Qualitative Research to Improve Recruitment to Randomised Controlled Trials (QUARTET)

Lead Research Organisation: MRC Health Services Resrch Collaboration

Abstract

Medical research trials (studies) are vital for judging the effectiveness of treatments but recruiting people to take part in a trial is often difficult. If not enough people agree to take part serious health questions (such as which treatment is better than another) cannot be answered. At present, we know little about how best to present information about trials to people who might wish to take part. This is a complex question because, on the one hand, it is important to increase the numbers of people taking part in trials; on the other hand it is important to ensure that nobody feels pressured to do so. ||The Quartet study aims to provide some guidelines to help trial recruiters (who may be doctors, nurses or specially trained researchers) to provide trial information in a balanced way.||To improve our knowledge about recruitment to trials, Quartet is examining what actually happens during the recruitment process. To do this, we are audio-recording discussions between trial recruiters and the people they are inviting to join a trial. This will allow us to see how information about trials is presented at the moment. ||We are also interviewing trial recruiters and other members of the trial team to learn their views on what might be going well or badly with recruitment to their trial.||On the basis of what we find out, we then work out ways to improve this recruitment process. Quartet provides feedback and training to recruiters in order to support their work and help them to give trial information in the best way possible so that people are able to make an informed decision about whether to take part.||

Technical Summary

The randomised controlled trial (RCT) is the widely acknowledged design of choice for evaluating the effectiveness of medical and surgical interventions, but recruitment is often much lower than anticipated, threatening the external validity of trials. Systematic reviews have identified a range of barriers that inhibit recruitment, but there is little robust evidence about the effectiveness of strategies to improve recruitment. Qualitative methods were successfully used in the ProtecT (Prostate testing for cancer and Treatment) feasibility study to improve recruitment rates from 30-40% to 70%. This research identified, through examination of recruitment appointments, flaws in information delivery to potential participants; training was provided to recruiters in order to improve the process. High rates of acceptance of allocation indicated that the improvement in randomization rates was not achieved at the cost of obtaining informed consent. ||The Quartet study aims to build on the findings of the ProtecT feasibility study by asking whether qualitative research methods can lead to improvements in randomisation rates in two types of study: ||1) RCTs experiencing difficulties with recruitment ||2) Controversial or difficult trials during the feasibility phase||In order to do this, the Quartet team is:||1) Conducting in-depth interviews with principal investigators and recruiters to elicit their views on the relevant issues||2) Audio-recording recruitment appointments to understand interactional and information delivery issues||3) Conducting in-depth interviews with patients to elicit their perspective||4) Providing research-based training to recruiters||5) Monitoring the impact of the training on randomization rates||6) Producing good practice guidelines||Thematic analysis is being used to identify common and emergent themes in the interview data by employing constant comparison techniques. Content analysis is used to describe the terminology used by the recruiters and this is compared with written study information. ||Conversation analysis will be used to investigate the delivery of information during the recruitment appointments, with a particular focus on the interaction between recruiter and patient. There will be frequent assessments of recruitment rates - both randomisation and immediate acceptance of allocation. ||

Publications

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Hamilton DW (2013) The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer. in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery

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Tomlin Z (2014) Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent. in Health expectations : an international journal of public participation in health care and health policy

 
Description Improvment of recruitment to randomised trials
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact .
 
Description CRUK sub contract from SPARE RCT
Amount £50,000 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2009 
End 12/2010
 
Description CTAAC pout
Amount £400,000 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2012 
End 12/2018
 
Description HTA fashion
Amount £236,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 05/2012 
End 04/2018
 
Description HTA programme byband
Amount £2,900,000 (GBP)
Funding ID 09/127/53 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 04/2012 
End 03/2018
 
Description HTA romio
Amount £425,000 (GBP)
Funding ID HTA/10/50/65 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
 
Description Linbury Trust Project Grant
Amount £300,000 (GBP)
Organisation The Sainsbury Family Charitable Trusts 
Department Linbury Trust
Sector Charity/Non Profit
Country United Kingdom
Start 09/2010 
End 08/2012
 
Description MRC Hubs for Trial Methodology Research (HTMR)
Amount £1,900,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 04/2009 
End 03/2014
 
Description hta optima
Amount £2,000,000 (GBP)
Funding ID HTA/10/34/01 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start  
End 12/2014
 
Title QRI template 
Description Template for qualitative recruitment intervention that can initiate collaborative discussions and be used to optimise recruitment to randomised controlled trials 
Type Of Material Improvements to research infrastructure 
Year Produced 2011 
Provided To Others? Yes  
Impact Award of 19 grants to undertake recruitment research in RCTs; several more pending 
URL http://www.bristol.ac.uk/social-community-medicine/research/groups/social-sciences-health/quintet/in...
 
