Open Access

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

Health and Quality of Life Outcomes201311:145

https://doi.org/10.1186/1477-7525-11-145

Received: 14 February 2013

Accepted: 6 August 2013

Published: 27 August 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.

Keywords

Brain tumor Health-related quality of life QLQ-BN20 QLQ-C30 Validation Korea

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.

Abbreviations

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.

Declarations

Authors’ Affiliations

(1)
Department of Nursing, Changwon National University
(2)
Department of Neurology Surgery, University of Ulsan College of Medicine, Asan Medical Center

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Copyright

© Shin and Kim; licensee BioMed Central Ltd. 2013

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.

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