CLI NI CAL I SSUES

Development process and psychometric testing of foot health

assessment instrument
Minna Stolt, Riitta Suhonen, Pauli Puukka, Matti Viitanen, Pa ivi Voutilainen and Helena Leino-Kilpi
Aims and objectives. To describe the development process of the foot health assessment instrument for the assessment of foot
health in older people and to evaluate the psychometric properties of the foot health assessment instrument.
Background. In clinical nursing, assessment of foot health and recognition of foot problems in older people is fundamental
for maintain older persons independent functional ability. However, valid and reliable nurse-administered foot health
assessment instruments are lacking.
Design. A cross-sectional methodological design.
Methods. The foot health assessment instrument was developed in 20082011 based on a literature review and expertise in
podiatry and nursing. Content validity was evaluated in four expert panels. Inter-rater reliability between nurses and
researcher (MS) assessments was evaluated in the pilot test and in the empirical testing of the instrument with a sample of
visiting home nurses. Inter-rater reliability was calculated with Cohens kappa, internal consistency reliability was examined
with Cronbachs alpha coefcients and item analysis, and construct validity was evaluated by principal component analysis
with Varimax rotation and conrmatory factor analysis.
Results. Content validity was guaranteed by the expert analyses. Inter-rater reliability improved after pilot test. The Cron-
bachs alpha coefcient for the total foot health assessment instrument was satisfactory. Item-to-total correlations varied
between but most of them were acceptable. Principal component analysis and conrmatory factor analysis supported the
four component structure of the foot health assessment instrument.
Conclusions. The 23-item foot health assessment instrument showed preliminary acceptable psychometric properties. However,
further modications and testing are needed to strengthen the psychometric properties of the foot health assessment instrument.
Relevance to clinical practice. The existence of a foot health assessment instrument and its application would considerably
improve the assessment of foot health in daily nursing practice. The foot health assessment instrument developed in this
study is short and easy to administer.
Key words: assessment, foot, foot health, home care, instrument development, nursing, older people
Accepted for publication: 11 September 2012
Introduction
During the next decades the population ageing will acceler-
ate (Eurostat 2010), challenging health services worldwide
(WHO 2007). The care of older people has increasingly
shifted towards supportive and rehabilitative care, and
active ageing or independent functioning have become com-
monly accepted goals in both internationally (e.g. European
Authors: Minna Stolt, MNSc, PhD Student, Podiatrist, Finnish
Doctoral Programme in Nursing Science, Department of Nursing
Science, University of Turku, Turku; Riitta Suhonen, PhD, RN,
Professor, Department of Nursing Science, University of Turku,
Turku; Pauli Puukka, MSocSc, Senior Research Statistician,
National Institute for Health and Welfare, Turku; Matti Viitanen,
PhD, MD, Professor, Department of Geriatrics, University of
Turku, Turku; Pa ivi Voutilainen, PhD, RN, Adjunct Professor,
Ministry of Social Affairs and Health, Helsinki; Helena Leino-
Kilpi, PhD, RN, Professor and Chair, Department of Nursing
Science, University of Turku, Turku, Finland.
Correspondence: Minna Stolt, Podiatrist, Department of Nursing
Science, University of Turku, Turku FI-20014, Finland. Telephone:
+358 2 333 8456.
E-mail: minna.stolt@utu.
2013 Blackwell Publishing Ltd
1310 Journal of Clinical Nursing, 22, 13101321, doi: 10.1111/jocn.12078
Union 2007) and nationally in many countries (e.g. Minis-
try of Social Affairs & Health 2008). One component of
healthy ageing is good foot health in older people.
Health complaints are common among older people
(e.g. Hellstro m & Hallberg 2001), yet comprehensive assess-
ments of older peoples health are not common (Karlsson
et al. 2010). Foot health in people without a serious foot
condition is often neglected (Campbell 2006), although foot
health is an important factor affecting independent function-
ing among older people. Poor foot health can increase the
risk of falls (Menz et al. 2006a), decrease walking speed
(Benvenuti et al. 1995), and even threaten quality of life
(Chen et al. 2003). In clinical practice, nurses encounter a
wide range of foot problems in older people, among which
thickened toenails, dry and callused skin, and toe deformities
affect one in three individuals (e.g. Helfand 2004, Barr et al.
2005). Despite the large number of foot problems, interven-
tions to identify and prevent these are scarce.
Nurses and other health care professionals are in key
position to identify and prevent foot problems. They have
direct contact with older people (e.g. in home care) and
hence should assess and regularly follow up foot health.
