A systematic literature review of quality of life in lower limb amputees
17
REVIEW A systematic literature review of quality of life in lower limb amputees RICHA SINHA & WIM J. A. VAN DEN HEUVEL Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands Accepted August 2010 Abstract Purpose. To systematically review studies on quality of life (QoL) in lower limb amputees. Method. Computerised literature search of MEDLINE, CINAHL, PUBMED and PsycINFO databases was performed using the keywords, amputee, leg, knee, foot, amputation, QoL, prosthesis, orthopaedic equipment, ADL, phantom, mobility, rehabilitation, psychosocial, psychology and social. Eligible studies published from database inception through March 2009 were selected. The study was included if (1) the study population comprised of adolescent and adult lower-limb amputees as a group or a sub-group, and had ten or more subjects; (2) the study involved subjective assessment of QoL or self-appraisal of life or satisfaction with life; (3) the study was an empirical research study and (4) at least one of the study outcomes was QoL or self-appreciation of life, and QoL results were presented. The selected articles were assessed for study quality based on a standardised set of 19 criteria. The criteria list was pilot-tested for applicability and operationalisation by the authors. Objectives, study population description, QoL instruments used and study outcomes were summarised for the included studies. Results. Twenty-six articles met the inclusion criteria. Fifteen studies were cross-sectional, four prospective, six retrospective and one mixed study-design. The studies were found to be heterogeneous with respect to the study objectives and instruments used to assess QoL. The summary quality score was 50% or more for ten studies, with the maximum being 81%. Conclusions. Lacunas were found in the methodological and study population characteristics of most of the studies. Prospective longitudinal studies are envisaged to systematically study the events following amputation, and the change in QoL over time. To enable this, amputee specific standardised and validated QoL instruments are needed to capture the multitude of facets influencing QoL in amputees, and thereby, facilitating direct comparison across studies. Keywords: Amputees, lower extremity, quality of life Introduction The prevalence of amputation varies country-wise. There is no up-to-date published information avail- able about the worldwide incidence. The National Health Interview Survey 1996 (NHIS 1996) esti- mated that approximately 1.2 million people were living with limb loss in the United States of America [1], and 185,000 persons undergo upper or lower limb amputations each year [2]. In the Netherlands, 18–20 major lower limb amputations per 100,000 of population are performed every year [3]. In France, the incidence of lower limb amputation is estimated at 6.6 per 100,000 inhabitants per year [4]. The causes of amputation vary, and mostly depend on morbidity patterns, ageing of population, poor infrastructure, war/civil conflicts, terrorism and natural calamities. In patients up to 60 years, trauma and cancer are the main causes of amputation [5,6]. Vascular disorders are the major contributors to lower limb amputations in western countries [3,7], whereas traumatic accidents are the major cause of amputation in developing countries [5]. Irrespective of the cause, amputation brings a dramatic change in the life situation of an individual in almost all aspects of daily living and functioning. Quality of life (QoL) of amputees gets affected due to limitations posed by body function and structure, which hinders the activity level and thereby partici- pation, and further influenced by the environmental and personal factors as envisaged in the International Classification of Functioning, Disability and Health (ICF) framework of World Health Organisation [8]. QoL is described as a multidimensional concept [9– Correspondence: Mrs. Richa Sinha, MPH, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands. E-mail: [email protected] Disability and Rehabilitation, 2011; 33(11): 883–899 ISSN 0963-8288 print/ISSN 1464-5165 online ª 2011 Informa UK, Ltd. DOI: 10.3109/09638288.2010.514646 Disabil Rehabil Downloaded from informahealthcare.com by Athlone Institute of Technology on 08/31/13 For personal use only.
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To systematically review studies on quality of life (QoL) in lower limb amputees.
Transcript of A systematic literature review of quality of life in lower limb amputees
REVIEW
A systematic literature review of quality of life in lower limb amputees
RICHA SINHA & WIM J. A. VAN DEN HEUVEL
Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
Accepted August 2010
AbstractPurpose. To systematically review studies on quality of life (QoL) in lower limb amputees.Method. Computerised literature search of MEDLINE, CINAHL, PUBMED and PsycINFO databases was performedusing the keywords, amputee, leg, knee, foot, amputation, QoL, prosthesis, orthopaedic equipment, ADL, phantom,mobility, rehabilitation, psychosocial, psychology and social. Eligible studies published from database inception throughMarch 2009 were selected. The study was included if (1) the study population comprised of adolescent and adult lower-limbamputees as a group or a sub-group, and had ten or more subjects; (2) the study involved subjective assessment of QoL orself-appraisal of life or satisfaction with life; (3) the study was an empirical research study and (4) at least one of the studyoutcomes was QoL or self-appreciation of life, and QoL results were presented. The selected articles were assessed for studyquality based on a standardised set of 19 criteria. The criteria list was pilot-tested for applicability and operationalisation bythe authors. Objectives, study population description, QoL instruments used and study outcomes were summarised for theincluded studies.Results. Twenty-six articles met the inclusion criteria. Fifteen studies were cross-sectional, four prospective, sixretrospective and one mixed study-design. The studies were found to be heterogeneous with respect to the study objectivesand instruments used to assess QoL. The summary quality score was 50% or more for ten studies, with the maximum being81%.Conclusions. Lacunas were found in the methodological and study population characteristics of most of the studies.Prospective longitudinal studies are envisaged to systematically study the events following amputation, and the change inQoL over time. To enable this, amputee specific standardised and validated QoL instruments are needed to capture themultitude of facets influencing QoL in amputees, and thereby, facilitating direct comparison across studies.
Keywords: Amputees, lower extremity, quality of life
Introduction
The prevalence of amputation varies country-wise.
There is no up-to-date published information avail-
able about the worldwide incidence. The National
Health Interview Survey 1996 (NHIS 1996) esti-
mated that approximately 1.2 million people were
living with limb loss in the United States of America
[1], and 185,000 persons undergo upper or lower
limb amputations each year [2]. In the Netherlands,
18–20 major lower limb amputations per 100,000 of
population are performed every year [3]. In France,
the incidence of lower limb amputation is estimated
at 6.6 per 100,000 inhabitants per year [4].
The causes of amputation vary, and mostly depend
on morbidity patterns, ageing of population, poor
infrastructure, war/civil conflicts, terrorism and
natural calamities. In patients up to 60 years, trauma
and cancer are the main causes of amputation [5,6].
Vascular disorders are the major contributors to
lower limb amputations in western countries [3,7],
whereas traumatic accidents are the major cause of
amputation in developing countries [5].
Irrespective of the cause, amputation brings a
dramatic change in the life situation of an individual
in almost all aspects of daily living and functioning.
Quality of life (QoL) of amputees gets affected due to
limitations posed by body function and structure,
which hinders the activity level and thereby partici-
pation, and further influenced by the environmental
and personal factors as envisaged in the International
Classification of Functioning, Disability and Health
(ICF) framework of World Health Organisation [8].
QoL is described as a multidimensional concept [9–
Correspondence: Mrs. Richa Sinha, MPH, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
E-mail: [email protected]
Disability and Rehabilitation, 2011; 33(11): 883–899
ISSN 0963-8288 print/ISSN 1464-5165 online ª 2011 Informa UK, Ltd.
DOI: 10.3109/09638288.2010.514646
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11], and as an emotional and cognitive judgment
about the person’s well being, life satisfaction,
morale, and happiness and as such may be best
assessed by the person himself [12]. Therefore, a
multitude of facets need to be taken into considera-
tion to comprehensively assess QoL.
In order to gain an understanding about QoL in
amputees, it’s important to study the factors influen-
cing amputees’ QoL and how the different facets of
QoL are measured, which determine the overall QoL
in amputees. This objective will be achieved by
systematically searching studies on QoL in lower
limb amputees, followed by the quality assessment of
included studies and summarising the study results.
Methods
Search strategy
Computerised search was performed using four
databases: MEDLINE database (1966 to March
2009), CINAHL database (1982 to March 2009),
EMBASE (1989 to March 2009) and PsycINFO
(1972 to March 2009). The search strategy was
developed taking into consideration the population
under study, namely lower limb amputees and the
outcome variable of interest, i.e., QoL. To include all
relevant studies, not only the primary keywords
namely, amputation and QoL, but also, other key-
words as potential factors affecting amputees’ QoL
were included. The search was restricted to the
citations with the keywords appearing in title,
abstract or as major or minor keywords.
The Medical Search History (MeSH) terms from
the thesaurus were primarily used as the keywords.
The major keywords or the synonyms used for search
were amputee, leg, knee, foot, amputation, QoL,
prosthesis, orthopaedic equipment, ADL, phantom,
mobility, rehabilitation, psychosocial, psychology
and social. Further narrow keywords derived from
the broad keywords were chosen from the search-
database, which were also thesaurus terms, like
psychosocial as the broad keyword and psychosocial
factors, psychosocial readjustment as the narrow
keywords, and prosthesis as the broad keyword and
limb prosthesis, leg prosthesis, above-knee prosthesis
and below-knee prosthesis as the narrow keywords.
Combinations of keywords were made in order to
refine the search results.
Selection criteria
All citations obtained were screened for relevance by
one of the reviewers (RS) by studying the title and
abstract of each reference. A set of exclusion criteria
were developed for this review, which were: (1) the
study was published in a language other than
English, (2) the study was a case-study/review/
editorial/opinion papers/testimony/biography/inter-
view/book/progress report/discussion papers/guide-
lines, etc., (3) the article was related to amputation
but QoL was not being studied/measured, (4) the
article discussed QoL from others perspective, like
health care provider, care-giver, community mem-
bers, (5) the study involved development or valida-
tion of QoL instrument.
Next, two reviewers (RS and WvdH) read the
abstracts of the references included in the first step
and critically judged them for inclusion/exclusion
following the exclusion criteria. If the abstract of a
particular study was not available or it was difficult to
judge its relevance from the abstract, then the full
article was retrieved. A study was finally included if
(1) the study population comprised of adolescent
and adult lower-limb amputees as a group or a sub-
group, and had 10 or more amputees under study,
(2) the study involved assessment of QoL, (3) the
study was an empirical research study, and described
methods for measures of QoL, and (4) at least one of
the study outcomes was QoL or self-appreciation of
life and the outcomes were presented in the results.
Quality assessment
There are no strict guidelines for methodological
quality assessment of systematic reviews. Quality of a
study refers to measures of internal validity, external
validity and statistical criteria, i.e. whether calcula-
tions can be made and conclusions can be drawn
independently to those of the original author(s) [13].
For this review, representative study population,
type of study, use of standardised and validated QoL
measures, appropriate statistical tests, control for
confounding variables, consideration of non-response
bias and data presentation of relevant outcome
measures were considered as quality criteria. The
criteria list for this systematic review was formulated by
adopting and modifying criteria lists from other
systematic reviews for observational studies [14–16].
The criteria list was pilot-tested in two steps, firstly
with studies on QoL in kidney transplant patients,
and secondly with a selection of studies from the list
of potentially relevant articles selected for this review.
Following this two-step process, the operationalisa-
tion of the criteria list got more focussed, and the
definition of criteria more elaborated. Table A1 (in
Appendix) describes the final quality criteria list.
Finally, two reviewers (RS and WvdH) indepen-
dently assessed the quality of the included studies by
scoring the studies using the standardised quality
criteria list. In total, 19 criteria were used encompassing
884 R. Sinha & W. J. A. van den Heuvel
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three quality aspects: source population, study popula-
tion and methodological characteristics. The scoring
was solely based on the information provided in the
study. The scoring discrepancies for the respective
studies were discussed during consensus meetings to
reach an agreement.
Results
Search results and study selection
The literature search from various databases resulted
in identification of 2041 citations in total [CINAHL
508 (24.9%), EMBASE 844 (41.4%), MEDLINE
349 (17.1%), PsycINFO 340 (16.7%)]. There were
229 references, which were common in two or more
of the databases leading to 1812 non-duplicate
articles. After initial screening by one of the reviewers
(RS), 124 out of 1812 references (6.8%) remained.
Articles were excluded based on primary criteria
considering the language (151), study population
(661), study outcome (742), publication type (110),
and instrument development or validation (24).
Next, two reviewers (RS and WvdH) applied the
inclusion and exclusion criteria to the 124 references
from the initial screening by reading the abstracts or
the full article, if needed. Neither the abstract nor the
full article could be retrieved for four references, and
therefore they were excluded from the study. After
following these procedures, 25 out of 120 (21%)
studies got included. Studies in this step were
excluded based on primary criteria considering the
language (1), study population (11), study outcome
(48), publication type (33), and instrument develop-
ment or validation (2). One extra study was retrieved
from back referencing the included 25 studies. Quality
assessment scoring was done for these 26 studies.
Figure 1 depicts the study eligibility flowchart.
Study quality assessment
Results of the quality assessment are presented in
Table I under the categories of source population,
study population and methodological characteristics,
followed by a summary score. The summary quality
score was 50% or more for 10 studies, with the
maximum being 81%.
Study characteristics
The main characteristics of the selected studies,
namely aim(s) of the study, study population, QoL
assessment methodology, study outcomes and sum-
mary quality score are outlined in Table II. Ten
studies [19,20,28,31–33,35,38,40,41] were pub-
lished during 1990–1999, and the remaining sixteen
[17,18,21–27,29,30,34,36,37,39,42] from 2000 on-
wards. Thirteen [19,20,23,26,28,29,31,34–38,42]
studies were focused on either critical limb ischemic
or diabetic foot ulcer patients, and four [23,30,
33,42] on cancer amputees.
Study population was recruited from hospitals,
limb-fitting centres and amputee support organisa-
tions. QoL was measured in conjunction with
other outcome variables in seven studies [23,27,
30,34,36,40,42], and was also used as an outcome
variable in eight studies [23,28,29,32,36–38,42]
to compare different groups of amputees or inter-
ventions.
The studies have assessed QoL using quantitative
measures. The generic QoL instruments used were:
SF-36 in seven studies [20,23–25,27,35,36],
RAND-36 in two studies [29,39], Nottingham
Health Profile (NHP) in three studies [22,27,34],
SIP (Sickness Impact Profile) in one study [34],
WHOQOL-Bref in one study [21], EuroQoL in two
studies [34,37], Prosthesis Evaluation Questionnaire
(PEQ) in one study [26], visual analogue scales in
four studies [17,32,37,41] and QoL ladder in one
study [19]. Disease-specific QoL scales were used in
three studies [18,30,42].
Figure 1. Study eligibility flow chart.
QoL in lower limb amputees 885
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Tab
leI.
Res
ult
so
fq
ual
ity
asse
ssm
ent
of
incl
ud
edst
ud
ies.
Stu
dy
SR
CP
OP
*S
TU
DP
OP
CH
AR{
ME
TH
CH
AR{
QSx
AB
%C
DE
FG
HI
J%
KL
MN
OP
QR
S%
%
Asa
no
etal
.(2
00
8)
[17]
02
25
02
22
22
12
21
59
42
11
22
21
01
12
75
29
81
Beh
elet
al.
(20
02
)[1
8]
01
12
52
20
02
02
21
06
30
10
12
21
01
85
01
95
3
Car
rin
gto
net
al.
(199
6)
[19]
02
25
02
20
00
10
27
44
01
01
21
00
16
38
15
42
Ch
ette
ret
al.
(19
98
)[2
0]
11
25
02
20
00
20
28
50
13
10
20
21
11
16
92
15
8
Dea
ns
etal
.(2
00
8)
[21
]0
22
50
12
20
20
02
95
60
11
21
00
01
63
81
74
7
Dem
etet
al.
(20
03
)[2
2]
02
25
02
20
00
00
26
38
01
02
22
00
18
50
16
44
Eis
eret
al.
(20
01
)[2
3]
02
25
02
20
00
00
15
31
01
01
21
20
18
50
15
42
Hag
ber
gan
dB
ran
emar
k(2
00
1)
[24]
02
25
01
20
20
10
17
44
02
01
10
10
16
38
15
42
Hag
ber
get
al.
(200
8)
[25]
22
410
02
20
10
00
27
44
23
12
21
21
11
59
42
67
2
Har
nes
san
dP
inzu
r(2
001
)[2
6]
02
25
02
20
00
00
26
38
01
02
20
00
16
38
14
39
Ho
gen
do
orn
and
Wer
ken
(200
1)
[27]
12
37
51
20
00
00
25
31
12
02
10
20
19
56
17
47
Joh
nso
net
al.
(199
5)
[28
]0
22
50
22
00
02
01
74
40
11
21
01
01
74
41
64
4
McC
utc
heo
net
al.
(200
5)
[29
]0
22
50
22
00
20
02
85
00
11
21
00
01
63
81
64
4
Nag
araj
anet
al.
(20
04
)[3
0]
12
37
52
22
02
01
21
16
90
11
22
10
01
85
02
26
1
Pel
let
al.
(19
93
)[3
1]
12
37
50
00
00
00
11
62
10
22
12
11
12
75
16
44
Po
stm
aet
al.
(19
92
)[3
2]
01
12
52
20
00
00
26
38
02
02
10
20
18
50
15
42
Ro
ugra
ffet
al.
(19
94)
[33]
22
410
01
20
10
11
17
44
02
11
21
00
18
50
19
53
Sp
ince
mai
lle
etal
.(2
00
0)
[34]
02
25
02
20
00
20
17
44
03
12
20
00
19
56
18
50
Tan
gel
der
etal
.(1
99
9)
[35
]0
11
25
12
00
00
02
53
10
31
22
00
01
95
61
54
2
Tek
inet
al.
(20
09
)[3
6]
02
25
02
20
00
00
26
38
02
12
21
20
11
16
91
95
3
Ten
nva
llan
dA
pel
qvi
st(2
00
0)
[37
]2
24
10
02
20
00
20
28
50
21
12
22
11
11
38
12
56
9
Th
om
pso
net
al.
(199
5)
[38]
01
12
51
00
00
00
12
13
02
11
10
00
16
38
92
5
van
der
Sch
ans
etal
.(2
00
2)
[39]
00
00
22
00
00
02
63
80
11
22
20
01
95
61
54
2
Wal
ters
and
William
son
(19
98
)[4
0]
02
25
02
22
02
01
21
16
90
10
12
10
01
63
81
95
3
Wei
sset
al.
(199
0)
[41]
01
12
51
20
00
20
27
44
02
01
21
00
17
44
15
42
Zah
lten
-Hin
gu
ran
age
etal
.(2
004
)[4
2]
02
25
02
20
00
00
15
31
01
11
10
10
16
38
13
36
Qu
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lect
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easu
rin
gin
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men
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O:
Sta
tist
ical
met
ho
ds,
P:
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nfo
un
din
gva
riab
les
con
sid
ered
,Q
:R
esp
on
sera
te,
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Ch
arac
teri
stic
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fd
rop
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ts,
S:
Ou
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me
mea
sure
s).
*S
RC
PO
P¼
So
urc
eP
op
ula
tio
n.
{ ST
UD
PO
PC
HA
R¼
Stu
dy
Pop
ula
tio
nC
har
acte
rist
ics.
{ ME
TH
CH
AR¼
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ho
do
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alC
har
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rist
ics.
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mm
ary
Qu
alit
yS
core
.
886 R. Sinha & W. J. A. van den Heuvel
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Tab
leII
.S
um
mar
yo
fin
clu
ded
stu
die
scl
assi
fied
asp
erst
ud
yd
esig
n.
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
A.
