Breast Cancer Data Standards

Transcription

1 For reference only Do Not Use For more information, contact; Breast Cancer Data Standards These are standards current on 21st May 2007 National Clinical Dataset Development Programme (NCDDP) Support Team Information Services Area 54E Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Tel: to: NCDDPsupportteam@isd.csa.scot.nhs.uk Website: Breast Cancer Data Standards Page I

2 Contents Overview & Background...V Overview... V Background to NCDDP... VI Breast Cancer Data Standards... VI Breast Cancer, Cancer Generic and Generic Data Items... VI Approval and Consultation... VII Pathology... VII Clinical Terminology... VII Legacy National Audit Codes... VII Date Recording... VII 1. Demographics... 1 Relevant Data Items Referral Details... 2 Relevant Data Items Diagnostic Information... 2 Relevant Data Items Laterality {Cancer} Date of Diagnosis {Breast Cancer} Mass Position {Breast Cancer} Mass Size {Cancer} Clinical Rating {Breast Cancer} Nodes - Axilla {Breast Cancer} Nodes - Supraclavicular Fossa {Breast Cancer} Anatomical Imaging Site {Cancer} Date of Imaging {Cancer} Ultrasound Findings {Breast Cancer} Mammography Interpretation {Breast Cancer} Nipple Discharge Discharge Dipstick Testing for Blood (Result) Clinical Diagnosis {Breast Cancer} TNM Tumour Classification (Clinical) {Breast Cancer} TNM Nodal Classification (Clinical) {Breast Cancer} TNM Metastases Classification (Clinical) {Breast Cancer} Date of Clinical TNM Staging {Cancer} Investigations Pathology Haematology (Investigation) Performed Biochemistry (Investigation) Performed Bone Marrow (Investigation) Performed Bone Marrow (Investigation) Method Clinical Examination Performed Core biopsy (Investigation) Performed Fine Needle Aspiration (FNA) (Investigation) Performed Bone scan (Investigation) Performed Ultrasound (Investigation) Performed Computerised Tomography (CT) (Investigation) Performed Breast Cancer Data Standards Page II

3 4.11 Magnetic Resonance Imaging (MRI) (Investigation) Performed Assessment and Management Relevant Data Items Care Team Meeting Type {Cancer} Care Team Meeting Actions {Cancer} Cancer Care Plan Intent {Cancer} Date Care Plan Communication Sent to Primary Care {Cancer} Treatment Outwith Protocol Reason Treatment Outwith Protocol Main Presenting Complaint {Breast Cancer} Duration of Main Presenting Complaint {Breast Cancer} Personal History of Breast Disease {Breast Cancer} Previous Clinical Diagnosis {Breast Cancer} Previous Mammogram (Investigation) {Breast Cancer} Previous Mammogram (Investigation) Type {Breast Cancer} Date of Last Mammogram {Breast Cancer} Other Cancers {Cancer} Family History of Cancer {Cancer} Associated Person Relationship to Client/Patient {Cancer} Family History Cancer Type {Cancer} Age at Onset in Family Member {Cancer} Menopausal Status Last Menstrual Period Pregnancy Status Lactation Status Oral Contraception Status Hormone Replacement Therapy Administration History Duration of Hormone Replacement Therapy Treatment Relevant Data Items Cancer Surgery Information {Cancer} Relevant Data Items Patient Offered Reconstructive Surgery {Breast Cancer} Cancer Surgery Type {Breast Cancer} Side Effects of Surgical Treatment {Breast Cancer} External Beam Radiotherapy Information {Cancer} Relevant Data Items External Beam Radiotherapy Course Number {Cancer} External Beam Radiotherapy Dose: Total Planned {Cancer} External Beam Radiotherapy Dose: Total Administered {Cancer} External Beam Radiotherapy Fractions: Total Planned {Cancer} External Beam Radiotherapy Fractions: Total Administered {Cancer} Reasons for External Beam Radiotherapy Gaps {Cancer} Site of External Beam Radiotherapy {Breast Cancer} External Beam Radiotherapy Boost {Breast Cancer} External Beam Radiotherapy Boost Dose: Total Administered {Breast Cancer} External Beam Radiotherapy Boost Fractions: Total Administered {Cancer} Side Effects of External Beam Radiotherapy {Cancer} Chemotherapy Information {Cancer} Breast Cancer Data Standards Page III

4 Relevant Data Items Chemotherapy Course Number {Cancer} Chemotherapy Agent {Breast Cancer} Side Effects of Chemotherapy {Cancer} Biological Therapy Information {Cancer} Biological Agent {Breast Cancer} Hormone Therapy Information {Cancer} Relevant Data Items Hormonal Agent {Breast Cancer} Hormone Therapy Type {Cancer} Side Effects of Hormone Therapy {Breast Cancer} Supportive Therapy Information {Cancer} Relevant Data Items Supportive Therapy Agent {Cancer} Clinical Trials Clinical Trial Name {Breast Cancer} Clinical Trial Proposed Discussed with Patient Potential Trial Entry Follow-up Date of Clinical Status Assessment {Cancer} Cancer Recurrence {Breast Cancer} Site of Recurrence {Cancer} Recurrence Status {Breast Cancer} Date Recurrence First Suspected {Cancer} Date of Cancer Proven Recurrence {Cancer} Cancer Registration and Audit Standards Appendix 1 - Consultation Distribution List Breast Cancer Data Standards Page IV

