Agenda Item 10(b)
MEETING OF THE QUALITY COMMITTEE
January 2015
Agenda Item: 14/177
Report Date: January 2015
Author of the Paper:
Brendan Prescott,
Deputy Chief Nurse,
NHS South Sefton CCG,
Email: Brendan.prescott@southseftonccg.nhs.uk
Tel : 0151 247 7000
Title: Rotavirus Study
Summary/Key Issues:
Ecological assessment of the direct and indirect effects of routine rotavirus vaccination in
Merseyside, UK using data from multiple health systems
Recommendation
The Committee is asked to approve the study and data sharing agreement
Receive
Approve
Ratify
Links to Corporate Objectives (x those that apply)
X
Improve quality of commissioned services, whilst achieving financial balance.
Sustain reduction in non-elective admissions in 2014/15.
Implementation of 2014/15 phase of Virtual Ward plan.
Review and re-specification of community nursing services ready for re-commissioning
from April 2015 in conjunction with membership, partners and public.
Implementation of 2014/15 phase of Primary Care quality strategy/transformation.
Agreed three year integration plan with Sefton Council and implementation of year one
(2014/15) to include an intermediate care strategy.
Review the population health needs for all mental health services to inform enhanced
delivery.
x
Agenda Item 10(b)
Process
Yes
No
Patient and Public
Engagement
Clinical Engagement
N/A
Comments/Detail (x those that apply)
x
x
Equality Impact
Assessment
x
Legal Advice Sought
x
Resource Implications
Considered
x
Locality Engagement
x
Presented to other
Committees
x
Links to National Outcomes Framework (x those that apply)
Preventing people from dying prematurely
Enhancing quality of life for people with long-term conditions
Helping people to recover from episodes of ill health or following injury
X
Ensuring that people have a positive experience of care
X
Treating and caring for people in a safe environment and protecting them from avoidable
harm
Agenda Item 10(b)
Report to the Quality Committee
January 2015
1.
Executive Summary
Rotavirus is the most common cause of severe gastroenteritis in infants and young children
worldwide. Currently 67 countries include rotavirus vaccine in childhood immunisation programmes,
but uptake in Western Europe has been slow. In July 2013 rotavirus vaccine was introduced into the
UK’s routine childhood immunisation programme. Prior to vaccine introduction in the UK rotavirus
was estimated to result in 750,000 diarrhoea episodes and 80,000 GP consultations each year,
together with 45% and 20% of hospital admissions and emergency department attendances for
acute gastroenteritis, in children under five-years of age. It is therefore important to assess vaccine
impact in the UK, to support continued vaccination and to inform rotavirus immunisation policy in
other Western European countries.
2.
Introduction and Background
Rotavirus vaccination was introduced for babies last year. The evaluation is looking at the impact of
the vaccine on the whole community—not just on hospital admissions for babies but on levels of
sickness across all ages. The evaluation wants to assess to see if rotavirus vaccination of babies
actually reduces the whole burden of rotavirus and diarrhoea across the whole community, adults
and children of all ages. The results should be very valuable to determine to what extent the
vaccination has benefited the people of South Sefton and beyond, including impact on GP
consultations and hospital admissions. Further information on the study is provided in Appendix 1.
3.
Key Issues
There is a requirement for an information sharing agreement between General Practice, NHS South
Sefton CCG and the University of Liverpool. Appendix 2 proposes the data sharing agreement and
this will need to be completed by individual constituent practices and the University of Liverpool.
4.
Recommendations
The Committee is recommended to approve the study and proposed data sharing agreement.
Appendices
1. Study Summary
2. Data Sharing Agreement
Brendan Prescott
January2015
Appendix 1
document1
Print date: 09 February 2016
3
Agenda Item 10(b)
Ecological assessment of the direct and indirect effects of routine rotavirus
vaccination in Merseyside, UK using data from multiple health systems
Dan Hungerford1,4 (d.hungerford@liverpool.ac.uk, 0151 795 9609 (corresponding author), Dr Roberto
Vivancos4, Professor Neil French1,3, Dr Miren Iturriza-Gomara1, Professor Nigel Cunliffe1,2
1. Department of Clinical Infection, Microbiology & Immunology, Institute of Infection and Global Health,
University of Liverpool, Liverpool, L69 7BE, UK
2. Alder Hey Children’s NHS Foundation Trust, Liverpool, L12 2AP, UK
3. Royal Liverpool and Broadgreen University Hospitals NHS Trust, Prescot St, Liverpool, L7 8XP, UK
4. Public Health England, Field Epidemiology Services, Liverpool, L1 1JF, UK
Project summary
Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide.
