Identifying comorbidities and lifestyle factors contributing to the cognitive profile of early Parkinson's disease.

BACKGROUND: Identifying modifiable risk factors for cognitive impairment in the early stages of Parkinson's disease (PD) and estimating their impact on cognitive status may help prevent dementia (PDD) and the design of cognitive trials. METHODS: Using a standard approach for the assessment of global cognition in PD and controlling for the effects of age, education and disease duration, we explored the associations between cognitive status, comorbidities, metabolic variables and lifestyle variables in 533 PD participants from the COPPADIS study. RESULTS: Among the overall sample, 21% of participants were classified as PD-MCI (n = 114) and 4% as PDD (n = 26). The prevalence of hypertension, diabetes and dyslipidemia was significantly higher in cognitively impaired patients while no between-group differences were found for smoking, alcohol intake or use of supplementary vitamins. Better cognitive scores were significantly associated with regular physical exercise (p < 0.05) and cognitive stimulation (< 0.01). Cognitive performance was negatively associated with interleukin 2 (Il2) (p < 0.05), Il6 (p < 0.05), iron (p < 0.05), and homocysteine (p < 0.005) levels, and positively associated with vitamin B12 levels (p < 0.005). CONCLUSIONS: We extend previous findings regarding the positive and negative influence of various comorbidities and lifestyle factors on cognitive status in early PD patients, and reinforce the need to identify and treat potentially modifiable variables with the intention of exploring the possible improvement of the global cognitive status of patients with PD.

Nonmotor symptom burden grading as predictor of cognitive impairment in Parkinson's disease.

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.

Beneficial effect of 24-month bilateral subthalamic stimulation on quality of sleep in Parkinson's disease.

BACKGROUND: Subthalamic nucleus (STN) deep brain stimulation (DBS) improves quality of life (QoL), motor, and sleep symptoms in Parkinson's disease (PD). However, the long-term effects of STN-DBS on sleep and its relationship with QoL outcome are unclear. METHODS: In this prospective, observational, multicenter study including 73 PD patients undergoing bilateral STN-DBS, we examined PDSleep Scale (PDSS), PDQuestionnaire-8 (PDQ-8), Scales for Outcomes in PD-motor examination, -activities of daily living, and -complications (SCOPA-A, -B, -C), and levodopa-equivalent daily dose (LEDD) preoperatively, at 5 and 24 months follow-up. Longitudinal changes were analyzed with Friedman-tests or repeated-measures ANOVA, when parametric tests were applicable, and Bonferroni-correction for multiple comparisons. Post-hoc, visits were compared with Wilcoxon signed-rank/t-tests. The magnitude of clinical responses was investigated using effect size. RESULTS: Significant beneficial effects of STN-DBS were observed for PDSS, PDQ-8, SCOPA-A, -B, and -C. All outcomes improved significantly at 5 months with subsequent decrements in gains at 24 months follow-up which were significant for PDSS, PDQ-8, and SCOPA-B. Comparing baseline and 24 months follow-up, we observed significant improvements of PDSS (small effect), SCOPA-A (moderate effect), -C, and LEDD (large effects). PDSS and PDQ-8 improvements correlated significantly at 5 and 24 months follow-up. CONCLUSIONS: In this multicenter study with a 24 months follow-up, we report significant sustained improvements after bilateral STN-DBS using a PD-specific sleep scale and a significant relationship between sleep and QoL improvements. This highlights the importance of sleep in holistic assessments of DBS outcomes.

Non-motor outcomes depend on location of neurostimulation in Parkinson's disease.

