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Erschienen in: Health and Quality of Life Outcomes 1/2013

Open Access 01.12.2013 | Short report

Validation of the Korean version of the European Organization for Research and Treatment of Cancer brain cancer module (EORTC QLQ-BN20) in patients with brain tumors

verfasst von: Yong Soon Shin, Jeong Hoon Kim

Erschienen in: Health and Quality of Life Outcomes | Ausgabe 1/2013

Abstract

Background

The European Organization for Research and Treatment of Cancer Quality of Life Brain Cancer Module has been translated into Korean, but to date, its reliability and validity have been evaluated in a pilot study alone. The European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire is, overall, a valid instrument to assess the health-related quality of life in Korean cancer patients, although its reliability and validity have not yet been evaluated in patients with brain tumors. This study aimed at evaluating the psychometric properties of these instruments in patients with brain tumors.

Findings

The 2 instruments were used for 307 Korean patients with brain tumors. Multi-trait scaling confirmed the scale structure of the instruments with good item convergent and discriminant validity. The reliability was acceptable for all scales except for cognitive functioning and nausea and vomiting. The instruments could be used to distinguish between clinically distinct groups of patients.

Conclusions

The study findings indicate that the instruments are valid and suitable for the assessment of the health-related quality of life in patients with brain tumors as well as in those with primary brain cancer.
Hinweise

Competing interests

The authors confirm that no research funding or any support was received for this study and declare that they have no financial or other conflicts of interest related to this research and its publication.

Authors’ contributions

SYS and KJH designed the study, KJH collected the data, and both SYS and KJH interpreted the data and revised the manuscript. SYS managed the statistical analyse. Both authors read and approved the final manuscript.
Abkürzungen
EORTC QLQ-BN20
European organization for research and treatment of cancer quality of life questionnaire brain cancer module
HRQOL
Health-related quality of life
EORTC QLQ-C30
Quality of life core questionnaire
QOL
Quality of life
KPS
Karnofsky performance scale.

Background

Despite improvements, many treatments for brain tumors are not curative and these patients have a poor prognosis. In addition, such treatments may be neurotoxic and, thus, negatively affect patient health-related quality of life (HRQOL). Therefore, the use of well-validated instruments when assessing the HRQOL of patients with brain tumors is particularly important. Most HRQOL instruments were developed in English for a predominantly English-speaking population. The European Organization for Research and Treatment of Cancer brain cancer module (EORTC QLQ-BN20) has previously been tested in English-speaking patients and was shown to have adequate psychometric properties [1]. The QLQ-BN20 was translated into Korean by the EORTC group [2], and its reliability and validity have been evaluated, although only in a pilot study. The standard Korean version of EORTC Quality of Life Core Questionnaire (QLQ-C30) is, overall, a valid instrument for the assessment of HRQOL in Korean patients with breast, stomach, colon, and rectal cancers [3], although its reliability and validity have not yet been specifically evaluated in patients with brain tumors. Hence, the purpose of the current study was to examine the validity and reliability of the Korean version of the QLQ-BN20 and QLQ- C30 in patients with brain tumors.

Methods

Sample and setting

This study used a prospective, descriptive cross-sectional design in which the convenience sampling was performed at a tertiary-care university hospital in Seoul, Korea. To be included in the study, patients had to be aged >18 years, fluent in Korean, and diagnosed with a histologically verified brain tumor. Patients who had not undergone surgery or those with metastatic brain tumors were excluded. The study was approved by the institutional review board of Asan Medical Center. Written informed consent was obtained from all patients or their legally authorized representative.

Instruments

The EORTC QLQ-BN20 is a 20-item questionnaire grouped into 4 domains and 7 single items [1], while the QLQ-C30 comprises a 30-item questionnaire. Raw scores were standardized by linear transformation so that the final scores were in the range of 0 –100. Higher scores on the global QOL and functional scales represent a better QOL, whereas high symptom scale scores indicate significant symptoms or greater difficulty.

Statistical analysis

Multi-trait scaling was employed to examine the scale structure of the instruments. Item-scale correlations ≥ 0.40 were considered to validate item convergent. Item-scale discriminant validity was examined by comparing the correlation of each item with its own scale versus that with other scales. We expected a high correlation between items (2 standard errors) with their own scale rather than with other scales. The internal consistency reliability of the instruments was estimated using Cronbach’s alpha coefficient (α). Values of α ≥ 0.70 were considered acceptable for group comparisons.
The known group validities were tested by comparing the score of the Korean version of the QLQ-BN20 and QLQ-C30 between patient groups. First, we hypothesized that patients with a high performance status (Karnofsky performance scale [KPS] score > 70) would report lower levels of symptoms and a better QOL than patients with a low performance status (KPS score ≤ 70). Second, patients with glioma were expected to report a higher level of symptoms than patients with meningioma. Finally, patients who received adjuvant therapy (chemotherapy, radiation therapy, or both) were expected to report a higher level of future uncertainty than patients who underwent surgery alone.
Construct validity was then examined by calculating the correlations between the multi-item scales of the QLQ-BN20 and QLQ-C30. We expected moderate correlations between future uncertainty and emotional functioning, visual disorder and cognitive functioning, motor dysfunction and physical functioning, and communication deficit and social functioning (r > 0.40). We used SPSS 20.0 (SPSS Inc., Chicago, IL, USA) for data analysis. Values of p < 0.05 were considered statistically significant. Missing data were excluded from the analysis.

