ArticlePDF Available

The 'Wound-QoL': A Short Questionnaire Measuring Quality of Life in Patients with Chronic Wounds Based on Three Established Disease-specific Instruments.

Authors:

Abstract and Figures

Aim of this study was to develop a short questionnaire measuring health-related quality of life (HRQoL) in chronic wounds. Three validated instruments assessing HRQoL in chronic wounds, the Freiburg Life Quality Assessment for wounds, the Cardiff Wound Impact Schedule, and the Würzburg Wound Score, were completed by 154 German leg ulcer patients in a longitudinal study. For implementation in the new, shorter questionnaire Wound-QoL, those of all 92 items were selected that covered the core content of the three questionnaires and showed good psychometric properties. Internal consistency, convergent validity, and responsiveness were analysed using the study data on the selected items (a new approach called virtual validation). Subscales were determined with factor analysis. Item, instruction, and response scale wording were harmonized. 17 items were included in the Wound-QoL which could be attributed to three subscales on everyday life, body, and psyche. Both global score and subscale scores were internally consistent with Cronbach's alpha between 0.71 and 0.91. The global score showed significant convergent validity (r = 0.48 to 0.69) and responsiveness (r = 0.18 to 0.52); the same was true for the subscale scores. The Wound-QoL for measurement of HRQoL in chronic wounds proved to be internally consistent, valid, and responsive in German leg ulcer patients. The findings of this virtual validation study need to be confirmed in a longitudinal validation study on the final Wound-QoL which is currently being conducted.
Content may be subject to copyright.
The “Wound-QoL”: A short questionnaire measuring quality
of life in patients with chronic wounds based on three
established disease-specific instruments
Christine Blome, PhD1; Katrin Baade1; Eike Sebastian Debus, MD2; Patricia Price, PhD3;
Matthias Augustin, MD1
1. Institute for Health Services Research in Dermatology and Healthcare (IVDP),
2. Department of Vascular Medicine, University Heart Center Hamburg-Eppendorf, University Medical Center Hamburg-Eppendorf, Hamburg,
Germany, and
3. Department of Wound Healing Research Unit, Cardiff University, Cardiff, United Kingdom
Reprint requests:
Dr. Christine Blome, German Center for
Health Services Research in Dermatology
(CVderm), Institute for Health Services
Research in Dermatology and Nursing
(IVDP), University Medical Center
Hamburg-Eppendorf (UKE), Martinistr. 52,
20246 Hamburg, Germany.
Tel: +49 (40) 7410 57387;
Fax: +49 (40) 7410 40160;
Email: c.blome@uke.de
Manuscript received: September 27, 2013
Accepted in final form: April 21, 2014
DOI:10.1111/wrr.12193
ABSTRACT
The aim of this study was to develop a short questionnaire measuring health-related
quality of life (HRQoL) in chronic wounds. Three validated instruments assessing
HRQoL in chronic wounds—the Freiburg Life Quality Assessment for wounds, the
Cardiff Wound Impact Schedule, and the Würzburg Wound Score—were completed
by 154 German leg ulcer patients in a longitudinal study. For implementation in the
new, shorter questionnaire Wound-QoL, all of those 92 items that covered the core
content of the three questionnaires and showed good psychometric properties were
selected. Internal consistency, convergent validity, and responsiveness were analyzed
using the study data on the selected items (a new approach called virtual validation).
Subscales were determined with factor analysis. Item, instruction, and response scale
wording were harmonized. Seventeen items were included in the Wound-QoL, which
could be attributed to three subscales on everyday life, body, and psyche. Both global
score and subscale scores were internally consistent with Cronbach’s alpha between
0.71 and 0.91. The global score showed significant convergent validity (r=0.48 to
0.69) and responsiveness (r=0.18 to 0.52); the same was true for the subscale scores.
The Wound-QoL for measurement of HRQoL in chronic wounds proved to be
internally consistent, valid, and responsive in German leg ulcer patients. The findings
of this virtual validation study need to be confirmed in a longitudinal validation study
on the final Wound-QoL, which is currently being conducted.
Chronic wounds can heavily impair the patients’ quality of
life by causing severe pain, social isolation, restricted mobil-
ity, and sleeping problems, to name only some of many pos-
sible effects on the patients’ daily life.1,2 Wounds are
considered chronic if they do not heal, i.e., reach complete
epithelialization within, for example, 8 weeks.3Chronic
wounds can, for example, result from diabetes (diabetic foot
ulcers), chronic venous insufficiency, or from being confined
to bed (decubitus ulcer).
Valid measurement of health-related quality of life
(HRQoL) in these patients is indispensable for evaluating
patient impairment and patient-relevant treatment effects.
Accordingly, evaluation of HRQoL has become a standard in
wound research and wound care.4Three wound-specific
HRQoL questionnaires are available in German language and
are currently being used in treatment evaluation: the Freiburg
Life Quality Assessment for wounds (FLQA-w),5the Cardiff
Wound Impact Schedule (CWIS),6and the Würzburg Wound
Score (WWS).7FLQA-w and WWS have been developed and
validated in German, and the CWIS has been translated to
German using a standard linguistic validation process.8
All three instruments have been shown to have high internal
consistency and validity in a head-to-head comparison.9
However, these instruments are quite long, covering 4 to 7
pages with up to 47 items. The WWS has the lowest number
of items (n=19), but provides no possibility of evaluating
different domains of HRQoL by calculating subscale scores.
Furthermore, the instruments comprise a lot of text in instruc-
tions, item questions, and response scales that further
increases the patient burden for completing the questionnaire.
Long questionnaires may impair patient acceptance and
increase the number of missing values, as observed for
example in the Swedish version of the CWIS.10 This is of
particular relevance in chronic wounds, because the majority
of affected patients are elderly11 who can benefit from short
and easy-to-read questionnaires.12 Therefore, there is need for
CWIS Cardiff Wound Impact Schedule
EQ VAS EuroQol visual analog scale on current health state
FLQA-w Freiburg Life Quality Assessment for wounds
HRQoL Health-related quality of life
NRS Numerical rating scale
WWS Würzburg Wound Scale
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society504
a short multidimensional instrument for usage in clinical
research and practice where time is restricted and often mul-
tiple assessments are made.
This article presents the development and preliminary vali-
dation of the “Wound-QoL,” a short, multidimensional ques-
tionnaire measuring HRQoL in chronic wounds. The content
of the Wound-QoL is based on the items of the three above-
mentioned wound-specific instruments FLQA-w, CWIS, and
WWS. We chose this approach because we assumed that all
relevant areas of HRQoL impairment due to chronic wounds
will be covered by at least one of the three instruments that
were developed by three different research groups indepen-
dently from each other.
METHODS
This study comprised the following steps that are described in
more detail below: (1) The three HRQoL instruments
FLQA-w, CWIS, and WWS were completed by patients
under routine care. (2) After defining the exact item pool, (3)
all items in the pool were grouped by content, and (4) psy-
chometric item properties were determined. (5) Based upon
these qualitative and quantitative analyses, items for imple-
mentation in the Wound-QoL were selected and wording was
harmonized. (6) Subscales were determined via factor analy-
sis. (7) The Wound-QoL was examined for internal consis-
tency and validity in a so-called virtual validation, which is a
newly developed approach that has—to our knowledge—not
been used previously.
Internal consistency refers to the degree of the interrelat-
edness among the items. It can be seen as an estimate of
reliability, i.e., the degree to which the measurement is free
from measurement error.13
Validity refers to the degree to which an instrument mea-
sures the construct it purports to measure.13
The wound-specific HRQoL instruments FLQA-w,
CWIS, and WWS
The FLQA-w5measures wound-specific HRQoL with 30
Likert-scaled items divided into the following subscales:
physical complaints (seven items), occupational and everyday
life (six items), social life (three items), psyche (eight items),
and stress caused by therapy (six items). Global HRQoL
ratings are additionally assessed with three 11-point visual
numeric rating scales.
