Breast Cancer. Definitions developed by the Scottish Cancer Therapy Network

Transcription

1 Breast Cancer Data Definitions for Minimum Core Data Set in SIGN/SCTN Guideline on Breast Cancer Pilot Edition October 1998 SIGN Publication Number 29 Definitions developed by the Scottish Cancer Therapy Network Version 1: August 1999 & June 2001 Revisions + January - July Waiting Times Revisions Revised 01/07/2005 to amend Waiting Times

2 CONTENTS Preface Notes for implementation of changes Conventions used in definitions Criteria for inclusion of patients in audit Specifications for databases i ii iv v vi Section 1 Patient Identifiers Patient Forename 1 Patient Surname 2 Patient Address 3 Patient Postcode 4 Date of Birth 5 Sex 6 Hospital of Diagnosis (Referral) 7 General Practitioner (Referring) 8 Date Of Cancer Referral 9 Date Referral Received 10 Urgency of Cancer Referral 11 Unit Number (Hospital Patient Identifier) 12 CHI Number 13 Section 2 Hospital Clinicians and Specialties Clinician Specialty of Clinician Date of First Seeing Clinician Section 3 Presentation Details Source of Cancer Referral 20 Menopausal Status 21 Side (Tumour) 22 Clinical TNM Tumour stage 23 Clinical TNM Nodal Stage 24 Clinical TNM Metastases Stage 25 Date of Diagnosis 26 Section 4 Pathology Details Laboratory (Pathology) 28 Pathology Report Number 29 Date Pathology Report Issued 30 Type of Tumour 31 Distance from Excision Margin 32 Maximum Pathological Diameter 33 Tumour Grade 34 Number of Lymph Nodes Examined 35 Number of Lymph Nodes Involved 36 Multifocal/multicentric Disease 37 ER status 38

3 Section 5 Investigations Cytology Breast 40 Date of Cytology Breast 41 Needle Core Biopsy 42 Date of Needle Core Biopsy 43 Section 6 Surgery Final Definitive (or Only) Surgery Performed to Breast 45 Date of Final (or Only) Definitive Surgery Performed to Breast 46 Date of First Definitive Breast Surgery 47 Surgery Performed on Axilla 48 Level of Axillary Clearance 49 Type of First Cancer Treatment 50 Date of First Cancer Treatment 51 Reason for Delay In Starting First Cancer Treatment (2005) 52 Reason for Delay In Starting First Cancer Treatment (2001) 53 Section 7 Radiotherapy Radiotherapy (Type) 55 Date Radiotherapy Started 56 Date Radiotherapy Completed 57 Site of Radiotherapy Radiotherapy Boost 59 Section 8 Systemic Therapy Hormonal Therapy (Allow for 2 Courses) 61 Date Hormonal Therapy Started 62 Type Of Hormonal Therapy 63 Chemotherapy (Type) (Allow For 2 Courses) 64 Date Chemotherapy Started 65 Date Chemotherapy Completed 66 Chemotherapy Agent 67 Section 9 Reconstructive Surgery Date of First Reconstructive Procedure 69 Type of Reconstructive Procedure 70 Section 10 Clinical Trial Entry Clinical Trial 72 Entry into Clinical Trial 73 Section 11 Follow up and Death Details First Local Recurrence 75 Date of First Local Recurrence 76 First Axillary Recurrence 77 Date of First Axillary Recurrence 78 First Distant Recurrence 79 Date of First Distant Recurrence 80 Date of Death 81 Primary Cause of Death 82 Page revised July 2004

4 PREFACE The Scottish Cancer Therapy Network (SCTN) in collaboration with the Scottish Intercollegiate Guideline Network (SIGN) developed a clinical guideline for the management of breast cancer in Scotland. This evidence-based guideline was developed using SIGN methodology and the pilot edition was published in October Included in the pilot guideline is a minimum core data set for monitoring its implementation. For data to be collected in a consistent manner and thus allow comparisons to be made between different areas, or on a national scale, definitions are required for individual items in the data set. SCTN has produced data definitions, in conjunction with Information and Statistics Division of NHSScotland, for the breast cancer data set and these were issued in September Audit of female breast cancer using the SIGN minimum core data set and the accompanying definitions has now been in place for over a year in different parts of the country. Feedback from audits has indicated that some refinement of a number of definitions is required. In addition the establishment of the Clinical Standards Board for Scotland (CSBS) and the production of standards for female breast cancer has indicated a number of additional data requirements that nationwide audit could address. New data items and some further refinements to definitions have been included to meet these additional requirements. To ensure consistency across Scotland, these changes to nationwide audit should be introduced for all new patients commencing treatment on 1 July It is acknowledged that changes to audit require resources to implement, therefore no further changes are envisaged until after the current SIGN review of the guideline is complete. Dr John Dewar, Chair of SIGN Breast Cancer Guideline Development Group Ms Philippa Whitford, Chair of CSBS Breast Cancer Project Group Page i

