Clinical utility of a personalized and long-term monitoring device for Parkinson's disease in a real clinical practice setting: An expert opinion survey on STAT-ON™

Neu ología 38 (2023) 326—333 NEUROLOGÍA www.else ie .es/neu ologia ORIGINAL ARTICLE Clinical u ili y o a pe sonalized and long- e m moni o ing de ice o Pa kinson’s disease in a eal clinical p ac ice se ing: An expe opinion su ey on STAT-ONTM D. San os Ga cíaa,∗, N. López A iz eguib, E. Cuboc, A. Vinag e A agónd, R. Ga cía-Ramose, C. Bo ué , G. Fe nández-Paja íng, N. Caballolh, I. Caboi, J.M. Ba ios-Lópezj, J. He nández Va a k, M.A. Á ila Ri e al, C. Gasca-Salasm, S. Escalan en, P. Man ique de La ao, R. Pé ez Nogue ap, M. Ál a ez Saucoq, M. Sie a , M.H.G. Monjem, A. Sánchez Fe om, S. No o Pon es, F. Alonso-F eche, D. Macías-Ga cía , I. Lega dau, A. Rojo , I. Ál a ez Fe nándezw, M.T. Buongio now, P. Pas o w, P. Ga cía Ruízx aCHUAC, Complejo Hospi ala io Uni e si a io de A Co u˜ na, Spain bComplejo Hospi ala io de Toledo, Toledo, Spain cComplejo Asis encial Uni e si a io de Bu gos, Bu gos, Spain dHospi al Donos ia, San Sebas ián, Spain eHospi al Clínico San Ca los, Mad id, Spain Hospi al In an a So ía, Mad id, Spain gComplejo Hospi ala io Uni e si a io de San iago de Compos ela (CHUS), Spain hConso ci Sani a i In eg al, Hospi al Moisés B oggi, San Joan Despí, Ba celona, Spain iComplejo Hospi ala io Uni e si a io de Pon e ed a (CHOP), Pon e ed a, Spain jHospi al Uni e si a io Vi gen de las Nie es, G anada, Spain kHospi al Uni e si a io Vall d’Heb on, Ba celona, Spain lConso ci Sani a i In eg al, Hospi al Gene al de L’Hospi ale , L’Hospi ale de Llob ega , Ba celona, Spain mCINAC, Hospi al Pue a del Su , Mad id, Spain nHospi al de To osa Ve ge de la Cin a (HTVC), To osa, Ta agona, Spain oClínica Uni e sidad de Na a a, Pamplona, Spain pHospi al Uni e si a io Vi gen Maca ena, Se illa, Spain qHospi al Uni e si a io de Elche, Spain Hospi al Uni e si a io Ma qués de Valdecilla, San ande , Spain sHospi al Pue a de Hie o, Mad id, Spain Hospi al Uni e si a io Vi gen del Rocío, Se illa, Spain uHospi al Uni e si a io Son Espases, Palma de Mallo ca, Spain Hospi al Uni e si a io P íncipe de As u ias, Alcalá de Hena es, Mad id, Spain wHospi al Uni e si a i Mu ua de Te assa, Te assa, Ba celona, Spain xHospi al Fundación Jiménez Díaz, Mad id, Spain Recei ed 6 Augus 2020; accep ed 5 Oc obe 2020 A ailable online 25 Decembe 2020 ∗Co esponding au ho . E-mail add ess: [email p o ec ed] (D. San os Ga cía). h ps://doi.o g/10.1016/j.n l.2020.10.013 0213-4853/© 2020 Sociedad Espa˜ nola de Neu olog´ ıa. Published by Else ie Espa˜ na, S.L.U. This is an open access a icle unde he CC BY-NC-ND license (h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/). Neu ología 38 (2023) 326—333 KEYWORDS De ice; Fluc ua ions; Hol e ; Moni o ing; Mo o complica ions; Pa kinson’s disease Abs ac Backg ound: STAT-ONTM is an objec i e ool ha egis e s ON-OFF fluc ua ions making possible o know he s a e o he pa ien a e e y momen o he day in no mal li e. Ou aim was o analyze he opinion o di e en Pa kinson’s disease expe s abou he STAT-ONTM ool a e using he de ice in a eal clinical p ac ice se ing (RCPS). Me hods: STAT-ONTM was p o ided by he Company Sense4Ca e o Spanish neu ologis s o using i in a RCPS. Each neu ologis had he de ice o a leas h ee mon hs and could use i in PD pa ien s a his/he own disc e ion. In Feb ua y 2020, a su ey wi h 30 ques ions was sen o all pa icipan s. Resul s: Two hi ds o neu ologis s (53.8% emales; mean age 44.9 ± 9 yea s old) wo ked in a Mo emen Diso de s Uni , he a e age expe ience in PD was 16 ± 6.9 yea s, and 40.7% o hem had p e iously used o he de ices. A o al o 119 e alua ions we e pe o med in 114 pa ien s ( ange 2—9 by neu ologis ; mean 4.5 ± 2.3). STAT-ONTM was conside ed ‘‘qui