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.

CRANE collects information on these children at birth or at diagnosis, and into childhood. This includes information about the surgical treatments children have had, and how they are getting on in terms of their speech, hearing, growth, dental health and overall health. You can read a bit more about this in the sections below.

Parents and carers are asked for their full and informed consent at all stages and can withdraw their child from the database at any time. No identifiable information is included in reports.

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 Project Team at the CEU of the RCS.

3. Why is CRANE important as a clinical audit?

The CRANE Database collects birth, demographic, epidemiological and treatment information 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; 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. Which hospitals participate in the CRANE Database project?

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 project.

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.

Regional Cleft Centre / Managed Clinical Network Cleft Team (Administrative Unit)
Northern & Yorkshire Newcastle
Leeds
N.West / N.Wales Liverpool
Manchester
Trent Nottingham
West Midlands Birmingham
East Cambridge
North Thames Great Ormond Street Hospital (GOSH) / Chelmsford
The Spires Oxford / Salisbury
S.Wales / S.West Swansea
Bristol
South Thames Guy’s and St Thomas’ (GSTT)
Northern Ireland Belfast

5. 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.

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.

For more information about CRANE privacy policy and data sharing, please click here.

6. How can cleft teams implement National data opt-outs, coming into effect from the 31 March 2021?

The national data opt-out service allows patients to opt-out of their information being used for purposes other than their immediate clinical care; such as for audit and research purposes. All NHS organisations are required to be compliant with the national data opt-out policy.

The deadline for compliance with the national data-opt out policy has been further extended to 31 March 2021, in line with the extension of the Control of Patient Information (COPI) Notices.

Guidance on 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 in advance of the 31 March 2021 deadline extension. You can do this by contacting us.

7. 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 Database Information Leaflet – September 2020 – English

CRANE Database Data Linkage Leaflet – September 2020 – English 

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

8. 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 project, such as the Research Fellows, 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 project team Research Fellows 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.

9. 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).

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 ‘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 macrostamia. Nor patients for whom you cannot use a LAHSAL code to describe it, such as a child born with lateral clefts.

10. 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).

11. 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.

12. 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.