BURLINGAME, CA, United States
BURLINGAME, CA, United States
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Graham D.J.,U.S. Food and Drug Administration | Ouellet-Hellstrom R.,U.S. Food and Drug Administration | Macurdy T.E.,Stanford University | Macurdy T.E.,Acumen, Llc | And 4 more authors.
JAMA - Journal of the American Medical Association | Year: 2010

Context: Studies have suggested that the use of rosiglitazone may be associated with an increased risk of serious cardiovascular events compared with other treatments for type 2 diabetes. Objective: To determine if the risk of serious cardiovascular harm is increased by rosiglitazone compared with pioglitazone, the other thiazolidinedione marketed in the United States. Design, Setting, and Patients: Nationwide, observational, retrospective, inception cohort of 227 571 Medicare beneficiaries aged 65 years or older (mean age, 74.4 years) who initiated treatment with rosiglitazone or pioglitazone through a Medicare Part D prescription drug plan from July 2006-June 2009 and who underwent follow-up for up to 3 years after thiazolidinedione initiation. Main Outcome Measures: Individual end points of acute myocardial infarction (AMI), stroke, heart failure, and all-cause mortality (death), and composite end point of AMI, stroke, heart failure, or death, assessed using incidence rates by thiazolidinedione, attributable risk, number needed to harm, Kaplan-Meier plots of time to event, and Cox proportional hazard ratios for time to event, adjusted for potential confounding factors, with pioglitazone as reference. Results: A total of 8667 end points were observed during the study period. The adjusted hazard ratio for rosiglitazone compared with pioglitazone was 1.06 (95% confidence interval [CI], 0.96-1.18) for AMI; 1.27 (95% CI, 1.12-1.45) for stroke; 1.25 (95% CI, 1.16-1.34) for heart failure; 1.14 (95% CI, 1.05-1.24) for death; and 1.18 (95% CI, 1.12-1.23) for the composite of AMI, stroke, heart failure, or death. The attributable risk for this composite end point was 1.68 (95% CI, 1.27-2.08) excess events per 100 person-years of treatment with rosiglitazone compared with pioglitazone. The corresponding number needed to harm was 60 (95% CI, 48-79) treated for 1 year. Conclusion: Compared with prescription of pioglitazone, prescription of rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older. ©2010 American Medical Association. All rights reserved.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 738.46K | Year: 2011

DESCRIPTION (provided by applicant): This STTR proposal to the National Institute on Aging (NIA) requests funding to expand the capabilities of the Medicare Research Information Center (MedRIC) recently established by Acumen, LLC with support from NIA. Thepurpose of MedRIC is to facilitate the acquisition and linking of data from the Centers for Medicare and Medicaid Services (CMS) to participants of surveys and registries sponsored by NIA and other related federal agencies, and to advance the use of thesedata for research and public policy. By expanding MedRIC's capabilities, Acumen will vastly reduce the financial and time costs that researchers must currently bear to acquire and use CMS administrative data. To date, MedRIC's activities have already linked Medicare enrollment and claims files to NIA surveys and registries. The aim of this STTR project is to expand the scope of the project to include the national assessment records for nursing home residents in the Long-term Care Minimum Data Set (MDS) andfor home health patients in the Outcomes and Assessment Instrument Set (OASIS). By successfully expanding MedRIC's capabilities, this project will vastly relieve the burden that researchers and policy analysts currently face as they investigate health care utilization, quality, and expenditure patterns for nursing home and home health patients. PUBLIC HEALTH RELEVANCE: To promote more effective public policy research on patients receiving home health and nursing home care, this project will create new data resources linking NIH survey data with Medicare patient assessment files. This integration will not only provide researchers higher quality information, but will also reduce the cost for NIH-funded researchers to access and use this linked data.


Trademark
Acumen, Llc | Date: 2016-10-27

Apparatus for pathogen detection biological field testing; PCR platforms; incubators; software for providing a user interface for pathogen detection biological field testing.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.31M | Year: 2014

