Journal of Parkinson's disease · 2025
Addressing the need for standardization of symptomatic medication documentation in Parkinson's disease clinical research: A call to action.
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Spott Mikayla, Javidnia Monica, Pedata Anne, Müller Martijn, Carrillo Laura, Simuni Tanya, Pagano Gennaro, Kwok Kevin, Romero Klaus, Stephenson Diane
Аннотация
People with Parkinson's disease (PD) are prescribed a variety of medications to mitigate symptoms and improve their quality of life. These symptomatic therapies cover a range of pharmacological classes, including classical dopaminergic treatments, other antiparkinsonian agents, and pharmacotherapies for non-PD conditions. Often, medications are prescribed for concomitant use and in increasing doses, particularly as the disease progresses. Documentation of these interventions in clinical trials is necessary to accurately capture medication usage, compare medication utilization across different studies, understand factors contributing to experimental therapeutic response, and analyze clinical trial data in a precise manner. At the present time, there is no current international standard for how these medications are documented within clinical trials. As a case example, we will highlight medication use documentation in a large international multicenter observational study commonly used as a reference for design of clinical trials. This review aims to raise awareness within the scientific community of the importance of proper medication documentation and the need for standardization to harmonize prescriptive practices, improve treatment interpretability, and perform consistently robust analyses from clinical trials data.