Objective assessment by a qualied nurse is important as
older people often do not consider foot problems as medi-
cal conditions (Munro & Steele 1998) and self-rate their
foot health higher than objective evaluations (Garrow et al.
2004). Insufcient attention to the foot health of older peo-
ple may also be due to the lack of valid and reliable foot
health assessment instruments (FHAI). With a valid instru-
ment the foot health of older people can be assessed regu-
larly to prevent foot problems. Therefore, the purpose of
this study was to develop an objective FHAI in older people
for visiting home nurses to prevent foot problems.
Background
A literature search from Medline and Cinahl databases was
conducted to identify instruments that measure foot health
(Table 1). The used search terms included the term foot
and instrument or one of its synonyms: foot AND (instru-
ment OR scale OR tool OR index OR questionnaire OR
checklist OR score OR measure). The search was limited to
the English language and titles. The search produced 274
articles: 171 articles from Medline and 103 from Cinahl.
Duplicates (n = 58) were excluded. All the articles were
read and analysed with the aim of nding instruments to
measure foot health in adults or older people. Instruments
concerned with foot surgery or post-surgical foot health
were excluded from the analyses as the focus of this study
was on instruments measuring foot health or prevalence of
foot health problems rather than the effects of different sur-
gical procedures on foot health. Altogether 15 instruments
measuring foot health were identied and analysed.
The foot health instruments have different aims, contents
and target populations. Most of the instruments are disease-
or foot problem-based measuring foot pathology on
function or functional limitation (e.g. Budiman-Mak et al.
1991, Roos et al. 2001) or the impact of foot status in
different diseases: rheumatoid arthritis (Helliwell et al.
2005, Coaccioli et al. 2006), diabetes (Evans & Chance
2005, Bergin et al. 2009) or tinea pedis (Cohen et al.
2002). The target populations of the existing instruments
vary, and many have been developed for treating specic
diseases, for example, rheumatoid arthritis and diabetes.
Some are foot-specic instruments evaluating for example
foot health-related quality of life (Bennet et al. 1998) or
disability (Garrow et al. 2000). Most of the instruments
were administered by the patient (n = 11). A general, non-
specic FHAI appears to be lacking.
The psychometric testing of previous instruments has been
inconsistent. For some instruments, the psychometric
properties have been evaluated widely and systematically
(e.g. Foot Health Status Questionnaire, Manchester Foot Pain
and Disability Index, Foot and Ankle Ability Measure), and
for others relatively little (e.g. Rowan Foot Pain Assessment
Questionnaire), while two instruments (Athletes Foot Sever-
ity Score, Diabetic Foot Assessment Tool) (Rowan 2001) are
not mentioned as having any reliability or validity testing.
Despite the systematic development of the Foot Function
Index and the Foot Health Status Questionnaire, both instru-
ments have been criticised regarding their validity and reli-
ability (Trevethan 2010). Overall, validity testing has more
frequently been undertaken than reliability testing. Content
and criterion validity have been tested in nine instruments
and construct validity in eight. In reliability testing, evalua-
tion of stability has been done in ten instruments mainly with
testretest testing, followed by internal consistency testing
with Cronbachs alpha in seven and with item analysis in
four. Equivalence has been tested in two instruments.
In summary, all the previous instruments seem to focus on
evaluating specic foot problems and their impact on general
well-being rather than assessing foot health. All the instru-
ments are problem-oriented and lack the preventative dimen-
sion in the promotion of foot health. Most of instruments
are intended for patient self-report, some for physicians.
However, valid and reliable instruments for use by nursing
personnel in assessing foot health or the prevalence of foot
problems, specically in older people, are lacking. Hence,
this study, which reports on the development process of a
new instrument, the FHAI, and tests its validity and reliabil-
2013 Blackwell Publishing Ltd
Journal of Clinical Nursing, 22, 13101321 1311
Clinical issues Testing of foot health assessment instrument
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2013 Blackwell Publishing Ltd
1312 Journal of Clinical Nursing, 22, 13101321
M Stolt et al.
ity. The study aim was to (1) describe the development pro-
cess of the FHAI for the assessment of foot health in older
people and (2) to evaluate the psychometric properties of the
instrument. The instrument is intended for use by visiting
home nurses in assessing general foot health in older people.
The instrument could help nurses to maintain, and identify
possible threats to foot health in older people. With the early
recognition of foot health problems, care can be started and
problems prevented from worsening. The instrument also
enables foot health to be documented, regularly monitored
and response to care followed up. The ultimate goal is to
help older people to maintain healthy feet, prevent the onset
of foot problems, and raise awareness of the importance of
foot health in everyday life.
