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Parkinson's disease (PD) is the second most common neurodegenerative disorder, and the condition is complicated by the emergence of wearing off/motor fluctuations with levodopa treatment after a variable period. COMT inhibitors when used as adjunct therapy to levodopa tend to smoothen out these wearing off fluctuations by enhancing delivery of levodopa and increasing its bioavailability to the brain. The study was conducted to investigate the motor and nonmotor effect, safety and tolerability of the third generation once-daily COMT inhibitor (opicapone), as add-on, adjuvant therapy to levodopa and at 6 and 12 months follow-up in a real-life cohort of consecutive Emirati and non-White PD patients. A real-life observational analysis using tolerability parameters as used previously by Rizos et al. and Shulman et al. based on clinical database of cases rat Kings College Hospital Dubai Parkinson care database. This was a prospective, single-arm follow-up clinical evaluation study that evaluated the effectiveness of opicapone 50 mg once-daily regime in 50 patients diagnosed with idiopathic neurodegenerative disorder. All patients were assessed with scales used in clinical pathway and include motor Unified Parkinson's Disease Rating Scale (UPDRS), nonmotor symptom scale (NMSS), quality of life (PDQ8) Parkinson's fatigue scale (PFS16) and King's Parkinson's Pain Scale (KIPS). Out of 50 patients treated with opicapone (72% male, mean age 66.9 years (SD 9.9, range 41-82 years) and mean duration of disease 5.7 years (SD 2.5 range (2-11), there was significant statistical improvements shown in motor function-UPDRS part 3: baseline 40.64 ± 2.7, at 6 months 32.12 ± 3.14 and after 12 months 33.72 ± 3.76. Nonmotor burden NMSS: 107.00 ± 21.86, at 6 months 100.78 ± 17.28 and 12 months 96.88 ± 16.11. Reduction in dyskinesias (UPDRS part 4): baseline 8.78 ± 1.07, at 6 months 7.4 ± 0.81 and 12 months 6.82 ± 0.75. Opicapone provides beneficial motor and nonmotor effects in Emirati and other non-White Parkinson's patients, resident in UAE, proving its efficacy across different racial groups as COMT activity may vary between races., (© 2023. Crown.)

Advanced Parkinson's Disease (APD) is complicated by the emergence of motor and non-motor fluctuations, which are initially predictable and eventually become unpredictable, in part due to erratic gastric absorption and short half of oral levodopa. Attempts to manage such fluctuations with oral dopaminergic drugs often lead to disabling dyskinesias. Continuous Subcutaneous Apomorphine Infusion (CSAI), despite being approved for the treatment of APD since 1993, was approved in India only in 2019. We studied the safety, tolerability and efficacy of CSAI in Indian patients with APD in a registry design to raise local awareness of this important treatment. We conducted a prospective registry-based observational audit at 10 centers across different states of India. Patients with APD, not responding to or with significant side effects from oral dopaminergic therapy, were assessed at baseline and at month 6 and 12 following CSAI infusion. Fifty-one patients completed the study, CSAI significantly reduced the functional impact of dyskinesia (p < 0.01 at 6 months and p < 0.001 at 12 months). There was a significant improvement in the OFF-state from baseline (p < 0.01 at 6 months and p < 0.001 at 12 months) No discernible side effects were observed apart from mild site reaction (n = 7), nausea (n = 7) skin nodules (n = 2). CSAI demonstrated safety, efficacy, tolerability and improved quality of life in patients with APD, as shown in previous studies. Our study highlighted current existing inequalities in treatment availability, lack of awareness, knowledge gap, affordability and cost remains a concern regarding apomorphine use in Indian PD population., (© 2023. Crown.)

Objective: To evaluate the long-term, real-life effects on non-motor symptoms (NMS) of opicapone compared to entacapone in levodopa-treated people with Parkinson's disease (PwP)., Methods: A retrospective data analysis, with pre- and post-opicapone initiation data of 17 PwP with motor fluctuations compared to a comparable group of 18 PwP introduced on entacapone. The primary outcome was changes in the NMS Scale (NMSS) total score after 1-year follow-up. Secondary outcomes included changes in the NMSS domains, and Parkinson's Disease Sleep Scale (PDSS) total and item scores after the same time span., Results: Groups were comparable for baseline demographics and Parkinson's-related features (p ≥ 0.314) as well as duration of follow-up (1.33 ± 0.66 years for PwP on opicapone and 1.23 ± 0.49 years for those on entacapone; p = 0.858). PwP who were introduced on opicapone showed no changes in NMSS and PDSS total scores after 1 year (p = 0.605 and p = 0.507, respectively), whereas PwP who were introduced on entacapone showed significant worsening of NMSS and PDSS total scores at follow-up (p = 0.005 and p = 0.001, respectively). In neither group changes in individual NMSS domains from baseline to follow-up were observed (p ≥ 0.288 for entacapone and p ≥ 0.816 for opicapone, respectively). In PwP on entacapone significant worsening was seen in the distressing dreams, hallucinations, and limb numbness items of the PDSS (p ≤ 0.05)., Conclusions: Introduction of opicapone in real-life PwP with motor fluctuations seems to stabilise NMS burden and aspects of sleep dysfunction, in contrast to entacapone where there was a worsening of NMS burden and PDSS scores over 1 year follow-up., (© 2023. The Author(s).)

