QUARTET
(Qualitative Research to Improve Recruitment to Randomised Controlled Trials)
Background
The randomised controlled trial is the widely acknowledged design of choice for evaluating the effectiveness of medical and surgical interventions, but recruitment is often much lower than anticipated and desired. Low recruitment rates threaten the external validity of trials and lead to inefficient use of scarce resources. Many trials close because of low recruitment, meaning that serious evaluative questions remain unanswered. Systematic reviews have identified a range of barriers for clinicians and trial participants that inhibit recruitment, but there is little robust evidence about the effectiveness of strategies to improve the recruitment process, and little advice for recruiters on how best to present trial information to potential participants. Quartet seeks to address this theoretical and practical gap.
The Quartet study builds on work from the ProtecT (Prostate testing for cancer and Treatment) feasibility study – a controversial randomised trial of treatments for prostate cancer, which sought to randomise men between very different treatments: radical surgery, radical radiotherapy, and active monitoring. It was expected that recruitment would be difficult and so qualitative research was included to explore recruitment issues from the perspectives of trial participants and recruitment staff. On the basis of this research, a training programme for recruiters was developed and delivered. As a result, the rate of consent to randomisation increased from 30-40% in May 2000 to 70% by May 2001. Moreover, the findings of the ProtecT study indicate increased levels of informed consent among the men, as training helped recruiters to present trial information in a more balanced, less ambiguous manner.
Aims
QUARTET has four main aims:
- To work together with PIs and recruiters to improve recruitment to individual trials.
- To investigate whether qualitative research methods can lead to improvements in randomisation rates in two types of trial:
randomised controlled trials currently underway but experiencing difficulties with recruitment
controversial or ‘difficult’ trials during the feasibility phase - To improve recruitment rates while simultaneously ensuring that recruitment is not coercive – that participants are enabled to make an informed choice
- To develop guidelines for good practice in trial recruitment
How QUARTET Works
The study works through collaboration with principal investigators of randomised trials. The Quartet team offers support to recruiters by providing training tailored to the specific needs of the trial as identified through three forms of qualitative research:
- Information (“recruitment”) appointments are routinely audio-taped and subsequently examined in detail to investigate the content and method of delivery of information.
- Interviews are conducted with a sample of potential trial participants after they have attended the information appointment in order to investigate interpretations of trial information and experiences of the recruitment process.
- Interviews are conducted with recruitment staff to understand their perspectives and explore their understandings of the trial, experiences of the recruitment process, and recruitment strategies.
This three-part approach is particularly useful because it makes it possible to examine what actually happens during appointments, as well as participants’ interpretations of the information provided and the recruitment process more generally.
Funding And Location
The Quartet study is funded by the Medical Research Council and is based within the Department of Social Medicine at the University of Bristol, with collaborators throughout the UK. Quartet is led by Professor Jenny Donovan.
Further Information
Please contact: