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doi: 10.2522/ptj.20150264 Originally published online October 29, 2015 2016; 96:143-166. PHYS THER. Thigpen, Dennis C. Sobush and Beth Auten Ellen Hillegass, Michael Puthoff, Ethel M. Frese, Mary Guideline Thromboembolism: Evidence-Based Clinical Practice Individuals at Risk for or Diagnosed With Venous Role of Physical Therapists in the Management of http://ptjournal.apta.org/content/96/2/143 found online at: The online version of this article, along with updated information and services, can be Online-Only Material 50264.DC1.html http://ptjournal.apta.org/content/suppl/2016/01/21/ptj.201 Collections Venous Thrombosis Practice Guidelines Clinical Decision Making Cardiac Conditions in the following collection(s): This article, along with others on similar topics, appears e-Letters "Responses" in the online version of this article. "Submit a response" in the right-hand menu under or click on here To submit an e-Letter on this article, click E-mail alerts to receive free e-mail alerts here Sign up at 86062336 on February 3, 2016 http://ptjournal.apta.org/ Downloaded from at 86062336 on February 3, 2016 http://ptjournal.apta.org/ Downloaded from

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Page 1: Originally published online October 29, 2015 Collections e ...Originally published online October 29, 2015 PHYS THER.€2016; 96:143-166. Thigpen, Dennis C. Sobush and Beth Auten Ellen

doi: 10.2522/ptj.20150264Originally published online October 29, 2015

2016; 96:143-166.PHYS THER. Thigpen, Dennis C. Sobush and Beth AutenEllen Hillegass, Michael Puthoff, Ethel M. Frese, MaryGuidelineThromboembolism: Evidence-Based Clinical PracticeIndividuals at Risk for or Diagnosed With Venous Role of Physical Therapists in the Management of

http://ptjournal.apta.org/content/96/2/143found online at: The online version of this article, along with updated information and services, can be

Online-Only Material 50264.DC1.html

http://ptjournal.apta.org/content/suppl/2016/01/21/ptj.201

Collections

Venous Thrombosis     Practice Guidelines    

Clinical Decision Making     Cardiac Conditions    

in the following collection(s): This article, along with others on similar topics, appears

e-Letters

"Responses" in the online version of this article. "Submit a response" in the right-hand menu under

or click onhere To submit an e-Letter on this article, click

E-mail alerts to receive free e-mail alerts hereSign up

at 86062336 on February 3, 2016http://ptjournal.apta.org/Downloaded from at 86062336 on February 3, 2016http://ptjournal.apta.org/Downloaded from

Page 2: Originally published online October 29, 2015 Collections e ...Originally published online October 29, 2015 PHYS THER.€2016; 96:143-166. Thigpen, Dennis C. Sobush and Beth Auten Ellen

Role of Physical Therapists in theManagement of Individuals at Riskfor or Diagnosed With VenousThromboembolism: Evidence-BasedClinical Practice GuidelineEllen Hillegass, Michael Puthoff, Ethel M. Frese, Mary Thigpen, Dennis C. Sobush,Beth Auten; for the Guideline Development Group

The American Physical Therapy Association (APTA), in conjunction with the Cardiovascular &Pulmonary and Acute Care sections of APTA, have developed this clinical practice guideline toassist physical therapists in their decision-making process when treating patients at risk forvenous thromboembolism (VTE) or diagnosed with a lower extremity deep vein thrombosis(LE DVT). No matter the practice setting, physical therapists work with patients who are at riskfor or have a history of VTE. This document will guide physical therapist practice in theprevention of, screening for, and treatment of patients at risk for or diagnosed with LE DVT.Through a systematic review of published studies and a structured appraisal process, keyaction statements were written to guide the physical therapist. The evidence supporting eachaction was rated, and the strength of statement was determined. Clinical practice algorithms,based on the key action statements, were developed that can assist with clinical decisionmaking. Physical therapists, along with other members of the health care team, should workto implement these key action statements to decrease the incidence of VTE, improve thediagnosis and acute management of LE DVT, and reduce the long-term complications of LEDVT.

E. Hillegass, PT, EdD, CCS,FAACVPR, FAPTA, Department ofPhysical Therapy, Mercer Univer-sity, 220 Lackland Ct, Atlanta, GA30350 (USA). Address all corre-spondence to Dr Hillegass at:[email protected].

M. Puthoff, PT, PhD, GCS, Depart-ment of Physical Therapy, StAmbrose University, Davenport,Iowa.

E.M. Frese, PT, DPT, MHS, CCS,Department of Physical Therapy,St Louis University, St Louis,Missouri.

M. Thigpen, PT, PhD, NCS,Department of Physical Therapy,Brenau University, Gainesville,Georgia.

D.C. Sobush, PT, MA, DPT, CCS,CEEAA, Department of PhysicalTherapy, Marquette University,Milwaukee, Wisconsin.

B. Auten, MLIS, MA, AHIP, Library,South Piedmont Community Col-lege, Monroe, North Carolina.

See eAppendix 1 (available atptjournal.apta.org) for briefauthor biographies.

[Hillegass E, Puthoff M, Frese EM,et al; for the Guideline Develop-ment Group. Role of physical ther-apists in the management of indi-viduals at risk for or diagnosedwith venous thromboembolism:evidence-based clinical practiceguideline. Phys Ther. 2016;96:143–166.]

© 2016 American Physical TherapyAssociation

Published Ahead of Print:October 29, 2015

Accepted: September 24, 2015Submitted: May 12, 2015

Clinical PracticeGuideline

Post a Rapid Response tothis article at:ptjournal.apta.org

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Venous thromboembolism (VTE) isthe formation of a blood clot in adeep vein that can lead to compli-

cations, including deep vein thrombosis(DVT), a pulmonary embolism (PE), orpostthrombotic syndrome (PTS). Venousthromboembolism is a serious condition,with an incidence of 10% to 30% of peo-ple dying within 1 month of diagnosis,and half of those diagnosed with a DVThave long-term complications.1 Evenwith a standard course of anticoagulanttherapy, one third of individuals willexperience another VTE within 10years.1 For those who survive a VTE,quality of life can be decreased due tothe need for long-term anticoagulation toprevent another VTE.2

No matter the practice setting, physicaltherapists work with patients who are atrisk for or have a history of VTE. Addi-tionally, physical therapists are routinelytasked with mobilizing patients immedi-ately after diagnosis of a VTE. Because ofthe seriousness of VTE, the frequencythat physical therapists encounterpatients with a suspected or confirmedVTE, and the need to prevent future VTE,the American Physical Therapy Associa-tion (APTA) in conjunction with the Car-diovascular & Pulmonary and Acute Caresections of APTA, support the develop-ment of this clinical practice guideline(CPG). It is intended to assist all physicaltherapists in their decision making pro-cess when managing patients at risk forVTE or diagnosed with a lower extremitydeep vein thrombosis (LE DVT).

In general, CPGs optimize the care ofpatients by building upon the best evi-dence available while examining thebenefits and risks of each care option.3

The VTE Guideline Development Group(GDG) followed a systematic process towrite this CPG with the overall objectiveof providing physical therapists with thebest evidence in preventing VTE, screen-ing for LE DVT, mobilization of patientswith LE DVT, and management of com-plications of LE DVT. Specifically, thisCPG will:

• Discuss the role of physical thera-pists in identifying patients who areat high risk for a VTE and actionsthat can be taken to decrease therisk of a first or recurring VTE.

• Provide physical therapists withspecific tools to identify patientswho may have an LE DVT and deter-mine the likelihood of an LE DVT.

• Assist physical therapists in deter-mining when mobilization is safefor a patient diagnosed with an LEDVT based on the treatment cho-sen by the interprofessional team.

• Describe interventions that willdecrease diagnosis complications,such as PTS or another VTE.

• Create a reference publication forhealth care providers, patients, fam-ilies and caretakers, educators, pol-icy makers, and payers on the bestcurrent practice of physical thera-pist management of patients at riskfor VTE and diagnosed with an LEDVT.

• Identify areas of research that areneeded to improve the evidencebase for physical therapist manage-ment of patients at risk for or diag-nosed with VTE.

This CPG, which contains 14 key actionstatements (Tab. 1), can be applied toadult patients across all practice settings,but it does not address or apply towomen who are pregnant or to children.Additionally, this guideline does not dis-cuss the management of PE, upperextremity DVT (UE DVT), or chronicthromboembolic pulmonary hyperten-sion (CTEPH). Although primarily writ-ten for physical therapists, other healthcare professionals should find this CPGhelpful in their treatment of patientswho are at risk for or have a diagnosedVTE.

Background and Need for aCPG on VTEVenous thromboembolism is a life-threatening disorder that ranks as thethird most common cardiovascular ill-ness, after acute coronary syndrome andstroke.4 This disorder consists of DVTand PE, 2 interrelated primary conditionscaused by venous blood clots, along withseveral secondary conditions includingPTS and CTEPH.5 From primary and sec-ondary prevention perspectives, the seri-ousness of VTE development related tomortality, morbidity, and diminished lifequality is a worldwide concern.6 Theincidence of VTE differs greatly amongcountries. For example, the United States

ranges from 70 to 120 cases per 100,000inhabitants per year, and in Europe thereare between 140 and 240 cases per100,000 inhabitants per year, with sud-den death being a frequent outcome.7

Deep vein thrombosis is a serious, yetpotentially preventable, medical condi-tion that occurs when a blood clot formsin a deep vein, most commonly in thecalf, thigh, or pelvis. A life-threatening,acute complication of LE DVT is PE. Thiscomplication occurs when the clot dis-lodges, travels through the venous sys-tem, and causes a blockage in the pulmo-nary circulatory system. A proximal LEDVT, defined as occurring in the popli-teal vein or veins more cephalad, is asso-ciated with an estimated 50% risk of PE ifnot treated, as compared with approxi-mately 20% to 25% of LE DVTs below theknee.8 Approximately 1 in 5 individualswith acute PE die almost immediately,and 40% will die within 3 months.9 Inthose who survive PE, significant cardio-pulmonary morbidity can occur, mostnotably CTEPH.

Chronic thromboembolic pulmonaryhypertension can be the result of a singlePE, multiple PEs, or recurrent PEs.Acutely, PE causes an obstruction offlow. This narrowing of the lumen maylead to reduced oxygenation and pulmo-nary hypertension. Chronically, theinfarction of lung tissue following PEmay result in a reduction of vasculariza-tion and concomitant pulmonary hyper-tension. Over time, the workloadimposed on the right heart increases andcontributes to right heart dysfunctionand then failure.10 A new syndrome,post-PE syndrome, has more recentlybeen proposed to capture those patientswith persistent abnormal cardiac and

Available WithThis Article atptjournal.apta.org

• eTable: CurrentAnticoagulation Options in Use

• eAppendix 1: Brief AuthorBiographies

• eAppendix 2: AGREE II Review ofCurrent Guideline

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Table 1.Key Action Statementsa

Number Statement Key Phrase

1 Physical therapists should advocate for a culture of mobility and physical activity unlessmedical contraindications for mobility exist.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Advocate for a culture of mobility and physicalactivity

2 Physical therapists should screen for risk of VTE during the initial patient interview andphysical examination.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Screen for risk of VTE

3 Physical therapists should provide preventive measures for patients who are identifiedas high risk for LE DVT. These measures should include education regarding signsand symptoms of LE DVT, activity, hydration, mechanical compression, and referralfor medication.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Provide preventive measures for LE DVT

4 Physical therapists should recommend mechanical compression (eg, IPC, GCS) whenindividuals are at high risk for LE DVT.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Recommend mechanical compression as apreventive measure for LE DVT

5 Physical therapists should establish the likelihood of an LE DVT when the patient haspain, tenderness, swelling, warmth, or discoloration in the lower extremity.