e’’ o ‘‘ e y use ul’’ by 74% o he neu ologis s wi h an o e all opinion o 6.9 ± 1.7 (0, wo s ; 10, bes ). STAT-ONTM was conside ed be e han dia ies by 70.3% o neu ologis s and a use ul ool o he iden ifica ion o pa ien s wi h ad anced PD by 81.5%. P ope iden ifica ion o eezing o gai episodes and alls we e equen limi a ions epo ed. Conclusion: STAT-ONTM could be a use ul de ice o using in PD pa ien s in clinical p ac ice. © 2020 Sociedad Espa˜ nola de Neu olog´ ıa. Published by Else ie Espa˜ na, S.L.U. This is an open access a icle unde he CC BY-NC-ND license (h p://c ea i ecommons.o g/licenses/by-nc-nd/ 4.0/). PALABRAS CLAVE Disposi i o; Fluc uaciones; Hol e ; Moni o eo; Complicaciones mo o as; En e medad de Pa kinson U ilidad clínica del disposi i o pa a la moni o ización pe sonalizada de la en e medad de Pa kinson, STAT-ON, en condiciones de p ác ica clínica dia ia: esul ados de una encues a de opinión de neu ólogos expe os Resumen In oducción: STAT-ON es un disposi i o que egis a las fluc uaciones on-o que pe mi e conoce el es ado del pacien e con en e medad de Pa kinson (EP) en cada momen o del día. Nues o obje i o ue analiza la opinión de di e en es expe os en EP sob e STAT-ON, después de usa el disposi i o en un en o no de p ác ica clínica eal (PCR). Mé odos: STAT-ON ue p opo cionado po la compa˜ nía Sense4Ca e a neu ólogos espa˜ noles pa a usa lo en PCR. Cada neu ólogo dispuso del disposi i o du an e al menos es meses y podía usa lo en pacien es con EP, según su c i e io. En eb e o de 2020, se en ió una encues a con 30 p egun as a odos los pa icipan es. Resul ados: Dos e cios de los neu ólogos (53,8% muje es; edad p omedio 44,9 ± 9 a˜ nos) a- bajaban en una Unidad de T as o nos del Mo imien o, con una expe iencia en EP de 16 ± 6,9 a˜ nos, habiendo el 40,7% usado o os disposi i os p e iamen e. Se ealiza on un o al de 119 e aluaciones en 114 pacien es ( ango dos a nue e po neu ólogo; media 4,5 ± 2,3). STAT-ON ue conside ado «bas an e» a «muy ú il» po el 74% de los neu ólogos, con una opinión gene al de 6,9 ± 1,7 (0, peo ; 10, mejo ). STAT-ON ue conside ado mejo que los dia ios po el 70,3% de los neu ólogos y una he amien a ú il pa a la iden ificación de pacien es con EP a anzada po un 81,5%. La iden ificación adecuada de los episodios de congelación de la ma cha y las caídas ue on las limi aciones más epo adas. Conclusiones: STAT-ON pod ía se un disposi i o ú il pa a usa en la PCR. © 2020 Sociedad Espa˜ nola de Neu olog´ ıa. Publicado po Else ie Espa˜ na, S.L.U. Es e es un a ´ ıculo Open Access bajo la licencia CC BY-NC-ND (h p://c ea i ecommons.o g/licenses/by- nc-nd/4.0/). In oduc ion The symp oma ic ea men o Pa kinson’s disease (PD) wi h cu en he apies is e ec i e. Howe e , o e ime, mo o complica ions appea , impac ing on he pa ien ’s quali y o li e and he au onomy o pe o ming daily-li ing ac i i ies. Al hough p e ious epo s demons a ed ha app oxima ely 40% o PD pa ien s who we e ea ed wi h le odopa o 4—6 yea s expe ienced mo o complica ions,1s udies, examin- ing mo e specifically wea ing-o , ha e obse ed ha his is a po en ially ea ly phenomenon. As an example, his mani- es a ion a ec s al eady 42% o he PD pa ien s wi h <2.5 yea s disease when a sc eening ool was used (WOQ-19) and 21% acco ding o a neu ologis assessmen .2Ga he - ing accu a e in o ma ion abou he clinical s a us o he pa ien is essen ial o planning ea men and assessing i s e ec . Daily mo o unc ion assessmen wi h pape dia ies o de ec ing ime pe iods o he day du ing he OFF s a e, ON s a e wi hou dyskinesia and ON s a e wi h disabling o non-disabling dyskinesia, esul in issues o compliance and 327 D. San os Ga cía, N. López A iz egui, E. Cubo e al. eliabili y.3Elec onic dia ies ha e he ad an ages o acil- i a ing he ansmission o he in o ma ion di ec ly by PD pa