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Background: Drooling is a clinically relevant non-motor symptom of people with Parkinson’s disease (PwP). Several drooling rating scales are available. Nevertheless, the compelling scientific evidence supporting their validity is limited. This study aims to evaluate clinical rating scales for drooling, assessing their characteristics, clinimetric properties, and clinical utility classification. Methods: A systematic review was undertaken. Two reviewers performed independent literature searches using the CENTRAL®, CINAHL®, Embase®, MEDLINE®, SciElo®, and SPEECH BITE® databases. We used consensusbased standards for the selection of health measurement instruments (COSMIN) and the International Parkinson’s disease and the Movement Disorders (MDS) criteria to evaluate the included rating scales. Results: The following six rating scales were identified: Drooling Impact Scale (DIS), Sialorrhea Scoring Scale (SSS), Drooling Severity and Frequency Scale (DSFS), Drooling Rating Scale (DRS), Sialorrhea Clinical Scale for Parkinson Disease (SCS-PD), and the Radboud Oral Motor inventory for Parkinson’s disease – Saliva (ROMPsaliva). The scales had heterogeneous characteristics: (i) not all were created/adapted for PwP; (ii) different dimensions associated with drooling are assessed; (iii) cross-cultural adaptations are limited to some languages. The clinimetric properties showed: (i) target population size limitations; (ii) incomplete reliability analysis; (iii) lack of robust validity; (iv) sensitivity to change not fully explored. Following the MDS criteria, only one tool was classified as “recommended”, the ROMP-saliva. Conclusions: This review provides information for an adequate selection of a drooling rating scale for clinical and/or research purposes. To date, ROMP-saliva is the only scale with substantial evidence of its clinimetric properties adequacy and data in PwP. info:eu-repo/semantics/publishedVersion

The motor features in Parkinson's disease (PD) are associated with the degeneration of dopaminergic cells in the substantia nigra in the brain. Thus, the gold-standard in PD therapeutics still consists of dopamine replacement with levodopa. However, as the disease progresses, this therapeutic option becomes less effective and can be accompanied by levodopa-induced complications. On the other hand, several other neuronal pathways have been implicated in the pathological mechanisms of PD. In this context, the development of alternative therapeutic options that modulate non-dopaminergic targets is emerging as a major goal in the field. In a phenotypic-based screen in a zebrafish model of PD, we identified tapentadol as a candidate molecule for PD. The therapeutic potential of an agent that modulates the opioid and noradrenergic systems has not been explored, despite the implication of both neuronal pathways in parkinsonism. Therefore, we assessed the therapeutic properties of this µ-opioid receptor agonist and norepinephrine reuptake inhibitor in the 6-hydroxydopamine mouse model of parkinsonism. We further submitted 6-hydroxydopamine-lesioned mice to chronic treatment with levodopa and evaluated the effects of tapentadol during levodopa OFF states and on levodopa-induced dyskinesia. Importantly, we found that tapentadol halted the aggravation of dyskinesia and improved the motor impairments during levodopa OFF states. Altogether, our findings raise the hypothesis that concomitant modulation of µ-opioid receptor and norepinephrine transporter might constitute relevant intervention strategies in PD and that tapentadol holds therapeutic potential that may be translated into the clinical practice.

