Sleep Problems Are Related to a Worse Quality of Life and a Greater Non-Motor Symptoms Burden in Parkinson's Disease.

INTRODUCTION: The aim of the present study was to examine the frequency of self-reported sleep problems and their associated factors in a large cohort of PD patients. METHODS: PD patients and controls, recruited from 35 centers of Spain from the COPPADIS cohort were included in this cross-sectional study. Sleep problems were assessed by the Spanish version of the Parkinson's disease Sleep Scale version 1 (PDSS-1). An overall score below 82 or a score below 5 on at least 1 item was defined as sleep problems. RESULTS: The frequency of sleep problems was nearly double in PD patients compared to controls: 65.8% (448/681) vs 33.5% (65/206) (p < 0.0001). Mean total PDSS score was lower in PD patients than controls: 114.9 ± 28.8 vs 132.8 ± 16.3 (p < 0.0001). Quality of life (QoL) was worse in PD patients with sleep problems compared to those without: PDQ-39SI, 19.3 ± 14 vs 13 ± 11.6 (p < 0.0001); EUROHIS-QoL8, 3.7 ± 0.5 vs 3.9 ± 0.5 (p < 0.0001). Non-motor symptoms burden (NMSS; OR = 1.029; 95%CI 1.015-1.043; p < 0.0001) and impulse control behaviors (QUIP-RS; OR = 1.054; 95%CI 1.009-1.101; p = 0.018) were associated with sleep problems after adjustment for age, gender, disease duration, daily equivalent levodopa dose, H&Y, UPDRS-III, UPDRS-IV, PD-CRS, BDI-II, NPI, VAS-Pain, VAFS, FOGQ, and total number of non-antiparkinsonian treatments. CONCLUSION: Sleep problems were frequent in PD patients and were related to both a worse QoL and a greater non-motor symptoms burden in PD. These findings call for increased awareness of sleep problems in PD patients.

Tolerability of non-ergot oral and transdermal dopamine agonists in younger and older Parkinson's disease patients: an European multicentre survey.

In older patients with Parkinson's disease (PD), the use of dopamine agonists (DA) has been limited due to uncertainties related to their tolerability in spite of potential gains with the advent of longer acting or transdermal therapies. Comparative real-life data addressing the tolerability of DA therapy across age ranges are currently sparse. This study addressed the tolerability (Shulman criteria, continued intake of DA therapy for at least 6 months) in PD patients across several European centres treated with long-acting and transdermal DA (Rotigotine skin patch, Ropinirole extended release, or Pramipexole prolonged release) as part of routine clinical care in younger and older PD patients. A medical record-based retrospective data capture and clinical interview-based follow-up survey of patients initiating or initiated on DA treatment (short and long acting) in a real-life setting. 425 cases were included [mean age 68.3 years (range 37-90), mean duration of disease 7.5 years (range 0-37), 31.5% older age (≥ 75 years of age)]. Tolerability was above 90% irrespective of age, with no significant differences between younger and older patients. Based on our findings, we suggest that long-acting/transdermal DA are tolerated in non-demented older patients, as well as in younger patients, however, with lower daily dose in older patients.

Impulse control and related behaviors in Parkinson's disease with dementia.

BACKGROUND AND PURPOSE: The objective was to determine the frequency, demographic and clinical correlates [such as age, sex, Parkinson's disease (PD) severity and dopaminergic treatment] of impulse control disorder (ICD) symptoms and related behaviors in patients with PD with (PD-D) and without (PD-ND) dementia. METHODS: We analyzed historical data from a national, multi-center, cross-sectional database and assessed ICDs and related behaviors with the Scale for Evaluation of Neuropsychiatric Disorders in Parkinson's Disease administered as a semi-structured interview to patients with PD-D (n = 85) and PD-ND (n = 444) and their informants. RESULTS: Dopamine agonist therapy use was common and similar in the two groups (78.8% in PD-D vs. 82.9% in PD-ND), but ICDs (23.5% vs. 13.3%, P = 0.02), hobbyism-punding (32.9% vs. 10.6%, P < 0.001) and dopaminergic medication abuse (8.2% vs. 3.2%, P = 0.03) were more common in the PD-D group. CONCLUSIONS: The finding that ICDs and related behaviors are more common in patients with PD frequently treated with dopamine agonists who also have comorbid dementia suggests that the neural substrates associated with PD dementia may also predispose to development of compulsive behaviors.

