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While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. The aim of this study was to describe the landscape of technology-enhanced approaches that could be used to facilitate medical chart review within and across distributed data networks. We conducted a semi-structured survey regarding processes for medical chart review with organizations that either routinely do medical chart review or use technologies that could facilitate chart review. Fifteen out of 17 interviewed organizations used optical character recognition (OCR) or natural language processing (NLP) in their chart review process. None used handwriting recognition software. While these organizations found OCR and NLP to be useful for expediting extraction of useful information from medical charts, they also mentioned several challenges. Quality of medical scans can be variable, interfering with the accuracy of OCR. Additionally, linguistic complexity in medical notes and heterogeneity in reporting templates used by different healthcare systems can reduce the transportability of NLP-based algorithms to diverse healthcare settings. New technologies including OCR and NLP are currently in use by various organizations involved in medical chart review. While technology-enhanced approaches could scale up capacity to validate key variables and make information about important clinical variables from medical records more generally available for research purposes, they often require considerable customization when employed in a distributed data environment with multiple, diverse healthcare settings.

Hybrid aortic arch repair is increasingly used for the management of aortic arch aneurysm. Pseudoaneurysm is a newly described late complication of this procedure. A 57-year-old man underwent emergent supra-aortic debranching and aortic arch stent grafting after rupture of an arch aneurysm. Three years later, the patient presented with a pseudoaneurysm at the junction between the stent graft's proximal landing zone and the origin of the debranching graft. At reoperative repair, the proximal stent graft had eroded through the aortic wall at the junction of the endograft proximal landing zone and the proximal anastomosis of the debranching graft. The presence of a dilated, fragile ascending aorta at the initial procedure seemed to be a risk factor for development of the pseudoaneurysm. Replacement of the ascending aorta combined with supra-aortic debranching has become an accepted strategy in hybrid arch repair to establish a suitable landing zone for the endograft.

Purpose We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA. Methods A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data. Results As of July 2011, information on 99 260 976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316 009 067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center. Conclusion This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system. Copyright © 2012 John Wiley & Sons, Ltd.

Summary Background Medication adherence is important in managing COPD. This study analyzed real-world use of inhaled medications for COPD to characterize relationships between daily dosing frequency, adherence, healthcare resource utilization, and cost. Methods This retrospective study used a large administrative claims database covering 8 million insured lives in the US from 1999 to 2006. Patients were stratified based on the recommended daily dosing frequency of their first COPD drug claim following COPD diagnosis. Adherence was measured using proportion of days covered (PDC) over 12 months following treatment initiation. Healthcare resource use included inpatient, outpatient, and emergency room visits. A multivariate regression model assessed the relationship between adherence and one-year healthcare resource use, controlling for demographics, comorbidities, and baseline resource use. Unit healthcare costs were obtained from the 2005 Medical Expenditure Panel Survey, adjusted to 2008 dollars. Results Based on a sample of 55,076 COPD patients, adherence was strongly correlated with dosing frequency. PDC was 43.3%, 37.0%, 30.2% and 23.0% for QD, BID, TID, and QID patient cohorts, respectively. Regression analysis showed that one-year adherence was correlated with healthcare resource utilization. For 1000 COPD patients, a 5% point increase in PDC reduced the annual number of inpatient visits (−2.5%) and emergency room visits (−1.8%) and slightly increased outpatient visits (+.2%); the net reduction in annual cost was approximately $300,000. Conclusion COPD patients who initiated treatment with once-daily dosing had significantly higher adherence than other daily dosing frequencies. Better treatment adherence was found to yield reductions in healthcare resource utilization and cost.

