Successful recruitment to trials : findings from the SCIMITAR+ Trial

BACKGROUND: Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. METHODS: SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. RESULTS: Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. CONCLUSIONS: This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment

Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children : a systematic review

Background Randomised controlled trials (RCTs) are recommended as the ‘gold standard’ in evaluating health care interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. Aim To identify predictors of recruitment and retention in RCTs involving children. Methods A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0–12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. Results Twenty-eight studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socioeconomic status (SES)) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. Conclusion Parent characteristics may predict participation of children and their families to RCTs; however, there was a lack of consensus. Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention

Creating the eXtension Family Caregiving Community of Practice

The Family Caregiving Community of Practice, part of eXtension, provides a national one-stop site for Extension's caregiving educational resources. The developmental process of this community's creation is discussed within the "expansive learning" framework. Negatively, community members found too much emphasis on process and a lack of criteria for academic credit. Positively, they experienced increased knowledge, improved networking, and innovation. Recommendations for others creating communities are to: 1) promote the benefits of networking; 2) seek out others with similar passions; 3) provide graduated opportunities for learning; 4) help members transition from an individual perspective; and 5) provide systems for academic recognition

Testing Self-Efficacy as a Pathway that Supports Self Care among Family Caregivers in a Psychoeducational Intervention

This study investigated the extent to which a psychoeducational intervention supports family-centered care by influencing health risk and self-care behaviors of caregivers of individuals with Alzheimer\u27s disease (N = 325). Moreover, this study investigated the extent to which changes in self-efficacy explained changes in health risk and self-care behaviors. Data were analyzed using repeated measures and multivariate analysis of variance and multiple regression. Qualitative written accounts of the impact of the intervention augmented the quantitative findings. The study\u27s findings revealed that family caregivers experienced reductions in health risk behaviors and improvements in exercise, stress management, and relaxation activities as a result of participating in the psychoeducational intervention. Improvement in self-efficacy was linked with reductions in health risk behaviors and increased involvement in stress management and relaxation activities. Implications are discussed in terms of the need to understand the mechanisms by which interventions influence family caregivers and the role these mechanisms play in supporting family-centered care