Optimising Recruitment and Informed Consent in Randomized Controlled Trials: the Development and Implementation of the Quintet Recruitment Intervention (QRI)

Posted: Jun 10, 2016
Trials. 17. 283. DOI: 10.1186/s13063-016-1391-4.
KEYWORDS: Verbal Communications, Non-Cancer, Cancer

Highlights

A recruitment intervention, the QRI, has been developed to address recruitment challenges and has been applied successfully in 13 randomized clinical trials. 

Why this item may be useful

A major aim of the QuinteT Recruitment Intervention (QRI) is to understand the recruitment process as it happens and to address clear obstacles and hidden challenges to the provision of clear and accurate information to facilitate informed decision-making by patients about trial participation. The QRI uses standard and innovative research methods (primarily qualitative and some simple quantification) to provide a clear understanding of the application of the randomized clinical trial in clinical settings. The intervention is conducted in two phases. Phase I involves an assessment of the protocol development and the recruitment process using interviews, recordings, and review of log data. In Phase II, the research team is provided anonymized feedback of the findings and a tailored plan for improving recruitment and informed consent. The feedback encourages reflection about the emotional and intellectual challenges that recruiters often experience, particularly around equipoise, patient eligibility, and perceived role-conflict. 

Details

The QRI was developed to address the limitation with existing interventions in 3 ways:

  • To understand the recruitment process as it occured in clinical settings from the perspective of recruiters and patients.
  • During the QRI development period, it was applied in as many different types of trials as possible.
  • It sought to address the difficulties that arose for recruiters and potential participants by optimizing recruitment quality and informed consent.