American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evidenced-Based Medicine:Where Does it Fit in Foot
and Ankle Surgery?MODULE: DVT PROPHYLAXIS
Jarrett D. Cain, DPM, AACFASRosalind Franklin University School of Medicine and Sciences
North Chicago, Illinois
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evidence-Based Medicine
The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of the individual patient
It means integrating individual clinical expertise with the best available external clinical evidence from systematic research
Dr. David Sackett, 1996
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evidence-Based Medicine
Clinical Expertise
Patient Values Best Evidence
Patient Care
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Fundamental Principles
Evidence is never enoughHierarchy within EBM
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Steps In EBM Process
Clinical ProblemQuestionResourceEvaluationPatient
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Asking the Question
Foreground Question
Background Question
Novice Expert
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Meta-Analysis
Systematic Review
Randomized Controlled Trial
Cohort Studies
Case Control Studies
Case Series/Case Reports
Animal Research/Laboratory Studies
Hierarchy of EBM
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
“P.I.C.O.”
Patient + ProblemInterventionComparisonOutcome
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Levels of Evidence
January 2003• Journal of Bone and Joint Surgery American
February 2005• American Academy of Orthopaedic Surgeons
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
JBJS Am:Levels of Evidence
I, II, III, IV, V based on designTypes • Therapeutic• Prognostic• Economic• Decision Analysis
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
JBJS Am:Levels of EvidenceRandomized Control Trial: Prospective• Level I or IICohort: Prospective comparative study• Level II or IIICase Control: Retrospective study• Level IIICase Series• Level IVExpert Opinions• Level V
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Grades of RecommendationGrade A• Treatment options supported by strong evidence• Level I or II studies
Grade B• Treatment options supported by fair evidence • Level II or III studies
Grade C • Treatment options supported by either conflicting or poor
quality evidence • Level III or IV studies
Grade I• Insufficient evidence exists to make recommendation
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Journal of Bone and Joint Surgery Am + BrJournal of Orthopaedic TraumaJournal of Shoulder and Elbow SurgeryAmerican Journal of Sports MedicineJournal of Prosthetics and OrthoticsFoot and Ankle InternationalJournal Hand SurgeryJournal of Athroplasty JBJS 87A(12), 2005
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Levels of Evidence
0
10
20
30
40
50
60
70
80
Level I Level II Level III Level IV
Am J Sports Med
FAI
J Arthroplasty
JBJS Am
JBJS Br
J Hand Surg
JOT
JPO
J Shoulder/Elbow
JBJS 87A(12), 2005
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Levels of Evidence
0
10
20
30
40
50
60
Level ILevel IILevel IIILevel IV
JBJS 87A(12), 2005
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evaluation of the Foot and Ankle Literature
Journal Foot and Ankle SurgeryFoot and Ankle International
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evaluation of the Literature
Jan/Feb 2005 –Jan/Feb 2007
• 157 Articles• 3 RCT
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evaluation of the Literature
January 2005 –January 2007
• 387 Articles• 4 RCT
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Evaluation of the Literature
“Target your reading to particular issues related
to the patient”
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
EBM Literature Sources
Cochrane Database: http://www.cochrane.org/
Medline: http://www4.infotrieve.com/newmedline/search.asp
UpToDate: http://www.uptodate.com/
Best Evidence: http://www.cebm.net/searching.asp
OVID: http://www.ovid.com/site/index.jsp
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
AGAINST FOR
“Old Hat”Cook Book MedicinePopulation StudiesLack of Gold StandardAccess Difficulty
Strong EvidenceOne PartPatient DecisionEvidence PyramidTrained Professionals
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
MODULE: DVT prophylaxis59 year old female presents with a painful
neuroma in the 3rd interspace of the left foot-patient desires surgical correction of her condition
PMH: high cholesterol, varicose veins; no history of blood clots
Meds: LipitorAllergies: NKDASocial History: h/0 EtOH useFamily History: no family history of DVTs/PE
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
??Treatment Options??
• Surgical correction• Excision of neuroma
•• No DVT prophylaxisNo DVT prophylaxis•• DVT prophylaxis DVT prophylaxis
•• AspirinAspirin•• HeparinHeparin•• Low Molecular Weight HeparinLow Molecular Weight Heparin•• CoumadinCoumadin
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
ConcernsSurgical excision without DVT prophylaxis• DVT may present significant challenge in certain
orthopedic procedures• Can lead to PE which may lead to death
Surgical excision with DVT prophylaxis• Increase chance of post-operative bleeding• Increase skin ecchymosis
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Concerns
Question• SHOULD WE PROVIDE
PROPHYLACTIC TREATMENT FOR SUCH A MINOR FOOT PROCEDURE?
