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Vol. 45 No.

1 January 2013 Journal of Pain and Symptom Management 129

Brief Methodological Report

The Spanish Version of the Edmonton


Symptom Assessment System-Revised
(ESAS-r): First Psychometric Analysis
Involving Patients With Advanced Cancer
Ana Carvajal, RN, PhD, Nezka Hribernik, MD, Eva Duarte, MD,
Alvaro Sanz-Rubiales, PhD, MD, and Carlos Centeno, PhD, MD
Faculty of Nursing (A.C.), University of Navarra, Pamplona, Spain; Faculty of Medicine (N.H.),
University of Ljubljana, Ljubljana, Slovenia; Palliative Medicine Department (E.D.), National
Cancer Institute, Ciudad de Guatemala, Guatemala; Medical Oncology Department (A.S.-R.),
University Hospital Rı o Hortega, Valladolid, Spain; and Palliative Medicine Unit (C.C.), University
of Navarra Hospital, Pamplona, Spain

Abstract
Context. The Edmonton Symptom Assessment System (ESAS) is a measure
widely used in palliative care for the assessment of symptoms in patients with
advanced cancer. The tool has been validated in different languages,
including Spanish. A revised version (ESAS-r) was developed by Watanabe et al.
in 2010.
Objectives. To develop the Spanish version of the ESAS-r and examine its
psychometric properties.
Methods. Based on the original English version, a group of experts created
a Spanish version of the ESAS-r and administered it to a group of advanced cancer
patients. Patients completed the ESAS and ESAS-r and were asked for their
perceptions of the tool. The psychometric properties of the ESAS-r that were
analyzed were equivalence, internal consistency, and discriminant validity.
Results. Sixty-six patients from Spain and Guatemala participated in the survey.
Patients perceived the ESAS-r to be significantly easier to understand and easier to
complete than the ESAS. Significantly, patients preferred the ESAS-r (47%) to the
ESAS (15%; P < 0.0007). As to reliability, we found good internal consistency
(Cronbach’s alpha 0.86), and the equivalence of the two versions was between 0.71
and 0.94. The ESAS-r discriminates between inpatients and outpatients (Mann-
Whitney U test; P ¼ 0.02) and among those with different palliative performance
status (Spearman’s rho for pain, tiredness, drowsiness, lack of appetite, well-being;
P < 0.01).
Conclusion. The ESAS-r is a valid instrument with adequate psychometric
characteristics. This version is preferred by patients with advanced cancer. The

Address correspondence to: Ana Carvajal, RN, PhD, Fac- Accepted for publication: January 19, 2012.
ulty of Nursing, University of Navarra, C/ Irunlarrea
s/n 31009 Pamplona, Spain. E-mail: acarvajal@
unav.es

Ó 2013 U.S. Cancer Pain Relief Committee. 0885-3924/$ - see front matter
Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpainsymman.2012.01.014
130 Carvajal et al. Vol. 45 No. 1 January 2013

Spanish version of the ESAS-r can, therefore, replace the use of the ESAS. J Pain
Symptom Manage 2013;45:129e136. Ó 2013 U.S. Cancer Pain Relief Committee.
Published by Elsevier Inc. All rights reserved.

Key Words
Edmonton Symptom Assessment System, ESAS, ESAS-r, symptom assessment, test, validity,
reliability, palliative care

