{"doi":"10.1002/acn3.51236","title":"Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD)","abstract":"OBJECTIVE: The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site-centric therapeutic trials in Parkinson's disease and generate novel insights. The value of this approach has never been more evident than during the current COVID-19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow-up of clinical trial participants, (2) compare changes in smartphone-based assessments, online patient-reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson's disease disability and progression. METHODS: Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease trials (AT-HOME PD), a two-year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone-based assessments of motor function and socialization, and patient-reported outcomes online. RESULTS: From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study's smartphone application and 161 (71%) have completed patient-reported outcomes on the online platform. INTERPRETATION: It is feasible to conduct a large-scale, international virtual observational study following the completion of participation in brick-and-mortar clinical trials in Parkinson's disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow-up of clinical trial participants and design of future clinical trials.","journal":"Annals of Clinical and Translational Neurology","year":2020,"id":97504,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":33,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9424,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":13888,"name":"Larsson Omberg","orcid":"0000-0002-4719-9120","position":1,"is_corresponding":false},{"id":226503,"name":"Eric A. 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Tarolli","orcid":"0000-0003-0422-4020","position":11,"is_corresponding":false},{"id":317498,"name":"Jamie Adams","orcid":"0000-0002-1170-6688","position":12,"is_corresponding":false},{"id":483719,"name":"Katherine F. Callahan","orcid":null,"position":13,"is_corresponding":false},{"id":482493,"name":"Joshua Gottesman","orcid":"0009-0004-8959-8754","position":14,"is_corresponding":false},{"id":482494,"name":"Catherine Kopil","orcid":"0000-0001-8678-7550","position":15,"is_corresponding":false},{"id":253927,"name":"Codrin Lungu","orcid":"0000-0001-6253-3281","position":16,"is_corresponding":false},{"id":230962,"name":"Alberto Ascherio","orcid":"0000-0002-0585-3294","position":17,"is_corresponding":false},{"id":482495,"name":"James C. Beck","orcid":"0000-0002-4884-9893","position":18,"is_corresponding":false},{"id":310955,"name":"Kevin Biglan","orcid":"0000-0001-5114-3755","position":19,"is_corresponding":false},{"id":233015,"name":"Alberto J. 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