How much is the lack of retention evidence costing trial teams in Ireland and the UK?

Acknowledgements The authors would like to acknowledge those who provided information regarding the conduct of trials and retention strategies and the costs involved to make the assumptions regarding the conduct of retention strategies in clinical trials that we based the costing model on. Funding This work was supported by a grant from the Health Research Board, Ireland - HRB TMRN 2017-1.Peer reviewedPublisher PD

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol : an analysis of adult participant information leaflets and their corresponding protocols

We would like to acknowledge the EXCELSIOR group for collecting and providing access to the patient information leaflets reviewed in this project. We would also like to thank the members of the trial teams who provided protocols that were not publicly available.Peer reviewe

How do trial teams plan for retention during the design stage of the trial? : A scoping review protocol

Funding This research forms part of a doctoral research project supported by the Health Research Board Trial Methodology Research Network (HRB-TMRN) PhD scholarship awarded to EM. The funder had no role in the design, data collection, and analysis or preparation of the protocol.Peer reviewedPublisher PD

Information about dissemination of trial results in patient information leaflets for clinicals trials in the UK and Ireland : the what and the when.

Acknowledgments Ellen Murphy and Genevieve Shiely Hayes for their contributions to data collection. Funding: MB was funded for a summer period by the Health Research Board, Ireland through funding from the HRB Trials Methodology Research Network (Ref: HRB TMRN-2017-1). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates (CZU/3/3). The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.Peer reviewedPublisher PD

The Effect of Small Group Tutors on Student Engagement in the Computer Laboratory Lecture

Background: Student engagement is widely recognised as being influential on learning and achievement in higher education. What is less clear is how the knowledge transfers, i.e., the process of engagement by the student with any new forms of teaching demonstrated by the teacher. Aim: To investigate the effect of small group tutors on student engagement in the computer laboratory lecture. Methods: Participants were undergraduate, second year BSc Public Health students taking the Health Information Systems II module. Teaching consisted of 12 x 2-hour face-to-to face classes. Tutors were assigned to groups of 6/7 students from weeks 5-12. Quantitative data from the Irish Survey of Student Engagement was collected in week 12 and analysed using the Statistical Package for the Social Sciences. Qualitative data from a 1-minute pre-and post-module CAT, tutor post lesson appraisals and two focus groups (one student and one tutor group, respectively) were analysed thematically. Findings: This study provided evidence that student engagement and learning was indeed enhanced by the addition of small group tutors in the computer laboratory lecture. In addition, students’ attitude to engaging with their programme of study improved and their positivity towards learning increased as the term progressed. Furthermore, there was evidence of an improved student experience and improved personal development that was highly valued by the students

Patient and Public Involvement (PPI) in outcome selection in breast cancer and nephrology trials

Acknowledgements We would like to acknowledge our PPI colleagues on Twitter who read and commented on our work, helping bring the importance of PPI in clinical trials to the fore. Funding There was no direct funding received for this research. The HRB CRF-C at UCC facilitated the placement of an undergraduate BSc Public Health Sciences student, CB, who led this study under supervision. The HRB Clinical Research Facility receives core funding from the Health Research Board, Ireland, and matched funding from University College Cork. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.Peer reviewedPublisher PD

Training and education on inclusivity in clinical trials : the SENSITISE project.

Peer reviewe

Barriers and facilitators to the implementation of a community-based, multidisciplinary, family focused childhood weight management programme in Ireland: a qualitative study

Objective: To explore the barriers and facilitators experienced by those implementing a government-funded, community-based childhood weight management programme. Design: Qualitative using semistructured interviews. Setting Two geographical regions in the south and west of Ireland. Participants 29 national-level and local-level stakeholders responsible for implementing the programme, including professionals from dietetics, psychology, public health nursing, physiotherapy, health promotion and administration. Methods Framework analysis was used to identify barriers and facilitators, which were mapped onto six levels of factors influencing implementation outlined by Grol and Wensing: the innovation, the individual professional, the patient, the social context, the organisational context and the external environment. Results Most barriers occurred at the level of the organisational context. For all stakeholders, barriers arose due to the multidisciplinary nature of the programme, including the lack of role clarity and added complexity of working in different locations. Health professionals’ low-perceived self-efficacy in approaching the subject of weight with parents and parental resistance to hearing about their child’s weight status were barriers to programme implementation at the individual professional and patient levels, respectively. The main facilitators of implementation, occurring at the level of the health professional, included stakeholders’ recognition of the need for a weight management programme and personal interest in the area of childhood obesity. Having a local lead and supportive colleagues were further implementation drivers. Conclusions This study highlights the complexities associated with implementing a multidisciplinary childhood weight management programme, particularly translating such a programme to a community setting. Our results suggest the assignment of clear roles and responsibilities, the provision of sufficient practical training and resources, and organisational support play pivotal roles in overcoming barriers to change. This evidence can be used to develop an implementation plan to support the translation of interventions into real-world settings

Knowledge, attitudes and beliefs of parents regarding fever in children: a Danish interview study

Aim: Fever and febrile illness are some of the most common conditions managed by parents. The aim of this study was to examine the knowledge, attitudes and beliefs of parents around fever in children under five years of age. Methods: Between July and August 2014, a convenience sample of parents was invited to participate in this study in Copenhagen, Denmark. Results were analysed thematically using a constant comparison method. Results: Twenty-one parents participated in the study. Five themes emerged from the data: parental concern, help-seeking behaviour, parental knowledge, parent fever management practices and initiatives. Parents used a range of information sources to obtain their knowledge on management of fever; however, due to issues of trust with these sources, reassurance was often sought from healthcare practitioners. There was a desire amongst most parents for initiatives to be introduced which provide general information on how to manage fever in children. Conclusion: Parents were very concerned when their child was febrile and instigated practices obtained from accessible information sources. This study has identified a need for specific and reliable information initiatives to be introduced as a means of reducing parental concern and ensuring evidence-based strategies for managing a child with fever

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study.

BACKGROUND: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. METHODS: This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. RESULTS: Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants' legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. CONCLUSION: The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake