Evidence map›Paper›PMID 35989898›Full record

ArticleContemporary clinical trials communications2022

The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

David Pogorzelski, Paula McKay, Michael J Weaver, Todd Jaeblon, Robert A Hymes, Greg E Gaski, Joanne Fraifogl, James S Ahn, Sofia Bzovsky, Gerard Slobogean and 22 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

32 authors.

David PogorzelskiDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Paula McKayDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Michael J WeaverDepartment of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Todd JaeblonDepartment of Orthopaedics, University of Maryland, University of Maryland School of Medicine, Baltimore, MD, USA.
Robert A HymesDepartment of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.
Greg E GaskiDepartment of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.
Joanne FraifoglDepartment of Orthopaedics, The MetroHealth System, Cleveland, OH, USA.
James S AhnDepartment of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.
Sofia BzovskyDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Gerard SlobogeanDepartment of Orthopaedics, University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Sheila SpragueDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Gerard P SlobogeanUniversity of Maryland School of Medicine, Baltimore, MD, USA.
Sheila SpragueMcMaster University, Hamilton, ON, Canada.
Jeffrey WellsTrauma Survivors Network, Falls Church, VA, USA.
Mohit BhandariMcMaster University, Hamilton, ON, Canada.
Robert V O'TooleUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Jean-Claude D'AlleyrandUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Andrew EglsederUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Aaron JohnsonUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Christopher LanghammerUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Christopher LebrunUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Jason NasconeUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Raymond PensyUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Andrew PollakUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Marcus SciadiniUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Gerard P SlobogeanUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Yasmin DeganiUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Haley K DemyanovichUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Andrea HoweUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Nathan N O'HaraUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Heather PhippsUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Eric HempenUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7-121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

Indexed as

COVID-19EnrollmentPragmatic trialsPREPARE trial

Identifiers

PMID35989898
PMCPMC9384338

What OpenQuestion holds

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Registered trials

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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.