Plain English Summary
Background and study aims.
This study is an anonymous online survey to establish patient and public views on the sharing of identifiable health data for clinical purposes, and de-identified health data for research within the UK. By health data we mean any information collected about a person’s health, including things like medical notes, blood test results, etc. This may have personal information such as names and addresses attached (identifiable), or personal information removed (de-identified). Currently there is only limited sharing of health data for clinical purposes via implicit consent across the NHS. Recent reviews of public attitudes to using patient health data for research found little research about how acceptable it is to share patient health data for groups with specific health conditions, and that sharing some types of sensitive data (on mental health, sexual health, sexuality, religion, etc.) held greater concern than for other types of data. This study seeks opinions on whether the public holds different views about the sharing of mental versus physical health data, and, in the context of research, about structured versus “free text” de-identified data. It will also seek views about a national consent form, about data linkage for research, and about a national web portal to sign up to be contacted about health research. The study aims to recruit >1000 people over 6 months.
Who can participate?
The survey is open to anyone residing in the UK over the age of 16 (or under 16 with parental permission) who can access the online survey.
What does the study involve?
Completing an online survey. The survey takes about 18-25 minutes to complete but does not have to be completed in one sitting. It does ask questions about the respondent’s own physical and mental health, and some personal demographics, but all questions have a “prefer not to answer” choice.
What are the possible benefits and risks of participating?
There are potential future benefits to others via the research, but no direct benefits to participants. No risks to participants are anticipated.
Where is the study run from?
University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
March 2019 to December 2020
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Mrs Linda Jones
laj28@cam.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rudolf Cardinal
ORCID ID
http://orcid.org/0000-0002-8751-5167
Contact details
Chief Investigator
Department of Psychiatry
University of Cambridge
Behavioural and Clinical Neuroscience Institute
Sir William Hardy Building
Downing Site
Cambridge
CB2 3EB
United Kingdom
+44 (0)1223 768501
rnc1001@cam.ac.uk
Type
Public
Additional contact
Mrs Linda Jones
ORCID ID
Contact details
Study Co-ordinator
University of Cambridge
Department of Psychiatry
Behavioural and Clinical Neuroscience Institute
Sir William Hardy Building
Downing Site
Cambridge
CB2 3EB
United Kingdom
+44 (0)1223 764670
laj28@cam.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 44205, IRAS 268811
Study information
Scientific title
University of Cambridge NHS health data consent survey
Acronym
Study hypothesis
Null hypotheses include:
1. The public's views on sharing mental health data will not differ from their views regarding physical health data
2. Their views on sharing will be uninfluenced by recipient type (e.g. NHS, academia, commercial researchers), or their own situation (demographics, experience of mental/physical health services)
3. Their views on sharing structured (coded) data for research will not differ from those on sharing de-identified free-text (narrative) data
Ethics approval
Approved 20/12/2019, East of Scotland Research Ethics Service (Tayside Medical Science Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9S, UK; Tel: +44 (0)1382 383878; Email: eosres.tayside@nhs.net), REC ref: 19/ES/0144
Study design
Observational; Design type: Cross-sectional
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Internet
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Health data sharing
Intervention
This study is an anonymous online survey to establish patient and public views on the sharing of identifiable health data for clinical purposes, and de-identified health data for research within the UK. Currently, there is limited sharing of health data for clinical purposes via implicit consent across the National Health Service (NHS; HSC in Northern Ireland). Recent literature reviews of public attitudes to using patient health data for research noted there were few studies relating to the acceptability of sharing patient health data for groups with specific health conditions, and that sharing some types of sensitive data (on mental health, sexual health, sexuality, religion, etc.) held greater concern than for other types of data.
In conjunction with the study team's research advisory group, made up of mental health service users and carers, an online survey has been designed to seek public views on data sharing across the UK and the design of a unified consent form. The survey has been thoroughly tested by members of the public, both with and without mental health conditions.
Participants living in the UK will be invited to take part in the survey through advertising leaflets, posters and postcards as well as messages for social media. The study team also hope to use the NHS National Institute for Health Research (NIHR) Clinical Research Network (CRN) to reach out across the UK. The team will engage with other MRC MHDP-funded university sites and UK charities to promote the survey. Local media (radio, TV, and written) will be approached with the hope that it may gain some national coverage. The study team also have contacts in other hospitals and universities across the UK. ‘Pop-ups’ in towns and cities may be used, as well as stands at local and national events.
