Validity, reliability and understanding of the
					EORTC-C30 and EORTC-BR23, quality of life questionnaires specific for breast
					cancer

Michels, Fernanda Alessandra Silva; Latorre, Maria do Rosario Dias de Oliveira; Maciel, Maria do Socorro

doi:10.1590/S1415-790X2013000200011

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Brasil

Revista Brasileira de Epidemiologia

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Sumário

Artigos Originais • Rev. bras. epidemiol. 16 (2) • June 2013 • https://doi.org/10.1590/S1415-790X2013000200011 copy

Validity, reliability and understanding of the EORTC-C30 and EORTC-BR23, quality of life questionnaires specific for breast cancer

Authorship SCIMAGO INSTITUTIONS RANKINGS

Objective:

To validate and assess reliability and understanding of the EORTC–C30 quality of life questionnaire and its breast cancer specific module, the EORTC-BR23.

Methods:

This study was conducted at the AC Camargo Cancer Hospital, São Paulo, Brazil. A total of 100 women diagnosed with breast cancer were interviewed. Internal consistency, confirmatory factorial analysis, convergent validity, construct validity and degree of understanding were examined. Reliability was assessed by comparison of means at times 1 and 2, inter-class coefficient and Bland-Altman graphics.

Results:

Cronbach’s alpha ranged from 0.72 to 0.86 for the EORTC-C30 and from 0.78 to 0.83 for the EORTC-BR23 questionnaire. Most questions were confirmed in the confirmatory factorial analysis. In the construct validity analysis, the questionnaires were capable of differentiating patients with or without lymphedema, apart from the symptom scales of both questionnaires. Both questionnaires presented a significant correlation in most domains of the SF-36, in the convergent validity analysis. Only a few criticisms were reported concerning questions, and the mean grade of understanding was high (C30 = 4.91 and BR23 = 4.89). The questionnaires presented good rates of reliability, with the exception of the functional scale of the C30 and the symptom scale of the BR23.

Conclusions:

The EORTC-C30 and EORTC-BR23 quality of life questionnaires were validated, presented good rates of reliability and are easily understood, allowing them to be used in Brazil to assess quality of life among women with breast cancer.

Validation; Reliability; Quality of life; Questionnaire; Breast cancer; Brazil

Associação Brasileira de Saúde Coletiva Av. Dr. Arnaldo, 715 - 2º andar - sl. 3 - Cerqueira César, 01246-904 São Paulo SP Brasil , Tel./FAX: +55 11 3085-5411 - São Paulo - SP - Brazil
E-mail: revbrepi@usp.br

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[1] Corresponding author: Fernanda Alessandra Silva Michels. Coordenação do Registro de Câncer de Base Populacional de São Paulo, Faculdade de Saúde Pública da Universidade de São Paulo. Av. Dr. Arnaldo, 715 – sala 109, Cerqueira César, 01246-904 São Paulo, SP, Brazil. E-mail: fmichels@usp.br

	Parameter
C30 - Scales	Mean (sd)	Median	Min-max	Cronbach´s α
Global health	74.58 (19.55)	75.00	8.33-100.00	0.72
Functional	75.64 (17.68)	80.00	22.22-100.00	0.86
Symptom	17.51 (14.76)	12.82	0.00-76.92	0.81
BR23 - Scales	Mean (sd)	Median	Min-max	Cronbach´s α
Functional	63.05 (18.06)	66.67	19.05-91.67	0.78
Symptom	22.54 (16.46)	19.04	0.00-71.11	0.83

