Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

BACKGROUND: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial. METHODS: We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis. RESULTS: Twenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway. CONCLUSIONS: Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013

How do parents experience being asked to enter a child in a randomised controlled trial?

<p>Abstract</p> <p>Background</p> <p>As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.</p> <p>Discussion</p> <p>Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.</p> <p>Summary</p> <p>Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.</p

A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

<p>Abstract</p> <p>Background</p> <p>Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.</p> <p>Methods</p> <p>We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.</p> <p>Results</p> <p>110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.</p> <p>Conclusions</p> <p>Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.</p

The shifting discourses of educational leadership:International trends and Scotland’s response

Increasing emphasis has been placed on leadership within educational theory, policy and practice. Drawing on a wide range of academic literature and policy documents, this paper explores how the discourse of leadership has shifted and for what purposes. The authors are critical of the lack of conceptual underpinning for that discourse, evident both nationally and internationally, and they identify key issues that the teaching profession has been left to try to understand and make sense of. They caution that, despite attempts to align contemporary policy developments to position leadership as inherent in the role of every teacher, flaws in the conceptualisation of leadership, and particularly in favoured forms such as ‘distributed leadership’ and ‘teacher leadership’, pose significant challenges to a serious attempt to ‘reprofessionalise’ teachers. Contemporary developments in Scottish education are referred to, exemplifying key tensions inherent in translating international trends into practice

Changing models of research to inform educational policy

This contribution explores changes in the way that educational researchers engage with policy‐makers in England. The traditional relationship between research and policy was linear, with funders supporting the efforts of researchers, who carried out research and then disseminated it to those responsible for shaping and implementing policy. This model of ‘knowledge transfer’ is fast being supplemented and sometimes replaced by one of ‘knowledge exchange’ as policy‐makers participate in new forms of research. ‘Knowledge exchange’ consists of collaborative problem‐solving between researchers and decision‐makers that happens through linkage and exchange. This contribution uses one large‐scale English study to illustrate the new relationship between research and policy. The Effective Pre‐school and Primary Education (EPPE) project is a longitudinal study of the effects of pre‐ and primary school on the academic and social development of more than 3,000 children in England. The study's findings have been used as part of the ‘evidence base’ for UK policy on universal pre‐school provision as well as targeted services in disadvantaged communities, for example, Sure Start and Children's Centres. From the earliest days of the study researchers worked in partnership with policy‐makers. Although the overall design was agreed at contract‐stage, major modifications to sampling, assessments, and analyses were made as the study progressed. The researcher/policy‐maker engagement continued throughout the study and consisted of sustained interaction, shared decision‐making and mutual respect. Supportive organisational structures allowed two‐way exchange and decision‐making. Although the researchers were responsible for scientific integrity in all phases, there was shared ownership of the findings with regular and collaborative review and amendment to suit emerging policy needs. The EPPE project was one of the first in the UK to work interactively with Government partners in the shaping of both ‘research’ and ‘policy’ outputs. This partnership enabled the research to have a significant impact on UK policy. The contribution concludes with discussion of how the Furlong and Oancea ‘quality assessment framework’ can be applied to research based on policy partnerships