Download The quality of life of Brazilian patients in palliative care: validation of

Support Care Cancer (2014) 22:1595–1600
DOI 10.1007/s00520-014-2119-1
ORIGINAL ARTICLE
The quality of life of Brazilian patients in palliative care:
validation of the European Organization for Research
and Treatment of Cancer Quality of Life Questionnaire
Core 15 PAL (EORTC QLQ-C15-PAL)
Natália Abou Hala Nunes
Received: 21 May 2013 / Accepted: 6 January 2014 / Published online: 26 January 2014
# Springer-Verlag Berlin Heidelberg 2014
Palliative care is the condition that the treatment don’t is the
goal, but the control of the progression. Most cancer patients
had or will have low quality of life during the course of their
disease [1, 2]. Thus, the regular assessment of the quality of life
is important to early identification and control of symptoms.
Cancer is one of the most frequent diseases. The incidence
of cancer increases considerably, the survival is 5 years in
general [3, 4].
The evaluation of the quality of life of patients in palliative
care is made with instruments not specific to these patients.
The European Organization for Research and Treatment of
Cancer Quality of Life Core 30 (EORTC QLQ-C30) is the
most common instrument to evaluate the quality of life of
patients with palliative care, but it is extensive and contains
items irrelevant to palliative care [5].
There are no validated instruments to evaluate the quality
of life of Brazilians patients in palliative care [6]. Thus, it is
very important to make available an instrument that healthcare
providers can use daily to assess the quality of life of patients
in palliative care.
The European Organization for Research and Treatment of
Cancer Quality of Life Core 15PAL (EORTC QLQ-C15-PAL)
has already been translated to Brazilian Portuguese. This scale
has been translated into many different languages such as
Russian, Chinese, Italian, German, Greek, Spanish, and
Japanese [7, 8], and validated to be use in Korea [9],
Japan [10], and Mexico [11]. The EORTC QLQ-C15-PAL is a
short scale and is easy to understand. However, this scale has
not yet been validated into Brazilian Portuguese. Thus, the
purpose of this study was to present the Brazilian version of
the EORTC QLQ-C15-PAL to evaluate its psychometric
properties among Brazilian patients in palliative care.
N. A. H. Nunes
University of Guarulhos-UnG, Guarulhos, SP, Brazil
Patients and methods
N. A. H. Nunes (*)
Praça Santa Terezinha, 67, ap. 51, Centro, Taubate, SP, Brazil
12010-130
e-mail: [email protected]
We performed a cross-sectional study at the Pain Clinic of the
Oncological Center for Interdisciplinary Pain in Ambulatory
Gynecology, Urology and Pulmonology of the Hospital das
Abstract
Purpose The purpose of this study was to validate the Brazilian
version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 PAL
(EORTC QLQ-C15-PAL) to be used in patients with cancer in
palliative care.
Methods One hundred four outpatients with advanced cancer
were recruited in Hospital das Clinicas—University of Sao
Paulo, Brazil.
Results The confirmatory factor analysis confirmed that
Cronbach-α is ≥0.7 except for fatigue (α=0.58). Convergent
validity was shown by the correlation observed between the
EORTC QLQ-C15-PAL dimensions with the EORTC QLQC30, Brief Pain Inventory, and Beck Depression Inventory.
The EORTC QLQ-C15-PAL detected significant differences
in the performance status, supporting known-group validity.
Conclusions Our data show that EORTC QLQ-C15-PAL is a
brief, useful, and valid tool for assessing the quality of life of
Brazilian patients in palliative care.
Keywords Quality of life . Palliative care . Validation
studies . Reliability . Validity . Neoplasm
Introduction
1596
Clinicas, University of Sao Paulo in Sao Paulo, Brazil after
receiving approval from the institution’s ethics committee. We
recruited 104 cancer patients between February 2004 and July
2007.
