18
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 func- tional 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 mea- sures 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 out- comes 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 Amputation is widely regarded as the end stage for peripheral vascular disease, but life does go on for these patients. Major lower extremity (MLE) ampu- tation remains an extremely prevalent procedure that represents a significant cost to the US health care system. In the United States, there are approxi- mately 1.7 million people living with limb loss. 1 Sig- nificant research is undertaken in the MLE amputee population, and the past decade has seen a shift in metrics used to evaluate outcomes after vascular sur- gery. Amputation research is transitioning to exam- ining 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 per- formance systems. Section 3022 of the Affordable Supported by the Arthur Tracy Cabot Fellowship though the Brig- ham & Women’s 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 & Women’s Hospital, Boston, Massachusetts. 3 Massachusetts General Hospital, Boston, Massachusetts. 4 Spaulding Rehabilitation Hospital, Charlestown, Massachusetts. 5 Harvard Medical School, Boston, Massachusetts. Correspondence to: Louis L. Nguyen, MD, MBA, MPH, Division of Vascular and Endovascular Surgery, Brigham & Women’s 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 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: April 9, 2013; manuscript accepted: July 18, 2013; published online: February 2, 2014. 763

Calidad de Vida Amputados

Embed Size (px)

DESCRIPTION

calidad

Citation preview

Page 1: Calidad de Vida Amputados

Supportedham & Womethe Harvard-LNIH 5T32HL0

1Center for2Brigham3Massachu4Spaulding5Harvard M

CorrespondVascular and75 Francis Spartners.org

Ann Vasc Surghttp://dx.doi.or� 2014 Elsevi

Manuscript rec

published onli

A Systematic Review of Functional andQuality of Life Assessment after Major LowerExtremity 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. Theheterogeneity of the scales and tests in the current literature is confusing and makes it difficult tocompare results. We provide a primer for outcome assessment after amputation and assess theneed for the additional development of novel instruments.Methods: MEDLINE, EMBASE, and Google Scholar were searched for all studies using func-tional and QOL instruments after MLE amputation. Assessment instruments were divided intofunctional and QOL categories. Within each category, they were subdivided into global andamputation-specific instruments. An overall assessment of instrument quality was obtained.Results: The initial search revealed 746 potential studies. After a review of abstracts, 102 wereselected for full review, and 40 studies were then included in this review. From the studies, 21different assessment instruments were used 63 times. There were 14 (67%) functional mea-sures 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 includedthat 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 out-comes make it difficult to compare MLE amputation outcome studies. Future researchers shouldseek to use high-quality instruments. Clinical and research societies should endorse the bestvalidated instruments for future use in order to strengthen overall research in the field.

by the Arthur Tracy Cabot Fellowship though the Brig-n’s Hospital Center for Surgery and Public Health andongwood T-32 Vascular Training Grant (to A.T.H.;07734).

Surgery and Public Health, Boston, Massachusetts.

& Women’s Hospital, Boston, Massachusetts.

setts General Hospital, Boston, Massachusetts.

Rehabilitation Hospital, Charlestown, Massachusetts.

edical School, Boston, Massachusetts.

ence to: Louis L. Nguyen, MD, MBA, MPH, Division ofEndovascular Surgery, Brigham & Women’s Hospital,treet, Boston, MA 02115, USA; E-mail: llnguyen@

2014; 28: 763e780g/10.1016/j.avsg.2013.07.011er Inc. All rights reserved.

eived: April 9, 2013; manuscript accepted: July 18, 2013;

ne: February 2, 2014.

INTRODUCTION

Amputation is widely regarded as the end stage for

peripheral vascular disease, but life does go on for

these patients. Major lower extremity (MLE) ampu-

tation remains an extremely prevalent procedure

that represents a significant cost to the US health

care system. In the United States, there are approxi-

mately 1.7 million people living with limb loss.1 Sig-

nificant research is undertaken in the MLE amputee

population, and the past decade has seen a shift in

metrics used to evaluate outcomes after vascular sur-

gery. Amputation research is transitioning to exam-

ining 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 per-

formance systems. Section 3022 of the Affordable

763

Page 2: Calidad de Vida Amputados

764 Hawkins et al. Annals of Vascular Surgery

CareAct (ACA) establishes theMedicare SharedSav-

ings 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 func-

tional status as a key measure for reimbursement.

It is paramount for the vascular specialist to under-

stand how outcomes are assessed.

Unfortunately, the assessment instruments used

to define outcomes are varied and often confusing.4

This review describes the current assessment instru-

ments 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 cur-

rent 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 litera-

ture 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 ampu-

tation from January 2001 toMarch 2012. Key terms

were used, such as lower extremity amputation,

treatment outcomes, assessment instruments, mo-

bility, and quality of life (Appendix I). References

of methodologic studies, existing reviews, and bibli-

ographies 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 outcomemeasures to assess an adult, non-

oncologic amputee population. Studies were not

assessed for quality of thework, because our primary

focus was to determine which assessment

instruments were being used. In addition to instru-

ments 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 question-

naires 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 accord-

ing to the World Health Organization (WHO) Inter-

national Classification of Functioning, Disability and

Health. They focused only on functional outcome

measures. Finally, Sinha and Van Den Heuvel9 per-

formed 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, in-

struments were again categorized into general and

amputation-specific instruments.10 An overall as-

sessment 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 assess-

ment of quality as follows: 4 points (++++) indicated

that the scale was extensively validated, with excel-

lent 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,

Page 3: Calidad de Vida Amputados

Vol. 28, No. 3, April 2014 Functional and QOL assessment after MLE amputation 765

but firm conclusions are not possible given the pre-

liminary and modest degrees of validity evidence;

and 1 point (+) indicated that the scale was ques-

tionable 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. Af-

ter a review of abstracts, 102 were selected for full

review. Of these, another 62 were excluded accord-

ing to the above exclusion criteria. Forty studies

were then included in this review (Appendix III).

From the studies, 21 different assessment instru-

ments were used 63 times (Table 1). There were 14

(67%) functional measures and 7 (33%) QOL mea-

sures identified. Five (36%) of the functional instru-

ments 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 Form-

12 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 Mea-

sure (4 times), the modified Barthel Index (3 times),

the Frenchay Activity Index (FAI; 3 times), the

Locomotor Capabilities Index (3 times), the Hough-

ton Scale (3 times), the WHOQOL-100/short ver-

sion of the WHOQOL (WHOQOL-BREF; 3 times),

the Simple Walking test (2 times), the Sickness

Impact Profile (2 times), the Special Interest Group

in AmputeeMedicine assessment (SIGAM; 2 times),

the Nottingham Health Profile (2 times), the Euro-

pean 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.

Instruments of Function: Walking Tests

A collection of instruments measure function by

assessing a patient’s 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 me-

ters, 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 ampu-

tation, 1-leg balance on the unaffected limb, and

cognitive impairment.

The 10MWT (+++) records the time it takes a pa-

tient 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 dis-

tances up to 500 meters. One well described down-

side to both the TUG test and the 10MWT is a

significant ceiling effect. Munin et al.15 used amodi-

fied version of the 10MWT to show that early pros-

thetic 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 neuro-

logic), and these must be taken into account when

judging a patient’s performance on these tests.17

Overall, walk tests have been shown to have excel-

lent reliability and adequate to excellent valid-

ity.14,16,18,19 Rau et al.20 used the 6MWT to show

that physiotherapy is effective in improving func-

tional 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 popula-

tions23e25 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

Page 4: Calidad de Vida Amputados

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) ++

Day’s 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) +

766 Hawkins et al. Annals of Vascular Surgery

problems, age, and social activity participation pre-

dict perceived QOL.27

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 an-

swer. The scores are summed with a range from

0 (poor mobility) to 15 (excellent mobility).29

Though reliable and responsive to longitudinal

change, the RMI is noted to have mild ceiling effects

after analysis in amputees.30

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

Page 5: Calidad de Vida Amputados

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

Test First authorYear ofpublication Domains Items

Time toperform(min)

Validated inamputee? Cost Scoring range

Overall quality(adapted fromJohnston andGraves11)

Functiondgeneral

6MWT/2MWT d d d d 10/5 Yes Free 0eN m +++

TUG d d d d 1e10 Yes Free 0eN min +++

10-m walk d d d d 0eN min Yes Free 0eN min +++

FAI Holbrook 1983 3 15 5 No Free 15e60, with 60 representing

the highest level of activity

+++

RMI Franchignoni 2003 d 14 questions

plus standing

10 Yes Free 0 (poor mobility) to 15

(excellent mobility)

+++

Functiondamputee-specific

SIGAM Ryall 2003 6 21 2 Yes Free AeF (ranging from A

[nonlimb user] to F

[normal or near normal

walking])

+++

Houghton scale Houghton 1992 4 6 5 Yes Free 0e12 (12 represents excellent

performance)

+++

LCI-5 Franchignoni 2004 1 14 5 Yes Free 0e56, with 56 being the best

possible

+++

Quality of lifedgeneral

SF-36 Ware 1992 8 36 10e15 No Requires license 0e100 (100 is best possible

score)

++++

SF-12 Ware 1996 8 12 2e3 No Requires license 0e100 (100 is best possible

score)

+++

EQ5D Euro QOL 1990 5 + VAS 5 + VAS 3 No Free with

registration

0e1, with 1 representing

perfect health state

++++

WHOQOL-100/BREF WHOQOL

Group

1994 6/4 100/26 20e30/10 No Free Scores available for domains,

facets, and overall; higher

scores indicate lower

quality of life

++++/+++

NHP Hunt 1990 7 45 5e10 No Requires

administrative

fee

0e100, with higher scores

representing greater health

problems

+++

Quality of lifedamputee-specific

PEQ Legro 1998 9 82 10 Yes Free 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.

Vol.28,No.3,April

2014

Function

alandQOLassessm

entafter

MLEamputation

767

Page 6: Calidad de Vida Amputados

768 Hawkins et al. Annals of Vascular Surgery

Met et al.33 used the SIGAM to show that it is pref-

erable to perform a straight above the knee ampu-

tation (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 de-

scribed in a vascular amputee population.34,35 It is

a self-reported assessment of performance com-

prised of 4 sections. The test quantifies prosthetic

use by time, context, ambulatory aids, and confi-

dence over variable terrain. It is designed to assess

activities that are independent of age, sex, gait qual-

ity, and comorbidities. The first 3 categories are

measured on a 4-point scale, and the last has 3 ques-

tions with yes/no answers. The total score is on a

12-point scale; a higher score indicates better perfor-

mance. 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 func-

tional 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 compre-

hensive 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, reli-

ability, 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 possi-

bility of improving the level of autonomy and that

good stump quality is one of themajor 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 re-

search.44 It contains 8 domains: physical, role and

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 SF-

36 and the SF-12 have been translated into >140

languages. Both have been extensively validated,

including in the MLE amputee population. Penn-

Barwel 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 cul-

tures and disease states and is a popular test world-

wide.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 partici-

pation predict perceived QOL.27

The WHOQOL-100 (++++) is a generic, patient-

completed 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 individual’s 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 andmaintaining

a level of physical activity conducive to health ben-

efits should be implemented within a supportive so-

ciable environment for the patient with lower-limb

amputation.

The Nottingham Health Profile (NHP; +++) is a

questionnaire that assesses function and health-

related 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,

Page 7: Calidad de Vida Amputados

Vol. 28, No. 3, April 2014 Functional and QOL assessment after MLE amputation 769

physical mobility, and pain). The second session ad-

dresses 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 pros-

thesis.55 The PEQ is a self-administered question-

naire consisting of 82 items with a linear analog

scale response format. Nine scales are computed

from 42 items (i.e., ambulation, appearance, frustra-

tion, perceived response, residual limb health, social

burden, sounds, utility, and well-being). Scales are

reported with a range from 0e100, with 100 repre-

senting the best score possible. The PEQ has good

reliability and good to excellent construct valid-

ity.55,56 Pinzur et al.57 used the PEQ to show that pa-

tients 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 awide range of outcome assess-