5 NOTES FOR IMPLEMENTATION OF CHANGES This document updates on the version issued by the former SCTN covering the first version issued in August 1999 and subsequent revisions issued in June Changes included from the previous version are: Addition of waiting times fields: Mode of first treatment, date of first treatment, reason for delay in first treatment (implementation date for all new patients diagnosed from 1 January 2004) Revisions to fields: Date of referral, mode of referral (implementation date for all new patients diagnosed from 1 January 2004) Addition of field: Sex to enable the collection of data on males (implementation date for all new patients diagnosed from 1 April 2004) Addition of waiting times fields: Urgency of referral, date referral received (implementation date for all new patients diagnosed from 1 July 2004) If you have difficulties in using individual definitions within this document please contact Jean Harvey, Cancer Data Definitions Manager (Jean.Harvey@isd.csa.scot.nhs.uk). General Enquiries on the Collection of the Minimum Core Data Set If you have any comments on the attached data definitions ISD would welcome your feedback. Please contact: CONVENTIONS Kathy Clarke Cancer Information Coordinator ISD Scotland Tel: kathy.clarke@isd.csa.scot.nhs.uk In the following definitions the layout for each item is standard. Two conventions have been used in the document as follows: {curly brackets} - definition relates to one specific named data set 'described elsewhere' - indicates there is a definition for the named item within this document Page revised June 2004 Page ii

6 CRITERIA FOR INCLUSION OF PATIENTS IN AUDIT To facilitate national comparisons the same patients must be audited throughout Scotland. The following eligibility criteria have been documented for this purpose. Include all female and male patients with a confirmed new primary cancer of the breast with invasive or in situ disease (International Classification of Diseases, Tenth Revision [ICD 10] codes C50 and D05 - these codes include connective tissue of the breast but exclude skin). This includes patients with Paget's disease and patients who have had a previous primary malignancy of any site or a concurrent primary malignancy of another site all patients with normal residence in Scotland even if they only received part of their therapy within a health board/region Exclude patients where the origin of the primary is uncertain patients with recurrent disease (as opposed to a new primary tumour) patients with normal residence outwith Scotland patients with lymphoma of the breast patients with 'sarcoma' or 'phylloides' Page revised June 2004 Page iii

7 DATABASE SPECIFICATION To assist with the development of a national comparative reporting system for breast cancer it is recommended that all sites collecting data should use this database specification, if a decision is made to use a system other than that developed by ISD. If you wish to discuss technical issues relating to the database please contact: Chris Muir chris.muir@isd.csa.scot.nhs.uk Page revised July 2004 Page iv

8 DATABASE SPECIFICATION (contd) Data Item FIELD NAME Field Type Size Definition (codes on page) Patient identifiers Patient Number PATNO Text 12 n/a Patient Forename PATFNAME Text 20 1 Patient Surname PATSNAME Text 30 2 Patient Address1-4 PATADD(1-4) Text Patient Postcode PATPCODE Text 9 4 Date of Birth DOB Date/Time 8 5 Sex SEX Number (Byte) 1 6 Hospital of Diagnosis (Referral) HOSP Text 5 7 GP (Referring) GP Text Date of Referral REFDATE Date/Time 8 9 Date referral received REFRECDATE Date/Time 8 10 Urgency of referral URGENCYREF Number (Byte) 1 11 Unit Number UNITNUM Text (Hospital Patient Identifier) CHI Number CHINUM Text Hospital Clinicians and Specialties Clinician 1-4 CLINAM1-4 Text Specialty of Clinician 1-4 CLINSPEC1-4 Text 3 16 Date of First Seeing Clinician1-4 FCLINDATE1-4 Date/Time 8 18 Presentation Details Mode of Referral MREFER Number (Byte) 1 20 Menopausal Status MSTATUS Number (Byte) 1 21 Side (Tumour) SIDE Number (Byte) 1 22 Clinical TNM Tumour stage T Text 6 23 (Tumour (of Clinical TNM)) Clinical TNM Nodal stage N Text 6 24 (Nodal (of Clinical TNM)) Clinical TNM Metastases stage M Text 6 25 (Metastases (of Clinical TNM)) Date of Diagnosis (Date of DIAGDATE Date/Time 8 26 Definitive Diagnosis) Pathology details Laboratory (Pathology) PATHLAB Text 5 28 Pathology Report Number PATHNUM Text Date Pathology Report Issued PATHDATE Date/Time 8 30 Type of Tumour TUMOUR Number (Byte) 1 31 Distance from Excision Margin DISTEX Number (Byte) 1 32 Maximum Pathological Diameter (Invasive Tumours Only) MAXPATH Page revised July 2004 Number (Integer) 4 33 Page v

9 DATABASE SPECIFICATIONS (contd) Data Item FIELD NAME Field Type Size Definition and codes on page Tumour Grade TGRADE Number (Byte) 1 34 Number of Lymph Nodes EXNODES Number 4 35 Examined (Integer) Number of Lymph Nodes INVNODES Number 4 36 Involved (Integer) Multifocal/multicentric Disease MFOCAL Number (Byte) 1 37 ER status ERSTATUS Number (Byte) 1 38 Investigations Cytology Breast CYTOLOGY Text 3 40 Date of Cytology CYTDATE Date/time 8 41 Needle Core Biopsy NEEDBIO Text 3 42 Date of Needle Core Biopsy NBIODATE Date/time 8 43 Surgery Final Definitive (or Only) SURGBRST Number (Byte) 1 45 Surgery Performed to Breast Final Definitive Surgery othersurgbrst Text 50 Performed to Breast- Other Date of Final Definitive (or LSURGDATE Date/Time 8 46 Only) Surgery Performed to Breast Date of First Definitive Breast BSURGDATE Date/Time 8 47 Surgery Surgery Performed on Axilla SURGAXIL Number (Byte) 1 48 Surgery Performed on Axilla- othersurgaxil Text 50 Other Level of Axillary Clearance ACLEVEL Number (Byte) 1 49 Mode of First Treatment MODE Number (Byte) 1 50 Date of First Treatment FIRSTTREATDATE Date/Time 8 51 Reason for Delay in First DELAY Number (Byte) 1 52 Treatment (2005) Reason for Delay in First DELAY2001 Number (Byte) 1 53 Treatment (2001) Radiotherapy Radiotherapy (Type) RADIO Number (Byte) 1 55 Radiotherapy- Other otherradio Text 50 Date Radiotherapy Started RADDATE Date/Time 8 56 Date Radiotherapy Completed RCOMPDATE Date/Time 8 57 Site of Radiotherapy 1-4 RADSITE 1-4 Number (Byte) 1 58 (Site to which Radiotherapy Given) Site of Radiotherapy 1-4 Other Otherradsite1-4 Text 50 Radiotherapy Boost RADBOOST Number (Byte) 1 59 Page revised July 2004 Page vi