ien s. S ill bo h ype o dia ies, pape and elec onic, a e limi ed by compliance and eliabili y issues. Impo an ly, p e ious s udies ha e shown ha dia ies esul ed in a e age esponse compliance o app oxima ely 1 h.4The e o e, mo e objec i e and p ecise sys ems a e necessa y o complemen dia ies. Wea able ine ial senso s ha e been widely used o moni o he mo o s a us and analyze symp oms o PD such as emo , b adykinesia, o dyskinesia.5—12 The REMPARK sys em (REMPARK Pe sonal heal h de ice o he emo e and au onomous managemen o Pa kinson’s disease, FP7 p ojec REMPARK ICT-287677) is a wea able sys em, de eloped be ween 2011 and 2015, o moni o mo o s a es h ough a sys em equi ing a single senso .13,14 Analogous o he ‘‘Hol e ’’ o he moni o ing o ca diac pa ame e s, he REMPARK sys em has been designed o eco d he pa ien ’s mo o condi ion du ing dayligh hou s and o aid in managing he disease ia he sma phone. By using a single senso (an ine ial measu emen uni called 9 × 3) ad anced algo i hms, and signal p ocessing me hods, his sys em moni o s and eco ds PD mo o mani es a ions.15 The de ice con ains an accele ome e , echa geable ba - e y o 7 days, da a s o age o a leas 1 yea . I is able o acqui e and s o e aw ine ial da a o a ificial in elli- gence algo i hmic aining pu poses. I has been ma ke ed as STAT-ONTM by he Company Sense4Ca e. STAT-ONTM p o- ides in o ma ion abou b adykinesia index based on fluidi y mo emen s, dyskinesia, eezing o gai (FOG), ON and OFF s a es, gai pa ame e s (speed o s ide, cadence, ime walking, s ep leng h, numbe o s eps), numbe o alls and ene gy expendi u e and pos u es. STAT-ONTM demon- s a ed an o e all classifica ion accu acy o 92.2% o de ec OFF pe iods unde eal condi ions o use in 23 ad anced PD pa ien s wea ing he kinema ic senso o 1—3 days a home.16 Mo e ecen ly, i demons a ed in 41 pa ien s wi h mode a e o se e e idiopa hic PD using he sys em in he sensi i i y and 88% specifici y in de ec ing OFF s a es.16,17 Al hough he e a e no cos /e ec i eness s udies, he use o he de ice could, hypo he ically, help o iden i y mo o fluc ua ions p ope ly, which could imp o e wi h an adequa e ea men op imiza ion. This could help educe cos s (e.g., eme gency assis ance, ins i u ionaliza ion, e c.). Despi e he mul iple s udies showing he accu acy o he sys em o de ec mo o fluc ua ions, he e is no in o ma ion abou i s possible clinical u ili y. He e, we epo he opin- ion o di e en PD expe neu ologis s abou he STAT-ONTM u ili y in a eal clinical p ac ice se ing (RCPS). Me hods CE Ma k Medical De ice STAT-ONTM was p o ided by he Com- pany Sense4Ca e o di e en Spanish neu ologis s o using i in a RCPS be ween Oc obe and Decembe 2019. All neu- ologis s we e selec ed because hey we e PD expe s. Each neu ologis had he oppo uni y o use he de ice in PD pa ien s o a leas 3 mon hs a his/he own disc e ion. In Feb ua y 2020, a su ey wi h 30 ques ions on STAT-ONTM u ili y was sen o all pa icipan s (Supplemen a y Ma e ial). The da a was anonymized and h ee wa es we e made o ob ain he esponses. The pa icipa ion was olun a y. S anda d p o ocol app o als, egis a ions, and pa ien consen s Since he p esen s udy was an anonymized opinion su ey abou he use ulness o a CE ma ke ed de ice o clinical p ac ice use, app o al was no sough om any e hics com- mi ee. No pa ien da a was eco ded. Da a a ailabili y The p o ocol, s a is ical analysis plan and uniden ifiable da a a e a ailable upon eques . Da a analysis Da a we e p ocessed using SPSS 20.0 o Windows. A fi s desc ip i e analysis was ca ied ou in which he esul s we e shown in coun s (pe cen ages) o as mean ± de ia ion acco ding o he ype o a iable. Depending on he esul s o he fi s analysis, co ela ion be ween specific a ia- bles we e analyzed. The S uden ’s - es , Mann—Whi ney U es , Chi-squa e es o Fishe