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Cardiff Wound Impact
Schedule: the development
of a condition-specific
questionnaire to assess
health-related quality of life
in patients with chronic
wounds of the lower limb
Patricia Price, Keith Harding
ABSTRACT
The purpose of this study was to develop and validate a questionnaire to measure the impact of chronic wounds
(leg ulcers and diabetic foot ulcers) on patient health-related quality of life (HRQoL) and identify areas of patient
concern. The Cardiff Wound Impact Schedule (CWIS) was created following a three-stage process. Stage 1
included a focus group (n = 10) and a series of semi-structured interviews (n = 13) to generate items for the
questionnaire. Stage 2 involved piloting the 28-item questionnaire on 124 patients (64�5% with leg ulceration
and 35�5% with diabetic foot ulceration): data from this stage were analysed using factor analysis. The reliability,
validity and reproducibility of the resulting scale were assessed in Stage 3, a 3-month follow-up study of 135
patients in which patients completed the CWIS and the SF-36. Factor analysis identified three domains of HRQoL:
physical symptoms and daily living, social life and well-being. There were no significant differences in scores
across the wound types. Internal consistency was good (�= 0�77—0�96) as was reproducibility (P < 0�001). The
CWIS was able to discriminate between those with healed ulcers and active ulcers (P < 0�01). Construct validity
was demonstrated by strong correlations between related items on CWIS and SF-36 (P < 0�01—P < 0�0001). The
data suggest that CWIS has high internal consistency and the ability to discriminate between health states and
good reproducibility. CWIS is a valid tool for studying the impact of chronic wounds of the lower leg on HRQoL.
CWIS allows clinicians to identify items of patient concern, which can then be used to negotiate options of care
most suited to individual patients.
Key words: Quality of life assessment tool . Health-related . Wound care . Questionnaire . Chronic lower limb wounds
INTRODUCTION
The presence of a chronic non healing wound
can result in a profound impact on everyday
life. Chronic leg ulceration represents a major
health problem for many people over the age
of 60, affecting in the region of 0�1—0�3% of the
general population, although this figure rises
to 2% in complications over the age of 80 (1).
Foot complication associated with diabetes
mellitus is also a major problem (2); for such
Authors: P Price, PhD, Wound Healing Research Unit, University
of Wales College of Medicine, Heath Park, Cardiff, UK; K Harding,
FRCS, Wound Healing Research Unit, University of Wales College
of Medicine, Heath Park, Cardiff, UK
Address for correspondence: Prof. P Price, Wound Healing
Research Unit, University of Wales College of Medicine, Heath
Park, Cardiff CF14 4UJ, UK
E-mail: pricepe@whru.co.uk
� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 110
& RESEARCH
individuals, the development of neuropathy
can lead to foot wounds that can result in
amputation. The presence of foot ulceration
is a strong predictor of further foot deteriora-
tion, with major impacts on an individual’s
QoL (3). This article outlines the development
of a condition-specific tool to measure the
impact of these two chronic wound types on
patients’ self-reported QoL.
The main focus of treatment for patients
with chronic wounds is complete healing,
with the aim of achieving a healed state as
quickly as possible. Even so, patients face the
prospect of challenging local and systemic
care with frequent dressing changes, episodes
of infection, a possible cycle of re-ulceration
and fears of a deteriorating health state. There
has also been debate about the existence of a
subgroup of patients for whom healing is not
a possible outcome (4) but for whom QoL
issues remain paramount.
A limited amount of work has already been
completed in the investigation of the impact of
a chronic wound on health-related QoL
(HRQoL). A number of qualitative studies
have been completed that outline the extent
of the impact of a wound on everyday living
for patients with chronic leg ulceration (5—12),
but there has been less work on diabetes-
related foot problems (13—15). General health
status has also been investigated using generic
tools for those with chronic leg ulceration
(16—20) and for those with diabetes-related
foot ulceration (21). In the majority of these
studies, those with chronic wounds are
reported to experience poorer HRQoL than
sex- or age-matched controls.
It is, however, increasingly recognised that
such generic measures do not address areas
that are salient to specific diseases or health
states. Condition-specific instruments are
more likely to be relevant to areas prioritised
by the attending clinicians and contain items
considered important by the relevant patient
group (22,23). Condition-specific measures
have been developed which relate to venous
disease generally (24—27), to leg ulceration
specifically (28) and diabetic peripheral neu-
ropathy (29) or foot ulcer problems (30,31), but
no scale exists that focuses on chronic wounds
irrespective of aetiology.
The development of such a scale would
allow for the HRQoL of patients with chronic
wounds to be more fully understood, leading
to possible changes in clinical practice if such
a questionnaire were to be fully adopted. One
of the concerns about the transformation of
HRQoL from a speculative concept to a recog-
nised clinical endpoint is that, to date, the
concept has not really been introduced into
routine clinical practice (32). This study
aimed to produce a questionnaire that would
provide both a valid and a reliable form of
measuring condition-specific QoL across a
range of wound types and a framework for
informing clinicians about specific areas of
patient concern that could be used for joint
prioritisation of clinical care. The aim was
also to develop an instrument sufficiently
short and easy to use, so that it could be
used in a range of health care settings and in
both research and clinical work. This article
outlines the development and validation of
the Cardiff Wound Impact Schedule (CWIS)
for use with patients with chronic wounds.
The underlying philosophy behind the devel-
opment of the tool was the involvement of the
patient both in the construction of the instru-
ment and in the weighting of the importance
of issues to them as individuals.
METHODS
Stage 1: item generation
It is generally agreed that the content of
HRQoL instruments should be based directly
on the information provided by relevant
patients, in terms of both coverage of relevant
items and the specific wording of questions
(33). A focus group was held, involving 10
patients (three males and seven females,
mean age = 74�3 years; SD = 4�9) presenting at
a specialist outpatient clinic with chronic non
healing wounds that had been present for a
minimum of 3 months. The point at which no
new themes or ideas emerged from the groups
(thematic exhaustion) determined the end of
the session. Patients were asked to describe
the impact of the wound on their everyday
lives, and a list of topics was compiled from
the session.
In-depth semi-structured interviews with 13
patients (one male and 12 females, mean
age = 83�5 years; SD = 3�2) who presented to
the same specialist unit were completed. The
interviews took place in the patients’ homes
and lasted about an hour. Patients were asked
about their everyday experiences of living with
Key Points
. a limited amount of work has
already been completed in the
investigation of the impact of a
chronic wound on health-related
quality of life (HRQoL)
. this article outlines the develop-
ment and validation of the Cardiff
Wound Impact Schedule (CWIS)
. a three stage process was used
todevelop and validate the tool
Cardiff Wound Impact Schedule
� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 1 11
a non healing wound and to identify the
aspect of this experience that they found
stressful. All interviews were tape-recorded
for subsequent analysis, when common
themes were identified using content analysis.
A subset of tapes were analysed by a second
researcher to minimise bias at this stage (inter-
rater reliability was 93%).
Stage 2: scale generation
The information from Stage 1 was used to
compile a 28-item questionnaire, which was
piloted on 50 consecutive consenting patients
with chronic wounds attending a specialist
outpatient clinic (half with leg ulceration and
the others with diabetic foot wounds), none of
whom had been involved in Stage 1. The
male : female ratio was 23 : 27, with an age
range of 34—90 years and a mean age of 65�9
years. Patients completed the questionnaire
whilst sitting in the waiting area of the out-
patient clinic; those who experienced any
visual or writing difficulties were assisted by
a researcher. Patients were asked to indicate
the extent to which they had experienced a
difficulty in relation to the presence of a
wound plus the extent to which they found
that experience stressful.
