The Cleft Registry and Audit NEtwork (CRANE) Database collects information about all children born with cleft lip and/or cleft palate in England, Scotland, Wales and Northern Ireland.
This database was set up by the Department of Health in 2000 and is funded by the National Health Service through the Specialist Service Commissioners, who have responsibility for the delivery of care to children born with cleft lip and palate in England and Wales.
CRANE is a national clinical audit run by a multi-disciplinary team the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons (RCS) of England. We are commissioned by the National Health Service (NHS), through a Specialised Commissioning Group (SCG).
The Cleft Development Group (CDG) has the overall responsibility for steering the work of the CRANE Database – on behalf of NHS England – and has representation from patient groups, clinicians and commissioners. It includes members of the Craniofacial Society of Great Britain and Ireland (CFSGBI) and the Cleft Lip & Palate Association (CLAPA).
Day to day running of the CRANE Database is managed by a team at the CEU of the RCS.
The CRANE Database collects registry information from birth – including demographic, epidemiological and treatment information for on all children born in England, Scotland, Wales and Northern Ireland with a cleft lip and/or palate. This allows us to monitor the incidence of clefting among children.
CRANE also collects audit information, with explicit consent, which allows us to assess and report the quality of care and clinical management of patients with clefts; and link to other national databases to assess the impact of cleft care on patients’ outcomes.
Yes, all services providing Cleft care are required to submit information to the CRANE Database.
The database is commissioned to produce both annual and preliminary reports , and contributes to the quarterly Specialised Services Quality (SSQ) Dashboard. CRANE data analysis is also reported to the national Cleft Development Group who use the information to drive quality services and interrogate variation.
All patient data held is done so in accordance with the General Data Protection Regulation (GDPR) and in line with Department of Health guidelines.
All NHS cleft services in England, Scotland, Wales and Northern Ireland providing specialist support and clinical care to children born with cleft lip and/or palate and their families, from diagnosis to adulthood, participate in the CRANE Database.
NHS cleft services are centralised. So not all Hospitals / Trusts have a cleft service.
If a Hospital / Trust does not have a cleft service, any baby born there with a cleft will be referred to one of the cleft services below. They will be responsible for these cases’ cleft care and the data entry for these cases.
| Cleft Services in the UK | Host Hospital(s) |
| Newcastle | Newcastle Hospitals NHS Foundation Trust |
| Leeds | Leeds Teaching Hospitals NHS Trust |
| Liverpool* | Liverpool Alder Hey Children’s Hospital |
| Manchester* | Royal Manchester Children’s Hospital |
| Trent | Nottingham University Hospitals NHS Foundation Trust |
| West Midlands | Birmingham Children’s Hospital |
| Cleft Net East | Cambridge University Hospitals NHS Foundation Trust |
| North Thames | Great Ormond Street Hospital (GOSH), jointly with
Broomfield Hospital in Essex |
| The Spires | Salisbury District Hospital, jointly with
John Radcliffe Hospital, Oxford |
| South Wales | Swansea Bay University Health Board |
| South West | University Hospitals Bristol NHS Foundation Trust |
| Evelina London | Guy’s and St Thomas’ NHS Foundation Trust |
| Northern Ireland | Royal Belfast Hospital for Sick Children |
| Scotland | Royal Hospital for Sick Children, Glasgow |
*The North West, Isle of Man and North Wales Cleft Lip and Palate Network
More information on Cleft Teams can be found on the Cleft Lip & Palate Association (CLAPA) website https://www.clapa.com/treatment/nhs-cleft-teams/
The CRANE Database’s patient data collection is carried out in accordance with the Data Protection Act 2018 and the General Data Protection Regulation (GDPR).
One of the key functions of the CRANE Database is to serve as a registry for all babies born with a cleft, within NHS hospitals and private practices. A minimum notification dataset is collected for all children for this registration purpose with Section 251 approval.
However parents need to provide explicit consent for their child’s data on outcomes to be collected by their local cleft team and added to the CRANE Database – for the audit function of CRANE.
Please visit the following pages for more information about CRANE data flows and privacy policy.
The national data opt-out service allows patients to opt-out of their confidential patient information being used for purposes other than their immediate clinical care. All NHS organisations are required to be compliant with the national data opt-out policy.
