Data Definitions for the National Minimum Core Dataset to Support the Introduction of

Transcription

1 Head and Neck Cancer Data Definitions for the National Minimum Core Dataset to Support the Introduction of Head and Neck Cancer Quality Performance Indicators Definitions developed by ISD Scotland in Collaboration with the Head and Neck Quality Performance Indicator Development Group Version 2.7: July 2017 To be used in conjunction with: 1. Head and Neck Cancer Quality Performance Indicators 2. Head and Neck QPI Dataset Validations (latest published version) 3. Head and Neck Measurability of QPI (latest published version)

2 DOCUMENT CONTROL SHEET Key Information Title Date Published/Issued July 2017 Date Effective From 1 St April 2015 Version/Issue Number V2.7 Head and Neck Cancer Data Definitions for Minimum Core Dataset for Quality Performance Indicators (QPIs) Document Type Document Status Standard Audience Cross References Author Guidance Final NHS staff involved in implementing and recording Head and Neck Cancer Quality Performance Indicators Head and Neck Cancer Quality Performance Indicators Head and Neck Cancer Measurability of Quality Performance Indicators Information Services Division of NHS National Services Scotland Version Date Summary of Changes Name Changes Marked /07/2014 Amendment to Site of Origin of Primary Tumour (SITE) values Brian Murray, Charlotte See page iii New data item added Anthony, ISD Changes to be applied for patients diagnosed from 1 st April /09/2014 Amend Definitive Operative Procedure Jane See page iii Garrett /10/2014 Change in version number due to Jane See page iii validation changes Garrett /2014 Changes agreed outwith review to Jane See page iii support data collection /2015 Changes agreed at 9 month review. Changes to be applied for patients diagnosed from 1 st April 2015 Garrett Charlotte Anthony /2015 Changes made out-with review Charlotte Anthony /2015 Changes made out-with review Charlotte Anthony /2015 Changes made out-with review Charlotte Anthony /2016 Amendments following Baseline Review Charlotte Anthony /2016 Changes made out-with review Karen Heatlie /2017 Changes made out-with review Charlotte Anthony See page iii See page iii See page iii See page iii See page iii See page iii See page iii

3 2.7 07/2017 Changes made outwith review Charlotte Anthony See page iii

4 CONTENTS PREFACE... i NOTES FOR IMPLEMENTATION OF CHANGES... ii CONVENTIONS... ii REVISIONS TO DATASET:...iii CRITERIA FOR INCLUSION OF PATIENTS IN AUDIT... ix DATABASE SPECIFICATION... xi Section 1: Demographic Items... 1 Person Family Name (at Diagnosis)... 2 Person Given Name... 3 Patient Postcode (at Diagnosis)... 4 Date of Birth... 5 Person Sex at Birth... 6 CHI Number... 7 Section 2: Pre-treatment Imaging & Staging Investigations... 8 Location of Diagnosis {Cancer}... 9 Date of Diagnosis {Cancer} Site of Origin of Primary Tumour {Cancer} Date of Histological/Cytological Diagnosis {Cancer} Imaging Completed (Pre-treatment) Date of Imaging Completed (Pre-treatment) Date Discussed by Care Team (MDT) Smoking Smoking Cessation Date Referred for Smoking Cessation Date of Oral Assessment (Pre-treatment) Nutritional Screening Date of Nutritional Screening Specialist Speech and Language Therapist Access Date of Specialist Speech and Language Therapist Access TNM Tumour Classification (Final) {Head and Neck Cancer} TNM Nodal Classification (Final) {Head and Neck Cancer} TNM Metastases Classification (Final) {Head and Neck Cancer} WHO/ ECOG Performance Status Type of First Cancer Treatment Date of First Cancer Treatment Date of Definitive Treatment {Head and Neck Cancer} Section 3: Surgery Location Code {Cancer Surgery} Consultant in Charge of Surgery Date of Definitive Surgery Intent of Definitive Surgery Definitive Operative Procedure 1-9 {Head and Neck Cancer} Section 4: Pathological Details Morphology of Tumour HPV Status of Tumour P16 Status of Tumour Surgical Margins Extracapsular Spread Section 5: Oncology Location Code 1-2 {Oncology Treatment} Date Treatment Started (Radiotherapy) {Head and Neck Cancer} (1-2) Date Treatment Completed (Radiotherapy) {Head and Neck Cancer} (1-2) Radiotherapy Course Type {Head and Neck Cancer} (1-2) Intensity-Modulated Radiation Therapy (IMRT) Date Treatment Started Systemic Anti-Cancer Therapy (SACT) {Cancer} Date Treatment Completed Systemic Anti-Cancer Therapy (SACT) {Cancer} Type of Systemic Anti-Cancer Therapy (SACT) 1-2 {Head and Neck Cancer} Section 6: Clinical Trial Entry... 65

