Hye Young Kim; Jeong Hee Kang; Hyun Jo Youn; Hyang Sook So; Chi Eun Song; Seo Young Chae; Sung Hoo Jung; Sung Reul Kim; Ji Young Kim

doi:10.4040/jkan.2014.44.6.735

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Original Article
Reliability and Validity of the Korean Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to Assess Chemotherapy-induced Peripheral Neuropathy: Hye Young Kim¹, Jeong Hee Kang¹, Hyun Jo Youn², Hyang Sook So³, Chi Eun Song⁴, Seo Young Chae⁵, Sung Hoo Jung², Sung Reul Kim¹, Ji Young Kim¹; Journal of Korean Academy of Nursing 2014;44(6):735-742.
DOI: https://doi.org/10.4040/jkan.2014.44.6.735
Published online: December 15, 2014

¹College of Nursing, Chonbuk National University, Jeonju

²Department of Surgery, Chonbuk National University Medical School, Jeonju

³College of Nursing, Chonnam National University, Gwangju

⁴Department of Hematology, Chonnam National University Hwasun Hospital, Hwasun

⁵Department of Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea

¹College of Nursing, Chonbuk National University, Jeonju

²Department of Surgery, Chonbuk National University Medical School, Jeonju

³College of Nursing, Chonnam National University, Gwangju

⁴Department of Hematology, Chonnam National University Hwasun Hospital, Hwasun

⁵Department of Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea

Address reprint requests to : Kang, Jeong Hee College of Nursing, Chonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju 561-756, Korea Tel: +82-63-270-3125 Fax: +82-63-270-3127 E-mail: jeonghee@jbnu.ac.kr

• Received: July 14, 2014 • Revised: July 18, 2014 • Accepted: October 14, 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution NoDerivs License. (http://creativecommons.org/licenses/by-nd/4.0) If the original work is properly cited and retained without any modification or reproduction, it can be used and re-distributed in any format and medium.

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Abstract
REFERENCES

Abstract

Purpose
This study was performed to assess the reliability and validity of the Korean version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-induced peripheral neuropathy 20 items (EORTC QLQ-CIPN20) in patients receiving neurotoxic chemotherapy.
Methods
A convenience sample of 249 Korean cancer patients, previously or currently, being treated with peripheral neurotoxic chemotherapeutic agents were asked to fill in the questionnaire. Collected data were analyzed using SPSS 21.0 and AMOS 21.0. Construct validity, known-group validity, concurrent validity, and internal consistency reliability of the Korean version of the QLQ-CIPN20 were evaluated.
Results
Factor analysis confirmed 3 dimensions of CIPN: sensory, motor, and autonomic. The factor loadings of the 20 items on the 3 subscales ranged from .38 to .85. The 3 subscale-model was validated by confirmatory factor analysis (GFI= .90, AGFI= .86, RMSR= .05, NFI= .87, and CFI= .94), and concurrent validity was demonstrated with the EORTC QLQ-C30. Furthermore, the QLQ-CIPN20 established known-group validity. The Cronbach's alpha coefficients for internal consistency of the subscales ranged from .73 to .89.
Conclusion
The Korean version of the EORTC QLQ-CIPN20 showed satisfactory construct, concurrent, and known-group validity, as well as internal reliability.
Keywords: Validity; Reliability; Chemotherapy; Peripheral neuropathies

Table 1.

General and Clinical Characteristics (N=249)

Characteristics	Categories	n (%)	M±SD
Age (year)	<49	50 (20.1)	59.92±11.62
	50-59	84 (33.7)
	60-69	61 (24.5)
	≥70	54 (21.7)
Gender	Female	136 (54.6)
Gender	Male	113 (45.4)
Occupation	Employed	57 (22.9)
Occupation	Unemployed	192 (77.1)
Education	Under or equal to elementary school graduate	62 (24.9)
	Middle school graduate	41 (16.4)
	High school graduate	101 (40.6)
	Over or equal to college graduate	45 (18.1)
Type of cancer	Breast cancer	82 (32.9)
	Colon & rectal cancer	51 (20.5)
	Gastric cancer	24 (9.6)
	Esophageal cancer	4 (1.6)
	Bile duct cancer	5 (2.8)
	Ovarian cancer	4 (1.6)
	Lung cancer	3 (1.2)
	Malignant lymphoma	31 (12.4)
	Multiple myeloma	32 (12.9)
	Leukemia	8 (3.2)
	Others	5 (1.3)
Time since diagnosis (month)	<5	35 (14.0)
	5-12	65 (26.1)
	13-24	48 (19.3)
	25-36	37 (14.9)
	37-48	18 (7.2)
	≥49	46 (18.5)
Stage (n=178)	Stage 2	22 (12.4)
	Stage 3	52 (29.2)
	Stage 4	104 (58.4)
Current chemotherapy	Yes	169 (67.9)
Current chemotherapy	No	80 (32.1)
Duration of CIPN (month)	<5	73 (29.3)
	5-12	68 (27.3)
	13-24	48 (19.3)
	≥25	60 (24.1)
ECOG PS	0	71 (28.5)
	1	151 (60.6)
	2	27 (10.9)

CIPN=Chemotherapy-induced peripheral neuropathy; ECOG PS=Eastern Cooperative Oncology Group performance status.

