Evidence map›Paper›PMID 35550639›Full record

Trial reportTrials2022

E-Consent-a guide to maintain recruitment in clinical trials during the COVID-19 pandemic.

Ricardo Almeida-Magana, Hanna Maroof, Jack Grierson, Rosie Clow, Eoin Dinneen, Tarek Al-Hammouri, Nicola Muirhead, Chris Brew-Graves, John Kelly, Greg Shaw

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03317990 (A Single Blinded, IDEAL Stage 3, Multi-Centre, Randomised Controlled Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–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.

NCT03317990 naactive not recruitingnot on this map

A Single Blinded, IDEAL Stage 3, Multi-Centre, Randomised Controlled Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy (RARP) vs Standard Robotic Assisted Radical Prostatectomy (RARP) in Men With Prostate Cancer

TypeinterventionalSponsorUniversity College, LondonRan2018 to 2027Enrolled407ConditionsProstate CancerArmsNeuroSAFE procedure, Standard RARP
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. 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

10 authors.

Ricardo Almeida-Magana *Division of Surgery & Interventional Science, University College London, Charles Bell House, 3rd Floor, 43-45 Foley Street, London, W1W 7TY, UK. r.magana@ucl.ac.uk.ORCID http://orcid.org/0000-0002-3437-1649
Hanna Maroof *Department of Urology, Westmoreland Street Hospital, University College London Hospital, 16-18 Westmoreland Street, London, W1G 8PH, UK.
Jack Grierson *Division of Surgery & Interventional Science, University College London, Charles Bell House, 3rd Floor, 43-45 Foley Street, London, W1W 7TY, UK.
Rosie ClowDivision of Surgery & Interventional Science, University College London, Charles Bell House, 3rd Floor, 43-45 Foley Street, London, W1W 7TY, UK.
Eoin DinneenDepartment of Urology, Westmoreland Street Hospital, University College London Hospital, 16-18 Westmoreland Street, London, W1G 8PH, UK.
Tarek Al-HammouriDepartment of Urology, Westmoreland Street Hospital, University College London Hospital, 16-18 Westmoreland Street, London, W1G 8PH, UK.
Nicola MuirheadNCITA Clinical Trials Unit, Division of Medicine, University College London, Charles Bell House, 2nd Floor, 43-45 Foley Street, London, W1W 7TY, UK.
Chris Brew-GravesNCITA Clinical Trials Unit, Division of Medicine, University College London, Charles Bell House, 2nd Floor, 43-45 Foley Street, London, W1W 7TY, UK.
John KellyDivision of Surgery & Interventional Science, University College London, Charles Bell House, 3rd Floor, 43-45 Foley Street, London, W1W 7TY, UK.
Greg ShawDepartment of Urology, Westmoreland Street Hospital, University College London Hospital, 16-18 Westmoreland Street, London, W1G 8PH, UK.

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
NCATS NIH HHS UL1 TR000445
6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomized clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate, and patients' experience using e-Consent.

methodsA substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. Although e-Consent obviated the need for in-person meeting, there was nonetheless counselling sessions performed interactively online. This new pathway offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation.

resultsBefore the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation.

conclusionRemote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues.

trial registrationNeuroSAFE PROOF trial NCT03317990 . Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978.

Indexed as

COVID-19Communicable Disease ControlHumansInformed ConsentMalePandemicsSARS-CoV-2Consent managemente-ConsentInformed consentProstate-cancer

Identifiers

PMID35550639
PMCPMC9096749

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.