Eligible patients were required to (1) be diagnosed with
cancer confirmed by biopsy, (2) be 18 years of age or older,
and (3) have a metastatic disease confirmed by imaging and
medical diagnosis, according to information recorded in the
patient record. If an eligible patient agreed to participate, we
obtained written informed consent.
The mean age of the 104 outpatients participating in the
study was 57.55, and 54.81 % (n=57) of them were women.
About 52.88 % (n=55) had completed high school. Only
22.12 % (n=23) was illiterate, and 22.12 % (n=23) had
completed the elementary school.
All patients had metastatic cancer. The most common types
of cancer were lung and breast (50.96 %, n=53), and surgery
(63.46 %, n=66) and chemotherapy (53.85 %, n=56) were the
most performed treatments. Metastases were found more frequently in the lymphatic system (65.38 %, n=68) and bone
(47.12 %, n=49), and the averaged time of cancer diagnosis,
in months, was 27.96 (SD=34.11). The functional capacity
score (KPS) medium was moderate, 69.23 (SD=12.89).
Measurements
Subjects were required to complete the EORTC QLQ-C30,
Brief Pain Inventory (BPI-B), Beck Depression Inventory
(BDI), and sociodemographic and clinical data. In addition,
the demographic and clinical characteristics and the performance status were also assessed.
We retrieved data on the patients’ diagnosis, disease stage,
and treatment from the hospital medical records. Demographic data were obtained from the patients by interview. The
Karnofsky Performance Status scale (KPS) was used to assess
performance status [12].
Linguistic adaptation
The EORTC QLQ-C15-PAL was translated into Brazilian
Portuguese using a standard translation and back-translation
procedure. The English-language items were initially translated into Portuguese by two native Brazilians who spoke fluent
English. A committee of bilingually fluent Brazilian pain
experts evaluated and approved these item translations. The
items were then translated back into English by a bilingual
translator who had not seen the original English version. The
English back-translation and the original versions were compared. Finally, a Brazilian version of the EORTC QLQ-C15PAL was produced.
The resulting questionnaire was pilot tested among patients
with cancer in palliative care. On the basis of the results from
the pilot test, we made further translation refinements and
Support Care Cancer (2014) 22:1595–1600
finalized the tool. The BPI consists of 15 items that are
arranged in three dimensions: symptom status (items 4, 5, 6,
7, 8, 9, 10, 11, 12), functional status (items 1 to 3, and 13 and
14), and global health status (item 15) [7]. The EORTC QLQC15-PAL asks patients to rate their global health status in a 7point scale ranging from 0 (as bad as it can be) to 7 (excellent),
functional status (physical and emotional functioning), and
symptom status (fatigue, nausea and vomiting, pain, dyspnea,
insomnia, appetite loss, constipation) in a Likert scales 1 (not
at all) to 4 (very much). The scores are calculated equal
EORTC QLQ-C30 [7, 13].
The EORTC QLQ-C30 version 3.0 was used to evaluate
symptom status, functional status, and quality of life about
participants [11]. The EORTC QLQ-C30 consists of 30 items
that assess health-related quality of life. The pain scale
included two items that assess pain intensity (item 9) and
pain interference in daily activities (item 19). The score
range from 0 to 100. A higher score represented a higher
(“better”) level of pain and a higher (“worse”) level. In
our sample, the EORTC QLQ-C30 showed internal consistency in functional scales (Cronbach-α=0.74) and symptom scales (Cronbach-α=0.72) [14].
The BDI was used to assess depression compared with
emotional functional about EORTC QLQ-C15-PAL. The
BDI includes 21 items that are arranged in two dimensions:
somatic (items 1 to 13) and cognitive–affective (items 14 to
21), in which the higher the score, the higher the level of
depression of the participant. In this study, it had a cutoff ≥21
for depression [15, 16].