Cro
ss-s
ecti
on
al
Asa
no
etal
.
(200
8)
[17]
Iden
tify
ing
fact
ors
pre
dic
tin
g
ind
ivid
ual
’ssu
bje
ctiv
eq
ual
ity
of
life
(Qo
L)
afte
rlo
wer
lim
b
amp
uta
tio
n
Vis
ual
An
alo
gu
eS
cale
(VA
S)
a)4
15
ou
to
f5
35
abo
ve-k
nee
and
bel
ow
-kn
eeam
pu
tees
par
tici
pat
ed
Dep
ress
ion
was
the
mo
st
imp
ort
ant
pre
dic
tor
of
Qo
L
follo
wed
by
per
ceiv
edp
rost
het
ic
mo
bilit
yan
dso
cial
sup
po
rt.
Oth
erp
red
icto
rso
fQ
oL
wer
e
com
orb
idit
y,p
rost
hes
is
pro
ble
ms,
age
and
soci
alac
tivi
ty
par
tici
pat
ion
.L
ess
dep
ress
ion
was
asso
ciat
edw
ith
hig
her
Qo
L.
Su
bje
cts
rep
ort
edre
lati
vely
hig
her
Qo
L(7
.4+
2.1
ou
to
f
10),
wh
ich
cou
ldb
eb
ecau
se
sub
ject
sw
ou
ldin
itia
lly
rep
ort
a
red
uce
dQ
oL
imm
edia
tely
afte
r
amp
uta
tio
n,
and
ove
r-ti
me
thei
r
resp
on
sem
ayb
em
od
ified
du
e
toad
apta
tio
nto
thei
rsi
tuat
ion
81
b)
Pat
ien
tsre
cru
ited
fro
mtw
o
ou
tpat
ien
tam
pu
tee
clin
ics
in
So
uth
Wes
tern
On
tari
o,
Can
ada
c)M
ean
age:
61
.9+
15
.7ye
ars
d)
Avg
.ti
me
sin
ceam
pu
tati
on
:
14
.5+
16
.5ye
ars
Beh
elet
al.
(200
2)
[18]
Exam
inin
gth
ero
leo
ffe
elin
gs
of
vuln
erab
ilit
yin
po
st-a
mp
uta
tio
n
adju
stm
ent
pro
ble
ms,
such
as
dep
ress
ion
and
dim
inis
hed
QO
L
QO
Lsc
ale
–3
item
sub
scal
efr
om
the
HIV
-Pat
ien
tA
sses
sed
Rep
ort
of
Sta
tus
and
Exp
erie
nce
(HIV
-PA
RS
E)
a)8
4o
ut
of
11
2le
gam
pu
tees
par
tici
pat
ed
Age,
gen
der
,ti
me
sin
ce
amp
uta
tio
n,
leve
lo
fam
pu
tati
on
,
inco
me
and
vuln
erab
ilit
y
pre
dic
ted
Qo
L.
Ah
igh
leve
lo
f
vuln
erab
ilit
yw
asas
soci
ated
wit
h
hig
her
leve
lso
fd
epre
ssio
n,
low
erQ
oL
,an
dp
oo
rer
ove
rall
adju
stm
ent
53
b)
Pat
ien
tsre
cru
ited
fro
m5
pro
sth
etic
clin
ics
inth
eC
hic
ago
Met
rop
olita
nar
ea,
US
A
c)M
ean
age:
48
.4+
15
.4ye
ars
d)
Avg
.ti
me
sin
ceam
pu
tati
on
:1
7
year
s(9
mo
nth
sto
49
year
s)
Car
rin
gto
net
al.
(199
6)
[19]
Co
mp
arin
gth
eQ
OL
bet
wee
n
dia
bet
icp
eop
lew
ith
chro
nic
foo
t
ulc
ers
or
low
erlim
bam
pu
tati
on
and
dia
bet
icco
ntr
ols
Qu
alit
yo
flife
lad
der
,a
sim
ple
un
idim
ensi
on
al,
gen
eric
scal
e
use
das
am
easu
reo
flife
sati
sfac
tio
n
a)1
3d
iab
etic
un
ilat
eral
low
erlim
b
amp
ute
e(D
A),
13
dia
bet
ic
un
ilat
eral
chro
nic
foo
tu
lcer
pat
ien
ts(D
U)
and
26
dia
bet
ic
peo
ple
wit
hn
oh
isto
ryo
f
chro
nic
foo
tu
lcer
asco
ntr
ols
(DC
)
Th
eQ
oL
lad
der
reve
aled
that
DU
was
sign
ifica
ntl
ym
ore
dis
sati
sfied
wit
hth
eir
per
son
al
live
sth
anD
C,
wh
erea
slife
-
sati
sfac
tion
of
DA
was
mid
-way
bet
wee
nD
Uan
dD
C,
bu
tw
as
no
tsi
gn
ifica
ntl
yd
iffe
ren
tfr
om
eith
ergro
up
.D
Aan
dD
Uw
ere
sign
ifica
ntl
ym
ore
dep
ress
ed
than
DC
.D
Uan
dD
Ah
ad
sign
ifica
ntl
yp
oo
rer
psy
cho
soci
al
adju
stm
ents
toth
eir
situ
atio
ns
than
DC
42
b)
Stu
dy
on
UK
po
pu
lati
on
(no
t
exp
lici
tly
rep
ort
ed)
c)A
ge
ran
ge:
DC
:4
7–7
1ye
ars
DA
:4
2–7
2ye
ars
DU
:43
–7
0ye
ars
d)
Tim
esi
nce
amp
uta
tio
n:
6–1
8
mo
nth
s
(con
tinued
)
QoL in lower limb amputees 887
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
Dea
ns
etal
.
(200
8)
[21]
Det
erm
inin
gth
ere
lati
on
ship
bet
wee
nq
ual
ity
of
life
and
rest
rict
ion
of
ph
ysic
alac
tivi
tyin
peo
ple
wit
hlo
wer
-lim
bva
scu
lar
amp
uta
tio
n
Wo
rld
Hea
lth
Org
aniz
atio
n
Qu
alit
y-o
f-L
ife
Sca
le
(WH
OQ
OL
-Bre
f)
a)2
5o
ut
of
75
tran
s-ti
bia
lo
rtr
ans-
fem
ora
lu
nilat
eral
amp
ute
esd
ue
top
erip
her
alva
scu
lar
dis
ease
par
tici
pat
ed
Ph
ysic
ald
om
ain
of
Qo
Lw
asth
e
mo
staf
fect
edan
den
viro
nm
enta
l
do
mai
nw
asth
ele
ast
affe
cted
.
Am
pu
tees
gav
eh
igh
er
imp
ort
ance
on
soci
alst
and
ing
and
frie
nd
ship
sw
ith
fam
ily
and
frie
nd
sth
ano
np
hys
ical
abilit
y
47
b)
Pat
ien
tsre
cru
ited
fro
m
Gla
sgo
w-b
ased
reh
abilit
atio
n
and
mo
bilit
yce
ntr
eb
ased
in
UK
c)T
her
ew
ere
5tr
ans-
tib
ial
amp
ute
es�
60
year
s,1
74
60
year
s;an
d3
tran
s-fe
mo
ral
amp
ute
es4
60
year
s
d)
Tim
esi
nce
amp
uta
tio
n:4
2
year
s
Dem
etet
al.
(200
3)
[22]
Ass
essi
ng
the
nat
ure
of
fact
ors
rela
ted
toh
ealt
hre
late
dq
ual
ity
of
life
(HR
QL
)o
fp
erso
ns
wit
h
lim
bam
pu
tati
on
Par
t1
of
No
ttin
gh
amH
ealt
h
Pro
file
(NH
P)
a)5
39
ou
to
f1
01
1p
ote
nti
al
resp
on
den
tsw
ith
maj
or
up
per
and
low
erlim
bam
pu
tati
on
s
Yo
un
gag
eat
the
tim
eo
f
amp
uta
tio
nan
dtr
aum
atic
ori
gin
wer
eas
soci
ated
wit
hb
ette
r
HR
QL
.M
enh
adb
ette
rH
RQ
L
than
wo
men
ind
om
ain
so
f
ph
ysic
ald
isab
ilit
y,en
ergy
leve
l,
emoti
on
alre
acti
on
san
dso
cial
iso
lati
on
.Y
ou
ng
age
was
also
asso
ciat
edw
ith
bet
ter
HR
QL
in
all
thes
ed
om
ain
s.V
ascu
lar
amp
ute
esh
adgre
ater
ph
ysic
al
dis
abilit
yan
dgre
ater
soci
al
iso
lati
on
44
b)
Pat
ien
tsre
cru
ited
fro
mN
ancy
Reg
ion
Pro
sth
esis
Cen
tre
of
War
Vic
tim
sin
east
ern
Fra
nce
c)M
ean
age:
66
.1+
14
.1ye
ars
d)
Mea
nag
eat
the
tim
eo
f
amp
uta
tio
n:
29
.9+
20
.2ye
ars
Eis
eret
al.