Description ByBand 
Organisation University of Bristol
Department School of Clinical Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution I am contiributing the qualitative research component to investigate and improve recruitment to the trial.
Collaborator Contribution Helped to refine qualitative research protocol
Impact Successful grant award by NIHR HTA programme
Start Year 2009
 
Description FASHIoN trial 
Organisation University of Warwick
Department Warwick Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution I contributed the qualitative research to understand and improve recruitment to the RCT.
Collaborator Contribution Helped to refine qualitative research protocol
Impact Successful grant award by NHS HTA programme
Start Year 2010
 
Description Lightening RCT 
Organisation University of Bristol
Department School of Social and Community Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Design of feasibility study for RCT in the area of chronic fatigue syndrome; specific contribution of qualitative research
Collaborator Contribution This RCT will provide opportunties to further develop and implement the intervention to improve recruitment.
Impact Successful grant award from LinburyTrust
Start Year 2009
 
Description OPTIMA trial group 
Organisation University of Warwick
Department Warwick Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution I contributed the qualitative study to understand recruitment to the RCT.
Collaborator Contribution Helped to refine qualitative research protocol
Impact Output so far is grant awarded by NIHR HTA programme. This is a large multi-disciplinary RCT.
Start Year 2010
 
Description POUT trial 
Organisation Institute of Cancer Research UK
Country United Kingdom 
Sector Academic/University 
PI Contribution I am contributing the qualitative research component to understand and support recruitment to the trial
Collaborator Contribution Helped to refine qualitative research protocol
Impact Successful grant award by CTAAC/CRUK. This is a multidisciplinary RCT
Start Year 2010
 
Description QUARTZ trial recruitment 
Organisation Medical Research Council (MRC)
Department MRC Clinical Trials Unit
Country United Kingdom 
Sector Public 
PI Contribution A brief intervention comprising telephone exchanges about recruitment difficulties and face-to-face meetings to discuss recruitment was applied by the team.
Collaborator Contribution Quartz trial provided opportunties to test out brief intervention to improve recruitment
Impact General improvement in recruitment.
Start Year 2007
 
Description ROMIO trial 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Adding qualitative research component to help recruitment to trial
Collaborator Contribution Helped to refine qualitative research protocol
Impact Successful grant award by NIHR HTA programme
Start Year 2010
 
Description SPARE trial qualitative recruitment research 
Organisation Institute of Cancer Research UK
Country United Kingdom 
Sector Academic/University 
PI Contribution We carried out interviews and documenta analysis which led to changes to the Patient Information sheets and trial protocol. We implemented a training programme to improve recruitment rates.
Collaborator Contribution ICR are leading SPARE RCT which has provided opportunities for further developing and implementing the interventions developed in the MRC Quartet study to improve recruitment
Impact Changes to Patient Informatin Sheet; changes to RCT protocol. Changes in approaches to patients for recruitment. Paper submitted for publication.
Start Year 2009
 
Description Systemativc review of qualitative research in RCTs 
Organisation University of Aberdeen
Department Health Services Research Unit
Country United Kingdom 
Sector Public 
PI Contribution Contribution of expertise to development of joint grant application to MRC methodology programme
Collaborator Contribution Leadership of development of grant proposal
Impact Application to MRC Methodology Programme
Start Year 2008
 
Description Invited lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Primary Audience Public/other audiences
Results and Impact Approximately 100 participants (consumers and researchers) attended a session at the NCRI annual conference to discuss consumer participation in research. The balance of the audience was 50:50 (researchers:consumers) compared with 20:80 the previous year. There were many questions.

Feedback was very encouraging, indicating more researchers who will include consumers, and consumers pleased to have a session devoted to this area.
Year(s) Of Engagement Activity 2010