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Russom Desta,1 Charlotte Blumrosen,2 Heather E Laferriere,3 Aades Saluja,4,5 Marino A Bruce,6 Tom A Elasy,7 Derek M Griffith,8,9 Keith C Norris,10 Kerri L Cavanaugh,4,5 Ebele M Umeukeje4,5 1Department of Medicine, University of Washington Medical Center, Seattle, WA, USA; 2Department of Medicine and Pediatrics, University of Rochester Medical Center, New York, NY, USA; 3Eskind Biomedical Library, Vanderbilt University, Nashville, TN, USA; 4Vanderbilt Center for Kidney Disease, Nashville, TN, USA; 5Division of Nephrology, Vanderbilt University Medical Center, Nashville, TN, USA; 6Department of Behavioral and Social Sciences, University of Houston, Tilman J. Fertitta Family College of Medicine, Houston, TX, USA; 7Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN, USA; 8Department of Health Management & Policy, School of Health, Georgetown University, Washington, DC, USA; 9Center for Men’s Health Equity, Racial Justice Institute, Georgetown University, Washington, DC, USA; 10Division of General Internal Medicine & Health Services Research, UCLA, Los Angeles, CA, USACorrespondence: Ebele M Umeukeje, Division of Nephrology, Vanderbilt University Medical Center, 1161 21 st Avenue MCN S-3223, Nashville, TN, USA, Tel +1 615 936-3283, Fax +1 615 875-5626, Email ebele.m.umeukeje@vumc.orgBackground: Black Americans have a disproportionately increased risk of diabetes, hypertension, and kidney disease, and higher associated morbidity, mortality, and hospitalization rates than their White peers. Structural racism amplifies these disparities, and negatively impacts self-care including medication adherence, critical to chronic disease management. Systematic evidence of successful interventions to improve medication adherence in Black patients with diabetes, hypertension, and kidney disease is lacking. Knowledge of the impact of therapeutic alliance, ie, the unique relationship between patients and providers, which optimizes outcomes especially for minority populations, is unclear. The role and application of behavioral theories in successful development of medication adherence interventions specific to this context also remains unclear.Objective: To evaluate the existing evidence on the salience of a therapeutic alliance in effective interventions to improve medication adherence in Black patients with diabetes, hypertension, or kidney disease.Data Sources: Medline (via PubMed), EMBASE (OvidSP), Cumulative Index of Nursing and Allied Health Literature (CINAHL) (EBSCOhost), and PsycINFO (ProQuest) databases.Review Methods: Only randomized clinical trials and pre/post intervention studies published in English between 2009 and 2022 with a proportion of Black patients greater than 25% were included. Narrative synthesis was done.Results: Eleven intervention studies met the study criteria and eight of those studies had all-Black samples. Medication adherence outcome measures were heterogenous. Five out of six studies which effectively improved medication adherence, incorporated therapeutic alliance. Seven studies informed by behavioral theories led to significant improvement in medication adherence.Discussion/Conclusion: Study findings suggest that therapeutic alliance-based interventions are effective in improving medication adherence in Black patients with diabetes and hypertension. Further research to test the efficacy of therapeutic alliance-based interventions to improve medication adherence in Black patients should ideally incorporate cultural adaptation, theoretical framework, face-to-face delivery mode, and convenient locations.Keywords: diabetes mellitus, hypertension, medication adherence, African Americans

