Using digital tools in the recruitment and retention in randomised controlled trials: survey of UK Clinical Trial Units and a qualitative study.

BACKGROUND: Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful. METHODS: A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March-June 2018. Qualitative data were analysed using a content analysis and inductive approach. RESULTS: Responses from 24 (46%) CTUs identified that database-screening tools were the most widely used digital tool for recruitment, with the majority being considered effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). Fewer retention tools were used, with short message service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: 'security and transparency'; 'inclusivity and engagement'; 'human interaction'; 'obstacles and risks'; and 'potential benefits'. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants. CONCLUSIONS: Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.

Health research systems in change: the case of 'Push the Pace' in the National Institute for Health Research.

BACKGROUND: Those running well-organised health research systems are likely to be alert for ways in which they might increase the quality of the services they provide and address any problems identified. This is important because the efficiency of the research system can have a major impact on how long it takes for new treatments to be developed and reach patients. This opinion piece reflects on the experience and learning of the United Kingdom-based National Institute for Health Research (NIHR) when it implemented continuous improvement activity to improve its processes. DISCUSSION: This paper describes the structure and work of the NIHR and why, despite is successes as a health research system and ongoing local continuous improvement, it believed in the value of an organisation-wide continuous improvement activity. It did this by implementing an approach called 'Push the Pace'. Initially, the organisation focused on reducing the amount of time it took for research to transition from an early concept to evidence that changes lives. This scrutiny enabled the NIHR to realise further areas of improvement it could make - additional goals were increased transparency, process simplification, and improved customer and stakeholder experience. We discuss our experience of Push the Pace with reference to literature on continuous improvement. CONCLUSION: Continuous improvement is a cycle, an activity that is done constantly and over time, rather than an act or linear activity (such as Push the Pace). We believe that the work of Push the Pace has initiated a strong commitment to a culture of continuous improvement in the NIHR. This is significant because culture change is widely recognised as immensely challenging, particularly in such a large and distributed organisation. However, our biggest challenge will be to enable all staff and stakeholders of the NIHR to participate in the continuous improvement cycle.

Evaluation of stakeholder views on peer review of NIHR applications for funding: a qualitative study.

OBJECTIVES: Innovations resulting from research have both national and global impact, so selecting the most promising research studies to fund is crucial. Peer review of research funding applications is part of the selection process, and requires considerable resources. This study aimed to elicit stakeholder opinions about which factors contribute to and influence effective peer review of funding applications to the UK National Institute for Health Research (NIHR), and to identify possible minor improvements to current processes and any major changes or potential innovations to achieve a more efficient peer review process. DESIGN: Qualitative interviews with 30 stakeholders involved in the peer review process. PARTICIPANTS: Participants were drawn from three NIHR coordinating centres and represented four types of stakeholders: board members with responsibility for making funding decisions, applicants, external peer reviewers and NIHR staff. METHODS: All interviews were conducted by telephone apart from three that were face to face with NIHR staff. Data were analysed using a thematic template method. RESULTS: The responses from NIHR staff, board members and reviewers differed from those received from applicants. The first three groups focused on how well the process of peer review did or did not function. The applicants mentioned these points but in addition often reflected on how their personal application was assessed. Process improvements suggested included: developing a more proportionate review process; providing greater guidance, feedback, training, acknowledgement or incentives for peer reviewers; reducing the time commitment and amount of paperwork; and asking reviewers to comment on the importance, strengths and weaknesses of applications and flaws which are potentially 'fixable'. CONCLUSIONS: Overall, participants were supportive of the need for peer review in evaluating applications for research funding. This study revealed which parts of the process are working well and are valued, and barriers, difficulties and potential areas for improvement and development.