5 Overview & Background Overview The Scottish Cancer Group is the key sponsor for the development of Breast Cancer Data Standards for NHS Scotland in order to ensure a national approach to the collection of clinical and non-clinical data items relating to this cancer. The aim is to ensure inter-compatibility of national clinical information systems, and support the implementation of an electronic integrated health record. Cancer already has a range of individual national data sets for audit, screening and registration and this set of standards build on these systems. National data standards will support data sharing and allow secondary use of data for these purposes. A multi-disciplinary Clinical Working Group, established in October 2004 and supported by the National Clinical Dataset Development Programme (NCDDP) Support Team in Information Services Division (ISD), carried out the development of generic data standards for cancer which were recently approved by the NCDDP Board. In addition site-specific standards are required to support the Generic Clinical System (GCS) early implementers which includes breast cancer. These standards were developed under the direction of the early implementer lead clinician in South East of Scotland Cancer Area Network (SCAN). The Breast Cancer Data Standards will: Define common data items recommended for collection in a wide variety of clinical settings Support the exchange of patient information between healthcare providers Support the consistent recording of patient information throughout NHS Scotland. It is important to emphasise that these are data standards, not a dataset. This means that the individual data items included in this document need not all be recorded together in clinical information systems but where it is considered appropriate to record a particular data item as part of a persons care record, it should be recorded in accordance with the nationally agreed standard. Comments are now sought from the wider clinical community in order to ensure that these data standards are fit for purpose as Breast Standards and ready for inclusion in the national Health and Social Care Data Dictionary. We invite all interested organisations and individuals to take part in this consultation by completing the attached Consultation Response Form dix 3) and then returning it to the NCDDP Support Team. Comments on all or a part of the document are welcome (see Appendix 1 for consultation distribution list). Some background information on the NCDDP and Cancer Generic Data Standard development can be found below. If you have any further queries, please go to our website or contact us at NCDDP Support Team. Breast Cancer Data Standards Page V

6 Background to NCDDP To date, much of the data collected in NHS Scotland in a nationally consistent way has been through central returns to ISD relating to patient administrative and demographic data and NHS activity data - the content of the SMR Data Manual and the Definitions and Codes Manual reflect this. A limited amount of clinical information is collected at national level, mostly describing diagnoses, operations and procedures and the small number of national audits. Such information is not usually automatically generated as a by-product of operational clinical information, but may require intensive data collection that is quite discrete from any patient care process. There is now a drive from many clinical bodies to collect more meaningful clinical information, in particular to inform clinical audit and clinical governance requirements. The climate of IM&T development within NHS Scotland is an important facilitator and more clinicians are now embracing electronic means of recording clinical information, particularly in primary care. The move towards an integrated care record (ICR) with the availability electronically of appropriate clinical information to health care professionals for direct patient care purposes is one of the key aims of the National e- Health Strategy (April 2004). Electronic integration of clinical information, facilitating appropriate sharing and communication of information is desirable, particularly for the care of patients with chronic disease. Good clinical information systems are required which support direct patient care in this way, whilst also generating secondary information, such as that required for audit, as a by product where possible. The ability to link patient data across journeys of care requires alignment of clinical data standards across specialties, including their coding schema and clinical definitions. The NCDDP Programme was established in 2003 in response to the health white paper Partnership for Care (February 2003), to provide coordination and support at a national level for the clinically led development of national clinical data standards. The goal is to develop a set of interoperable national datasets initially focusing on the clinical priority areas. More information can be found on our website. Breast Cancer Data Standards Data standards were developed under the direction of clinical staff from SCAN and involved consultation with colleagues in all three regional cancer networks. It was agreed the inclusion of individual data items using the following criteria: 1. Is the data item required by multiple care professionals involved in the care of the patient? 2. Is the data item specific to the cancer grouping? Breast Cancer, Cancer Generic and Generic Data Items Data standards that are relevant to all patients or all cancer patients and are used across specialties, disciplines and settings have been developed by wider Generic Data Standards and Cancer Generic clinical working groups and approved as national data standards for NHS Scotland. In development of Breast cancer standards several generic and cancer generic data items were selected for inclusion in the standards. These data items names and definitions are listed in this document for information under the heading Relevant Published Data Items. The detail of these existing standards are available on the web based Health and Social Care Data Dictionary. Where it has been determined that a new standard is required for Breast Cancer which is specifically applicable or includes detail specific to Breast Cancer, this is recorded with the suffix {Breast Cancer}. It may be that equivalent standards are required in the context of other cancers or specialties. These may have similar names with an appropriate suffix. Breast Cancer Data Standards Page VI

