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1.  High-Priority Research Needs for Insulin Delivery and Glucose Monitoring Methods 
PMCID: PMC3876346  PMID: 24351194
comparative effectiveness; continuous subcutaneous insulin infusion; diabetes mellitus; meta-analysis; multiple daily injections; realtime continuous glucose monitoring; safety; self-monitoring of blood glucose; sensor-augmented pump; systematic review
2.  Longitudinal Accuracy of Web-Based Self-Reported Weights: Results From the Hopkins POWER Trial 
Background
Websites and phone apps are increasingly used to track weights during weight loss interventions, yet the longitudinal accuracy of these self-reported weights is uncertain.
Objective
Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic. We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5% weight loss when using self-reported compared to clinic weights.
Methods
This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction (POWER) trial, a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor. One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions. All intervention participants (n=277) received a digital scale and were asked to track their weight weekly on a study website. Research staff used a standard protocol to measure weight in the clinic. Differences (self-reported weight – clinic weight) indicate if self-report under (-) or over (+) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month (n=225) and 24-month (n=191) clinic visits. The absolute value of the differences (absolute difference) describes the overall accuracy.
Results
Underestimation of self-reported weights increased significantly from 6 months (mean -0.5kg, SD 1.0kg) to 24 months (mean -1.1kg, SD 2.0kg; P=.002). The average absolute difference also increased from 6 months (mean 0.7kg, SD 0.8kg) to 24 months (mean 1.3, SD 1.8kg; P<.001). Participants who achieved the study weight loss goal at 24 months (based on clinic weights) had lower absolute differences (P=.01) compared to those who did not meet this goal. At 24 months, there was 9% misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome. At 24 months, those with self-reported weights (n=191) had three times the weight loss compared to those (n=73) without self-reported weights (P<.001).
Conclusions
Underestimation of weight increased over time and was associated with less weight loss. In addition to intervention adherence, weight loss programs should emphasize accuracy in self-reporting.
Trial Registration
ClinicalTrials.gov: NCT00783315; http://clinicaltrials.gov/show/NCT00783315 (Archived by WebCite at http://www.webcitation.org/6R4gDAK5K).
doi:10.2196/jmir.3332
PMCID: PMC4129117  PMID: 25042773
self-report; weight loss; obesity; Internet
3.  Applying the PRECIS Criteria to Describe Three Effectiveness Trials of Weight Loss in Obese Patients with Comorbid Conditions 
Health Services Research  2011;47(3 Pt 1):1051-1067.
Objectives
To characterize Practice-Based Opportunities for Weight Reduction (POWER) trials along the pragmatic-explanatory continuum.
Settings
The POWER trials consist of three individual studies that target obesity treatment in primary care settings.
Design
Using the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) criteria, nine reviewers independently scored each trial.
Methods
Average and median ratings, inter-rater reliability, and relationships to additional ratings of the extent to which study designs were explanatory (i.e., efficacy) versus pragmatic (i.e., practical) and related to external validity were determined.
Principal Findings
One trial was consistently rated as being significantly more pragmatic than the others (R2 = 0.43, p < .001), although all three were in the moderate range on the PRECIS scales. Ratings varied across PRECIS dimensions, being most pragmatic on comparison condition and primary outcome. Raters, although undergoing training and using identical definitions, scored their own study as more pragmatic than the other studies/interventions.
Conclusions
These results highlight the need for more comprehensive reporting on PRECIS and related criteria for research translation. The PRECIS criteria provide a richer understanding of the POWER studies. It is not clear whether the original criteria are sufficient to provide a comprehensive profile.
doi:10.1111/j.1475-6773.2011.01347.x
PMCID: PMC3423177  PMID: 22092292
Methodology; CONSORT; RCT design; research design; pragmatic trials; dissemination; external validity
4.  A Prospective Study of the Associations Between Treated Diabetes and Cancer Outcomes 
Diabetes Care  2011;35(1):113-118.
OBJECTIVE
To quantify the association of treated diabetes with cancer incidence and cancer mortality as well as cancer case fatality and all-cause mortality in adults who subsequently develop cancer and to calculate attributable fractions due to diabetes on various cancer outcomes.
RESEARCH DESIGN AND METHODS
Prospective data on 599 diabetic and 17,681 nondiabetic adults from the CLUE II (Give Us a Clue to Cancer and Heart Disease) cohort in Washington County, Maryland, were analyzed. Diabetes was defined by self-reported use of diabetes medications at baseline. Cancer incidence was ascertained using county and state cancer registries. Mortality data were obtained from death certificates.
RESULTS
From 1989 to 2006, 116 diabetic and 2,365 nondiabetic adults developed cancer, corresponding to age-adjusted incidence of 13.25 and 10.58 per 1,000 person-years, respectively. Adjusting for age, sex, education, BMI, smoking, hypertension treatment, and high cholesterol treatment using Cox proportional hazards regression, diabetes was associated with a higher risk of incident cancer (hazard ratio 1.22 [95% CI 0.98–1.53]) and cancer mortality (1.36 [1.02–1.81]). In individuals who developed cancer, adults with diabetes had a higher risk of cancer case fatality (1.34 [1.002–1.79]) and all-cause mortality (1.61 [1.29–2.01]). For colorectal, breast, and prostate cancers, the attributable fractions resulting from diabetes were larger for cancer fatality and mortality than cancer incidence.
