A Systematic Review of Functional and

Quality of Life Assessment after Major Lower

Extremity Amputation
Alexander T. Hawkins,1,2,3 Antonia J. Henry,2 David M. Crandell,4,5 and Louis L. Nguyen,1,2,5
Boston and Charlestown, Massachusetts

Background: When judging the success or failure of major lower extremity (MLE) amputation,
the assessment of appropriate functional and quality of life (QOL) outcomes is paramount. The
heterogeneity of the scales and tests in the current literature is confusing and makes it difficult to
compare results. We provide a primer for outcome assessment after amputation and assess the
need for the additional development of novel instruments.
Methods: MEDLINE, EMBASE, and Google Scholar were searched for all studies using functional and QOL instruments after MLE amputation. Assessment instruments were divided into
functional and QOL categories. Within each category, they were subdivided into global and
amputation-specific instruments. An overall assessment of instrument quality was obtained.
Results: The initial search revealed 746 potential studies. After a review of abstracts, 102 were
selected for full review, and 40 studies were then included in this review. From the studies, 21
different assessment instruments were used 63 times. There were 14 (67%) functional measures and 7 (33%) QOL measures identified. Five (36%) of the functional instruments and 3
(43%) of the QOL measures were specific for MLE amputees. Sixteen instruments were used
>1 time, but only 5 instruments were used >3 times. An additional 5 instruments were included
that were deemed important by expert opinion. The 26 assessment instruments were rated.
Fourteen of the best-rated instruments were then described.
Conclusions: The heterogeneity of instruments used to measure both functional and QOL outcomes make it difficult to compare MLE amputation outcome studies. Future researchers should
seek to use high-quality instruments. Clinical and research societies should endorse the best
validated instruments for future use in order to strengthen overall research in the field.

INTRODUCTION
Supported by the Arthur Tracy Cabot Fellowship though the Brigham & Womens Hospital Center for Surgery and Public Health and
the Harvard-Longwood T-32 Vascular Training Grant (to A.T.H.;
NIH 5T32HL007734).
1
Center for Surgery and Public Health, Boston, Massachusetts.
2

Brigham & Womens Hospital, Boston, Massachusetts.

Massachusetts General Hospital, Boston, Massachusetts.

Spaulding Rehabilitation Hospital, Charlestown, Massachusetts.

Harvard Medical School, Boston, Massachusetts.

Correspondence to: Louis L. Nguyen, MD, MBA, MPH, Division of

Vascular and Endovascular Surgery, Brigham & Womens Hospital,
75 Francis Street, Boston, MA 02115, USA; E-mail: llnguyen@
partners.org
Ann Vasc Surg 2014; 28: 763e780
http://dx.doi.org/10.1016/j.avsg.2013.07.011
2014 Elsevier Inc. All rights reserved.
Manuscript received: April 9, 2013; manuscript accepted: July 18, 2013;
published online: February 2, 2014.

Amputation is widely regarded as the end stage for

peripheral vascular disease, but life does go on for
these patients. Major lower extremity (MLE) amputation remains an extremely prevalent procedure
that represents a significant cost to the US health
care system. In the United States, there are approximately 1.7 million people living with limb loss.1 Significant research is undertaken in the MLE amputee
population, and the past decade has seen a shift in
metrics used to evaluate outcomes after vascular surgery. Amputation research is transitioning to examining patient-oriented outcomes as opposed to
traditional surgeon-oriented or technically oriented
outcomes.2 This will become increasingly topical as
our health care system moves toward pay for performance systems. Section 3022 of the Affordable
763

764 Hawkins et al.

Care Act (ACA) establishes the Medicare Shared Savings Program for Accountable Care Organizations
(ACOs) to reduce health care costs and promote
quality.3 One of the main sections, Patient and
Caregiver Experience, includes health and functional status as a key measure for reimbursement.
It is paramount for the vascular specialist to understand how outcomes are assessed.
Unfortunately, the assessment instruments used
to define outcomes are varied and often confusing.4
This review describes the current assessment instruments available for the clinician and identifies areas
for improvement. Because outcomes measure is a
broad topic, this review focuses on functional and
quality of life (QOL) instruments that are most
important to the vascular specialist. Assessment of
function is integral to understanding the effects of
amputation and rehabilitation. QOL is a broader
measure that seeks to provide a singular assessment
of multiple aspects of how a patient views their current health state.
For pre-, peri-, and postoperative planning, it is
important for the vascular specialist to understand
the functional and QOL instruments used to assess
amputees in both the clinical and research realms.
Understanding the instruments used in the literature and selecting the correct instrument to use in
a research project are daunting tasks. Compounding
this is the lack of consensus regarding the criterion
standard measures for both function and QOL.5
We sought to systematically review the current
instruments and perform a needs assessment for
the development of new outcomes instruments.

METHODS
Search
A comprehensive search of MEDLINE, EMBASE,
and Google Scholar was performed with customized
search terms in April 2012. Databases were searched
for clinical studies examining outcome after amputation from January 2001 to March 2012. Key terms
were used, such as lower extremity amputation,
treatment outcomes, assessment instruments, mobility, and quality of life (Appendix I). References
of methodologic studies, existing reviews, and bibliographies of journal articles were also selectively
hand-searched.
Full inclusion and exclusion criteria are available
in Appendix II. The focus was on full-length papers
that used outcome measures to assess an adult, nononcologic amputee population. Studies were not
assessed for quality of the work, because our primary
focus was to determine which assessment

