Annals of Surgical Oncology

, Volume 16, Issue 1, pp 88–95 | Cite as

Validation of the Mexican Spanish Version of the EORTC C30 and STO22 Questionnaires for the Evaluation of Health-Related Quality of Life in Patients with Gastric Cancer

  • Luis F. Oñate-Ocaña
  • Alberto Alcántara-Pilar
  • Diana Vilar-Compte
  • Gabriela García-Hubard
  • Edith Rojas-Castillo
  • Salvador Alvarado-Aguilar
  • José F. Carrillo
  • Jane M. Blazeby
  • Vincenzo Aiello-Crocifoglio
Healthcare Policy and Outcomes

Abstract

Health-related quality of life (HRQL) is a fundamental outcome in surgical oncology and culturally valid tools are essential for this purpose. Our aim was to validate the Mexican-Spanish versions of the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire QLQ-C30 and the QLQ-STO22 disease-specific questionnaire module in Mexican patients with gastric cancer (GC). The translation procedure followed EORTC guidelines. Both instruments were completed by patients with GC and analyses were performed within three clinically distinct groups: (1) patients undergoing palliative treatment, (2) patients undergoing treatment with curative intent, and (3) GC survivors. Tests for reliability and validity were performed. One hundred and fifty patients (mean age 54.2 years) completed both questionnaires. Sixty-seven, 55, and 28 patients were allocated to groups 1, 2, and 3, respectively. Compliance rates were high, and questionnaires were well-accepted. Survivors of treatment for GC reported better functional HRQL scores and lower symptom scores than patients in group 2 who were currently undergoing treatment. Patients selected for potentially curative treatment had better HRQL than group 1 (palliative treatments). Scales in the QLQ-C30 and QLQ-STO22 distinguished between other clinically distinct groups of patients. Cronbach’s α coefficients of 14 scales of both questionnaires were >0.7. Multitrait scaling analysis demonstrated good convergent and discriminant validity. Test–retest scores were consistent. We conclude that the Mexican-Spanish versions of EORTC QLQ-C30 and QLQ-C22 questionnaires are reliable and valid for HRQL measurement in patients with GC and are therefore recommended for use in clinical trials of Mexican community.

In Mexico, according to the Histopathology Registry of Malignant Neoplasms, gastric carcinoma (GC) is the fifth cause of all cancer incidences and the second cause of cancer-related deaths.1 GC remains the most common gastrointestinal cancer.1,2

Radical resection is the only curative treatment in GC, but many patients receive adjuvant chemotherapy or chemoradiation or palliative treatments.3 Traditionally, the main outcomes of these treatments comprise overall survival, clinical responses, toxicity profiles, disease-free survival, or even time-to-progression, although these treatments have adverse effects that result in profound deterioration in health-related quality of life (HRQL). Thus, there is increasing interest in the oncology community in the use the HRQL evaluation as an important outcome measurement in some groups of patients with cancer.4

The definition of HRQL continues to be very controversial: a universally accepted definition does not exist to date. However, HRQL can refer to a multidimensional construct that encompasses patient perceptions of both the negative and positive aspects of at least four dimensions: physical; emotional functions; social functions; and disease- and treatment-related symptoms.5

There are two internationally validated questionnaires currently in use for patients with cancer: the Functional Assessment of Chronic Illness and Treatments (FACT-G) and the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.6,7 These questionnaires have been compared and were found to measure markedly different aspects of HRQL, despite considerable overlap, and were considered noncomparable and even complementary.8 Both core questionnaires possess modules for use in the specific setting of GC: the FACT-Ga and the EORTC QLQ-STO22.9,10

The QLQ-C30 and its QLQ-STO22 disease-specific questionnaire module are used in combination, and these questionnaires are usually selected because they are fully validated, translated into many languages, and adequate for multicultural comparisons.11,12

On the other hand, published information regarding HRQL in the medical literature is scarce in Mexico, and an adequately validated instrument in Mexican Spanish is lacking. Therefore, our aim was to translate and validate the QLQ-C30 and QLQ-STO22 questionnaires in their Mexican-Spanish versions for use in Mexican patients with GC.