Guidance on the deadline for compliance and how to comply is provided on the NHS website: https://digital.nhs.uk/services/national-data-opt-out/operational-policy-guidance-document/compliance-with-the-national-data-opt-out
For national clinical audits such as the CRANE, where families consent to the audit function of CRANE, and registry information is collected with Section 251 approval:
1. Cleft services are advised to continue to verify the consent status of patients, to be able to collect both registry and audit (outcomes) information – as detailed in our information leaflets.
2. An important consideration for cleft services is to remember that CRANE also has a registry function.
A flow diagram providing a visual representation of the information above is available here.
If you would like further information on how cleft services can ensure they are compliant with the national data opt-out, specifically with regard to the CRANE, please do contact us with your questions.
The CRANE Database accepts informed consent – for data collection and linkage – provided to cleft teams via any suitable written or electronic means. So long as the method is in compliance with cleft teams’ own Hospital’s / Trust’s Information Governance’s policies.
For more information about CRANE consent – as per our leaflets – and the ICO’s guidance on ‘What is valid consent?’ please visit the links below:
Informed consent can be taken at any time after the birth of a child. We appreciate that each cleft service will have a different processes in place to do this.
We have been asked whether or not it is too late to take consent once the child is no longer an infant. For example, when the child turns 5 years of age and attends five-year clinics.
It is not too late to allow families to make an informed decision at this point in time – or at any other point in time. There is no statute of limitations on the age at which consent is taken.
We have also been asked whether or not consent can be sought at a second point in time, if previously declined by the family.
Having considered the ethics of asking for consent again, when a family has declined previously, with a steer from our Data Protection Officer, we advise that: If, after full discussion, a family decline to consent to CRANE audit data collection further discussion could be perceived as coercive. We advise that, once a decision is made, unless the family approach themselves having changed their mind then we should respect the original decision.
When a child is adopted there are two possible ways in which you can manage their CRANE record.
Update the existing CRANE record with the child’s new NHS number and name. This prevents duplicate records being created and means you do not need to transfer data that could lead to potential errors or lost information. The field ‘surname at birth (if different)’ can be entered (optional) and the child’s old NHS number can be documented in the notes section, if appropriate.
Create a new record for the child with their new NHS number and name. This may be appropriate when the new parents/guardians are particularly cautious about the existence of records created from their child’s previous identity. If you decide to use this option please ensure that you transfer all of the previous registry data from the child’s original record (date of birth, diagnosis time, cleft description etc…) to the new record. Specifically, all the information flagged (as notification data) by a red asterisk in our data dictionary. There is no data within this that could identify a child or their birth parents. The only item that could identify a child is if ‘surname at birth (if different)’ is completed. If there is parental concern about this data field we suggest that you leave it blank. If outcome data has been recorded previously then this should also be transferred. You will then need to contact the CRANE project team and ask them to delete the child’s original CRANE record and perform the final checks.
If the child is moving to a new region we recommend that the original record is ‘pushed’ to the new team first and then the new team update the record using the steps outlined above.
When a consented child is adopted, the previously obtained consent from the birth parents still stands. This has been confirmed by the Data Protection Officer at the Royal College of Surgeons of England. The adoptive parents have the power to opt out and withdraw consent, but they would need to initiate this. Please visit the ICO website for more information relating to the following statement: “The right to erasure does not necessarily have to be exercised by the same person as provided the original consent. If consent was originally provided by a holder of parental responsibility this does not mean that they will also have to request the erasure. If the data subject is no longer a child, or if they are now competent to exercise their rights on their own behalf then you should usually accept their request for erasure without needing to involve the parent (or holder of parental responsibility).”
If the adoptive parents decide to withdraw consent then you would need to amend the record accordingly, keeping all the registry data and deleting any outcome data entered.
Only people involved in providing children’s cleft care, and a small number of staff who are directly involved in the CRANE Database, such as the analysts, and administrative members of Crown Informatics Ltd, can see all the details of children’s records on the CRANE Database.
Local cleft teams, involved in providing children’s cleft care, can only access the data of their patients via the secure online CRANE IT system. For more information about this see the CRANE privacy policy.
CRANE team analysts access your child’s information for analysis purposes, to draft audit reports.
Members of Crown Informatics Ltd team manage the CRANE online IT system.
All the people who can access children’s records have signed contracts that make sure information about your child remains confidential. For more information about how children’s data is kept confidential, please view our information leaflets.