Table 2.

Construct Validity and Reliability

Constructs	Items	Factor loading	Error estimate	CR	AVE	Inter-subscale correlation	Cronbach’s alpha
Sensory	Did you have tingling fingers or hands?	.62	.46	.90	.50	.42~.53^*	.89
	Did you have tingling toes or feet?	.70	.43
	Did you have numbness in your fingers or hands?	.68	.44
	Did you have numbness in your toes or feet?	.72	.38
	Did you have shooting or burning pain in your fingers or hands?	.66	.44
	Did you have shooting or burning pain in your toes or feet?	.67	.45
	Did you have problems standing or walking because of difficulty feeling the ground under your feet?	.85	.29
	Did you have difficulty distinguishing between hot and cold water?	.54	.55
	Did you have difficulty hearing?	.54	.55
Motor	Did you have cramps in your hands? Did you have cramps in your feet?	.38 .70	.78 .50	.89	.52	.53~.54^*	.88
	Did you have a problem holding a pen, which made writing difficult?	.80	.38
	Did you have difficulty manipulating small objects with your fingers (for example, fastening small buttons)?	.71	.40
	Did you have difficulty opening a jar or bottle because of weakness in your hands?	.83	.30
	Did you have difficulty walking because your feet dropped downwards?	.67	.47
	Did you have difficulty climbing stairs or getting up out of a chair because of weakness in your legs?	.68	.49
	If you drive a car, did you have difficulty using the pedals?	.66	.44
Autonomic	Were you dizzy when standing up from a sitting or lying position?	.83	.30	.74	.60	.42~.54^*	.73
	Did you have blurred vision?	.78	.39
	If you are a man, did you have difficulty getting or maintaining an erection?	.39	.75

^*p<.001; CR=Composite reliability; AVE=Average variance extracted.

Table 3.

Model Fit Test

Model	Items	Absolute fit index					Incremental fit index
Model	Items	^χ² (p)	^χ²/df	GFI	AGFI	RMSR	NFI	CFI
Model 1	20	231.89 (<.001)	1.58	.90	.86	.05	.87	.94
Model 2	18	209.66 (<.001)	1.58	.91	.87	.05	.87	.95

GFI=Goodness of fit index; AGFI=Adjusted goodness of fit index; RMSR=Root mean square residual; NFI=Normal fit index; CFI=Comparative fit index.

Table 4.

Correlations between the QLQ-C30 and QLQ-CIPN20 for Concurrent Validity

QLQ-C30	QLQ-CIPN20
	Sensory	Motor	Autonomic
	r (p)	r (p)	r (p)
Global health status	−.32 (<.001)	−.28 (<.001)	−.30 (<.001)
Functional	−.51 (<.001)	−.58 (<.001)	−.60 (<.001)
Symptom	.49 (<.001)	.51 (<.001)	.57 (<.001)

QLQ-C30=Cancer Core Quality of Life Questionnaire 30 items; QLQ-CIPN20=Quality of life questionnaire chemotherapy-induced peripheral neuropathy 20 items.

Table 5.

Known-group Validity Tests

ECOG PS	QLQ-CIPN20
	Sensory		Motor		Autonomic
	M±SD	F (p)	M±SD	F (p)	M±SD	F (p)
0	15.39±16.12	13.28 (<.001)	14.92±16.51	12.62 (<.001)	30.97±19.51	10.34 (<.001)
1	28.73±19.57		26.72±19.48		37.18±20.35
2	39.23±19.85		37.45±17.37		55.00±22.78

ECOG PS=Eastern Cooperative Oncology Group performance status; QLQ-CIPN20=Quality of life questionnaire chemotherapy-induced peripheral neuropathy 20 items.

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Reliability and Validity of the Korean Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to Assess Chemotherapy-induced Peripheral Neuropathy

J Korean Acad Nurs. 2014;44(6):735-742. Published online December 15, 2014

DOI: https://doi.org/10.4040/jkan.2014.44.6.735

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Reliability and Validity of the Korean Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to Assess Chemotherapy-induced Peripheral Neuropathy