es we e used as app op i- a e (no mali y assump ion was e ified wi h a one-sample Kolmogo o —Smi no es ). Spea man’s o Pea son’s co ela- ion coe ficien we e also used o analyzing he ela ionship be ween con inuous a iables depending also on he da a dis ibu ion. Co ela ions we e conside ed weak o coe fi- cien alues ≤0.29, mode a e o alues be ween 0.30 and 0.59, and s ong o alues ≥0.60. The alue o p was con- side ed significan when i was <0.05. Resul s A o al o 37 neu ologis s om 35 Spanish cen e s ecei ed he de ice om he manu ac u e o using i in PD pa ien s in a RCPS. Twen y-se en su eys (73%) we e ecei ed (53.8% emales; mean age 44.9 ± 9 yea s old). Two hi ds o he neu ologis s wo ked in a Mo emen Dis- o de s Uni , he mean expe ience on PD was o 16 ± 6.9 yea s, and 40.7% o hem had used p e iously di e en de ices o PD. A o al o 119 e alua ions in 114 pa ien s ( ange om 2 o 9 pe neu ologis ; mean 4.5 ± 2.3) we e pe - o med. Using a sco e om 1 (unhelp ul) o 7 ( e y help ul), he opinion abou di e en usabili y aspec s was eco ded (Table 1). ON-OFF daily dis ibu ion was he bes sco ed (5.5 ± 1.5) whe eas alls de ec ion he wo s (3.6 ± 2). The subjec i e gene al opinion abou he de ice ( om 0, he wo s , o 10, he bes ) was 6.9 ± 1.7. STAT-ONTM was conside ed be e han he dia ies by 70.3% o he neu ologis s (Fig. 1A) and a use ul de ice o iden i ying ad anced PD pa ien s by 81.5%. A high pe cen - age o PD pa ien s we e conside ed ha could benefi om using STAT-ONTM (Fig. 1B). STAT-ONTM was conside ed om qui e o e y use ul by 74% o he neu ologis s (Fig. 1C). A significan mode a e posi i e co ela ion was obse ed be ween he numbe o assessmen s pe o med and he 328 Neu ología 38 (2023) 326—333 Table 1 Sco e om 1 (unhelp ul) o 7 ( e y help ul) o he opinion abou di e en usabili y aspec s o he STAT-ON de ice. Pa ame e Mean ± SD Range n ON—OFF daily dis ibu ion 5.5 ± 1.5 2—7 27 Weekly hou s du ing he OFF s a e dis ibu ion 5.1 ± 1.4 1—7 27 Dyskinesia dis ibu ion 4.7 ± 1.9 1—7 27 FOG episodes dis ibu ion 4.1 ± 1.7 1—7 27 Numbe o FOG episodes and du a ion 3.7 ± 1.7 1—7 27 Falls de ec ion 3.6 ± 2.0 0—7 25 Da a abou gai 4.6 ± 1.4 0—7 25 Amoun o mo emen 4.7 ± 1.5 1—7 23 FOG, eezing o gai ; SD, s anda d de ia ion. Figu e 1 A. Opinion abou STAT-ONTM compa ed o OFF-ON dia ies. B. Pe cen age o Pa kinson’s disease pa ien s (1-25% s 26-50% s 51-75% s76-100% o all Pa kinson’s disease pa ien s assessed in eal clinical p ac ice se ing) who, e alua ed in daily clinical p ac ice, a he disc e ion o he e alua o , could benefi om he usage o STAT-ONTM. C. Use ulness o he in o ma ion collec ed wi h he de ice. gene al opinion abou he de ice ( = 0.403; p = 0.046). By he con a y, no di e ences we e obse ed in he gene al opinion abou he de ice ( om 0 o 10) wi h espec o he age o he PD expe ( = 0.030; p = 0.830), he numbe o yea s ea ing PD pa ien s ( = 0.032; p = 0.881), he p e ious use o de ices o PD (7.2 ± 2.1 s 6.9 ± 1.5; p = 0.703), and he p ac ice se ing (Mo emen Diso de s Uni s. s anda d ou pa ien clinic) (7.2 ± 2.3 s 6.9 ± 1.5; p = 0.784). STAT-ONTM was specifically used by 13 o he 27 neu olo- gis s (48.1%) in 21 ad anced PD pa ien s who we e ea ed wi h an ad anced he apy: 10 deep b ain s imula ion (DBS); 6 subcu aneous apomo phine in usion; 3 in aduodenal le - odopa in usion (2 wi hou in o ma ion). Only one neu ologis conside ed STAT-ONTM as no use ul in hese pa ien s. Six y h ee pe cen conside ed i om qui e o e y use ul (N = 11; 2 wi hou answe ) o using in his popula ion and wi h a pe iodici y ha should be indi idualized (67%). Wi h ega ds o he limi a ions o he in o ma ion p o- ided by he de ice o o he ela ed usabili y p oblems, 17 neu ologis s (63%) demanded o he ele an in o ma ion o ound p oblems (Table 2). The mos equen we e p ob- lems wi h he in e p e a ion o ime in