Participants will enter, consent, and complete the survey online (pilot work indicates that this takes 18-25 minutes). There is no contact from the University of Cambridge study team to the participants, unless they wish to receive the results of the survey or contact the study team directly themselves. Once the survey has been completed by the participant, their involvement in the study ends.
For one question in the survey, the team have superimposed a randomised intervention, namely a framing statement, prior to seeking views relating to the sharing of mental versus physical health data. The framing statement will be one of three: a "security" framing emphasising previous work reporting others' greater concerns about sharing mental health data versus other kinds of health data; a "neutral" statement; and a "holistic" framing emphasising the interrelationship between mental and physical illness. Randomisation to the three framing statements will be in a 1:1:1 ratio, without stratification.
The study team hope to complete the survey over 6 months with an aim to produce the final report within 3 months of the study closing.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Views on how health data may be shared across the UK, how these are related to demographic variables, and how opinions on sharing mental versus physical health data are affected by the framing of risk versus benefit. All preferences in relation to data sharing will be measured using Likert-style scales, yielding interval/ordinal data on preferences (e.g. "very unlikely to share"/"strongly disagree" through to "very likely to share"). Self-reported overall degree of support for:
1. Sharing physical health data for NHS clinical care without explicit consent each time, and how far such sharing should extend
2. Likewise for mental health data
3. Sharing de-identified structured physical health data for research without explicit consent, and how far such sharing should extend (e.g. NHS, academic, charities, industry, publicly)
4. Likewise for mental health data
5. As for 3 but with de-identified free text data
6. As for 4 but with de-identified free text data
Measured using an online survey at a single timepoint
Secondary outcome measures
Views on the design of a national consent form and on whether there should be a separate national web portal for mental health research as well as views on data linkage. Secondary measures will include:
1. The effect of the framing interventions
2. The degree of support for a single national sign-up mechanism for sharing one's health data for clinical care and/or research
3. Views on a prototype national NHS data sharing consent form
4. Views on trusted-third-party linkages between health data and a range of other UK state-held data sources (e.g. education, criminal justice)
Measured using an online survey at a single timepoint
Overall trial start date
01/03/2019
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant is willing and able to give informed consent for participation in the study
2. Participant currently resides in the UK
3. Participant is able to access the online survey
Participant type
All
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1266; UK Sample Size: 1266
Participant exclusion criteria
Under 16 years of age without parent or guardian permission (the researchers have put 8 as a lower age limit as one is required; they would not wish to exclude anyone with parental permission on the basis of age but the numbers of participants < 16 is likely to be very low)
Recruitment start date
21/01/2020
Recruitment end date
30/09/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House
Fulbourn Hospital
Cambridge Road
Fulbourn
Cambridge
CB21 5EF
United Kingdom
Trial participating centre
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Royal Bournemouth General Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Trial participating centre
North Staffordshire Combined Healthcare NHS Trust
Bellringer Road
Trentham
Stoke-On-Trent
ST4 8HH
United Kingdom
Trial participating centre
North Staffordshire Combined Healthcare NHS Trust
Bellringer Road
Trentham
Stoke-On-Trent
ST4 8HH
United Kingdom
Trial participating centre
Norfolk and Suffolk NHS Foundation Trust
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom
Trial participating centre
Salisbury NHS Foundation Trust
Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Trial participating centre
Kent and Medway NHS and Social Care Partnership Trust
Farm Villa
Hermitage Lane
Maidstone
ME16 9PH
United Kingdom
Trial participating centre
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield Road
Sutton-In-Ashfield
NG17 4JL
United Kingdom
Trial participating centre
Royal Cornwall Hospitals NHS Trust
Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
Trial participating centre
East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Trial participating centre