Characteristics	Categories	n (%)	M±SD
Age (year)	<49	50 (20.1)	59.92±11.62
	50-59	84 (33.7)
	60-69	61 (24.5)
	≥70	54 (21.7)
Gender	Female	136 (54.6)
Gender	Male	113 (45.4)
Occupation	Employed	57 (22.9)
Occupation	Unemployed	192 (77.1)
Education	Under or equal to elementary school graduate	62 (24.9)
	Middle school graduate	41 (16.4)
	High school graduate	101 (40.6)
	Over or equal to college graduate	45 (18.1)
Type of cancer	Breast cancer	82 (32.9)
	Colon & rectal cancer	51 (20.5)
	Gastric cancer	24 (9.6)
	Esophageal cancer	4 (1.6)
	Bile duct cancer	5 (2.8)
	Ovarian cancer	4 (1.6)
	Lung cancer	3 (1.2)
	Malignant lymphoma	31 (12.4)
	Multiple myeloma	32 (12.9)
	Leukemia	8 (3.2)
	Others	5 (1.3)
Time since diagnosis (month)	<5	35 (14.0)
	5-12	65 (26.1)
	13-24	48 (19.3)
	25-36	37 (14.9)
	37-48	18 (7.2)
	≥49	46 (18.5)
Stage (n=178)	Stage 2	22 (12.4)
	Stage 3	52 (29.2)
	Stage 4	104 (58.4)
Current chemotherapy	Yes	169 (67.9)
Current chemotherapy	No	80 (32.1)
Duration of CIPN (month)	<5	73 (29.3)
	5-12	68 (27.3)
	13-24	48 (19.3)
	≥25	60 (24.1)
ECOG PS	0	71 (28.5)
	1	151 (60.6)
	2	27 (10.9)

Constructs	Items	Factor loading	Error estimate	CR	AVE	Inter-subscale correlation	Cronbach’s alpha
Sensory	Did you have tingling fingers or hands?	.62	.46	.90	.50	.42~.53^*	.89
	Did you have tingling toes or feet?	.70	.43
	Did you have numbness in your fingers or hands?	.68	.44
	Did you have numbness in your toes or feet?	.72	.38
	Did you have shooting or burning pain in your fingers or hands?	.66	.44
	Did you have shooting or burning pain in your toes or feet?	.67	.45
	Did you have problems standing or walking because of difficulty feeling the ground under your feet?	.85	.29
	Did you have difficulty distinguishing between hot and cold water?	.54	.55
	Did you have difficulty hearing?	.54	.55
Motor	Did you have cramps in your hands? Did you have cramps in your feet?	.38 .70	.78 .50	.89	.52	.53~.54^*	.88
	Did you have a problem holding a pen, which made writing difficult?	.80	.38
	Did you have difficulty manipulating small objects with your fingers (for example, fastening small buttons)?	.71	.40
	Did you have difficulty opening a jar or bottle because of weakness in your hands?	.83	.30
	Did you have difficulty walking because your feet dropped downwards?	.67	.47
	Did you have difficulty climbing stairs or getting up out of a chair because of weakness in your legs?	.68	.49
	If you drive a car, did you have difficulty using the pedals?	.66	.44
Autonomic	Were you dizzy when standing up from a sitting or lying position?	.83	.30	.74	.60	.42~.54^*	.73
	Did you have blurred vision?	.78	.39
	If you are a man, did you have difficulty getting or maintaining an erection?	.39	.75

Model	Items	Absolute fit index					Incremental fit index
Model	Items	^χ² (p)	^χ²/df	GFI	AGFI	RMSR	NFI	CFI
Model 1	20	231.89 (<.001)	1.58	.90	.86	.05	.87	.94
Model 2	18	209.66 (<.001)	1.58	.91	.87	.05	.87	.95

QLQ-C30	QLQ-CIPN20
	Sensory	Motor	Autonomic
	r (p)	r (p)	r (p)
Global health status	−.32 (<.001)	−.28 (<.001)	−.30 (<.001)
Functional	−.51 (<.001)	−.58 (<.001)	−.60 (<.001)
Symptom	.49 (<.001)	.51 (<.001)	.57 (<.001)

ECOG PS	QLQ-CIPN20
	Sensory		Motor		Autonomic
	M±SD	F (p)	M±SD	F (p)	M±SD	F (p)
0	15.39±16.12	13.28 (<.001)	14.92±16.51	12.62 (<.001)	30.97±19.51	10.34 (<.001)
1	28.73±19.57		26.72±19.48		37.18±20.35
2	39.23±19.85		37.45±17.37		55.00±22.78

Table 1. General and Clinical Characteristics (N=249)

CIPN=Chemotherapy-induced peripheral neuropathy; ECOG PS=Eastern Cooperative Oncology Group performance status.

Table 2. Construct Validity and Reliability

p<.001; CR=Composite reliability; AVE=Average variance extracted.

Table 3. Model Fit Test

GFI=Goodness of fit index; AGFI=Adjusted goodness of fit index; RMSR=Root mean square residual; NFI=Normal fit index; CFI=Comparative fit index.

Table 4. Correlations between the QLQ-C30 and QLQ-CIPN20 for Concurrent Validity

QLQ-C30=Cancer Core Quality of Life Questionnaire 30 items; QLQ-CIPN20=Quality of life questionnaire chemotherapy-induced peripheral neuropathy 20 items.

Table 5. Known-group Validity Tests

ECOG PS=Eastern Cooperative Oncology Group performance status; QLQ-CIPN20=Quality of life questionnaire chemotherapy-induced peripheral neuropathy 20 items.