Children's views on microneedle use as an alternative to blood sampling for patient monitoring

Objectives: To explore children's views on microneedle use for this population, particularly as an alternative approach to blood sampling, in monitoring applications, and so, examine the acceptability of this approach to children.

Methods: Focus groups were conducted with children (aged 10-14 years) in a range of schools across Northern Ireland. Convenience sampling was employed, i.e. children involved in a university-directed community-outreach project (Pharmacists in Schools) were recruited.

Key findings: A total of 86 children participated in 13 focus groups across seven schools in Northern Ireland. A widespread disapproval for blood sampling was evident, with pain, blood and traditional needle visualisation particularly unpopular aspects. In general, microneedles had greater visual acceptability and caused less fear. A patch-based design enabled minimal patient awareness of the monitoring procedure, with personalised designs, e.g. cartoon themes, favoured. Children's concerns included possible allergy and potential inaccuracies with this novel approach; however, many had confidence in the judgement of healthcare professionals if deeming this technique appropriate. They considered paediatric patient education critical for acceptance of this new approach and called for an alternative name, without any reference to 'needles'.

Conclusions: The findings presented here support the development of blood-free, minimally invasive techniques and provide an initial indication of microneedle acceptability in children, particularly for monitoring purposes. A proactive response to these unique insights should enable microneedle array design to better meet the needs of this end-user group. Further work in this area is recommended to ascertain the perspectives of a purposive sample of children with chronic conditions who require regular monitoring. © 2013 Royal Pharmaceutical Society.

Hydrogel-Forming Microneedle Arrays Can Be Effectively Inserted in Skin by Self-Application: A Pilot Study Centred on Pharmacist Intervention and a Patient Information Leaflet

Purpose: To investigate, for the first time, the influence of pharmacist intervention and the use of a patient information leaflet on self-application of hydrogel-forming microneedle arrays by human volunteers without the aid of an applicator device.
Methods: A patient information leaflet was drafted and pharmacist counselling strategy devised. Twenty human volunteers applied 11 × 11 arrays of 400 μm hydrogel-forming microneedle arrays to their own skin following the instructions provided. Skin barrier function disruption was assessed using transepidermal water loss measurements and optical coherence tomography and results compared to those obtained when more experienced researchers applied the microneedles to the volunteers or themselves.
Results: Volunteer self-application of the 400 μm microneedle design resulted in an approximately 30% increase in skin transepidermal water loss, which was not significantly different from that seen with self-application by the more experienced researchers or application to the volunteers. Use of optical coherence tomography showed that self-application of microneedles of the same density (400 μm, 600 μm and 900 μm) led to percentage penetration depths of approximately 75%, 70% and 60%, respectively, though the diameter of the micropores created remained quite constant at approximately 200 μm. Transepidermal water loss progressively increased with increasing height of the applied microneedles and this data, like that for penetration depth, was consistent, regardless of applicant.
Conclusion: We have shown that hydrogel-forming microneedle arrays can be successfully and reproducibly applied by human volunteers given appropriate instruction. If these outcomes were able to be extrapolated to the general patient population, then use of bespoke MN applicator devices may not be necessary, thus possibly enhancing patient compliance.

Comparing a trauma focused and non trauma focused intervention with war affected Congolese youth: a preliminary randomised trial

While there is broad consensus about the need for interventions to help psychologically distressed, war affected youth, there is also limited research and even less agreement on which interventions work best. Therefore, this paper presents a randomised trial of trauma focused, and non trauma focused, interventions with war affected Congolese youth. Fifty war affected Congolese youth, who had been exposed to multiple adverse life events, were randomly assigned to either a Trauma Focused Cognitive Behavioural Therapy group or a non trauma based psychosocial intervention (Child Friendly Spaces). Non clinically trained, Congolese facilitators ran both groups. A convenience sample, waiting list group was also formed. Using blind assessors, participants were individually interviewed at pre intervention, post intervention and a 6-month follow-up using self-report posttraumatic stress and internalising symptoms, conduct problems and pro social behaviour. Both treatment groups made statistically significant improvements, compared to the control group. Large, within subject, effect sizes were reported at both post intervention and follow-up. At the 6-month follow-up, only the Child Friendly Spaces group showed a significant decrease in pro social behaviour. The paper concludes that both trauma focused and non trauma focused interventions led to reductions in psychological distress in war affected youth.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this article, we explain how reporting guidelines have improved the quality of reports in medicine and describe the ongoing development of a new reporting guideline for RCTs: Consolidated Standards of Reporting Trials-SPI (an extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study).