5 Patient Entered into Clinical Trial {Cancer} Section 7: Death Details Date of Death... 68

6 PREFACE Following the publication of Better Cancer Care: An Action Plan in October 2008, the Scottish Government established the Scottish Cancer Taskforce to oversee its implementation. The NHS Scotland Healthcare Quality Strategy in 2010 expands on this by articulating quality ambitions. A quality measurement framework has been developed setting out measures and targets which will be used to monitor, challenge, manage and report progress. Part of this strategy is the development of quality performance indicators (QPIs) to drive quality improvement in cancer care throughout NHS Scotland. As high quality data are required to enable comparisons over time and between regions, it is important that national data definitions are used to facilitate consistent data collection. National data definitions already in use have been used as much as possible to allow electronic data capture, thereby minimising duplication of data collection. Where national data definitions do not already exist, definitions used in other systems have been incorporated. To ensure that findings are comparable across Scotland, the national dataset and data definitions in conjunction with the final quality performance indicators were agreed through public engagement and are now ready for implementation for patients diagnosed from 1 st April i

7 NOTES FOR IMPLEMENTATION OF CHANGES The following changes should be implemented for all patients who are diagnosed with Head and Neck cancer on or after 1 st April 2015, who are eligible for inclusion in the Head and Neck cancer audit. Changes to definitions fall into the following categories: to address problems with ongoing audit and standardise data definitions, where feasible, between different cancer sites to address problems with existing definitions to allow Quality Performance Indicators to be measured and reported against If you have difficulties in using individual definitions within this document please contact 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: NSS.ISDCANCERAUDIT@NHS.NET CONVENTIONS The layout for each item is standard as shown below where it is applicable: Common Name(s): Main Source of Data Item Standard: Definition: Field Name: Field Type: Field Length: Notes for Users: Codes and Values: Related Data Item(s): In addition the following two conventions have been used in the document: {curly brackets} - definition relates to one specific named data set 'described elsewhere' - indicates there is a definition for the named item within this document ii

8 REVISIONS TO DATASET: The following changes have been made to facilitate the recording of data. Changes to take effect for patients diagnosed from 01/04/2015 Change made outwith review July 2017 (Query 1404, 1420, 1428, 1442, 1450) Inclusion criteria - Date of Imaging Completed (Pre-treatment) amended definition from This denotes the date the CT and/or MRI of the primary site, lymph node draining and chest were completed. for staging and assessment. to This denotes the date the CT or MRI of the primary site and draining lymph nodes and CT chest were completed for staging and assessment. Definitive Operative Procedure 1-9 {Head and Neck Cancer} (OPCODE1-9) the following OPCS4 codes have added; Y66.8 Other specified harvest of bone. S18.1 Distant fasciocutaneous subcutaneous pedicle flap to head or neck T Biopsy of sentinel lymph node NEC V Extensive Excision of bone of face Z Right side operation Z Left side operation Morphology of Tumour inserted the following code; 9081/3 Teratocarcinoma mixed embryonal carcinoma and teratoma Change made out-with review February 2017 (Query 1263, 1300) Definitive Operative Procedure (OPCODE 1-9) inserted new code under Maxilla, Nose & Craniofacial ETC Y Endonasal endoscopic approach to other body cavity (excludes Functional endoscopic nasal surgery Inserted new code under Salivary Gland D10.4 Simple mastoidectomy (includes Mastoidectomy NEC) Morphology of Tumour inserted new code 9522/3 - olfactory (nasal cavity) neuroblastoma Change made out-with review June 2016 (Query 1217) Add to the Inclusion Criteria Exclusions: Patients with Neuroendocrine tumours Remove the code 8041/3 Small cell carcinoma, NOS from the data item Morphology of Tumour (MORPHOL) Revisions following Baseline Review Dataset Date of Oral Assessment (Pre-operative) - name changed to Date of Oral Assessment (Pretreatment) Intent of Definitive Surgery under Required for QPI(s) inserted 2, 3; Added new code & value 03 Diagnostic Excision Biopsy Only Surgical Margins Notes for Users changed code R0 to 01; Removed all explanatory notes and changed codes R0 to 01, R1 to 02, R2 to 03 Database Specification iii

9 Date of Oral Assessment (Pre-operative) - name changed to Date of Oral Assessment (Pretreatment) Definitive Operative Procedure 1-9 {Head and Neck Cancer} (Query 1059)- The following code and value added Description OPCS Endoscopic Destruction of Lesion of Larynx E35.3 REVISIONS TO DATASET OUTWITH 9 MONTH REVIEW (August 2015) Morphology of Tumour The following codes and values added Code Description 8032/3 Spindle Cell Carcinoma 8720/3 Malignant Melanoma, NOS REVISIONS TO DATASET OUTWITH 9 MONTH REVIEW (June 2015) Location of Diagnosis removed X1010 Not applicable HPV Status of Tumour the following text added to notes for users and explanatory notes: A patient with oropharynx cancer with no HPV/P16 tested should be recorded as not recorded. Codes & Values Code Description Explanatory notes 01 Positive 02 Negative 03 Not Accessible where there is insufficient tissue to perform HPV/P16 testing 96 Not Applicable Site not an Oropharynx 99 Not Recorded P16 Status of Tumour - A patient with oropharynx cancer with no HPV/P16 tested should be recorded as not recorded Codes & Values Code Description Explanatory notes 01 Positive 02 Negative 03 Not Accessible 96 Not Applicable Site not an Oropharynx 99 Not Recorded Moved HPV Status of Tumour and P16 Status of Tumour from Pre-treatment Imaging and Staging Investigations to Pathological Details iv