(Evidence Quality: II; Recommendation Strength: B–Moderate)

Identify the likelihood of LE DVT when signsand symptoms are present

6 Physical therapists should recommend further medical testing after the completion ofthe Wells criteria for LE DVT prior to mobilization.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Communicate the likelihood of LE DVT andrecommend further medical testing

7 When a patient has a recently diagnosed LE DVT, physical therapists should verifywhether the patient is taking an anticoagulant medication, what type ofanticoagulant medication, and when the anticoagulant medication was initiated.

(Evidence Quality: V; Recommendation Strength: D–Theoretical/Foundational)

Verify the patient is taking an anticoagulant

8 When a patient has a recently diagnosed LE DVT, physical therapists should initiatemobilization when therapeutic threshold levels of anticoagulants have been reached.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Mobilize patients who are at a therapeuticlevel of anticoagulation

9 Physical therapists should recommend mechanical compression (eg, IPC, GCS) when apatient has an LE DVT.

(Evidence Quality: II; Recommendation Strength: B–Moderate)

Recommend mechanical compression forpatients with LE DVT

10 Physical therapists should recommend that patients be mobilized, oncehemodynamically stable, following IVC filter placement.

(Evidence Quality: V; Recommendation Strength: P–Best Practice)

Mobilize patients after IVC filter placementonce hemodynamically stable

11 When a patient with a documented LE DVT below the knee is not treated withanticoagulation and does not have an IVC filter and is prescribed out of bedmobility by the physician, the physical therapist should consult with the medicalteam regarding mobilizing versus keeping the patient on bed rest.

(Evidence Quality: V; Recommendation Strength: P–Best Practice)

Consult with the medical team when a patientis not anticoagulated and without an IVCfilter

12 Physical therapists should screen for fall risk whenever a patient is taking ananticoagulant medication.

(Evidence Quality: III; Recommendation Strength: C–Weak)

Screen for fall risk

13 Physical therapists should recommend mechanical compression (eg, intermittentpneumatic compression, graduated compression stockings) when a patient has signsand symptoms suggestive of PTS.

(Evidence Quality: I; Recommendation Strength: A–Strong)

Recommend mechanical compression whensigns and symptoms of PTS are present

14 Physical therapists should monitor patients who may develop long-term consequencesof LE DVT (eg, PTS severity) and provide management strategies that prevent themfrom occurring to improve the human experience and increase quality oflife. (Evidence Quality: V; Recommendation Strength: P–Best Practice)

Implement management strategies to preventfuture VTE

a VTE�venous thromboembolism, LE DVT�lower extremity deep vein thrombosis, IPC�intermittent pneumatic compression, GCS�graduated compressionstockings, IVC�inferior vena cava, PTS�postthrombotic syndrome.

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pulmonary function who do not meetthe criteria for CTEPH.5 These condi-tions are associated with diminishedfunction and lowered quality of life.11

Beyond the threat of PE and its sequelae,LE DVT may lead to long-term complica-tions. Postthrombotic syndrome is themost frequent complication and devel-ops in up to 50% of these patients evenwhen an appropriate anticoagulant isused.12,13 A clot remaining in the vein ofthe lower extremity can obstruct bloodflow, leading to venous hypertension.Additionally, damage to the vein itselfoccurs and leads to inflammation andnecrosis of the vein, which eventuallyare removed by phagocytic cells, leadingto venous hypertension. This impairedblood flow can lead to classic symptomsof PTS, which often includes chronicaching pain, intractable edema, limbheaviness, and leg ulcers.10 This chronicpathology can cause serious long-term illhealth, impaired functional mobility,poor quality of life, and increased costsfor the patient and the health care system.

Across various practice settings, physicaltherapists encounter patients who are atrisk for VTE, may have an undiagnosedLE DVT, or have recently been diagnosedwith an LE DVT. The physical therapist’sresponsibility to every patient is 5-fold:(1) prevention of VTE, (2) screening forLE DVT, (3) contributing to the healthcare team in making prudent decisionsregarding safe mobility for thesepatients, (4) patient education andshared decision making, and (5) preven-tion of long-term consequences of LEDVT. Such decisions should always bemade in collaboration with the referringphysician and other members of thehealth care team (ie, it is assumed thatsuch decisions will not be made in isola-tion and that the physical therapist willcommunicate with the medical team).

Due to the long-standing controversyregarding mobilization versus bed restfollowing VTE diagnosis and with thedevelopment of new anticoagulationmedications, the physical therapy com-munity needs evidence-based guidelinesto assist in clinical decision making. ThisCPG is intended to be used as a referencedocument to guide physical therapist

practice in the prevention of, screeningfor, and treatment of patients at risk foror diagnosed with LE DVT. This CPG isbased on a systematic review of pub-lished studies on the risks of early ambu-lation in patients with diagnosed DVTand on other established clinical guide-lines on prevention, risk factors, andscreening for VTE and PTS. In addition toproviding practice recommendations,this guideline also addresses gaps in theevidence and areas that warrant furtherinvestigation.

MethodsThe GDG, which comprised physicaltherapists with special interest in acutecare and cardiovascular and pulmonarypractice, was appointed by the Cardio-vascular & Pulmonary and the AcuteCare sections of APTA to develop aguideline to address the physical thera-pist’s role in the management of VTE.Specifically, the role of mobility wasidentified as a major issue facing bothsections. Models used by the APTA Pedi-atric Section for its CPG on physical ther-apy management of congenital musculartorticollis14 were primarily used todevelop this CPG, as well as other APTA-supported CPGs and international pro-cesses. In July 2012, the GDG initiatedthe process under the guidance of APTAand developed a list of topic areas to becovered by the CPG. In addition, topicareas were solicited from clinicians withcontent experience in the area of VTEwho volunteered to assist. A resultant listof topic areas was developed to deter-mine the scope of the CPG and providedthe GPG with limits to the literaturesearch.

Literature ReviewA search strategy was developed and per-formed by a librarian to identify literaturepublished between May 1, 2003, andMay 2014 addressing mobilizationand anticoagulation therapy to preventand treat VTE. Searches were performedin the following databases: PubMed,CINAHL, Web of Science, CochraneDatabase of Systematic Reviews, Data-base of Abstracts of Reviews of Effects(DARE), and the Physiotherapy EvidenceDatabase (PEDro). Controlled vocabular-ies, such as MeSH and CINAHL headings,were used whenever possible in addition

to key words. Results were limited toarticles written in English. The searchstrategy by key words, MeSH terms, anddatabases is shown in Table 2. Using thissearch strategy, 350 out of 8,652abstracts and citations of relevance wereobtained from Web of Science, CINAHL,PubMed, and Cochrane Database of Sys-tematic Reviews.

Clinical practice guidelines publishedbetween 2003 and 2014 were searchedincluding the same key words and MeSHterms using the National Guideline Clear-inghouse (NGC, http://www.guideline.gov/) database and the Trip database(http://www.tripdatabase.com/). TheNGC database identified 169 guidelines,of which 40 were deemed as appropriateto be reviewed. Three additional guide-lines were identified through the Tripdatabase, and the appropriate target pop-ulations were included.

Method: Literature ReviewProceduresThe results of the literature and guidelinesearches were distributed to the mem-bers of the GDG. One member of thegroup reviewed a list of citations, andanother member performed a secondreview of the same list of citations. Arti-cles were included based on whetherkey topics were addressed and theappropriate target populations wereincluded. Case reports and pediatric arti-cles were excluded. The GDG, alongwith clinicians and academicians whovolunteered from both the Cardiovascu-lar & Pulmonary Section and the AcuteCare Section, were invited to review theidentified literature.

Reliability of appraisers was establishedprior to articles being reviewed. Selectedarticles were reviewed by 3 individualswho used 1 of 3 critical appraisal toolsadapted from an evidence-based practicetextbook to evaluate each according toits type (ie, critical appraisal for studiesof prognosis, diagnosis, or interven-tion).15 The Assessment of Multiple Sys-tematic Reviews (AMSTAR) tool wasused for systematic reviews.16 Selecteddiagnosis, prognosis, and interventionarticles and systematic reviews were crit-ically appraised by the GDG to establishtest standards. Interrater reliability

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among the 4 core group members wasfirst established on test articles. Volun-teers completed critical appraisals of thetest articles to establish interrater reliabil-ity. Volunteers qualified to be appraiserswith agreement of 90% or more. Apprais-ers were randomly paired to read each ofthe remaining diagnostic, prognostic, orintervention articles. Discrepancies inscoring between the readers wereresolved by a member of the GDG.

Clinical practice guidelines werereviewed that fit the scope of this CPGand the patient population. Guidelineswere included based on whether keytopics were addressed and the targetpopulations were included. The resultsof the CPG search were reviewed by onemember of the GDG. Four additionalclinical expert volunteers underwenttraining in the Appraisal of Guidelines forResearch and Evaluation II (AGREE II)17

tool to evaluate CPGs with subsequentreliability testing being performed on allreviewers.

Levels of Evidence and Grades ofRecommendationsThe GDG followed a previously pub-lished process on developing physicaltherapy CPGs.14 Table 3 lists criteria usedto determine the level of evidence asso-ciated with each practice statement,

Table 2.Search Strategy by Key Words, MeSH Terms, and Databases

Key Words MeSH Terms Databases

DVT“Venous Thrombosis”“Deep Vein Thrombosis”VTE“Venous Thromboembolism““Pulmonary Embolism”WalkingWalkAmbulationAmbulateAmbulatedMovementMobilityImmobilizationImmobilisation“Mobility Limitation”“Motor Activity”“Early Ambulation”“Early Activization”“Early Activisation”“Early Mobilization”“Early Mobilisation”AnticoagulantsAnticoagulantAnticoagulationDabigatranDesirudinXimelagatranEdoxabanRivaroxabanApixabanBetrixaban“YM150”Razaxaban“Factor Xa Inhibitor”“Direct Thrombin Inhibitors”“Direct Thrombin Inhibitor”CoumadinWarfarinFondaparinuxIdraparinux“International Normalized Ratio““INR”“Prothrombin Time”“Vena Cava Filter*”“Intermittent Pneumatic Compression Devices”“Compression Stockings”“Compression Socks”“Compression Hose”“Compression Hosiery”

“Venous Thrombosis”“Pulmonary Embolism”“Walking”“Movement”“Immobilization”“Mobility Limitation”“Motor Activity”“Early Ambulation”“Activities of Daily Living”“Anticoagulants”“Coumarins”“Fibrin Modulating Agents”“Factor Xa/antagonists and inhibitors”“Thrombosis/prevention and control”“Antithrombins”“Citric Acid”“Heparinoids”“Vitamin K/antagonists and inhibitors”“Antithrombin Proteins”“Fibrinolytic Agents”“International Normalized Ratio”“Prothrombin Time”“Vena Cava Filters”“Intermittent Pneumatic Compression Devices”“Stockings, Compression”

PubMedCINAHLWeb of ScienceCochrane Database of Systematic ReviewsDatabase of Abstracts of Reviews of Effects (DARE)Physiotherapy Evidence Database (PEDro)

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with level I as the highest level of evi-dence and level V as the lowest level ofevidence. Table 4 presents the criteriafor the grades assigned to each actionstatement. The grade reflects the overalland highest levels of evidence availableto support the action statement.

Statements that received an A or B gradeshould be considered as well supported.The CPG lists each key action statementfollowed by rating of level of evidenceand grade of the recommendation.Under each statement is a summary pro-viding the supporting evidence and clin-

ical interpretation. The statements areorganized in Table 1 according to theaction statement number, the statement,and the key phrase or action statement.

