Clinical Databases – Business Case
The maximum number of words for each response is indicated, where applicable.
Database Title
National Audit of Pulmonary Hypertension
Database Lead
Julie Michalowski
Clinical Lead
Simon Gibbs
Organisation
Health and Social Care Information Centre
Partner
organisations
National Pulmonary Hypertension Centres of the UK and
Ireland Physicians Committee
National Services Division, Scotland
Welsh health Specialised Services Committee
The Pulmonary Hypertension Association
Potential joint
commissioners
or funding
partners
PROJECT OVERVIEW
Provide a summary of the purpose and essential features of the register or
clinical database.
Maximum response 250 words
The national Audit of Pulmonary Hypertension is a prospective annual audit of clinical
processes and outcomes and has the participation of all 8 designated centres.
A dataset has been developed to meet the requirements of the pulmonary
hypertension clinicians who manage the service and the Specialist Commissioning
Groups (and newly formed CRG) who commission the services and the audit.
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1.AIMS AND OUTCOMES
1.1 Clear description of project which demonstrates the purpose or aim(s) of
data collection and clearly sets out what data will be collected; data should be
simple, valid, reproducible and objective
Maximum response 250 words
The purpose of data collection is to be able to demonstrate national outcomes, a comparison
between designated centres and to monitor the SCG Commissioning Policy.
The data items collected can be found in appendix A
1.2 Please provide a description of the resources used to operate the system
Maximum response 250 words
Data entry within the designated centres is provided by a variety of staff –
administrative, clinical, IT.
An IT developer maintains the system along with helpdesk support to users.
1.3 Outline of the relevance of the register to Specialised Commissioning.
Specify any relevant quality initiative or other governmental policy initiative the
register may align with.
Maximum response 250 words
The audit allows the measurement of compliance against the national Pulmonary
Hypertension prescribing guidelines and provides clinical indicators.
1.4 Scale; please identify the scope and size of dataset
Maximum response 100 words
All patients referred to pulmonary hypertension services nationally
See Appendix A
1.5 Geographical coverage; please provide details of regional data collection
Maximum response 100 words
England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man, Gibraltar &
other British Overseas Territories
Republic of Ireland have asked to join the audit and it is under consideration
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2. DATA QUALITY, GOVERNANCE AND TRANSPARENCY
2.1 The database has a clear communication strategy which demonstrates how
collected information will be accessible to both professionals and members of
the public and at what level of detail.
Maximum response 100 words
Information is provided in the annual report published on the internet. We hope to
provide published clinical indicators
2.2 The database demonstrates how data are disseminated to commissioners to
aid commissioning of services. How frequently will data be fed back? Will the
reports be fixed or will there be scope for flexibility in data provided?
Maximum response 100 words
SCG reports are produced on a monthly basis. The required data items have been
identified by the SCG and can be modified to include other data items (assuming
appropriate permissions are granted where applicable).
An annual report is published of findings which is available to the SCGs
2.3 The data adheres to relevant published governmental guidance:
http://www.coi.gov.uk/documents/guidance/TG113-legal-issues-v1-2.pdf
Maximum response 50 words
Yes, the data adheres to the published guidance
2.4 There must be a clear information governance policy which sets out how
the data will be gathered, maintained and kept securely and released in line
with recommended guidance. Data collection must align with rules set out by
relevant organisations where appropriate, such as the NIGB.
Maximum response 100 words
The audit has section 251 approval to collect patient identifiable data. Data sharing
agreements (DSA) are in place with organisations that use the data from the audit. These
DSAs details how the data is to be used, how it is stored, who can access it, how long it is
stored and how the data is transferred and the System Level Security Policies of those
organisations.
The audit has a System Level Security Policy which details how the data is stored,
maintained, and destroyed.
2.5 The database must demonstrate how the data will be collected and what
efforts will be made to maximise data quantity, maximum case ascertainment
and statistical validity.
Maximum response 100 words
Data is collected within the designated centres via a secure database system. The
system is currently being re-developed to reduce the data set and improve quality. The
new system will provide each of the centres with real-time data quality reports and a
data export facility to promote data capture. The quarterly User Groups focus on data
quality with reports being discussed at this forum.
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2.6 The database must show how data quality will be maintained such as by
statistical and audit processes to determine data accuracy and avoid data
duplication.
Maximum response 100 words
Data quality is assessed prior to the publication of the annual report by the clinical
lead.
2.7 The database must show how the burden on local collection will be kept to
a minimum and how pre-existent data sources are used to supply data or for
data triangulation, verification etc.