Patients and Methods

Patients

All patients attending the outpatient clinic of the Gastroenterology Department in the Instituto Nacional de Cancerología (INCan) in Mexico City from January 2007 to September 2007 with gastric endoscopy and a biopsy demonstrating gastric adenocarcinoma were invited to participate in this study. Clinical status of patients was defined according to the Sixth Edition of the Tumor, Node, Metastases (TNM) Staging System of the American Joint Committee on Cancer (AJCC).13 Additionally, clinical status was defined according to the objective of treatment and to the purpose of patient hospitalization in or attendance at the clinic.

Patients scheduled for surgery, chemotherapy, or chemoradiation were interviewed during their hospitalization prior to initiation of surgery or chemotherapy. Patients who had surgery, chemotherapy, or chemoradiation after 6 months were defined as the follow-up group, and were contacted during their return visits at the Gastroenterology or Medical Oncology clinics.

Exclusion criteria included refusal to participate, presence of concurrent secondary malignancy, inability to understand or complete the questionnaires, and any patient declared with critical illness or acute complication development related with surgery, chemotherapy or chemoradiation.

All patients were asked to read and sign the written consent form. Study purpose and safety protection policy were detailed in a printed form accompanying the questionnaires.

The research protocol was evaluated and approved by the Institutional Review Board and Ethics Committee of the Institute (registry no. 006/026/GAI). This protocol was supervised by the Quality of Life Group of the European Organization for Research and Treatment of Cancer. The authors have no conflict of interest, and this study was conducted under Psycho-oncology and Gastroenterology Department budgets.

Translation and Pilot Testing

The Mexican-Spanish version of the EORTC QLQ-C30 questionnaire was previously translated. The translation process of the Mexican-Spanish version of the EORTC QLQ-STO22 was authorized by the EORTC; we followed the official guidelines of rigid forward/backward translation and pilot test.14 We developed an initial proposal of the instrument, which was pilot tested on ten Mexican subjects with GC. Once minor translation difficulties were overcome, we developed the second version, which was tested on ten additional subjects. After these procedures, we proposed the final translated version. This version was revised and approved by the EORTC Quality-of-Life Study Group.

Clinical Data

Clinical history and physical examination were registered for all patients, along with blood cell count, blood chemistry, basal tumor markers (carcinoembryonic antigen and Ca19–9 antigen) chest X-rays, computed tomography (CT) scan of the abdomen, Karnofsky performance status (KPS) and Eastern Cooperative Oncology Group (ECOG) functional status, TNM stage classification, location in stomach, Lauren type, Siewert type for esophagogastric junction tumors, and treatment group.

Analyses were performed, dividing patients into three groups: (1) patients undergoing palliative treatment, (2) patients undergoing treatment with curative intent, and (3) survivors of GC.

Instruments

The QLQ-C30 (version 3) is comprised of a global health status, five multi-item functional subscales, and several single- or multi-item symptom subscales. Four- to seven-level Likert scales (seven for global health status and four for the remaining scales) were linearly transformed into a 0–100 score, with 100 representing best global health, functional status, or worst symptoms, depending on the measuring property of each multi-item subscale or single-item symptom.

The QLQ-STO22 is a 22-item GC site-specific supplemental module designed to augment the QLQ-C30 in terms of sensitivity and specificity for HRQL measurements. This module comprises five multi-item subscales and four single-item symptoms, with higher scores indicating worse symptomatic problems.

The original versions in English of both questionnaires have been validated (QLQ-C30 and QLQ-STO22), together with translations into many languages, including Spanish.7,9

Data Analysis

Scores for multi-item functional or symptom scales and for single items were calculated by linear transformation of raw scores as described by the EORTC.15

Initially, data analysis was performed independently for QLQ-C30 and for QLQ-STO22 questionnaires. Discriminant validation was evaluated with item convergent validity for each scale assessed employing the correlation between each item and its own scale. Divergent validity was evaluated correlating each item and any other scale. The criterion for success for any item was that the correlation between an item and its own scale was significantly higher than its correlation with any other scale.

