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19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
391
6
The proportion of
asymptomatic
(Rutherford class 0)
patients increased from
0% at baseline to 51% at
24months while being
primary patency and
target vessel
revascularization
satisfactorily extend over
24months in patients
EQ-5D PCBs benets on
24months
Yes 12,
58% at the 12-month
follow-up assessment.
EQ-5D: At 12months,
there was signicant
improvement from
undergoing percutaneous
transluminal angioplasty
for symptomatic
femoropopliteal disease.
of 70.4%, with major
adverse events rate of
Not stated Primary patency rate
89%
baseline as well as in
10%.
7
7
(continued)
walking impairment at
12months (p=0.01).
This was sustained until
24-month follow-up.
Improvement compared
with baseline in all
outcome metrics
(Rutherford category,
ankle-brachial index
(ABI), WIQ, EQ-5D)
All Rutherford Cat 4
outcome 99% at
30days.
Yes 12months EQ-5D, WIQ Primary safety
patients—>Cat 3
patency estimated
91%.
2.9%.
Consistent with other
EQ-5D 92% Low rate of CD=TLR
WIQ-walking
IN.PACT DCB trials.
impairment
92%
Improvement trend, but
WIQ-distance,
speed, stair
climbing 60%
EQ-5D At 1year, the survival
Yes 12 and
not signicant.
(VAS) score increased
from 65.8±14.1 at
rate was 96±2.7% and
freedom from TLR and
TER were 90.2±4.2%
and 85±5%,
respectively. Sustained
18months
baseline to 76.2±16.3 at
12months (p=0.10) and
72.3±17.7 at 18months
(p=0.14).
18months, 77% and 67%
of the patients were
asymptomatic
primary and secondary
clinical improvements
were 78.6±5.7% and
92.0±3.8%,
respectively. At 1year,
the primary patency
rate was 83.7±5.0%.
(Rutherford 0),
respectively.
Rutherford class 2–4
disease due to
femoropopliteal lesions
>15cm long.
105 Consecutive patients with
To appraise 2-year
outcomes after
percutaneous
transluminal
angioplasty of long
femoropopliteal
(2017) [12]
DCB Micari et al.
Mean age 68±9years;
81.9% men
Italy
artery disease using
paclitaxel-coated
IN.PACT Admiral
balloons (PCBs)
[SFA-Long study]
2012–2014 Six centres in
Paclitaxel-eluting
balloon
Rutherford 2/3/4 and
5=28%/62%/10%
143 Mean age 66.8±7.7years;
To conrm the
study
In.Pact Admiral Prospective
DCB Chen et al.
75% men
safety and
effectiveness of the
IN.PACT Admiral
drug-coated balloon
(2019) [37]
Rutherford category 2, 3,
(DCB) as a
treatment for de
novo and native
artery restenotic
lesions in the
supercial femoral
2014–2015 15 centres HTN (73%), DM (46%) Not stated High 1-year primary
Paclitaxel-eluting
balloon
In.Pact Admiral Prospective
4=48%, 39%, 13%
artery (SFA) and/or
proximal popliteal
artery in Chinese
subjects.
study
(13%) CLI
Mean age 69 (SD 12) Not stated The visual analog scale
53 (55 limbs) 48 (87%) claudication, 7
France
To assess 18-month
outcomes of the
paclitaxel eluting
balloon (PEB) in
patients with
femoropopliteal
(FP) in-stent
restenosis (ISR).
(2017) [38]
2012–2013 Ten centres in
DCB Bague et al.
Paclitaxel-eluting
balloon
Male 79% 94% At 12months and
HTN 81%, DM (30%)
Ten violated protocol.
Three died.
cohort study
In.Pact Admiral Prospective
392
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8
Quality
score
WIQ change from
baseline: DCB
29.2±28.9 (n=71);
PTA 21.6±29.5
Main ndings related to
HRQOL
(n=33)
patency rate was 80%
vs. 58% (p=0.015)
and the composite
safety endpoint rate
was 94% vs. 72%
baseline: DCB
0.11±0.21 (n=70);
PTA 0.14±0.18
(n=34)
(p=0.001),
respectively. Freedom
from TLR was higher
for DCBs (96%) vs.
PTA (82%,
p=0.012). Major
improved at 12months
adverse events were
similar for both
groups. The benet
favouring DCB over
for 91.2% of DCB
patients compared to
78.8% in the PTA group
(p=0.08). Sustained
clinical benet was
observed for 85.3% of
PTA was observed in
German men and
women.
DCB-treated patients
compared with 58.6%
for PTA (p<0.001).
J. K. Tun et al.
HRQOL
instrument(s)
used, Method
ofdelivery,
Completion
rate Key outcomes
Follow-up
period
Yes 12months EQ-5D, WIQ 12-month primary
Preop
HRQOL
assessment
DCB (n=83), PTA
126 Randomised into Lutonix
Cohort size, Study
centre(s) Patient characteristics
To report a
subanalysis of the
Study intent/
associated study
Not stated EQ-5D change from
(n=43)
Demographic, clinical, and
lesion characteristics were
Germany
German centres
enrolling patients in
the prospective,
global, multicentre,
randomized
LEVANT 2 pivotal
WIQ 83% Rutherford category was
matched between Lutonix
DCB and PTA groups, as
were the nal percent
diameter stenosis (19%)
and procedure success
(91%).
Mean age 67.1±9.6years;
63% men
trial (n=476)
(ClinicalTrials.gov
identier
NCT01412541) of
the Lutonix
drug-coated balloon
(DCB) for the
treatment of
EQ-5D 83%
Severe calcication was
present in 11% of lesions,
and 23% were total
occlusions.
SFA 92%, Popliteal 8%
Rutherford 2/3/4=32%,
65%, 3%
femoropopliteal
occlusive disease.
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
(2016) [39]
Study period,
Study type
DCB Scheinert et al.
Device type, Brand
name (if applicable)
2011–2012 Eight centres in
Paclitaxel-coated
balloon
control trial
Lutonix Randomised
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
9
(continued)
SF-36 change from
baseline: Physical
component DCB
6.0±11.4, PTA
5.4±10.2; no
signicant change in
Mental component
EQ-5D change from
baseline: No signicant
change in both groups
WIQ change from
baseline: Improved
signicantly in both
groups across all
domains. Walking
distance showed
signicant intergroup
difference of 9.3±36.5
(95% CI: 1.6–17.0).
Rutherford: −1.9±1.1
(DCB), −1.7±1.1
(PTA)
DCB higher primary
patency rate at
12months (65.2% vs.
52.6%, p=0.02).
safety events was
83.9% DCB, 79.0%
PTA (p=0.005 for
noninferiority).
signicant
between-group
differences in
functional outcomes
or in the rates of
death, amputation,
thrombosis, or
reintervention.
393
WIQ
Yes 12months SF-36, EQ-5D,
(n=316): PTA only
(n=160)
476 Randomised into 2:1 DCB
To assess efcacy
and safety of
Paclitaxel-coated
balloon for the
Not stated Free from primary
Rutherford
treatment of
symptomatic
femoropopliteal
peripheral artery
2/3/4=31%/61%/8%
(Europe, USA)
disease (cf. PTA
100% There were no
Both groups well-matched
at baseline. 42.9% of the
only).
patients had diabetes, and
34.7% were current
smokers.
Mean age 68.2±9.7, Male
63%
al. (2015) [40]
DCB Roseneld et
2011–2012 54 centres
Paclitaxel-coated
balloon
control trial
Lutonix Randomised
394
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7
Quality
score
12months: EQ-5D
change from baseline:
No signicant difference
between treatment
groups but trended in
Main ndings related to
HRQOL
signicantly higher
favour of DCB.
primary patency and
lower reintervention
rates. DCB had a
lower overall
mortality rate.
WIQ: Both groups
showed improvement in
Walking distance from
baseline.
improved from baseline
procedure related
deaths and no major
amputations in either
group during
follow-up period. No
in all assessments.
in favour of DCB group
WIQ: favoured DCB
new vessel
thrombosis reported.
across all domains,
notably walking
distance and stair
climbing
Patients treated with
DCB achieved these
similar levels of
quality-of-life
improvement despite
58% fewer
reinterventions than
with PTA.
With the exception of
patients having ischemic
J. K. Tun et al.
rest pain (Rutherford
Category 4), all
subgroups showed better
results with DCB.
HRQOL
instrument(s)
used, Method
EQ-5D, WIQ DCB group showed
ofdelivery,
Completion
rate Key outcomes
24months
Follow-up
period
Yes 12,
Preop
HRQOL
assessment
ratio to treatment with
DCB (n=220) or PTA
331 Randomly assigned in a 2:1
Cohort size, Study
centre(s) Patient characteristics
Investigate the
longer-term
Study intent/
outcomes (beyond
associated study
(n=111)
1year) of a
paclitaxel-eluting
DCB compared to
PTA for
symptomatic
femoropopliteal
lesions (Rutherford
2–4) up to 18cm in
Not stated No device or
Groups were well matched
Multicentre
length.
