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Development, validation and psychometric

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Journal of Tissue Viability (2015) 24, 24e34

www.elsevier.com/locate/jtv

Clinical study

Development, validation and psychometric

analysis of the diabetic foot self-care
questionnaire of the University of Malaga,
Spain (DFSQ-UMA)
Emmanuel Navarro-Flores a,*, José Miguel Morales-Asencio a,
José Antonio Cervera-Marı́n a, Ma Teresa Labajos-
Manzanares b, Gabriel Gijon-Nogueron a

a
Department of Nursing and Podiatry, Faculty of Health Sciences, University of Malaga,
C/Arquitecto Francisco Peñalosa, Ampliación del Campus de Teatinos, 29071 Málaga,
Spain
b
Department of Physiotherapy, Faculty of Health Sciences, University of Malaga,
C/Arquitecto Francisco Peñalosa, Ampliación del Campus de Teatinos, 29071 Málaga,
Spain

KEYWORDS Abstract This paper assessed the reliability and construct validity of a tool to
Diabetes; evaluate the foot self-care of diabetic patients. The education of diabetic patients
Diabetic foot; about their foot care is a major issue to avoid complications like amputations and
Self-care; ulcers. Specific tools aimed to assess patient’s knowledge in this area are needed.
Instrument develop- The study had two phases: in Phase 1, item-generation was carried out through a
ment; literature review, expert review by a Delphi technique and cognitive interviews
Reliability; with diabetic patients for testing readability and comprehension. In Phase 2, dia-
Validity betic patients participated in a cross-sectional study for a psychometric evaluation
(reliability and construct validity) was carried out on a sample of type I and II dia-
betic patients. The study was conducted at the University of Malaga (Spain), podi-
atric clinics and a Diabetic Foot Unit between October 2012 and March 2013.
After psychometric-test analyses on a sample of 209 diabetic patients, the ques-
tionnaire resulted in 16 questions. Cronbach’s alpha was 0.89 after removing 4
items because of their low reliability. Inter-item correlations gave a mean value

* Corresponding author.
E-mail addresses: emmnavflo@uma.es (E. Navarro-Flores),
jmmasen@uma.es (J.M. Morales-Asencio), jacervera@uma.es
(J.A. Cervera-Marı́n), mtlabajos@uma.es (M aT. Labajos-
Manzanares), gagijon@uma.es (G. Gijon-Nogueron).

http://dx.doi.org/10.1016/j.jtv.2014.11.001
0965-206X/ª 2014 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.
Questionnaire of the diabetic foot self-care 25

of 0.34 (range: 0.06e0.74). The rotated solution showed a 3-factor structure (self-
care, foot care, and footwear and socks) that jointly accounted for 60.88% of the
variance observed. The correlation between the questionnaire scores and HbA1c
was significant and inverse, (r ¼ 0.15; p < 0.01). The findings show that the ques-
tionnaire is a valid and reliable tool for evaluating foot self-care behavior in dia-
betic patients.
ª 2014 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.