Correlation assessment between single scores was obtained with the Spearman correlation coefficient (CC), and multi-item correlation of scores was evaluated by the Cronbach α. In addition, clinical validity was evaluated by the extent to which questionnaire scores were able to discriminate between subgroups of patients differing in terms of their clinical status (including KPS, ECOG performance status, body mass index (BMI), blood hemoglobin and hematocrit, serum albumin level, and TNM clinical stage). These differences between groups were tested with one-way analysis of variance (ANOVA), chi-squared, and Kruskal–Wallis tests, as appropriate.

Validity was also evaluated comparing the differences of scale scores over time, before treatment and after treatment (repeated ANOVA measurement was utilized to test significance of these changes). Finally, correlation between different QLQ-C30 and QLQ-STO22 scales was explored to demonstrate differences and clinical overlapping.

Sample Size

Sample size was based on the recommendation of Tabachnik and Fidell, which stipulates that, in order to obtain reliable estimates through multivariate analysis, the number of observations should be five times the number of variables in the model.16 Thus, for primary scaling analyses a minimal ratio of five patients per questionnaire item was required, i.e., a minimum sample size of 110 patients. Subsets of patients would complete two questionnaires (n = 25 for test–retest). The simple Hill be inflated to allow for some dropout due to disease progression and to analyze results within clinically distinct groups.

Any probability value of 0.01 or less was considered significant because of multiple testing. Two-tailed statistics were taken into account in all cases. The SPSS for Windows version 10 software program was employed to perform all computations (SPSS Inc., Chicago, IL, USA).

Results

Patients

One hundred and fifty patients were included in this study; 62 were females (41.3%) with a mean age of 54.2 years [standard deviation (SD) 12.1 years]. During the study period, 67 patients under palliative treatment (44.7%; group 1), 55 patients under active, curative-intention treatment, including those who had undergone the preoperative clinical workup, were selected for neoadjuvant chemotherapy or neoadjuvant chemoradiation (36.7%; group 2), and 28 patients were identified survivors of GC with >6 months of survival after treatment or under long-term follow-up (18.7%; group 3). Relevant demographic and clinical information for all three treatment groups are described in Table 1. One patient declined the invitation to participate during the period of this study, and there were no missing values of individual items.
Table 1

Demographical and clinical information in three treatment groups

 

Group 1 (= 67), palliative treatment

Group 2 (= 55), curative treatment

Group 3 (= 28), survivors of GC

p

Sex

Women

27

22

13

0.83

Men

40

33

15

Agea (years)

Mean (SD)

54.2 (12.3)

54.3 (12.7)

53.9 (10.9)

0.98

Socioeconomic group (income)

High

13

9

2

0.59

Intermediate

29

27

13

Low

25

19

13

 

Marital status

Single

3

7

2

0.22

Married

47

32

21

Divorced

3

1

1

Other

14

15

4

Years of study

None

16

7

4

0.04

Elementary

25

25

11

High school

17

13

3

More

9

10

10

KPS

100–80

14

25

21

<0.0001

<80

53

30

7

Hemoglobina (g/dl)

Mean (SD)

11.6 (2.5)

12.03 (1.9)

13.6 (2.8)

0.001

Serum albumina (g/dl)

Mean (SD)

3.05 (0.72)

3.29 (0.64)

3.77 (0.69)

<0.0001

Lymphocyte counta (cell/mm3 )

Mean (SD)

1,399 (497)

1,469 (680)

1,518 (606)

0.001

Body mass indexa (kg/m2)

Mean (SD)

22.4 (5)

23 (3.9)

28.6 (13.9)

0.001

Clinical stage

Ia, Ib, II, IIIa

5

31

22

<0.0001

IIIb, IV

62

24

6

aContinuous variables; SD standard deviation; p probability value; KPS Karnofsky performance status

All 150 patients answered both questionnaires, and 25 of these were asked to repeat these after treatment was initiated. The majority of patients completed both questionnaires in <30 min in a quiet environment.

