Araştırma özeti
Aşağıdaki metin kaynak makalenin lisansı doğrulanmış orijinal özetidir. cc by
Background and objectiveDevice-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.Patients and methodsWe 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.).ResultsThe 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.ConclusionThe present study will help improve the care of PD patients treated with a DAT.
Bilimsel değerlendirme
Araştırma sorusu
Sorunun kapsamı orijinal çalışma üzerinden değerlendirilir.
Yöntem ve örneklem
Çalışma tasarımı ve örneklem için kaynak makaleyi kontrol edin.
Temel bulgular
Bu kayıt için editoryal olarak onaylanmış bulgu özeti henüz yayımlanmadı.
Sınırlılıklar
Sonuçların genellenebilirliği, yanlılık ve klinik anlamı ayrıca incelenmelidir.
Bibliyografik veriden yöntem, örneklem veya klinik sonuç çıkarımı yapılmaz.