Lisa Maguire

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.

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.

The SWAT (study within a trial) programme; embedding trials to improve the methodological design and conduct of future research.

Researchers and trialists face many uncertainties when designing and conducting research. Embedded methodology studies can help to resolve these. However, despite hundreds of thousands of trials, there are probably only a few hundred studies assessing the effects of different methods for doing this research. The concept of the SWAT (Study Within A Trial) programme is to aid the development of such research by increasing awareness of, and stimulating interest in the need for this research and providing a framework and resource to inspire and generate ideas, and to store, disseminate and modify such research. The programme was established as part of the development of an All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Councils Network of Hubs in the UK and the Global Health Network. It will facilitate this research into research. Each SWAT comprises of simple, one or two page protocols and, as of April 2015, 19 different SWAT outlines have been registered. This presentation will detail the SWAT concept, and describe the core outline which consists of the following sections: background, intervention, comparator, allocation, primary outcomes, secondary outcomes, analysis, possible problems, likely costs, publications, and version information. The SWAT website will be available to view, and examples of completed SWATs will be shown. The presentation should stimulate ideas for future SWAT, and encourage researchers to see how they might maximize the impact of embedding research into research, leading to improvements in the design of future clinical trials and other studies.

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.

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.

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.

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

BackgroundThe 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.MethodsThe 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.ResultsWith 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.ConclusionsReflecting 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 registrationISRCTN 11632300. Registered on 19 December 2014.

Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial (NCT02092480)

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, viceprincipals, teachers and parents recruited to the study.

Smiley faces and the need for careful planning in trials

Background Trialists need to plan the data they will collect, how they will do so and how they will analyse it. If data are not collected at the appropriate time, it may be impossible to obtain them later. Inconsistencies in the understanding of participants about the data they are asked to provide may make it impossible to combine it. A lack of advance planning of the analyses may mean that knowledge of the data introduces bias into the reported results.

Respecting and fulfilling the right of post-primary pupils to consent to participate in trials and evaluative research: a discussion paper

ABSTRACT This paper provides an introduction to issues surrounding the participation rights of young people in research and the implications of their growing involvement in research as well as providing a discourse on the ethical implications related to consent. The unique contribution of this paper is that it considers children’s rights in respect to the increasing opportunities for young people to take part in evaluation research. The aim of this paper, therefore, is to acknowledge the growing involvement for young people in research and the implications of ensuring that their rights of participation are respected. Secondly, we will consider the children’s rights legislation and our obligations as researchers to implement this. Finally, we will explore consent as an issue in its own right as well as the practicalities of accessing participants. This paper will postulate that any research about young people should involve and prioritize at all stages of the research process; including participation in decision-making. We conclude by identifying five key principles, which we believe can help to facilitate the fulfilment of post-primary pupils’ ability to consent to participate in trials and evaluative research.