British Journal of Orthodontics, Vol. 26, No. 2, 152-157,
June 1999
© 1999 British Orthodontic Society
Do You CARE? A National Register for Cleft Lip and Palate Patients
Mark Hammond
Department of Orthodontics, Dudley Group & Hospitals NHS Trust, Corbett Hospital,
Vicarage Road, Stourbridge, West Midlands DY8 4JB, UK
Leo Stassen, F.R.C.S. (ED.), F.D.S., R.C.S., M.A., D.I.P., M.G.M.T. (O.U.)
Royal Hospital, Kayll Road, Sunderland SR4 7TP, UK
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Abstract
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The Cleft Palate Index and, more recently, the Craniofacial Anomalies Register-CARE
-have been in operation since 1982. This paper summarizes its development and plans
for the future. CARE is a multidisciplinary committee involving all specialities involved in the
treatment of this group of patients therefore it should and can be well placed to co-ordinate the
cleft data arising from these patients.
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Development
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CARE was instigated as a data registry for all specialities involved in cleft care. The founding
members of the Cleft Palate Index were elected at a Craniofacial Society meeting in 1980.
Representatives were elected from the four main Specialities involved in Cleft
care—Orthodontics, Plastic Surgery, Maxillofacial Surgery and Speech and Language
Therapy. Input forms were subsequently designed and the Central Cleft Palate Index was
established in 1982 with 30 participating units. Data was collected under the
auspices of the Craniofacial Society. CARE is a Standing committee of the Craniofacial Society.
Improvements to the methods of data collection were made and the group was renamed the
Craniofacial Anomalies Register CARE. Revised input forms were issued called
`CP1reg' to record birth details and `CP1surg' to record details of
operative procedures. Another arm of CARE has been concerned with the development of
standards. CARE has been funded by contributions from the Craniofacial Society, British
Orthodontic Society, British Association of Oral & Maxillofacial Surgery and the British
Association of Plastic Surgeons.
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Why Collect Data
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There are several important reasons why we should collect data.
- Research and audit—There are a small number of cleft patients born in
each Health District, so pooling of data will in the future produce a larger resource for research,
often making statistical significance greater. The emerging possibilities offered by clinical and
molecular genetics require a clearly defined family genetic pedigree, to assess effectiveness of
any new treatments.
- Audit—The recording of consecutive cases of a condition helps in
preparing a series of patients with similar cleft deformities and allows comparison for audit
purposes, in order to assess the effectiveness of treatment and set standards for the future.
- Purchasing and planning cleft services—Recording the incidence of birth
deformities allows for the planning and provision of services to cater for these children. It has
generally been regarded that the incidence of cleft subtypes in the United Kingdom is about
1:700
[Clinical Standards Advisory Group CSAG, 1998
].
It is important to have
accurate figures for the number of children requiring treatment to perform a population-based
needs assessment.
- CARE records cleft registrations against the hospitals and cleft teams that treat these cases. It
therefore has information about cleft teams and workload that is useful in planning training
centres for future cleft team members.
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How CARE Works
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The `Caretaker' registers the patient on the `registration form' with
the CARE database. Caretakers are either a member of a Cleft team at the `hub' or
may be at a `spoke' to the Cleft team. This wide coverage helps to ensure that as
many cleft babies are registered as possible
(see Figure 1).
Children with clefts are usually
registered in the first year of life. The registration form is designed to collect those details usually
obtained at an early consultation with the parents. However, the peak registrations of cleft
patients is not for 3-4 years, as some of the less obvious cleft types are at first not noticed or
diagnosed, and may only become apparent when speech problems develop. The registration form
is a 4-page `no carbon required' form. One copy is sent to the CARE co-ordinator
to place the patient on the CARE database; another goes to the Regional co-ordinator, and one
copy is retained in the patient's hospital notes or retained by the Caretaker for their own
records. The last sheet is given to the parents so that they can understand and know what
information is held on the database. It is also hoped that the parents will contact CARE with any
amendments if the information changes.
A network of Regional co-ordinators has been established by Iain Hathorn. The Regional
co-ordinator's role is two-fold. First, they have local knowledge of the cleft teams
operating in their Region, and act as a link between the CARE committee and the
Caretaker's and cleft teams. Secondly, they also act as `motivators' to
maintain a flow of registrations from the Cleft teams in their Region. Estimates of the number of
potential cleft subtypes, in each Region, are calculated from the number of births in each region
(data supplied by ONS). Caretakers and regional co-ordinators have access to web pages on the
internet. These pages show the estimated number of cleft sub-types and the number of patients
actually registered with CARE both by Region. The Regional co-ordinator can then assess how
completely the data is being collected in their Region. The information provided on the Internet
is anonymised and simply quantitative.