(200
1)
[23]
Inve
stig
atin
gQ
oL
,b
od
yim
age
and
dai
lyco
mp
eten
ceo
fp
atie
nts
asa
con
seq
uen
ceo
flim
bsa
lvag
e
surg
ery
(LS
S),
pri
mar
yo
r
seco
nd
ary
amp
uta
tio
n,
and
view
so
fp
atie
nts
follo
win
g
seco
nd
ary
amp
uta
tio
n
SF
-36
Hea
lth
Su
rvey
a)3
4o
ut
of
37
pat
ien
tsfr
eeo
f
dis
ease
and
on
eye
arp
ost
-
pri
mar
yo
rse
con
dar
y
amp
uta
tion
du
eto
ost
eosa
rco
ma
or
Ew
ing’s
sarc
om
a.S
emi-
stru
ctu
red
inte
rvie
ww
asd
on
ein
10
of
11
pat
ien
tsu
nd
ergo
ing
seco
nd
ary
amp
uta
tion
Reg
ard
less
of
surg
ery,
pat
ien
ts’
trea
ted
for
ab
on
etu
mo
ur
rep
ort
po
ore
rQ
oL
than
exp
ecte
d
po
pu
lati
on
no
rms,
exce
pt
in
emoti
on
alfu
nct
ion
ing
and
men
tal
hea
lth
.M
enre
port
ed
bet
ter
ph
ysic
alfu
nct
ion
ing
than
wo
man
.B
ette
rb
od
yim
age
and
ever
yday
com
pet
ence
wer
e
asso
ciat
edw
ith
gre
ater
QoL
.N
o
dif
fere
nce
inQ
oL
in
Am
pu
tati
on
vs.
LS
Sgro
up
,
42
b)
Pat
ien
tsre
cru
ited
fro
mth
e
Ro
yal
ort
ho
pae
dic
sh
osp
ital
,
Bir
min
gh
am,
UK
(con
tinued
)
888 R. Sinha & W. J. A. van den Heuvel
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
ho
wev
erL
SS
rep
ort
edb
ette
r
dai
lyco
mp
eten
cean
dw
ere
less
likel
yto
use
aw
alkin
gai
d.
LS
S
gro
up
rep
ort
bet
ter
ever
yday
com
pet
ence
than
amp
ute
es.
Pat
ien
tsw
ho
acce
pt
resp
on
sib
ilit
yfo
rth
ed
ecis
ion
to
amp
uta
tete
nd
tob
em
ore
sati
sfied
and
bet
ter
adju
sted
c)M
edia
nag
efo
rP
rim
ary
amp
uta
tio
n,
LS
San
d
Sec
on
dar
yam
pu
tati
on
gro
up
s
wer
e3
2,
30
and
32
.5ye
ars
resp
ecti
vely
d)
Tim
esi
nce
amp
uta
tio
n:
No
t
rep
ort
ed
Har
nes
san
dP
inzu
r
(200
1)
[26]
Ob
tain
ing
hea
lth
rela
ted
QO
L
(HR
QO
L)
dat
ain
pat
ien
tsw
ith
no
n-t
rau
mat
ictr
anst
ibia
l
amp
uta
tio
ns,
and
wh
ow
ere
succ
essf
ul
pro
sth
etic
use
rs
Lin
ear
anal
ogu
eP
rost
het
ic
Eva
luat
ion
Qu
esti
on
nai
re(P
EQ
)
a)6
0ad
ult
sse
lect
edw
ith
un
ilat
eral
no
n-t
rau
mat
ictr
anst
ibia
l
amp
uta
tio
n,
bec
ause
of
dia
bet
es
or
per
iph
eral
vasc
ula
rd
isea
se
Pat
ien
ts’
ove
rall
per
cep
tio
no
fth
eir
fun
ctio
n,
mo
bilit
y,p
sych
oso
cial
resp
on
se,
ove
rall
wel
l-b
ein
gan
d
sati
sfac
tion
wer
efa
vou
rab
le.
Pat
ien
ts’
per
cep
tio
no
fth
eir
ove
rall
HR
QO
Lw
asd
iffe
ren
t
from
the
pre
dic
tio
ns
of
exp
erts
,
asp
atie
nts
sco
red
reas
on
ably
wel
lin
ove
rall
wel
l-b
ein
gas
com
par
edto
mo
bilit
y
39
b)
Pat
ien
tsre
cru
ited
fro
mL
oyo
la
Ort
ho
pae
dic
Clin
ic,
the
Ed
war
d
R.
Hin
esV
eter
ans
Ho
spit
al
amp
ute
ecl
inic
,an
dtw
olo
cal
pro
sth
etic
lim
bco
mp
anie
s
bas
edin
US
A
c)M
ean
age:
65
.9+
1.4
;M
edia
n
age:
68
d)
Avg
.ti
me
usi
ng
pro
sth
esis
:
38
.1+
4.7
mo
nth
s
Joh
nso
net
al.
(199
5)
[28]
Stu
dyi
ng
the
Qo
Lo
fam
pu
tees
and
reva
scu
lari
zati
on
and
lim
b
salv
age
(RL
S)
pat
ien
tsfo
r
crit
ical
lim
bis
chem
iaat
6
mo
nth
saf
ter
init
ial
inte
rven
tio
n
Six
sep
arat
eQ
oL
mea
sure
so
fp
ain
(Bu
rfo
rdth
erm
om
eter
,a
visu
al
anal
ogu
esc
ale)
,m
ob
ilit
y
(gra
ded
scal
efr
om
tota
l
imm
ob
ilit
yto
un
lim
ited
amb
ula
tio
n),
the
Ho
spit
al
An
xie
tyan
dD
epre
ssio
nsc
ale,
the
Bar
thel
ind
epen
den
tA
DL
ind
exan
dth
eF
ren
chay
acti
viti
es
ind
exfo
rlife
styl
e
a)4
7o
ut
of
79
pat
ien
tsw
ho
had
eith
era
succ
essf
ul
reva
scu
lari
zati
on
or
am
ajo
r
amp
uta
tio
n,
and
wh
ow
ere
aliv
e,p
arti
cip
ated
RL
Sre
sult
edin
gre
ater
mo
bilit
y
and
bet
ter
per
form
ance
inse
lf-
care
and
life
styl
e,b
ut
pro
du
ced
mo
rean
xie
tyan
dd
epre
ssio
n
than
maj
or
amp
uta
tio
n.
Ove
rall
amp
uta
tio
nw
asm
ore
cost
ly
than
succ
essf
ul
reva
scu
lari
zati
on
and
lim
bsa
lvag
e.P
atie
nts
wh
o
had
maj
or
amp
uta
tio
naf
ter
failed
lim
bsa
lvag
eh
adm
ob
ilit
y
sim
ilar
toam
pu
tees
,an
dse
lf-
care
and
life
styl
esi
milar
tolim
b
salv
age
pat
ien
ts
44
b)
Pat
ien
tsre
cru
ited
fro
mR
oya
l
Hal
lam
shir
eH
osp
ital
,U
K
c)M
edia
nag
e:7
5ye
ars
d)
Tim
esi
nce
amp
uta
tio
n:
6
mo
nth
s
McC
utc
heo
net
al.
(200
5)
[29]
Co
mp
arin
gth
eQ
oL
of
per
son
s
wh
oh
ave
exp
erie
nce
d
amp
uta
tio
ns,
and
per
son
sw
ho
hav
eh
adb
ow
elre
sect
ion
s
RA
ND
36
-Ite
mH
ealt
hS
urv
eya)
28
ou
to
f1
50
Cro
hn
dis
ease
(CD
)an
dre
sect
edp
atie
nts
,an
d
16
ou
to
f1
50
Per
iph
eral
vasc
ula
ram
pu
tati
on
(PV
A)
pat
ien
ts
PV
Asu
bje
cts
had
alo
wer
ove
rall
leve
lo
fQ
oL
inal
ld
om
ain
s,an
d
had
anav
erag
esc
ore
on
lyin
do
mai
ns
of
pai
n,
emo
tio
nal
wel
l-
bei
ng,
soci
alfu
nct
ion
ing,
and
44
(con
tinued
)
QoL in lower limb amputees 889
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
role
lim
itat
ion
cau
sed
by
emoti
on
alh
ealt
h.
So
cial
fun
ctio
nin
g,
emo
tio
nal
wel
l-b
ein
g,
and
role
lim
itat
ion
s
cau
sed
by
emoti
on
alp
rob
lem
s
wer
ear
eas
inw
hic
hP
VA
and
CD
pat
ien
tsex
per
ien
ced
po
st-
op
erat
ive
imp
airm
ent
b)
Pra
ctic
eso
fva
riou
sgen
eral
surg
eon
s,gas
tro
ente
rolo
gis
ts
and
ort
ho
pae
dic
surg
eon
sb
ased
inU
SA
c)M
ean
age:
CD
:4
5.5
year
s
PV
A:
62
.2ye
ars
d)
Tim
esi
nce
amp
uta
tio
n:
No
t
rep
ort
ed
Nag
araj
anet
al.
(200
4)
[30]
Ass
essi
ng
self
-rep
ort
edfu
nct
ion
and
Qo
Lam
on
glo
ng-t
erm
surv
ivo
rso
fch
ild
ho
od
low
er
extr
emit
yb
on
etu
mo
urs
Qo
Lfo
rC
ance
rS
urv
ivo
rs
(QoL
-CS
)
a)5
28
ou
to
f6
29
adu
ltlo
ng
term
surv
ivo
rso
fp
aed
iatr
iclo
wer
extr
emit
yb
on
etu
mo
urs
par
tici
pat
ed
Ove
rall
surv
ivo
rsre
po
rted
exce
llen
tQ
oL
and
fun
ctio
nin
g.
Am
pu
tees
wer
en
ot
mo
relikel
y
toh
ave
low
erfu
nct
ion
and
Qo
L
asco
mp
ared
tolim
bsp
arin
g
pro
ced
ure
.F
emal
esre
po
rted
sign
ifica
ntl
ylo
wer
Qo
L,
bu
tn
ot
mo
red
isab
ilit
y.B
ein
gfe
mal
e,
low
ered
uca
tio
nan
do
lder
curr
ent
age
had
an
egat
ive
infl
uen
ceo
nQ
oL
,fu
nct
ion
and
dis
abilit
y.S
elf-
per
cep
tio
no
f
dis
abilit
yw
asaf
fect
edb
ygen
eral
hea
lth
stat
us,
low
ered
uca
tio
n,
old
erag
ean
db
ein
gfe
mal
e
61
b)
Rec
ruit
men
tso
urc
en
ot
exp
lici
tly
rep
ort
ed
c)M
ean
age:
34
.8ye
ars
d)
Ave
rage
year
sfr
om
dia
gn
osi
sto
qu
esti
on
nai
reco
mp
leti
on
:2
0.8
Pel
let
al.
