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1.  Tailored case management for diabetes and hypertension (TEACH-DM) in a community population: Study design and baseline sample characteristics 
Contemporary clinical trials  2013;36(1):10.1016/j.cct.2013.07.010.
Background
Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension.
Methods
Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness.
Results
Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort’s mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending.
Conclusions
If effective, the TEACH-DM intervention’s telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.
doi:10.1016/j.cct.2013.07.010
PMCID: PMC3828629  PMID: 23916915
Diabetes; Hypertension; Behavioral Intervention; Telemedicine; Self-management; Case Management
2.  Adverse Respiratory Symptoms and Environmental Exposures Among Children and Adolescents Following Hurricane Katrina 
Public Health Reports  2011;126(6):853-860.
Objectives
Children and adolescents are especially vulnerable to environmental exposures and their respiratory effects. Following Hurricane Katrina in 2005, residents experienced multiple adverse environmental exposures. We characterized the association between upper respiratory symptoms (URS) and lower respiratory symptoms (LRS) and environmental exposures among children and adolescents affected by Hurricane Katrina.
Methods
We conducted a cross-sectional study following the return of the population to New Orleans after Hurricane Katrina (October 2005 and February 2006) among a convenience sample of children and adolescents attending New Orleans health facilities. We used uni-, bi-, and multivariable analyses to describe participants, exposures, and associations with URS/LRS.
Results
Of 1,243 participants, 47% were Caucasian, 50% were male, and 72% were younger than 11 years of age. Multiple environmental exposures were identified during and after the storm and at current residences: roof/glass/storm damage (50%), outside mold (22%), dust (18%), and flood damage (15%). Self-reported URS and LRS (76% and 36%, respectively) were higher after the hurricane than before the hurricane (22% and 9%, respectively, p<0.0001). Roof/glass/storm damage at home was associated with URS (adjusted odds ratio [AOR] = 1.59, 95% confidence interval [CI] = 1.15, 2.21) and LRS (AOR=1.35, 95% CI 1.01, 1.80), while mold growth at home was associated with LRS (AOR=1.47, 95% CI 1.02, 2.12).
Conclusions
Children and adolescents affected by Hurricane Katrina experienced environmental exposures associated with increased prevalence of reported URS and LRS. Additional research is needed to investigate the long-term health impacts of Hurricane Katrina.
PMCID: PMC3185321  PMID: 22043101
3.  Assessing the Acceptability and Usability of an Interactive Serious Game in Aiding Treatment Decisions for Patients with Localized Prostate Cancer 
Background
Men diagnosed with localized prostate cancer face a potentially life-altering treatment decision that can be overwhelming. Enhancing patient knowledge through education can significantly reduce feelings of uncertainty while simultaneously increasing confidence in decision making. Serious games have been shown in other populations to increase health knowledge and assist with the health decision-making process. We developed an interactive serious game, Time After Time, which translates evidence-based treatment outcome data into an accessible and understandable format that men can utilize in their prostate cancer treatment decision-making process. The game specifically aims to raise men’s awareness and understanding of the impact of health-related quality of life issues associated with the major treatment options and to enrich their conversations with their health care providers.
Objective
This study determined the acceptability and usability of the alpha version of Time After Time, an interactive decision aid for men diagnosed with localized prostate cancer, in order to inform future iterations of the serious game.
Methods
The study employed a mixed methods approach to assess the acceptability and usability of the Time After Time serious game using qualitative focus groups and a quantitative Likert scale survey.
Results
A total of 13 men who had already completed treatment for localized prostate cancer completed the survey and participated in focus group meetings. The majority of the study participants rated Time After Time as an appropriate decision tool for localized prostate cancer and verified that it meets its goals of increasing focus on side effects and generating questions for the patient’s health care team. However, participants also expressed concerns about game usability and the diversity of information covered regarding treatment options and potential treatment outcomes.