Introduction original ESAS. The study stressed that to validate


the ESAS further, a future research priority
The Edmonton Symptom Assessment System
should be to examine the use of the ESAS-r in
(ESAS)1 has been widely2 used in clinical prac-
languages other than English.
tice, hospital settings, home-based care, and
We have chosen to replicate the study by
even by telephone to assess the evolution of
Watanabe et al.15 using the Spanish version,
symptoms.3 The ESAS has been effectively
with an international cohort of Spanish-
used to measure the prevalence of symptoms,4,5
speaking patients. In addition, to obtain the
assess the effectiveness of palliative care pro-
first proof of validity of the new Spanish
grams in hospital centers,6e8 and measure
ESAS-r version, its psychometric properties
health outcomes following interventions. Some
were evaluated and compared with data from
regional cancer and palliative care programs
the original version.14
(e.g., Ontario9) and cancer centers (e.g., M. D.
Anderson Cancer Center, Houston10) have in-
cluded ESAS evaluation in a systematic way.
The European Palliative Care Cancer Symptom Methods
Study: A Prospective Data Collection11 also has Bilingual professionals experienced in pallia-
adopted the ESAS-r. tive care and in using the ESAS drafted a Span-
Validation studies of the ESAS were published ish version of the ESAS-r based both on the
in 200812 and 2009.13 More recently, Carvajal previous Spanish version and on the English
et al.14 carried out a comprehensive study of revised version. A reverse translation method
the psychometric properties of the Spanish was used by bilingual translators to translate
ESAS when used with patients with advanced the ESAS into Spanish.17 The details of this
cancer. This version is slightly different than process have been reported elsewhere.14 A
the original English version used by Watanabe pilot study with advanced cancer patients was
et al.15 because it includes an additional item undertaken to obtain patient perceptions
to evaluate sleep disturbance. This item was about the new version of the instrument. The
added by the creator of the ESAS and is currently group of experts reviewed the comments
used at the M. D. Anderson Cancer Center.10 made by the patients and created a final Span-
After a study that examined difficulties in ish version of the ESAS-r to be tested.
interpreting and completing the ESAS,16 and A group of patients with advanced cancer
based on the literature, a revised version completed the Spanish ESAS and ESAS-r; the
(ESAS-r) of the ESAS was created.15 The changes order of the two instruments was not predeter-
made in the ESAS-r include clarification of mined. All patients were older than 18 years,
a number of terms, a change in the format, def- with normal cognitive function on the Mini-
inition of a specific time frame relating to the Mental State Examination (MMSE). Patients
ESAS, and the reordering of items. Professional from oncology departments of tertiary hospitals
assistance and support for the patient are pro- were included (Spain: University of Navarra
vided when they complete the form initially. Hospital; Guatemala: National Cancer Insti-
This revised version was submitted to an in- tute). Patients with advanced cancer receiving
ternational cohort of patients who were re- palliative radiotherapy or chemotherapy also
quested to compare it with the original version. were eligible. We anticipated collecting data
Results showed that patients ‘‘significantly pre- from a minimum of 30 patients in each center,
ferred’’ the revised version compared with the as in the study by Watanabe et al.15 Patients
Vol. 45 No. 1 January 2013 Spanish Version of the ESAS-r 131

also were asked about their perceptions of both Edmonton Classification System for Cancer
forms and how they compared with each other. Pain,20 and a questionnaire requesting the pa-
Data were gathered between December 2010 tient’s perception of the two versions of the
and February 2011. ESAS (the original ESAS and the revised ESAS-
The study was approved by the Ethics Com- r). This questionnaire was derived from the study
mittee on Clinical Research at the University undertaken by Watanabe et al.15 It comprises
of Navarra Hospital. Written informed consent eight questions focused on the patient’s familiar-
was obtained from each patient. ity with the ESAS, ease of understanding and
The instruments used in this study were completion, and the assessment of differences
the Spanish version of the ESAS,14 the Spanish between the two versions. For quantitative analy-
version of the ESAS-r (Fig. 1), the Palliative sis, patient opinion was collected on a five-point
Performance Scale (PPS),18 the MMSE,19 the Likert scale ranging from 1 (very easy) to 5 (very

Fig. 1. Spanish version of the ESAS-r. Original terms of the English version of the ESAS: no pain, worst possible pain,
no tiredness, worst possible tiredness, no drowsiness, worst possible drowsiness, no nausea, worst possible nausea, no
lack of appetite, worst possible lack of appetite, no shortness of breath, worst possible shortness of breath, no depres-
sion, worst possible depression, no anxiety, worst possible anxiety, best sleep, worst possible sleep, best well-being,
worst possible well-being, other problem. ESAS-r ¼ Edmonton Symptom Assessment System-revised.
132 Carvajal et al. Vol. 45 No. 1 January 2013

