Evidence map›Paper›PMID 38238170›Full record

ArticleBMJ open2024

Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the

Sean W X Ong, Todd C Lee, Robert A Fowler, Robert Mahar, Ruxandra L Pinto, Asgar Rishu, Lina Petrella, Lyn Whiteway, Matthew Cheng, Emily McDonald and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06168474 (Evaluating the Impact of a SIMPlified LaYered Consent Process on Recruitment of Potential Participants to the Staphylococcus Aureus Network Adaptive Platform Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.2field-weighted citation impact, top 14% 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.

NCT06168474 narecruitingnot on this map

Evaluating the Impact of a SIMPlified LaYered Consent Process on Recruitment of Potential Participants to the Staphylococcus Aureus Network Adaptive Platform Trial: a Pragmatic Nested Randomized Clinical Trial

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2023 to 2026Enrolled346ConditionsStaphylococcus Aureus BacteremiaArmsSimplified layered consent form, Full-length consent form
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. 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

17 authors at 9 institutions in 4 countries.

Sean W X OngInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada s.ong@mail.utoronto.ca.ORCID 0000-0002-8570-436X
Todd C LeeClinical Practice Assessment Unit, McGill University Health Centre, Montréal, Quebec, Canada.ORCID 0000-0002-2267-4239
Robert A FowlerInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Robert MaharCentre for Epidemiology and Biostatistics, The University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0002-3643-923X
Ruxandra L PintoInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Asgar RishuSunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Lina PetrellaClinical Practice Assessment Unit, McGill University Health Centre, Montréal, Quebec, Canada.
Lyn WhitewayFreelance Health Consumer Advocate, Adelaide, South Australia, Australia.
Matthew ChengDivision of Infectious Diseases, McGill Univesrity Health Centre, Montréal, Quebec, Canada.
Emily McDonaldClinical Practice Assessment Unit, McGill University Health Centre, Montréal, Quebec, Canada.
Jennie JohnstoneDivision of Infectious Diseases, Sinai Health, Toronto, Ontario, Canada.
Dominik MertzDivision of Infectious Diseases, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0003-4337-1613
Christopher KandelMichael Garron Hospital, Toronto East Health Network, Toronto, Ontario, Canada.
Ranjani SomayajiDivision of Infectious Diseases, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0003-3731-9675
Joshua S DavisSchool of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.
Steven Y C Tong *Department of Infectious Diseases, University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
Nick Daneman *Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0001-8827-3764
Sunnybrook Health Science Centre · CAMcGill University Health Centre · CAOffice of Infectious Diseases · USJohn Hunter Hospital · AUSA Health · AUThe Royal Melbourne Hospital · AUThe University of Melbourne · AUToronto East General Hospital · CAUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInformed consent forms (ICFs) for randomised clinical trials (RCTs) can be onerous and lengthy. The process has the potential to overwhelm patients with information, leading them to miss elements of the study that are critical for an informed decision. Specifically, overly long and complicated ICFs have the potential to increase barriers to trial participation for patients with mild cognitive impairment, those who do not speak English as a first language or among those with lower medical literacy. In turn, this can influence trial recruitment, completion and external validity. METHODS AND ANALYSIS: SIMPLY-SNAP is a pragmatic, multicentre, open-label, two-arm parallel-group superiority RCT, nested within a larger trial, the ETHICS AND DISSEMINATION: The study has been approved by the ethics review board (Sunnybrook Health Sciences Research Ethics Board) at sites in Ontario. We will disseminate study results via the SNAP trial group and other collaborating clinical trial networks. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT06168474; www. CLINICALTRIALS: gov).

Indexed as

COVID-19Staphylococcal InfectionsAdaptive Clinical Trials as TopicEquivalence Trials as TopicHumansInformed ConsentMulticenter Studies as TopicOntarioPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeClinical TrialHealth EquityINFECTIOUS DISEASESMEDICAL ETHICS

Identifiers

PMID38238170
PMCPMC10806654
OpenAlexW4391004795

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.