Methods
Design
A cross-sectional methodological design was used. Such a
design is preferred in developing, validating, evaluating and
rening a research instrument (Burns & Grove 2005, Polit
& Beck 2008).
Development of the FHAI
The FHAI was developed in Finland in two phases (Fig. 1)
during 20082011 for use by visiting home nurses to objec-
tively assess foot health in older people. In the rst phase
the instrument was constructed, and in the second, the psy-
chometric properties of the instrument were empirically
evaluated. The development process and psychometric test-
ing of the FHAI was conducted in Finnish; however, for the
purpose of international reporting, the content areas of the
FHAI were translated from Finnish to English.
The construction of the instrument was begun by making
a blueprint with the item pool and response scale obtained
from earlier research (see Stolt et al. 2010) and based on
the researchers (MS) clinical expertise in podiatry and
nursing. The blueprint comprised 20 items in four catego-
ries: skin health (seven items), nail health (ve items), foot
structure (four items) and foot pain (four items).
Content validity was evaluated in expert panels: three
expert panels before, and one after the pilot study. The rst
panel consisted of experts (n = 8) with a degree in nursing
and varied experience in health care. The nurses were
familiar with foot health through their clinical practice.
The second panel comprised graduating podiatry students
(n = 11) who were familiar with various dimensions of foot
health and thus had content expertise to the conceptual
framework. The third panel included podiatrists (n = 5,
expertise in the area of foot health in older people), visiting
home nurses (n = 4, expertise in older peoples care) and
researchers in gerontological nursing science (n = 4, exper-
tise in research and instrument development).
Each expert panel evaluated and scored each item from
four perspectives: (1) relevance = the item expresses a typical
core concept of foot health, according to the experts under-
standing and interpretation of foot health; (2) representative-
ness = the item adequately measures all dimensions of the
content, (3) clarity = the item is clearly stated and easy to
understand; and (4) importance = the item is important in
foot health evaluation. Experts gave their evaluation on a
four-point Likert scale: (1) irrelevant and should be deleted,
(2) seemingly relevant but large scale revision needed, (3) rel-
evant, but in need of small adjustments or revisions, (4) rele-
vant, clear and precise. The experts were asked to suggest
appropriate items and revisions for items where necessary.
The FHAI was pilot-tested by 50 nurses working in shel-
tered housing between January and March 2010. The aim
was to test the functionality and inter-rater reliability of the
FHAI. Each nurse assessed one older persons feet with the
FHAI. The researcher (MS) assessed the same individuals
feet to determine inter-rater reliability.
The fourth expert panel evaluated the functionality of the
FHAI after revision following the pilot test. Functionality
was evaluated from six viewpoints: clarity of the item, clar-
ity of wording of the assessment criteria, intelligibility of
Phase 1
Construction of the FHAI
Phase 2
Testing of the reliability and
validity of the FHAI
Theoretical background and content validity
Expert analysis
1st panel n = 8 with degree in nursing
2nd panel n = 11 podiatry students
3rd panel n = 13 podiatrist (n = 5), visiting
home nurses (n = 4), researchers (n = 4)
Pilot test, n = 50
Inter-rater reliability
Expert analysis
4th panel n = 8, nurses in older people care
setting
Testing
Data n = 309 visiting home nurses, response rate
47%
Distributions
Inter-rater reliability (n = 20)
Internal consistency reliability: Cronbachs
alpha and item analysis
Construct validity
Principal component analysis, Varimax
/Promax rotation
Confirmatory factor analysis
Figure 1 Development process of the foot health assessment instru-
ment (FHAI).
2013 Blackwell Publishing Ltd
Journal of Clinical Nursing, 22, 13101321 1313
Clinical issues Testing of foot health assessment instrument
the assessment criteria, clarity of the response instructions,
the items relevance in foot health assessment and usability
of the item. The scale was dichotomous (yes/no) and the
experts could comment on written items they considered
needed revision. The expert panel comprised eight of the
nurses who pilot-tested the FHAI.
In the second phase, to explore the psychometric proper-
ties of FHAI, empirical data were collected between May
and October 2010 from the target population consisted of
651 visiting home nurses working in nine public home care
agencies in Finland. Convenience sampling on the organisa-
tion level and total sampling among the visiting home nurses
was conducted. The inclusion criteria for the visiting home
nurses were as follows: (1) professional education (registered
nurse, public health nurse or licensed practical nurse),
(2) currently working in home care and (3) Finnish speaking.