hard); data were analyzed using the paired similar to that of the English version of the
sample t-test and binomial test. Qualitative com- ESAS-r. It was noted that patients perceived
ments also were obtained. the new version of the ESAS (ESAS-r) as diffi-
A researcher administered the MMSE,19 cult to read, so some changes in the format
PPS,18 and the Edmonton Classification System were made to obtain a clearer design, that is,
for Cancer Pain20 and also gathered demo- print size of the items was changed and shad-
graphic and clinical data from the patients. ing was added (Fig. 1).
The ESAS and ESAS-r were completed consecu- A total of 66 patients with advanced cancer
tively by the patients in the presence of the completed the ESAS and ESAS-r. Table 1 de-
researcher. The patient also filled out the struc- scribes the demographic and clinical character-
tured questionnaire about their perception of istics of the participants. Average scores for the
the two versions of the ESAS. ESAS and ESAS-r are summarized in Table 2.
The psychometric properties of the ESAS-r Overall, the ESAS-r was easier to understand
that were analyzed were equivalence between and complete than the ESAS (Table 3). Pa-
the ESAS and ESAS-r by the intraclass correla- tients ‘‘significantly preferred’’ the ESAS-r to
tion coefficient, the internal consistency of the the ESAS (Table 3), the most frequent reason
ESAS-r measured by calculating Cronbach’s being that alternative terms provided more ex-
alpha, the correlation between the sum of the planation of the items (n ¼ 14). Patients also
specific items within the ESAS-r and the item thought that the ESAS-r was visually clearer
‘‘well-being’’ explored by the Spearman corre- and easier to read with the gray shadow
lation, and discriminant validity evaluated by
testing the difference of the ESAS-r score
Table 1
among patients with different functional Patient Characteristics (N ¼ 66)
status (measured using the PPS) by the Spear- Characteristics n (%)
man correlation. Discrimination between inpa-
tients and outpatients was evaluated by the Gender
Female 46 (70)
Mann-Whitney U test. Male 20 (30)
Primary cancer diagnosis
Gastrointestinal 24 (36)
Results Genitourinary
Lung
16 (24)
3 (5)
A Spanish version of the ESAS-r was created Breast 12 (18)
(Fig. 1). This version differs from the English Other cancer 11 (17)
Current cancer treatment
version in that 1) it includes alternative terms Chemotherapy 34 (51)
for ‘‘fatigue’’ (agotamiento/exhaustion, cansan- Radiotherapy 5 (8)
cio/tiredness, or debilidad/weakness) and ‘‘anxiety’’ Chemo and radiotherapy 1 (2)
Palliative care only 26 (39)
(nerviosismo/nervousness, intranquilidad/disquiet, Education level (years)
or ansiedad/anxiousness) obtained through pre- Primary (0e8) 31 (47)
vious studies,21,22 2) it includes alternative Secondary (8e12) 20 (30)
High (>12) 15 (23)
terms for ‘‘drowsiness’’ (somnolencia/drowsiness Prognostic factors in pain control as per ECS-CP
or adormilado/sleepiness) and ‘‘well-being’’ (sen- Neuropathic pain 15 (23)
tirse perfectamente/feeling perfectly or sensacio n de Incident pain 19 (29)
Psychological distress 3 (5)
bienestar/feeling of well-being), 3) it includes the Addictive behavior 0 (0)
item ‘‘difficulty in sleeping’’ as did the previous Cognitive status impaired 1 (2)
Spanish version, and 4) it was decided that the Previously filled out ESAS
No 52 (79)
alternative term for ‘‘other problems’’ should Yes 9 (14)
be ‘‘dry mouth,’’ a very prevalent symptom in Unknown 5 (7)
palliative care,23 rather than ‘‘constipation’’ be- Patient setting
Outpatient 54 (82)
cause a previous study24 found that patients with Inpatient 12 (18)
a perception of constipation, based on visual Age (years), mean (range) 54 (18e84)
numerical scales, did not have good correlation MMSE (average), range 0e30 28 (23e30)
PPS (average), range 0e100% 78 (40e100)
with symptoms of constipation and vice versa.
ECS-CP ¼ The Edmonton Classification System for Cancer Pain;
A total of 14 patients with advanced cancer ESAS ¼ Edmonton Symptom Assessment System; MMSE ¼ Mini-
participated in the pilot study, using a format Mental State Examination; PPS ¼ Palliative Performance Scale.
Vol. 45 No. 1 January 2013 Spanish Version of the ESAS-r 133

Table 2
ICC for Symptom Rating Using ESAS and ESAS-r Average Symptom Rating
Mean (SD)

Symptoms (N ¼ 66) ESAS ESAS-r ICC 95% CI

Insomnia 3.8 (3.5) 3.8 (3.6) 0.94 0.91e0.96


Depression 2.8 (3.3) 2.9 (3.4) 0.92 0.87e0.95
Drowsiness 3.4 (3.2) 3.3 (3.1) 0.90 0.85e0.94
Lack of appetite 3.6 (3.4) 3.4 (3.7) 0.88 0.81e0.92
Tiredness 3.7 (3.3) 3.5 (3.0) 0.86 0.78e0.91
Pain 2.9 (3.0) 2.9 (3.1) 0.85 0.77e0.90
Well-being 3.8 (3.1) 3.9 (2.8) 0.85 0.77e0.90
Anxiety 2.1 (2.9) 2.2 (2.8) 0.82 0.72e0.88
Nausea 1.0 (2.1) 1.0 (2.2) 0.75 0.62e0.83
Shortness of breath 1.5 (2.7) 1.5 (2.5) 0.71 0.56e0.81
ICC ¼ intraclass correlation coefficient; ESAS ¼ Edmonton Symptom Assessment System; ESAS-r ¼ Edmonton Symptom Assessment System-
revised.

