Frequently asked questions (FAQs)
- which patients are included in the audit?
- what pathology data do I complete if a patient has both an invasive carcinoma and DCIS?
- is participation in the audit mandatory?
- what are the benefits of participating?
- how do I register for the audit?
- what is my national code and where can I find it?
- how do I add other users?
- what are the key documents that I need?
- do I have to use the data sheets?
- where can I find more detailed information on the dataset?
- is consent needed to participate in the audit?
- what do I do with the consent forms once they have been signed?
- is consent needed for receipt of follow-up questionnaires or is this done on an 'opt out' basis?
- who will have access to the data produced by the prospective study?
- where will the data be stored and how will it be secured?
- how will data be protected?
- how long will the data be stored?
- at the end of this period how will the data be disposed?
- if a patient has a wide local excision and then goes on to have a mastectomy due to the margins not being large enough, should the path be from the wide local excision, from the mastectomy or from both?
- what should the grading be based upon?
- what node data should be recorded?
- What is the final deadline for prospective data submission?
- How should the data be entered if a patient has been offered delayed reconstruction but is in the process of weighing up their options?
All women (aged 16 or over) undergoing a unilateral mastectomy and / or a unilateral breast reconstruction operation for breast cancer between January and September 2008 are included in the Audit. This includes patients treated in both the NHS and independent sector.
Prophylactic mastectomy procedures (unilateral or bilateral) and reconstruction following this are not included in the audit.
Bilateral mastectomies performed to treat bilateral cancers are not included in the audit.
Previous breast-conserving surgery (on either side) and or simultaneous symmetrisation procedures do not exclude them from the audit.
Back to top- What pathology data do I complete if a patient has both an invasive carcinoma and ductil carcinoma in situ (DCIS)?
If any patient has both invasive carcinoma and DCIS, please provide the invasive tumour details. We require information on the 'prognostically significant' invasive component; this will be used to determine prognostic factors rather than why the mastectomy was performed.
Back to topThe audit has been funded by the Healthcare Commission and submission of data is one of the indicators in the Healthcare Commission's Annual Health Check.
BUPA will also be using participation as a quality measure in its accreditation of private hospitals that provide breast cancer surgery.
Back to topThe audit will:
- provide accurate and up-to-date information on the range of mastectomy and reconstructive services available
- identify barriers to reconstruction, whether in terms of provision or patient access
- measure patient satisfaction with the care pathway and those outcomes attained
- quantify such outcomes to better inform patients and aid reconstructive decision making
- provide comparative local, regional and national data on practice and outcomes
- directly support the cancer measures element of the Peer Review process
- satisfy GMC requirements for performance assessment and revalidation expand the evidence base in this area and inform future reconstructive guidelines.
Registration is easy and can be completed by downloading and returning one form, the data user certificate.
On the data user certificate you will have to decide locally who will be the clinical lead, the primary contact and how many users will be able to enter or change data (editors) or simply look at the data entered (readers).
You also need to enter the name of your Trust / hospital and its unique national 5 digit code. The code can be obtained from http://nww.connectingforhealth.nhs.uk/ods/enquiries or by calling the project team on 0113 2547139.
All these details need to be written out on the certificate and signed off by the Caldicott Guardian.
The certificate should then be faxed to 0113 2547299 or emailed to mbr@ic.nhs.uk. Once you have sent the certificate you should receive a confirmation email and, shortly afterwards, your log in details.
Once you have received your log in details, you will need to respond to the email agreeing the terms and conditions of usage. Following this you will need to call the IT helpdesk (0845 300 6016 option 2) to obtain your password. You will then be registered for the audit and will be able to upload data via the internet portal.
A registration checklist document is now available for download, outlining the procedure for successful registration.
Back to topThe national code is a mandatory 5 digit code that needs to be included in the data user certificate and is unique to every hospital and private unit in the UK. It can be obtained on the website www.nhs.uk/nacs or by calling the project team on 020 7832 4167.
Back to topComplete a data user certificate. You do not need to complete the primary and clinical contact details again. This needs to be authorised by your Caldecott Guardian and faxed back to 020 7832 4199.
Back to topThere are several key documents, the most important of which is the data user certificate. In order to participate successfully in the audit the data user certificate needs to be completed for registration purposes.
Once registered, you will need:
1. the datasheet for patients undergoing mastectomy (with or without immediate reconstruction)
2. the datasheet for patients undergoing delayed reconstruction
3. the three distinct patient information sheets (with enclosed consent forms).
The datasheets are designed to be printed and used to collect in-patient prospective data on all patients at appropriate points in the patient pathway. Their structure exactly matches the online web-based IT system to allow easy data transcription.
The information sheets (mastectomy, immediate reconstruction and delayed reconstruction versions) are designed to help inform and consent patients for the patient-reported outcomes study. They also include a helpline number (020 7869 6619) if patients or clinicians wish further information about this questionnaire-based study.
