​​​​​​​​​​​​QResearch Practice information sheet

 

 

Background

 

In 2003, the University of Nottingham and EMIS established a new high quality ethical database for research known as QRESEARCH. This database, which is now the largest of its kind worldwide, consists of the pseudonymised records of over 24 million patients who have been registered with over 1300 practices spread throughout the UK. Results of research undertaken using QRESEARCH are all published and can be found at http://www.qresearch.org.

 

We have many examples of projects which have helped inform health care policy or enrich understanding of the causes and outcomes from diseases and their treatments.

Click here to see an overview of QResearch and related projects.

 

Why is QRESEARCH wanting to expand?

 

We want to expand the size of QRESEARCH in order to

• get better coverage of some parts of the UK (we need at least three practices in a geographical area in order to be able to report at that level)
• increase to increase the number of practices with longitudinal data tracking back over a decade to enable us to develop new risk prediction algorithms such as QRISK (new CVD risk score developed - see http:\\www.qrisk.org) which can be integrated back into the clinical system
• enhance our ability to undertake research on rare diseases
• to enable the rapid evaluation of the safety and effectiveness of newly introduced medication.

  

Why has my practice been invited to participate?

 

We are inviting all practices using EMIS Web to take part. 

 

Does the practice have to take part?

 

It is entirely up to the practice as to whether they wish to take part. Practices who agree to take part will activate QRESEARCH within their surgery system. The practice will only be included in the project once this activation has been done.

 

 

What will happen if the practice takes part in QRESEARCH ?

 

GP computer systems are currently connected to EMIS via the NHSNet for support and patching of system upgrades. EMIS will use this link to first upload key census related variables such as the deprivation score (called the Townsend Score) and a marker of rurality into the patient’s electronic record. These data items will be stored in the patients’ record but will not be available on the patient’s registration screen. The scores are derived from the national census and are linked to the electoral ward or output areat in which the patient lives. The scores are used in research to measure or monitor uptake and provision of health services.

 

The practice system will then generate an upload of the pseudoymised data and transmit this data via the N3 network to a dedicated server within EMIS. The data are pseudonymised with a 'one way' hashing algorithm which cannot be reversed theereby protecting patient confidentiality. The data are updated on a daily basis and this update does not interfere with the running of the practice or any back-ups. 

 

EMIS undertakes a secure transmission of the aggregated data to the University of Nottingham . To ensure maximum security, the data are encrypted and will be stored on a very secure server in the University of Nottingham. Physical access to the database is very restricted. The University of Nottingham is the only point of access to the full database.

 

What data is uploaded? 

 

QResearch only uploads pseudonymised coded data: year of birth, sex, registration dates, date of death, deprivation scores, ethnicity, referrals, consultations, prescriptions, clinical values (eg blood pressure), test results (eg full blood count) and clinical problems/events such as diagnoses.  Users are assigned a pseduonymised code. Patient dates of birth are rounded to year of birth. No free text or strong patient identifiers are uploaded. Patients are excluded from the uploads if they have a read code indicating they have opted out of QResearch (EMISNQOP15) or the Summary Care Record. Any items marked as confidential by the GP are also excluded from the uploads. 

 

How does the data linkage work? 

 

The QResearch database is be linked to other sources of data such as cancer registries, deaths data and hospital episode statistics. The linked hospital data (HES), cause of death supplied by the Office of National Statistics and cancer registration data supplied by Public Health England are only available for analysis on site at the University of Nottingham as this is the license condition stipulated by the data suppliers. The HSCIC retains copyright© of HES data and it is re-used with permission of the HSCIC (all rights reserved). This information is linked to Qresearch using the same pseudonymisation process which is applied to the NHS number in the secondary data source before the data is released to the University of Nottingham. The data is then be linked on the pseudonymn without the need for disclosure of any strong identifiers to QResearch. 

 

How do I activate QRESEARCH in EMIS Web?

 

Please click here​ for instructions on how to activate QResearch in EMIS Web.

 

 

Can the practice withdraw from QRESEARCH at any time?

 

Practices can withdraw from QRESEARCH at any time and without giving a reason.  If a practice does decide to withdraw, no further data from the practice will be extracted for future research projects. If a practice wishes to withdraw, it just selects the ‘deactivation’ option from the QRESEARCH agreement in the ‘Information Upload Services” module  within their surgery computer system.

 

 

What are the benefits of taking part?

 

Practices will be contributing to the improvement of patient care through a good quality ethical research programme, carried out on large volumes of data. Practices are able to access tools and utilities within their practice system based on research findings from QRESEARCH such as the QRISK2, QDiabetes, QFracture and QCancer risk prediction tools. In addition, we will try to facilitate any of our practices who wish to undertake their own research project by discussing the project with them and providing advice on how to get the submission to the Scientific Committee ready.

 

QRESEARCH has been set up on a not-for-profit basis and there is no funding available to cover practice time. However, the amount of time involved in activating the upload is minimal.

 

 

Are there any risks to taking part?

