determine the frequency that diabetes is reported on death certificates of decedents with known diabetes and describe trends in reporting over 8 years.
Data were obtained from 11,927 participants with diabetes who were enrolled in Translating Research into Action for Diabetes, a multicenter prospective observational study of diabetes care in managed care. Data on decedents (N = 2,261) were obtained from the National Death Index from 1 January 2000 through 31 December 2007. The primary dependent variables were the presence of the ICD-10 codes for diabetes listed anywhere on the death certificate or as the underlying cause of death.
Diabetes was recorded on 41% of death certificates and as the underlying cause of death for 13% of decedents with diabetes. Diabetes was significantly more likely to be reported on the death certificate of decedents dying of cardiovascular disease than all other causes. There was a statistically significant trend of increased reporting of diabetes as the underlying cause of death over time (P < 0.001), which persisted after controlling for duration of diabetes at death. The increase in reporting of diabetes as the underlying cause of death was associated with a decrease in the reporting of cardiovascular disease as the underlying cause of death (P < 0.001).
Death certificates continue to underestimate the prevalence of diabetes among decedents. The increase in reporting of diabetes as the underlying cause of death over the past 8 years will likely impact estimates of the burden of diabetes in the U.S.
PMCID: PMC3120163  PMID: 21709292
17.  Contracting and Monitoring Relationships for Adolescents with Type 1 Diabetes: A Pilot Study 
Adolescents are developmentally in a period of transition—from children cared for by their parents to young adults capable of self-care, independent judgment, and self-directed problem solving. We wished to develop a behavioral contract for adolescent diabetes management that addresses some negotiable points of conflict within the parent–child relationship regarding self-monitoring and then assess its effectiveness in a pilot study as part of a novel cell phone–based glucose monitoring system.
In the first phase of this study we used semistructured interview techniques to determine the major sources of diabetes-related conflict in the adolescent–parent relationship, to identify factors that could facilitate or inhibit control, and to determine reasonable goals and expectations. These data were then used to inform development of a behavioral contract that addressed the negotiable sources of conflict between parents and their adolescent. The second phase of this research was a 3-month pilot study to measure how a novel cell phone glucose monitoring system would support the contract and have an effect on glucose management, family conflict, and quality of life.
Interviews were conducted with 10 adolescent–caregiver pairs. The major theme of contention was nagging about diabetes management. Two additional themes emerged as points of negotiation for the behavioral contract: glucose testing and contact with the diabetes clinical team. Ten adolescent–parent pairs participated in the pilot test of the system and contract. There was a significant improvement in the Diabetes Self-Management Profile from 55.2 to 61.1 (P < 0.01). A significant reduction in hemoglobin A1c also occurred, from 8.1% at the start of the trial to 7.6% at 3 months (P < 0.04).
This study confirms previous findings that mobile technologies do offer significant potential in improving the care of adolescents with type 1 diabetes. Moreover, behavioral contracts may be an important adjunct to reduce nagging and improve outcomes with behavioral changes.
PMCID: PMC3132067  PMID: 21406011
18.  Antidepressant Medicine Use and Risk of Developing Diabetes During the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study 
Diabetes Care  2010;33(12):2549-2551.
To assess the association between antidepressant medicine use and risk of developing diabetes during the Diabetes Prevention Program (DPP) and Diabetes Prevention Program Outcomes Study (DPPOS).
DPP/DPPOS participants were assessed for diabetes every 6 months and for antidepressant use every 3 months in DPP and every 6 months in DPPOS for a median 10.0-year follow-up.
Controlled for factors associated with diabetes risk, continuous antidepressant use compared with no use was associated with diabetes risk in the placebo (adjusted hazard ratio 2.34 [95% CI 1.32–4.15]) and lifestyle (2.48 [1.45–4.22]) arms, but not in the metformin arm (0.55 [0.25–1.19]).
Continuous antidepressant use was significantly associated with diabetes risk in the placebo and lifestyle arms. Measured confounders and mediators did not account for this association, which could represent a drug effect or reflect differences not assessed in this study between antidepressant users and nonusers.
PMCID: PMC2992187  PMID: 20805256
19.  Changes in Health State Utilities With Changes in Body Mass in the Diabetes Prevention Program 
Obesity (Silver Spring, Md.)  2009;17(12):2176-2181.
