To expand our knowledge of current options for post-mastectomy breast reconstruction, we propose to build a multicenter, international consortium of centers and a Web-based patient registry to track long-term outcomes of post-mastectomy reconstruction. Eleven centers in the United States, Canada, and Belgium with demonstrated expertise and high case volumes in these procedures have agreed to participate. The overall purpose of the proposed project is to establish the infrastructure and to pilot test the instruments and other data-gathering processes for a later Department of Defense Breast Cancer Research Program (DoD BCRP) Center of Excellence grant. Eventual DoD funding will enable the consortium to recruit and track breast reconstruction patients among the eleven sites for at least three years following reconstruction. Specific aims of the proposed PSEF/NEPS project are as follows:

1. To establish an international consortium of institutions and a central, on-line patient registry/database for tracking long-term outcomes in breast reconstruction.
2. To establish a standard panel of instruments for assessing the following outcomes of breast reconstruction: complication rates, patient satisfaction; health-related quality of life, including psychosocial and physical functioning; and resource costs.
3. To pilot test the survey instruments, on-line database, and other data-gathering infrastructure required for a long-term outcome study of common breast reconstruction procedures, including tissue expanders/implants; latissimus dorsi (LD) flaps; pedicle TRAM flaps with and without surgical delays; deep inferior epigastric perforator (DIEP) flaps; and gluteal artery perforator (GAP) flaps.

The proposed PSEF/NEPS pilot project will run for one year and will include three phases: 1) Creation of the on-line survey process and database; 2) Obtaining institutional review board approvals from the eleven centers for both the PSEF/NEPS pilot study and for the upcoming DoD-funded IBROC outcome study; and 3) Pilot testing of the survey process with patients from the eleven IBROC members.

The primary products of this research will be the establishment of a Web database, as well as mechanisms for recruiting and enrolling patients, obtaining their survey data via the Web, and analyzing the data on a regular basis to produce periodic reports comparing the long-term outcomes of breast reconstruction procedures. Ultimately, this information will support patients and plastic surgeons in evidence-based decision-making and may prove useful in negotiations with health payers to improve reimbursement for breast reconstruction.