Case Study: Registry #1
Objectives - Case #1
• To compile a clinical database on the medical management of patients hospitalized with acute heart failure (HF), using information collected from acute care hospitals across Australia.
• To assist hospitals in evaluating and improving quality of care for patients with acute HF by tracking quality indicators and providing benchmark data reports.
• To describe the demographic and clinical characteristics of patients who are hospitalized with acute HF.
• To characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute HF.
• To identify patient characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute HF.
• To characterize trends and changes over time in the management of acute HF.
• To offer surveillance of adherence to practice guidelines as these emerge for the inpatient management of acute HF.
This is a multi-center, observational, quality assurance, disease cohort study of the management of patients treated in the hospital for acute HF in Australia. The target population consists of patients admitted to an acute care hospital who are actively treated for acute HF, where acute HF is defined as: i) new-onset HF with decompensation; or ii) chronic HF with decompensation. Patient eligibility is based upon the presence of an acute HF diagnosis and is not tied to the use of any specific therapeutic agent or regimen. The scope of this study applies to 720 patients in 8 sites in Australia addressing Project Management and Clinical monitoring for program start-up phase only.
Cost of the program was a major client consideration
• Flexibility & timeliness to adapt to specific requests of client.
• Implementation of rapid turn around time to issue invoices.
• Maximising our experience of current clinical staff with sites used for client's registry trial.
Successfully delivered the milestone expected by the client by 28th Feb. 2006.
Objectives - Case #2
In the population at risk of atherothrombotic events, the objectives were to evaluate the long-term risk (yearly event rate) of atherothrombotic events in the global population and in different population subgroups, to compare long-term outcomes within different subject profiles, to evaluate the importance of cross risks of subjects at risk, and to define predictors of risk for subsequent atherothrombotic events.
Secondary objectives were to obtain data on treatment strategies used during the registry follow-up and on patient management for pharmaco-economic analysis.
64,000 patients were included (40,000 to 55,000 patients were planned) in approximately 5,500 sites in 38 countries (Europe, North and Latin America, and Asia). Services included data management, statistics, and medical writing.
• Size of the registry in terms of number of patients, sites and countries.
• Patient follow-up over a period of 2 years.
• Data collection (paper and electronic; 4 languages).
One core protocol and 6 sub-studies.
• Development of a user-friendly, multi-lingual, hybrid paper-EDC solution.
• Centralized site Management.
Client very satisfied with the outcome of the registry in particular as concerns subject recruitment, quality of data and drop out rate at year 1 and 2.