iGlarLixi versus premixed insulin initiation in adults with type 2 diabetes advancing from basal insulin therapy: The SoliComplex real-world study.

AIM: To compare outcomes in adults with type 2 diabetes (T2D) suboptimally controlled with basal insulin who initiated treatment with iGlarLixi or premixed insulin. METHODS: This retrospective real-world analysis was conducted using data from adults (age ≥ 18 years) with T2D in the US Optum Clinformatics database who had previously received basal insulin and newly initiated iGlarLixi or premixed insulin. Cohorts were propensity-score matched on baseline characteristics using a greedy nearest neighbour-matching algorithm, and outcomes were assessed at 12 months. Subgroup analyses were performed for those aged 65 years or older and those with a baseline HbA1c of 9% or higher. The primary endpoint was treatment persistence in the overall population. Secondary endpoints were treatment adherence, healthcare resource utilization (HRU), costs, hypoglycaemia events and change in HbA1c from baseline. RESULTS: Each cohort comprised 834 participants. In the overall population, treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus premixed insulin: 42.5% versus 39.1%; hazard ratio 0.88; 95% confidence interval 0.778-0.998; P = .0465. Adherence and HbA1c reduction were similar between groups, whereas hypoglycaemia events, HRU and costs were numerically lower for iGlarLixi. Outcomes in both the age 65 years or older subgroup and in those with an HbA1c of 9% or higher were consistent with those for the overall population. CONCLUSIONS: In this observational study in people with T2D suboptimally controlled on basal insulin, once-daily iGlarLixi was an effective treatment alternative to premixed insulin with significantly higher treatment persistence, similar adherence and HbA1c reduction, and numerically lower hypoglycaemia events, HRU and costs, regardless of age or baseline HbA1c.

Initiation of iGlarLixi Versus Basal-Bolus Insulin in Adults With Type 2 Diabetes Advancing From Basal Insulin Therapy: The SoliComplex Real-World Study.

Background: When type 2 diabetes is suboptimally controlled with basal insulin, prandial insulin injections are commonly added (i.e., a basal-bolus insulin regimen), which can increase treatment burden and hypoglycemia risk. The once-daily injectable iGlarLixi is an alternative treatment. Methods: This retrospective analysis of the U.S. Optum Clinformatics database compared outcomes in adults (≥18 years of age) with type 2 diabetes who previously received basal insulin and were newly initiated on iGlarLixi or basal-bolus insulin therapy. Cohorts were propensity score-matched in a 1:1 ratio on baseline characteristics, and imbalances were adjusted in multivariate analyses. Subgroup analyses were performed for people ≥65 years of age and those with a baseline A1C ≥9%. The primary end point was persistence with therapy at 12 months in the overall population. Secondary end points were treatment adherence, health care resource utilization (HCRU), costs, any hypoglycemia, and A1C change at 12 months. Results: Cohorts each comprised 1,070 participants. Treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus basal-bolus insulin therapy (43.7 vs. 22.3%, hazard ratio 0.51, 95% CI 0.46-0.57, adjusted P <0.001). Adherence was numerically higher for iGlarLixi, and hypoglycemia events, HCRU, and costs were numerically lower for iGlarLixi. A1C reduction from baseline was slightly greater for basal-bolus insulin. Results for both subgroups (≥65 years of age and baseline A1C ≥9%) were similar to those of the overall population. Conclusion: In this observational study, initiation of once-daily iGlarLixi versus basal-bolus insulin was associated with higher persistence, lower hypoglycemia, and similar A1C reduction without increasing HCRU or costs regardless of age or A1C. iGlarLixi could be an alternative to basal-bolus insulin, particularly for older adults with type 2 diabetes who require treatment simplification with lower hypoglycemia risk.

The association between social needs and chronic conditions in a large, urban primary care population.

