Systematic Techniques for Assessing Recruitment to Trials (START): a programme to test recruitment interventions

Lead Research Organisation: University of Manchester
Department Name: Medical and Human Sciences

Abstract

The best way to test new treatments is to see how well they work in a randomised controlled trial (RCT). This means some patients get the treatment and some do not, and the results of the different groups are compared to see if the treatment leads to better health. Although many trials like this are run in the NHS, recruiting patients to these trials is often difficult and takes longer than planned. This means that research is delayed and that patients and professionals cannot benefit from the knowledge about what treatments work best.

Our aim is to develop new ways of helping to recruit patients to trials, and to test them in randomised controlled trials that are ongoing in the NHS.

To achieve this, we will do three things:

(a) We will develop methods to help us test recruitment methods, by looking at the published work worldwide and exploring different statistical issues

(b) We will develop new methods to help patients take part in trials, such as new ways of providing information to patients to help them understand randomised controlled trials

(c) We will work with researchers who are running trials in primary care and community settings, helping them to use our new patient information with their patients. We will collect data from these trials and test whether our new methods improve recruitment rates

As well as testing our new methods, we hope our work will help us to understand how best to test recruitment methods in trials, and will encourage researchers in the future to get involved in such testing. This will help the NHS to do research and use the knowledge to improve the health and well being of patients.

Technical Summary

Our aim is to improve the evidence-base concerning recruitment to trials, enhance recruitment rates and make research more accessible to the public.



Randomised controlled trials (RCTs) are critical to evidence-based practice, but recruitment is often problematic, with little rigorous evidence to assist research teams in recruitment and retention of participants. Without the development of reliable methods, the policy goal of improving health and wealth through research will be hard to realise.



A robust test of the effectiveness of a recruitment method is an RCT comparing one method with an alternative, nested in a host trial. Such nested studies are rare, largely delivered in an ad hoc way, and always tested in the context of a single host trial, limiting their utility



Our vision is to develop a methodology to develop, deploy and test recruitment interventions nested within ongoing host RCTs, to rapidly and systematically improve the evidence base. To achieve this, we propose a programme of three interrelated work packages:



(a) Methodology ? We will develop methods for design and analysis of nested recruitment studies



(b) Interventions ? We will develop recruitment interventions



(c) Implementation ? We will recruit a cohort of host RCTs and test our recruitment interventions through nested studies across multiple trials

Publications

10 25 50

 
Description Health Improvement, Protection and Services Research Committee
Amount £199,858 (GBP)
Funding ID HIPS/16/46 
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 08/2017 
End 07/2019
 
Description NIHR Doctoral Research Fellowship
Amount £266,514 (GBP)
Funding ID NIHR-DRF-2012-05-1128 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 11/2012 
End 10/2015
 
Description NIHR Senior Investigator Award
Amount £75,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2017 
End 03/2022
 
Description Network of Hubs for Trials Methodology Research
Amount £92,697 (GBP)
Funding ID P15 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 10/2014 
End 09/2017
 
Description Network of Hubs for Trials Methodology Research
Amount £21,286 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 11/2015 
End 08/2016
 
Description Network of Hubs for Trials Methodology Research
Amount £21,286 (GBP)
Funding ID N73 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 10/2015 
End 08/2016
 
Description Network of Hubs for Trials Methodology Research
Amount £40,263 (GBP)
Funding ID N64 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 03/2015 
End 12/2015
 
Description Routinely embedding recruitment and retention interventions within randomised controlled trials
Amount £494,522 (GBP)
Funding ID MR/R013748/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 01/2018 
End 09/2020
 
Title Reporting guidelines for embedded studies of recruitment interventions 
Description We have developed guidelines to standardise and enhance the reporting of embedded studies of recruitment interventions. The guidelines were created through a detailed process, including two meetings with grant applicants and a range of other contributors 
Type Of Material Improvements to research infrastructure 
Year Produced 2014 
Provided To Others? Yes  
Impact The guidelines have just been published, and we have used them in the first submission from the MRC START programme. We have provided them to other researchers within START, and plan to publish them more widely in due course 
 