Non-motor symptom burden is strongly correlated to motor complications in patients with Parkinson's disease.

BACKGROUND AND PURPOSE: The objective of this study was to analyze the relationship between motor complications and non-motor symptom (NMS) burden in a population of patients with Parkinson's disease (PD) and also in a subgroup of patients with early PD. METHODS: Patients with PD from the COPPADIS cohort were included in this cross-sectional study. NMS burden was defined according to the Non-Motor Symptoms Scale (NMSS) total score. Unified Parkinson's Disease Rating Scale (UPDRS) part IV was used to establish motor complication types and their severity. Patients with ≤5 years of symptoms from onset were included as patients with early PD. RESULTS: Of 690 patients with PD (62.6 ± 8.9 years old, 60.1% males), 33.9% and 18.1% presented motor fluctuations and dyskinesia, respectively. The NMS total score was higher in patients with motor fluctuations (59.2 ± 43.1 vs. 38.3 ± 33.1; P < 0.0001) and dyskinesia (63.5 ± 40.7 vs. 41.4 ± 36.3; P < 0.0001). In a multiple linear regression model and after adjustment for age, sex, disease duration, Hoehn & Yahr stage, UPDRS-III score and levodopa equivalent daily dose, UPDRS-IV score was significantly related to a higher NMSS total score (ß = 0.27; 95% confidence intervals, 2.81-5.61; P < 0.0001), as it was in a logistic regression model on dichotomous NMSS total score (≤40, mild or moderate vs. >40, severe or very severe) (odds ratio, 1.31; 95% confidence intervals, 1.17-1.47; P < 0.0001). In the subgroup of patients with early PD (n = 396; mean disease duration 2.7 ± 1.5 years), motor fluctuations were frequent (18.1%) and similar results were obtained. CONCLUSIONS: Motor complications were frequent and were associated with a greater NMS burden in patients with PD even during the first 5 years of disease duration.

Discussing sexuality with Parkinson's disease patients: a multinational survey among neurologists.

Sexual dysfunction is a major non-motor feature of Parkinson's disease (PD) that may affect the quality of life of many patients. In a Dutch survey, we demonstrated that neurologists often fail to discuss sexuality with their patients. Our objective was to determine to which extent neurologists in Spain and Germany address sexuality with their patients and whether cross-cultural differences exist. A 30-item questionnaire was sent out to 1650 German and 460 Spanish neurologists. The questionnaire addressed attitudes, knowledge, barriers, and feelings of responsibility regarding sexuality in PD. 160 German and 32 Spanish respondents completed and returned the questionnaire. The majority of German and Spanish participants discuss sexual dysfunction 'regularly' with male patients (61.7% and 78.9%, respectively), but 'seldom' with female patients (68.8% and 78.1%, respectively). Important barriers for German and Spanish respondents to discuss sexual dysfunction were patients not expressing sexual complaints spontaneously (52.9% and 75.0%, respectively) and insufficient consultation time (32.2% and 71.9%, respectively). Sexual dysfunction in PD was considered important by 68.3% of German and 96.9% of Spanish participants. German and Spanish neurologists do not routinely discuss sexual dysfunction with their patients, although many of them consider it important to address this topic. It is unclear why this lack of discussing sexual dysfunction is especially found for female patients and whether cultural aspects are involved. We recommend a self-assessment tool for patients to track their symptoms prior to consultation visits and advocate local guidelines that formulate who is responsible for discussing sexual dysfunction.

High ultrasensitive serum C-reactive protein may be related to freezing of gait in Parkinson's disease patients.