Aim: To analyze the responsiveness and interpretability of the Living with Chronic Illness Scale in patients with Parkinson's disease (LW-CI-PD)., Methods: Longitudinal, international study, with a convenience sample of 153 PD Spanish and Latin-American patients assessed at baseline and one year later. The LW-CI-PD and other clinical measures were applied. For responsiveness, Wilcoxon-Mann-Whitney test of differences, correlation of change between rating scales, standard error of difference, relative change, Cohen's effect size and standardized response mean of LW-CI-PD were computed. The minimally clinical important difference was calculated using anchor- (applying the Patient Global Impression of Severity) and distribution-based methods. A triangulation of interpretability indexes was performed to determine the range of the minimally clinical important difference values., Results: The LW-CI-PD scored 65.7 (11.7, range: 33-101) at baseline, and 68.6 (10.3, range: 33-102) one year later (p < 0.001). Change in LW-CI-PD correlated -0.26 with change in psychosocial status, 0.18 with change in motor function and -0.15 with change in social support. Responsiveness statistics were: relative change = 4.5%; effect size = 0.25; standardized response mean = 0.46. Using PGI-S as anchor, 29 patients worsened, and the value of minimally clinical important difference for worsening in LW-CI-PD total score was 4.7. Minimally clinical important difference values using distribution-based methods were between 4.5 (1 standard error of measurement) and 10.4 (10% of total score), with a mean of 6.9., Conclusions: Our study suggest the LW-CI-PD is responsive to changes over time. The use of different methods for calculating the minimally clinical important difference allows to determine a range of the real change for the LW-CI-PD., (Copyright © 2022. Published by Elsevier Ltd.)

Sexual dysfunction is a very frequent non-motor symptom in Parkinson's disease (PD). However, patients are often reluctant to declare their sexual problems and many clinicians do not inquire about them during routine visits. The use of validated rating scales and questionnaires allows overcoming these difficulties, characterizing the nature and causes of the patient's sexual dysfunction, and helping to implement and monitor the most adequate interventions. There is a wide range of instruments available for assessing sexual dysfunction in PD, including generic and specific ones. In this chapter, we review the most used rating scales and questionnaires, with a description of its components, characteristics and psychometric attributes., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Identification of Parkinson's disease subtypes may help understand underlying disease mechanisms and provide personalized management. Although clustering methods have been previously used for subtyping, they have reported generic subtypes of limited relevance in real life practice because patients do not always fit into a single category. The aim of this study was to identify new subtypes assuming that patients could be grouped differently according to certain sets of related symptoms. To this purpose, a novel model-based multi-partition clustering method was applied on data from an international, multi-center, cross-sectional study of 402 Parkinson's disease patients. Both motor and non-motor symptoms were considered. As a result, eight sets of related symptoms were identified. Each of them provided a different way to group patients: impulse control issues, overall non-motor symptoms, presence of dyskinesias and pyschosis, fatigue, axial symptoms and motor fluctuations, autonomic dysfunction, depression, and excessive sweating. Each of these groups could be seen as a subtype of the disease. Significant differences between subtypes (P< 0.01) were found in sex, age, age of onset, disease duration, Hoehn & Yahr stage, and treatment. Independent confirmation of these results could have implications for the clinical management of Parkinson's disease patients., (© 2021. The Author(s).)

Objective: Neuropathic pain is a type of pain reported in people with Parkinson's disease. There are various scales to evaluate the characteristics of this kind of pain. The purpose of this study was to investigate the psychometric properties of the Neuropathic Pain Symptom Inventory (NPSI), a specific scale that measures neuropathic pain in Iranian people with Parkinson's disease., Method: Four hundred forty-seven individuals with Parkinson's disease were recruited in the study. Acceptability, internal consistency (Cronbach's alpha), and test-retest reliability (intraclass correlation coefficient, ICC) of NPSI were calculated. Dimensionality was examined through exploratory factor analysis. For convergent validity, correlations of NPSI with Douleur Neuropathic 4, Brief Pain Inventory, King's Pain Parkinson disease Scale, and Visual Analog Scale-Pain were used. Discriminative validity and sensitivity to change between On- and Off- medication states were analyzed., Results: A marked floor effect was observed for this scale (64.2%). Cronbach's alpha and ICC were 0.90 and 0.87, respectively. Items of NPSI were placed in 4 factors. A moderate to the strong association (r s  = 0.55 to 0.85) between NPSI and other scales was obtained. The results of discriminative validity and sensitivity to change indicate the ability of NPSI to show differences between medication states., Conclusion: The results of this study suggest that NPSI has acceptable reliability, validity, and sensitivity to change, indicating that this scale is suitable for measuring neuropathic pain in Iranian people with Parkinson's disease., (© 2020. Fondazione Società Italiana di Neurologia.)

Growing evidence suggests that non-motor symptoms (NMS) in Parkinson's disease (PD) have differential progression patterns that have a different natural history from motor progression and may be geographically influenced. We conducted a cross-sectional analysis of 1607 PD patients of whom 1327 were from Europe, 208 from the Americas, and 72 from Asia. The primary objective was to assess baseline non-motor burden, defined by Non-Motor Symptoms Scale (NMSS) total scores. Other aims included identifying the factors predicting quality of life, differences in non-motor burden between drug-naïve and non-drug-naïve treated patients, and non-motor phenotypes across different geographical locations. Mean age was 65.9 ± 10.8 years, mean disease duration 6.3 ± 5.6 years, median Hoehn and Yahr stage was 2 (2-3), and 64.2% were male. In this cohort, mean NMSS scores were 46.7 ± 37.2. Differences in non-motor burden and patterns differed significantly between drug-naïve participants, those with a disease duration of less than five years, and those with a duration of five years or over (p ≤ 0.018). Significant differences were observed in geographical distribution (NMSS Europe: 46.4 ± 36.3; Americas: 55.3 ± 42.8; Asia: 26.6 ± 25.1; p < 0.001), with differences in sleep/fatigue, urinary, sexual, and miscellaneous domains (p ≤ 0.020). The best predictor of quality of life was the mood/apathy domain (β = 0.308, p < 0.001). This global study reveals that while non-motor symptoms are globally present with severe NMS burden impacting quality of life in PD, there appear to be differences depending on disease duration and geographical distribution.