AGREE II ReviewThis CPG was evaluated by 5 GPG mem-bers using the AGREE II instrument toassess the methodological quality of theguideline. The 5 members scored thisguideline as high quality according to theAGREE II tool (eAppendix 2, available atptjournal.apta.org).

External Review Process byStakeholdersThis CPG underwent 2 formal reviews.First, draft reviewers were invited stake-holders representing the American Col-lege of Chest Physicians, Society for Vas-cular Nursing, physical therapy cliniciansand researchers, and patient representa-tives. The second draft was posted forpublic comment on both the APTA Car-diovascular & Pulmonary Section andAcute Care Section websites; noticeswere sent via email and an electronicnewsletter to Cardiovascular & Pulmo-nary Section members, literature apprais-ers, and clinicians who inquired aboutthe CPG during its development.

Document StructureThe action statements organized in Table1 are introduced with their assigned rec-ommendation grade, followed by a stan-dardized content outline generated byBRIDGE-Wiz software (http://gem.med.yale.edu/BRIDGE-Wiz/).18 Each state-ment has a content title, a recommenda-tion in the form of an observable actionstatement, indicators of the evidencequality, and the strength of the recom-mendation. The action statement profiledescribes the benefits, harms, and costsassociated with the recommendation; adelineation of the assumptions or judg-ments made by the GDG in formattingthe recommendation; reasons for anyintentional vagueness in the recommen-dation; and a summary and clinical inter-pretation of the evidence supporting therecommendation. The Delphi processwas used to determine level of evidenceand recommended strength for each keyaction statement. Each member of theGPG reviewed the supporting evidencefor each key action statement and voted

Table 3.Levels of Evidencea

Level Criteria

I Evidence obtained from high-quality diagnostic studies, prognostic or prospective studies,cohort studies or randomized controlled trials, meta-analyses or systematic reviews(critical appraisal score �50% of criteria)

II Evidence obtained from lesser-quality diagnostic studies, prognostic or prospective studies,cohort studies or randomized controlled trials, meta-analyses or systematic reviews (eg,weaker diagnostic criteria and reference standards, improper randomization, noblinding, �80% follow-up) (critical appraisal score �50% of criteria)

III Case-controlled studies or retrospective studies

IV Case studies and case series

V Expert opinion

a Reprinted from Kaplan S, Coulter C, Fetters L. Developing evidence-based physical therapyclinical practice guidelines. Pediatr Phys Ther. 2013;25:257–270, with permission of Wolters KluwerHealth Inc.

Table 4.Grades of Recommendation for Action Statementsa

Grade Recommendation Quality of Evidence

A Strong A preponderance of level I studies but at least 1 level Istudy directly on the topic support therecommendation.

B Moderate A preponderance of level II studies but at least 1 levelII study directly on the topic support therecommendation.

C Weak A single level II study at �25% critical appraisal scoreor a preponderance of level III and IV studies,including statements of consensus by contentexperts support the recommendation.

D Theoretical/foundational A preponderance of evidence from animal or cadaverstudies, from conceptual/theoreticalmodels/principles, or from basic science/benchresearch, or published expert opinion in peer-reviewed journals supports the recommendation.

P Best practice Recommended practice based on current clinicalpractice norms, exceptional situations wherevalidating studies have not or cannot be performedand there is a clear benefit, harm, or cost, and/orthe clinical experience of the guidelinedevelopment group.

R Research There is an absence of research on the topic, orhigher-quality studies conducted on the topicdisagree with respect to their conclusions. Therecommendation is based on these conflictingconclusions or absent studies.

a Reprinted from Kaplan S, Coulter C, Fetters L. Developing evidence-based physical therapy clinicalpractice guidelines. Pediatr Phys Ther. 2013;25:257–270, with permission of Wolters Kluwer Health Inc.

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on level of evidence and strength of rec-ommendation independent of the othergroup members using a Google surveyupon which all votes were tallied andthen reported.

Scope of the GuidelineThis CPG uses literature available from2003 through 2014 to address the follow-

ing aspects of physical therapists’ man-agement of patients with potential ordiagnosed VTE. The CPG addresses theseaspects of VTE management via 14action statements. Clinical practice algo-rithms (Figs. 1, 2, and 3), based on thekey action statements, were developedthat can assist with clinical decisionmaking.

Key Action StatementsWith EvidenceAction Statement 1: Advocate fora culture of mobility and physicalactivityPhysical therapists and other healthcare practitioners should advocatefor a culture of mobility and physicalactivity. (Evidence Quality: I; Recom-mendation Strength: A–Strong)

Action statement profileAggregate Evidence Quality: Level IBenefits: Decreased likelihood of LEDVT and/or PE and/or PTSRisk, Harm, Cost: Injuries from fallsBenefit-Harm Assessment: Preponder-ance of benefitValue Judgments: Physical therapistsshould advocate for mobility in all situa-tions due to the evidence on the benefitsof activity and risks associated with inac-tivity and bed rest except when therecould be a risk of harm (eg, embolidepositing in the pulmonary system).Intentional Vagueness: NoneRole of Patient Preferences: As theevidence for risks associated with inac-tivity is strong and with little associatedrisk of mobility in the absence of throm-boembolism, patients should be edu-

Figure 1.Algorithm for screening for risk of venous thromboembolism (VTE).

Figure 2.Algorithm for determining likelihood of a lower extremity deep vein thrombosis (LE DVT). DVT�deep vein thrombosis.

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cated regarding the benefits of mobilityand encouraged to maintain mobility asmuch as possible to decrease the risk ofadverse outcomes.Exclusions: None

Summary of evidenceReduced mobility is a known risk factorfor VTE, yet the quantity and duration ofthe reduced mobility that defines degreeof risk for VTE are not known.19–21 Sig-nificant variability exists in the literatureregarding reduced mobility and theresulting risk for VTE.22 Patients whowere ambulatory were found to be atincreased risk for developing a VTE witha standing time of 6 or more hours (oddsratio [OR]�1.9) or resting in bed or achair (OR�5.6).23 Likewise, a significantcorrelation exists between loss of mobil-ity status for 3 or more days and thepresence of LE DVT on duplexultrasound.24

When additional risk factors for VTE arepresent in an individual who has any

reduction in mobility, the risk for VTE issignificantly increased. Increased ageserves as an example. One study of hos-pitalized patients older than 65 yearsfound reduced mobility to be an inde-pendent risk factor for VTE. The riskincreased based on the degree of immo-bility, and relative risk scores werederived according to the degree of immo-bility (Tab. 5).19,25 The OR risk wasfound to be higher in older patients withmore severe limitation of mobility (bedrest versus wheelchair) and when theloss of mobility was more recent (�15days versus �30 days).

Recent national guidelines have associ-ated reduced mobility with increasedrisk for VTE.20,26 The National Institutefor Health and Care Excellence (NICE)guidelines present strong recommenda-tions for the need to regard patientsundergoing surgery and patients withtrauma as at an increased risk of VTE.When patients undergo surgery with ananesthesia time of greater than 90 min-

utes or if the surgical procedure involvesthe pelvis or lower limb and anesthesiatime is greater than 60 minutes, the riskis much greater. Individuals who areadmitted acutely for surgical reasons oradmitted with inflammatory or intra-abdominal conditions also are at highrisk for developing a VTE. These sameguidelines emphasized the need to iden-tify all individuals who are expected tohave any significant reductions in mobil-ity to be at risk for VTE and to mobilizethem as soon as possible.20 The Ameri-can College of Chest Physicians (ACCP)guidelines emphasize prevention of VTEin patients not undergoing surgery byincorporating nonpharmacological pro-phylaxis measures, including frequentambulation, calf muscle exercise, and sit-ting in the aisle and mobilizing the lowerextremities when traveling (Grade 2Crecommendations).26,27

Previously, when individuals were diag-nosed with an LE DVT, they were placedon bed rest due to the concern that

Figure 3.Algorithm for mobilizing patients with known lower extremity deep vein thrombosis. DVT�deep vein thrombosis, LMWH�low-molecular-weight heparin, UFH�unfractionated heparin, NOAC�novel oral anticoagulants, INR�international normalized ratio, IVC�inferior venacava. *If started on Coumadin, LMWH usually also started. Use LMWH guidelines for mobilization decision in these situations.

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ambulation would cause clot dislodg-ment and lead to a potentially fatal PE.However, a meta-analysis compiled datafrom 5 randomized controlled trials(RCTs) on more than 3,000 patients andconcluded that early ambulation follow-ing diagnosis of an LE DVT was not asso-ciated with a higher incidence of a newPE or progression of LE DVT comparedwith bed rest.28 Rather, there was alower incidence of new PE and overallmortality in those patients who engagedin early ambulation. Similar findings, aswell as more rapid resolution of pain,were reported in a systematic reviewthat included 7 RCTs and 2 prospectiveobservational studies.29 The importanceof mobility is further discussed in keyAction Statement 8.

In summary, mobility should be encour-aged in patients while in the hospital andwhen discharged to prevent the compli-cations associated with immobility. Inaddition, mobility is recommended forthose diagnosed with VTE once thera-peutic anticoagulant levels have beenreached (see Action Statement 8).

Action Statement 2: Screen forrisk of VTEPhysical therapists should screen forrisk of VTE during the initial patientinterview and physical examination(Evidence Quality: I; Recommenda-tion Strength: A–Strong)

Action statement profileAggregate Evidence Quality: Level IBenefits: Prevention or early detectionof LE DVTRisk, Harm, and Cost: Adverse effectsof prophylaxis interventionsBenefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: NoneIntentional Vagueness: Physical thera-pists should work within their healthcare system to determine specific algo-rithms or risk assessment models (RAMs)to use.Role of Patient Preferences: NoneExclusions: None

Summary of evidenceThe Guide to Physical Therapist Prac-tice states that the physical therapistexamination is a comprehensive screen-ing and specific testing process leadingto diagnostic classification or, as appro-priate, to a referral to another practitio-ner.30 Understanding the factors thatplace individuals at risk for a VTE isimportant for all physical therapists. Dur-ing the patient interview, physical ther-apists should ask questions and reviewthe medical history to determinewhether the patient is at risk for LE DVT.Risk factors include previous venousthrombosis or embolism, age, active can-cer or cancer treatment, severe infec-tion, oral contraceptives, hormonalreplacement therapy, pregnancy orgiven birth within the previous 6 weeks,immobility (bed rest, flight travel, frac-tures), surgery, anesthesia, critical careadmission, central venous catheters,

inherited thrombophilia, and obesity.The relationship between particular riskfactors and presence of LE DVT has beenfound through retrospective and pro-spective studies and identified as havingsupport from level I evidence in otherCPGs.19,31–34

The need for all health care providers toscreen for risk of LE DVT throughsystem-wide approaches has been high-lighted by the US Agency for HealthcareResearch and Quality,35 the Finnish Med-ical Society,31 and the Scottish Intercol-legiate Guidelines Network,36 and suchscreening is strongly recommended byeach of these groups. Furthermore, theimportance of screening was stronglysupported in a 2008 multinational cross-sectional study of patients from morethan 350 hospitals across 32 countries.The findings revealed that 39.5% ofpatients at risk for VTE were not receiv-ing appropriate prophylaxis.37 Hospital-wide strategies were recommended toassess patients’ VTE risk and to monitorwhether those at risk received appropri-ate prophylaxis.

To facilitate and standardize the processof screening for risk within health caresystems and across professions, RAMsshould be considered.36,38 Risk assess-ment models use a checklist to deter-mine whether risk factors for LE DVT arepresent and each risk factor is assigned apoint value. If a set point level is reached,the patient is considered at an increasedrisk, and more aggressive prophylacticinterventions can be used. There arenumerous examples of RAMs in the liter-ature, including the Padua score forassessing VTE risk in hospitalizedpatients,39 the IMPROVE VTE RAM,40 theAutar DVT Risk Assessment Scale,41 andthe Geneva Risk Score.42 None havebeen shown to be superior to othersthrough direct comparisons, and, for thisreason, the GDG cannot recommend asingle RAM. It is more important thatphysical therapists work within theirhealth care system to understand andeven help develop an overall VTE proto-col that uses an agreed-upon tool for VTErisk assessment.