Worcestershire Acute Hospitals NHS Trust
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Trial participating centre
Worcestershire Health and Care NHS Trust
Isaac Maddox House
Shrub Hill
Industrial Estate
Worcester
WR4 9RW
United Kingdom
Trial participating centre
Airedale NHS Foundation Trust
Airedale General Hospital
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom
Trial participating centre
Taunton and Somerset NHS Foundation Trust
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Trial participating centre
University Hospital Southampton NHS Foundation Trust
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Somerset Partnership NHS Foundation Trust
2nd Floor
Mallard Court
Express Park
Bristol Road
Bridgwater
TA6 4RN
United Kingdom
Trial participating centre
Dorset Healthcare University NHS Foundation Trust
Sentinel House
4-6 Nuffield Road
Nuffield Industrial Estate
Poole
BH17 0RB
United Kingdom
Trial participating centre
University Hospitals Plymouth NHS Trust
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Trial participating centre
University Hospitals Birmingham NHS Foundation Trust
Trust HQ, PO Box 9551
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom
Trial participating centre
Dudley and Walsall Mental Health Partnership NHS Trust
Trafalgar House
47-49 King Street
Dudley
DY2 8PS
United Kingdom
Trial participating centre
East Suffolk and North Essex NHS Foundation Trust
Colchester District General Ho
Turner Road
Colchester
CO4 5JL
United Kingdom
Trial participating centre
Tameside and Glossop Integrated Care NHS Foundation Trust
Tameside General Hospital
Fountain Street
Ashton-Under-Lyne
OL6 9RW
United Kingdom
Trial participating centre
Nottinghamshire Healthcare NHS Foundation Trust
The Resource
Trust HQ
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Trial participating centre
Avon and Wiltshire Mental Health Partnership NHS Trust
Jenner House
Avon Way
Langley Park
Chippenham
SN15 1GG
United Kingdom
Trial participating centre
Nottingham University Hospitals NHS Trust
Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Trial participating centre
Surrey and Borders Partnership NHS Foundation Trust
18 Mole Business Park
Randalls Road
Leatherhead
KT22 7AD
United Kingdom
Trial participating centre
Birmingham and Solihull Mental Health NHS Foundation Trust
Unit 1
50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom
Trial participating centre
James Paget University Hospitals NHS Foundation Trust
Lowestoft Road
Gorleston
Great Yarmouth
Norfolk
NR31 6LA
United Kingdom
Trial participating centre
The Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust
Queen Elizabeth Hospital
Gayton Road
Kings Lynn
PE30 4ET
United Kingdom
Trial participating centre
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Trial participating centre
Derbyshire Healthcare NHS Foundation Trust
Trust Headquarters
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
Trial participating centre
The Royal Orthopaedic Hospital NHS Foundation Trust
The Woodlands
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Trial participating centre
Hertfordshire Partnership University NHS Foundation Trust
99 Waverley Road
St. Albans
AL3 5TL
United Kingdom
Trial participating centre
Bedford Hospital NHS Trust
South Wing
Kempston Road
Bedford
MK42 9DJ
United Kingdom
Trial participating centre
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Trial participating centre
Lincolnshire Partnership NHS Foundation Trust
Units 8 & 9
The Point
Lions Way
Sleaford
NG34 8GG
United Kingdom
Trial participating centre
Leicestershire Partnership NHS Trust
Riverside House
Bridge Park Plaza
Bridge Park Road
Thurmaston
Leicester
LE4 8PQ
United Kingdom
Trial participating centre
Cambridgeshire Community Services NHS Trust
Unit 3
Meadow Lane
St. Ives
PE27 4LG
United Kingdom
Trial participating centre
East of England Ambulance Service NHS Trust
Ambulance Station
Hospital Lane
Hellesdon
Norwich
NR6 5NA
United Kingdom
Trial participating centre
Bridgewater Community Healthcare NHS Foundation Trust
Bevan House
17 Beecham Court
Wigan
WN3 6PR
United Kingdom
Trial participating centre
Torbay and South Devon NHS Foundation Trust
Hengrave House
Torbay Hospital
Newton Road
Torquay
TQ2 7AA
United Kingdom
Trial participating centre
Cornwall Partnership NHS Foundation Trust
Porthpean Road
St Austell
PL26 6AD
United Kingdom
Trial participating centre
Pennine Acute Hospitals NHS Trust
Trust Headquarters
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
Trial participating centre
North East London NHS Foundation Trust
West Wing
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Trial participating centre
Southern Health NHS Foundation Trust
Maples Buildings
Tatchbury Mount Hospital
Calmore
Southampton
SO40 2RZ
United Kingdom
Trial participating centre
Essex Partnership University NHS Foundation Trust
The Lodge