CONCLUSIONS
In this prospective cohort, diabetes appears to exert a greater influence downstream on the risk of mortality in people with cancer than on upstream risk of incident cancer.
doi:10.2337/dc11-0255
PMCID: PMC3241297  PMID: 22100961
6.  Trends in the Prevalence of Type 2 Diabetes in Asians Versus Whites 
Diabetes Care  2011;34(2):353-357.
OBJECTIVE
To examine trends in the prevalence of type 2 diabetes and related conditions in Asian Americans compared with non-Hispanic whites.
RESEARCH DESIGN AND METHODS
We analyzed data from the National Health Interview Survey (NHIS) from 1997 to 2008 to construct a nationally representative sample of 230,503 U.S. adults aged ≥18 years. Of these adults, 11,056 identified themselves as Asian Americans and 219,447 as non-Hispanic whites.
RESULTS
The age- and sex-adjusted prevalence of type 2 diabetes was higher in Asian Americans than in whites throughout the study period (4.3–8.2% vs. 3.8–6.0%), and there was a significant upward trend in both ethnic groups (P < 0.01). BMI also was increased in both groups, but age- and sex-adjusted BMI was consistently lower in Asian Americans. In fully adjusted logistic regression models, Asian Americans remained 30–50% more likely to have diabetes than their white counterparts. In addition, Asian Indians had the highest odds of prevalent type 2 diabetes, followed by Filipinos, other Asians, and Chinese.
CONCLUSIONS
Compared with their white counterparts, Asian Americans have a significantly higher risk for type 2 diabetes, despite having substantially lower BMI. Additional investigation of this disparity is warranted, with the aim of tailoring optimal diabetes prevention strategies to Asian Americans.
doi:10.2337/dc10-0746
PMCID: PMC3024348  PMID: 21216863
7.  Independent but Coordinated Trials: Insights from the Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group 
Background
The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the “Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.”
Purpose
We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach.
Methods
The Collaborative Research Group consists of three individual studies: “Be Fit, Be Well“(Washington University in St. Louis/Harvard University), “POWER Hopkins” (Johns Hopkins), and “POWER-UP” (University of Pennsylvania). There are a total of 15 participating clinics with ~1,100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support.
Results
The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial.
Limitations
The challenges of the organizational design include the complex decision making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.
Conclusions
The POWER Trials Collaborative Research Group is a case study of an alternative organizational model to conduct independent, yet coordinated trials. Such a model is increasingly being used in NHLBI supported trials , especially given the interest in comparative effectiveness research. Nevertheless, the ultimate utility of this model will not be fully understood until the trials are completed.
doi:10.1177/1740774510374213
PMCID: PMC3266125  PMID: 20573639
POWER; clinical trial; weight loss; effectiveness; primary care; obesity
8.  Postoperative Mortality in Cancer Patients With Preexisting Diabetes 
Diabetes Care  2010;33(4):931-939.
OBJECTIVE
Diabetes appears to increase risk for some cancers, but the association between preexisting diabetes and postoperative mortality in cancer patients is less clear. Our objective was to systematically review postoperative mortality in cancer patients with and without preexisting diabetes and summarize results using meta-analysis.
RSEARCH DESIGN AND METHODS
We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE) and Excerpta Medica Database (EMBASE) for articles published on or before 1 July 2009, including references of qualifying articles. We included English language investigations of short-term postoperative mortality after initial cancer treatment. Titles, abstracts, and articles were reviewed by at least two independent readers. Study population and design, results, and quality components were abstracted with standard protocols by one reviewer and checked for accuracy by additional reviewers.
RESULTS
Of 8,828 titles identified in our original search, 20 articles met inclusion criteria for qualitative systematic review. Of these, 15 reported sufficient information to be combined in meta-analysis. Preexisting diabetes was associated with increased odds of postoperative mortality across all cancer types (OR = 1.85 [95% CI 1.40–2.45]). The risk associated with preexisting diabetes was attenuated but remained significant when we restricted the meta-analysis to models that controlled for confounders (1.51 [1.13–2.02]) or when we accounted for publication bias using the trim and fill method (1.52 [1.13–2.04]).
CONCLUSIONS
Compared with their nondiabetic counterparts, cancer patients with preexisting diabetes are ∼50% more likely to die after surgery. Future research should investigate physiologic pathways to mortality risk and determine whether improvements in perioperative diabetes care can reduce postoperative mortality.
doi:10.2337/dc09-1721
PMCID: PMC2845055  PMID: 20351229
9.  Body-Mass Index and All-Cause Mortality in US Adults With and Without Diabetes 
ABSTRACT
BACKGROUND
Previous studies found normal weight compared to overweight/obese adults with type 2 diabetes had a higher mortality risk, and body-mass index (BMI)–mortality studies do not typically account for baseline diabetes status.
