Trial of Feedback on Blood Use

Trial of Feedback on Blood Use (TOFU)

The TOFU study will represent the first attempt to rigorously assess the impact of
audit-feedback on changing transfusion practice. The primary hypothesis is that providing
individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC
transfusions in the postoperative period.

TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data
will be collected at all study sites. Next, the PI at each site will give a short
educational presentation to the orthopedic surgeons. The presentation will consist of a
standardized 10-minute presentation reviewing the data from the FOCUS trial and the
recommended red blood cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based
on that data. Clusters of orthopedic surgeons will then be randomized to either the Control
arm (no feedback) or the Intervention arm (monthly feedback). All of the surgeons at a given
site will either receive or not receive feedback. The feedback will take the form of emailed
monthly reports detailing blood use by each surgeon post-hip surgery. Surgeons will be
anonymized in the reports as "A, B, C . . ." but each surgeon will know which data are his
own. The primary end point is the decrease from baseline in the proportion of patients
transfused with a pretransfusion hemoglobin of > 8 g/dL.

TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken
to minimize the labor and costs required to conduct this study. The only data collected will
be: patient age/gender; procedure; surgeon (anonymized); surgery & discharge dates; RBC
units transfused; Hgb levels. The data will be entered at each site into a web-based Case
Report Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC
will generate monthly feedback reports and email them to each Intervention arm site PI. The
site PI will then email the reports to each local orthopedic surgeon.