Results

Of 350 invited patients, 317 (90.6%) agreed to participate, and a total of 307 (87.7%) useful questionnaires were analysed. The mean age was 47.95 ± 13.64 years (range, 18–81 years). Fifty-seven percent of the patients were women. Most patients were married (72%), and 37.5% had completed college or graduate school. Gliomas (39.7%) constituted the most frequent tumor type. More than half of the patients underwent surgery alone (Table 1).
Table 1
Socio-demographic and clinical characteristics (N=307)
Variable
Mean (SD, range) or N (%)
Age (years)
47.95 (13.64, 18–81)
Gender
 
   Female
175 (57.0)
   Male
132 (43.0)
Education
 
   Middle school or less
77 (25.1)
   High school
104 (33.9)
   College
105 (34.2)
   Graduate school
10 (3.3)
   Nonresponse
11 (3.5)
Marital status
 
   Married
221 (72.0)
   Single
53 (17.3)
   Widowed/divorced
27 (8.8)
   Nonresponse
6 (1.9)
KPS
 
   ≤70
35 (11.4)
   >70
272 (88.6)
Treatment modality
 
   Surgery only
177 (57.7)
   Surgery plus CTx or RTx or both
130 (42.3)
Tumor type
 
   Glioma
122 (39.7)
   Meningioma
107 (34.9)
   Others
78 (25.4)
KPS Karnofsky performance scale, CTx chemotherapy, RTx radiation therapy.

Scale reliability and scale structures

As shown Table 2, with the exception of the cognitive functioning (0.60) and nausea and vomiting scales (0.64), most of the multi-item scales of the QLQ-C30 and the all scales of the QLQ-BN20 met the minimal standard of reliability (α > 0.70).
Table 2
Scale reliability and structures
 
Mean (SD)
Cronbach’s alpha
Number of items
Item-own scale correlation
Item-other scale correlation
QLQ-C30
     
Functional scales
     
Physical functioning
71.16 (24.94)
.87
5
0.55–0.90
0.16–0.55
Role functioning
69.74 (31.43)
.89
2
0.93–0.94
0.25–0.69
Emotional functioning
71.51 (23.81)
.87
4
0.79–0.87
0.27–0.56
Cognitive functioning
69.82 (25.80)
.60
2
0.77–0.87
0.23–0.55
Social functioning
71.73 (30.72)
.85
2
0.90–0.94
0.28–0.50
Global quality of life
54.19 (25.18)
.88
2
0.94–0.94
0.29–0.50
Symptom scales/items
     
Fatigue
37.42 (23.04)
.77
3
0.76–0.87
0.27–0.62
Nausea and vomiting
11.67 (17.53)
.64
2
0.66–0.94
0.19–0.38
Pain
25.11 (26.93)
.81
2
0.89–0.91
0.26–0.55
Dyspnea
20.37 (26.22)
 
1
1.00
0.30-0.51
Sleep disturbance
25.08 (31.61)
 
1
1.00
0.27–0.44
Appetite Loss
16.94 (24.90)
 
1
1.00
0.21–0.42
Constipation
17.10 (25.78)
 
1
1.00
0.14–0.25
Diarrhea
12.46 (22.57)
 
1
1.00
0.12–0.20
Financial difficulty
31.38 (35.19)
 
1
1.00
0.24–0.63
QLQ-BN20 scales
     
Future uncertainty
34.38 (23.67)
.80
4
0.72–0.84
0.21–0.47
Visual disorder
27.27 (28.22)
.83
3
0.73–0.90
0.19–0.36
Motor dysfunction
29.14 (28.92)
.85
3
0.81–0.85
0.25–0.49
Communication deficit
22.41 (27.82)
.90
3
0.84–0.92
0.18–0.50
QLQ-BN20 single items
     
Headache
33.44 (31.07)
 
1
1.00
0.30–0.41
Seizure
9.84 (23.06)
 
1
1.00
0.13–0.32
Drowsiness
43.32 (28.03)
 
1
1.00
0.26–0.42
Hair loss
21.57 (31.01)
 
1
1.00
0.00–0.26
Itchy skin
16.61 (25.05)
 
1
1.00
0.16–0.26
Weakness of legs
35.42 (33.27)
 
1
1.00
0.28–0.73
Bladder control
21.39 (30.88)
 
1
1.00
0.28–0.39
QLQ-C30 Quality of Life Core Questionnaire, QLQ-BN20 Quality of Life Questionnaire Brain Cancer Module.
The all-item scale of the QLQ-C30 correlated with its own scale with a value of r ≥ 0.50, corrected for overlap, and met the recommended psychometric standards. Item-scale correlations of the QLQ-BN20 indicated that each item had a stronger significant correlation with its own scale (range, 0.72–0.92) than with other scales (range, 0.18–0.50).