7 Where it has been determined that a new standard is required for Breast Cancer which is equally applicable to other cancers this is recorded with the suffix {Cancer}. This will be added to the approved Cancer Generic standards and be available for use in the context of other cancer standards. Where it has been determined that a new standard is required for Breast Cancer which is a generic standard, applicable in contexts other than cancer, this is recorded with no suffix. This will be added to the approved Generic standards and will be available for use in any context. Approval and Consultation Following consultation, the Breast Cancer Data Standards will be submitted to the NCDDP Programme Board for formal approval as a national standard, and subsequently passed to the ehealth National Clinical Information Steering Group and the NHS Scotland Information Standards Group for endorsement. The Breast Cancer Data Standards will then be freely and widely available through publication in the Health and Social care data dictionary. As far as possible they are UK compatible. It is recommended that these data standards should be implemented within existing and emerging national clinical information systems and commercially procured national products, as well as being available to commercial developers to ensure the ability of their systems to support national information requirements. The recent Health Department Letter, HDL(2005)46 mandates the implementation of data standards published through the Data Dictionary in any new IT systems developed for use in NHS Scotland. Pathology In the consultation document all pathology items were treated as interim standards and therefore not presented to the Program Board for approval. It is envisaged that pathology data standards will be developed as a separate exercise and will be aligned with structured reporting as agreed by the Royal College of Pathologists. Clinical Terminology The strategic standard for clinical terminology in NHS Scotland is SNOMED-Clinical Terms. This means that clinical information systems will record clinical data using this international standard. It is intended that the NCDDP Support Team will develop recommended SNOMED CT specifications as part of the data standards and datasets it supports. Legacy National Audit Codes It is recommended that all new systems should use 96 for Not applicable and 99 for Not known. However, we acknowledge that legacy systems will need to continue to use 09 and 10 for a period of time. Therefore, we have avoided using the code 09 or 10 where a conflict may have occurred. Date Recording It is good record-keeping practice always to identify the date of recording of any clinical information. It is expected that all clinical information systems should include date stamping as standard functionality; therefore the Breast Cancer Data Standards do not deal with this issue. In many clinical situations, the date of an event, investigation, etc. is required for clinical purposes and should be visible to the health care professional. This date may not be the same as the date on which the data Breast Cancer Data Standards Page VII

8 are entered onto the system. In these instances the system must allow the health care professional to enter whichever date is appropriate. These issues must be addressed during system specification and development. The Breast Cancer Data Standards do not include standards for recording dates, though the date format for storage and management within a system should conform to the Government Data Standards Catalogue format: CCYY-MM-DD. However, this does not preclude entry or display of data on the user interface using the traditional DD-MM-CCYY format. Breast Cancer Data Standards Page VIII

9 1. Demographics Relevant Data Items 1 Generic Data Items CHI Number Structured Name 2 - Person Title - Person Family Name - Person Given Name - Person Preferred - Forename - Previous Person Family Name Address (BS7666) 3 Postcode 3 Person Birth Date Person Current Gender Person Sex at Birth Ethnic Group Ancestry Related Health Risk Registered GP Practice Code GP General Medical Council Number Definition The Community Health Index (CHI) is a population register, which is used in Scotland for health care purposes. The CHI number uniquely identifies a person on the index. An ordered sequence of person name elements such as title, forename(s) and family name. A collection of data describing the addressing of locations. The code allocated by the Post Office to identify a group of postal delivery points. The date on which a person was born or is officially deemed to have been born, as recorded on the Birth Certificate. A statement by the individual about the gender they currently identify themselves to be (i.e. self-assigned). This is a factual statement, as far as is known, about the phenotypic (biological) sex of the person at birth. A statement made by the service user about their current ethnic group. A statement made by the individual about the geographic area(s) in which they have their ancestral origin. This information may assist Health Care Professionals in providing health care to an individual where there may be altered health risk associated with ancestral origin. General Medical Practitioners provide general medical services to the population either in partnership with other GMPs or on a single-handed basis. The term GP practice covers both partnerships and single-handed practices. Each GP practice in Scotland is identified by a unique GP practice code. The practice code is a four-digit code plus a check digit with ranges of codes allocated to each Health Board. (SMR) The GMC (General Medical Council) number is the personal identification number issued to each doctor in the UK by the General Medical Council. 1 All data items in the table above are existing nationally approved generic data standards, which can be found in the Health and Social Care Data Dictionary. 2 It is recommended that Structured Name should be used in all new IT systems. Person Full Name (Unstructured) should only be used in legacy systems, which should migrate to use of Structured Name in due course. 3 It is recommended that Address (BS7666), which is a structured address, should be used in all new IT systems. Unstructured UK Postal Address plus Postcode should only be used in legacy systems, which should migrate to use of Address (BS7666) in due course. Breast Cancer Data Standards Page 1

