Validation of a reduced instrument Diabetes-21 for assessing health-related quality of life among people with diabetes

Sousa, Árlen Almeida Duarte de; Brito, Ana Monique Gomes; Silveira, Marise Fagundes; Martins, Andréa Maria Eleutério de Barros Lima

Árlen Almeida Duarte de Sousa ^**Corresponding: Árlen Almeida Duarte de Sousa. arlenduarte@gmail.com

Universidade Estadual de Montes Claros, Departamento de Métodos e Técnicas Educacionais, Montes Claros, MG, Brazil

http://orcid.org/0000-0002-7690-5282

Ana Monique Gomes Brito

Faculdades Unidas do Norte de Minas, Departamento de Enfermagem, Montes Claros, MG, Brazil

http://orcid.org/0000-0002-0490-9479

Marise Fagundes Silveira

Universidade Estadual de Montes Claros, Programa de Pós-Graduação em Ciências da Saúde, Montes Claros, MG, Brazil

http://orcid.org/0000-0002-8821-3160

Andréa Maria Eleutério de Barros Lima Martins

Universidade Estadual de Montes Claros, Programa de Pós-Graduação em Ciências da Saúde, Montes Claros, MG, Brasil.

http://orcid.org/0000-0002-1205-9910

*Corresponding: Árlen Almeida Duarte de Sousa. arlenduarte@gmail.com

Authors’ Contribution

Sousa AAD collaborated with the study conception, data collection, analysis and interpretation of the results and critical reviewing of intellectual content. Brito AMG collaborated with data collection, analysis and interpretation of the results, and critical reviewing of intellectual content. Silveira MF collaborated with the analysis and interpretation of the results, and critical reviewing of intellectual content. Martins AMEBL collaborated with the study conception and critical reviewing of intellectual content. All authors have approved the final version of the manuscript and declared themselves to be responsible for all aspects of the work, including ensuring its accuracy and integrity.

Conflicts of Interest

The authors declared that they have no conflicts of interest.

Associate editor

Doroteia Aparecida Höfelmann - 0000-0003-1046-3319

Sociodemographic and economic status	Study Population			Quality of life affected in the Diabetes-21 domains (n=288)
	n=50	n=288		Sexual functioning				Energy e mobility				Diabetes control and social burden				Anxiety and worry
	Total			Yes		No		Yes		No		Yes		No		Yes		No
	N	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%
Sex
Female	34	189	65.6	133	73.1	56	52.8	93	59.2	96	73.3	100	64.1	89	67.4	87	60.0	102	71.3
Male	16	99	34.4	49	26.9	50	47.2	64	40.8	35	26.7	56	35.9	43	32.6	58	40.0	41	28.7
Age group (years)^a
22-54	8	81	28.1	50	27.5	31	29.3	39	24.8	42	32.1	37	23.7	44	33.4	29	20.0	52	36.3
55-61	14	62	21.5	39	21.4	23	21.7	35	22.3	27	20.6	30	19.2	32	24.2	28	19.3	34	23.8
62-68	11	78	27.1	43	23.6	35	33.0	45	28.7	33	25.2	46	29.5	32	24.2	45	31.0	33	23.1
≥69	11	67	23.3	50	27.5	17	16.0	38	24.2	29	22.1	43	27.6	24	18.2	43	29.7	24	16.8
Schooling (years)^a
0	2	17	6.0	12	6.7	5	4.7	8	5.3	9	7.0	8	5.1	9	6.8	8	5.5	9	6.2
1-4	11	65	22.6	37	20.3	28	26.7	28	17.9	37	28.2	34	21.9	31	23.5	30	20.8	35	24.5
5-8	11	89	31.0	59	32.4	30	28.6	52	33.3	37	28.2	48	31.0	41	31.1	43	29.9	46	32.2
9-11	10	49	17.1	31	17.0	18	17.1	28	17.9	21	16.0	28	18.1	21	15.9	25	17.4	24	16.8
≥12	8	67	23.3	43	23.6	24	22.9	40	25.6	27	20.6	37	23.9	30	22.7	38	26.4	29	20.3
Marital status
Married/stable union	33	174	60.4	103	56.5	71	67.0	96	61.1	78	59.5	88	56.4	86	65.2	85	58.6	89	62.2
Single/widowed/divorced/separated	17	114	39.6	79	43.5	35	33.0	61	38.9	53	40.5	68	43.6	46	34.8	60	41.4	54	37.8
Race/skin color
White	22	89	30.9	58	31.9	31	29.2	47	29.9	42	32.1	46	29.5	43	32.5	46	31.7	43	30.0
Asian	4	14	4.9	7	3.8	7	6.6	5	3.2	9	6.9	5	3.2	9	6.8	5	3.4	9	6.3
Black	4	36	12.5	25	13.7	11	10.4	20	12.7	16	12.2	16	10.3	20	15.2	14	9.7	22	15.4
Brown	20	134	46.5	82	45.1	52	49.1	75	47.8	59	45.0	79	50.6	55	41.7	72	49.7	62	43.4
Indigenous	-	3	1.0	2	1.1	1	0.9	3	1.9	-	0.0	3	1.9	-	0.0	2	1.4	1	0.7
No information provided	-	12	4.2	8	4.4	4	3.8	7	4.5	5	3.8	7	4.5	5	3.8	6	4.1	6	4.2
Household income^a
Up to BRL 998.00	8	81	30.2	54	31.8	27	27.6	38	26.2	43	35.0	38	26.2	43	35.0	34	25.6	47	34.8
Over BRL 998.00	42	187	69.8	116	68.2	71	72.4	107	73.8	80	65.0	107	73.8	80	65.0	99	74.4	88	65.2
Spending on medicines
Yes	-	147	51.0	89	48.9	52	49.1	79	50.3	62	47.3	78	50.0	63	47.7	74	51.0	67	46.9
No	-	141	49.0	93	51.1	54	50.9	78	49.7	69	52.7	78	50.0	69	52.3	71	49.0	76	53.1

