Addressing barriers and identifying facilitators to support informed consent and recruitment in the Cavernous malformations A Randomised Effectiveness (CARE) pilot phase trial: insights from the integrated QuinteT recruitment intervention (QRI)

Julia Wade*, Nicola L Farrar, Alba Realpe, Jenny L Donovan , Laura Forsyth, Kirsty Harkness, Peter J Hutchinson, Neil Kitchen, Steff C. Lewis, James Loan, Jaqueline Stephen, Rustam Al-Shahi Salman

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

1 Citation (Scopus)
34 Downloads (Pure)

Abstract

Background
It was anticipated that recruitment to the Cavernous malformations: A Randomised Effectiveness (CARE) pilot randomised trial would be challenging. The trial compared medical management and surgery (neurosurgical resection or stereotactic radiosurgery) with medical management alone, for people with symptomatic cerebral cavernous malformation (ISRCTN41647111). Previous trials comparing surgical and medical management for intracranial vascular malformations failed to recruit to target. A QuinteT Recruitment Intervention was integrated during trial accrual, September 2021–April 2023 inclusive, to improve informed consent and recruitment.

Methods
The QuinteT Recruitment Intervention combined iterative collection and analysis of quantitative data (28 trial site screening logs recording numbers/proportions screened, eligible, approached and randomised) and qualitative data (79 audio-recorded recruitment discussions, 19 interviews with healthcare professionals, 11 interviews with patients, 2 investigator workshops, and observations of study meetings, all subject to thematic, content or conversation analysis). We triangulated quantitative and qualitative data to identify barriers and facilitators to recruitment and how and why these arose. Working with the chief investigators and trial management group, we addressed barriers and facilitators with corresponding actions to improve informed consent and recruitment.

Findings
Barriers identified included how usual care practices made equipoise challenging, multi-disciplinary teams sometimes overrode recruiter equipoise and logistical issues rendered symptomatic cavernoma diagnosis and assessment for stereotactic radiosurgery challenging. Facilitators identified included the preparedness of some neurosurgeons’ to offer surgery to people otherwise offered medical management alone, multi-disciplinary team equipoise, and effective information provision presenting participation as a solution to equipoise regarding management. Actions, before and during recruitment, to improve inclusivity of site screening, approach and effectiveness of information provision resulted in 72 participants recruited following a 5-month extension, exceeding the target of 60 participants.

Interpretation
QuinteT Recruitment Intervention insights revealed barriers and facilitators, enabling identification of remedial actions. Recruitment to a definitive trial would benefit from further training/support to encourage clinicians to be comfortable approaching patients to whom medical management is usually offered, and broadening the pool of neurosurgeons and multi-disciplinary team members prepared to offer surgery, particularly stereotactic radiosurgery.
Original languageEnglish
Article number102557
JournalEClinicalMedicine
Volume71
Early online date18 Apr 2024
DOIs
Publication statusE-pub ahead of print - 18 Apr 2024

Bibliographical note

Publisher Copyright:
© 2024 The Authors

Keywords

  • Adult
  • Child
  • Humans
  • Hemangioma
  • Cavernous
  • Central Nervous System
  • Neurosurgery
  • Radiosurgery
  • Feasibility Studies
  • Pilot Projects
  • Qualitative Research
  • randomised controlled trials as topic

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