10 2. Referral Details Relevant Data Items 4 Generic Data Items Health Record Identifier Date of Contact (Date of Clinic) Clinic Code Cancer Generic Data Items Date of Referral {Cancer} Referral Source {Cancer} Urgency of Referral {Cancer} Date Referral Received {Cancer} 3. Diagnostic Information Definition The hospital patient identifier is a code which uniquely identifies a patient on the main index of the hospital (i.e. within the hospital health records system). The date on which a contact took place between a patient/client and an individual care professional for the purpose of care A contact can take place when the Health Care Professional (HCP) is on care premises or visiting the patient and may be in person, by telephone, , letter, text message or telemedicine. This is a locally assigned code used to identify a clinic session or group of clinic sessions. Definition The date on which a referral is made by a primary care or hospital clinician for symptoms that led to a diagnosis of cancer. The route by which the patient was referred for investigation of signs or symptoms that lead to a diagnosis of cancer. The urgency of referral for investigation of cancer as assigned by the referring primary care clinician. It is also applied for direct emergency referral and formal risk based triage. Date referral received is the date on which a healthcare service receives a referral for investigation of signs or symptoms that lead to a diagnosis of cancer. Relevant Data Items 4 Generic Data Items Imaging Modality 5 Location Code Associated Professional - Identifier - Group - Role Histo / Cytopathology Report Number Histo / Cytopathology Investigation Report Date Date Histo / Cytopathological Specimen Taken Cancer Generic Data Items Tumour Type (Morphology of Tumour) {Cancer} Definition This is the reference number of any building or set of buildings where events pertinent to NHS Scotland take place. Locations include hospitals, health centres, GP surgeries, clinics, NHS board offices, nursing homes, schools and patient/client s home. Associated Professionals are those individuals who are involved with the client/ patient in a professional capacity e.g. consultant, social worker, occupational therapist, etc. The reference number of the histo/ cytopathology specimen. The date that the result of the specimen was reported by the pathology laboratory. This is the date the histo/ cytopathogical specimen was taken. Definition The morphology of the tumour according to the International Classification of Diseases for Oncology (ICD-O(3)). 4 All data items in the table above are existing nationally approved generic data standards, which can be found in the Health and Social Care Data Dictionary. 5 Imaging Modality is one of the data items to be developed through the next phase of Generic Data Standards development. Breast Cancer Data Standards Page 2

11 3.1 Laterality {Cancer} Main source of standard: The National Cancer Datasets developed by the Cancer Networks supported by ISD and the Scottish Cancer Registry Guidelines, Fourth Edition, Definition: Side or laterality (i.e. left or right) of the body in which the tumour is located. Code Value Explanatory Notes 01 Right 02 Left 03 Bilateral 04 Midline 96 Not applicable e.g. Non-paired organs Recording guidance: This item should be recorded for all paired organs and may be applicable for other tumours e.g. skin, tonsil. 3.2 Date of Diagnosis {Breast Cancer} Definition: The date on which there was confirmation of the diagnosis of breast cancer whether by histology, cytology or clinical methods. Format : 10 characters (CCYY-MM-DD) Sub data items: Verification level Code Value Level 0 Actual Level 1 Estimated Level 2 Not known Further Information: If multiple histological or cytological findings have been carried out, the date of the first procedure that confirmed a positive diagnosis of breast cancer is taken. If no histological or cytological procedures were undertaken, the date of diagnosis will be the date of any imaging procedure performed that confirmed a diagnosis of breast cancer; otherwise the date will be based on clinical findings and will be the first date upon which the clinician concludes a diagnosis of breast cancer. The date recorded is the date the procedure was performed, not the date the report was issued. Breast Cancer Data Standards Page 3

12 3.3 Mass Position {Breast Cancer} Definition: The position of the palpable mass on the patient s breast. Code Value 00 No mass palpable 01 One o clock 02 Two o clock 03 Three o clock 04 Four o clock 05 Five o clock 06 Six o clock 07 Seven o clock 08 Eight o clock 09 Nine o clock 10 Ten o clock 11 Eleven o clock 12 Twelve o clock 13 Nipple 99 Not known Attributes: Laterality {Cancer} Related data items: Mass Size {Cancer} Further information: A patient may have one or several masses detected on examination. Recording guidance: IT systems should allow for the recording of multiple mass positions. 3.4 Mass Size {Cancer} Definition: The largest dimension of the palpable mass, recorded in millimetres. Format and Length: 4 numeric Sub Data item: Status Code Value Explanatory Notes 96 Not applicable Related data items: Mass Position {Breast Cancer} Further information: A patient may have one or several masses detected on examination. Recording guidance: IT systems should allow for the recording of multiple mass sizes. IT systems should ensure that the unit of measurement for values is always clear to users, in whatever medium values are recorded. Breast Cancer Data Standards Page 4

13 3.5 Clinical Rating {Breast Cancer} Definition: The clinician s impression of their findings following physical examination of the patient suspected of having breast cancer. Format and Length: 2 characters Code Value Explanatory Notes 01 Normal May be referred to as (E1) 02 Benign May be referred to as (E2) 03 Suspicious probably benign May be referred to as (E3) 04 Suspicious probably malignant May be referred to as (E4) 05 Malignant May be referred to as (E5) 96 Not applicable Patient not examined Attributes: Laterality {Cancer} Further information: A patient may have one or several masses detected on examination. Recording guidance: IT systems should allow for the recording of multiple clinical ratings. 3.6 Nodes - Axilla {Breast Cancer} Definition: An indicator of whether or not lymph nodes are palpable in the axilla on clinical examination of the patient, and if so the clinical judgement of their nature. Code Value Explanatory Notes 00 Not palpable No lymph nodes palpable 01 Benign 02 Malignant/movable 03 Malignant/fixed 96 Not applicable Patient not examined Attributes: Laterality {Cancer} 3.7 Nodes - Supraclavicular Fossa {Breast Cancer} Breast Cancer Data Standards Page 5