The BPI [17, 18] was used to assess pain and consists of
nine items that are arranged in two dimensions: intensity/
severity of pain (sensory dimension, items 3 to 6) and interference of pain (impact) in the patient’s life (reactive dimension, items 9a to 9g). The BPI asks patients to rate their pain
intensity and the pain interference (with general activities,
mood, walking ability, normal work, relationships with others,
sleep, and enjoyment of life) in an 11-point scale ranging from
0 (no pain/no interference) to 10 (as bad as it can be). The
scores for the two dimensions range from 0 to 10 and are
calculated using the mean of the total items. A high score
represents a high-pain intensity or pain interference [17, 18].
Statistical analysis
The internal consistency reliability of the EORTC QLQ-C15PAL was evaluated by Cronbach’s coefficient alpha. This
coefficient was computed for the interference and severity
scales of the EORTC QLQ-C15-PAL. A value of 0.70 or
greater was considered adequate for group comparisons [19].
Construct validity was determined by confirmatory factor
analysis (CFA). CFA was conducted using structural equation
modeling in LISREL version 8.8 for Windows [20]. Indices
used to evaluate model fit in CFA included the comparative fit
Support Care Cancer (2014) 22:1595–1600
1597
Table 1 Distribution of domains and items on the version of the EORTC
QLQ-C15-PAL, after modification of the EORTC QLQ-C30
Escalas/Domínios
Global health status/QoL
Global health status/QoL
Functional scales
Physical functioning
Role functioning
Emotional functioning
Cognitive functioning
Social functioning
Symptom scales
Fatigue
Nausea and vomiting
Pain
Dyspnea
Insomnia
Appetite loss
Constipation
Diarrhea
Financial difficulties
Financial difficulties
Items (EORTC
QLQ-C30)
Items (EORTC
QLQ-C15-PAL)
29, 30
30
1, 5
6.7
21, 24
20, 25
26, 27
3, 5
–
21, 24
–
–
10, 12, 18
14, 15
9, 19
8
11
13
16
17
–
28
12, 18
14
9, 19
8
11
13
16
–
–
–
Results
Descriptive analysis
index (CFI), normed chi-square (chi-square/degree of freedom), and root-mean-square error of approximation
(RMSEA). If the models are fit, their CFI should be higher
than 0.90, the RMSEA lower than 0.10, and the normed chisquare lower than 5 [21].
Fig. 1 Confirmatory factor
analysis of the EORTC
QLQ-C15-PAL
The Spearman correlation coefficients were calculated to
assess convergent validity between the EORTC QLQ-C15PAL, EORTC QLQ-C30, BPI, and BDI.
Known-group validity was evaluated by comparing subgroups of patients known to differ on clinical variables using
the ANOVA or Kruskal–Wallis tests and depends on their
adherence to normal distribution.
For all tests, a P value of <0.05 was considered statistically
significant.
Most of the Brazilian patients filled out the EORTC QLQ-C30
during an interview. Table 1 presents the descriptive analyses
from the version of the EORTC QLQ-C15-PAL and EORT
QLQ-C30.
Construct validity
A CFA was used to determine the adjustment of the
EORTC QLQ-C15-PAL factors identified in the English
version: global health status, functional scale, and symptom scale. The hypothesized model is presented in Fig. 1.
The independent model that tests the hypothesis that all
variables are uncorrelated was rejected in EORTC QLQC15-PAL model, normed χ2 = 61.77, P= 0.12283. The
EORTC QLQ-C15-PAL model showed a good fit to data:
CFI=0.90 and RMSEA=0.048.
1598
Table 2 Distribution of
Cronbach’s alpha, item–total correlation, and Cronbach’s alpha if
domain items and -QLQ-C15PAL items (n=104) are deleted
SD standard deviation, P25–P75
percentile 25 and percentile 75
Support Care Cancer (2014) 22:1595–1600
Domain/item
Coefficient of
Cronbach’s alpha
Functional scales
Physical functioning
Do you have any difficulty when doing a short
walk away from home?
Do you have to stay in bed or in a chair during
the day?