g ay colo and p ope iden ifica ion o eezing o gai (FOG) episodes and/o alls. Almos 89% o he neu ologis s conside ed ha he sen- so had a pleasan appea ance o he pa ien and ha he wais was a p ope place o wea ing i . Mo eo e , 85% o he neu ologis s conside ed, based on hei expe ience using he sys em, ha he pa ien ’s opinion abou he de ice was good. Howe e , he ime in es ed in explaining he pa ien Table 2 Limi a ions o he in o ma ion p o ided by he de ice eco ded by he neu ologis s. Limi a ion epo ed n P oblems wi h he in e p e a ion o ime inac i e 6 P ope iden ifica ion o FOG episodes and/o alls 5 No di e en ia ion be ween disabling and non-disabling dyskinesia 3 No in o ma ion abou he ela ion be ween s a es and he ime o aking he medica ion 2 No iden ifica ion o emo 1 No iden ifica ion o non-mo o symp oms 1 No iden ifica ion o unk la e aliza ion 1 No iden ifica ion o mo o s a us du ing sleep 1 P oblems wi h he bel whe e he de ice is placed 1 T aining is necessa y o he pa ien and doc o 1 FOG, eezing o gai . he de ice and he analysis o he esul s was conside ed a limi a ion by he 40.7% o he neu ologis s. Impo an ly, 89% would use he de ice in hei daily clinical p ac ice. In Supplemen a y Ma e ial all he in o ma ion abou he answe s o he 30 ques ions o he su ey is shown. 329 D. San os Ga cía, N. López A iz egui, E. Cubo e al. Discussion This is he fi s publica ion abou he opinion o a g oup o PD expe s on he STAT-ONTM sys em a e using i in a RCPS. In gene al, he opinion was a o able al hough he e a e aspec s ha could be imp o ed. Despi e he analysis being based on su ey da a, i is aluable as i has been ca ied ou by an independen la ge g oup o expe s in PD, wi h p e ious expe ience wi h o he de ices o moni o he disease, and a e ha ing join ly e alua ed mo e han 100 pa ien s wi h his no el sys em. STAT-ONTM is a non-in asi e Class II A medical de ice acco ding o Di ec i e 93/42/EEC ha has been de eloped a e di e en R&D Eu opean p ojec s since 2009 and being alida ed in di e en clinical s udies.13—23 Howe e , un il now, no in o ma ion abou he opinion o he neu ologis s on STAT-ONTM a e using i in a RCPS had been epo ed. In ou s udy, he su ey esponse a e was accep able (73%).24 Addi ional s eng hs o he s udy we e he e e ed expe ience on PD o he neu ologis s, he numbe o neu ol- ogis s who pa icipa ed and he ac ha he ques ionnai e was anonymous and he esponses we e independen . The bes sco ed pa ame e s abou he usabili y o STAT-ONTM we e ‘‘ON-OFF daily dis ibu ion’’ and ‘‘Weekly hou s du ing he OFF s a e dis ibu ion’’, ag eeing wi h he p io e i- dence on he abili y o he sys em o de ec ON-OFF s a es in PD pa ien s in eal condi ions.16,17 One o he main ad an- ages o he sys em is ha pa ien s need o wea only a single senso , making i compa ible wi h an ac i e li e. Pa icipan s in p e ious s udies conside ed STAT-ONTM o be use - iendly and we e sa isfied wi h he sys em,16,25 being hese findings in acco dance wi h he opinion exp essed by he neu ologis s in he su ey. One o he impo an findings is ha a la ge majo - i y o he neu ologis s conside ed STAT-ONTM o be a be e me hod o moni o ing PD pa ien s han dia ies. Al hough dia ies ha e been used in ials as he gold s an- da d, wha me hod is be e has no been epo ed and a ial o compa ing PD hol e s PD dia y is on-going (h ps://clinical ials.go /c 2/show/NCT04176302). A sec- ond impo an aspec is, as he esul o he su ey sugges , he possibili y o using STAT-ONTM in a high pe cen age o PD pa ien s due o he ac ha mo o fluc ua ions a e e- quen and disabling e en in ea ly PD pa ien s.26 Finally, a e y impo an finding is ha STAT-ONTM could be a use ul me hod o moni o ing PD pa ien s unde DBS o an in u- sion he apy.27 Al hough he expe ience was limi ed o 21 pa ien s ea ed by 13 neu ologis s, 10 ou o 11 ha eplied o