Annals of Vascular Surgery

instruments were being used. In addition to instruments identified in the studies, expert opinion was
sought for any other instruments that warranted
discussion.
Existing Reviews
Five previous review articles were identified.
Rommers et al.6 focused on scales and questionnaires regarding patients with MLE amputation.
Gautier-Gagnon and Grise7 developed a handbook
for LEA outcome but did not include walk tests.
Condie et al.5 performed a systematic review of all
instruments to assess lower extremity prosthetics
outcome between 1995 and 2005. Deathe et al.8
reviewed and classified outcome measures according to the World Health Organization (WHO) International Classification of Functioning, Disability and
Health. They focused only on functional outcome
measures. Finally, Sinha and Van Den Heuvel9 performed a systematic review of QOL in lower limb
amputees, focusing on instruments that measure
QOL.9 None of the previous reviews focused on
both function and QOL, and none were written for
an audience of vascular specialists.
Classification and Assessment
Assessment instruments were divided into those
measuring function and QOL. In each category, instruments were again categorized into general and
amputation-specific instruments.10 An overall assessment of instrument quality was performed using
the guidelines suggested by Johnston and Graves.11
Originally designed for use in spinal cord injury, the
guidelines have been previously adapted by Deathe
et al.8 to make them relevant to amputation. Studies
were scored on a 4-point scale for an overall assessment of quality as follows: 4 points (++++) indicated
that the scale was extensively validated, with excellent reliability and validity (i.e., it was very well
established as valid for MLE amputees); 3 points
(+++) indicated that the scale showed content
and metric reliability and validity (i.e., it was
adequately/reasonably valid for the main defined
purpose and could be used in studies, although
checking of assumptions or small improvements
may be desirable to further improve the measure);
2 points (++) indicated that the scale had minimal
validity (i.e., it had apparently applicable content
with good validity/reliability in another group
but little use in MLE amputees, or it was used in
MLE amputees but some limitations were evident
with little reliability/validity information)din these
scales, additional development was desirable, and
the scale could be used if there were no alternatives,

Vol. 28, No. 3, April 2014

but firm conclusions are not possible given the preliminary and modest degrees of validity evidence;
and 1 point (+) indicated that the scale was questionable or insufficient (i.e., there was little or no
formal validity or reliability evidence and possibly
questionable content for MLE amputees)din these
scales, development would be required in order for
the scale to be applicable to MLE amputees.
Quality was judged independently by all authors,
with group consensus reached only when there was
a discrepancy between evaluators.

RESULTS
The initial search revealed 746 potential studies. After a review of abstracts, 102 were selected for full
review. Of these, another 62 were excluded according to the above exclusion criteria. Forty studies
were then included in this review (Appendix III).
From the studies, 21 different assessment instruments were used 63 times (Table 1). There were 14
(67%) functional measures and 7 (33%) QOL measures identified. Five (36%) of the functional instruments and 3 (43%) of the QOL measures were
specific for MLE amputees. Sixteen instruments
were used >1 time, including the Short Form-36
General Health Status Survey (SF-36)/Short Form12 General Health Status Survey (SF-12; 13 times),
the Prosthetic Evaluation Questionnaire (5 times),
the 6-Minute Walk Test/2-Minute Walk Test
(6MWT/2MWT; 5 times), the Timed Up and Go
(TUG; 4 times), the Functional Independence Measure (4 times), the modified Barthel Index (3 times),
the Frenchay Activity Index (FAI; 3 times), the
Locomotor Capabilities Index (3 times), the Houghton Scale (3 times), the WHOQOL-100/short version of the WHOQOL (WHOQOL-BREF; 3 times),
the Simple Walking test (2 times), the Sickness
Impact Profile (2 times), the Special Interest Group
in Amputee Medicine assessment (SIGAM; 2 times),
the Nottingham Health Profile (2 times), the European QOL scale (EQ5D; 2 times), and the Trinity
Amputation and Prosthesis Experiences Scales
(2 times). A number of studies not included in this
review used original, nonvalidated assessment
instruments. The examination of previous review
papers and discussions with expert consultants
resulted in an additional 5 instruments included
for description, for a total of 26 instruments
(Table II). After rating, 14 instruments were graded
as +++ or above. They are described below, along
with studies that exemplify their usage. Descriptions
of the remaining 12 instruments can be found in
Appendix IV.

Functional and QOL assessment after MLE amputation 765

Instruments of Function: Walking Tests

A collection of instruments measure function by
assessing a patients ability to walk. All allow use
of a prosthesis. Two tests (the TUG and 10-meter
walk tests [10MWT]) set a fixed distance, while
the 6MWT sets a fixed time.
The TUG test (+++) assesses the ability of an
amputee to rise from a seated position, walk 3 meters, and then return to a seated position. Total
time is measured.12 Schoppen et al.13 used the
TUG test to show that functional outcome could be
predicted 2 weeks after amputation by age at amputation, 1-leg balance on the unaffected limb, and
cognitive impairment.
The 10MWT (+++) records the time it takes a patient to walk 10 meters. The purpose of the test is to
use usual walking speed as a measure of mobility.14
This simple test has been modified and used for distances up to 500 meters. One well described downside to both the TUG test and the 10MWT is a
significant ceiling effect. Munin et al.15 used a modified version of the 10MWT to show that early prosthetic rehabilitation resulted in greater ambulation
at rehabilitation discharge.
The 6MWT and the similar 2MWT (+++) both
have a patient walk a 100-foot course for 6 min (or
2 min) at their usual pace.16 Because it evaluates
the global and integrated responses of all the major
body systems, it can be confounded by comorbidities
(i.e., cardiopulmonary, musculoskeletal, and neurologic), and these must be taken into account when
judging a patients performance on these tests.17
Overall, walk tests have been shown to have excellent reliability and adequate to excellent validity.14,16,18,19 Rau et al.20 used the 6MWT to show
that physiotherapy is effective in improving functional performance of lower limb amputees in a
resource poor setting.
Instruments of Function: Activities of
Daily Living
The FAI (+++) assesses a broad range of activities of
daily living (ADL) and beyond in patients.21 It is
comprised of 15 questions and scored as 1e4, where
a score of 1 represents the lowest level of activity.
The scale provides a summed score ranging from
15e60. A modified 0e3 scoring system introduced
by Wade et al.22 yields a score of 0e3 for each
item, and a summed score from 0e45. The FAI
has been extensively validated in stroke populations23e25 and has shown excellent reliability in a
MLE amputation group.26 Asano et al.27 used the
FAI to show that depression, perceived prosthetic
mobility, social support, comorbidity, prosthesis

766 Hawkins et al.

Annals of Vascular Surgery

Table I. List of instruments by function versus quality of life and then by general versus amputee-specific
Instrument