Patients with chronic myeloid leukemia (CML) who do not adhere to treatment may experience suboptimal outcomes.To examine the association between adherence with imatinib and direct healthcare costs and resource utilization in a large group of privately insured CML patients.CML patients under age 65 were identified with ICD-9 code 205.1X using MarketScan Commercial Claims data between 1/1/02 and 7/31/08. Patients were required to be continuously enrolled in a private insurance plan during the baseline and study periods, defined respectively as the 4 months prior to and the 12 months following imatinib initiation. Non-adherence was evaluated by the medication possession ratio (MPR), defined as the fraction of days during the study period that patients had filled prescriptions for imatinib, and stratified into two groups (low MPR:85%, high MPR:or =85%). Costs, inpatient admissions, and hospital days were compared between high and low adherence groups using Wilcoxon tests. Regression models compared utilization and costs controlling for age, sex, CML severity, Charlson comorbidity index, baseline costs, and other factors.The study sample consisted of 592 patients, where 242 (40.9%) patients were classified with a low MPR, while 350 (59.1%) had a high MPR. Mean MPR was 79% (95% confidence interval 76-81%). Patients with a low MPR incurred more all-cause inpatient visits (4.1 vs. 0.4; p0.001) and all-cause inpatient days (14.8 vs. 1.8; p0.001). Regression models demonstrated a 283% increase (US$56 324; p0.001) in non-imatinib costs within the low- vs. high-MPR group. The generalizability of this study is limited by the use of a privately insured population under 65 years of age as well as by the limitations common to claims data analyses.Imatinib adherence is an important issue for patients and physicians. Better imatinib adherence was associated with significantly lower resource utilization and costs in CML patients, as lower imatinib costs in low MPR patients were more than offset by higher non-imatinib costs mostly driven by inpatient services.

This paper provides the first analysis of the intergenerational transmission of participation in a Canadian social assistance program. Two sources of intergenerational transmission are taken into account: one that is due to a possible causal link between parents' and children's participation, and one that is due to a correlation between individual and environment specific characteristics across generations. The basic data come from the Quebec government's administrative records and cover 17,203 young people who were 18 years old in 1990 and whose parents were recipients of social assistance during at least one month between 1979 and 1990. The results reveal that, on average, a one-percentage unit increase in parental participation during the youth's pre-adult years (age 7–17) raises the youth's participation rate by 0.29 percentage unit during early adulthood (age 18–21). This impact is stronger during the early stages of childhood (age 7–9) and during late adolescence (age 16–17).

Background/Aims To allow rapid response to FDA data inquiries, Mini-Sentinel Operations Center (MSOC) has developed seven modular programs (MP) for use within FDA’s Mini-Sentinel Pilot, a large, multi-institutional distributed database with 17 data partners (DP) designed to support the agency’s efforts to develop an active surveillance system for monitoring medical product safety in the United States.

Compare treatment persistence and health care costs of major depressive disorder (MDD) Medicaid patients treated with escitalopram versus citalopram.Retrospective analysis of Medicaid administrative claims data.Analyzed administrative claims data from the Florida Medicaid program (07/2002-06/2006) for patients ages 18-64 years with 21 inpatient claim or 2 independent medical claims for MDD. Outcomes included discontinuation and switching rates and prescription drug, medical, and total health care costs, all-cause and related to mental disorder. Contingency table analysis and survival analysis were used to compare outcomes between treatment groups, using both unadjusted analysis and multivariate analysis adjusting for baseline characteristics.The study included 2,650 patients initiated on escitalopram and 630 patients initiated on citalopram. Patients treated with escitalopram were less likely to discontinue the index drug (63.7% vs. 68.9%, P=0.015) or to switch to another second-generation antidepressant (14.9% vs. 18.4%, P=0.029) over the six months post-index date. Patients treated with escitalopram had $1,014 lower total health care costs (P=0.032) and $519 lower health care costs related to mental disorder (P=0.023). More than half of the total cost difference was attributable to savings in inpatient hospitalizations related to mental disorder ($571, P=0.003) and to outpatient costs ($53, P0.001). Escitalopram therapy was also associated with $736 lower medical costs related to mental disorder (P=0.009).In the Florida Medicaid program, compared to adult MDD patients initiated on citalopram, escitalopram patients have better treatment persistence and lower total health care costs due to any cause and due to mental disorder, mostly driven by lower hospitalization costs related to mental disorder.

To describe the incidence of diagnosis of gastroesophageal reflux disease and acid-related conditions (GERD/ARC) throughout childhood and characterize patterns of diagnosis and treatment with proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H(2)RAs).Cohorts of GERD/ARC children (age 0-18 years) were identified from a large US administrative claims database covering 1999-2005 using ICD-9 codes. Incidence, healthcare utilization (HCU), costs, therapy discontinuation and switching rates were compared between various age and patient groups.Between 2000 and 2005 annual incidence of GERD/ARC diagnosis among infants (age ≤1 year) more than tripled (from 3.4 to 12.3%) and increased by 30% to 50% in other age groups. Patients diagnosed by GI specialists (9.2%) were more likely to be treated with PPIs compared to patients diagnosed by primary care physician (PCP). PPI-initiated patients doubled (from 31.5% in 1999 to 62.6% in 2005) and, when compared with H(2)RA-initiated patients, were associated with 30% less discontinuation and 90% less therapy switching in the first month, and with higher comorbidity burden and pre-treatment total HCU and costs when diagnosed by GI specialists.The use of an exploratory definition for GERD/ARC, administrative claims data and potential coding errors in diagnosis codes used in selection process may limit the generalizability of the results.GERD/ARC incidence increased for children of all ages between 2000 and 2005. PCPs made the majority of diagnoses. PPI initiations have now surpassed H(2)RA initiations.