OBJECTIVE
To determine if diabetes influences the BMI–mortality relationship.
DESIGN
Using a prospective study design, we analyzed data from a nationally representative sample of US adults participating in the National Health Interview Survey from 1997 to 2002, and followed for mortality through 2006.
PARTICIPANTS
Excluding those with heart disease or cancer, our final analytic sample included 74,710 (34,805 never smoker) adults.
MAIN MEASURES
BMI was calculated from self-reported height and weight. Diabetes status was based on self-reported diagnosis from a health professional. We used direct age standardization to calculate all-cause mortality rates and adjusted Cox models for all-cause mortality hazard ratios by BMI quintile; this was done separately for adults with diabetes and without diabetes.
KEY RESULTS
Among never smokers, mean age was 50.1 years and 43 % were men. Mean BMI was 27.4 kg/m2, 26 % were obese, and 2,035 (5 %) reported diagnosed diabetes. After 9 years, there were 4,355 deaths (754 of 4,740 with diabetes; 3,601 of 69,970 without) among 74,710 participants, and 1,238 (247 of 2,035 with diabetes; 991 of 32,770 without) among 34,805 never smokers. We observed a qualitative interaction with diabetes on the BMI–mortality relationship (p = 0.002). Death rates were substantially higher among participants with diabetes compared to those without diabetes across all BMI quintiles. However, death rates in participants with diabetes fell with increasing BMI quintile, while rates followed a J-shaped curve among those without diabetes. In adjusted Cox models, BMI was positively associated with mortality in adults without diabetes, but inversely associated with mortality among participants with diabetes.
CONCLUSIONS
Mortality increased with increasing BMI in adults without diabetes, but decreased with increasing BMI among their counterparts with diabetes. Future studies need to be better designed to answer the question of whether normal weight adults with diabetes have a higher risk of mortality, by minimizing the possibility of reverse causation. Future studies should also account for prevalent diabetes in all investigations of the BMI–mortality relationship.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-013-2553-7) contains supplementary material, which is available to authorized users.
doi:10.1007/s11606-013-2553-7
PMCID: PMC3889975  PMID: 23929218
diabetes; body mass index; mortality
10.  Body-Mass Index and Mortality Risk in US Blacks Compared to Whites 
Obesity (Silver Spring, Md.)  2014;22(3):842-851.
Objective
To compare body-mass index (BMI)-related mortality risk in US Blacks vs. Whites as the relationship appears to differ across race/ethnicity groups.
Design and Methods
We pooled cross-sectional surveys of nationally representative samples of 11,934 Blacks and 59,741 Whites aged 35–75 in the National Health Interview Survey from 1997–2002 with no history of cardiovascular disease or cancer. Mortality follow-up was available through 2006. BMI was calculated from self-reported height and weight. We used adjusted Cox regression analysis to adjust for potential confounders.
Results
Over 9 years of follow-up, there were 4,303 deaths (1,205 among never smokers). Age-adjusted mortality rates were higher in Blacks compared to Whites at BMI < 25 kg/m2 and showed no increase at higher levels of BMI. In men, adjusted hazard ratios for all-cause death rose in a similar fashion across upper BMI quintiles in Blacks and Whites; in women, however, BMI was positively associated with mortality risk in Whites, but inversely associated in Blacks (p interaction = 0.01). Racial disparities were amplified in subsidiary analyses that introduced a 12-month lag for mortality or focused on CVD mortality.
Conclusions
The relationship of elevated BMI to mortality appears weaker in US Blacks than in Whites, especially among women.
doi:10.1002/oby.20471
PMCID: PMC3844096  PMID: 23554375
Body Mass Index; Mortality; Racial/Ethnic Health Disparities
11.  Insulin Requirements in Non-Critically Ill Hospitalized Patients With Diabetes and Steroid-Induced Hyperglycemia 
Hospital practice (1995)  2014;42(2):23-30.
Objective
Steroid-induced hyperglycemia is common in hospitalized patients with diabetes mellitus. Guidelines for glucose management in this setting are lacking.
Methods
We conducted a retrospective chart review of non-critically ill patients with diabetes receiving steroids, hospitalized from January 2009 to October 2012. Fifty-eight patients were identified from 247 consults. Multivariable linear regression was used to assess median daily insulin requirements of normoglycemic patients compared with hyperglycemic patients.