Back to topNo. The data sheets have been provided as an aid to collecting data. You may also choose to enter data directly onto the system or via a third party system (through CSV upload). The documents are available in word and pdf format to allow you to either use them as they are or amend them to incorporate any additional items you may wish to collect locally.
Back to topA full data manual has been produced. This gives more detailed explanations on each data item and where relevant, the source and references.
Back to topThe audit has exemption from Section 60 of the Health & Social Care act which has been granted by the Patient Information Advisory Group (PIAG). This PIAG coverage means that explicit consent is not required to send patient data for the Prospective audit to the Information Centre.
The data must be submitted via the web based audit IT system which is only accessible with a secure log in and password. Only users who are authorised by their Trust Caldicott Guardian (or head of Information Governance in private hospitals) will have access to the system. This authorisation is to ensure that only appropriate personnel have access to the system.
The project also includes a patient reported outcomes follow up study. The Information Centre will ensure that up to date addresses and mortality status for each patient are verified using the National Strategic Tracing Service.
To enable us to have access to this personal information, we ask that each eligible patient is given an information sheet and consent form. We are asking them to consent to us sending them a questionnaire. On receipt, if they do not wish to take part then they may then decide not to complete or return it.
The consent form does not need to be signed by anyone in the unit but a record of whether they have consented should be made on the datasheet before entry into the audit IT system. The consent form should then be kept locally.
Back to topOnce the consent forms have been signed they should be kept locally at a Trust/Unit level. It is the responsibility of the Trust/Unit to keep the consent forms in a safe and easily accessible location (either centrally or within the patients' notes) to enable future access if required.
Back to topEvery patient needs to be asked for their written consent to receive questionnaires at their home address. They do not need to be consented for you to collect their clinical data-this is done on an opt-out basis.
Back to topData analysis will be undertaken by the Clinical Effectiveness Unit (CEU) of the Royal College of Surgeons. Data will be anonymised within The IC prior to being provided to the CEU. CEU staff will not be able to identify individual patients as they will not have access to patients' names, NHS numbers, addresses, or full postcodes.
Back to topData is held on servers which are located at two centres CSC (Computer Sciences Corporation provide NHS IC and DOH with managed IT infrastructure services) data centre in Maidstone and InTechnology in Harrogate, where they are kept in purpose built rooms with appropriate physical security features.
The system incorporates SSL (Secure Socket Layer v3.0) security which is an extremely high level of web encryption. Only users who have authorised access to the system can access the database. This is accessed using a username and password.
Contributing trusts are responsible for the physical security of locally sited client computers. Users should not share log-on details. If an additional log-in is required, please contact the helpdesk.
Back to topPatient and medical staff confidentiality is a vital part of the MBR project. The MBR security mechanisms are designed to ensure that only authorised people can access the information on the data base - users can only see records submitted by their own organisation and published information contains only comparative analyses. There are several levels of security built in to the web system.
The NCASP technical support team at the Information Centre have combined the IBM Domino Advanced Security model with Secure Socket Layer v3.0.
Back to topThe minimum retention period for all NCASP audit records is 8 years; all records identified for retention for a period greater than 8 years will be subject to review and justification, this is consistent with NHS Records Management Code of Practice 2007 Annex 1D health records Retention schedule.
Back to topData will be destroyed in accordance with legislative requirements on destruction. NCASP'S Data and Retention protocol applies to all clinical audit data and records stored and analysed within The IC's boundaries of operation. This process will specifically exclude records collected, stored and analysed within NHS Trusts, Hospitals, clinical governance departments, professional bodies, and other organisations that are participating in the National Clinical Audit Programme.
- if a patient has a wide local excision and then goes on to have a mastectomy due to the margins not being large enough, should the path be from the wide local excision, from the mastectomy or from both?
Size should be the cumulative total for both wide local excision and mastectomy. Usually the wide local excision is complete, but the margins of normal tissue around are insufficient. In that case the mastectomy pathology would be clear, so wide local excision path size should be used.
If the wide local excision is incomplete, then the total size of wide local excision and mastectomy should be used.
The grade should be the highest obtained from the wide local excision and mastectomy specimen.
Node data should be the total over the two procedures, e.g. 1/1 from wide local excision and 3/15 from mastectomy with axillary clearance would be 4/16. This does not apply for recurrent cancers - only for incomplete breast-conserving surgery.
The final deadline for prospective data submission is the 14th November 2008.
- How should the data be entered if a patient has been offered delayed reconstruction but is in the process of weighing up their options?
If the patient is thinking about delayed reconstruction they should be regarded as not taking delayed reconstruction. If they change their mind at a later stage, this action will be picked up by the patient reported outcomes questionnaires (PROMS).