In summary, given the risks and harmsassociated with a VTE and the relation-

Table 5.Reduced Mobility as a Risk Factor for Venous Thromboembolism19,25,a

Degree ofImmobility OR 95% CI P

Normal 1.0

Limited 1.73 1.08, 2.75 .02

Wheelchair 30 d 2.43 1.37, 4.30 .002

Bed rest 30 d 2.73 1.20, 6.20 .02

Wheelchair 15–30 d 3.33 1.26, 8.84 .02

Bed rest 15–20 d 3.37 1.00, 11.29 .05

Wheelchair 15 d 4.32 1.50, 12.45 .007

Bed rest �15 d 5.64 2.04, 15.56 .0008

a OR�odds ratio, CI�confidence interval.

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ship of VTE incidence to the presence ofrisk factors, physical therapists shouldscreen for VTE risk. These results shouldbe communicated with the rest of thehealth care team.

Action Statement 3: Providepreventive measures for LE DVTPhysical therapists should providepreventive measures for LE DVTfor patients who are identified asbeing at risk for LE DVT. These mea-sures should include educationregarding signs and symptoms of LEDVT, activity, hydration, mechanicalcompression, and referral for medi-cation assessment. (Evidence Qual-ity: I; Recommendation Strength:A–Strong)

Action statement profileAggregate Evidence Quality: Level IBenefits: Prevention of LE DVTRisk, Harm, Cost: None to minimalBenefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: NoneIntentional Vagueness: NoneRole of Patient Preferences: Patientsmay or may not choose to adhere topreventive measures. There is a role forhaving shared decision making withregard to their priorities.Exclusions: None

Summary of evidenceFor individuals who are at risk for LEDVT, preventive measures should be ini-tiated immediately, including educationregarding leg exercises, ambulation,proper hydration, mechanical compres-sion, and assessment regarding the needfor medication referral.

Education is a key factor in risk reductionof VTE and should be provided forpatients who are at elevated risk for LEDVT and for their families. Documenta-tion of the patient’s understanding ofthese concepts also should beincluded.43 Topics that should beincluded in this education program forthese patients and their families are: riskfactors for DVT, possible consequencesof DVT, interventions to decrease therisk of DVT, signs and symptoms of DVTand importance of seeking medical helpif DVT is suspected, importance of

follow-up monitoring, importance oftreatment adherence, and medicationissues (eg, regimen, adverse side effectsand interactions, dietary restrictions).44

Immobilization is one of the primary riskfactors for VTE and is a problem forpatients in the home and in acute caresettings and long-term care facilities.Immobility, as it relates to residents inlong-term care facilities, is defined by thepresence of at least one of the following:lower limb cast, bedridden, bedriddenexcept for bathroom privileges, recentdecreased ability to walk at least 3.1 m(10 ft) for a least 72 hours, and inabilityto walk at least 3.1 m (10 ft).45 Patientswho are limited to a chair or bed greaterthan half the day during waking hoursare considered at elevated risk for VTE.The acuteness and severity of the immo-bility determines the elevated risk levelof developing VTE.19

As immobility also occurs with long-distance travel, travelers on planes forgreater than 2 to 3 hours are also atincreased risk for LE DVT. The ACCP27

recommends that such travelers ambu-late frequently, perform calf muscle exer-cises, sit in an aisle seat, and use below-the-knee compression stockings with atleast 15 to 30 mm Hg compression (2Crecommendation).

Action Statement 4: Recommendmechanical compression as apreventive measure for DVTPhysical therapists should recom-mend mechanical compression (eg,intermittent pneumatic compres-sion [IPC], graded compressionstockings [GCS]) when individualsare at moderate to high riskfor LE DVT or when anticoagulationis contraindicated. (Evidence Quali-ty: I; Recommendation Strength:A–Strong)

Action statement profileAggregate Evidence Quality: Level IBenefits: Prevents LE DVT withoutincreasing the risk of bleedingRisk, Harm, Cost: Improper fit can leadto skin irritation, ulceration, or interrup-tion of blood flow.Benefit-Harm Assessment: Preponder-ance of benefit over harm

Value Judgments: NoneIntentional Vagueness: Specific typesof mechanical compression were notrecommended. Physical therapistsshould work within their health care sys-tem to develop institution-specificprotocols.Role of Patient Preferences: Ease ofuse, comfort level, and ability to operatemechanical compression equipmentproperly should be evaluated with eachpatient.Exclusions: Patients who have severeperipheral neuropathy, decompensatedheart failure, arterial insufficiency, der-matologic diseases, or lesions may havecontraindications to selective mechani-cal compression modes.

Summary of evidenceThe influence of mechanical compres-sion on LE DVT or PE prophylaxis wasexamined in 7 systematic reviews.46–52

The populations included patients whowere in postoperative recovery from avariety of surgical procedures, with orwithout pharmacological prophylaxis.Also included were airline travelers ofvarying VTE risk levels. These studiessupported that GCS used alone signifi-cantly decreased the incidence of LEDVT or PE and that this mechanical com-pression method provided additionalbenefit when combined with other pro-phylactic methods. Although GCS wasthe method of mechanical compressionin all 7 of these publications, the descrip-tive features of the GCS wereinconsistent.

Screening to identify VTE risk is essentialand will identify which, if any, mechan-ical compression method is appropriateto implement. In the CPG of the JapaneseCirculation Society for PE and LE DVTprevention, elastic stockings or IPC, IPCor anticoagulation, and anticoagulationplus IPC or elastic stockings are recom-mended for postoperative patients withelevated risk.53 The Institute for ClinicalSystems Improvement guidelines for VTEprophylaxis recommend that if contrain-dications exist for both low-molecular-weight heparin (LMWH) and low-doseunfractionated heparin (UFH) and thereis high risk for VTE but not high risk forbleeding, fondaparinux or low-dose aspi-rin or IPC be used.43 One example would

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be someone with a history of heparin-induced thrombocytopenia (HIT). Inter-mittent pneumatic compression or GCSare recommended for patients who areacutely or critically ill and who are bleed-ing or are at high risk for major bleeding,until bleeding risk decreases, at whichtime pharmacological thromboprophy-lactic methods can be substituted.38,54

A systematic review of 6 RCTs looked atpatients at high risk for VTE who under-went various surgical procedures toassess the effectiveness of IPC combinedwith pharmacological prophylaxis ver-sus single modality usage.55 CombiningIPC with an anticoagulant (eg, LMWH)was more effective in VTE preventionthan either IPC or anticoagulant usealone, which is consistent with the CPGrecommendation offered by the JapaneseCirculation Society.

In summary, there is substantial support-ive evidence for the use of mechanicalcompression methods for patients withmedical conditions or undergoing sur-gery,36,56–60 prolonged air-flight travel-ers,6,47,49 and patients in long-term carefacilities.45 For those people at increasedrisk for VTE, the use of GCS or IPC, withor without anticoagulation therapy, isconsidered to be beneficial. The evi-dence is inconsistent, however, indescribing the optimal protocols for useof GCS, elastic stockings, or IPC. Poten-tial for rare circulatory compromise withthe use of GCS (ie, knee or thigh length)warrants proper fitting and careful mon-itoring of skin condition by the patientand physical therapist.

Action Statement 5: Identify thelikelihood of LE DVT when signsand symptoms are presentPhysical therapists should establishthe likelihood of LE DVT when thepatient has pain, tenderness, swell-ing, warmth, or discoloration in thelower extremity. (Evidence Quality:II; Recommendation Strength: B–Moderate)

Action statement profileAggregate Evidence Quality: Level IIBenefit: Early intervention and preven-tion of adverse effects of LE DVTRisk, Harm, Cost: None

Benefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: Although the Wellscriteria for LE DVT are recommended bythis GDG, there are other tools that maybe preferred by other interprofessionalteams.Intentional Vagueness: NoneRole of Patient Preferences: NoneExclusions: None

Summary of evidenceThe major signs and symptoms of LEDVT include pitting edema, pain, tender-ness, swelling, warmth, redness or dis-coloration (erythema), and prominentsuperficial veins.36,45,61,62 The presenceof these signs and symptoms should raisethe suspicion of an LE DVT, but theycannot be used alone in the diagnosticprocess.31,61 The likelihood of LE DVTshould be established through use of astandardized tool. This recommendationis supported by numerous CPGs26,36,61,63

and a meta-analysis.62 A standardized tooluses the presence of clinical features ofan LE DVT to determine the likelihoodthat an LE DVT is present and guides theselection of the most appropriate test todiagnose an LE DVT. Physical therapistsshould use a standardized tool as part oftheir examination process when signsand symptoms of LE DVT are present.The results of the assessment shouldthen be communicated with the medicalteam.

The Wells criteria for LE DVT are themost commonly used tool to determinelikelihood of LE DVT (Tab. 6).21,64 Orig-inally, the Wells criteria for LE DVT useda 3-tier risk stratification of low, moder-ate, and high. A score of 3 or greater washigh risk, a score of 1 to 2 was moderaterisk, and a score of 0 or below was lowrisk. In a study of 593 patients, 16% hadan LE DVT. When the rate of LE DVT wasexamined in each stratification level, therates were 3% (95% confidence interval[CI]�1.7%, 5.9%), 16.6% (95% CI�12%,23%), and 74.6% (95% CI�63%, 84%) forlow, moderate, and high risk, respec-tively. Other studies have shown a cleardistinction in the rate of LE DVT amongthe 3 risk stratification levels.62,65 A 2014systematic review showed that, as thescore on the Wells criteria increased, sodid the likelihood of an LE DVT.66 This

relationship has held up across multiplesubgroups of patients, including outpa-tients, inpatients, those with malignancy,and patients grouped by sex and previ-ous history of an LE DVT.

In 2003, the Wells criteria for LE DVTwere modified to a 2-stage stratification(ie, LE DVT likely or LE DVT unlikely),and a history of previous LE DVT wasadded to the tool.67 Reducing the modelto 2 levels made it easier to use and didnot compromise patient safety whenused in conjunction with a D-dimer test.Individuals with 2 or more points werecategorized as likely, and those with lessthan 2 points were categorized asunlikely. In a study of 1,082 outpatients,27.9% (95% CI�23.9%, 31.8%) of thoseclassified as likely had a proximal LE DVTor a PE. Of those patients classified asunlikely, 5.5% (95% CI�3.8%, 7.6%) hada proximal LE DVT or a PE.

Beyond the Wells criteria for LE DVT,other risk stratification tools have beendeveloped, but there are limited compar-ison studies among the tools. One exam-ple is the Oudega rule, developed forprimary care providers. When comparedto the Wells criteria for LE DVT, it hassimilar effectiveness.68,69

The Wells criteria for LE DVT have a longand well-supported history of success-fully stratifying risk or likelihood of LEDVT across patient populations and prac-tice settings; therefore, the GDG recom-mends this tool for risk stratification.Physical therapists should advocate forits use with their interdisciplinary teamand determine the best way to commu-nicate the results and risks.