 

We do not believe there are any significant risks to taking part in QRESEARCH. The main issue is security and confidentiality of the data collected and we have put systems in place to ensure maximum security of data. We have approval from Trent Multi-Centre Ethics Committee and have consulted widely with professionals with expertise in this area. All information will be held in accordance with the principles and conditions set out in the Data Protection Act 1998 and with proper safeguards to ensure confidentiality. No patient identifiable information will be extracted from your database and therefore patient identifiers will never be released by QRESEARCH. The identity of practices in QRESEARCH will be kept confidential. Although the practice identifiers will be known to the EMIS and one member of the QRESEARCH team, no practice identifiable data will be released by QRESEARCH to a third party. Indeminty is provided by the University of Nottingham. All types of uses of the data, will require the approval of the National Advisory Board. Under no circumstances will a copy of the entire database be made available to any individual or organisation. 

 

Practice notice

Trent Multi-centre Ethics Committee have advised us that all practices contributing to collection of anonymised data for research need to display a notice in their waiting room informing patients. The notice can be found here​. Patients who do not wish their data to be included in the upload are able to opt out by informing their General Practitioner who then assigns a specific EMIS Read code (EMISNQOP15) which will cancel any future data collection from that patients’ record.

 

What is the Advisory Board and what is its role?

 

The role of the Advisory Board is:

 

Ø       To oversee the general working of QRESEARCH including the handling of the data, the type of analyses undertaken and access to the database.

Ø       To agree and update the criteria and principles for access to the QRESEARCH database and oversee their application.

Ø       To advise on policy for accessing data (i.e. how quickly should researchers get data; how much should it cost)

Ø       To offer general advice on professional issues to the QRESEARCH management team

 

The full board will represent the key stakeholders in QRESEARCH and to gain and retain the respect of the public, the NHS, practices and the research community. Its membership will include representatives of the following organisations:

 

Ø       The Royal College of General Practitioners

Ø       The British Medical Association itself and its General Practitioners Committee

Ø       EMIS National Users Group

Ø       A representative of the practices contributing data to QRESEARCH

Ø       EMIS

Ø       Two patient representatives

Ø       University of Nottingham

Ø       Chair of the Scientific Committee

 

 

What are the requirements for the projects undertaken using QRESEARCH?

 

There are two types of projects that will use QRESEARCH. The first type will be research projects and many of these will require a subset of QRESEARCH to analyse. Research projects undertaken using the QRESEARCH data will fulfil the following criteria

 

(a)     They have a named principal investigator and named co-investigators (at least one co-investigator will have an academic track record)

(b)     They will have a written protocol with a clear research question

(c)     They will have current ethical committee approval for the project

(d)     They will have a research sponsor and will meet the requirements of research governance

(e)     They will agree to acknowledge the source of data in any publication or report (which will never identify any individual practices).

(f)       They will guarantee their academic independence, including their ability to publish their findings regardless of the implications for any sponsor or funder

(g)     The QRESEARCH Scientific Committee will need to give approval within the guidelines set out by the QRESEARCH Advisory Board before any analysis can occur and before the data can be supplied to the user.

 

The second type of project will require tables of data. These morbidity surveys will not require the release of a subset containing patient level data, but just analyses. The results of these analyses will be placed on the QRESEARCH website (www.qresearch.org). Applicants for tabular data will need to be approved by the Advisory Board.

 

Under no circumstances will QRESEARCH data made available to pharmaceutical companies for post marketing surveillance. There may be circumstances in which is it may be in the public interest to undertake analyses of  safety for new and commonly used medications and in these special circumstances it may be necessary for QRESEARCH to have contact with the pharmaceutical industry via a third party such as the MHRA. For example, in a flu pandemic situation we may need to rapidly assess whether a newly developed flu vaccine is likely to be safe and effective. As with any research project however, will be undertaken by a researcher who can guarantee academic independence in design and analysis as well as freedom to publish in according with our governance framework.  All studies will be approved by the Scientific Board and notified to the Advisory Board. The protocol for the studies will be publically available as will any information on  funding to support this activity.

 

 

Will the identity of practices taking part in QRESEARCH be kept confidential?

 

Yes, the participation of the practice in QRESEARCH will be confidential. Although the practice identifiers will be known to the EMIS and one member of the QRESEARCH team, no practice identifiable data will be released by QRESEARCH to a third party. The practice will not be named in any report or publication.

 

 

What happens to the results of the research projects?

 

All projects undertaken using QRESEARCH are to be made publically available without charge. We expect researchers who use QRESEARCH data for their research to publish the findings in peer reviewed journals. We will keep a list of all publications which is available on http://www.qresearch.org.

 

 

Who is organising the research and who are the guarantors?

 

QRESEARCH is a joint venture between the Univeristy of Nottingham and EMIS. The project is organised and guaranteed by Professor Julia Hippisley-Cox, GP and professor of General Practice (University of Nottingham) and Dr Shaun O'Hanlon (Clinical and Development Director, EMIS).

Contact details:

E-mail: julia.hippisley-cox@nottingham.ac.uk

  

 

Further queries

 

If you have any queries about QRESEARCH, then please contact Professor Julia Hippisley-Cox email. Further details about QRESEARCH can be found on the QRESEARCH website (www.qresearch.org)

 

If you have any complaints about the way that QRESEARCH is being conducted, please contact:  

Dr Geoff Schrecker 

EMIS National User Group, Suite 15, Enterprise House, Kingsway North, Team Valley, Gateshead, Tyne & Wear.  NE11 0SR

Email: Geoff.schrecker@gmail.com

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