Case Studies

Get With the Guidelines^SM Coronary Artery Disease

This American Heart Association (AHA) program is a registry of more than 700 cardiovascular hospitals, and is perhaps the most successful quality improvement program ever launched.

Sponsored by a major pharmaceutical company and managed in partnership with the AHA, the program focuses on secondary prevention of heart disease in patients presenting with coronary artery disease or vascular events to acute care hospitals. The registry collects data for scientific publications and functions as a hospital-based, quality-improvement system to ensure that patients with cardiovascular disease are managed with appropriate medications and risk modification counseling.

An article in Archives of Internal Medicine (January, 2004) reported the dramatic results of the GWTG program in such areas as increasing compliance with lipid lowering therapy prescribed at discharge. With more than 400,000 patients enrolled so far, and more than 8 publications submitted in just the last 12 months, this project not only generates evidence but is projected to save up to 80,000 lives annually when the registry reaches 1,800 hospitals.

ATHENA

ASCUS Triage & HPV: Evaluation and National Averages (ATHENA) was an observational study designed to collect data on women with a community diagnosis of ASCUS, including their demographics, cervical cancer risk factors, and cytology and biopsy results. ATHENA collected outcomes data on the performance of human papilloma virus (HPV) testing for women with ASCUS among practicing physicians and assisted physicians in patient follow-up and management. The registry identified inter-practice variation in rates of HPV positivity, and correlated cytology and HPV testing results to pathology results in patients who went on to a surgical biopsy or cervical excision procedure. ATHENA also collected data showing how ASCUS patients were managed in clinical practice, including demographic and clinical variables, results of HPV testing, referrals for colposcopy and directed biopsy, and follow-up data at six-month intervals.

The purpose of ATHENA was to help physicians determine the most clinically beneficial, appropriate and cost-effective use of HPV testing in the management of ASCUS patients.

The primary objective of ATHENA was to acquire data to evaluate correlations between clinical, cytology and HPV assay results and pathological cervical cancer diagnoses for ASCUS patients in real-world clinical practice. Secondary objectives included:

1. Assess for variability in the primary objective between different regions and practice types in the United States
2. Document the actual real-world strategies for patients with a diagnosis of ASCUS managed by HPV testing
3. Provide data to health care providers to characterize temporal trends in practice patterns and their relation to patient outcomes
4. Facilitate quality assurance and continuing quality improvement efforts for clinicians and women’s health practices

ATHENA provided a unique, geographically representative sample of more than 900 practicing clinicians, primarily from community-based practices. The 12,000 women included in the study were consistent with the population of women described by the United States census and the results far more generalizable than a similar study performed by the National Institutes of Health.

Myocardial Infarction

In 2001, the world’s largest registry was transformed by Outcome from paper to the Outcome web platform. The move streamlined data entry, quality checking, and reporting. Outcome eliminated the problems of the paper registry with instant, automatic error correction, zero time-to-data, and on-demand reporting. Outcome’s design, training, and support ensured that this registry fit well into the sites’ workflow.

By making the switch with Outcome, the major biopharmaceutical company sponsor reported that it not only cut data management costs by more than 40%, but Outcome’s enhanced feedback and reporting actually increased the business value of the registry. Initially, the sponsor expected only 50% of its paper-based participants to switch to the online program during the first year after launch. As word spread about Outcome’s user-friendly, time-saving features, nearly 100% of the registry participants were using the program online within 9 months of the launch.

This registry has produced more than 170 peer-reviewed publications, many of which have been in tier 1 journals such as Journal of the American Medical Association and New England Journal of Medicine.

National Breast Care Registry (NBCR™)

This registry was sponsored by a medical device division of a major pharmaceutical company. The intention of the study was to enroll physicians and to record and improve the best practices of physicians who treat breast disease nationwide. The National Breast Care Registry (NBCR™) linked physicians and facilities for national benchmarking of breast disease, capturing detailed biopsy data and outcomes. In addition, the NBCR would remind office personnel when a patient was due for follow-up, provide individualized and comparative reports, and help physicians meet accreditation requirements. NBCR reports were generated in “real time” and were constantly updated based on the most current data in the system. This module enabled breast centers and individuals performing breast biopsy to track all patients undergoing histological breast biopsies, sentinel node biopsies, or subsequent surgery.

The program produced reports that met current and proposed credentialing requirements for physicians practicing image-guided breast biopsy. The NBCR™ Clinical Advisory Board was formed comprised of a number of thought leaders in breast care. The study allowed physicians to benchmark themselves against the national average to identify areas for change in the hope of improving quality and efficiency in their practices. The goals were to improve patient care and reduce costs.

The program enrolled more than 13,000 patients and tracked patients prospectively for recurrence rates, mortality, and so forth. The registry was viewed as high value to the participants, and key opinion leaders perceived the sponsor as a major “thought partner.” It provided unique data on real-world clinical practice from a representative sample of 250 academic and community-based centers.

OPTIMIZE-HF

OPTIMIZE-HF was a hospital-based heart failure quality improvement program and registry, which enrolled 50,000 patients at hundreds of hospitals. OPTIMIZE-HF combined an internet-based registry with a comprehensive process of care improvement strategy, including a hospital toolkit and structured educational initiatives. The program implemented quality improvement based on current evidence and guidelines for patients with heart failure and measured meaningful outcomes around the management of heart failure using real-time benchmarking tools.

OPTIMIZE-HF utilized Outcome’s online capabilities to enhance the ability to deliver best practice information by integrating relevant patient education materials and comprehensive discharge summaries into the web interface. Participating hospitals were given tools to customize a heart failure program based on current evidence and templates and to use real-time reports in tracking performance against benchmarks from similar institutions, both regionally and nationally.

COMPARE

COMPARE (Comprehensive, Observational, Multicenter Prostate Adenocarcinoma REgistry) measures practice patterns and benchmarks clinical outcomes of physicians on an individual, regional, and global basis in order to generate hypotheses for use in future clinical trials and provide data that may help define optimal standards of care. In addition, the registry assesses efficacy and evaluates safety and tolerability of various treatment strategies used in the management of advanced prostate cancer, including their health-related quality of life implications. The goal of the registry is to help the medical community better understand physicians’ practice, decision-making patterns and the subsequent patient outcomes in the treatment of prostate cancer. The objectives of the registry are:

• To document the determinants of treatment decisions for men with rising PSA levels, following definitive surgical or radiological treatment of prostate cancer
• To estimate disease progression for these patients as measured by biochemical, clinical, and radiological indicators
• To collect information on patient quality of life before and after therapeutic interventions for men with a rising PSA through the use of a patient questionnaire
• To measure the crucial outcomes of various disease management strategies

The site enrollment goal of 250 sites includes most of the premier oncology centers in the country. Patient enrollment is scheduled for approximately 4,000 patients with a strong emphasis on robust quality of life and utility measurements.

The seamless hybrid approach to data capture allows participation by sites both with and without Internet access and for direct patient reported outcomes data to be collected. A number of real-time user and administrative reports are available to practitioners to compare their measures against other facilities; these are also available to the sponsor.

The registry provides participating centers with a unique opportunity to understand real-world treatment decisions and to evaluate outcomes, including patient reported quality of life, in a comprehensive and comparative manner. The registry will lead to a better understanding of the role of patient quality of life in treatment decisions and the resulting outcomes. Through a commitment to real-world evidence, the sponsor has established the registry as a major resource in the field of prostate cancer.