ABSTRACT
BACKGROUND: STAT-ON™ is an objective tool that registers ON-OFF fluctuations making possible to know the state of the patient at every moment of the day in normal life. Our aim was to analyze the opinion of different Parkinson's disease experts about the STAT-ON™ tool after using the device in a real clinical practice setting (RCPS). METHODS: STAT-ON™ was provided by the Company Sense4Care to Spanish neurologists for using it in a RCPS. Each neurologist had the device for at least three months and could use it in PD patients at his/her own discretion. In February 2020, a survey with 30 questions was sent to all participants. RESULTS: Two thirds of neurologists (53.8% females; mean age 44.9±9 years old) worked in a Movement Disorders Unit, the average experience in PD was 16±6.9 years, and 40.7% of them had previously used other devices. A total of 119 evaluations were performed in 114 patients (range 2-9 by neurologist; mean 4.5±2.3). STAT-ON™ was considered "quite" to "very useful" by 74% of the neurologists with an overall opinion of 6.9±1.7 (0, worst; 10, best). STAT-ON™ was considered better than diaries by 70.3% of neurologists and a useful tool for the identification of patients with advanced PD by 81.5%. Proper identification of freezing of gait episodes and falls were frequent limitations reported. CONCLUSION: STAT-ON™ could be a useful device for using in PD patients in clinical practice.
Subject(s)
Gait Disorders, Neurologic , Parkinson Disease , Humans , Male , Female , Adult , Middle Aged , Expert Testimony , Surveys and Questionnaires , NeurologistsABSTRACT
Background: STAT-ON TM is an objective tool that registers ON-OFF fluctuations making possibleto know the state of the patient at every moment of the day in normal life. Our aim was toanalyze the opinion of different Parkinsons disease experts about the STAT-ON TM tool afterusing the device in a real clinical practice setting (RCPS). Methods: STAT-ON TM was provided by the Company Sense4Care to Spanish neurologists for usingit in a RCPS. Each neurologist had the device for at least three months and could use it in PDpatients at his/her own discretion. In February 2020, a survey with 30 questions was sent to allparticipants. Results: Two thirds of neurologists (53.8% females; mean age 44.9 ± 9 years old) worked ina Movement Disorders Unit, the average experience in PD was 16 ± 6.9 years, and 40.7% ofthem had previously used other devices. A total of 119 evaluations were performed in 114patients (range 29 by neurologist; mean 4.5 ± 2.3). STAT-ON TM was considered quite tovery useful by 74% of the neurologists with an overall opinion of 6.9 ± 1.7 (0, worst; 10,best). STAT-ON TM was considered better than diaries by 70.3% of neurologists and a useful toolfor the identification of patients with advanced PD by 81.5%. Proper identification of freezingof gait episodes and falls were frequent limitations reported. Conclusion: STAT-ON TM could be a useful device for using in PD patients in clinical practice.(AU)
Introducción: STAT-ON es un dispositivo que registra las fluctuaciones on-off que permiteconocer el estado del paciente con enfermedad de Parkinson (EP) en cada momento del día.Nuestro objetivo fue analizar la opinión de diferentes expertos en EP sobre STAT-ON, después de usar el dispositivo en un entorno de práctica clínica real (PCR). Métodos: STAT-ON fue proporcionado por la compa ̃nía Sense4Care a neurólogos espa ̃noles para usarlo en PCR. Cada neurólogo dispuso del dispositivo durante al menos tres meses y podíausarlo en pacientes con EP, según su criterio. En febrero de 2020, se envió una encuesta con 30 preguntas a todos los participantes. Resultados: Dos tercios de los neurólogos (53,8% mujeres; edad promedio 44,9 ± 9 a ̃nos) trabajaban en una Unidad de Trastornos del Movimiento, con una experiencia en EP de 16 ± 6,9 a ̃nos, habiendo el 40,7% usado otros dispositivos previamente. Se realizaron un total de 119evaluaciones en 114 pacientes (rango dos a nueve por neurólogo; media 4,5 ± 2,3). STAT-ONfue considerado «bastante» a «muy útil» por el 74% de los neurólogos, con una opinión generalde 6,9 ± 1,7 (0, peor; 10, mejor). STAT-ON fue considerado mejor que los diarios por el 70,3% de los neurólogos y una herramienta útil para la identificación de pacientes con EP avanzadapor un 81,5%. La identificación adecuada de los episodios de congelación de la marcha y lascaídas fueron las limitaciones más reportadas.Conclusiones: STAT-ON podría ser un dispositivo útil para usar en la PCR.(AU)
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Parkinson Disease/complications , 34628 , Neurologists , Electrocardiography, Ambulatory , Expert Testimony , Neurology , Nervous System Diseases , Surveys and Questionnaires , Movement DisordersABSTRACT
Opicapone is a catechol-O-methyl-transferase (iCOMT) inhibitor authorized in Europe in 2016 and indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. The efficacy of opicapone in these patients has been demonstrated in two pivotal randomized clinical trials, BIPARK I and BIPARK II, in which it has demonstrated its superiority versus placebo and non-inferiority versus entacapone. Although they constitute the gold standard for the evaluation of interventions, randomized clinical trials present limitations of external validity due to the use of strict eligibility criteria. Therefore, it is considered necessary to have a more comprehensive evaluation of the efficacy of the drug, complementing the information obtained from randomized clinical trials with that of "real world or real clinical practice" studies. The objective of this review has been to collect and put into perspective the information available on opicapone coming from real clinical practice studies in Spain. The data from Spain with opicapone in 18 series with more than 1,000 patients in total, confirm the safety and efficacy previously reported with this iCOMT. Furthermore, they show that opicapone is especially useful in patients with a less advanced stage of the disease and mild motor fluctuations, which would suggest that the earlier its introduction in the therapeutic scheme for the management of motor fluctuations, the better is the benefit-risk ratio for the drug.