© 2019 Elsevier Ltd. All rights reserved., Background: Few data exist on the rate of clinical progression for Parkinson's disease (PD) patients who have entered a late stage of the disease. Objective: Study the clinical progression of a late-stage PD (LSPD) population over one year follow-up. Methods: 50 LSPD patients (Schwab and England ADL Scale 3 in MED ON) underwent an extensive clinical assessment at baseline and after one year and an acute levodopa test at baseline. Results: Mean age of LSPD patients (female 46%) was 77.5 ± 5.9 years and mean disease duration was 15.5 ± 6.5 years. At baseline, 76% had levodopa-induced motor complications (MC), usually non-troublesome, 68% were demented, 54% had psychosis and 68% depression. Caregiver distress was high. l-dopa responsiveness was mild (18% ± 12 of improvement on MDS-UPDRS-III). After one-year, 20% of the patients were dead, institutionalized or HY 5. MDS-UPDRS-motor mean score worsened 7.2 ± 10.3 points although there was heterogeneity between patients, and there was a global worsening of non-motor symptoms, mostly in cognition/mood, urinary and gastrointestinal domains. Nevertheless, MC improved despite similar levodopa equivalent dose. Functional independence and quality of life worsened. Dysphagia severity at baseline predicted a poor outcome (death, institutionalization or HY 5) (Hazard ratio 2.3, 95% CI 1.12-4.4; p = 0.01), whereas magnitude of l-dopa response of LSPD patients did not. Conclusions: LSPD patients still present a significant, although heterogeneous, motor and non-motor progression over 1 year. Dysphagia severity predicts the occurrence of additional disease severity milestones and its management must be prioritized.

Background and aims: Opicapone (OPC) proved to be effective in the treatment of end-of-dose motor fluctuations in Parkinson's disease (PD) patients. About 80–100% of PD patients show some degree of wearing-off within 10 years of levodopa (L-dopa) therapy. Approaches to optimize the L-dopa regimen include increasing the dose or ‘fractionating’ the total daily dose. This study aims to explore the potential of adjunctive OPC versus an additional dose of L-dopa/dopa decarboxylase inhibitor (DDCi) to optimize the L-dopa/DDCi regimen as first-line approach to treat wearing-off. Methods: Approximately 100 patients (aged ≥30 years) with idiopathic PD, treated with 3–4 daily oral L-dopa doses up to 600 mg, and signs of wearing-off (

Background and aims: Opicapone (OPC) proved to be effective in the treatment of end-of-dose motor fluctuations in Parkinson's disease (PD) patients. Non-motor symptoms have a substantial impact on health-related quality of life and are reported in approximately 90% of idiopathic PD patients. End-of-dose motor fluctuations and associated sleep disorders are commonly observed in PD patients who receive treatment with levodopa (L-dopa)/DOPA decarboxylase inhibitors (DDCI). This study aims to evaluate the effects of OPC treatment on sleep disorders in PD patients with ‘wearing-off’. Methods: Approximately 30 patients (aged ≥30 years) with idiopathic PD, treated with 3–8 daily doses of L-dopa/DDCI, with ‘wearing-off’ and sleep disorders will receive OPC 50 mg once daily during a 6-week evaluation period. L-dopa/DDCI daily dose, but not number of intakes, may be adjusted according to the patients' response in the first 2 weeks, and is kept unchanged afterwards (Fig. 1). As a pilot study, no formal sample size calculation was performed. [Formula presented] Results: The primary endpoint is change from baseline in total score of Parkinson's Disease Sleep Scale-2. Secondary endpoints include tolerability, functional motor and non-motor assessments (Movement Disorder Society-Non-Motor Symptoms Scale, Parkinson's Disease Questionnaire-8, Parkinson's Fatigue Scale, ON/OFF home diary), and Clinical and Patient Global Impression of Change scales. Study sites are in Germany and Portugal. First-patient-in is expected for early 2021 and last-patient-out for late 2021. Timelines might be impacted by the COVID-19 situation. Conclusions: This pilot study will provide preliminary data on the potential effect of OPC 50 mg once daily as adjunctive therapy to L-dopa/DDCI on PD-associated sleep disorders.