24months 24months: Both groups
at baseline with similar
demographics,
comorbidities, and lesion
characteristics (incl.
Rutherford)
(Europe, USA)
SFA Trial
EQ-5D: 80% EQ-5D: results trended
WIQ-walking
impairment:
79%
WIQ-walking
distance: 48%
WIQ-walking
speed: 48%
WIQ-stair
climbing: 48%
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
(2015) [7]
Study period,
Study type
DCB vs. PTA Laird et al.
Device type, Brand
name (if applicable)
2010–2017 Part of IN.PACT
Paclitaxel-eluting
balloon
control trial
In.Pact Admiral Randomised
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
8
(continued)
WIQ: 78% improved
from baseline patients in
both groups. Mean
change 20.1±29.4
(n=176) DCB;
22.5±28.1 (n=93)
PTA
0.10 (55.9% improved)
in DCB; 0.04 (53%
improved) in PTA
change—1.9 in both
groups
TLR rate.
superior safety and
effectiveness of the
Stellarex DCB in
comparison with
PTA, and plasma
levels of paclitaxel
fall to low levels
within 1h.
395
Yes 12months WIQ, EQ-5D The data demonstrate
Popliteal lesions with
Rutherford Cat 2–4; DCB
n=200, PTA n=100
300 Obstructive SFA or
Pharmacokinetic
and clinical
outcomes of two
studies
(ILLUMENATE
Pivotal RCT and PK
Prospective studies)
Not stated EQ-5D: Mean change
Majority Rutherford Cat 3
in Stellarex DCB
WIQ 90% Rutherford: Mean
in both groups.
SFA, Pop=191, 9 (DCB),
Austria
treatment of
femoropopliteal
disease.
191, 9 (PTA)
EQ-5D 61% DCB had 46.9% lower
Rutherford 90%
Higher percentage of men
(DCB: 56.0% versus PTA:
64.0%, p=0.185), patients
with diabetes mellitus
(DCB: 49.5% versus PTA:
52.0%, p=0.683), obesity
(DCB: 39.5% versus PTA:
30.0%, p=0.107)
(2017) [41]
DCB vs. PTA Krishnan et al.
2013–2015 41 USA, two
Paclitaxel-coated
balloon
control trial
Stellarex Randomised
396
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7
Quality
score
Rutherford: Signicant
improvement in
distribution across
Rutherford categories
was observed in both
Main ndings related to
HRQOL
The DCB group had a
greater primary
the DCB and control
patency rate at
12months
(Kaplan-Meier
estimate 86.4% vs.
groups (Kruskal-Wallis
rank sum test p<0.001
for each group), but the
difference between the
groups was not
statistically signicant
(p=0.638).
56.5%), with a
signicantly longer
time to patency
failure (log-rank
p<0.001). The
estimated freedom
from target lesion
scores increased from
38±22 at baseline to
66±26 at 6months and
were sustained at
64±28 at 12months in
revascularization rate
was 91.2% in the
DCB group and
69.9% in the control
group at 12months,
with a signicantly
the DCB group, with a
similar increase
observed in the control
group. The WIQ total
scores and parameters
of distance, speed, and
stair climbing did not
longer time to
reintervention
(p=0.010). No target
limb amputations or
device-related deaths
occurred in either
group.
differ signicantly
between the DCB and
control groups at any
time point.
differences in
J. K. Tun et al.
health-related quality of
life scores (EQ-5D-3L,
SF12v2) were observed
between the DCB and
control groups.
HRQOL
instrument(s)
used, Method
ofdelivery,
Preop
SF-12V2, WIQ
Completion
rate Key outcomes
Follow-up
period
Yes 12months EQ-5D-3L,
HRQOL
assessment
lower limb ischemia
105 Patients with symptomatic
Cohort size, Study
centre(s) Patient characteristics
To evaluate the
performance of the
Study intent/
associated study
(Rutherford category 2–4)
and stenotic lesions in the
nonstented femoropopliteal
segment.
Ranger
paclitaxel-coated
balloon versus
uncoated balloon
angioplasty for
femoropopliteal
lesions at
12months.