Rating

Tests of function
General tests
Walking tests
Six-minute Walk Test (6MWT)
Timed Up and Go (TUG)
10 m Walk
Simple Walking
General function
Activities of daily living
Frenchay Activity Index (FAI)
Modified Barthel Index (BI)
Functional Independence Measure (FIM)
International Physical Activity Questionnaire (IPAQ)
Sickness Impact Profile (SIP)
Mobility
Rivermead Mobility Index (RMI)
Amputee-specific
Special Interest Group in Amputee Medicine (SIGAM)
Houghton Scale
Locomotor Capabilities Index (LCI-5)
Questionnaire for Persons with a Transfemoral Amputation (Q-TFA)
Prosthetic Profile of the Amputee (PPA)
Days Amputee Activity Score (AAS)
Amputee Mobility Predictor (AMP)
Functional Measure for Amputees (FMA)
Test of quality of life
General
Short Form 36- General Health Status Survey (SF-36)
Short Form 12- General Health Status Survey (SF-12)
World Health Organization Quality of Life Assessment Instrument 100 (WHOQOL-100)
European Quality of Life (EQ5D)
Nottingham Health Profile (NHP)
Satisfaction with Life Scale (SWLS)
Amputee-specific
Prosthesis Evaluation Questionnaire (PEQ)
Trinity Amputation and Prosthesis Experiences Scales (TAPES)
Attitude to Artificial Limb Questionnaire (AALQ)

problems, age, and social activity participation predict perceived QOL.27

+++
+++
+++
+

+++
++
++
++
++
+++
+++
+++
+++
++
++
++
++
++

++++
+++
++++
++++
+++
++
+++
++
+

Though reliable and responsive to longitudinal

change, the RMI is noted to have mild ceiling effects
after analysis in amputees.30

Tests of Function: Mobility

The Rivermead Mobility Index (RMI; +++) was
initially developed to measure mobility for patients
with brain injuries and has since been expanded to
assess mobility in other disease processes, including
amputees.28 A range of activities is covered, from
turning over in bed to running. The test is comprised
of 14 questions, and the patient is then asked to
stand for 10 seconds without any aid. Each response
is scored yes or no with 1 point for each yes answer. The scores are summed with a range from
0 (poor mobility) to 15 (excellent mobility).29

Instruments of Function:
Amputee-Specific
The SIGAM (+++) test is a single-item scale
comprising 6 clinical grades (AeF) of amputee
mobility.30 Grades range from A (nonlimb user) to
F (normal or near normal walking). SIGAM was
based on the Harald Wood Stanmore observer rated
measure.31 The test is a self-report questionnaire
answered yes/no that then uses an algorithm to
facilitate grade assignment. Reliability is excellent,
but there are sparse data to determine validity.32

Test

First author

Year of
publication Domains

Items

Time to
perform
(min)

Functiondgeneral
6MWT/2MWT
TUG
10-m walk
FAI

d
d
d
Holbrook

d
d
d
1983

d
d
d
3

d
d
d
15

10/5
1e10
0eN min
5

RMI

Franchignoni 2003

14 questions
10
plus standing

Yes

Free

Validated in
amputee?
Cost

Yes
Yes
Yes
No

Free
Free
Free
Free

Scoring range

0eN m
0eN min
0eN min
15e60, with 60 representing
the highest level of activity
0 (poor mobility) to 15
(excellent mobility)

Functiondamputee-specific
SIGAM
Ryall

2003

21

Yes

Free

Houghton scale

Houghton

1992

Yes

Free

LCI-5

Franchignoni 2004

14

Yes

Free

Requires license 0e100 (100 is best possible

score)
Requires license 0e100 (100 is best possible
score)
Free with
0e1, with 1 representing
registration
perfect health state
Free
Scores available for domains,
facets, and overall; higher
scores indicate lower
quality of life
0e100, with higher scores
Requires
representing greater health
administrative
problems
fee

1992

36

10e15

No

SF-12

Ware

1996

12

2e3

No

EQ5D

Euro QOL

1990

5 + VAS 5 + VAS

No

WHOQOL-100/BREF WHOQOL
Group

1994

6/4

100/26

20e30/10 No

NHP

1990

45

5e10

No

1998

82

10

Yes

Hunt

Quality of lifedamputee-specific
PEQ
Legro

Free

+++
+++
+++
+++
+++

+++
AeF (ranging from A
[nonlimb user] to F
[normal or near normal
walking])
0e12 (12 represents excellent +++
performance)
0e56, with 56 being the best +++
possible

0e100, with 100 being the

best possible

++++
+++
++++
++++/+++

+++

+++

6MWT/2MWT, 6-min walk test/2-min walk test; EQ5D, European Quality of Life; FAI, Frenchay Activity Index; MET, metabolic equivalent; NHP, Nottingham Health Profile; LCI-5,
Locomotor Capabilities Index; PEQ, Prosthesis Evaluation Questionnaire; RMI, Rivermead Mobility Index; SF-12, Short-Form 12; SF-36, Short-Form 36; SIGAM, Special Interest
Group in Amputee Medicine; TUG, Timed Up and Go; VAS, Visual Analog Scale; WHOQOL-100, World Health Organization Quality of Life Assessment 100.

Functional and QOL assessment after MLE amputation 767

Quality of lifedgeneral
SF-36
Ware

Overall quality
(adapted from
Johnston and
Graves11)

Vol. 28, No. 3, April 2014

Table II. Summary including test, first author, domains, items, time to perform, and scoring range

768 Hawkins et al.

Met et al.33 used the SIGAM to show that it is preferable to perform a straight above the knee amputation (AKA) instead of a through the knee
amputation if the correct amputation level is in
doubt in high-risk patients.
The Houghton Scale (+++) was originally described in a vascular amputee population.34,35 It is
a self-reported assessment of performance comprised of 4 sections. The test quantifies prosthetic
use by time, context, ambulatory aids, and confidence over variable terrain. It is designed to assess
activities that are independent of age, sex, gait quality, and comorbidities. The first 3 categories are
measured on a 4-point scale, and the last has 3 questions with yes/no answers. The total score is on a
12-point scale; a higher score indicates better performance. The Houghton Scale has high reliability and
is appropriately responsive to change in prosthetic
use in individuals with lower-limb amputation after
rehabilitation.36 The Houghton Scale has been used
by Bhangu et al.37 to show that the overall functional outcome of individuals with a combination
of below the knee amputation (BKA) and AKA
because of dysvascular causes is poor, with a low
level of ambulation, activity, and prosthetic use.
The Locomotor Capabilities Index (LCI; +++) is a
stand-alone subset of the Prosthetic Profile of the
Amputee (PPA). It was designed to trace a comprehensive profile of ambulatory skills of the lower
limb amputee with the prosthesis and to evaluate
their level of independence while performing these
activities.38 Like the PPA, it is self-reported and
comprised of 4-point ordinal scales and provides
an aggregated score for the 14 items. Franchignoni
et al.39 transformed the original scale of the LCI
into a 5-level version, the LCI-5. The upper ordinal
level of each LCI item Yes, alone was split into
2 levels: Yes, alone, with ambulation aids (score:
3 points) and Yes, alone, without ambulation
aids (score: 4 points). Therefore, the total score of
the index is 56, with maximum subscores of 26.
The test is widely used, with good consistency, reliability, and validity.40e42 Ceiling effects have been
reduced by 50% in the LCI-5.40 Traballesi et al.43
used the LCI-5 to show that age reduced the possibility of improving the level of autonomy and that
good stump quality is one of the major determinants
of mobility outcome.
Instruments of Quality of Life: General
The SF-36 (also known as the MOS-36; ++++) was
developed by the medical outcomes study as an
instrument for both clinical assessment and research.44 It contains 8 domains: physical, role and