14 Definition: An indicator of whether or not lymph nodes are palpable in the supraclavicular fossa (SCF) on clinical examination of the patient, and if so the clinical judgement of their nature. Code Value Explanatory Notes 00 Not palpable No lymph nodes palpable 01 Benign 02 Malignant/movable 03 Malignant/fixed 96 Not applicable Patient not examined Attributes: Laterality {Cancer} 3.8 Anatomical Imaging Site {Cancer} Main source of standard: NHSIA cancer dataset. Definition: A classification of the part of the body that is subject to the imaging or radiodiagnostic event. Format: 4 characters, OPCS site coding (In the future all Anatomical Imaging Sites should be recorded using SNOMED CT). Attributes: Laterality {Cancer} Related data items: Imaging Modality, Date of Imaging {Cancer} Further information: In the context of breast cancer, the following are examples of the relevant codes: Code Value Z15.1 Upper inner quadrant of breast Z15.2 Upper outer quadrant of breast Z15.3 Lower inner quadrant of breast Z15.4 Lower outer quadrant of breast Z15.5 Axillary tail of breast Z15.6 Nipple Z15.8 Specified breast nec Z15.9 Breast nec Z52.1 Pleura Z52.3 Pleural cavity Z52.8 Specified chest wall nec Z52.9 Chest wall nec Z61.1 Cervical lymph node Z61.2 Scalene lymph node Z61.3 Axillary lymph node Z61.4 Mediastinal lymph node Z61.5 Paraaortic lymph node Z61.6 Inguinal lymph node Breast Cancer Data Standards Page 6

15 Z61.8 Specified lymph node nec Z61.9 Lymph node nec Recording guidance: IT systems should allow for the recording of multiple anatomical imaging sites. 3.9 Date of Imaging {Cancer} Common name: Imaging Date Definition: The date that imaging was undertaken for the purposes of of investigating, diagnosing or managing cancer. Format and Length: 10 characters (CCYY-MM-DD) Sub data items: Verification level Code Value Level 0 Actual Level 1 Estimated Level 2 Date not required Level 3 Not known Related data items: Imaging Modality, Anatomical Imaging Site {Cancer} 3.10 Ultrasound Findings {Breast Cancer} Definition: The findings from ultrasound examination of the breast and axilla in a patient suspected of having breast cancer. Code Value Explanatory Notes 01 Normal May be referred to as (U1) 02 Benign May be referred to as (U2) 03 Suspicious probably benign May be referred to as (U3) 04 Suspicious probably malignant May be referred to as (U4) 05 Malignant May be referred to as (U5) 96 Not applicable Includes not performed Attributes: Laterality {Cancer} Related data items: Imaging Modality, Date of Imaging {Cancer}, Anatomical Imaging Site {Cancer} Breast Cancer Data Standards Page 7

16 Further information: An ultrasound scanner uses sound waves to scan an organ or area of the body. It does not use ionising radiation or a contrast agent. Recording guidance: IT systems should allow for the recording of multiple ultrasound findings Mammography Interpretation {Breast Cancer} Main source of standard: BI-RADS Assessment Categories Definition: The interpretation of the findings from X-ray examination of the breast in relation to possible breast cancer. Code Value Explanatory Notes 00 Need additional imaging evaluation May be referred to as (R1) 01 Negative May be referred to as (R2) 02 Benign finding May be referred to as (R3) 03 Probably benign finding Short interval follow-up suggested, Includes (R3) 04 Suspicious abnormality Biopsy should be considered, Includes (R4) 05 Highly suggestive of malignancy Appropriate action should be taken, Includes (R5) 96 Not applicable Includes not performed Attributes: Laterality {Cancer} Further information: BI-RADS is a Breast Imaging and Reporting Data System. A method used by radiologists and radiographers to interpret and report in a standardised manner the results of mammography, ultrasound and Magnetic Resonance Imaging (MRI) used in breast cancer screening and diagnosis. Recording guidance: IT systems should allow for the recording of multiple mammography Interpretations Nipple Discharge Definition: An indicator of whether or not the patient had discharge from the nipple, and if so whether from single or multiple ducts. Code Value Subcode 00 None 01 Single duct A B Sub-value With bilateral discharge sufficient to stain clothes With bloodstained discharge Explanatory Notes Breast Cancer Data Standards Page 8

17 02 Multiple ducts C With any nipple discharge A With bilateral discharge sufficient to stain clothes B With bloodstained discharge C With any nipple discharge 96 Not applicable Patients not having natural nipples. 99 Not known Includes not recorded Attributes: Laterality {Cancer} 3.13 Discharge Dipstick Testing for Blood (Result) Common name: Discharge testing result Definition: An indicator of whether or not blood was detected in a specific bodily discharge using a dipstick test, and if so to what degree. Code Value Explanatory Notes 00 None No blood detected 01 Trace + 02 Trace Trace Trace Not applicable Test not performed 3.14 Clinical Diagnosis {Breast Cancer} Definition: The agreed clinical diagnosis following the completion of assessment. Format: 3 characters Code Value Subcode Sub-value 00 Normal 01 Abscess A Lactational B Non-lactational 02 Benign 03 Cancer 04 Congenital abnormality A Accessory nipple B Breast tissue Explanatory Notes Breast Cancer Data Standards Page 9