The CWIS6consists of three scales: well-being (7 items),
social life (7 items), and physical symptoms and daily living
(12 items), with the latter two scales being assessed twice for
(1) the extent of experience and (2) how stressful the experi-
ence was during the preceding 7 days. This results in 45
Likert-scaled items overall. No global score is computed for
the CWIS. In addition, overall HRQoL is assessed with two
11-point numeric rating scales (0 to 10).
The WWS7consists of 17 Likert-scaled items, but no
subdimensions of HRQoL are assessed. In addition, it is
assessed if the patients need a walking aid and how many
minutes daily wound treatment takes.
Some item wordings within the three questionnaires refer
explicitly to impairments due to the wound (e.g., “To what
extent are you restricted in mobility due to the wound?” in
the WWS). Other items do not explicitly refer to the wound
(e.g., “disturbed sleep” in the CWIS), or the relation is made
only in the instruction (e.g., “The following questions
concern how you manage in everyday life with your wounds”
in the FLQA-w).
Step 1: longitudinal assessment of FLQA-w, CWIS,
and WWS
The questionnaires FLQA-w, CWIS, and WWS were imple-
mented in a prospective, noninterventional multicenter study
on adult patients with chronic wounds under routine care. The
patients were recruited at the University Medical Center in
Hamburg, Germany (Comprehensive Wound Center) and at
the Bundeswehrkrankenhaus (Armed Forces Hospital;
Department of Vascular Medicine) in Ulm, Germany. An
approval from the local ethics committee of the Hamburg
Medical Chamber was obtained prior to the study, and written
informed consent was obtained from all patients.
Each patient filled in all three questionnaires in randomly
varied order at baseline (T1) and at a follow-up visit after
4 to 12 weeks (T2). As concordant criteria, four measures
of generic HRQoL were assessed at both T1 and T2: Current
health state was measured with the EQ-5D-3L questionnaire
covering five dimensions (mobility, self-care, usual activities,
pain/discomfort, and anxiety/depression) and with the
EuroQol visual analog scale (EQ VAS) ranging from 0 =worst
imaginable to 100 =best imaginable health.14,15 The two
11-point numerical rating scales (NRSs) that are part of the
CWIS measured quality of life and satisfaction with quality of
life in the preceding 7 days.
In addition, sociodemographic data were collected in the
patient questionnaire at T1. Clinical data were collected in
physician questionnaires at both T1 and T2.
Step 2: determination of item pool
The three instruments FLQA-w, CWIS, and WWS comprise
a total number of 92 five-point Likert-scaled items. In the
CWIS, 19 items are assessed twice regarding how often the
patient had experienced the respective impairment and how
stressful the experience was. That is, item wording is equal,
but instruction and response scale differ. We computed
Pearson correlations between each of these 19 pairs of cor-
responding items to determine the extent of redundancy in
the information collected using T1 data of the longitudinal
study. No cutoff value for considering an intercorrelation as
highly redundant was defined a priori. Based upon these
data, we decided on whether to keep both experience and
stress items in the item pool or to use only one of these two
item groups.
Step 3: item grouping by content
All items of the item pool were grouped qualitatively. Items in
each group covered equal or similar content, and items could
be assigned to more than one group if they related to more
than one area of life. This step was performed by a method-
ologist specialized in quality of life measurement; the results
were double-checked by two clinicians with daily experience
with chronic wound patients.
Blome et al. Development of the Wound-QoL
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society 505
Step 4: determination of psychometric
item properties
As supporting data for the process of item selection, the
following quantitative properties of the items were deter-
mined, using T1 data of the longitudinal study:
Percentage of missing values, i.e., percentage of patients
who did not give an answer to the respective item
Pearson intercorrelation of each pair of items as an indi-
cator of redundant item information
Percentage of patients who chose the top boxes, i.e., one
of the two response levels indicating the highest impair-
ment (e.g., “often” or “always” for the FLQA-w item
“feelings of anger and rage”), assuming that a high per-
centage indicates that the respective item content is of
high relevance to the patients and should therefore be
included in the Wound-QoL.
Step 5: item selection and harmonization
The results of the qualitative and quantitative item analysis
(step 3 and 4) were discussed in depth by an expert group
including CB (research psychologist and methodologist spe-
cialized in patient-reported outcomes development), KB
(study nurse with several years’ experience in both manage-
ment of chronic wounds and patient-reported outcomes
assessment in patients with chronic wounds), and MA (leader
of a special consultation hour for chronic wound patients;
professor of quality of life research and health economics).
All relevant areas of HRQoL in chronic wounds as covered
by the item pool should be included in the Wound-QoL.
Therefore, from each group of items, at least one item should
be selected for implementation in the new questionnaire
Wound-QoL on the basis of the criteria of patient relevance,
nonredundancy, generality, and unambiguity, as described
below:
Patient relevance of the impairment assessed by the item
was judged by both clinical experience (qualitative)
and percentage of patient responses in top boxes
(quantitative).
No two items of redundant content should be chosen for
the Wound-QoL, as judged by qualitative item grouping
and quantitative level of intercorrelation.
Among similar items the more general ones (e.g., an item
on mobility in general) were preferred over the more
specific ones (e.g., an item on mobility outside the
home). This was done in order to cover a wider range of
impairments in one item and to thereby reduce the
overall number of items in the Wound-QoL.
• Items should be unambiguous, i.e., no two different
impairments should be addressed in the same item, and
items should use only common words.
The reasons for each choice of items by the expert group
were documented.
Upon selecting items for the Wound-QoL, instruction
wording and a consistent response scale for all items were
chosen. In some cases, item wording was improved and har-
monized to make items more understandable and less
ambiguous.
In addition, it was made explicit within each item that only
impairments resulting from the wound were assessed to make
sure that only disease-specific quality of life is measured but
not impairments due to comorbidities or life circumstances
(e.g., worrying in general vs. worrying about the wound).
The final Wound-QoL questionnaire was designed in two
different layouts, which were given to n=18 members of the
working group who were asked for aspects of the layout they
regarded as suitable and easy to fill in for patients with
chronic wounds. The results of this small survey were dis-
cussed in the working group, finding a consensus on the final
layout.
Step 6: determination of subscales
An explorative principal axes factor analysis with both
orthogonal and oblique rotation was performed on the final
items of the Wound-QoL using the study data of T1. Items
were assigned to the factor they loaded highest on to derive
Wound-QoL subscales on different dimensions of HRQoL in
chronic wounds.
Step 7: virtual validation of the Wound-QoL
Finally, a so-called virtual validation of the Wound-QoL was
conducted. With “virtual,” we mean that we used the data of
the longitudinal study (see step 1) and analyzed the items that
were selected for the Wound-QoL as if they had been given in
a single questionnaire (instead of being scattered over the
three original questionnaires). Thus, in the virtual validation,
item order and the partly changed wording and questionnaire
instructions in the final Wound-QoL could not be taken into
account.
A Wound-QoL global score was computed as the arithmetic
mean over all items, allowing for one missing response. The
subscale scores were computed as the arithmetic means over
the respective items; in case of missing data in any of the
respective items, the subscale score was considered missing
for the patient.
The following psychometrical properties of the Wound-
QoL were analyzed within the virtual validation:
To examine internal consistency (a form of reliability),13
Cronbach’s alpha was computed for the Wound-QoL
global and subscale scores at T1.
Item selectivity was computed for each item as corrected
item score correlation, both with regard to the Wound-
QoL global score and to the subscale scores at T1.
To determine convergent validity, the Pearson correlation
of the Wound-QoL global and subscale scores with the
following convergent criteria, as described in step 1, was
calculated: (1) NRS on overall quality of life; (2) NRS on
satisfaction with quality of life; (3) current health state as
measured with EQ-5D-3L; (4) EQ VAS on current health
state.
Responsiveness was determined by computing Pearson
correlations of Wound-QoL global and subscale scores
with change in the above-mentioned convergent criteria.
This was done by computing partial correlations of T2
data using T1 data as covariates. Responsiveness refers
to the ability of an instrument to detect change over time
in the construct to be measured; it can be estimated by
the association of change in the instrument score with
change in other measures on convergent criteria.13
For comparison, we also determined internal consistency,
validity, and responsiveness for the FLQA-w and WWS
Development of the Wound-QoL Blome et al.