Annals of Vascular Surgery

social functioning, mental health, patient health

perceptions, vitality, body pain, and change in
health. The SF-36 has seen wide adoption and has
broad use across languages and disease states. It is
scored on a scale between 0e100, with 100 being
the best possible score. The SF-12 (+++) was
designed to be a simpler and quicker version of the
SF-36.45 It selects items from all domains of SF-36
and shortens the test to 12 questions. Both the SF36 and the SF-12 have been translated into >140
languages. Both have been extensively validated,
including in the MLE amputee population. PennBarwel et al.46 used the SF-36 to show that patients
with a through the knee amputation have a better
physical QOL than those with an AKA.
The EQ5D (++++) is a widely used instrument
that assesses QOL over 5 dimensions (i.e., mobility,
self-care, usual activities, pain/discomfort, and
depression/anxiety), with scoring standardized for
the population.47 The EQ5D also uses a 100-point
visual analog scale (VAS) to generate a health state
based on the weighted time trade-off methodda
value state suitable for cost effectiveness analysis.48
The EQ5D has been extensively validated across cultures and disease states and is a popular test worldwide.49 The EQ5D was also used by Asano et al.27
in their study to show that depression, perceived
prosthetic mobility, social support, comorbidity,
prosthesis problems, age, and social activity participation predict perceived QOL.27
The WHOQOL-100 (++++) is a generic, patientcompleted measure of health-related QOL that was
simultaneously developed in 15 sites worldwide.50
It is focused around the definition of QOL advanced
by the WHO, which includes the culture and
context that influence an individuals perception
of health. The WHOQOL-BREF (+++) is a shorter
version of the original instrument that may be
more convenient for use in large research studies
or clinical trials. The WHOQOL-BREF instrument
comprises 26 items that measure the following
broad domains: physical health, psychological
health, social relationships, and environment.
Both are available in >20 languages. Deans et al.51
used the WHOQOL-100 to show that education
about the importance of increasing and maintaining
a level of physical activity conducive to health benefits should be implemented within a supportive sociable environment for the patient with lower-limb
amputation.
The Nottingham Health Profile (NHP; +++) is a
questionnaire that assesses function and healthrelated QOL.52,53 It is made up of 2 sections; the first
contains 38 yes/no questions over 6 domains (i.e.,
sleep, energy, emotional reactions, social isolation,

Vol. 28, No. 3, April 2014

physical mobility, and pain). The second session addresses difficulty with ADLs with 7 yes/no questions
(i.e., employment, housework, family relationships,
social life, sex life, hobbies, and vacations). Scores
range from 0e100, with a higher score indicating a
poorer level of health. The test has been translated
into many languages. The original papers describe
high reliability and validity. The NHP was used by
Demet et al.54 to show that young age at the time
of amputation, traumatic origin, and upper limb
amputation were independently associated with
better QOL.
Instruments of Quality of Life: Amputee
Specific
The Prosthetics Evaluation Questionnaire (PEQ;
+++) was developed from 1995e1997 to fill the
need for a comprehensive self-report instrument
for individuals with lower limb loss who use a prosthesis.55 The PEQ is a self-administered questionnaire consisting of 82 items with a linear analog
scale response format. Nine scales are computed
from 42 items (i.e., ambulation, appearance, frustration, perceived response, residual limb health, social
burden, sounds, utility, and well-being). Scales are
reported with a range from 0e100, with 100 representing the best score possible. The PEQ has good
reliability and good to excellent construct validity.55,56 Pinzur et al.57 used the PEQ to show that patients with bone bridging had scores better than or
comparable to those of a selected group of highly
functional traditional BKAs.

DISCUSSION
While there is no criterion standard available for
outcome measures, there are a number of validated
instruments that are of high quality and are widely
used. We found that a wide range of outcome assessment instruments are available to both the researcher and clinician. While the large choice of
potential instruments to fit to the particular study
question is useful, the heterogeneity of the tests
means that it is difficult to compare results from
study to study.
Identifying the perfect universal functional and
QOL instrument is difficult for 2 reasons. First,
each instrument has its strengths and weakness.
Some trade brevity for comprehensiveness; others
aim for generalizability across disease states rather
than amputee specificity. Second, each research
study or clinical practice has its own specific goals
and needs. However, there are certain instruments
in each category that are easy to administer, have

Functional and QOL assessment after MLE amputation 769

been better validated, and appear appropriate for

use in the amputee population. Researchers should
be cautioned against creating their own questionnaires and instead opt for a validated, reliable, and
widely used metric.
In the generic instruments of function group, the
timed walk tests (6MWT and TUG) are widely used
and well validated. While they require an administrator, they are simple to perform and could be
seen as a criterion standard for mobility. The FAI
has been widely used and appears to be appropriate
for amputees. In the amputee-specific instrument of
function, the SIGAM is simple and easy to use. The
Houghton Scale tests well, but it is better suited for
the clinical setting.42
For generic QOL instruments, the SF-36, SF-12,
and the EQ5D are both widely used and extensively
validated. The EQ5D has the ability to be converted
into single index value for health status, which can
then be used in the cost/utility analysis of health interventions and programs. Neither has been extensively tested in an amputee population, and more
data would be useful. For amputee-specific QOL instruments, the PEQ has shown reliability and validity, but its length and scoring restrict it to research
settings. Table III offers a guide for selection of
appropriate instruments.
Over the past 10 years, there has been an increase
in the use of both functional and QOL assessment
tools in the study of outcomes after amputation.
This is clear evidence of the recognition by both
vascular specialists and physical medicine and rehabilitation researchers of the importance of outcome
measures in assessing the technical and functional
success of amputation and rehabilitation. From the
literature, vascular specialists tend to favor more
dichotomous (walk versus no walk) functional tests
and simpler tests of QOL than physical medicine and
rehabilitation physicians.
In examining the current state of assessment instruments after amputation, 3 needs become apparent. First, there needs to be additional research to
move toward a consensus of what the best tests
are for outcomes after amputation. National professional organizations should seek to standardize and
make strong recommendations for the use of assessment instruments. Second, there needs to be additional research into assessment instrument use in
the clinical setting. The use of assessment instruments by the clinician to evaluate an individual
patients progress in response to treatment or aging
is poorly understood. Finally, there needs to be
additional investigation into amputee-specific instruments compared to instruments designed for
the general population. Though amputee-specific