18 05 Cyst 06 Duct ectasia 07 Duct papilloma Eczema Epidermoid cyst 10 Fat necrosis 11 Fibroadenoma 12 Galactorrhoea 13 Granulomatous mastitis 14 Gynaecomastia 15 Lumpy breasts 16 Mammary duct fistula 17 Mastalgia A Cyclical B Non-cyclical 18 Nipple discharge A Bloodstained B Physiological 19 Nipple inversion 20 Oedema 21 Papilloma of nipple 22 Periductal mastitis 23 Patient died before diagnosis reached 98 Other specify Recording guidance: Users may wish to augment code 98 Other specify with a free text field for recording other clinical diagnosis. IT systems should allow for recording of multiple clinical diagnoses TNM Tumour Classification (Clinical) {Breast Cancer} Common name: Clinical TNM Tumour stage {Breast Cancer} Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002) Definition: Size of the tumour as determined by physical examination and imaging techniques (not pathological), and coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: 3 characters Code Value Subcode Sub-value Explanatory Notes 00 TNM Classification T0 No evidence of primary tumour 01 TNM Classification Tis Carcinoma in situ (CIS) A Tis (DCIS) Ductal carcinoma in situ B Tis (LCIS) Lobular carcinoma in situ C Tis (Paget) Paget s disease of the nipple with no tumour. 02 TNM ClassificationT1 Tumour up to 2cm A T1mic Tumour <0.1 cm; = 0.1cm Breast Cancer Data Standards Page 10

19 B T1a Tumour > 0.1 cm; = 0.5cm C T1b Tumour >0.5 cm; =1 cm D T1c Tumour >1 cm; =2 cm 03 TNM Classification T2 Tumour >2 cm; =5 cm TNM Classification T3 TNM Classification T4 Tumour >5 cm Tumour of any size with direct extension to chest wall or skin only as described in T4a to T4d A T4a Extension to chest wall B T4b Oedema (including peau d orange), or ulceration of the skin of the breast, or satellite skin nodules confined to the same breast C T4c Both T4a and T4b D T4d Inflammatory carcinoma 06 TNM Classification TX Primary tumour cannot be assessed Related data items: TNM Nodal Classification (Clinical) {Breast Cancer} TNM Metastases Classification (Clinical) {Breast Cancer} Date of Clinical TNM Staging {Cancer} Further Information: The TNM system is a classification of malignant tumours used by oncologists to aid in the planning of treatment, give an indication of prognosis, assess the results of treatment, exchange information between treatment centres and contribute to the continuing investigation of human cancer. Clinical TNM is derived from all the information prior to surgical treatment. This should not be confused with pathological TNM classification, or ptnm, which combines all clinical staging information plus findings from examination of the pathological specimen. The TNM system is based on the assessment of three components (tumour, node and metastases) and the addition of numbers after the letter components to indicate the extent of the malignant disease. Clinical measurements should be made with calipers. In the case of multiple simultaneous tumours in a breast, the tumour with the highest T category should be used for classification TNM Nodal Classification (Clinical) {Breast Cancer} Common name: Clinical TNM Nodal stage {Breast Cancer} Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002) Breast Cancer Data Standards Page 11

20 Definition: Size and position of nodes in the axilla detected by physical examination and imaging techniques (not pathological), and coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: 3 characters Code Value Subcode Sub-value Explanatory Notes 00 TNM Classification N0 No regional lymph nodes metastasis 01 TNM Classification N1 Metastases to movable ipsilateral axillary lymph node(s) TNM Classification N2 Metastases in fixed ipsilateral axillary lymph node(s) or in clinically apparent ipsilateral internal mammary lymph node(s) in the absence of clinically evident axillary lymph node metastasis. A N2a N2a Metastases in axillary lymph nodes(s) fixed to one another or to other structures. B N2b N2b Metastases only in clinically apparent internal mammary lymph nodes and in the absence of clinically evident axillary lymph node metastasis. 03 TNM Classification N3 Metastasis in ipsilateral infraclavicular lymph node(s), with or without axillary lymph node involvement, or in clinically apparent ipsilateral internal mammary lymph node(s) and in the presence of clinically evident axillary lymph node metastasis; or metastasis in ipsilateral supraclavicular lymph node(s), with or without axillary or internal mammary lymph node involvement. A N3a Metastasis in infraclavicular lymph node(s) B N3b Metastasis in l internal mammary lymph node(s) and axillary lymph node(s) C N3c Metastasis in supraclavicular lymph node(s) 04 TNM Classification Regional lymph nodes cannot be assessed (e.g. previously removed) NX 99 Not known Includes Not recorded Related Data items: TNM Tumour Classification (Clinical) {Breast Cancer} TNM Metastases Classification (Clinical) {Breast Cancer} Date of Clinical TNM Staging {Cancer} Further Information: The TNM system is a classification of malignant tumours used by oncologists to aid in the planning of treatment, give an indication of prognosis, assess the results of treatment, exchange information between treatment centres and contribute to the continuing investigation of human cancer. Clinical TNM is derived from all the information prior to surgical treatment. This should not be confused with pathological TNM classification, or ptnm, which combines all clinical staging information plus findings from examination of the pathological specimen. The TNM system is based on the assessment of three components (tumour, node and metastases) and the addition of numbers after the letter components to indicate the extent of the malignant disease TNM Metastases Classification (Clinical) {Breast Cancer} Breast Cancer Data Standards Page 12