EORTC-C30	Factor 1	Variance	*Uniqueness*
*Functional Scale*
1-Do you have any trouble doing strenuous activities?	0.586	0.657	0.343
2-Do you have any trouble taking a long walk?	0.531	0.718	0.282
6-Were you limited in doing either your work or other daily activities?	0.641	0.589	0.411
7-Were you limited in pursuing your hobbies or other leisure time activities?	0.704	0.505	0.495
20-Have you had difficulty in concentrating on things, like reading a newspaper or watching television?	0.849	0.280	0.720
21-Did you feel tense?	0.919	0.155	0.845
22-Did you feel worried?	0.924	0.146	0.854
23-Did you feel irritable?	0.911	0.170	0.830
24-Did you feel depressed?	0.926	0.143	0.857
25-Have you had difficulty remembering things?	0.828	0.315	0.685
26-Has your physical condition or medical treatment interfered with your family life?	0.789	0.378	0.622
27-Has your physical condition or medical treatment interfered with your social activities?	0.652	0.574	0.426
		4.630	7.370
Total variance		12.00
% Explained variance		38.58%
*Symptoms Scale*
9-Have you had pain?	0.963	0.073	0.927
10-Did you need to rest?	0.856	0.268	0.732
11-Have you had trouble sleeping	0.670	0.552	0.448
12-Have you felt weak?	0.816	0.335	0.665
14-Have you felt nauseated?	0.786	0.382	0.618
16-Have you been constipated?	0.682	0.535	0.465
18-Were you tired?	0.808	0.346	0.654
19-Did pain interfere with your daily activities?	0.960	0.079	0.921
28-Has your physical condition or medical treatment caused you financial difficulties?	0.591	0.650	0.350
		3.220	5.780
Total variance		9.00
% Explained variance		35.78%
*Global Health Scale*
29-How would you rate your overall health during the past week?	0.901	0.187	0.813
30-How would you rate your overall quality of life during the past week?	0.931	0.134	0.866
		0.321	1.679
Total variance		2.00
% Explained variance		16.05%
EORTC-BR23	Factor 1	Variance	*Uniqueness*
*Functional Scale*
39-Have you felt physically less attractive as a result of your disease or treatment?	0.966	0.067	0.933
40-Have you been feeling less feminine as a result of your disease or treatment?	0.975	0.049	0.951
41-Did you find it difficult to look at yourself naked?	0.929	0.136	0.864
43-Were you worried about your health in the future?	0.790	0.377	0.623
46-Answer this question only if you have been sexually active: to what extent was sex enjoyable for you?	0.030	0.999	0.001
		1.628	3.372
Total variance		5.00
% Explained variance		32.56%
EORTC-BR23	Factor 1	Variance	*Uniqueness*
*Symptoms Scale*
31-Did you have a dry mouth?	0.460	0.789	0.211
35-Answer the question only if you had any hair loss: were you upset by the loss of your hair?	0.473	0.777	0.223
36-Did you feel ill or unwell?	0.874	0.236	0.764
37-Did you have hot flushes?	0.435	0.811	0.189
47-Did you have any pain in your arms or shoulders?	0.924	0.145	0.855
48-Did you have a swollen arm or hand?	0.960	0.078	0.922
49-Was it difficult to raise your arm or to move it sideways?	0.906	0.180	0.820
52-Was the area of your affected breast oversensitive?	0.926	0.143	0.857
		3.159	4.841
Total variance		8.00
% Explained variance		39.49%

Scales SF-36	C30 GHS*	C30 FS^#	C30 SS⁺	BR23 FS^#	BR23 SS⁺
Scales SF-36	r (p)^**	r (p)^**	r (p)^**	r (p)^**	r (p)^**
Physical functioning	0.28 (0.005)	0.47 (<0.001)	- 0.50 (<0.001)	0.42 (<0.001)	-0.29 (0.003)
Role-physical	0.27 (0.006)	0.41 (<0.001)	-0.37 (<0.001)	0.26 (0.008)	-0.32 (0.001)
Bodily pain	-0.49 (<0.001)	-0.48 (<0.001)	0.56 (<0.001)	-0.29 (0.004)	0.57 (<0.001)
General Health	-0.37 (<0.001)	-0.24 (0.019)	0.19 (0.054)	-0.23 (0.023)	0.18 (0.070)
Vitality	0.01 (0.962)	-0.01 (0.970)	-0.02 (0.882)	-019 (0.064)	0.04 (0.633)
Social functioning	-0.13 (0.199)	0.03 (0.806)	0.11 (0.206)	0.05 (0.615)	0.09 (0.361)
Role-emotional	0.35 (<0.001)	0.53 (<0.001)	-0.36 (<0.001)	0.39 (<0.001)	-0.23 (0.021)
Mental Health	0.18 (0.081)	0.34 (0.001)	-0.29 (0.004)	0.18 (0.072)	-0.23 (0.023)

Scales	M1 mean (dp)	M 2 mean (dp)	p *	r_icc (p)^**
C30 – GHS	74.91 (18.93)	71.49 (20.03)	0.064	0.45 (<0.001)
C30 – FS	75.77 (17.91)	77.87 (17.74)	0.040	0.76 (<0.001)
C30 – SS	17.98 (14.88)	17.19 (16.04)	0.275	0.75 (<0.001)
BR23 – FS	63.30 (18.39)	63.43 (17.93)	0.784	0.70 (<0.001)
BR23 – SS	23.09 (16.59)	19.80 (15.42)	0.006	0.77 (<0.001)