Deep brain stimulation of the subthalamic nucleus is an effective and established therapy for patients with advanced Parkinson's disease improving quality of life, motor symptoms and non-motor symptoms. However, there is a considerable degree of interindividual variability for these outcomes, likely due to variability in electrode placement and stimulation settings. Here, we present probabilistic mapping data from a prospective, open-label, multicentre, international study to investigate the influence of the location of subthalamic nucleus deep brain stimulation on non-motor symptoms in patients with Parkinson's disease. A total of 91 Parkinson's disease patients undergoing bilateral deep brain stimulation of the subthalamic nucleus were included, and we investigated NMSScale, NMSQuestionnaire, Scales for Outcomes in Parkinson's disease-motor examination, -activities of daily living, and -motor complications, and Parkinson's disease Questionnaire-8 preoperatively and at 6-month follow-up after surgery. Leads were localized in standard space using the Lead-DBS toolbox and individual volumes of tissue activated were calculated based on clinical stimulation settings. Probabilistic stimulation maps and non-parametric permutation statistics were applied to identify voxels with significant above or below average improvement for each scale and analysed using the DISTAL atlas. All outcomes improved significantly at follow-up. Significant spatial distribution patterns of neurostimulation were observed for NMSScale total score and its mood/apathy and attention/memory domains. For both domains, voxels associated with below average improvement were mainly located dorsal to the subthalamic nucleus. In contrast, above average improvement for mood/apathy was observed in the ventral border region of the subthalamic nucleus and in its sensorimotor subregion and for attention/memory in the associative subregion. A trend was observed for NMSScale sleep domain showing voxels with above average improvement located ventral to the subthalamic nucleus. Our study provides evidence that the interindividual variability of mood/apathy, attention/memory, and sleep outcomes after subthalamic nucleus deep brain stimulation depends on the location of neurostimulation. This study highlights the importance of holistic assessments of motor and non-motor aspects of Parkinson's disease to tailor surgical targeting and stimulation parameter settings to patients' personal profiles.

EuroInf 2: Subthalamic stimulation, apomorphine, and levodopa infusion in Parkinson's disease.

OBJECTIVE: Real-life observational report of clinical efficacy of bilateral subthalamic stimulation (STN-DBS), apomorphine (APO), and intrajejunal levodopa infusion (IJLI) on quality of life, motor, and nonmotor symptoms (NMS) in Parkinson's disease (PD). METHODS: In this prospective, multicenter, international, real-life cohort observation study of 173 PD patients undergoing STN-DBS (n = 101), IJLI (n = 33), or APO (n = 39) were followed-up using PDQuestionnaire-8, NMSScale (NMSS), Unified PD Rating Scale (UPDRS)-III, UPDRS-IV, and levodopa equivalent daily dose (LEDD) before and 6 months after intervention. Outcome changes were analyzed with Wilcoxon signed-rank or paired t test when parametric tests were applicable. Multiple comparisons were corrected (multiple treatments/scales). Effect strengths were quantified with relative changes, effect size, and number needed to treat. Analyses were computed before and after propensity score matching, balancing demographic and clinical characteristics. RESULTS: In all groups, PDQuestionnaire-8, UPDRS-IV, and NMSS total scores improved significantly at follow-up. Levodopa equivalent daily dose was significantly reduced after STN-DBS. Explorative NMSS domain analyses resulted in distinct profiles: STN-DBS improved urinary/sexual functions, mood/cognition, sleep/fatigue, and the miscellaneous domain. IJLI improved the 3 latter domains and gastrointestinal symptoms. APO improved mood/cognition, perceptual problems/hallucinations, attention/memory, and the miscellaneous domain. Overall, STN-DBS and IJLI seemed favorable for NMSS total score, and APO favorable for neuropsychological/neuropsychiatric NMS and PDQuestionnaire-8 outcome. CONCLUSIONS: This is the first comparison of quality of life, nonmotor. and motor outcomes in PD patients undergoing STN-DBS, IJLI, and APO in a real-life cohort. Distinct effect profiles were identified for each treatment option. Our results highlight the importance of holistic nonmotor and motor symptoms assessments to personalize treatment choices. © 2019 International Parkinson and Movement Disorder Society.

Nonmotor symptoms evolution during 24 months of bilateral subthalamic stimulation in Parkinson's disease.

