Authors: Diego Santos García 1, Nuria López Ariztegui 2, Esther Cubo 3, Ana Vinagre Aragón 4, Rosario García Ramos 5, Carmen Borrué 6, Gustavo Fernández Pajarín 7, Nuria Caballol 8, Iria Cabo 9, Jose Barrios López 10, Jorge Hernández Vara 11, Maria Avila 12, Carmen Gasca Salas 13, Sonia Escalante 14, Pablo Manrique 15, Rafael Pérez Noguera 16, María Álvarez Sauco 17, María Sierra 18, Mariana Monje 13, Álvaro Sánchez Ferro 13, Sabela Novo 19, Fernando Alonso 5, Daniel Macías 20, Inés Legarda 21, Ana Rojo 22, Ignacio Fernández 23, María Buongiorno 23, Pau Pastor 23, Pedro García Ruíz 24
1CHUAC (Complejo Hospitalario Universitario de A Coruña), A Coruña, Spain, 2Complejo Hospitalario de Toledo, Toledo, Spain, 3Complejo Asistencial Universitario de Burgos, Burgos, Spain, 4Hospital Donostia, San Sebastián, Spain, 5Hospital Universitario Clínico San Carlos, Madrid, Spain, 6Hospital Infanta Sofía, Madrid, Spain, 7CHUS (Complejo Hospitalario Universitario de Santiago de Compostela), Santiago de Compostela, Spain, 8Consorci Sanitari Integral, Hospital Moisés Broggi, Sant Joan Despí, Barcelona, Spain, 9Complejo Hospitalario Universitario de Pontevedra (CHOP), Pontvedra, Spain, 10Hospital Virgen de las Nieves, Granada, Spain, 11Hospital Universitario Vall d´Hebron, Barcelona, Spain, 12Consorci Sanitari Integral, Hospital General de L´Hospitalet, L´Hospitalet de Llobregat, Barcelona, Spain, 13CINAC, Hospital Puerta del Sur, Madrid, Spain, 14Hospital de Tortosa Verge de la Cinta (HTVC), Tortosa, Tarragona, Spain, 15Clínica Universitaria de Navarra, Pamplona, Spain, 16Hospital Universitario Virgen Macarena, Sevilla, Spain, 17Hospital General Universitario de Elche, Elche, Spain, 18Hospital Universitario Marqués de Valdecilla, Santander, Spain, 19Hospital Universitario Puerta de Hierro, Madrid, Spain, 20Hospital Universitario Virgen del Rocío, Sevilla, Spain, 21Hospital Universitario Son Espases, Palma de Mallorca, Spain, 22Hospital Universitario Príncipe de Asturias, Madrid, Spain, 23Hospital Universitari Mutua de Terrassa, Barcelona, Spain, 24Hospital Fundación Jiménez Díaz, Madrid, Spain
Objective: To analyze the opinion of different neurologists from Spain about the STAT-ON tool after using the device in a real clinical practice setting (RCPS).
Background: The identification of motor fluctuations in Parkinson´s disease (PD) patients is important for PD treatment but not straightforward. STAT-ON is an objective tool that registers ON-OFF fluctuations making possible to know the state of the patient for a week (1,2).
Methods: CE Mark Medical Device STAT-ON was provided by the Company Sense4Care to Spanish neurologists for using it in a RCPS. All neurologists were expert on PD. Each neurologist had the device for at least 3 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. The data was anonymized and 3 waves were made to obtain the responses.
Results: A total of 27 surveys were received (51.9% females; mean age 44.9 ± 9 years old). Two thirds of the neurologists worked in a Movement Disorders Unit, the mean experience on PD was of 16 ± 6.9 years, and 59.3% of them had used previous different devices for PD. A total of 119 evaluations in 114 patients (range from 2 to 9 per neurologist; mean 4.5 ± 2.3) were performed. Using a score from 1 (unhelpful) to 7 (very helpful), the opinion about different usability aspects was recorded (Table 1). The subjective general opinion about the device (from 0, the worst, to 10, the best) was 6.9 ± 1.7. STAT-ON was considered better than the diaries by 70.3% of the neurologists (Figure 1A) and a useful tool for identification of advanced PD patients by 81.5%. A high percentage of PD patients were considered that could benefit from using STAT-ON (Figure 1B). STAT-ON was considered from quite to very useful by 74% of the neurologists (Figure 1C). A correlation was observed between the number of assessments performed and the opinion about the device (r=0.403; p=0.046). Proper identification of FOG episodes and falls were the most frequent limitations reported.
Conclusions: STAT-ON could be a useful device for using in PD patients in clinical practice.