Introduction any professional mediation [20] and are intended

There are many instruments available for evalu-
ating care and self-care behaviors in diabetic pa-
tients, like Neuropathic Total Symptom Score or
S4-MAD [7,35], but very few exclusively evaluate
foot self-care and they mix questions about self-
care with questions relative to general care, as
the Diabetic Foot Ulcer Scale (DFS) or the Foot
Ulcer Scale-short form (DFS-SF) [1,6]. On the other
hand, current instruments more specific for foot
self-care present some shortfalls, as an elevated
number of items [12] or an insufficient or non-
thorough validation process [27].
Generally, education on foot care is directed
mainly at patients with a history of complications,
above all those with rising levels of HbA1c and
those having had diabetes for several years [33]. In
addition, while many of the studies focus on pre-
venting the risk of ulcers and amputations
[9,11,15,41], very few are aimed to determine the
specific degree of foot self-care in the population
having diabetes mellitus [27,32,33,36,42].
World prevalence of diabetes is predicted to
rise from 2.9% in the year 2000 to 4.4% by the year
2030, when an estimated 366 million people will
suffer the disease [22]. Foot ulcers, one of the
main complications of diabetes, appear in 15%e
25% of the patients at some point along their lives
[13,41,45]reducing their health-related quality of
life (HRQoL), both in terms of physical integrity, as
well as psychological function [46].
All these factors can be prevented by adequate
prevention measures and early diagnosis of alter-
ations [9], particularly by patient’s self-care. Dia-
betological education is one of the key elements
for this aim, being recommended in most of clin-
ical guidelines as the standard for managing the
diabetic foot [23].
In this sense, the development of tools with
informed results for the patients themselves (Pa-
tient-Reported Outcomes, PRO) constitutes a
growing approach in recent years, especially in the
field of attention to chronic diseases. PRO are self-
reports on the health status of patients without
to record concepts related to the patients’ expe-
riences and feelings, or how they function in
relation to their illness and treatment [26]. These
reports go further the classical end-points in trials
(efficacy, safety, etc) and their use in experi-
mental studies is proliferating, particularly in drug
clinical trials. HRQoL is one of the most wide-
spread, although it can also be applied to other
areas, such as self-care.
One of the consequences is the scarcity of the
specific information, based on solid evidence when
advising diabetic patients on foot care [21].
Currently, only two specific guides exist for this
problem: the one published by the American Dia-
betes Association (ADA) and the one by the Inter-
national Working Group on the diabetic foot
[5,23].
Furthermore, patients qualified as low-risk can
develop complications relatively fast in the
absence of good glycemia monitoring and
adequate self-care practices [33]. Consequently,
focus should not be placed exclusively on patients
with a record of complications. The foot care
carried out by diabetic patients, regardless of their
history of complications, would help to ensure
early interventions in cases of deficient self-care.
For this, it would be recommendable to use an
instructive tool for the patient, easy to use in the
daily practice, and with adequate validity and
reliability. The aim of this study is to design and
validate a tool to evaluate the foot self-care of
diabetic patients in order to generate a specific
PRO.
Methods
Sample and setting
A cross-sectional validation study was conducted
at the University of Malaga (Spain), podiatric
clinics and a Diabetic Foot Unit between October
2012 and March 2013. The study had two phases: in
Phase 1, item generation was carried out through a
literature review. This items list underwent an
26
expert review and consensus by Delphi technique.
Experts were professors from the Department of
Nursing and Podiatry and two external reviewers,
one of them a clinical nurse specialist on diabetic
foot and the other one an endocrinologist.
Following, cognitive interviews to diabetic pa-
tients for testing readability and comprehension
were performed. In Phase 2, diabetic patients
participated in a cross-sectional study for a psy-
chometric evaluation of the questionnaire devel-
oped in the first phase (Fig. 1).
Phase 1 item generation and content validity
The authors reviewed the literature on HRQoL,
pain and functionality instruments for foot care
questionnaires, selecting the Spanish versions of SF
36 [3], the Spanish versions of Manchester Foot
Pain and Disability Index (MFPDI) [18], Disabilities
of the Arm, Shoulder and Hand [38], Western
Ontario and McMaster Universities Osteoarthritis
Index [8], and Nottingham Assessment of Func-
tional Footcare (NAFF) [28]. From this review, a
total of 60 items for analysis were proposed to the
expert panel to evaluate their appropriateness.
The expert panel was integrated by two podia-
trists specialized on diabetic foot, one endocri-
nologist, one specialist nurse on diabetic foot and
one expert on questionnaire development and
validation. All of them had more than 10 years of
expertise on treating diabetic patients, except the
methodologist. Additionally, panelists were asked
Fig. 1 Process of item evaluation.
E. Navarro-Flores et al.
to respond to the following open-ended questions:
“What are the most important aspects of foot self-
care in diabetic patients? Why are they so impor-
tant? Why do you think that other self-care aspects
are not as much important as those ones that you