The CRANE Database records data on:
Children born with cleft lip (CL), cleft palate (CP), unilateral cleft lip and palate (UCLP), and bilateral cleft lip and palate (BCLP).
We also record data for children born with submucous cleft palates (SMCP). We do not derive SMCP classification from the LAHSAL code. We know whether or not a child has a SMCP based on the ‘yes’/’no’ data item completed by cleft teams. SMCP cases are included in CRANE’s registration data, but excluded when reporting outcomes. This is because they are a heterogeneous group, do not have typical care, and are rarely audited.
The CRANE Database does not record data on patients diagnosed with Tessier cleft types.
Patients born with a submucous cleft palate (SMCP) are recorded in the CRANE Database.
Children born with a submucous cleft palate may have classic signs such as a bifid uvula, a blue line along the palate (also known as ‘zona pellucida’ which occurs when the muscles of the palate do not cross the midline and the palate in the middle is a thin layer made of mucosa only) and/or a notch in the hard palate. Children may also have an occult SMCP, a condition where there are no overt clinical signs (no bifidity to the uvula, no blue line / zona pellucida in the palatal midline and/or no hard palate notch) but still have symptoms of nasal regurgitation or altered speech.
So that we can accurately record the number – of these patients, we ask that you please tick the box that says SMCP in the cleft details section of the database (as per Data Dictionary).
This means that CRANE can include them in registry information, so that we can accurately report the number of these cases. This is helpful in future service planning and commissioning. Currently, children with SMCP are excluded from indicator reporting –for example, the timing of diagnosis – and outcome indicator reporting in Annual Reports and SSQ Dashboards as the presentation is highly variable and as such not appropriate for auditing with children affected by overt clefting (such exclusion has Cleft Development Group approval). However as more data is collected on this cohort of children this decision may be revisited, though any future audit would be stratified (separate) for SMCP.
For children with a bifid uvula, the guidance depends on whether the bifid uvula occurs as part of a possible diagnosis of submucous cleft palate or if this has occurred in isolation.
Some children can have a bifid uvula without having any problems with their speech or evidence of nasal regurgitation. These children are likely to be discharged from cleft services once a speech assessment has taken place and there are no concerns regarding cleft type articulation or resonance. If these children are added to the database because the diagnosis is unclear, and a decision is made subsequently to discharged the patient from your service following confirmation of ‘normal’ speech / absence of non-cleft speech errors, a request for them to be removed from the database can be made. For patients with a bifid uvula and symptoms/signs to suggest a submucous cleft palate, please record these by ticking the SMCP box in the cleft details section of the database. This is important for CRANE to maintain an accurate record of registrations.
For further updates relating to children born with a SMCP please click here.
Patients born with an atypical facial cleft (Tessier cleft) are not currently considered to be within the remit of the CRANE audit. Atypical facial clefts are extremely rare congenital anomalies that often require different management, although this may still be within the cleft service.
The 15 different types of cleft described by Tessier are numbered 0 to 14 around the orbit and can be divided into four groups based on their position: midline clefts, paramedian clefts, orbital clefts and lateral clefts. Macrostomia (number 7, lateral cleft) is the most common of the atypical cleft types.
Please only include patients born with a cleft lip and/or palate or submucous cleft palate in the CRANE Database.
One of the key functions of the CRANE Database is to serve as a registry for all babies born with a cleft, within NHS hospitals and private practices. Both should be registered in CRANE.
Specifically, the following children should be registered in the CRANE Database:
Registration of babies born in both NHS and private practices in England, Scotland, Wales and Northern Ireland improves our estimation of incidence of cleft and our ability to monitor the epidemiology of oro-nasal clefting in these countries.
Where these children – registered in CRANE – go on to receive care services from one of the 15 NHS centralised cleft teams (as listed in CRANE Database Annual Reports), at any stage of their care journey, this outcome data should also be recorded in the CRANE Database (with the appropriate consent).
Patients who are not resident in England, Scotland, Wales and Northern Ireland, should not be registered in the CRANE Database.
Specifically, the following children should not be registered in the CRANE Database, nor have outcome data collected in CRANE:
The current guidance by the Cleft Development Group is that patients from abroad are not registered in CRANE. Their treatment pathway started elsewhere and have not been accessing our health care system from birth. This is particularly important in the context of evaluating the burden on cleft team services.
If you have any other questions about the CRANE Database that are not answered by our information leaflets, or reports, please contact us.
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