Percepção e aceitação de risco em pacientes brasileiros com esclerose múltipla

Bichuetti, Denis Bernardi; Franco, Carolina Azze; Elias, Isaac; Mendonça, Andreia C. R.; Carvalho, Lorraine Fiama Diniz; Diniz, Denise Sisterolli; Tur, Carmen; Tintoré, Mar; Oliveira, Enedina Maria Lobato de

doi:10.1590/0004-282X20170167

Denis Bernardi Bichuetti

Universidade Federal de São Paulo, Disciplina de Neurologia, São Paulo SP, Brasil;

Carolina Azze Franco

Universidade Federal de São Paulo, Disciplina de Neurologia, São Paulo SP, Brasil;

Isaac Elias

Universidade Federal de São Paulo, Disciplina de Neurologia, São Paulo SP, Brasil;

Andreia C. R. Mendonça

Universidade Federal de Goiás, Faculdade Estácio de Sá de Goiás,Centro de Referência e Investigação em Esclerose Múltipla, Goiânia GO, Brasil;

Lorraine Fiama Diniz Carvalho

Universidade Federal de Goiás, Faculdade Estácio de Sá de Goiás,Centro de Referência e Investigação em Esclerose Múltipla, Goiânia GO, Brasil;

Denise Sisterolli Diniz

Universidade Federal de Goiás,Centro de Referência e Investigação em Esclerose Múltipla, Goiânia GO, Brasil;

Carmen Tur

Universitat Autònoma de Barcelona, Hospital Universitari Valld’Hebron, Centre of Catalonia, Department of Neurology-Neuroimmunology and Multiple Sclerosis, Barcelona Spain;

University College London, Institute of Neurology, Department of Neuroinflammation, London, United Kingdom.

Mar Tintoré

Universitat Autònoma de Barcelona, Hospital Universitari Valld’Hebron, Centre of Catalonia, Department of Neurology-Neuroimmunology and Multiple Sclerosis, Barcelona Spain;

Enedina Maria Lobato de Oliveira

Universidade Federal de São Paulo, Disciplina de Neurologia, São Paulo SP, Brasil;

Correspondence:Denis Bernardi Bichuetti; Disciplina de Neurologia / UNIFESP; Rua Botucatu,740; 04023-900 São Paulo SP, Brasil; E-mail: bichuetti@unifesp.br

Age (years, mean +/- SD)	39.3 (+/- 11.9)
Years of schooling (years, mean +/- SD)	12.6 (+/- 3.0)
Age at first relapse (years, mean +/-SD)	30.2 (+/- 10.5)
Disease duration (years, mean +/-SD)	9.1 (+/- 6.8)
Current treatment (n, %)
Interferon Beta 1a IM	7 (7%)
Interferon Beta 1a SC	13 (13%)
Interferon Beta 1b SC	7 (7%)
Glatiramer acetate	20 (21%)
Fingolimod	29 (30%)
Fumarate	2 (2%)
Teriflunomide	4 (4%)
Natalizumab	12 (13%)
No treatment	2 (2%)
Duration of current treatment (years, mean +/-SD)	3.5 (+/- 3.4)
Number of previous treatments (n, %)*
0 (only received current treatment)	32 (33%)
1	35 (36%)
2	21 (22%)
3	4 (4%)
4	3 (3%)
5	1 (1%)
Current or previous use of natalizumab (n, %)	20 (21%)
EDSS** at the moment of interview (mean +/- SD)	2.6 (+/- 1.5)
Progression index*** (mean +/- SD)	0.4 (+/- 0.4)

Disease severity perception of MS	7.3 (+/- 2.4)

(0 = MS is not at all a severe disease; 10 = MS is the most severe disease you can think of)
Knowledge of the risk for developing PML under natalizumab use
1:100,000	14 (15%)
1:10,000	12 (13%)
1:1,000	37 (39%)
1:500	8 (8%)
1:200	25 (26%)
Putative progressive multifocal leukoencephalopathy risk patients considered high enough to stop or be unwilling to receive natalizumab
1:100,000	10 (10%)
1:10,000	13 (14%)
1:1,000	27 (28%)
1:500	13 (14%)
1:200	33 (34%)
Opinion on the risk of developing PML under natalizumab use (VAS; 0 = very low risk, 10 = very high risk)	5.9 (+/- 2.9)
Impeditive risk for use of a theoretical drug (VAS; 0 = unlikely to accept, 10 = very likely to accept risk)
1:2,000,000	5.5 (+/- 3.9)
1:600,000	5.4 (+/- 3.5)
1:5,000	4.4 (+/- 3.5)
1:100	3.0 (+/- 3.4)
1:50	2.5 (+/- 3.3)
Personality traits
Neuroticism	50.5 (+/- 9.3)
Extroversion	48.1 (+/- 9.5)
Openness	44.8 (+/- 9.4)
Agreeableness	48.4 (+/- 8.7)
Responsibility	50.3 (+/- 7.4)