have selected? The open responses were analyzed,
grouping them by frequency and commonalities.
The most frequent responses were some particular
aspects of foot care as use of adequate shoes, foot
hygiene, and the main reason argued was that they
were associated with a decrease in foot
amputations.
The questionnaire was filled out individually by
each expert scoring the 60 items on a scale from 1
to 9. Two rounds were necessary for obtaining
consensus. Following the first round, 30 items were
selected after applying the following criteria:
consensus was determined when the median score
given by more than 75% of the experts was over 6
(consensus on item selection), or below 4
(consensus on item deletion) [30]. Those items
scored between 4 and 6 were undergone to a new
round. Following this phase, the 22 items version
was obtained [40]. Some examples of items
deleted were “Use of socks for warming your
feet”, “Use of sport shoes”, “Use of flip-flops”.
This preliminary 22 items version was validated
by diabetic patients through cognitive interviews. A
group of 30 diabetic patients that regularly visit the
Podiatry Clinic at the Faculty of Health Sciences in
the University of Malaga were invited to participate
in the interviews with the aim of evaluating the
Questionnaire of the diabetic foot self-care
readability and understandability of the proposed
items. Respondents first were asked to interpret in
a consistent manner what did they understand
about each item. They had to recall the information
available to them in order to make a judgment and
fit it into the question. All interviews were con-
ducted in person by a member of the team, who
recorded the answers by mean of a Likert scale
(range 1e5 in ascending order of readability, un-
derstandability and fit of their information to the
question), that represented their difficulties with
the item. Moreover, verbal and non-verbal cues
about their perception of the item contents were
taken into account for the evaluation of their un-
derstanding [39]. The information given by the pa-
tients during the cognitive interviews led to revise
or delete some items for clarity reasons (those
items scored by patients below 3), and the ques-
tionnaire was reduced to 20 items.
Once designed the definitive items, a scale with
5 possible options that represented the adequacy
of the self-care behavior was added: (1, very
inadequate; 2, inadequate; 3, fair; 4, adequate;
and 5, very adequate), except some items that
explored the frequency of a determined self-care
activity (1, Never; 2, Rarely; 3, Sometimes; 4,
Often; 5, Always) (Fig. 2).
Fig. 2 represents the whole process from the
item generation to the final version.
Phase 2 reliability analysis and construct
validity test instrument
1) Inclusion criteria
The inclusion criteria were: to have diabetes
mellitus type I or II and to be over 18 years of age.
The exclusion criteria were: to be illiterate, or to
have any amputation of the lower limbs.
2) Recruitment process
The Podiatry Clinic of the Faculty of Health
Sciences of the University of Malaga were
selected, private podiatric clinics and from the
Diabetic Foot Unit, in Malaga.
3) Procedure
After the patients gave their informed consent,
they individually filled out the questionnaire of 20
items.
In addition, the questionnaire included socio-
demographic information and health information
(sex, age, glycosylated hemoglobin (HbA1c), and
27
years with diabetes, weight, height, and educa-
tional level).
Data analysis
An exploratory data analysis was performed which
included descriptive statistics and an analysis of
data normality by the KolmogoroveSmirnov test.
Internal consistency was evaluated by Cronbach’s
a coefficient. Cronbach’s a coefficient of 0.7 or
above was considered satisfactory [29], and Pear-
son’s correlations were used for inter-item and
item-total correlations.
Floor and ceiling effects were evaluated, select-
ing values between 1% and 15% as optimal [31].
For test-retest reliability, a sub-sample of pa-
tients (n ¼ 30) completed the questionnaire. Kappa
statistics with 95% CIs were computed to verify the
level of inter-rater agreement concerning the
different care categories (minimum, intermediate,
semi-intensive, and intensive). Weighted kappa
was chosen to consider the level of disagreement,
in terms of the seriousness between evaluators [4].
The k-values were interpreted using [4] levels of
agreement, as follows: <0.20 (poor), 0.21e0.40
(fair), 0.41e0.60 (moderate), 0.61e0.80 (good),
and 0.81e1.00 (very good).
Exploratory factor analysis (EFA) and its factor
structure were analyzed using the principal-
component analysis with non-orthogonal rotation
(oblimin). The Kaiser-Meyer-Olkin (KMO) test and
Bartlett’s test of sphericity were used to assess the
appropriateness of the sample for the factor
analysis. Eigen values above 1 and a scree plot
were used to determine the number of factors.
Factor loadings equal to or greater than 0.4 were
considered appropriate [36]. Criterion validity was
analyzed by parametric and nonparametric corre-
lation coefficients between the questionnaire and
glycosylated hemoglobin (HbA1c) and glucose. This
gold standard was used because of the high risk of
foot complications derived from HbA1 values over
7% [17] and the relation between HbA1 levels and
patient self-care.
All statistical analyses were performed using the
SPSS version 20.0 [IBM SPSS Statistics SPSS Inc,
2010].
Ethical considerations
Before undertaking the research, the procedures
were approved by The Medical Research Ethics
Committee of Faculty of Health Sciences, Univer-
sity of Malaga (ID: 07/2011) and conducted in
accordance with the Declaration of Helsinki.
28 E. Navarro-Flores et al.

