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BMC Pediatr. 2018 Jul 25;18(1):244. doi: 10.1186/s12887-018-1210-z.

A prospective, mixed-methods, before and after study to identify the evidence base for the core components of an effective Paediatric Early Warning System and the development of an implementation package containing those core recommendations for use in the UK: Paediatric early warning system - utilisation and mortality avoidance- the PUMA study protocol.

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Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Cardiff, CF14 4YS, UK.
Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, 7th Floor Neuadd Meirionnydd, Cardiff, CF14 4YS, UK.
SAPPHIRE Group, Health Sciences, Centre for Medicine, Leciester Univeristy, LE1 7RH, Leicester, UK.
Paediatric Emergency Medicine Leicester Academic (PEMLA) Group, Children's Emergency Department, Leicester Royal Infirmary, Leicester, LE1 5WW, UK.
Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, L14 5AB, UK.
The University of West England, Bristol, UK.
Hull York Medical School, University of Hull, Hull, HU6 7RX, UK.
Morriston Hospital, Abertawe Bro Morgannwg University Health Board, Swansea, SA6 6NL, UK.
Noah's Ark Children's Hospital of Wales, Cardiff and Vale University Health Board, Heath Park, Cardiff, CF14 4XN, UK.
NIHR NIHR Alder Hey Clinical Research Facility, Eaton Rd, Liverpool, L12 2AP, UK.
Swansea University Medical School, Swansea University, Grove Building, Singleton Park, Swansea, SA2 8PP, UK.
School of Healthcare Sciences, Cardiff University, East Gate House, 35-43 Newport Road, Cardiff, CF24 0AB, UK.
Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Arrowe Park Hospital, Arrowe Park Road, Merseyside, Wirral, CH49 5PE, UK.



In hospital, staff need to routinely monitor patients to identify those who are seriously ill, so that they receive timely treatment to improve their condition. A Paediatric Early Warning System is a multi-faceted socio-technical system to detect deterioration in children, which may or may not include a track and trigger tool. It functions to monitor, detect and prompt an urgent response to signs of deterioration, with the aim of preventing morbidity and mortality. The purpose of this study is to develop an evidence-based improvement programme to optimise the effectiveness of Paediatric Early Warning Systems in different inpatient contexts, and to evaluate the feasibility and potential effectiveness of the programme in predicting deterioration and triggering timely interventions.


This study will be conducted in two district and two specialist children's hospitals. It deploys an Interrupted Time Series (ITS) design in conjunction with ethnographic cases studies with embedded process evaluation. Informed by Translational Mobilisation Theory and Normalisation Process Theory, the study is underpinned by a functions based approach to improvement. Workstream (1) will develop an evidence-based improvement programme to optimise Paediatric Early Warning System based on systematic reviews. Workstream (2) consists of observation and recording outcomes in current practice in the four sites, implementation of the improvement programme and concurrent process evaluation, and evaluation of the impact of the programme. Outcomes will be mortality and critical events, unplanned admission to Paediatric Intensive Care (PICU) or Paediatric High Dependency Unit (PHDU), cardiac arrest, respiratory arrest, medical emergencies requiring immediate assistance, reviews by PICU staff, and critical deterioration, with qualitative evidence of the impact of the intervention on Paediatric Early Warning System and learning from the implementation process.


This paper presents the background, rationale and design for this mixed methods study. This will be the most comprehensive study of Paediatric Early Warning Systems and the first to deploy a functions-based approach to improvement in the UK with the aim to improve paediatric patient safety and reduce mortality. Our findings will inform recommendations about the safety processes for every hospital treating paediatric in-patients across the NHS.


Sponsor: Cardiff University, 30-36 Newport Road, Cardiff, CF24 0DE Sponsor ref.: SPON1362-14. Funder: National Institute for Health Research, Health Services & Delivery Research Programme (NIHR HS&DR) Funder reference: 12/178/17. Research Ethics Committee reference: 15/SW/0084 [13/04/2015]. PROSPERO reference: CRD42015015326 [23/01/2015].


94228292 [date of application 13/05/2015; date of registration: 18/08/2015]. Prospective registration prior to data collection and participant consent commencing in September 2014.


And quality improvement; Mortality; Paediatric-early warning systems; Patient safety; Track-and-trigger tools

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