Background: Identifying predictors of incident cognitive impairment (CI), one of the most problematic long-term outcomes, in Parkinson's disease (PD) is highly relevant for personalized medicine and prognostic counseling. The Nonmotor Symptoms Scale (NMSS) provides a global clinical assessment of a range of NMS, reflecting NMS burden (NMSB), and thus may assist in the identification of an "at-risk" CI group based on overall NMSB cutoff scores., Methods: To investigate whether specific patterns of PD NMS profiles predict incident CI, we performed a retrospective longitudinal study on a convenience sample of 541 nondemented PD patients taking part in the Nonmotor Longitudinal International Study (NILS) cohort, with Mini-Mental State Examination (MMSE), NMSS, and Scales for Outcomes in PD Motor Scale (SCOPA Motor) scores at baseline and last follow-up (mean 3.2 years) being available., Results: PD patients with incident CI (i.e., MMSE score ≤ 25) at last follow-up (n = 107) had severe overall NMSB level, significantly worse NMSS hallucinations/perceptual problems and higher NMSS attention/memory scores at baseline. Patients with CI also were older and with more advanced disease, but with no differences in disease duration, dopamine replacement therapy, sex, and comorbid depression, anxiety, and sleep disorders., Conclusions: Our findings suggest that a comprehensive baseline measure of NMS and in particular hallucinations and perceptual problems assessed with a validated single instrument can be used to predict incident CI in PD. This approach provides a simple, holistic strategy to predict future CI in this population., (© 2021 The Authors. Brain and Behavior published by Wiley Periodicals LLC.)

Background: Constipation is regarded as one of the prodromal features of Parkinson's disease (PD) and there is emerging evidence linking gastrointestinal dysfunction and cognitive impairment (CI) in PD., Objective: We explored whether constipation is associated with development of CI in two independent cohorts of de novo PD patients (n = 196 from the Non-motor International Longitudinal Study [NILS] and n = 423 from the Parkinson's Progression Markers Initiative [PPMI] study)., Methods: Constipation was clinically defined using the Non-Motor Symptoms Scale (NMSS) item-21 [NILS] and Scales for Outcomes in PD-Autonomic (SCOPA-AUT) item-5 [PPMI]. We assessed baseline group differences (PD with or without constipation) in CI, global non-motor symptoms burden, motor dysfunction, and striatal dopaminergic denervation. Kaplan-Meier method estimated group differences in cumulative proportion of patients with incident CI over three years. In PPMI, we subsequently performed univariate and multivariate Cox survival analyses to evaluate whether constipation predicts incident mild cognitive impairment or dementia over a 6-year period, including constipation and other known predictors of CI as covariates., Results: Patients with constipation had greater motor and global non-motor burden in both cohorts at baseline (p < 0.05). Kaplan-Meier plots showed faster conversion to CI in patients with constipation in both cohorts (p < 0.05). In PPMI, 37 subjects developed dementia during a mean follow-up of 4.9 years, and constipation was an independent predictor of dementia onset (hazard ratio = 2.311; p = 0.02)., Conclusion: Constipation in de novo PD patients is associated with development of cognitive decline and may serve as a clinical biomarker for identification of patients at risk for cognitive impairment.

Background: Neurologists play an essential role in facilitating the patient's process of living with Parkinson's disease (PD). The Living with Chronic Illness Scale-PD (LW-CI-PD) is a unique available clinical tool that evaluates how the patient is living with PD. The objective of the study was to analyse the LW-CI-PD properties according to the Rasch model., Methods: An open, international, cross-sectional study was carried out in 324 patients with Parkinson's disease from four Latin American countries and Spain. Psychometric properties of the LW-CI-PD were tested using Rasch analysis: fit to the Rasch model, item local independency, unidimensionality, reliability, and differential item functioning by age and gender., Results: Original LW-CI-PD do not fit Rasch model. Modifications emerged included simplifying the response scale and deleting misfit items, the dimensions Acceptance, Coping and Integration showed a satisfactory fit to the Rasch model, with reliability indices greater than 0.70. The dimensions Self-management and Adjustment to the disease did not reach fit to the Rasch model., Conclusion: Suggestions for improving the LW-CI-PD include a multidimensional and shorter scale with 12 items grouped in three subscales with a simpler response scheme. The final LW-CI-PD Scale version is a reliable scale, with good internal construct validity, that provides Rasch transformed results on linear metric scale.

Background: The Movement Disorder Society-sponsored Nonmotor Rating Scale is an update of the existing Parkinson's disease Nonmotor Symptoms Scale modified to address some limitations in Nonmotor Symptoms Scale scoring, structure, and symptom coverage., Methods: PD patients were recruited from movement disorder centers in an international, multicenter study. The Movement Disorder Society Nonmotor Rating Scale, consisting of 13 domains plus a subscale for nonmotor fluctuations, was rater administered, along with the Nonmotor Symptoms Scale and other clinical assessments. Standard reliability and validity testing were conducted., Results: Four hundred and two PD patients were recruited (mean age ± standard deviation, 67.42 ± 9.96 years; mean age at PD onset ± standard deviation, 59.27 ± 10.67 years; median Hoehn and Yahr stage 2 (interquartile range 2-3). Data quality was satisfactory for all Movement Disorder Society Nonmotor Rating Scale domains except sexual (6.7% missing data). There were no floor or ceiling effects for the Movement Disorder Society Nonmotor Rating Scale and nonmotor fluctuations total score; domains had no ceiling effects, but some floor effects (13.5%-83.5%). The Movement Disorder Society Nonmotor Rating Scale and nonmotor fluctuations total score internal consistency were acceptable (average Cronbach's alpha, 0.66 and 0.84, respectively); interrater reliability was excellent (intraclass correlation coefficient, >0.95); for test-retest reliability, the intraclass correlation coefficient was 0.84 for the Movement Disorder Society Nonmotor Rating Scale and 0.70 for Movement Disorder Society nonmotor fluctuations total score, and precision was excellent for the Movement Disorder Society Nonmotor Rating Scale (standard error of measurement, 25.30) and fair for nonmotor fluctuations (standard error of measurement, 7.06). Correlations between Movement Disorder Society Nonmotor Rating Scale score and the corresponding Nonmotor Symptoms Scale and Movement Disorder Society UPDRS scores were high. There were no significant sex or age effects. The Movement Disorder Society Nonmotor Rating Scale score increased with increasing PD duration, disease severity, and PD medication dose (all P < 0.001)., Conclusions: The Movement Disorder Society Nonmotor Rating Scale is a valid measure for measuring the burden of a wide range of Nonmotor Rating Scale scores, including nonmotor fluctuations, in PD patients. © 2019 International Parkinson and Movement Disorder Society., (© 2019 International Parkinson and Movement Disorder Society.)

