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Recruitment of participants and their retention in randomized controlled trials (RCTs) is key for research efficiency. However, for many trials, recruiting and retaining participants meeting the eligible criteria is extremely challenging. Digital tools are increasingly being used to identify, recruit and retain participants. While these tools are being used, there is a lack of quality evidence to determine their value in trial recruitment.
The aim of the main study was to identify the benefits and characteristics of innovative digital recruitment and retention tools for more efficient conduct of RCTs. Here we report on the qualitative data collected on the characteristics of digital tools required by trialists, research participants, primary care staff, research funders and Clinical Trials Units (CTUs) to judge them useful. A purposive sampling strategy was used to identify 16 participants from five stakeholder groups. A theoretical framework was informed from results of a survey with UKCRC registered CTUs. Semi-structured interviews were conducted and analysed using an inductive approach. A content and thematic analysis was used to explore the stakeholder's viewpoint and the value of digital tools.
The content analysis revealed that ‘barriers / challenges ‘ and ‘awareness of evidence’ were the most commonly discussed areas. Three key emergent themes were present across all groups: ‘security and legitimacy of information’, ‘inclusivity’, and ‘availability of human interaction’. Other themes focused on the engagement of stakeholders in their use and adoption of digital technology to enhance the recruitment/retention process. We also noted some interesting similarities and differences between practitioner and participant groups.
The key emergent themes clearly demonstrate the use of digital technology in the recruitment and retention of participants in trials. The challenge, however, is using these existing tools without sufficient evidence to support the usefulness compared to traditional techniques. This raises important questions around the potential value for future research.
The National Institute for Health Research (NIHR) is a major funder of health research in the United Kingdom. Selecting the most promising studies to fund is crucial, and external expert peer review is used to inform the funding boards. Our aim was to evaluate the influence of different kinds and numbers of peer review and reviewer scores on Board funding decisions, and how we might modify the process to reduce the workload for stakeholders.
Our mixed method study included i) retrospective cross sectional analysis of funding board and external reviewer scores for second stage applications for research funding, using Receiver Operator Characteristic (ROC) curves to quantify the influence of reviewer scores on funding decisions and ii) qualitative interviews with thirty stakeholders (funding board members, applicants, external peer reviewers and NIHR staff).
Analysis of ROC area for reviewers indicated that areas changed very little with increasing numbers of reviewers from four to seven or more. External reviewers with clinical, methodological or patient expertise all appeared to influence Board funding decisions to a similar extent. The stakeholders interviewed valued peer review but felt it was important to develop a more proportionate process, to better balance its benefit with the workload of obtaining, preparing, reading and responding to reviews. Reviews are of most value when they fill gaps in expertise on the Board. Less than four reviews was felt to be insufficient but more than six, excessive. Workload could be reduced by making reviews more focused on the strengths and weaknesses of applications and identifying flaws which are potentially “fixable”.
Stakeholders supported the need for peer review in evaluating funding applications. Our results suggest that four to six peer reviews per application is optimum, depending on the expertise needed to complement that of advisory boards.
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