ment instruments are available to both the re-

searcher 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

been better validated, and appear appropriate for

use in the amputee population. Researchers should

be cautioned against creating their own question-

naires 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 adminis-

trator, 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 in-

terventions and programs. Neither has been exten-

sively tested in an amputee population, and more

data would be useful. For amputee-specific QOL in-

struments, the PEQ has shown reliability and valid-

ity, 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 reha-

bilitation 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 in-

struments after amputation, 3 needs become appar-

ent. First, there needs to be additional research to

move toward a consensus of what the best tests

are for outcomes after amputation. National profes-

sional organizations should seek to standardize and

make strong recommendations for the use of assess-

ment instruments. Second, there needs to be addi-

tional research into assessment instrument use in

the clinical setting. The use of assessment instru-

ments by the clinician to evaluate an individual

patient’s progress in response to treatment or aging

is poorly understood. Finally, there needs to be

additional investigation into amputee-specific in-

struments compared to instruments designed for

the general population. Though amputee-specific

Page 8: Calidad de Vida Amputados

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

Test

Time (min) Setting Use

LanguagesMode ofadministration<5 5e20 >20 Clinic Inpatient Clinical Research

Functiondgeneral

6MWT/2MWT � � � � � N/A Observation

TUG � � � � � N/A Observation

10 M WALK � � � � � N/A Observation

FAI � � � � � English, Dutch, and

Chinese

Questionnaire

RMI � � � English, Italian, and

Dutch

Questionnaire/

observational

Functiondamputee-

specific

SIGAM � � � � English Questionnaire

Houghton scale � � � English Questionnaire

LCI-5 � � � � � Dutch, English, French,

Italian, Portuguese,

Spanish, and Swedish

Questionnaire

Quality of lifedgeneral

SF-36 � � � � � >50 Questionnaire

SF-12 � � � � � >50 Questionnaire

EQ5D � � � � � >150 Questionnaire

WHOQOL-100 � � � � � >20 Questionnaire

NHP � � 19 Questionnaire

Quality of lifedamputee-specific

PEQ � � � � English, French, and

Arabic

Questionnaire

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.

770 Hawkins et al. Annals of Vascular Surgery

instruments may seem more appropriate a priori,

there have been no studies that have shown superi-

ority 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.

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 in-

struments. Clinical and research societies should

endorse the best validated instruments for future

use to strengthen overall research in the field.

REFERENCES

1. Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al.

Estimating the prevalence of limb loss in the United

States: 2005 to 2050. Arch Phys Med Rehabil 2008;89:

422e9.

2. Landry GJ. Functional outcome of critical limb ischemia.

J Vasc Surg 2007;45(Suppl A):A141e8.

3. Patient Protection and Affordable Care Act of 2009, HR

3590, 111th Cong, 2nd session (2009).

4. Brundage M, Bass B, Davidson J, et al. Patterns of reporting

health-related quality of life outcomes in randomized clin-

ical trials: implications for clinicians and quality of life

researchers. Qual Life Res 2011;20:653e64.

5. Condie E, Scott H, Treweek S. Lower limb prosthetic

outcome measures: a review of the literature 1995-2005.

J Prosthet Orthot 2006;18:13e45.

6. Rommers GM, Vos LD, Groothoff JW, et al. Mobility of peo-

ple with lower limb amputations: scales and questionnaires:

a review. Clin Rehabil 2001;15:92e102.7. Gauthier-Gagnon C, Grise MC. Tools for outcome measure-

ment in lower limb amputee rehabilitation. 10th World

Congress of the International Society for Prosthetics and

Orthotics, Glasgow Scotland, 2001, Institute de Readaption

de Montreal, Quebec, Canada.

8. Deathe AB, Wolfe DL, Devlin M, et al. Selection of outcome

measures in lower extremity amputation rehabilitation: ICF

activities. Disabil Rehabil 2009;31:1455e73.

9. Sinha R, Van Den Heuvel WJ. A systematic literature review

of quality of life in lower limb amputees. Disabil Rehabil

2011;33:883e99.

Page 9: Calidad de Vida Amputados

Vol. 28, No. 3, April 2014 Functional and QOL assessment after MLE amputation 771

10. Mays RJ, Casserly IP, Kohrt WM, et al. Assessment of func-

tional status and quality of life in claudication. J Vasc Surg

2011;53:1410e21.

11. Johnston MV, Graves DE. Towards guidelines for evaluation

of measures: an introduction with application to spinal cord

injury. J Spinal Cord Med 2008;31:13e26.

12. Schoppen T, Boonstra A, Groothoff JW, et al. The timed ‘‘up

and go‘‘ test: reliability and validity in persons with unilat-

eral lower limb amputation. Arch Phys Med Rehabil 1999;

80:825e8.

13. Schoppen T, Boonstra A, Groothoff JW, et al. Physical,

mental, and social predictors of functional outcome in uni-

lateral lower-limb amputees. Arch Phys Med Rehabil

2003;84:803e11.

14. Boonstra AM, Fidler V, Eisma WH. Walking speed of normal

subjects and amputees: aspects of validity of gait analysis.

Prosthet Orthot Int 1993;17:78e82.

15. Munin MC, Espejo-De Guzman MC, Boninger ML, et al.

Predictive factors for successful early prosthetic ambulation

among lower-limb amputees. J Rehabil Res Dev 2001;38:

379e84.

16. Brooks D, Hunter JP, Parsons J, et al. Reliability of the two-

minute walk test in individuals with transtibial amputation.

Arch Phys Med Rehabil 2002;83:1562e5.17. ATS Committee on Proficiency Standards for Clinical Pul-

monary Function Laboratories. ATS statement: guidelines

for the six-minute walk test. Am J Respir Crit Care Med

2002;166:111e7.

18. Collin C, Wade D, Cochrane G. Functional outcome of lower

limb amputees with peripheral vascular disease. Clin Reha-

bil 1992;6:13e21.19. Datta D, Ariyararatnam R, Hilton S. Timed walking testdan

all-embracing outcome measure for lower-limb amputees?

Clin Rehabil 1996;10:227.

20. Rau B, Bonvin F, de Bie R. Short-term effect of physio-

therapy rehabilitation on functional performance of lower

limb amputees. Prosthet Orthot Int 2007;31:258e70.