Conclusions
Serious games are a promising approach to health education and decision support for older men. Participants were receptive to the idea of a serious game as a decision aid in localized prostate cancer. However, usability issues are a major concern for this demographic, as is clarity and transparency of data sources.
doi:10.2196/jmir.1519
PMCID: PMC3221354  PMID: 21239374
serious games; prostate cancer; shared decision-making; usability
4.  Hematologic, biochemical, and cardiopulmonary effects of L-arginine supplementation or phosphodiesterase 5 inhibition in patients with sickle cell disease who are on hydroxyurea therapy 
European journal of haematology  2008;82(4):315-321.
Objectives
Fetal hemoglobin (HbF) induction involves NO-cGMP signaling pathways. L-arginine, an NO precursor, and the phosphodiesterase (PDE) 5 inhibitor sildenafil, which potentiates cGMP, were studied in adults with sickle cell disease (SCD) who were stably on HU.
Methods
24 courses of L-arginine (0.1–0.2 g/Kg divided TID) or sildenafil (25–100 mg TID), assigned based on gender due to concerns about sildenafil-related priapism, were successfully completed. Biochemical assays, pulmonary pressures, and cardiopulmonary exercise capacity are reported from patients in whom serial values are available. Hematologic responses are reported in 14 subjects with HbSS who had stable baseline HbF levels.
Results and Conclusions
L-arginine increased plasma arginine and ornithine, but not citrulline, suggesting diversion by plasma arginase from NO, and citrulline, generation. Glutathione (GSH) increased only in patients on L-arginine. Sildenafil increased plasma cGMP and citrulline, but not other amino acids. Pulmonary pressures and 6-minute walk distances improved only in patients on sildenafil.
In subjects with stable baseline HbF levels, HbF levels changed little from a normalized baseline on L-arginine, decreasing by 2.9±16.1%, n=6; p=n.s., but increased on sildenafil, by 7.5±11.7%, n=8, p<.05. Absolute reticulocyte counts initially decreased in patients on sildenafil.
L-arginine, at doses that increase plasma arginine levels, altered redox potential in red cells. The lack of clinically detectable efficacy of L-arginine may be due to increased arginine metabolism in SCD patients.
In vivo augmentation of the cyclic nucleotide pathway by PDE inhibition may induce HbF slightly, but strikingly improves hemodynamic and functional status in SCD
doi:10.1111/j.1600-0609.2009.01210.x
PMCID: PMC2775051  PMID: 19215288
5.  Amplified Expression Profiling of Platelet Transcriptome Reveals Changes in Arginine Metabolic Pathways in Patients With Sickle Cell Disease 
Circulation  2007;115(12):1551-1562.
Background
In sickle cell disease, ischemia-reperfusion injury and intravascular hemolysis produce endothelial dysfunction and vasculopathy characterized by reduced nitric oxide and arginine bioavailability. Recent functional studies of platelets in patients with sickle cell disease reveal a basally activated state, which suggests that pathological platelet activation may contribute to sickle cell disease vasculopathy.
Methods and Results
Studies were therefore undertaken to examine transcriptional signaling pathways in platelets that may be dysregulated in sickle cell disease. We demonstrate and validate in the present study the feasibility of comparative platelet transcriptome studies on clinical samples from single donors by the application of RNA amplification followed by microarray-based analysis of 54 000 probe sets. Data mining an existing microarray database, we identified 220 highly abundant genes in platelets and a subset of 72 relatively platelet-specific genes, defined by >10-fold increased expression compared with the median of other cell types in the database with amplified transcripts. The highly abundant platelet transcripts found in the present study included 82% or 70% of platelet-abundant genes identified in 2 previous gene expression studies on nonamplified mRNA from pooled or apheresis samples, respectively. On comparing the platelet gene expression profiles in 18 patients with sickle cell disease in steady state to those of 12 black control subjects, at a 3-fold cutoff and 5% false-discovery rate, we identified ≈100 differentially expressed genes, including multiple genes involved in arginine metabolism and redox homeostasis. Further characterization of these pathways with real-time polymerase chain reaction and biochemical assays revealed increased arginase II expression and activity and decreased platelet polyamine levels.