Gastroesophageal reflux disease and acid-related conditions (GERD/ARC) are common in pediatric practice but their costs have not been well characterized.To compare healthcare costs (HCC) and healthcare utilization (HCU) of pediatric GERD/ARC between groups of GERD/ARC patients initiated on histamine-2 receptor antagonists (H(2)RAs) or proton pump inhibitors (PPIs) and matched controls.Children (age18 years) diagnosed with GERD or ARC (exploratory category) were identified from a large US claims database (1999-2005) using ICD-9 codes. Costs of pediatric GERD/ARC were estimated by comparing 6-month post-diagnosis HCC between cases and matched controls. GERD/ARC-related HCC and HCU for the year 2005 were further compared between GERD/ARC patients initiated with PPIs vs. H(2)RAs in terms of the cost differences relative to pre-initiation (difference-in-difference) and using multivariate regression to adjust for demographics, pre-treatment health status and pre-treatment costs.A total of 27 865 matched pairs were identified. GERD/ARC patients incurred on average more 6-month total HCC than controls ($2386). In 2005, 1010 pediatric patients were initiated on H(2)RAs or PPIs. About 61% were initiated on PPIs and incurred 1.8 times higher 6-month post-initiation GERD/ARC-related HCC than H(2)RA-initiated patients ($661 vs. $372, p0.001). Although total 6-month GERD/ARC-related HCC increased for both PPI- and H(2)RA-treated patients, the increase was 30% less for PPI-treated patients ($173 vs. $246, p = 0.521) in the difference-in-difference analysis and 69% less in the multivariate analysis ($109 vs. $347, p = 0.040).The use of an exploratory definition for GERD/ARC, administrative claims data and potential coding errors in diagnosis codes used in selection process may limit the generalizability of the results.Pediatric GERD/ARC patients incurred significantly higher healthcare costs compared to similar children without GERD/ARC. Compared to patients initiated with H(2)RAs, patients initiated with PPIs had more baseline comorbidities, and lower GERD/ARC-related HCC after beginning treatment.

Proton pump inhibitors (PPIs) are the most commonly used pharmacological treatment for gastroesophageal reflux disease (GERD).To examine the utilization patterns of PPIs and other GERD-related medications, satisfaction with PPI treatment and presence of GERD symptoms.GERD patients using prescription PPIs were identified from a mixed-model HMO health plan. Utilization patterns of PPIs and other GERD medications, satisfaction with PPI treatment and presence of GERD symptoms were assessed using questionnaires.Among the 617 patients who completed the survey, 71.0% used PPIs once a day (QD), 22.2% used twice a day (BID) and 6.8% more than twice a day or on an as-needed basis. Approximately 42.1% of all patients supplemented their prescription PPIs with other GERD medications, including over-the-counter medications and H(2)-receptor antagonists. Over 85% of the patients still experienced GERD symptoms and 82.7% nighttime symptoms. Overall, 72.8% of all patients were satisfied or very satisfied with their PPI treatment.The study used self-reported data which may have been subject to recall bias. As the study was conducted in a specific region of the US, the results may have limited generalizability to other US regions or countries.Patients on PPI treatment often experience GERD symptoms and supplement their prescription PPIs with other GERD medications. A substantial proportion of GERD patients receiving PPI treatment are on a BID regimen. Furthermore, more than a quarter of the patients are not completely satisfied with their PPI treatment.

Background/Aims Multi-site, multi-purpose networks such as the HMO Research Network consortia projects and the FDA Mini-Sentinel need an efficient mechanism to track project activities and specific queries, organize local resources, and create a searchable index to enable communication of lessons learned and re-use of resources. To this end, the Mini-Sentinel Operations Center (MSOC) has created the Mini-Sentinel Data Catalog (MSDC) to track all Mini-Sentinel projects.