Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
accepted:
27
09
2020
pubmed:
14
10
2020
medline:
10
2
2022
entrez:
13
10
2020
Statut:
ppublish
Résumé
Patient reporting adds value to pharmacovigilance. Encouraging it to be done through a mobile device application (App) is a method that should be evaluated. This study aimed to determine whether the use of an App, compared to traditional use through e-mail, telephone, or the national website, increased suspected adverse drug reaction (ADR) reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug. An open multi-centric, cluster-randomized controlled trial was conducted (VigipSEP study). Clusters were centers allocated (1:1) to the use of the My eReport France Twenty-four centers (12 per arm: six public neurologists from the multiple sclerosis academic expert centers, three public neurologists from general hospitals, and three private practice neurologists) were randomized, including 159 patients. The mean number of ADR reports per patient was significantly higher in centers that used the App: 0.47 vs 0.03 in control centers (p = 0.002). At an individual-level analysis, the experimental arm was significantly associated with a relative risk of ADR reports at 18.6 (95% confidence interval 4.1-84.2; p < 0.001), compared to the control arm, adjusted for sex and type of disease-modifying drug. The use of a mobile App increased the ADR reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug. CLINICALTRIALS. NCT03029897, registered in 2017.
Identifiants
pubmed: 33048319
doi: 10.1007/s40264-020-01009-z
pii: 10.1007/s40264-020-01009-z
doi:
Banques de données
ClinicalTrials.gov
['NCT03029897']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
223-233Investigateurs
G Defer
(G)
N Derache
(N)
P Branger
(P)
O Casez
(O)
M Vaillant
(M)
P Labauge
(P)
L Magy
(L)
A Montcuquet
(A)
G Castelnovo
(G)
M Cohen
(M)
B Bourre
(B)
A Kwiatkowski
(A)
T De Broucker
(T)
A Creange
(A)
O Heinzlef
(O)
S Wiertlewski
(S)
A Gueguen
(A)
J Romero
(J)
P Devos
(P)
E Planque
(E)
S Schaeffer
(S)
N Collongues
(N)
J De Seze
(J)
J Senant
(J)
M Bonnan
(M)
D Ciocanu
(D)
S Pittion
(S)
X Douay
(X)
H Zephir
(H)
D Peaureaux
(D)
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