he su ey s a ed ha STAT-ONTM could be use ul, being his obse a ion in e es ing because i would allow o mon- i o he esponse be o e and a e he he apy. Since hese a e expensi e ea men s and no ee o complica ions, his is a g ea a ea o in e es o using hese new sys ems. STAT-ONTM is an objec i e me hod o moni o ing OFF- ON fluc ua ions. Howe e , he subjec i e componen o he pa ien ’s opinion is necessa y o know wha happens when he pa ien is no mo ing as he senso does no collec da a in inac i i y pe iods. This limi a ion was he mos e- quen ly epo ed and should be aken in o accoun when using STAT-ONTM in pa ien s who spend a lo o ime si - ing o inac i e. Al hough p e ious ials demons a ed a high sensi i i y and specifici y o de ec ing dyskinesia and FOG,18,20—22 a limi a ion epo ed by he neu ologis s was ha he de ice was no capable o dis inguishing disabling and non-disabling dyskinesias. Mo eo e , he p ope iden i- fica ion o FOG episodes and/o alls was he second mos equen limi a ion epo ed. Some expe s conside ed ha he sys em o e es ima ed alls in some ins ances. In eg a ed in o ma ion on medica ion in ake hou s was also demanded by he expe s. Finally, al hough only one neu ologis com- men ed he ac o no in o ming abou non-mo o symp oms as a limi a ion o he sys em, his is an essen ial poin because non-mo o symp oms a e equen and ela ed o mo o fluc ua ions.26,28 Al e na i ely, he pa ien could be ained o p ess he ala m bu on when a specific non-mo o symp oms, such as pain o anxie y, appea and analyze hei appea ance in ela ion o he mo o s a e a ha momen .29 The de ice was used a o al o 119 imes in 114 pa ien s. Howe e , he a e age use by neu ologis was less han fi e wi h a ange om 2 o 9 imes, he de ice was used o a b ie ime, and o he as majo i y i was hei fi s expe- ience wi h he sys em (da a no collec ed) being necessa y o lea n abou he usage o he de ice, so ou findings on he possible use ulness o STAT-ONTM o moni o PD pa ien s in a RCPS should be conside ed wi h cau ion. Al hough 81.5% o he e alua o s conside ed ha he de ice could be use- ul o de ec ing pa ien s wi h ad anced PD, ob iously, i is an opinion su ey and no a s udy designed o de e mine he sensi i i y and specifici y o he de ice o de ec ing ad anced PD based on defined c i e ia (e.g., CDEPA30). The ac ha he e was a be e opinion on he de ice in mo e equen use s should be confi med in u u e s udies o ule ou di e en pe cep ion acco ding o echnology adop ion and exposu e. Finally, o he biases ela ed o he me hodol- ogy o he p esen s udy canno be excluded (e.g., ques ion ypes). In summa y, his is he fi s opinion su ey o a g oup o PD expe s who e alua ed he u ili y o STAT-ONTM in a RCPS. STAT-ONTM could be a use ul de ice o moni o ing PD pa ien s in clinical p ac ice. Mo e expe ience is needed o ha ing a con as ed and confiden opinion. Decla a ions E hics app o al and consen o pa icipa e The p esen s udy consis s o an opinion poll and he e a e no iden ifiable da a collec ed om pa ien s and/o pa i- cipan s. The e o e, i does no equi e he app o al o an e hical commi ee. The fi s au ho , Diego San os Ga cía, is a membe o an au onomous e hics commi ee, he ‘‘Comi é Au onómico de É ica de In es igación de Galicia’’, and is ully amilia wi h he egula ions as hey apply. Consen o publica ion No applicable. A ailabili y o da a and ma e ial The da ase s used and/o analyzed du ing he cu en s udy a e a ailable om he co esponding au ho on easonable eques . 330 Neu ología 38 (2023) 326—333 Au ho s’ con ibu ions San os Ga cía D.: concep ion, o ganiza ion, and execu- ion o he p ojec ; s a is ical analysis; w i ing o he fi s d a o he manusc ip ; e alua ion o pa icipan s; su ey esponse. López A iz egui N.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Cubo E.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Vinag e A agón A.