Disease burden of urinary tract infections among type 2 diabetes mellitus patients in the U.S.

AbstractAimsType 2 diabetes is a reported risk factor for more frequent and severe urinary tract infections (UTI). We sought to quantify the annual healthcare cost burden of UTI in type 2 diabetic patients.MethodsAdult patients diagnosed with type 2 diabetes were identified in MarketScan administrative claims data. UTI occurrence and costs were assessed during a 1-year period. We examined UTI-related visit and antibiotic costs among patients diagnosed with UTI, comparing those with versus without a history of UTI in the previous year (prevalent vs. incident UTI cases). We estimated the total incremental cost of UTI by comparing all-cause healthcare costs in patients with versus without UTI, using propensity score-matched samples.ResultsWithin the year, 8.2% (6,014/73,151) of subjects had ≥1 UTI, of whom 33.8% had a history of UTI. UTI-related costs among prevalent versus incident cases were, respectively, $603 versus$447 (p=0.033) for outpatient services, $1,607 versus$1,819 (p=NS) for hospitalizations, and $61 versus$35 (p<0.0001) for antibiotics. UTI was associated with a total all-cause incremental cost of $7,045 (95% CI: 4,130, 13,051) per patient with UTI per year.ConclusionsUTI is common and may impose a substantial direct medical cost burden among patients with type 2 diabetes

Patients with stricturing or penetrating Crohn\u27s disease phenotypes report high disease burden and treatment needs

BACKGROUND: Crohn\u27s disease (CD) is a chronic autoimmune disease in which inflammation can progress to complications of stricturing and/or penetrating disease. Real-world data on burden of complicated CD phenotypes are limited. METHODS: We analyzed cross-sectional data from the SPARC IBD (Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease) registry from 2016 to 2020. Four mutually exclusive phenotype cohorts were created: inflammatory CD (CD-I), complicated CD (stricturing CD, penetrating CD, and stricturing and penetrating CD [CD-SP]). Statistical analyses were performed using CD-I as the reference. RESULTS: A total of 1557 patients were identified: CD-I (n = 674, 43.3%), stricturing CD (n = 457, 29.4%), penetrating CD (n = 166, 10.7%), and CD-SP (n = 260, 16.7%). Patients with complicated phenotypes reported significantly greater use of tumor necrosis factor inhibitors (84.2%-86.7% vs 66.0%; P \u3c .001) and corticosteroids (75.3%-82.7% vs 68.0%; P \u3c .001). Patients with CD-SP reported significantly more aphthous ulcer (15.4% vs 10.5%; P \u3c .05), erythema nodosum (6.5% vs 3.6%; P \u3c .05), inflammatory bowel disease-related arthropathy (25.8% vs 17.2%; P \u3c .01), liquid stools (24.2% vs 9.3%; P \u3c .001), nocturnal fecal incontinence (10.8% vs 2.5%; P \u3c .001), and CD-related surgery (77.7% vs 12.2%; P \u3c .001). CONCLUSIONS: Patients with complicated CD phenotypes reported higher rates of active CD-related luminal and extraintestinal manifestations, and underwent more surgeries, despite being more likely to have received biologics than those with CD-I. The potential for early recognition and management of CD-I to prevent progression to complicated phenotypes should be explored in longitudinal studies

Assessing the Impact of Propensity Score Estimation and Implementation on Covariate Balance and Confounding Control Within and Across Important Subgroups in Comparative Effectiveness Research

Researchers are often interested in estimating treatment effects in subgroups controlling for confounding based on a propensity score (PS) estimated in the overall study population

Predictive Modeling of Hypoglycemia for Clinical Decision Support in Evaluating Outpatients with Diabetes Mellitus

Objective: Hypoglycemia occurs in 20–60% of patients with diabetes mellitus. Identifying at-risk patients can facilitate interventions to lower risk. We sought to develop a hypoglycemia prediction model. Methods: In this retrospective cohort study, urban adults prescribed a diabetes drug between 2004 and 2013 were identified. Demographic and clinical data were extracted from an electronic medical record (EMR). Laboratory tests, diagnostic codes and natural language processing (NLP) identified hypoglycemia. We compared multiple logistic regression, classification and regression trees (CART), and random forest. Models were evaluated on an independent test set or through cross-validation. Results: The 38,780 patients had mean age 57 years; 56% were female, 40% African-American and 39% uninsured. Hypoglycemia occurred in 8128 (539 identified only by NLP). In logistic regression, factors positively associated with hypoglycemia included infection, non-long-acting insulin, dementia and recent hypoglycemia. Negatively associated factors included long-acting insulin plus sulfonylurea, and age 75 or older. The models’ area under curve was similar (logistic regression, 89%; CART, 88%; random forest, 90%, with ten-fold cross-validation). Conclusions: NLP improved identification of hypoglycemia. Non-long-acting insulin was an important risk factor. Decreased risk with age may reflect treatment or diminished awareness of hypoglycemia. More complex models did not improve prediction

