Evidence map›Paper›PMID 36865634›Full record

ArticleNeurology. Clinical practice2023

Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials.

Daniel G Di Luca, Eric A Macklin, Karen Hodgeman, Gisel Lopez, Lindsay Pothier, Katherine F Callahan, Jill Lowell, James Chan, Aleksandar Videnovic, Codrin Lungu and 4 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Neurology. Clinical practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 6% of its field
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.

NCT02168842 phase3completednot on this map

Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease

TypeinterventionalSponsorUniversity of RochesterRan2014 to 2018Enrolled336ConditionsParkinson DiseaseArmsIsradipine, Placebo (for Isradipine)
NCT02642393 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease

TypeinterventionalSponsorMichael Alan SchwarzschildRan2016 to 2019Enrolled298ConditionsParkinson's DiseaseArmsInosine, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  5. Review
  6. Article
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  11. Article
  12. Observational
  13. Designing the First Trials for Parkinson's Prevention.Journal of Parkinson's disease · 2024
    Review
  14. Race and Ethnicity in Lewy Body Dementia: A Narrative Review.Journal of Alzheimer's disease : JAD · 2023
    Review
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

14 authors at 1 institution in 2 countries.

Daniel G Di LucaEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.ORCID https://orcid.org/0000-0002-1356-4919
Eric A MacklinEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.ORCID https://orcid.org/0000-0003-1618-3502
Karen HodgemanEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Gisel LopezEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Lindsay PothierEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Katherine F CallahanEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Jill LowellEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
James ChanEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Aleksandar VidenovicEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Codrin LunguEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Anthony E LangEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Irene LitvanEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.ORCID https://orcid.org/0000-0002-3485-3445
Michael A SchwarzschildEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Tatyana SimuniEdmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
Northwestern University · US

Funding

Phase 3 trial of inosine for Parkinson's disease CCCU01NS090259 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI SCHWARZSCHILD, MICHAEL A · 2015 to 2019
$16.9M
NINDS NIH HHS U01 NS090259
6 · The paper itself

Abstract

Background and Objectives: Representation of persons from marginalized racial and ethnic groups in Parkinson disease (PD) trials has been low, limiting the generalizability of therapeutic options for individuals with PD. Two large phase 3 randomized clinical trials sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), STEADY-PD III and SURE-PD3, screened participants from overlapping Parkinson Study Group clinical sites under similar eligibility criteria but differed in participation by underrepresented minorities. The goal of this research is to compare recruitment strategies of PD participants belonging to marginalized racial and ethnic groups. Methods: A total of 998 participants with identified race and ethnicity consented to STEADY-PD III and SURE-PD3 from 86 clinical sites. Demographics, clinical trial characteristics, and recruitment strategies were compared. NINDS imposed a minority recruitment mandate on STEADY-PD III but not SURE-PD3. Results: Ten percent of participants who consented to STEADY-PD III self-identified as belonging to marginalized racial and ethnic groups compared to 6.5% in SURE-PD3 (difference = 3.9%, 95% confidence interval [CI] 0.4%-7.5%, Discussion: Although both trials targeted similar participants, STEADY-PD III was able to consent and recruit a higher percentage of patients from racial and ethnic marginalized groups. Possible reasons include differential incentives for achieving minority recruitment goals. Trial Registration Information: This study used data from The Safety, Tolerability, and Efficacy Assessment of Isradipine for Parkinson Disease (STEADY-PD III; NCT02168842) and the Study of Urate Elevation in Parkinson's Disease (SURE-PD3; NCT02642393).

Identifiers

PMID36865634
PMCPMC9973288
OpenAlexW4317354958

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.