Results
Of the 58 total patients included in our study, 20 achieved normoglycemia during admission (patient-day weighted mean blood glucose [PDWMBG] level = 154 ± 16 mg/dL) and 38 remained hyperglycemic (PDWMBG level= 243 ± 39 mg/dL; P < 0.001). There were no differences between the 2 patient groups in age, sex, race, body weight, renal function, HbA1c level, glucose-altering medications, diabetes type, or disease duration. Following multivariable adjustment, compared with hyperglycemic patients, normoglycemic patients required similar units of basal insulin (median [interquartile range])(23.6 [17.9, 31.2] vs 20.1 [16.5, 24.4]; P = 0.35); higher units of nutritional insulin (45.5 [34.2, 60.4] vs 20.1 [16.4, 24.5]; P < 0.001]; and lower units of correctional insulin (5.8 [4.1, 8.1] vs 13.0 [10.2, 16.5]; P < 0.001]). Patients achieving normoglycemia required a significantly lower percentage of correction insulin (total daily dose [TDD]: 7.4% vs 23.4%; P < 0.001) and a higher percentage of nutritional insulin (TDD: 58.1% vs 36.2%; P < 0.001) than hyperglycemic patients. There was no difference in the TDD per kilogram, TDD per milligram hydrocortisone dose, or TDD per milligram hydrocortisone dose per kilogram weight between the 2 groups.
Conclusion
The data suggest that non-critically ill patients with hyperglycemia receiving steroids require a higher percentage of TDD insulin therapy as nutritional insulin to achieve normoglycemia.
doi:10.3810/hp.2014.04.1100
PMCID: PMC4109974  PMID: 24769781
steroids; hyperglycemia; diabetes; in-patient management; insulin
12.  Comparative Effectiveness of Weight-Loss Interventions in Clinical Practice 
The New England journal of medicine  2011;365(21):1959-1968.
Background
Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse.
Methods
We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely — through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months.
Results
At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was −0.8 kg in the control group, −4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and −5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups.
Conclusions
In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.)
doi:10.1056/NEJMoa1108660
PMCID: PMC4074540  PMID: 22085317
13.  Quadriceps Strength, Quadriceps Power, and Gait Speed in Older U.S. Adults with Diabetes: Results from the National Health and Nutrition Examination Survey (NHANES), 1999–2002 
Objectives
To examine the independent association of diabetes (and its duration and severity) with quadriceps strength, quadriceps power, and gait speed in a national population of older adults.
Design
Cross-sectional nationally representative survey.
Setting
U.S.
Participants
We examined 2573 adults ≥50 years of age in the National Health and Nutrition Examination Survey 1999–2002 who had assessment of quadriceps strength.
Methods
Diabetes was ascertained by questionnaire. Measurement of isokinetic knee extensors (quadriceps) strength was performed at 60 degrees/second. Gait speed was assessed using a 20-foot walk test. Multiple linear regression analyses were used to assess the association between diabetes status and outcomes, adjusting for potential confounders or mediators.
Results
Among older U.S. adults, those with versus without diabetes had significantly slower gait speed (0.96±0.02 versus 1.08±0.01 m/s; p<0.001). After adjusting for demographics, weight, and height, diabetes was also associated with significantly lower quadriceps strength (−4.6±1.9 Newton-meters; p=0.02), quadriceps power (−4.9±2.0 Watts; p=0.02), in addition to gait speed (−0.05±0.02 m/s; p=0.002). Associations remained significant after adjusting for physical activity and C-reactive protein. After accounting for comorbidities (cardiovascular disease, peripheral neuropathy, amputation, cancer, arthritis, fracture, COPD), diabetes was only independently associated with gait speed (−0.04±0.02 m/s; p=0.02). Diabetes duration in men and women was negatively associated with age-adjusted quadriceps strength (−5.7 and −3.5 Newton-meters/decade of diabetes, respectively) and power (−6.1 and −3.8 Watts/decade of diabetes, respectively) (all p≤0.001, no significant interactions by gender). Hemoglobin A1c was not associated with outcomes accounting for body weight.
Conclusion
Compared to persons without diabetes, older U.S. adults with diabetes have lower quadriceps strength and quadriceps power that is related to the presence of comorbidities. Persons with diabetes also walk slower. Future studies should investigate the relationship of hyperglycemia with subsequent declines in leg muscle function.
doi:10.1111/jgs.12204
PMCID: PMC3725774  PMID: 23617584
Type 2 diabetes mellitus; muscle loss; physical function; gait
14.  Comparable Ascertainment of Newly-Diagnosed Atrial Fibrillation Using Active Cohort Follow-Up versus Surveillance of Centers for Medicare and Medicaid Services in the Atherosclerosis Risk in Communities Study 
PLoS ONE  2014;9(4):e94321.
Objective
Increasingly, epidemiologic studies use administrative data to identify atrial fibrillation (AF). Capture of incident AF is not well documented. We examined incidence rates and concordance of AF diagnosis based on active cohort follow-up versus surveillance of Centers for Medicare and Medicaid Services data in the Atherosclerosis Risk in Communities study.
Methods
Atherosclerosis Risk in Communities cohort participants without prevalent AF enrolled in fee-for-service Medicare, with inpatient and outpatient coverage, for at least 12 continuous months between 1991 and 2009 were included. In active Atherosclerosis Risk in Communities study follow-up, annual telephone calls captured hospitalizations and deaths with incident AF diagnosis codes. For Centers for Medicare and Medicaid Services data, incident AF was defined by billed inpatient and outpatient diagnoses.
