Evidence map›Paper›PMID 33350601›Full record

Observational studyAnnals of clinical and translational neurology2021

Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD).

Ruth B Schneider, Larsson Omberg, Eric A Macklin, Margaret Daeschler, Lauren Bataille, Shalini Anthwal, Taylor L Myers, Elizabeth Baloga, Sidney Duquette, Phil Snyder and 21 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Annals of clinical and translational neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Article
  2. Review
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  5. Article
  6. Review
  7. Article
  8. Review
  9. Narrative review of telemedicine applications in decentralized research.Journal of clinical and translational science · 2024
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Ruth B SchneiderDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.ORCID 0000-0001-8094-4041
Larsson OmbergSage Bionetworks, Seattle, Washington, USA.
Eric A MacklinBiostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
Margaret DaeschlerThe Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
Lauren BatailleThe Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
Shalini AnthwalCenter for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
Taylor L MyersCenter for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
Elizabeth BalogaCenter for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
Sidney DuquetteCenter for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.
Phil SnyderSage Bionetworks, Seattle, Washington, USA.
Katherine AmodeoDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
Christopher G TarolliDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
Jamie L AdamsDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
Katherine F CallahanDepartment of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Joshua GottesmanThe Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
Catherine M KopilThe Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.
Codrin LunguDivision of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA.
Alberto AscherioDepartment of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
James C BeckParkinson's Foundation, New York, New York, USA.
Kevin BiglanDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
Alberto J EspayDepartment of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.
Caroline TannerDepartment of Neurology, Weill Institute for Neurosciences, University of California, San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.
David OakesDepartment of Biostatistics, University of Rochester Medical Center, Rochester, New York, USA.
Ira ShoulsonDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
Dan NovakParkinson's Foundation, New York, New York, USA.
Elise KaysonDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
Earl Ray DorseyDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.ORCID 0000-0002-5140-1248
Lara MangraviteSage Bionetworks, Seattle, Washington, USA.
Michael A SchwarzschildDepartment of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Tanya SimuniDepartment of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Parkinson Study Group AT-HOME PD Investigators

Funding

Tele-Health Extension for Phase 3 Parkinson's Disease Trial CohortsU01NS107009 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI DORSEY, EARL RAY, SCHWARZSCHILD, MICHAEL A · 2018 to 2022
$4.1M
NINDS NIH HHS U01 NS107009NINDS NIH HHS U01NS107009
6 · The paper itself

Abstract

objectiveThe 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.

methodsParticipants 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.

resultsFrom 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.

interpretationIt 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.

Indexed as

Mobile ApplicationsParkinson DiseasePatient Reported Outcome MeasuresResearch DesignSmartphoneTelemedicineVideoconferencingCanadaClinical Trials as TopicDisease ProgressionFollow-Up StudiesHumansLongitudinal StudiesUnited States

Identifiers

PMID33350601
PMCPMC7886038

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.