Aims and Objectives: To identify the personal- and disease-related factors that are associated with living with Parkinson's disease., Background: Living with Parkinson's disease affects the physical, psychological, social and spiritual areas of the person. Health professionals need to know which factors influence the daily living with Parkinson's disease, in order to facilitate a positive living., Design: A multicentre cross-sectional study., Methods: A total of 324 patients with Parkinson's disease diagnoses were included in the study through a consecutive case sampling. Data were collected from January-June 2015, in specialised units of movement disorders of public and private and community centres, from Spain, Argentina, Mexico, Ecuador and Cuba. Nine measures were applied to evaluate personal-related factors (age, gender, psychosocial function, satisfaction with life, social support, home economical situation) and Parkinson's disease-related factors (duration of disease, motor symptoms and non-motor symptoms). The STROBE checklist was used to ensure quality reporting during the study (see File S1). Multiple linear regression analysis was carried out., Results: Results indicated that social support, followed by satisfaction with life and home economical situation are the only three factors that significantly influence in living with Parkinson's disease. The rest of the factors analysed did not present significant influence in the daily living with this neurodegenerative disease., Conclusion: This study highlights the necessity to put more emphasis on the person and his/her daily living with the condition and less on symptoms and treatment. Health professionals need to develop person-centred interventions that also deal with other elements of the experience of living with a long-term condition like Parkinson's disease., Relevance to Clinical Practice: Interventions to foster positive living with Parkinson's disease in clinical practice should integrate strategies to tackle and prevent loneliness and interagency elements to increase community resources and systems of support., (© 2019 John Wiley & Sons Ltd.)

Background: The relationship between Health-Related Quality of Life (HRQoL) and MDS-UPDRS has not been fully studied so far. The aim of this study was to evaluate the relationship between all MDS-UPDRS components and HRQoL in a representative international cohort of PD patients., Methods: We collected demographic and disease-related data as well as MDS-UPDRS and PDQ8 scales. Data were analyzed using correlations between PDQ8 and all MDS-UPDRS items, subsequently two hierarchical multiple regressions were performed, first between the scores of the MDS-UPDRS Parts and PDQ8 and second between individual items from those Parts demonstrating significant relationship to PDQ8 scores in the first regression. LASSO regression analyses were performed to evaluate the relationship between PDQ8 and all individual MDS-UPDRS items., Results: A total of 3206 PD patients were included in the study. In the first regression analysis, PDQ8 was significantly related to MDS-UPDRS parts I and II, but not to III and IV. In the second regression model, significant contributions to PDQ8 were found for Part I items Fatigue, Pain, Depressed mood, Apathy; and Part II items Dressing, Doing hobbies, Freezing, Speech and Tremor. In the LASSO analysis, six Part I, seven Part II, three Part III and one Part IV items contributed to PDQ8 scores. The five items most significantly related to the model were Depressed mood, Dressing, Apathy, Pain and Fatigue., Conclusions: This is so far the largest study related to HRQoL issues in PD. Restrictions in activities of daily living and non-motor symptoms significantly contribute to HRQoL in PD., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Nonmotor symptoms constitute a prominent part of Parkinson's disease manifestations. They are present since the first phases of the disease, increase their number and severity with disease progression, and importantly impact on patients' health and quality of life, caregivers' burden, and social resources. Research on Parkinson's disease has traditionally focused on the motor aspects of the disease, but an increasing interest in the nonmotor manifestations has risen in the past decade. The availability of assessment instruments for detecting and measuring these symptoms has allowed understanding of their importance and course over time, as well as estimation of therapeutic effects on them. In this chapter, a review of the basic characteristics of nonmotor symptom assessments used in clinical practice and research are presented., (© 2017 Elsevier Inc. All rights reserved.)