In-ofce visit WIQ: Mean total WIQ
DCB (n=71): Mean age
68±8years, Male 75%,
DM 39%, HTN 82%;
Proximal/Mid/Distal
SFA=17%/44%/36%
(Europe)
TASC II A/B=66%/27% 83% No signicant
Control (n=34): Mean age
67±9years, Male 68%,
DM 35%, HTN 76%;
Proximal/Mid/Distal
SFA=6%/37%/53%
TASC II A/B=69%/22%
Author (year of
publication),
Type of intervention
Table 19.3 (continued)
(2018) [42]
Study period,
Study type
DCB vs. PTA Steiner et al.
Device type, Brand
name (if applicable)
2014–2016 Ten centres
Paclitaxel-coated
balloon
control trial
Ranger Randomised
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
8
Both treatment groups
showed similar
improvement from
baseline in all functional
outcomes assessed, but
with no signicant
intergroup differences.
from baseline to
12months was
0.081±0.149 for DCB
vs. 0.095±0.157 for
PTA (p=0.705).
showed similar
improvement in walking
distance (23.7±37.8m
DCB vs. 8.8±29.8m
PTA; p=0.156).
Despite improvement in
functional outcomes in
both groups, patients
treated with DCB
required 77% fewer
reinterventions than
their PTA-treated
counterparts.
MDT-2113 SFA
Japan trial showed
superior treatment
effect for DCB vs.
PTA, with excellent
patency and low
CD-TLR rates. These
results are consistent
with other IN.PACT
SFA DCB trials and
demonstrate the
safety and
effectiveness of this
DCB for the
treatment of
femoropopliteal
lesions in this
Japanese cohort.
397
Yes 12months EQ-5D, WIQ Results from the
patients (mean age
73.6±7.0years; 76 men)
to treatment with DCB
(n=68) or PTA (n=32).
Baseline characteristics
were similar between the
groups, including mean
100 Randomized (2:1) 100
To assess the safety
and effectiveness of
the MDT-2113 (IN.
PACT Admiral)
drug-coated balloon
(DCB) for the
treatment of de
novo and native
Not stated EQ-5D: mean change
lesion length
(9.15±5.85cm and
Japan
artery restenotic
lesions in the
96% WIQ: both groups
8.89±6.01cm for the
DCB and PTA groups,
respectively).
DCB: Rutherford
supercial femoral
and proximal
popliteal arteries vs.
percutaneous
2/3/4=54%/41%/4%
PTA: Rutherford
2/3/4=59%/38%/3%
transluminal
angioplasty (PTA)
with an uncoated
balloon in a
Japanese cohort.
(2018) [43]
DCB vs. PTA Iida et al.
2013–2018 11 centres in
Paclitaxel-eluting
balloon
control trial
In.Pact Admiral Randomised
398
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J. K. Tun et al.
was found in patients who developed lesion
restenosis [26].
A prospective cohort study investigating longterm outcomes (up to 10years) following use of
two bypass graft materials (PTFE and Dacron)
demonstrated that HRQOL outcomes were not
directly correlated to bypass patency in the long
term [25]. Higher WIQ scores were observed in
the Dacron group but no differences were found
in the other HRQOL measures.
A RCT which compared femoropopliteal surgical bypass to primary stenting using a Heparinbonded covered self-expanding stent
demonstrated signicantly better HRQOL measures in the endovascular group at early follow up (1 month) [27]. At 12 months, there was an
overall signicant improvement in HRQOL measures from baseline in both groups. No signicant difference in overall HRQOL measures at
12months was observed between the two groups;
subgroup analysis did demonstrate comparatively better outcomes in the endovascular group
for the given HRQOL questionnaire items
(Table19.3).
Two prospective cohort studies which investigated the use of endovascular atherectomy were
identied: one using directional atherectomy in
the popliteal segment and another using optical
coherence tomography (OCT)-guided atherectomy in the femoral and popliteal segments [23,
24]. Both studies demonstrated improved
HRQOL outcomes post intervention when compared to baseline.
Quality ofIncluded Studies
The methodological quality of the studies in
terms of QOL assessment ranged from 5 to 10
(median=8) according to the scoring system [6].
Eighteen papers scored 8 or above.
Timing andCompletion ofFollow-Up
The response rate ranged from 36% to 100%.
QOL was a primary outcome measure in six studies and secondary outcome measure in 28 stud-
ies. Follow-up period ranged from 6months to
11 years. Twenty-nine studies had a follow-up
period of 2years or less.