BACKGROUND: The objective of this study was to investigate 24-month of effects of bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) on nonmotor symptoms in Parkinson's disease (PD). METHODS: In this prospective, observational, multicenter, international study including 67 PD patients undergoing bilateral STN-DBS, we examined the Non-motor Symptom Scale, Non-Motor Symptoms Questionnaire, Parkinson's Disease Questionnaire-8, Scales for Outcomes in Parkinson's Disease-motor examination, -activities of daily living, and -complications, and levodopa-equivalent daily dose preoperatively and at 5 and 24-month of follow-up. After checking distribution normality, longitudinal outcome changes were investigated with Friedman tests or repeated-measures analysis of variance and Bonferroni correction for multiple comparisons using multiple tests. Post hoc, Wilcoxon signed rank t tests were computed to compare visits. The strength of clinical responses was analyzed using effect size. Explorative Spearman correlations of change scores from baseline to 24-month follow-up were calculated for all outcomes. RESULTS: The Non-motor Symptom Scale and all other outcome parameters significantly improved from baseline to the 5-month follow-up. From 5 to 24-month, partial decrements in these gains were found. Nonetheless, comparing baseline with 24-month follow-up, significant improvements were observed for the Non-motor Symptom Scale (small effect), Scales for Outcomes in PD-motor examination showed a moderate effect, and Scales for Outcomes in Parkinson's Disease-complications and levodopa-equivalent daily dose showed large effects. Non-motor Symptom Scale change scores from baseline to 24-month follow-up correlated significantly with Parkinson's Disease Questionnaire-8, Scales for Outcomes in Parkinson's Disease-activities of daily living, and -motor complications change scores. CONCLUSIONS: This study provides evidence of beneficial effects of bilateral STN-DBS on nonmotor symptoms at 24-month follow-up. The extent of nonmotor symptom improvement was directly proportionate to improvements in quality of life, activities of daily living, and motor complications. This study underlines the importance of nonmotor symptoms for holistic assessments of DBS outcomes. © 2018 International Parkinson and Movement Disorder Society.

Advanced Parkinson's or "complex phase" Parkinson's disease? Re-evaluation is needed.

Holistic management of Parkinson's disease, now recognised as a combined motor and nonmotor disorder, remains a key unmet need. Such management needs relatively accurate definition of the various stages of Parkinson's from early untreated to late palliative as each stage calls for personalised therapies. Management also needs to have a robust knowledge of the progression pattern and clinical heterogeneity of the presentation of Parkinson's which may manifest in a motor dominant or nonmotor dominant manner. The "advanced" stages of Parkinson's disease qualify for advanced treatments such as with continuous infusion or stereotactic surgery yet the concept of "advanced Parkinson's disease" (APD) remains controversial in spite of growing knowledge of the natural history of the motor syndrome of PD. Advanced PD is currently largely defined on the basis of consensus opinion and thus with several caveats. Nonmotor aspects of PD may also reflect advancing course of the disorder, so far not reflected in usual scale based assessments which are largely focussed on motor symptoms. In this paper, we discuss the problems with current definitions of "advanced" PD and also propose the term "complex phase" Parkinson's disease as an alternative which takes into account a multimodal symptoms and biomarker based approach in addition to patient preference.

Diseño de una escala de medida del grado de convivencia en pacientes con un proceso crónico / Design of a measuring scale to evaluate the degree of living wth a chronic illnes, such as Parkinson´disease

INTRODUCCIÓN. Conocer cómo los pacientes conviven con un proceso crónico es necesario para proporcionar un cuidado individualizado e integral. En la actualidad, no existe ninguna escala validada que evalúe la convivencia con un proceso crónico, como es la enfermedad de Parkinson. OBJETIVOS. Los objetivos fueron: 1) definir el concepto Convivencia con un proceso crónico; 2) diseñar una escala de medición del grado de convivencia en pacientes con un proceso crónico, y en concreto, con la enfermedad de Parkinson. METODOLOGÍA. Se llevaron a cabo dos pasos metodológicos. Respecto al primero, se realizó un análisis del concepto Convivencia con un proceso crónico, a través del método evolutivo de Rodgers. El segundo paso metodológico fue el diseño de la escala, a través de la guía propuesta por DeVellis. RESULTADOS. A través del análisis de concepto se identificó que la Convivencia con un proceso crónico es un proceso complejo, dinámico, cíclico y multidimensional compuesto por los atributos de Aceptación, Afrontamiento, Automanejo, Integración y Adaptación. En cuanto a los resultados del diseño de la escala, se desarrolló una medida autocumplimentada, con cinco opciones de respuesta, tipo Likert y 27 ítems. CONCLUSIONES. La escala diseñada, es una medida innovadora y de interés potencial clínico que permite identificar qué factor o factores hacen que la persona conviva mejor o peor con la enfermedad y, consecuentemente, intervenir de manera integral, acorde con las necesidades individuales de cada persona (AU)