In addition, a further 74 patients completed
the questionnaire using a postal method. The
patients were asked to complete the questions
relating to their experiences during the past
week and to comment on the wording and
layout of the questionnaire. The mean age of
this group was 70�4 years (range 48—86�2); 49
were females and 25 were males. Seventy-five
per cent had chronic leg ulceration; the
remaining 25% had diabetes-related foot
ulceration. There were no statistical differ-
ences in the number of missing items between
those who completed the questionnaire at
home or at the clinic.
Stage 3: testing reliability and validity
A new version of the questionnaire was devel-
oped on the basis of the results from Stage 2.
In addition, an overall rating of HRQoL using
a 10-point scale was included, plus a rating of
satisfaction with an individual’s overall
HRQoL.
The validity and reliability of the resulting
scale was assessed in a survey of 150 patients
attending two specialist wound outpatient
clinics. One hundred and thirty-five patients
agreed to participate, giving a 90% response
rate. This stage included the completion of the
CWIS and the SF-36 Health Survey Question-
naire (34), plus a clinical indication of the
wound state (healed versus non healed): the
respondents completed the questionnaires
whilst waiting for their clinic appointment.
Although half of the patients were asked to
complete the SF-36 first and the other half to
complete the CWIS first (to avoid order
effects), there is no guarantee that patients
complied with these instructions. These data
were used to determine the construct validity
of the new measure. The mean age of this
sample was 65�9 years (range 43—85�5 years),
with 55% of the sample males and 45%
females. Fifty-four of the patients had a dia-
betic foot wound and 81 had chronic leg
ulceration, with only 30 of these patients
living alone.
In addition, a second copy of the CWIS was
given to patients in an envelope to complete
within 5—7 days after attending the clinic,
together with a stamped, addressed envelope
to return the completed questionnaire. These
data allowed for the calculation of test—retest
reliability of the CWIS to be assessed. Ninety
patients returned their second questionnaire,
giving a response rate of 66%. The senior
clinician responsible for the clinical care of
these patients reported no important changes
in their health status during this short time
period.
Three months (±1 week) later, all 135
patients completed the CWIS at a follow-up
clinic visit. The health status of the patients
was assessed by the consultant and classified
as ‘wound present’ or ‘wound healed’.
RESULTS
There were no significant differences in the
scores of patients, dependent on wound
type. This section therefore includes the
responses of all patients who participated in
the study.
Scale generation
The data from Stage 2 were factor analysed
using varimax rotation to determine the
factors underlying the scale. The three factors
with Eigen values greater than 1�5 were
retained; these three factors contained 26
Key Points
. an initial 28-item questionnaire
was piloted on 50 patients with
chronic wounds, attending a
specialist outpatient clinic
. additionally a further 74 patients
were evaluated using a postal
method
. a second improved questionnaire
was developed and 150 patients
surveyed during clinic visits
. a follow-up questionnaire which
patients returned 5—7 days after
initial evaluation allowed follow-
up
Cardiff Wound Impact Schedule
� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 112
items and explained 51% of the variance. Only
two items caused any problems, these were
‘limited contact with family/friends’ and
‘family/friends being overprotective’. These
items loaded onto more than one factor.
However, given the qualitative comments
from earlier stages and the views of the
clinician involved, these items were retained
within those scales that produced the most
meaningful scales. Two items were with-
drawn from the scale as they did not load
onto any one factor (i.e, ‘changes in appetite’
and ‘I look forward to clinic visits’). This
resulted in three scales:
. Physical symptoms and everyday living
(12 items rated for the extent of the pro-
blem and associated stress, each on a 5-
point scale): this domain focuses on the
impact of symptoms on daily functioning
and comfort.
. Social life (seven items rated for the
extent of the problem and associated
stress, each on a 5-point scale): this
domain focuses on the individual’s abil-
ity to get out and about.
. Well-being (seven items rated on a 5-
point scale): this domain focuses on the
patient’s well-being in relation to the
wound, particularly anxieties about
outcome.
