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.
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
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



Hughes-Morley A
(2016)
The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial.
in Trials

Hughes-Morley A
(2015)
Factors affecting recruitment into depression trials: Systematic review, meta-synthesis and conceptual framework.
in Journal of affective disorders



Madurasinghe VW
(2016)
Guidelines for reporting embedded recruitment trials.
in Trials


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 | 07/2017 |
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 | 03/2017 |
End | 03/2022 |
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 | 09/2015 |
End | 08/2016 |
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 | £40,263 (GBP) |
Funding ID | N64 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2015 |
End | 12/2015 |
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 | 09/2014 |
End | 09/2017 |
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 |