Development of an online resource for recruitment research in clinical trials to organise and map current literature.

BACKGROUND: Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research. METHODS: MEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories. RESULTS: More than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%). DISCUSSION: Recruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.

Feasibility trial of a film-based educational intervention for increasing boys' and girls' intentions to avoid teenage pregnancy: Study protocol.

The World Health Organisation, amongst others, recognises that adolescent men have a vital yet neglected role in reducing teenage pregnancies and that there is a pressing need for educational interventions designed especially for them. This study seeks to fill this gap by determining the feasibility of conducting an effectiveness trial of the If I Were Jack intervention in post-primary schools. This 4-week intervention aims to increase teenagers' intentions to avoid unintended pregnancy and addresses gender inequalities in sex education by explicitly focusing on young men. A cluster randomised feasibility trial with embedded process evaluation will determine: recruitment, participation and retention rates; quality of implementation; acceptability and feasibility of the intervention and trial procedures; and costs.

Home-based child development interventions for preschool children from socially disadvantaged families.

BACKGROUND: Social disadvantage can have a significant impact on early child development, health and wellbeing. What happens during this critical period is important for all aspects of development. Caregiving competence and the quality of the environment play an important role in supporting development in young children and parents have an important role to play in optimising child development and mitigating the negative effects of social disadvantage. Home-based child development programmes aim to optimise children's developmental outcomes through educating, training and supporting parents in their own home to provide a more nurturing and stimulating environment for their child. OBJECTIVES: To determine the effects of home-based programmes aimed specifically at improving developmental outcomes for preschool children from socially disadvantaged families. SEARCH METHODS: We searched the following databases between 7 October and 12 October 2010: Cochrane Central Register of Controlled Trials (CENTRAL) (2010, Issue 4), MEDLINE (1950 to week 4, September 2010), EMBASE (1980 to Week 39, 2010), CINAHL (1937 to current), PsycINFO (1887 to current), ERIC (1966 to current), ASSIA (1987 to current), Sociological Abstracts (1952 to current), Social Science Citation Index (1970 to current). We also searched reference lists of articles. SELECTION CRITERIA: Randomised controlled trials comparing home-based preschool child development interventions with a 'standard care' control. Participants were parents with children up to the age of school entry who were socially disadvantaged in respect of poverty, lone parenthood or ethnic minority status. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed the trials' risk of bias and extracted data. MAIN RESULTS: We included seven studies, which involved 723 participants. We assessed four of the seven studies as being at high risk of bias and three had an unclear risk of bias; the quality of the evidence was difficult to assess as there was often insufficient detail reported to enable any conclusions to be drawn about the methodological rigour of the studies. Four trials involving 285 participants measured cognitive development and we synthesised these data in a meta-analysis. Compared to the control group, there was no statistically significant impact of the intervention on cognitive development (standardised mean difference (SMD) 0.30; 95% confidence interval -0.18 to 0.78). Only three studies reported socioemotional outcomes and there was insufficient data to combine into a meta-analysis. No study reported on adverse effects. AUTHORS' CONCLUSIONS: This review does not provide evidence of the effectiveness of home-based interventions that are specifically targeted at improving developmental outcomes for preschool children from socially disadvantaged families. Future studies should endeavour to better document and report their methodological processes.

Exploring the impact of depressive symptoms and medication beliefs on medication adherence in hypertension--a primary care study.

OBJECTIVE: This study aimed to assess the levels of adherence in a sample of hypertensive patients being cared for in primary care in Northern Ireland and to explore the impact of depressive symptoms and medication beliefs on medication adherence. METHODS: The study was conducted in 97 community pharmacies across Northern Ireland. A questionnaire containing measures of medication adherence, depressive symptoms and beliefs about medicines was completed by 327 patients receiving antihypertensive medications. RESULTS: Analysis found that 9.3% of participants were non-adherent with their antihypertensive medication (self-report adherence scale) and 37.9% had scores indicative of depressive symptoms as determined by the Center for Epidemiological Studies Depression Scale (CES-D). In the univariate analysis, concerns about medications had negative effects on both adherence and depressive symptomatology. However, logistic regression analysis revealed that patients over the age of 50 were more likely to be adherent with their medication than those younger than 50. Depressive symptomatology and medication beliefs (concerns) were not significantly related to adherence in the regression analysis. CONCLUSION: Depressive symptomatology was high in the sample as measured by the CES-D. Age was the only significant predictor of medication adherence in this population. PRACTICE IMPLICATIONS: Health care professionals should consider the beliefs of the patient about their hypertensive medications and counsel younger patients on adherence.

Inconsistencies in the drawing and interpretation of smiley faces: an observational study.