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society506
global scores. For the CWIS, these psychometric properties
were investigated for the three scales because there is no
global CWIS score.
All analyses were conducted with SPSS 20.0 for Windows
(IBM Corp, Armonk, NY). Significance level was set at
p=0.05.
Ethical considerations
This noninterventional questionnaire study was conducted in
accordance with the Declaration of Helsinki and was
approved by the local ethical review committee in Hamburg.
RESULTS
Step 1: longitudinal assessment of FLQA-w, CWIS,
and WWS
Among the n=165 patients included in the study, n=154
(93.3 %) at least partially completed the Likert-scaled
HRQoL items of the three questionnaires FLQA-w, CWIS,
and WWS and were thus eligible for inclusion in the analysis
reported here. Demographic and clinical characteristics of
these 154 patients are reported in Table 1. Of these patients,
54.5 % were male; mean age was 65.3 years. Most current
wounds were documented by the physician as ulcus cruris
(63.0 %). The wounds had persisted for an average 26.6
months.
Results on psychometric properties of the three original
HRQoL questionnaires, which were, among others, high
internal consistency and validity, are not subject of this
article.8
Step 2: determination of item pool
Pearson correlation between each of the 19 pairs of corre-
sponding “experience” and “stress” items in the CWIS ranged
from r=0.66 to r=0.90 at T1 (average correlation: r=0.84).
For all but three of these item pairs, intercorrelations were
higher than r=0.8. Thus, the items on experience of and
stress due to different impairments did not gather exactly the
same information, but were statistically highly redundant; in
average, the information overlap was 71%.As a consequence,
we decided to keep only the items on stress due to the impair-
ments in the item pool. This reduced the initial pool of 92
items to the final item pool of 73 items.
Step 3: item grouping by content
The 73 items could be assigned to 12 different categories with
2 to 12 items each. Five items were also assigned to a second
category, because they covered more than one area of
HRQoL. For example, the FLQA-w item “My leisure activi-
ties are impaired due to the wound treatment” was assigned to
the two categories “Impairment of leisure activities” and
“Impairment due to treatment.” The categorization of all 73
items cannot be given in this article on account of space
restrictions, but category names with the respective number of
items can be found in Table 2.
Step 4: determination of psychometric
item properties
Because of space restrictions, the complete table of psycho-
metric properties for the whole item pool is not given in this
article, but numbers are given for the items that were chosen
for implementation in the Wound-QoL (Table 2).
In summary, there were only three items with more than
5% missing values. The WWS item on “decreased income
opportunities due to the wound” was not answered by 11.7%
of respondents, possibly because of the high percentage of
retired persons among patients with chronic wounds. The
CWIS items on “family/friends being overly protective” and
“difficulty in finding appropriate footwear” showed 5.2% of
missing items each. The percentage in the remaining items
ranged from 0% to 3.2%. The percentage of patients choosing
the top boxes, which indicate high impairment, showed a
wide range from 5.8% to 77.9%, depending on the item.
Step 5: item selection and harmonization
The expert group meeting took place in May 2012. Based on
the qualitative item grouping complemented by the quantita-
Table 1. Demographic and clinical characteristics of the study
participants at T1 (n= 154)
Mean SD Minimum Maximum
Age (years) 65.3 14.8 28 91
Body mass index 28.9 7.8 15.5 63.6
Duration of wound
persistence
(months)
26.6 50.6 1 432
n%
Sex
Male 84 54.5
Female 70 45.5
School education degree
No qualification 3 1.9
General secondary education 67 43.5
Intermediate secondary
education
51 33.1
Advanced technical college
entrance qualification
9 5.8
General qualification for
university entrance
24 15.6
Current wound
Ulcus cruris 97 63.0
Pyoderma gangrenosum 14 9.1
Ulcers due to surgery 13 8.4
Vasculitis 11 7.1
Diabetic foot ulcers 7 4.5
Other 12 7.8
n, number of patients; SD, standard deviation; T1, baseline
assessment.
Blome et al. Development of the Wound-QoL
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society 507
Table 2. Overview on categorization of items, item selection, and item adaptation for the Wound-QoL
Category
Number
of items*
Items selected for the
Wound-QoL
Percentage of
missing values
at T1 (in n= 154
patients)
Percentage of
patients choosing
top boxes at T1 (in
n= 154 patients)
Final item wording
in the Wound-QoL:
“In the last seven
days . . .”
Physical
impairments
11 Pain from the wound site
(CWIS)
3.2 37.7 . . . my wound hurt.
Is your night’s sleep impaired
due to the wound? (WWS)
0.0 26.6 . . . the wound has affected
my sleep.
Impaired mobility 7 I worry about bumping the
wound site. (CWIS)
0.0 70.1 . . . I have been afraid of
knocking the wound.
To what extent is your mobility
restricted due to the wound?
(WWS)
0.0 48.1 . . . I have had trouble
moving about because of
the wound.
Climbing stairs is difficult for
me. (FLQA-w)
0.6 52.6 . . . climbing stairs has been
difficult because of the
wound.
Discharge, smell,
and
appearance
6 Discharge from the wound
(FLQA-w)
0.0 42.2 . . . there was a disturbing
discharge from the
wound.
Unpleasant odor or smell from
the wound(s) (CWIS)
3.2 13.6 . . . my wound had a bad
smell.
Psychological
impairment
12 I feel frustrated with the time it
is taking for the wound(s) to
heal. (CWIS)
0.6 77.9 . . . I have felt frustrated
because the wound is
taking so long to heal.
I feel anxious about my
wound(s). (CWIS)
0.0 65.6 . . . I have worried about my
wound.
Dejection (FLQA-w) 0.0 18.2 . . . the wound has made
me unhappy.
Feeling disabled 2 (None) (None)
Expectation of
healing
or worsening
5 (+3) I worry that I may get another
wound in the future. (CWIS)
0.0 46.1 . . . I have been afraid of the
wound getting worse or
of new wounds
appearing.
Impairment of
everyday life
7 Problems with everyday
activities (e.g., shopping)
(CWIS)
3.2 32.5 . . . I have had trouble with
day-to-day activities
because of the wound.
Impairment of
leisure
activities
3 (+2) My leisure activities are
restricted due to the
condition. (FLQA-w)
1.3 53.9 . . . the wound has limited
my leisure activities.
Impairment of
social life
7 I limited activities with others.
(FLQA-w)
0.0 41.6 . . . the wound has forced
me to limit my activities
with others.
Being dependent
on help
4 I felt dependent on the help of
others. (FLQA-w)
0.6 38.3 . . . I have felt dependent on
help from others because
of the wound.
Impairment due
to treatment
6 (+3) The treatment is a strain on
me. (FLQA-w)
1.9 29.2 . . . the treatment of the
wound has been a
burden.
Financial burden 3 The wound is a financial burden
for me. (FLQA-w)
1.9 23.4 . . . the wound has been a
financial burden to me.
Total number 73 17 17
*Multiple assignments were possible. In brackets, the number of items with primary assignment to another category is given.
In brackets, the questionnaire from which the item originated is given. CWIS, Cardiff Wound Impact Schedule; FLQA-w, Freiburg Life Quality
Assessment for wounds; WWS, Würzburg Wound Score.
Development of the Wound-QoL Blome et al.
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society508
tive item data, 17 items were chosen for implementation in the
Wound-QoL. These items covered all item groups apart from
one that consisted of two WWS items on feeling sick or
disabled in comparison with healthy people. We decided not to
include this topic for two reasons: Firstly, the items did not
assess whether the fact of being disabled was a subjective
burden to the single patient. Secondly, we feared that the items
might upset patients by suggesting they were sort of
“unnormal,” making it unethically questionable to include the
items.
Among the selected items, seven originated from the
CWIS, eight from the FLQA-w, and two from the WWS.
None of these items showed a pairwise correlation higher than
r=0.8. The percentage of patients choosing the top boxes of
these items, which indicate high impairment, in the respective
area ranged from 18.2 to 77.9 % at T1 (Table 2).