Fig. 2 Spanish questionnaire: The diabetic foot self-care questionnaire of the University of Malaga (DFSQ-UMA).
Questionnaire of the diabetic foot self-care 29

Table 1 Characteristics of the patients.

Male (n ¼ 101) Female (n ¼ 108) Total (n ¼ 209) p
X(SD) or n(%) X(SD) or n(%)
Age 57.78 (16.09) 64.66 (16.73) 0.03
Years with diabetes 12.16 (10.23) 14.63 (11.42) 0.101
Glucose 132.07 (40.30) 136.51 (40.17) 0.470
Hb1AC 7.02 (1.19) 7.32 (1.22) 0.167
BMI 27.88(4.43) 28.03 (5.89) 0.840
Type of diabetes
Type I 29 (60.4) 19 (39.6) 48
Type II non insulin-dependent 41 (43.6) 53 (56.4) 94 0.153
Type II insulin-dependent 31 (46.3) 36 (53.7) 67
Educational level
Minimum 18 (40.0) 27 (60.0) 45
Primary 29 (40.3) 43 (59.7) 72 0.042
Secondary 28 (53.8) 24 (46.2) 52
University 26 (65.0) 14 (35.0) 40

Results The results of the foot health questionnaire

Participants
A total of 209 diabetic patients responded to the
questionnaire. Of the sample, 108 (51.7%) were fe-
males and 101 (48.3%) were males. The average age
was 61.33 years (16.74 year), the average duration
of the diabetes was 13.44 years (10.90), the mean
glycemia was 134.43 (40.16), and the mean glyco-
sylated hemoglobin was 7.1 (1.20) (Table 1). By
sex, the only significant difference was age, which
was greater in females, and level of studies, with
males having more university education (Table 1).
showed a mean of 2.70 (1.45) points in all ı́tems,
with the item more high “Do you generally examine
your foot yourself? 3.31 (1.27) and the more down
“Is it hard to find socks that are right for your feet?”
2.21 (1.66). The distribution of scores for each item
is shown in Table 2. No ceiling/floor effect was
detected.
Reliability analysis
Cronbach’s alpha was 0.89. Inter-item correlations
obtained a mean value of 0.34 (range: 0.06e0.74).
Table 2 lists the distribution of scores and item-total

Table 2 Descriptive scores and reliability of items.

Mean (SD) Corrected item-total Cronbach’s alpha
correlation if item Deleted
Do you generally examine your foot yourself? 3.31 (1.27) 0.367 0.891
Do you inspect your nails? 3 (1.39) 0.515 0.887
Do you look for sores and examine the state 2.96 (1.5) 0.553 0.885
of the skin of your feet by yourself?
Is it hard for you to dry your feet after showering? 2.44 (1.59) 0.632 0.882
How often do your cut or treat your toenails? 2.37 (1.22) 0.557 0.885
To dry your feet . 2.92 (1.24) 0.531 0.886
To heat your feet . 2.55 (1.77) 0.543 0.886
To treat skin sores, dry skin patches, and calluses . 2.69 (1.77) 0.382 0.893
Regarding summer footwear, with excessive heat, . 2.71 (1.28) 0.609 0.883
Regarding conventional footwear, before using it . 2.86 (1.24) 0.504 0.887
Regarding socks . 2.89 (1.42) 0.578 0.884
Regarding new shoes . 2.35 (1.59) 0.635 0.882
Is it hard to find comfortable shoes for your feet? 2.31 (1.5) 0.541 0.886
Is it hard to find socks that are right for your feet? 2.21 (1.66) 0.589 0.884
How important do you consider personal 2.87 (1.37) 0.666 0.881
care of your feet?
Regarding the recommendations on how to 2.78 (1.55) 0.651 0.881
take care of your own feet .
30 E. Navarro-Flores et al.

Table 3 Inter-item correlation matrix.