Examples from each of the subscales are
shown in Figure 1 and the factor loadings for
the scales are summarised in Table 1.
To calculate the scale scores, the items for
each scale are summated. For ‘physical
symptoms and everyday living’ and ‘social
life’, the items are rated for the extent of the
experience of the item during the past week
and how stressful that experience was on an
item-by-item basis. This allows the patients to
weight the items included in the scale. For
example, the experience of ‘disturbed sleep’
may be rated as ‘rarely’ but ‘very stressful’.
Thus, the total score includes the patient’s
perception of the experience and the asso-
ciated stress. The well-being scale is scored
on a 5-point Likert scale, with response
options from ‘strongly agree’ to ‘strongly
disagree’. All three scales are then trans-
formed onto a 0—100 scale, where a high
score indicates a positive rating.
Reliability
Internal consistency was calculated using
Cronbach’s alpha (35), values of which range
from 0 to 1. Coefficients above 0�7 are gener-
ally regarded as acceptable for psychometric
measurements (26). Cronbach’s alpha was cal-
culated for the three factors within CWIS.
Each of the subscales resulted in an alpha
>0�75 [physical symptoms and everyday
living (experience alpha = 0�88 and stress
alpha = 0�95), social life (experience alpha = 0�96
and stress alpha = 0�93) and well-being
(alpha = 0�77). These findings confirm that
the internal consistency is high.
Reproducibility
A specific test—retest component was included
within Stage 3 of the development of the
Key Points
. three scales were used in the
evaluation
— physical symptoms and every-
day living
— social life
— well-being
. to calculate the scale, scores and
number of sub-evaluations are
summated
. all evaluations and summations
were rigorously checked for relia-
bility and reproducibility using
specific statistical approaches
Physicalsymptoms and daily living
Have you experienced any of the following during the past week?
Disturbed sleep
Not at all/
Not applicable
Seldom Sometimes Frequently Always
Social life
Have you experienced any of the following during the past week?
Difficulty getting out and
about
Not at all/
Not applicable
Seldom Sometimes Frequently Always
Well-being
To what extent do you agree/disagree with the following statements?
I feel anxious about my
wound(s)
Strongly
disagree
Disagree Not sure Agree Strongly
agree
Physical symptoms and daily living
How stressful has this experience been for you?
Disturbed sleep
Not at all/
Not applicable
Slightly Moderately Quite
a bit
Very
Social life
How stressful has this experience been for you?
Difficulty getting out and
about
Not at all/
Not applicable
Slightly Moderately Quite
a bit
Very
Figure 1. Examples of items from each of the subscales of Cardiff Wound Impact Schedule.
Cardiff Wound Impact Schedule
� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 1 13
questionnaire to confirm that items were answered
in a similar way by stable patients within a short
time scale (5—7 days). Correlation coefficients for
experience of items and their associated stress
between the two time points are summarised in
Table 2; all are significant at P < 0�001, indicating a
high level of reproducibility.
