AOFAS Research Collaboration
The AOFAS Board of Directors supports opportunities for AOFAS members to participate in quality of care and research initiatives that enhance patient care and improve the quality of orthopaedic foot and ankle research. The AOFAS Research Committee is developing guidelines and recommendations for the Society to consider as it contemplates collaborative research opportunities, and OFAR, the Orthopaedic Foot & Ankle Outcomes Research Network
, is the AOFAS infrastructure hub to facilitate collaborations on quality and research initiatives.
PIVoTED Trial News & Participation Opportunity!
In June 2014, a unique opportunity was presented to the AOFAS Board of Directors by member Christopher DiGiovanni, MD for membership participation in a large-scale research collaboration that has the potential to complement OFAR efforts and further overall AOFAS research goals. The proposal for the Society to partner with Dr. DiGiovanni as a subcontractor on a multicenter research study on VTED (venous thromboembolic disease) prophylaxis was approved by the Board. With active participation of OFAR Managerial Board members, preparations for this landmark study are underway.
The PIVoTED Trial, Comparative Patient Impact of Venous Thromboembolic Disease Prophylaxis Following Foot & Ankle Surgery, is designed to answer outstanding questions about prevention of VTED after foot and ankle procedures and to look at patient-reported outcomes in the context of current treatment options.
The PIVoTED Trial results will improve assessment and clinical care and provide guidance for appropriate management of VTED prophylaxis for foot and ankle patients. Dr. DiGiovanni explains,
“PIVoTED was inspired by the paucity of reliable, prospective, properly powered data available to assess both risk-benefit and appropriateness of the various treatments currently employed for venous thromboembolic disease (VTED) prevention in orthopaedic foot and ankle patients.”
Of equal importance, PIVoTED results will provide a stronger framework for meaningful shared decision making between orthopaedic foot and ankle patients and their families and providers to enable more informed, evidence-based clinical care decisions with respect to VTED risk and potential prevention.
The PIVoTED team is currently preparing for resubmission of the study proposal to PCORI (Patient-Centered Outcomes Research Institute), after encouraging feedback on the 2015 submission. The PIVoTED methodology will have a comparative effectiveness research focus to reflect real world treatment scenarios. In addition, the OFAR platform will serve as the PIVoTED data repository to enable valuable efficiencies for patients, providers, and sites and encourage robust and representative patient and AOFAS member site participation.
OFAR (The Orthopaedic Foot and Ankle Research Network)
is a network of AOFAS member orthopaedic foot and ankle surgeons, under the guidance of the OFAR Managerial Board, chaired by Kenneth J. Hunt, MD. An OFAR patient-reported outcomes (PROs) data collection infrastructure for foot and ankle procedures is currently under construction. The OFAR platform is designed to serve as a hub of AOFAS research collaboration, to enable efficient data entry for patients and physicians alike, to encompass most common orthopaedic foot and ankle conditions and surgical procedures, and to serve as a foundation for current and future collaborative research and quality initiatives.
How to Get Involved with PIVoTED
As part the PCORI application, AOFAS is recruiting members as key stakeholders and study participants, should it be funded. The goal is to enlist at least 40-50 sites representing 100 or more AOFAS Active or Candidate Member orthopaedic foot and ankle specialists across the U.S. and Canada. The PIVoTED team seeks commitments, letters of support, and basic investigator and demographic information from interested sites by mid-November 2016 for a late 2016 application deadline. a late 2016 application submission.
All participating investigators will need to be Active Members of the AOFAS with subspecialty fellowship training in foot and ankle and maintain a practice comprised predominately of foot and ankle patients. Additional eligibility requirements are detailed in the PIVoTED Site Commitment Letter and Study Overview provided by Dr. DiGiovanni, linked below:
PIVoTED 2016 Study Overview
PIVoTED 2016 Site Commitment Letter Template
If your site provided a commitment letter in 2015, please update that letter using the template linked above that reflects revisions in the study protocol and name. Methodology changes in part are intended to reflect real-world practice and enable wider site participation.
Sites simply wishing to update their prior letters of support should review the above-linked template and information and submit completed letters to: email@example.com no later than Friday, November 18, 2016.
For providers, patients, and other stakeholders new to PIVoTED -- or those wishing to learn more about recent study protocol changes and OFAR platform efficiencies with PIVoTED participation -- Dr. DiGiovanni and Dr. Hunt will present a webinar on Wednesday, November 2, 2016, 7:30-9 pm Central Time. Please register for the free webinar, and access details will be shared the day of the event.
For More Information
If you have questions or for more information about OFAR, the PIVoTED Trial, or AOFAS Research Collaboration, please contact:
Joy Keller, MS, MSLIS, AOFAS Director of Researchjkeller@aofas.org or 1-847-430-5085
About VTED (Venous Thromboembolic Disease)
Venous thromboembolic disease (VTED) is a pathological process that encompasses both deep venous thrombosis (DVT) and pulmonary embolism (PE). The condition, as well as the well-intentioned use of numerous commonly employed prophylactic agents designed to prevent it, can result in profoundly morbid and sometimes fatal complications following foot and ankle surgery. Although there remains significant controversy as to the ideal application of these various agents as well as the overall nature and prevalence of the disease process amongst foot and ankle post-surgical patients, experts agree that these complications would, with better science, become far more preventable. Current incidence estimates suggest that symptomatic VTED statistically impacts nearly 65,000 American foot and ankle patients every year. When factoring in “silent” DVT and PE rates, these numbers increase three fold—indicating that the true disease process of VTED adversely affects a substantial portion of this patient population.