Clinical validity

As hypothesized, patients with higher KPS scores had significantly better functioning and lower symptom scores on all of the QLQ-C30 and QLQ-BN20 multi-item scales than patients with lower KPS scores (p < 0.001–0.005, Table 3). Patients with glioma had significantly lower physical, cognitive, and social functioning scores as well as higher future uncertainty, motor dysfunction, and communication deficits than patients with meningioma (p < 0.001–0.02). Patients who underwent surgery plus adjuvant therapy reported lower functioning (p < 0.001–0.03) and poor QOL (p = 0.01), but higher future uncertainty (p = 0.02) and great communication deficits (p = 0.03) than those who underwent surgery alone. The 4 scales of the QLQ-BN20 were moderately correlated with some of the QLQ-C30 scales as hypothesized (r = −.410 – -.642, Table 4).
Table 3
Mean scores (standard deviation) of clinically distinct groups
 
Performance status
Tumor type
Treatment modality
 
KPS≤70
KPS>70
p *
Glioma
Meningioma
Others
p
OP only
OP+adjuvant therapy
p *
QLQ-C30
          
PF
29.8 (27.4)
76.4(19.0)
<.001
66.2 (29.0)
75.1 (20.0)
73.7 (22.8)
.02a
73.8 (22.2)
67.6 (27.9)
.11
RF
27.3 (31.1)
74.9 (27.3)
<.001
64.5 (35.7)
74.5 (24.7)
71.5 (31.6)
.05
71.8 (27.8)
66.9 (35.7)
.84
EF
56.2 (26.6)
73.5 (22.7)
<.001
68.4 (24.8)
74.1 (20.6)
72.9 (26.0)
.18
71.2 (24.1)
71.9 (23.5)
.89
CF
42.9 (30.3)
73.3 (23.0)
<.001
64.1 (27.7)
73.2 (24.6)
74.2 (22.7)
.008b
72.3 (25.3)
66.4 (26.2)
.03
SF
36.3 (32.7)
76.2 (27.4)
<.001
63.6 (33.6)
81.0 (26.4)
71.9 (29.4)
<.001c
77.2 (28.2)
64.2 (32.5)
<.001
QOL
29.4 (22.3)
57.3 (23.8)
<.001
50.8 (26.3)
58.1 (23.9)
54.1 (24.6)
.09
57.3 (24.7)
50.0 (25.4)
.01
FA
56.5 (24.2)
35.0 (21.7)
<.001
40.4 (25.6)
34.2 (20.4)
37.3 (21.9)
.13
36.2 (21.6)
39.2 (24.8)
.24
NV
21.4 (25.1)
10.4 (15.9)
.005
13.9 (18.7)
9.0 (14.4)
11.8 (19.2)
.12
10.9 (17.9)
12.7 (17.0)
.05
PA
51.4 (29.8)
21.7 (24.6)
<.001
26.2 (29.6)
23.7 (24.0)
25.2 (26.6)
.79
25.8 (26.3)
24.2 (27.9)
.36
QLQ-BN20
         
FU
47.1 (26.6)
32.7 (22.8)
.002
38.5 (24.2)
28.2 (21.1)
36.5 (24.7)
.003d
32.0 (23.8)
37.5 (23.3)
.02
VD
40.3 (31.4)
25.6 (27.4)
.002
22.3 (26.2)
30.6 (27.3)
30.5 (31.5)
.05
29.1 (29.4)
24.8 (26.4)
.23
MD
73.7 (29.4)
23.4 (23.3)
<.001
34.2 (32.6)
23.4 (23.0)
29.2 (28.9)
.02e
26.9 (26.3)
32.2 (32.0)
.33
CD
47.7 (34.5)
19.2 (25.2)
<.001
30.1 (31.4)
16.0 (23.4)
19.1 (24.7)
<.001f
19.3 (25.9)
26.6 (29.8)
.03
* p-value was calculated by Mann–Whitney U test.
p-value was calculated by ANOVA.
a, c Post-hoc test by Sheffe; glioma<meningioma.
b Post-hoc test by Sheffe; glioma<meningioma, glioma<others.
d, e, f Post-hoc test by Sheffe; glioma>meningioma.
KPS Karnofsky performance scale, OP operation, QLQ-C30 Quality of Life Core Questionnaire, PF physical functioning, RF role functioning, EF emotional functioning, CF cognitive functioning, SF social functioning, FA fatigue, NV nausea and vomiting, PA pain, QLQ-BN20 Quality of Life Questionnaire Brain Cancer Module, FU future uncertainty, VD visual disorder, MD motor dysfunction, CD communication deficit.
Table 4
Correlations between the Korean versions of the QLQ-C30 and QLQ-BN20
 
