Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.

<h4>Background and objective</h4>Device-aided therapies (DATs) are treatments indicated for people with Parkinson´s disease (PwP) experiencing clinical fluctuations that remain suboptimal despite conventional medication. New DATs have recently emerged such as levodopa-entacapone-carbidop...

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Main Authors: Diego Santos-García, Guillermo González-Ortega, Pilar Sánchez-Alonso, Anna Planas-Ballvé, Rocío García-Ramos, Iria Cabo, Marta Blázquez-Estrada, Álvaro Sánchez-Ferro, DATs-P. D. GETM Spanish Registry Group
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2025-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0316052
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author Diego Santos-García
Guillermo González-Ortega
Pilar Sánchez-Alonso
Anna Planas-Ballvé
Rocío García-Ramos
Iria Cabo
Marta Blázquez-Estrada
Álvaro Sánchez-Ferro
DATs-P. D. GETM Spanish Registry Group
author_facet Diego Santos-García
Guillermo González-Ortega
Pilar Sánchez-Alonso
Anna Planas-Ballvé
Rocío García-Ramos
Iria Cabo
Marta Blázquez-Estrada
Álvaro Sánchez-Ferro
DATs-P. D. GETM Spanish Registry Group
author_sort Diego Santos-García
collection DOAJ
description <h4>Background and objective</h4>Device-aided therapies (DATs) are treatments indicated for people with Parkinson´s disease (PwP) experiencing clinical fluctuations that remain suboptimal despite conventional medication. New DATs have recently emerged such as levodopa-entacapone-carbidopa intestinal gel infusion (LECIG) and subcutaneous infusion of foslevodopa/foscarbidopa (fLD/fCD). Understanding the differences between various DATs is essential.<h4>Patients and methods</h4>We present here the protocol study of the DATs-PD GETM Spanish Registry. This is a descriptive, observational, prospective, multicenter, open study that is proposed as a clinical registry with progressive inclusion of PwP treated with a DAT in daily clinical practice conditions in more 40 centers from Spain for 10 years. The principal aim is to know the type of DAT that PwP in our country (Spain) receive. Specific objectives are to compare the clinical characteristics of the patients, the effectiveness, safety and tolerability, to identify predictors of a good response and to analyze the response by groups (gender, disease duration, phenotype, etc.). There is a baseline visit (V1; indication of the therapy), start visit (V2; initiation of the therapy) and follow-up visits at 6 months ±  3 months (V3_6M) and after this annually ±  3 months for 10 years (V3_12M, V3_24M, etc.).<h4>Results</h4>The registry is on going. The first patient was included on April 10, 2024. Patient recruitment and follow-up will be conducted until 31/DEC/2033. It is estimated that the registry will include a minimum of 3,000 patients.<h4>Conclusion</h4>The present study will help improve the care of PD patients treated with a DAT.
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spelling doaj-art-c91b41b0ca0c43c9ba367a1237ce50202025-08-20T03:30:35ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01203e031605210.1371/journal.pone.0316052Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.Diego Santos-GarcíaGuillermo González-OrtegaPilar Sánchez-AlonsoAnna Planas-BallvéRocío García-RamosIria CaboMarta Blázquez-EstradaÁlvaro Sánchez-FerroDATs-P. D. GETM Spanish Registry Group<h4>Background and objective</h4>Device-aided therapies (DATs) are treatments indicated for people with Parkinson´s disease (PwP) experiencing clinical fluctuations that remain suboptimal despite conventional medication. New DATs have recently emerged such as levodopa-entacapone-carbidopa intestinal gel infusion (LECIG) and subcutaneous infusion of foslevodopa/foscarbidopa (fLD/fCD). Understanding the differences between various DATs is essential.<h4>Patients and methods</h4>We present here the protocol study of the DATs-PD GETM Spanish Registry. This is a descriptive, observational, prospective, multicenter, open study that is proposed as a clinical registry with progressive inclusion of PwP treated with a DAT in daily clinical practice conditions in more 40 centers from Spain for 10 years. The principal aim is to know the type of DAT that PwP in our country (Spain) receive. Specific objectives are to compare the clinical characteristics of the patients, the effectiveness, safety and tolerability, to identify predictors of a good response and to analyze the response by groups (gender, disease duration, phenotype, etc.). There is a baseline visit (V1; indication of the therapy), start visit (V2; initiation of the therapy) and follow-up visits at 6 months ±  3 months (V3_6M) and after this annually ±  3 months for 10 years (V3_12M, V3_24M, etc.).<h4>Results</h4>The registry is on going. The first patient was included on April 10, 2024. Patient recruitment and follow-up will be conducted until 31/DEC/2033. It is estimated that the registry will include a minimum of 3,000 patients.<h4>Conclusion</h4>The present study will help improve the care of PD patients treated with a DAT.https://doi.org/10.1371/journal.pone.0316052
spellingShingle Diego Santos-García
Guillermo González-Ortega
Pilar Sánchez-Alonso
Anna Planas-Ballvé
Rocío García-Ramos
Iria Cabo
Marta Blázquez-Estrada
Álvaro Sánchez-Ferro
DATs-P. D. GETM Spanish Registry Group
Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.
PLoS ONE
title Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.
title_full Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.
title_fullStr Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.
title_full_unstemmed Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.
title_short Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study.
title_sort device aided therapies dats in parkinson s disease pd the dats pd getm spanish registry protocol study
url https://doi.org/10.1371/journal.pone.0316052
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