The recruitment process of the older people followed the
research protocol. The chief nurses of each home care
agency informed their nurses about the study. The nurses
were asked to participate in the study and recruit one older
person for the foot health assessment. After giving their
consent the nurses (n = 309) recruited their patients in
consecutive order according to their days schedule in the
home care agencies. The nurses applied the following inclu-
sion criteria: (1) voluntary participation, (2) age 65 years
or older, (3) living at home and receiving formal public
home care services, (4) no lower limb amputations, (5) able
to give informed consent and (6) Finnish speaking. If an
older person declined to participate, the nurse asked the
next older person fullling the inclusion criteria to partici-
pate in the study. The foot health assessments were con-
ducted in connection with the standard home visit, to
minimise the burden on the nurses and patients.
The FHAI used in the empirical testing, comprised 23
items, assessing both feet, in four categories: skin health
(10 items), nail health (ve items), foot structure (four
items) and foot pain (four items). All items had structured
multiple choice scaling and assessment criteria to guarantee
uniformity between the visiting home nurses. Demographic
background data on the older people were collected on gen-
der, age, long-term diseases, self-rated evaluation of foot
health and type of indoor and outdoor footwear.
Data analysis
The data were analysed using SAS 9.1 (SAS Institute Inc.,
Cary, NC, USA). First, both item- and subscale-level analy-
sis was conducted using descriptive statistics (frequencies,
means and standard deviation). Foot health was assessed in
both feet, and the results combined for the statistical analy-
sis of the instrument. In the dichotomous no/yes (0/1) vari-
ables, combining the feet yielded a scale of 0, 1 or 2. In
items with more than two values the theoretical maximum
values were 4, 6 and 20 [Verbal Rating Scale (VRS) for
foot pain]. For comparability all the scales were converted
to theoretically range from 02. The combined assessments
were scored as follows: no problems in either foot = 0;
problems in one foot = 1; problems in both feet = 2.
The content validity of the instrument was assessed by an
expert panel. The item content validity index (I-CVI) was
calculated by summing the ratings of 3 and 4 and dividing
by the total number of raters. Items with a mean score of
078 or above were retained (Polit et al. 2007). The deci-
sion to delete or revise items scoring below 078 was then
made by researchers.
Inter-rater reliability between the nurses and researchers
(MS) assessments was tested with Cohens kappa statistics
(Cohen 1960). A kappa value of 041060 is considered
moderate, 061080 substantial and 081 and over almost
perfect (Landis & Koch 1977).
Internal consistency was calculated using Cronbachs alpha
coefcients and item analysis including item-to-total correla-
tions. The acceptable Cronbachs alpha coefcient value for
new instruments is 070 (Hu & Bentler 1999), whereas DeV-
ellis (2003) consider alphas below 060 unacceptable, 060
065 undesirable, 065070 minimally acceptable, 070080
respectable and 080090 very good. In the item analysis,
the minimum recommended correlation between items and
total scores is over 020 (Streiner & Norman 2003).
The construct validity of the FHAI was investigated with
principal component analysis (PCA) using Varimax rotation
and conrmatory factor analysis (CFA) with generalised
least squares estimation. Prior to performing PCA and
CFA, the suitability of the data for structural equation
modelling (SEM) was assessed using the KaiserMeyer
Olkin (KMO) test with the recommended value of 05 or
above and Bartletts test of sphericity with a p-value below
005 (Child 2006). To conrm the estimation of the ade-
quacy of the sample size for factor analysis, the variable to
subject ratio was calculated: 1:5 was considered the mini-
mum and 1:10 sufcient (Watson 1998). PCA was used to
explore the underlying structure of the 23-item FHAI.
Eigenvalues greater than one and the scree test were used
to determine the number of factors (Watson & Thompson
2006). Communalities were used to describe the amount of
variance in a single variable that is explained across all the
factors in the analysis and an item loading above 030 on a
component was considered acceptable (Child 2006).
Conrmatory factor analysis is a special type of SEM
used to test the hypothesised construct in the scale (Ullman
2013 Blackwell Publishing Ltd
1314 Journal of Clinical Nursing, 22, 13101321
M Stolt et al.
2006). First, chi-square statistics were used to evaluate the
t of the data to the model. Non-signicant chi-square val-
ues are acceptable, meaning that the data t the proposed
model structure (Child 2006). However, the chi-square sta-
tistics is sensitive to sample size (Ullman 2006), therefore,
several t indices were also used: comparative t index
(CFI), adjusted goodness-of-t Index (AGFI), root mean
square error of approximation (RMSEA), root mean square
residual (RMR), Normed Fin Index (NFI), Akaikes Infor-
mation Criterion (AIC).
