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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Public Library of Science (PLoS)
2025-01-01
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| 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. |
| format | Article |
| id | doaj-art-c91b41b0ca0c43c9ba367a1237ce5020 |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS ONE |
| 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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