There is consensus that social needs influence health outcomes, but less is known about the relationships between certain needs and chronic health conditions in large, diverse populations. This study sought to understand the association between social needs and specific chronic conditions using social needs screening and clinical data from Electronic Health Records. Between April 2018-December 2019, 33,550 adult (≥18y) patients completed a 10-item social needs screener during primary care visits in Bronx and Westchester counties, NY. Generalized linear models were used to estimate prevalence ratios for eight outcomes by number and type of needs with analyses completed in Summer 2020. There was a positive, cumulative association between social needs and each of the outcomes. The relationship was strongest for elevated PHQ-2, depression, alcohol/drug use disorder, and smoking. Those with ≥3 social needs were 3.90 times more likely to have an elevated PHQ-2 than those without needs (95% CI: 3.66, 4.16). Challenges with healthcare transportation was associated with each condition and was the most strongly associated need with half of conditions in the fully-adjusted models. For example, those with transportation needs were 84% more likely to have an alcohol/drug use disorder diagnosis (95% CI: 1.59, 2.13) and 41% more likely to smoke (95% CI: 1.25, 1.58). Specific social needs may influence clinical issues in distinct ways. These findings suggest that health systems need to develop strategies that address unmet social need in order to optimize health outcomes, particularly in communities with a dual burden of poverty and chronic disease.

Unmet Social Needs and No-Show Visits in Primary Care in a US Northeastern Urban Health System, 2018-2019.

Objectives. To characterize the association between social needs prevalence and no-show proportion and variation in these associations among specific social needs.Methods. In this study, we used results from a 10-item social needs screener conducted across 19 primary care practices in a large urban health system in Bronx County, New York, between April 2018 and July 2019. We estimated the association between unmet needs and 2-year history of missed appointments from 41 637 patients by using negative binomial regression models.Results. The overall no-show appointment proportion was 26.6%. Adjusted models suggest that patients with 1 or more social needs had a significantly higher no-show proportion (31.5%) than those without any social needs (26.3%), representing an 19.8% increase (P < .001). We observed a positive trend (P < .001) between the number of reported social needs and the no-show proportion-26.3% for those with no needs, 30.0% for 1 need, 32.1% for 2 needs, and 33.8% for 3 or more needs. The strongest association was for those with health care transportation need as compared with those without (36.0% vs 26.9%).Conclusions. We found unmet social needs to have a significant association with missed primary care appointments with potential implications on cost, quality, and access for health systems.

Assessing the sustainability of the Nigerian urban reproductive health initiative facility-level programming: longitudinal analysis of service quality.

BACKGROUND: To date, there is little information on the sustainability of family planning (FP) service quality after completion of a donor-funded program. This paper examines the sustainability of the Nigerian Urban Reproductive Health Initiative (NURHI) program on quality of FP services in two cities: Ilorin, where the program ended in March 2015 and Kaduna where the program continued. METHODS: Data come from three time periods: 2011, before program implementation; 2014, near Phase 1 completion; and 2017, two-years post Phase 1. In 2011, we undertook a facility audit and provider surveys in all public sector facilities in each city as well as all private facilities mentioned as the source for FP or maternal, newborn, and child health services in a 2010 women's household survey. In 2014 and 2017, we returned to the same facilities to undertake the facility audit and provider surveys. Quality is measured from principal component analyses of 30 items from the facility audit and provider surveys. Service use outcomes are measured as the ratio of FP clients (total and new) to the number of reproductive health staff members. Multivariate random effect models are estimated to examine changes in the outcomes over time, between NURHI and non-NURHI facilities and by city. RESULTS: We demonstrate that NURHI facilities had better quality and higher service use than non-NURHI facilities. Further, while quality of services was higher in Ilorin in 2011, by 2014 and three years later (2017), the quality was better in Kaduna where the program continued. In addition, while no difference was found in service utilization between Ilorin and Kaduna in 2014, by 2017, Kaduna had significantly more new FP users than Ilorin. CONCLUSIONS: In Ilorin, quality of services did not continue its strong upward trend after the program ended. Programs need to consider long-term strategies that support continuation of program components post program implementation. This may include ensuring continued training of providers and addressing equipment and commodity stock-outs through system changes rather than specific facility-level changes. The findings from this study can be used to inform future programs seeking to improve quality of FP services in a sustainable manner.

Optical spectral transmission to assess glucocorticoid therapy response in patients with arthritis: a longitudinal follow-up comparison with joint ultrasound.

