Registers-2012-Funding-Proposal-Form

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Clinical databases and Registers Proposal Form 2012
Each section of this form is based on the guidance criteria, which indicate in some
detail the sorts of issues that should be addressed.
The form should be submitted electronically to registers12@hqip.org.uk.
The maximum number of words for each response is indicated, where applicable.
Project Title
Proposal Lead Juan-José Blasco Ramos
Clinical Lead Mr Per Hall
Organisation Cleft-Net-East, Cambridge University Hospitals NHS Foundation Trust
Partner
organisations CLAPA-Cambridge (Cleft Lip and Palate Association)
Potential joint
commissioners or
funding partners
CLAPA (Head Office)
PROJECT OVERVIEW
Provide a summary of the purpose and essential features of the proposed
register or clinical database.
Maximum response 250 words
From existing legacy administrative and clinical information on cleft patients registered in
currently used in-house Cleft-Net-East database, develop a collaborative web-based
information system aimed to provide standardization for clinical data coding and clinical audit
trail for cleft patients throughout a 20 year care pathway.
One of the project’s goals is to ensure long-lasting usability of the data irrespective of the
system deployed or, in a nutshell, provision for interoperability, and namely semantic
interoperability. In order to accomplish this, we aim to deploy internationally agreed clinical
terminology SNOMED CT, derived from NHS Clinical Terms such as Read Codes and the
American SNOMED Reference Terminology.
In the long term, standardized clinical data registration would make it possible for the
clinicians within our multidisciplinary department to better ascertain patients’ diagnosis and
prognosis, considering all disciplines’ outcomes in terms of observations, evaluations,
instructions and actions over time, thereby providing them with more resources for the

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provision of better treatments.
1.AIMS, OUTCOMES AND CLINICAL VALUE
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
As a multidisciplinary team, a variety of clinical disciplines are to be considered, namely,
antenatal and postnatal nursing, paediatric assessments, audiology, speech and language
therapy, plastic and maxillofacial surgery, psychology and orthodontics. The approach for
serialization of data is intended to avoid inclusion of clinical information within the data
models as much as possible, and SNOMED CT would be the terminology of choice.
Traceability of history of clinical appointments, observations noted, assessments and
prospective planned activity as well as registration of action outcomes, would allow for an
audit trail to be monitored over time, not only from an administrative standpoint but also, and
most importantly, from a clinical care point of view.
Agreed cared pathways apply to each of the considered major cleft groups, so by
‘traceability’ we also mean accountability for every clinician to action in response to planned
activities, and hence an automated alert/reminder system is to be deployed.
A tailor-made cleft system allows for inclusion of multimedia resources such as surgery
footage and speech related videos performed on cleft patients. Linkage with third party
vendors as regards 3Dmd data in relation to an ongoing research study about facial growth
on cleft patients could also be deployed.
Valuable self-contained clinical data could be registered in chronological order and data
would be valid over time, irrespective of the system deployed.
As addressed by our Clinical Director and Lead Surgeon Mr Per Hall, availability of online
resources, whether it be within the hospital or offsite, would massively improve care delivery.
1.2 Please provide a description of the resources used to operate the system
It is envisaged that a PHP development framework, a mySQL database and an Apache web
server would be deployed. The PHP framework of choice is Symfony, which has a third party
built-in Object Relational Mapper (ORM) to allow a seamless communication and translation

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between a classical relational database and its object oriented counterpart. The ORM is
called Doctrine and allows automated creation of the object database straight from a
relational database or from its equivalent YAML schema.
Symfony follows the Model-View-Controller (MVC) paradigm, which is a way of breaking an
application into the three aforementioned parts. The Model is the data schema of the
information system and is the core of our design, where all the business data lives. The View
pertains to the presentation of such data to the user or, in other words, the user interface
which communicates with the underlying actual data. And the Controller governs the
business rules for the interaction between user and data (or View and Model). All three parts
can evolve separately without interfering with one another. As a result, this architecture
provides with the means for business continuity plans, as one of its key principles is to
standardize protocols for software development, what in other words is “convention over
configuration”. Therefore, maintenance of the system is facilitated for any IT person in
charge, irrespective of his/her actual involvement in its design. Layout and presentations
(View) can be delegated to Communications department and the maintenance of the system
applies mainly to the Controller.
1.3 Outline of the clinical or public health importance of the topic/what clinical
or other needs will be met by the register. Specify the relevant NICE or other
clinical guideline, quality standard or other governmental policy initiative the
register may align with.
In line with recommendations outlined by the NSCG1
following report on cleft lip and/or palate
(1998) conducted by CSAG2
, and endorsed by HSC3
1998/238 for Clinical Effectiveness in
CL/P services under the category of Health Improvement and Outcomes, Cleft-Net-East
maintains an audit database to allow lead commissioners to assess the appropriateness of
the cleft service specification. From an administrative point of view this has been very useful
for both parties to account for the service activity, and particularly important in issues
pertaining to identification and costing cleft lip and palate activity. As stated by the SSNDS4
in
its Definition No. 15 for Cleft Lip and Palate Services (third edition 2009), there is a currently
ongoing national CL/P development project looking at issues around data collection, costing
and tariff, including a local development project at CUH5
NHS Foundation Trust with which
we participate in collaboration with the Finance Department. This has been possible thanks
to the reporting capabilities of our existing database.
From a clinical standpoint, one step further would be to provide protocols for the coding of
clinical episodes throughout the 20 year care pathway. Although SSNDS definitions such as