Currently 67 countries include rotavirus vaccine in childhood immunisation programmes, but uptake in
Western Europe has been slow. In July 2013 rotavirus vaccine was introduced into the UK’s routine
childhood immunisation programme. Prior to vaccine introduction in the UK rotavirus was estimated to
result in 750,000 diarrhoea episodes and 80,000 GP consultations each year, together with 45% and 20% of
hospital admissions and emergency department attendances for acute gastroenteritis, in children under fiveyears of age. It is therefore important to assess vaccine impact in the UK, to support continued vaccination
and to inform rotavirus immunisation policy in other Western European countries.
In Merseyside, UK a research team from the University of Liverpool and Public Health England will conduct
an observational study using a before and after and cohort approach to examine changes in gastroenteritis
and rotavirus incidence following the introduction of rotavirus vaccination.






Data will be collected on mortality, hospital admissions, nosocomial infection, emergency
department attendances, GP consultations and community health consultations to capture all
healthcare providers in the region.
Vaccine uptake will be collected from Child Health Information Systems.
We will assess both the direct and indirect effects of the vaccine on the study population.
Comparisons of outcome indicator rates will be made in relation to vaccine uptake and
socioeconomic status.
The study has been approved by NHS Research Ethics Committee, South Central-Berkshire REC
Reference: 14/SC/1140. The study has also been registered on the NIHR LCRN portfolio. There will be
no primary recruitment and data collection. All data used for the study will be secondary data from
routine health systems. Data will be pseudoanonymised so that identification of participants will not
be possible for researchers.
The study will demonstrate the impact of rotavirus vaccination on the burden of disease from a
complete health system perspective.
GP practice data collection – Liverpool CCG specifications
How will the data be collected:The extract parameters are below
Search population: Currently registered patients (Excluding dummy patients)
Search date: Day of extraction
document1
Print date: 09 February 2016
4
Agenda Item 10(b)
Date range: Last 7 years initially - 1st January 2007 – 31st July 2014 then two subsequent extracts covers
data for previous 12-months. 1st August 2014-31st July 2015 and 1st August 2015-31st July 2016
Age range: all ages
Fields for extraction:
1. Patient Details
Unique anonymous patient ID
Lower Super Output Area of residence
MM/YYYY of Birth or age in months
Gender
Practice N82 number
2. Read codes
Diarrhoea
Time since last diarrhoea episode
Diarrhoea symptom NOS
Enteritis due to rotavirus
Infectious diarrhoea
Diarrhoea and vomiting
Diarrhoea of presumed infectious origin
Viral Gastroenteritis
Infectious gastroenteritis
Infantile viral gastroenteritis
Gastroenteritis - presumed infectious origin
Gastrointestinal symptoms NOS
First Rotavirus Vaccination
Second Rotavirus Vaccination
Rotavirus vaccination given by other health care provider
19F2
19F5
19FZ
A0762
A082
19G
A083
A07y0
A0803
A07y1
A0812
19Z
65d0
65d1
65d2
Appendix 2
Rotavirus Vaccine Evaluation
document1
Print date: 09 February 2016
5
Agenda Item 10(b)
Project:
Rotavirus Vaccine Evaluation
Version:
1.1
Summary and Benefits of the Project
This document outlines the requirements for an information sharing agreement between General Practice,
NHS South Sefton CCG and University of Liverpool.
The aim of this data sharing project is to enable the sharing of data to inform the evaluation of rotavirus
vaccine which was introduced in July 2013. The aim of this evaluation is to:
•
Understand if there any benefits to be gained through vaccinating children against rotavirus
•
Quantify any benefits or disbenefits identified.
This document contains the file specification for the fields required from primary care together with a
Sharing Agreement detailing how the information will be transmitted, stored and used by both NHS South
Sefton CCG and University of Liverpool. Appendix A shows a diagram of the data flow, the governance
principles and who has access at each point.