Do you Do you Do you look Is it hard How often To dry To
generally inspect for sores and for you to dry do your cut your heat
examine your nails? examine the your feet after or treat feet . your
your foot state of the showering? your feet .
yourself? skin of your toenails?
feet by yourself?
Do you generally 1
examine your foot
yourself?
Do you inspect your 0.578 1
nails?
Do you look for sores 0.688 0.612 1
and examine the
state of the skin of
your feet by yourself?
Is it hard for you to dry 0.15 0.346 0.279 1
your feet after
showering?
How often do your cut 0.141 0.401 0.253 0.539 1
or treat your
toenails?
To dry your feet . 0.345 0.345 0.387 0.448 0.301 1
To heat your feet . 0.116 0.26 0.289 0.326 0.345 0.284 1
To treat skin sores, dry 0.218 0.326 0.34 0.306 0.21 0.127 0.19
skin patches, and
calluses .
Regarding summer 0.109 0.2 0.208 0.494 0.372 0.437 0.404
footwear, with
excessive heat, .
Regarding conventional 0.152 0.227 0.305 0.274 0.217 0.373 0.302
footwear, before
using it .
Regarding socks . 0.199 0.274 0.349 0.326 0.3 0.248 0.493
Regarding new shoes . 0.045 0.185 0.173 0.489 0.438 0.41 0.459
Is it hard to find 0.066 0.115 0.129 0.529 0.48 0.288 0.389
comfortable shoes for
your feet?
Is it hard to find socks 0.052 0.127 0.11 0.564 0.489 0.318 0.474
that are right for your
feet?
How important do you 0.517 0.51 0.632 0.379 0.329 0.421 0.351
consider personal
care of your feet?
Regarding the 0.439 0.408 0.527 0.404 0.328 0.31 0.376
recommendations on
how to take care of
your own feet .

correlations. The inter-item correlation matrix is
detailed in Table 3.
Inter-rater reliability
Two independent researchers assessed the foot
health of 15 patients each with the instrument.
Agreement levels varied from kappa 0.84 (95% CI:
0.37e0.98) to 0.97 (95% CI: 0.93e1.0) and the ICC
ranged from 0.89 (95% CI: 0.78e0.94) to 0.92 (95%
CI: 0.81e0.96) (Table 4).
Construct validity (factor analysis)
The Kaiser-Meyer-Olkin was 0.89, and the Bar-
tlett’s test of sphericity was significant (p < 0.001)
Questionnaire of the diabetic foot self-care 31

To treat Regarding Regarding Regarding Regarding Is it hard Is it hard How Regarding

skin sores, summer conventional socks . new to find to find important the
dry skin footwear, footwear, shoes . comfortable socks that do you recommendations
patches, with before shoes for are right consider on how to take
and excessive using your feet? for your personal care of your
calluses . heat, . it . feet? care of own feet .
your feet?

0.206 1

0.241 0.428 1

0.22 0.432 0.434 1

0.137 0.602 0.512 0.478 1
0.18 0.492 0.249 0.307 0.53 1

0.158 0.48 0.289 0.403 0.661 0.74 1

0.362 0.374 0.374 0.453 0.389 0.248 0.323 1

0.424 0.396 0.361 0.442 0.382 0.353 0.332 0.539 1

showing sampling adequacy. The rotated solution Criterion validity

showed a 3-factor structure for the questionnaire
that jointly accounted for 60.88% of variance
observed: personal self care (items 1, 2, 3, 4, 5, 6,
7), podiatric care (items 8, 9, 10, 11), and foot-
wear and socks (items 12, 13, 14, 15, 16).
The correlation between the questionnaire scores
and HbA1c was significant and inverse, (r ¼ 0.15;
p < 0.01), as well as for plasma glucose (r ¼ .226;
p < 0.05).
32 E. Navarro-Flores et al.