BACKGROUND: Optical spectral transmission (OST) is a modern diagnostic modality, able to assess the blood-specific absorption of light transmitted through a tissue, promising quantification of inflammation in the finger and wrist joints of patients with arthritis. To date, there are no adequate data regarding the diagnostic value of OST in the evaluation of inflammatory activity changes, during arthritis follow-up. Objectives of this study were therefore to examine the performance of OST in assessing response to anti-inflammatory therapy in patients with active arthritis and to explore OST associations with clinical, laboratory, and ultrasonographic (US) activity markers. METHODS: 1173 joints of 54 patients with arthritides of the wrist and finger joints were examined by OST before and after oral administration of glucocorticoids (GC), during a disease flare. For the same time-points patients underwent clinical, laboratory, and joint US [grayscale (GSUS), power-Doppler (PDUS)] examinations. The distribution of ΔOST-values between the two time-points was compared with the respective distributions of ΔPDUS and ΔGSUS by Bayesian statistical analyses. Moreover, the diagnostic performance of OST compared to a control group (2508 joints of 114 subjects) was examined by receiver operating characteristics and associations of OST values with clinical, laboratory, and arthrosonographic parameters were evaluated by correlation analyses. RESULTS: OST and US performed similarly in the assessment of inflammatory changes caused by GC (same value-change tendency in 83.2% of the cases). Bayesian statistics revealed no significant differences between ΔOST and ΔPDUS for all 3 examined joint categories (accuracy: metacarpophalangeal (MCP): 68.1%; proximal interphalangeal (PIP): 60.4%; wrists: 50.4%) and between ΔOST and ΔGSUS for MCP and PIP joints (accuracy: 51.1% and 78.7%, respectively). OST diagnostic performance (patients vs. controls) was excellent in both time-points [area under the curve (AUC) before GC=0.883(95%CI=0.83-0.94) and after GC=0.811(95%CI=0.74-0.881); p<0.001]. Furthermore, OST correlated significantly with all examined sonographic activity scores (all; p<0.001) and with swollen joint counts (p<0.01). CONCLUSIONS: OST was able to assess response to therapy in a similar way to joint US and correlated significantly with arthritis activity markers. Therefore, OST has proved to be a valuable tool to assist disease activity monitoring in the examined cohort. TRIAL REGISTRATION: German Registry of Clinical Trials, DRKS00016752.

Development and Validation of Rheumatoid Arthritis Disease Activity Indices Including HandScan (Optical Spectral Transmission) Scores.

OBJECTIVE: To develop and validate a composite rheumatoid arthritis (RA) disease activity index using optical spectral transmission (OST) scores obtained with the HandScan, replacing tender and swollen joint counts. METHODS: RA patients from a single center routinely undergoing HandScan measurements with at least 1 concurrent OST score and Disease Activity Score in 28 joints (DAS28) were included. Data were extracted from medical records. Linear regression analyses with the DAS28 as the outcome were performed to create a disease activity index (DAS-OST). OST score, erythrocyte sedimentation rate (ESR), and patient global assessment (PtGA) visual analog scale (VAS), sex, age, disease duration, and rheumatoid factor status were evaluated as independent variables. Final models were derived based on the statistical significance of coefficients and model fit. Of the data, two-thirds were used for development and one-third for validation; external validation was performed in a cohort from another center. Agreement between DAS-OST and DAS28 was assessed using the Bland-Altman plot method and intraclass correlation coefficient (ICC). Diagnostic value of the DAS-OST was determined for established definitions of remission, low disease activity (LDA), and high disease activity (HDA). RESULTS: Data of 3,358 observations from 1,505 unique RA patients were extracted. DAS-OST was defined as: -0.44 + OST × 0.03 + male × -0.11 + LN(ESR) × 0.77 + PtGA VAS × 0.03. The ICCs between DAS-OST and DAS28 were 0.88 (95% confidence interval [95% CI] 0.87-0.90) and 0.82 (95% CI 0.75-0.86) and measurement errors were 0.58 and 0.87 in internal and external validation, respectively. Sensitivity for remission, LDA, and HDA was 79%, 91%, and 43%, respectively, and specificity was 92%, 80%, and 96% in external validation. CONCLUSION: Using the HandScan, RA disease activity can be accurately estimated if combined with ESR, PtGA VAS, and sex into a disease activity index (DAS-OST).

Toward Understanding Social Needs Among Primary Care Patients With Uncontrolled Diabetes.