C-reactive protein (CRP) is a biomarker of systemic inflammation that has been linked to accelerated decline in walking speed in older adults. The aim of the present study was to compare the CRP levels of PD patients with vs patients without freezing of gait (FOG). Patients and controls participating in the COPPADIS-2015 study that performed blood extraction for determining molecular serum biomarkers were included. Patients with FOG were identified as those with a score of 1 or greater on item-3 of the Freezing of Gait Questionnaire (FOG-Q). Immunoassay was used for determining ultrasensitive CRP (US-CRP) level (mg/dL). In the PD group (n = 225; 61.8 ± 9.5 years old, 61.8% males), 32% of the patients presented FOG but none in the control group (n = 65; 60.3 ± 6.1 years old, 56.9% males) (p < 0.0001). Differences in US-CRP level were significant in patients with FOG vs patients without FOG and vs controls (0.31 ± 0.52 vs 0.16 ± 0.21 vs 0.21 ± 0.22; p = 0.04). Significant differences were also observed between patients with vs without FOG (p = 0.001) but not between patients and controls (p = 0.163). US-CRP level was related to FOG (OR = 4.369; 95% CI 1.105-17.275; p = 0.036) along with H&Y (OR = 2.974; 95% CI 1.113-7.943; p = 0.030) and non-motor symptoms burden (NMSS total score; OR = 1.017; 95% CI 1.005-1.029; p = 0.006) after adjusting for age, gender, disease duration, equivalent daily levodopa dose, number of non-antiparkinsonian drugs per day, motor fluctuations, cognition, motor phenotype, and chronic use of anti-inflammatory drugs. The present study suggests that serum US-CRP level is related to FOG in PD patients. Inflammation could be linked to FOG development.

Extensive validation study of the Parkinson's Disease Composite Scale.

BACKGROUND AND PURPOSE: A composite instrument able to rapidly and reliably assess the most relevant motor and non-motor afflictions suffered by Parkinson's disease (PD) patients in a real world clinic setting is an unmet need. The recently validated PD Composite Scale (PDCS) was designed to fulfil this gap as a quick, comprehensive PD assessment. The objective of this study was extensive evaluation of the PDCS's clinimetric properties using a large international sample. METHODS: This was a cross-sectional study in which the PDCS, the Movement Disorder Society Unified Parkinson's Disease Rating Scale and the Clinical Impression of Severity Index for PD were applied. Basic clinimetric attributes of the PDCS were analysed. RESULTS: In total, 776 PD patients were included. The PDCS total score showed negligible floor and ceiling effects. Three factors (54.5% of the variance) were identified: factor 1 included motor impairment, fluctuations and disability; factor 2, non-motor symptoms; and factor 3, tremor and complications of therapy. Cronbach's alpha was from 0.66 to 0.79. Inter-rater reliability showed weighted kappa values from 0.79 to 0.98 for items and intraclass correlation coefficient values from 0.95 (Disability) to 0.99 (Motor and total score). The Bland-Altmann method, however, showed irregular concordance. PDCS standard error of measurement and convergent validity with equivalent constructs of other measures were satisfactory (≥0.70). PDCS scores significantly differed by Hoehn and Yahr stage. CONCLUSION: Overall, in line with previous findings, the PDCS is a feasible, acceptable, valid, reliable and precise instrument for quickly and comprehensively assessing PD patients.

COPPADIS-2015 (COhort of Patients with PArkinson's DIsease in Spain, 2015): an ongoing global Parkinson's disease project about disease progression with more than 1000 subjects included. Results from the baseline evaluation.