Results
Of 10,134 eligible cohort participants, 738 developed AF according to both Atherosclerosis Risk in Communities and Centers for Medicare and Medicaid Services data; an additional 93 and 288 incident cases were identified using only Atherosclerosis Risk in Communities and Centers for Medicare and Medicaid Services data, respectively. Incidence rates per 1,000 person-years were 10.8 (95% confidence interval: 10.1–11.6) and 13.6 (95% confidence interval: 12.8–14.4) in Atherosclerosis Risk in Communities and Centers for Medicare and Medicaid Services, respectively; agreement was 96%; kappa was 0.77 (95% confidence interval: 0.75–0.80). Earlier AF ascertainment by one system versus the other was not associated with any cardiovascular disease risk factors, after accounting for sociodemographic factors. Additional Centers for Medicare and Medicaid Services events did not alter observed associations between risk factors and AF.
Conclusion
Among fee-for-service enrollees, AF incidence rates were slightly lower for active cohort follow-up than for Centers for Medicare and Medicaid Services surveillance, because the latter included outpatient atrial fibrillation. Concordance was high and combining the two approaches could provide a more complete picture of newly-diagnosed AF.
doi:10.1371/journal.pone.0094321
PMCID: PMC3984174  PMID: 24727837
15.  Patient Safety Perceptions of Primary Care Providers after Implementation of an Electronic Medical Record System 
ABSTRACT
BACKGROUND
Increasing the use of electronic medical records (EMR) has been suggested as an important strategy for improving healthcare safety.
OBJECTIVE
To sequentially measure, evaluate, and respond to safety culture and practice safety concerns following EMR implementation.
DESIGN
Safety culture was assessed using a validated tool (Safety Attitudes Questionnaire; SAQ), immediately following EMR implementation (T1) and at 1.5 (T2) and 2.5 (T3) years post-implementation. The SAQ was supplemented with a practice-specific assessment tool to identify safety needs and barriers.
PARTICIPANTS
A large medical group practice with a primary care core of 17–18 practices, staffed by clinicians in family medicine, pediatrics, internal medicine.
INTERVENTIONS
Survey results were used to define and respond to areas of need between assessments with system changes and educational programs.
MAIN MEASURES
Change in safety culture over time; perceived impact of EMR on practice.
KEY RESULTS
Responses were received from 103 of 123 primary care providers in T1 (83.7 % response rate), 122 of 143 in T2 (85.3 %) and 142 of 181 in T3 (78.5 %). Safety culture improved over this period, with statistically significant improvement in all domains except for stress recognition. Time constraints, communications and patient adherence were perceived to be the most important safety issues. The majority of respondents in both T2 (77.9 %) and T3 (85.4 %) surveys agreed that the EMR improved their ability to provide care more safely.
CONCLUSIONS
Implementation of an EMR in a large primary care practice required redesign of many organizational processes, and was associated with improvements in safety culture. Most primary care providers agreed that the EMR allowed them to provide care more safely.
doi:10.1007/s11606-012-2153-y
PMCID: PMC3614133  PMID: 22887020
electronic medical records; EMR; safety culture; primary care; safety attitudes questionnaire
16.  Changes in weight and health behaviors after pregnancies complicated by gestational diabetes mellitus: The CARDIA Study 
Obesity (Silver Spring, Md.)  2013;21(6):1269-1275.
We compared pre- to post-pregnancy change in weight, body mass index (BMI), waist circumference, diet and physical activity in women with and without gestational diabetes mellitus (GDM).
Using the Coronary Artery Risk Development in Young Adults (CARDIA) study we identified women with at least one pregnancy during 20 years of follow-up (n=1,488 with 3,125 pregnancies). We used linear regression with generalized estimating equations to compare pre- to post-pregnancy changes in health behaviors and anthropometric measurements between 137 GDM pregnancies and 1,637 non GDM pregnancies, adjusted for parity, age at delivery, outcome measure at the pre-pregnancy exam, race, education, mode of delivery, and interval between delivery and post-pregnancy examination.
Compared with women without GDM in pregnancy, women with GDM had higher pre-pregnancy mean weight (158.3 vs. 149.6 lb, p=0.011) and BMI (26.7 vs. 25.1 kg/m2, p=0.002), but non-significantly lower total daily caloric intake and similar levels of physical activity. Both GDM and non GDM groups had higher average postpartum weight of 7–8 lbs and decreased physical activity on average 1.4 years after pregnancy. Both groups similarly increased total caloric intake but reduced fast food frequency. Pre- to post- pregnancy changes in body weight, BMI, waist circumference, physical activity and diet did not differ between women with and without GDM in pregnancy.
Following pregnancy women with and without GDM increased caloric intake, BMI and weight, decreased physical activity, but reduced their frequency of eating fast food. Given these trends, postpartum lifestyle interventions, particularly for women with GDM, are needed to reduce obesity and diabetes risk.
doi:10.1002/oby.20133
PMCID: PMC3735637  PMID: 23666593
17.  Black-White Disparities in Overweight and Obesity Trends by Educational Attainment in the United States, 1997–2008 
Journal of Obesity  2013;2013:140743.
