Identifying Patients With Relapsing-Remitting Multiple Sclerosis Using Algorithms Applied to US Integrated Delivery Network Healthcare Data.

BACKGROUND: Relapsing-remitting multiple sclerosis (RRMS) has a major impact on affected patients; therefore, improved understanding of RRMS is important, particularly in the context of real-world evidence. OBJECTIVES: To develop and validate algorithms for identifying patients with RRMS in both unstructured clinical notes found in electronic health records (EHRs) and structured/coded health care claims data. METHODS: US Integrated Delivery Network data (2010-2014) were queried for study inclusion criteria (possible multiple sclerosis [MS] base cohort): one or more MS diagnosis code, patients aged 18 years or older, 1 year or more baseline history, and no other demyelinating diseases. Sets of algorithms were developed to search narrative text of unstructured clinical notes (EHR clinical notes-based algorithms) and structured/coded data (claims-based algorithms) to identify adult patients with RRMS, excluding patients with evidence of progressive MS. Medical records were reviewed manually for algorithm validation. Positive predictive value was calculated for both EHR clinical notes-based and claims-based algorithms. RESULTS: From a sample of 5308 patients with possible MS, 837 patients with RRMS were identified using only the EHR clinical notes-based algorithms and 2271 patients were identified using only the claims-based algorithms; 779 patients were identified using both algorithms. The positive predictive value was 99.1% (95% confidence interval [CI], 94.2%-100%) for the EHR clinical notes-based algorithms and 94.6% (95% CI, 89.1%-97.8%) to 94.9% (95% CI, 89.8%-97.9%) for the claims-based algorithms. CONCLUSIONS: The algorithms evaluated in this study identified a real-world cohort of patients with RRMS without evidence of progressive MS that can be studied in clinical research with confidence.

Older renal cell cancer patients experience increased rates of venous thromboembolic events: a retrospective cohort study of SEER-Medicare data.

BACKGROUND: Venous thromboembolic co-morbidities can have a significant impact on treatment response, treatment options, quality of life, and ultimately, survival from cancer. The extent of venous thromboembolic co-morbidity among older renal cell cancer patients is poorly described in the literature. It is important to understand the scope of venous thromboembolic events, before and after diagnosis, in order to offer renal cell cancer patients optimal care and improved quality of life. METHODS: The main goal of this study was to estimate and describe the incidence of venous thromboembolic events before and after renal cell cancer diagnosis. SEER-Medicare linked data (1991-2003) was utilized for this retrospective cohort analysis (n = 11,950) of older renal cell cancer patients (≥ 65 years). Incidence rates and proportions in addition to multivariable Cox proportional hazard and logistic regression models were utilized to describe the incidence and relative risk of venous thromboembolic events. RESULTS: We observed that in the 12 months after diagnosis, 8.3% of renal cell cancer patients experienced a deep venous thrombosis, 2.4% experienced a pulmonary embolism, and 3.9% experienced other thromboembolic events. Nearly 70% of venous thromboembolic events occurred in the first 90 days after renal cell cancer diagnosis. Renal cell cancer patients were 2-4 times more likely to have a venous thromboembolic event in the 12 months after cancer diagnosis than non-cancer patients followed during the same time frame. Recent history of a venous event substantially increased the risk of that same event in the 12 months after diagnosis (HR = 5.2-18.8). CONCLUSION: Venous thromboembolic events are common and serious co-morbidities that should be closely monitored in older renal cell cancer patients, particularly during the first 3 months following diagnosis and among those with a recent history of a venous thromboembolic event.

Creating a Real-World Data, United States Healthcare Claims-Based Adaptation of Kurtzke Functional Systems Scores for Assessing Multiple Sclerosis Severity and Progression.

INTRODUCTION: This article describes the development of a unique mapping of the Kurtzke Functional Systems Scores (KFSS) from International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) codes among multiple sclerosis (MS) patients within a US Integrated Delivery Network (IDN). Valid identification of increasing disability may allow deeper insight into MS progression and possible treatments. METHODS: This cohort study identified MS patients in the IDN, Intermountain Healthcare. Experienced clinicians and informaticists mapped electronic health record ICD-9-CM codes to KFSS components generating a modified Kurtzke Expanded Disability Status Scale (EDSS). Modified EDSS scores were used to assess disability progression by calculating means, medians, ranges, and changes in KFSS and modified EDSS scores. RESULTS: Overall, 608/2960 (20.5%) patients were identified as having MS progression and presented a wide range of scores on the EDSS 10-point scale. The median (range) first and second EDSS scores were 0 (0-6) and 5 (1-8), respectively. The median (range) change from first to second score was 5 (1-7.5). The median first KFSS score for all systems was 0, and the mean differed among components. The highest mean first KFSS score (1.06) was measured for sensory function and lowest (0.12) for cerebellar functions. Of the 544 patients with their first EDSS scores in the ≤ 2.5 group, 75.2% and 15.1% had their second EDSS scores in group 3-5.5 and ≥ 6, respectively. Of the 62 patients with their first EDSS score in the 3-5.5 group, 58.1% had their second EDSS scores in group ≥ 6. CONCLUSION: This innovative mapping technique is a promising method for future comparative effectiveness and safety research of Disease-Modifying Therapy in Real-World Data repositories. Future research to validate and expand on this method in another healthcare database is encouraged.