The methods of HRQOL questionnaire administration were as follows: ofce visit in one study,
telephone interview in one study, selfadministered in ve studies (of which two papers
stated the availability of optional help from a
research assistant) and unstated in 27 studies.
Discussion
This systematic review provides a current evidence base on HRQOL outcomes following invasive intervention for aortoiliac and
femoropopliteal steno-occlusive disease. The
range of interventions include PTA, use of DCB,
stenting, atherectomy and bypass surgery.
The follow-up period in the majority of studies is short (2years or less). In general, all interventions, whether endovascular or surgical, in
both the aortoiliac and femoropopliteal segment
disease resulted in improved HRQOL outcomes
in the short term. None of the studies in this
review compared the HRQOL outcomes at
medium or long-term follow-up to baseline
measures.
A study by van Hattum et al. which is not
included in this review (as it included patients
with crural and pedal bypass surgery) demonstrated a deterioration in HRQOL, particularly in
physical parameters, following peripheral bypass
surgery in the long term regardless of bypass
patency [45]. The HRQOL further worsens in
patients who have had a subsequent adverse vascular event. This reects the fact that PAD is only
one manifestation of the more general atherosclerosis disease spectrum and with time these
patients’ general health and resultant HRQOL is
likely to decline. It also stresses the importance
of secondary prevention as well as lifestyle and
health optimisation. From the perspective of
conducting longer term HRQOL research, this
study also highlights an issue with measuring
HRQOL in PAD patients in that general deterioration is likely to be expected in the long term,
particularly in those with multiple risk factors. As
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
399
such, we feel this should be factored in when
measuring effectiveness of an intervention in
those with PAD.
There were nine studies which investigated
HRQOL outcomes following the use of DCB for
SFA disease, all of which demonstrated improved
HRQOL outcomes post intervention [8, 12, 36–
42]. Five of these were RCTs comparing PTA to
various Paclitaxel DCB devices, each with
slightly different properties in terms of drug dose
and delivery. Only one of these demonstrated a
signicant difference in an HRQOL outcome
(one item in the WIQ) between the two interventions; the rest did not demonstrate any signicant
difference in HRQOL outcomes. There were,
however, signicantly higher primary patency
and lower reintervention rates in the DCB group
in comparison to PTA. The authors in some of
these papers posited DCB to be the superior
intervention tool compared to PTA, as it achieves
the same HRQOL outcomes whilst requiring
fewer interventions. However, of concern, a
recent and controversial meta-analysis by
Katsanos etal. demonstrated an increased risk of
mortality amongst patients with intermittent
claudication or rest pain treated with Paclitaxel
DCBs when compared to PTA [46]. Whilst there
is ongoing debate as to whether this observed
increased mortality is directly caused by
Paclitaxel administration, it does raise serious
questions of whether DCBs should be used in
such patients, given that there has been no
reported signicant HRQOL benet over PTA.
On review of other studies which compared
different treatment modalities, they suggest that
the improvement seen in terms of patency outcomes does not uniformly translate to HRQOL
outcomes. For example, a large multicentre RCT
by Laird etal. which compared primary stenting
to PTA for SFA disease showed signicantly
improved freedom from CD-TLR rates, though
the HRQOL outcomes are variable. In this study,
the stent group had signicantly better WIQ
scores, however, no signicant differences were
observed in all other the HRQOL measures evaluated [44]. When comparing invasive revascularisation of a stenosed or occluded vessel over
non-invasive approaches, the evidence is also
unclear as to which leads to better HRQOL outcomes. One multicentre RCT which compared
iliac stenting to SET demonstrated no signicant
difference in the HRQOL outcomes [14]. Two
RCTs by Greenhalgh et al. and Marazi et al.
which compared SET to PTA for femoropopliteal
disease did not demonstrate any difference in
HRQOL outcomes [22, 35]. Interestingly, the
study by Greenhalgh also compared iliac PTA to
SET which did demonstrate signicantly better
HRQOL outcomes in the PTA group, though the
SET group did still demonstrate signicant
improvement from baseline. The latter does raise
the need to consider what degree of HRQOL
improvement one should aim for when deciding
on treatment options. For example, a patient may
prefer a less invasive treatment to an invasive
treatment if it sufciently improves their HRQOL
without the risk of surgical complications. Some
studies have been conducted to determine the
minimally clinically important difference
(MCID) for the VascuQol in PAD patients [47,
48]. Conjin etal. found that an improvement in
overall VascuQol score by between 1.19 and 1.66
is clinically relevant to patients. However, to the
best of our knowledge, no such studies have been
conducted for the other HRQOL tools in this
review in relation to PAD. Future studies are
required to determine the MCID for any existing
or indeed any future tools used to measure
HRQOL in PAD. This will allow for a more
meaningful interpretation of HRQOL outcomes
following PAD intervention.