Background. Few studies have examined racial and educational disparities in recent population-based trends. Methods. We analyzed data of a nationally representative sample of 174,228 US-born adults in the National Health Interview Survey from 1997 to 2008. We determined mean BMI trends by educational attainment and race and black-white prevalence ratios (PRs) for overweight/obesity (BMI > 25 kg/m2) using adjusted Poisson regression with robust variance. Results. From 1997 to 2008, BMI increased by ≥1 kg/m2 in all race-sex groups, and appeared to increase faster among whites. Blacks with greater than a high school education (GHSE) had a consistently higher BMI over time than whites in both women (28.3 ± 0.14 to 29.7 ± 0.18 kg/m2 versus 25.8 ± 0.58 to 26.5 ± 0.08 kg/m2) and men (28.1 ± 0.17 kg/m2 to 29.0 ± 0.20 versus 27.1 ± 0.04 kg/m2 to 28.1 ± 0.06 kg/m2). For participants of all educational attainment levels, age-adjusted overweight/obesity was greater by 44% (95% CI: 1.42–1.46) in black versus white women and 2% (1.01–1.04) in men. Among those with GHSE, overweight/obesity prevalence was greater (PR: 1.52; 1.49–1.55) in black versus white women, but greater (1.07; 1.05–1.09) in men. Conclusions. BMI increased steadily in all race-sex and education groups from 1997 to 2008, and blacks (particularly women) had a consistently higher BMI than their white counterparts. Overweight/obesity trends and racial disparities were more prominent among individuals with higher education levels, compared to their counterparts with lower education levels.
doi:10.1155/2013/140743
PMCID: PMC3649192  PMID: 23691282
18.  Serum and Dietary Potassium and Risk of Incident Type 2 Diabetes: The Atherosclerosis Risk in Communities (ARIC) Study 
Archives of internal medicine  2010;170(19):1745-1751.
Background
Serum potassium levels affect insulin secretion by pancreatic beta-cells, and hypokalemia associated with diuretic use has been associated with dysglycemia. We hypothesized that adults with lower serum potassium levels and lower dietary potassium intake are at higher risk for incident diabetes, independent of diuretic use.
Methods
We analyzed data from 12,209 participants from the Atherosclerosis Risk in Communities (ARIC) Study, an on-going prospective cohort study beginning in 1986, with 9 years of in-person follow-up and 17 years of telephone follow-up. Using multivariate Cox proportional hazard models, we estimated the relative hazard (RH) of incident diabetes associated with baseline serum potassium levels.
Results
During 9 years of in-person follow-up, 1475 participants developed incident diabetes. In multivariate analyses, we found an inverse association between serum potassium and risk of incident diabetes. Compared to those with a high-normal serum potassium (5.0-5.5 mEq/l), adults with serum potassium levels of < 4.0, 4.0-<4.5, and 4.5-<5.0, (mEq/L) had adjusted relative hazards (RH) (95% CI) of incident diabetes of 1.64 (1.29-2.08), 1.64 (1.34-2.01), and 1.39 (1.14-1.71) respectively. An increased risk persisted during an additional 8 years of telephone follow-up based on self-report with RHs of 1.2-1.3 for those with a serum potassium less than 5.0 mEq/L. Dietary potassium intake was significantly associated with risk of incident diabetes in unadjusted models but not in multivariate models.
Conclusions
Serum potassium is an independent predictor of incident diabetes in this cohort. Further study is needed to determine if modification of serum potassium could reduce the subsequent risk of diabetes.
doi:10.1001/archinternmed.2010.362
PMCID: PMC3469719  PMID: 20975023
19.  Learner feedback and educational outcomes with an internet-based ambulatory curriculum: a qualitative and quantitative analysis 
BMC Medical Education  2012;12:55.
Background
Online medical education curricula offer new tools to teach and evaluate learners. The effect on educational outcomes of using learner feedback to guide curricular revision for online learning is unknown.
Methods
In this study, qualitative analysis of learner feedback gathered from an online curriculum was used to identify themes of learner feedback, and changes to the online curriculum in response to this feedback were tracked. Learner satisfaction and knowledge gains were then compared from before and after implementation of learner feedback.
Results
37,755 learners from 122 internal medicine residency training programs were studied, including 9437 postgraduate year (PGY)1 residents (24.4 % of learners), 9864 PGY2 residents (25.5 %), 9653 PGY3 residents (25.0 %), and 6605 attending physicians (17.0 %). Qualitative analysis of learner feedback on how to improve the curriculum showed that learners commented most on the overall quality of the educational content, followed by specific comments on the content. When learner feedback was incorporated into curricular revision, learner satisfaction with the instructive value of the curriculum (1 = not instructive; 5 = highly instructive) increased from 3.8 to 4.1 (p < 0.001), and knowledge gains (i.e., post test scores minus pretest scores) increased from 17.0 % to 20.2 % (p < 0.001).