Change History
Version Date
1.0
Author Details
08/10/2014
LB
Document created
1.1
17/11/2014
LB
Expiry date amended, dates of extraction added, extraction field and
University of Liverpool details confirmed.
Extraction method
Signed up GP Practices will allow the extraction of patient level data via EMIS Web to be used only for the
purposes within this Information Sharing Agreement (ISA).
Extract Frequency
Three data extractions will be performed. The first will occur in December 2014, the second extract will
occur in August 2015. The third and final extract will be performed during August 2016.
Extract Parameters
The extract parameters are below
Search population: Currently registered patients (Excluding dummy patients)
Search Date: Day of extraction
Date range: Where Indicated - Last 7 years initially
Each subsequent extract covers data for previous 12-months.
document1
Print date: 09 February 2016
6
Agenda Item 10(b)
Fields for extraction:
Registration status
Post Code*
Date of Birth*
Gender
Diarrhoea
19F2
All instances & dates
Time since last diarrhoea episode
19F5
All instances & dates
Diarrhoea symptom NOS
19FZ
All instances & dates
Enteritis due to rotavirus
A0762 All instances & dates
Infectious diarrhoea
A082
All instances & dates
Diarrhoea and vomiting
19G
All instances & dates
Diarrhoea of presumed infectious origin
A083
All instances & dates
Viral Gastroenteritis
07y0
All instances & dates
Infectious gastroenteritis
A0803 All instances & dates
Infantile viral gastroenteritis
A07y1 All instances & dates
Gastroenteritis - presumed infectious origin
A0812 All instances & dates
Gastrointestinal symptoms NOS
19Z
All instances & dates
3.6 Rotavirus vaccination (Code & Date)
and data management
The data extraction from EMIS web will be stored temporarily on the CCG secure network for the purposes
of transmission to the University of Liverpool. The patient identifiable items within the dataset (DOB and
postcode) will be transformed prior to data sharing. This means that postcode will be converted to Lower
Super Output Area (LSOA) and date of birth will be converted to age in months. The data will be transmitted
to University of Liverpool in the form of batches of CSV files via the CCG Patient Identifiable Data (PID) NHS
net account (liverpool.pid@nhs.net). This is an acceptable form of data transmission of patient identifiable
data. The information will then be deleted from the CCG network.
For security features of this process please see Governance and Security section below. To understand Data
Management process - see below.
Governance and Security
Data Governance
document1
Print date: 09 February 2016
7
Agenda Item 10(b)
It is essential that all processing and use of personal data is in line with the Data Protection Act. In order to
protect the rights of individuals there is a statutory duty placed on those who decide ‘how’ and ‘why’ such
data is processed – the ‘data controller’. The data controller for this extraction is the GP Practice as they are
the statutory body. Therefore all proposed use of the data must be in agreement with GP practices.
This essentially means that ALL decisions regarding the use of the data rest with the GP Practice. The data
processors cannot utilise or disclose this information to a third party e.g., Department of Health, without
your express permission, unless covered by the terms of this agreement.
The information will only be used in accordance with the specific purpose that it is provided for and will be
at all times treated as confidential and handled in a secure manner.
The shared information will not be used for any of the following:
•
Advertising, Marketing & Public Relations
•
Trading/sharing in personal information
•
Future Research not covered by the parameters of this sharing agreement
Legal basis for Information Sharing
The information shared will not contain patient identifiable data items.
The Health and Social Care Act 2012 also allows sharing of information for the purpose of advancing the
health and wellbeing of the people in the area, to encourage persons who arrange for the provision of any
health or social care services in that area to work in an integrated manner.
Security of the servers/data warehouse
Data will be extracted and warehoused on a secure server hosted and administered by University of
Liverpool. The following security features are in place to ensure the data is secure.
•
Servers have routine, auditable back up procedure to prevent data loss
•
Secure anti-virus software
•
Servers in secure room with key access and log book for access
•
Building has swipe card access for every floor.
•
Computers have time out screens and screen lock functions for users.
•
Users have secure password to network
•
This process is regularly audited by external auditors to ensure fit for purpose
Data Management
The data extracted will be housed in a secure data warehouse as above. The University of Liverpool data
governance practices, which are informed by the Data Protection Act (1998), will be rigidly adhered to.