Background and Aims: Diet may play an important role in the development of hyperuricemia and gout. However, the association between dietary factors and hyperuricemia remains unclear, and few studies have investigated direct links between food intake and hyperuricemia. The aim of this study was to investigate associations between high purine-content foods and protein intake with the prevalence of hyperuricemia by using data from a cross-sectional study of 3978 men aged 40-74 yrs living in Shanghai, China.Methods and Results: Hyperuricemia was defined as blood uric acid level >7.0 mg/dl. One quarter of this population had hyperuricemia. Dietary information was collected by using a food frequency questionnaire. We collected information on anthropometric measurements and lifestyle factors and other potential confounding factors and disease history via interviews. Total protein consumption was not associated with hyperuricemia. We found a positive association between protein from animal sources and prevalence of hyperuricemia and an inverse association between protein from plant sources and hyperuricemia. However, these associations failed to reach significance in mutually adjusted analysis. Seafood intake was associated with higher prevalence of hyperuricemia. The ORs for quintiles of seafood intake (including fish and shellfish) were 1.00, 1.49, 1.35, 1.34, and 1.56 (p for trend: 0.01). An inverse association approaching significance between soy food consumption and hyperuricemia was observed (ORs: 1.00, 0.90, 0.70, 0.89, and 0.77 for quintiles of intake; p for trend: 0.07). No associations between consumption of purine-rich vegetables or meat and prevalence of hyperuricemia were observed.Conclusions: Our data suggest a direct association between seafood consumption and hyperuricemia and an inverse association between consumption of soy food and hyperuricemia among middle-aged, Chinese men. [ABSTRACT FROM AUTHOR]

Reliability and validity are criteria used to assess metric adequacy and are typically quantified by correlation coefficients. Reliability is described as the extent to which repeated measurements yield consistent results. Validity is described as the extent to which a measure actually measures what it purports to measure. These conceptualizations are less useful when applied to measures of subjective outcomes because they do not convey other influences that "drive" correlation coefficients. Consistency is a manifestation of a reliable instrument but does not ensure that an instrument is reliable. Establishing the validity of an instrument is a complex process that is heavily dependent on an investigator's hypothesis. Hence, validity coefficients may be more a reflection of hypothesis adequacy than of the extent to which instruments measure what they purport to measure. Appreciating how coefficients are influenced will better enable clinicians to assess the adequacy of subjective outcome measures. [ABSTRACT FROM AUTHOR]

Abstract Background Low literacy and numeracy skills are common. Adequate numeracy skills are crucial in the management of diabetes. Diabetes patients use numeracy skills to interpret glucose meters, administer medications, follow dietary guidelines and other tasks. Existing literacy scales may not be adequate to assess numeracy skills. This paper describes the development and psychometric properties of the Diabetes Numeracy Test (DNT), the first scale to specifically measure numeracy skills used in diabetes. Methods The items of the DNT were developed by an expert panel and refined using cognitive response interviews with potential respondents. The final version of the DNT (43 items) and other relevant measures were administered to a convenience sample of 398 patients with diabetes. Internal reliability was determined by the Kuder-Richardson coefficient (KR-20). An a priori hypothetical model was developed to determine construct validity. A shortened 15-item version, the DNT15, was created through split sample analysis. Results The DNT had excellent internal reliability (KR-20 = 0.95). The DNT was significantly correlated (p < 0.05) with education, income, literacy and math skills, and diabetes knowledge, supporting excellent construct validity. The mean score on the DNT was 61% and took an average of 33 minutes to complete. The DNT15 also had good internal reliability (KR-20 = 0.90 and 0.89). In split sample analysis, correlations of the DNT-15 with the full DNT in both sub-samples was high (rho = 0.96 and 0.97, respectively). Conclusion The DNT is a reliable and valid measure of diabetes related numeracy skills. An equally adequate but more time-efficient version of the DNT, the DNT15, can be used for research and clinical purposes to evaluate diabetes related numeracy.