Health utilities are measures of health-related quality of life (HRQL) used in cost-effectiveness research. We evaluated whether changes in body weight were associated with changes in health utilities in the Diabetes Prevention Program (DPP) and whether associations differed by treatment assignment (lifestyle intervention, metformin, placebo) or baseline obesity severity. We constructed physical (PCS-36) and mental component summary (MCS-36) subscales and short-form-6D (SF-6D) health utility index for all DPP participants completing a baseline 36-item short form (SF-36) HRQL assessment (N = 3,064). We used linear regression to test associations between changes in body weight and changes in HRQL indicators, while adjusting for other demographic and behavioral variables. Overall differences in HRQL between treatment groups were highly statistically significant but clinically small after 1 year. In multivariable models, weight change was independently associated with change in SF-6D score (increase of 0.007 for every 5 kg weight loss; P < 0.001), but treatment effects independent of weight loss were not. We found no significant interaction between baseline obesity severity and changes in SF-6D with changes in body weight. However, increases in physical function (PCS-36) with weight loss were greater in persons with higher baseline obesity severity. In summary, improvements in HRQL are associated with weight loss but not with other effects of obesity treatments that are unrelated to weight loss. Although improvements in the SF-6D did not exceed commonly reported thresholds for a minimally important difference (0.04), these changes, if causal, could still have a significant impact on clinical cost-effectiveness estimates if sustained over multiple years.
PMCID: PMC3135001  PMID: 19390518
20.  Barriers to Insulin Initiation 
Diabetes Care  2010;33(4):733-735.
Reasons for failing to initiate prescribed insulin (primary nonadherence) are poorly understood. We investigated barriers to insulin initiation following a new prescription.
We surveyed insulin-naïve patients with poorly controlled type 2 diabetes, already treated with two or more oral agents who were recently prescribed insulin. We compared responses for respondents prescribed, but never initiating, insulin (n = 69) with those dispensed insulin (n = 100).
Subjects failing to initiate prescribed insulin commonly reported misconceptions regarding insulin risk (35% believed that insulin causes blindness, renal failure, amputations, heart attacks, strokes, or early death), plans to instead work harder on behavioral goals, sense of personal failure, low self-efficacy, injection phobia, hypoglycemia concerns, negative impact on social life and job, inadequate health literacy, health care provider inadequately explaining risks/benefits, and limited insulin self-management training.
Primary adherence for insulin may be improved through better provider communication regarding risks, shared decision making, and insulin self-management training.
PMCID: PMC2845015  PMID: 20086256
21.  Race and Medication Adherence and Glycemic Control: Findings from an Operational Health Information Exchange 
AMIA Annual Symposium Proceedings  2011;2011:1649-1657.
The Central Indiana Beacon Community leads efforts for improving adherence to oral hypoglycemic agents (OHA) to achieve improvements in glycemic control for patients with type 2 diabetes. In this study, we explored how OHA adherence affected hemoglobin A1C (HbA1c) level in different racial groups. OHA adherence was measured by 6-month proportion of days covered (PDC). Of 3,976 eligible subjects, 12,874 pairs of 6-month PDC and HbA1c levels were formed between 2002 and 2008. The average HbA1c levels were 7.4% for African-Americans and 6.5% for Whites. The average 6-month PDCs were 40% for African-Americans and 50% for Whites. In mixed effect generalized linear regression analyses, OHA adherence was inversely correlated with HbA1c level for both African-Americans (−0.80, p<0.0001) and Whites (−0.53, p<0.0001). The coefficient was −0.26 (p<0.0001) for the interaction of 6-month PDC and African-Americans. Significant risk factors for OHA non-adherence were race, young age, non-commercial insurance, newly-treated status, and polypharmacy.
PMCID: PMC3243292  PMID: 22195231
22.  Primary Language, Income and the Intensification of Anti-glycemic Medications in Managed Care: the (TRIAD) Study 
Patients who speak Spanish and/or have low socioeconomic status are at greater risk of suboptimal glycemic control. Inadequate intensification of anti-glycemic medications may partially explain this disparity.
To examine the associations between primary language, income, and medication intensification.
Cohort study with 18-month follow-up.
One thousand nine hundred and thirty-nine patients with Type 2 diabetes who were not using insulin enrolled in the Translating Research into Action for Diabetes Study (TRIAD), a study of diabetes care in managed care.
Using administrative pharmacy data, we compared the odds of medication intensification for patients with baseline A1c ≥ 8%, by primary language and annual income. Covariates included age, sex, race/ethnicity, education, Charlson score, diabetes duration, baseline A1c, type of diabetes treatment, and health plan.
Overall, 42.4% of patients were taking intensified regimens at the time of follow-up. We found no difference in the odds of intensification for English speakers versus Spanish speakers. However, compared to patients with incomes <$15,000, patients with incomes of $15,000-$39,999 (OR 1.43, 1.07-1.92), $40,000-$74,999 (OR 1.62, 1.16-2.26) or >$75,000 (OR 2.22, 1.53-3.24) had increased odds of intensification. This latter pattern did not differ statistically by race.
