Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

Background Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers’ and participants’ experiences of its implementation and to inform future strategies to maximise recruitment and retention. Methods In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. Results We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners’ contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Conclusions Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.

The effects of a volunteer mentoring programme on reading outcomes among eight- to nine-year-old children: A follow up randomized controlled trial

This article presents the findings of a randomized controlled trial evaluation of the effects of a revised version of the volunteer mentoring programme, Time to Read. Participating children received two 30-minute mentoring sessions per week from volunteer mentors who carried out paired reading activities with the children. The current trial involved 512 children aged eight to nine years from 50 primary schools. The programme was found to be effective in improving decoding skills (d=+.15), reading rate (d=+.22) and reading fluency (d=+.14) and there was some evidence of a positive effect in relation to the children’s aspirations for the future (d=+.11). However, no evidence was found of the programme having an effect on reading comprehension or reading confidence and enjoyment of reading. The article concludes by suggesting that mentoring programmes using non-specialist volunteers can be effective in improving foundational reading skills but would appear to be less effective in terms of improving higher-order skills such as comprehension. The article also suggests that such programmes are likely to be most effective if concentrating on core reading activities rather than attempting to address reading outcomes indirectly through improving children’s confidence or wider enjoyment of reading.

A controlled trial of early interventions to promote maternal adjustment and development in infants born with severe congenital heart disease

Background: Congenital heart disease can have a negative impact on both infant development and maternal adjustment. This study considered the impact of a new programme of early psychosocial interventions on such outcomes, following the birth of a child with severe congenital heart disease.
Methods: Seventy infants and their mothers were assigned to an intervention or control group based on order of presentation to the unit. Interventions aimed at bolstering mother–infant transactions, through psychoeducation, parent skills training and narrative therapy techniques were implemented.
Results: Clinically and statistically signi?cant gains were observed at 6-month follow-up on the mental (but not the psychomotor) scale of the Bayleys-II. Positive gains were also manifested on feeding practices, maternal anxiety, worry and appraisal of their situation.
Conclusions: A programme of generalizable psychosocial interventions is shown to have a positive impact on the infant with severe congenital heart disease and the mother.

Clinical trial designs for rare diseases: Studies developed and discussed by the International Rare Cancers Initiative

BACKGROUND: The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research.

SETTINGS: The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional--usually randomized--clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed.

RESULTS: The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design.

INTERPRETATION: Trials can be designed using a wide array of possibilities. There is no 'one size fits all' solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases.

Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial

Background
Recruitment to school-based randomised trials is challenging; even more so when the focus of the study is a sensitive issue such as sexual health. The Jack Feasibility Trial aims to determine the facilitators and barriers to recruitment and retention to a school-based sexual health trial and identify optimal multi-level strategies for a full trial.
Method
The Jack Trial is an NIHR-funded feasibility study of a film-based sexual health intervention, recruiting over 800 adolescents from 8 post-primary schools in Northern Ireland. In order to examine the feasibility of piloted recruitment and retention methods and assess acceptability of participation across the range of schools and individuals approached, we analysed qualitative data from triangulated sources including a parents’ survey and semi-structured interviews with principals, vice-principals, teachers and parents recruited to the study.
Results
With reference to Social Learning Theory, we identified a number of individual, behavioural and environmental level factors which influenced recruitment and retention. Commonly identified facilitators included the perceived relevance and potential benefit of the intervention to adolescents, the credibility of the organisation running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with adolescent needs or school ethos.
Conclusion
This study highlights pertinent general and trial-specific facilitators and barriers to recruitment to a sexual health trial in a school setting, which will prove useful for successful conduct of future trials with schools, adolescents and parents.