10 DATABASE SPECIFICATIONS (contd) Data Item FIELD NAME Field Type Size Definition and codes on page Systemic Therapy Hormonal Therapy HORMON1-2 Number (Byte) 1 61 (Allow for 2 courses) Hormonal Therapy- Other otherhormon1-2 Text 50 Date Hormonal Therapy Started HORMDATE1-2 Date/Time 8 62 Type of Hormonal Therapy HORMTYPE1-2 Number (Byte) 1 63 Type of Hormonal Therapy- otherhormtype1-2 Text 50 Other Chemotherapy (Type) CHEM1-2 Number (Byte) 1 64 (Allow for two courses) Date Chemotherapy Started CHEMDATE1-2 Date/Time 8 65 Date Chemotherapy Completed CHEMENDATE1-2 Date/Time 8 66 Chemotherapy Agent CHEMAGENT1-2 Number (Byte) 1 67 Chemotherapy Agent- Other Reconstructive Surgery Date of First Reconstructive Procedure Type of Reconstructive otherchemagent1-2 Text 50 RCONDATE Date/time 8 69 TYPECON Date/time 8 70 Procedure Clinical Trial Entry Clinical Trial (Name) CLINTRIAL Number (Byte) 1 72 Clinical Trial- Other otherclintrial Text 50 Entry into Clinical Trial TENTRY Number (Byte) 1 73 Follow up and Death Details First Local Recurrence (In Breast for Conservation Patients; Chest Wall for Mastectomy) LOCREC Number (Byte) 1 75 Date of First Local Recurrence FLOCDATE Date/Time 8 76 First Axillary Recurrence AXILREC Number (Byte) 1 77 Date of First Axillary AXILDATE Date/Time 8 78 Recurrence First Distant Recurrence DISTREC Number (Byte) 1 79 Date of First Distant FDISTDATE Date/Time 8 80 Recurrence Date of Death DOD Date/Time 8 81 Primary Cause of Death COD Number (Byte) 1 82 Page revised July 2004 Page vii

11 Section 1: Patient Identifiers National Data Definitions for SIGN Minimum Core Data Set for Female Breast Cancer Developed by the Scottish Cancer Therapy Network, August 1999 and June 2001, plus January -

12 Patient Forename The forename of a person represents that part of the name of a person which, after the surname, is the principal identifier of a person. ISD Definitions & Codes for the NHS in Scotland - 5th update February 1997 None. None. Page 1

13 Patient Surname The surname of a person represents that part of the name of a person which indicates the family group of which the person is part. ISD Definitions & Codes for the NHS in Scotland - 5th update February 1997 It should be noted that in Western culture this is normally the latter part of the name of a person. However, this is not necessarily true of all cultures. This will, of course, give rise to some problems in the representation of the name. This is resolved by including with the name a preferred name format indicating amongst other things the order of various parts of the name. None. Page 2

14 Patient Address A patient's usual address is the address at which (s)he currently lives and/or which the patient states is his/her usual address. NHS standards for unstructured and structured addresses exist and are applicable in England and Scotland. They can be found in the "Definitions & Codes for the NHS in Scotland" manual produced by ISD Scotland. None. Page 3

15 Patient Postcode The postcode is a basic unit for identifying geographic locations. A postcode is associated with each address in the UK. A postcode has two component parts. Part one of the postcode is known as the outcode, and part two is known as the incode. ISD Definitions & Codes for the NHS in Scotland - 5th update February 1997 Details on incode, outcode and postcode format can be found in the "Definitions & Codes for the NHS in Scotland" manual produced by ISD Scotland. The instructions for determining a postcode given at the front of the Postcode Directories should be followed. Page 4

16 Date of Birth Not applicable. If the patient's date of birth is recorded differently on different occasions, the most frequently used or latest date should be recorded. The patient's full date of birth inclusive of the century should be recorded. The format should be DDMMCCYY. Page 5

17 Sex (Gender) The sex of the patient is the genetic sex of the patient, regardless of biological sex or the perception of the patient. None. Sex not known The sex of the person is not provided in the personal details i.e. the data has not been supplied and sex cannot be ascertained from the data provided. Sex not specified The sex of the person cannot be determined for physical reasons, e.g. a new born baby. Definitions and Codes Manual, 6th Update, April 2002 Code Description 0 Not known (not recorded) 1 Male 2 Female 9 Not specified Page inserted 1 April 2004 (for collection from 1 April 2004) Page 6

