The study protocol, statistical analysis, informed consent form, and study data, including de-identified participant data of the main manuscript will be made available to others with publication upon formal request and receipt of a signed material transfer agreement. Requests should be directed to the corresponding author. Data will only be shared via individual secured network connections.
Zusammenfassung Aufgrund der Legalisierung von medizinischem Cannabis und Derivaten in zahlreichen Ländern gelangt diese Behandlungsoption zunehmend in die wissenschaftliche und öffentliche Debatte. Zunehmend häufig werden Behandler von Patienten mit idiopathischer Parkinson-Erkrankung mit der Frage nach Cannabis als Behandlungsalternative insbesondere bei Levodopa-resistenten Symptomen konfrontiert. Im Gegensatz zu zahlreichen positiven Einzelfallberichten und Fallserien bieten die wenigen Placebo-kontrollierten Studien nur wenige Hinweise auf eine positive Wirkung von Cannabinoiden auf Parkinson-Symptome. Lediglich in einer Arbeit konnte eine leichte Reduktion von Levodopa-induzierten Dyskinesien nachgewiesen werden, die drei anderen Arbeiten zeigen keinen Effekt auf motorische Symptome. Diese Arbeit soll einen Überblick über die Wirkungsweise von Cannabis und Forschungsergebnisse zu Cannabinoiden in der Behandlung der idiopathischen Parkinson-Erkrankung geben.
Abstract Flexible Endoscopic Evaluation of Swallowing (FEES) is one of two diagnostic gold standards for pharyngeal dysphagia in Parkinson's disease (PD), however, validated global outcome measures at the patient level are widely lacking. The Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES) represents such an outcome measure but has been validated primarily for head and neck cancer collectives. The objective of this study was, therefore, to investigate the validity of the DIGEST-FEES in patients with PD. Content validity was evaluated with a modified Delphi expert survey. Subsequently, 66 FEES videos in PD patients were scored with the DIGEST-FEES. Criterion validity was determined using Spearman's correlation coefficient between the DIGEST-FEES and the Penetration-Aspiration Scale (PAS), the Yale-Residue-Rating-Scale, the Functional-Oral-Intake-Scale (FOIS), and the swallowing-related Unified-Parkinson-Disease-Rating-Scale (UPDRS) items. Inter-rater reliability was determined using 10 randomly selected FEES-videos examined by a second rater. As a result, the overall DIGEST-FEES-rating exhibited significant correlations with the Yale-Valleculae-Residue-Scale ( r = 0.84; p < 0.001), the Yale-Pyriform-Sinus-Residue-Scale ( r = 0.70; p < 0.001), the FOIS ( r = − 0.55, p < 0.001), and the UPDRS-Swallowing-Item-Score ( r = 0.42, p < 0.001). Further, the DIGEST-FEES-safety subscore correlated with the PAS ( r = 0.63, p < 0.001). Inter-rater reliability was high for the overall DIGEST-FEES rating (quadratic weighted kappa of 0.82). Therefore, DIGEST-FEES is a valid and reliable score to evaluate overall pharyngeal dysphagia severity in PD. Nevertheless, the modified Delphi survey identified domains where DIGEST-FEES may need to be specifically adapted to PD or neurological collectives in the future.
Background . Pain is common in Parkinson’s disease (PD) and impairs quality of life. The King’s PD pain questionnaire (KPPQ) is a standardized, reliable, and valid self‐administered questionnaire for screening of pain in PD. We developed a linguistically validated German version of the KPPQ and applied it to a cohort with fluctuating PD. Methods . The interculturally adapted German translation was performed according to internationally accepted procedures in coordination with the authors of the original publication but without further psychometric validation. After final approval by all translators and original authors, the German version was then tested for feasibility and comprehension in 30 PD patients. After final adaption, the German KPPQ together with the German quantitative KPPS were applied to an independent cohort of fluctuating PD patients within the VALIDATE‐PD study. Results . The use of the German version of the KPPQ in clinical practice or in the VALIDATE‐PD study revealed no significant problems of understanding. Sufficient datasets were available from 47 patients with motor fluctuations (24 (51%) males, 23 (49%) females; median (interquartile range (IQR)) age: 65 (58‐73) years; median (IQR) Hoehn and Yahr stage: 2.5 [2‐3]). Total pain was reported by 43 (92%) of participants with a median number of 4 (IQR: 2‐5) pain subtypes. We did not observe any associations of total pain frequency, neither with gender nor with other demographic or clinical parameters. Conclusions . The German version of the KPPQ is recommended as a questionnaire for assessing the frequency of pain and its subtypes in PD in clinical studies and/or routine care.
Sexual dysfunctions (SD) are common but underreported in Parkinson's disease (PD) and have negative impacts on the quality of life (QoL) and partnership.We analyzed the data set from the PRISM study for demographics of SD and their influence on quality of life and partnership.449/861 (52.1%) PD patients reported SD, with male patients being affected more often and having a longer course of disease. The most common SD in men was erectile dysfunction (ED) (n = 152), while women's most frequent complaints were orgasm dysfunction (n = 84) and reduced libido (n = 81). Hypersexual SDs were reported significantly more often by men. Spousal caregivers of patients reporting inability to relax and enjoy sex and reduced libido indicated a negative influence on the relationship in general. Negative effects on the sexual relationship were reported significantly more often for patients with ED, difficulties with sexual arousal, inability to relax and enjoy sex, and reduced libido. Hypersexual dysfunctions showed no effect on the relationship.SD is a common but underreported problem in the treatment of patients with PD. Due to the negative influence on the relationship and QoL of patients and caregivers, SD should be assessed routinely.
Objectives. Recent studies showed only fair agreement between observer and patients’ motor state assessments on the Parkinson’s disease (PD) home diary (HD). This could possibly be explained by the patients’ insufficient knowledge about motor fluctuations. Therefore, the study is aimed at investigating the effect of structured training concerning motor fluctuations on the agreement between observer and HD ratings and daily motor state times. Methods. Participants from a previous validation study of the HD were invited back for a study extension. This interventional study consisted of a screening visit including a structured training concerning motor fluctuations and one day of motor ratings onsite during which observer and patient simultaneously and independently evaluated the patient’s motor state every half hour. Results. Observer and 20 patients completed 316 pairs of motor state assessments. The overall agreement was 68% before training and 76% after training ( ) and Cohen’s κ increased from .438 to .559 ( ). There was no significant improvement in the correlation/reliability of HD-documented daily motor state time when compared with observer ratings. Moreover, before training, the agreement in observed “on with dyskinesias” was 58%, and after training, it was 80% ( ). Conclusion. Our structured patient training in motor fluctuations did not significantly improve the agreement between observer and HD or the reliability of daily times spent in the different motor states as an aggregate measure of HD in this PD patient group. However, there are indications of an improvement in the participants’ ability to detect dyskinesias.
