Useful documents

The following dataset and documentation contain the technical specification of the proposed dataset for the prospective audit phase of the Mastectomy and Breast Reconstruction Audit.

Prospective clinical study

• clinical dataset.

This provides a full list of all data items (and their definitions) being collected in the prospective clinical study.

• clinical data manual.

This fully explains the purpose, source and definitions of all data items (along with their options), as well as information about their availability within the patient pathway.

• the datasheet for patients undergoing delayed reconstruction
• the datasheet for patients undergoing delayed reconstruction.

This version of the datasheet is designed to be printed and used to collect in-patient prospective data on all delayed reconstruction patients at appropriate points in the patient pathway. Its structure exactly matches the online web-based IT system to allow easy data transcription.

• the datasheet for patients undergoing mastectomy (with or without immediate reconstruction)
• the datasheet for patients undergoing mastectomy (with or without immediate reconstruction).

This version of the datasheet is designed to be printed and used to collect in-patient prospective data on all mastectomy patients (with or without immediate reconstruction) at appropriate points in the patient pathway. Its structure exactly matches the online web-based IT system to allow easy data transcription.

Please contact mbr@ic.nhs.uk or 0845 300 6016 option 2, with enquiries about this part of the audit.

Patient-reported outcomes study and consent for questionnaires

Although the audit itself does not require explicit patient consent, Units will be asked to obtain written consent from patients to allow distribution of patient-reported outcome questionnaires to their home address after discharge.

• consent would ideally be undertaken at the time of pre-operative surgical consent
• a record of the consent would then be made on the paper datasheet / website.

The full list of patient consent forms can be found below:

• the clinician information sheet.

This provides further information about this part of the Audit, including full details of all items contained within the patient-reported outcome questionnaires.

• the mastectomy patient information sheet and consent form.

This information sheet should be provided to all mastectomy patients and the consent form used to register their consent to be sent Audit questionnaires to their home address.

• the immediate reconstruction patient information sheet and consent form.

This information sheet should be provided to all immediate reconstruction patients and the consent form used to register their consent to be sent Audit questionnaires to their home address.

• the delayed reconstruction patient information sheet and consent form.

This information sheet should be provided to all delayed reconstruction patients and the consent form used to document their consent to be sent Audit questionnaires to their home address.

Please contact rjeevan@rcseng.ac.uk or 0207 869 6619 with enquires about this part of the audit.

IT system information and support

• Data User Certificate
• MBR IT User Manual (only for the web system)
• CSV Specification.
• MBR IT Extract Tool Manual
• CCAD Security Policy Document
• MBR Online Reports User Guide

Please contact mbr@ic.nhs.uk or 0845 300 6016 option 2, with enquiries about this part of the audit.