The CARE committee is composed of one member from each of the main Specialities involved
in the management of these patients,
(Figure 2).
Another member is elected from the
`Other Specialities' section of the Craniofacial Society. A further member is
elected to give advice in the field of clinical genetics. Election of the co-ordinator revolves
between the main Specialities, over an agreed term of office. The Deputy Coordinator becomes
the Coordinator in due course.
The CARE co-ordinator oversees the operation of the regional co-ordinators and maintains the
CARE database with the help of an elected committee. The Co-ordinator liaises with ONS
through their BINOCAR initiative (British Isles Network of Congenital Anomaly Registers) to
validate the data and produce more accurate data for ONS to disseminate. The CARE
co-ordinator receives requests for data. At the inception of CARE, a confidentiality barrier was
used centrally so that the information released would only be with the approval of the local
Caretaker and team. A request for data would be forwarded to the units where patient records are
held to obtain their approval before data is released. This method of data output was thought to
be most appropriate to protect locally sensitive information and obtain the co-operation of cleft
teams. Nearly all units now find this unnecessary and have withdrawn the need for a
confidentiality barrier. However, some University departments who have been recording
information about patients still like to protect this data and have expressed some reservations
about the availability of their data.
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The Data Collected So Far
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CARE at present collects data for England and Wales. CARE has been largely concerned with
descriptive data. This was seen as a useful first step in the epidemiology of this condition to
provide an overview of clefts. The original intention in collecting data was that it would act as a
signpost to locate further patient details, rather than be an exhaustive data set. Consequently, the
early datasets were minimal. They collected data on cleft type, Hospital number and the presence
or absence of `other abnormalities'. In an increasingly busy working life it has
become important to balance the needs for a useful dataset against the time involved in
completing the registration form and entering the data on the database. The form now in use is
shown in
Figure 3.
Looking to the future multicentre audit may well involve European centres
more frequently. We will liaise with European Biomed and ensure our datasets are compatible
with theirs.
The value of a national database is to provide descriptive data for cleft teams, to show changes in
the incidence of the condition and to maintain surveillance for increases in the incidence of
clefting. To help ensure the accuracy of this data, cases registered since 1995 are
being validated against data held by the Office for National Statistics (ONS).
CARE has been more successful in recording cleft cases then ONS (Williamson personal
communication)
Figure 4.
The true number of cases being seen is important to record as the
planning and provision of services by Public Health departments is usually based around ONS
data. Recording data of this type is beset with difficulties. Inaccuracies may arise from simply
being unable to read someone's handwriting, inaccurate data input and, in many cases, the
Caretaker thinking they have registered a patient when they have not. The only way to improve
the accuracy of the data is to regularly send lists of the patients registered on the database
together with their details, so that the local team can verify the accuracy of the data and correct
any mistakes.
Form CP1surg tried to capture information about operative procedures and dates of operations.
However, the infinite number of variations on the basic operative procedures make it difficult to
compare one centre's operative procedure with another. In future, it is hoped to record
information that will be more useful for audit. Therefore, we will still record dates of the primary
lip and palate operations, and some secondary procedures, but will not record details of operative
procedures. This should allow us to produce lists of consecutive operations for retrospective
audit purposes. It is increasingly important to record outcome audit data in addition to
registration data to provide useful information for Cleft teams. This is likely to be a main theme
for CARE in future years.
Requests for data from CARE are encouraged. Data can be despatched quickly if only an
anonymised response is required. If data are likely to identify patients or a particular Cleft team,
then the request is either discussed by the CARE committee or is forwarded to the centres
involved to ask their permission to release the data.
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How Complete is the Data?
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The committee at CARE appreciates that the database is not complete, because not all patients
are registered. Voluntary reporting of clefts is not ideal and until reporting becomes mandatory
the database is unlikely to hold all the patients. Therefore, other ways of obtaining patient details
are being sought to remedy this. Details of these patients can then be transferred to the CARE
database. Two ways used are:
- Other databases: ascertainment of congenital anomalies arose from the Thalidomide
disaster of the 1960s. However, today only in Denmark is the reporting of facial
clefts compulsory, where, the incidence is reported to be 1:529 live born infants in 1981
(Jensen et al.1988).