(n ¼ 5) and appreciated that the time frame Discriminant validity of the ESAS-r was evalu-
on symptom assessment was included (n ¼ 2). ated by measuring whether the ESAS scores dif-
In regard to preference for one or the other fered depending on the patient’s functional
version, there were no significant differences status (using the PPS). Negative correlation
either in the educational level or previous ex- (r ¼ 0.38 to 0.45) was found for five items
perience with the ESAS. However, there were (pain, tiredness, drowsiness, lack of appetite,
significant differences in this preference and well-being). Nevertheless, no significant
when the ESAS-r was the first questionnaire correlation with the PPS was found for the other
filled out; most of these patients preferred symptoms (nausea, anxiety, depression, diffi-
the ESAS-r (Table 4). culty in sleeping and breathing). Even being
When asked how different their responses a significant value (P < 0.001), the low correla-
were between the ESAS and ESAS-r on a five- tion indicates a weak clinical relevance. A signif-
point Likert scale, most patients reported icant correlation between the scores of the
that there was ‘‘no difference,’’ 31 participants ESAS-r for inpatients and outpatients also was
reported that the difference was ‘‘not important’’ found (P ¼ 0.02).
(rating ¼ 1), whereas 11 participants said that
the difference was ‘‘very important’’ (rating ¼ 5).
Table 5 presents the results of the psycho- Discussion
metric properties measured in the Spanish A revised Spanish version of the ESAS (ESAS-
version of the ESAS-r. Internal consistency ob- r) was developed, and it was perceived by pa-
tained a coefficient of 0.86 using Cronbach’s tients as both easier to understand and complete
alpha. The equivalence reliability between than the ESAS. Moreover, the ESAS-r was ‘‘signif-
the ESAS and ESAS-r obtained a correlation icantly preferred’’ by the patients because of the
higher than 0.7 in all the symptoms by the inclusion of alternative terms that clarified
intraclass correlation coefficient (Table 2). symptoms and also because of the clarity of the
The correlation of the item ‘‘well-being’’ also format. Watanabe et al.15 drew the same conclu-
was evaluated with the sum of the individual sions as the present study and highlighted how
items, and a moderate correlation between the definition of certain terms can be helpful
the two variables was found (r ¼ 0.67). in training new staff to administer the tool.

Table 3
Comparison of the Spanish Versions of the ESAS and ESAS-r in 66 Patients With Advanced Cancer
Questions ESAS ESAS-r No Preference P-value

How easy was it to understand each form?a Mean (SD) 1.88 (0.95) 1.51 (0.92) d 0.001b
How easy was it to fill out each form?a Mean (SD) 1.77 (0.99) 1.56 (0.93) d 0.042b
Overall, which form do you prefer? n (%) 10 (15) 31 (47) 25 (38) 0.0007b
ESAS ¼ Edmonton Symptom Assessment System; ESAS-r ¼ Edmonton Symptom Assessment System-revised.
a
Scale ¼ 1 (very easy) to 5 (very hard).
b
P < 0.05.
134 Carvajal et al. Vol. 45 No. 1 January 2013

Table 4
Associations Among Preference for ESAS or ESAS-r and Level of Education, Order of Completion, and
Whether Patients Previously Completed the Questionnaire
Characteristics ESAS Preference (%) ESAS-r Preference (%) Same Preference (%) P-valuea

Level of education
Primary (n ¼ 31) 7 (23) 14 (45) 10 (32) 0.116
Secondary (n ¼ 20) 2 (10) 6 (30) 12 (60)
High level (n ¼ 15) 1 (7) 11 (73) 3 (20)
First version completed
ESAS (n ¼ 40) 9 (23) 15 (37) 16 (40) 0.02b
ESAS-r (n ¼ 26) 1 (4) 16 (61) 9 (35)
Previous experience with ESAS
Yes (n ¼ 9) 0 (0) 7 (78) 2 (22) 0.098
No (n ¼ 52) 9 (17) 23 (44) 20 (39)
Does not remember (n ¼ 5) 1 (20) 1 (20) 3 (60)
ESAS ¼ Edmonton Symptom Assessment System; ESAS-r ¼ Edmonton Symptom Assessment System-revised.
a
ESAS vs. ESAS-r by Chi-squared analysis.
b
P < 0.05.