Introduction Mutations in the GBA gene, encoding for the lysosomal enzyme glucocerebrosidase, are associated with Gaucher disease. Alterations in plasma sphingolipids have been reported in Gaucher, and similarly in brain extracts in Lewy body disease. As GBA mutations are prevalent risk factors for Parkinson's disease and overlap of molecular pathways are presumable, here we assessed the lipid profiles in Parkinson's patients with and without GBA mutations. Methods We sequenced all GBA exons in 415 Parkinson's patients, previously genotyped for LRRK2. 64 patients (29 GBA positive vs. 35 non-GBA-carriers including 18 LRRK2 positive and 17 non-mutated) were analyzed for chitotriosidase activity and for the concentration of 40 lipid classes using HPLC-MS. Results 29/415 patients (6.9%) carried 8 different GBA mutations associated with Gaucher or Parkinson's, including one novel mutation. Chitotriosidase activity was similar across the genetic groups, while the levels of key lipids were altered in GBA mutation carriers: Monohexosylceramide, Ceramide and Sphingomyelin were elevated; while Phosphatidic acid (PA), Phosphatidylethanolamine (PE), Plasmalogen phosphatidylethanolamine (PEp) and Acyl Phosphatidylglycerol (AcylPG) were decreased. Conclusion The results suggest an important role for these lipids in GBA mediated Parkinson's disease and assist in the identification of common pathways between Gaucher and Parkinson's. Ultimately, our findings may lead to the identification of novel biomarkers for individuals at increased risk of developing Parkinson's disease.

Background Legionnaires' disease (LD) is recognized as an important hospital-acquired disease. Despite the several methods available, the optimal method to control hospital-acquired LD is not well established and their overall efficacy requires further evaluation. Objective To systematically review all controlled trials evaluating the efficacy of interventions to prevent hospital-acquired LD in patients at high risk of developing the disease and its effects on environmental colonization. Methods A database search was performed through PubMed and the Cochrane Central Register of Controlled Trials (inception-November 2014). Eligible studies included all controlled studies evaluating interventions to prevent hospital-acquired LD in patients at high risk or evaluating the effect on environmental colonization. Both individual and pooled risk estimates were reported using risk ratio (RR) and 95% confidence intervals (95% CIs). Results There were no studies evaluating the risk reduction in hospital-acquired LD, but 4 studies evaluated the influence of copper-silver ionization and ultraviolet light in the reduction of environmental reservoirs of Legionella . The meta-analysis showed a significant 95% risk reduction of Legionella positivity in environmental samples using copper-silver ionization (RR, 0.05; 95% CI, 0.01-0.17) and 97% risk reduction with ultraviolet light (RR, 0.03; 95% CI, 0.002-0.41). Conclusions The best available evidence suggests that copper-silver ionization and ultraviolet light are effective in reducing Legionella positivity in environmental samples. Nevertheless, the low quality of evidence weakens the robustness of conclusions.

Background Daytime sleepiness and sleep disorders are frequently reported in Parkinson's disease (PD). However, their impact on quality of life has been underestimated and few clinical trials have been performed. Objectives We aimed to assess the efficacy and safety of pharmacological interventions for daytime sleepiness and sleep disorders in PD. Methods Systematic review of randomized controlled trials comparing any pharmacological intervention with no intervention or placebo for the treatment of daytime sleepiness and sleep problems in PD patients. Results Ten studies (n = 338 patients) were included. Four trials addressed interventions for excessive daytime sleepiness. Meta-analysis of the three trials evaluating modafinil showed a significant reduction in sleepiness, as assessed by the Epworth Sleepiness Scale (ESS) (– 2.24 points, 95% CI – 3.90 to – 0.57, p Conclusions Whilst providing recommendations, this systematic review depicts the lack of a body of evidence regarding the treatment of sleep disorders in PD patients; hence, further studies are warranted.