Factors associated with adherence to oral antihyperglycemic monotherapy in patients with type 2 diabetes

Kaan Tunceli,1 Changgeng Zhao,1 Michael J Davies,2 Kimberly G Brodovicz,3 Charles M Alexander,4 Kristy Iglay,1 Larry Radican1 1Global Health Outcomes, Merck &amp; Co, Inc, Whitehouse Station, NJ, USA; 2Global Scientific and Medical Publications, Merck &amp; Co, Inc, Whitehouse Station, NJ, USA; 3Global Epidemiology, Merck &amp; Co, Inc, Whitehouse Station, NJ, USA; 4Global Medical Affairs, Merck &amp; Co, Inc, Whitehouse Station, NJ, USA Aim: To estimate the rate of adherence to oral antihyperglycemic monotherapy for patients with type 2 diabetes in the US and describe factors associated with adherence in these patients.Materials and methods: In this retrospective cohort analysis, patients aged 18 years or older with a type 2 diabetes diagnosis received between 1 January 2007 and 31 March 2010 were identified using a large US-based health care claims database. The index date was defined as the date of the first prescription for oral antihyperglycemic monotherapy during this period. Patients had to have continuous enrollment in the claims database for 12 months before and after the index date. Adherence was assessed using proportion of days covered (PDC) and an adjusted logistic regression analysis was performed to evaluate factors associated with adherence (PDC &ge;80%).Results: Of the 133,449 eligible patients, the mean age was 61 years and 51% were men. Mean PDC was 75% and the proportion of patients adherent to oral antihyperglycemic monotherapy was 59%. Both mean PDC and PDC &ge;80% increased with increasing age and the number of concomitant medications, and were slightly higher in men compared to women. Results from the logistic regression demonstrate an increased likelihood of non-adherence for patients who were younger, new to therapy, on a twice-daily dose, female, or on fewer than three concomitant medications compared to their reference groups. Higher average daily out-of-pocket pharmacy expense was also associated with an increased likelihood of non-adherence. All results were statistically significant (P&lt;0.05).Conclusion: Patient characteristics, treatment regimens, and out-of-pocket expenses were associated with adherence to oral antihyperglycemic monotherapy in our study. Keywords: compliance, proportion of days covered, PDC, MPR, T2DM, treatment, medication&nbsp

Reliability and Feasibility of Methods to Quantitatively Assess Peripheral Edema

Objective: To evaluate methods to assess peripheral edema for reliability, feasibility and correlation with the classic clinical assessment of pitting edema

Assessing the Impact of Propensity Score Estimation and Implementation on Covariate Balance and Confounding Control Within and Across Important Subgroups in Comparative Effectiveness Research

PURPOSE: Researchers are often interested in estimating treatment effects in subgroups controlling for confounding based on a propensity score (PS) estimated in the overall study population. OBJECTIVE: To evaluate covariate balance and confounding control in sulfonylurea (SU) versus metformin (MET) initiators within subgroups defined by cardiovascular disease history (CVD) comparing an overall PS with subgroup-specific PSs implemented by 1:1 matching and stratification. METHODS: We analyzed younger patients from a US insurance claims database and older patients from two Medicare (Humana Medicare Advantage, fee-for-service Medicare Parts A, B and D) datasets. Confounders and risk factors for acute myocardial infarction (AMI) were included in an overall PS and subgroup PSs with and without CVD. Covariate balance was assessed using the average standardized absolute mean difference (ASAMD). RESULTS: Compared to crude estimates, ASAMD across covariates was improved 70–94% for stratification for Medicare cohorts and 44–99% for the younger cohort, with minimal differences between overall and subgroup-specific PSs. With matching, 75–99% balance improvement was achieved regardless of cohort and PS, but with smaller sample size. Hazard Ratios within each CVD subgroup differed minimally among PS and cohorts. CONCLUSION: Both overall PSs and CVD subgroup-specific PSs achieved good balance on measured covariates when assessing the relative association of diabetes monotherapy with nonfatal MI. PS matching generally led to better balance than stratification, but with smaller sample size. Our study is limited insofar as crude differences were minimal, suggesting that the new user, active comparator design identified patients with some equipoise between treatments