INTRODUCTION/OBJECTIVES: Uncontrolled diabetes can lead to major health complications, and significantly contributes to diabetes-related morbidity, mortality, and healthcare costs. Few studies have examined the relationship between unmet social needs and diabetes control among predominantly Black and Hispanic patient populations. METHODS: In a large urban hospital system in the Bronx, NY, 5846 unique patients with diabetes seen at a primary care visit between April 2018 and December 2019 completed a social needs screener. Measures included diabetes control (categorized as Hemoglobin (Hb) A1c <9.0 as controlled and Hb A1C ≥9.0 as uncontrolled), social needs (10-item screen), and demographic covariates, including age, sex, race/ethnicity, insurance status, percentage of block-group poverty, patient's preferred language, and the Elixhauser Comorbidity Index. RESULTS: Twenty-two percent (22%) of the patient sample had at least 1 unmet social need, and the most prevalent unmet social needs were housing issues (including housing quality and insecurity), food insecurity, and lack of healthcare transportation. Logistic regression analysis showed a significant relationship between social needs and uncontrolled diabetes, with more social needs indicating a greater likelihood of uncontrolled diabetes (Adjusted Odds Ratio (AOR) for ≥3 needs: 1.59, 95% CI: 1.26, 2.00). Of the patients with most frequently occurring unmet social needs, lack of healthcare transportation (AOR: 1.54, 95% CI: 1.22, 1.95) and food insecurity (AOR: 1.50, 95% CI: 1.19, 1.89) had the greatest likelihood of having uncontrolled diabetes, after adjusting for covariates. CONCLUSION: Unmet social needs appear to be linked to a greater likelihood of uncontrolled diabetes. Implications for healthcare systems to screen and address social needs for patients with diabetes are discussed.

Scaling-up social needs screening in practice: a retrospective, cross-sectional analysis of data from electronic health records from Bronx county, New York, USA.

OBJECTIVES: There has been renewed focus on health systems integrating social care to improve health outcomes with relatively less related research focusing on 'real-world' practice. This study describes a health system's experience from 2018 to 2020, following the successful pilot in 2017, to scale social needs screening of patients within a large urban primary care ambulatory network. SETTING: Academic medical centre with an ambulatory network of 18 primary care practices located in an urban county in New York City (USA). PARTICIPANTS: This retrospective, cross-sectional study used electronic health records of 244 764 patients who had a clinical visit between 10 April 2018 and 8 December 2019 across any one of 18 primary care practices. METHODS: We organised measures using the RE-AIM framework domains of reach and adoption to ascertain the number of patients who were screened and the number of providers who adopted screening and associated documentation, respectively. We used descriptive statistics to summarise factors comparing patients screened versus those not screened, the prevalence of social needs screening and adoption across 18 practices. RESULTS: Between April 2018 and December 2019, 53 093 patients were screened for social needs, representing approximately 21.7% of the patients seen. Almost one-fifth (19.6%) of patients reported at least one unmet social need. The percentage of screened patients varied by both practice location (range 1.6%-81.6%) and specialty within practices. 51.8% of providers (n=1316) screened at least one patient. CONCLUSIONS: These findings demonstrate both the potential and challenges of integrating social care in practice. We observed significant variability in uptake across the health system. More research is needed to better understand factors driving adoption and may include harmonising workflows, establishing unified targets and using data to drive improvement.

Chronic pediatric health conditions among youth living in public housing and receiving care in a large hospital system in Bronx, NY.

This study compared the prevalence of chronic pediatric health conditions for youth in public housing with youth not in public housing using clinical electronic health record (EHR) and housing data. Youth (ages 2-17 years) in a large urban health system were identified and categorized into two housing types-public housing (n = 10 770) and not in public housing (n = 84 883) by age (young childhood, middle childhood, young adolescence). The prevalence of some pediatric conditions was higher in public housing but varied by age. Disparities in health conditions among youth in public housing were more common in early adolescence: asthma (26.4 vs 18.6; P < .001); obesity (28.5 vs 24.6; P < .001); depression/anxiety (19.2 vs 17.3; P = .008); behavioral disorders (8.1 vs 5.3; P < .001). These results show that chronic pediatric conditions like asthma and obesity that lead to significant morbidity into adulthood are more common among youth living in public housing. However, this pattern is not consistent across all chronic conditions.

Diagnostic Value of Optical Spectral Transmission in Rheumatoid Arthritis: Associations with Clinical Characteristics and Comparison with Joint Ultrasonography.