21 Common name: Clinical TNM Metastases Classification {Breast Cancer} Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002) Definition: Indicates the extent of the spread of the disease outwith the breast and axilla as determined by clinical, imaging and biochemical methods (not pathological), and coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Code Value Explanatory Notes 00 TNM Classification M0 No distant metastases 01 TNM Classification M1 Distant metastases present 02 TNM Classification MX Presence of distant metastases cannot be assessed 99 TNM Classification M9 Not recorded Related data items: TNM Nodal Classification (Clinical) {Breast Cancer} TNM Tumour Classification (Clinical) {Breast Cancer} Date of Clinical TNM Staging {Cancer} 3.18 Date of Clinical TNM Staging {Cancer} Definition: The date the tumour was staged clinically using the TNM classification. Format: 10 characters (CCYY-MM-DD) Sub-data items: Verification level Code Value Level 0 Actual Level 1 Estimated Level 2 Not known Related data items: TNM Tumour Classification (Clinical) {Breast Cancer} TNM Nodal Classification (Clinical) {Breast Cancer} TNM Metastases Classification (Clinical) {Breast Cancer} 4. Investigations Pathology In the consultation document all pathology items were treated as interim standards and therefore not presented to the Program Board for approval. It is envisaged that pathology data standards will be developed as a separate exercise and will be aligned with structured reporting as agreed by the Royal College of Pathologists. Breast Cancer Data Standards Page 13

22 4.1 Haematology (Investigation) Performed Definition: An indicator of whether or not samples for haematological investigation have been taken. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled 4.2 Biochemistry (Investigation) Performed Definition: An indicator of whether or not samples for biochemical analysis have been taken. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled 4.3 Bone Marrow (Investigation) Performed Definition: An indicator of whether or not a bone marrow sample has been taken. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled 4.4 Bone Marrow (Investigation) Method Definition: The method used to obtain a bone marrow sample. Breast Cancer Data Standards Page 14

23 Code Value Explanatory Notes 01 Aspirate 02 Trephine biopsy 4.5 Clinical Examination Performed Definition: An indicator of which general clinical examination has been performed. Code Value Explanatory Notes 00 Not done 01 Breasts 02 Regional Nodes 03 Abdomen 98 Other specify Recording guidance Where 98 Other specify is recorded, systems may be configured to include a text box to allow specification of the clinical examination performed. Recording guidance: IT systems should allow for the recording of multiple clinical examinations. 4.6 Core biopsy (Investigation) Performed Definition: An indicator of whether or not a core biopsy has been performed. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled 4.7 Fine Needle Aspiration (FNA) (Investigation) Performed Definition: An indicator of whether or not fine needle aspiration (FNA) has been performed. Breast Cancer Data Standards Page 15

24 Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled 4.8 Bone scan (Investigation) Performed Definition: An indicator of whether or not a bone scan has been performed. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled Related data items: Anatomical Imaging Site 4.9 Ultrasound (Investigation) Performed Definition: An indicator of whether or not an ultrasound has been performed. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled Related data items: Anatomical Imaging Site 4.10 Computerised Tomography (CT) (Investigation) Performed Definition: An indicator of whether or not computerised tomography (CT) has been performed. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled Breast Cancer Data Standards Page 16

25 03 Requested Test scheduled Related data items: Anatomical Imaging Site 4.11 Magnetic Resonance Imaging (MRI) (Investigation) Performed Definition: An indicator of whether or not magnetic resonance imaging (MRI) has been performed. Code Value Explanatory Notes 00 Not done 01 Done 02 Planned Test to be scheduled 03 Requested Test scheduled Related data items: Anatomical Imaging Site Breast Cancer Data Standards Page 17

26 5. Assessment and Management Relevant Data Items 6 Generic Data Items Associated Professional - Identifier - Group - Role Discussed by Care Team Reason not Discussed by Care Team Definition Associated Professionals are those individuals who are involved with the client/ patient in a professional capacity e.g. consultant, social worker, occupational therapist, etc. This denotes whether the proposed management and treatment of the patient was discussed by the care/ multidisciplinary team. The reason why the patient was not discussed by a care/ multidisciplinary team. Associated Person Relationship to Client/Patient Current Tobacco and Nicotine Consumption Status Specific Medication Record Patient Allergies, Adverse Reactions and Intolerance 7 Height Weight Body Mass Index Systolic Blood Pressure Diastolic Blood Pressure WHO/ ECOG Performance Status Women and Children s data item Parity 8 Cancer Generic Data items Date first seen by Associated Professional {Cancer} Date discussed by Care Team {Cancer} The relationship of an Associated Person to the client/patient. Tobacco consumption at date of contact including smoking, chewing and use of other nicotine substances Record of whether or not a specific medication was prescribed for an individual as recommended in specific clinical guidelines. Height in metres - measured without shoes Weight in kilograms taken without shoes or outdoor clothing Body Mass Index (BMI) = weight/height (2) (kg/m(2)) Systolic Blood Pressure measured using a technique and equipment approved by the British Hypertension Society Diastolic Blood Pressure measured using a technique and equipment approved by the British Hypertension Society. An overall assessment of the functional/physical performance of the patient. Definition Parity indicates the number of pregnancies a woman has had prior to any current pregnancy. These pregnancies are expressed as firstly the number that have resulted in the birth of an infant capable of survival or stillborn and secondly the number of pregnancies that have ended in miscarriage or termination. Definition Date of first seeing responsible Associated Care Professional is the date on which an Associated Care Professional first sees a patient for investigation or management of cancer following referral from primary or secondary healthcare. The date the care/ multidisciplinary team meeting was held to discuss and agree the management of the cancer patient. 6 All data items in the table above are existing nationally approved data standards, which can be found in the Health and Social Care Data Dictionary. 7 Patient Allergies, Adverse Reactions and Intolerance Data Standards will be developed through the next phase of Generic Data Standards development. 8 This item is being consulted within the Women and Children s Standards Breast Cancer Data Standards Page 18