Do you need any help to eat, get dressed, take
a shower or use the toilet?
Emotional functioning
Did you feel nervous?
Did you feel depressed?
Symptoms scales
Fatigue
Have you been feeling tired?
Have you been feeling weak?
Pain
Have you had pain?
Did the pain bother you in your daily activities?
Reliability
The reliability of the EORTC QLQ-C15-PAL was evaluated
by the internal consistency (Cronbach’s α coefficient). We
Correlation
of item–total
Cronbach’s alpha
(if item is deleted)
0.75
0.82
0.78
0.80
0.74
0.84
0.56
0.56
–
–
0.41
0.41
–
–
0.76
0.76
–
–
0.87
0.65
0.58
0.86
separately calculated coefficient alpha for the functional
scales (physical functioning and emotional functioning)
and symptoms scales (fatigue and pain). Cronbach’s alpha
coefficient results are presented in Table 2. The internal
Table 3 Correlation results (r) and p value of the EORTC QLQ-C15-PAL items with the EORTC QLQ-C30, Brief Pain Inventory, and Beck’s
Depression Inventory for the verification of criterion validity (n=104)
Domains and scales (EORTC QLQ-C15-PAL) EORTC QLQ-C30
r
Global health status/QoL (QL)
Global health status/QoL (QL)
Functional scales
Physical functioning (PF)
Emotional functioning (EF)
p†
QL
QL
0.80
<0.01
PF
EF
0.96
0.30
<0.01
<0.01
Symptoms scales
Fatigue (FA)
Nauseas e vomits (NV)
Pain (PA)
FA
NV
PA
0.89
0.97
1.0
<0.01
<0.01
–
Dyspnea(Dy)
Insomnia (Sl)
Appetite loss (Ap)
Constipation (Co)
Dy
Sl
Ap
Co
1.0
1.0
1.0
1.0
–
–
–
–
r correlation coefficient of Spearman
†
p≤0.05 (statistically significant)
Brief Pain Inventory
Beck’s Depression Inventory
r
–
–
–
–
–
p†
r
–
–
–
–
C. Somatic
p†
−0.65 <0.01
C. Cognitive–affective −0.50 <0.01
Instrument total score −0.62 <0.01
–
–
–
Item 17
0.66 <0.01
–
–
C. Intensity
0.83 <0.01 –
C. Impact
0.81 <0.01
Instrument total score 0.84 <0.01
–
–
–
–
–
Item 18
0.86 <0.01
–
–
Support Care Cancer (2014) 22:1595–1600
1599
Table 4 Distribution and statistical analysis of the known-groups validity (n=104)
Domains/scale
Global health status/QoL
Functional scales
Physical functioning (PF)
Emotional functioning (EF)
Symptom scale
Fatigue (FA)
Nauseas e vomits (NV)
Pain (PA)
Dyspnea (Dy)
Insomnia (Sl)
Loss of appetite (AP)
Constipation (Co)
p value†
KPS
80 and 100 (n=34)
Median (P25–P75)
average
60 and 70 (n=46)
Median (P25–P75)
average
≤50 (n=19)
Median (P25–P75)
average
66.66 (50.00–87.50)
66.18
66.66 (33.33–83.33)
58.33
50.00 (33.33–83.33)
57.01
100.00 (88.88–100.00)
93.27
75.00 (33.33–100.00)
64.70
55.55 (22.22–80.55)
54.44
58.33 (29.16–83.33)
53.00
0.00 (0.00–11.11)
8.77
33.33 (0.00–83.33)
39.53
<0.01
16.66 (0.00–33.33)
25.50
0.00 (0.00–0.00)
8.82
33.33 (12.50–50.00)
37.34
0.00 (0.00–33.33)
16.66
0.00 (0.00–50.00)
28.43
0.00 (0.00–33.33)
20.68
0.00 (0.00–33.33)
21.68
33.33 (16.66–66.66)
39.33
0.00 (0.00–33.33)
22.00
100.00 (66.66–100.00)
81.33
0.00 (0.00–33.33)
26.66
66.66 (0.00–100.00)
60.66
66.66 (0.00–100.00)
45.33
33.33 (0.00–100.00)
45.33
66.66 (33.33–83.33)
63.27
0.00 (0.00–33.33)
21.05
100.00 (83.33–100.00)
86.84
66.66 (0.00–66.66)
45.61
66.66 (33.33–100.00)
59.64
66.66 (0.00–100.00)
52.63
66.66 (0.00–100.00)
54.46
<0.01
0.351
0.048
0.080
<0.01
0.012
<0.01
0.010
<0.01
P25–P75 25th percentile and 75th percentile
†
p≤0.05 (statistically significant, Kruskal–Wallis)
consistency for the physical functioning was 0.87, for
emotional functioning was 0.65, for fatigue was 0.58,
and for pain was 0.86. Table 2 also shows that the values
for Cronbach’s α coefficients, if items were deleted, were
comparable to the overall alpha value of each of the two
dimensions, and thus each of the items contributes to the
underlying constructs.
