Versão em português, adaptação transcultural e validação do Questionário de Claudicação de Edimburgo

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The Portuguese Version, Cross-Cultural Adaptation and Validation of Specific Quality-of-Life Questionnaire AQUAREL - for Pacemaker Patients Bruna Guimarães Oliveira, Jorge Gustavo Velasquez Melendez, Rozana Mesquita Ciconelli, Leonor Garcia Rincón, Ana Amélia Soares Torres, Lidiane Aparecida Pereira de Sousa, Antonio Luiz Pinho Ribeiro Faculdade de Medicina, Escola de Enfermagem e Hospital das Clínicas da Universidade Federal de Minas Gerais e Universidade Federal de São Paulo - Belo Horizonte, MG - Brazil

OBJECTIVE

CONCLUSION

To translate, to make the cultural adaptation and to evaluate reproducibility and validity of the Portuguese version of the AQUAREL (Assessment of QUAlity of life and RELated events) questionnaire, which is a specific tool to assess quality of life in pacemaker patients.

The Portuguese version of the AQUAREL questionnaire is easy and rapid to apply, and could be used as a specific questionnaire to assess quality of life in pacemaker patients.

METHODS We evaluated 202 pacemaker patients: 63 patients during the cross-cultural adaptation stage and 139 during the reproducibility and validity evaluation stages. The questionnaire translation was reviewed repeatedly until ≥85% of patients correctly understood the questions. Reproducibility of the final version was tested in 69 patients in whom the interview was performed twice by the same researcher. Validity was checked by the correlation between scores obtained in AQUAREL domains and those obtained in SF36 domains, in the functional class and the distance walked in the six-minute test.

KEY

WORDS

Quality of life, pacemaker, cross-cultural adaptation, translation.

RESULTS The internal consistency of AQUAREL was adequate, with Cronbach’s alpha coefficient varying between 0.59 and 0.85. Reproducibility was good, with high correlation coefficients (0.68-0.89) and random distribution of data in Bland and Altman plots, without systematic bias. A significant association was observed among AQUAREL domains and those obtained in SF36 domains and the functional class (p0.05) were considered indicators of appropriate reproducibility; 2) Bland and Altman plots17 which graphically shows the difference of scores obtained from the interviews in the group of mean values; 3) Pearson’s correlation coefficient among the individual values obtained in the first and second interviews. The analysis of internal consistency of the components in each domain of the questionnaire was

performed through the calculation of Cronbach’s alpha coefficient18. Values higher than 0.5 indicate acceptable internal consistency, and higher than 0.7 are considered optimal values. The validity of the AQUAREL questionnaire final version in Portuguese was assessed through the participation of 139 patients in the study associating the scores obtained in the domains of the AQUAREL questionnaire and the SF36 questionnaire, the functional class score and the distance walked in the 6-minute test (performed in 74 patients). The selection of such parameters, considered here as a reference standard to assess the validity of the instrument to recognize the clinically significant differences, took into consideration their clinical importance and their use in the validation of the AQUAREL questionnaire in its original version. SF-36 is a largely used and duly validated generic questionnaire that is part of the evaluation of the general aspects. A positive correlation is expected to be found among the scores of the domains of SF-36 questionnaire and the questionnaire under evaluation. The functional class was evaluated by the researcher with the use of a scale of specific activity according to functional class I-IV, similar to that used by the New York Heart Association and proposed by Goldman et al19. The 6-minute walk test is a method for evaluation of the submaximal functional capacity. Before the test, the individuals remained at rest for at least 10 minutes, an interval when their personal data was obtained and the individuals were given the necessary instructions. The possible contraindications to the procedure were also analyzed. Participants were previously trained and

Arquivos Brasileiros de Cardiologia - Volume 87, Nº 2, August 2006

Oliveira et al THE PORTUGUESE VERSION, CROSS-CULTURAL ADAPTATION AND VALIDATION OF SPECIFIC QUALITY-OF-LIFE QUESTIONNAIRE - AQUAREL - FOR PACEMAKER PATIENTS

submitted to two tests with a 20-minute interval for resting. The two evaluations with the 6-minute walk tests aimed to eliminate the learning effect of the procedure. Additionally, if a difference greater than 10% was found in the distance walked between the first and the second test, a third evaluation would be performed20 . The subjects were encouraged in a standardized manner during the test, and in case of chest pain, disproportional exertional dyspnea, excessive sudoresis, paleness or malaise, the test would be immediately interrupted. It is considered a simple test that reproduces daily activities and can be easily performed. Moreover, it requires little equipment, it is safe and fast, and presents good correlation with other types of physical exercises such as the treadmill or stationary bicycle test21-23. Evaluation of validity of the Portuguese version of the AQUAREL questionnaire was conducted through analysis of Pearson’s correlation, as well as comparison of mean values using the analysis of variance and Tukey’s test. The results were considered statistically significant at a p ≤ 0.05.