Item and domains	Weighted Kappa	p-value^a
Energy and mobility
1. By feeling of weakness	0.67	<0.001
2. By how far you can walk	0.60	<0.001
3. By any daily exercise requirements	0.85	<0.001
4. By not being able to do housework or other jobs around the house	0.93	<0.001
5. By needing to rest often	0.83	<0.001
6. By having trouble caring for yourself (dressing, bathing or using the toilet)	0.76	<0.001
7. By walking more slowly than others	0.92	<0.001
Diabetes control and social burden
8. By food restrictions required to control your diabetes	0.82	<0.001
9. By losing control of your blood sugar levels	0.76	<0.001
10. By testing your blood sugar levels	0.77	<0.001
11. By getting your diabetes well controlled	0.82	<0.001
12. By the need to eat at regular intervals	0.83	<0.001
13. By the restrictions your diabetes places on your family and friends	0.84	<0.001
14. By being embarrassed because you have diabetes	0.73	<0.001
15. By doing things your family and friends do not do	0.87	<0.001
Sexual functioning
16. By diabetes interfering with your sex life	0.61	<0.001
17. By problems with sexual functioning	0.90	<0.001
18. By a decreased interest in sex	0.87	<0.001
Anxiety and worry
19. By worries about money matters	0.82	<0.001
20. By stress or pressure in your life	0.90	<0.001
21. By feeling depressed or low	0.90	<0.001

Diabetes-21 - Item and domains	Commonalities	Factor 1	Factor 2	Factor 3	Factor 4	Cronbach’s alpha
Factor: energy and mobility
1. By feeling of weakness	0.47	0.49	0.20	0.16	0.41	0.83
2. By how far you can walk	0.62	0.72	0.26	0.03	0.19
3. By any daily exercise requirements	0.46	0.59	0.34	-0.01	0.01
4. By not being able to do housework or other jobs around the house	0.61	0.74	0.07	0.21	0.10
5. By needing to rest often	0.57	0.70	0.18	0.17	0.17
6. By having trouble caring for yourself (dressing, bathing or using the toilet)	0.43	0.61	0.05	0.20	0.11
7. By walking more slowly than others	0.61	0.67	0.298	0.12	0.25
Factor: diabetes control and social burden
8. By food restrictions required to control your diabetes	0.55	0.06	0.73	-0.07	0.11	0.86
9. By losing control of your blood sugar levels	0.46	0.28	0.54	0.22	0.20
10. By testing your blood sugar levels	0.60	0.24	0.71	0.06	0.17
11. By getting your diabetes well controlled	0.63	0.17	0.73	0.23	0.13
12. By the need to eat at regular intervals	0.58	0.28	0.66	0.23	0.13
13. By the restrictions your diabetes places on your family and friends	0.62	0.33	0.64	0.23	0.22
14. By being embarrassed because you have diabetes	0.49	0.14	0.47	0.29	0.40
15. By doing things your family and friends do not do	0.54	0.57	0.41	0.10	0.19
Factor: sexual functioning
16. By diabetes interfering with your sex life	0.79	0.16	0.14	0.85	0.10	0.86
17. By problems with sexual functioning	0.84	0.09	0.14	0.90	0.07
18. By a decreased interest in sex	0.71	0.29	0.20	0.76	0.11
Factor: anxiety and worry
19. By worries about money matters	0.56	0.15	0.16	0.07	0.71	0.70
20. By stress or pressure in your life	0.77	0.16	0.19	-0.00	0.84
21. By feeling depressed or low	0.55	0.32	0.22	0.23	0.59