Convergent validity
As expected, positive and moderate to perfect correlations
were obtained among the EORTC QLQ-C15-PAL and
EORTC QLQ-C30 ranged from 0.30 to 1; moderate and
strong correlations were obtained among the EORTC
QLQ-C15-PAL, BPI, and BDI ranged from 0.50 to 0.86
(Table 3).
Known-group validity
Known-group validity was examined by comparing the
total score of quality of life, stratified by low (≤50),
moderate (60 to 70), and high (80 to 100) KPS. The
total score was able to differentiate patients according to
the disease status (Table 4).
Discussion
Based on our findings, we conclude that the EORTC QLQC15-PAL is a valid and reliable measurement to assess the
quality of life of Brazilian patients in palliative care.
The construct validity and convergent validity of EORTC
QLQ-C15-PAL performed in other studies were not done. In
this study, the EORTC QLQ-C15-PAL is really actually measuring the constructs since it showed a moderate to perfect
correlation with valid questionnaires such as EORTC QLQC30, BDI, and BPI.
The Cronbach’s alpha coefficients for both the severity and
interference items were high, except for fatigue. The
Cronbach’s-α was similar in Japan EORTC QLQ-C15-PAL
validation studies (α=0.4) [10]. These values exceed 0.7, a
typical standard for acceptable scale stability, but other authors
accept α>0.6 as quite satisfying [22].
The present study has some limitations in that we did not
evaluate the EORTC QLQ-C15-PAL test–retest reliability and
responsiveness. However, we did observe that the EORTC
QLQ-C15-PAL was able to differentiate between patients with
low, moderate, and high performance status. We can imply
that if we use the EORT QLQ-C15-PAL to assess the quality
of life of patients in palliative care.
1600
In conclusion, we can say that the EORTC QLQ-C15-PAL
is a useful and reliable tool to assess the quality of life of
Brazilian patients in palliative care. We hope this instrument
can help researchers and clinicians to assess the quality of life
of these patients to select interventions and to evaluate their
effectiveness. Thus, the use of this tool will be able to improve
the quality of life of Brazilians patients in palliative care.
Acknowledgments The authors would like to thank the physicians,
nurses, and physical therapists from the Hospital das Clinicas, School of
Medicine, University of Sao Paulo who helped us to enroll patients in our
study.
Conflict of interest None declared.
References
1. DeVita VT, Lawrence TS, Rosenberg SA (2011) Cancer: principles
& practice of oncology: primer of the molecular biology of cancer.