Action Statement 6:Communicate the likelihood ofLE DVT and recommend furthermedical testingPhysical therapists should recom-mend further medical testing afterthe completion of the Wells criteriafor LE DVT prior to mobilization(Evidence quality: I; Recommenda-tion strength: A–Strong)

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Action statement profileAggregate Evidence Quality: Level IBenefit: Risk stratification can ensureproper diagnostic testing is completedRisk, Harm, Cost: NoneBenefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: NoneIntentional Vagueness: NoneRole of Patient Preferences: NoneExclusions: None

Summary of evidenceOnce the Wells criteria for LE DVT arecomplete, medical testing can beordered by the medical team to diagnoseor rule out an LE DVT. The selection ofwhich medical test is beyond the scopeof physical therapist practice, but thereis benefit in understanding why tests areselected and how results guide the diag-nostic process. If a patient is classified asunlikely to have an LE DVT, the over-whelming recommendation is for themedical team to order a D-dimer testover other more costly and invasivetools.26,31,43,44,70 Within the referencedCPGs, the evidence is rated as level I,with grade of A to B for the recommen-dation. The D-dimer test is a measure ofthe breakdown or degradation of cross-linked fibrin, which increases in thepresence of a thrombosis. In patients

with an LE DVT–unlikely classificationand a negative D-dimer test, fewer than1% have an LE DVT, and studies reportsensitivity in the upper 90% to 100%.71–73

These patients need no further testingand can be considered safe tomobilize.26,31,36,43,70

Although the D-dimer test has high sen-sitivity, it has poor specificity. A positiveD-dimer test does not indicate a definiteLE DVT. A range of conditions, such asolder age, infections, burns, and heartfailure, can lead to an elevated D-dimertest, and hospitalized individuals have ahigh rate of false positives when theD-dimer is used for a suspected LEDVT.74 When a patient who is LE DVT–unlikely has a positive or high D-dimerlevel, further testing is necessary. Mostguidelines recommend a duplex ultra-sound to confirm an LE DVT.26,43,44,63

There is some debate on the type ofultrasound that is ordered, but this factoris beyond the focus of these guidelines. Ifthe ultrasound confirms an LE DVT, med-ical treatment should be initiated andmobilization postponed. If the ultra-sound is negative, the patient is safe tomobilize.

A patient rated as LE DVT–likely shouldimmediately undergo a duplex ultra-

sound.26,31,44,63 Individuals in the DVT–likely category will test positive on theD-dimer test, so the D-dimer test has lit-tle value. If the ultrasound is negative,the physical therapist should considerthe patient safe to mobilize. If the ultra-sound is positive, the physical therapistshould defer mobility until medical treat-ment has achieved therapeutic levels.

In summary, the results of the Wells cri-teria for LE DVT should guide the selec-tion of medical testing. Following theresults of the medical testing, the physi-cal therapist can then make a decisionabout when it is safe to mobilize thepatient.

Action Statement 7: Verify thepatient is taking ananticoagulantWhen a patient has a recentlydiagnosed LE DVT, the physical ther-apist should verify whether thepatient is taking an anticoagulantmedication, what type of anticoagu-lant medication, and when theanticoagulant medication wasinitiated. (Evidence Quality: V;Recommendation Strength: D–Theoretical/Foundational)

Action statement profileAggregate Evidence Quality: Level VBenefit: Decreased risk of a PE inpatients who are adequately anticoagu-latedRisk, Harm, Cost: Risk of bleeding withanticoagulation, risk of adverse effectswith restrictions in inactivity, and cost ofnew anticoagulants may be prohibitivein those with inadequate pharmacyinsurance coverage.Benefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: Intentional vague-ness. This CPG has provided therapeuticranges for anticoagulants that have beenprovided by the manufacturers due tothe limited evidence beyond this.Although the recommendation strengthis weak based on scientific evidence, theGDG considers it prudent to follow themanufacturer’s recommendations.Role of Patient Preference: Patientsshould be informed of the importancefor continuing anticoagulation upon dis-charge from the hospital as different anti-

Table 6.Two-Level Deep Vein Thrombosis (DVT) Wells Criteria Scorea

Clinical Feature Points

Active cancer (treatment ongoing, within 6 mo, or palliative) 1

Paralysis, paresis, or recent plaster immobilization of the lower extremities 1

Recently bedridden for 3 d or longer or major surgery within 12 wkrequiring general or regional anesthesia

1

Localized tenderness along the distribution of the deep venous system 1

Entire leg swollen 1

Calf swelling at least 3 cm larger than asymptomatic side 1

Pitting edema confined to the symptomatic leg 1

Collateral superficial veins (nonvaricose) 1

Previously documented DVT 1

Alternative diagnosis at least as likely as DVT �2

Clinical probability simplified score

DVT likely 2 points or more

DVT unlikely Less than 2 points

a Reprinted from Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis ofsuspected deep-vein thrombosis. N Engl J Med. 2003;349:1227–1235. © 2003 Massachusetts MedicalSociety. Reprinted with permission from the Massachusetts Medical Society.

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coagulants require monitoring, cost, andmodification of diet and bleeding risk.Exclusions: None

Summary of evidenceAnticoagulants are the primary defenseused to prevent and treat an LE DVT andconsequent PE or PTS. Contrary to pop-ular belief, anticoagulants do not activelydissolve a blood clot but instead preventnew clots from forming. Although anti-coagulants are often referred to as bloodthinners, they do not actually thin theblood. This class of drugs works by alter-ing certain chemicals in the blood nec-essary for clotting to occur. Conse-quently, blood clots are less likely toform in the veins or arteries, and yetcontinue to form where needed.Although anticoagulants do not breakdown clots that have already formed,they do allow the body’s natural clot lysismechanisms to work normally to breakdown clots that have formed.

Once an LE DVT is diagnosed, anticoag-ulant therapy is initiated, most com-monly with LMWH. Anticoagulant ther-apy will help to stop an existing clotfrom getting larger and prevent any newclots from forming. In addition, LMWHhas been shown to stabilize an existingclot and resolve symptoms through thedrug’s anti-inflammatory properties,making a clot less likely to migrate as anembolus.

A patient diagnosed with an LE DVT is atrisk of developing a PE; therefore, mobil-ity is contraindicated until intervention isinitiated to reduce the chance of embolitraveling to the lungs.75–79 According tothe ACCP guidelines on antithrombotictherapy, anticoagulation is the mainintervention and should be initiated assoon as possible (level I, strong evi-dence).26,43,44,61 If the patient is at a highrisk for bleeding, the primary contraindi-cation to anticoagulation, then medica-tions may not be prescribed. Therefore,prior to initiating mobility out of bed, aphysical therapist should review all med-ications the patient has been prescribedand verify that the patient is taking ananticoagulant. The physical therapistshould next consult with the medicalteam regarding appropriateness of mobil-ity. Although physical therapists do not

play a role in recommending the antico-agulant of choice, they should identifywhich anticoagulant the patient has beenprescribed and date and time of the firstdose. This approach will assist the phys-ical therapist in determining when thepatient has reached a therapeutic dose,and consequently, when mobility may beinitiated safely.

The current options for anticoagulationinclude UFH, LMWH, Coumadin (Bristol-Myers Squibb, New York, New York)(warfarin), fondaparinux, and oralthrombin or Xa inhibitors (eTable, avail-able at ptjournal.apta.org). Most patientswith a confirmed diagnosis of LE DVT orPE are prescribed a form of LMWH orfondaparinux (both given with subcuta-neous injections).31,44,61 Low-molecular-weight heparin is principally used totreat any LE DVT below the knee, atthigh level, and more proximalthrombi.31 It is the anticoagulant ofchoice for pregnancy and for active can-cer and the primary choice of physiciansfor treatment of VTE in the outpatient orhome setting due to ease of use and lowincidence of side effects.31,43,61 Low-molecular-weight heparin is used in mostcases except when a patient has renaldysfunction or a creatinine clearance lessthan 30 mL/min. Concomitant Coumadinuse may be started and provided for 3days, with subsequent international nor-malized ratio (INR) values being deter-mined. Most individuals will continuewith their initial anticoagulant (LMWH orfondaparinux) for 3 to 6 months for thefirst episode of diagnosed thrombosis. IfCoumadin is given concomitantly, theywill likely be removed from the initialanticoagulant and continued on Couma-din for 3 to 6 months.44,80

Anti-Xa levels can be used to monitorLMWH. However, evidence does notsupport the use of anti-Xa assay levels forpredicting thrombosis and bleedingrisk.81 Pharmacokinetic studies onLMWH report that maximum anti-factorXa and antithrombin IIa activities occur 3to 5 hours after subcutaneous injectionof LMWH.82 The optimal therapeuticanti-Xa levels for treatment are 0.5 to 1.0U/mL. Due to the fact that LMWH isexcreted primarily by the kidneys,increased bleeding complications have

been reported when LMWH is used inpatients with renal insufficiency andother populations. Therefore, precau-tions for bruising and bleeding withphysical therapy interventions should betaken when LMWH is used in patientswith kidney injury or dysfunction,patients in extreme weight ranges,patients who are pregnant, and neonatesand infants.63

Unfractionated heparin is indicated forindividuals with high bleeding risk(eTable) or renal disease. Patients withestablished or severe renal impairmentare defined as those with an estimatedglomerular filtration rate of less than 30mL/min/1.73 m2. Unfractionated heparinis often prescribed and dosed to achievetherapeutic levels quickly. Lower speedsof infusion are usually given in acute cor-onary syndromes, whereas higher speedsof infusion are given with VTE. Severalinstitutions have transitioned from mon-itoring heparin with anti-factor Xa levelsinstead of activated partial thromboplas-tin time (aPTT) due to influencing factorsthat can alter aPTT levels.83 One studyhas shown anti-Xa detects therapeuticlevels faster than aPTT (patients withUFH achieved therapeutic anticoagula-tion in approximately 24 hours com-pared with patients monitored withaPTT, which averaged 48 hours).83

Patients with a documented PE, includ-ing those who are hemodynamicallyunstable, are often prescribed UFH, andsimilar aPTT monitoring should bereviewed by the physical therapist see-ing the patient.44

Coumadin is usually not the first medica-tion choice for anticoagulation due tothe length of time to achieve peak ther-apeutic levels. Coumadin is typicallyintroduced on day 1 during administra-tion of another anticoagulation, usuallywith LMWH or UFH.61 The loading anti-coagulant (LMWH or UFH) is continuedfor at least 5 days until an INR greaterthan 2.0 is achieved for at least 24 hours,prior to discontinuing the loading antico-agulant, and first episodes of VTE shouldbe treated with a target INR range of2.5.80 The UFH or LMWH is often discon-tinued when the INR is greater than2.0.61

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Fondaparinux (Arixtra, GlaxoSmith-Kline, Research Triangle Park, North Car-olina) is similar to LMWH, is monitoredusing anti-Xa assays, and is often usedwhen individuals need treatment or pro-phylaxis for VTE but have a history ofHIT.43 The maximal therapeutic dosageis reached in approximately 2 to 3hours.43,79 Fondaparinux also is used forthromboprophylaxis in patients withmedical and surgical conditions, as isLMWH.63

Both UFH and LMWH are associated withHIT, defined as an immune-mediatedreaction to heparins. Heparin-inducedthrombocytopenia can occur in 2% to 3%of patients treated with UFH and inapproximately 1% of patients treatedwith LMWH.43 Heparin-induced throm-bocytopenia will result in a paradoxicalincreased risk for venous and arterialthrombosis, and this risk lasts approxi-mately for 100 days following initial reac-tion. Therefore, patients with a history ofHIT should not receive either LMWH orUFH with subsequent VTE.43,84 Treat-ment for anticoagulation in individualswith HIT involves using fondaparinux orother thrombin-specific inhibitors suchas lepirudin or argatroban. Indicators ofHIT are: skin lesion reaction at injectionsite, systemic reaction to a bolus admin-istration of heparin, and 50% decrease inplatelet count from normal ranges whileon heparin. Indicators of delayed-onsetHIT are: thromboembolic complications1 to 2 weeks after receiving the last doseof LMWH or UFH, and mild-to-moderatethrombocytopenia.