We decided to assess all impairments within the period of
“the last 7 days” in both instruction and the introductory
phrase. We chose the five-step intensity assessment of “not at
all” to “very much” as the uniform response scale instead of
relating to frequency (e.g., “never” to “always”) or agreement
(e.g., “strongly agree” to “strongly disagree”).
Lastly, the final item wording (Table 2, right column) was
adapted in order to be compatible with the introductory phrase
and the response scale and to ensure easy and unambiguous
understanding by the patients. Furthermore, each item was
related explicitly to the wound, e.g., by adding the term “. . .
because of the wound.
Step 6: determination of subscales
Data of n=142 patients without missing values among the 17
items at T1 could be included in the factor analysis. Both
factor analysis with oblique and with orthogonal rotation led
to the same number of three factors with eigenvalue >1 (“Kai-
ser’s criterion”) and to the same assignment of items to
factors. Here, results of the orthogonal rotation, i.e., the solu-
tion with independent factors, are reported.
According to factor loadings, the items were assigned to
three subscales: The first scale was called “body”; it covered
five items on physical impairments such as pain, wound dis-
charge, and problems with sleeping. The second scale on
“psyche” covered five items on psychological problems such
as being afraid of deterioration, being unhappy, or feeling
frustrated because of slow healing. The scale on “everyday
life” covered six items on, e.g., leisure activities and depen-
dency on help by others. These three factors explained 23.3%
(everyday life), 15,2% (body), and 13.1% (psyche) of overall
variation, summing up to 51.6% cumulative explanation of
variance.
The item on financial burden showed its highest loading on
the physical dimension, but we chose not to include it in the
respective subscale, because the item content was not related
to the body and the factor loading was rather low with 0.40.
However, the item remained in the Wound-QoL and its global
score.
Step 7: virtual validation of the Wound-QoL
The Wound-QoL global score at baseline was 2.94 on
average, which corresponds with the response “moderately”
on the five-point response scale (Table 3). The stated impair-
Table 3. Change in Wound-QoL scales and convergent criteria from T1 to T2
Mean T1 SD T1 Mean T2 SD T2
Change from
T1 to T2 (mean)
Change from
T1 to T2 (SD)
Change from
T1 to T2 (p)
Correlation of
T1 and T2 (r)n
Wound-QoL scales (scaled 1–5):
Global score 2.94 0.85 2.76 0.87 0.18 0.52 <.001 0.82 126
Subscale 1: “everyday life” 2.94 1.18 2.76 1.20 0.17 0.74 0.011 0.81 121
Subscale 2: “body” 2.60 1.01 2.44 0.98 0.17 0.67 0.005 0.78 126
Subscale 3: “psyche” 3.36 3.15 0.77 0.89 0.20 0.67 <.001 0.69 137
Convergent criteria:
Overall satisfaction with quality of life (NRS, scaled
0–10)
5.40 2.15 5.68 2.06 0.28 2.05 0.115 0.53 136
Satisfaction with quality of life (NRS, scaled 0–10) 5.64 2.42 5.78 2.36 0.14 2.10 0.438 0.62 136
Current health state as assessed with the five-item
questionnaire EQ-5D-3L (scaled 0–100)
61.80 28.81 62.86 29.38 1.05 21.37 0.568 0.73 135
Current health state as assessed with the visual analog
scale EQ VAS (scaled 0–100)
55.65 21.64 57.01 22.27 1.36 17.68 1.36 0.68 137
EQ VAS, EuroQol visual analog scale; n, number of patients; NRS, numerical rating scale; p, level of significance in ttest for paired samples; r, Pearson correlation
coefficient; SD, standard deviation; T1, baseline assessment; T2, follow-up assessment.
Blome et al. Development of the Wound-QoL
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society 509
ment was slightly lower in the body subscale with 2.60 and
slightly higher in the psyche subscale with 3.36.
The distribution of global score and subscales at baseline is
given in Figure 1. It shows that the global score is about
normally distributed around the value 3 (“moderately”),
which represents the middle of the response scale.
At T2, the average global score was only slightly (however
significantly) lower with an average reduction of 0.18 points
(Table 3). The same was true for the subscales with an average
reduction of 0.17 to 0.20. Impairment in generic HRQoL and
current health state as measured by the convergent criteria
instruments also decreased on average, but this change was
not significant.
The internal consistency of both Wound-QoL global score
and subscale 1 was high with Cronbach’s alpha =0.91
(Table 4). Internal consistencies of subscales 2 and 3 were
also acceptable with 0.83 and 0.71, especially considering the
small number of only five items in each of both scales.
Convergent validity testing showed moderate correlations
of the Wound-QoL global score with all four criteria
(Table 4). The highest association was found regarding the
EQ-5D-3L questionnaire on current health state with r=0.69.
The Wound-QoL subscales showed a similar pattern of con-
vergent validity, with the associations being lower for
subscale 3 (psyche) with r=0.33 to 0.48. All correlations
were highly significant (p<0.001). The convergent validity
of the other HRQoL questionnaires FLQA-w, CWIS, and
WWS regarding the four criteria was lower or about as high as
that of the Wound-QoL. At maximum, there was a difference
of 0.04 units in favor of the WWS: Convergent validity
regarding overall QoL was r=0.48 in the Wound-QoL and
r=0.52 in the WWS.
As compared with convergent validity, responsiveness
values were lower (Table 4): The Wound-QoL global score
correlated to a small extent with the visual and NRSs (r=0.18
to 0.33) and moderately with the health state questionnaire
EQ-5D-3L (r=0.52; all p<0.05). For the Wound-QoL
subscales, a similar pattern of responsiveness values was
found, with the associations again being lower for subscale 3
(psyche). Except for the criterion EQ VAS, all subscale
responsiveness results were statistically significant (p<0.05).
Responsiveness of the other QoL questionnaires regarding the
four criteria was lower or about as high as that of the Wound-
QoL. However, with respect to the criterion of satisfaction
with QoL, a higher correlation of r=0.42 was found for the
WWS than for the Wound-QoL with r=0.32.
Item selectivity of the 17 items regarding the Wound-QoL
global score ranged from 0.31 to 0.71. The items with the
highest selectivity, i.e., those being most typical of the global
score, were those on limited activities with others (item selec-
tivity =0.75) and limited leisure activities (0.73). Item selec-
tivity for subscale 1 on everyday life ranged from 0.66 to 0.83
(the latter again in the item on activities with others). The
values for subscale 2 on body ranged from 0.56 to 0.70
(highest for the item on pain), and the values for subscale 3 on
psyche ranged from 0.34 to 0.59 (highest for the item on
being worried because of the wound).
The Wound-QoL in its final layout (English version) is
shown in Figure 2.
DISCUSSION
There has been need for a multidimensional instrument mea-
suring HRQoL in patients with chronic wounds that is both
short and easy to understand. Their features should help mini-
mize patient burden and ensure high data quality. We devel-
oped the one-page questionnaire Wound-QoL on the basis of
three different wound-specific instruments by covering the
instruments’ core contents with a smaller number of items.
Using data of a longitudinal study including the three instru-
ments, we performed a so-called virtual validation of the
newly developed Wound-QoL questionnaire. The results indi-
cate good internal consistency, validity, and responsiveness.
The main limitation of this study is that the questionnaire
could not be assessed in its final format yet. The Wound-QoL
items differ from the original items with regard to item order,
instruction wording, and response scale. Item wording was
optimized while largely keeping item content. Thus, the
virtual validation results can only serve as an estimation of the
true psychometric properties of the Wound-QoL. We are,
however, optimistic that the Wound-QoL will also prove valu-
able in the longitudinal validation study, which is currently
being conducted, for the following reasons: Because of its
brevity (one page), its consistent response-scale, and its focus
on comprehensible and consistently wound-related item
wording, we assume that the Wound-QoL may provide an
even more reliable and valid HRQoL evaluation than the
original instruments have been proved to do.
For a patient-reported outcomes instrument to be valid, it
must measure exactly what it is meant to measure. The
problem with proving the validity of quality of life instru-
ments is that in virtually all of these instruments—except for
mere short versions of existing questionnaires—there is no
proven gold standard to measure them against.16 If there was,
there would be no need to develop a new questionnaire. As a
substitute, correlations with existing questionnaires on the
same or on a related concept such as generic instead of
Figure 1. Distribution of Wound-QoL global score and
subscales at T1. T1, baseline assessment.
