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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=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 Spanish version of the ESAS-r can, therefore, replace the use of the ESAS.
Complexity and assessment of symptom control in outpatients unit of palliative care. [in Spanish]. Abstract of the 5th National Congress of the Spanish Society of Palliative Care.
carried out a comprehensive study of the psychometric properties of the Spanish ESAS when used with patients with advanced cancer. This version is slightly different than the original English version used by Watanabe et al.
because it includes an additional item to evaluate sleep disturbance. This item was added by the creator of the ESAS and is currently used at the M. D. Anderson Cancer Center.
The changes made in the ESAS-r include clarification of a number of terms, a change in the format, definition of a specific time frame relating to the ESAS, and the reordering of items. Professional assistance and support for the patient are provided when they complete the form initially. This revised version was submitted to an international cohort of patients who were requested to compare it with the original version. Results showed that patients “significantly preferred” the revised version compared with the original ESAS. The study stressed that to validate the ESAS further, a future research priority should be to examine the use of the ESAS-r in languages other than English.
We have chosen to replicate the study by Watanabe et al.
using the Spanish version, with an international cohort of Spanish-speaking patients. In addition, to obtain the first proof of validity of the new Spanish ESAS-r version, its psychometric properties were evaluated and compared with data from the original version.
Bilingual professionals experienced in palliative care and in using the ESAS drafted a Spanish version of the ESAS-r based both on the previous Spanish version and on the English revised version. A reverse translation method was used by bilingual translators to translate the ESAS into Spanish.
A pilot study with advanced cancer patients was undertaken to obtain patient perceptions about the new version of the instrument. The group of experts reviewed the comments made by the patients and created a final Spanish version of the ESAS-r to be tested.
A group of patients with advanced cancer completed the Spanish ESAS and ESAS-r; the order of the two instruments was not predetermined. All patients were older than 18 years, with normal cognitive function on the Mini-Mental State Examination (MMSE). Patients from oncology departments of tertiary hospitals were included (Spain: University of Navarra Hospital; Guatemala: National Cancer Institute). Patients with advanced cancer receiving palliative radiotherapy or chemotherapy also were eligible. We anticipated collecting data from a minimum of 30 patients in each center, as in the study by Watanabe et al.
Patients also were asked about their perceptions of both forms and how they compared with each other. Data were gathered between December 2010 and February 2011.
The study was approved by the Ethics Committee on Clinical Research at the University of Navarra Hospital. Written informed consent was obtained from each patient.
The instruments used in this study were the Spanish version of the ESAS,
and a questionnaire requesting the patient's perception of the two versions of the ESAS (the original ESAS and the revised ESAS-r). This questionnaire was derived from the study undertaken by Watanabe et al.
It comprises eight questions focused on the patient's familiarity with the ESAS, ease of understanding and completion, and the assessment of differences between the two versions. For quantitative analysis, patient opinion was collected on a five-point Likert scale ranging from 1 (very easy) to 5 (very hard); data were analyzed using the paired sample t-test and binomial test. Qualitative comments also were obtained.
Fig. 1Spanish 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 depression, worst possible depression, no anxiety, worst possible anxiety, best sleep, worst possible sleep, best well-being, worst possible well-being, other problem. ESAS-r=Edmonton Symptom Assessment System-revised.
and also gathered demographic and clinical data from the patients. The ESAS and ESAS-r were completed consecutively by the patients in the presence of the researcher. The patient also filled out the structured questionnaire about their perception of the two versions of the ESAS.
The psychometric properties of the ESAS-r that were analyzed were equivalence between the ESAS and ESAS-r by the intraclass correlation coefficient, the internal consistency of the ESAS-r measured by calculating Cronbach's alpha, the correlation between the sum of the specific items within the ESAS-r and the item “well-being” explored by the Spearman correlation, and discriminant validity evaluated by testing the difference of the ESAS-r score among patients with different functional status (measured using the PPS) by the Spearman correlation. Discrimination between inpatients and outpatients was evaluated by the Mann-Whitney U test.