INTRODUCTION. Understanding how a person lives with a chronic illness is necessary to provide care according to the individual’s needs. Nowadays, there is no validated scale to measure how the person is living with a chronic condition, such as Parkinson’s disease. OBJECTIVES. The objectives were to: 1) define the concept of Living with a chronic illness; 2) design a measuring scale of the degree of Living with a chronic illness, in particular with Parkinson’s disease. METHODOLOGY. Two methodological steps were carried out. Regarding the first methodological step, a concept analysis of Living with a chronic illness was done using Rodgers’ evolutionary method. The second methodological step was the design of the scale, following DeVellis guideline. RESULTS. Through the concept analysis it was identified that Living with a chronic illness is a complex, dynamic, cyclic and multidimensional process, involving the attributes of Acceptance, Coping, Self-management, Integration and Adjustment. In relation to the design of the scale, it was developed a self-reported measure, with five Likert response options and 27 items. CONCLUSIONS. The designed scale, is an innovative measure with a high potential interest in clinical community to identify with are the factor(s) that make the person have a positive or negative living with the disease. Consequently, nurses could intervene in a holistic way, according to the patient individual needs (AU)

[Design of a Measuring Scale to Evaluate the Degree of Living with a Chonic Illness, Such as Parkinson's Disease]. / quirúrgica Diseño de una escala de medida del grado de convivencia en pacientes con un proceso crónico, como la enfermedad de Parkinson.

Introduction: Understanding how a person lives with chronic illness is necessary to provide care according to the individual's needs. Nowadays, there is no validated scale to measure how the person is living with a chronic condition, such as Parkinson's disease. Objectives: The objectives were to: 1) define the concept of Living with a chronic illness; 2) design a measuring scale of the degree of Living with a chronic illness, in particular with Parkinson's disease. Methodology: Two methodological steps were carried out. Regarding the first methodological step, a concept analysis of Living with a chronic illness was done using Rodgers' evolutionary method. the second methodological step was the design of the scale, following DeVellis guideline. Results: Through the concept analysis it was identified that Living with a chronic illness is a complex, dynamic, cyclic and multidimensional process, involving the attributes of Acceptance, Coping, Self-management, Integration and Adjustment. In relation to the design of the scale, it was developed a self-reported measure, with five Likert response options and 27 items. Conclusions: The designed scale, is an innovative measure with a high potential interest in clinical community to identify with are the factor(s) that make the person have a positive or negative living with the disease. Consequently, nurses could intervene in a holistic way, according to the patient individual needs.

Measuring the Burden of Hospitalization in Patients with Parkinson´s Disease in Spain.

INTRODUCTION: This epidemiological survey estimates the hospitalization burden related to Parkinson´s Disease in Spain. METHODS: This observational retrospective survey was performed by reviewing data from the National Surveillance System for Hospital Data, which includes more than 98% of Spanish hospitals. All hospitalizations of patients with Parkinson´s disease that were reported from 1997-2012 were analyzed. Codes were selected using the 9th International Classification of Diseases: ICD-9-CM: 332.0. RESULTS: A total of 438,513 hospital discharges of patients with Parkinson´s Disease were reported during the study period. The annual hospitalization rate was 64.2 cases per 100,000. The average length of hospital stay was 10 days. The trend for the annual hospitalization rate differed significantly depending on whether Parkinson´s disease was the main cause of hospitalization (n = 23,086, 1.14% annual increase) or was not the main cause of hospitalization (n = 415,427, 15.37% annual increase). The overall case-fatality rate among hospitalized patients was 10%. The case fatality rate among patient´s hospitalized with Parkinson´s disease as the main cause of hospitalization was 2.5%. The hospitalization rate and case-fatality rate significantly increased with age. The primary causes of hospitalization when Parkinson´s disease was not coded as the main cause of hospitalization were as follows: respiratory system diseases (24%), circulatory system diseases (19%), injuries and poisoning, including fractures (12%), diseases of the digestive system (10%) and neoplasms (5%). The annual average cost for National Health Care System was € 120 M, with a mean hospitalization cost of €4,378. CONCLUSIONS: Parkinson´s disease poses a significant health threat in Spain, particularly in the elderly. While hospitalizations due to Parkinson´s Disease are relatively stable over time, the number of patients presenting with Parkinson´s disease as an important comorbidity has increased dramatically. Medical staff must be specifically trained to treat the particular needs of hospitalized patients suffering from Parkinson´s disease as an important comorbidity.

Social robots in advanced dementia.