Abstract Background The Problem Areas in Diabetes (PAID) survey is a measure of diabetes-related stress for which reported use has been in largely Caucasian populations. Our purpose was to assess the psychometric properties of the PAID in Southern rural African American women with Type 2 diabetes. Methods A convenience sample of African American women (N = 131) ranging from 21–50 years of age and diagnosed with Type 2 diabetes were recruited for a survey study from two rural Southern community health centers. Participants completed the PAID, Center for Epidemiological Studies-Depression Scale (CES-D), and the Summary of Diabetes Self-Care Activities Scale (SDSCA). Factor analysis, Cronbach's coefficient alpha, and construct validation facilitated psychometric evaluation. Results A principle component factor analysis of the PAID yielded two factors, 1) a lack of confidence subscale, and 2) a negative emotional consequences subscale. The Lack of Confidence and Negative Emotional Consequences subscales, but not the overall PAID scale, were associated with glycemic control and body mass index, respectively. Relationships with measures of depression and diabetes self-care supported construct validity of both subscales. Both subscales had acceptable (alpha = 0.85 and 0.94) internal consistency measures. Conclusion A psychometrically sound two-factor solution to the PAID survey is identified in Southern, rural African American women with Type 2 diabetes. Lack of confidence in and negative emotional consequences of diabetes self-care implementation provide a better understanding of determinants of glycemic control and weight than an aggregate of the two scales.

Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive), routine care with phone contact every three months (moderate intensity) or routine care with phone contact every month (most intensive). Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

Abstract Background Coronary heart disease (CHD) is the leading cause of death in the United States. Previous research examining physicians ability to estimate cardiovascular risk has shown that physicians' generally overestimate the absolute risk of CHD events. This question has, however, only studied risk prediction for a limited number of patient care scenarios. The aim of this study is to measure the ability of physicians to estimate the risk of CHD events in patients with no previous history of coronary heart disease. Methods Twelve primary prevention scenarios with a 5-year risk of CHD events were developed. This questionnaire was surveyed at 3 university teaching hospitals where the participants were a convenience sample of internal medicine residents and fellows or attending physicians in general internal medicine or cardiology. For each scenario, physicians were asked to estimate the baseline 5-year risk of a coronary heart disease event and the revised risk if the patient were to receive lipid-lowering drug therapy. Estimates of the baseline 5-year risk were compared with values calculated from Framingham risk equations. Inaccurate responses were defined as those with a ratio of estimated to actual risk of more than 1.5 or less than 0.67. Physicians' estimates of the relative risk reduction with therapy were considered to be accurate if they were between 25% and 40%. Results 79 physicians (53 residents, 8 fellows, 18 attending physicians) completed the survey. Only 24% of physicians' risk estimates were accurate. In most cases, physicians overestimated the absolute risk of cardiovascular events without therapy (proportion overestimating ranged from 32–92% for the 12 individual scenarios). Physicians made larger errors in patient scenarios involving patients with high total or LDL cholesterol levels. Physicians' estimates of the relative risk reduction from treatment were more accurate: 43% of estimates were between 25 and 40%. Over 85% of physicians recommended treatment in 10 of 12 scenarios. Conclusions Physicians overestimate the absolute risk of CHD events and the potential absolute benefit of drug therapy.

Presents the summary of the study "A Three-Part Intervention To Change the Use of Hormone Replacement Therapy in Response to New Evidence," which was published in the July 20, 2004 issue of Annals of Internal Medicine.

Novel approaches to treat cholesterol are needed to effectively manage post-myocardial infarction patients in a public hospital setting. Although cardiologists were more likely to prescribe cholesterol-lowering agents than primary care practitioners, their impact on cholesterol reduction was still negligible. [ABSTRACT FROM AUTHOR]