Mobility decisions with an individualreceiving Coumadin are based on the ini-tial anticoagulant and not Coumadin.Concern regarding exercise and out-of-bed activity should be raised for elevatedINRs greater than 4.0 when patients aretaking warfarin.85 If the INR is between4.0 and 5.0, resistive exercises should beavoided, with participation in light exer-cise only (eg, rating of perceived exer-tion �11) due to increased risk of bleed-ing.85 Ambulation should be restricted ifgait is unsteady to prevent falls.85 Thelikelihood of bleeding rises steeply asINR increases above 5.0.86–88 If the INRis greater than 5.0, discussion should beheld with the referring physician regard-

ing patient safety. When the INR isgreater than 6.0, the medical teamshould consider bed rest until the INR iscorrected.85,86 In most cases, INRs canbe corrected within 2 days.85 Whenreversal of anticoagulation is needed forsurgery and the patient is taking Couma-din, fresh frozen plasma is the choice toreplace the anticoagulation.86

New oral anticoagulant drugs (directthrombin inhibitors and direct factor Xainhibitors) are growing in popularity dueto their ease of use (no laboratory mon-itoring, no adverse dietary or other druginteractions) and their rapid time to peaktherapeutic levels. In addition, thereappears to be less risk of cerebral hem-orrhage, as occurs in vitamin K antago-nists.86 Rivaroxaban (Xarelto, JanssenPharmaceuticals Inc, Titusville, New Jer-sey), dabigatran (Pradaxa, BoehringerIngelheim Pharmaceuticals Inc, Ridge-field, Connecticut), and apixaban(Eliquis, Bristol-Myers Squibb Co) are the3 new oral anticoagulant drugs in use atthis time (refer to eTable for dosage,method of delivery, and peaktherapeutic-level time frames). The neworal anticoagulant drugs are recom-mended by the American Academy ofOrthopaedic Surgeons for hip and kneearthroplasty but have not been tested orrecommended for individuals who havecancer, are undergoing treatment forcancer, or are pregnant.89 There are con-cerns regarding reversal of anticoagula-tion with these medications. However,reconstructed recombinant factor Xa oractivated charcoal have both been pro-posed as antidotes.89,90 The time forreversal is the amount of time to elimi-nate the drug from the body, which isbased on the drug’s half-life, usuallywithin 12 to 24 hours. With all anticoag-ulants there is a risk of bleeding. There-fore, in addition to the risk of VTE, phys-ical therapists should be aware of andassess for risk of bleeding in all patients.Factors associated with high risk ofbleeding are: active bleeding; acutestroke; acquired bleeding disorders (eg,acute liver failure); concurrent use ofanticoagulants known to increase therisk of bleeding (eg, Coumadin with aninternational normalized ratio �2); lum-bar puncture, epidural, or spinal anesthe-sia expected to be given within next 12

hours; thrombocytopenia (platelet countless than 7,500); uncontrolled systolichypertension (defined as blood pressureof 230/120 mm Hg or higher), anduntreated inherited bleeding disorders,such as hemophilia or von Willebranddisease.20

Action Statement 8: Mobilizepatients who are at a therapeuticlevel of anticoagulationWhen a patient has a recently diag-nosed LE DVT, physical therapistsshould initiate mobilization whentherapeutic threshold levels of anti-coagulants have been reached. (Evi-dence Quality: I; RecommendationStrength: A–Strong)

Action statement profileAggregate Evidence Quality: Level IBenefit: Decreased risk of subsequentLE DVT or PE; decreased risk of adverseeffects of bed restRisk, Harm, Cost: Risks associated withuse of anticoagulants include increasedrisk of bleeding. If an anticoagulant is notat a therapeutic level, there may be anincreased risk of PE with mobilization.Benefit-Harm Assessment: Preponder-ance of benefitValue Judgments: The evidence formobility to prevent VTE is strong,although the evidence on when to initi-ate mobility may not be as strong and isbased on the patient achieving the ther-apeutic level of the anticoagulant. Phys-ical therapists should mobilize patientsas soon as possible after diagnosis of VTEas long as the risk of PE is decreased.Achieving the therapeutic level of theanticoagulant has been shown to dimin-ish the risk of developing a PE.Intentional Vagueness: Specific antico-agulants or their therapeutic levels arenot recommended. Instead, evidence-based guidelines and algorithms havebeen provided for guidance. Physicaltherapists should work within theirhealth care system to develop institution-specific protocols.Role of Patient Preference: Patientsshould be aware of the anticoagulationthey are prescribed and the effect thatthe anticoagulant will have on their life-style (eg, amount of medical monitoring,risk of bleeding, foods to avoid, risk ofbrain bleed). In addition, patients should

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be informed regarding the risk of immo-bility in developing further VTE and thebenefit of mobility.Exclusions: The risk of bleeding is pres-ent when anyone takes anticoagulants.However, patients with HIT, a history ofHIT, recent bleeding events, or increasedrisk of bleeding should be prescribedtreatment other than anticoagulation,including mechanical compression orintravenous filters.

Summary of evidencePatients who have a documented LE DVTand have reached therapeutic levels ofthe prescribed anticoagulant should bemobilized out of bed and ambulate toprevent venous stasis. In doing so,deconditioning is minimized, length ofhospital stay may be shortened, andother adverse effects of prolonged bedrest (eg, decubiti) can be avoided. Acommon concern for mobilizing apatient with an LE DVT is that the clotwill dislodge and embolize to the lungs,causing a potentially fatal PE. However,early ambulation has been shown to leadto no greater risk of PE than bed rest forpeople with a diagnosed LE DVT whohave been treated with anticoagulants.28

A meta-analysis showed the absence of ahigher risk of new PE or other adverseclinical events when individuals wereambulated instead of kept on bed rest.28

The studies included in this meta-analysishad differences in the timing of ambula-tion following initiation of anticoagula-tion. Nevertheless, the conclusionarrived at was that “early” ambulationwas possible as soon as the level of effec-tive anticoagulation had been reached.28

In 2 earlier systematic reviews, 1 with 3studies totaling 300 patients91 and 1 with9 studies,23 similar conclusions werereported. A potentially reduced risk forextension of a proximal LE DVT andreduced long-term symptoms of PTSwith early mobility was reported, dem-onstrating the benefits of early mobiliza-tion of patients having LE DVT.29

In 2012, the ACCP published guidelineson antithrombotic therapy and preven-tion of thrombosis provided a moderatestrength recommendation that patientswith an acute LE DVT should receiveearly ambulation over initial bed rest

because of the potential to decrease PTSand improve quality of life.27

In summary, early mobilization ofpatients with an LE DVT who are antico-agulated does not put the patient atincreased risk of PE. Early mobilizationhas added benefits. The GDG recom-mends mobilizing patients with an LEDVT once anticoagulation is initiated andtherapeutic levels have been achieved.Based on the evidence that exists on timeto peak therapeutic levels of the antico-agulants (refer to eTable), expert consen-sus exists to recommend early ambula-tion of individuals with an LE DVT whoare receiving anticoagulation and havereached their peak therapeutic levelsbased on the specific anticoagulationmedication they are prescribed.

Action Statement 9: Recommendmechanical compression forpatients with LE DVTPhysical therapists should recom-mend mechanical compression (eg,IPC, GCS) when a patient has an LEDVT. (Evidence Quality: II; Recom-mendation Strength: B–Moderate)

Action statement profileAggregate Evidence Quality: Level IIBenefit: Secondary prevention of recur-rent DVT/PE or PTS and faster resolutionof LE DVT signs and symptomsRisk, Harm, Cost: Improper fit can leadto skin irritation, ulceration, or interrup-tion of blood flowBenefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: NoneIntentional Vagueness: Types ofmechanical compression were not rec-ommended. Physical therapists shouldwork within their health care system todevelop institution-specific protocols.Role of Patient Preference: Ease ofuse, comfort level, and ability to operatemechanical compression equipmentproperly should be discussed withpatients and their families or caregivers.Exclusions: Patients who have severeperipheral neuropathy, arterial insuffi-ciency, dermatologic diseases, or lesionsmay have contraindications to selectivemechanical compression modes.

Summary of evidenceIn the ninth edition (2012) CPG by theACCP, recommendations pertaining tomechanical compression based onmoderate-quality data for patients withdiagnosed LE DVT were given.91 Forpatients with acute symptomatic LE DVTand in those having PTS, GCS were sug-gested based on studies using at least 30mm Hg of pressure at the ankle. Inpatients with severe PTS of the leg notadequately relieved with GCS, a trial withIPC was suggested.

Systematic reviews pertaining to theadjuvant use of mechanical compressiongarments for patients who are anticoag-ulated and have acute VTE (eg, LE DVT)while on bed rest or with early ambula-tion compared with controls providesupportive evidence for their use.92 The7 RCTs in these reviews concluded thatmechanical compression lowered therelative risk for progression of a throm-bus or the development of a newthrombus.

Two earlier RCTs conducted over 2 yearson patients who had symptomatic, first-occurrence proximal LE DVTs con-cluded that knee-length elastic GCS withinterface pressures of 30 to 40 mm Hg atthe ankle reduced the incidence of mild,moderate, and severe PTS comparedwith controls who did not wear GCS.93,94

In stark contrast, a more recent random-ized placebo-controlled multicenter trialwith 410 patients having a first proximalLE DVT followed for 2 years (ie, SOXtrial) did not support the routine wearingof GCS (ie, knee length at 30–40 mm Hgcompared with �5 mm Hg placeboknee-length stockings) after LE DVT.95

Two additional RCTs96,97 on patientswho were anticoagulated and had acuteLE DVT combined early ambulation withthe wearing of either inelastic (rigid)stockings above the knee (ie, zinc plasterUnna boots providing 50 mm Hg of inter-face pressure at the ankle) or thigh-length elastic stockings (ie, providing aninterface pressure of 30 mm Hg at theankle) compared with control patientson bed rest. The combination of GCSwith ambulation resulted in a fasterresolution of pain and swelling and an

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increased quality-of-life outcomemeasure.