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
What does the literature say?Foot surgery with DVT prophylaxis• Mizel M. et al, CORR March 1998 (EBM Level IV)
–– 2733 pts evaluated2733 pts evaluated–– 0.22% DVT; 0.15% nonfatal pulmonary emboli0.22% DVT; 0.15% nonfatal pulmonary emboli–– Factors for DVT included NWB status and immobilizationFactors for DVT included NWB status and immobilization–– Routine prophylaxis is not warranted Routine prophylaxis is not warranted
• Solis S. et al, Foot and Ankle International 2002 (EBM Level IV)– 201 patients evaluated after foot and ankle surgery– Ultrasound performed from popliteal vein during first post operative visit– DVT found in 7 pts (3.5%) with none progressing during the post op
course– Rate and progression of DVT after surgery is low and does not require
routine prophylaxis
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
What does the literature say?Foot Surgery with DVT prophylaxis• Radl R et al., JBJS-A 2003( EBM Level II)
–– 100 consecutive pts who underwent hallux valgus surgery and 100 consecutive pts who underwent hallux valgus surgery and did not receive medical prophylaxisdid not receive medical prophylaxis
–– Pts with clinical/hematological risk factors for DVT were Pts with clinical/hematological risk factors for DVT were excludedexcluded
–– Evaluated 29 days postEvaluated 29 days post--op with phlebographyop with phlebography–– 4% pts developed venous thrombosis4% pts developed venous thrombosis–– Concluded pts who undergo hallux valgus surgery is at low risk Concluded pts who undergo hallux valgus surgery is at low risk
and routine prophylaxis and routine prophylaxis mightmight be justified in pts over 60be justified in pts over 60
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
What does the literature say?Foot surgery with DVT prophylaxis• Hanslow et al., Foot Ankle Int 2006 (EBM Level IV)
–– Retrospectively reviewed 602 foot/ankle surgery patients Retrospectively reviewed 602 foot/ankle surgery patients for risks factors associated with DVTfor risks factors associated with DVT
–– 24 patients(4%) had post op thromboembolic events24 patients(4%) had post op thromboembolic events–– Risk factors included: RA, h/o air travel, previous DVT Risk factors included: RA, h/o air travel, previous DVT
or PE, immobilizationor PE, immobilization–– Prospective RCT are needed to establish true incidence Prospective RCT are needed to establish true incidence
and define indications for prophylaxisand define indications for prophylaxis
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
What does the literature say?Foot Surgery with DVT prophylaxis• Lapidus et al, Journal of Ortho Trauma, Jan. 2007 (EBM
Level I)–– RCT double blind study of 105 consecutive surgically treated RCT double blind study of 105 consecutive surgically treated
Achilles tendon rupturesAchilles tendon ruptures–– DVT screening with color duplex sonography was conducted 3 DVT screening with color duplex sonography was conducted 3
weeks and 6 weeks after surgeryweeks and 6 weeks after surgery–– Intervention was placebo or dalteparin (5000 U) given Intervention was placebo or dalteparin (5000 U) given
subcutaneously once daily for 6 weeks postoperativelysubcutaneously once daily for 6 weeks postoperatively–– 16/47 in dalteparin group; 16/44 in placebo group had diagnosed 16/47 in dalteparin group; 16/44 in placebo group had diagnosed
DVTDVT–– DVT is common after surgical treatment of achilles tendon DVT is common after surgical treatment of achilles tendon
rupture and effective thromoboprophylaxis is desirablerupture and effective thromoboprophylaxis is desirable
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
What does the literature say??Foot surgery with DVT prophylaxis• Gadgil A., Foot Ankle International 2007 (EBM
Level V)–– Survey of American and British foot and ankle Survey of American and British foot and ankle
surgeonssurgeons–– 31% response rate (140 out of 455)31% response rate (140 out of 455)–– Only 19%(27/140) routinely used prophylaxis in Only 19%(27/140) routinely used prophylaxis in
trauma or elective foot and ankle surgery.trauma or elective foot and ankle surgery.most commonmost common--elective hindfoot, ORIF ankle, and trauma elective hindfoot, ORIF ankle, and trauma treated with conservative with NWB in a plastar casttreated with conservative with NWB in a plastar cast
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Review
Based on the literature:• Prophylaxis is not needed for minor foot and ankle
procedures
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
ReviewHowever based on critical review of the literature:• Studies focused on elective foot surgery were EBM Level IV• Not enough EBM Level I or II studies to establish a
treatment protocol of DVT prophylaxis• No standard to the surgeons’ approach to determining if pts
had DVT• Inconsistencies in the inclusion/exclusion criteria• Greater need for larger multi-center studies to clarify rate
and risk observed in high risk subjects
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Foot Surgery with DVT prophylaxis
Grade C Recommendation:• Treatment options are supported by conflicting or
poor quality evidence
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
My treatmentPatient underwent excision of neuroma of the left foot• Patient did not have DVT prophylaxis of any form• Patient was immobilized in a dressing of the left
foot and was limited weightbearing in a surgical shoe
• During the postop course, patient had painful swollen left calf. After being sent to the ER, patient had developed of the left popliteal vein which was diagnosed by ultrasound.
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Where Does EBM Fit with Foot and Ankle Surgery??
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
Where Does EBM Fit ?
ACFASResearchEBM ONLY??Your Step
American College of Foot and Ankle Surgeons
Research and Evidence-Based Medicine Committee: 2007
ACFAS.orgFootPhysicians.com
THANK YOU !