Objective: To compare the effects of insulin sensitivity and β-cell function over time on HbA1c and durability of glycemic control in response to dual therapy., Research Design and Methods: GRADE participants were randomized to glimepiride (n = 1,254), liraglutide (n = 1,262), or sitagliptin (n = 1,268) added to baseline metformin and followed for mean ± SD 5.0 ± 1.3 years, with HbA1c assessed quarterly and oral glucose tolerance tests at baseline, 1, 3, and 5 years. We related time-varying insulin sensitivity (HOMA 2 of insulin sensitivity [HOMA2-%S]) and early (0-30 min) and total (0-120 min) C-peptide (CP) responses to changes in HbA1c and glycemic failure (primary outcome HbA1c ≥7% [53 mmol/mol] and secondary outcome HbA1c >7.5% [58 mmol/mol]) and examined differential treatment responses., Results: Higher HOMA2-%S was associated with greater initial HbA1c lowering (3 months) but not subsequent HbA1c rise. Greater CP responses were associated with a greater initial treatment response and slower subsequent HbA1c rise. Higher HOMA2-%S and CP responses were each associated with lower risk of primary and secondary outcomes. These associations differed by treatment. In the sitagliptin group, HOMA2-%S and CP responses had greater impact on initial HbA1c reduction (test of heterogeneity, P = 0.009 HOMA2-%S, P = 0.018 early CP, P = 0.001 total CP) and risk of primary outcome (P = 0.005 HOMA2-%S, P = 0.11 early CP, P = 0.025 total CP) but lesser impact on HbA1c rise (P = 0.175 HOMA2-%S, P = 0.006 early CP, P < 0.001 total CP) in comparisons with the glimepiride and liraglutide groups. There were no differential treatment effects on secondary outcome., Conclusions: Insulin sensitivity and β-cell function affected treatment outcomes irrespective of drug assignment, with greater impact in the sitagliptin group on initial (short-term) HbA1c response in comparison with the glimepiride and liraglutide groups., (© 2024 by the American Diabetes Association.)

Background: Clinical trials indicate continuous glucose monitor (CGM) use may benefit adults with type 2 diabetes, but CGM rates and correlates in real-world care settings are unknown., Objective: We sought to ascertain prevalence and correlates of CGM use and to examine rates of new CGM prescriptions across clinic types and medication regimens., Design: Retrospective cohort using electronic health records in a large academic medical center in the Southeastern US., Participants: Adults with type 2 diabetes and a primary care or endocrinology visit during 2021., Main Measures: Age, gender, race, ethnicity, insurance, clinic type, insulin regimen, hemoglobin A1c values, CGM prescriptions, and prescribing clinic type., Key Results: Among 30,585 adults with type 2 diabetes, 13% had used a CGM. CGM users were younger and more had private health insurance (p < .05) as compared to non-users; 72% of CGM users had an intensive insulin regimen, but 12% were not taking insulin. CGM users had higher hemoglobin A1c values (both most recent and most proximal to the first CGM prescription) than non-users. CGM users were more likely to receive endocrinology care than non-users, but 23% had only primary care visits in 2021. For each month in 2021, a mean of 90.5 (SD 12.5) people started using CGM. From 2020 to 2021, monthly rates of CGM prescriptions to new users grew 36% overall, but 125% in primary care. Most starting CGM in endocrinology had an intensive insulin regimen (82% vs. 49% starting in primary care), whereas 28% starting CGM in primary care were not using insulin (vs. 5% in endocrinology)., Conclusion: CGM uptake for type 2 diabetes is increasing rapidly, with most growth in primary care. These trends present opportunities for healthcare system adaptations to support CGM use and related workflows in primary care to support growth in uptake., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Objective: The aim of this study was to design and assess the formative usability of a novel patient portal intervention designed to empower patients with diabetes to initiate orders for diabetes-related monitoring and preventive services., Materials and Methods: We used a user-centered Design Sprint methodology to create our intervention prototype and assess its usability with 3 rounds of iterative testing. Participants (5/round) were presented with the prototype and asked to perform common, standardized tasks using think-aloud procedures. A facilitator rated task performance using a scale: (1) completed with ease, (2) completed with difficulty, and (3) failed. Participants completed the System Usability Scale (SUS) scored 0-worst to 100-best. All testing occurred remotely via Zoom., Results: We identified 3 main categories of usability issues: distrust about the automated system, content concerns, and layout difficulties. Changes included improving clarity about the ordering process and simplifying language; however, design constraints inherent to the electronic health record system limited our ability to respond to all usability issues (eg, could not modify fixed elements in layout). Percent of tasks completed with ease across each round were 67%, 60%, and 80%, respectively. Average SUS scores were 87, 74, and 93, respectively. Across rounds, participants found the intervention valuable and appreciated the concept of patient-initiated ordering., Conclusions: Through iterative user-centered design and testing, we improved the usability of the patient portal intervention. A tool that empowers patients to initiate orders for disease-specific services as part of their existing patient portal account has potential to enhance the completion of recommended health services and improve clinical outcomes., Competing Interests: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Objective: To compare the risk of lactic acidosis hospitalization between patients treated with metformin versus sulfonylureas following development of reduced kidney function., Research Design and Methods: This retrospective cohort combined data from the National Veterans Health Administration, Medicare, Medicaid, and the National Death Index. New users of metformin or sulfonylureas were followed from development of reduced kidney function (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 or serum creatinine ≥1.4 mg/dL [female] or 1.5 mg/dL [male]) through hospitalization for lactic acidosis, death, loss to follow-up, or study end. Lactic acidosis hospitalization was defined as a composite of primary discharge diagnosis or laboratory-confirmed lactic acidosis (lactic acid ≥2.5 mmol/L and either arterial blood pH <7.35 or serum bicarbonate ≤19 mmol/L within 24 h of admission). We report the cause-specific hazard of lactic acidosis hospitalization between metformin and sulfonylureas from a propensity score-matched weighted cohort and conduct an additional competing risks analysis to account for treatment change and death., Results: The weighted cohort included 24,542 metformin users and 24,662 sulfonylurea users who developed reduced kidney function (median age 70 years, median eGFR 55.8 mL/min/1.73 m 2 ). There were 4.18 (95% CI 3.63, 4.81) vs. 3.69 (3.19, 4.27) lactic acidosis hospitalizations per 1,000 person-years among metformin and sulfonylurea users, respectively (adjusted hazard ratio [aHR] 1.21 [95% CI 0.99, 1.50]). Results were consistent for both primary discharge diagnosis (aHR 1.11 [0.87, 1.44]) and laboratory-confirmed lactic acidosis (1.25 [0.92, 1.70])., Conclusions: Among veterans with diabetes who developed reduced kidney function, occurrence of lactic acidosis hospitalization was uncommon and not statistically different between patients who continued metformin and those patients who continued sulfonylureas., (© 2020 by the American Diabetes Association.)