In summary, the evidence to supportmechanical compression methods aseffective treatment interventions for sec-ondary VTE prevention varies accordingto patient VTE risk profile, acute (eg,hemodynamic stability) versus chronic(eg, PTS concern) status, degree of signs(eg, swelling) and symptoms (eg, pain),and consideration for potentially harmfuloutcomes (eg, skin lesions). Whetherused adjunctively along with anticoagu-lants, alone as in patients when antico-agulant use is contraindicated, or in com-bination (eg, ambulation plus GCS) withor without anticoagulation, mechanicalcompression use has mostly been favor-able. Controversy persists, however,regarding whether to support the rou-tine use of mechanical compression (eg,GCS) for LE DVT management and sec-ondary prevention. Studies tend to sug-gest that having GCS compression forcesat the ankle, regardless of whether elasticor rigid, is beneficial when �30 mm Hg,especially when combined with earlyambulation. Regardless of whether themode of mechanical compression is byGCS or another means (eg, IPC), the opti-mal mechanical compression treatmentstrategy has yet to be identified.98

Action Statement 10: Mobilizepatients after inferior vena cava(IVC) filter placement oncehemodynamically stablePhysical therapists should mobilizepatients after IVC filter placementonce they are hemodynamically sta-

ble and there is no bleeding at thepuncture site. (Evidence Quality: V;Recommendation Strength: P–BestPractice)

Action statement profileAggregate Evidence Quality: Level VBenefits: Decreased risk of PE reducedin-hospital fatality rate in patients whoare stable and those who are unstableRisk, Harm, Cost: IVC complicationsand potential overuse of IVC filters mayincrease costsBenefit-Harm Assessment: Preponder-ance of benefit over harm for patientswho have an acute proximal LE DVT andcontraindications to anticoagulantsValue Judgments: An IVC filter is valu-able for patients at high risk who areunable to be given anticoagulants.Intentional Vagueness: NoneRole of Patient Preference: NoneExclusions: Patients with contraindica-tions to IVC filter placement

Summary of evidenceInferior vena cava filter placement is atype of percutaneous endovascular inter-vention for venous thromboembolic dis-ease and is usually performed by an inter-ventional radiologist. Venous access isvia the right internal jugular or right fem-oral veins. The best placement locationfor the IVC filter to prevent lowerextremity and pelvic VTE is just inferiorto the renal veins.99 Table 7 lists theindications and contraindications for IVCfilter placement. In general, IVC filtersare used to prevent PE in patients whoare thought to be at high risk for LE DVTor PE, have contraindications to antico-

agulants, or for whom medications havenot been effective. Findings are mixedregarding the effectiveness of IVC filtersin preventing PE, and there are risks asso-ciated with IVC filter placement (Tab. 8).Following placement of an IVC filter, thepatient should be mobilized once he orshe is hemodynamically stable and thereis no bleeding at the puncture site.99

Physical therapists should monitor ambu-lation and mobility to ensure patientsafety and to determine the appropriatelevel of required assistance prior to thepatient being discharged.99

Action Statement 11: Consultwith the medical team when apatient is not anticoagulated andwithout an IVC filterWhen a patient with a documentedLE DVT below the knee is not treatedwith anticoagulation and does nothave an IVC filter and is prescribedout of bed mobility by the physician,the physical therapist should consultwith the medical team regardingmobilizing versus keeping thepatient on bed rest. (Evidence Qual-ity: V; Recommendation Strength:P–Best Practice)

Action statement profileAggregate Evidence Quality: Level VBenefits: Mobility has demonstrated adecreased risk of VTERisk, Harm, Cost: Potential increasedrisk of PE should the LE DVT embolizeBenefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: As movement spe-cialists, physical therapists recommendmobilization over bed rest due to thedocumented benefits of early mobilization.Intentional Vagueness: Specific guide-lines are not provided because it is rarethat a patient will not have anticoagu-lants prescribed or an IVC filter in thiscountry. Each patient should be consid-ered individually.Role of Patient Preferences: Patientsshould be informed of the risks and ben-efits of bed rest and inactivity and ofmobilization.Exclusions: Any LE DVT present abovethe knee

Table 7.Indications and Contraindications to Inferior Vena Cava Filter Placement138

Absolute Indications Relative Indications

Contraindication to anticoagulation Large free-floating proximal deep vein thrombosis

Therapeutic anticoagulation is unable to beachieved or maintained

Therapeutic anticoagulation not achieved

Venous thromboembolism with decreasedcardiopulmonary reserve

Poor adherence to anticoagulation medication

High risk of complication from anticoagulation

Absolute Contraindications Relative Contraindications

Complete, chronic thrombosis of theinferior vena cava filter

Severe, uncorrectable coagulopathy

Inability to gain central venous access Bacteremia or sepsis

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Summary of evidenceThere may be times when a patient has adiagnosed LE DVT but no medical inter-ventions are initiated. The patients mayhave contraindications for receiving anti-coagulant medications or they do notmeet the criteria for an IVC (eg, in palli-ative care or hospice care). In these sit-uations, a consult with the primary phy-sician or medical team should guide thedecision to mobilize the patient. Con-tinuing to remain on bed rest will onlyincrease the risk of additional VTE andother adverse effects of immobilization.At some point, the patient needs toreturn to daily activities, and it might beappropriate to begin mobilization eventhough an untreated LE DVT is present.In other situations, the reason for notaddressing the LE DVT may be shortterm. It may be wise to wait until antico-agulation can begin. The physical thera-pist needs to discuss all of these factorswith the interprofessional team and thepatient when making a clinical judgmentabout mobilization. Although a physicianmay order physical therapy to increasethe physical activity level of a patient, itis the physical therapist’s clinical deci-sion whether to mobilize the patientbased on the available information aboutthe patient’s LE DVT and risk status.

Action Statement 12: Screen forfall riskPhysical therapists should screen forfall risk whenever a patient is takingan anticoagulant medication. (Evi-dence Quality: III; RecommendationStrength: C–Weak)

Action statement profileAggregate Evidence Quality: Level IIIBenefits: Decreased risk of hemorrhagedue to fallsRisk, Harm, Cost: Immobility versusrisk of fallingBenefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: Fall prevention is aprudent step in managing patients whoare at increased risk for bleeding.Role of Patient Preference: NoneExclusions: None

Summary of evidenceA major bleed event is a possible compli-cation in patients taking an anticoagulantmedication. Use of oral anticoagulantsincreases the risk of intracerebral bleedsby 7 to 10 times.100 Individuals who fallwhile on long-term anticoagulation havehigher rates of mortality than those noton these medications due to a subse-quent major bleed.101,102 However, thebenefits of being on an anticoagulant out-weigh the risk of a major bleed.103,104

Therefore, patients at high risk for fallsare not automatically excluded fromreceiving anticoagulants and will receivethese medications when it is consideredmedically beneficial.

Age is considered a major risk factor forfalls. People 75 years of age and olderhave the highest rate of falls, and 1 in 3individuals over the age of 65 years falleach year.105,106 Because of the risk offalls associated with age, the NationalInstitute for Health and Care Excellence,the American Geriatrics Society, and theUS Preventive Services Task Force all rec-

ommend screening for fall risk in allolder adults.107–109 Individuals should beasked about feelings of unsteadiness andfalls over the last year. If a fall orunsteadiness has been reported, furtherassessment of strength, balance, andother risk factors should be completed.In general, the population of individualson anticoagulants is made up of olderadults who would benefit from fall riskscreening.4,110 The Centers for DiseaseControl and Prevention’s StoppingElderly Accidents, Deaths and Injuries(STEADI) toolkit provides physical ther-apists and interprofessional team mem-bers with an evidence-based tool toimprove fall prevention in clinicalpractice.

Action Statement 13:Recommend mechanicalcompression when signs andsymptoms of PTS are presentPhysical therapists should recom-mend mechanical compression (eg,IPC, GCS) when a patient has signsand symptoms suggestive of PTS.(Evidence Quality: I; Recommenda-tion Strength: A–Strong)

Action statement profileAggregate Evidence Quality: Level IBenefit: Faster resolution of LE DVTsigns and symptoms and decreasing PTSseverityRisk, Harm, Cost: Improper fit can leadto skin irritation, ulceration, and inter-ruption of blood flow.Benefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: NoneIntentional Vagueness: The specifictypes of mechanical compression werenot recommended. Physical therapistsshould work within their health care sys-tem to develop institution-specificprotocols.Role of Patient Preference: Ease ofuse, comfort level, and ability to operatemechanical compression equipmentproperly should be discussed with thepatient and caregiver.Exclusions: Patients who have severeperipheral neuropathy, arterial insuffi-ciency, dermatologic diseases, or lesionsmay have contraindications to selectivemechanical compression modes.

Table 8.Complications Related to Inferior Vena Cava Filters138,139

Insertion Complications Thrombotic Complications

Hematoma at insertion site Insertion site thrombosis

Misplacement Inferior vena cava filter thrombosis

Pneumothorax New or progression of deep vein thrombosis

Inferior vena cava damage/wall penetration New or progression of pulmonary embolism

Filter migration Postthrombotic syndrome

Air embolism

Carotid artery puncture

Arteriovenous fistula

Infection

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Summary of evidenceApproximately 1 in 3 patients with LEDVT will experience PTS within 5 years,and in 5% to 10% of these patients, PTSoccurs in its most severe form as venousulceration.13,111,112 The potential existsthat should infection develop, septice-mia or septic shock could result.113

Patients with PTS experience chroniccomplaints of leg pain secondary to theDVT, which may include the sense of theleg feeling heavy, cramping, and itching,and, in severe cases, venous ulcer-ation.13,98,114 The pathogenesis of PTS isthought to be related to venous hyper-tension. As the thrombus initiates aninflammatory response, venous valvesmay become damaged during this pro-cess of thrombus resolution, which isoften incomplete over time. The dam-aged venous valves cause valvular reflux,and as remodeling of the vein walloccurs, they may become stiff and con-tribute to increased outflow resistance,which increases blood pressure in theveins. This increase in transluminal pres-sure causes leakage into the interstitialspace, leading to edema and skinchanges. Microcirculation and bloodsupply to the leg muscles become com-promised, which can lead to venousulcerations in the more severe instancesof PTS.98 With clinical findings of PTSbeing similar to that of an acute LE DVT,concern is raised regarding the negativeimpact that PTS may have on a person’squality-of-life experience.13,111,113,115–117

For reasons described above, physicaltherapists should consider screening allpatients with a history of LE DVT, pastand current, for signs and symptoms ofPTS. Once PTS is suspected, a specificand sensitive rating instrument referredto as the Villalta scale can be used tograde the severity of PTS.117–120

A meta-analysis conducted on 5 RCTsdetermined that venous compressionstockings or compression bandages areeffective in reducing PTS in patients.119

In patients with LE DVT receiving GCScompared with controls, mild-to-moderate PTS occurred in 64 (22%) of296 patients treated with venous com-pression compared with 106 (37%) of284 controls. Severe PTS occurred in 14(5%) of 296 patients treated comparedwith 33 (12%) of 284 controls. Develop-

ment of any degree of PTS occurred in 89(26%) of 338 patients treated comparedwith 150 (46%) of 324 controls. Thus,GCS reduces the severity of PTS,although there was a wide variation inthe type of stockings used, time intervalfrom diagnosis to application of stock-ings, and duration of treatment.

Two Cochrane reviews, separated by 1year, were conducted to determine thetreatment interventions of IPC or GCSaccording to PTS severity. Findings fromthe first review based on 2 RCTs112

included favorable trends using higherpressures of IPC over that of lower pres-sures and that there was not enough evi-dence to support the use of elastic GCS(30–40 mm Hg pressures at the ankleversus placebo stockings) in patientswith mild-to-moderate PTS severity. Thesecond review, based on 3 RCTs,120 pro-vided statistically significant evidencethat elastic GCS of 20 to 40 mm Hg inter-face pressure at the ankle reduce theseverity of PTS after LE DVT.

A separate RCT involving 169 patientswith a first or recurrent proximal LE DVTafter receiving 6 months of standardtreatment to wear GCS or not was con-ducted.121 The incidence of PTS was 11patients (13.1%) in the treatment groupcompared with 17 individuals (20.0%) inthe control group. No venous ulcerationwas observed in either group, withsymptom relief significantly in favor ofcompression treatment during the firstyear but not thereafter. The conclusionreached was that prolonged use of GCSafter proximal DVT significantly reducessymptoms and signs of postthromboticskin changes.

In the evidence-based guideline by theFinnish Medical Society Duodecim,immediate bandaging for compressionduring the acute phase of DVT (up to thegroin, if needed) is recommended in cir-cular rather than figure-eight turns.31 Inaddition, the patient should be mobilizedas soon as clinically possible, and GCS(class II compression) should be wornfor at least 2 years.

Pooled results from 4 RCTs in anothersystematic review122 in patients withconfirmed proximal LE DVT used com-

pression bandaging (inelastic or elastic),with or without early ambulation, as anintervention for PTS.122 Results stressedthe importance of activating the calfmuscle pump in addition to compressionbandaging, a message echoed by otherauthors more recently.123

The lack of uniformity in reporting stan-dards, such as the timing, duration, anddegree of compression interface pres-sure, among other descriptors, makes itdifficult for meaningful comparisonsamong studies. This concern has beenraised by more than one investigativegroup.98,122–125

In summary, mechanical compression(eg, with IPC or compression bandaging,activation of the calf muscle pump), withor without ambulation, is the corner-stone in the treatment of PTS. The inter-vention strategy is primarily focused ondecreasing venous pressure in theinvolved lower extremity, enhancementof the microcirculation, and reduction ofthe edema. The efficacy in treating PTSafter confirmed acute LE DVT and itsdevelopment during the subacute periodor as a debilitating chronic conditionthereafter do favor the early applicationand prolonged use of mechanical com-pression. The lack in uniformity of themethods and prescriptive protocolsfollowed in the use of mechanical com-pression lends itself to controversy. Nev-ertheless, the preponderance of qualityevidence does warrant a strongrecommendation.