21. Holbrook M, Skilbeck CE. An activities index for use with

stroke patients. Age Ageing 1983;12:166e70.22. Wade DT, Legh-Smith J, Langton Hewer R. Social activities

after stroke: measurement and natural history using the

Frenchay activities index. Int Rehabil Med 1985;7:176e81.23. Schuling J, de Haan R, Limburg M, et al. The Frenchay

Activities Index. Assessment of functional status in stroke

patients. Stroke 1993;24:1173e7.

24. Schepers VP, Ketelaar M, Visser-Meily JM, et al. Respon-

siveness of functional health status measures frequently

used in stroke research. Disabil Rehabil 2006;28:1035e40.

25. Green J, Forster A, Young J. A test-retest reliability study of

the Barthel Index, the Rivermead Mobility Index, the Not-

tingham Extended Activities of Daily Living Scale and the

Frenchay Activities Index in stroke patients. Disabil Rehabil

2001;23:670e6.26. Miller WC, Deathe AB, Harris J. Measurement properties of

the Frenchay Activities Index among individuals with a

lower limb amputation. Clin Rehabil 2004;18:414e22.

27. Asano M, Rushton P, Miller WC, et al. Predictors of quality

of life among individuals who have a lower limb amputa-

tion. Prosthet Orthot Int 2008;32:231e43.

28. Franchignoni F, Brunelli S, Orlandini D, et al. Is the River-

mead Mobility Index a suitable outcome measure in lower

limb amputees?dA psychometric validation study. J Reha-

bil Med 2003;35:141e4.

29. Forlander DA, Bohannon RW. Rivermead mobility index: a

brief reviewof research to date. ClinRehabil 1999;13:97e100.

30. Ryall NH, Eyres SB, Neumann VC, et al. The SIGAM

mobility grades: a new population-specific measure for

lower limb amputees. Disabil Rehabil 2003;25:833e44.

31. Hanspal RS, Newman WP. Mobility grades in amputee reha-

bilitation. Clin Rehabil 1991;5:344.

32. Gardiner MD, Faux S, Jones LE. Inter-observer reliability of

clinical outcome measures in a lower limb amputee popula-

tion. Disabil Rehabil 2002;24:219e25.

33. Met R, Janssen LI, Wille J, et al. Functional results after

through-kneeand above-knee amputations: doesmore length

mean better outcome? Vasc Endovascular Surg 2008;42:

456e61.

34. Houghton A, Allen A, Luff R, et al. Rehabilitation after

lower limb amputation: a comparative study of above-

knee, through-knee and Gritti-Stokes amputations. Br J

Surg 1989;76:622e4.35. Houghton AD, Taylor PR, Thurlow S, et al. Success rates for

rehabilitation of vascular amputees: implications for preop-

erative assessment and amputation level. Br J Surg 1992;

79:753e5.36. Devlin M, Pauley T, Head K, et al. Houghton scale of pros-

thetic use in people with lower-extremity amputations: reli-

ability, validity, and responsiveness to change. Arch Phys

Med Rehabil 2004;85:1339e44.37. Bhangu S, Devlin M, Pauley T. Outcomes of individuals

with transfemoral and contralateral transtibial amputation

due to dysvascular etiologies. Prosthet Orthot Int 2009;33:

33e40.

38. Gauthier-Gagnon C, Grise MC. Prosthetic profile of the

amputee questionnaire: validity and reliability. Arch Phys

Med Rehabil 1994;75:1309e14.39. Streppel KR, de Vries J, van Harten WH. Functional status

and prosthesis use in amputees, measured with the Pros-

thetic Profile of the Amputee (PPA) and the short version

of the Sickness Impact Profile (SIP68). Int J Rehabil Res

2001;24:251e6.

40. Franchignoni F, Orlandini D, Ferriero G, et al. Reliability,

validity, and responsiveness of the locomotor capabilities in-

dex in adults with lower-limb amputation undergoing pros-

thetic training. Arch Phys Med Rehabil 2004;85:743e8.

41. Miller WC, Deathe AB, Speechley M. Lower extremity pros-

thetic mobility: a comparison of 3 self-report scales. Arch

Phys Med Rehabil 2001;82:1432e40.

42. Gauthier-Gagnon C, Grise M, Lepage Y. The locomotor

capabilities index: content validity. J Rehabil Outcomes

Measurement 1998;4:40e6.43. Traballesi M, Porcacchia P, Averna T, et al. Prognostic factors

in prosthetic rehabilitation of bilateral dysvascular above-

knee amputee: Is the stump condition an influencing factor?

Eura Medicophys 2007;43:1e6.44. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form

health survey (SF-36). I. conceptual framework and item

selection. Med Care 1992;30:473e83.45. Ware J Jr, Kosinski M, Keller SD. A 12-item short-form

health survey: construction of scales and preliminary tests

of reliability and validity. Med Care 1996;34:220e33.

46. Penn-Barwell JG. Outcomes in lower limb amputation

following trauma: a systematic review and meta-analysis.

Injury 2011;42:1474e9.

47. EuroQol Group. EuroQolda new facility for the measure-

ment of health-related quality of life. Health Policy 1990;

16:199e208.

48. Chilcott J, McCabe C, Tappenden P, et al. Modelling the cost

effectiveness of interferon beta and glatiramer acetate in the

management of multiple sclerosis. Commentary: evaluating

Page 10: Calidad de Vida Amputados

772 Hawkins et al. Annals of Vascular Surgery

disease modifying treatments in multiple sclerosis. BMJ

2003;326:522.

49. De Fretes A, Boonstra AM, Vos LD. Functional outcome of

rehabilitated bilateral lower limb amputees. Prosthet Orthot

Int 1994;18:18e24.50. WHOQOL Group. Development of the WHOQOL: rationale

and current status. Int J Men Health 1994;23:24.

51. Deans SA, McFadyen AK, Rowe PJ. Physical activity and

quality of life: a study of a lower-limb amputee population.

Prosthet Orthot Int 2008;32:186e200.

52. Hunt SM, McEwen J. The development of a subjective

health indicator. Sociol Health Illn 1980;2:231e46.