Different t indices have different meanings in the assess-
ment of the hypothesised construct of the scale. The CFI is
an incremental t index that compares the proposed model
with the null model and uses an approach based on the non-
central chi-square distribution (Bentler 1990). A CFI of at
least 090 and preferably 095 or higher are considered evi-
dence of an acceptable t of the model to the data (Byrne
1994). The AGFI is a measure of goodness-of-t while tak-
ing into account the degrees of freedom available (Wan
2002). An AGFI close to 1 means good t of the model (Rao
et al. 2008). The RMSEA is a measure of the discrepancy
per degree of freedom in the model. Values below 005 indi-
cate excellent t, values 005008 moderate and values 008
010 fair t (Musil et al. 1998). The RMR in testing of the
hypothesised construct should be <005 (Child 2006). The
Normed Fit Index is based on the difference between the
chi-square value for the proposed model and independence
model (Soeken 2005). NFI values above 095 are desirable
(Hu & Bentler 1999). AIC was used to test how well the
models would be expected to t sample data drawn from the
same population. The AIC is not informative in determining
how well a single model ts the data but is generally used to
choose between models (Weston et al. 2008). AIC values
can be positive or negative and the lower the value, the bet-
ter the model t (Motulsky & Christopoulos 2004).
Ethical considerations
At all phases, this study followed the principles of the Hel-
sinki Declaration (World Medical Association 2008). Ethical
approval was obtained from the local hospital district ethics
review committee (14/180/2009) and permission to conduct
the study from the chief of the sheltered housing and home
care services of each agency. Visiting home nurses and older
people in home care were informed in writing that participa-
tion was voluntary, they had the right to withdraw at any
time, their research records would remain anonymous and
all information would be treated condentially. Both patients
and visiting home nurses gave their written informed consent
(The National Advisory Board on Health Care Ethics 2002).
Results
Content validity
Content validity was based on the evaluations of the three
expert panels before the pilot test. In the rst expert panel,
all the experts agreed (I-CVI above 078) on the clarity,
importance and relevance of the items. Regarding represen-
tativeness the experts proposed that items on blood circula-
tion and sensation should be added. Accordingly, four
items were added: palpation of the dorsalis pedis and
posterior tibial artery pulses, skin colour and sensation of
the sole of the foot, increasing the total to 24 items. After
the second expert panel, three items were reworded and
the response scale of two items was modied. However, the
I-CVI remained above 078 for each item. Following the
suggestion of the third expert panel, assessment criteria for
each item was added to guarantee congruent assessments
among nurses. Pictures to guide palpation of the dorsalis
pedis and posterior tibial artery pulses and identication of
the participants nail cutting style were also added. The
I-CVI values were higher than 078 for every item.
Inter-rater reliability and the functionality of the FHAI
were tested in the pilot study. The inter-rater reliability test-
ing only concerned the 20 objectively assessed items (omit-
ting the four subjectively rated foot pain items). The kappa
values ranged between 03441000. In nine items the
kappa values were above 060, and in 11 items below 060.
Following the pilot test, the items assessing the prevalence
of corns and calluses were combined, reducing the total
number of items to 23. To improve the functionality of the
FHAI, the nurses were asked to comment on the items and
scaling of the instrument. Based on their comments, the
FHAI assessment criteria were modied by specifying the
level for each criterion and the instructions for completing
the FHAI were reworded.
After the pilot test, the feasibility of the revised FHAI
was assessed by the fourth expert panel comprising nurses
who had pilot-tested the FHAI in sheltered housing. The
expert panel did not suggest any revisions to the FHAI.
Next, the inter-rater reliability, internal validity and con-
struct validity of the FHAI were empirically tested with a
sample of visiting home nurses. A total of 309 anonymous
foot health assessments were obtained with an overall
response rate of 47%. The visiting home nurses who assessed
the older peoples foot health had a professional degree in
health care. On average, the nurses were age 41 (range 19
62, SD 11) and the older people age 834 (range 65101,
SD 682). Most of the older people were female (85%,
n = 263).
2013 Blackwell Publishing Ltd
Journal of Clinical Nursing, 22, 13101321 1315
Clinical issues Testing of foot health assessment instrument
Inter-rater reliability
The inter-rater reliability of the foot health assessments
between the nurses and the researcher (MS) was evaluated
in 20 foot health assessment situations. The kappa coef-
cients were higher than in the pilot test, ranging between
01871000. Four items (oedema, ingrown toe nail, hallux
valgus and Taylors bunion) had kappa values below 060.