OBJECTIVES: Pre-prepared smiley face symbols are used widely to gather information on, for example, satisfaction with services or health and well-being. We investigated how women and men of different ages respond when asked to draw a smiley face for themselves. Our objectives were to investigate how they differ by generating a unique set of data to explore this simple human behaviour and to illustrate the importance of considering gender and age mix in any study. RESULTS: We collected 723 drawings, in a variety of settings. Gender and age were provided for 676 drawings (women: 511; men: 165; ≤ 30 years: 335; > 30 years: 341). Although similar proportions of women and men drew some features, such as closed mouths; women and those aged ≤ 30 were less likely to draw noses and outlines around the faces, and more likely to draw a classic smiley face. Our analyses provide a novel way to highlight that whenever self-reported outcomes are compared between groups, the group composition for characteristics such as gender and age may need to be considered carefully to explore whether differences in outcomes might simply arise from imbalances in those characteristics.

JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives.

INTRODUCTION: Teenage pregnancy remains a worldwide health concern which is an outcome of, and contributor to, health inequalities. The need for gender-aware interventions with a focus on males in addressing teenage pregnancy has been highlighted as a global health need by WHO and identified in systematic reviews of (relationship and sexuality education (RSE)). This study aims to test the effectiveness of an interactive film-based RSE intervention, which draws explicit attention to the role of males in preventing an unintended pregnancy by reducing unprotected heterosexual teenage sex among males and females under age 16 years. METHODS AND ANALYSIS: A phase III cluster randomised trial with embedded process and economic evaluations. If I Were Jack encompasses a culturally sensitive interactive film, classroom materials, a teacher-trainer session and parent animations and will be delivered to replace some of the usual RSE for the target age group in schools in the intervention group. Schools in the control group will not receive the intervention and will continue with usual RSE. Participants will not be blinded to allocation. Schools are the unit of randomisation stratified per country and socioeconomic status. We aim to recruit 66 UK schools (24 in Northern Ireland; 14 in each of England, Scotland and Wales), including approximately 7900 pupils. A questionnaire will be administered at baseline and at 12-14 months postintervention. The primary outcome is reported unprotected sex, a surrogate measure associated with unintended teenage pregnancy. Secondary outcomes include knowledge, attitudes, skills and intentions relating to avoiding teenage pregnancy in addition to frequency of engagement in sexual intercourse, contraception use and diagnosis of sexually transmitted infections. ETHICS AND DISSEMINATION: Ethical approval was obtained from Queen's University Belfast. Results will be published in peer-reviewed journals and disseminated to stakeholders. Funding is from the National Institute for Health Research. TRIAL REGISTRATION NUMBER: ISRCTN99459996.

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.

BACKGROUND: The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. 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. 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. METHODS: The Jack Trial was funded by the UK National Institute for Health Research. 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. 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. 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. RESULTS: With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. 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. 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN 11632300 . Registered on 19 December 2014.

Emotional development among early school-age children: gender differences in the role of problem behaviours.

There has been an increasing focus on social and emotional development in educational programmes in early childhood as both variables are believed to influence behavioural outcomes in the classroom. However, relationships between social and emotional development and behaviour in early childhood have rarely been explored. This article sets out to investigate the conceptualisation of these variables and their interrelationships. Structural equation models were used to assess whether differences exist between boys and girls in relation to social and emotional competences, which could affect the relative success of such programmes. This article is based on cross-sectional data collected from 749 four- to six-year-olds and their teachers. The findings generally supported the hypothesised relationships between social and emotional development variables and prosocial behaviour (including internalising behaviour) for boys and girls. However, some gender differences were noted in externalising behaviour, which teachers often consider to be most significant due to its potentially disruptive nature in the classroom.

How much do you need: a randomised experiment of whether readers can understand the key messages from summaries of Cochrane Reviews without reading the full review.

OBJECTIVE: We explored whether readers can understand key messages without having to read the full review, and if there were differences in understanding between various types of summary. DESIGN: A randomised experiment of review summaries which compared understanding of a key outcome. PARTICIPANTS: Members of university staff (n = 36). SETTING: Universities on the island of Ireland. METHOD: The Cochrane Review chosen examines the health impacts of the use of electric fans during heat waves. Participants were asked their expectation of the effect these would have on mortality. They were then randomly assigned a summary of the review (i.e. abstract, plain language summary, podcast or podcast transcription) and asked to spend a short time reading/listening to the summary. After this they were again asked about the effects of electric fans on mortality and to indicate if they would want to read the full Review. MAIN OUTCOME MEASURE: Correct identification of a key review outcome. RESULTS: Just over half (53%) of the participants identified its key message on mortality after engaging with their summary. The figures were 33% for the abstract group, 50% for both the plain language and transcript groups and 78% for the podcast group. CONCLUSIONS: The differences between the groups were not statistically significant but suggest that the audio summary might improve knowledge transfer compared to written summaries. These findings should be explored further using a larger sample size and with other reviews.

SWAT 1: what effects do site visits by the principal investigator have on recruitment in a multicentre randomized trial?

The SWAT (Study Within A Trial) programme has been established to develop a series of studies that would embed research within research, so as to resolve uncertainties about the effects of different ways of designing, conducting, analyzing and interpreting evaluations of health and social care. It was described in an Education piece in the Journal of Evidence-Based Medicine in 2012. We have now prepared the first example of the design summary for a SWAT, using the template that will be used for other SWAT. This is presented in this article.