Maximum response 100 words
The recent review of the audit has taken into account the above criteria and reduced
the number of data items from the previous dataset to focus data collection on those
required to measure the Commissioning Policy Guidelines and relevant clinical
outcomes and processes.
MRIS data will be used to identify life status and to validate date of death entered into
the database
2.8 The database should use agreed and accepted data dictionary definitions
and terminology in relation to conditions, procedures and other data items.
Maximum response 50 words
Where possible all data items are mapped to accepted data dictionary definitions.
2.9 Where appropriate, risk adjustment and case mix adjustment systems
should be identified
Maximum response 100 words
A new method of risk adjustment is being introduced for the production of funnel plots
of mortality
2.10 The database should show how the data collected will be capable of
linkage to other data sets
Maximum response 100 words
NHS number is used as the unique identifier. This is currently used for life status
linkage to the MRIS database and, if appropriate, be used to link to other national
databases.
3. USES OF THE DATA
3.1 The data are available on a real time basis if not what plans are in place to
do so?)
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Maximum response 100 words
It will be available on a real-time basis.
3.1 The data support local quality improvement (QIPP, CQUINS, Quality
Dashboards)
Maximum response 100 words
The data supports local quality improvement and will support a CQUINS later in
2012 when agreed
3.2 The data support local planning (needs assessment)
Maximum response 100 words
The annual report provides local and national epidemiological data
3.3 The data support procurement of services
Maximum response 100 words
Yes, through regular reports to the SCGs (and CRG)
3.4 Which metrics will be available for inclusion in NHS Outcome Framework?
Maximum response 100 words
Mortality, improvement in symptoms, exercise capacity, QoL, hospital readmission.
4. PATIENT ENGAGEMENT
4.1 The database demonstrates patient involvement as part of its governance
and direction
Maximum response 100 words
Membership of the Project Board includes representatives from the Pulmonary
Hypertension Patients Association (PHA-UK).
4.2 Information is presented for public access in an understandable form
Maximum response 100 words
The report is reviewed by the PHA-UK
5. COST EFFECTIVENESS
5.1 The database includes a costed work plan, an annual itemised budget and
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willingness to report on the financial management. There is clarity about
identified posts and resources to be funded solely by this funding source or
met also from other sources. SCGs will not fund data entry
Maximum response 100 words
Please attach itemised budget to this proposal form (no word limit)
Appendix B
5.2 Please give details below of any confirmed funding from other sources
Maximum response 100 words
None
5.3 The database demonstrates cost effectiveness and value for money
Maximum response 100 words
Cost effectiveness & value for money will be demonstrated through clinical outcomes
5.4 Declaration of the specific value SCG funding will bring to the database
Maximum response 100 words
The SCG funding allows for the development of the measurement of clinical outcomes
for patients with pulmonary hypertension. There is no other source of funding
6. ORGANISATIONAL GOVERNANCE
6.1 Governance arrangements and reporting structure for the database are
clearly described. There must be clearly identified clinical leadership and a
suitable project management group.
Maximum response 100 words
A Project Board is established (membership in Appendix C)
Clinical leadership is provided by the lead clinician, Simon Gibbs
6.2 The database demonstrates how its success will be measured, and what
outcomes might be relevant in judging whether the desired impact was
achieved
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Maximum response 100 words
Success will be measured by clinical outcomes which will influence commissioning of
the clinical service
7. DEVELOPMENT
7.1 The database should have broad scope for the widest possible application.
Outcomes should have general implications (rather than be of local/regional
interest only).
Maximum response 200 words
The database covers all aspects of pulmonary hypertension and all patients
referred to the national service. National data is provided.
7.2 Describe future plans for the database or register (to include prospects for
longer- term project sustainability/future alternative funding sources).
Maximum response 200 words
We intend to maintain a long term sustainable database to describe the evolution and
improvement of patient care and mortality as well as the effects of expensive drug
therapies.
7.3 Project demonstrates support from, or a clear alignment with, a specialist
college or professional society or association.
Maximum response 200 words
The project has support from
National Pulmonary Hypertension Centres of the UK and Ireland Physicians
Committee
National Services Division, Scotland
Welsh health Specialised Services Committee
The Pulmonary Hypertension Association
The SCG through the Joint Commissioning Forum and the CRG
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7.4 A condition of funding is that registers agree with commissioners
information to be supplied by the database to commissioners
Yes. The lead clinical has agreed the information supplied to commissioners through
the annual report and monthly SCG reports.
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