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## Complete Summary

#### GUIDELINE TITLE

Use of ultrasound for the diagnosis of deep venous thrombosis in
asymptomatic inpatients: A recommendation statement from the University
of Pennsylvania Health System Center for Evidence-based Practice.

#### BIBLIOGRAPHIC SOURCE(S)

Agarwal R, Carpenter J, Davis J, Hanson CW, Iyoob S, Langer J,
Maloney-Wilensky E, Mohler E, Reilly P, Umscheid CA, Wernsing D,
Williams K, University of Pennsylvania Health System Ultrasound Task
Force. Use of ultrasound for the diagnosis of deep venous thrombosis in
asymptomatic inpatients: a recommendation statement from the University
of Pennsylvania Health System Center for Evidence-based Practice.
Philadelphia (PA): University of Pennsylvania Health System; 2007 Feb
21. 39 p. \[38 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Deep venous thrombosis (DVT)

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Prevention\
Risk Assessment\
Screening

#### CLINICAL SPECIALTY

Critical Care\
Internal Medicine\
Neurological Surgery\
Neurology\
Orthopedic Surgery\
Pulmonary Medicine\
Radiology\
Surgery

#### INTENDED USERS

Health Care Providers\
Hospitals\
Managed Care Organizations\
Physician Assistants\
Physicians\
Utilization Management

#### GUIDELINE OBJECTIVE(S)

To provide a guideline for the indications of ultrasound use for the
diagnosis of deep venous thrombosis (DVT) in asymptomatic inpatients

#### TARGET POPULATION

Adult inpatients asymptomatic for deep venous thrombosis

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Color duplex ultrasound

2.  D-dimer assay (considered, but not recommended)

3.  Risk scores based on history and physical

4.  Routine thromboprophylaxis

#### MAJOR OUTCOMES CONSIDERED

-   Test characteristics (i.e., sensitivity, specificity, predictive
    values) of color duplex ultrasound, D-dimer assays, and risk scores
    based on history and physical for the diagnosis of deep venous
    thrombosis (DVT) in asymptomatic inpatients

-   The association of ultrasound use and risk score directed
    anticoagulation with the incidence of DVT, pulmonary embolism (PE),
    bleeding or death

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Center representatives performed a search of MEDLINE and the Cochrane
libraries for systematic reviews, meta-analyses, prospective clinical
trials and diagnostic studies evaluating the use of color duplex
ultrasound in Western adult inpatients with no signs or symptoms of deep
venous thrombosis (DVT). The MEDLINE database was searched using the
terms \"venous thrombosis \[MeSH\]\" AND (\"asymptomatic\[kw\]\" OR
\"surveillance\[kw\]\" OR (\"screening\[kw\]\" OR \"mass
screening\[MeSH\]\") limited to humans and English language and \"all
adult (19 plus years)\" and (clinical trial or controlled clinical trial
or meta analysis or randomized controlled trial).

The Cochrane libraries (The Cochrane Database of Systematic Reviews,
Database of Abstracts of Reviews of Effects, and The Cochrane Central
Register of Controlled Trials) were searched using the terms
\"ultrasound\" in Title, Abstract or Keywords AND \"venous thrombosis\"
in Title, Abstract or Keywords.

In total, 62 studies were initially identified from the MEDLINE and
Cochrane databases of which 6 studies were ultimately used for the
review.

Local guidelines were also reviewed (see Appendices 1 and 2 in the
original guideline document), and a systematic review of national
guidelines was performed using the National Guideline Clearinghouse and
following criteria:

**Keyword**: *deep venous thrombosis* **Methods Used to Assess the
Quality and Strength of the Evidence**: *Weighting According to a Rating
Scheme (Scheme Given), Weighting According to a Rating Scheme (Scheme
Not Given)* **Methods Used to Analyze the Evidence**: *Meta-Analysis,
Meta-Analysis of Individual Patient Data, Meta-Analysis of Randomized
Controlled Trials, Meta-Analysis of Summarized Patient Data, Review,
Review of Published Meta-Analyses, Systematic Review, Systematic Review
with Evidence Tables* **Age Range**: *Adult (19 to 44 years), Aged (65
to 79 years), Aged (80 and over), Middle Age (45 to 64 years)*
**Publication Date(s)**: *2006, 2005, 2004, 2003, 2002, 2001*

The search was limited to guidelines developed in the United States. In
total, three guidelines were found. In addition, Task Force participants
recommended the use of two other guidelines (Eastern Association for the
Surgery of Trauma \[Trauma EAST\] Group and Physicians\' Information and
Education Resource \[PIER\]).