53. Hunt SM, McEwen J, McKenna SP. Measuring health sta-

tus: a new tool for clinicians and epidemiologists. J R Coll

Gen Pract 1985;35:185e8.

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 evalua-

tion 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 pa-

tients 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.

APPENDIX I: SEARCH TERMS

(‘‘Amputation’’ [Mesh] OR ‘‘Amputation

Stumps’’ [Mesh] OR ‘‘Amputation, Traumatic’’

[Mesh] OR (amputable [Text Word] OR amputa-

ciones [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 ampu-

tated [Text Word] OR amputated/denervated [Text

Word] OR amputated/dismembered [Text Word]

OR amputated/inactive [Text Word] OR ampu-

tated/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 amputa-

tion/83 [Text Word] OR amputation/absorption

[Text Word] OR amputation/avulsion [Text Word]

OR amputation/bypass [Text Word] OR amputa-

tion/chest [TextWord] 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 amputa-

tion/grafting [Text Word] OR amputation/hemisec-

tion [Text Word] OR amputation/injury [Text

Word] OR amputation/neuropathy [Text Word]

OR amputation/occlusion [Text Word] OR amputa-

tion/penetrating [Text Word] OR amputation/per-

son [Text Word] OR amputation/plexus [Text

Word] OR amputation/pulmonary [Text Word]

OR amputation/radical [Text Word] OR amputa-

tion/readmission [Text Word] OR amputation/

regeneration [Text Word] OR amputation/replanta-

tion [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/

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 amputa-

tionplasty [Text Word] OR amputations [Text

Word] OR amputations/crush [Text Word] OR am-

putations/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 amputee’s [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 ampu-

tierten [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 II: INCLUSION/EXCLUSION

CRITERIA

Inclusion criteria

� Major lower extremity amputee population

� Full paper

� Written in English

Page 11: Calidad de Vida Amputados

Table.

First author (year) Population (etiology)Sample size(amputees only) Country Assessment instruments Outcomes

Eijk et al (2012)29 Geriatric MLE Amputees 48 Netherlands BI 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

Cox et al (2011)30 MLE amputees because of

diabetes

87 Jamaica WHOQOL-BREF and

FIM

BKA functioned better than those with AKA;

womens were more likely to cope and

function with disability than men

Frlan-Vrgoc et al (2011)31 MLE amputees with

prosthesis

50 Croatia 2MWT Age, sex, level and cause of amputation,

including the time from the first prosthetic

supply, have an effect on the 2MWT

da Silva et al (2011)32 MLE amputees 22 Brazil IPAQ and WHOQOL-

BREF

Physical activity is not associated with QOL

except for the psychological domain

Kark and Simmons (2011)33 MLE amputees 20 Australia PEQ, TUG, and 6MWT 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

Sinha et al (2011)34 MLE amputees 184 Netherlands SF-36 Amputees scored lower on SF-36 than

general population

Penn-Barwell (2011)35 Lower limb (trauma) 3,105 UK SF-36, ability to walk

500 m

Patients with a TKA have a better physical

quality of life than those with an AKA

Mazari et al (2010)36 BKA amputees 29 UK SF-36 No difference in clinical and QOL outcomes

between 2 types of walking aides

Stineman et al (2010)37 Veterans with a new lower

extremity

amputation (DM, PVD, and

trauma)

1,502 US FIM Patients who receive specialized

rehabilitation make greater gains than

patients who receive consultative services

Raya et al (2010)38 MLE amputees 72 US 6MWT 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)

Vol.28,No.3,April

2014

Function

alandQOLassessm

entafter

MLEamputation

773

Page 12: Calidad de Vida Amputados

Table. Continued

First author (year) Population (etiology)Sample size(amputees only) Country Assessment instruments Outcomes

Remes et al (2010)39 MLE amputees with PAD 59 Finland SF 36 and SWLS Home-dwelling amputees had a relatively

good QOL, whereas institutionalization

was associated with depressive symptoms;

in rehabilitation programs, QOL should be

considered

Davidson et al (2010)40 MLE amputees 39 Australia SF-36 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

Taghipour et al (2009)41 Veterans with a war-related

unilateral lower

extremity amputation

(trauma)

141 Iran SF-36 Alleviation of pain, education, and

employment are issues that should be

addressed

Giannoudis et al (2009)42 Tibial trauma patients

(trauma)

22 UK EQ5D Patients with tibial injuries report long-term

health-related QOL problems of varying

degrees

Kurichi et al (2009)43 MLE amputees 1,339 US FIM Receipt of specialized compared with

generalized rehabilitation during the acute

postoperative inpatient period was

associated with better outcomes

Bhangu et al (2009)44 Bilteral MLE amputees

because of

dysvascular disease

31 Canada 2MWT, Houghton

scale, and FAI

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

Boutoille et al (2008)45 Amputation after diabetic foot

ulcer (DM)

25 France SF-36 No difference in QOL between patients with

foot ulcers and amputees

MacNeill et al (2008)46 Bilateral transtibial amputees

(DM, PVD)

82 Canada SF-12 Patients undergoing rehabilitation for BTTA

do well at long-term follow-up and to

survive, on average, for >4 years after

discharge

Asano et al (2008)47 MLE amputation 415 Canada FAI and EQ5D VAS Depression, perceived prosthetic mobility,

social support, comorbidity, prosthesis

problems, age, and social activity

participation predict subjects’ perceived

QOL

774

Hawkinsetal.