never attended school. A larger proportion among the 139 patients who underwent the evaluation of measurement property (reproducibility and validity) was already retired; however, no other significant differences were found between the two groups. The study involved three tests with two timepoints of cultural adjustment until the index defined as 85% of correct understanding was reached. In the first test (with 10 patients), 16 out of 20 questions presented an index higher than 15% of incorrect or dubious understanding; in the second test (23 patients), 10 questions had to be adjusted; and, in the third test (30 patients), all the questions presented pre-established indexes considered acceptable, with less than 5% of incorrect or dubious understanding. Out of 139 patients who participated in the second phase of the study, 69 patients (47.5%) participated in the reproducibility study and returned for the second application of the AQUAREL questionnaire after seven days, in average. Table 2 presents the means and standard deviations of the scores obtained in both interviews. There are no significant differences between the scores obtained in two timepoints in any domain of the AQUAREL questionnaire. Therefore, the mean difference between the scores obtained is close to zero in spite of a relatively large confidence interval (figure 2 to 4).

RESULTS A total of 202 patients with mean age of 60.1 years (17-82) participated in the study; in that, 56.4% were females and 61.4% were patients retired or on leave (table 1). More than 50% of patients reported a marital relationship; 84.7% of patients reported they had attended school for less than 4 years and 32.7% had

Intraobserver correlation coefficients obtained between the first and second interviews were elevated and highly

Table 1 – Social-demographic characteristics and mode of artificial cardiac stimulation of patients participating in the study during the phases of cultural adaptation and evaluation of the measurement properties Variables

Cultural adaptation (n = 63)

Measurement properties (n = 139)

N

%

N

%

Male

33

52.4

55

39.6

Female

30

47.6

84

60.4

Total (n = 202)

p N

%

Sex 0.12

88

43.6

114

56.4

Age Mean (standard deviation)

61.4 (14.0)

58.7 (14.5)

0.20

60.1 (14.8)

Marital status Has a partner

40

63.5

71

51.4

No partner

23

36.5

68

49.6

0.14

111

54.9

91

45.1

Schooling Illiterate

19

30.1

47

33.8

Up to 4 years

36

57.1

69

49.7

Over 4 years

08

12.8

23

16.5

Retired

25

39.8

99

71.3

Active

19

30.1

17

12.2

Housewife

19

30.1

23

DDDR

31

49.2

DDD

03

04.9

0.58

66

32.7

105

52.0

31

15.3

Occupation 124

61.4

36

18.8

16.5

42

20.8

77

55.4

108

53.5

05

03.6

08

03.9

< 0.001

Type of cardiac stimulation

0.59

VVIR

19

30.1

43

30.9

62

30.7

VVI

06

09.5

11

07.9

17

08.4

Other

04

06.3

03

02.2

07

03.5

Arquivos Brasileiros de Cardiologia - Volume 87, Nº 2, August 2006

Oliveira et al THE PORTUGUESE VERSION, CROSS-CULTURAL ADAPTATION AND VALIDATION OF SPECIFIC QUALITY-OF-LIFE QUESTIONNAIRE - AQUAREL - FOR PACEMAKER PATIENTS

significant (p ≤ 0.001) in the domains of chest discomfort (fig. 2A), dyspnea (figure 3A) and arrhythmia (figure 4A) of the AQUAREL questionnaire. The Bland and Altman plots, displayed in figures 2 to 4 (B), show the absence of a systematic bias between the first and second evaluations in the three domains; however, they reveal a relatively large variation of scores between the interviews.

internal consistency among the items that make up each domain by means of Cronbach’s alpha coefficient. The scores ranged from 0.678 to 0.849 in the first application of the questionnaire, and from 0.592 to 0.818 in the second application; the lowest scores were found in the arrhythmia domain. The questionnaire’s validity was evaluated in 139 patients, of which 74 (53.2%) performed the 6-minute

Table 3 shows the values calculated for verification of

Table 2 – Scores of the AQUAREL questionnaire domains in two distinct timepoints in patients participating in the study during the phase of reproducibility evaluation (n=69) Interview 1 Mean (SD)

Interview 2 Mean (SD)

Mean difference (95% CI)

p

Chest discomfort

86.2 (20.0)

86.8 (18.0)

0.6 (-29.7 to 30.9)

0.74

Dyspnea

76.3 (23.59)

77.1 (22.1)

0.8 (-20.7 to 22.3)

0.55

Arrhythmia

83.0 (17.7)

83.4 (16.6)

0.4 (-20.9 to 22.0)

0.77

AQUAREL Domains

SD- Standard deviation; CI- confidence interval.

r = 0.69 CI 95% 0.54 - 0.80 p
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