The Office for National Statistics formed on April 1st 1996 by the merger of the
Central Statistical Office, and the Office for Population Censuses and Surveys, is a government
agency for compiling, analysing, and disseminating many of the United Kingdom's
economic, social, and demographic statistics. It collects congenital anomaly statistics for England
and Wales on the National Congenital Anomalies System register. ONS receives data about
congenital malformations by completion of form SD56 locally at the place of birth. Form SD56
is completed mainly by Physicians and Midwives, with data supplemented by reports from
Neonatal and Special Care Baby Units. Community Trusts forward this information to ONS on
behalf of the District Health Authorities. Reporting anomalies through this system is again
voluntary. Data is stored using the International Statistical Classification of Diseases and Related
health Problems, 1992 (ICD 10). Congenital Anomaly Statistics notifications are
published every two years by ONS. The most recent report covers the years 1995
and 1996. ONS has formed the BINOCAR initiative (British Isles Network of
Congenital Anomaly Registers) to pool data from registers such as CARE that exist throughout
the Country.
The Office for National Statistics contributes information to the International Clearing House for
Birth Defects Monitoring Systems. This monitoring programme, based in Rome, was started in
1964 and was instigated as a surveillance system to record congenital anomalies.
Significant changes in incidence of a congenital anomaly are reported to the local District Health
Authority. Significant changes do not only occur because a rise in birth incidence but also
through better diagnosis and reporting as may occur when a new Midwife or Physician starts to
work in an area. It is therefore important that ONS collaborates with others to ensure the data is
accurate. ONS also contributes data to the European Registration of Congenital Anomalies
Register (EUROCAT).
In the United Kingdom reporting is on a voluntary basis so it is important for CARE to liaise
with ONS to improve the accuracy of the data. The data collected by ONS is not sufficiently
detailed for prospective clinical audit and research so CARE data and ONS data should be used
to complement each other.
- The second method is to obtain data held by the Regional outposts of the NHS relating to
operation codes for primary lip and palate surgery. Outposts hold data on hospital number, date
of birth, district code, and type of operation. The data relating to operation codes for primary lip
and palate is sourced. Details of patients who appear to have had primary repairs are noted and
the local team is contacted for further details so they can be entered on the database. However,
not all Regional outposts are able to supply this data.
Complete registration of all cleft patients is unlikely to occur unless:
- Reporting is made compulsory through legislation.
- Data clerks are available to help collect data.
- Efficient forms are used that are not too elaborate and can be completed accurately without
ambiguity. Some centres have already combined their basic stationery, for example discharge
letters, with the details required by CARE.
- Cleft teams are confident that the information will not be used to undermine their work. This
requires strict protocols for data input and output.
- Some units will require help in setting up systems to capture the data.
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A National Register for Outcome Data
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It is hoped that CARE, following wide discussion, can record outcome audit data and put in place
a mechanism for external audit. Consequently, CARE will become a national register of both
cleft patients and their treatment outcomes. It is important to know what outcomes measures are
being achieved to set appropriate standards and aid protocol setting for the future. CARE will
review with Cleft teams the outcome data and help set up regular reviews of this data to improve
treatment in all centres. These standards should be tested by regular externally assessed audit
(Williams & Markus, 1998).
CARE will discuss with cleft teams and purchasers
what are the appropriate outcome measures to record.
National registers already exist for many clinical conditions, for example, the United Kingdom
Children's Cancer Study Group (UKCCSG), which provides support to programmes of
research. The UKCCSG is fed data through a network of 22 regional assistants. In some clinical
conditions the outcome is clear-cut, for instance survival times following diagnosis. Registers
can record theses survival times and then put in place reviews of services not meeting the
currently acceptable standards. Clearly, in the treatment of cleft patients the outcomes are more
complex and discussions need to be held to determine the outcome criteria.
Recent reforms in the National Health Service following the consultative document `The
new NHS—Commissioning Specialised Services' and the White Paper
`The New NHS' clearly point to new commissioning mechanisms for specialist
services, such as Cleft Lip & Palate, through the Regional Specialised Commissioning Groups
(RSCG). The RCSG will set targets for cleft teams in the future. To set these targets they will
need comparative data. CARE should play a vital role in collecting and disseminating this data
because of its multidisciplinary nature. Comparative information and target setting (contracting)
will be in the public domain as it is with other services. For example, data comparing survival
times following cancer diagnosis and treatment are already collected, and are being used to
compare and improve teams. Comparative data and `league tables' already exist in
Cleft services, for instance, those in Eurocleft and the CSAG reports. These may be anonymized,
but they do show the range of results that are being achieved. Purchasers will be looking to
improve the work of all cleft teams and especially the less good, to deliver quality treatment. The
RSCG will require information on audit and cleft teams to help in planning services.
