Evidence map›Paper›PMID 33553471›Full record

ReviewOpen forum infectious diseases2021

Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic.

Matthew F Pullen, Katelyn A Pastick, Darlisha A Williams, Alanna A Nascene, Ananta S Bangdiwala, Elizabeth C Okafor, Katherine Huppler Hullsiek, Caleb P Skipper, Sarah M Lofgren, Nicole Engen and 5 more

Registry-linked trialAbstract readReview
In one paragraph

Review in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04308668 (Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT04308668 phase3completednot on this map

Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

TypeinterventionalSponsorUniversity of MinnesotaRan2020 to 2020Enrolled1,312ConditionsCorona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection, CoronavirusArmsHydroxychloroquine, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
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

15 authors.

Matthew F PullenDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0002-4644-7487
Katelyn A PastickDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Darlisha A WilliamsDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Alanna A NasceneDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Ananta S BangdiwalaSchool of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0003-0062-9434
Elizabeth C OkaforDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0003-1495-4596
Katherine Huppler HullsiekSchool of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
Caleb P SkipperDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0002-0000-8876
Sarah M LofgrenDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0001-6717-2614
Nicole EngenSchool of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0003-1118-4194
Mahsa AbassiDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Emily G McDonaldDepartment of Medicine, McGill University, Montreal, Québec, Canada.ORCID 0000-0003-0783-0624
Todd C LeeDepartment of Medicine, McGill University, Montreal, Québec, Canada.
Radha RajasinghamDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0001-5531-0231
David R BoulwareDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0002-4715-0060

Funding

Medical Student Summer Research Program in Infection and ImmunityT35AI118620 · NIAID · UNIVERSITY OF MINNESOTA · PI MUELLER, DANIEL L · 2015 to 2025
$351k
NIAID NIH HHS T35 AI118620
6 · The paper itself

Abstract

As the severe acute respiratory syndrome coronavirus 2 pandemic evolved, it was apparent that well designed and rapidly conducted randomized clinical trials were urgently needed. However, traditional clinical trial design presented several challenges. Notably, disease prevalence initially varied by time and region, and the pockets of outbreaks evolved geographically over time. Coupled with an occupational hazard from in-person study visits, timely recruitment would prove difficult in a traditional in-person clinical trial. Thus, our team opted to launch nationwide internet-based clinical trials using patient-reported outcome measures. In total, 2795 participants were recruited using traditional and social media, with screening and enrollment performed via an online data capture system. Follow-up surveys and survey reminders were similarly managed through this online system with manual participant outreach in the event of missing data. In this report, we present a narrative of our experience running internet-based clinical trials and provide recommendations for the design of future clinical trials during a world pandemic.

Indexed as

coronavirusCOVID-19internet-based clinical trialmethodologySARS-CoV-2

Identifiers

PMID33553471
PMCPMC7798626

What OpenQuestion holds

Textmetadata
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.