BACKGROUND AND PURPOSE: In Parkinson's disease (PD), the course of the disorder is highly variable between patients. Well-designed, prospective studies for identifying PD progression biomarkers are necessary. Our aim was to show the results of baseline evaluations of an ongoing global PD project, COPPADIS-2015 (Cohort of Patients with PArkinson's DIsease in Spain, 2015). METHODS: This was an observational, descriptive, nationwide study (Spain). The recruitment period ended in October 2017. Baseline evaluation included more than 15 validated scales and complementary studies in a subgroup of participants. RESULTS: In total, 1174 subjects from 35 centres were considered valid for baseline analysis: 694 patients (62.6 ± 8.9 years old, 60.3% males), 273 caregivers (58.5 ± 11.9 years old, 31.8% males) and 207 controls (61 ± 8.3 years old, 49.5% males). The mean disease duration was 5.5 ± 4.4 years. Hoehn and Yahr stage was 1 or 2 in 90.7% of the patients whilst 33.9% and 18.1% of them presented motor fluctuations and dyskinesias, respectively. The mean Non-Motor Symptoms Scale total score was 45.4 ± 38.1, and 30.4% of the patients presented cognitive impairment, 16.1% major depression, 12.7% impulse control disorder, 7.2% compulsive behaviour, 57.2% pain and 13.2% falls. Compared to the control group, PD patients presented a significantly higher burden of non-motor symptoms and a worse quality of life. More than 300 subjects conducted complementary studies (serum biomarkers, genetic and neuroimaging). CONCLUSIONS: Parkinson's disease is a complex disorder and different non-motor symptoms are frequently present and are more prevalent than in controls. In real clinical practice it is important to ask for them.

The Parkinson's Disease Composite Scale: results of the first validation study.

BACKGROUND AND PURPOSE: The aim was to validate the Parkinson's Disease Composite Scale (PDCS). METHODS: The study included 194 Parkinson's disease (PD) patients in five countries. Investigators completed the following scales: PDCS, the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Sleep Scale Version 2, Montreal Cognitive Assessment, the Scale for Evaluation of Neuropsychiatric Disorders in Parkinson's Disease and the Clinical Impression of Severity Index for PD (CISI-PD). For test-retest analysis, a second administration of the PDCS was carried out in 61 stable patients (as per the CISI-PD) in 7-14 days after the first evaluation. The PDCS is a novel scale for PD with a total of 17 items divided into four domains: motor, non-motor, treatment complications and disability. RESULTS: Parkinson's Disease Composite Scale mean and median values were close. Skewness values were into the criterion limits (-1 to +1). The complete range of scores was covered for 14 of the 17 items (83.4%). A floor effect of 25.26% and 28.25% was observed in the complications and disability level dimensions due to the proportion of patients free of these difficulties. No relevant floor or ceiling effect was observed for the PDCS total score (1.03% and 0.52%, respectively). The stability of the scale appeared excellent with most items meeting weighted kappa and intraclass correlation coefficient values >0.80. The convergent validity of the PDCS with corresponding scores of the MDS-UPDRS showed high correlation values (rS  ≥ 0.60). The internal validity was into acceptable limits, with the majority of values higher than the minimal 0.30 threshold. The standard error of measurement suggested a satisfactory precision (SEM 3.81, <30% of the PDCS total score standard deviation). CONCLUSION: The PDCS appears to be a feasible, acceptable, reproducible and valid scale.

Pain in Parkinson's disease: facts and uncertainties.

Pain is one of the most common and troublesome non-motor symptoms of Parkinson's disease (PD). It can appear at any time during the disease and is often present before diagnosis. However, there is little or no consensus on its definition. An expert group of clinicians with relevant research experience met to review the existing evidence and to identify gaps in our understanding leading towards AUTHOR: 'understanding towards' has been changed to 'understanding leading towards'. Please check and confirm that this is appropriate an optimized therapy of pain in PD. Key findings from epidemiologic, neurophysiologic, neuroimaging and clinical studies are reviewed. In each case, the evidence base is limited by wide variations in the definitions of pain applied, study methodologies and populations evaluated. Disease-related and medical conditions trigger spontaneous pain in patients with PD, which is then abnormally processed and results in painful manifestations in specific body parts. Dopaminergic medications, such as rotigotine, as well as opiate analgesics, such as oxycodone, have shown positive results but future studies with more detailed pain characterization at inclusion are warranted.

