Date of Approval:
Parkinson's disease (PD) is a chronic movement disorder that progresses variably in patients to severe debilitation. The treatment of PD varies across regions due to recommended guidelines and regulations. Therefore results from studies cannot be generalized to different regions. There is limited information available on the treatment patterns of PD patients in the UK. The purpose of this study therefore is to describe characteristics and treatment patterns of newly diagnosed PD patients in the UK. We will use data from the Clinical Practice Research Database linked to the Hospital Episode Statistics database from 1 January 2004 to 30 September 2015 to conduct the study. We will obtain information using coded data that will be extracted from the database to identify patients with a new diagnosis of PD, and to describe their treatment history. We will describe the types of PD medications prescribed, the duration of the prescribed medication and the outcome of each prescribed treatment. Results from this study will provide rich information on the treatment pathways that PD patients in the UK experience from the time of diagnosis. The study will also assess whether or not treatment is in line with the recommended treatment guidelines for PD in the UK.
There is limited published data available on treatment patterns of patients with Parkinson's disease (PD). Variability of reimbursement policies and treatment guidelines limit the ability to generalize study results of treatment patterns across regions. The objective of the study is to describe the characteristics and treatment patterns of newly diagnosed adult PD patients in the United Kingdom. We will conduct a descriptive retrospective cohort study using the Clinical Practice Research Database linked to the Hospital Episode Statistics database from 01 January 2004 to 30 Septmber 2015. We will only include data from practices that are up to standard and use patients that satisfy our pre-specified inclusion and exclusion criteria. We will identify patients using the Read diagnostic codes for PD assigned by physicians and obtain information on medications using product codes from physician prescriptions. The follow-up period will be from date of diagnosis to the fourth treatment line. For each treatment line we will describe the name of medication, type of prescription (monotherapy versus polytherapy), duration, and outcome of the treatment line (discontinuation, continuation, augmentation and switching). Statistical analysis will be descriptive; continuous variables will be presented as means and standard deviation or median and interquartile ranges, while categorical variables will be presented as frequencies and percentages.
Health Outcomes to be Measured:
Each treatment line will be assessed for the following outcomes: augmentation, discontinuation, switching and censoring (representing treatment lines that continue to the date of censoring) as defined below. Augmentation: The outcome of a line will be Augmentation if the next line contains every PD medication present in the current line plus one or more PD medications in addition. Discontinuation: The outcome of a line will be Discontinuation if the current line contains every PD medication present in the next line plus one or more PD medications in addition. Switching: The outcome of a line will be Switching if the current line contains PD medications not present in the next line AND the next line contains PD medications not present in the current line. Censored: The outcome of a line will be Censored if it is the last line before the end of follow-up.
Linda Kalilani - Chief Investigator - UCB BioSciences, Inc.
Linda Kalilani - Corresponding Applicant - UCB BioSciences, Inc.
Knut Mueller - Collaborator - UCB Pharma SA - UK
Mahnaz Asgharnejad - Collaborator - UCB BioSciences, Inc.