Both Spanish versions correlated well (eight the items was weaker, especially for the follow-
of 10 items more than 0.82) (Table 2). The ing three symptoms: drowsiness, appetite, and
correlation was higher than that in the study well-being. The authors justified these differ-
by Watanabe et al.15 This is possibly because ences in the correlation, suggesting that the
the terms used in the Spanish versions of the definitions included in the ESAS-r provided
ESAS and ESAS-r in this study were amended greater clarity in the interpretation of the
after studies of clarification of terms21,22 that items and that the responses obtained between
could be problematic for patients; subse- the two scales were different.
quently, the terminology used in this study A comparison of results relating to the psy-
was adequate in the Spanish context. In the chometric properties of both Spanish versions
study by Watanabe et al.,15 the correlation of of the ESAS is shown in Table 5. The internal

Table 5
Results of the Psychometric Analysis for the Spanish Versions of the ESAS-r and ESAS (N ¼ 66)
Aspect Instrument Statistical Test ESAS-r ESAS14

Reliability
Internal consistency ESAS-r Cronbach’s alpha 0.86 0.75
Correlation sum of ESAS-r Spearman’s rho r ¼ 0.67 r ¼ 0.73
individual items
and item well-being
Equivalence ESAS and ESAS-r ICC From r ¼ 0.71 d
(shortness of breath)
to r ¼ 0.94
(depression)
Validity
Discriminant validity ESAS-r between Mann-Whitney U (P ¼ 0.02) (P < 0.001)
outpatients (n ¼ 54) (outpatients n ¼ 154;
and inpatients inpatients n ¼ 57)
(n ¼ 12)
Inpatients with Spearman’s rho Pain, tiredness, Pain, tiredness,
different drowsiness, lack of drowsiness, lack of
performance statusa appetite, well-being, appetite, well-being,
difficulty breathing depression, difficulty
(r ¼ 0.38 to 0.49) in breathing, anxiety
(P < 0.01) (r ¼ 0.21 to e0.54)
Other symptoms: (P < 0.001)
nausea, anxiety, Nausea and difficulty in
depression, difficulty sleeping (r ¼ 0.12e
in sleeping 0.18) (P > 0.01)
(r ¼ 0.10 to 0.19)
(P > 0.01)
ESAS-r ¼ Edmonton Symptom Assessment System-revised; ESAS ¼ Edmonton Symptom Assessment System; ICC ¼ intraclass correlation coefficient.
a
Palliative Performance Scale was used in the ESAS-r survey, and the Karnofsky Performance Status was used in the ESAS survey.
Vol. 45 No. 1 January 2013 Spanish Version of the ESAS-r 135

consistency of the ESAS-r was better than the completing the ESAS, which may have affected
Spanish ESAS version (0.75).14 These results their perception of the measure. Also, it
suggest that the items are interrelated and should be noted that the functional status of
they confirm the consistency of the instru- the sample in this study was high.
ment. The results obtained in the English ver- We conclude that the ESAS-r is a valid instru-
sions of the ESAS also demonstrated good ment that improves the psychometric proper-
values in different studies: 0.79,25 0.80,26 and ties of previous versions of the ESAS and that
0.93.27 Between 0.8 and 0.9, reliability is patients find it both easier to understand and
good. Higher values mean excellent reliabil- complete. The new Spanish version of the
ity.28 The correlation of the item ‘‘feeling of ESAS-r can, therefore, replace other previous
well-being’’ with the sum of the individual versions of the instrument.
items was moderate (r ¼ 0.67). This result is
similar to that of a previous study,14 suggesting
that this item can be related to the overall bur- Disclosures and Acknowledgments
den of symptoms.
No funding was received for this study and
We investigated whether ESAS scores varied
the authors declare no conflicts of interest.
according to the patient’s functional status;
The authors acknowledge the advice of Shar-
this was determined by means of the PPS. A
on Watanabe and Cheryl Nekolaichuck, who
significant correlation was found in five items.
reviewed the manuscript.
These results seem consistent with the fact that
those patients with higher scores for symptoms
on the ESAS have lower worsened functional
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