AnnalsofVascu

larSurgery

Page 13: Calidad de Vida Amputados

Deans et al (2008)48 MLE amputees 75 UK TAPES and WHOQOL-

BREF

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

Desmond et al (2008)49 MLE amputation 89 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

Johannesson et al (2008)50 BKA for dysvascular disease 27 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 patient’s function with prosthesis

Met et al (2008)51 TKA and AKA (PVD, DM, and

trauma)

50 Netherlands SIGAM Preferable to perform a straight AKA instead

of a TKA if the correct amputation level is

in doubt in high-risk patients

Stasik et al (2008)52 Redo BKA (DM and PVD) 23 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

Yazicioglu et al (2007)53 Unilateral BKA fitted with

prostheses

24 Turkey Houhgton scale, LCI,

and SF-36

Playing football (soccer) may have positive

effects on balance and health-related QOL

Rau et al (2007)54 Male unilateral lower limb

amputees

58 Myanmar 2MWT, TUG, and FMA Physiotherapy is effective in improving

functional performance of lower limb

amputees in a resource poor setting

Pinzur et al (2006)55 BKA with distal tibial-fibular

bone-bridge

(DM, PVD, and trauma)

49 US PEQ Patients with bone-bridging had scores better

than or comparable to those of a selected

group of highly functional traditional BKA

Cannada and Jones (2006)56 Traumatic amputees 601 US SIP Factors other than the traditional variables,

such as fracture healing, joint function,

and ability to ambulate, have a profound

effect on the patient’s estimation of

improvement

Traballesi et al (2006)57 Bilateral AKA for PVD 30 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)

Vol.28,No.3,April

2014

Function

alandQOLassessm

entafter

MLEamputation

775

Page 14: Calidad de Vida Amputados

Table. Continued

First author (year) Population (etiology)Sample size(amputees only) Country Assessment instruments Outcomes

Gunawardena et al (2006)58 Unilateral, traumatic lower

limb amputees

461 Sri Lanka SF-36 Amputees have comparatively poor

functional outcomes, which could be

improved by modifying stump length and

problems with the stump and sound leg

Wan Hazmy et al (2006)59 MLE amputation (DM, PVD,

and trauma)

213 Malaysia BI Most amputees had a good functional

outcome; some were unhappy that they

were insufficiently informed regarding

postamputation expectation

Meatherall et al (2005)60 MLE amputation because of

DM

44 Canada PEQ and PPA Major functional changes were noted after

MLE amputation that had a large negative

impact on QOL

Van de Weg and Van der

Windt (2005)61BKA amputees 220 Netherlands PEQ Liner prescription should not be employed as

a matter of course for all BKA amputees

Selles et al (2005)62 Unilateral BKA (DM, PVD,

and trauma)

26 Netherlands FIM and PEQ Patients receiving an ICEX TSB socket and a

conventional PTB socket had similar

outcomes

Davies and Datta (2003)63 Unilateral BKA or AKA (DM,

PVD, and trauma)

281 UK Harold Wood Stanmore

mobility grade

(precursor to SIGAM)

Mobility rates 1 year after prosthetic

provision for unilateral BKA and AKA

worsen with increasing age and higher

level of amputation

Schoppen et al (2003)64 Patients >60 years of age with

MLE amputation because of

PVD

46 Netherlands 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

Demet et al (2003)65 Major upper and lower

extremity amputation

539 France NHP Young age at the time of amputation,

traumatic origin, and upper limb

amputation were independently associated

with better QOL

van der Schans et al (2002)66 MLE amputees 437 Netherlands SF-36 The most important amputation-specific

determinants of health-related QOL were

‘‘walking distance’’ and ‘‘stump pain’’

Munin et al (2001)67 MLE amputees 75 US 45-m walk test Early prosthetic rehabilitation resulted in

greater ambulation at rehabilitation

discharge

Hoogendoorn and van der

Werken (2001)68Grade III open tibial fractures

(trauma)

43 Netherlands 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.

776

Hawkinsetal.

AnnalsofVascu

larSurgery

Page 15: Calidad de Vida Amputados

Vol. 28, No. 3, April 2014 Functional and QOL assessment after MLE amputation 777

� The study must assess a population, not simply

validate an assessment instrument

� More than 20 patients

� Major outcome must be either function or qual-

ity 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, OUT-

COMES 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 observa-

tion. 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 in-

dependence). 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 por-

tion has 13 components scored 1e7 for a summed

score (range: 13e81) that indicates a patient’s phys-

ical 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 pa-

tient’s 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

The International Physical Activity Question-

naire (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 surveil-

lance systems, whereas the long version (27 ques-

tions 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 meta-

bolic 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 do-

mains and/or categories and at the total SIP level.

Higher scores indicate more health-related behav-

ioral 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 Transfe-

moral 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 pros-

thesis 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

Page 16: Calidad de Vida Amputados

Appendix References

1. Mahoney FI, Barthel DW. Functional evaluation: the Barthel

index. Md State Med J 1965;14:61e5.2. Treweek SP, Condie ME. Three measures of functional

outcome for lower limb amputees: a retrospective review.

Prosthet Orthot Int 1998;22:178e85.

3. Keith RA, Granger CV, Hamilton BB, et al. The functional in-

dependence measure: a new tool for rehabilitation. Adv Clin

Rehabil 1987;1:6e18.

4. Granger CV, Hamilton BB, Keith RA, et al. Advances in func-

tional assessment for medical rehabilitation. Top Geriatr

Rehabil 1986;1:59e74.

5. Hamilton BB, Laughlin JA, Fiedler RC, et al. Interrater reli-

ability of the 7-level functional independence measure

(FIM). Scand J Rehabil Med 1994;26:115e9.

6. Stineman MG, Shea JA, Jette A, et al. The functional inde-

pendence measure: tests of scaling assumptions, structure,

778 Hawkins et al. Annals of Vascular Surgery

close-ended questions in whichmeasurement 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 ques-

tions 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 Day’s 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 wheel-

chair use. There are 20 questions and it takes 15 mi-

nutes 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 amputee’s prog-

ress during rehabilitation.

The Amputee Mobility Predictor (AMP; ++) was

designed to measure an amputee patient’s func-

tional capabilities without a prosthesis (AMPno-

PRO) 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 rehabilita-

tion setting.

The Functional Measure for Amputees (++) mea-

sures the function of amputees mainly in terms of

prosthetic wear, use, and function with a pros-

thesis.22 It is modeled on a subset of the PPA ques-

tionnaire. 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.

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 one’s 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 pa-

tients.24 Scores range from 5e35, with 20e24 repre-

senting average satisfaction with life.

Instruments of Quality of Life: Amputee-Specific

The Trinity Amputation and Prosthesis Experi-

ences Scales (TAPES; ++) measures the health-

related 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, re-

striction, 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 atti-

tude 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 psycho-

metric properties have yet to be assessed.28

Page 17: Calidad de Vida Amputados

and reliability across 20 diverse impairment categories. Arch

Phys Med Rehabil 1996;77:1101e8.7. Gauthier-Gagnon C, GM. Tools for outcome measurement in

lower limb amputee rehabilitation 2001.