(199
3)
[31]
Ass
essi
ng
the
ove
rall
effe
cto
f
amp
uta
tio
no
nq
ual
ity
of
life
,
incl
ud
ing
psy
cho
-so
cial
fun
ctio
nin
gas
wel
las
mo
bilit
y,
and
mea
sure
so
fth
eex
ten
tto
wh
ich
ou
tco
mes
are
inte
r-re
late
d
No
ttin
gh
amH
ealt
hP
rofi
le(N
HP
)a)
14
9al
ive
pat
ien
tso
ut
of
64
8
maj
or
low
erlim
bam
pu
tees
Am
pu
tees
had
sign
ifica
ntl
ym
ore
pro
ble
ms
inal
ld
om
ain
so
fQ
oL
such
asm
ob
ilit
y,so
cial
iso
lati
on
,
ener
gy,
pai
n,
slee
pan
d
emoti
on
ald
istu
rban
ceth
an
con
tro
ls;
ho
wev
erm
ob
ilit
yw
as
the
on
lyo
utc
om
efo
rw
hic
hth
e
dif
fere
nce
bet
wee
nth
etw
o
gro
up
sre
mai
ned
sign
ifica
nt
afte
r
step
wis
elo
gis
tic
regre
ssio
n.
Ove
rall
Qo
Lfo
llo
win
g
amp
uta
tio
nfo
rp
erip
her
al
44
b)
Pat
ien
tsre
cru
ited
fro
m
Ed
inb
urg
hR
oya
lIn
firm
ary,
and
age
and
sex
mat
ched
con
tro
l
gro
up
sele
cted
fro
mth
ere
gis
ter
of
agen
eral
pra
ctic
ein
Lo
thia
n,
UK
c)M
edia
nag
e:7
3ye
ars
d)
Med
ian
tim
esi
nce
last
amp
uta
tio
n:
38
mo
nth
s
(con
tinued
)
890 R. Sinha & W. J. A. van den Heuvel
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
arte
rial
dis
ease
was
po
or,
bu
t
mu
cho
fit
isse
con
dar
yto
rest
rict
edm
ob
ilit
y
van
der
Sch
ans
etal
.
(200
2)
[39]
Des
crib
ing
hea
lth
-rel
ated
Qo
Lin
low
erlim
bam
pu
tees
and
inve
stig
atin
gp
ote
nti
al
det
erm
inan
ts,
incl
ud
ing
ph
anto
mp
ain
RA
ND
-36
Du
tch
Lan
gu
age
Ver
sio
n
a)4
37
ou
to
f1
43
6lo
wer
lim
b
amp
ute
es
Am
pu
tees
wit
hp
han
tom
pai
nh
ad
ap
oo
rer
hea
lth
-rel
ated
Qo
L
than
amp
ute
esw
ith
ou
tp
han
tom
pai
n.
Th
em
ost
imp
ort
ant
amp
uta
tio
n-s
pec
ific
det
erm
inan
tso
fh
ealt
h-r
elat
ed
QoL
wer
ew
alkin
gd
ista
nce
and
stu
mp
pai
n
42
b)
Pat
ien
tsre
cru
ited
fro
man
ort
ho
pae
dic
wo
rksh
op
dat
abas
e
inT
he
Net
her
lan
ds
c)M
ean
age:
65+
15
year
s
d)
Tim
esi
nce
amp
uta
tio
n,
med
ian
(min
–m
ax):
10
(1–8
0)
year
s
Ten
nva
llan
d
Ap
elq
vist
(200
0)
[37]
Inve
stig
atin
gh
ealt
h-r
elat
edq
ual
ity
of
life
(HR
QL
)in
dia
bet
es
pat
ien
tsw
ith
foo
tu
lcer
s(F
U),
pri
mar
yh
eale
du
lcer
s(P
HU
),o
r
tho
sew
ith
min
or
(MIA
)o
r
maj
or
amp
uta
tio
ns
(MA
A)
Eu
roQ
oL
(EQ
-5D
)in
clu
din
ga
visu
alan
alo
gu
esc
ale
(VA
S)
a)3
10
ou
to
f4
40
pat
ien
ts
par
tici
pat
ed
MIA
pat
ien
tsh
adb
ette
rH
RQ
L
than
FU
wit
hn
op
revi
ou
s
amp
uta
tio
n.
MA
Ah
adlo
wer
HR
QL
than
PH
Uw
ith
no
amp
uta
tio
nan
dM
IA.
VA
S
valu
ew
asre
du
ced
inM
AA
du
e
tod
iab
etic
com
plica
tio
ns,
and
incr
ease
db
ylivi
ng
wit
ha
hea
lth
y
par
tner
.Q
oL
was
red
uce
daf
ter
MA
A
69
b)
Pat
ien
tsre
cru
ited
fro
mL
un
d
Un
iver
sity
Ho
spit
al,
Sw
eden
c)M
ean
age:
67
year
s
d)
Tim
esi
nce
amp
uta
tio
n:
No
t
rep
ort
ed
Wal
ters
and
William
son
(199
8)
[40]
Inve
stig
atin
gp
red
icto
rso
fse
xu
al
sati
sfac
tio
n,
exp
erie
nce
wit
h
pai
n,
and
per
ceiv
edQ
oL
Par
tici
pan
tsd
escr
ibed
thei
rQ
oL
as
com
par
edto
bef
ore
amp
uta
tio
n
on
afi
ve-p
oin
tsc
ale
a)7
7p
atie
nts
par
tici
pat
ed
(nu
mb
ero
fp
rosp
ecti
ve
par
tici
pan
tsn
ot
rep
ort
ed)
Hig
her
edu
cati
on
or
pro
fess
ion
al
trai
nin
gw
asas
soci
ated
wit
h
hig
her
Qo
L.
Mo
rese
xu
al
sati
sfac
tion
was
rela
ted
toh
igh
er
QoL
.M
ore
amp
uta
tio
nre
late
d
pai
nw
asas
soci
ated
wit
hle
ss
sexu
alsa
tisf
acti
on
and
low
er
QoL
.A
mp
uta
tio
nre
late
dp
ain
ind
epen
den
tly
pre
dic
ted
Qo
L
53
Ass
essi
ng
asso
ciat
ion
sb
etw
een
sexu
alsa
tisf
acti
on
and
seve
ral
mea
sure
so
fp
hys
ical
and
psy
cho
logic
alad
just
men
t,an
d
that
amo
ng
sexu
alsa
tisf
acti
on
,
amp
uta
tio
n-r
elat
edp
ain
and
Qo
L
b)
Pat
ien
tsre
cru
ited
fro
man
ou
t-
pat
ien
tam
pu
tee
clin
ican
d
amp
ute
esu
pp
ort
org
aniz
atio
ns
bas
edin
US
A
c)M
ean
age:
57
year
s
d)
Ave
rage
tim
esi
nce
amp
uta
tio
n:
14
.5ye
ars
Zah
lten
-
Hin
gu
ran
age
etal
.
(200
4)
[42]
Ass
essi
ng
po
ten
tial
dif
fere
nce
in
trea
tmen
to
utc
om
eb
etw
een
amp
uta
tio
nan
dlim
bsa
lvag
e
surg
ery
(LS
S)
by
inve
stig
atin
g
Qo
Lan
dfu
nct
ion
Dis
ease
spec
ific
Qo
L-
Sta
nd
ard
Ger
man
vers
ion
of
EO
RT
C
QL
Q-C
30
Gen
eric
Qo
L-F
LZ
Lif
eS
atis
fact
ion
Qu
esti
on
nai
re
a)1
02
LS
Sp
atie
nts
and
22
amp
ute
es,
ou
to
f1
89
elig
ible
surv
ivo
rso
fa
mal
ign
ant
low
er
extr
emit
ysa
rcom
a
Sim
ilar
Qo
Lin
amp
ute
esan
dL
SS
gro
up
s.A
mp
ute
es’
asso
ciat
ed
QoL
wit
hso
cial
acce
pta
bilit
y,
wh
ile
LS
Sas
soci
ated
itw
ith
hig
her
ph
ysic
alp
erfo
rman
cein
spo
rts
and
recr
eati
on
alac
tivi
ties
36
b)
Pat
ien
tsre
cru
ited
fro
m
Ort
ho
pae
dic
Un
iver
sity
Clin
ic
Hei
del
ber
g,
Ger
man
y
c)M
edia
nag
e:
LS
S:
33
year
s
Am
pu
tees
:3
7ye
ars
d)
Ave
rage
tim
esi
nce
surg
ery:
5
year
s
(con
tinued
)
QoL in lower limb amputees 891
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
B.
Pro
spec
tive
Ch
ette
ret
al.
(199
8)
[20]
An
alyz
ing
the
hea
lth
-rel
ated
Qo
L
chan
ges
asso
ciat
edw
ith
infr
ain
gu
inal
arte
rial
reco
nst
ruct
ion
for
chro
nic
crit
ical
lim
bis
chem
ia,
and
to
asse
ssth
eim
pac
to
fgra
ft
pat
ency
and
lim
bsa
lvag
e
UK
vers
ion
of
SF
-36
hea
lth
surv
ey
qu
esti
on
nai
re,
com
ple
ted
bef
ore
and
at1
,3
,6
and
12
mo
nth
s
follo
win
gsu
rger
y
a)5
5o
ut
of
65
pat
ien
ts
par
tici
pat
ed
Pat
ien
tsw
ith
crit
ical
lim
bis
chem
ia
had
seve
rely
imp
aire
dQ
oL
58
b)
Rec
ruit
men
tce
ntr
en
ot
exp
lici
tly
rep
ort
ed
Rec
on
stru
ctio
nh
adsi
gn
ifica
nt
imp
rove
men
tsin
Ph
ysic
al
Fu
nct
ion
ing,
Pai
n,
Vit
alit
yan
d
So
cial
Fu
nct
ion
ing,
and
wit
ha
pat
ent
gra
ftth
ese
imp
rove
men
ts
beg
anso
on
afte
rsu
rger
yan
d
mai
nta
ined
for
12
mo
nth
s.