Low-income patients were less likely to receive medication intensification compared to higher-income patients, but primary language (Spanish vs. English) was not associated with differences in intensification in a managed care setting. Future studies are needed to explain the reduced rate of intensification among low income patients in managed care.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-010-1588-2) contains supplementary material, which is available to authorized users.
PMCID: PMC3077478  PMID: 21174165
23.  The Prevention of Type 2 Diabetes: An Overview 
Type 2 diabetes mellitus is one of the major public health threats in the United States today, reaching epidemic rates. Epidemiological evidence suggests a strong link between obesity and the risk of developing diabetes. Increasing evidence demonstrates that lifestyle interventions can significantly delay or possibly prevent the onset of type 2 diabetes in persons with increased risk. Despite these findings, there remain important barriers to the translation of this research to the public health. These include identifying persons with an increased risk for developing the disease and the lack of easily accessible, cost-effective intervention programs. At least one study, however, has effectively implemented an evidenced-based intervention in community settings, suggesting that it may be possible to develop a model for the national scalability of primary prevention in the United States.
PMCID: PMC2769939  PMID: 20144325
community programs; lifestyle interventions; primary prevention; review; type 2 diabetes
24.  Effect of Advanced Access Scheduling on Processes and Intermediate Outcomes of Diabetes Care and Utilization 
The impact of open access (OA) scheduling on chronic disease care and outcomes has not been studied.
To assess the effect of OA implementation at 1 year on: (1) diabetes care processes (testing for A1c, LDL, and urine microalbumin), (2) intermediate outcomes of diabetes care (SBP, A1c, and LDL level), and (3) health-care utilization (ED visits, hospitalization, and outpatient visits).
We used a retrospective cohort study design to compare process and outcomes for 4,060 continuously enrolled adult patients with diabetes from six OA clinics and six control clinics. Using a generalized linear model framework, data were modeled with linear regression for continuous, logistic regression for dichotomous, and Poisson regression for utilization outcomes.
Patients in the OA clinics were older, with a higher percentage being African American (51% vs 34%) and on insulin. In multivariate analyses, for A1c testing, the odds ratio for African-American patients in OA clinics was 0.47 (CI: 0.29-0.77), compared to non-African Americans [OR 0.27 (CI: 0.21-0.36)]. For urine microablumin, the odds ratio for non-African Americans in OA clinics was 0.37 (CI: 0.17-0.81). At 1 year, in adjusted analyses, patients in OA clinics had significantly higher SBP (mean 6.4 mmHg, 95% CI 5.4 – 7.5). There were no differences by clinic type in any of the three health-care utilization outcomes.
OA scheduling was associated with worse processes of care and SBP at 1 year. OA clinic scheduling should be examined more critically in larger systems of care, multiple health-care settings, and/or in a randomized controlled trial.
PMCID: PMC2642566  PMID: 19132326
diabetes; open access; process of care; outcomes; utilization
25.  Value of Urinary Albumin-to-Creatinine Ratio as a Predictor of Type 2 Diabetes in Pre-Diabetic Individuals  
Diabetes Care  2008;31(12):2344-2348.
OBJECTIVE—The albumin-to-creatinine ratio (ACR) reflects urinary albumin excretion and is increasingly being accepted as an important clinical outcome predictor. Because of the great public health need for a simple and inexpensive test to identify individuals at high risk for developing type 2 diabetes, it has been suggested that the ACR might serve this purpose. We therefore determined whether the ACR could predict incident diabetes in a well-characterized cohort of pre-diabetic Americans.
RESEARCH DESIGN AND METHODS—A total of 3,188 Diabetes Prevention Program (DPP) participants with a mean BMI of 34 kg/m2 and elevated fasting glucose, impaired glucose tolerance, and baseline urinary albumin excretion measurements were followed for incident diabetes over a mean of 3.2 years.
RESULTS—Of the participants, 94% manifested ACR levels below the microalbuminuria range and 21% ultimately developed diabetes during follow-up. Quartiles of ACR (median [range] within quartiles: 1, 3.0 [0.7–3.7]; 2, 4.6 [3.7–5.5]; 3, 7.1 [5.5–9.7]; and 4, 16.5 [9.7–1,578]) were positively associated with age, markers of adiposity and insulin secretion and resistance, blood pressure, and use of antihypertensive agents with antiproteinuric effects and inversely related to male sex and serum creatinine. An elevated hazard rate for developing diabetes with doubling of ACR disappeared after adjustment for covariates. Within the DPP intervention groups (placebo, lifestyle, and metformin), we found no consistent trend in incident diabetes by quartile or decile of ACR.
CONCLUSIONS—An ACR at levels below the microalbuminuria range does not independently predict incident diabetes in adults at high risk of developing type 2 diabetes.
PMCID: PMC2584193  PMID: 18796622

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