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During recruitment, potential trial participants are usually given a written study patient information sheet (PIS). These are often long, complex and visually unappealing documents, which may have a negative impact on recruitment. Improving their readability by employing user testing, and their presentation by using graphic designers may improve patient understanding and aid recruitment. We undertook an embedded randomised controlled trial within the NIHR-funded REFORM study, as part of the MRC START initiative, to evaluate whether enhancing PIS improves trial recruitment and retention. 6,900 patients due to be mailed a REFORM recruitment pack were randomised in a 1:1:1 ratio to receive one of three types of PIS: the original based on the NHS ethics template (n=2,298); an enhanced, user tested PIS (n=2,301); or a ‘template’ PIS which was developed using an enhanced PIS from another trial in a similar population (n=2,301). 193 participants (2.8%) were randomised to the trial: 62 (2.7%) in the control group; 63 (2.7%) in the user tested group; and 68 (3.0%) in the template group (OR: template vs control 1.10 (95% CI 0.77-1.56, p=60); user tested vs control 1.01 (95% CI 0.71-1.45, p=0.94); and user tested vs template 0.92 (95% CI 0.65-1.31, p=0.65)). Logistic regression analysis demonstrated that PIS allocation did not significantly predict recruitment (p= 0.33) or retention in the trial (p=0.83). There was no evidence to suggest that enhanced PIS increased recruitment and retention rates to the REFORM trial. However, the number of patients randomised was low and we may be underpowered to detect a difference.

Background Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions. Methods The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD). Results In Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61). Conclusions Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population. Trial registration Current Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012 Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0820-0) contains supplementary material, which is available to authorized users.

Testing the effectiveness of user-tested patient information on recruitment rates across multiple trials: meta-analysis of data from the start programme Peter Bower, Jo Rick, Anne Kennedy, Chris Salisbury, David Collier, David Torgerson, Jonathan Graffy, Shaun Treweek, Sandra Eldridge, Vichithranie Madurasinghe, Peter Knapp, Adwoa Hughes-Morley, Nicola Small, CASPER Research team, Healthlines Research team, ECLS Research team

RCTs are critical to evidence-based medicine, but recruitment is routinely problematic. Robust tests of recruitment methods, where alternative approaches are compared within RCTs, are rare. The MRC funded START programme aims to test the feasibility of routinely nesting recruitment interventions in host RCTs. This will rapidly extend the evidence base, allow promising recruitment interventions to be tested across multiple trials, and improve our understanding of the impact of contextual factors on recruitment. Newly commissioned or recruiting trials were identified via PCRN and HTA portfolios. A total of 225 PIs were sent a flyer describing the MRC START programme with a covering email (from PCRN or HTA) inviting them to contact the team if they would like to know more about the study. Preliminary discussions were held with interested trials to screen them for suitability. Formal agreements were then put in place and trial specific intervention content was developed. Nearly a third (32%) of PIs approached expressed an interest in the study. Just over half (52%) were excluded, reasons included incompatible recruitment strategies, timetable issues or trial size. Reaction to the additional burden placed on trials has so far been positive. Documentation has been found fit for purpose and the process of implementation supported by a ‘can do' culture and complex research skills in trial managers. This presentation will: • (a) describe START and report on progress to date, • (b) discuss early findings in relation to feasibility and host trial experience, • (c) present materials to support the recruitment of host trials.

Results Nineteen reviews were included. Multimedia interventions offer a platform for learning which can include study-specific information (e.g. study purpose, risks), and generic information (e.g. confidentiality). There was evidence that multimedia interventions improved various outcomes including perceived risk, personal choice and feeling informed. PPI forum members and qualitative experts developed study-specific components involving bespoke themes such as investigator details and benefits of participation, and generic information components including informed consent, randomisation and confidentiality. Existing video clips of patients discussing their experiences of participation were carefully matched to these components.