770 Hawkins et al.

Annals of Vascular Surgery

Table III. A guide to the selection of functional and quality of life assessment instruments for amputees
Time (min)

Setting

Use

Test

<5 5e20 >20 Clinic Inpatient Clinical Research Languages

Functiondgeneral
6MWT/2MWT
TUG
10 M WALK
FAI





RMI
Functiondamputeespecific
SIGAM
Houghton scale
LCI-5



















Quality of lifedgeneral
SF-36
SF-12

EQ5D

WHOQOL-100
NHP
Quality of lifed
amputee-specific
PEQ














N/A
N/A
N/A
English, Dutch, and
Chinese
English, Italian, and
Dutch

Mode of
administration

Observation
Observation
Observation
Questionnaire
Questionnaire/
observational


























>50
>50
>150
>20
19

Questionnaire
Questionnaire
Questionnaire
Questionnaire
Questionnaire

English, French, and

Arabic

Questionnaire

English
Questionnaire
English
Questionnaire
Dutch, English, French, Questionnaire
Italian, Portuguese,
Spanish, and Swedish

6MWT/2MWT, 6-min walk test/2-min walk test; EQ5D, European Quality of Life; FAI, Frenchay Activity Index; MET, metabolic
equivalent; NHP, Nottingham Health Profile; LCI-5, Locomotor Capabilities Index; PEQ, Prosthesis Evaluation Questionnaire; RMI,
Rivermead Mobility Index; SF-12, Short-Form 12; SF-36, Short-Form 36; SIGAM, Special Interest Group in Amputee Medicine;
TUG, Timed Up and Go; VAS, Visual Analog Scale; WHOQOL-100, World Health Organization Quality of Life Assessment 100.

instruments may seem more appropriate a priori,

there have been no studies that have shown superiority to general assessment instruments. In addition,
general assessment instruments can be compared
across disease states. This feature is increasingly
important as the focus of health care reform turns
to optimizing patient-centered outcomes and the
allocation of limited health care resources.

2.
3.
4.

5.

CONCLUSION
The heterogeneity of methods used to measure both
functional and QOL outcomes makes it difficult to
compare MLE amputation outcome studies. Future
researchers should seek to use well-established instruments. Clinical and research societies should
endorse the best validated instruments for future
use to strengthen overall research in the field.

6.

7.

8.

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39. Streppel KR, de Vries J, van Harten WH. Functional status
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40. Franchignoni F, Orlandini D, Ferriero G, et al. Reliability,
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41. Miller WC, Deathe AB, Speechley M. Lower extremity prosthetic mobility: a comparison of 3 self-report scales. Arch
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43. Traballesi M, Porcacchia P, Averna T, et al. Prognostic factors
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Deans SA, McFadyen AK, Rowe PJ. Physical activity and
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Hunt SM, McEwen J, McKenna SP. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll
Gen Pract 1985;35:185e8.

APPENDIX I: SEARCH TERMS

(Amputation [Mesh] OR Amputation
Stumps [Mesh] OR Amputation, Traumatic
[Mesh] OR (amputable [Text Word] OR amputaciones [Text Word] OR amputaion [Text Word]
OR amputaiton [Text Word] OR amputaled [Text
Word] OR amputatatio [Text Word] OR amputate
[Text Word] OR amputate [Text Word] OR amputated [Text Word] OR amputated/denervated [Text
Word] OR amputated/dismembered [Text Word]
OR amputated/inactive [Text Word] OR amputated/intact [Text Word] OR amputated/referent
[Text Word] OR amputated [Text Word] OR
amputatee [Text Word] OR amputates [Text
Word] OR amputating [Text Word] OR amputatio
[Text Word] OR amputatiointerthoraco [Text
Word] OR amputation [Text Word] OR amputation/83 [Text Word] OR amputation/absorption
[Text Word] OR amputation/avulsion [Text Word]
OR amputation/bypass [Text Word] OR amputation/chest [Text Word] OR amputation/denervation
[Text Word] OR amputation/devascularization
[Text Word] OR amputation/disarticulation [Text
Word] OR amputation/exarticulation [Text Word]
OR amputation/fullness [Text Word] OR amputation/grafting [Text Word] OR amputation/hemisection [Text Word] OR amputation/injury [Text
Word] OR amputation/neuropathy [Text Word]
OR amputation/occlusion [Text Word] OR amputation/penetrating [Text Word] OR amputation/person [Text Word] OR amputation/plexus [Text
Word] OR amputation/pulmonary [Text Word]
OR amputation/radical [Text Word] OR amputation/readmission [Text Word] OR amputation/
regeneration [Text Word] OR amputation/replantation [Text Word] OR amputation/revision [Text
Word] OR amputation/salvage [Text Word] OR
amputation/sparing [Text Word] OR amputation/
trisection [Text Word] OR amputation/ulcer/

Annals of Vascular Surgery

54. Demet K, Martinet N, Guillemin F, et al. Health related

quality of life and related factors in 539 persons with
amputation of upper and lower limb. Disabil Rehabil
2003;25:480e6.
55. Legro MW, Reiber GD, Smith DG, et al. Prosthesis evaluation questionnaire for persons with lower limb amputations:
assessing prosthesis-related quality of life. Arch Phys Med
Rehabil 1998;79:931e8.
56. Harness N, Pinzur MS. Health related quality of life in patients with dysvascular transtibial amputation. Clin Orthop
Relat Res 2001;383:204e7.
57. Pinzur MS, Pinto MA, Saltzman M, et al. Health-related
quality of life in patients with transtibial amputation and
reconstruction with bone bridging of the distal tibia and
fibula. Foot Ankle Int 2006;27:907e12.