Results
A Spanish version of the ESAS-r was created (Fig. 1). This version differs from the English version in that 1) it includes alternative terms for “fatigue” (agotamiento/exhaustion, cansancio/tiredness, or debilidad/weakness) and “anxiety” (nerviosismo/nervousness, intranquilidad/disquiet, or ansiedad/anxiousness) obtained through previous studies,
2) it includes alternative terms for “drowsiness” (somnolencia/drowsiness or adormilado/sleepiness) and “well-being” (sentirse perfectamente/feeling perfectly or sensación de bienestar/feeling of well-being), 3) it includes the item “difficulty in sleeping” as did the previous Spanish version, and 4) it was decided that the alternative term for “other problems” should be “dry mouth,” a very prevalent symptom in palliative care,
found that patients with a perception of constipation, based on visual numerical scales, did not have good correlation with symptoms of constipation and vice versa.
A total of 14 patients with advanced cancer participated in the pilot study, using a format similar to that of the English version of the ESAS-r. It was noted that patients perceived the new version of the ESAS (ESAS-r) as difficult to read, so some changes in the format were made to obtain a clearer design, that is, print size of the items was changed and shading was added (Fig. 1).
A total of 66 patients with advanced cancer completed the ESAS and ESAS-r. Table 1 describes the demographic and clinical characteristics of the participants. Average scores for the ESAS and ESAS-r are summarized in Table 2.
Table 1Patient Characteristics (N=66)
Characteristics
n (%)
Gender
Female
46 (70)
Male
20 (30)
Primary cancer diagnosis
Gastrointestinal
24 (36)
Genitourinary
16 (24)
Lung
3 (5)
Breast
12 (18)
Other cancer
11 (17)
Current cancer treatment
Chemotherapy
34 (51)
Radiotherapy
5 (8)
Chemo and radiotherapy
1 (2)
Palliative care only
26 (39)
Education level (years)
Primary (0–8)
31 (47)
Secondary (8–12)
20 (30)
High (>12)
15 (23)
Prognostic factors in pain control as per ECS-CP
Neuropathic pain
15 (23)
Incident pain
19 (29)
Psychological distress
3 (5)
Addictive behavior
0 (0)
Cognitive status impaired
1 (2)
Previously filled out ESAS
No
52 (79)
Yes
9 (14)
Unknown
5 (7)
Patient setting
Outpatient
54 (82)
Inpatient
12 (18)
Age (years), mean (range)
54 (18–84)
MMSE (average), range 0–30
28 (23–30)
PPS (average), range 0–100%
78 (40–100)
ECS-CP=The Edmonton Classification System for Cancer Pain; ESAS=Edmonton Symptom Assessment System; MMSE=Mini-Mental State Examination; PPS=Palliative Performance Scale.
Overall, the ESAS-r was easier to understand and complete than the ESAS (Table 3). Patients “significantly preferred” the ESAS-r to the ESAS (Table 3), the most frequent reason being that alternative terms provided more explanation of the items (n=14). Patients also thought that the ESAS-r was visually clearer and easier to read with the gray shadow (n=5) and appreciated that the time frame on symptom assessment was included (n=2). In regard to preference for one or the other version, there were no significant differences either in the educational level or previous experience with the ESAS. However, there were significant differences in this preference when the ESAS-r was the first questionnaire filled out; most of these patients preferred the ESAS-r (Table 4).
Table 3Comparison of the Spanish Versions of the ESAS and ESAS-r in 66 Patients With Advanced Cancer
Table 4Associations Among Preference for ESAS or ESAS-r and Level of Education, Order of Completion, and Whether Patients Previously Completed the Questionnaire
When asked how different their responses were between the ESAS and ESAS-r on a five-point Likert scale, most patients reported that there was “no difference,” 31 participants reported that the difference was “not important” (rating=1), whereas 11 participants said that the difference was “very important” (rating=5).
Table 5 presents the results of the psychometric properties measured in the Spanish version of the ESAS-r. Internal consistency obtained a coefficient of 0.86 using Cronbach's alpha. The equivalence reliability between the ESAS and ESAS-r obtained a correlation higher than 0.7 in all the symptoms by the intraclass correlation coefficient (Table 2). The correlation of the item “well-being” also was evaluated with the sum of the individual items, and a moderate correlation between the two variables was found (r=0.67).