Reliability and Validity

Results of multitrait scaling analyses are shown in Table 2. The majority of items presented good own-scale correlation, except for the cognitive function scale. An important observation not shown in this table is that the global health/quality-of-life scale is highly correlated with the fatigue scale. Better global health/quality-of-life scores are associated with less fatigue. Moreover, all items on the physical scale (items 1–5) showed significant correlation with the fatigue scale (particularly items 10 and 18; CC, 0.35–0.53).
Table 2

EORTC QLQ-C30 and QLQ-STO22: convergent and discriminant validity of multi-item scales (n = 150)

 

Item own-scale correlationsa

Item other-scale correlationsa

Multi-item correlationsb

QLQ-C30

Global health/QoL

0.8

0.003–0.56

0.9

Functional scales

Physical

0.27–0.55

0.01–0.62

0.79

Role

0.66

0.01–0.56

0.8

Emotional

0.41–0.62

0.02–0.47

0.85

Cognitive

0.15

0.004–0.45

0.32

Social

0.7

0.05–0.49

0.8

Symptom scales

Fatigue

0.49–0.64

0.004–0.62

0.78

Nausea and vomiting

0.59

0.02–0.5

0.8

Pain

0.45

0.04–0.5

0.55

QLQ-STO22

Multi-item scales

Dysphagia

0.35–0.4

0.002–0.5

0.71

Pain

0.47–0.74

0.04–0.52

0.81

Reflux

0.2–0.36

0.03–0.46

0.59

Eating

0.25–0.5

0.08–0.59

0.74

Anxiety

0.37–0.5

0.01–0.57

0.71

Single items were not included in this table

aSpearman correlation coefficients; b Cronbach α

Regarding QLQ-STO22, the majority of items from the eating scale (items 41–43) presented significant correlations with the dysphagia scale (particularly item 31; CC, 0.4–0.48).

Table 2 shows the correlations between scales. The majority of multi-item-scale correlations showed Cronbach α > 0.7. Only 3 of 14 scales did not presented multi-item correlations >0.7 (cognitive scale from QLQ-C30 and pain and reflux scales from QLQ-STO22) (Table 2).

As expected, the majority of multi-item-scale and single-item scores of the QLQ-C30 were weakly correlated with those of the QLQ-STO22. Also not surprisingly, correlations between QLQ-STO22 and QLQ-C30 pain scales and anxiety scales were observed. Remarkably, QLQ-STO22 body image scale correlated strongly with QLQ-C30 physical, role, emotional, and social scales (CC −0.52, −0.47, −0.5, and −0.36; p = 0.008; p = 0.017; p = 0.003, and p = 0.075, respectively).

Clinical Validity

Comparison of global scores of multi-item scales and single items among the three groups are shown in Table 3, while Table 4 depicts correlations between KPS scores and multi-item scales and single items. Many expected differences among groups and KPS scores were statistically significant. Other relevant clinical parameters were correlated with scores from both questionnaires and are shown in Table 5. Retest was done 117.3 days after original test (SD 97.7). Differences of test–retest score values are described in Table 6.
Table 3

Known group comparisons. EORTC QLQ-C30 and QLQ-STO22: mean scores (SD) in each group

 

Group 1 (= 67), palliative treatment

Group 2 (= 55), curative treatment

Group 3 (= 28), survivors of GC

p

QLQ-C30

Global health/QoL

51.7 (25.9)

70 (25.6)

78.6 (21.3)

<0.0001

Functional scales

Physical

64.4 (26.3)

76.9 (19.5)

88.3 (15.5)

<0.0001

Role

53.2 (32.7)

72.4 (31.6)

91.1 (16)

<0.0001

Emotional

63.9 (28.3)

73.8 (22.1)

77.9 (25.6)

0.025

Cognitive

80.6 (23.7)

90 (15.6)

85.1 (17.2)

0.053

Social

71.1 (33)

82.7 (23.3)

93.5 (14.3)

0.002

Symptom scales

Fatigue

46.6 (26.7)

28.8 (18.8)

21 (21.2)

<0.0001

Nausea and vomiting

34.3 (32.4)

17.9 (25.2)

13.7 (23.6)

<0.0001

Pain

37.1 (26.4)

20.9 (20.3)

10.1 (15.3)

<0.0001

Single items

Dyspnea

21.9 (29.9)

13.3 (20.9)

7.1 (13.9)

