![]() ![]() concluded that effective strategies include: (i) the use of opt-out rather than opt-in procedures, (ii) telephone reminders to non-respondents and (iii) open designs, which permit participants to know which treatment they are receiving in the trial. In a recent systematic review of methods to improve recruitment to clinical RCTs, Treweek, et al. The development of methods to improve recruitment is, therefore, a top priority for trial methodologists. ![]() As many as 45 % of publicly funded RCTs do not reach their recruitment targets, with almost half requiring an extension due to recruitment difficulties. While slight improvements have been reported in recent times, recruitment to RCTs remains a problematic issue. This highlights that extreme care needs to be taken in the design and recruitment of such trials. While the process of randomisation eliminates selection bias, cluster randomised trials, in which groups are randomised rather than individuals, may be more susceptible to bias, with one systematic review finding 40 % with identifiable biases. Recruiting adequate numbers of participants to randomised controlled trials (RCTs) and retaining them for the entire duration of a study, while challenging, is essential for internal and external validity and minimising bias, which can be introduced when certain groups of individuals refuse participation. Reflecting on the methodological challenges of recruiting to a school-based sexual-health feasibility trial, this study highlights pertinent general and trial-specific facilitators and barriers to recruitment, which will prove useful for future trials with schools, adolescent pupils and parents. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with pupil or parent needs or the school ethos. Commonly identified facilitators included perceptions of the relevance and potential benefit of the intervention to adolescents, the credibility of the organisation and individuals running the study, support offered by trial staff, and financial incentives. ![]() With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. ![]() As part of an embedded process evaluation, we conducted semi-structured interviews and focus groups with principals, vice-principals, teachers, pupils and parents recruited to the study as well as classroom observations and a parents’ survey. It aimed to determine the facilitators and barriers to recruitment and retention to a school-based sexual-health trial and identify optimal multi-level strategies for an effectiveness study. It comprised a feasibility study of an interactive film-based sexual-health intervention entitled If I Were Jack, recruiting over 800 adolescents from eight socio-demographically diverse post-primary schools in Northern Ireland. The Jack Trial was funded by the UK National Institute for Health Research. This article reflects on the challenges of recruiting post-primary schools, adolescent pupils and parents to a cluster randomised feasibility trial of a sexual-health intervention, and the strategies employed to address them. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue such as sexual health. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. The move toward evidence-based education has led to increasing numbers of randomised trials in schools. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |