Addressing the need for standardization of symptomatic medication documentation in Parkinson's disease clinical research: A call to action.

IF 5 3区 医学 Q2 NEUROSCIENCES Journal of Parkinson's disease Pub Date : 2025-02-01 Epub Date: 2025-01-14 DOI:10.1177/1877718X241305711
Mikayla Spott, Monica Javidnia, Anne Pedata, Martijn Müller, Laura Carrillo, Tanya Simuni, Gennaro Pagano, Kevin Kwok, Klaus Romero, Diane Stephenson
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Abstract

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.

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解决帕金森病临床研究中对症用药文件标准化的需要:行动呼吁。
帕金森氏症(PD)患者需要服用多种药物来减轻症状,提高生活质量。这些对症治疗涵盖了一系列药理学类别,包括经典的多巴胺能治疗,其他抗帕金森药物和非帕金森病的药物治疗。通常情况下,处方药物同时使用并增加剂量,特别是随着疾病的进展。在临床试验中记录这些干预措施对于准确捕捉药物使用情况、比较不同研究中的药物使用情况、了解影响实验治疗反应的因素以及精确分析临床试验数据是必要的。目前,对于如何在临床试验中记录这些药物,还没有现行的国际标准。作为一个案例,我们将重点介绍一项大型国际多中心观察性研究中的药物使用文件,该研究通常用作临床试验设计的参考。这篇综述的目的是提高科学界对适当的药物记录的重要性的认识,以及标准化的必要性,以协调处方实践,提高治疗的可解释性,并从临床试验数据中进行一致的可靠分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
8.40
自引率
5.80%
发文量
338
审稿时长
>12 weeks
期刊介绍: The Journal of Parkinson''s Disease (JPD) publishes original research in basic science, translational research and clinical medicine in Parkinson’s disease in cooperation with the Journal of Alzheimer''s Disease. It features a first class Editorial Board and provides rigorous peer review and rapid online publication.
期刊最新文献
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