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Ga cía-Ramos R.: e iew and c i ique; e alua ion o pa - icipan s; su ey esponse. Bo ué C.: e iew and c i ique; e alua ion o pa ici- pan s; su ey esponse. Fe nández-Paja ín G.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Caballol N.: e iew and c i ique; e alua ion o pa ici- pan s; su ey esponse. Cabo I.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Ba ios López J M.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. He nández Va a J.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Á ila Ri e a M. A.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Gasca-Salas C.: e iew and c i ique; e alua ion o pa i- cipan s; su ey esponse. Escalan e S.: e iew and c i ique; e alua ion o pa ici- pan s; su ey esponse. Man ique de La a P. : e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Pé ez Nogue a R.: e iew and c i ique; e alua ion o pa - icipan s; su ey esponse. Ál a ez Sauco M.: e iew and c i ique; e alua ion o pa - icipan s; su ey esponse. Sie a M.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Monje M. H. G.: e iew and c i ique; e alua ion o pa i- cipan s; su ey esponse. Sánchez Fe o A.: e iew and c i ique; e alua ion o pa - icipan s. No o Pon e S.: e iew and c i ique; e alua ion o pa i- cipan s; su ey esponse. Alonso-F ech F. : e iew and c i ique; e alua ion o pa i- cipan s; su ey esponse. Macías-Ga cía D.: e iew and c i ique; e alua ion o pa - icipan s; su ey esponse. Lega da I.: e iew and c i ique; e alua ion o pa ici- pan s; su ey esponse. Rojo A.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Ál a ez Fe nández I.: e iew and c i ique; e alua ion o pa icipan s; su ey esponse. Buongio no M. T.: e iew and c i ique; e alua ion o pa - icipan s; su ey esponse. Pas o P. : e iew and c i ique; e alua ion o pa icipan s. Ga cía Ruíz P. : e iew and c i ique; e alua ion o pa i- cipan s; su ey esponse. Financial disclosu es San os Ga cía D. has ecei ed hono a ia o educa ional p esen a ions and ad ice se ice by Abb ie, UCB Pha ma, Lundbeck, KRKA, Zambon, Bial and Te a. López A iz egui N. has ecei ed hono a ia o educa ional p esen a ions and ad ice se ice by Abb ie, I al a maco, Zambon, and Bial. Cubo E: T a el g an s: Abb ie, Alle gan, Bos on; Lec- u ing hono a ia: Abb ie, In e na ional Pa kinson’s disease Mo emen Diso de Socie y. Vinag e A agón A. has ecei ed hono a ia o educa ional p esen a ions by UCB Pha ma. Ga cía-Ramos R. has ecei ed hono a ia o educa ional p esen a ions and ad ice se ice by Abb ie, Zambon, Me z, Alle gan, Bial, K ka, Te a and I al a maco. Bo ué C.: None. Fe nández-Paja ín G. has ecei ed hono a ia om I al a - maco, Zambon and Bial and sponso ship om I al a maco, Bos on Scien ific and Zambon o a ending con e ences. Caballol N. has ecei ed hono a ia om Bial, I al á maco, Qualigen, Zambon, UCB, Te a and KRKA and sponso ship om Zambon, TEVA and Abb ie o a ending medical con- e ences. Cabo I. has ecei ed hono a ia o educa ional p esen a- ions and ad ice se ice by Abb ie, Zambon and Bial. Ba ios López J.M.: None. He nández Va a J. has ecei ed a el bu sa ies and edu- ca ional g an s om Abb ie and has ecei ed hono a ia o educa ional p esen a ions om Abb ie, Te a, Bial, Zambon, I al a maco and Sanofi-Genzyme. Á ila Ri e a M. A. has ecei ed hono a ia om Zambon, UCB Pha ma, Qualigen, Bial, and Te a, and sponso ship om Zambon and Te a o a ending con e ences. Gasca-Salas C.: None. Escalan e S. has ecei ed hono a ia o educa ional p e- sen a ions and ad ice se ice by Abb ie, Zambon, and Bial. Man ique de La a P. : None. Pé ez Nogue a R.: Ál a ez Sauco M. has ecei ed hono a ia o educa ional p esen a ions and ad ice se ice by Abb ie, UCB Pha ma, Zambon, Bial and Te a. Sie a M. Monje M.H.G. has ecei ed speake and a el hono a