Life Science Solutions

LSS™

LIFE SCIENCE SOLUTIONS

The Power to Obtain Complete, Real-World Patient Data

Rethink what is possible….Obtain timely real-world patient data through Outcomes Health’s proven Health Care Data Acquisition, Abstraction, and Analysis Capabilities

To achieve the most accurate results, a sound clinical data process is vital. Outcomes Health’s trained team made up of registered nurses expertly acquires and reviews healthcare data, specific to your study’s objectives and measurement parameters.

Using Outcomes Health’s proprietary processes and technology, our nationwide network of 4,000 data acquisition specialists collect evidentiary data from the point-of-care settings following study-specific criteria. Our centralized staff of nurses investigates the raw data, extracts the information you need, and objectively presents the findings. It’s all part of best-in-class health information services.

Our proprietary processes and technology have been developed to efficiently gather patient data. To do this we have the ability to work across paper and electronic based medical record platforms, including proprietary platforms used by payers and managed care. We leverage on-site data acquisition in combination with fax/mail and EMR record transmittal from provider locations. Additionally, our centralized acquisition and abstracting processes and resources ensure you receive high-quality data faster than current industry models.

Our solutions for the Life Sciences include:

• Case Study: Efficient, Scalable Health Care Data Capture

• Case Study: Health Care Data Capture for Life Sciences

• Data Driven Study Design, Site Selection, and Patient Recruitment

• Consulting Services to Optimize Medical Record Data Capture

• Patient Outreach Programs to Support Study Protocol Compliance

• Adverse Event Data Collection, Triage, Tracking, and Reporting

Case Study: Efficient, Scalable Health Care Data Capture

On an annual basis, Outcomes Health is involved in helping our health plan clients meet quality of care compliance requirements. For example, last year our team acquired, abstracted, analyzed, and reported data from more than 550,000 charts across 21 clients within 10 weeks.

Acquiring the data entailed coordinating transmittal processes with more than 179,000 providers at more than 118,000 locations in 43 US states. Outcomes Health utilized a blend of acquisition techniques including on-site data acquisition for more than 69,000 providers. We also gathered patient data via EMR, fax, and mail transmittals.

The projects were completed on-time with 100% of compliance audits passed. Critical to our success in completing these projects were our flexible staff deployment processes, technology platform, and centralized abstraction and monitoring services. These tools and technologies are available to our life sciences clients and can be appropriately scaled to meet the needs of the project.

Case Study: Health Care Data Capture for Life Sciences

Outcomes Health was asked to provide chart collection and abstraction services for a comparative effectiveness study of antiplatelet agents in an in-patient setting. For this retrospective chart review Outcomes Health requested charts for 645 patients at 150 differentU.S. provider sites.

The complex CRF for this study had 320 data elements and required a careful selection of readers. A small group abstractors was trained for the study, all were Registered Nurses with a minimum of 2 years of experience in a cardiac surgery or ICU setting and with demonstrated skills in coding cardiac events.

Outcomes health delivered a dataset to to the client less than 12 weeks from receipt of the list subjects.

When it comes to gathering data, you’re only as fast as your slowest site. By putting abstraction and data submission in the hands of a dedicated group, timelines are accelerated. Quality also increases as a small group of dedicated and specially trained abstractors will have higher inter-reader reliability than 150 site coordinators abstracting a few charts each.

Data Driven Study Design, Site Selection, and Patient Recruitment

ODIS AlertIQ™ is Outcomes Health’s proprietary data engine used for the identification, quantification, and ranking of medical records. ODIS AlertIQ™ has unique compliance-based logic that identifies and ranks providers of health care services for each patient that is most likely to have the maximum amount of well-documented diagnoses within their medical records. The result is more robust data to identify providers with eligible study patients.

Identifying Best Sites for a Late Phase Protocol: Diabetes Mellitus Type 2 with Vascular Disease

Eligibility Assumptions

U.S. population for which diagnosis and/or procedural codes met inclusion and exclusion criteria.

Data Source

Patient population from seven payers and 3.5 years of claims history (2007 – 2010)

All patient information was de-identified

Search Patients were included for:

Diagnosis code for type 2 diabetes mellitus AND

1.Evidence of clinical vascular disease and age > 50 years with diagnosis or procedural codes indicative of (at least one):

a) prior myocardial infarction

b) prior stroke

c) prior coronary, carotid or peripheral arterial revascularization

d) >50% stenosis on angiography of coronary, carotid or lower extremity arteries

e) history of angina with documented ischemia on an exercise stress test, or on any cardiac imaging, or unstable angina with ECG changes or cardiac enzyme elevation

f) asymptomatic angina with positive nuclear imaging test

g) chronic heart failure NYHA class II-III

2. Evidence of subclinical vascular disease and age > 60 years with diagnosis or procedural codes indicative of (at least one):

a) microalbuminuria or proteinuria

b) history of hypertension or previously treated hypertension and left ventricular hypertrophy by ECG or imaging

c) left ventricular systolic or diastolic dysfunction by imaging

d) ankle/brachial index <0.9

Search patients were excluded for:

1. Current or previous treatment with insulin

2. An acute coronary or cerebro-vascular event within 14 days prior to screening

3. Current continuous renal replacement therapy, prior kidney transplant or awaiting kidney transplant

4. A prior heart transplant

5. Current malignant neoplasm

6. History of acute, chronic or recurrent pancreatitis

Results from Outcomes ODIS AlertIQ™ Search:

Results were mapped to a single patient/provider relationship, prioritized by specialty and most recent visit if more than one patient/provider pair was identified. Hospitals as providers were excluded.

18,068 unique eligible patients from 9,346 providers (reported only a single provider for each patient and did not list hospitals as providers)

Top 10% of providers (N=935): 7,506 eligible patients

Top 3% providers (N=280): 4,426 eligible patients

Consulting Services to Optimize Medical Record Data Capture

We understand the privacy laws, documentation, and methodologies under which regulatory authorities and health care providers grant access to medical record data. We know how these vary by provider specialty, medical indication, and level of authorization.

Outcomes Health clinicians read over 2 million medical records each year. We know where within the record you are most likely to find the data elements you need and the common pitfalls to avoid. We can provide the critical direction required for your protocol-driven clinical abstraction guidelines.

Let our expert staff consult with you during protocol development to determine the optimal design for your health data capture needs.

Patient Outreach Programs to Support Protocol Compliance

Outcomes Health provides outreach to providers and subjects to help clients meet their goals of 100% complete and accurate data. Our experienced Health Advocates provide protocol education and visit reminders to subjects and can offer 3-way calling assistance to schedule appointments with providers. Documentation is faxed to providers upon scheduling of the appointments and follow-up calls are made to ensure that scheduled appointments are kept.

Adverse Event Data Collection, Triage, Tracking and Reporting

Outcomes Health clinicians can partner with in-house and external pharmacovigilance experts to manage data collection, triage, tracking, and reporting of your adverse events from start to finish. Analyzing, assessing and reporting important safety data requires best practices for data entry, follow-up, quality control, medical review and quality assurance. Outcomes Health adheres to industry-recognized best practices for health data capture.

Clinicians at Outcomes Health transform descriptions of adverse events, medications, and other clinical data into universal medical code numbers or terms using the following:

•World Health Organizations Drug Dictionary (WHODRUG)

•Medical Dictionary for Regulatory Affairs (MedDRA)

•Any agreed upon hierarchically-structured dictionary

Contact our Life Sciences team at lifesciences@outcomes-health.com or 678.942.2200 Prompt 4 for more information.