Frequently asked questions for professionals

1. What is the CRANE Database?

The Cleft Registry and Audit NEtwork (CRANE) Database collects information about all children born with cleft lip and/or cleft palate in England, 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.

https://www.england.nhs.uk/wp-content/uploads/2018/08/Cleft-lip-and-or-palate-services-including-non-cleft-velopharyngeal-dysfunction-all-ages.pdf

2. Who is running the CRANE Database?

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.

3. Why is CRANE important as a registry and national clinical audit?

The CRANE Database collects registry information from birth – including demographic, epidemiological and treatment information for on all children born in England, 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.

4. Does my hospital have to participate in CRANE? Is it mandatory?

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.

5. Which hospitals participate in the CRANE Database registry and national clinical audit?

All NHS cleft services in England, 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 England, Wales and Northern Ireland 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

*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/

6. How are patient data being collected?

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.

7. How can cleft teams implement National data opt-outs, coming into effect from 2022?

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, cleft teams are advised to:

  • Change patients’ consent status to ‘No’ if the parents/patient chooses to opt-out of their information being used for audit purposes.

Remember that CRANE also has a registry function as well. Therefore there is a minimum dataset that CRANE is allowed to collect, on all children born with a cleft, under our Section 251 approval. For a reminder of these data items please consult the CRANE Data Dictionary found in the Resources section of this website.

If you would like further information on how cleft teams can ensure they are compliant with the national data opt-out, specifically with regard to the CRANE, please do contact us with your questions.

8. Is possible for cleft teams to accept consent via electronic means?

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:

CRANE Information Leaflets and Parental Consent Forms

https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/consent/what-is-valid-consent/

9. When can consent be taken, and can it be requested on a second occasion?

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.

10. Who can access the data stored in the CRANE Database?

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.

11. What types of cleft lip and/or cleft palate are recorded in the CRANE Database?

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.

12. Are patients born with a submucous cleft palate or bifid uvula recorded on the CRANE Database?

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 submucous nature of these patients we ask that you please tick the box that says SMCP in the cleft details section of the database. This means that CRANE can including them in registry information, but then appropriately exclude this cohort from outcome reporting (according to current Cleft Development Group guidance, which may be refined in future).

For children with a bifid uvula the guidance depends on if 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 / 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.

13. Do I need to record patients with a Tessier cleft on the CRANE Database?

Patients born with a Tessier cleft are not currently considered to be within the remit of the CRANE audit. Only patients born with a cleft lip and/or palate or submucous cleft palate need to be included.

14. Should private care patients be included/excluded from being registered on 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:

  • Babies born in UK private practices, and receiving cleft care services either from NHS services or from private cleft care providers.
  • Babies born in NHS hospitals and remaining under the care of NHS services. This includes children who also receive some private cleft care treatment, in addition to the NHS care treatment.

Registration of babies born in both NHS and private practices in England, 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).

15. Should families not based in England, Wales and Northern Ireland be included/excluded from being registered on the CRANE Database?

Patients who are not resident in England, 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:

  • Babies from parents not based in the UK, born with a cleft in a UK hospital who then returned to their home country. This is because CRANE is a registry for babies from families residing in England, Wales and Northern Ireland.
  • Babies born outside of the UK with a cleft and who travel to the UK to receive cleft care services, from either the NHS or private cleft care providers, then return to their home country after their cleft care. Recording of this information would distort the estimation of incidence of cleft and evaluation of cleft care services in England, Wales and Northern Ireland.

Note: Where we have made reference to the United Kingdom (UK), in the text above for simplicity, we are referring to England, Wales and Northern Ireland. As these are the countries currently submitting data to the CRANE Database.

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.

16. I have a question that is not answered in the FAQs. How can I find out more?

If you have any other questions about the CRANE Database that are not answered by our information leaflets, or reports, please contact us.