Development of the Wound-QoL Blome et al.
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society510
Table 4. Psychometric properties of the Wound-QoL global and subscale scores and of the WWS, CWIS, and FLQA-w in the “virtual validation”
Wound-QoL
global score
Wound-QoL
subscale 1:
“everyday life”
Wound-QoL
subscale 2:
“body”
Wound-QoL
subscale 3:
“psyche”
FLQA-w
global
score
CWIS
subscale
“well-being”
CWIS
subscale
“social life”
CWIS subscale
“physical symptoms
and daily living”
WWS
global
score
Number of Likert-scaled items 17 6 5 5 30 7 14 24 17
Internal consistency, T1
Cronbach’s alpha 0.91 0.91 0.83 0.71 0.89 0.75 0.93 0.95 0.92
n142 146 148 153 148 151 142 133 133
Convergent validity regarding
overall QoL (NRS), T1
r0.48 0.43 0.43 0.33 0.49 0.31 0.33 0.46 0.52
p<0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
n147 145 147 152 152 150 141 133 132
Convergent validity regarding
satisfaction with QoL (NRS),
T1
r0.55 0.50 0.45 0.44 0.53 0.46 0.48 0.53 0.59
p<0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
n147 145 147 152 152 150 141 133 132
Convergent validity regarding
current health state
(EQ-5D-3L), T1
r0.69 0.66 0.57 0.48 0.70 0.47 0.67 0.68 0.60
p<0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
n144 142 144 149 149 147 138 131 130
Convergent validity regarding
current health state (EQ VAS),
T1
r0.60 0.61 0.50 0.40 0.62 0.42 0.51 0.61 0.55
p<0.001 <.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
n148 146 148 153 153 151 142 133 133
Blome et al. Development of the Wound-QoL
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society 511
Table 4. Continued.
Wound-QoL
global score
Wound-QoL
subscale 1:
“everyday life”
Wound-QoL
subscale 2:
“body”
Wound-QoL
subscale 3:
“psyche”
FLQA-w
global
score
CWIS
subscale
“well-being”
CWIS
subscale
“social life”
CWIS subscale
“physical symptoms
and daily living”
WWS
global
score
Responsiveness regarding change
in overall QoL (NRS), T1
r0.33 0.36 0.32 0.19 0.32 0.16 0.20 0.26 0.34
p<0.001 <0.001 <0.001 0.026 <0.001 0.063 0.027 0.007 <0.001
n124 119 124 135 135 133 123 106 108
Responsiveness regarding change
in satisfaction with QoL
(NRS), T1
r0.32 0.35 0.28 0.22 0.36 0.24 0.32 0.27 0.42
p<0.001 <0.001 0.002 0.010 <0.001 0.006 <0.001 0.005 <0.001
n124 119 124 135 135 133 123 106 108
Responsiveness regarding change
in current health state
(EQ-5D-3L), T1
r0.52 0.54 0.39 0.28 0.51 0.24 0.48 0.51 0.52
p<0.001 <0.001 <0.001 0.001 <0.001 0.006 <0.001 <0.001 <0.001
n123 119 123 134 134 132 122 106 108
Responsiveness regarding change
in current health state (EQ
VAS), T1
r0.18 0.15 0.15 0.12 0.21 0.12 0.19 0.26 0.29
p0.046 0.111 0.096 0.169 0.015 0.181 0.034 0.009 0.003
n125 120 125 134 136 134 124 106 110
CWIS, Cardiff Wound Impact Schedule; EQ VAS, EuroQol visual analog scale; FLQA-w, Freiburg Life Quality Assessment for wounds; n, number of patients; NRS,
numerical rating scale; p, level of significance; QoL, quality of life; r, Pearson correlation coefficient; T1, baseline assessment; WWS, Würzburg Wound Score.
Development of the Wound-QoL Blome et al.
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society512
disease-specific HRQoL are often used as proxy criteria. This
is why we put so much emphasis on qualitative, content-based
development of the Wound-QoL instead of just picking those
items that in combination would show the highest correlation
with convergent criteria.
There was only a small increase in average quality of life as
measured with the Wound-QoL and other patient-reported
outcomes during the observation period of the study. This
might be due to the fact that within the period of 4–12 weeks
between the study assessments, chronic wound treatment
could not yet have a huge impact on HRQoL in many cases.
However, for validation purposes, it is only important that
there is interindividual heterogeneity in both current HRQoL
and change in HRQoL; in contrast, the size of the group effect
when averaging changes over all patients is not relevant.
Accordingly, the responsiveness correlations reported here
showed that changes in the Wound-QoL correspond with
changes in convergent criteria.
A further limitation of this study is the focus mainly on leg
ulcers. The three questionnaires WWS, FLQA-w, and CWIS
have been developed predominantly for patients with leg
ulcers. Only in the CWIS were diabetic foot ulcers included.
The majority of patients in our longitudinal study also had leg
ulcers. Thus, generalization of the study findings to other sorts
of chronic wounds needs to be done carefully. Furthermore,
two of the three established instruments were validated in
German language, whereas the third had been developed in
English and was subsequently translated to German.
Data assessment was conducted by two centers, a specialist
wound center and a military hospital, where patients may not
be representative for the population of patients with leg
wounds in Germany. In order to increase the representative
character of the study, we also included patients with commu-
nity ulcers in different regions as the Hamburg Comprehensive
Wound Center includes four peripheral office-based practices
that mostly provide health care to the general population.
In the virtual validation, it was found that the WWS had
good—in some cases even slightly better—validity and
responsiveness values as compared with the Wound-QoL. The
WWS also consists of only 17 Likert-scaled items as the
Wound-QoL does, but it covers four pages instead of only one
because of repetition of the response scale. More importantly,
no subscales have been developed for the WWS, and it is only
available in the original German version. In contrast, the
Wound-QoL has been translated to English using a thorough
procedure including double translation by professional trans-
lators, double back translation, comparison of all translations
against the original, developers’ and translators’ conference
discussing each single item, and final verification by a fifth,
independent translator.
In conclusion, the newly developed Wound-QoL was found
to be internally consistent, valid, and responsive in German
leg ulcer patients in the virtual validation analysis. It can be
used as a short and easy-to-understand instrument to assess
HRQoL in patients with chronic wounds, especially leg
ulcers. These findings need to be confirmed in the longitudi-
nal validation study on the final Wound-QoL, which is cur-
rently being conducted.
ACKNOWLEDGMENT
We thank Ms Zografia Anastasiadou for statistical advice.
Source of Funding: This study was not financially
supported.
Conflict of Interest: The authors declare no conflicts of
interests.
REFERENCES
1. Herber OR, Schnepp W, Rieger MA. A systematic review on the
impact of leg ulceration on patients’ quality of life. Health Qual
Life Outcomes 2007; 5: 44.
2. Gorecki C, Brown JM, Nelson EA, Briggs M, Schoonhoven L,
Dealey C, et al. Impact of pressure ulcers on quality of life in
older patients: a systematic review. J Am Geriatr Soc 2009; 57:
1175–83.
3. Lawall H. Treatment of chronic wounds. Vasa 2012; 41: 396–
409.
4. Gottrup F, Apelqvist J, Price P. Outcomes in controlled and
comparative studies on non-healing wounds: recommendations
to improve the quality of evidence in wound management. J
Wound Care 2010; 19: 237–68.
5. Augustin M, Herberger K, Rustenbach SJ, Schäfer I, Zschocke I,
Blome C. Quality of life evaluation in wounds: validation of the
Freiburg Life Quality Assessment-wound module, a disease-
specific instrument (FLQA-w). Int Wound J 2010; 7: 493–
501.
6. Price P, Harding K. Cardiff wound impact schedule: the devel-
opment of a condition-specific questionnaire to assess health-
related quality of life in patients with chronic wounds of the
lower limb (CWIS). Int Wound J 2004; 1: 10–17.
7. Spech E. Lebensqualität bei Patienten mit chronisch venösen
und arteriellen Ulcera cruris [dissertation]. Würzburg:
Universität zu Würzburg; 2003.