An interesting nding within this review is
that in some of the comparative studies (e.g. stent
versus PTA), even if a signicant difference in
conventional outcomes measures (e.g. patency
rate) is seen, there is often no signicant difference seen in HRQOL outcomes. No justication
for this observation is posited by the studies
reviewed, however, there are some possible
explanations. First, by taking the study results at
face value, it may simply be that clinically the
comparative, improved patency rates alone (such
as for DCB over PTA) may not directly translate
to increased HRQOL outcomes. Second, it is
possible that the studies are insufciently powered to detect a difference in HRQOL between
400
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J. K. Tun et al.
the different interventions. As stated earlier, in
most studies, HRQOL was a secondary outcome
measure and studies may have only been sufciently powered to the primary outcome measures (i.e. patency rates). Third, it may be that
there are inherent issues with the psychometric
properties of the HRQOL tools, resulting in them
being insufciently sensitive or accurate in
detecting differences in patient outcomes. As an
example, a study evaluating the VascuQoL-6
questionnaire demonstrated poor test-retest reliability (<70%) [49]. A recent in-depth study evaluating VascuQol demonstrated a number of
signicant aws including nine ‘weak’ questionnaire items. On interviewing patients and clinicians, a number of items identied were
considered irrelevant to the majority of patients
such as Item 2: “I have been worried that I might
injure my leg”; others were only relevant to a subgroup of PAD patients with CLTI such as Item
17: “Ulcers or sores on my leg (or foot) have
caused me pain or distress”. These ndings suggest the need for more robust HRQOL measures
which take in to account the symptoms of different types of PAD patients, i.e. claudicants who
primarily suffer from limited walking distance
and CLTI patients who may have rest pain and
tissue loss.
Interestingly, there remains a difference in
opinion as to the best tools to measure HRQOL
in PAD.Vries etal. compared the disease specic
VascuQol to the generic HRQOL questionnaires
(SF-36 and EuroQol-5D) and demonstrated that
VascuQoL was better at discriminating a large
versus a small change in disease severity [50].
Another study by Petersohn et al. of generic
HRQOL questionnaires suggested that EQ-5D
may be superior to SF-36 and VAS [5]. A recent
systematic review by Poku etal. which looked at
the properties of seven disease specic and six
generic HRQOL tools, did not demonstrate the
superiority of one over the other [51]. Whilst a
recent consensus paper strongly recommended
the inclusion of HRQOL outcomes within a trial
design, no expert statement has been published to
date which either addresses the issues with the
current methods of measuring HRQOL or how
best to incorporate them into studies [52]. Given
this, further research on how best to measure
HRQOL outcomes both for research and clinical
practice would seem prudent.
Although the increasing inclusion of HRQOL
outcomes in PAD studies is encouraging, a
number of issues should rst be addressed. As
stated, for most of the studies in this review,
HRQOL outcomes were included as a secondary outcome measure. As such, these are likely
to be insufciently powered and therefore making interpretation of the results in such instances
challenging. The approach to measuring
HRQOL outcomes was also highly variable.
Most studies did not describe the method of
administering the HRQOL questionnaires, e.g.
whether it was performed in clinic, via post, and
with or without assistance from the research
team. However, the method of administration
could have an effect on both the validity and
reliability of the questionnaire. The rationale for
why specic HRQOL questionnaires were used
was also not always evident. Many studies used
a combination of HRQOL questionnaires.
However, when many of these questionnaires
were originally designed, they were tested for
their psychometric properties as standalone
tools. Administering multiple questionnaires in
combination may potentially result in unintentional bias. For example, a question in Tool A
may inadvertently inuence a patient’s response
to a question in Tool B. Combining questionnaires may also have the inadvertent effect of
causing response fatigue due to the increased
length of time spent by the respondents [53].
These are some issues that warrant more consideration in future HRQOL studies in PAD. In
particular, we argue for the need for a standardised approach to HRQOL assessment in
order to improve the quality, consistency and
comparability of future studies.
In addition to the issues with measuring
HRQOL outcomes in PAD intervention, this
review also highlighted some areas relating to the
interventions and surgical procedures that require
future research. For example, there is no study at
present comparing techniques such as covered
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