Lippincott Williams & Wilkins/Wolters Kluwer. 9TH
2. World Health Organization (2009) WHO Definition of Palliative
Care. Acesso em: 04 jan 2012 Disponível em: http://www.who.int/
cancer/palliative/definition/en
3. Jemal A et al (2009) Cancer statistics, 2009 CA. Cancer J Clini 59(4):
225–249
4. American Cancer Society (2009) Cancer Facts&Figures. Atlanta:
American Cancer Society [periódico na internet] 2009. [acesso em
27 nov 2011] Disponível em: http://www.cancer.org/acs/groups/
content/@nho/documents/document/500809webpdf.pdf
5. EORTC-QLQ-C15-PAL (2006) the new standard in the assessment
of health-related quality of life in palliative care? Letter to the Editor.
A response to Echteld MA et al. Palliative Medicine; 20: 59_/61
6. Correia FR, De Carlo MMR (2012) de P Avaliação de qualidade de
vida no contexto dos cuidados paliativos: revisão integrativa de
literatura. Rev. Latino-Am. Enfermagem 20(2):[10 telas] mar.-abr
7. Groenvold M et al (2006) The development of the EORTC QLQC15-PAL: a shortened questionnaire for cancer patients in palliative
care. Eur J Cancer 42:55–64
8. Translations. European Organization for Research and Treatment
http://groups.eortc.be/qol/eortc-qlq-c15-palhttp://groups.eortc.be/
Support Care Cancer (2014) 22:1595–1600
qol/Validated%20modules%20by%20language_November%
202011.pdf
9. Shin et al (2011) Cross-cultural application of the Korean version of
the European Organization for Research and Treatment of Cancer
Quality of Life Questionnaire-Core 15-Palliative Care. J Pain
Symptom Manag 41(2):478–484
10. Miyazaki K, Suzukamo Y, Shimozuma K, Nakayama T (2012)
Verification of the psychometric properties of the Japanese version
of the European Organization for Research and Treatment of Cancer
Quality of Life Questionnaire Core 15 Palliative (EORTCQLQ-C15PAL). Qual Life Res 21(2):335–340
11. Del-Real YS et al (2011) Validation of the Mexican–Spanish version
of the EORTC QLQ-C15-PAL questionnaire for the evaluation of
health related quality of life in patients on palliative care. PsychoOncology 20:889–896
12. Karnofsky DA, Abelmann WH, Craver LF, Burchenal JH (1948) The
use of nitrogen mustard in the palliative treatment of cancer. Cancer
1(4):634–656
13. Fayers GJ et al (2001) The EORTC QLQ C30 Scoring Manual, 3rd
edn. European Organization for Research and Treatment of Cancer,
Brussels
14. Aaronson N et al (1993) The European Organization for Research
and Treatment of Cancer QLQ-C30: a quality-of-life instrument for
use in international clinical trials in oncology. J Natl Cancer Inst
85(5):365–376
15. Beck AT, Rush AJ, Shaw BF, Emery G (1977) Terapia Cognitiva da
Depressão, 9th edn. Porto Alegre, Artes Médicas
16. Gorenstein C, Andrade L (1998) Inventário de Depressão de Beck:
propriedades psicométricas da versão em português. Rev Psiquiatr
Clín 25(5):245–250
17. Cleeland C, Ryan K (1994) Pain assessment: global use of the Brief
Pain Inventory. Ann Acad Med Singap 23(2):129–138
18. Ferreira KASL, Teixeira MJ, Mendonza TR, Cleeland CS (2011)
Validation of brief pain inventory to Brazilian patients with pain.
Support Care Cancer 19(4):505–511
19. Cronbach LJ (1951) Coefficient alpha and the internal structure of
tests. Psychometrika 16(3):297–334
20. Jöreskog KG, Sörbom D (2006) LISREL 8.80 for Windows
[Computer Software] Lincolnwood. Scientific Software International,
Inc., IL
21. Hair J, Anderson R, Tatham R, Black W (1998) Multivariate data
analysis, 5th edn. Prentice-Hall, Englewood Cliffs
22. Boyle GJ (1991) Does item homogeneity indicate internal consistency
or item redundancy in psychometric scales? Personal Individ Differ
12(3):291–294