First comprehensive tool for screening pain in Parkinson's disease: the King's Parkinson's Disease Pain Questionnaire.

BACKGROUND AND PURPOSE: Pain is highly prevalent in Parkinson's disease (PD), impacting patients' ability, mood and quality of life. Detecting the presence of pain in its multiple modalities is necessary for adequate personalized management of PD. A 14-item, PD-specific, patient-based questionnaire (the King's Parkinson's Disease Pain Questionnaire, KPPQ) was designed corresponding to the rater-based KPP Scale (KPPS). The present multicentre study was aimed at testing the validity of this screening tool. METHODS: First, a comparison between the KPPQ scores of patients and matched controls was performed. Next, convergent validity, reproducibility (test-retest) and diagnostic performance of the questionnaire were analysed. RESULTS: Data from 300 patients and 150 controls are reported. PD patients declared significantly more pain symptoms than controls (3.96 ± 2.56 vs. 2.17 ± 1.39; P < 0.0001). The KPPQ convergent validity was high with KPPS total score (rS  = 0.80) but weak or moderate with other pain assessments. Test-retest reliability was satisfactory with kappa values ≥0.65 except for item 5, Dyskinetic pains (κ = 0.44), and the intraclass correlation coefficient (ICC) for the KPPQ total score was 0.98. After the scores of the KPPS were adapted for screening (0, no symptom; ≥1, symptom present), a good agreement was found between the KPPQ and the KPPS (ICC = 0.88). A strong correlation (rS  = 0.80) between the two instruments was found. The diagnostic parameters of the KPPQ were very satisfactory as a whole, with a global accuracy of 78.3%-98.3%. CONCLUSIONS: These results suggest that the KPPQ is a useful, reliable and valid screening instrument for pain in PD to advance patient-related outcomes.

Night-time sleep in Parkinson's disease - the potential use of Parkinson's KinetiGraph: a prospective comparative study.

BACKGROUND AND PURPOSE: Night-time sleep disturbances are important non-motor symptoms and key determinants of health-related quality of life (HRQoL) in patients with Parkinson's disease (PD). The Parkinson's KinetiGraph (PKG) can be used as an objective measure of different motor states and periods of immobility may reflect episodes of sleep. Our aim was to evaluate whether PKG can be used as an objective marker of disturbed night-time sleep in PD. METHODS: In this prospective comparative study, data from PKG recordings over six consecutive 24 h periods are compared with Hauser diaries and scales focusing on motor state, sleep and HRQoL in PD patients. Thirty-three 'non-sleepy' PD patients (PD-NS) were compared with 30 PD patients presenting with excessive daytime sleepiness (PD-EDS). The groups were matched for age, gender and Hoehn and Yahr state. RESULTS: In the PD-EDS group subjective sleep reports correlated with the PKG's parameters for quantity and quality night-time sleep, but not in the PD-NS group. There were no significant correlations of the night-time sleep quantity parameters of the Hauser diary with subjective sleep perception, neither in the PD-EDS nor in the PD-NS group. CONCLUSIONS: This first PKG based study of night-time sleep in PD suggests that PKG could be used to provide an easy to use and rough evaluation of aspects of night-time sleep and one that could flag patients where polysomnography may be required. In sleepy PD patients for instance, quantity and quality PKG parameters correlate with different aspects of sleep such as insomnia, parasomnia and restless legs syndrome.

A European multicentre survey of impulse control behaviours in Parkinson's disease patients treated with short- and long-acting dopamine agonists.