Objective: Differences in disease progression in Parkinson disease (PD) have variously been attributed to 2 motor subtypes: tremor-dominant (TD) and postural instability and gait difficulty (PIGD)-dominant (PG). We evaluated the role of these phenotypic variants in severity and progression of nondopaminergic manifestations of PD and motor complications., Methods: Linear mixed models were applied to data from the Profiling Parkinson's disease (PROPARK) cohort (n = 396) to evaluate the effect of motor subtype on severity and progression of cognitive impairment (Scales for Outcomes in Parkinson's disease [SCOPA]-Cognition [SCOPA-COG]), depression (Hospital Anxiety and Depression Scale [HADS]), autonomic dysfunction (SCOPA-Autonomic [SCOPA-AUT]), excessive daytime sleepiness, psychotic symptoms (SCOPA-Psychiatric Complications [SCOPA-PC]), and motor complications. In first analyses, subtype as determined by the commonly used ratio of tremor over PIGD score was entered as a factor, whereas in second analyses separate tremor and PIGD scores were used. Results were verified in an independent cohort (Estudio Longitudinal de Pacientes con Enfermedad de Parkinson [ELEP]; n = 365)., Results: The first analyses showed that PG subtype patients had worse SCOPA-COG, HADS, SCOPA-AUT, SCOPA-PC, and motor complications scores, and exhibited faster progression on the SCOPA-COG. The second analyses showed that only higher PIGD scores were associated with worse scores for these variables; tremor score was not associated with severity or progression of any symptom. Analyses in the independent cohort yielded similar results., Conclusions: In contrast to PIGD, which consistently was associated with greater severity of nondopaminergic symptoms, there was no evidence of a benign effect of tremor. Our findings do not support the use of the TD subtype as a prognostic trait in PD. The results showed that severity of PIGD is a useful indicator of severity and prognosis in PD by itself., (© 2016 American Academy of Neurology.)

Introduction: To explore the psychometric attributes of a new Satisfaction with Life Scale (SLS-6) in a wide Spanish-speaking population with Parkinson's disease (PD)., Methods: This was an international, cross-sectional study. Several rater-based and patient-reported outcomes measures for evaluation of PD (e.g., Scales for Outcomes in Parkinson's Disease-Motor) and other constructs (e.g., Duke-UNC Functional Social Support Questionnaire, Scale for Living with Chronic Illness) were applied together with the SLS-6. Acceptability, scaling assumptions, reliability, precision, and construct validity were tested., Results: The study included 324 patients from five countries, with age (mean ± standard deviation) 66.67 ± 10.68 years. None of the SLS-6 items had missing values and all acceptability parameters fulfilled the standard criteria. Scaling assumptions allowed the calculation of a summary index from items 2 to 6, complementary to the global evaluation (item 1). For these five items, Cronbach's alpha was 0.85; the corrected item-total correlation 0.53-0.73; inter-item correlation, 0.45-0.70, with an item homogeneity index of 0.55. The standard error of measurement, based on Cronbach's alpha for a single observation, was 3.48. SLS-6 correlations were moderate to strong (rs ≥ 0.35) with the patient-reported outcomes and weak to moderate with the rater-based assessments used in the study. The SLS-6 total score was significantly different according to PD severity levels established according to Hoehn and Yahr staging, Clinical Impression of Severity Index, and Patient-Based Global Impression of Severity scale., Conclusion: The results suggest that SLS-6 is an easy, feasible, acceptable, consistent, precise and valid measure to evaluate satisfaction with life in PD patients., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Objective: To estimate the magnitude in which Parkinson's disease (PD) symptoms and health- related quality of life (HRQoL) determined PD costs over a 4-year period., Materials and Methods: Data collected during 3-month, each year, for 4 years, from the ELEP study, included sociodemographic, clinical and use of resources information. Costs were calculated yearly, as mean 3-month costs/patient and updated to Spanish €, 2012. Mixed linear models were performed to analyze total, direct and indirect costs based on symptoms and HRQoL., Results: One-hundred and seventy four patients were included. Mean (SD) age: 63 (11) years, mean (SD) disease duration: 8 (6) years. Ninety-three percent were HY I, II or III (mild or moderate disease). Forty-nine percent remained in the same stage during the study period. Clinical evaluation and HRQoL scales showed relatively slight changes over time, demonstrating a stable group overall. Mean (SD) PD total costs augmented 92.5%, from € 2,082.17 (€ 2,889.86) in year 1 to € 4,008.6 (€ 7,757.35) in year 4. Total, direct and indirect cost incremented 45.96%, 35.63%, and 69.69% for mild disease, respectively, whereas increased 166.52% for total, 55.68% for direct and 347.85% for indirect cost in patients with moderate PD. For severe patients, cost remained almost the same throughout the study. For each additional point in the SCOPA-Motor scale total costs increased € 75.72 (p = 0.0174); for each additional point on SCOPA-Motor and the SCOPA-COG, direct costs incremented € 49.21 (p = 0.0094) and € 44.81 (p = 0.0404), respectively; and for each extra point on the pain scale, indirect costs increased € 16.31 (p = 0.0228)., Conclusions: PD is an expensive disease in Spain. Disease progression and severity as well as motor and cognitive dysfunctions are major drivers of costs increments. Therapeutic measures aimed at controlling progression and symptoms could help contain disease expenses.

Background: This article proposes an International Parkinson and Movement Disorder Society (MDS)-UPDRS tremor-based scale and describes its measurement properties, with a view to developing an improved scale for assessing tremor in Parkinson's disease (PD)., Methods: This was a cross-sectional, multicenter study of 435 PD patients. Rasch analysis was performed on the 11 MDS-UPDRS tremor items. Construct validity, precision, and test-retest reliability were also analyzed., Results: After some modifications, which included removal of an item owing to redundancy, the obtained MDS-UPDRS tremor scale showed moderate reliability, unidimensionality, absence of differential item functioning, satisfactory convergent validity with medication, and better precision than the raw sum score. However, the scale displayed a floor effect and a need for more items measuring lower levels of tremor., Conclusions: The MDS-UPDRS tremor scale provides linear scores that can be used to assess tremor in PD in a valid, reliable way. The scale might benefit from modifications and studies that analyze its responsiveness., (© 2015 International Parkinson and Movement Disorder Society.)