Internal consistency
Cronbachs alpha coefcient for the total FHAI was 064.
For the subscale levels, the coefcients were as follows: skin
health 049, nail health 046, foot structure 046 and foot
pain 071. Item-to-total correlations were calculated for
each of the subscales: skin health, nail health, foot structure
and foot pain. On the subscale level, the item-to-total cor-
relations were all acceptable (r > 020). On the item level,
the correlations ranged from 003058 (Table 2), the
majority (65%) being acceptable. The lowest correlations
were obtained for arch height, verruca, sensation and nail
cutting style (003, 010, 010 and 010, respectively). These
items were, however, not deleted from the instrument as
their content is crucial in this context.
Construct validity
Principal component analysis
Calculated KMO was 0661 and Bartletts test of sphericity
110373 (p < 00001) indicating that the sample was large
enough to perform PCA. Also, the subject ratio
(23:399 = 1:13) indicated acceptable sample size for factor
analysis. The PCA with Varimax rotation revealed nine
components with an eigenvalue above 1 (range 1000
3188). However, the scree plot (DeVellis 2003) and pilot
study supported the four-component structure which
explained 36% of the total variance in FHAI with variances
between 74106. PCA with Promax rotation produced
results similar to those obtained by Varimax rotation.
Conrmatory factor analysis
The hypothesised model FHAI with four subscales was
assessed with CFA. All the hypothesised factors were free
to vary in accordance with the sample data. First, the
hypothesised model was assessed for its signicance and
overall t, using chi-square statistics, and the GFI (good-
ness-of-t index). The structure of the hypothetical model
for skin health (Table 3) was not supported by the
chi-square results (v
2
= 6998, d.f. = 35, p = 00004). In
model testing, the aim is to nd small, non-signicant
chi-square values (Weston et al. 2008). The GFI for the
overall model was 095, suggesting that the model tted the
data. However, the other statistics indicated unacceptable
t of the data with the skin health model. The RMSEA
006, CFI 0620, NFI 0490, also suggested unacceptable
t. The nail health (v
2
= 6315, d.f. = 5, p = 0378), struc-
ture (v
2
= 1680, d.f. = 2, p = 0432) and pain (v
2
= 3893,
d.f. = 2, p = 0143) models were acceptable indicating that
the models tted the data. The models t to the data was
also supported with other indices (Table 3).
The statistics indicated unacceptable t of the skin health
model to the data. Consequently, the model was revised.
This was done by adding additional paths based on the
largest Lagrange multipliers provided by the statistical soft-
ware. The rst revision was done by allowing covariances
between the error terms of skin condition and ssures and
between the error terms of ADP-pulse and ATP-pulse.
The structure of the second model of skin health was
supported by the chi-squared statistics (v
2
= 3974,
d.f. = 33, p = 020). All the other indices supported the
revised model (GFI = 097, CFI = 093, NFI = 071,
RMSEA 0026), suggesting that the model tted the data
well and providing evidence for structural validity. The AIC
was notably lower (2626) than in the rst model.
Discussion
This study aimed to (1) describe the development process a
FHAI for the assessment of foot health in older people and
(2) to evaluate the reliability and validity of the instrument.
The results of this study provided support for the reliabil-
ity and validity of the FHAI. The content validity of the
FHAI, evaluated by four different expert panels, led to revi-
sion of some items. Cronbachs alpha values for the catego-
ries ranged between 046071, while the overall alpha for
the whole instrument was 064, and thus slightly under the
acceptable level (070) for newly developed instruments
(DeVellis 2003). The item-to-total correlations varied, but
most (65%, n = 15) were acceptable (over 02, Streiner &
Norman 2003). However, the remaining correlations 35%
(n = 8) were low, indicating that the items were problem-
atic (e.g. arch height 003, nail cutting style 010, sensation
010, verruca 010). Item-to-total correlations are depen-
dent on sample size, higher sample size leads to higher
correlations (Hartig et al. 2007). In this study, for example,
very few older people had a verruca, and therefore, the data
had low statistical power. On the other hand, this might
also reveal the sensitivity of the FHAI in that when the
number of estimates is low, the correlations are also low.
There is clearly a need to assess the sensitivity of the items.
2013 Blackwell Publishing Ltd
1316 Journal of Clinical Nursing, 22, 13101321
M Stolt et al.
Table 2 Item and scale description, item-to-total correlations, Cronbachs alpha values and principal component analysis with Varimax
rotation
Item no.