BACKGROUND AND PURPOSE: Impulse control disorders (ICDs) in Parkinson's disease (PD) are associated primarily with dopamine agonist (DA) use. Comparative surveys of clinical occurrence of impulse control behaviours on longer acting/transdermal DA therapy across age ranges are lacking. The aim of this study was to assess the occurrence of ICDs in PD patients across several European centres treated with short- or long-acting [ropinirole (ROP); pramipexole (PPX)] and transdermal [rotigotine skin patch (RTG)] DAs, based on clinical survey as part of routine clinical care. METHODS: A survey based on medical records and clinical interviews of patients initiating or initiated on DA treatment (both short- and long-acting, and transdermal) across a broad range of disease stages and age groups was performed. RESULTS: Four hundred and twenty-five cases were included [mean age 68.3 years (range 37-90), mean duration of disease 7.5 years (range 0-37)]. ICD frequencies (as assessed by clinical interview) were significantly lower with RTG (4.9%; P < 0.05) compared with any other assessed DAs except for prolonged release PPX (PPX-PR). The rate of ICDs for PPX-PR (6.6%) was significantly lower than for immediate release PPX (PPX-IR) (19.0%; P < 0.05). Discontinuation rates of DA therapy due to ICDs were low. CONCLUSION: Our data suggest a relatively low rate of ICDs with long-acting or transdermal DAs, however these preliminary observational data need to be confirmed with prospective studies controlling for possible confounding factors.

Improvement of dyskinesias with L-dopa infusion in advanced Parkinson's disease.

OBJECTIVES: We wanted to investigate whether continuous intrajejunal levodopa-carbidopa intestinal gel (LCIG) therapy has an antidyskinetic effect in patients with Parkinson's disease (PD) and troublesome dyskinesias. We also sought to examine the effect of LCIG therapy on motor function and health-related quality of life (HRQoL). MATERIALS AND METHODS: This open-label pilot study used a single group pre-post design with follow-up at 6 months. Nine patients with PD who reported to spend at least 3 h per day in on with troublesome dyskinesia were included. The patients were examined at baseline using clinical and self-assessment measures and then switched from peroral/transdermal pharmacotherapy to LCIG therapy. Data collection was repeated 6 months after the pharmaceutical intervention. Nonparametric statistical methods were used for data analyses. RESULTS: The mean time spent in on with troublesome dyskinesia per day after 6 months of LCIG therapy decreased by 47% (P < 0.05). This observation was paralleled by a 112% increase in mean time spent in on without troublesome dyskinesia (P < 0.01). Patient self-assessment of dyskinesia intensity on the visual analog scale displayed a 90% reduction of mean dyskinesia intensity (P < 0.01) and patients also exhibited less dyskinesia during standardized levodopa tests. Furthermore, we noted improvements in motor function and HRQoL. CONCLUSIONS: In this pilot study, we found indications that LCIG therapy has a substantial antidyskinetic effect and could be an alternative also for PD patients with dyskinesias as a major symptom. However, further studies with blinded evaluation and larger numbers of patients are warranted to confirm the findings.

Assessing health-related quality of life with the SCOPA-PS in French individuals with Parkinson's disease having undergone DBS-STN: A validation study.

INTRODUCTION: The aims of this study were to validate the French version of the SCales for Outcomes in Parkinson's Disease-PsychoSocial (SCOPA-PS) in individuals with Parkinson's disease (PD) who underwent deep brain stimulation of the subthalamic nucleus (DBS-STN), to confirm the unifactorial structure of this questionnaire, and to establish its psychometric properties. METHODS: Routinely used psychological questionnaires (BDI-II, STAI-Y, PDQ-39, UPDRS III) and the SCOPA-PS were used for a cross-sectional observational study of 154 PD patients. SCOPA-PS acceptability, scaling assumption, reliability, ordinal confirmatory factor analysis and validity were assessed. RESULTS: The ICC for two-week test-retest reliability was 0.88. SEM was 8.42. In confirmatory factor analysis, the one-factor model showed an acceptable fit to the data (Chi(2)/df=2.130; CFI=0.976; RMSEA=0.086). No floor or ceiling effects were observed. Skewness was 0.33. Item-total correlation coefficients ranged from 0.47 to 0.71. Cronbach's alpha was 0.86. SCOPA-PS SI correlated with PDQ-39 SI (rs=0.83) and with state-anxiety and depression (rs=0.56 and 0.69 respectively). The SCOPA-PS SI was higher in more depressed patients and in those with the most severe PD motor symptoms. CONCLUSION AND DISCUSSION: SCOPA-PS French version is a one-factor scale with satisfactory psychometric properties consistent with other language versions. This short scale can be used to evaluate the psychosocial component of QoL in PD patients treated with DBS-STN.