Irre
dee
mab
legra
fto
cclu
sio
n
pat
ien
tsw
ho
had
seco
nd
ary
amp
uta
tio
nre
po
rted
mo
der
ate
QoL
imp
rove
men
ts
c)M
edia
nag
e:7
1ye
ars
d)
Tim
esi
nce
surg
ery:
No
t
rep
ort
ed
Hag
ber
get
al.
(200
8)
[25]
An
alyz
ing
gen
eral
and
con
dit
ion
-
spec
ific
hea
lth
rela
ted
qu
alit
yo
f
life
(HR
QL
)at
2-y
ear
follo
w-u
p
asco
mp
ared
toth
ep
re-o
per
ativ
e
situ
atio
n
SF
-36
adm
inis
tere
dp
re-
op
erat
ivel
yan
dat
follo
w-u
p,an
d
Q-T
FA
(Qu
esti
on
nai
refo
r
per
son
sw
ith
aT
ran
sfem
ora
l
Am
pu
tati
on
),a
con
dit
ion
-
spec
ific
ou
tco
me
mea
sure
that
refl
ects
curr
ent
pro
sth
etic
use
,
mo
bilit
y,p
rob
lem
san
dglo
bal
hea
lth
a)1
7o
ut
of1
8co
nse
cuti
vep
atie
nts
par
tici
pat
ed,
and
wh
ow
ere
trea
ted
wit
hei
ther
asu
rger
y
invo
lvin
gti
tan
ium
imp
lan
t
inse
rted
inth
ere
sid
ual
bo
ne
and
left
un
load
edfo
rab
ou
tsi
x
mo
nth
so
ra
surg
ery
invo
lvin
g
tita
niu
mro
din
sert
edin
toth
e
dis
talen
do
fth
efi
xtu
rean
dth
en
pen
etra
tin
gth
esk
in
Gen
eral
ph
ysic
alH
RQ
L(P
hys
ical
Fu
nct
ion
ing,
Ro
leP
hys
ical
,
Bo
dily
Pai
n),
PC
S(P
hys
ical
Co
mp
on
ent
Su
mm
ary)
sco
re
and
Q-T
FA
(Pro
sth
etic
Use
,
Pro
sth
etic
Mo
bilit
y,P
rob
lem
s
and
Glo
bal
Hea
lth
)si
gn
ifica
ntl
y
imp
rove
dat
2-y
ear
follo
w-u
p
72
b)
Pat
ien
tsre
cru
ited
fro
m
Un
iver
sity
ho
spit
alin
Sw
eden
c)M
ean
age:
45
year
s
d)
Ave
rage
tim
esi
nce
amp
uta
tio
n:
15
year
s
Sp
ince
mai
lle
etal
.
(200
0)
[34]
Ass
essm
ent
of
pai
nan
dq
ual
ity
of
life
of
pat
ien
tsw
ith
crit
ical
lim
b
isch
emia
atfo
llo
w-u
p
NH
P,
Eu
roQ
oL
and
mo
bilit
y
sub
sco
reo
fS
ickn
ess
Imp
act
Pro
file
(SIP
)ad
min
iste
red
at
inta
ke,
and
at1
,3
,6
,1
2an
d1
8
mo
nth
s
a)1
20
ou
to
f1
41
pat
ien
ts
par
tici
pat
ed,
ou
to
fw
hic
h6
0
had
stan
dar
dtr
eatm
ent
(ST
)
and
60
had
stan
dar
dtr
eatm
ent
com
bin
edw
ith
spin
alco
rd
stim
ula
tio
n(S
CS
)
Ove
rall
Qo
Lim
pro
ved
sign
ifica
ntl
yin
bo
thth
egro
up
s,
bu
tw
ith
no
dif
fere
nce
bet
wee
n
gro
up
s.A
mp
uta
tio
nh
ada
neg
ativ
eef
fect
on
mo
bilit
y,
resu
ltin
gin
dif
ficu
lt
reh
abilit
atio
nb
ut
reliev
edp
ain
sub
stan
tial
ly
50
b)
Pat
ien
tsre
cru
ited
fro
m1
7
ho
spit
als
inT
he
Net
her
lan
ds
c)M
ean
age:
ST
:7
2+
10
.6
SC
S:
73+
9.8
d)
Tim
esi
nce
surg
ery:
No
t
rep
ort
ed
(con
tinued
)
892 R. Sinha & W. J. A. van den Heuvel
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
Tan
gel
der
etal
.
(199
9)
[35]
Co
mp
arin
gQ
oL
inp
atie
nts
,w
ith
and
wit
ho
ut
vari
ou
sis
chem
ic
com
plica
tio
ns
afte
rin
frai
ngu
inal
byp
ass
gra
ftin
gsu
rger
yfo
r
occ
lusi
veva
scu
lar
dis
ease
Eu
roQ
oL
and
SF
-36
was
adm
inis
tere
dev
ery
hal
fye
ar
fro
mN
ove
mb
er1
99
5u
nti
lA
pri
l
19
98
a)6
82
of
74
6p
atie
nts
(pat
ent
gra
ft¼
40
9,
asym
pto
mat
ic
occ
lusi
on¼
32
,sy
mp
tom
atic
occ
lusi
on¼
65
,
reva
scu
lari
zati
on¼
19
4,p
rim
ary
amp
uta
tion¼
36
and
seco
nd
ary
amp
uta
tion¼
38
)p
arti
cip
ated
and
com
ple
ted
the
qu
esti
on
nai
re
Am
pu
tati
on
det
erio
rate
dp
hys
ical
fun
ctio
nin
gan
dm
ore
soaf
ter
failed
seco
nd
ary
reva
scu
lari
zati
on
.S
oci
al
fun
ctio
nin
g,
ph
ysic
alan
d
emoti
on
alro
le,
and
men
tal
hea
lth
wer
ep
oo
rer
than
all
oth
er
gro
up
s.Q
oL
det
erio
rate
daf
ter
all
even
ts,
exce
pt
for
asym
pto
mat
ico
cclu
sio
ns.
Qo
L
was
con
stan
to
ver
tim
ein
all
the
gro
up
sin
the
ob
serv
edp
erio
d
42
b)
Su
bje
cts
recr
uit
edfr
om
Du
tch
BO
A(B
ypas
s,O
ral
An
tico
agu
lan
tan
dA
spir
in)
mu
lti-
cen
tre
stu
dy
c)M
ean
age
of
74
6p
atie
nts
:7
0
year
s
d)
Tim
esi
nce
surg
ery:
No
t
rep
ort
ed
C.
Ret
rosp
ecti
ve
Hag
ber
gan
d
Bra
nem
ark
(200
1)
[24]
Des
crib
ing
HR
QL
(Hea
lth
-rel
ated
qu
alit
y-o
f-life
),p
rost
het
icu
se
and
pro
ble
ms
inin
div
idu
als
wit
h
un
ilat
eral
tran
s-fe
mo
ral
amp
uta
tio
nfr
om
no
n-p
erip
her
al
vasc
ula
rd
isea
se
Sw
edis
hS
F-3
6H
ealt
hS
urv
eya)
97
ou
to
f1
40
no
n-v
ascu
lar
tran
s-fe
mo
ral
amp
ute
es
Gen
eral
HR
QL
was
sign
ifica
ntl
y
low
erth
anS
wed
ish
age-
and
gen
der
-mat
ched
no
rms
inal
l
eigh
td
imen
sio
ns,
and
ther
ew
ere
con
sid
erab
lep
rob
lem
sw
ith
amp
uta
tio
nan
dp
rost
hes
is.
Pro
ble
ms
that
led
tore
du
ctio
n
inQ
oL
wer
eh
eat/
swea
tin
gin
pro
sth
etic
sock
et,
sore
s/sk
in
irri
tati
on
fro
mso
cket
,in
abilit
y
tow
alk
inw
oo
ds
and
fiel
ds
and
inab
ilit
yto
wal
kq
uic
kly
.A
lmo
st
hal
fam
pu
tees
wer
etr
ou
ble
db
y
stu
mp
pai
n,
ph
anto
mlim
bp
ain
,
bac
kp
ain
and
pai
nin
the
oth
er
leg
42
b)
Pat
ien
tsre
cru
ited
fro
mtw
o
Sw
edis
has
soci
atio
ns
for
amp
ute
esan
dsi
xo
rth
op
aed
ic
wo
rksh
op
san
d/o
rw
alkin
g
sch
oo
lu
nit
s
c)M
ean
age:
48
year
s
d)
Ave
rage
tim
esi
nce
amp
uta
tio
n:
22
year
s
Po
stm
aet
al.
