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  1. Article

    Open Access

    Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

    Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having commun...

    Amy M. Russell, Victoria Shepherd, Kerry Woolfall, Bridget Young, Katie Gillies in Trials (2023)

  2. Article

    Open Access

    Can they stomach it? Parent and practitioner acceptability of a trial comparing gastric residual volume measurement versus no gastric residual volume in UK NNU and PICUs: a feasibility study

    Routine measurement of gastric residual volume (GRV) to guide feeding in neonatal and paediatric intensive care is widespread. However, this practice is not evidence based and may cause harm. As part of a feas...

    Elizabeth Deja, Louise Roper, Lyvonne N. Tume, Jon Dorling in Pilot and Feasibility Studies (2021)

  3. Article

    Open Access

    The PLANES study: a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test-informed care versus standard care alone for women with a small for gestational age fetus at or after 32 + 0 weeks’ gestation

    Stillbirth remains a major concern across the globe and in some high-resource countries, such as the UK; efforts to reduce the rate have achieved only modest reductions. One third of stillborn babies are small...

    Joanna Gent, Sian Bullough, Jane Harrold, Richard Jackson in Pilot and Feasibility Studies (2020)

  4. Article

    Open Access

    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

    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 immediate...

    Kerry Woolfall, Louise Roper, Amy Humphreys, Mark D. Lyttle, Shrouk Messahel in Trials (2019)

  5. Article

    Open Access

    Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences

    Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We ai...

    Joanna C. Crocker, Keira Pratt-Boyden, Jenny Hislop, Sian Rees, Louise Locock in Trials (2019)

  6. Article

    Open Access

    Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol

    Bronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and...

    Clare van Miert, Ricardo M. Fernandes, Helen Eccleson, Emma Bedson, Steven Lane in Trials (2018)

  7. Article

    Open Access

    Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

    Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the famil...

    Mark D. Lyttle, Carrol Gamble, Shrouk Messahel, Helen Hickey, Anand Iyer in Trials (2017)

  8. Article

    Open Access

    Good practice principles for sharing individual participant data from publicly funded clinical trials

    Catrin Tudur Smith, Carolyn Hopkins, Matt Sydes, Kerry Woolfall, Mike Clarke in Trials (2015)

  9. Article

    Open Access

    Develo** a patient and public involvement intervention to enhance recruitment and retention in surgical trials (PIRRIST): study protocol

    Joanna Crocker, Sian Rees, Louise Locock, Sophie Petit-Zeman, Alan Chant in Trials (2015)

  10. Article

    Open Access

    Develo** a toolkit for patient and public involvement in a clinical trials unit

    Heather Bagley, Nicola Harman, Kerry Woolfall, Bridget Young, Hannah Short in Trials (2015)

  11. Article

    Open Access

    What are parents’ priorities when being invited to enter their child into a clinical trial and how far do they voice their priorities?

    Bridget Young, Kerry Woolfall, Paula Williamson in Trials (2013)

  12. Article

    Open Access

    Practitioner views and experiences of deferred consent in paediatric and neonatal emergency care trials: the connect study

    Kerry Woolfall, Lucy Frith, Carrol Gamble, Bridget Young in Trials (2013)