Global Feedback® System “eClinical”
Clinical Outcomes Programme from Zimmer International Clinical Affairs
Overview
“Proof of performance” is an increasing demand on orthopaedic surgeons today. With the Zimmer Global Feedback System “eClinical”, it is a need that is easily met.
The Feedback Programme is a simple but thorough system designed to provide the orthopaedic community with quality “proof of performance” through careful clinical outcomes research. Our outcomes programmes are intended to allow the orthopaedic surgeon to track clinical and radiographic outcomes for Zimmer products.
The system can be implemented in any medical practice that supports the principles of routine clinical audit. It minimises the requirement for local administrative facilities by providing a centralised data-handling service.
Worldwide, the Feedback Programme currently involves clinical outcomes
tracking on thousands of joint arthroplasty cases.
Go here to see - Our Mission
Contact us: ica.feedback@zimmer.com
Results are focused on:
- Demonstrating quality in health care delivery
- Improving patient care and efficiency
- Personal, confidential performance benchmarking
- Providing opportunities to participate in academic research, publications, and presentations
What Feedback Provides
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Database Management and Analysis
Custom Reports and Presentations
Professional Staff Support
Clinical outcomes support is provided by the Zimmer International Clinical Affairs Department. Our trained, professional clinical research staff follow best practice to ensure quality ethical treatment in line with Good Clinical Practice (GCP) and as described by ISO 14155 and the European Data Protection Directive (95/46/EC).
Data Review and Entry
The Feedback Programme is a complete, streamlined system for the collection, handling, and analysis of clinical data. All data are stored in a secure database and rigorously screened for quality and accuracy by our professional staff.
Database Management and Analysis
The programme provides complete database management to maintain the integrity of the results. Statistical analysis and compilation of results are performed at regular intervals. In addition, surgeons are prompted for follow-up data to keep the database current and help ensure patient compliance.
Data Ownership
Ownership of the data remains with the surgeons and use of the data for publication purposes is only possible after their permission has been obtained. Zimmer reserves the right to use pooled data for necessary regulatory requirements.
Annual Reports
Participating surgeons receive personal, confidential annual reports for their own cases, together with a study-wide report which pools information from all contributors. The personal surgeon report can be used for benchmarking individual outcomes against international patient outcomes norms. This allows surgeons to compare their practices with those of the wider orthopaedic community.
Custom Reports and Presentations
Programme participants are provided with custom reports and presentations to meet the specific needs and requirements of individual surgeons.
Support Materials
The programme provides all necessary logistical support materials, including case report forms, patient consent forms, follow-up reminders, and compliance reports.
User Group Meetings
Optional informal meetings are held where surgeons can discuss their findings, as well as specific issues and practices, with other surgeons involved in the study. This provides a scientific forum for interaction and discussion.
Clinical Affairs: Mission Statement
Our worldwide mission is to conduct registry programmes and clinical research studies with the highest concern for quality and ethics, and to utilise clinical research to help foster the success of our products through:
- Developing strong relationships with our customers;
- Publishing significant and credible scientific evidence of excellent clinical performance;
- Using clinical performance information to guide future device design and development efforts.
More information
- For more information on:
- How Feedback Works
- Feedback Programmes
- On the Web – eClinical Community
- The Laptop Option
- Example Longitudinal Patient Report
- Examples of Individual and Study-Wide Annual Report Data