Diabetes-21
People’s quality of life is affected by many things. These things might include health, leisure and vacation opportunities, friends and family, and a job. This questionnaire is designed to help us understand what affects the quality of life of people with diabetes. Below, there are some questions about your quality of life. For each sentence, put a check in the box to show how much that factor affects your quality of life, according to the legend: (1) not affected (2) little affected (3) sometimes affected (4) very affected (5) extremely affected
During the past month, how much was the quality of your life affected by:	1	2	3	4	5
1. feelings of weakness
2. how far you can walk
3. Any daily exercise requirements
4. not being able to do housework or other jobs around the house
5. needing to rest often
6. having trouble caring for yourself (dressing, bathing or using the toilet)
7. walking more slowly than others
8. food restrictions required to control your diabetes
9. losing control of your blood sugar levels
10. having to test your blood sugar levels
11. getting your diabetes well controlled
12. the need to eat at regular intervals
13. the restrictions your diabetes places on your family and friends
14. being embarrassed because you have diabetes
15. doing things that your family and friends don’t do
16. diabetes interfering with your sex life
17. problems with sexual functioning
18. a decreased interest in sex
19. worries about money matters
20. stress or pressure in your life
21. feeling depressed or low
Overall assessment
How satisfied are you with your overall quality of life?
(1) not satisfied at all (2) dissatisfied (3) neither satisfied nor dissatisfied (4) satisfied (5) very satisfied
How serious do you think your diabetes is?
(1) not serious (2) serious (3) more or less serious (4) very serious (5) extremely serious

Diabetes-21
A qualidade de vida das pessoas é afetada por muitas coisas. Estas coisas podem incluir saúde, oportunidade de lazer e férias, amigos e família, e um trabalho. Este questionário é realizado para nos ajudar a compreender o que afeta a qualidade de vida de pessoas com diabetes. A seguir, pergunta-se sobre sua qualidade de vida. Para cada frase, assinale o grau em que concorda com as afirmativas, de acordo com a legenda: (1) não foi afetada (2) pouco afetada (3) às vezes afetada (4) muito afetada (5) extremamente afetada
Durante o MÊS PASSADO, quanto sua qualidade de vida foi afetada:	1	2	3	4	5
1. Pela sensação de fraqueza
2. Pelo quanto você consegue andar
3. Pela necessidade de realizar exercícios regularmente
4. Por não ser capaz de fazer atividades domésticas ou outros trabalhos que estão relacionados com a casa
5. Pela necessidade de descansar várias vezes no dia
6. Por dificuldades em cuidar de você mesmo(a) (de se vestir, tomar banho ou usar o vaso sanitário)
7. Por andar mais devagar que os outros
8. Pelas restrições alimentares necessárias para o controle do seu diabetes
9. Por perder o controle dos níveis de açúcar no sangue
10. Por ter que testar seus níveis de açúcar
11. Por tentar manter seu diabetes bem controlado
12. Pela necessidade de comer a intervalos regulares
13. Pelas restrições que seu diabetes impõe sobre sua família e amigos
14. Pelo constrangimento por ter diabetes
15. Por fazer coisas que sua família ou seus amigos não fazem
16. Pelo diabetes interferir na sua vida sexual
17. Por problemas com função sexual
18. Pela diminuição do interesse pelo sexo
19. Pela preocupação relacionada com questões financeiras
20. Pelo estresse ou pressão em sua vida
21. Por sentimento de tristeza ou depressão
Avaliações gerais
O quanto o(a) senhor(a) está satisfeito(a) com sua qualidade de vida geral?
(1) muito insatisfeito (2) insatisfeito (3) nem insatisfeito, nem satisfeito (4) satisfeito (5) muito satisfeito
O quão grave você acha que é o seu diabetes?
(1) nada grave (2) grave (3) mais ou menos grave (4) muito grave (5) extremamente grave

[1] *Corresponding: Árlen Almeida Duarte de Sousa. arlenduarte@gmail.com

Brasil

Brasil

Validation of a reduced instrument Diabetes-21 for assessing health-related quality of life among people with diabetes

Abstract

Objective

Methods

Results

Conclusion