TITLE: Opicapona para el tratamiento de la enfermedad de Parkinson: datos de vida real en España.Resumen. La opicapona es un inhibidor de la catecol-O-metiltransferasa (iCOMT) autorizado en Europa en 2016 como terapia adyuvante a las preparaciones de levodopa/inhibidores de la dopa descarboxilasa en pacientes adultos con enfermedad de Parkinson y fluctuaciones motoras de final de dosis que no puedan ser estabilizados con esas combinaciones. La eficacia de la opicapona en estos pacientes ha sido demostrada en dos ensayos clínicos pivotales, BIPARK I y BIPARK II, en los que se ha demostrado la superioridad frente al placebo y la no inferioridad frente a la entacapona. A pesar de que constituyen el estándar para la evaluación de intervenciones, los ensayos clínicos aleatorizados presentan limitaciones de validez externa debidas a la utilización de criterios estrictos de elegibilidad. Por tanto, se considera necesario disponer de una evaluación más amplia de la eficacia general del fármaco, complementando la información de los ensayos clínicos aleatorizados con estudios de 'vida real o práctica clínica real'. El objetivo de esta revisión ha sido recopilar y poner en perspectiva la información disponible sobre los resultados de la opicapona en estudios de práctica clínica real en España. Los datos acumulados en España con opicapona en 18 series con más de 1.000 pacientes confirman la seguridad y la eficacia de este iCOMT comunicadas previamente. Además, muestran que la opicapona es especialmente útil en pacientes en un estadio de la enfermedad menos avanzado y fluctuaciones motores leves, lo que sugeriría una mejor relación beneficio-riesgo cuanto más temprana sea su introducción en el esquema terapéutico para el tratamiento de las fluctuaciones motoras.
Subject(s)
Antiparkinson Agents/therapeutic use , Catechol O-Methyltransferase Inhibitors/therapeutic use , Oxadiazoles/therapeutic use , Parkinson Disease/drug therapy , Antiparkinson Agents/administration & dosage , Antiparkinson Agents/adverse effects , Combined Modality Therapy , Deep Brain Stimulation , Drug Therapy, Combination , Humans , Levodopa/administration & dosage , Levodopa/therapeutic use , Oxadiazoles/administration & dosage , Oxadiazoles/adverse effects , Parkinson Disease/therapy , Quality of Life , Randomized Controlled Trials as Topic , Retrospective Studies , Risk Assessment , Spain , Treatment OutcomeABSTRACT
BACKGROUND: STAT-ON™ is an objective tool that registers ON-OFF fluctuations making possible to know the state of the patient at every moment of the day in normal life. Our aim was to analyze the opinion of different Parkinson's disease experts about the STAT-ON™ tool after using the device in a real clinical practice setting (RCPS). METHODS: STAT-ON™ was provided by the Company Sense4Care to Spanish neurologists for using it in a RCPS. Each neurologist had the device for at least three months and could use it in PD patients at his/her own discretion. In February 2020, a survey with 30 questions was sent to all participants. RESULTS: Two thirds of neurologists (53.8% females; mean age 44.9±9 years old) worked in a Movement Disorders Unit, the average experience in PD was 16±6.9 years, and 40.7% of them had previously used other devices. A total of 119 evaluations were performed in 114 patients (range 2-9 by neurologist; mean 4.5±2.3). STAT-ON™ was considered "quite" to "very useful" by 74% of the neurologists with an overall opinion of 6.9±1.7 (0, worst; 10, best). STAT-ON™ was considered better than diaries by 70.3% of neurologists and a useful tool for the identification of patients with advanced PD by 81.5%. Proper identification of freezing of gait episodes and falls were frequent limitations reported. CONCLUSION: STAT-ON™ could be a useful device for using in PD patients in clinical practice.
ABSTRACT
The neurological toxicity of many antibiotics has been reported in a number of articles and clinical notes. In this review antibiotics are classified according to the physiopathogenic mechanism that can give rise to a gait disorder, taking both clinical and experimental data into account. An exhaustive search was conducted in Google Scholar and PubMed with the aim of finding reviews, articles and clinical cases dealing with gait disorders secondary to different antibiotics. The different antibiotics were separated according to the physiopathogenic mechanism that could cause them to trigger a gait disorder. They were classified into antibiotics capable of producing cerebellar ataxia, vestibular ataxia, sensitive ataxia or an extrapyramidal gait disorder. The main aim was to group all the drugs that can give rise to a gait disorder, in order to facilitate the clinical suspicion and, consequently, the management of patients.
TITLE: Antibioticos y trastornos de la marcha.La toxicidad neurologica de muchos antibioticos se ha documentado en numerosos articulos y notas clinicas. En esta revision se clasifican los antibioticos en funcion del mecanismo fisiopatogenico por el que pueden provocar un trastorno de la marcha, teniendo en cuenta tanto datos clinicos como experimentales. Se ha realizado una busqueda exhaustiva en Google Scholar y PubMed con el objetivo de encontrar revisiones, articulos y casos clinicos acerca de trastornos de la marcha secundarios a distintos antibioticos. Se han separado los diferentes antibioticos en funcion del mecanismo fisiopatogenico por el cual podrian producir una alteracion de la marcha. Se han clasificado en antibioticos capaces de producir ataxia cerebelosa, ataxia vestibular, ataxia sensitiva o un trastorno de la marcha extrapiramidal. El principal objetivo era agrupar todos los farmacos que pueden provocar un trastorno de la marcha, para facilitar la sospecha clinica y, en consecuencia, el tratamiento de los pacientes.
