Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement.

OBJECTIVE: This study evaluates the effectiveness of the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program on enhancing referrals of underrepresented patients to lupus clinical trials. TIMELY leverages two existing American College of Rheumatology online educational initiatives: Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a continuing medical education activity for health care providers, and the community health worker (CHW) Lupus Clinical Trials Training (LuCTT). TIMELY introduced a unique roundtable meeting format to build on the existing online educational programs and facilitate discussions between local clinical trial sites and provider and CHW participants. METHODS: This study used an online pretest and posttest design to assess changes in theory-based behavioral predictors of lupus clinical trial referrals and engagement (ie, knowledge, attitudes, self-efficacy, and intentions) among providers and CHWs. Participants completed MIMICT or LuCTT and then were eligible to participate in roundtable meetings. Paired t-tests were used to assess changes in composite scores before and after the intervention for each of the outcomes. RESULTS: The final sample included 40 providers and 18 CHWs. Knowledge scores increased significantly for both providers (P < 0.01) and CHWs (P < 0.001) on completion of MIMICT and LuCTT, respectively. After participating in the TIMELY roundtable, providers' composite scores for self-efficacy and intentions significantly increased (P < 0.001). Provider self-efficacy gains were sustained at three months' follow-up (P < 0.001). CONCLUSION: These promising findings highlight the potential and opportunities for the TIMELY program to improve behavioral predictors of trial referrals, including CHW knowledge and providers' knowledge, self-efficacy, and intentions to refer underrepresented patients to lupus clinical trials.

Feasibility and Utility of a Pilot Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials: Implementation and Evaluation in a Multisite Model Within a Lupus Clinical Trials Network.

OBJECTIVE: To assess outcomes related to Lupus Therapeutics' Patient Advocates for Lupus Studies (LT-PALS), a peer-to-peer lupus clinical trial (LCT) education program designed to improve representation of diverse groups in LCTs. Patients with lupus and clinical trial participation experience were trained as peer educators (PALs) providing trial-agnostic education to trial-naive patients with lupus. METHODS: We used a two-arm, randomized pretest/posttest study design to evaluate outcomes related to LCT participation: knowledge, attitudes, self-efficacy, and intentions to participate in an LCT. Five academic medical centers piloted the program. The intervention group (IG) individually received peer-to-peer education sessions with trained PALs, primarily via telephone; the control group (CG) received a 3-week waiting period. We conducted within/between-group t-tests and multiple linear regressions with posttest scores as dependent variables and participation in LT-PALS as the exposure variable. RESULTS: The sample (n = 136) included 64 IG and 72 CG participants, with 67.7% identifying as Black. At posttest, IG participants had higher knowledge (P < 0.01) scores than the CG participants. Regression models controlling for participant characteristics showed higher IG posttest scores for knowledge (P < 0.001) and intentions (P < 0.05). From pretest to 3-month follow-up, IG self-efficacy scores increased (P < 0.01). About half (46.9%) of IG participants reported engagement with an LCT at 1-year follow-up. Black and Hispanic participants rated higher overall program satisfaction compared with White (P < 0.01) and non-Hispanic (P < 0.05) participants. CONCLUSION: Findings demonstrated feasibility of LT-PALS and showed promise in increasing engagement from groups underrepresented in LCTs.

Outcomes of coronavirus disease 2019 (COVID-19) and risk factors associated with severe COVID-19 in patients with mature B-cell non-Hodgkin lymphomas: A US electronic health record cohort study.

OBJECTIVES: The objectives of this study were to assess the risk of severe coronavirus disease 2019 (COVID-19) outcomes in patients with mature B-cell non-Hodgkin lymphoma (mature B-cell NHL) compared with other cancers and to identify risk factors associated with severe COVID-19. METHODS: This study used Optum's electronic health record database. Risk factors were evaluated using multivariable logistic regression. RESULTS: Patients with mature B-cell NHL were more likely to be hospitalized or die from COVID-19 (age- and sex-standardized risk: 15.6%, 2.1%, respectively) than those without cancer (9.5%, 1.2%), or with solid tumors (9.7%, 1.3%). In patients with mature B-cell NHL, factors associated with severe COVID-19 outcomes included: greater age (75-84 years, adjusted odds ratio, 1.6 [95% CI, 1.3-2.0]; ≥85, 2.6 [2.0-3.4]), male sex (1.4 [1.2-1.6]), chronic kidney disease (1.4 [1.1-1.7]), chronic obstructive pulmonary disease (1.3 [1.0-1.6]), type 2 diabetes (1.3 [1.1-1.5]), and receiving treatment for NHL (1.5 [1.1-2.1]). CONCLUSIONS: These data suggest that patients with mature B-cell NHL are at a higher risk of severe COVID-19 than patients with solid tumors or without cancer and that risk factors are largely consistent with those in the general population.