0.045

Insomnia

31.3 (30.6)

23 (34.5)

20.2 (33.1)

0.043

Appetite loss

43.8 (39)

24.8 (35.8)

9.5 (27)

<0.0001

Constipation

39.3 (36.7)

23 (29.3)

9.5 (21.9)

<0.0001

Diarrhea

14.4 (24.1)

15.2 (25.5)

10.7 (18.3)

0.86

Financial difficulties

65.7 (37.6)

48.5 (36.7)

30.9 (25.5)

<0.0001

QLQ-STO22

Multi-item scales

Dysphagia

31.7 (25.3)

24.8 (22.8)

12.2 (19.6)

<0.0001

Pain

36.8 (26.5)

20 (21.3)

11.9 (15.7)

<0.0001

Reflux

31.2 (26.4)

18.8 (19.5)

16.7 (13)

0.01

Eating

38.9 (28)

26.1 (24)

14.6 (14.5)

<0.0001

Anxiety

58 (28.9)

42.4 (25.8)

31.7 (24.1)

<0.0001

Single items

Dry mouth

41.8 (34.5)

28.5 (36.5)

22.6 (28.8)

0.009

Taste

41.3 (35.8)

23.6 (35.5)

3.5 (10.5)

<0.0001

Body image

33.8 (34.6)

32.7 (31.1)

14.3 (24.7)

0.011

Hair loss

49.3 (50.4)

47.3 (50.4)

39.3 (49.7)

0.67

SD standard deviation; p probability values

Table 4

EORTC QLQ-C30 and QLQ-STO22: mean scores (SD) by Karnofsky performance status

 

KPS 100−80% (n = 60)

KPS < 80% (n = 90)

p

QLQ-C30

Global Health/QoL

76.3 (20)

54.9 (28.1)

<0.0001

Functional scales

Physical

91 (8.4)

61.8 (23.8)

<0.0001

Role

87.5 (21.8)

53.9 (32.4)

<0.0001

Emotional

82.2 (17.5)

62.1 (27.9)

<0.0001

Cognitive

91.9 (13.5)

80.2 (22.5)

<0.0001

Social

89.4 (20.1)

73 (30.9)

<0.0001

Symptom scales

   

Fatigue

18.1 (14.3)

46.8 (24.5)

<0.0001

Nausea and vomiting

12.5 (17.5)

32.4 (33.3)

<0.0001

Pain

13.1 (17.9)

34.8 (24.9)

<0.0001

Single items

Dyspnea

4.4 (13)

23.7 (27.9)

<0.0001

Insomnia

9.4 (16.3)

37.4 (36)

<0.0001

Appetite loss

11.7 (24.4)

43 (40.3)

<0.0001

Constipation

15.6 (26.4)

35.9 (35.4)

<0.0001

Diarrhea

11.1 (21.8)

15.9 (24.6)

0.15

Financial difficulties

43.9 (34.4)

58.9 (38.4)

0.014

QLQ-STO22

Multi-item scales

Dysphagia

12.4 (14.6)

34.4 (25.5)

<0.0001

Pain

12.2 (13.8)

35.2 (26.5)

<0.0001

Reflux

16.3 (17.2)

29 (24.7)

0.001

Eating

14.3 (17.6)

39.9 (25.9)

<0.0001

Anxiety

29.3 (20.6)

59.5 (26.9)

<0.0001

Single items

Dry mouth

13.9 (20.6)

46.3 (36.6)

<0.0001

Taste

12.2 (22.9)

38.1 (38.2)

<0.0001

Body image

17.2 (24.2)

38.1 (34.5)

<0.0001

Hair loss

43.3 (50)

48.9 (50.3)

0.5

SD standard deviation; p probability values; KPS Karnofsky status performance

Table 5

EORTC QLQ-C30 and QLQ-STO22: correlation coefficients of scores with some relevant clinical parameters

 