ia om No a is Pha maceu ical. She is employed by Fundación HM Hospi ales. She is membe o he Elec onic De elop- men o Ra ing Scales Commi ee o he Mo emen Diso de s Socie y. Sánchez Fe o A. has ecei ed unding om he Join P og am o Neu odegene a i e Diseases (p ojec Re e ence Numbe : HESOCARE-329-073) and has also ecei ed speake and a el hono a ia om Te a, Zambon, Abb ie, and No a is Pha maceu ical. He is employed by Leuko Imag- ing Sys ems S.L. and Fundación HM Hospi ales. He owns common s ock in Leuko Labs, Inc a company wi h comme - cial in e es s in a Medical De ice de eloped o neu openia de ec ion. He is also an in en o o a Me hod and Appa a us o Mo o Func ion cha ac e iza ion (US 2020/0060622 Al) ha has been licensed o an independen comme cial en i y (nQ-Medical) by he Massachuse s o Technology. He se es as Chai o he Ad Hoc Commi ee on Technology o he 331 D. San os Ga cía, N. López A iz egui, E. Cubo e al. Spanish Neu ological Socie y, Chai o Commi ee on Elec- onic De elopmen o Ra ing Scales o he Mo emen Diso de s Socie y and is a membe o he Mo emen Dis- o de s Socie y Technology Task o ce and Scien ific and Educa ion (Eu opean Sec ion) Commi ee. No o Pon e S. has ecei ed un es ic ed educa ional sup- po om Abb ie and Zambon and hono a ia o educa ional p esen a ions om Abb ie and I al a maco. Alonso-F ech F. : None. Macías-Ga cía D. has ecei ed hono a ia o educa ional p esen a ions by Abb ie, Te a and Zambom. Lega da I. has ecei ed hono a ia o educa ional p esen- a ions and ad ice se ice by Abb ie, UCB Pha ma, Zambon, Bial and Te a. Rojo A. has ecei ed a el bu sa ies om Abb ie and Zambon and hono a ia o educa ional p esen a ions om Te a, Bial, UCB and Zambon. Ál a ez Fe nández I.: None. Buongio no M. T.: None. Pas o P: None. Ga cía Ruíz P. Conflic o in e es s None. This wo k has been ca ied ou absolu ely indepen- den ly om he company sense4ca e, who has only p o ided he de ices and has no pa icipa ed in i . Appendix A. Supplemen a y da a Supplemen a y da a associa ed wi h his a i- cle can be ound, in he online e sion, a doi:10.1016/j.n l.2020.10.013. Re e ences 1. Ahlskog JE, Muen e MD. F equency o le odopa- ela ed dyski- nesias and mo o fluc ua ions as es ima ed om he cumula i e li e a u e. Mo Diso d. 2001;16:448—58. 2. S occhi F, An onini A, Ba one P, Tinazzi M, Zappia M, Ono j M, e al. DEEP s udy g oup. 2014;20:204—11. 3. Hause RA, Decke s F, Lehe P. A home dia y o assess unc- ional s a us in pa ien s wi h Pa kinson’s disease wi h mo o fluc ua ions and dyskinesia. Mo Diso d. 2004;19:1409—13. 4. Lyons KE, Pahwa R. Elec onic mo o unc ion dia y o pa ien s wi h Pa kinson’s disease: a easibili y s udy. Pa kinsonism Rela Diso d. 2007;13:304—7. 5. Fishe JM, Hamme la NY, Ploe z T, And as P, Roches e L, Walke RW. Unsupe ised home moni o ing o Pa kinson’s disease mo o symp oms using body-wo n accele ome e s. Pa kinsonism Rela Diso d. 2016;33:44—50. 6. Me a TO, Filipkowski DE, Riley DE, Whi ney CM, Wal e BL, Gun- zle SA, e al. Quan i a i e analysis o gai and balance esponse o deep b ain s imula ion in Pa kinson’s disease. Gai Pos u e. 2013;38:109—14. 7. Cancela J, Pas o ino M, A edondo MT, Niki a KS, Villag a F, Pas o MA. Feasibili y s udy o a wea able sys em based on a wi eless body a ea ne wo k o gai assessmen in Pa kinson’s disease pa ien s. Senso s (Basel). 2014;14:4618—33. 8. Tzallas AT, Tsipou as MG, Rigas G, Tsalikakis DG, Ka ounis EC, Chond ogio gi M, e al. PERFORM: a sys em o moni o - ing assessmen and managemen o pa ien s wi h Pa kinson’s disease. Senso s (Basel). 2014;14:21329—57. 9. Ho ne MK, McG ego S, Be gquis F. An objec i e fluc ua ion sco e o Pa kinson’s disease. PLOS ONE. 2015;10:e0124522. 10. Godinho C, Domingos J, Cunha G, San os AT, Fe nandes RM, Ab eu D, e al. 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