Figure 2. The final Wound-QoL questionnaire (English
version: translated from the original German version used in
this study).
Blome et al. Development of the Wound-QoL
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society 513
8. Acquadro C, Price P, Wollina U. Linguistic validation of the
Cardiff Wound Impact Schedule into French, German and US
English. J Wound Care 2005; 14: 14–17.
9. Augustin M, Baade K, Heyer K, Price P, Herberger K,
Engelhardt M, et al. Methodolody of quality of life evaluation in
chronic wounds: head to head comparison of three disease spe-
cific questionaires. Poster session presented at: Health Economy,
Outcome and Telemedicine, EWMA Conference,Vienna,
Austria. 2012.
10. Fagerdahl AM, Boström L, Ulfvarson J, Bergström G, Ottosson
C. Translation and validation of the wound-specific quality of
life instrument Cardiff Wound Impact Schedule in a Swedish
population. Scand J Caring Sci 2014; 28: 398–404.
11. Margolis DJ, Bilker W, Santanna J, Baumgarten M. Venous leg
ulcer: incidence and prevalence in the elderly. J Am Acad
Dermatol 2002; 46: 381–6.
12. Hickey A, Barker M, McGee H, Oboyle C. Measuring health-
related quality of life in older patient populations: a review of
current approaches. Pharmacoeconomics 2005; 23: 971–93.
13. Mokkink LB, Terwee CV, Patrick DL, Alonso J, Stratford PW,
Knol DL, et al. The COSMIN checklist for assessing the meth-
odological quality of studies on measurement properties of
health status measurement instruments: an international Delphi
study. Qual Life Res 2010; 19: 539–49.
14. EuroQol Group. EuroQol: a new facility for the measurement of
health-related quality of life. Health Policy (New York) 1990; 16:
199–208.
15. Schulenburg VDJ, Claes C, Greiner W, Uber A. Die deutsche
Version des EuroQoL Fragebogen. Z Gesundh Wiss 1998; 6:
3–20.
16. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW,
Knol DL, et al. The COSMIN study reached international con-
sensus on taxonomy, terminology, and definitions of measure-
ment properties for health-related patient-reported outcomes. J
Clin Epidemiol 2010; 63: 737–45.
Development of the Wound-QoL Blome et al.
Wound Rep Reg (2014) 22 504–514 © 2014 by the Wound Healing Society514
... To compensate for these defects, Blome et al. developed the Wound-QoL based on the above three wound-specific tools. 11 It was designed to assess the quality of life of patients with chronic wounds and has been translated and verified in numerous countries in Europe and North America. [12][13][14][15][16] However, it has not been verified and applied to the Chinese population. ...
... The Likert 5 scoring system (0-4) was adopted to indicate the impairment of life quality, with "0" indicating "not at all" and "4" indicating "very much." The questionnaire includes three subscales: the body subscale (items 1-5), the psyche subscale (items 6-10), and the day life subscale (items [11][12][13][14][15][16]. Item 17, regarding the financial burden, does not belong to any subscale. ...
... df = 120, P < 0.01, indicating suitability for exploratory factor analysis. Adopting the principal component method and orthogonal rotation of the maximum variance, four factors were extracted according to the gravel map: inner body (items 1 and 4), F I G U R E 1 Flow chart of translation procedure outer body (items 2 and 3), psyche (items 5-10), and daily life (items [11][12][13][14][15][16]. The cumulative variance contribution rate was 72.23%. ...
Article
We aimed to translate the 17‐item questionnaire to measure the quality of life of patients with chronic wounds (Wound‐QoL‐17) and verify its reliability and validity in the Chinese population. The standard Chinese version of the Wound‐QoL‐17 was determined through translation, back translation, and cultural adaptation. A total of 121 patients with chronic wounds from the wound center of a tertiary hospital in Beijing were recruited. Through a questionnaire and physical examination, we tested the criterion‐related validity, known group validity, structural validity, internal consistency coefficient (Cronbach's alpha), and test–retest correlation. A new structure of four factors was extracted by exploratory factor analysis, and the cumulative contribution rate was 72.23%. The total score and that of the four factors, which were significantly correlated with the EuroQol Five Dimensions Questionnaire (EQ‐5D) and the Short Form‐36 Health Survey (SF‐36) (P < 0.05), also showed statistically significant differences between patients with different pain grades, with or without wound odour, and between different groups of patients reporting wound changes in the past 2 weeks. Cronbach's alpha was between 0.779 and 0.906, while the test–retest reliability was between 0.532 and 0.802. We concluded that the Chinese Wound‐QoL‐17 has good reliability and validity and is suitable for evaluating the quality of life of patients with chronic wounds.
... In 5 of the 10 identified PROMs, 34,36,44,54,70 the development methodological quality was rated as inadequate because the design was not performed on a sample representing the target population. Regarding Wound-QoL design, 34 although members of the target population participated in it, the selection of items was based on their quantitative properties and on expert judgment of their relevance and comprehensibility. ...
... In 5 of the 10 identified PROMs, 34,36,44,54,70 the development methodological quality was rated as inadequate because the design was not performed on a sample representing the target population. Regarding Wound-QoL design, 34 although members of the target population participated in it, the selection of items was based on their quantitative properties and on expert judgment of their relevance and comprehensibility. Moreover, only the HRQLQDFU 44 was pilot tested to evaluate comprehensibility and comprehensiveness in its development stage. ...
... QoL,31,32,34,35,38,39,55,[67][68][69][70][71] and the Wound-QoL revised version. ...
Article
Full-text available
Objectives This psychometric systematic review aimed to identify the most suitable patient-reported outcome measures (PROMs) of quality of life (QoL) in people affected by diabetic foot. Methods We performed a literature search in MEDLINE (PubMed), CINAHL (EBSCOhost), and PsycINFO (EBSCOhost) databases from inception to February 1, 2022. We also searched gray literature databases. Eligible studies were full-text reports developing a QoL condition-specific PROM or assessing one or more of its measurement properties in people affected by diabetic foot. We assessed the methodological quality of included studies independently using the “Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of Bias” checklist. The measurement properties were evaluated using specific criteria. We graded the quality of the evidence using a “Grading of Recommendations Assessment, Development and Evaluation” approach modified by Consensus-Based Standards for the Selection of Health Measurement Instruments. Results Forty-three reports (46 studies) providing information on the measurement properties of 10 different PROMs were included. We did not identify any instruments that could be recommended for use. We identified 2 PROMs that were not recommended for use and 8 that were potentially recommended but would require further investigation. Of these 8 PROMs, 4 had better evidence for content validity. Conclusions Available PROMs to measure QoL in people affected by diabetic foot have limited evidence for their measurement properties. There is no fully suitable PROM. Pending further evidence, 4 PROMs could potentially be recommended for use.
... Each question was rated as 0 (no problem), 1 (some problem), or 2 (a lot of problems) (18), (4) The quality of life was assessed based on the 17-item Wound-QoL questionnaire, which includes items of physical disorder, local movement disorder, physical condition, psychological disorder, feeling of disability, daily activity disorder, social dysfunction, dependence on others, treatment disorder, and the financial burden (19). The items in this inventory ranged from 0 (not at all) to 1 (a little), 2 (moderate), 3 (quite a lot), and 4 (very much), and a higher total score indicated a poorer wound-related quality of life (20). The items of the questionnaire were structured in three subscales of "body" (items 1 to 5), "psyche" (items 6 to 10), and "everyday life" (items 11 to 16). ...
... Item 17 does not belong to either of the subscales. The total score ranged from 17 to 85; a higher score indicates a poorer quality of life (20). ...
