Doing challenging research studies in a patient centred way: qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

Objective: To inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process. Design: Qualitative interview and focus group study. Setting: 8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care. Participants: 17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE. Results: Most parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information. Conclusions: Our study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making

Spontaneous intramural jejunal haematoma: a case report

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Refining and testing the diagnostic accuracy of an assessment tool (PAT-POPS) to predict admission and discharge of children and young people who attend an emergency department : protocol for an observational study

Background: Increasing attendances by children (aged 0–16 years) to United Kingdom Emergency Departments (EDs) challenges patient safety within the National Health Service (NHS) with health professionals required to make complex judgements on whether children attending urgent and emergency care services can be sent home safely or require admission. Health regulation bodies have recommended that an early identification systems should be developed to recognise children developing critical illnesses. The Pennine Acute Hospitals NHS Trust Paediatric Observation Priority Score (PAT-POPS) was developed as an ED-specific tool for this purpose. This study aims to revise and improve the existing tool and determine its utility in determining safe admission and discharge decision making. Methods/design: An observational study to improve diagnostic accuracy using data from children and young people attending the ED and Urgent Care Centre (UCC) at three hospitals over a 12 month period. The data being collected is part of routine practice; therefore opt-out methods of consent will be used. The reference standard is admission or discharge. A revised PAT-POPs scoring tool will be developed using clinically guided logistic regression models to explore which components best predict hospital admission and safe discharge. Suitable cut-points for safe admission and discharge will be established using sensitivity and specificity as judged by an expert consensus meeting. The diagnostic accuracy of the revised tool will be assessed, and it will be compared to the former version of PAT-POPS using ROC analysis. Discussion: This new predictive tool will aid discharge and admission decision-making in relation to children and young people in hospital urgent and emergency care facilities. Trial registration: NIHR RfPB Grant: PB-PG-0815-20034. ClinicalTrials.gov: 213469. Retrospectively registered on 11 April 2018. Keywords: Paediatric, Emergency department, Diagnostic accuracy, Early identification systems, screening tool, Observational, Early warning score, Early warning system, hospital admission

Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors

Objective Clinical trials and studies in intensive care units (ICUs) have complex consent processes and often encounter problems in recruiting patients. By interviewing research team members about the challenges in critical care research, we aimed to identify strategies to enhance recruitment and consent to ICU studies. Methods Semistructured interviews with UK-based researchers (N=17) and patient–public involvement (PPI) contributors (N=8) with experience of ICU studies. Analysis of transcripts of audio-recorded interviews drew on thematic approaches. Results Seven themes were identified. Participants emphasised the need for substitute decision-making processes in critical care studies, yet some researchers reported that research ethics committees (RECs) were reluctant to approve such processes. Researchers spoke about the potential benefits of research without prior consent (RWPC) for studies with narrow recruitment windows but believed RECs would not approve them. Participants indicated that the activity of PPI contributors was limited in critical care studies, though researchers who had involved PPI contributors more extensively were clear that their input when designing consent processes was important. Researchers and PPI contributors pointed to resource and staffing limitations as barriers to patient recruitment. Researchers varied in whether and how they used professional consultees as substitute decision-makers, in whether they approached families by telephone to discuss research and in whether they disclosed details of research participation to bereaved relatives. Conclusion Critical care research could benefit from RECs having expertise in consent processes that are suited to this setting, better staffing at research sites, more extensive PPI and an evidence base on stakeholder perspectives on critical care research processes. Guidance on professional consultee processes, telephoning relatives to discuss research, RWPC and disclosure of research participation to bereaved relatives could help to harmonise practice in these areas and enhance recruitment and consent to critical care studies

Establishing and augmenting acceptability of the Fever trial: a mixed methods feasibility study

Introduction: Paediatric clinical trials in critical care settings are challenging to conduct. Establishing trial acceptability can help inform trial design and avoid research waste. This paper reports on how research with parents and staff established and augmented perspectives and the design of a trial investigating temperature thresholds in critically ill children with fever and infection (Fever trial). // Methods: We used a mixed methods approach to explore perspectives at three time points: 1) before, 2) during and 3) after a pilot trial. This included: 1) pre-trial focus groups with staff and interviews with parents; 2) questionnaires with parents of randomised children following trial recruitment; 3) post-trial interviews with parents and focus groups and a survey with staff. Data analysis drew on Sekhon et al (2017) theoretical framework of acceptability. // Results: 1) 25 parents were interviewed and 56 staff took part focus groups, 2) 60 parents of 57 randomised children took part in questionnaires, 3) 19 parents were interviewed and 50 staff took part in focus group and 48 in a survey. There was initial support for the trial, although both groups raised concerns regarding proposed thresholds and not using paracetamol for pain or discomfort. Pre-trial findings informed pilot trial protocol changes and training, which assisted practitioner ‘buy in’. However, concerns about children being in pain or discomfort when weaned from ventilation led to cases of withdrawal and protocol non-adherence. Nevertheless, 95% of parents provided consent and all supported the trial. Those trained by the Fever team found the trial more acceptable than those trained by colleagues. Trusting parent and staff relationships were linked to trial acceptability. // Conclusions: Pre-trial findings and pilot trial experience augmented perspectives, providing insight into how challenges may be overcome. The proposed trial was deemed feasible. We present an adapted theoretical framework of acceptability to inform the design of future trial feasibility studies

Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the FEVER trial): a mixed methods study

OBJECTIVE: To explore parent and staff views on the acceptability of a randomised controlled trial investigating temperature thresholds for antipyretic intervention in critically ill children with fever and infection (the FEVER trial) during a multi-phase pilot study. DESIGN: Mixed methods study with data collected at three time points: (1) before, (2) during and (3) after a pilot trial. SETTING: English, Paediatric Intensive Care Units (PICUs). PARTICIPANTS: (1) Pre-pilot trial focus groups with pilot site staff (n=56) and interviews with parents (n=25) whose child had been admitted to PICU in the last 3 years with a fever and suspected infection, (2) Questionnaires with parents of randomised children following pilot trial recruitment (n=48 from 47 families) and (3) post-pilot trial interviews with parents (n=19), focus groups (n=50) and a survey (n=48) with site staff. Analysis drew on Sekhon et al's theoretical framework of acceptability. RESULTS: There was initial support for the trial, yet some held concerns regarding the proposed temperature thresholds and not using paracetamol for pain or discomfort. Pre-trial findings informed protocol changes and training, which influenced views on trial acceptability. Staff trained by the FEVER team found the trial more acceptable than those trained by colleagues. Parents and staff found the trial acceptable. Some concerns about pain or discomfort during weaning from ventilation remained. CONCLUSIONS: Pre-trial findings and pilot trial experience influenced acceptability, providing insight into how challenges may be overcome. We present an adapted theoretical framework of acceptability to inform future trial feasibility studies. TRIAL REGISTRATION NUMBERS: ISRCTN16022198 and NCT03028818

Recruitment and retention of participants in UK surgical trials : survey of key issues reported by trial staff

Source of Funding This research was supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) (NIHR-BRC-1215-20008) and by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/1-N66), as part of the wider PIRRIST project. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates. The funders had no input into the study design, data collection, analysis, interpretation or manuscript writing. ACKNOWLEDGEMENTS We are grateful to all survey respondents and to PIRRIST study collaborators and advisers who helped to promote survey. We thank Caroline Jordan and Liz Woolliams for providing administrative support; Rebecca Harmston for providing valuable advice from a patient perspective; Murat Akkulak at the Royal College of Surgeons for providing the RCS portfolio of surgical trials; Amadea Turk for helping to identify potential participants; and colleagues who kindly piloted and helped to improve the survey including Kerry Avery, Karen Barnett, Helen Bulbeck, Marloes Franssen, Nicola Higgins, Jennifer Hirst, Lynne Maddocks, Peter McCulloch, James Shepperd, Jean Simmonds and Sharon Tonner. Anonymised survey data can be made available on request. Please contact the corresponding author. This study was not preregistered. The authors declare no potential competing interests.Peer reviewedPublisher PD

National survey of feasibility of NIV trials for management of children with bronchiolitis.

Background: Bronchiolitis is a major cause of admission to hospital in children. Non-invasive ventilation (NIV) support with continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) oxygen is routinely used for infants in the UK with bronchiolitis. Objective: To establish UK paediatric practice regarding management of bronchiolitis, and to explore issues pertinent to the design of a potential future randomised controlled trial of NIV. Design: Screening logs were completed in hospitals in England capturing information on paediatric bronchiolitis admissions. An online national survey of clinical practice was disseminated to healthcare professionals (HCPs) across the UK to ascertain current management strategies. Results: Screening logs captured data on 393 infants from 8 hospitals. Reasons for admission were most commonly respiratory distress and/or poor fluid intake. Oxygen was administered for 54% of admissions. Respiratory (CPAP and HFNC) and non-respiratory support administered varied considerably. The national survey was completed by 111 HCPs from 76 hospitals. Data were obtained on criteria used to commence and wean NIV, responsibilities for altering NIV settings, minimum training requirements for staff managing a child on NIV, and numbers of trained staff. Most centres were interested in and capable of running a trial of NIV, even out of normal office hours. Conclusions: Respiratory and non-respiratory management of bronchiolitis in UK centres varies widely. A trial of HFNC oxygen therapy in this group of patients is feasible and HCPs would be willing to randomise patients into such a trial. Future work should focus on defining trial eligibility criteria