Description Collaboration with START team led from Manchester 
Organisation University of Manchester
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual contribution to the START colloboration
Collaborator Contribution Led from Manchester, but intellectual contributions from various academics
Impact see publications section
Start Year 2013
 
Description MRC Conduct Hub 
Organisation University of Bristol
Department Collaboration and Innovation for Difficult or Complex Randomised Controlled Trials (ConDuCT)
Country United Kingdom 
Sector Academic/University 
PI Contribution I provide methodological advice and advice about primary care
Collaborator Contribution Coordination of work on trials methodology
Impact NA
Start Year 2015
 
Description North West Hub for Trials Methodology Research 
Organisation Medical Research Council (MRC)
Department MRC North West Hub for Trials Methodology Research
Country United Kingdom 
Sector Academic/University 
PI Contribution I have been co-opted as joint lead of the Patient Perspectives Theme, and to provide expertise in relation to recruitment interventions
Collaborator Contribution The Hub has significant interest in the development of recruitment interventions, and we ran a workshop for 2013 to explore these issues further, leading to an open access publication
Impact http://www.trialsjournal.com/content/15/1/399
Start Year 2012
 
Description TrialsForge 
Organisation University of Aberdeen
Department Centre for Healthcare Randomised Trials
Country United Kingdom 
Sector Academic/University 
PI Contribution We have mutual interests in recruitment methods, and we have contributed to the initial meetings and papers around the TrialsForge idea
Collaborator Contribution The leader of TrialsForge is an applicant on MRC START, and we expect the products of START to be made available through TrialsForge
Impact There is a summary paper being prepared from the TrialsForge meeting, to which we contributed
Start Year 2014
 
Title MRC START recruitment website 
Description A website to support informed decision making about participation in trials 
Type Support Tool - For Medical Intervention
Current Stage Of Development Initial development
Year Development Stage Completed 2013
Development Status Under active development/distribution
Impact No notable impacts yet 
 
Description Invited presentation at the Bristol MRC CONDUCT II annual meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact Randomising our way to recruitment success: the lure and the limits of 'Studies within Trials (SWATs). Invited presentation at the Bristol MRC CONDUCT II annual meeting, 29th June 2016.
Year(s) Of Engagement Activity 2016
 
Description Presentation and workshop at REC members training day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact What happens when researchers embed studies within studies? Presentation and workshop at REC members training day, London, 16th February 2017
Year(s) Of Engagement Activity 2017
 
Description Presentation at Keele University seminar series 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact From Mistletoe to Pilot Fish - embedding recruitment studies into RCTs. Presentation at Keele University seminar series, 9th May 2016
Year(s) Of Engagement Activity 2016
 
Description Presentation to 2015 Society for Clinical Trials Annual conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited session at the 2015 Society for Clinical Trials Annual conference, Arlington Virginia, 20th May 2015
Year(s) Of Engagement Activity 2015
 
Description Presentation to NIHR Trial Managers Network 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Approximately 100 trial managers attended, and we gained useful contacts for our research, as well as raising the profile of recruitment trial studies

Some studies showed interest in being involved in the project, although ultimately none met the inclusion criteria
Year(s) Of Engagement Activity 2013
 
Description Presentation to North West Clinical Trials Collaborative 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact 50 people involved in the design and delivery of clinical trials heard a talk on MRC START and discussed how it might be adopted in their work

We identified possible collaborators for future work
Year(s) Of Engagement Activity 2014
 
Description Webinar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Webinar for Trials Management Network
Year(s) Of Engagement Activity 2015
URL https://htmr-ctsu.webex.com/htmr-ctsu/lsr.php?RCID=44db34fb0ef3d78fd93fbfbc851e2d6a