Conclusions
The present studies suggest a potential pathogenic role for platelet arginase and altered arginine and polyamine metabolism in sickle cell disease and provide a novel framework for the study of disease-specific platelet biology.
doi:10.1161/CIRCULATIONAHA.106.658641
PMCID: PMC2225987  PMID: 17353439
platelets; genes; enzymes; metabolism; thrombolysis; polymerase chain reaction; signal transduction
6.  A Multidimensional Integrative Medicine Intervention to Improve Cardiovascular Risk 
BACKGROUND
Integrative medicine is an individualized, patient-centered approach to health, combining a whole-person model with evidence-based medicine. Interventions based in integrative medicine theory have not been tested as cardiovascular risk-reduction strategies. Our objective was to determine whether personalized health planning (PHP), an intervention based on the theories and principles underlying integrative medicine, reduces 10-year risk of coronary heart disease (CHD).
METHODS
We conducted a randomized, controlled trial among 154 outpatients age 45 or over, with 1 or more known cardiovascular risk factors. Subjects were enrolled from primary care practices near an academic medical center, and the intervention was delivered at a university Center for Integrative Medicine. Following a health risk assessment, each subject in the intervention arm worked with a health coach and a medical provider to construct a personalized health plan. The plan identified specific health behaviors important for each subject to modify; the choice of behaviors was driven both by cardiovascular risk reduction and the interests of each individual subject. The coach then assisted each subject in implementing her/his health plan. Techniques used in implementation included mindfulness meditation, relaxation training, stress management, motivational techniques, and health education and coaching. Subjects randomized to the comparison group received usual care (UC) without access to the intervention. Our primary outcome measure was 10-year risk of CHD, as measured by a standard Framingham risk score, and assessed at baseline, 5, and 10 months. Differences between arms were assessed by linear mixed effects modeling, with time and study arm as independent variables.
RESULTS
Baseline 10-year risk of CHD was 11.1% for subjects randomized to UC (n = 77), and 9.3% for subjects randomized to PHP (n = 77). Over 10 months of the intervention, CHD risk decreased to 9.8% for UC subjects and 7.8% for intervention subjects. Based on a linear mixed-effects model, there was a statistically significant difference in the rate of risk improvement between the 2 arms (P = 0.04). In secondary analyses, subjects in the PHP arm were found to have increased days of exercise per week compared with UC (3.7 vs 2.4, P = 0.002), and subjects who were overweight on entry into the study had greater weight loss in the PHP arm compared with UC (P = 0.06).
CONCLUSIONS
A multidimensional intervention based on integrative medicine principles reduced risk of CHD, possibly by increasing exercise and improving weight loss.
doi:10.1111/j.1525-1497.2006.00495.x
PMCID: PMC1924710  PMID: 16808774
integrative medicine; randomized-controlled trial; cardiovascular risk reduction
7.  Utility of Hemoglobin A1c in Predicting Diabetes Risk 
Journal of General Internal Medicine  2004;19(12):1175-1180.
BACKGROUND
There is controversy surrounding the issue of whether, and how, to screen adults for type 2 diabetes. Our objective was to measure the incidence of new diabetes among outpatients enrolled in a health care system, and to determine whether hemoglobin A1c (HbA1c) values would allow risk stratification for Patients' likelihood of developing diabetes over 3 years.
METHODS
We conducted a prospective cohort study with 3-year follow-up at a single large, tertiary care, Department of Veterans Affairs Medical Center (VAMC). A convenience sample of 1,253 outpatients without diabetes, age 45 to 64, with a scheduled visit at the VAMC, were screened for diabetes using an initial HbA1c measurement. All subjects with HbA1c ≥ 6.0% (normal, 4.0% to 6.0%) were invited for follow-up fasting plasma glucose (FPG). We then surveyed patients annually for 3 years to ascertain interval diagnosis of diabetes by a physician. The baseline screening process was repeated 3 years after initial screening. After the baseline screening, new cases of diabetes were defined as either the self-report of a physician's diagnosis of diabetes, or by HbA1c ≥ 7.0% or FPG ≥ 7.0 mmol/L at 3-year follow-up. The incidence of diabetes was calculated as the number of new cases per person-year of follow-up.
RESULTS
One thousand two hundred fifty-three patients were screened initially, and 56 (4.5%) were found to have prevalent unrecognized diabetes at baseline. The 1,197 patients without diabetes at baseline accrued 3,257 person-years of follow-up. There were 73 new cases of diabetes over 3 years of follow-up, with an annual incidence of 2.2% (95% confidence interval [CI], 1.7% to 2.7%). In a multivariable logistic regression model, baseline HbA1c and baseline body mass index (BMI) were the only significant predictors of new onset diabetes, with HbA1c having a greater effect than BMI. The annual incidence of diabetes for patients with baseline HbA1c ≤ 5.5 was 0.8% (CI, 0.4% to 1.2%); for HbA1c 5.6 to 6.0, 2.5% (CI, 1.6% to 3.5%); and for HbA1c 6.1 to 6.9, 7.8% (CI, 5.2% to 10.4%). Obese patients with HbA1c 5.6 to 6.0 had an annual incidence of diabetes of 4.1% (CI, 2.2% to 6.0%).
CONCLUSIONS
HbA1c testing helps predict the likelihood that patients will develop diabetes in the future. Patients with normal HbA1c have a low incidence of diabetes and may not require rescreening in 3 years. However, patients with elevated HbA1c who do not have diabetes may need more careful follow-up and possibly aggressive treatment to reduce the risk of diabetes. Patients with high-normal HbA1c may require follow-up sooner than 3 years, especially if they are significantly overweight or obese. This predictive value suggests that HbA1c may be a useful test for periodic diabetes screening.
doi:10.1111/j.1525-1497.2004.40178.x
PMCID: PMC1492588  PMID: 15610327
diabetes; screening; hemoglobin A1c
8.  Screening for Diabetes in an Outpatient Clinic Population 
BACKGROUND
Opportunistic disease screening is the routine, asymptomatic disease screening of patients at the time of a physician encounter for other reasons. While the prevalence of unrecognized diabetes in community populations is well known, the prevalence in clinical populations is unknown.
OBJECTIVE
To describe the prevalence, predictors, and clinical severity of unrecognized diabetes among outpatients at a major medical center.
DESIGN AND SETTING
A cross-sectional observational study at the Durham Veterans Affairs Medical Center.
SUBJECTS
Outpatients without recognized diabetes (N = 1,253).
METHODS
We screened patients for diabetes by using an initial random Hemoglobin A1c (HbA1c) measurement, and then obtaining follow-up fasting plasma glucose (FPG) for all subjects with HbA1c ≥6.0%. A case of unrecognized diabetes was defined as either HbA1c ≥7.0% or FPG ≥7 mmol/L (126 mg/dL). Height and weight were obtained for all subjects. We also obtained resting blood pressure, fasting lipids, and urine protein in subjects with HbA1c ≥6.0%.
RESULTS
The prevalence of unrecognized diabetes was 4.5% (95% confidence interval [CI], 3.4 to 5.7). Factors associated with unrecognized diabetes were the diagnosis of hypertension (adjusted odds ratio [OR], 2.5; P = .004), weight >120% of ideal (adjusted OR, 2.2; P = .02), and history of a parent or sibling with diabetes (adjusted OR, 1.7; P = .06). Having a primary care provider did not raise or lower the risk for unrecognized diabetes (P = .73). Based on the new diagnosis, most patients (61%) found to have diabetes required a change in treatment either of their blood sugar or comorbid hypertension or hyperlipidemia in order to achieve targets recommended in published treatment guidelines. Patients reporting a primary care provider were no less likely to require a change in treatment (P = .20).
CONCLUSIONS
If diabetes screening is an effective intervention, opportunistic screening for diabetes may be the preferred method for screening, because there is substantial potential for case-finding in a medical center outpatient setting. A majority of patients with diabetes diagnosed at opportunistic screening will require a change in treatment of blood sugar, blood pressure, or lipids to receive optimal care.
doi:10.1046/j.1525-1497.2002.10420.x
PMCID: PMC1494994  PMID: 11903772
diabetes; disease screening; metabolic syndrome

Results 1-8 (8)