Distance to glycemic goal at the time of treatment intensification in patients with type 2 diabetes mellitus failing metformin monotherapy in the United States.

Background: A substantial proportion of patients with type 2 diabetes mellitus (T2DM) do not reach their target HbA1c level on metformin. The objective of this retrospective observational cohort study is to better characterize the distance between HbA1c target and patient's actual HbA1c level (the distance to goal), using a target HbA1c of 7.0% (53 mmol/mol), in patients with T2DM who have started metformin monotherapy.Methods: We used data from the GE Centricity Electronic Medical Record database by IQVIA in 2016 in the United States (US) to identify adults with T2DM who started metformin monotherapy (MM) and received at least 90 days of treatment. Patients were categorized into three groups: those who achieved the goal of HbA1c <7.0%, those who did not achieve the goal of HbA1c <7.0% (i.e. failed MM) and received intensified treatment, and those who failed MM and did not receive intensified treatment. Distance to goal was computed for patients in each group.Results: We identified 20,704 patients in the US database who started MM; 1741 (8.4%) failed MM and received intensified treatment, while 4977 (24.0%) failed MM and did not receive intensified treatment. The mean post-MM HbA1c for those who failed MM and received intensified treatment was 8.7% (72 mmol/mol) (median 8.2%, 66 mmol/mol) and the mean distance to goal was 1.7% (median 1.2%). The mean post-MM HbA1c for those who failed MM and did not receive intensified treatment was 8.0% (64 mmol/mol) (median 7.5%, 58 mmol/mol) and the mean distance to goal was 1.0% (median 0.5%).Conclusion: A proportion of US T2DM patients do not achieve glycemic control (target HbA1c < 7.0%) despite 90 days of MM. Patients who failed MM and eventually received intensified treatment did so when their HbA1c distance to goal exceeded the level at which one add-on therapy alone might be sufficient to bring them to goal.

Patient and prescriber characteristics among patients with type 2 diabetes mellitus continuing or discontinuing sulfonylureas following insulin initiation: data from a large commercial database.

OBJECTIVE: To describe patient and provider characteristics for patients with type 2 diabetes (T2DM) initiating basal insulin and describe basal insulin's impact on sulfonylurea (SU) discontinuation. METHODS: A retrospective cohort study was conducted using the HealthCore Integrated Research Database. Patients had ≥12 months of continuous coverage prior to initiating insulin, and were utilizing at least one anti-hyperglycemic drug at the time of insulin initiation. Predictors for SU discontinuation were evaluated utilizing Cox proportional hazards models. RESULTS: Among the 74,334 individuals aged ≥18 years with T2DM who initiated basal insulin from 2006-2015, 30% were taking metformin (MET) and SU when initiating insulin. Among the 22,418 MET/SU patients, 31% discontinued SU within 3 months of insulin initiation and, by 12 months, 55% had discontinued SU. Sulfonylurea discontinuation was similar among many patient and provider characteristics, while being modestly positively associated (p < .05; HRs <1.5) with female gender, more co-morbidities, cardiac revascularization, chronic liver disease, hospitalizations with a T2DM diagnosis, and hypoglycemia prior to insulin initiation. SU discontinuation was modestly inversely associated with receiving an insulin prescription from an endocrinologist (HR = 0.90, 95% CI = 0.85-0.95). CONCLUSIONS: Roughly half of commercially-insured T2DM patients discontinued SU within 1 year after insulin initiation, and SU discontinuation was not strongly associated with a range of patient and provider characteristics.

Impact of worsening renal function during hospital admission on resource utilization in patients with heart failure.

Renal impairment frequently accompanies heart failure (HF) and is a recognized independent risk factor for morbidity and mortality. Few data are available assessing the impact of worsening renal function (WRF) during hospitalization on health care resource use in patients with HF. Health Insurance Portability and Accountability Act-compliant, de-identified, clinical, laboratory, and economic data for patients admitted to a tertiary care medical center with a primary diagnosis of HF were extracted by MedMining and reviewed retrospectively by the authors. Patients were excluded if they had no previous HF or were admitted for acute coronary syndrome or coronary artery bypass grafting within 30 days of index hospitalization. WRF was defined as ≥ 0.3 mg/dl increase in serum creatinine from baseline at any time during hospitalization. Of 5,803 hospitalized patients with primary HF diagnosis, 827 patients (14%) fulfilled all prespecified inclusion and exclusion criteria (74 ± 14 years of age, 43% men, 98% white, admission serum creatinine 1.4 ± 0.9 mg/dl, estimated glomerular filtration rate < 90 ml/min/1.73 m(2) at admission in 83%). During index hospitalization, WRF was identified in nearly 33%. Compared to patients without WRF, those with WRF had greater prevalence of diabetes (54% vs 43%), lower estimated glomerular filtration rate (44 ± 30 vs 62 ± 35 ml/min/1.73 m(2)), higher serum potassium (4.3 ± 0.7 vs 4.2 ± 0.7 mEq/L), and higher B-type natriuretic peptide (845 ± 821 vs 795 ± 947 pg/ml) at baseline (all p values < 0.05). Patients developing WRF incurred higher total inpatient costs ($10,977, range 671 to 212,819, vs $7,820, range 697 to 269,797, p < 0.001) and longer hospital stay (8.2 ± 6.8 vs 5.7 ± 5.5 days, p < 0.001). In conclusion, occurrence of WRF during HF-related hospitalization is associated with higher hospitalization costs and longer hospital stay.

Life course socioeconomic conditions and metabolic syndrome in adults: the Atherosclerosis Risk in Communities (ARIC) Study.

PURPOSE: This study examined the effect of childhood, adulthood, and cumulative socioeconomic status (cumSES) on the prevalence of metabolic syndrome (MetS) in middle-aged adults in the Atherosclerosis Risk in Communities Study (1987-1989). METHODS: Participants included 2,461 black and 8,536 white men and women 45 to 64 years of age without diabetes. Socioeconomic status (SES) measures from childhood, early adulthood, and mature adulthood were used to create a cumSES score. Childhood SES, early adult SES, mature adult SES and cumSES scores were grouped into two categories (high/low). Age- and center-adjusted prevalence ratios and 95% confidence intervals for MetS, using the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) criteria, by SES were estimated by log-linear regression for race-sex groups. RESULTS: Black and white women with low childhood SES, early adult SES, mature adult SES or cumSES were more likely to have the MetS than those with high SES. These associations remained after adjustment for physical activity, smoking status, and drinking status. In contrast, there was no association of SES with MetS in men. CONCLUSIONS: Our findings suggest that socioeconomic disadvantage early in life and across the life course influences risk of the MetS in black and white women.

Individual and neighborhood socioeconomic status characteristics and prevalence of metabolic syndrome: the Atherosclerosis Risk in Communities (ARIC) Study.

OBJECTIVE: The objective of this study was to examine the association of individual socioeconomic status (iSES) and neighborhood SES (nSES) on the prevalence of metabolic syndrome (MetS) in the Atherosclerosis Risk in Communities Study (1987-1999). METHODS: Participants included 2932 black and 9777 white men and women aged 45 to 64 years without diabetes at baseline. Total combined family income for the past 12 months and six census tract socioeconomic measures combined into a composite index were used to quantify iSES and nSES, respectively. Poisson regression was used to assess associations of the joint contribution of iSES and nSES on the MetS, stratified by gender and race and adjusting for multiple covariates. For analyses that included nSES, hierarchical modeling techniques were used. RESULTS: Using 2005 Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults criteria, MetS was identified in 40% of black women, 30% of white women, 28% of black men, and 35% of white men. Among black and white men, there was no association between MetS and iSES or nSES. In contrast, after adjustment for risk factors, black and white women with low (L)-iSES and medium (M)-iSES were more likely to have MetS than those with high (H)-iSES. Similar but weaker patterns were noted for L-nSES and M-nSES. CONCLUSIONS: In summary, both iSES and nSES were independently associated with an increased prevalence of MetS among women but not men. Efforts aimed at understanding the causes of these gender differences may offer insight into avenues for reducing the prevalence of the MetS and its chronic disease sequelae.