Conclusions
Learners give more feedback on the factual content of a curriculum than on other areas such as interactivity or website design. Incorporating learner feedback into curricular revision was associated with improved educational outcomes. Online curricula should be designed to include a mechanism for learner feedback and that feedback should be used for future curricular revision.
doi:10.1186/1472-6920-12-55
PMCID: PMC3418189  PMID: 22788677
Online education; Curriculum development; Feedback; Learner satisfaction
20.  Potassium and risk of Type 2 diabetes 
The rising incidence and prevalence of Type 2 diabetes worldwide requires us to try to identify the determinants of this epidemic and to identify improved measures to prevent and treat this condition. While obesity is a major risk factor for diabetes, there are other risk factors that could potentially be corrected more easily. Potassium, both serum levels and to a lesser extent dietary intake levels, has been associated with incident diabetes. Lower levels of potassium have been found to be associated with a higher risk of diabetes in some studies. This article will review the literature available describing these associations and will help to identify where further research is needed.
doi:10.1586/eem.11.60
PMCID: PMC3197792  PMID: 22025927
antihypertensives affecting potassium; diabetes risk; dietary potassium; serum potassium
21.  Diabetes Mellitus and Breast Cancer Outcomes: A Systematic Review and Meta-Analysis 
Journal of Clinical Oncology  2010;29(1):40-46.
Purpose
The goal of this study was to perform a systematic review and meta-analysis to examine the effect of pre-existing diabetes on breast cancer–related outcomes.
Methods
We searched EMBASE and MEDLINE databases from inception through July 1, 2009, using search terms related to diabetes mellitus, cancer, and prognostic outcome. Studies were included if they reported a prognostic outcome by diabetes status, evaluated a cancer population, and contained original data published in the English language. We performed a meta-analysis of pre-existing diabetes and its effect on all-cause mortality in patients with breast cancer and qualitatively summarized other prognostic outcomes.
Results
Of 8,828 titles identified, eight articles met inclusion/exclusion criteria and described outcomes in patients with breast cancer and diabetes. Pre-existing diabetes was significantly associated with all-cause mortality in six of seven studies. In a meta-analysis, patients with breast cancer and diabetes had a significantly higher all-cause mortality risk (pooled hazard ratio [HR], 1.49; 95% CI, 1.35 to 1.65) compared with their nondiabetic counterparts. Three of four studies found pre-existing diabetes to be associated with more advanced stage at presentation. Diabetes was also associated with altered regimens for breast cancer treatment and increased toxicity from chemotherapy.
Conclusion
Compared with their nondiabetic counterparts, patients with breast cancer and pre-existing diabetes have a greater risk of death and tend to present at later stages and receive altered treatment regimens. Studies are needed to investigate pathophysiologic interactions between diabetes and breast cancer and determine whether improvements in diabetes care can reduce mortality in patients with breast cancer.
doi:10.1200/JCO.2009.27.3011
PMCID: PMC3055858  PMID: 21115865
22.  Associations between quality indicators of internal medicine residency training programs 
BMC Medical Education  2011;11:30.
Background
Several residency program characteristics have been suggested as measures of program quality, but associations between these measures are unknown. We set out to determine associations between these potential measures of program quality.
Methods
Survey of internal medicine residency programs that shared an online ambulatory curriculum on hospital type, faculty size, number of trainees, proportion of international medical graduate (IMG) trainees, Internal Medicine In-Training Examination (IM-ITE) scores, three-year American Board of Internal Medicine Certifying Examination (ABIM-CE) first-try pass rates, Residency Review Committee-Internal Medicine (RRC-IM) certification length, program director clinical duties, and use of pharmaceutical funding to support education. Associations assessed using Chi-square, Spearman rank correlation, univariate and multivariable linear regression.
Results
Fifty one of 67 programs responded (response rate 76.1%), including 29 (56.9%) community teaching and 17 (33.3%) university hospitals, with a mean of 68 trainees and 101 faculty. Forty four percent of trainees were IMGs. The average post-graduate year (PGY)-2 IM-ITE raw score was 63.1, which was 66.8 for PGY3s. Average 3-year ABIM-CE pass rate was 95.8%; average RRC-IM certification was 4.3 years. ABIM-CE results, IM-ITE results, and length of RRC-IM certification were strongly associated with each other (p < 0.05). PGY3 IM-ITE scores were higher in programs with more IMGs and in programs that accepted pharmaceutical support (p < 0.05). RRC-IM certification was shorter in programs with higher numbers of IMGs. In multivariable analysis, a higher proportion of IMGs was associated with 1.17 years shorter RRC accreditation.
Conclusions
Associations between quality indicators are complex, but suggest that the presence of IMGs is associated with better performance on standardized tests but decreased duration of RRC-IM certification.
doi:10.1186/1472-6920-11-30
PMCID: PMC3126786  PMID: 21651768
program quality; Residency Review Committee; American Board of Internal Medicine Certifying Examination
23.  Colorectal Cancer Outcomes, Recurrence, and Complications in Persons With and Without Diabetes Mellitus: A Systematic Review and Meta-Analysis 
Digestive diseases and sciences  2010;55(7):1839-1851.