8. Craig CL, Marshall AL, Sjostrom M, et al. International phys-

ical activity questionnaire: 12-country reliability and validity.

Med Sci Sports Exerc 2003;35:1381e95.

9. BrownWJ, Trost SG, Bauman A, et al. Test-retest reliability of

four physical activity measures used in population surveys.

J Sci Med Sport 2004;7:205e15.

10. Hallal PC, Victora CG. Reliability and validity of the interna-

tional physical activity questionnaire (IPAQ). Med Sci Sports

Exerc 2004;36:556.

11. Fogelholm M, Malmberg J, Suni J, et al. International phys-

ical activity questionnaire: validity against fitness. Med Sci

Sports Exerc 2006;38:753e60.12. Lee PH, Macfarlane DJ, Lam TH, et al. Validity of the interna-

tional physical activity questionnaire short form (IPAQ-SF): a

systematic review. Int J Behav Nutr Phys Act 2011;8:115.

13. Gilson BS, Gilson JS, Bergner M, et al. The sickness impact

profile. development of an outcome measure of health

care. Am J Public Health 1975;65:1304e10.

14. Bergner M, Bobbitt RA, Pollard WE, et al. The sickness

impact profile: validation of a health status measure. Med

Care 1976;14:57e67.

15. Pollard WE, Bobbitt RA, Bergner M, et al. The sickness

impact profile: reliability of a health status measure. Med

Care 1976;14:146e55.

16. Carter WB, Bobbitt RA, Bergner M, et al. Validation of an

interval scaling: the Sickness Impact Profile. Health Serv

Res 1976;11:516e28.17. de Bruin AF, Diederiks JP, de Witte LP, et al. The develop-

ment of a short generic version of the sickness impact pro-

file. J Clin Epidemiol 1994;47:407e18.

18. Hagberg K, Branemark R, Hagg O. Questionnaire for persons

with a transfemoral amputation (Q-TFA): initial validity and

reliability of a new outcome measure. J Rehabil Res Dev

2004;41:695e706.

19. Grise MC, Gauthier-Gagnon C, Martineau GG. Prosthetic

profile of people with lower extremity amputation: concep-

tion and design of a follow-up questionnaire. Arch Phys

Med Rehabil 1993;74:862e70.20. Day HJ. The assessment and description of amputee activity.

Prosthet Orthot Int 1981;5:23e8.

21. Gailey RS, Roach KE, Applegate EB, et al. The amputee

mobility predictor: an instrument to assess determinants of

the lower-limb amputee’s ability to ambulate. Arch Phys

Med Rehabil 2002;83:613e27.

22. Callaghan BG, Sockalingam S, Treweek SP, et al. A post-

discharge functional outcome measure for lower limb am-

putees: test-retest reliability with trans-tibial amputees.

Prosthet Orthot Int 2002;26:113e9.

23. Diener E, Emmons RA, Larsen RJ, et al. The satisfaction

with life scale. J Pers Assess 1985;49:71e5.

24. Pavot W, Diener E, Colvin CR, et al. Further validation of

the satisfaction with life scale: evidence for the cross-

method convergence of well-being measures. J Pers Assess

1991;57:149e61.

25. Gallagher P, Maclachlan M. Development and psychometric

evaluation of the Trinity Amputation and Prosthesis Experi-

ence Scales (TAPES). Rehabil Psychol 2000;45:130e54.26. Gallagher P, Maclachlan M. The Trinity Amputation and

Prosthesis Experience Scales and quality of life in people

with lower-limb amputation. Arch Phys Med Rehabil

2004;85:730e6.

7. Gallagher P, Franchignoni F, Giordano A, et al. Trinity

Vol. 28, No. 3, April 2014 Functional and QOL assessment after MLE amputation 779

2

Amputation and Prosthesis Experience Scales: a psychomet-

ric assessment using classical test theory and Rasch analysis.

Am J Phys Med Rehabil 2010;89:487e96.

28. Fisher K, Hanspal R. Body image and patients with amputa-

tions: does the prosthesis maintain the balance? Int J Reha-

bil Res 1998;21:355e63.

29. Eijk MS, van der Linde H, Buijck BI, et al. Geriatric rehabil-

itation of lower limb amputees: a multicenter study. Disabil

Rehabil 2012;34:145e50.

30. Cox PS, Williams SK, Weaver SR. Life after lower extremity

amputation in diabetics. West Indian Med J 2011;60:

536e40.31. Frlan-Vrgoc L, Vrbanic TS, Kraguljac D, et al. Functional

outcome assessment of lower limb amputees and prosthetic

users with a 2-minute walk test. Coll Antropol 2011;35:

1215e8.

32. da Silva R, Rizzo JG, Gutierres Filho PJ, et al. Physical activ-

ity and quality of life of amputees in southern Brazil. Pros-

thet Orthot Int 2011;35:432e8.33. Kark L, Simmons A. Patient satisfaction following lower-

limb amputation: the role of gait deviation. Prosthet Orthot

Int 2011;35:225e33.

34. Sinha R, van den Heuvel WJ, Arokiasamy P. Factors

affecting quality of life in lower limb amputees. Prosthet

Orthot Int 2011;35:90e6.

35. Penn-Barwell JG. Outcomes in lower limb amputation

following trauma: a systematic review and meta-analysis.

Injury 2011;42:1474e9.

36. Mazari FA, Mockford K, Barnett C, et al. Hull early walking

aid for rehabilitation of transtibial amputeeserandomized

controlled trial (HEART). J Vasc Surg 2010;52:1564e71.

37. StinemanMG, Kwong PL, Xie D, et al. Prognostic differences

for functional recovery after major lower limb amputation:

effects of the timing and type of inpatient rehabilitation ser-

vices in the Veterans Health Administration. PM R 2010;2:

232e43.

38. Raya MA, Gailey RS, Fiebert IM, et al. Impairment variables

predicting activity limitation in individuals with lower limb

amputation. Prosthet Orthot Int 2010;34:73e84.