(199
2)
[32]
Co
mp
arin
glo
ng-
term
QO
Lin
lim
bsa
lvag
e(L
S)
vs.
amp
ute
es
(AM
P)
inlo
wer
lim
bb
on
e
tum
ou
rp
atie
nts
Ho
pkin
sS
ymp
tom
Ch
ecklist
(HS
CL
)
a)1
4L
San
d1
9A
MP
ou
to
f3
6
pat
ien
ts
Alt
ho
ugh
Qo
Lw
assi
milar
inb
oth
the
gro
up
s,b
oth
the
gro
up
sfe
lt
dim
inu
tio
no
fQ
oL
asw
ell
asa
sen
seo
fd
isab
ilit
y.N
osi
gn
ifica
nt
dif
fere
nce
bet
wee
nb
oth
the
gro
up
sin
psy
cho
logic
alan
d
ph
ysic
ald
istr
ess,
acti
viti
eso
f
dai
lylivi
ng
and
self
-est
eem
,n
or
wer
eth
eyd
iffe
ren
tfr
om
no
rmal
42
Gro
nin
gen
Act
ivit
yR
estr
icti
on
Sca
le(G
AR
S)
b)
Rec
ruit
men
tso
urc
en
ot
exp
lici
tly
rep
ort
ed
Ro
sen
ber
gse
lfes
teem
scal
e(s
hort
vers
ion
)
c)M
edia
nag
e:
LS
:2
4ye
ars
AM
P:
27
year
s
d)
Med
ian
tim
esi
nce
amp
uta
tio
n:
10
year
s
(con
tinued
)
QoL in lower limb amputees 893
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
Sem
i-st
ruct
ure
din
terv
iew
com
pri
sin
ged
uca
tio
nal
and
voca
tio
nal
imp
act
of
trea
tmen
t,
mar
ital
stat
us,
po
ssib
ilit
yto
mo
vein
dep
end
entl
y,so
me
asp
ects
of
cost
so
flivi
ng,
and
par
tici
pat
ion
inso
cial
life
.
Su
bje
cts
wer
eas
ked
toco
mm
ent
on
psy
cho
logic
alim
pac
tof
trea
tmen
t
Vis
ual
anal
ogu
esc
ale
(VA
S)
to
asse
sssa
tisf
acti
on
on
qu
alit
yo
f
life
and
ind
ivid
ual
per
cep
tio
no
f
bei
ng
dis
able
d
Ro
ugra
ffet
al.
(199
4)
[33]
Stu
dyi
ng
the
ou
tco
me
of
trea
tmen
t
of
no
n-m
etas
tati
ch
igh
-gra
de
ost
eosa
rco
ma
inth
ed
ista
lp
art
of
fem
ur
Bri
efsy
mp
tom
inve
nto
ryfo
ra
psy
cho
pat
ho
logic
alev
alu
atio
n,
the
psy
cho
soci
alad
just
men
tto
illn
ess
scal
e,th
eM
elza
ckp
ain
qu
esti
on
nai
re,
dem
ogra
ph
ics,
fert
ilit
yan
dse
xu
alfu
nct
ion
.
Su
bje
ctiv
era
tin
go
fp
hys
ical
fun
ctio
n;
chan
ge
of
sati
sfac
tio
n
wit
hlife
ran
ked
fro
m7
10
to
þ1
0an
dth
ato
fap
pre
ciat
ion
of
life
,fr
om
0toþ
10
a)2
9o
f1
09
pat
ien
tsco
mp
lete
dth
e
psy
cho
soci
al(Q
oL
)
qu
esti
on
nai
re
Fu
nct
ion
was
bet
ter
inL
SS
than
AM
P,h
ow
ever
itd
idn
ot
pro
vid
e
am
easu
rab
leb
enefi
tin
Qo
L.N
o
dif
fere
nce
bet
wee
ngro
up
sw
ith
regar
dto
pat
ien
t’s
acce
pta
nce
of
the
po
sto
per
ativ
est
ate,
abilit
yto
wal
k,
or
the
amo
un
to
fp
ain
.N
o
dif
fere
nce
inp
sych
oso
cial
ou
tco
mes
bet
wee
nth
egro
up
s.
Sco
res
on
bri
efsy
mpto
m
inve
nto
ryan
dpsy
choso
cial
adju
stm
ent
toilln
ess
scal
ew
ere
gen
eral
lyw
ithin
the
norm
sof
the
gen
eral
pop
ula
tion
.N
od
iffe
ren
ce
inlife
appre
ciat
ion
bef
ore
and
afte
rca
nce
r.N
osi
gn
ifica
nt
diffe
ren
ces
bet
wee
nth
eth
ree
gro
ups
bas
edon
QoL
dat
a
53
b)
Pat
ien
tsfr
om
mu
lti-
inst
itu
tio
nal
Mu
scu
losk
elet
alT
um
ou
r
So
ciet
yst
ud
yco
nd
uct
edin
US
A
c)M
ean
age
atd
iagn
osi
s:1
6ye
ars
d)
Ave
rage
du
rati
on
of
follo
w-u
p:
11
year
s
Tek
inet
al.
(200
9)
[36]
Co
mp
arin
gfu
nct
ion
alit
yin
dai
ly
acti
viti
esan
dq
ual
ity
of
life
in
tran
stib
ial
amp
ute
esan
d.l
imb
salv
age
surg
ery
pat
ien
tsaf
ter
seve
relo
wer
lim
btr
aum
a
SF
-36
(Tu
rkis
hva
lid
ated
vers
ion
)a)
10
and
9yo
un
gm
ale
sold
iers
wit
hu
nilat
eral
bel
ow
kn
ee
amp
uta
tio
nan
dw
ith
salv
age
surg
ery
resp
ecti
vely
Ove
rall
Qo
L(g
ener
alh
ealt
han
d
vita
lity
bei
ng
sign
ifica
ntl
y
bet
ter)
,re
op
erat
ion
rate
san
d
pai
nw
asb
ette
rin
amp
ute
esth
an
lim
bsp
arin
gsu
rger
y
53
b)
Tu
rkis
hA
rmed
Fo
rces
Reh
abilit
atio
nC
entr
e
c)M
ean
age:
Am
pu
tees
-
27
.70+
5.3
1an
dsa
lvag
e
pat
ien
ts-
28
.44+
4.2
1
(con
tinued
)
894 R. Sinha & W. J. A. van den Heuvel
Dis
abil
Reh
abil
Dow
nloa
ded
from
info
rmah
ealth
care
.com
by
Ath
lone
Ins
titut
e of
Tec
hnol
ogy
on 0
8/31
/13
For
pers
onal
use
onl
y.
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
d)
Ave
rage
du
rati
on
of
inju
ry:
Am
pu
tees
-50
.30+
54
.18
and
salv
age-
66
.11+
49
.58
Th
om
pso
net
al.
(199
5)
[38]
Ass
essi
ng
QoL
afte
rfe
moro
dis
tal
byp
ass
(FB
),an
dco
mp
arin
git
wit
hQ
oL
follo
win
gp
rim
ary
low
erlim
bam
pu
tati
on
(LL
A)
Ho
spit
alan
xie
tyan
dd
epre
ssio
n
scal
e
So
cial
fun
ctio
nin
g:
imp
airm
ent
of
wo
rk,
fam
ily
rela
tio
nsh
ips,
soci
al
acti
viti
es,
leis
ure
acti
viti
esan
d
ho
me
man
agem
ent
Pat
ien
tm
ob
ilit
yan
du
seo
fw
alkin
g
aid
fro
mu
nre
stri
cted
wal
kin
gto
ind
epen
den
tw
alkin
g
a)8
2o
ut
of
11
2p
atie
nts
par
tici
pat
ed,
31
pat
ien
ts
pri
mar
yp
aten
tgra
ft;
17
seco
nd
ary
pat
ent
gra
ft;
7
seco
nd
ary
amp
uta
tio
nan
d1
7
pri
mar
yam
pu
tati
on
Qo
Laf
ter
succ
essf
ul
FB
ish
igh
er
than
afte
rp
rim
ary
or
seco
nd
ary
LL
A.
Pat
ien
tsw
ith
pat
ent
gra
fts
had
low
erim
pai
rmen
to
fQ
oL
than
pat
ien
tsu
nd
ergo
ing
pri
mar
yo
rse
con
dar
y
amp
uta
tio
n.
Ase
con
dar
y
pro
ced
ure
tom
ain
tain
gra
ft
pat
ency
did
no
tad
vers
ely
affe
ct
QoL
.A
dd
itio
nal
ly,
pat
ien
ts
un
der
go
ing
seco
nd
ary
amp
uta
tio
naf
ter
gra
ftfa
ilu
re
had
anid
enti
cal
Qo
Lto
tho
se
un
der
go
ing
pri
mar
yam
pu
tati
on
25
b)
Pat
ien
tsre
cru
ited
fro
m
Lei
cest
erR
oya
lIn
firm
ato
ry,
UK
c)M
edia
nag
e:6
9ye
ars
d)
Med
ian
tim
esi
nce
amp
uta
tio
n
and
reco
nst
ruct
ion
wer
e1
6an
d
18
mo
nth
s
Wei
sset
al.
(19
90
)
[41]
Iden
tify
ing
fact
ors
that
pre
dic
t
ou
tco
mes
,in
clu
din
g
po
sto
per
ativ
eco
mp
lica
tio
ns,
stu
mp
revi
sio
n,
mo
rtal
ity,
and
po
or
Qo
L
Aq
ues
tio
nas
kin
gth
ep
atie
nt
to
rate
his
/her
hea
lth
asex
cellen
t,
go
od
,fa
ir,o
rp
oo
ran
dth
eA
ffec
t
Bal
ance
Sca
le(a
sses
ses
the
deg
ree
tow
hic
hp
osi
tive
feel
ings
abo
ut
life
ou
twei
gh
neg
ativ
e
feel
ings.
An
oth
erq
ues
tio
nra
ted
Qo
Lo
na
visu
alan
alo
gu
esc
ale
a)9
7p
atie
nts
wh
ou
nd
erw
ent
eith
erlo
wer
extr
emit
y
amp
uta
tio
n,
revi
sio
n,
seco
nd
ary
closu
re,
or
deb
rid
emen
t
Am
pu
tees
’Q
oL
was
fair
lyp
oo
r
com
par
edw
ith
old
erp
erso
ns.