C30-PF
C30-RF
C30-EF
C30-CF
C30-SF
C30-QOL
BN20 - FU
-.475*
-.455*
-.634*
-.486*
-.534*
-.548*
    VD
-.319*
-.340*
-.367*
-.447*
-.282*
-.348*
    MD
-.642*
-.617*
-.499*
-.553*
-.532*
-.507*
    CD
-.379*
-.396*
-.388*
-.511*
-.410*
-.378*
* Correlation is significant at the 0.01 level (2-tailed).
QLQ-C30 Quality of Life Core Questionnaire, QLQ-BN20 Quality of Life Questionnaire Brain Cancer Module, PF physical functioning, RF role functioning, EF emotional functioning, CF cognitive functioning, SF social functioning, QOL quality of life; FU future uncertainty, VD visual disorder, MD motor dysfunction, CD communication deficit.

Discussion

The validity and reliability of the EORTC QLQ-BN20 and QLQ-C30 have been shown in studies across various countries [4, 5]. Here we present the results of a study using the Korean version of the QLQ-BN20 and QLQ-C30 in patients with brain tumors.
The internal consistency reliability coefficients of the QLQ-BN20 were high, although our subjects had various types of brain tumors. These reliability coefficients are higher than those reported in studies of the English [1] and other language versions [4, 6]. Our results suggest that the QLQ-BN20 can be used to assess the HRQOL in patients with other brain tumors as well as in those with brain cancer.
Most of the item-subscale correlation coefficients in the QLQ-C30 met the required convergent and discriminant validity standards. This has not always been the case; for example, the structures of the Mexican-Spanish and Greek versions of the QLQ-C30 had weaknesses with respect to both their assessment of the cognitive functioning scale and the nausea and vomiting item [710]. In this study, we confirmed that the cognitive functioning scale and the nausea and vomiting item were improved as shown in an earlier study of Korean patients with cancer [3].
Most scores of the 2 instruments could clearly distinguish between patient groups according to performance status as shown in earlier studies [4, 6, 10, 11]. The second hypothesis, that the 2 instruments could distinguish patients with glioma from those with meningioma, was partially supported. A Chinese group [12] reported that most scores of the EORTC-C30 were able to distinguish among patients with different brain tumor types. However, they did not compare differences of functioning, QOL and symptoms among specific tumor types (e.g. glioma vs meningioma) using a post-hoc test.
The third hypothesis, that the adjuvant treatment group had greater future uncertainty than the group who underwent surgery alone, was supported. This may have been because the patients who received adjuvant therapy after surgery perceived themselves to have more severe disease than those who underwent surgery alone.
Finally, we confirmed that the construction validities of the QLQ-BN20 and QLQ-C30 were acceptable, with correlation coefficients values of r > 0.40. These results are similar to those of the previous validation studies of the QLQ-BN20 and QLQ-C30 conducted for patients speaking English [1], Persian [6], and 15 other languages [4].
The present study had some limitations. First, there might have been sampling bias since all participants were recruited from a single hospital and accurate sample size for this study was not calculated. Second, we did not include responsiveness analysis because of the lack of follow-up data. Therefore, these results should be carefully interpreted and implemented.
In conclusion, our findings suggest that the Korean versions of the EORTC QLQ-BN20 and QLQ-C30 are clinically valid and reliable for measuring HRQOL and are suitable for use in both clinical practice and clinical studies, involving Korean patients with brain tumors.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://​creativecommons.​org/​licenses/​by/​2.​0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Competing interests

The authors confirm that no research funding or any support was received for this study and declare that they have no financial or other conflicts of interest related to this research and its publication.

Authors’ contributions

SYS and KJH designed the study, KJH collected the data, and both SYS and KJH interpreted the data and revised the manuscript. SYS managed the statistical analyse. Both authors read and approved the final manuscript.
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Metadaten
Titel
Validation of the Korean version of the European Organization for Research and Treatment of Cancer brain cancer module (EORTC QLQ-BN20) in patients with brain tumors
verfasst von
Yong Soon Shin
Jeong Hoon Kim
Publikationsdatum
01.12.2013
Verlag
BioMed Central
Erschienen in
Health and Quality of Life Outcomes / Ausgabe 1/2013
Elektronische ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-11-145

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