[German Translation and Validation of the Scale for Evaluation of Neuropsychiatric Disorders in Parkinson's disease (SEND-PD)]. / Deutsche Übersetzung und Validierung der Checkliste zur Erfassung neuropsychiatrischer Störungen bei Parkinsonerkrankung (CENS-PE).

OBJECTIVE: The aim of the present study was to validate and provide a German version of the Scale for Evaluation of Neuropsychiatric Disorders in Parkinson's disease (SEND-PD) of Martínez-Martín et al. (2012). METHOD: The German version of the SEND-PD was evaluated in a sample consisting of 96 patients with Parkinson's disease (PD) (mean age: 65.3 years ±â€Š9.6, 29 female). This scale includes 12 items, representing the domains psychotic symptoms, mood/apathy and impulse control disorders. Reliability and validity analyses were conducted. RESULTS: The examined patients presented a few neuropsychiatric symptoms. Explorative factor analyses identified the proposed three dimensions solution. The items of the mood/apathy domain were homogenous and selective, and the domain showed acceptable internal consistency. For the other two domains, the values were only partially acceptable. Convergent, discriminate and construct validity were shown. CONCLUSION: The German version of the SEND-PD is sufficiently reliable and valid to be adopted in German speaking countries. However, since patients showed only a few symptoms in the dimensions of psychotic symptoms and impulse control disorders, these two domains can be evaluated only to a limited extent.

King's Parkinson's disease pain scale, the first scale for pain in PD: An international validation.

Pain is a key unmet need and a major aspect of non-motor symptoms of Parkinson's disease (PD). No specific validated scales exist to identify and grade the various types of pain in PD. We report an international, cross-sectional, open, multicenter, one-point-in-time evaluation with retest study of the first PD-specific pain scale, the King's PD Pain Scale. Its seven domains include 14 items, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a subscore of 0 to 12, with a total possible score range from 0 to 168. One hundred seventy-eight PD patients with otherwise unexplained pain (age [mean ± SD], 64.38 ± 11.38 y [range, 29-85]; 62.92% male; duration of disease, 5.40 ± 4.93 y) and 83 nonspousal non-PD controls, matched by age (64.25 ± 11.10 y) and sex (61.45% males) were studied. No missing data were noted, and floor effect was observed in all domains. The difference between mean and median King's PD Pain Scale total score was less than 10% of the maximum observed value. Skewness was marginally high (1.48 for patients). Factor analysis showed four factors in the King's PD Pain Scale, explaining 57% of the variance (Kaiser-Mayer-Olkin, 0.73; sphericity test). Cronbach's alpha was 0.78, item-total correlation mean value 0.40, and item homogeneity 0.22. Correlation coefficients of the King's PD Pain Scale domains and total score with other pain measures were high. Correlation with the Scale for Outcomes in PD-Motor, Non-Motor Symptoms Scale total score, and quality of life measures was high. The King's PD Pain Scale seems to be a reliable and valid scale for grade rating of various types of pain in PD.

Non-motor symptoms burden in treated and untreated early Parkinson's disease patients: argument for non-motor subtypes.