neuropathic [Text Word] OR amputation/ulcers

[Text Word] OR amputation [Text Word] OR
amputation [Text Word] OR amputational [Text
Word] OR amputationes [Text Word] OR amputationplasty [Text Word] OR amputations [Text
Word] OR amputations/crush [Text Word] OR amputations/ulcers [Text Word] OR amputations/
year/10,000 [Text Word] OR amputations [Text
Word] OR amputative [Text Word] OR amputatrix
[Text Word] OR amputatus [Text Word] OR
amputed [Text Word] OR amputee [Text Word]
OR amputee [Text Word] OR amputees [Text
Word] OR amputees [Text Word] OR amputees/
100 [Text Word] OR amputees/year/10,000 [Text
Word] OR amputees [Text Word] OR amputeez
[Text Word] OR amputer [Text Word] OR amputers
[Text Word] OR amputes [Text Word] OR amputierten [Text Word] OR ampution [Text Word] OR
amputive [Text Word] OR amputostypos [Text
Word])) AND (Outcome Assessment (Health
Care) [Mesh] OR Quality of Life [Mesh] OR
Treatment Outcome [Mesh]) AND (Leg
[Mesh] OR Artificial Limbs [Mesh] OR Lower
Extremity [Mesh]) AND ((hasabstract [text] AND
loattrfull text [sb]) AND 2002/07/23 [PDat]:
2012/07/19 [PDat] AND humans [MeSH
Terms] AND English [lang] AND adult [MeSH
Terms])

APPENDIX
CRITERIA

II:

INCLUSION/EXCLUSION

Inclusion criteria
 Major lower extremity amputee population
 Full paper
 Written in English

Sample size
(amputees only) Country

Population (etiology)

Eijk et al (2012)29

Geriatric MLE Amputees

48

Netherlands BI

Cox et al (2011)30

MLE amputees because of

diabetes

87

Jamaica

WHOQOL-BREF and
FIM

Frlan-Vrgoc et al (2011)31

MLE amputees with

prosthesis

50

Croatia

2MWT

da Silva et al (2011)32

MLE amputees

22

Brazil

Kark and Simmons (2011)33

MLE amputees

20

Australia

IPAQ and WHOQOLBREF

PEQ, TUG, and 6MWT

Sinha et al (2011)34

MLE amputees

184

Penn-Barwell (2011)35

Lower limb (trauma)

Mazari et al (2010)36

BKA amputees

Stineman et al (2010)37

Raya et al (2010)38

Assessment instruments

Netherlands SF-36

3,105

UK

29

UK

SF-36, ability to walk

500 m
SF-36

Veterans with a new lower

1,502
extremity
amputation (DM, PVD, and
trauma)
MLE amputees
72

US

FIM

US

6MWT

Outcomes

DM and high premorbid BI were associated

with discharge to an independent living
situation; premorbid BI, admission BI, and
1-leg balance were independently
associated to discharge BI
BKA functioned better than those with AKA;
womens were more likely to cope and
function with disability than men
Age, sex, level and cause of amputation,
including the time from the first prosthetic
supply, have an effect on the 2MWT
Physical activity is not associated with QOL
except for the psychological domain
For high functioning MLE amputees, gait
deviation was not associated with
satisfaction; improving self-perceived
functional ability and attitudes toward the
prosthesis will improve patient satisfaction
Amputees scored lower on SF-36 than
general population
Patients with a TKA have a better physical
quality of life than those with an AKA
No difference in clinical and QOL outcomes
between 2 types of walking aides
Patients who receive specialized
rehabilitation make greater gains than
patients who receive consultative services
Impairments in hip strength and balance
impact 6MWT scores; the findings of this
study support the use of the 6MWT to
underscore impairments of the
musculoskeletal system that can affect
ambulation ability in the amputee
(Continued)

Functional and QOL assessment after MLE amputation 773

First author (year)

Vol. 28, No. 3, April 2014

Table.

Sample size
(amputees only) Country

First author (year)

Population (etiology)

Remes et al (2010)39

MLE amputees with PAD

59

Davidson et al (2010)40

MLE amputees

39

Taghipour et al (2009)41

Veterans with a war-related

unilateral lower
extremity amputation
(trauma)
Tibial trauma patients
(trauma)

Giannoudis et al (2009)42

Assessment instruments

Outcomes

Finland

SF 36 and SWLS

Australia

SF-36

141

Iran

SF-36

Home-dwelling amputees had a relatively

good QOL, whereas institutionalization
was associated with depressive symptoms;
in rehabilitation programs, QOL should be
considered
Upper limb amputees suffer postamputation
pain more than MLE amputees and have
reduced HR-QOL; the overall health status
of amputees is lower than the Australian
population norm
Alleviation of pain, education, and
employment are issues that should be
addressed

22

UK

EQ5D

1,339

US

FIM

MLE amputees

Bhangu et al (2009)44

Bilteral MLE amputees

because of
dysvascular disease

31

Canada

2MWT, Houghton
scale, and FAI

Boutoille et al (2008)45

Amputation after diabetic foot

ulcer (DM)
Bilateral transtibial amputees
(DM, PVD)

25

France

SF-36

82

Canada

SF-12

415

Canada

FAI and EQ5D VAS

MacNeill et al (2008)46

Asano et al (2008)47

MLE amputation

Annals of Vascular Surgery

Kurichi et al (2009)43

Patients with tibial injuries report long-term

health-related QOL problems of varying
degrees
Receipt of specialized compared with
generalized rehabilitation during the acute
postoperative inpatient period was
associated with better outcomes
Overall functional outcome of individuals
with a combination of BKA and AKA
amputation because of dysvascular causes
is poor, with a low level of ambulation,
activity, and prosthetic use
No difference in QOL between patients with
foot ulcers and amputees
Patients undergoing rehabilitation for BTTA
do well at long-term follow-up and to
survive, on average, for >4 years after
discharge
Depression, perceived prosthetic mobility,
social support, comorbidity, prosthesis
problems, age, and social activity
participation predict subjects perceived
QOL

774 Hawkins et al.

Table. Continued

75

Desmond et al (2008)49

MLE amputation

89

Johannesson et al (2008)50

BKA for dysvascular disease

27

Met et al (2008)51

TKA and AKA (PVD, DM, and

trauma)