Prevalence of and risk for gastrointestinal bleeding and peptic ulcerative disorders in a cohort of HIV patients from a U.S. healthcare claims database.

The primary study objectives were to estimate the frequencies and rates of gastrointestinal bleeding and peptic ulcerative disorder in HIV-positive patients compared with age- and sex-matched HIV-negative subjects. Data from a US insurance claims database was used for this analysis. Among 89,207 patients with HIV, 9.0% had a GI bleed, 1.0% had an upper gastrointestinal bleed, 5.6% had a lower gastrointestinal bleed, 1.9% had a peptic ulcerative disorder diagnosis, and 0.6% had both gastrointestinal/peptic ulcerative disorder. Among 267,615 HIV-negative subjects, the respective frequencies were 6.9%, 0.6%, 4.3%, 1.4%, and 0.4% (p<0.0001 for each diagnosis subcategory). After combining effect measure modifiers into comedication and comorbidity strata, gastrointestinal bleeding hazard ratios (HRs) were higher for HIV-positive patients without comedication/comorbidity, and those with comedication alone (HR, 2.73; 95% confidence interval [CI], 2.62-2.84; HR, 1.59; 95% CI, 1.47-1.71). The rate of peptic ulcerative disorder among those without a history of ulcers and no comorbidity/comedication was also elevated (HR, 2.72; 95% CI, 2.48-2.99). Hazard ratios of gastrointestinal bleeding, and peptic ulcerative disorder without a history of ulcers were lower among patients infected with HIV with comedication/comorbidity (HR, 0.64; 95% CI, 0.56-0.73; HR, 0.46; 95% CI, 0.33-0.65). Rates of gastrointestinal bleeding plus peptic ulcerative disorder followed a similar pattern. In summary, the rates of gastrointestinal/peptic ulcerative disorder events comparing HIV-infected subjects to non-HIV-infected subjects were differential based on comorbidity and comedication status.

Older soft tissue sarcoma patients experience increased rates of venous thromboembolic events: a retrospective cohort study of SEER-Medicare data.

BACKGROUND: Venous thromboembolic co-morbidities can have a significant impact on treatment response, treatment options, quality of life, and ultimately, survival from cancer. There is a dearth of published information on venous thromboembolic co-morbidity among older soft tissue sarcoma patients. METHODS: SEER-Medicare linked data (1993-2005) was utilized for this retrospective cohort analysis (n = 3,480 soft tissue sarcoma patients). Non-cancer patients were frequency-matched by age to cancer patients at a ratio of 1:1; coverage and follow-up requirements were the same as for soft tissue sarcoma cases. Venous thromboembolic events were divided into three groups of interest: deep vein thrombosis, pulmonary embolism, and other thromboembolic events. Relative incidence rates of venous thromboembolic events in soft tissue sarcoma patients with a recent history of cardiovascular event or venous thromboembolic event (12 months before diagnosis) versus soft tissue sarcoma patients without such a recent history were calculated using the Cox proportional hazard models. The Cox proportional hazard model was used to build predictive models to identify important risk factors for each venous thromboembolic event of interest among soft tissue sarcoma patients. Relative incidence rate of VTEs in cancer patients (12 months after diagnosis) versus non-cancer cases (12 months after index date) was calculated using multivariable Cox proportional hazard models. RESULTS: We observed that among older soft tissue sarcoma patients, 10.6% experienced a deep vein thrombosis, 3.0% experienced a pulmonary embolism, and 3.1% experienced other thromboembolic events in the 12 months after sarcoma diagnosis. On average, 60% of venous thromboembolic events occurred in the first 90 days after sarcoma diagnosis. The highest rates of deep vein thrombosis and pulmonary embolism after sarcoma diagnosis were seen in patients with sarcoma not otherwise specified (deep vein thrombosis: 204/1,000 p-y and pulmonary embolism: 50/1,000 p-y). Recent history of a venous thromboembolic event was the strongest predictor of a subsequent venous thromboembolic event after soft tissue sarcoma diagnosis. CONCLUSION: Venous thromboembolic events are common and serious co-morbidities that should be closely monitored in older soft tissue sarcoma patients.