18 Hospital of Diagnosis (Referral) {Breast Cancer} This denotes the hospital location in which the definitive diagnosis of breast cancer was first made. This may be the Breast Screening Service. Details of location codes for hospitals can be found in the "Definitions & Codes for the NHS in Scotland" manual produced by ISD Scotland. See date of definitive diagnosis described elsewhere for details of definitive diagnosis. Location codes for hospitals are five character codes maintained by ISD Scotland and the General Register Office (Scotland). The first character denotes the health board, the next three are assigned and the fifth denotes the type of location (H=hospital) eg A111H=Crosshouse Hospital G107H=Glasgow Royal Infirmary X1010=Inapplicable X9999=Not recorded Page 7

19 General Practitioner (Referring) {Breast Cancer} This is the general practitioner who referred the patient for investigation of symptoms suggestive of breast cancer. A general practitioner is a registered practitioner who provides general medical services to the community in partnership with other GPs or on a single handed basis. GPs may also be responsible for inpatient care and day case care in community hospitals. For patients not referred directly from general practice (ie referrals from breast screening, other hospital clinician) the patient's registered GP should be recorded. Page 8

20 Formal name: Date of cancer referral Main source of data standard: The National Cancer Datasets developed by the Cancer Networks supported by ISD from SEHD guidance issued 13 April Definition : Date of cancer referral is the date on which a referral is made by a primary care or hospital clinician for symptoms that lead to a diagnosis of cancer. Format: Store as 10 characters in the format CCYY-MM-DD. Display as DDMMCCYY. Codes and values: N/A Related data item: Source of cancer referral, Urgency of cancer referral. Further information: This is the date on the referral letter (if there are a number of dates record the date the letter was typed) or fax message, or of the telephone call or and may be the same date as the date on which the referral is received or earlier. If there is not a referral correspondence, the date documented in the case notes should be recorded. If the patient is referred by another hospital clinician while being investigated for a condition unrelated to their cancer (incidental finding), the date the patient was referred for investigation of their cancer should be recorded. For patients where the cancer was detected at a review clinic for pre-cancerous conditions or an existing cancer, or at a cancer genetic clinic, the date the decision was made to refer for further investigation of the cancer should be recorded. For patients referred from screening the date the patient is first referred to a hospital clinician for investigation of their cancer should be recorded. This may take place at a screening centre or a hospital. If a patient is referred from primary care but is admitted as an emergency before the clinic date, record date of referral as the original referral date. If a patient has not been referred previously for investigation of the cancer record the date the patient presents to A&E or Acute Admissions, (self or GP referral). If the exact date is not documented, record as 09/09/0909. Date of referral may be after the date of diagnosis e.g. where the GP has excised the tumour for melanoma. Draft standard under discussion with the National Clinical Dataset Development Programme (NCDDP) Page Revised 01/07/2005 for Patients diagnosed from 01/07/2005 Page 9

21 Date Referral Received Date referral received is the date on which a healthcare service receives a referral. This may be the same as the date of referral or later. Also known as Referral Received Date. Definitions and Codes Manual, 6th Update, April 2002 Page inserted 1 July 2004 (for collection from 1 July 2004) Page 10

22 Formal name: Urgency of cancer referral Main source of data standard: ISD Definitions and Codes Manual, 6th Update, April 2002 and SEHD guidance issued 13 April Definition : This denotes the urgency of referral for investigation of cancer as assigned by the referring primary care clinician. Format: 2 characters. Codes and values: Code Description 01 Urgent 02 Soon 03 Routine 09 Not recorded 10 Inapplicable Related data item: Source of cancer referral, Date of cancer referral. Further information: Outpatient referral category is the classification of an outpatient referral into urgent, soon and routine as perceived by the source of referral. Urgent - for clinical reasons, a patient requires an appointment at the earliest possible opportunity. This includes patients referred by a primary care clinician to where a risk based triage system is formally in place and the patient is subsequently categorised as high risk or urgent. Soon - for clinical reasons, a patient requires an earlier appointment than he/she would receive if given the next available routine appointment. Routine - a patient requires the next available routine appointment. Emergency referrals should be classed as urgent. This includes self-referral to A & E or Acute Admissions. If a primary care clinician has not referred a patient then code as inapplicable. If a patient is referred from primary care but is admitted as an emergency before the clinic date, record urgency of referral as denoted by the referring primary care clinician at the time of the original referral. Draft standard under discussion with the National Clinical Dataset Development Programme (NCDDP) Page Revised 01/07/2005 for Patients diagnosed from 01/07/2005 Page 11

23 Unit Number (Hospital Patient Identifier) The hospital patient identifier is a code which uniquely identifies a patient on the main index of a hospital (ie. within the hospital health records system). ISD Definitions & Codes for the NHS in Scotland - 5th update February 1997 The code is normally allocated on the patient's first contact with the hospital except where the contact is through Accident & Emergency. If there is more than one unit number record the unit number relating to the hospital of diagnosis as described elsewhere. Page 12

24 CHI Number The Community Health Index (CHI) is a population register which is used for health care purposes. The CHI number uniquely identifies a person on the index. Currently there are eight such indexes each covering a defined geographical area which together cover most of Scotland. A person may be registered on more than one index. ISD Definitions & Codes for the NHS in Scotland - 5th update February 1997 It is planned to merge these indexes, together with the NHS Central Register, to form a single national Central Index. This will allow a single, nationally unique identifier to be allocated to each person for health care purposes within Scotland. Discussions with England, Wales and Northern Ireland may extend the use of these unique person identifiers throughout the UK. It is therefore important that all new patient level information systems should define a field which can hold the CHI number. If there is more than one CHI number, record the number relating to the geographical location of diagnosis for the breast cancer. Page 13