29%
rep
ort
edb
ette
rh
ealt
hat
follo
w-u
pth
anb
efore
amp
uta
tio
n,
pri
mar
ily
bec
ause
of
less
pai
n,
on
e-q
uar
ter
rep
ort
edw
ors
eh
ealt
h,
and
maj
ori
tyra
ted
thei
rh
ealt
hei
ther
fair
or
po
or.
Ab
ilit
yto
per
form
acti
viti
eso
fd
aily
livi
ng
(AD
L)
was
the
mo
stim
po
rtan
t
pre
dic
tor
for
self
-per
ceiv
ed
hea
lth
,w
ell-
bei
ng
(Aff
ect
Bal
ance
),an
dQ
oL
.P
oo
rh
ealt
h
stat
us
was
bes
tp
red
icte
db
y
dep
end
ency
inA
DL
,h
igh
leve
l
of
amp
uta
tio
nan
do
lder
age.
Neg
ativ
efe
elin
gs
wer
e
pre
do
min
atel
yaf
fect
edb
y
dep
end
ency
inA
DL
and
dia
bet
es
42
b)
Pat
ien
tsre
cru
ited
fro
mJo
hn
L.
McC
lellan
Mem
ori
alV
eter
ans
Ho
spit
al,
Ark
ansa
s,U
SA
c)M
edia
nag
e:6
4ye
ars
d)
Ave
rage
tim
esi
nce
surg
ery:
15
mo
nth
s
(con
tinued
)
QoL in lower limb amputees 895
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QoL findings
Amputees’ QoL was found to be mostly poor
compared to the general population or controls
[23,24,27,30,31,41]. Women reported worse QoL
than men [22,23,26]. Age was an important predictor
of QoL [17,22,30], and so was education [30,40].
QoL was adversely affected by phantom and stump
pain [39,40], and depression [17,18]. Limitation in
physical functioning affected QoL to a great extent
[21,22,31,35,39], and it affected vascular amputees
more negatively [22]. ADL [41] and sexual satisfaction
[40] were found to be important factors affecting QoL.
Low social acceptance and low social functioning also
affected QoL adversely [35,40].
Discussions
Study identification
The search strategy adopted for the systematic search
was exhaustive, since several keywords associated
with ‘amputees’ and ‘QoL’ available in different
databases were used. Back-referencing of the in-
cluded articles led to inclusion of only one extra
article, which indicates comprehensiveness of search
strategy. A limitation of this systematic search is that
only articles published in English language were
considered for inclusion. The number of non-
English articles during the initial search was 151
(8.33%) out of 1812 references. Generally, metho-
dologically sound studies tend to get published in
English language, and thereby perhaps lowering the
possibility of high quality studies getting excluded
because of the possible language bias.
During the screening process, it was noticed that
QoL as a term was loosely used in many studies in
the articles, and it also appeared as a keyword in
several citations, even though the study did not
involve assessment of QoL. We included studies in
which QoL was the outcome variable, so it might be
possible that studies which have used QoL instru-
ment, but to study outcomes other than QoL would
have got excluded from this review.
Study design
The systematic review revealed a lack of longitudinal
prospective studies, and therefore, evidence-base
about the change in QoL of amputees over time as
a result of the immediate changed life situation and
adjustments following amputation is inadequate.
The few prospective studies found mainly assessed
the outcomes of intervention in critical limb ischemic
patients [20,34,35].
Tab
leII
.(C
onti
nued
).
Stu
dy
Aim
of
stu
dy
Qo
Las
sess
men
tS
tud
yp
op
ula
tio
nd
escr
ipti
on
Stu
dy
ou
tco
mes
QS
D.
Mix
edD
esig
n
Ho
ogen
do
orn
and
Wer
ken
(20
01
)
[27]
Ass
essi
ng
the
lon
g-t
erm
fun
ctio
nal
ou
tco
me
and
QoL
of
pat
ien
ts
wh
ow
ere
trea
ted
for
Gra
de
3
op
enti
bia
lfr
actu
re
No
ttin
gh
amH
ealt
hP
rofi
le(N
HP
),
SF
-36
and
on
eq
ues
tio
nn
aire
des
ign
edfo
rth
est
ud
y,w
hic
h
con
sist
edo
fq
ues
tio
ns
rela
ted
to
pai
n,
dai
lyfu
nct
ion
ing,
psy
cho
logic
alfa
cto
rsan
d
han
dic
apw
ith
wo
rkin
g
a)6
4o
ut
of
72
pat
ien
tsco
mp
risi
ng
of
43
succ
essf
ul
lim
bsa
lvag
e
(LS
)p
atie
nts
and
21
amp
ute
es
LS
and
amp
ute
esh
ada
wo
rse
Qo
L
inm
ost
cate
go
ries
than
ah
ealt
hy
refe
ren
cegro
up
.6
5%
pat
ien
ts
rep
ort
edp
rob
lem
sw
ith
wal
kin
g,
du
eto
fati
gu
e,p
ain
and
sho
rtn
ess
of
bre
ath
.4
8%
pat
ien
tsfe
eld
isab
led
,as
they
wer
en
ot
able
tod
oev
eryt
hin
gas
bef
ore
acci
den
t.45
%re
port
ed
pro
ble
ms
wit
hw
ork
ing
47
b)
Pat
ien
tsre
cru
ited
fro
mU
trec
ht
Un
iver
sity
Med
ical
cen
tre,
Th
e
Net
her
lan
ds
c)M
ean
age:
LS
:3
9.9+
16
.2
Am
pu
tees
:3
9.4
+1
5.9
d)
Tim
esi
nce
surg
ery:
no
t
rep
ort
ed
896 R. Sinha & W. J. A. van den Heuvel
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Representativeness of study population might be
an issue for most of the studies, as the characteristics
of the source population from which the study
population was derived, were not presented. So,
the chance of selection bias cannot be totally
disregarded. Especially, for studies in which the
patients have been recruited from orthopaedic work-
shops and rehabilitation centres [18,21,22,24,
39,40], a selective group of amputees who were
interested in rehabilitation, and who would be using
prosthesis might have participated. Studies recruiting
patients from primary sources, like hospitals and
clinics would have better external validity and enable
the generalisation of the results. Sample size and
power calculations have been performed only in one
study [34]. Therefore, results of other studies need
to be interpreted with care.
Background information and QoL
Although the studies provided information about the
age and gender characteristics of the study popula-
tion, QoL variation across different age groups and
gender has mostly not been reported. Because of
relatively lower representation of females in the study
population, their QoL comparison with males has to
be judged with care.
Most of the studies lacked information about
background variables, like education, employment,
economic, civil status and co-morbidity, which limit
the QoL analysis in a holistic manner, as these factors
also play an important role in determining QoL. The
effect of these variables as well as amputation and
limb-related variables should be studied. Other data,
for example, number of failed reconstructions,
number of amputations and duration between these,
duration of hospitalisation, number of visits to
hospitals/clinics or utilisation of paramedical care,
etc. and the effect of these factors on QoL should be
studied.
The number of QoL studies was relatively low for
amputees who were victims of accidents or war.
Disease was found to be the most frequent reason for
amputation except two studies [22,36].
Methodological quality
Seven studies had response rate equal to or more
than 80%. Characteristics of non-respondents have
been reported in only four studies. Since many
background variables were not included in the
studies and the confounding variables have only
been considered partially in some studies; there-
fore, the study results need to be interpreted with
care.
QoL measures
A general health-related QoL and/or combination of
questionnaires have generally been used to measure
QoL. The variation in QoL instruments in the
studies is large, which hinders a systematic compar-
ison of outcomes. Although a generic QoL instru-
ment comprises of several multi-dimensional facets,
it still might not be able to capture specific issues
relevant to amputees. Asano et al. [17] and Johnson
et al. [28] used a combination of different instru-
ments to study QoL.
Environmental factors, like family condition,
family support, life situation before amputation,
etc. determine outcomes after amputation, but the
influence of these factors on QoL has been assessed
only by a few studies. It is envisaged that QoL of
amputees should be studied using the ICF frame-
work [8] and including all the pertinent facets, such
as amputation-related, personal and environmental
factors, which might affect QoL directly or indirectly.
To conclude, very few methodologically sound
studies were found in this systematic review, which
limits the generalisation of the findings. Prospective
longitudinal studies are envisaged to systematically
study the events following amputation, and the change
in QoL over time. To enable this, amputee specific
standardised and validated QoL instruments are
needed to capture the multitude of facets influencing
QoL in amputees, and which would make assessment
of QoL easier, comprehensive and useful in clinical
practise, and enable effective decision making. Ad-
ditionally, qualitative studies are encouraged to garner
insights to complement the quantitative findings.
Declaration of interest: The authors report no
conflicts of interest. The authors alone are respon-
sible for the content and writing of the paper.
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Appendix
Table A1. Quality criteria list.
Criteria Scores
Source population
A Description of source population Not available (0), Ambiguous (1), Available (2)
B Description of inclusion and/or exclusion criteria
Study population characteristics
C Age Not available (0), Partially available (1), Available (2)
D Gender
E Education
F Employment status
G Marital status
H Comorbidity
I Economic status
J Data presentation of relevant outcome measures
Methodological characteristics
K Representative population Not clear (0), Partially (1), Yes (2)
L Study design/study type Not clear (0), Cross sectional design (1), Retrospective/Mixed design (2),
Prospective design (3)
M Population selection Non randomized (0), Randomized / NA (1)
N Instruments used Non-validated (0), Partially validated (1), Validated (2)
O Statistical methods for measures Non-appropriate (0), Partially appropriate (1), Appropriate (2)
P Control for confounding variables Not considered (0), Partially considered (1), Fully considered (2)
Q Response rate vs. drop out 560% / Not mentioned (0), 60% - 80% (1), 4 80% (2)
R Characteristics of drop-outs Not reported (0), Reported (1)
S Relevant outcome measures Not well-defined (0), Well-defined (1)
QoL in lower limb amputees 899
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