Löhle Matthias, Bremer Alexander, Gandor Florin, Timpka Jonathan, Odin Per, Ebersbach Georg, Storch Alexander
Department of Neurology, University Medical Center Rostock, Rostock, Germany.
German Center for Neurodegenerative Diseases (DZNE) Rostock-Greifswald, Rostock, Germany.
NPJ Parkinsons Dis. 2022 Jun 2;8(1):69. doi: 10.1038/s41531-022-00331-w.
The Parkinson's disease (PD) home diary is frequently used in clinical trials to measure efficacy of medical treatments for motor fluctuations in advanced PD. This prospective study in fluctuating PD patients examines the validity of the diary for quantification of motor states in comparison to direct clinical observation. 51 patients (median age: 65 years, disease duration: 11 years) completed the diary half-hourly for two consecutive days and were simultaneously rated by an experienced observer, who independently evaluated motor states half-hourly throughout daytime. Overall agreement (Cohen's kappa) between patient and observer diary entries was 59.8% (0.387). Patients documented more On without dyskinesia (52.3% vs. 38.9%, P < 0.001) and less On with dyskinesia (21.5% vs. 34.2%, P < 0.001), whereas proportions for Off intervals were not different between patient and observer diaries (26.2% vs. 27.0%, P = 0.97). Temporal agreement between diary ratings was unsatisfactory, particularly for On with dyskinesia. Taken together, our study suggests that the PD home diary only inadequately reflects actual motor states compared to direct clinical observation.
帕金森病（PD）家庭日记常用于临床试验，以衡量晚期PD运动波动的药物治疗效果。这项针对波动型PD患者的前瞻性研究，将日记与直接临床观察相比较，检验了日记对运动状态量化的有效性。51名患者（中位年龄：65岁，病程：11年）连续两天每半小时完成一次日记记录，同时由一名经验丰富的观察者进行评分，该观察者在白天每半小时独立评估一次运动状态。患者与观察者日记记录的总体一致性（Cohen's kappa）为59.8%（0.387）。患者记录的无异动症“开”期更多（52.3%对38.9%，P < 0.001），有异动症“开”期更少（21.5%对34.2%，P < 0.001），而患者与观察者日记中“关”期的比例没有差异（26.2%对27.0%，P = 0.97）。日记评分之间的时间一致性不令人满意，尤其是有异动症的“开”期。综上所述，我们的研究表明，与直接临床观察相比，PD家庭日记只能不充分地反映实际运动状态。
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