Introduction: In Parkinson's disease (PD), neuropsychiatric symptoms (NPS) can be particularly burdensome for caregivers. The main goal of this study was to assess the impact of NPS, assessed by means of a new specific scale, on caregiver burden., Methods: A sample of 584 pairs of PD patients and their primary caregivers was studied. Patients' NPS were measured with the Scale for Evaluation of Neuropsychiatric Disorders in PD (SEND-PD), and the Zarit Caregiver Burden Inventory was used to quantify caregiver burden. Three linear regression models were built to check factors associated with caregiver burden, one for the total sample and two for subgroups stratified by the presence of dementia., Results: The most frequent NPS were depression (in 66% of the sample), anxiety (65%) and mental fatigue (57%). Patients with dementia (n = 94; 16% of sample) consistently presented more NPS than patients without dementia (p < 0.001). On linear regression models, the main determinants of caregiver burden (for the total sample and the sample of patients without dementia) were SEND-PD dimensions mood/apathy and psychosis, PD-related disability and disease duration. For patients with dementia, the only significant caregiver burden determinants were SEND-PD psychosis and mood/apathy subscale scores., Conclusions: NPS in PD are highly associated with and are determinants of caregiver burden, and are more prevalent and burdensome in patients with dementia. Detailed assessment and specific interventions aimed at NPS could alleviate caregiver burden., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Quality of life (QoL) is a patient-reported outcome frequently included in Parkinson's disease (PD) clinical trials as a secondary or tertiary endpoint. However, QoL is an important variable that reflects the impact of disease and treatment from the patients' perspective. In a chronic, neurodegenerative disease such as PD, with a wide range of complex symptoms, QoL provides valuable and comprehensive information on the patients' health status. This narrative review aims to evaluate the effect of specific PD treatments currently in use on patients' QoL measured with the Parkinson's Disease Questionnaire, 39-item (PDQ-39) or 8-item (PDQ-8) version. A quantification of this effect is provided by calculation of the relative change and effect size. These two parameters allow an intuitive standardized approach to the importance of change based on its magnitude. Some high-quality studies (Level I) were found for levodopa (immediate- or extended-release formulations), levodopa with added-on catechol-O-methyltransferase (COMT) inhibitors, levodopa/carbidopa gel for intestinal infusion, some dopamine agonists (ropinirole, cabergoline, pergolide), and the monoamine oxidase B (MAO-B) inhibitor safinamide. As a whole, these studies found a beneficial effect of variable magnitude, weak to moderate, on patients' QoL. Studies with a lower level of evidence or not providing enough data to estimate relative change and effect size, including those for the apomorphine subcutaneous pump, also reported improvement of QoL, but the evidence was insufficient to confirm the effect. More high-quality studies focused on QoL are needed to determine the real impact of PD drug treatments for this important outcome.

Background: Non-motor symptoms (NMS) of Parkinson's disease (PD) affect virtually every patient, yet they are under-recognized and under-treated. The NMS Questionnaire (NMSQuest) is a validated 30-item self-assessment instrument useful for NMS screening in clinic., Objective: Development of a straight forward grading classification of the burden of non-motor symptoms in PD based on the number of NMS as assessed by the NMS Questionnaire., Methods: In an observational, cross-sectional, international study of 383 consecutive patients distribution of the declared NMS as per NMSQuest was analyzed according to previously published levels based on the Non-Motor Symptoms Scale and also the median and interquartile range (IR, percentiles 25 and 75) of the total NMSQuest scores. After post hoc checking, these values were proposed as cut-off points for estimating NMS burden based only on the accumulation of symptoms., Results: Burden and number of NMS correlate closely (r ≥ 0.80). On the basis of this finding, five levels (0 = No NMS to 4 = Very severe) of NMSQuest grading were proposed after identification of their cut-offs by ordinal logistic regression and median and interquartile range distribution. These values coincided almost completely with those obtained by median and interquartile range in an independent sample. Concordance between this classification and HY staging was weak (weighted kappa = 0.30), but was substantial (weighted kappa = 0.68) with the Non-Motor Symptoms Scale grading., Conclusion: Completion of NMSQuest and subsequent grading of the burden could allow the health care professional to approach the severity of NMS burden using the self completed NMSQuest in a primary care setting., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: There are limited data in terms of the clinical profile of Parkinson's disease in sub-Saharan African patients., Objective: To compare the clinical profile and access to standard antiparkinsonian therapies of a Cameroonian cohort of patients with an age, sex, and disease duration-matched Spanish cohort (Longitudinal Study of Parkinson's disease, ELEP)., Methods: Observational, cross-sectional design. Demographic data were collected and the following ELEP assessments were applied: Scales for Outcomes in Parkinson's disease (SCOPA) Motor, Autonomic, Cognition, Sleep and Psychosocial; Hoehn and Yahr staging; modified Parkinson Psychosis Rating Scale; Cumulative Illness Rating Scale-Geriatrics; Hospital Anxiety and Depression Scale; pain and fatigue visual analog scales; Zarit, and EuroQoL., Results: 74 patients with idiopathic Parkinson's disease were included (37 from each country) with a mean age of 64.4±10.5 years old, 70.3% males, and mean disease duration of 5.6±5.9 years. Compared to the Spanish cohort, Cameroonians were intermittently treated, less frequently received dopaminergic agonists (p<0.001), had a trend for taking lower doses of levodopa (p=0.06), and were more frequently on anticholinergics (p<0.0005). Cameroonians were more severely impaired in terms of motor (Hoehn Yahr stage, p=0.03; SCOPA-Motor, p<0.001), cognitive status (p<0.001), anxiety and depression (p<0.001), psychosis (p=0.008), somnolence, fatigue and pain (p<0.001, respectively), caregiver burden (p<0.0001), and quality of life (p=0.002). Instead, autonomic, comorbidity, and nocturnal sleep problems were similarly found., Conclusions: Limited and intermittent access to dopaminergic drugs has a negative impact on motor symptoms, nonmotor symptoms and quality of life in patients with Parkinson's disease and their caregivers., (© 2013.)