39. Remes L, Isoaho R, Vahlberg T, et al. Quality of life three

years after major lower extremity amputation due to periph-

eral arterial disease. Aging Clin Exp Res 2010;22:395e405.

40. Davidson JH, Khor KE, Jones LE. A cross-sectional study of

post-amputation pain in upper and lower limb amputees,

experience of a tertiary referral amputee clinic. Disabil

Rehabil 2010;32:1855e62.

41. Taghipour H, Moharamzad Y, Mafi AR, et al. Quality of life

among veterans with war-related unilateral lower extremity

amputation: a long-term survey in a prosthesis center in

iran. J Orthop Trauma 2009;23:525e30.

42. Giannoudis PV, Harwood PJ, Kontakis G, et al. Long-term

quality of life in trauma patients following the full spectrum

of tibial injury (fasciotomy, closed fracture, grade IIIB/IIIC

open fracture and amputation). Injury 2009;40:213e9.

43. Kurichi JE, Small DS, Bates BE, et al. Possible incremental

benefits of specialized rehabilitation bed units among veter-

ans after lower extremity amputation. Med Care 2009;47:

457e65.

44. Bhangu S, Devlin M, Pauley T. Outcomes of individuals

with transfemoral and contralateral transtibial amputation

due to dysvascular etiologies. Prosthet Orthot Int 2009;33:

33e40.

45. Boutoille D, Feraille A, Maulaz D, et al. Quality of life with

diabetes-associated foot complications: comparison between

Page 18: Calidad de Vida Amputados

lower-limb amputation and chronic foot ulceration. Foot

Ankle Int 2008;29:1074e8.46. Mac Neill HL, Devlin M, Pauley T, et al. Long-term out-

comes and survival of patients with bilateral transtibial

amputations after rehabilitation. Am J Phys Med Rehabil

2008;87:189e96.

47. Asano M, Rushton P, Miller WC, et al. Predictors of quality

of life among individuals who have a lower limb amputa-

tion. Prosthet Orthot Int 2008;32:231e43.48. Deans SA, McFadyen AK, Rowe PJ. Physical activity and

quality of life: a study of a lower-limb amputee population.

Prosthet Orthot Int 2008;32:186e200.

49. Desmond D, Gallagher P, Henderson-Slater D, et al. Pain

and psychosocial adjustment to lower limb amputation

amongst prosthesis users. Prosthet Orthot Int 2008;32:

244e52.

50. Johannesson A, Larsson GU, Oberg T, et al. Comparison of

vacuum-formed removable rigid dressing with conventional

rigid dressing after transtibial amputation: similar outcome

in a randomized controlled trial involving 27 patients.

Acta Orthop 2008;79:361e9.

51. Met R, Janssen LI, Wille J, et al. Functional results after

through-kneeand above-knee amputations: doesmore length

mean better outcome? Vasc Endovascular Surg 2008;42:

456e61.

52. Stasik CN, Berceli SA, Nelson PR, et al. Functional outcome

after redo below-knee amputation. World J Surg 2008;32:

1823e6.

53. Yazicioglu K, Taskaynatan MA, Guzelkucuk U, et al. Effect

of playing football (soccer) on balance, strength, and quality

of life in unilateral below-knee amputees. Am J Phys Med

Rehabil 2007;86:800e5.

54. Rau B, Bonvin F, de Bie R. Short-term effect of physio-

therapy rehabilitation on functional performance of lower

limb amputees. Prosthet Orthot Int 2007;31:258e70.55. 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 fib-

ula. Foot Ankle Int 2006;27:907e12.56. Cannada LK, Jones AL. Demographic, social and economic

variables that affect lower extremity injury outcomes. Injury

2006;37:1109e16.

57. Traballesi M, Porcacchia P, Averna T, et al. Prognostic factors

in prosthetic rehabilitation of bilateral dysvascular above-

knee amputee: is the stump condition an influencing factor?

Eura Medicophys 2007;43:1e6.58. Gunawardena NS, Seneviratne Rde A, Athauda T. Func-

tional outcomes of unilateral lower limb amputee soldiers

in two districts of Sri Lanka. Mil Med 2006;171:283e7.59. Wan Hazmy CH, Chia WY, Fong TS, et al. Functional

outcome after major lower extremity amputation: s survey

on lower extremity amputees. Med J Malaysia 2006;

61(Suppl A):3e9.60. Meatherall BL, Garrett MR, Kaufert J, et al. Disability and

quality of life in Canadian aboriginal and non-aboriginal

diabetic lower-extremity amputees. Arch Phys Med Rehabil

2005;86:1594e602.

61. Van de Weg FB, Van der Windt DA. A questionnaire survey

of the effect of different interface types on patient satisfac-

tion and perceived problems among trans-tibial amputees.

Prosthet Orthot Int 2005;29:231e9.

62. Selles RW, Janssens PJ, Jongenengel CD, et al. A random-

ized controlled trial comparing functional outcome and

cost efficiency of a total surface-bearing socket versus a con-

ventional patellar tendon-bearing socket in transtibial am-

putees. Arch Phys Med Rehabil 2005;86:154e61.

63. Davies B, Datta D. Mobility outcome following unilateral

lower limb amputation. Prosthet Orthot Int 2003;27:

186e90.

64. Schoppen T, Boonstra A, Groothoff JW, et al. Physical,

mental, and social predictors of functional outcome in unilat-

eral lower-limb amputees. Arch Phys Med Rehabil 2003;84:

803e11.

65. 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.

66. van der Schans CP, Geertzen JH, Schoppen T, et al. Phantom

pain and health-related quality of life in lower limb ampu-

tees. J Pain Symptom Manage 2002;24:429e36.

67. Munin MC, Espejo-De Guzman MC, Boninger ML, et al.

Predictive factors for successful early prosthetic ambulation

among lower-limb amputees. J Rehabil Res Dev 2001;38:

379e84.

68. Hoogendoorn JM, van der Werken C. Grade III open tibial

fractures: functional outcome and quality of life in amputees

versus patients with successful reconstruction. Injury 2001;

32:329e34.

780 Hawkins et al. Annals of Vascular Surgery