Evidence map›Paper›PMID 33605946›Full record

ArticleContemporary clinical trials communications2021

Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.

David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J Brett Goodman, Sheketha McGee, Joanne Fraifogl and 23 more

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Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

33 authors.

David PogorzelskiDepartment of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
Uyen NguyenDepartment of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
Paula McKayDepartment of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main St. W., Hamilton, ON, Canada.
Megan CamaraR Adams Cowley Shock Trauma Center, 22 S Greene St., Baltimore, MD, United States.
Lolita RamseyInova Fairfax Medical Campus, 3300 Gallows Rd., Falls Church, VA, United States.
Rachel SeymourDepartment of Orthopaedic Surgery, Atrium Health Musculoskeletal Institute, NC, United States.
J Brett GoodmanDepartment of Orthopaedic Surgery, Wake Forest Baptist Medical Center, 1 Medical Center Blvd., Winston-Salem, NC, United States.
Sheketha McGeeUniversity of Mississippi Medical Center, 2500 N State St., Jackson, MS, United States.
Joanne FraifoglThe MetroHealth System, 2500 Metrohealth Dr., Cleveland, OH, United States.
Andrea HudginsIU School of Medicine, 340 W 10th St., Indianapolis, IN, United States.
Stephanie L TannerDepartment of Orthopaedic Surgery, Prisma Health - Upstate, 701 Grove Rd., Greenville, SC, United States.
Mohit BhandariDepartment of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
Gerard P SlobogeanUniversity of Maryland School of Medicine, 655 W Baltimore St. S., Baltimore, MD, United States.
Sheila SpragueDepartment of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
PREP-IT Investigators Executive Committee:
Steering Committee
Adjudication Committee
Data and Safety Monitoring Committee
Research Methodology Core
Patient Centred Outcomes Core
Orthopaedic Surgery Core
Operating Room Core
Infectious Disease Core
Military Core
McMaster University Methods Center
University of Maryland School of Medicine Administrative Center
University of Maryland School of Pharmacy, The PATIENTS Program
PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE)
Aqueous-PREP and PREPARE
Aqueous-PREP
PREPARE
PREP-IT Investigators Executive Committee

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167
6 · The paper itself

Abstract

introductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.

methodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.

results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).

conclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Indexed as

Cluster crossoverPragmaticSamplingSampling frameworkSampling strategyWork flow

Identifiers

PMID33605946
PMCPMC7873628

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LicenceCC BY-NC-ND
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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.