OBJECTIVE: To examine the value of optical spectral transmission (OST) in detecting joint inflammation in patients with rheumatoid arthritis (RA) and to evaluate whether OST correlates with certain patient characteristics. METHODS: OST measurements were performed in the metacarpophalangeal, proximal intraphalangeal, and wrist joints of 168 patients with RA and 114 controls. OST difference between the 2 groups was statistically examined and subsequently controlled for the effect of possible confounding factors. Diagnostic OST performance was tested by receiver-operating characteristics. Moreover, associations of OST with clinical and serological activity markers (patient group), joint ultrasound (US; patient subgroup) and various anthropometric and epidemiologic parameters (patient and control group) were evaluated by Spearman correlation coefficient and a generalized linear statistical adjustment model. RESULTS: OST was significantly higher in the RA group than in the control group, even after adjustment for confounding factors (1.89; 95% CI 0.709-3.070, padj = 0.002). Taking US as a reference, area under the curve for all 1251 joints simultaneously was 0.67 (95% CI 0.631-0.709). In the patient group, correlation and adjustment analyses showed associations of OST with various disease activity markers [28-joint count Disease Activity Score (rho 0.313), swollen joint counts (rho 0.361), C-reactive protein (rho 0.389); all, padj = 0.001], age (rho 0.276, p < 0.001), and osteoarthritis (p = 0.022). Moreover, OST associated with a power Doppler US score (rho 0.442; p = 0.001) and a greyscale US score (rho 0.591; p < 0.001). In both groups males had significantly higher OST values than females and OST associated moderately weakly with body mass index (rho patients 0.316, rho controls 0.24; all, p < 0.001). CONCLUSION: Patients with RA showed higher OST values in comparison to controls. Moreover, OST associated with clinical, US, and laboratory disease activity markers.

Social Risks Among Primary Care Patients in a Large Urban Health System.

INTRODUCTION: Health systems are increasingly interested in addressing the social determinants of health via social risk screening. The objective of this study is to understand the variability in the number and types of social risks overall and in population subgroups among primary care patients routinely screened in a large urban health system. METHODS: Between April and December 2018, a total of 24,633 primary care patients completed a 10-item screener across 19 ambulatory sites within a health system in the Bronx, NY. The prevalence of any social risk and specific social risks was estimated overall and for population subgroups. Wald tests were used to determine statistically significant differences by subgroup. Data were analyzed in winter/spring 2019. RESULTS: Twenty percent of patients presented with at least 1 social risk. The most frequently reported risks included housing quality (6.5%) and food insecurity (6.1%). Middle-aged (30-59 years) respondents (24.7%, 95% CI=23.6%, 25.7%) compared with those aged 18-29 years (17.7%, 95% CI=16.4%, 19.2%, p<0.001), and Medicaid patients (24.8%, 95% CI=24.0%, 25.5%) compared with commercially insured patients (11.8%, 95% CI=11.1%, 12.5%, p<0.001), were more likely to report social risks. The strongest predictor of housing quality risk was residing in public housing (15.1%, 95% CI=13.8%, 16.6%) compared with those not in public housing (5.6%, 95% CI=5.3%, 5.9%, p<0.001). Housing quality was the most frequently reported risk for children (aged <18 years) and older adults (aged ≥70 years), whereas, for middle-aged respondents (30-69 years), it was food insecurity. CONCLUSIONS: There are important differences in the prevalence of overall and individual social risks by subgroup. These findings should be considered to inform clinical care and social risk screening and interventions.

Emergency Contraception Use: The Influence of Awareness, Attitudes, and Beliefs Among Non-Hispanic White, Non-Hispanic Black, and Hispanic Women in the United States.

OBJECTIVES: Given persistent racial/ethnic disparities in unintended pregnancies, this study aims to understand factors associated with emergency contraception (EC) use among non-Hispanic White, non-Hispanic Black, and Hispanic women. METHODS: This study used a nationally representative sample of 1,990 women of reproductive age in the United States who participated in the 2016 Survey of Family Planning and Women's Lives. Logistic regressions were estimated to assess the association of sexual/pregnancy history, attitudes toward pregnancy, attitudes toward contraception, awareness and beliefs about EC, and source of information regarding contraception with ever using EC. RESULTS: After adjusting for demographic characteristics, we found no significant differences in ever using EC by race/ethnicity. Among non-Hispanic White women, those who used barrier methods of contraception, reported a previous unplanned pregnancy, reported having heard some or a lot about EC, and believed that EC is somewhat to very effective had higher odds of EC use. Among non-Hispanic Black women, those who reported a previous unplanned pregnancy and believed that EC was somewhat to very effective had higher odds of EC use. Among Hispanic women, those who reported using long-acting reversible contraceptives, having recent male sexual partners, and believing that EC is both somewhat to very safe and effective had higher odds of EC use. CONCLUSIONS: Awareness and beliefs about safety and effectiveness are modifiable factors that may influence EC use. Population-level interventions can focus on improving awareness and understanding of the safety and effectiveness of EC.