Summary Background Opicapone is a novel, once-daily, potent third-generation catechol-O-methyltransferase inhibitor. We aimed to assess the safety and efficacy of opicapone as an adjunct to levodopa compared with placebo or entacapone in patients with Parkinson's disease and motor fluctuations. Methods We did a randomised, double-blind, placebo-controlled and active-controlled trial of opicapone as an adjunct to levodopa in patients with Parkinson's disease with end-of-dose motor fluctuations. Patients aged 30–83 years were enrolled at 106 specialist centres across 19 European countries and Russia and were randomly assigned (1:1:1:1:1) by a proprietary computer-generated sequence to oral treatment with opicapone (5 mg, 25 mg, or 50 mg once daily), placebo, or entacapone (200 mg with every levodopa intake) for 14–15 weeks. Patients and investigators (ie, outcome assessors) were masked to treatment allocation. The primary endpoint was the change from baseline to end of study treatment in absolute time in the off state, as assessed by daily paper patient diaries; the primary analysis followed a hierarchical procedure for each opicapone dose in which superiority compared with placebo in the full analysis set was first tested and then, if positive, non-inferiority to entacapone was tested in the per-protocol set with a margin of 30 min. This trial is registered with EudraCT, 2010-021860-13, and ClinicalTrials.gov, NCT01568073. Findings Between March 31, 2011, and Nov 30, 2013, of 679 patients screened, 600 were randomly assigned. 590 patients were included in the full analysis set (120 in the placebo group, 120 in the entacapone group, 119 in the opicapone 5 mg group, 116 in the opicapone 25 mg group, and 115 in the opicapone 50 mg group) and 537 in the per-protocol set (112 in the placebo group, 104 in the entacapone group, 110 in the opicapone 5 mg group, 105 in the opicapone 25 mg group, and 106 in the opicapone 50 mg group). The mean change in time in the off state was −56·0 min (SE 13·4; 95% CI −82·3 to −29·7) for placebo, −96·3 min (13·4; −122·6 to −70·0) for entacapone, −91·3 min (13·5; −117·7 to −64·8) for opicapone 5 mg, −85·9 min (13·7; −112·8 to −59·1) for opicapone 25 mg, and −116·8 min (14·0; −144·2 to −89·4) for opicapone 50 mg. Treatment with opicapone 50 mg was superior to placebo (mean difference in change from baseline −60·8 min, 95% CI −97·2 to −24·4; p=0·0015) and non-inferior to entacapone (−26·2 min, −63·8 to 11·4; p=0·0051). Treatment with opicapone 5 mg (p=0·056) or 25 mg (p=0·080) was not significantly different from treatment with placebo. Treatment-emergent adverse events were reported in 60 (50%) of 121 patients in the placebo group, 69 (57%) of 122 in the entacapone group, 63 (52%) of 122 in the opicapone 5 mg group, 65 (55%) of 119 in the opicapone 25 mg group, and 62 (54%) of 115 in the opicapone 50 mg group. The most common adverse events were dyskinesia (in five patients in the placebo group, ten in the entacapone group, 17 in the opicapone 5 mg group, nine in the opicapone 25 mg group, and 18 in the opicapone 50 mg group), insomnia (in one, seven, two, seven, and seven patients, respectively), and constipation (in three, five, four, none, and seven patients, respectively). Serious adverse events were reported in six patients in the placebo group, eight in the entacapone group, four each in the opicapone 5 mg and opicapone 50 mg groups, and one in the opicapone 25 mg group. Interpretation The addition of opicapone 50 mg to levodopa treatment in patients with Parkinson's disease and end-of-dose motor fluctuations could enable a simplified drug regimen that allows physicians to individually tailor the existing levodopa daily regimen, by potentially reducing the total daily levodopa dose, increasing the dosing interval, and ultimately reducing the number of intakes, thereby maximising its benefit. Funding BIAL.

Background The development of secondary non-response (SNR) to botulinum neurotoxin type-A (BoNT-A) is considered a key issue in the management of cervical dystonia (CD). This case-controlled study was performed to systematically identify factors influencing SNR during BoNT-A therapy. Methods This was a retrospective, international, non-interventional study of CD patients. Patients with SNR were matched with up to three responder patients (control) on the basis of duration of therapy and number of injection cycles. Factors influencing the development of SNR were screened using a univariate logistic regression model and confirmed using a multivariate conditional logistic regression model. Results 216 patients were enrolled, and 201 (SNR = 52; responder = 149) were matched and subdivided into blocks (doublets, triplets or quadruplets). At baseline, a significantly higher proportion of SNR patients had received previous or concomitant therapies (p = 0.038) and surgery for CD (p = 0.007) compared with controls. Although disease severity at onset was similar between groups, a significantly higher proportion of SNR patients experienced severe CD at the time of SNR compared with controls at the last documented visit. Multivariate analyses identified five factors that were significantly associated in predicting SNR (odds ratio [OR] > 1 indicated higher chances for being SNR): previous surgical procedure for CD (OR 9.8, p = 0.013), previous BoNT-A related severe adverse event (AE) (OR 5.6 p = 0.027), physical therapy (OR 4.6, p = 0.028), neuroleptic use (OR 3.3, p = 0.019) and average BoNT-A dose (OR 2.7, p = 0.010). Conclusions These findings suggest that SNR may not reflect true pharmacological resistance to BoNT-A therapy, but may be related to underlying disease severity.

Resumo: Introdução e objetivo: A anticoagulação oral é uma terapêutica eficaz na prevenção de eventos tromboembólicos, em doentes com fibrilhação auricular (FA). A presente revisão pretendeu estimar a prevalência da terapêutica anticoagulante oral em doentes com FA em Portugal. Métodos: Foi realizada uma pesquisa nas bases de dados MEDLINE, Índex de Revistas Médicas Portuguesas e Catálogo Bibliográfico do Sistema Integrado de Bibliotecas da antiga Universidade Clássica de Lisboa (SIBUL). Estudos observacionais nacionais que reportavam a proporção de doentes anticoagulados com fibrilhação auricular foram incluídos. A estimativa combinada de prevalência de doentes com FA anticoagulados e o respetivo intervalo de confiança 95% (IC95%) foi determinada com recurso a meta‐análise. Resultados: Dos sete estudos incluídos, três estudos foram realizados em ambiente hospitalar e quatro foram realizados na comunidade em geral. Do total de 891 doentes com FA, a estimativa de prevalência de doentes anticoagulados foi de 40% (IC95% 32‐48%). Conclusões: A prevalência de doentes com FA anticoagulados na população estudada é baixa. É necessário promover a mudança dos hábitos de prescrição de anticoagulantes em doentes com FA em Portugal, em concordância com as recomendações internacionais. Abstract: Introduction and Objectives: Oral anticoagulation (OAC) is an effective treatment in the prevention of thromboembolic events in patients with atrial fibrillation (AF). The aim of this review was to estimate the prevalence of OAC therapy in patients with AF in Portugal. Methods: MEDLINE, the Index of Portuguese Medical Journals and SIBUL (the Bibliographic Catalog of the Integrated Library System of the University of Lisbon) were searched for Portuguese observational studies reporting the proportion of anticoagulated patients with AF. The pooled estimated prevalence of anticoagulated patients and respective 95% confidence interval (CI) were determined by means of a meta‐analysis. Results: Seven studies were included for analysis, of which four were conducted in a hospital environment and three in the general community. These studies enrolled a total of 891 patients with AF. The pooled estimated prevalence of anticoagulated patients was 40% (95% CI: 32–48%). Conclusions: The prevalence of OAC in Portuguese AF patients is low. There is a need to promote change in OAC prescribing habits for AF patients in Portugal, in accordance with international guidelines. Palavras‐chave: Fibrilhação auricular, Anticoagulação, Prevalência, Coumarinicos, Varfarina, Antagonistas da vitamina K, Keywords: Atrial fibrillation, Anticoagulation, Prevalence, Coumarins, Warfarin, Vitamin K antagonists

Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved., Background: Uncertainty exists about the benefit of oral anticoagulation in the treatment of pulmonary arterial hypertension (PAH), which is a lethal disease. We aimed to review and quantify the effect of oral anticoagulants in overall survival of PAH patients. Methods: We searched for randomized and observational studies that evaluated oral anticoagulants in PAH in the electronic databases MEDLINE, CENTRAL and ISI Web of Knowledge (December 2013). Review articles and references were also screened. We performed a random effects meta-analysis to estimate pooled HRs and 95% confidence intervals. Statistical heterogeneity was evaluated using the I 2 test. Results: No randomized controlled trials were identified. Nine cohort studies (2 prospective and 7 retrospective) of overall moderate quality that enrolled 1730 PAH patients were included. Oral anticoagulation (warfarin) was associated with a 31% mortality risk reduction (HR,0.69; 95% confidence interval, 0.57-0.82; I 2 ¼ 28%). Subgroup and sensitivity analyses showed similar results and no significant heterogeneity. Conclusions: There is no randomized evidence to support the use of oral anticoagulation in PAH. Pooled results from cohort studies suggest a survival benefit, but the moderate study quality, the high risk of publication bias, and the methodological limitations inherent in the analysis of observational studies preclude a definite conclusion. There is an urgent need for pragmatic randomized evidence to definitely answer this important clinical question