Age

BMI

Hemoglobin

Lymphocyte count

Serum albumin

QLQ-C30

Global health/QoL

−0.002

0.27a

0.22a

0.26a

0.37a

Functional scales

Physical

−0.02

0.3a

0.33a

0.18a

0.44a

Role

0.11

0.21a

0.21a

0.21a

0.43a

Emotional

−0.01

0.18

0.02

0.18

0.06

Cognitive

−0.11

0.04

−0.02

0.04

0.03

Social

0.17

0.14

0.06

0.3a

0.07

Symptom scales

Fatigue

0.07

−0.24a

−0.24a

−0.28a

−0.33a

Nausea and vomiting

−0.09

−0.14

−0.04

−0.22a

−0.18

Pain

−0.03

−0.14

−0.29a

−0.19

−0.38a

Single items

Dyspnea

0.02

−0.25a

−0.06

−0.17

−0.25a

Insomnia

−0.09

−0.17

−0.08

−0.2a

−0.17

Appetite loss

−0.008

−0.07

−0.15

−0.16

−0.21

Constipation

0.06

−0.08

0.05

−0.05

−0.09

Diarrhea

0.03

−0.06

0.01

−0.09

0.03

Financial difficulties

−0.26a

−0.22a

−0.17

−0.37a

−0.19

QLQ-STO22

Multi-item scales

Dysphagia

0.11

−0.25a

−0.23a

−0.1

−0.31a

Pain

−0.05

−0.19

−0.21a

−0.21a

−0.29a

Reflux

−0.005

−0.12

−0.04

−0.1

−0.06

Eating

0.03

−0.21a

−0.18

−0.19

−0.29a

Anxiety

0.05

−0.24a

−0.18

−0.11

−0.24a

Single items

Dry mouth

−0.03

−0.14

−0.24a

−0.12

−0.28a

Taste

0.07

−0.13

−0.19

−0.15a

−0.27a

Body image

0.12

−0.35a

−0.13

−0.24a

−0.09

Hair loss

−0.14a

−0.18

−0.14

−0.1

0.004

BMI body mass index; a probability value < 0.01

Table 6

EORTC QLQ-C30 and QLQ-STO22: test-retest mean scores by clinical stage

 

Stages I, II, and IIIa (n = 10)

Stages IIIb and IV (n = 15)

P

Before

After

Before

After

QLQ-C30

Global health/QoL

62.5

72.5

56.1

69.4

0.044

Functional scales

Physical

82.7

82.7

74.7

72.0

0.79

Role

71.7

73.3

55.6

61.1

0.64

Emotional

69.2

76.7

66.1

72.2

0.29

Cognitive

93.3

98.3

91.1

86.7

0.95

Social

88.3

91.7

70.0

70.0

0.83

Symptom scales

Fatigue

22.2

25.6

35.6

34.8

0.84

Nausea and vomiting

11.7

18.3

24.4

30.0

0.42

Pain

28.3

28.3

27.8

27.8

1.00

Single items

Dyspnea

13.3

16.7

8.89

13.3

0.36

Insomnia

30.0

13.3

17.8

28.9

0.72

Appetite loss

23.3

16.7

35.6

40.0

0.89

Constipation

10.0

13.3

24.4

17.8

0.81

Diarrhea

13.3

16.7

6.67

20.0

0.18

Financial difficulties

46.7

50.0

46.7

55.6

0.44

QLQ-STO22

Multi-item scales

Dysphagia

16.7

10.8

28.9

22.2

0.28

Pain

17.8

21.1

31.8

27.4

0.9

Reflux

12.2

6.67

20.7

20.0

0.56

Eating

22.5

22.5

37.2

23.3

0.18

Anxiety

50.0

35.7

49.6

44.4

0.12

Single items

Dry mouth

16.7

26.7

40.0

22.2

0.62

Taste

6.67

6.67

31.1

13.3

0.23

Body image

26.7

16.7

22.2

22.2

0.51

Hair loss

30.0

70.0

60.0

93.3

0.04

Discussion

There is a need to supplement traditional oncological outcomes with information regarding patients’ views, and HRQL measurements are increasingly being recognized as fulfilling this purpose. Measurement of the patients’ perspective of outcome may guide management or aid treatment evaluation.5

Although GC is very common worldwide, there is a lack of randomized clinical trials with validated HRQL assessments, yet the increasing use of laparoscopic surgery, adjuvant chemotherapy, or chemoradiation requires full assessment of clinical and patient-reported outcomes.4,17