Action Statement 14: Providemanagement strategies toprevent recurrent VTE andminimize secondary VTEcomplicationsPhysical therapists should monitorpatients who may develop long-termconsequences of VTE (eg, LE DVTrecurrence, PTS severity) and pro-vide management strategies in orderto improve quality of life. (Evi-dence quality: V; Recommendationstrength: P–Best Practice)

Action statement profileAggregate evidence quality: Level VBenefit: Decreasing the incidence of LEDVT recurrence and minimizing the

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severity of PTS signs and symptoms inorder to enhance functional mobility anda person’s quality of life experienceRisk, Harm, Cost: Improper fit ofmechanical compression can lead to skinirritation, ulceration, and interruption ofblood flow.Benefit-Harm Assessment: Preponder-ance of benefit over harmValue Judgments: NoneIntentional Vagueness: No specifictypes of mechanical compression wererecommended. Physical therapistsshould work within their health care sys-tem to develop institution-specificprotocols.Role of Patient Preference: Ease ofuse, comfort level, and ability to operatemechanical compression equipmentproperlyExclusions: Patients who have severeperipheral neuropathy, arterial insuffi-ciency, decompensated heart failure,dermatologic diseases, or lesions mayhave contraindications to selectivemechanical compression modes.

Summary of evidenceWhether or not a VTE (ie, LE DVT, PE, orPTS) has a clear cause (eg, surgery,trauma, forced immobilization) or isunprovoked (ie, in the absence of aknown risk factor), physical therapistsshould remain vigilant in screeningpatients for signs and symptoms of recur-rent VTE.126 It is estimated that the riskof recurrence can reach 5% to 10% dur-ing the first 6 to 12 months127 and 10% to30% within 5 years128 following a docu-mented first-episode VTE. According toone recent CPG, the rate of VTE recur-rence for patients not on long-term anti-coagulation is 5% per year.36 When phar-macologic anticoagulation is provided,the recurrence rate for VTE within thefirst 6 months was reported to be lessthan 2.5% in one RCT129 and between1.3% and 7.1% over a period of 18 to 24months in another RCT.130 Nevertheless,the incidence of fatal and nonfatal VTErecurrence in patients who are anticoag-ulated following confirmed VTE in theshort term of 3 months was reported tobe 0.4% and 3%, respectively, in onemeta-analysis,131 and a fatality incidencedue to PE of 1.68% was found in a largecohort study.132 These findings serve tounderscore the importance of having

physical therapists monitor patients forVTE recurrence regardless of whetherover the short term or the long term.

The ability of a clinician to accuratelypredict level of risk for recurrent VTE(eg, low versus high) has been investi-gated using the Pulmonary EmbolismSeverity Index (PESI) clinical predictionrule and found to be of merit.129,133 Addi-tionally, the use of global clinical judg-ment that takes into account all of apatient’s signs and symptoms (ie,unstructured clinician gestalt) may besuperior to clinical prediction ruleuse.130

The ability to distinguish or recognizethat PTS is present is important for theclinician to determine. Postthromboticsyndrome is defined as a combination ofclinical signs and symptoms occurringafter an LE DVT. One study examined 6different scoring systems that areintended to document the presence andseverity of PTS based on variable clinicalsigns (ie, 11) and symptoms (ie, 12) usedbetween them.114 Because PTS alsoinvolves a patient’s subjective report ofsymptoms, using the objective PTS indi-cator of skin pigmentation changes thathighly correlate with findings fromduplex sonography for venous refluxocclusion was advocated.

Thrombosis resolution is often incom-plete, with as many as 50% of legsaffected by DVT still having residual veinthrombosis years after the LE DVT is firstdiagnosed.98 The negative impact ongeneric life-of-quality measures (eg,36-Item Short-Form Health Survey [SF-36] sections for physical functioning andbodily pain) has life-quality consequencecomparable to chronic medical condi-tions such as diabetes and heart fail-ure.117 It is prudent, therefore, that phys-ical therapists recognize signs andsymptoms of PTS and intervene witheducation, hydration, early mobilization,mechanical compression, and referral formedication when appropriate (refer tokey Action Statement 3). For example,mechanical compression aims to managefactors responsible for the pathogenesisof VTE (ie, Virchow’s triad of hyperco-agulopathy, venous stasis, and endothe-lial damage) by reducing swelling, accel-

erating venous return, and improvingmuscle pump function.122

In summary, patients who have a priorhistory of VTE are at high risk for recur-rent VTE, especially when they areimmobilized or are of advanced age. It isjudicious to screen for VTE recurrenceusing a clinical prediction rule (eg, PESI,Padua score, Wells criteria for LE DVT;Geneva Risk Score) for objective docu-mentation purposes, although globalclinical judgment that would favor inter-vention for secondary VTE preventionshould not be overlooked. Once VTE isdiagnosed, clinical practice has shiftedaway from immobilization with bed restand toward early ambulation with orwithout adjunctive mechanical compres-sion. From the literature examined, thedegree to which recurrent VTE is treatedas a secondary prevention should be apriority. Thus, clinical judgment andexpert opinion remain for deciding theclinical actions to take.

ConclusionThe major findings of this CPG are thefollowing:

• Physical therapists should play alarge role in identifying patientswho are at high risk for a VTE.Once these individuals are identi-fied, preventive measures such asreferral for medication, initiation ofactivity or mobilization, mechanicalcompression, and education shouldbe implemented to decrease therisk of a first or reoccurring VTE.

• Physical therapists should be awareof the signs and symptoms of an LEDVT. When signs and symptomsare present, the likelihood of an LEDVT should be determined throughthe Wells criteria for LE DVT, andresults should be shared with theinterprofessional team to considertreatment options.

• In patients with a diagnosed LEDVT, once a medication’s therapeu-tic levels or an acceptable timeperiod has been reached afteradministration, mobilization shouldbegin. Although there are risksassociated with mobilization, therisk of inactivity is greater.

• Complications following LE DVTcan continue for years or even a

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lifetime. Physical therapists canhelp decrease these complicationsthrough education, mechanicalcompression, and exercise.

ImplementationIn order to implement and disseminatethe recommendations of this CPG, theGDG has taken or is in the process oftaking the following steps:

• Preliminary sharing of CPG recom-mendations at APTA’s CombinedSections Meeting 2015.

• Open access to the CPG and allreference materials.

• Creation of a pocket guide aboutVTE for physical therapists.

• Creation of patient brochures andinformation flyers about the role ofphysical therapists in preventingVTE and managing patients with LEDVT.

• Production of podcasts about theCPG aimed at physical therapists.

• Presentations on the CPG by theGDG at local, state, regional, andnational seminars.

• Creation of checklist and sampleevaluation forms incorporating therecommendations of the CPG.

In order to implement these recommen-dations, physical therapists and theentire health care team should take thefollowing steps:

• Integrate key action statementswithin this article into clinical prac-tice. Making resources easily acces-sible in the clinic, such as lists ofsigns and symptoms of LE DVT,copies of the Wells criteria for LEDVT tool, and the algorithms in thisCPG, are some examples.

• Form interprofessional teams thataddress VTE and ensure all provid-ers know about and then imple-ment the recommendations in thisCPG. This recommendation may bedone through embedding riskassessment into standardized exam-ination forms or working withreferral sources to encourage earlymobilization after diagnoses ofVTE. As demonstrated in the areasof early mobilization in the inten-sive care unit and diabetes andchronic pain management, inter-professional teams are effective

when attempting to change the cul-ture of an organization to improvepatient outcomes.134–136

• Physical therapists need to seek outmembership in these interprofes-sional committees and serve as clin-ical champions in the areas of VTEprevention and management. Asmovement specialists, physicaltherapists understand the impor-tance of mobilization and activityand have the ability to modify inter-ventions based on medical historyand patient problems. Physicaltherapists can add greatly to thescope and depth of these teams.

Research NeedsAlthough researchers have addressedmultiple aspects of VTE management,there are still many unanswered ques-tions. A few future research questionsthat are specific to the physical therapymanagement are listed below:

• Does aggressive screening for LEDVT lead to a decline in the inci-dence of PE?

• Does the implementation of guide-lines for mobilization of patientswith LE DVT lead to earlier mobili-zation and improved patientoutcomes?

• How should patients with UE DVTbe treated by physical therapists?

• What are guidelines for mobiliza-tion of individuals with a hemo-dynamically unstable PE?

• What is the appropriate degree ofgraded compression (eg, elastic,inelastic stockings, IPC) and timingof treatment intervention for PTSand LE DVT prevention?

Dr Hillegass, Dr Puthoff, and Dr Frese pro-vided concept/idea/research design. Allauthors provided writing and data analysis.Dr Hillegass, Dr Frese, Dr Thigpen, DrSobush, and Ms Auten provided data collec-tion. Dr Hillegass provided project manage-ment, fund procurement, and consultation(including review of manuscript before sub-mission). Dr Thigpen provided institutionalliaisons.

The authors would like to thank the follow-ing people for their participation in thedevelopment of these guidelines: ChristaStout, our fabulous guideline assistant, andSt Ambrose University graduate assistant

Catherine Berger. Guideline Reviewers:John Heick, Kate MacPhedran, John Low-man, and Steve Tepper. Article Reviewers:Andrew Bartlett, Karen Holtgrafe, JosephAdler, Gabrielle Shumrak, Iancu Cap-usan, Amy Nordon-Craft, Nancy Smith, andAndrew Mills. Patient Reviewer: ElizabethOlszewski. Alogrithm Reviewers: KatieKoester, Heidi M. Feuling, David Schweis-berger, and Karen Collins. Grant Support:The Cardiovascular & Pulmonary Section,the Acute Care Section, and the AmericanPhysical Therapy Association provided fundsto support the development and preparationof this document but had no influence onthe content or the key action statements ofthis clinical practice guideline. The authorsdeclare no conflicts of interest. This guidelineis scheduled to be updated 5 years from dateof publication.

Each of the panel members was asked todisclose any existing or potential conflicts ofinterest, including financial relationshipswith pharmaceutical, medical device, or bio-technology companies, prior to beingincluded in the panel. The panel declared noconflicts of interest.

This CPG is not intended as the sole source ofguidance in managing patients at risk for ordiagnosed with venous thromboembolism.Rather, it is designed to assist clinicians byproviding an evidence-based framework fordecision-making strategies. This CPG is notintended to replace clinical judgment orestablish a protocol for all individuals withthis condition and may not provide the onlyappropriate approach to managing theproblem. This CPG may be used to developpolicy or suggest policy changes, or it mayprovide discussion about current policy.However, it is up to individual facilities todetermine whether they want to adopt theseCPG key action statement recommendationsin place of their existing policies or protocols.

DOI: 10.2522/ptj.20150264

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doi: 10.2522/ptj.20150264Originally published online October 29, 2015

2016; 96:143-166.PHYS THER. Thigpen, Dennis C. Sobush and Beth AutenEllen Hillegass, Michael Puthoff, Ethel M. Frese, MaryGuidelineThromboembolism: Evidence-Based Clinical PracticeIndividuals at Risk for or Diagnosed With Venous Role of Physical Therapists in the Management of

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