Importance: Before 2016, safety concerns limited metformin use in patients with kidney disease; however, the effectiveness of metformin on clinical outcomes in patients with reduced kidney function remains unknown., Objective: To compare major adverse cardiovascular events (MACE) among patients with diabetes and reduced kidney function who continued treatment with metformin or a sulfonylurea., Design, Setting, and Participants: Retrospective cohort study of US veterans receiving care within the national Veterans Health Administration, with data supplemented by linkage to Medicare, Medicaid, and National Death Index data from 2001 through 2016. There were 174 882 persistent new users of metformin and sulfonylureas who reached a reduced kidney function threshold (estimated glomerular filtration rate <60 mL/min/1.73 m2 or creatinine ≥1.4 mg/dL for women or ≥1.5 mg/dL for men). Patients were followed up from reduced kidney function threshold until MACE, treatment change, loss to follow-up, death, or study end (December 2016)., Exposures: New users of metformin or sulfonylurea monotherapy who continued treatment with their glucose-lowering medication after reaching reduced kidney function., Main Outcomes and Measures: MACE included hospitalization for acute myocardial infarction, stroke, transient ischemic attack, or cardiovascular death. The analyses used propensity score weighting to compare the cause-specific hazard of MACE between treatments and estimate cumulative risk accounting for the competing risks of changing therapy or noncardiovascular death., Results: There were 67 749 metformin and 28 976 sulfonylurea persistent monotherapy users; the weighted cohort included 24 679 metformin and 24 799 sulfonylurea users (median age, 70 years [interquartile range {IQR}, 62.8-77.8]; 48 497 men [98%]; and 40 476 white individuals [82%], with median estimated glomerular filtration rate of 55.8 mL/min/1.73 m2 [IQR, 51.6-58.2] and hemoglobin A1c level of 6.6% [IQR, 6.1%-7.2%] at cohort entry). During follow-up (median, 1.0 year for metformin vs 1.2 years for sulfonylurea), there were 1048 MACE outcomes (23.0 per 1000 person-years) among metformin users and 1394 events (29.2 per 1000 person-years) among sulfonylurea users. The cause-specific adjusted hazard ratio of MACE for metformin was 0.80 (95% CI, 0.75-0.86) compared with sulfonylureas, yielding an adjusted rate difference of 5.8 (95% CI, 4.1-7.3) fewer events per 1000 person-years of metformin use compared with sulfonylurea use., Conclusions and Relevance: Among patients with diabetes and reduced kidney function persisting with monotherapy, treatment with metformin, compared with a sulfonylurea, was associated with a lower risk of MACE.

Background: Medications that impact insulin sensitivity or cause weight gain may increase heart failure risk. Our aim was to compare heart failure and cardiovascular death outcomes among patients initiating sulfonylureas for diabetes mellitus treatment versus metformin., Methods and Results: National Veterans Health Administration databases were linked to Medicare, Medicaid, and National Death Index data. Veterans aged ≥18 years who initiated metformin or sulfonylureas between 2001 and 2011 and whose creatinine was <1.4 (females) or 1.5 mg/dL (males) were included. Each metformin patient was propensity score-matched to a sulfonylurea initiator. The outcome was hospitalization for acute decompensated heart failure as the primary reason for admission or a cardiovascular death. There were 126 867 and 79 192 new users of metformin and sulfonylurea, respectively. Propensity score matching yielded 65 986 per group. Median age was 66 years, and 97% of patients were male; hemoglobin A 1c 6.9% (6.3, 7.7); body mass index 30.7 kg/m 2 (27.4, 34.6); and 6% had heart failure history. There were 1236 events (1184 heart failure hospitalizations and 52 cardiovascular deaths) among sulfonylurea initiators and 1078 events (1043 heart failure hospitalizations and 35 cardiovascular deaths) among metformin initiators. There were 12.4 versus 8.9 events per 1000 person-years of use (adjusted hazard ratio 1.32, 95%CI 1.21, 1.43). The rate difference was 4 heart failure hospitalizations or cardiovascular deaths per 1000 users of sulfonylureas versus metformin annually., Conclusions: Predominantly male patients initiating treatment for diabetes mellitus with sulfonylurea had a higher risk of heart failure and cardiovascular death compared to similar patients initiating metformin., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Objective: To compare the effectiveness of different approaches to nutrition education in diabetes self-management education and support (DSME/S)., Methods: We randomized 150 adults with type 2 diabetes to either certified diabetes educator (CDE)-delivered DSME/S with carbohydrate gram counting or the modified plate method versus general health education. The primary outcome was change in HbA1C over 6 months., Results: At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34]. Change in HbA1C from baseline between the control and intervention groups was not significant at 6 months (carbohydrate counting, P=0.36; modified plate method, P=0.08). In a pre-specified subgroup analysis of patients with a baseline HbA1C 7-10%, change in HbA1C from baseline improved in the carbohydrate counting [-0.86% (-1.47, -0.26), P=0.006] and plate method groups [-0.76% (-1.33, -0.19), P=0.01] compared to controls., Conclusion: CDE-delivered DSME/S focused on carbohydrate counting or the modified plate method improved glycemic control in patients with an initial HbA1C between 7 and 10%., Practice Implications: Both carbohydrate counting and the modified plate method improve glycemic control as part of DSME/S., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)