This study provides evidence that the Mexican-Spanish versions of the EORTC QLQ-C30 and QLQ-STO 22 are clinically valid and reliable and suitable to use in randomized trials, longitudinal studies or other research settings to assess patient health-related quality of life. The findings of this study add additional evidence supporting the crosscultural validity of QLQ-C30 and QLQ-STO22 in other countries with non-English-speaking individuals. However, it must be stated that, in a recent analysis of an international database, the relationship between overall HRQL and its subdimensions was influenced by the specific culture in which it is evaluated.18 This study supplies important evidence that ethnicity influences perceptions of health and sickness, and that different cultural groups may emphasize different HRQL aspects. Caution is necessary when comparing scores among heterogeneous ethnic groups, but in the majority of cases these differences appear to be relatively minor.19,20 The QLQ-C30 cognitive scale exhibits low convergent validity and multi-item correlation in our study. This observation has been reported in Taiwanese and Thai versions of the questionnaire, as well as in the original version in English.7,12,20

The majority of QLQ-C30 and QLQ-STO22 scores clearly distinguished between other clinically distinct groups of patients. Both questionnaires present important correlation scores with some relevant clinical parameters as well, particularly nutritional status, an observation previously reported by others.21

We have not employed these questionnaires for evaluating the effect of anti-neoplasic treatment on HRQL. However, the performance of different scales may demonstrate that cancer treatment can have some benefits on some scales or symptoms, while being simultaneously detrimental to generic HRQL aspects. The study from Huang et al. showed that, after second-line chemotherapy for advanced GC, patients presented relief in global health/quality of life, emotional, and cognitive scales, but not in the appetite scale.22

In conclusion, the Mexican-Spanish versions of both questionnaires are reliable and valid for HRQL measure for patients suffering from GC, and can be utilized in clinical cancer research in Mexican community.

Notes

Acknowledgements

We thank the European Organization for Research and Treatment of Cancer Quality of Life Group for their extensive support in the translation and validation procedures of the C30 and STO22 questionnaires. We thank Maggie Brunner, M.A., for her English-language editorial review, as well as Alejandra García-Hubard and Blanca Rosas-Rosas because of their kind support in the logistics of this protocol.