Discrimination between health states
The ability of CWIS to discriminate between
health states (healed versus non healed) was
calculated using independent t-tests to ana-
lyse the scores of patients in the 3-month
follow-up. Those identified as ‘healed’ had
consistently higher scores across the three
Key Points
. the results were also tested for dis-
crimination between health states
i.e. can the tool discriminate bet-
ween healed and non healed
Table 1 Factor analysis: Stage 2 (n = 124)
Factor 1 Factor 2 Factor 3
Disturbed sleep 0�749 0�108 0�009
Mobility around home 0�721 0�038 0�27
Pain 0�770 0�306 0�123
Discomfort with bandages 0�769 0�118 0�346
Difficulty in everyday tasks 0�743 0�252 0�244
Mobility outside home 0�707 0�063 0�191
Leakage 0�703 0�047 0�384
Odour 0�679 0�214 0�244
Difficulties in bathing 0�574 0�192 0�358
Difficulties with footwear 0�530 0�179 0�127
Time needed to look after the wound 0�566 0�204 0�024
Financial difficulties 0�421 0�249 0�179
Getting out and about 0�207 0�729 0�254
Relying more on others 0�351 0�641 0�032
Enable to enjoy usual social life 0�262 0�638 0�006
Not going out for fear of bumping wound 0�204 0�566 0�024
Limited contact with family and friends 0�137 0�572 0�496
Wanting to withdraw from others 0�055 0�565 0�326
Family/friends being overprotective 0�156 0�470 0�320
Anxious about the wound 0�192 0�144 0�760
Worry about recurrence 0�299 0�286 0�641
Frustration at the time to healing 0�201 0�216 0�629
Appearance of the wound is upsetting 0�239 0�327 0�619
Anxious about bumping the wound 0�264 0�363 0�609
Worry about the impact on family/friends 0�348 0�118 0�544
Confident the wound will heal 0�013 0�261 0�441
Eigen values 9�31 2�27 1�92
% of variance explained 36�26 8�12 6�87
Table 2 Pearson’s correlation coefficients components of Cardiff Wound Impact Schedule on day 1 and 5—7 days later (n = 90)
Correlation coefficients
Experience Associated stress
Physical functioning and everyday living 0�93 0�86
Social functioning 0�93 0�92
Well-being 0�90 —
Global HRQoL 0�92 —
Satisfaction with HRQoL 0�93 —
Values are significant at P < 0�001. HRQoL, health-related quality of life.
Cardiff Wound Impact Schedule
� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 114
subscales, and differences between the two
groups were all significant (Table 3). Although
the global ratings for HRQoL were higher for
those with a ‘healed wound’, the difference
was not significant, but satisfaction with
HRQoL was significantly higher for this
group (P < 0�01).
Relationship between CWIS and SF-36
The construct validity was examined by cor-
relating scales in CWIS with relevant scales of
SF-36. Physical symptoms and everyday liv-
ing total score (CWIS) correlated with physical
function (SF-36) (r = 0�53, P < 0�0001). Specific
items on CWIS related to mobility and its
associated stress correlated with physical
function (SF-36) at between r = 0�34—0�52 (all
items P < 0�0001). Items related to pain and
the associated stress (CWIS) correlated with
bodily pain (SF-36) (r = –0�53, P < 0�0001: cor-
relation is negative due to the different direc-
tion of the scales). Social life (CWIS) correlated
with social functioning (SF-36) (r = 0�47,
P < 0�0001) and role limitation (physical)
(r = 0�56, P < 0�0001). Well-being (CWIS) corre-
lated with mental health (SF-36) (r = 0�217,
P = 0�01) and role limitation (emotional) (SF-36)
(r = 0�332, P < 0�0001).
DISCUSSION
Individuals with chronic non healing wounds
may experience a wide range of adverse
effects on their everyday lives. Studies to
date have either focused on one type of
wound (e.g. leg ulceration), have used quali-
tative methods or generic tools. However,
there are a number of aspects of experience
of living with a chronic wound that are not
addressed by generic instruments. Problems
such as leakage and odour are not assessed
directly by such instruments, yet can have a
profound impact on the patient’s life.
The results of this study suggest that the
content of the CWIS is appropriate for indi-
viduals with chronic wounds, with high inter-
nal consistency, the ability to discriminate
between health states and good reproducibil-
ity. Further studies that confirm the factored
scales used in CWIS are currently being
undertaken. It is also important to increase
the sample size involved in such studies to
ensure the representativeness of the items
included in the tool, which are currently
based on patients from a relatively small geo-
graphical area (South Wales).
In addition, the scales correlate well with
relevant scales from a well-validated generic
tool (SF-36). Whilst the correlations are not
very strong, the patients involved in this
study were all elderly and many had other
concomitant disorders of older age (e.g.
arthritis). As such, items from CWIS that
focus directly on the symptoms of a wound
are sensitive to experiences directly attribut-
able to that wound, but the profile may not be
matched by responses to items on a generic
questionnaire that focus on a general level of
functioning. These data support the use of
both a generic and a condition-specific tool
for the measurement of HRQoL.