Retention period
document1
Print date: 09 February 2016
8
Agenda Item 10(b)
The data will be stored by University of Liverpool for 10 years after the expiry of this data sharing agreement
(31/05/2017). No further data will be shared between the University of Liverpool and GP after the expiry of
this data sharing agreement (31/05/2017).
Subject Access
Subject access requests will be dealt with by the data controller in accordance with the provisions of the
Data Protection Act 1998.
Complaints
Complaints will be dealt with in accordance with NHS South Sefton CCG Complaints Policy.
Transmission
In line with Department of Health recommendations, the use of laptops or other portable media for
storing/transferring person identifiable or other sensitive information is not allowed under this agreement
unless it is encrypted to standards approved by the DoH. Data will be transmitted via approved secure routes
in this case NHS net to NHS net or encrypted email.
Information breaches
Partners will take steps to avoid any breach (intentional or otherwise) or disclosure to third parties outside
the remit of this Agreement. Breaches must be reported through to NHS South Sefton CCG Incident
reporting procedures, fully investigated and a report provided to NHS South Sefton CCG.
Any Serious Untoward Incidents occurring within the scope of the information shared under this agreement
must be reported to the participating organisations within 1 day of the incident occurring. The SUI must be
fully investigated. The GP practices reserves the right to be informed at every stage of the investigation.
Disciplinary action will be the responsibility of the organisation where the incident has occurred. This
agreement will be reviewed in light of any lessons learnt from such incidents.
Information will only be accessible to those authorised by this agreement or for whom it is essential to
access the information to complete the purpose of the sharing.
Confidentiality
Partner organisations must have confidentiality clause within staff contracts of employment and or require
staff participating in this agreement to sign confidentiality agreements. Staff must have current CRB checks
where agreements require the sharing of sensitive data in particular children’s data
Where training needs to meet the requirements of this agreement are assessed and identified, each
organisation will ensure that the resource is made available to staff.
Patient Confidentiality
document1
Print date: 09 February 2016
9
Agenda Item 10(b)
Some patients may still wish to opt out of sharing data in the same way as they may have done for the
national spine. Patients’ data will not be shared if the read codes of 93C3 (Refused consent for upload to
national shared electronic record) and 93C1 (Refused consent for upload to local shared electronic record).
Patients will also be hidden from the extract if a practice marks their records as ‘private’ from within the
clinical system. Both methods are acceptable.
Dissemination
Copies of this agreement will be provided to each of the signatory organisations. A master copy will be held
by NHS South Sefton CCG. NHS South Sefton CCG will support any changes or amendments to this
agreement.
This information sharing agreement will be adopted by the signatory organisations. Key staff will be
identified in each organisation to ensure that the protocols in this agreement are adhered to.
Information Governance
All signatories to this agreement are required to have approved Information Governance Policies in place
that state the legal, ethical and professional obligations to protect service user information.
Signatories to this agreement must ensure that all staff, contractors or other third parties who are involved
in the processing of information covered by this agreement have received appropriate Information
Governance training.
Monitoring & Review
Review of this agreement will be overseen by NHS South Sefton CCG, with reference to the signatory
organisations, and in particular if there are changes to the agreed purpose or processes. This document will
also be reviewed whenever there are changes to legislation or guidelines that may affect the sharing of the
information covered by the agreement.
Staff are required to report any adverse incidents that may affect the validity of the statements in this
agreement and any breaches of security or confidentiality to Information Intelligence Services at NHS South
Sefton CCG.
Any queries relating to this agreement should be addressed to NHS South Sefton CCG.
This agreement will be sent to practices once Practices will be communicated to every two years providing
them with an opportunity to opt out.
Effective Date
This ISA is considered to be effective following signature of all parties and from the date on the signature
page of the agreement unless prior authorisation to share has been approved by the Caldicott Guardian.
Information Sharing Agreement
document1
Print date: 09 February 2016
10
Agenda Item 10(b)
You agree to share the data specified within this sharing agreement for the purpose specified.
NHS South Sefton CCG
Signed …………………………
Designation………………….
Date of expiry 31/05/2017
University of Liverpool
Signed …………………………
Designation………………….
Date of expiry 31/05/2017
GP Practice Name:
Signed …………………………
Designation………………….
Date of expiry 31/05/2017
document1
Print date: 09 February 2016
11