References

  1. 1.
    Ferlay J, Bray F, Pisani P, Parkin DM. Globocan 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5, version 2.0; IARC, Lyon, France; 2004.Google Scholar
  2. 2.
    Oñate-Ocaña LF. Gastric cancer in Mexico. Gastric Cancer. 2001;4:162–4.CrossRefPubMedGoogle Scholar
  3. 3.
    Dicken BJ, Bigam DL, Cass C, Mackey JR, Joy AA, Hamilton SM. Gastric adenocarcinoma: review and considerations for future directions. Ann Surg. 2005;241:27–39.PubMedPubMedCentralGoogle Scholar
  4. 4.
    Blazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol. 2006;24:3178–86.CrossRefPubMedGoogle Scholar
  5. 5.
    Fayers PM, Machin D, editors. Quality of life. The assessment, analysis, and interpretation of patient-reported outcomes. 2nd ed. West Sussex: Wiley; 2007.Google Scholar
  6. 6.
    Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11:570–9.PubMedGoogle Scholar
  7. 7.
    Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organisation 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. 1993;85:365–76.CrossRefPubMedGoogle Scholar
  8. 8.
    Kemmler G, Holzner B, Kopp M, Dunser M, Margreiter R, Greil R, et al. Comparison of two quality-of-life instruments for cancer patients: the functional assessment of cancer therapy-general and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. J Clin Oncol. 1999;17:2932–40.PubMedGoogle Scholar
  9. 9.
    Functional Assessment of Chronic Illness Therapy (FACIT). http://www.facit.org/qview/qlist.aspx. Accessed 23 Oct 2008.
  10. 10.
    Blazeby JM, Conroy T, Bottomley A, et al. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer. Eur J Cancer. 2004;40:2260–8.CrossRefPubMedGoogle Scholar
  11. 11.
    Conroy T, Marchal F, Blazeby JM. Quality of life in patients with oesophageal and gastric cancer: an overview. Oncology. 2006;70:391–402.CrossRefPubMedGoogle Scholar
  12. 12.
    Huang CC, Lien HH, Sung YC, Liu HT, Chie WC. Quality of life of patients with gastric cancer in Taiwan: validation and clinical application of the Taiwan Chinese version of the EORTC QLQ-C30 and EORTC QLQSTO22. Psychooncology. 2007;16:945–9.CrossRefPubMedGoogle Scholar
  13. 13.
    Greene FL, Page DL, Fleming ID, Fritz A, Balch CM; American Joint Committee on Cancer. AJCC cancer staging manual. 6th ed. New York: Springer-Verlag; 2002.CrossRefGoogle Scholar
  14. 14.
    Koller M, Aaronson NK, Blazeby JM, et al. Translation procedures for standardised quality of life questionnaires: the European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer. 2007;43:1810–20.CrossRefPubMedGoogle Scholar
  15. 15.
    Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 scoring manual. 3rd ed. Brussels, Belgium: European Organisation for Research and Treatment of Cancer; 2001.Google Scholar
  16. 16.
    Tabachnik BJ, Fidell LS. Using multivariate statistics. London: Harper & Row; 1993.Google Scholar
  17. 17.
    Kaptein AA, Morita S, Sakamoto J. Quality of life in gastric cancer. World J Gastroenterol. 2005;11:3189–96.CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Scott NW, Fayers PM, Aaronson NK, et al. The relationship between overall quality of life and its subdimensions was influenced by culture: analysis of an international database. J Clin Epidemiol. 2008;61:788–95.CrossRefPubMedGoogle Scholar
  19. 19.
    Morita S, Kaptein AA, Oba K, Sakamoto J. The domain structure of the EORTC QLQ-STO22 supported by Japanese validation data. Psychooncology. 2008;17:474–9.CrossRefPubMedGoogle Scholar
  20. 20.
    Silpakit C, Sirilerttrakul S, Jirajarus M, Sirisinha T, Sirachainan E, Ratanatharathorn V. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): validation study of the Thai version. Qual Life Res. 2006;15:167–72.CrossRefPubMedGoogle Scholar
  21. 21.
    Nourissat A, Vasson MP, Merrouche Y, et al. Relationship between nutritional status and quality of life in patients with cancer. Eur J Cancer. 2008;44:1238–42.CrossRefPubMedGoogle Scholar
  22. 22.
    Park SE, Lee WK, Chung M, Bang SM, Cho EK, Lee JH, et al. Quality of life in patients with advanced gastric cancer treated with second-line chemotherapy. Cancer Chemother Pharmacol. 2006;57:289–94.CrossRefPubMedGoogle Scholar

Copyright information

© Society of Surgical Oncology 2008

Authors and Affiliations

  • Luis F. Oñate-Ocaña
    • 1
  • Alberto Alcántara-Pilar
    • 2
  • Diana Vilar-Compte
    • 3
  • Gabriela García-Hubard
    • 4
  • Edith Rojas-Castillo
    • 2
  • Salvador Alvarado-Aguilar
    • 2
  • José F. Carrillo
    • 5
  • Jane M. Blazeby
    • 6
  • Vincenzo Aiello-Crocifoglio
    • 1
  1. 1.Departamento de Gastroenterología, Clínica de Neoplasias GástricasInstituto Nacional de CancerologíaMéxicoMexico
  2. 2.Departamento de Psico-oncologíaInstituto Nacional de CancerologíaMéxicoMexico
  3. 3.Departamento de InfectologíaInstituto Nacional de CancerologíaMéxicoMexico
  4. 4.Facultad de Filosofía y Letras, and Histoire et Semiologie de texte et de l’imageUniversidad Nacional Autónoma de México, and Université de Paris 7 Denis DiderotParisFrance
  5. 5.División de CirugíaInstituto Nacional de CancerologíaMexico CityMexico
  6. 6.EORTC Quality of Life Group and Department of Social Medicine and Clinical Sciences at South BristolUniversity of BristolBristolUK

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