Article
Full-text available
Background: Both purse-string sutures for surgical skin lesions and laser coagulation therapy are widely used to treat facial vascular malformations. The ultimate goal of using such treatments is to improve the appearance of these lesions and the patient's long-term satisfaction and quality of life. Objectives: Our study aimed to address the outcome of different therapeutic procedures in patients suffering from facial vascular malformations regarding long-term satisfaction, quality of scars, and quality of life. Methods: This self-control before-after interventional case series study was conducted on 60 consecutive patients with congenital vascular lesions. Patients were treated with purse-string methods along with coagulation, excision, and graft and ablation catheter. Before surgery and at intervals of one week, three weeks, six weeks, three months, and six months after surgery, the subjects were evaluated in terms of satisfaction, quality of scars, procedural outcomes, and quality of life. Results: There were significant changes in patients' satisfaction, quality of the scar, procedural outcomes based on the patient-reported outcome measures, and quality of life within six months after interventions. The improvement of the lesions was independent of gender, age, size, and the location of lesions. Conclusions: Regardless of the therapeutic approaches, significant improvements in postoperative outcomes concerning patients' satisfaction, quality of the scar, daily activities, and quality of life are expected in patients suffering from facial vascular malformations.
... They received education on infection indicators and asked to contact the clinic with concerns. Patients completed the wound quality-oflife (Wound-QoL) questionnaire 12,13 and scored their pain intensity on a scale of 0 to 10 using a visual analogue scale (VAS). After failing sufficient progress during the 2-week run-in period, subject eligibility was reconfirmed, and all eligible patients proceeded to randomisation. ...
Article
Full-text available
Diabetic foot infections continue to be a major challenge for health care delivery systems. Following encouraging results from a pilot study using a novel purified reconstituted bilayer matrix (PRBM) to treat chronic diabetic foot ulcers (DFUs), we designed a prospective, multi-centre randomised trial comparing outcomes of PRBM at 12 weeks compared with a standard of care (SOC) using a collagen alginate dressing. The primary endpoint was percentage of wounds closed after 12 weeks. Secondary outcomes included assessments of complications, healing time, quality of life, and cost to closure. Forty patients were included in an intent-to-treat (ITT) and per-protocol (PP) analysis, with 39 completing the study protocol (n = 19 PRBM, n = 20 SOC). Wounds treated with PRBM were significantly more likely to close than wounds treated with SOC (ITT: 85% vs 30%, P = .0004, PP: 94% vs 30% P = .00008), healed significantly faster (mean 37 days vs 67 days for SOC, P = .002), and achieved a mean wound area reduction within 12 weeks of 96% vs 8.9% for SOC. No adverse events (AEs) directly related to PRBM treatment were reported. Mean PRBM cost of healing was $1731. Use of PRBM was safe and effective for treatment of chronic DFUs.
Article
Objective The primary aim of this research was to investigate the combination effect of polyhexamethylene biguanide (PHMB) and low-frequency contact ultrasonic debridement (LFCUD) on the bacterial load in hard-to-heal wounds in adults, compared with ultrasonic debridement alone. Secondary outcomes included wound healing, quality of life (QoL) and pain scores. Method In this single-blinded, randomised, controlled trial participants were randomised to two groups. All participants received LFCUD weekly for six weeks, plus six weeks of weekly follow-up. The intervention group received an additional 15-minute topical application of PHMB post-LFCUD, at each dressing change and in a sustained dressing product. The control group received non-antimicrobial products and the wounds were cleansed with clean water or saline. Wound swabs were taken from all wounds for microbiological analysis at weeks 1, 3, 6 and 12. Results A total of 50 participants took part. The intervention group (n=25) had a lower bacterial load at week 12 compared with the control group (n=25) (p<0.001). There was no difference in complete wound healing between the groups (p=0.47) or wound-related QoL (p=0.15). However, more wounds deteriorated in the control group (44%) compared with the intervention group (8%, p=0.01). A higher proportion of wounds reduced in size in the intervention group (61% versus 12%, p=0.019). Pain was lower in the intervention group at week six, compared with controls (p=0.04). Conclusion LFCUD without the addition of an antimicrobial agent such as PHMB, cannot be recommended. Further research requires longer follow-up time and would benefit from being powered sufficiently to test the effects of multiple covariates.
Article
Foreword. Wound Hygiene: the next stage Since a panel published the first consensus document on Wound Hygiene in March 2020, there has been a flurry of activity in support of this newly established concept in proactive wound healing. ¹ The document concluded that all wounds, particularly hard-to-heal ones, will benefit from Wound Hygiene, which should be initiated at the first referral, following a full holistic assessment to identify the wound aetiology and comorbidities, and then implemented at every dressing change until full healing occurs. ¹ The consensus has since been bolstered by educational webinars; competency-based skills training and support; development of international Wound Hygiene ambassadors; a survey of 1478 respondents, published in July 2021; ² and a case study supplement, published in January 2022, featuring a range of wound types, anatomies and underlying conditions on the improvements in wound-healing progress that can be achieved. ³ Wound Hygiene has gained its own identity and is now a term in and of itself, that encompasses a 4-step protocol of care. It is an antibiofilm approach that is increasingly being used across wound care. The results of the survey ² were particularly encouraging for seeing how far Wound Hygiene has come, and how quickly: More than half (57.4%) had heard of the concept of Wound Hygiene Of those, 75.3% have implemented Wound Hygiene Overall, following implementation of Wound Hygiene, 80.3% of respondents reported improved healing rates. ² However, the top three barriers identified by the survey—lack of confidence, competence and research data—show that there is more to be done to support Wound Hygiene in practice. ² As a result, a consensus panel of international key opinion leaders convened virtually in the summer of 2021 to discuss what has been done so far, the outputs of the survey, and ideas for addressing the unmet needs identified by the results. The result is this publication, which represents an addendum to the initial consensus document, broadening support for implementation of Wound Hygiene. This document will reflect on the reasons Wound Hygiene has been successful in its first two years of implementation, reiterating its DNA: Do not wait to treat hard-to-heal wounds Use a simple 4-step approach Enable all healthcare professionals to implement and use Wound Hygiene. The document will also discuss the evolution of the Wound Hygiene concept, focusing on how and when to implement Wound Hygiene on all tissue types of hard-to-heal wounds, and proposing what these are. The panel has expanded the framework in which Wound Hygiene is used, with the ultimate objective of introducing the concept of ‘embedding Wound Hygiene intro a proactive wound healing strategy.’ Key inefficiencies are often observed along the journeys of people living with hard-to-heal wounds. The limited number of specialised healthcare professionals and the resulting delays in reaching them may increase the likelihood of a hard-to-heal wound developing. In a world where so much is happening so quickly that we may, at times, feel powerless to drive change, the panel wants to provide further guidance to propel the use of Wound Hygiene. The concept of Wound Hygiene is resonating, and the panel wants you to know that in whatever region you work, in whatever area of clinical practice, you are enabled to make this change. Wielding the 4-step Wound Hygiene protocol consistently is a key action every healthcare professional in every care setting can take to tackle the global wound care crisis. Wound Hygiene has taken off—now, where do we want to land? In a place where Wound Hygiene is practised on all wounds, at every stage, until healing. The panel once again recognises that the community of global healthcare providers should consider their local standards and guidelines when applying the recommendations of this document. To this end, the panel has created a flexible 3-phase framework that situates Wound Hygiene as integral to proactive wound healing. The panel hopes you will continue to implement Wound Hygiene and see the benefits it can bring to people living with wounds, as well as those who care for them.
Article
Full-text available
Healing time is protracted and ulcer recurrence is common in patients with venous leg ulcers. Although compression is the mainstay treatment, many patients do not heal timely. Physical activity may be a clinically effective adjunct treatment to compression to improve healing outcomes. This scoping review provides a broad overview of the effect of physical activity as an adjunct treatment to compression on wound healing and recurrence. We followed the six‐step framework developed by Arksey and O'Malley. We searched electronic databases and trial registration websites for relevant studies and ongoing trials. Two authors independently screened and selected articles. Findings were presented in a descriptive statistical narrative summary. We consulted and presented our findings to the wound consumer group to ensure the relevance of our study. Physical activity interventions in 12 out of the 16 eligible studies consisted of only one component, eight studies were resistance exercises, three studies reported ankle and/or foot range of motion exercises, and one study reported aerobic/walking exercises. The remaining four studies involved multicomponent exercise interventions. Resistance exercise combined with ankle and/or foot range of motion exercise minimised ulcer size on day 12 (intervention group: 4.55 ± 1.14 cm2 vs. control group: 7.43 ± 0.56 cm2) and improved calf muscle pump performance on day 8 (ejection fraction: 40%–65%; residual volume fraction: 56%–40%). We identified one study that reported ulcer recurrence rate with no clinical difference in the intervention group versus the control group (i.e., 12% in intervention vs. 5% in control). Our review identified that resistance exercise was the most common type of physical activity intervention trialled in the published literature. Resistance exercise combined with ankle and/or foot range of motion exercise appears to be effective adjunct treatments; however, the overall evidence is still relatively weak as most programmes had a short intervention period which limited clinical outcomes.