Another arm of the recent reforms is performance monitoring and this is to be introduced into
clinical areas through the evidence-based National Service Frameworks, inspired by the
Calman-Hine Cancer Report 1995. The consultation document outlines standards
of service and availability of services. Information will be collected and disseminated about
individual performances. Medical directors will be charged with ensuring that the trusts data
meets nationally agreed national standards. The National Institute for Clinical Excellence (NICE)
will be set up to provide information about both clinical and cost effectiveness. It will produce
and disseminate clinical guidelines with linked information on clinical audit and will bring
together work currently undertaken by different organisations. CARE is well placed to present
information and offer advice to these new agencies.
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The Future
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Following the publication of the CSAG report and discussions with cleft teams CARE wishes to
pursue the following.
- The strength of CARE is in its network of participants that cover the majority of England
and
Wales. It is hoped to encourage those centres not presently contributing to CARE to enter CARE
data in future.
- The Craniofacial Society contributes to the funding of CARE but has no role in its
management. A report is sent to the funding organizations annually. If data are to be collected
more accurately than at present this will involve greater resources. We will lobby the government
through groups such as the CSAG Implementation Group to fund CARE's activities
through contracts with the RSCG. It may then be appropriate to consider developing CARE as a
separate identity, independent of the Craniofacial Society, with a new constitution.
- It is hoped that CARE will act as an umbrella organisation for the collection of cleft lip
and palate data for the United Kingdom, making this information available to all concerned with
the
care of these patients. We are collaborating with Welsh, Northern Ireland and Scottish (SCALP)
databases to ensure the datasets are comparable and that data is exchangeable.
- Until reporting of clefts becomes compulsory, CARE will work with the Office for
National
Statistics to produce as accurate incidence rates of cleft types as possible. We will lobby the
government to make recording of congenital anomalies compulsory.
- Output from any database is essential, otherwise the data are redundant. CARE will
encourage
greater use of the data. A World Wide Web site has been established to publicise the work of
CARE and publish a limited subset of data for Cleft teams information. This can be viewed at
`www.cfsgb.org.uk/care/'. It is hoped to publish more data
in the future with the
approval of the contributing centres and when the data is acceptably accurate.
- CARE will prompt for the collection of clinical records, so that regular externally
assessed
audit can be accomplished more readily. How external audit is to be organized is subject to
discussion. However, if the necessary records are available it should make the work easier. We
will use the recommendations of the Royal College 1995 as a basis for record
keeping. Form CP1surg will be redrafted to record basic treatment details and as a prompt for
record collection.
- Perhaps the greatest challenge for the future is recording outcome data in a meaningful
and
accurate way. The establishment of a National Register of outcome data, we hope, will be a
priority for cleft teams. This has to be done in a non threatening way to ensure compliance. It is
hoped that the Implementation Group will see this as a priority and recommend funding a
multidisciplinary group such as CARE through contracting to carry this out.
The CARE database is not a clinical management tool for individual units. Software of this
nature already exists. CARE does not have the resources to develop and field test such a
program. Each centre will have a different wish for properties in such a software program which
makes the development of such a tool expensive. Obviously, the core datasets in such a program
should be compatible with CARE to avoid double entry of data and CARE is happy to work with
software programmers to achieve this.
The committee looks forward to working with cleft teams to improve data collection in the
future. Data collection is not easy! The committee appreciates everyone's time and
patience to collect the data and ensure it is accurate. Please return forms to us steadily throughout
the year. On our part we will send you information that is on the database regularly.
If you are interested in joining CARE please contact Mark Hammond
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References
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Clinical Standards Advisory Group (1998)
Cleft Lip and/or Palate
London, The Stationery Office.
HMSO (1995)
A Policy Framework for Commissioning Cancer Services. Report of the Chief Medical Officers
of England and Wales,
London, The Stationery Office.
HMSO (1998)
Congenital Anomaly Statistics Notifications Series MB3 No. 11 (1998). Office for National
Statistics.
London, The Stationery Office.
Jensen, B. L., Kreiborg, S., Dahl, E. and Fogh-Anderson, P. (1988)
Cleft lip palate in Denmark, (1976)-(1981). Epidemiology, variability, and early somatic
development.Cleft Palate Journal
, 25
, 258
–269.[Medline]
Royal College of Surgeons of England Surgical Audit Unit Cleft Lip and Palate Steering Group
(1995)
Minimum Standards for the Care of Children with Clefts of the Lip and/or Palate.
Williams, J. J. and Markus, A. F. (1998)
Cleft Care: life after CSAG, Editorial,British Journal of Oral and Maxillofacial Surgery
, 36
, 81
–83.
This article has been cited by other articles:
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R. R. J. Cousley and D. Roberts-Harry
An Audit of the Yorkshire Regional Cleft Database
J. Orthod.,
December 1, 2000;
27(4):
319 - 322.
[Abstract]
[Full Text]
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Abstract
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