© 2014 International Society on Thrombosis and Haemostasis, Background: Low molecular weight heparins (LMWHs) are not approved for patients with mechanical heart valves (MHVs). However, in several guidelines, temporary LMWH off‐label use in this clinical setting is considered to be a valid treatment option. Therefore, we reviewed the efficacy and safety of LMWHs in patients with MHVs. Methods: MEDLINE and CENTRAL databases were searched from inception to June 2013. Review articles and references were also searched. We included experimental and observational studies that compared LMWHs with unfractionated heparin (UFH) or vitamin K antagonists (VKAs). Data were analyzed and pooled to estimate odds ratios (ORs) with 95% confidence intervals (CIs) for thromboembolic and major bleeding events. Statistical heterogeneity was evaluated with the I2‐test. Results: Nine studies were included: one randomized controlled trial (RCT) and eight observational studies, with a total of 1042 patients. No differences were found between LMWHs and UFH/VKAs in the risk of thromboembolic events (OR 0.67; 95% CI 0.27–1.68; I2 = 9%) or major bleeding events (OR 0.66; 95% CI 0.36–1.19; I2 = 0%). Conclusions: The best evidence available might support the temporary use of LMWHs as a prophylactic treatment option in patients with MHVs. However, conclusions are mostly based on observational data (with large CIs), and an adequately powered RCT is urgently needed in this clinical setting.

Deep brain stimulation of the subthalamic nuclei (STN-DBS) for the treatment of levodopa-induced motor complications in advanced Parkinson’s disease (APD) has been associated with neuropsychiatric disorders. It has been suggested that a postoperative decline in visual emotion recognition is responsible for those adverse events, although there is also evidence that emotional processing deficits can be present before surgery. The aim of the present study is to compare the ability to recognize emotions before and one year after surgery in APD. Methods: Consecutively operated APD patients were tested pre-operatively and one year after STN-DBS by the Comprehensive Affect Testing System (CATS), which evaluates visual recognition of 7 basic emotions (happiness, sadness, anger, fear, surprise, disgust and neutral) on facial expressions and 4 emotions on prosody (happiness, sadness, anger and fear). Results: In a sample of 30 patients 6 had depression or apathy at baseline that significantly increased to 14 post-surgery. There were no significant changes in the tests of identity discrimination, discrimination of emotional faces, naming of emotional faces, recognition of emotional prosody, and naming of emotional prosody after STN-DBS. The results of emotion tests could not predict the development of the neuropsychiatric symptoms. Discussion: This study does not support the hypothesis of an acquired change in emotion recognition, either in faces or in prosody, after STN-DBS in APD patients. Neuropsychiatric symptoms appearing after STN-DBS should not be attributed to new deficits in emotional recognition.

Anticoagulation is the cornerstone treatment in patients with atrial fibrillation for stroke prevention. In the last decades, oral vitamin K antagonists (VKA) have been the most used drug of this class. The clinical management of these patients is not straightforward due to the need of periodical evaluation of the INR, as well as due to the numerous drug– drug and drug–food interactions. In addition, recent studies have provided new insights of potential problems associated with VKA treatment