Table 4 Factor analysis. The definitive questionnaire showed an excellent

Component
1 2
Do you generally examine your 0.898
foot yourself?
Do you inspect your nails? 0.850
Do you look for sores and 0.821
examine the state of the skin
of your feet by yourself?
Is it hard for you to dry your feet 0.618
after showering?
How often do your cut or treat 0.504
your toenails?
To dry your feet . 0.464
To heat your feet . 0.430
To treat skin sores, dry skin 0.836
patches, and calluses .
Regarding summer footwear, 0.835
with excessive heat, .
Regarding conventional 0.802
footwear, before using it .
Regarding socks . 0.768
Regarding new shoes .
Is it hard to find comfortable
shoes for your feet?
Is it hard to find socks that are
right for your feet?
How important do you consider
personal care of your feet?
Regarding the recommendations
on how to take care of your
own feet .
Discussion
The aim of this study was to design and validate a
PRO for the levels of foot self-care among diabetic
patients, and in a self-administered version,
focused on self-assessment, self-care activities,
and shoe and socks use.
This instrument has obtained a strong face and
content validity as a result of the comprehensive
initial validation process that included an exten-
sive review of related instruments and question-
naires, a panel of experts that judged and
proposed items, and cognitive interviews with
patients. This last measure allowed to obtain
direct patients’ input to assess their underlying
comprehension about each item and, above all,
how their previous knowledge and information
about foot self-care was represented in each item
[24] Despite cognitive interviews has been used in
different areas to develop PROs for people with
chronic conditions and concretely in diabetic pa-
tients [10,34], some of the current instruments for
evaluating foot self-care did not incorporate this
methods during its development [12,27].
overall internal consistency in a trifactorial struc-
ture that represents 60.88% of the total observed
3
variance, indicating a good psychometric perfor-
mance. The general results of the questionnaire
showed that the patients scored their self-care as
good, which constitutes an encouraging finding,
inasmuch as the foot self-examination is one of the
critical elements in the prevention of foot ulcers
[14]. These data coincide with those reported by
Gallardo [16], where 70% of the diabetic patients
responded favorably concerning self-care of their
feet. In our study, the only two questions where the
patient scored lower were those related to the
acquisition of footwear and socks, with a mean
score of 2.31 and 2.21, respectively. This reveals
that the diabetic education was adequate, as indi-
cated in other studies [43], but that the patient had
difficulties in applying this knowledge to everyday
life because of barriers to find the recommended
foot wear. Nevertheless, this information should be
0.890 interpreted with caution, as the subjects of our
0.774 study were patients without amputations, indi-
cating that their knowledge of self-care of their
0.632 feet was greater than in amputees, who are the
main population included in most studies, as it has
0.549 been confirmed that education helps reduce the
number of amputations [2].
0.524
Some differences were found in the responses
to questions relative to foot care with respect to
those of other studies. For example, “knowledge
of the correct technique of nail cutting”, for which
Gondal reported that 52% of the subjects did not
know this technique [19] or Khamesh, with 62%
[25]. Nevertheless, cultural differences require to
take these comparisons with caution.
As a validity criterion, the HbA1c and glucose
were used due to its relation with complications
[5]giving an inverse relation between high HbA1c
levels with low test scores. These results agree
with the findings of Garcia Morales [17] and Ribu
[37], who showed a correlation of high HbA1c
levels with the risk of presenting diabetic foot
complications, given that the glycemia values did
not prove reliable to quantify the degree of com-
plications derived from the diabetic foot [23].
One of the advantages of the tool developed is
that many of the existing approaches are based on
questionnaires developed to measure the risk of
ulceration, in which the perception of self-care is
hardly evaluated [28,44]. The present study fo-
cuses on a scale composed of the three most
important aspects of diabetic foot self-care of the:
knowledge of foot hygiene [11,22,27,33,44], the
appropriate use of footwear and socks, and podi-
atric self-care [1,6,12,28].
Questionnaire of the diabetic foot self-care
Study limitations
First of all, we deliberately did not include people
with amputations and therefore in the future the
questionnaire should be evaluated including this
population. Consequently, to this point, it can be
recommended only for patients without amputa-
tion. Another limitation, given that many of the
patients were of advanced age, is the possibility
that some of them had a care giver that un-
dertakes foot care, a question that can be solved
by evaluating the care givers.
Future studies with different populations should
be carried out to test the instrument in different
contexts of care and cultural diversity.
Conclusion
The questionnaire SDFQ-UMA is a valid and reliable
tool to evaluate foot self-care in diabetic patients
without amputations. Thus, it is of value in clinical
practice and could be used to guide nursing man-
agement decisions on education of diabetic pa-
tients, or for the follow-up of diabetic patients, or
health promotion initiatives.
Conflict of interest
All authors have completed the Unified Com- peting
Interest form at www.icmje.org/coi_disclosure.
pdf (available from the corresponding author) and
declared no support from any organisation for the
submitted work; no financial relationships with any
organisations that might have an interest in the
submitted work in the previous 3 years; no other
relationships or activities that could appear to have
influenced the submitted work.
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