27 5.1 Care Team Meeting Type {Cancer} Common name: Type of Multidisciplinary Meeting {Cancer} Definition: The stage in the patient s investigation and treatment when they were discussed at a particular care/ multidisciplinary meeting. Code Value 01 Post-operative/pathology 02 Staging/new patient 03 Relapse 99 Not known Related data items: Discussed by Care Team, Date Discussed by Care Team {Cancer}, Care Team Meeting Actions {Cancer} 5.2 Care Team Meeting Actions {Cancer} Common name: Multidisciplinary Meeting Actions {Cancer} Definition: Future actions planned to be carried out by members of the care/ multidisciplinary team as agreed at the Multidisciplinary Team Meeting. Code Value 00 Not discussed at Multidisciplinary Team Meeting 01 Place on operating list 03 Further investigations 04 Follow-up 05 Discharge 06 Radiotherapy 07 Chemotherapy 08 Hormone therapy 98 Other - specify 99 Not known Related data items: Discussed by Care Team, Date Discussed by Care Team {Cancer}, Care Team Meeting Type {Cancer} Recording guidance: Users may wish to augment code 98 Other specify with a free text field for recording other Care Team Meeting Actions. IT systems should allow for recording of multiple care team meeting actions. Breast Cancer Data Standards Page 19

28 5.3 Cancer Care Plan Intent {Cancer} Main source of standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by the Information Services Definition: The therapeutic intention of the treatment which is planned for the patient at a particular point in time. Code Value Explanatory Note 01 Curative Treatment given with the potential for cure (radical treatment) even if the proportion of patients achieving long term disease control (> 2 years) is small. 02 Palliative Anti-cancer treatment for symptom control 03 Supportive care only Care aimed at sustaining the patient s and / or carer s ability to cope with a slowly deteriorating condition. 99 Not known Includes Not recorded. It is highly unlikely that any treatment plan would be drawn up, where the intention of the treatment is Not known. The use of this code should be carefully monitored Further Information: It is appreciated that this decision may change as treatment is given and the patient s response to this treatment is assessed. At each stage, a new cancer care plan would be drawn up and details recorded. 5.4 Date Care Plan Communication Sent to Primary Care {Cancer} Main source of standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by the Information Services Definition: The date of sending notification of the care plan details to primary care following the care plan being agreed with the patient. Format: 10 characters (CCYY-MM-DD) Sub-data items: Verification level Code Value Level 0 Actual Level 1 Estimated Level 2 Date not required Level 3 Not known Breast Cancer Data Standards Page 20

29 Related data items: Cancer Care Plan Intent. 5.5 Treatment Outwith Protocol Definition: An indicator of whether or not the patient s planned treatment is outwith the agreed protocol. Code Value Explanatory Notes 00 No 01 Yes 02 No protocol available 96 Not applicable Not performed 99 Not known Includes Not recorded Related data items: Reason Treatment Outwith Protocol Further information: In this context the protocol relates to that formally agreed within the managed clinical network for the care of a particular patient group. Protocols are normally adapted from SIGN Guidelines. 5.6 Reason Treatment Outwith Protocol Main source of standard: NHSQIS Definition: The reason why treatment was planned outwith the agreed protocol. Code Value Explanatory Notes 01 No reason given 02 Contraindicated Patient unfit 03 Clinical decision 04 Patient declined Patient refused 05 Clinical trial 06 No protocol available 07 Patient died before therapy started Related data items: Treatment Out-with Protocol, Cancer Surgery Information {Cancer} 5.7 Main Presenting Complaint {Breast Cancer} Common name: Main Presenting Symptom Breast Cancer Data Standards Page 21

30 Main source of standard: Scottish Referral Guidelines for Suspected Cancer April Definition: The patient's stated reason for seeking care (or as stated by the patient's representative, such as parent, legal guardian, or paramedic) (Official ICD-9-CM Guidelines for Coding and Reporting). Code Value 00 None 01 Lump 02 Pain 03 Ulceration 04 Nipple discharge 05 Nipple retraction or distortion 06 Nipple eczema 07 Change in contour 08 Swelling or lump in the armpit 98 Other specify Attributes: Laterality {Cancer} Related data items: Duration of Main Presenting Complaint {Breast Cancer} Further Information: Users may wish to augment code 98 Other specify with a free text field for recording other Main Presenting Symptoms. Recording guidance: IT systems should allow for recording of multiple main presenting complaints. 5.8 Duration of Main Presenting Complaint {Breast Cancer} Common name: Duration of Main Symptom Definition: The number of weeks since the onset of the main presenting complaint(s). Format: 2 numeric Sub Data item: Status Code Value Explanatory Notes 96 Not applicable Related data items: Main Presenting Complaint {Breast Cancer} 5.9 Personal History of Breast Disease {Breast Cancer} Breast Cancer Data Standards Page 22