Working with fathers to improve children's well-being: Results of a survey exploring service provision and intervention approach in the UK

Interventions for fathers are a recent growth area in family services. Although some specific approaches are beginning to be evaluated, there is little known about what kinds of interventions are more generally being used in practice. A web-based survey of practitioners was conducted in the UK, with contact being made via local authority service managers. Two hundred and twenty-one responses were received from 53% of local authorities. Both interventions specifically for fathers and services for both parents were targeted in the survey. Results are reported on organisational location; targeting of services; type of intervention; numbers and percentages of men attending services, recruitment of fathers; evaluation strategies; and ideological and theoretical approaches. Numbers of fathers engaged are relatively low - e.g. the median annual number of fathers attending structured parenting courses was eight and in courses for both parents, 21% of those attending were men. Responses on ideological and theoretical approaches suggest that overt gender politics play only a small part, but that the dominant views of practitioners are in line with mainstream approaches to parenting support. Cognitive and behavioral approaches were the most popular.

Feasibility trial of a film-based educational intervention for increasing boy's and girl's 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. (C) 2014 The Authors. Published by Elsevier Ltd.

Young people, crime and justice in Northern Ireland

Many children and young people in conflict with the law in Northern Ireland have experienced living in poverty, truancy or exclusion from school, limited educational attainment, neglect or abuse within their families, placement in alternative care, drug or alcohol misuse, physical and mental ill-health. However, their lives are also affected by the legacy and particular circumstances of a society in transition from conflict. In addition to historical under-investment in services for children and their families, this includes discriminatory policing alongside informal regulation by ‘paramilitaries’ or members of ‘the community’ and community-based restorative justice schemes as an alternative way of dealing with low-level crime and ‘anti-social’ behaviour.

Following a Criminal Justice Review, the 2002 Justice (Northern Ireland) Act affirmed that the principal aim of the youth justice system is to protect the public by preventing offending by children’. Youth justice initiatives therefore encompass a range of responses: early intervention to prevent offending and the application of civil Anti-Social Behaviour Orders, diversionary measures (including community-based restorative justice schemes), non-custodial disposals for those found guilty of offences, and custodial sentences. While ‘policy transfer’ prevailed during periods of ‘direct rule’ from Westminster, the punitive responses to ‘sub-criminal’ and ‘anti-social’ behaviour introduced by the 1998 Crime and Disorder Act in England and Wales were resisted or not implemented in the same way in Northern Ireland.

This Chapter will critically analyse the debates informing recent developments, noting key issues raised by the 2011 review of youth justice initiated as a priority following the devolution of justice and policing to the Northern Ireland Assembly. It will focus on promotion and protection of the rights of children and young people in conflict with the law.

Design and Development of a Film-based Intervention about Teenage Men and Unintended Pregnancy: Applying the Medical Research Council Framework in Practice

Following the UK Medical Research Council’s (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys’ and girls’ intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: 1) know and engage the target population and engage gatekeepers in addressing contextual complexities; 2) know the targeted behaviours and model a process of change; and 3) look beyond development to evaluation and implementation.

Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents

Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range.

Fruits and vegetables:measuring intake and encouraging increased consumption

A high intake of fruit and vegetables (FV) is associated with reduced risk of chronic disease, although the evidence base is mostly observational. Blood biomarkers offer an objective indicator of FV intake, potentially improving estimates of intakes based on traditional methods. A valid biomarker of overall FV intake would be able to confirm population intakes, more precisely evaluate the association between intakes and health outcomes and confirm compliance in FV interventions. Several substances have been proposed as biomarkers of FV intake: vitamin C, the carotenoids and polyphenols. Certain biomarkers are strong predictors of single FV; however, the proposed single biomarkers of FV consumption are only modestly predictive of overall FV consumption. This is likely to be due to the complexity of the FV food group. While accurately measuring FV intake is important in nutrition research, another critical question is: how best can an increase in FV intake be achieved? Increased FV intake has been achieved in efficacy studies using intensive dietary advice. Alternative, less intensive methods for encouraging FV consumption need to be developed and tested for population level intervention. Systematic reviews suggest peer support to be an effective strategy to promote dietary change. This review will describe the evidence for a link between increased FV intake and good health, outline possible novel biomarkers of FV consumption, present the most recently available data on population intake of FV and examine the usefulness of different approaches to encourage increased consumption of FV.