The guidelines were used in a number of ways. First, the reference lists
of the five guidelines were searched using the criteria established for
the MEDLINE and Cochrane searches above, but no additional studies
meeting the inclusion criteria were found. Next, the task force
abstracted guideline recommendations that addressed the question of
interest (see Appendix 4 in the original guideline document). In
addition, the task force searched the reference lists of the two leading
guidelines (the Seventh American College of Chest Physicians \[ACCP\]
Guideline and the Trauma East Guideline) for references addressing the
risk of incident DVT and pulmonary embolism (PE) in populations
receiving anticoagulation. Risk groups, risk of venous thromboembolism
(VTE), method of ascertainment, follow up period, and number of studies
were abstracted from the relevant references into an evidence table
(Table 7 in the original guideline document). In a separate table, the
task force further abstracted the risk of all VTE, all DVT, Proximal
DVT, Distal DVT, and PE from all randomized clinical trials (RCTs) using
low molecular weight heparin (LMWH) in [\>]{.underline}1 arm from risk
groups that demonstrated a risk of VTE of [\>]{.underline}20% as
ascertained by venography (Table 8 in the original guideline document).
In total, data from 28 orthopedic studies, 2 neurosurgery studies, 2
major trauma studies, and 1 spinal cord injury study were abstracted.

#### NUMBER OF SOURCE DOCUMENTS

6 studies from the MEDLINE and Cochrane databases

5 guideline documents

33 studies identified through review of guideline documents

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

The following grades of overall quality developed by the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) working
group were used to grade the overall quality of evidence for each
outcome:

**High** - Further research is very unlikely to change confidence in the
estimate of effect

**Moderate** - Further research is likely to impact confidence in the
estimate of effect and may change the estimate

**Low** - Further research is very likely to impact confidence in the
estimate of effect and is likely to change the estimate

**Very low** - Any estimate of effect is very uncertain

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis\
Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The quality of the individual studies was assessed using a four point
diagnostic study criteria score for diagnostic studies and a seven point
modified Jadad score for randomized clinical trials (RCTs). Following
data abstraction into evidence tables, pooling of results was done when
appropriate, and the results were reviewed with task force members.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

At the first Task Force meeting, Center for Evidence-Based Practice
(CEP) procedures were introduced, as were local ultrasound use
statistics and local guidelines (see Appendices 1--3 in the original
guideline document). Next, the results of a systematic review performed
by CEP to address the risks and benefits of color duplex ultrasound in
the diagnosis of deep venous thrombosis (DVT) in asymptomatic inpatients
were presented.

For consideration of the association of ultrasound use with the
incidence of DVT, pulmonary embolism (PE), bleeding or death, the
intervention was not restricted to color duplex ultrasound but instead
was extended to studies assessing the association of any mode of
ultrasound with incident DVT, PE, bleeding or death as there were no
studies evaluating the association of color duplex with these outcomes.
When evaluating risk scores based on history and physical, symptomatic
patients were included.

The important trade-offs between the potential benefits and harms of the
interventions were examined, and levels of recommendations were used
(See \"Rating Scheme for the Strength of the Recommendations\").

The draft guideline was finalized using methods of consensus
development.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Strong** - Test should or should not be used for routine surveillance
of deep venous thrombosis (DVT)

**Weak** - Test may be useful for surveillance of DVT in certain
circumstances

**Further research** - No evidence exists for the usefulness of test in
surveillance of DVT

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The guideline was approved by the chief medical officer (CMO) of each
hospital in the University of Pennsylvania Health System (UPHS) for
dissemination and implementation.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions for the quality of evidence (high, moderate, low, very low)
and strength of recommendations (strong, weak, further research) are
repeated at the end of the Major Recommendations.

