Professor Kerry Woolfall BA; MA; PhD

A pragmatic randomised controlled trial of intravenous levetiracetam versus intravenous phenytoin in terminating acute, prolonged tonic-clonic seizures including convulsive status epilepticus in children, the 'EcLIPSE' Study: Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus.
Kerry is leading the Consent study within EcLiPSE exploring 'research without prior consent' (also called deferred consent) from the perspective of parents, clinicians and researchers involved in clinical trials in emergency care settings. From June 2015 ‘The Consent Study will develop, provide and evaluate training for Site Initiation Visits at the 25+ hospitals across the UK, analyse recorded recruitment conversations between parents and clinicians, develop then analyse questionnaire data and develop then conduct & analyse interviews with parents exploring their experience of research without consent.

EcLiPSE is funded by the NIHR HTA

PPI in research refers to the practice of patients, members of the public and researchers working together to prioritise, plan, design, conduct and disseminate research. Despite increasing international interest in PPI, there is a lack of evidence about the most efficient, effective and acceptable ways to implement PPI and uncertainty remains about its impact upon research, practice and policy. There is a need for methodology research to help inform how PPI is conducted to ensure it is fit for purpose, proportionate and impactful. Aims: to identify the priorities of key PPI stakeholders for methodology research to resolve uncertainties about PPI in clinical trials, as well as to help coordinate and improve to the design of future PPI work and avoid unnecessary duplication and resource waste. Methods: On-line Delphi priority setting exercise and a key stakeholder meeting. Sample: Clinical Trials Unit (CTU) and Clinical Research Network (CRN) staff working in PPI; trialists; Research Design Services members; funders; PPI guidance developers; and experienced PPI contributors. Findings will provide a distinct and timely contribution to addressing uncertainties around PPI by identifying which types of methodology research should be prioritised and informing future collaborative PPI research in clinical trials. Delphi findings will be published in an open access journal, whilst a short (lay summary) report will summarise the stakeholder meeting discussions and provide key recommendations to inform collaborative research agendas. The stakeholder meeting will bring together CTU PPI Coordinators to discuss the potential for setting up a working group to assist the delivery of PPI research priorities, encourage sharing of best practice and resources and collaboration on future projects to help avoid duplication and waste in research on PPI.

The METHODICAL Study is funded by the MRC Network of Hubs for Trials Methodology Research (Project N62)

CONNECT study website

CONNECT was the first UK study to explore parent and practitioner perceptions and experiences of deferred consent in children’s clinical trials. The aim of CONNECT was to provide new evidence to inform how consent should be sought for children’s critical care trials. Between 2011 and 2015, 354 people took part, including 292 parents, 39, nurses, 19 doctors and 4 clinical trials unit practitioners. Surveys, interviews and focus groups were used to explore their views and experiences on approaches to consent in emergency and urgent care settings. CONNECT findings (please see the publications section) have been integrated with wider research and ethical theory to produce guidance to inform approaches to recruitment and consent in paediatric and neonatal critical care trials. Please see the CONNECT website for a copy of the guidance

CONNECT was funded by Wellcome Trust (WT095874MF) and supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1- R/N42).