Article
Full-text available
Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for measurement of clinical effectiveness, cost effectiveness, and for shared decision making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, while other PROMs exist for patients with pain, while still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps which need to be addressed to develop a unifying PROM instrument for CLTI.
Article
Full-text available
In this trial, we evaluated the role of alginate dressings in the secondary intention wound healing and quality of life (QoL) after pilonidal sinus resection. The study was designed as a prospective randomised controlled trial (RCT). In the experimental group, alginate dressings with silver and high-G cellulose were introduced after elective pilonidal cyst excision, whereas in the control group, simple gauges were used. The primary end point was the difference in terms of the wound healing period. Blinding existed at the level of the investigator. Overall, 65 patients were included during the study period. Wound healing duration was comparable between the two groups (P = .381). No difference in postoperative pain scores or recovery outcomes was found. The experimental group was associated with reduced wound secretions at specific time end points. Similarly, no effect was identified, on overall Wound-QoL or SF-36 scores. Alginate dressings do not accelerate wound healing or improve QoL. Due to suboptimal sample size and several study limitations, further RCTs are required to confirm our findings.
Article
Full-text available
While there is a consensus that clinical practice should be evidence based, this can be difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group whose remit was to produce recommendations on clinical data collection in wound care. This document, produced by the group and disseminated by JWC, identifies criteria for producing rigorous outcomes in both randomised controlled trials and clinical studies, and describes how to ensure studies are consistent and reproducible.
Article
Full-text available
Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'. Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.
Article
The study directly compared the feasibility and performance of three instruments measuring health-related quality of life (HRQoL) in chronic ulcers: the Freiburg Life Quality Assessment for wounds (FLQA-w), the Cardiff Wound Impact Schedule (CWIS) and the Würzburg Wound Score (WWS). The questionnaires were evaluated in a randomly assigned order in a longitudinal observational study of leg ulcer patients. Psychometric properties (internal consistency, responsiveness and construct validity) were analysed. Patient acceptance was recorded. Analysis of n = 154 patients revealed good internal consistency (Cronbach's alpha ≥ 0·85) for all instruments. There were minor floor effects in all questionnaires (<1%) and some ceiling effects in the CWIS. Construct validity was satisfactory, for example, correlation with EuroQoL-5D was r = 0·70 in the FLQA-w, r = 0·47/0·67/0·68 in the CWIS dimensions and r = 0·60 in the WWS. The proportion of missing values was higher in the CWIS, and overall patient acceptance was highest in the FLQA-w for wounds (54% best preferences) and lowest in the WWS (14%). In conclusion, the FLQA-w, the CWIS and the WWS are reliable, sensitive and valid instruments for the assessment of HRQoL in leg ulcers. However, they show differences in clinical feasibility and patient acceptance.
Article
The EuroQol questionnaire is an index-instrument for measuring health- related quality of life. The aim of the research reported in this paper was to translate the EuroQol questionnaire into German, to prove the reliability, practicability and validity of this version and to compare with results of other European countries. 1,000 households across Germany were randomly selected. The questionnaires were sent oat by mail in June 1994. In the third part of the questionnaire only sixteen health states are valued directly. As there are 243 possible states the remaining scores have to be modelled. OLS regression model was employed to do this. The validity of the questionnaire was tested by focusing on the health status of different groups. Three of the well established hypotheses in the published literature were considered. The discriminant validity of the EuroQol was tested by examining the floor and the ceiling effect of the measure. As a result of the study it can be concluded that the questionnaire has sufficient validity and reliability to be used in economic evaluation studies. The sensitivity of the questionnaire is low, so it is recommended for use in studies in which higher differences in quality-of-life are expected.
Article
The EuroQol questionnaire is an index-instrument for measuring health-related quality of life. The aim of the research reported in this paper was to translate the EuroQol questionnaire into German, to prove the reliability, practicability and validity of this version and to compare with results of other European countries. 1,000 households across Germany were randomly selected. The questionnaires were sent out by mail in June 1994. In the third part of the questionnaire only sixteen health states are valued directly. As there are 243 possible states the remaining scores have to be modelled. OLS regression model was employed to do this. The validity of the questionnaire was tested by focusing on the health status of different groups. Three of the well established hypotheses in the published literature were considered. The discriminant validity of the EuroQol was tested by examining the floor and the ceiling effect of the measure. As a result of the study it can be concluded that the questionnaire has sufficient validity and reliability to be used in economic evaluation studies. The sensitivity of the questionnaire is low, so it is recommended for use in studies in which higher differences in quality-of-life are expected.
Article
Purpose: To translate and validate the wound-specific health-related quality of life instrument, the Cardiff Wound Impact Schedule (CWIS) in a Swedish population. Methods: The instrument was first translated into Swedish, using the Standard Linguistic Validation Process. The Swedish version of the CWIS was then tested for its psychometric properties in a Swedish context. A total of 117 patients with acute and hard-to-heal wounds were included. The patients were asked to fill in the Swedish version of the CWIS and the generic instrument SF-36 at baseline and after 1 week. Patients with acute wounds were also asked to fill in both instruments after 6 weeks. Results: Face validity and content validity were assessed by patients and an expert group, and judged as good. Criterion validity was calculated with correlation between CWIS and SF-36, reaching moderate to high values. Reliability of the three domains of the CWIS measured with internal consistency and test-retest stability was acceptable to excellent. Internal responsiveness was assessed with standardised response mean and showed moderate to high sensitivity. Conclusions: This study concludes that the Swedish version of CWIS is a valid and reliable tool for measuring health-related quality of life in patients with acute and hard-to-heal wounds.
Article
In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed In the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states (see Table 3). The data were collected using a visual analogue scale similar to a thermometer (see Table 2). The EuroQol Instrument Is Intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group.
Article
Treatment of underlying diseases is of paramount importance due to the complex genesis of chronic wounds. This should be followed by a stage-adapted wound treatment, which usually consists of a phase-adapted wound debridement, ensued by a moist wound treatment. In case of epithelialization, a phase-specific shift to dry wound treatment should be performed. Despite the growing number of new wound dressings and therapeutics, current scientific data is incomplete, and evidence for the effectiveness of these wound dressings is only sparse. No significant advantage of one wound dressing over the other exists. The status of negative pressure treatment is still controversial, and no clear evidence is present. In order to achieve a permanent treatment success, causal therapy of venous obstructions and/or arterial disorders is of importance. Systematic and consistent compression therapy is of utmost significance when treating venous wounds.
Article
Many patients with chronic wounds suffer not only directly from their wounds but also from high financial, social and psychological impairments, significantly reducing their quality of life. In order to provide an instrument both applicable to different patient populations and sensitive to areas of impact specific to certain skin diseases, the modular instrument ‘Freiburg Life Quality Assessment' has been developed. Each disease-specific version of the instrument consists of a core module of generic items and items specific for a distinct skin disease. Objective of the study was to assess reliability, sensitivity to change, and validity of the module for chronic ulcers. The instrument was implemented in a longitudinal observational study on vacuum-seal therapy (n = 175), in a cross-sectional observational study involving patients with chronic leg ulcers (n = 384) and in a randomised clinical trial on keratinocyte transplantation (n = 198). The instrument showed good internal consistency (Cronbach's alpha ≥0·85). There were minor floor effects ≤4·3%, but no ceiling effects. Retest-reliability and convergent validity with the EuroQol quality of life questionnaire (EQ-5D) (visual analogue scale) were satisfactory. Change scores correlated with change in other quality-of-life instruments (r = 0·59–0·61), but not with change in wound status.