Abbreviated item
and response scale*
Item-to-total
correlation a Communality
FHAI
C1 C2 C3 C4
Skin health 023 049
05 Skin between toes
Healthy/Macerated/Broken
031 0270 0431 0042 0266 0110
06 Skin condition
Normal/Dry/Fissured
030 0431 0637 0084 0085 0106
07 Skin colour
Normal/Bluish/Rubor/Brown
022 0237 0211 0180 0274 0291
08 Corns or calluses
No/Yes: Toes/Between
toes/Sole of foot/Heel/Lateral side
019 0199 0365 0152 0182 0097
09 Verruca
No/Yes: Toes/Between
toes/Sole of foot/Heel
010 0034 0101 0010 0148 0040
10 Fissures
No/Yes: Toes/Sole of foot/Heel
017 0348 0494 0139 0110 0270
11 Oedema
No/Yes: Toes/Instep/Ankle/Shin
012 0299 0120 0189 0053 0500
12 Sensation
Normal/Dimished/Insensitive
010 0134 00239 0307 0026 0196
13 Dorsalis pedis artery pulse
Palpable/Absent
040 0617 0152 0051 0076 0766
14 Posterior tibial artery pulse
Palpable/Absent
041 0488 0139 0045 0061 0681
Nail health 030 046
15 Nail length
Normal/Short/Elongated
030 0297 0515 0109 0088 0110
16 Nail thickness
Normal/Thin/Thickened
037 0568 0701 0031 0168 0219
17 Nail colour
Normal/Yellow/Brown/Black
058 0599 0737 0041 0156 0173
18 Ingrowing nails
No/Yes: 1st toe/2nd toe/3rd
toe/4th toe/5th toe
014 0201 0084 0228 0352 0132
19 Nail cutting style
Corners removed/Along
the top of toe/Straight
010 0075 0120 0244 0011 0031
Foot structure 026 046
20 Hallux valgus
No/Yes
040 0554 0021 0037 0740 0075
21 Taylors bunion
No/Yes
031 0429 0007 0038 0647 0099
22 Lesser toe deformities
No/Yes: 1st toe/2nd toe/3rd
toe/4th toe/5th toe
031 0418 0009 0021 0645 0041
23 Foot arch
Normal/Low/High
003 0015 0097 0037 0052 0036
Foot pain 051 071
24 Pain: toes
VRS 04 scale
051 0533 0026 0688 0087 0226
2013 Blackwell Publishing Ltd
Journal of Clinical Nursing, 22, 13101321 1317
Clinical issues Testing of foot health assessment instrument
The low Cronbachs alpha value and item-to-total correla-
tions could be improved in the future by analysing some
items need weighting.
The inter-rater reliability of the foot health assessments
between the visiting home nurses and researcher (MS)
improved following the modications made after the pilot
test. However, four problematic items remain in need of
improved inter-rater reliability before the instrument can be
used in clinical practice. One possible reason for the low
inter-rater agreement might be that the nurses may have
interpreted the instruments scaling differently. Therefore,
in the future, minor revisions to the terminology used in
these four items and clarication of the assessment criteria
are needed to reduce the chances of differential use. For
example, adding pictures to illustrate each item may sup-
port nurses to distinguish between problematic and healthy
feet. This may also improve the item-to-total correlations.
Factor analysis [exploratory factor analysis (EFA) or
CFA] is a step in scale construction (Watson & Thompson
2006) which can enhance condence in the structure and
psychometric properties of a new measure (Noar 2003).
The construct validity of the FHAI was assessed with EFA
using PCA, which is an important tool for providing evi-
dence on the validity of instrument (Child 2006). Four
components, explaining 36% of the variance, were
extracted by PCA. These four underlying components
showed a logical connection to the theoretical framework
used during the design of the instrument, testifying its con-
struct validity. In this study CFA was used to determine
construct validity. The rst skin health model showed poor
t to the data, although the other subscale models tted the
data. Subsequent revision of the skin health model, by
permitting error covariances between some items, improved
the skin health model indices, such as GFI, NFI, RMSEA
Table 2 (Continued)
Item no.
Abbreviated item
and response scale*
Item-to-total
correlation a Communality
FHAI
C1 C2 C3 C4
25 Pain: foot sole
VRS 04 scale
049 0498 0001 0705 0015 0013
26 Pain: heel
VRS 04 scale
050 0519 0158 0701 0042 0035
27 Pain: ankle
VRS 04 scale
054 0569 0007 0741 0111 0085
Cronbachs alpha for total FHAI 064
Eigenvalues 3188 2128 1672 1346
Percentage of explained variance 106 103 79 74
Cumulative percentage of explained variance 106 209 288 362
Bold gures indicate that the highest loading of an item is on its theoretical component.