Introduction Limited data is available regarding motivations and concerns of Parkinson’s disease (PD) patients when participating in clinical trials (CTs). Knowledge of these factors may improve the recruitment and quality of future trials. Objectives To assess the motivations and concerns of PD patients concerning participation in CTs and to evaluate the extent to which patients understand informed consent materials and placebo effect concept. Methods Cross-sectional study in PD patients enrolled in CTs between 2002 and 2007. Two questionnaires designed for placebo-controlled and active-controlled studies were mailed to patients. Results From the 93/127 replied questionnaires (response rate: 73.2%) 91 were evaluable. Fifty-nine percent of the participants were women with a mean age of 66.8 years. The main reasons for participating in CTs were to help the advance of science (63.7%), to gain access to a better treatment (56.0%), and to benefit others (51.6%). Risk of adverse events (49.5%) and negative effects of treatment (35.2%) were the major concerns. Ninety percent reported they had understood the informed consent. Of 80 patients included in placebo-controlled studies, 63.9% understood the placebo effect concept. Globally, 66% of patients would participate in another CT and 41.6% in a placebo-controlled trial. Conclusions The main motivations of PD patients to participate in CTs were the benefit to the patient himself and to others. The major concern was safety. PD patients understood the informed consent, but more educational efforts must be made to explain the placebo effect. Most PD patients were very positive toward CTs and would participate in another trial.

This paper is a narrative review of the concept of evidence-based medicine (EBM) and its application in the movement disorders field. The paper has three parts: 1. Discussion of the generic concept of EBM and of the most commonly voiced criticisms; explanation of how relevant are for the comprehension of EBM procedures the notion of implicit and explicit knowledge; discussion of the scientific basis of the hierarchical organization of the evidence and the recent challenges to it; the different robustness of data pertaining to efficacy and to safety. 2. Accessibility of the evidence relevant for the treatment of Parkinson disease. Description of the most relevant tools to bring unbiased data to the hands of the practicing physician; namely the product of Movement Disorders Cochane Review Group and the Movement Disorders Society Evidence-Based Review of Parkinson Disease treatments. The concept of management guidelines is presented along with commentaries to the potential variability of recommendations across the world. 3. Limitations of the clinical trials on Parkinson disease treatment so far available.

Background. Psychosocial impact of dysphonia in people with Parkinson disease (PD) has been described with the Voice Handicap Index (VHI); however, its psychometric properties when applied in this population are not described. Objective. The objective of this study was to examine the psychometric properties of the VHI in people with PD. Methods. A cross-sectional study of 151 subjects without cognitive impairment (90 people with PD and 61 controls) was carried out. The VHI was applied along with clinician-based (Mini Mental State Examination, Hoehn and Yahr staging, and Movement Disorder Society-Unified Parkinson’s Disease Rating Scale) and patient-based (selfrated voice severity) outcome measures. The psychometric properties of the VHI analyzed were the feasibility, reliability, and construct validity. Results. The average age of the PD population studied was 67 years; 51% had a primary level of education and 81% were retired. On average, they had disease onset duration of 11 years, a mild disease stage, mild to moderate global motor disability and impairment, and a normal to mild self-rated voice severity. The psychometric attributes of the VHI demonstrated that the questionnaire is feasible (missing data less than 1%), reliable (Cronbach α > 0.9), and valid (71.5% of the total variance is explained by five factors, correlates with voice severity, PD disability, and impairment, and differentiates subjects with PD from subjects without PD). Conclusion. The VHI is a reliable and valid tool that can be recommended for the population under study although further work is required to investigate its utility in advanced stages of disease. info:eu-repo/semantics/publishedVersion

a Clinical Pharmacology Unit, Instituto de Medicina Molecular, Lisbon, Portugal b Laboratory of Clinical Pharmacology, Faculty of Medicine, University of Lisbon, Portugal c Cardiology Department, Hospital Garcia de Orta, Almada, Portugal d Cardiology Department, CCUL, CAML, Faculty of Medicine, Lisbon, Portugal e Portuguese Collaborating Centre of the Cochrane Iberoamerican Network, Faculty of Medicine, University of Lisbon, Portugal f Evidence Based Medicine Centre, Faculty of Medicine, University of Lisbon, Portugal