Background
Diabetes mellitus increases the risk of incident colorectal cancer, but it is less clear if pre-existing diabetes mellitus influences mortality outcomes, recurrence risk, and/or treatment-related complications in persons with colorectal cancer.
Methods
We performed a systematic review and meta-analysis comparing colorectal cancer mortality outcomes, cancer recurrence, and treatment-related complications in persons with and without diabetes mellitus. We searched MEDLINE and EMBASE through October 1, 2008, including hand-searching references of qualifying articles. We included studies in English that evaluated diabetes mellitus and cancer treatment outcomes, prognosis, and/or mortality. The initial search identified 8,208 titles, of which 15 articles met inclusion criteria. Each article was abstracted by one author using a standardized form and re-reviewed by another author for accuracy. Authors graded quality based on pre-determined criteria.
Results
We found significantly increased short-term perioperative mortality in persons with diabetes mellitus. In the meta-analysis of long-term mortality, persons with diabetes mellitus had a 32% increase in all-cause mortality compared to those without diabetes mellitus (95% CI: 1.24, 1.41). Although data on other outcomes are limited, available studies suggest that pre-existing diabetes mellitus predicts increased risk of some post-operative complications as well as 5-year cancer recurrence. In contrast, there is little evidence that diabetes confers increased risk for long-term cancer-specific mortality.
Conclusions
Patients with colorectal cancer and pre-existing diabetes mellitus have an increased risk of short- and long-term mortality. Future research should determine whether improvements in prevention and treatment of diabetes mellitus will improve outcomes for colorectal cancer patients.
doi:10.1007/s10620-009-0944-8
PMCID: PMC3093049  PMID: 19731028
Colorectal carcinoma; Diabetes mellitus; Mortality; Treatment outcome; Fatal outcome
24.  Long-term All-Cause Mortality in Cancer Patients With Preexisting Diabetes Mellitus 
Context
Diabetes mellitus appears to be a risk factor for some cancers, but the effect of preexisting diabetes on all-cause mortality in newly diagnosed cancer patients is less clear.
Objective
To perform a systematic review and meta-analysis comparing overall survival in cancer patients with and without preexisting diabetes.
Data Sources
We searched MEDLINE and EMBASE through May 15, 2008, including references of qualifying articles.
Study Selection
English-language, original investigations in humans with at least 3 months of follow-up were included. Titles, abstracts, and articles were reviewed by at least 2 independent readers. Of 7858 titles identified in our original search, 48 articles met our criteria.
Data Extraction
One reviewer performed a full abstraction and other reviewers verified accuracy. We contacted authors and obtained additional information for 3 articles with insufficient reported data.
Results
Studies reporting cumulative survival rates were summarized qualitatively. Studies reporting Cox proportional hazard ratios (HRs) or Poisson relative risks were combined in a meta-analysis. A random-effects model meta-analysis of 23 articles showed that diabetes was associated with an increased mortality HR of 1.41 (95% confidence interval [CI], 1.28-1.55) compared with normoglycemic individuals across all cancer types. Subgroup analyses by type of cancer showed increased risk for cancers of the endometrium (HR, 1.76; 95% CI, 1.34-2.31), breast (HR, 1.61; 95% CI, 1.46-1.78), and colorectum (HR, 1.32; 95% CI, 1.24-1.41).
Conclusions
Patients diagnosed with cancer who have preexisting diabetes are at increased risk for long-term, all-cause mortality compared with those without diabetes.
doi:10.1001/jama.2008.824
PMCID: PMC3093051  PMID: 19088353
25.  DOES PRE-EXISTING DIABETES AFFECT PROSTATE CANCER PROGNOSIS? A SYSTEMATIC REVIEW 
Objectives
To summarize the influence of pre-existing diabetes on mortality and morbidity in men with prostate cancer.
Methods
We searched MEDLINE and EMBASE from inception through October 1, 2008. Search terms were related to diabetes, cancer, and prognosis. Studies were included if they reported an original data analysis of prostate cancer prognosis, compared outcomes between men with and without diabetes, and were in English. Titles, abstracts, and articles were reviewed independently by two authors. Conflicts were settled by consensus or third review. We abstracted data on study design, analytic methods, outcomes, and quality. We summarized mortality and morbidity outcomes qualitatively and conducted a preliminary meta-analysis to quantify the risk of long-term (>3 months), overall mortality.
Results
11 articles were included in the review. 1/4 studies found increased prostate-cancer mortality, 1/2 studies found increased non-prostate cancer mortality, and 1/1 study found increased 30-day mortality. Data from 4 studies could be included in a preliminary meta-analysis for long-term, overall mortality and produced a pooled hazard ratio of 1.57 (95% CI: 1.12-2.20). Diabetes was also associated with receiving radiation therapy, complication rates, recurrence, and treatment failure.
Conclusions
Our analysis suggests that pre-existing diabetes affects the treatment and outcomes of men with prostate cancer.
doi:10.1038/pcan.2009.39
PMCID: PMC3085982  PMID: 20145631
diabetes; prostate cancer; prognosis; meta-analysis

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