**Use of Ultrasound for the Diagnosis of Deep Venous Thrombosis in
Asymptomatic Patients**

1.  Routine thromboprophylaxis instead of ultrasound surveillance should
    be the cornerstone of venous thromboembolic event (VTE) prevention
    in asymptomatic inpatients. The Anticoagulation Task Force provides
    guidelines for routine thromboprophylaxis. (*Strong Recommendation,
    Moderate to Low Quality Evidence*)

2.  Ultrasound surveillance of the bilateral proximal lower extremities
    may be most appropriate in situations where thromboprophylaxis is
    not possible. (*Weak Recommendation, Very Low Quality Evidence*)

3.  Ultrasound surveillance of the bilateral proximal lower extremities
    may also be appropriate in patients at the highest risk of deep
    venous thrombosis (DVT) or pulmonary embolism (PE) despite
    thromboprophylaxis (i.e., spinal cord injury patients, major trauma
    patients with high severity scores, and the highest risk orthopedic
    patients), and should likely be performed no more frequently than
    approximately once weekly. (*Weak Recommendation, Very Low Quality
    Evidence*)

4.  Color duplex ultrasound has adequate sensitivity and specificity to
    diagnose DVT in asymptomatic inpatients, and should be the test of
    choice for the diagnosis of DVT in asymptomatic inpatients when
    compared with D-Dimer assays or risk scores based on history and
    physical. (*Strong Recommendation, Moderate Quality Evidence*)

5.  D-Dimer assays should not be used to diagnose DVT in asymptomatic
    inpatients. (*Strong Recommendation, Moderate Quality Evidence*)

**Definitions**:

**Quality of Evidence**

The following grades of overall quality developed by the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) working
group were used to grade the overall quality of evidence for each
outcome:

**High** - Further research is very unlikely to change confidence in the
estimate of effect

**Moderate** - Further research is likely to impact confidence in the
estimate of effect and may change the estimate

**Low** - Further research is very likely to impact confidence in the
estimate of effect and is likely to change the estimate

**Very low** - Any estimate of effect is very uncertain

**Strength of Recommendations**

**Strong** - Test should or should not be used for routine surveillance
of deep venous thrombosis (DVT)

**Weak** - Test may be useful for surveillance of DVT in certain
circumstances

**Further research** - No evidence exists for the usefulness of test in
surveillance of DVT

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate use of ultrasound for the diagnosis of deep venous
thrombosis in asymptomatic patients

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Recommendations are based on an assessment of the overall quality of
evidence for each outcome examined as well as the important trade-offs
between the potential benefits and harms of the interventions examined,
and is a guideline that should inform, but not replace, expert clinical
judgment.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Agarwal R, Carpenter J, Davis J, Hanson CW, Iyoob S, Langer J,
Maloney-Wilensky E, Mohler E, Reilly P, Umscheid CA, Wernsing D,
Williams K, University of Pennsylvania Health System Ultrasound Task
Force. Use of ultrasound for the diagnosis of deep venous thrombosis in
asymptomatic inpatients: a recommendation statement from the University
of Pennsylvania Health System Center for Evidence-based Practice.
Philadelphia (PA): University of Pennsylvania Health System; 2007 Feb
21. 39 p. \[38 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007 Feb

#### GUIDELINE DEVELOPER(S)

University of Pennsylvania Health System - Academic Institution

#### SOURCE(S) OF FUNDING

University PA Health System

#### GUIDELINE COMMITTEE

University of Pennsylvania Health System (UPHS) Ultrasound Task Force

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Rajender Agarwal, Jeffery Carpenter, Julia Davis, C. William Hanson,
Suzanne Iyoob, Jill Langer, Eileen Maloney-Wilensky, Emile Mohler, Pat
Reilly, Craig A. Umscheid, David Wernsing, Kendal Williams

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Voting members of the Task Force were free of conflicts of interest.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) by
request. Please contact <Katie.thomas@uphs.upenn.edu>.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on April 2, 2008. The
information was verified by the guideline developer on April 30, 2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008