Purpose: Caring for a patient with Parkinson's disease (PD) is stressful and has a significant impact on the carer's physical and mental health. This article is aimed at assessing which characteristics are most frequently associated with the stress symptoms of PD carers., Method: Data from the Parkinson's UK Members' Survey were drawn from 1881 valid self-completion surveys, filled in by carers of a patient with PD., Results: The carers, 95.6% of whom were a first-degree relative, reported an average of 2.7 ± 3.1 stress-related symptoms. In multiple regression analysis, a greater number of symptoms were associated (p < 0.01) with: the more tasks that the carer carried out (β = 0.35), an increased number of carer's co-morbidities (0.22) and worsening financial status (0.16)., Conclusions: It is important to consider the health of both the patient with PD as well as that of the family carer to reduce the impact of caring activity on the carer's stress.

Background: The association between sleep disorders and other non-motor symptoms (NMS) in Parkinson's disease (PD) has been scarcely investigated., Objective: To describe the prevalence of insomnia and hypersomnia in PD and analyze their relationship with other NMS., Methods: Cross-sectional, multicenter study including 388 PD patients evaluated with Hoehn and Yahr, Clinical Impression of Severity Index for PD, Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep(S), SCOPA-Cognition, SCOPA-Psychiatric Complications, SCOPA-Autonomic, Hospital Anxiety and Depression Scale, and fatigue and pain visual analogue scales. Spearman correlation coefficients, Mann-Whitney test and multiple linear regression analysis were applied., Results: Mean age (54% male) was 65.9 ± 11.2 years old, with disease duration of 8.1 ± 6.0 years and median HY = 2 (range: 1-5). Mean SCOPA-S nocturnal sleep (NS) was 5.4 ± 4.0 (range: 0-15), daytime sleepiness (DS) was 3.76 ± 3.04 (range: 0-15). Most of the sample declared nocturnal or daytime sleep problems (87.4%). Weak-to-moderate correlations were found between sleep disturbances and other NMS (range: 0.14-0.37). SCOPA-S subscales showed higher scores with the presence of most other NMS such as psychiatric complications and autonomic dysfunctions (p < 0.05). Regression models showed that fatigue, depression, urinary, cardiovascular, and thermoregulatory dysfunctions were significant determinants of SCOPA-NS score (variance: 23%); cognitive impairment, urinary, cardiovascular, and pupillomotor disorders influenced SCOPA-DS score (variance: 14%)., Conclusions: Insomnia and daytime sleepiness are extremely prevalent in PD. Depression, fatigue, cognitive impairment, cardiovascular, urinary and thermoregulatory dysfunctions may contribute to insomnia/hypersomnia. This is the first clinical study to relate cardiovascular and thermoregulatory dysfunctions with sleep in PD., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objective: To evaluate the motor experiences of daily living section of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS M-EDL) for assessing disability in PD patients; to determine the association between disability and quality of life; and to identify cut-off score ranges for no, mild, moderate and severe disability with this measure., Methods: International, observational, cross-sectional study of 435 PD patients, assessed with: MDS-UPDRS, Hoehn and Yahr staging, Rapid Assessment of Disability Scale, Clinical Impression of Severity Index for PD, Parkinson's Disease Questionnaire-8 and EQ-5D. Descriptive statistics, Spearman's rank correlation coefficients, Kruskal-Wallis test for group comparisons, ordinal logistic regression analysis for setting cut-off values and a step-wise multiple linear regression model were calculated., Results: MDS-UPDRS M-EDL correlated 0.70-0.80 with other disability measures, and -0.46 to 0.74 with quality of life scales. Scores significantly increased with higher disease duration and severity (p < 0.001). Cut-off values for the M-EDL were: 0-2 points, no disability; 3-16, mild; 17-31, moderate; and 32 points or more, severe. Linear regression analysis identified the MDS-UPDRS nM-EDL section as the main determinant of M-EDL, followed by the rest of MDS-UPDRS sections (explained variance: 59%)., Conclusions: MDS-UPDRS M-EDL proved to be useful for assessing disability in PD., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The Movement Disorder Society-UPDRS (MDS-UPDRS) was published in 2008, showing satisfactory clinimetric results and has been proposed as the official benchmark scale for Parkinson's disease. The present study, based on the official MDS-UPDRS Spanish version, performed the first independent testing of the scale and adds information on its clinimetric properties. The cross-culturally adapted MDS-UPDRS Spanish version showed a comparative fit index ≥ 0.90 for each part (I-IV) relative to the English-language version and was accepted as the Official MDS-UPDRS Spanish version. Data from this scale, applied with other assessments to Spanish-speaking Parkinson's disease patients in five countries, were analyzed for an independent and complementary clinimetric evaluation. In total, 435 patients were included. Missing data were negligible and moderate floor effect (30 %) was found for Part IV. Cronbach's α index ranged between 0.79 and 0.93 and only five items did not reach the 0.30 threshold value of item-total correlation. Test-retest reliability was adequate with only two sub-scores of the item 3.17, Rest tremor amplitude, reaching κ values lower than 0.60. The intraclass correlation coefficient was higher than 0.85 for the total score of each part. Correlation of the MDS-UPDRS parts with other measures for related constructs was high (≥ 0.60) and the standard error of measurement lower than one-third baseline standard deviation for all subscales. Results confirm those of the original study and add information on scale reliability, construct validity, and precision. The MDS-UPDRS Spanish version shows satisfactory clinimetric characteristics.

