ºù«Ӱҵ

PHEWS Protocol

Background

Sepsis is a life-threatening condition caused by the body having an abnormal response to infection that leads to heart, lung and kidney failure.

People with sepsis need urgent treatment with antibiotics and intravenous fluids, and may need urgent intensive care treatment for heart, lung or kidney failure.

However, features of sepsis may be seen with other illnesses, particularly in people with underlying heart, lung or kidney disease. This can make it difficult to correctly identify who has sepsis and who has another diagnosis. Furthermore, treatments for sepsis may be futile or not in the patient’s best interests if the patient has severe medical problems or terminal illness.

Unnecessary tests and treatments are distressing for patients and use valuable NHS resources.

Early warning scores can be used to identify patients with sepsis who need urgent treatment. They use simple measurements such as blood pressure, heart rate and breathing rate to determine whether a patient is likely to have sepsis.

An accurate early warning score could help paramedics, doctors and nurses ensure that people with sepsis are identified and treated quickly. However, an inaccurate early warning score might miss cases of sepsis or falsely identify people with other conditions who are then given unnecessary tests and treatments.

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The study

We are planning a study to test early warning scores for identifying sepsis.

We plan to collect data from a large group of people who are brought to hospital by ambulance and might have sepsis. We will follow them up to determine whether they actually have sepsis and whether they needed urgent treatment.

We will use the data to determine how accurately the early warning scores identified people with and without sepsis that needed urgent treatment. We will then use mathematical modelling to compare different early warning scores in terms of how well they might improve patient survival and how they might affect organisation of the emergency department and the costs of providing care.

This will allow us to identify the best early warning score for the NHS.

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Study team

Name	Role	Organisation	Contact
Prof Steve Goodacre	Chief Investigator	ScHARR, University of ºù«Ӱҵ	s.goodacre@sheffield.ac.uk
Dr Daniel Hind	Assistant Director, CTRU	CTRU, University of ºù«Ӱҵ	d.hind@sheffield.ac.uk
Liv Hawksworth	Study Manager	CTRU, University of ºù«Ӱҵ	o.hawksworth@sheffield.ac.uk
Mike Bradburn	Senior Medical Statistician	CTRU, University of ºù«Ӱҵ	m.bradburn@sheffield.ac.uk
Jack Rose	Trials Support Officer	CTRU, University of ºù«Ӱҵ	j.rose@sheffield.ac.uk

Funder

This project is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 17/136/10). Any views or opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.).

Sponsor

This study is sponsored by ºù«Ӱҵ Teaching Hospitals NHS Foundation Trust.

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PHEWS Privacy Notice

 ºù«Ӱҵ will obtain personal data, including direct patient identifiers (dates of birth and NHS numbers) for this research. The handling of personal data is controlled by the General Data Protection Regulation (GDPR) and associated legislation. The following information explains in detail how and why we are processing your personal data, and explains your legal rights.

Please also see the University’s Privacy Notices.

We will also obtain approval from both the  and the  before obtaining any data. General information on Data Protection law is available from the .

1. The name and contact details of the lead evaluation organisation:
   ScHARR, ºù«Ӱҵ, Regent Court, 30 Regent St, ºù«Ӱҵ. S1 4DA

2. The name and contact details of our representative:
   Liv Hawksworth, Trial Manager for Sepsis, o.hawksworth@sheffield.ac.uk

3. The contact details of the ºù«Ӱҵ University data protection officer:
   Anne Cutler, Data Protection Officer, ºù«Ӱҵ, Western Bank, ºù«Ӱҵ S10

4. The purposes of the processing:
   Undertaking research, to determine the accuracy, impact and cost-effectiveness of prehospital early warning scores for adults with suspected sepsis.

5. The lawful basis for the processing:

   • Research involving living humans:

     • Article 6 (1) e: processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

     • Article 9 (j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject

6. The legitimate interests for the processing: 
   Not applicable

7. The categories of personal and identifying data:

   • Data that is routinely collected by the West Midlands Ambulance service: Data, relevant to the study of sepsis early warning scores, from West Midlands Ambulance Service’s electronic patient report forms. Individual patient health data without direct identifiers will be sent to the University of ºù«Ӱҵ. This health data includes details on patients' pre-hospital vitals, prognosis, and observations. The indirect identifiers of patient age, gender, and ethnicity are also being requested.

   • Data that is routinely collected by the Yorkshire Ambulance Service: Data, relevant to the study of sepsis early warning scores, from Yorkshire Ambulance service’s electronic patient report forms. Individual patient health data, including direct identifiers will be sent to the University of ºù«Ӱҵ. This health data includes patients’ NHS numbers, dates of birth, and details on their pre-hospital vitals, prognosis, and observations. The indirect identifiers of patient age, gender, and ethnicity are also being requested. This data will ºù«Ӱҵ Teaching Hospitals to identify patients with potential sepsis for inclusion in the study’s reference standard for patients with sepsis.

   • Data from NHS digital: Clinical data, relevant to the study of sepsis early warning scores. The NHS digital data consists of data from HES admitted patient care, HES critical care, HES A&E, and ECDS datasets. The NHS digital data is aimed at providing a description of the cohort and allow the University of ºù«Ӱҵ and ºù«Ӱҵ Teaching Hospitals to identify patients with potential sepsis for inclusion in the studies reference standard of patients with sepsis.

   • Data that is routinely collected from the participating hospital: ºù«Ӱҵ Teaching Hospitals will send the University of ºù«Ӱҵ details of patients' inclusion into the study reference standard, the patients who have a confirmed diagnosis of sepsis. ºù«Ӱҵ Teaching Hospitals will send information on the severity of a patients' sepsis, the treatment they received, their chances of benefiting from treatment, and details of their wider health condition/co-morbidities.

8. The recipients or categories of recipients of the personal data. The sponsor is ºù«Ӱҵ Teaching Hospitals NHS Foundation Trust. The recipients of the study data are the PHEWS research team at ºù«Ӱҵ and delegated staff at ºù«Ӱҵ Teaching Hospitals. ºù«Ӱҵ will receive personal health data and direct patient identifiers (dates of birth and NHS numbers) from the Yorkshire Ambulance Service, and this will be securely transferred to ºù«Ӱҵ Teaching Hospitals so that it can be linked to the reference standard data..

9. The details of transfers of the personal data to any third countries or international organisations:
   Not applicable

10. The retention periods for the personal data.
    Data collected during the study will be stored in archive for 20 years.

11. The rights available to individuals in respect of the processing.
    NHS digital will check their data for any patients who have registered for the NHS ‘National data opt-out’, and remove any patients as necessary before the transfer of data. Patients can view or change their national data opt-out choice at any time by using the online service at . Alternatively, you can contact Prof. Steve Goodacre (s.goodacre@sheffield.ac.uk), Chief Investigator, to ask for your information to be removed from the study.

12. The right to withdraw consent:
    Not applicable

13. The right to lodge a complaint with a supervisory authority.
    If you feel that the University has not dealt correctly with your personal data you can complain to the .

14. The source of the personal data:
    Yorkshire and West Midlands Ambulance service, NHS Digital databases (ECDS, HES, and ONS), ºù«Ӱҵ Teaching Hospitals.

15. The details of whether individuals are under a statutory or contractual obligation to provide the personal data:
    Not applicable

16. The details of the existence of automated decision-making, including profiling:
    Not applicable 

ºù«Ӱҵ GDPR Privacy Notice can be found here