AIMS: Pilot studies applying a humanoid robot (NAO), a pet robot (PARO) and a real animal (DOG) in therapy sessions of patients with dementia in a nursing home and a day care center. METHODS: In the nursing home, patients were assigned by living units, based on dementia severity, to one of the three parallel therapeutic arms to compare: CONTROL, PARO and NAO (Phase 1) and CONTROL, PARO, and DOG (Phase 2). In the day care center, all patients received therapy with NAO (Phase 1) and PARO (Phase 2). Therapy sessions were held 2 days per week during 3 months. Evaluation, at baseline and follow-up, was carried out by blind raters using: the Global Deterioration Scale (GDS), the Severe Mini Mental State Examination (sMMSE), the Mini Mental State Examination (MMSE), the Neuropsychiatric Inventory (NPI), the Apathy Scale for Institutionalized Patients with Dementia Nursing Home version (APADEM-NH), the Apathy Inventory (AI) and the Quality of Life Scale (QUALID). Statistical analysis included descriptive statistics and non-parametric tests performed by a blinded investigator. RESULTS: In the nursing home, 101 patients (Phase 1) and 110 patients (Phase 2) were included. There were no significant differences at baseline. The relevant changes at follow-up were: (Phase 1) patients in the robot groups showed an improvement in apathy; patients in NAO group showed a decline in cognition as measured by the MMSE scores, but not the sMMSE; the robot groups showed no significant changes between them; (Phase 2) QUALID scores increased in the PARO group. In the day care center, 20 patients (Phase 1) and 17 patients (Phase 2) were included. The main findings were: (Phase 1) improvement in the NPI irritability and the NPI total score; (Phase 2) no differences were observed at follow-up.

Fiabilidad y validez de la batería de evaluación del deterioro grave, versión abreviada (SIB-s), en pacientes con demencia en España / Reliability and validity of the Severe Impairment Battery, short form (SIB-s), in patients with dementia in Spain

Introducción. Las personas con demencia progresiva evolucionan hacia un estado donde los tests neuropsicológicos tradicionales dejan de ser eficaces. La batería de evaluación del deterioro grave, en su forma completa (SIB) y abreviada (SIB-s), se desarrolló para evaluar el estado cognitivo de pacientes con demencia avanzada. Objetivo. Evaluar los atributos psicométricos de la SIB-s en población española. Pacientes y métodos. Estudio transversal de 127 pacientes con demencia (86,6%, mujeres; edad media: 82,6 ± 7,5 años) evaluados con la SIB-s y las siguientes medidas: escala de deterioro global, miniexamen cognitivo (MEC), miniexamen del estado mental grave (sMMSE), índice de Barthel y escala del estado funcional. Resultados. La puntuación media total de la SIB-s fue de 19,1 ± 15,34 (rango: 0-48). Efectos suelo y techo < 20%. El análisis factorial identificó un único factor que explica el 68% de la varianza total de la escala. La consistencia interna fue alta (α de Cronbach: 0,96). La correlación ítem-total corregida osciló entre 0,27 y 0,83, y la homogeneidad de los ítems fue de 0,43. La fiabilidad test-retest e interevaluador fue satisfactoria (coeficiente de correlación intraclase: 0,96 y 0,95, respectivamente), así como la validez de constructo convergente con otras medidas cognitivas (MEC: 0,83; sMMSE: 0,9). La SIB-s mostró una correlación moderada con escalas cognitivas de dependencia funcional (índice de Barthel: 0,48; FAST: –0,74). El error estándar de la medida fue de 3,07 para el total de la escala. Conclusiones. La SIB-s es un instrumento fiable y válido, relativamente breve, para evaluar a pacientes con demencia avanzada en la población española (AU)

