Evidence map›Paper›PMID 34195467›Full record

ArticleContemporary clinical trials communications2021

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.

Guillermo Pechero, Branden Pfaff, Mayank Rao, David Pogorzelski, Paula McKay, Ella Spicer, Andrea Howe, Haley K Demyanovich, Debra L Sietsema, Michael F McTague and 45 more

Abstract read
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In one paragraph

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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

55 authors.

Guillermo PecheroMcGovern Medical School, The University of Texas Health Science Center at Houston, 7000 Fannin Street, Houston, TX, USA.
Branden PfaffSanford USD Medical Center and Hospital, 1305 W. 18th St., Sioux Falls, SD, USA.
Mayank RaoMcGovern Medical School, The University of Texas Health Science Center at Houston, 7000 Fannin Street, Houston, TX, USA.
David PogorzelskiDepartment 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.
Ella SpicerFraser Health Authority/Royal Columbian Hospital, 403-233 Nelson's Crescent, New Westminster, BC, Canada.
Andrea HoweDepartment of Orthopaedic Surgery, University of Maryland School of Medicine, 655 W Baltimore St. S., Baltimore, MD, USA.
Haley K DemyanovichDepartment of Orthopaedic Surgery, University of Maryland School of Medicine, 655 W Baltimore St. S., Baltimore, MD, USA.
Debra L SietsemaThe CORE Institute®, 6501 North 19th Avenue, Phoenix, AZ, USA.
Michael F McTagueDepartment of Orthopaedic Surgery, Harvard Medical School Orthopedic Trauma Initiative, Brigham and Women's Hospital, Boston, USA.
Lolita RamseyInova Fairfax Medical Campus, 3300 Gallows Road, Falls Church, VA, USA.
Martha HoldenDepartment of Orthopaedic Surgery, Wake Forest Baptist Health, 1 Medical Center Blvd, Winston-Salem, NC, USA.
Joshua RudnickiDepartment of Orthopaedic Surgery, University of Maryland School of Medicine, 655 W Baltimore St. S., Baltimore, MD, USA.
Jeff WellsTrauma Survivors Network, 8110 Gatehouse Road, Falls Church, VA, USA.
Michelle MedeirosUniversity of Maryland School of Pharmacy, The PATIENTS Program, 220 Arch Street, Baltimore, MD, USA.
Gerard P SlobogeanDepartment of Orthopaedic Surgery, University of Maryland School of Medicine, 655 W Baltimore St. S., Baltimore, MD, USA.
Sheila SpragueDepartment of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
PREP-IT Investigators
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.
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
PREP-IT Clinical Sites
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.
Theodore MansonUniversity 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.
Ebrahim ParyaviUniversity 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.
Katherine JosephUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Joshua RudnickiUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Megan CamaraUniversity of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Aqueous-PREP and PREPARE
Aqueous-PREP
PREPARE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.

methodsThe PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.

resultsPatient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. DISCUSSION: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Indexed as

Cluster randomized crossoverConsentDeferred consentPatient advisorsStakeholder engagementTrial design

Identifiers

PMID34195467
PMCPMC8239736

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.