50

Stasik et al (2008)52

Redo BKA (DM and PVD)

23

Yazicioglu et al (2007)53

Unilateral BKA fitted with

prostheses
Male unilateral lower limb
amputees

24

49

Cannada and Jones (2006)56

BKA with distal tibial-fibular

bone-bridge
(DM, PVD, and trauma)
Traumatic amputees

Traballesi et al (2006)57

Bilateral AKA for PVD

Rau et al (2007)54

Pinzur et al (2006)55

58

601

30

UK

TAPES and WHOQOLBREF

Education about the importance of

increasing and maintaining a level of
physical activity conducive to health
benefits should be implemented within a
supportive sociable environment for the
patient with lower-limb amputation
Ireland
TAPES
Important for clinicians to ascertain the type
and level of pain and to separate the
experiences of the pain from the
experiences of the prosthetic limb
Sweden
LCI and TUG
A vacuum-formed dressing appears to give
results similar to those of the conventional
dressing regarding time to prosthetic fitting
and patients function with prosthesis
Netherlands SIGAM
Preferable to perform a straight AKA instead
of a TKA if the correct amputation level is
in doubt in high-risk patients
Florida
Ability to walk
Redo BKA yields excellent functional
outcomes; a history of minor stump
trauma and a palpable popliteal pulse favor
redo BKA compared with conversion to
AKA
Turkey
Houhgton scale, LCI,
Playing football (soccer) may have positive
and SF-36
effects on balance and health-related QOL
Myanmar
2MWT, TUG, and FMA Physiotherapy is effective in improving
functional performance of lower limb
amputees in a resource poor setting
US
PEQ
Patients with bone-bridging had scores better
than or comparable to those of a selected
group of highly functional traditional BKA
US
SIP
Factors other than the traditional variables,
such as fracture healing, joint function,
and ability to ambulate, have a profound
effect on the patients estimation of
improvement
Italy
BI and LCI
Age reduced the possibility of improving the
level of autonomy; good stump quality is
one of the major determinants of mobility
outcome
(Continued)

Functional and QOL assessment after MLE amputation 775

MLE amputees

Vol. 28, No. 3, April 2014

Deans et al (2008)48

Sample size
(amputees only) Country

First author (year)

Population (etiology)

Gunawardena et al (2006)58

Unilateral, traumatic lower

limb amputees

461

Sri Lanka

Wan Hazmy et al (2006)59

MLE amputation (DM, PVD,

and trauma)

213

Malaysia

Meatherall et al (2005)60

MLE amputation because of

DM

44

Van de Weg and Van der

Windt (2005)61
Selles et al (2005)62

BKA amputees

Davies and Datta (2003)63

Unilateral BKA or AKA (DM,

PVD, and trauma)

281

Schoppen et al (2003)64

Patients >60 years of age with

MLE amputation because of
PVD

46

Demet et al (2003)65

Major upper and lower

extremity amputation

Unilateral BKA (DM, PVD,

and trauma)

van der Schans et al (2002)66 MLE amputees

Canada

220

Netherlands

26

Netherlands

UK

Netherlands

539

France

437

Netherlands

MLE amputees

75

US

Hoogendoorn and van der

Werken (2001)68

Grade III open tibial fractures

(trauma)

43

Netherlands

Outcomes

SF-36

Amputees have comparatively poor

functional outcomes, which could be
improved by modifying stump length and
problems with the stump and sound leg
BI
Most amputees had a good functional
outcome; some were unhappy that they
were insufficiently informed regarding
postamputation expectation
PEQ and PPA
Major functional changes were noted after
MLE amputation that had a large negative
impact on QOL
PEQ
Liner prescription should not be employed as
a matter of course for all BKA amputees
FIM and PEQ
Patients receiving an ICEX TSB socket and a
conventional PTB socket had similar
outcomes
Harold Wood Stanmore Mobility rates 1 year after prosthetic
mobility grade
provision for unilateral BKA and AKA
(precursor to SIGAM)
worsen with increasing age and higher
level of amputation
SIP and TUG
Functional outcome could be predicted 2
weeks after amputation by age at
amputation, 1-leg balance on the
unaffected limb, and cognitive impairment
NHP
Young age at the time of amputation,
traumatic origin, and upper limb
amputation were independently associated
with better QOL
SF-36
The most important amputation-specific
determinants of health-related QOL were
walking distance and stump pain
45-m walk test
Early prosthetic rehabilitation resulted in
greater ambulation at rehabilitation
discharge
NHP and SF-36
Amputees have greater impairment than
those with successful limb salvage, but
QOL is the same

AKA, Above-knee amputation; BKA, below-knee amputation; BTTA, bilateral trans tibial amputation; CLI, critical limb ischemia; DM, diabetes mellitus; MLE, major lower extremity;
PVD, peripheral vascular disease; TKA, trans-knee amputation; UK, United Kingdom; US, United States.
Dysvascular includes both PVD and DM.

Annals of Vascular Surgery

Munin et al (2001)67

Assessment instruments

776 Hawkins et al.

Table. Continued

Vol. 28, No. 3, April 2014

 The study must assess a population, not simply

validate an assessment instrument
 More than 20 patients
 Major outcome must be either function or quality of life

Exclusion criteria
 Amputations caused by oncologic or congenital
etiologies
 Pediatric populations
 Review papers

APPENDIX III: TABLE OF STUDIES WITH

AUTHOR, YEAR, SAMPLE SIZE, OUTCOMES INSTRUMENTS, AND OUTCOMES
APPENDIX IV DESCRIPTION OF
INSTRUMENTS SCORED D AND DD
Instruments of Function: Activities of Daily Living
The Barthel Index (++) assesses 10 activities, 8
of which are self-care and 2 are mobility.1 It was
originally developed in 1965 with the intent of
measuring what a patient is able to do with various
neurologic conditions, but has been since used
with amputees. It can be administered as either
an interview questionnaire or by direct observation. The questionnaire method takes 5 min while
the observation method takes 20 to 60 min. The 10
items are totaled to give a score out of 100 (total independence). The Barthel Index has been well
studied in amputee populations and shows good
validity and reliability, but is limited by ceiling
effects.2
The Functional Independence Measure (FIM;
++) is a widely used test of function. It is comprised
of motor and cognitive subscales.3,4 The motor portion has 13 components scored 1e7 for a summed
score (range: 13e81) that indicates a patients physical ability to move about their environment and
manage activities of daily living. The cognitive
portion has 5 components, again scored 1e7 for a
summed score (range: 5e35) that indicates a patients ability to perform basic cognitive functions
and communicate. The FIM was developed by a
consensus panel to both determine the burden of
care and document progress in rehabilitation. The
FIM has been proven to be reliable but with poor
to moderate construct validity.5,6 In the amputee
population, the FIM is hampered by ceiling effects
and lack of responsiveness.7