Introduction. People with progressive dementia evolve into a state where traditional neuropsychological tests are not effective. Severe Impairment Battery (SIB) and short form (SIB-s) were developed for evaluating the cognitive status in patients with severe dementia. Aim. To evaluate the psychometric attributes of the SIB-s in patients with severe dementia. Patients and methods. 127 institutionalized patients (female: 86.6%; mean age: 82.6 ± 7.5 years-old) with dementia were assessed with the SIB-s, the Global Deterioration Scale (GDS), Mini-Mental State Examination (MMSE), Severe Mini- Mental State Examination (sMMSE), Barthel Index and FAST. Results. SIB-s acceptability, reliability, validity and precision were analyzed. The mean total score for scale was 19.1 ± 15.34 (range: 0-48). Floor effect was 18.1%, only marginally higher than the desirable 15%. Factor analysis identified a single factor explaining 68% of the total variance of the scale. Cronbach’s α coefficient was 0.96 and the item-total corrected correlation ranged from 0.27 to 0.83. The item homogeneity value was 0.43. Test-retest and inter-rater reliability for the total score was satisfactory (ICC: 0.96 and 0.95, respectively). The SIB-s showed moderate correlation with functional dependency scales (Barthel Index: 0.48, FAST: –0.74). Standard error of measurement was 3.07 for the total score. Conclusions. The SIB-s is a reliable and valid instrument for evaluating patients with severe dementia in the Spanish population of relatively brief instruments (AU)

Motor effects of radio electric asymmetric conveyer in Alzheimer's disease: results from a cross-over trial.

We conducted a randomized, cross-over trial to investigate the feasibility, safety, and motor effects of brain stimulation with radio electric asymmetric conveyer (REAC) technique in patients with Alzheimer's disease (AD). Neuropostural optimization (NPO) and sham protocol were administered to 60 patients from the nursing home and day care units of the Alzheimer Center Reina Sofía Foundation. The mean age was 84.1 (SD 7.9) years and 86.7% of the subjects were female. Motor measures were collected at baseline (T1), immediately (T2), seven (T3), and 11 days (T4) after treatment and, following cross-over, immediately (T5), seven (T6), and 11 (T7) days after treatment. Close safety surveillance was conducted from seven days before T1 to the end of the study (T7), with total study duration of 35 days. Wilcoxon test was utilized in the efficacy analysis, considering T1 and T5 as independent baseline assessments and using a threshold of p < 0.05 (corrected) for statistical significance. The NPO protocol was easily administered and well accepted by the participants. Axial movements improved at T3 and T4 after NPO and at T2 after sham NPO, but no significant effects were observed in axial movements in the second phase of the trial. The effects of NPO in gait performance were not consistent. There were six falls between T2 and T7, but only two of them occurred in patients who had received NPO. In light of safety and feasibility of REAC, a trial with the more intense neuropsycho-physical optimization protocol is warranted.

Perceptions of symptoms and expectations of advanced therapy for Parkinson's disease: preliminary report of a Patient-Reported Outcome tool for Advanced Parkinson's disease (PRO-APD).

BACKGROUND: What do patients expect from a treatment? A patient-centred approach to treatment is becoming necessary given the choices for invasive treatments for Parkinson's disease. Patient's perceptions of severity and expectations from complex therapies have not been studied. We describe the rationale and concept of developing a Patient-Reported Outcome (PRO) tool to assess perceptions of symptom severity and expectations of therapy. We report preliminary findings from use of the tool, association with clinical factors, and illustrate the potential use in individual patients awaiting therapy. METHODS: Patient symptoms were grouped into four domains, with 8 motor, 7 non-motor, 7 psychological and 4 social questions. For each question, symptom severity was rated on a Likert scale scoring from 0 (no problem) to 7 (perceived as a severe problem). Similarly, the expectation for each symptom to change after therapy was rated on a Likert scale: score -3 (expected to be very much worse) to + 3 (expected to be very much improved). RESULTS: 22 consecutive patients, routinely planned to receive one of Deep Brain Stimulation/Intrajejunal Levodopa Infusion/Apomorphine Infusion therapies, were recruited: 13 male, mean (+/-sd) age: 65.6 (+/-9.5) years, mean (+/-sd) disease duration: 14.3 (+/-5.7) years. Subjective severity scores are reported as mean (+/-sd) / maximum possible score: (i) motor 23.5 (+/-7.5) / 56, (ii) non-motor 15.5 (+/-5.6) / 49, (iii) cognitive - psychological 12.4 (+/-5.8) / 49, (iv) social 9.3 (+/-4.1) / 28. Expectation of change (improvement) scores are reported as mean (+/-sd) / maximum possible score of: (i) motor 14.0 (+/-5.6) / 24, (ii) non-motor 8.5 (+/-4.1) / 21, (iii) cognitive - psychological 7.4 (+/-4.4)/ 21, and (iv) social 5.5 (+/-2.8) / 12. For each domain, Spearman correlation coefficient showed significant associations between severity and expectation within-domain. CONCLUSION: This tool (PRO-APD) provides a description of perceived problem severity and expectation of treatments encompassing a holistic patient-driven view of care. PD patients about to receive complex therapy have moderately high perception of symptom load in multiple domains, and expect substantial improvements in multiple domains. These preliminary findings may be useful in documenting multi-domain symptoms, as well as counseling patients to help them reach realistic expectations and reduce potential dissatisfaction following therapy.