25 Section 2: Hospital Clinicians and Specialties Page 14

26 Clinician 1-4 Clinicians are consultants responsible for the management and care of a patient at a given time. The data set allows for the full name of up to four hospital consultants to be recorded. Record, in chronological sequence, the first four consultants seeing the patient for their diagnosis and primary treatment. This also applies to those patients where diagnosis is an incidental finding. Clinician 1 should be the first contact with a secondary health care consultant that started the referral pathway leading to the definitive diagnosis and subsequent treatment. If the patient is referred from breast screening, consultant screening radiologist should not be recorded in these fields. The surname and forename of each clinician should be recorded to distinguish between consultants with common surnames. If there are two consultants with the same forename and surname, the specialty of consultant will be required. If the patient is seen by a member of the consultant s junior staff, record the name of the consultant in charge of the patient. If the patient is seen by a clinician who is working as a locum, record only that the clinician is a locum consultant i.e. enter locum. Clinicians names should be stored in databases as General Medical Council (GMC) number. If a clinicians name is not recorded code enter '9999'. If the patient does not see clinician 2, 3 or 4 code as 1010 (inapplicable). Page 15

27 Specialty of Clinician 1-4 The specialty of the clinician is the specialty in which he/she is formally recognised and contracted to work. A clinician may be formally recognised and contracted to work in more than one specialty; in these cases one specialty is recognised as the main one. The specialty of up to four clinicians can be recorded. The first specialty should relate to the first hospital clinician recorded in the clinician field, the second for the second clinician etc. If the clinician is a locum the specialty should still be recorded. Code A1 A2 A3 A5 A6 A7 A8 A9 AA AB AC AD AF AFA AG AH AK AM AN AP AQ AR C1 C2 C3 C4 C5 C6 C7 C8 Specialty General Medicine Cardiology Clinical Genetics Clin Pharm. & Therap. Communicable Diseases Dermatology Endocrin. & Diabetes Gastroenterology Genito-Urinary Med Geriatric Medicine Homoepathy Medical Oncology Medical Paediatrics Community Child Health Nephrology Neurology Occupational Health Palliative Medicine Public Health Medicine Rehabilitation Med. Respiratory Medicine Rheumatology General Surgery Accident & Emergency Anaesthetics Cardiothoracic Surgery Ent Surgery Neurosurgery Ophthalmology Orthopaedic Surgery Page 16

28 Specialty codes continued Code Specialty C9 Plastic Surgery CA Surgical Paediatrics CB Urology D1 Community Dentistry D3 Oral Surgery D4 Oral Medicine D5 Orthodontics D6 Restorative Dentistry D7 Community Dental Health D8 Paediatric Dentistry F1 Obstetrics & Gynaecology F1A Well Woman Service F1B Family Planning Service G1 General Psychiatry G1A Community Psychiatry G2 Child & Adolescent Psych G3 Forensic Psychiatry G4 Old Age Psychiatry G5 Mental Handicap G6 Psychotherapy H1 Diagnostic Radiology H1A Breast Screening Serv H2 Radiotherapy H3 Nuclear Medicine J1 Pathology J2 Blood Transfusion J3 Clinical Chemistry J4 Haematology J5 Immunology J6 Microbiology J7 Virology 99 Not recorded Page 17

29 Date of First Seeing Clinician 1-4 Date of first seeing clinician is the date on which a consultant clinician (or one of his/her team) first sees a patient for investigation or management of breast cancer following referral from primary or secondary healthcare. Dates for up to four clinicians can be recorded. The first date should relate to the first clinician in the first specialty, the second for the second clinician etc. The date format should be DDMMCCYY. If the exact date is not documented, record as 09/09/0909. The patient may not see clinicians 2, 3 or 4. In this case record 10/10/1010 (inapplicable). Page 18

30 Section 3: Presentation Details Page 19

31 Formal name: Source of cancer referral Main source of data standard: Cancer Networks supported by ISD. The National Cancer Datasets developed by the Definition : This denotes the route by which the patient was referred for investigation of signs or symptoms that lead to a diagnosis of cancer. Format: 2 characters. Codes and values: Code Specialty 01 Primary care clinician (GP, Nurse practitioner) 02 Screening service 03 Incidental finding 04 Review clinic 05 Cancer genetic clinic 06 Self-referral to A&E 07 GP referral directly to hospital (A&E or other) 08 Previous GP referral but subsequently admitted to hospital (A & E or other) 09 subsequently Not recorded 11 Primary care clinician (Dental) 12 Referral from private healthcare 13 Other Related data item: Date of cancer referral, Urgency of cancer referral. Further information: Patients may be referred by a general or dental practitioner to a clinic if the patient presents with symptoms requiring further investigation which lead to a diagnosis of cancer. A general practitioner is a registered practitioner who provides general medical services to the community in partnership with other GPs or on a single-handed basis. Patients presenting at A&E or acute admissions are often referred by their general practitioner (and may already have an outstanding primary care referral for cancer) so should be recorded under (code 8). Patients without a previous GP referral should be coded as 6 (self referral) or 7 (GP referral). After attending for routine screening in a Screening Programme a patient may be referred for further investigation, 2 (screening service). Some patients may be attending or referred to hospital for investigation or treatment of a condition unrelated to their cancer and a tumour is diagnosed, 3 (incidental finding). Patients may attend an outpatient cancer clinic as they are being followed up for benign disease or a previous cancer of the same site as diagnosed (4 review clinic) or because of a strong family history of cancer (5 genetic clinic). 13 (Other) includes following a domiciliary visit by a hospital clinician. Draft standard under discussion with the National Clinical Dataset Development Programme (NCDDP) NOTE: Referrals from private health care are still excluded from waiting times reporting. Page Revised 01/07/2005 for Patients diagnosed from 01/07/2005 Page 20

