Translation and validation of Pediatric Quality of Life Inventory<sup>TM</sup> 3.0 Diabetes Module (PedsQL<sup>TM</sup> 3.0 Diabetes Module) in Brazil-Portuguese language

Garcia, Leila F. dos S.; Manna, Thais Della; Passone, Caroline de Gouveia Buff; Oliveira, Lygia Spassapan de

doi:10.1016/j.jped.2017.09.009

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Original articles • J. Pediatr. (Rio J.) 94 (6) • Nov-Dec 2018 • https://doi.org/10.1016/j.jped.2017.09.009 copy

Translation and validation of Pediatric Quality of Life Inventory^TM 3.0 Diabetes Module (PedsQL^TM 3.0 Diabetes Module) in Brazil-Portuguese language^☆ ☆ Please cite this article as: Garcia LF, Manna TD, Passone CG, Oliveira LS. Translation and validation of Pediatric Quality of Life InventoryTM 3.0 Diabetes Module (PedsQLTM 3.0 Diabetes Module) in Brazil-Portuguese language. J Pediatr (Rio J). 2018;94:680-8. , ^☆☆ ☆☆ Study presented at Universidade de São Paulo (USP), Faculdade de Medicina, São Paulo, SP, Brazil, in order to obtain a Master's Degree in Pediatrics.

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objective:

The aim of the present study was to create a translated version of the Pediatric Quality of Life Inventory^TM 3.0 Diabetes Module (PedsQL^TM 3.0 Diabetes Module) in Brazilian Portuguese that was conceptually equivalent to the original American English version and to linguistically validate it in a Brazilian pediatric population with type 1 diabetes mellitus and their parents or caregivers.

Methods:

The instrument was translated, back-translated, and then administered to 83 children/adolescents (5-18 years) with type 1 diabetes mellitus and their family members and to 25 parents/caregivers of patients aged between 2 and 4 years. The final translated version was tested for reliability by analyzing internal consistency, intraobserver (test-retest) reliability, and concurrent validity.

Results:

Cronbach's alpha coefficient for the total score of the questionnaires of children/adolescents (α = 0.85) and their parents (α = 0.82) was above the recommended minimum of 0.70 for group comparisons. Intraobserver reliability and concurrent validity exhibited a significant positive correlation (p < 0.001), indicating the reliability of the translated instrument. A moderate but significant positive correlation (r = 0.40; p < 0.001) was demonstrated between the total scores of patient self-report and parent proxy-report scales. There was no significant correlation between glycated hemoglobin (HbA1c) levels and the respective scores in the questionnaires answered by patients and their parents/caregivers.

Conclusion:

The analysis of the translated version of the PedsQL^TM 3.0 Diabetes Module revealed adequate psychometric characteristics with respect to reliability and validity following administration to a sample of Brazilian children/adolescents with type 1 diabetes mellitus and their caregivers.

KEYWORDS
Validation studies; Quality of life; Type 1 diabetes mellitus; Child; Adolescent

	n	Characteristics of the study population
Gender (female/male)	108	49/59
Age group
2-4 years	25
5-7 years	25
8-12 years	29
13-18 years	29
Age at diabetes onset (years) (mean ± SD)	105	4.40 ± 3.09
Duration of diabetes (years) (mean ± SD)	105	5.14 ± 4.09
HbA1c (mean)	104	8.9%
2-4 years	24	8.6%
5-7 years	25	8.3%
8-12 years	27	8.7%
13-18 years	28	9.8%
Time gap between test and retest (days) (mean ± SD)	108	67.68 ± 19.54
15-45 days (%)	17	15.7%
46-75 days (%)	54	50.0%
76-90 days (%)	37	34.3%

Scale	n	Test			Retest
		Mean	Minimum	Maximum	Mean	Minimum	Maximum
PedsQL™ 3.0 Módulo Diabetes
Child self-report ^a a Children/adolescents aged 5-18 years.
Diabetes symptoms	83	59.5	20.5	100.0	57.9	22.7	93.2
Treatment barriers	83	63.6	12.5	100.0	64.4	6.3	100.0
Treatment adherence	83	60.0	14.3	100.0	72.2	7.1	100.0
Worry	83	49.7	0.0	100.0	46.6	0.0	100.0
Communication	83	63.5	0.0	100.0	65.6	0.0	100.0
Total score	83	62.1	25.0	100.0	62.0	25.9	91.1
Parent proxy-report ^b b Parents of children/adolescents aged 2-18 years.
Diabetes symptoms	108	57.4	15.9	95.5	57.3	15.9	100.0
Treatment barriers	108	58.4	18.8	100.0	61.1	6.3	100.0
Treatment adherence	108	71.4	17.9	100.0	71.5	10.7	100.0
Worry	108	39.0	0.0	100.0	42.4	0.0	100.0
Communication	108	65.3	0.0	100.0	64.8	0.0	100.0
Total score	108	59.9	33.0	97.3	60.6	30.4	94.6
PedsQL™ Questionário pediátrico sobre qualidade de vida versão 4.0 - Português (Brasil)
Child self-report ^a a Children/adolescents aged 5-18 years.
Physical health	83	78.8	37.5	100.0	-	-	-
Emotional functioning	83	62.1	5.0	100.0	-	-	-
Social functioning	83	84.0	20.0	100.0	-	-	-
School functioning	83	67.6	25.0	100.0	-	-	-
Total score	83	73.86	41.30	95.65	-	-	-
Parent proxy-report ^b b Parents of children/adolescents aged 2-18 years.
Physical health	108	75.1	28.1	100.0	-	-	-
Emotional functioning	108	61.5	20.0	100.0	-	-	-
Social functioning	108	84.1	35.0	100.0	-	-	-
School functioning	108	62.8	15.0	100.0	-	-	-
Total score	108	70.9	38.0	92.4	-	-	-

Scale	Number of items	n	α	r (test-retest)	p-Value
Child self-report (5-18 years)
Diabetes symptoms	11	83	0.76	0.60	<0.001
Treatment barriers	4	83	0.58	0.56	<0.001
Treatment adherence	7	83	0.71	0.59	<0.001
Worry	3	83	0.72	0.48	<0.001
Communication	3	83	0.79	0.52	<0.001
Total score	28	83	0.85	0.61	<0.001
Parent proxy-report (2-4 years)
Diabetes symptoms	11	25	-	0.83	<0.001
Treatment barriers	4	25	-	0.62	0.001
Treatment adherence	7	25	-	0.66	<0.001
Worry	3	25	-	0.65	<0.001
Communication	3	25	-	0.28	0.180
Total score	28	25	-	0.72	<0.001
Parent proxy-report (5-18 years)
Diabetes symptoms	11	83	-	0.57	<0.001
Treatment barriers	4	83	-	0.65	<0.001
Treatment adherence	7	83	-	0.58	<0.001
Worry	3	83	-	0.71	<0.001
Communication	3	83	-	0.52	<0.001
Total score	28	83	-	0.66	<0.001
Parent proxy-report (2-18 years)
Diabetes symptoms	11	108	0.77	-	-
Treatment barriers	4	108	0.54	-	-
Treatment adherence	7	108	0.68	-	-
Worry	3	108	0.82	-	-
Communication	3	108	0.82	-	-
Total score	28	108	0.82	-	-

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[1] * Corresponding author. E-mail:leila.garcia@hc.fm.usp.br (L.F. Garcia).