Instruments for holistic assessment of Parkinson's disease.

Assessment of Parkinson's disease is a complex matter as a consequence of the variety of manifestations and complications that can be present in a patient. Although a really holistic assessment is probably a utopia, a comprehensive evaluation is possible using a combination of measures completed by health professionals, patients and/or caregivers. In PD, main domains requiring assessment include motor impairment, motor complications, non-motor symptoms, disability, and patient-reported outcomes. Such scales like the Movement Disorder Society-Unified Parkinson's Disease Rating Scale and the battery of Scales for Outcomes in Parkinson's disease (SCOPA) provide a wide information on the most relevant aspects of the disease. Hoehn and Yahr staging, global impression, and quality of life measures furnish summarized whole evaluations and comprehensive non-motor symptom assessments help to identify and evaluate this kind of manifestations. This article shows a pragmatic review of common instruments (rating scales and questionnaires) usable for a comprehensive assessment of PD and provides information about sources for guiding the selection of measures and outcome analyses.

Rasch analysis of the International Wellbeing Index in older adults.

BACKGROUND: The International Wellbeing Index is a measure of general quality of life formed by two scales: the Personal Wellbeing Index (PWI) and the National Wellbeing Index (NWI). This paper studies the psychometric properties of the PWI and NWI, using Rasch analysis and classic psychometric methods. METHODS: The PWI and NWI were applied to a representative sample of 1106 community-dwelling adults, aged 60 years and over, residing in Spain. Mean ± standard deviation age was 72.07 ± 7.83 years and 56.3% were women. RESULTS: Five PWI items (achieving in life, relationships, safety, community connectedness, and future security), and five NWI items (economic situation, state of environment, social conditions, business, and national security of the country) fitted the Rasch model. After adjusting the response scale format, satisfactory fit was obtained, with good reliability (person separation index of 0.91 for both the PSI and NWI), local independency of items, and strict unidimensionality. The measures showed adequate external construct validity with related measures. CONCLUSIONS: The PWI and the NWI, with fewer items and simpler response scale formats, provided valid and reliable linear measures in older adults, according to Rasch and classic psychometric analyses.

The impact of non-motor symptoms on health-related quality of life of patients with Parkinson's disease.

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.

Bilateral subthalamic nucleus stimulation and quality of life in advanced Parkinson's disease.

We examined the impact of the subthalamic nuclei (STN) deep brain stimulation (DBS) on the health-related quality of life (QoL) of patients with advanced Parkinson's disease (PD). Seventeen consecutive patients with refractory motor fluctuations and dyskinesia were included in the study (mean age, 60.9 +/- 7.7 years [range, 43-74 years]; disease duration, 16.4 +/- 8.5 years [range, 7-38 years]; mean off-medication Hoehn and Yahr stage, 4.23 +/- 0.66 [range, 2.5-5]). Each patient's assessment was carried out using common rating scales, following the Core Assessment Program for Intracerebral Transplantation (CAPIT) protocol. Dyskinesia and emotional state were evaluated through the Abnormal Involuntary Movement Scale (AIMS) and the Hospital Anxiety and Depression Scale (HAD). QoL was assessed by means of the Parkinson's Disease Questionnaire Spanish version (PDQ-39). Significant benefit was obtained in the motor manifestations and complications of disease, as well as in the functional state and mood (P < 0.001). Some QoL dimensions (mobility and activities of daily living) and the PDQ-39 Summary Index (PDQ-39SI) showed a significant improvement (P < 0.001). Benefit was modest (P < 0.05) for three other domains (emotional well-being, stigma, bodily discomfort) and nil for the rest. There was no correlation between the change obtained in the QoL (PDQ-39SI) and in the other variables. As measured by the PDQ-39, STN-DBS significantly improves important aspects of QoL in patients with advanced PD.