DESCRIPTION provided by applicant To enhance the utility of federally funded surveys Acumen through a project entitled the Medicare Medicaid Research Information Center MedRIC has pursued adding individual linked administrative data from the Centers for Medicare andamp Medicaid Services CMS to supplement information in these survey data Two prominent surveys are the Health and Retirement Survey HRS and the Panel Study of Income Dynamics PSID both of which provide a wealth of longitudinal data for conducting research on a wide range of economic health retirement and social circumstances of the American public MedRIC has created comprehensive CMS linked research files for these surveys that include all forms of information from Medicare and Medicaid claims for institutional physician and pharmaceutical services In addition MedRIC has produced linked files integrating information from CMS assessment datasets which report numerous health and functional assessments for patients entering certified nursing homes and home health agencies Under this SBIR application Acumen will develop and launch a data enclave as a service of MedRIC that will provide for secure remote access to researchers and policy analysts enabling them to conduct statistical analyses utilizing the linked CMS HRS and CMS PSID data We expect availability of the MedRIC Enclave to markedly expand use of Medicare and Medicaid healthcare data in both scholarly and policy studies using the HRS and PSID while making empirical work easier and less expensive Enclave users will not need to acquire either the computing capacities or the facilities required to analyze the data and to protect against disclosures of confidential information Moreover overall data security will be substantially enhanced over alternative access methods since no personally identifying information will be distributed and the use of such information will be fully controllable at the individual researcher level The design and use of the MedRIC Enclave will fully comply with the Data Use Agreement DUA procedures and data security protocols established by CMS and HRS PSID The Enclaveandapos s internet interface and computing infrastructure will support a broad array of privacy policies through remote access Further the Enclave will incorporate a series of statistical data algorithms that limit disclosure of confidential information Because of these security features it will be possible to extend access to users currently excluded by the restrictions imposed by CMS and HRS PSID which will especially benefit junior faculty post doctoral scholars graduate students and policy analysts PUBLIC HEALTH RELEVANCE Acumen aims to improve the quality of scholarly and policy related healthcare research through the andquot Remote Access Data Enclave for Analysis of HRS PSID Linked to Administrative Dataandquot project by facilitating access to high quality confidential data The Enclave will provide for secure remote access to a platform that enables researchers to conduct statistical analyses utilizing data files that link CMS administrative data with survey data from the Health and Retirement Survey HRS and the Panel Study of Income Dynamics PSID Because Enclave users will not need to acquire either the extensive computing capacities currently required to utilize MedRICandapos s survey linked healthcare files the Enclave will extend access to users currently excluded from accessing the data by CMS or HRS PSID restrictions further by storing these linked healthcare files in a secure and centralized location the MedRIC Enclave will greatly lower the risks of disclosure of personally identifiable information


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 96.00K | Year: 2012

DESCRIPTION (provided by applicant): In the Enhancing Confidentiality of Research Files Based on Medicare Data project, Acumen, LLC aims to expand the overall capabilities of researchers to use survey-linked Medicare claims data. Currently the processfor obtaining approval from the Centers for Medicare and Medicaid Services (CMS) to access these files entails significant paperwork and delays, which imposes a substantial burden on researchers. To facilitate access to high-quality data, Acumen will create survey-linked Medicare claims-level files that meet CMS's expedited DUA process requirements. This process allows researchers to forego components of the standard procedures required to obtain data with personally identifiable information (PII). The Limited Data Set (LDS) files currently available under the expedited process, however, have significant shortcomings. Specifically, the LDS files encrypt, mask, or omit a large number of data elements. Further, the variable do not contain sufficient information to permit linking to survey data, stratified analyses, or the study of geographic variation, among other research purposes. By creating more detailed survey-linked claim-level files available through the expedited process, Acumen will not only reduce thedemand for PII data (thus, enhancing beneficiary confidentiality), but also will allow more researchers to access detailed CMS data. To create these enhanced survey-linked Medicare files, Acumen will leverage our existing Medicare/Medicaid Research Information Center (MedRIC). MedRIC is Acumen's established mechanism for creating and distributing survey-data linked to various CMS administrative files. To meet researcher demand and CMS regulations, Acumen will closely collaborate with NIA surveys and the CMS to accomplish the following Phase I aims: 1. Review CMS data structure and variable encryption criteria for the expedited DUA process 2. Design candidate data structures that comply with the CMS expedited DUA regulations 3. Consult with NIA surveys to refine candidate data structures 4. Secure CMS approval for finalized data structure 5. Establish a design for a data request process with NIA surveys and CMS 6. Determine additional computer infrastructure needed for data storage and extraction In Phase IIof this Fast Track application, Acumen will build the data file designed in Phase I, create documentation, begin data distribution, and obtain user feedback. The creation of these files aims to shift research community's data use paradigm by improving researcher access to CMS data while enhancing beneficiary confidentiality protections. PUBLIC HEALTH RELEVANCE: Currently, researchers who wish to acquire detailed Medicare administrative data must undergo a lengthy application process to access this information. Under the Enhancing the Confidentiality of Research Files Based on Medicare Data project, Acumen will create enhanced Medicare files linked to NIA survey data that: i) researchers will be able to access through an existing expedited acquisition process, and ii) will better protect beneficiary confidentiality by reducing the demand for CMS data containing personally identifiable information. By facilitating access to high-quality data, Acumen aims to improve the quality of healthcare research currently conducted across a wide range of research disciplines.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 702.36K | Year: 2012