BACKGROUND AND PURPOSE: Non-motor symptoms (NMSs) occurring at an early stage of Parkinson's disease (PD) may impair quality of life more than motor symptoms. This study aimed to evaluate the severity of overall NMS profile and burden of NMSs in early PD patients, treated (time since confirmed diagnosis of 5 years or less) or drug naive (DN). METHODS: Cross-sectional data from an ongoing multicentre study (16 sites) were obtained and specifically an NMS data set from validated scales was analysed in treated and DN PD patients. RESULTS: A full data set was available in 234 unique early PD patients. Of them, there were 170 treated (63.5% males, mean age 68.2 years) and 64DN patients (64.1% males, mean age 66.5 years). Compared to DN patients the time since confirmed diagnosis was significantly longer in treated PD patients (1.9 years vs. 3.7 years, P < 0.001). Fatigue (57.7%), urinary urgency (57.1%), nocturia (55.3%), memory difficulties (51.2%) and urinary frequency (48.8%) were the most prevalent NMSs amongst treated PD, whereas DN PD reported most frequently sadness (57.8%), fatigue (57.8%), lightheadedness (53.1%), memory difficulties (48.4%) and urinary urgency (46.9%). CONCLUSIONS: Our results suggest that NMSs are dominant in the untreated and early phase of PD causing a considerable burden. This warrants investigation of the issue of NMS subtyping within PD.

Assessing the non-motor symptoms of Parkinson's disease: MDS-UPDRS and NMS Scale.

BACKGROUND AND PURPOSE: Although Parkinson's disease (PD) is characterized by typical motor manifestations, non-motor symptoms (NMS) are an outstanding part of the disease. At present, several specific instruments for assessment of NMS are available. The objective of our study was to determine the performance of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I - Non-Motor Aspects of Experiences of Daily Living (nM-EDL) compared with the Non-Motor Symptoms Scale (NMSS). METHODS: To this purpose, 434 consecutive patients with PD were included in an international, observational, cross-sectional study. The association between scores of both scales was determined by the Spearman rank correlation coefficient. Equations for transformation of total score of a scale to the other were constructed from weighted regression models and both, transformed and observed score, contrasted by means of the Lin's Concordance Correlation Coefficient (LCCC) and Bland-Altman plot. RESULTS: As a whole, the prevalence of the NMS according to each scale was quite similar, and most of the correlations between their corresponding components were high (r(S) > 0.60). The total score correlation of the MDS-UPDRS Part I with the NMSS was high (r(S) = 0.81). Concerning the transformed scores, estimated scores only partially approach the observed ones (sharing about 60-64% of the variance) because residual variance increased with increasing magnitudes of the scores, i.e. the most severe patients (Bland-Altman plot; LCCC < 0.60 for severe patients). CONCLUSIONS: (i) MDS-UPDRS Part I (nM-EDL) and NMSS showed a strong convergent validity; (ii) however, transformed scores using the equations from weighted regression models showed that for patients with the most severe NMS they are not concordant.

Relationship between the MDS-UPDRS domains and the health-related quality of life of Parkinson's disease patients.

BACKGROUND AND PURPOSE: The Movement Disorder Society sponsored version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive instrument for assessing Parkinson's disease (PD). The present study was aimed at determining the relationships between MDS-UPDRS components and health-related quality of life (HRQoL) evaluations in PD patients. METHODS: An international, multicenter, cross-sectional study was carried out of 435 PD patients assessed with the MDS-UPDRS, Hoehn and Yahr (HY), Clinical Impression Severity for PD, EQ-5D and PD Questionnaire - eight items (PDQ-8). Spearman's rank correlation coefficients, exploratory factor analysis and multiple linear regression models (dependent variables EQ-5D and PDQ-8) were performed. RESULTS: The participants' age was 66.71 ± 10.32 years (51.5% men). PD duration was 8.52 ± 6.14, and median HY was 2 (range 1-5). The correlation between the EQ-5D index and the MDS-UPDRS ranged from -0.46 (Part IV) to -0.72 (Part II) and for the PDQ-8 index from 0.47 (Part III) to 0.74 (Part II). In multiple regression models with the MDS-UPDRS domains as independent variables, the main determinant for both the EQ-5D index and the PDQ-8 was Part II followed by Part I. After factorial grouping of the cardinal PD manifestations embedded in the MDS-UPDRS Parts III and IV for inclusion into multiple regression models, a factor formed by M-EDL, nM-EDL and fluctuations was the main determinant for both the EQ-5D and PDQ-8 indexes. CONCLUSIONS: The MDS-UPDRS component most tightly related with the HRQoL measures was a combination of motor and non-motor experiences of daily living.