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ICD6
and OPCS7
codes are currently deployed locally (but not on our database), provision of
international SNOMED clinical terminology capabilities would massively enhance clinical data
in the long term. As a terminology, SNOMED overcomes the drawbacks of the
aforementioned classifications (ICD/OPCS) and its definitions include backwards
compatibility with different classifications, so mapping between them would not be an issue.
1. National Specialised Commissioning Group
2. Clinical Standards Advisory Group
3. Health Service Circular
4. Specialised Services National Definitions Set
5. Cambridge University Hospitals
6. International Classification of Diseases
7. Classification of Intervention and Procedures conducted by the Office of Population Censuses and Surveys
1.4 Scale; please identify the intended scope and size of dataset
Taking into account a 20 year care pathway and an average of 80 new babies per year, the
cumulative number of active truly bony cleft patients for Cleft-Net-East will continue to grow
from around 1430 patients expected by the end of current financial year until more or less
year 2025, when it will reach the steady state with roughly 1620 active patients.
By active patients we mean patients who have not been discharged, deceased or moved out
of the area. The steady state happens when yearly number of patients turning inactive equals
number of patients referred to the network yearly.

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1.5 What similar work has taken place on this topic in the UK to date? What of
the international picture?
There is a clinical system deployed in Scotland Clinical Managed Network (CleftSiS)
developed by AxSys Technology Ltd. Its name is ExcelicareTM
and it is an Electronic Patient
Record (EPR) and collaborative care system aimed to enable CLEFTSiS to meet their aims
and objectives as a cleft network.
On the other hand, the Cleft Development Group is responsible for the national Craniofacial
Anomalies Register (CRANE database) which, although not an EPR, is intended for national
benchmarking and also to ensure CSAG recommendations are met based on the guidelines
of the Craniofacial Society of Great Britain and Ireland.
1.6 Geographical coverage; please provide details of regional data collection
This project applies to all patients born with cleft lip and/or palate in the region of East of
England. Although the scope of this project is therefore local, outcomes could be
extrapolated to other networks or even nationally. In the long term, the project aims to
uncover trends in clinical care by cleft group throughout a 20 year period and also facilitate
interoperability of clinical data with other systems.
2. DATA QUALITY, GOVERNANCE AND TRANSPARENCY
2.1 Project 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.
Audience Action / Detail
CUH Plastic Surgery management Initiative mandate outlining project’s aims
and arrangement of an IT Lead Person
CUH Information Governance Lead Email briefing as regards compliance
with Data Protection Act, CUH policy and
national guidance
CUH Clinical Coding Team Arrange meeting in relation to SNOMED
CT deployment
CUH E-Hospital Team Arrange meeting concerning currently
ongoing clinical systems within the Trust
Cleft Lip & Palate Association (CLAPA) Email briefing pertaining to stakeholders

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and potential funding partners.
CUH R&D Department Request for ethical assessment and/or
approval for proposed project
CUH IT Integration Manager Arrange meeting for linkage with SQL
repository of currently deployed HISS
PAS system or eHospital future hospital’s
PAS system.
2.2 Project demonstrates how data is disseminated to clinicians to aid clinical
practice
The proposal aims to be a collaborative web-based EPR (Electronic Patient Record), so
availability of data across the hospital to a variety of clinicians of different specialties is crucial
for the success of this project. Data input on currently deployed in-house database relies on a
data input clerk, but validity of clinical data depends upon direct clinicians’ contributions
throughout a 20 year care pathway. Hence the need for an electronic collaborative
environment, which allows for a multidisciplinary view of patients as the sum of all the
clinicians contributions and the means for clinicians’ actions accountability.
2.3 The data adheres to relevant published governmental guidance:
http://www.coi.gov.uk/documents/guidance/TG113-legal-issues-v1-2.pdf
Cambridge University Hospitals NHS Foundation Trust has appropriate policies in place to
ensure compliance with legal areas such as the Data Protection Act, through the information
governance approval process compliance with legal issues will be ensured.
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.
Cambridge University Hospitals NHS Foundation Trust has achieved at least level 2 in all of
the requirements of the information governance toolkit. Information governance approval will
be sought throughout the stages of the development of this database to ensure compliance
with CUH policy and national guidance.
2.5 The project must demonstrate how the data will be collected and what
efforts will be made to maximise data quantity, maximum case ascertainment