In order for the tool to be useful in clinical trials
related to a range of chronic wounds, CWIS needs
to isolate the impact of the experiences of a
wound from those related to other factors present
in this age group. Whilst this is a difficult task, the
ability of CWIS to discriminate between different
health states indicates that the tool is sensitive to
this issue. The profile of scores using CWIS across
wound types was similar, with no significant dif-
ferences in scores dependent on wound type.
Further studies which analyse scores related to
severity of wound rather than ‘healed’ versus
‘non healed’ need to be completed to maximise
the potential for use in clinical trials.
Key Points
. current assessment and evalua-
tion tools generally don’t deal
with patients’ problems such as
leakage and odour
. such parameters can have pro-
found impact on the patient’s life
. results of the study indicate that
the CWIS tool is appropriate for
individuals with chronic wounds
with high internal consistency
and the ability to discriminate
between health states with
good reproducibility
Table 3 Mean scale scores for Cardiff Wound Impact Schedule by clinical assessment of healed status of wound
Healed (n = 46) Nonhealed (n = 89) P-value
Physical symptoms and everyday living 87�6 71�7 <0�0001
Social life 84�7 76�1 0�025
Well-being 50�8 38�7 <0�0001
Global HRQoL 7�2 6�9 NS
Satisfaction with HRQoL7�8 6�7 <0�01
HRQoL, health-related quality of life; NS, not significant.
Cardiff Wound Impact Schedule
� Blackwell Publishing Ltd and Medicalhelplines.com Inc. 2004 . International Wound Journal . Vol 1 No 1 15
In the area of wound healing, the focus has
been on healing as the only measure of suc-
cess. Many patients with chronic wounds will
not heal speedily despite optimum care (4);
indeed complete healing may be an unrealistic
goal for this subset of patients such that
HRQoL becomes a particularly significant
part of planning care. Traditionally, the inte-
gration of HRQoL issues into clinical care has
been done on an informal basis, without the
support of well-defined measurement tools.
The use of CWIS in a routine clinical setting
is currently under investigation. The ‘stress’
component of the scales gives a useful guide
to a clinician of the concerns that a given
patient may have at any one time. The stress
scale, particularly in relation to physical symp-
toms and everyday life, can form the basis
for patient involvement in clinical decision-
making. This requires the clinician to be
sensitive to those aspects of the wound that
are most stressful to the individual and use
that information to guide clinical decisions or
to prioritise information/educational input
with the patient. In addition, the well-being
scale allows for clinician—patient communica-
tion to focus on the worries of the patient. The
long-term goal is for CWIS to be used routinely
as part of clinical assessment and care planning.
The questionnaire was developed with the
aim of producing an instrument that could be
used with several chronic wound types. The
aim was also to develop an instrument suffi-
ciently short and easy to use, so that it could
be used in a range of health care settings and
in both research and clinical work. The devel-
opment of such a tool is an essential step if we
are to evaluate interventions across a range of
wounds, particularly given the necessity for
multiprofessional teams to provide compre-
hensive care for such patients. This article
provides evidence of a patient-centred tool
which focuses on the concerns of the indivi-
dual whilst retaining psychometric integrity.
Additional work is now required to evaluate
its use in clinical trials and health-care settings
to confirm the current promising data.
ACKNOWLEDGEMENTS
The authors thank Smith and Nephew Ltd
(Medical) for an unrestricted research grant
used for the initial stages of this work.
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Key Points
. HRQoL is a significant compon-
ent of planning care for patients
. traditionally, the integration of
HRQoL issues into clinical care
has been done on an informal
basis, without the support of
well-defined tools
. the long term goal is for the
CWIS to be used routinely as
part of clinical assessment and
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