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      Enhancing practitioners’ confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training – a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study

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          Abstract

          Background

          EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents’ perspectives and research without prior consent (RWPC) guidance, we developed an interactive training package (including videos, simulation and question and answer sessions) and evaluated its dissemination and impact upon on practitioners’ confidence in recruitment and consent.

          Methods

          Questionnaires were administered before and immediately after training followed by telephone interviews (mean 11 months later), focus groups (mean 14 months later) and an online questionnaire (8 months before trial closure).

          Results

          One hundred and twenty-five practitioners from 26/30 (87%) participating hospitals completed a questionnaire before and after training. We conducted 10 interviews and six focus groups (comprising 36 practitioners); 199 practitioners working in all recruiting hospitals completed the online questionnaire. Before training, practitioners were concerned about recruitment and consent. Confidence increased after training for explaining (all scale 0–5, 95% CIs above 0 and p values < 0.05): the study (66% improved mean score before 3.28 and after 4.52), randomisation (47% improvement, 3.86 to 4.63), RWPC (72% improvement, 2.98 to 4.39), and addressing parents’ objections to randomisation (51% improvement, 3.37 to 4.25). Practitioners rated highly the content and clarity of the training, which was successfully disseminated. Some concerns about staff availability for training and consent discussions remained.

          Conclusions

          Training improved practitioners’ confidence in recruitment and RWPC. Our findings highlight the value of using parents’ perspectives to inform training and to engage practitioners in trials that are at high risk of being too challenging to conduct.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-019-3273-z) contains supplementary material, which is available to authorized users.

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          Most cited references 8

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          What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

          Background A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. Methods The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.
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            Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities

            Background Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions. Methods In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions. Results Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives. Conclusions Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required. Electronic supplementary material The online version of this article (doi:10.1186/1745-6215-15-399) contains supplementary material, which is available to authorized users.
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              Pediatric Emergency Research in the UK and Ireland (PERUKI): developing a collaborative for multicentre research.

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                Author and article information

                Contributors
                K.Woolfall@liverpool.ac.uk
                Louise.Roper@liverpool.ac.uk
                amyh@liverpool.ac.uk
                mdlyttle77@gmail.com
                shrouk@doctors.org.uk
                Liz.Lee@alderhey.nhs.uk
                jonoblet@yahoo.co.uk
                Anand.Iyer@alderhey.nhs.uk
                carrolp@liverpool.ac.uk
                hickeyh@liverpool.ac.uk
                naomi.rainford@liverpool.ac.uk
                richardappleton55@hotmail.co.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                21 March 2019
                21 March 2019
                2019
                : 20
                Affiliations
                [1 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, Department of Health Service Research, Institute of Population Health and Society, , University of Liverpool, ; Liverpool, UK
                [2 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, Clinical Trials Research Centre (CTRC) North West Hub for Trials Methodology, , University of Liverpool, ; Liverpool, UK
                [3 ]ISNI 0000 0004 0399 4960, GRID grid.415172.4, Emergency Department, , Bristol Royal Hospital for Children, ; Bristol, UK
                [4 ]ISNI 0000 0001 2034 5266, GRID grid.6518.a, Faculty of Health and Applied Sciences, , University of the West of England, ; Bristol, UK
                [5 ]ISNI 0000 0004 0421 1374, GRID grid.417858.7, Emergency Department, , Alder Hey Children’s NHS Foundation Trust, ; Liverpool, UK
                [6 ]ISNI 0000 0004 0421 1374, GRID grid.417858.7, Neurology Department Alder Hey Children’s NHS Foundation Trust, ; Liverpool, UK
                Article
                3273
                10.1186/s13063-019-3273-z
                6429745
                30898169
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000664, Health Technology Assessment Programme;
                Award ID: 12/127/134
                Award Recipient :
                Categories
                Research
                Custom metadata
                © The Author(s) 2019

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