32 Menopausal Status Menopausal status is the term used to indicate where a woman is in her menstrual history Notes for users: This term categorises women into three main groups as follows: 1. For women with an intact uterus and at least one ovary post-menopausal - last menstrual period was more than 12 months before initial surgery peri-menopausal - woman experiencing menopausal symptoms (hot flushes, night sweats and genito-urinary symptoms) and whose last menstruation was less than 12 months ago pre-menopausal - last menstrual period was less than 12 months before initial surgery or are on continuous hormonal contraception. 2. For women who have had a hysterectomy post-menopausal - aged 50 or over peri-menopausal - women experiencing menopausal symptoms (hot flushes, night sweats and genito-urinary symptoms) pre-menopausal - aged under For women who have had a bilateral oophorectomy post-menopausal - any age group peri-menopausal - not applicable pre-menopausal - not applicable The results of hormonal assays, if at variance with the above classifications will take precedence. If the patient is male then code as (10) Inapplicable. Code Description 1 Premenopausal 2 Perimenopausal 3 Postmenopausal 9 Not recorded 10 Inapplicable Page 21

33 Side (Tumour) {Breast Cancer} Definition : This indicates the breast in which the tumour has been diagnosed. Notes for users: If there are bilateral tumours the subsequent data items relate to the tumour with the highest tumour stage (clinical) as classified according to the TNM Classification described elsewhere. Code Description 1 Left 2 Right 3 Bilateral 9 Not recorded Notes by Users Page 22

34 Clinical TNM Tumour Stage {Breast Cancer} This is the size of the tumour as determined by physical examination and imaging techniques (not pathological), and is coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Fifth Edition, 1997). 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 one or two breasts, the tumour with the highest T category should be used for classification. Code TX T0 Tis T1 T2 T3 T4 T9 Description Tumour cannot be assessed No evidence of primary tumour Carcinoma in situ Tumour 2cm or less Tumour more than 2cm but less than 5cm Tumour more than 5cm Tumour of any size with direct extension to chest wall or skin Not recorded Page 23

35 Clinical TNM Nodal Stage {Breast Cancer} This is the size and position of nodes in the axilla detected by physical examination and imaging techniques (not pathological), and is coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Fifth Edition, 1997). 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. Code NX N0 N1 N2 N3 N9 Description Regional lymph nodes cannot be assessed (e.g. previously removed) No regional lymph nodes metastasis Metastasis to movable ipsilateral axillary node(s) Metastasis to ipsilateral axillary nodes(s) fixed to one another or to other structures Metastasis to ipsilateral internal mammary lymph node (s) Not recorded Page 24

36 Clinical TNM Metastases Stage {Breast Cancer} This 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 is coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Fifth Edition, 1997). 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. Patients who have primary operable breast cancer and are asymptomatic do not require staging for distant metastatic disease and are classed as M0. Code MX M0 M1 M9 Description Presence of distant metastasis cannot be assessed No distant metastasis Distant metastasis ( includes metastasis to supraclavicular lymph nodes) Not recorded Page 25

37 Date of Diagnosis {Breast Cancer} The date of diagnosis is the date on which there was confirmation of the diagnosis of breast cancer whether by histology, cytology or clinical methods. 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. The date format should be DDMMCCYY. If the exact date is not documented, record as 09/09/0909. Page 26

38 Section 4: Pathology Details Page 27

39 Laboratory (Pathology) This denotes the hospital laboratory issuing the pathology report described by the pathology number. None. Code A111H A210H B120H C115H C206H C313H C418H F704H F805H G010A G107H G207H G306H G405H G516H H103H H202H L106H L208H L302H N101H N411H S116H S226H S308H T101H T202H V102H V201H W107H Y104H X9999 X1010 Location CROSSHOUSE HOSPITAL THE AYR HOSPITAL BORDERS GENERAL HOSPITAL WEST HIGHLAND HOSPITAL VALE OF LEVEN DISTRICT GENERAL HOSP INVERCLYDE ROYAL HOSPITAL ROYAL ALEXANDRIA HOSPITAL VICTORIA HOSPITAL, KIRKCALDY QUEEN MARGARET HOSPITAL SOUTHERN GENERAL HOSPITALS NHS TRUST GLASGOW ROYAL INFIRMARY STOBHILL HOSPITAL VICTORIA INFIRMARY, GLASGOW SOUTHERN GENERAL HOSPITAL, GLASGOW WESTERN INFIRMARY/GARTNAVEL GENERAL CAITHNESS GENERAL HOSPITAL RAIGMORE HOSPITAL MONKLANDS HOSPITAL, AIRDRIE LAW HOSPITAL, CARLUKE HAIRMYRES HOSPITAL, EAST KILBRIDE ABERDEEN ROYAL INFIRMARY DR GRAY s HOSPITAL WESTERN GENERAL HOSPITAL, EDINBURGH ROYAL INFIRMARY, EDINBURGH St JOHN s HOSPITAL NINEWELLS HOSPITAL PERTH ROYAL INFIRMARY FALKIRK & DISTRICT ROYAL INFIRMARY STIRLING ROYAL INFIRMARY WESTERN ISLES HOSPITAL DUMFRIES & GALLOWAY ROYAL INFIRMARY NOT RECORDED INAPPLICABLE Page 28