Functional and QOL assessment after MLE amputation 777

The International Physical Activity Questionnaire (IPAQ; ++) is designed to provide a set of
well-developed instruments that can be used
internationally to obtain comparable estimates of
physical activity.8 There are 2 versions of the
questionnaire, and each has been translated into
22 languages. The short version (7 questions) is
suitable for use in national and regional surveillance systems, whereas the long version (27 questions over 5 domains) provides more detailed
information often required in research work or
for evaluation purposes. Results are reported
both as categorical (i.e., low, moderate, and high
physical activity) and continuous (median metabolic equivalent of a task minutes). The IPAQ
has been extensively validated among a number
of different groups, but has seen little use in
amputee populations.9e12
The Sickness Impact Profile (SIP; ++) is a
136-question, behaviorally based health status
questionnaire.13,14 It assesses activities in 2 domains
(physical and psychological health) and 12 everyday
categories (i.e., sleep and rest, emotional behavior,
body care and movement, home management,
mobility, social interaction, ambulation, alertness
behavior, communication, work, recreation and
pastimes, and eating). The test is administered by
either a questionnaire or by an interviewer (training
is required). Scoring can be done at the level of domains and/or categories and at the total SIP level.
Higher scores indicate more health-related behavioral problems (i.e., a poorer health state). The SIP
has well documented reliability and validity.15,16
Scaled down versions are also available, most
notably the SIP-68.17
Instruments of Function: Amputee-Specific
The Questionnaire for Persons with a Transfemoral Amputation (Q-TFA; ++) is a self-reported,
70-question measure developed for nonelderly
transfemoral amputees who use a prosthesis.18 The
test generates a separate score (range: 0e100) for 4
categories: prosthetic use, mobility, problems, and
global health. Scores of 100 indicate normal prosthesis wear, best possible mobility, more serious
problems, and the best possible overall situation,
respectively. The Q-TFA is a very specific survey
for patients with an above the knee amputation
who wear a prosthesis.
The Prosthetic Profile of the Amputee (PPA; ++) is
an instrument to evaluate prosthetic wear and
active use of the prosthesis and to identify the factors
that predispose to, enable, and reinforce prosthetic
use.19,20 The PPA questionnaire consists of 44

778 Hawkins et al.

close-ended questions in which measurement scales

are qualitative, nominal, and ordinal with a few
quantitative ratios. The questions are grouped into
6 basic sections: the physical condition (4 questions;
20 items), the prosthesis (5 questions; 21 items), the
prosthetic capabilities (7 questions; 23 items), the
environment (10 questions; 22 items), the leisure
activities (6 questions; 13 items), and demographic
characteristics (5 questions; 5 items). In addition to
the factors being evaluated, the questionnaire also
includes questions pertaining to the behavior of
prosthetic use (6 questions; 27 items). Two questions are specific to nonprosthetic users. The PPA
has excellent reliability and validity, but issues
have been reported with self-administration and
understanding of the questions.7
The Days Amputee Activity Score (++) is an
interview-based assessment instrument that rates
the usual activity of the major lower extremity
amputee living in the community.20 The 8 domains
of activity include independence in dressing and
undressing, regular walking habits, employment,
domestic responsibilities, social activity, and wheelchair use. There are 20 questions and it takes 15 minutes in an interview setting. The individual section
scores are summed to provide the overall activity
score, which lies between 70 and 50, with the
higher number representing better function. It has
been validated and shown to be reliable.20 Because
it can be difficult to interpret, it is best used in the
community setting to monitor an amputees progress during rehabilitation.
The Amputee Mobility Predictor (AMP; ++) was
designed to measure an amputee patients functional capabilities without a prosthesis (AMPnoPRO) and to predict his/her ability to ambulate
with a prosthesis (AMPPRO).21 It consists of 21
functional tasks rated by a clinician. The total score
range for the AMP is 0e42 points, with higher
numbers representing greater functional potential.
Reliability and validity are described in the original
article. It is specifically designed to assess amputee
patients and is most useful in the clinical rehabilitation setting.
The Functional Measure for Amputees (++) measures the function of amputees mainly in terms of
prosthetic wear, use, and function with a prosthesis.22 It is modeled on a subset of the PPA questionnaire. It is comprised of 14 questions including
the Locomotor Capabilities Index (mobility scale).
Scores are calculated using a computerized guide
and there is no overall score. Reliability was shown
in the original paper. The instrument is probably
best used in the clinical setting to assess how well
a patient is using their prosthesis.

Annals of Vascular Surgery

Instruments of Quality of Life: General

The Satisfaction with Life Scale (SWLS; ++) is a
short 5-item instrument designed to measure global
cognitive judgments of satisfaction with ones life.23
The 5 questions are answered on a 7-point Likert
scale. Strengths of the SWLS include its brevity
and its ability to be used on a wide range of patients.24 Scores range from 5e35, with 20e24 representing average satisfaction with life.
Instruments of Quality of Life: Amputee-Specific
The Trinity Amputation and Prosthesis Experiences Scales (TAPES; ++) measures the healthrelated quality of life of major lower extremity
amputees fitted with a prosthesis.25,26 It is made up
of 9 subscales with a total of 38 items. Each item is
rated on either a 3- or 5-point scale, with a greater
score representing a greater degree of adjustment, restriction, and satisfaction. TAPES has good internal
consistency, but further reliability and validity are
unreported.25,26 A newer version, TAPES-R, has
been recently developed with a simplified general
structure. Additional studies are needed to confirm
and further explore its measurement properties.26
The Attitude to Artificial Limb Questionnaire (+)
was designed to measure quality of life in an
amputee fitted with a prosthesis.27 It contains 10
items that measure satisfaction with prosthesis,
restoration of body image, walking ability, and attitude of others toward them. Each item is scored on a
5-point ordinal scale from not at all to
completely. The overall score ranges from 0e50,
with a low score indicating a poorer quality of life.
While internal consistency is good, other psychometric properties have yet to be assessed.28

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