Runwell Chase
Runwell
Wickford
SS11 7XX
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
Salford Royal
Stott Lane
Salford
M6 8HD
United Kingdom
Trial participating centre
Midlands Partnership NHS Foundation Trust
Trust Headquarters
St. Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
Trial participating centre
Pennine Care NHS Foundation Trust
225 Old Street
Ashton-Under-Lyne
Lancashire
OL6 7SR
United Kingdom
Trial participating centre
Norfolk Community Health and Care NHS Trust
Norwich Community Hospital
Bowthorpe Road
Norwich
NR2 3TU
United Kingdom
Trial participating centre
Coventry and Warwickshire Partnership NHS Trust
Wayside House
Wilsons Lane
Coventry
CV6 6NY
United Kingdom
Trial participating centre
Calderdale and Huddersfield NHS Foundation Trust
Royal Infirmary
Acre Street
Huddersfield
HD3 3EA
United Kingdom
Trial participating centre
Wye Valley NHS Trust
County Hospital
Union Walk
Hereford
HR1 2ER
United Kingdom
Trial participating centre
Greater Manchester Mental Health NHS Foundation Trust
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Trial participating centre
Devon Partnership NHS Trust
Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
United Kingdom
Trial participating centre
North West Ambulance Service NHS Trust
Ladybridge Hall
399 Chorley New Road
Bolton
BL1 5DD
United Kingdom
Trial participating centre
Solent NHS Trust
Solent NHS Trust Headquarters
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Trial participating centre
Isle of Wight NHS Trust
St Mary's Hospital
Parkhurst Road
Newport
PO30 5TG
United Kingdom
Trial participating centre
Central London Community Healthcare NHS Trust
Ground Floor
15 Marylebone Road
London
NW1 5JD
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Trial participating centre
Shrewsbury and Telford Hospital NHS Trust
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
Trial participating centre
Walsall Healthcare NHS Trust
Manor Hospital
Moat Road
Walsall
WS2 9PS
United Kingdom
Trial participating centre
Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
Trial participating centre
University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Trial participating centre
Black Country Partnership NHS Foundation Trust
Delta Point
Greets Green Road
West Bromwich
B70 9PL
United Kingdom
Trial participating centre
The Royal Wolverhampton NHS Trust
New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Trial participating centre
Portsmouth Hospitals NHS Trust
De La Court House
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Trial participating centre
Sussex Partnership NHS Foundation Trust
Assessment and Treatment Centre
Chapel Street
Chichester
PO19 1BX
United Kingdom
Trial participating centre
Hampshire Hospitals NHS Foundation Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Trial participating centre
The Christie NHS Foundation Trust
550 Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Trial participating centre
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-On-Trent
ST4 6QG
United Kingdom
Trial participating centre
North West Anglia NHS Foundation Trust
Edith Cavell Hospital
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Trial participating centre
Oxford Health NHS Foundation Trust
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Trial participating centre
Tees, Esk and Wear Valleys NHS Foundation Trust
Trust Headquarters
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Trial participating centre
South Central Ambulance Service NHS Foundation Trust
7-8 Talisman Road
Bicester
OX26 6HR
United Kingdom
Trial participating centre
East and North Hertfordshire NHS Trust
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Trial participating centre
South West London and St George's Mental Health NHS Trust
Springfield Hospital
61 Glenburnie Road
London
SW17 7DJ
United Kingdom
Trial participating centre
Yeovil District Hospital NHS Foundation Trust
Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Trial participating centre
NHS Greater Glasgow and Clyde
J B Russell House
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Trial participating centre
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Gobowen
Oswestry
SY10 7AG
United Kingdom
Trial participating centre
South Warwickshire NHS Foundation Trust
Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom
Trial participating centre
The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
Trial participating centre
Southern Health NHS Foundation Trust
Maples Buildings
Tatchbury Mount Hospital
Calmore
Southampton
SO40 2RZ
United Kingdom
Trial participating centre
The Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom
Trial participating centre
York Teaching Hospital NHS Foundation Trust
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Trial participating centre
West Suffolk NHS Foundation Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom
Trial participating centre
The Dudley Group NHS Foundation Trust
C Block
Russells Hall
Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Trial participating centre
Gloucestershire Care Services NHS Trust
Edward Jenner Court
1010 Pioneer Avenue
Gloucester Business Pk
Brockworth
Gloucester
GL3 4AW
United Kingdom
Trial participating centre
East Cheshire NHS Trust
Macclesfield District Gen Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Trial participating centre
North Cumbria University Hospitals NHS Trust
West Cumberland Hospital
Hensingham
Whitehaven
CA28 8JG
United Kingdom
Trial participating centre
Northern Devon Healthcare NHS Trust
North Devon District Hospital
Raleigh Park
Barnstaple
EX31 4JB
United Kingdom
Trial participating centre
Lincolnshire Community Health Services NHS Trust
Beech House
Witham Park
Waterside South
Lincoln
LN5 7JH
United Kingdom
Trial participating centre
Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom
Trial participating centre
Whittington Health NHS Trust
The Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom
Trial participating centre
Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
East London NHS Foundation Trust
9 Alie Street
Aldgate
London
E1 8DE
United Kingdom
Trial participating centre
Birmingham Community Healthcare NHS Foundation Trust
3, Priestley Wharf
Holt Street
Birmingham Science Park
Aston
Birmingham
B7 4BN
United Kingdom
Trial participating centre
South Western Ambulance Service NHS Foundation Trust
Westcountry House
Abbey Court, Eagle Way
Sowton Industrial Estate
Exeter
EX2 7HY
United Kingdom
Trial participating centre
Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
Trial participating centre
George Eliot Hospital NHS Trust
Lewes House
College Street
Nuneaton
CV10 7DJ
United Kingdom
Trial participating centre
Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Trial participating centre
Dorset County Hospital NHS Foundation Trust
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Trial participating centre
St George's University Hospitals NHS Foundation Trust
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Trial participating centre
Croydon Health Services NHS Trust
Croydon University Hospital
London Road
Thornton Heath
CR7 7YE
United Kingdom
Trial participating centre
NIHR CRN: North East and North Cumbria
NE3 3HD
United Kingdom
Trial participating centre
NIHR CRN: North West Coast
L7 8XP
United Kingdom
Trial participating centre
NIHR CRN: Yorkshire and Humber
S10 2SB
United Kingdom
Trial participating centre
NIHR CRN: Greater Manchester
M13 9WL
United Kingdom
Trial participating centre
NIHR CRN: East Midlands
LE1 5WW
United Kingdom
Trial participating centre
NIHR CRN: West Midlands
CV3 2TX
United Kingdom
Trial participating centre
NIHR CRN: West of England
BS1 2NT
United Kingdom
Trial participating centre
NIHR CRN: Thames Valley and South Midlands
OX3 9DU
United Kingdom
Trial participating centre
NIHR CRN: Eastern
NR1 1QQ
United Kingdom
Trial participating centre
NIHR CRN: Kent, Surrey and Sussex
ME8 0NZ
United Kingdom
Trial participating centre
NIHR CRN: Wessex
SO30 2UN
United Kingdom
Trial participating centre
NIHR CRN: South West Peninsula
PL6 8BX
United Kingdom
Trial participating centre
NIHR CRN: North Thames
W1T 7HA
United Kingdom
Trial participating centre
NIHR CRN: South London
SE1 9RT
United Kingdom
Trial participating centre
NIHR CRN: North West London
W12 0HT
United Kingdom
Sponsor information
Organisation
Cambridgeshire and Peterborough NHS Foundation Trust
Sponsor details
Elizabeth House
Fulbourn Hospital
Cambridge Road
Fulbourn
Cambridge
CB21 5EF
United Kingdom
+44 (0)1223217418
R&D@cpft.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Medical Research Council; Grant Codes: MC_PC_17213
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
4. Publication on website
5. Other publication
6. Submission to regulatory authorities
7. Access to raw data and right to publish freely by all investigators in study or by Independent Steering Committee
on behalf of all investigators
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publicly available repository:
1. University of Cambridge Research Data Repository, https://www.data.cam.ac.uk/repository
2. Available from publication
3. Indefinitely
4. Public, unrestricted
5. Consent obtained from all participants for publication of anonymised data
6. Re anonymisation:
6.1. All e-mail addresses (given optionally for receipt of results) removed prior to final data set creation and analysis
6.2. All free-text data removed from raw data
6.3. Ages pre-blurred to ranges
6.4. All geographic indicators blurred to UK Lower Layer Super Output Area (LSOA) codes (England and Wales), Data Zones (Scotland), and Super Output Areas (Northern Ireland)
Intention to publish date
31/12/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN37444142_PROTOCOL_v4_19Dec19.pdf Uploaded 17/01/2020