40 Pathology Report Number {Breast Cancer} This is the reference number of the specimen resulting in the histological diagnosis of breast cancer. If there is more than one report (from several surgical procedures), record the reference number of the report resulting in the definitive diagnosis. If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 'N/A' (inapplicable). Code as 'N/R' if the number is not recorded. Page 29

41 Date Pathology Report Issued This is the date on which the pathology report described by the pathology report number described elsewhere was issued. None. The date format should be DDMMCCYY. If the exact date is not documented, record as 09/09/0909. If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 10/10/1010 (inapplicable). Page 30

42 Type of Tumour {Breast Cancer} This denotes the classification of tumour based on tissue or origin in the breast. This determines whether the tumour is invasive or in situ (these are lesions which show cytology of malignancy but are contained within the ductal and lobular structures). In tumours with both invasive and non-invasive components record the invasive part. Code Description 2 DCIS (non-invasive) 9 Not recorded 10 Inapplicable 11 'Ductal'/no specific type (NST) 12 Lobular carcinoma 13 Medullary carcinoma 14 Mucinous carcinoma 15 Tubular carcinoma 16 Mixed (invasive) 17 Other invasive, specify 19 LCIS (non-invasive) 20 Paget's (non-invasive) 21 Other non-invasive, specify If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 10 (inapplicable). On occasions a biopsy specimen and a specimen from definitive surgery may give differing tumour types. In this case code as the definitive type agreed by the pathologist. Page revised February 2005 Page 31

43 Distance from Excision Margin {Breast Cancer} This denotes the distance of the invasive or ductal carcinoma in situ (DCIS) component of the tumour from the nearest resection margin. This will be confirmed by microscopic examination and the result can be found on the pathology report relating to the specimen from the final definitive (or only) surgery performed to breast or axilla as described elsewhere. Lobular carcinoma in situ (LCIS) is a multifocal disease which is not localised therefore, for LCIS, record this item as inapplicable. The distance is measured in millimetres. Code Description 1 <1mm 2 1-5mm 3 >5mm 4 Re-excision no residual disease 9 Not known 10 Inapplicable If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 10 (inapplicable). Page 32

44 Maximum Pathological Diameter (Invasive Tumours Only) This is the size of the tumour in millimetres as measured by the pathologist. Pathological tumour size is the maximum diameter in millimetres of the invasive component of the tumour in the fresh or fixed state on the histological preparation. If the two measurements are discrepant then that obtained from the histological (fixed) section(s) should be recorded. The tumour (not the excised specimen) with the greatest diameter should be used. If the patient had conservation surgery followed by subsequent surgery with contiguous tumour in both specimens, the diameters of tumour from both specimens should therefore be added together. If the measurement is not recorded code as If the definitive diagnosis is made clinically or by imaging techniques only (i.e. no histology is available), code as 1010 (inapplicable). Page 33

45 Tumour Grade {Breast Cancer} Tumour grade is a pathological measure of the tumour used as a prognostic indicator. For invasive tumours tumour grade is based on three factors; tubule formation, nuclear pleomorphism and mitosis. Each factor is given a score from 1-3 and adding the scores gives the overall histological grade. Grade 1 equals a score of 3-5, grade 2 a score of 6-7, and grade 3 a score of 8-9. If the grade is not mentioned by the pathologist then it may be possible to estimate the grade utilising the following statements in the pathology report: well differentiated (Grade I), moderately differentiated (Grade II), poorly differentiated (Grade III). If the report includes mixed statements (e.g. moderate to poorly differentiated) code to the worst situation (poorly in this example). For DCIS the pathology report should state grade as high, intermediate or low. If there are mixed statements (e.g. low to intermediate grade) record to the worst situation (intermediate in this example). In specimens with both invasive and non-invasive tumour record the grade for the invasive component. Occasionally a biopsy specimen and a specimen from definitive surgery may give differing tumour grades. In this case record the grade agreed by the pathologist. Record lobular carcinoma in situ (LCIS) or Paget s disease as inapplicable; it is not possible to grade these tumours. Code Description 1 Grade I (invasive) 2 Grade II (invasive) 3 Grade III (invasive) 4 Not assessable 9 Not recorded 10 Inapplicable 11 High grade DCIS 12 Intermediate grade DCIS 13 Low grade DCIS If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 10 (inapplicable). Page 34

46 Number of Lymph Nodes Examined {Breast Cancer} This is the number of lymph nodes found in axillary contents removed from the patient at the time of surgery and sent to pathology for analysis. The examination of axillary nodes is associated with invasive breast cancer only. If sentinel, apical and axillary nodes are reported separately, then they should be added together to give the total nodes examined. If bilateral breast surgery and bilateral axillary surgery is carried out, record the number of nodes from the side from which breast surgery is recorded if both axillary pathology is negative but if one is negative and one positive, record the side with the positive nodes. If both axillary pathology is positive, record the nodes from the side with the highest number of positive nodes. Code Description 9999 Not recorded 1010 Inapplicable If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 1010 (inapplicable). Page 35

47 Number of Lymph Nodes Involved {Breast Cancer} This is the number of lymph nodes found in axillary contents removed from the patient at the time of surgery and sent to pathology for analysis that are involved with tumour. Examination of axillary nodes is associated with invasive breast cancer only. If bilateral breast surgery and bilateral axillary surgery is carried out, record the number of nodes from the side from which breast surgery is recorded if both axillary pathology is negative but if one is negative and one positive, record the side with the positive nodes. If both axillary pathology is positive, record the nodes from the side with the highest number of positive nodes. Code Description 1010 Inapplicable 7777 Nodes positive but number unknown 9999 Not recorded If the definitive diagnosis is made clinically or by imaging techniques only (ie no histology is available), code as 1010 (inapplicable). Page 36

48 Multifocal/Multicentric Disease {Breast Cancer} This denotes where there is more than one foci of disease observed within the pathological specimen. The pathologist will usually comment on the pathology form whether or not the disease is multifocal. Multifocal disease may be identified as either in situ or invasive disease and is determined by the 2 or more discrete foci of disease in the same quadrant of the breast. If there are 2 or more foci of disease in different quadrants of the breast then this is multicentral disease. If the patient has not had definitive surgery, code as 10. Code Description 1 Yes 2 No 9 Not recorded 10 Inapplicable Page 37

49 ER Status {Breast Cancer} ER status denotes the results of a biochemical assay or immunohistochemical staining technique used to determine the amount of oestrogen receptor sites in the tumour. The greater the value the greater the response will be to an anti-oestrogen eg tamoxifen. Assays may be found in a biochemical report (f/mols/mg) or in a pathology report (% cells staining positive). As many different assays are used a decision should be made locally as to how the local results are equated to the codes detailed below. Ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS) and Paget s disease should be recorded as inapplicable, this test has no diagnostic or therapeutic relevance to these conditions. Code Description 1 Positive 2 Negative 3 Borderline 9 Not recorded 10 Inapplicable If the definitive diagnosis is made clinically or by imaging techniques only (i.e. no histology is available), code as 10 (inapplicable). Page 38

50 Section 5: Investigations Page 39

51 Cytology {Breast Cancer} This is the findings from examination of cells obtained by fine needle aspiration (FNA) or other cytological procedure. If more than one FNA or other cytological procedure is carried out to the breast the first examination is the one to be recorded even if no malignancy is identified. If the procedure is repeated on the same day and the one result is malignant code as malignant. Coding details: Code C1 C2 C3 C4 C5 C9 C10 Description Acellular Benign Atypical Suspicious of malignancy Malignant Not recorded Inapplicable Page 40

52 Date of Cytology {Breast Cancer} This is the date the fine needle aspirate (FNA) or other cytological procedure described elsewhere was performed. The date recorded should be the date on which the first cytological procedure was carried out even if the result did not demonstrate malignancy. Coding details: The date format should be DDMMCCYY. If the exact date is not documented, record as 09/09/0909. If the procedure is not performed code as 10/10/1010 (inapplicable). Page 41

53 Needle Core Biopsy {Breast Cancer} This denotes the procedure carried out to determine the histology of the suspected tumour. A small sample of tissue is taken and sent for histological examination. A needle core biopsy may be documented as a core biopsy or a tru-cut biopsy. The result of the first core biopsy should be recorded even if this did not demonstrate malignancy. Code B1 B2 B3 B4 B5a B5b B9 B10 Description Normal/unsatisfactory specimen Benign Benign but equivocal Suspicious of malignancy In situ DCIS Invasive tumour Not recorded Inapplicable Page 42

54 Date of Needle Core Biopsy This is the date the needle core biopsy described elsewhere is performed. In these procedures a small sample of tissue is taken and sent for histological examination. The date of the first core biopsy should be recorded even if this did not demonstrate malignancy. Coding details: The date format should be DDMMCCYY. If the exact date is not documented, record as 09/09/0909. If the procedure is not performed code as 10/10/1010 (inapplicable). Page 43

55 Section 6: Surgery Page 44

56 Final Definitive (or Only) Surgery Performed to Breast {Breast Cancer} This is the final (or only) operation performed on the patient for primary treatment of the breast cancer. Types of procedures and categories: 1. Localising or excision biopsy is the removal of the tumour at biopsy without requirement for further surgery. 2. Conservation surgery is the removal of tumour with surrounding normal tissue without the removal of the whole breast. Wide local excision and re-excision are included in this category as are segmentectomy and quadrantectomy. 3. Mastectomy is the removal of breast/axillary contents and perhaps pectoral muscles - subcutaneous, radical and Patey s mastectomy come into this category. Code Description 11 Localising or excision biopsy 12 Conservation surgery 4 Mastectomy 5 Other, specify 8 Patient refused treatment 9 Not recorded 10 Inapplicable If the definitive diagnosis is made clinically or by imaging techniques only (ie no surgery is undertaken), code as 10 (inapplicable). Page 45

57 Date of Final Definitive (or Only) Surgery Performed to Breast or Axilla {Breast Cancer} This is the date of the final definitive operative procedure to the breast or axilla. This is the final (or only) operative procedure with the intention of removing all of the tumour. It may be the same procedure as the first (or only) definitive surgery as described elsewhere. Some patients undergo axillary surgery at a later date than the surgery performed to the breast. In these cases the date of the axillary surgery should be recorded. Procedures such as needle core biopsy (may be referred to as trucut or core biopsy) which are undertaken to establish a diagnosis in preparation of later breast surgery are not classed as definitive surgery. Excision or localising biopsies which both establish diagnosis and remove tumour are classed as definitive surgery. The date format should be DDMMCCYY. If the exact date is not documented, record as 09/09/0909. If no surgical procedure is carried out, code as 10/10/1010 (inapplicable). Page 46