Table 5Results of the Psychometric Analysis for the Spanish Versions of the ESAS-r and ESAS (N=66)
Discriminant validity of the ESAS-r was evaluated by measuring whether the ESAS scores differed depending on the patient's functional status (using the PPS). Negative correlation (r=−0.38 to −0.45) was found for five items (pain, tiredness, drowsiness, lack of appetite, and well-being). Nevertheless, no significant correlation with the PPS was found for the other symptoms (nausea, anxiety, depression, difficulty in sleeping and breathing). Even being a significant value (P<0.001), the low correlation indicates a weak clinical relevance. A significant correlation between the scores of the ESAS-r for inpatients and outpatients also was found (P=0.02).
Discussion
A revised Spanish version of the ESAS (ESAS-r) was developed, and it was perceived by patients as both easier to understand and complete than the ESAS. Moreover, the ESAS-r was “significantly preferred” by the patients because of the inclusion of alternative terms that clarified symptoms and also because of the clarity of the format. Watanabe et al.
drew the same conclusions as the present study and highlighted how the definition of certain terms can be helpful in training new staff to administer the tool.
Both Spanish versions correlated well (eight of 10 items more than 0.82) (Table 2). The correlation was higher than that in the study by Watanabe et al.
This is possibly because the terms used in the Spanish versions of the ESAS and ESAS-r in this study were amended after studies of clarification of terms
that could be problematic for patients; subsequently, the terminology used in this study was adequate in the Spanish context. In the study by Watanabe et al.,
the correlation of the items was weaker, especially for the following three symptoms: drowsiness, appetite, and well-being. The authors justified these differences in the correlation, suggesting that the definitions included in the ESAS-r provided greater clarity in the interpretation of the items and that the responses obtained between the two scales were different.
A comparison of results relating to the psychometric properties of both Spanish versions of the ESAS is shown in Table 5. The internal consistency of the ESAS-r was better than the Spanish ESAS version (0.75).
These results suggest that the items are interrelated and they confirm the consistency of the instrument. The results obtained in the English versions of the ESAS also demonstrated good values in different studies: 0.79,
The correlation of the item “feeling of well-being” with the sum of the individual items was moderate (r=0.67). This result is similar to that of a previous study,
suggesting that this item can be related to the overall burden of symptoms.
We investigated whether ESAS scores varied according to the patient's functional status; this was determined by means of the PPS. A significant correlation was found in five items. These results seem consistent with the fact that those patients with higher scores for symptoms on the ESAS have lower worsened functional status. These results are quite similar to those obtained in the study of the previous Spanish version of the ESAS
which did not find significant differences in ESAS-r preference between those who had previously completed the ESAS and those who had not. It could be hypothesized that patients who possess experience in using the ESAS have more information about the instrument, and this could, therefore, help them when comparing both versions. However, further studies with larger samples need to be carried out to support this result.
The ESAS was relatively easy to understand at different cultural levels. It was found that the level of patient education does not significantly influence preference for either the ESAS or ESAS-r, a finding confirmed by Watanabe et al.
However, some patients with basic education required varying degrees of assistance to understand the tool. Understanding of the ESAS and ESAS-r by patients with lower educational levels will require further investigation.
Some limitations of this study are worthy of mention. Most patients were unfamiliar with completing the ESAS, which may have affected their perception of the measure. Also, it should be noted that the functional status of the sample in this study was high.
We conclude that the ESAS-r is a valid instrument that improves the psychometric properties of previous versions of the ESAS and that patients find it both easier to understand and complete. The new Spanish version of the ESAS-r can, therefore, replace other previous versions of the instrument.
Disclosures and Acknowledgments
No funding was received for this study and the authors declare no conflicts of interest.
The authors acknowledge the advice of Sharon Watanabe and Cheryl Nekolaichuck, who reviewed the manuscript.
References
Bruera E.
MacDonald S.
Audit methods: the Edmonton Symptom Assessment System.
in: Higginson I. Clinical audit in palliative care. Radcliffe Medical Press,
Oxford, UK1993: 61-77
Complexity and assessment of symptom control in outpatients unit of palliative care. [in Spanish]. Abstract of the 5th National Congress of the Spanish Society of Palliative Care.
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