DESCRIPTION (provided by applicant): This STTR application requests funding to expand the capabilities of Acumen LLC's Medicare/Medicaid Research Information Center (MedRIC). To advance the quality of the data available for public policy research, MedRIC facilitates the acquisition of data from the Centers for Medicare and Medicaid Services (CMS) to participants of surveys and registries sponsored by the National Institute on Aging (NIA). By linking administrative and survey data into a cohesive structure,Acumen will significantly reduce the financial and time costs that researchers currently bear to acquire and use CMS administrative data. Although MedRIC has already linked NIA survey data to Medicare enrollment and claims files, this project will augmentthese efforts to include linkages to Medicaid claims databases. By successfully expanding MedRIC's capabilities, this project will significantly reduce the burden that researchers and policy analysts face as they investigate health care utilization, quality, and expenditure patterns among low- income individuals, children, and pregnant women.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 236.71K | Year: 2016

DESCRIPTION provided by applicant In the andquot Enhancing Confidentiality of Research Files Based on Medicare Dataandquot project Acumen LLC aims to expand the overall capabilities of researchers to use survey linked Medicare claims data Currently the process for obtaining approval from the Centers for Medicare andamp Medicaid Services CMS to access these files entails significant paperwork and delays which imposes a substantial burden on researchers To facilitate access to high quality data Acumen will create survey linked Medicare claims level files that meet CMSandapos s expedited DUA process requirements This process allows researchers to forego components of the standard procedures required to obtain data with personally identifiable information PII The Limited Data Set LDS files currently available under the expedited process however have significant shortcomings Specifically the LDS files encrypt mask or omit a large number of data elements Further the variable do not contain sufficient information to permit linking to survey data stratified analyses or the study of geographic variation among other research purposes By creating more detailed survey linked claim level files available through the expedited process Acumen will not only reduce the demand for PII data thus enhancing beneficiary confidentiality but also will allow more researchers to access detailed CMS data To create these enhanced survey linked Medicare files Acumen will leverage our existing Medicare Medicaid Research Information Center MedRIC MedRIC is Acumenandapos s established mechanism for creating and distributing survey data linked to various CMS administrative files To meet researcher demand and CMS regulations Acumen will closely collaborate with NIA surveys and the CMS to accomplish the following Phase I aims Review CMS data structure and variable encryption criteria for the expedited DUA process Design candidate data structures that comply with the CMS expedited DUA regulations Consult with NIA surveys to refine candidate data structures Secure CMS approval for finalized data structure Establish a design for a data request process with NIA surveys and CMS Determine additional computer infrastructure needed for data storage and extraction In Phase II of this Fast Track application Acumen will build the data file designed in Phase I create documentation begin data distribution and obtain user feedback The creation of these files aims to shift research communityandapos s data use paradigm by improving researcher access to CMS data while enhancing beneficiary confidentiality protections Currently researchers who wish to acquire detailed Medicare administrative data must undergo a lengthy application process to access this information Under the andquot Enhancing the Confidentiality of Research Files Based on Medicare Dataandquot project Acumen will create enhanced Medicare files linked to NIA survey data that i researchers will be able to access through an existing expedited acquisition process and ii will better protect beneficiary confidentiality by reducing the demand for CMS data containing personally identifiable information By facilitating access to high quality data Acumen aims to improve the quality of healthcare research currently conducted across a wide range of research disciplines


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 87.23K | Year: 2011

DESCRIPTION (provided by applicant): This STTR application requests funding to expand the capabilities of Acumen LLC's Medicare/Medicaid Research Information Center (MedRIC). To advance the quality of the data available for public policy research, MedRIC facilitates the acquisition of data from the Centers for Medicare and Medicaid Services (CMS) to participants of surveys and registries sponsored by the National Institute on Aging (NIA). By linking administrative and survey data into a cohesive structure,Acumen will significantly reduce the financial and time costs that researchers currently bear to acquire and use CMS administrative data. Although MedRIC has already linked NIA survey data to Medicare enrollment and claims files, this project will augmentthese efforts to include linkages to Medicaid claims databases. By successfully expanding MedRIC's capabilities, this project will significantly reduce the burden that researchers and policy analysts face as they investigate health care utilization, quality, and expenditure patterns among low- income individuals, children, and pregnant women. PUBLIC HEALTH RELEVANCE: To promote more effective public policy research on patients with limited income and resources, this project will create new data resources linking NIH survey data with Medicaid claims files. This integration will not only provide researchers higher quality information, but will also reduce the cost for NIH-funded researchers to access and use this linked data.


Trademark
Acumen, Llc | Date: 2016-10-21

Apparatus for pathogen and biological contaminant testing.


Trademark
Acumen, Llc | Date: 2016-10-21

Non-medical bio-assay.

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