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and statistical validity.
A SNOMED browser of choice will provide clinical terminology to any desired level of
granularity, so it is not the information system, but the user and, in particular, the clinician,
who decides the degree of detail necessary.
And when it comes to identifying clinical trends on samples not having yet covered set
timescales, and for the sake of valid extrapolations to whole cohorts, we can run our queries
on the basis of dynamically changing samples of the population of cleft patients complying
with pre-set conditions.
2.6 The project must show how data quality will be maintained such as by
statistical and audit processes to determine data accuracy and avoid data
duplication.
Usage of SNOMED Clinical Terminology entails data accuracy and avoidance of duplication.
The superiority of clinical terminologies over classifications is that the former take into
account, not only the clinical terms but also, and most importantly, the relationships between
them and other concepts, and every single concept has a unique identifier and the inclusion
of synonyms, with prevalence of the so-called Fully Specified Name (FSN). SNOMED is a
multi-hierarchical terminology allowing for the aforesaid relationships to exist. On the
contrary, in classifications there are no such relationships between concepts, which can lead
to duplication of information.
2.7 The project 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.
It is envisaged that this clinical database will connect via SQL repository to local data sources
such as Addenbrookes PAS1
system or to eHospital new PAS system. Demographics
information and some admin data would be retrieved from them. Existing legacy data from
currently used Cleft database would be translated into SNOMED terminology.
1. Patient Administration System
2.8 The project must give an ethics assessment where review of ethical issues
connected to the project has been assessed; and if ethical approval is needed
from the host organisation, this must be provided.

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There is no need for ethical approval on this project according to Addenbrookes Hospital
R&D Department.
2.9 Projects should use agreed and accepted data dictionary definitions and
terminology in relation to conditions, procedures and other data items.
Inherent to the usage of SNOMED CT, and as stated by NHS Connecting for Health, there is
a cross-mapping facility in place and a link between SNOMED and CTV3 (Clinical Terms
Version 3), ICD-10 and OPCS-4 codes.
2.10 Where appropriate, risk adjustment and case mix adjustment systems
should be identified
From a patient classification point of view and in relation to NHS HRG (Healthcare Resource
Group) codes, ad hoc queries providing aggregated data are already in place to assist
Finance department in monthly billing of truly bony cleft patients. In the long term,
deployment of standardized terminologies such as SNOMED CT as part of the clinical
database could potentially improve case mix adjustments by allowing more degree of
granularity in similar groups.
2.11 The project should show how the data collected will be capable of linkage
to other data sets
SNOMED capable systems not only provide standardization for clinical data storage, they
have in themselves third party data sets with inherent capabilities for mapping the variety of
classifications currently deployed in the NHS.
3. PATIENT ENGAGEMENT
3.1 Project demonstrates patient involvement as part of its governance and
direction
From a clinical care standpoint, a clinician’s workflow over time could be divided into for
categories, namely, observations, evaluations, instructions and actions. Whereas the last

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three exclusively depend on the clinician’s criteria, objective observations of phenomena may
include those reported by the patient. And that is precisely the kind of engagement a patient
might contribute with.
3.2 Project demonstrates a specific intention to influence the way clinicians
work with patients on the conditions/procedures involved
There is a tendency in the health arena and particularly amongst those involved in the
provision of medical care, to overlook the benefits of electronic storage of clinical information.
Availability of standardized information electronically could massively improve care delivery
as well as assist in decision support systems. In order to draw everybody’s attention,
amalgamation within the EPR of existing multimedia records such as DV (Digital Video) cleft
speech video and surgery footage seems to be a good starting point. A collaborative work
environment is also enticing to have.
.3 Information is presented for public access in an understandable form (see
3.1)
It is envisaged that, in the long term, electronically available standardized clinical data in a
multidisciplinary environment over a 20 year period would facilitate research and studies
about cleft patients. Taking advantage of existing CUH Cleft-Net-East website (link below),
reports and outcomes on progress made with project would be displayed.
http://www.cuh.org.uk/addenbrookes/services/clinical/cleft/cleft_lip_and_palate_index.html
4. COST EFFECTIVENESS
4.1 Proposal includes a costed work plan and itemised budget for each year of funding, and
willingness to report on the financial management of the project. There is clarity about
identified posts and resources to be funded solely by this funding source or met also from
other sources.
Please attach itemised budget to this proposal form (no word limit)

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ITEMIZED BUDGET
Activity Cost (£)
Design of clinical data models, including
administrative and user management
models.
0
Configuration of SNOMED server for
client applications requesting clinical
terminology.
0
Development of business logic of the
controller.
0
User interfaces creation by specialty or
domain.
0
Acquisition of server equipment through
the IT department.
500 to 1000 depending on server
requirements
In liaison with IT Department, setting up
and configuration of dedicated server for
cleft services.
Tbc and provided by local IT Department
Specification of fees for required hosting
services including those related to
backup and server maintenance.
Tbc and provided by local IT Department
Web layouts specification in collaboration
with Communications Department.
0
In collaboration with IT Department,
provision of linkage with local PAS
system.
0
Other mandatory project requirements
and guidance from local IT Department
Tbc
TOTALS: A minimum of £1000 plus other
amounts yet to be provided.

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.
4.2 Please give details below of any confirmed funding from other sources
There is currently no confirmed funding from other sources, but as of submission date of this application, CLAPA
has a pending meeting with its committee to discuss feasibility for a £990 fund.
4.3 Project demonstrates cost effectiveness and value for money
It is worth noting that the manpower for this project is self-contained within the Cleft Team at Addenbrookes
Hospital, so there are no expenses for the development itself other than the logistics of the project and some IT
service requirements.
4.4 Declaration of the specific value HQIP grant funding will bring to the project

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A third party grant funding would definitely jump-start the commencement of this project. HQIP involvement
would entail a valuable contribution as a stakeholder.
5. ORGANISATIONAL GOVERNANCE
5.1 Governance arrangements and reporting structure for the project are clearly
described. There must be clearly identified clinical leadership and a suitable
project management group.
In collaboration with Cleft Team Service Delivery Manager, project work plans would be
closely monitored and regular meetings would be held with Clinical Director and cleft leads,
reporting on project progression and creating an issues log. The Proposal Lead is actively
asking for opinions and guidance from a variety of departments such as Plastic Surgery
management, Data Awareness Team, Clinical Coding Team, Research & Development
Team and IT Department.
5.2 Describe experience to date in developing/managing databases for clinical
purposes
The proposal Lead of this project has more than 5 years experience as Cleft-Net-East
Database Administrator of in-house information system and he is currently the departmental
Activity & Information Manager. He is responsible for developing complex information
analyses to support the Cleft-Net-East service objectives, ensuring clinicians, finance and
costing personnel and the deputy operations manager have the information available for
patient care, planning and service development purposes.
5.3 Project demonstrates how the success or otherwise of the project will be
measured, and what outcomes might be relevant in judging whether the
desired impact was achieved
This project is an attempt to standardize clinical data registration deploying a terminology
dictionary. It aims to provide a clinical audit trail of patients care from a multidisciplinary point
of view and actions accountability for both clinicians and patients. Electronic provision of
clinical information should enhance patient follow-up as well as facilitate future audit and
research studies.

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6. DEVELOPMENT
6.1 The project should have broad scope for the widest possible application.
Outcomes should have general implications (rather than be of local/regional
interest only).
As outlined earlier in this document, clinical data would be self-contained and therefore could
be shared with other systems. Moreover, identified trends in cleft clinical care could be
extrapolated to wider samples of the population and therefore are not only applicable to the
East of England. As a result, we could improve the provision of care for cleft patients.
6.2 Describe future plans for the database or register (to include prospects for
longer- term project sustainability/future alternative funding sources).
In line with the IT Trust policy for business continuity plans, software developments must be
well documented to allow proper and effective maintenance.
Secondly, proprietary software deployment will be kept to a minimum, thereby minimizing
licence fee expenditure.
Thirdly, development tools of choice have high levels of abstraction for when it comes to
dealing with software from different vendors. Likewise, the web development framework of
choice prioritizes agreed conventions over non-standard software arrangements, so
maintenance is kept to a minimum and it facilitates development irrespective of who designed
the system in the first instance.
Finally, as stated throughout this document, it is the philosophy of the project to allow
interoperability of heterogeneous systems through usage of standardized self-contained
clinical terminologies.
6.3 Project demonstrates support from, or a clear alignment with, a specialist
college or professional society or association.
A quote from NHS Connecting for Health TRUD (Technology Reference data Update Distribution)
Service: “SNOMED CT is the coding system approved by the NHS for recording clinical
information in the patient record. This is planned to replace Read. It is already used in
Choose and Book, Summary Care Record and a number of the hospital systems”.

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6.4 A condition of funding is that registers supply information about the project
to HQIP’s Directory of Registers and Clinical Databases.
If you have not already done so, you can add your details to the Directory using the
electronic form provided, which can be found on the HQIP website. Please click here.
THANK YOU.

Registers-2012-Funding-Proposal-Form

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