*English language translations of the Finnish items that were tested.
C1, rst component; C2, second component; C3, third component; C4, fourth component; a, Cronbachs alpha; FHAI, Foot Health Assess-
ment Instrument.
Table 3 Testing (CFA) of the hypothesised structure of the FHAI, n = 309
Skin health
Nail health Structure Pain
Model 1 Modied Model 1 Model 1 Model 1
Goodness-of-t 0954 0974 0992 0997 0994
AGFI 0928 0957 0975 0986 0968
RMR 0093 0061 0037 0021 0023
Chi-square 69984 39739 6315 1680 3894
Chi-square d.f. 35 33 5 2 2
Pr >Chi-square <0001 0195 0268 0432 0143
RMSEA 0057 0026 0029 0000 0056
Bentlers CFI 0620 0927 0987 1000 0975
B&B NFI 0499 0710 0943 0965 0953
AGFI, Adjusted Goodness-of-Fit Index; CFA, Conrmatory Factor Analysis; CFI, Comparative Fit Index; FHAI, Foot Health Assessment
Instrument; NFI, Normed Fin Index; RMR, Root Mean Square Residual; RMSEA, Root Mean Square Error of Approximation.
2013 Blackwell Publishing Ltd
1318 Journal of Clinical Nursing, 22, 13101321
M Stolt et al.
and RMR, supporting the construct validity of the instru-
ment. In both EFA and CFA low communalities (arch
height, verruca, sensation and nail cutting style) were some-
what problematic and need further some more attention.
Use of the FHAI could yield valuable data on the foot
health of older people in home care including identication
of foot health problems and the need for podiatric care. In
addition, systematic foot health assessments with FHAI
could help to monitor the level of foot health, which could
lead to improvements in foot care and prevention of foot
health problems.
The FHAI seems to have considerable potential. This
study found evidence for the reliability and validity of the
FHAI when used by home care nurses to assess foot health
in older people. The FHAI can thus be used to document
and assess the general foot health of older people and if
needed further assessments can be done with the instru-
ments as mentioned earlier.
Additional studies using the FHAI are needed to analyse
further the validity and reliability of the instrument and
especially the utility in clinical nursing practice. The instru-
ment has advantage of being short (23 items) and easy to
administer and therefore could well be accepted by nurses
in clinical practice. Testing and rening a measure is an
iterative process and requires more than one large pilot test
and evaluation (DeVon et al. 2007).
Methodological considerations
There are some methodological considerations that need to
be discussed in relation to the interpretation and generalisa-
tion of the results. The response rate in this study was only
47%. To increase the response rate, reminders were sent to
the nurses, but resulted in only minor changes to the rate.
However, the sample represents the average Finnish home
care nursing personnel on their professional education and
age (National Institute for Health & Welfare 2011). Never-
theless, the sample size (n = 309) was large enough to
conduct multivariable analyses such as PCA. A ratio of at least
10 subjects for each variable is needed to perform, for exam-
ple, factor analysis (Watson 1998). As the survey was anony-
mous, it was not possible to analyse the non-responders. This
study presents evidence for the internal consistency, reliability,
content and constructs validity of the FHA-instrument. The
development process was conducted systematically, gathering
a variety of data on validity and reliability.
Conclusion
Assessing foot health in older people in clinical nursing
practice requires a measure that will accurately capture cur-
rent foot health. The psychometric properties of the FHAI,
developed in this study, were tested. The ndings showed
acceptable validity and reliability as well as satisfactory
content and construct validity and internal consistency for
the 23-item FHAI when administered by a sample of visit-
ing home nurses among older people in home care. Some of
the FHAI items need further testing with different samples
to determine whether the ndings can be replicated. This in
turn will provide information that of value in further
improving the instrument.
Relevance to clinical practice
The existence of a FHAI and its application would consider-
ably improve the assessment of foot health in daily practice
as healthy feet are important for the maintenance of func-
tional ability and a satisfactory quality of life in older peo-
ple. However, some items in the FHAI may need revision
and further testing. The development and testing of such as
instrument is a lengthy process. The results of this study on
the psychometric properties of the FHAI remain tentative.
Acknowledgements
We wish to thank Michael Freeman for his expertise with
the English language.
Funding
This study was funded by Finnish Doctoral Programme in
Nursing Science.
Contributions
Study design: MS, PV, HL-K; data collection and analysis:
MS, PP and manuscript preparation: MS, RS, PP, MV, PV,
HL-K.
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