Caregivers of Parkinson's disease patients face responsibilities stemming from providing assistance to a person, usually a family member, who suffers a progressively disabling disease characterized by both motor and nonmotor symptoms. These circumstances impact on the physical, emotional and psychosocial aspects of the caregivers' lives and, therefore, on their quality of life (QoL). Studies have identified factors related to caregivers' global QoL and health-related QoL, causing caregivers distress and affecting their QoL. These factors are related to patients' and caregivers' characteristics and may be classified as sociodemographic, psychological and disease related. Caregiver's burden refers to the multiplicity of difficulties ensuing as a consequence of caring, including, for example, health problems, modification of habits, economic loss and QoL deterioration. Therefore, burden-related factors are also briefly reviewed. The implementation of effective interventions to preserve the caregiver's wellbeing and allow the patients to remain at home and be properly assisted is a pragmatic consequence of this knowledge.

Background: Non-motor symptoms are detrimental to health-related quality of life (HRQoL) of Parkinson's disease patients. In this study, the Non-Motor Symptoms Scale (NMSS) was used to assess the impact of the non-motor symptoms on HRQoL of Parkinson's disease patients., Methods: In a multicenter, international, cross sectional study on 411 Parkinson's disease patients, the NMSS was applied along with clinical (Hoehn and Yahr staging and SCOPA-Motor) and HRQoL measures (PDQ-39, and EQ-5D). Prevalence of non-motor symptoms was determined also through the NMSS. The association of NMSS and SCOPA-Motor with HRQoL measures and the differences in HRQoL scores between patients with and without non-motor symptoms in each NMSS domain were estimated by non-parametric statistics. Predictors of HRQoL were sought through multiple linear regression analyses., Results: Nocturia (68.4% of the sample), fatigue (65.9%), and dribbling saliva (56.7%), were the most frequent complaints. Total NMSS score: (1) showed a higher correlation coefficient (r(S) = 0.70) with the PDQ-39 Summary Index (SI) than SCOPA-Motor (r(S) = 0.58); (2) showed high-moderate correlation (r(S) = 0.60 - 0.38) with all PDQ-39 domains; and (3) was the best predictor of HRQoL as measured by the PDQ-39 SI. For each NMSS domain, patients with symptoms had significantly worse HRQoL scores than patients without symptoms., Discussion: To our knowledge, this is the first study to determine in a holistic manner the impact of the non-motor symptoms on HRQoL of Parkinson's disease patients. The results show that non-motor symptoms have, as a whole, a greater impact on HRQoL than motor symptoms and non-motor symptoms progression contributes importantly to HRQoL decline in patients with Parkinson's disease., (Copyright © 2011 Movement Disorder Society.)

The objective of this study is to describe the characteristics of the caregivers of patients with Parkinson's disease (PD) and to analyze the association between these characteristics and caregiver burden, perceived health and mood status, and identify their predictors. A multicenter, nationwide, observational, cross-sectional study that included 289 patient-caregiver pairs was conducted. Caregiver self-assessments were the Hospital Anxiety and Depression Scale (HADS), EuroQol (EQ), and Zarit Caregiver Burden Inventory (ZCBI). Most caregivers in the study were women aged 60 years or thereabouts. Over two thirds were gainfully employed or housewives, 75% were patients' spouses, and the majority (96.5%) had been permanently taking care of the patient for 6 +/- 5.4 years. Less than 5% of patients were in the most advanced stages of disease, and direct costs were 6,350 euros per patient per year. Caregivers had more mood disorders and worse health-related quality of life (HRQol; EQ-Tariff) than did the general population. Caregiver HADS and EuroQol scores displayed a weak correlation (r(S) = 0.01-0.28) with patient-related variables (disease duration, HY, SCOPA-Motor, SCOPA-AUT, HADS, PPRS, and CISI-PD) whereas the ZCBI correlated moderately (r(S) = 0.27-0.47). Among caregivers, the EQ-Tariff was significantly lower and the HADS-Anxiety scores significantly higher for women. ZCBI and HADS-depression, though not EuroQol and HADS-anxiety, scores significantly increased with increasing PD severity levels. Caregivers' affective status proved the most important factor influencing their burden and perceived health, whereas patient-related variables influenced caregiver burden and mood but not health status. In PD, prevalence of affective disorders among patients' caregivers is high and influences both burden and HRQoL., ((c) 2007 Movement Disorder Society.)

This study evaluated the comparative validity and usefulness of the Parkinson's Disease Sleep Scale (PDSS) and the Scales for Outcomes in PD-Sleep Scale (SCOPA-S), two disease-specific rating scales for assessing sleep disorders in Parkinson's disease (PD). Hoehn and Yahr staging (HY), SCOPA-Motor, Mini-Mental State Examination, Clinical Impression of Severity Index for PD, Hospital Anxiety and Depression Scale, EuroQoL, and SCOPA-Psychosocial, in addition to PDSS and SCOPA-S (night-time sleep (NS) and daytime sleepiness (DS) subscales), were applied to 187 consecutive PD patients. PDSS and SCOPA-S proved similar in acceptability, scaling assumptions, precision, and internal consistency (Cronbach's alpha = 0.82-0.84). Factor analysis revealed five separate factors for PDSS (67% of the variance) and one factor for each SCOPA-S subscale (60% of the variance for NS and 57% for DS). Correlation coefficient between PDSS and SCOPA-S NS was -0.60. Sleep scales correlated moderately with mood, low-to-moderate with HRQoL, and low with the rest of measures. PDSS and SCOPA-S DS discriminated between patients grouped by HY severity levels and disease duration. Cutoff points of 82/83 for PDSS and 6/7 for SCOPA-S NS were drawn to identify PD patients with sleep problems. Depression/anxiety scores explained 26% for PDSS and 22% for SCOPA-S NS scores. Both scales provide valid, reliable, and useful means to evaluate sleep disorders in PD. PDSS may be used to obtain a profile about potential causes of "bad sleep," but is barely useful to assess DS, whereas SCOPA-S assesses nocturnal sleep disorders and daytime somnolence at a similar extent, without exploring the potential causes., ((c) 2007 Movement Disorder Society.)