Personality traits
Effect	Value	F	Hypothesis df	Error df		p-value
Neuroticism	0.009	0.159	5	86		0.977
Extroversion	0.029	0.51	5	86		0.768
Openness	0.053	0.96	5	86		0.447
Agreeableness	0.034	0.613	5	86		0.691
Responsibility	0.059	1.069	5	86		0.383
Sociodemographic and clinical features
Effect	Value	F	Hypothesis df	Error df		p-value
Sex	0.077	1.425^b	5	85		0.224
Natalizumab	0.099	1.863^b	5	85		0.109
Disease duration	0.099	1.874^b	5	85		0.107
EDSS	0.039	0.683^b	5	85		0.638
Years of schooling	0.027	0.468^b	5	85		0.799
Age	0.12	2.319^b	5	85		0.05
Tests of between-subjects effects for age as a predictor for risk acceptance scores
Source	Risk-acceptance scores	Type III sum of squares	df	Mean square	F	p-value
Age	Very low	232.656	1	232.656	1.942	0.167
	Low	229.368	1	229.368	1.971	0.164
	Medium	36.607	1	36.607	3.147	0.08
	High	84.794	1	84.794	7.871	0.006
	Very high	70.181	1	70.181	6.33	0.014
	Average	77.315	1	77.315	7.512	0.007
	High and very high	77.315	1	77.315	7.512	0.007

Variable	Heesen 2010¹²12. Heesen C, Kleiter I, Nguyen F, Schäffler N, Kasper J, Köpke S et al. Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists. Mult Scler. 2010;16(12):1507-12. https://doi.org/10.1177/1352458510379819 https://doi.org/10.1177/1352458510379819...	Tur 2013¹³13. Tur C, Tintoré M, Vidal-Jordana Á, Bichuetti D, Nieto González P, Arévalo MJ et al. Risk acceptance in multiple sclerosis patients on natalizumab treatment. PLoS One. 2013;8(12):e82796. https://doi.org/10.1371/journal.pone.0082796 https://doi.org/10.1371/journal.pone.008...	Tur 2013¹³13. Tur C, Tintoré M, Vidal-Jordana Á, Bichuetti D, Nieto González P, Arévalo MJ et al. Risk acceptance in multiple sclerosis patients on natalizumab treatment. PLoS One. 2013;8(12):e82796. https://doi.org/10.1371/journal.pone.0082796 https://doi.org/10.1371/journal.pone.008...	Bichuetti 2017 (present study)

	All	NTZ	DMD	All
Number of patients evaluated	69	114	22	96
Age (years, mean)	40	38	39	39
Disease duration (years, mean)	11	13	5	9
Previous or current natalizumab use (n, %)	69 (100%)	114 (84%)	22 (0%)	20 (21%)
Disease severity perception of MS*	8.5 (6.5-9.5)	7.0 +/- 2.0	7.6 +/- 1.8	7.3 (+/- 2.4)
Disease severity perception of MS*	median (range)	mean +/- SD	mean +/- SD	mean +/- SD
Attitude towards risk acceptance
Natalizumab-associated PML risk**	4.5 (1.7-6.0)	NA	NA	5.9 (+/- 2.9)
Putative progressive multifocal leukoencephalopathy risk patients considered high enough to stop or not willing to receive natalizumab.
1:100,000 (very low)	7%	NA	NA	-
1:5,000 (low)	10%			-
1:100 (high)	54%			-
1:10 (very high)	29%			-
1:100,000	-			10%
1:10,000	-			14%
1:1,000	-			28%
1:500	-			14%
1:200	-			34%
Impeditive risk for use of a theoretical drug***
1:2,000,000 (very low)	NA	8.9 (+/- 1.9)	7.5 (+/- 2.3)	5.2 (+/-3.7)
1:600,000 (low)		8.5 (+/- 2.2)	6.3 (+/- 2.7)	5.0 (+/-3.3)
1:5,000 (medium)		7.5 (+/- 2.8)	4.8 (+/- 3.1)	3.8 (+/-2.7)
1:100 (high)		4.3 (+/- 3.5)	2.4 (+/- 2.0)	2.4 (+/-2.7)
1:50 (very high)		3.0 (+/- 3.4)	1.6 (+/- 1.8)	1.8 (+/-2.6)
1:100 + 1/50 (high and very high)		3.7 (3.4)	2.0 (+/- 1.9)	2.8 (+/- 3.3)

[1] Correspondence:Denis Bernardi Bichuetti; Disciplina de Neurologia / UNIFESP; Rua Botucatu,740; 04023-900 São Paulo SP, Brasil; E-mail: bichuetti@unifesp.br

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Percepção e aceitação de risco em pacientes brasileiros com esclerose múltipla

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