10 TNM Tumour Classification (Final) {Head and Neck Cancer} the following text added to notes for users The original clinical/radiological staging would have precedence in patients who have neo-adjuvant therapy. TNM Nodal Classification (Final) {Head and Neck Cancer} the following text added to notes for users The original clinical/radiological staging would have precedence in patients who have neo-adjuvant therapy. TNM Metastatis Classification (Final) {Head and Neck Cancer} the following text added to notes for users The original clinical/radiological staging would have precedence in patients who have neo-adjuvant therapy. Date of Definitive Surgery removed required for QPI 3 and 12Intent of Definitive Surgery removed required for QPI 3 and changed 12 to 11 Definitive Operative Procedure 1-9 {Head and Neck Cancer} removed required for QPI 10 Additional codes added Trans-sphenoidal hypophysectomy B01.2 Lower leg flap of skin and fascia Y59.6 Distant fasciocutaneous flap to head or neck S18.3 Microvascular reconstruction of organ Y24.1 Other operations on skin - other specified S60.8 Harvest of flap of skin and fascia - other specified. Y59.8 Date Treatment Started (Radiotherapy) {Head and Neck Cancer} (1-2) removed required for QPI 3, 10, 11 Date Treatment Complete (Radiotherapy) {Head and Neck Cancer} (1-2) amended 12 to 11 Radiotherapy Course Type removed required for QPI 12 Amended explanatory notes in code 06 Chemoradiotherapy from Radical radiotherapy given in combination with chemotherapy, either concurrent or sequentially to Radical radiotherapy given in combination with concurrent chemotherapy. Date Treatment Started Systemic Anti-Cancer therapy (SACT) {Cancer} 1-2 amended from 11 to 12 Type of Systemic Anti-Cancer Therapy removed QPI 12 Amended explanatory notes in code 05 Chemoradiotherapy removed Can be sequential or concurrent added Radical radiotherapy given in combination with concurrent chemotherapy Morphology of Tumour new code added 8502/3 Mammary analogue secretory carcinoma Date of Death removed QPI 3 & 12 and kep QPI 11. REVISIONS TO DATASET FOLLOWING 9 MONTH REVIEW (March 2015) v

11 Person Given Name Field name updated to PATSFNAME to reflect validations Person Sex at Birth Added 0 to codes within codes and values table. Location of Diagnosis {Cancer} removed provisionally from last paragraph in notes for users and added the following text and would retain responsibility for collection of the patient record. Date of Diagnosis {Cancer} removed confirms and added the following text in the first paragraph in notes for users gives a provisional diagnosis of head and neck cancer, whether by cytology, histology or other methods and is subsequently confirmed. In circumstances where there is no cytological or histological diagnosis the date of clinical decision of cancer diagnosis should be recorded. Site of Origin of Primary Tumour {Cancer} Field length changed from 9 to 7; code C32.3A(2) changed to C32.3A2 TNM Tumour Classification (Clinical) {Head and Neck Cancer} Changed from (Clinical) to (Final); remove as determined by pre-treatment investigations (not pathological) from definition; removed Clinical TNM is derived from all the clinical, radiological and biochemical results prior to treatment. The TNM system is base on the assessment of three components (T tumour, N node and M metastases) and the addition of numbers after the letter components to indicate the extent of the malignant disease. This is a pre/non-operative classification as defined by the Multidisciplinary Team Meeting (MDT) based on best knowledge. This may be at any MDT meeting up until first treatment. Added Final TNM staging is a clinical/radiological/pathological classification of the size and extent of the patient s cancer. This represents the poorest (most advanced) stage of disease evident, as agreed by the MDT and informed by all available clinical, radiological and histopathological information. For patients undergoing surgery, the final TNM stage can be recorded from that agreed at the post-operative surgical MDT TNM Nodal Classification (Clinical {Head and Neck Cancer} - Changed from (Clinical) to (Final); remove as determined by pre-treatment investigations (not pathological) from definition; removed Clinical TNM is derived from all the clinical, radiological and biochemical results prior to treatment. The TNM system is base on the assessment of three components (T tumour, N node and M metastases) and the addition of numbers after the letter components to indicate the extent of the malignant disease. This is a pre/non-operative classification as defined by the Multidisciplinary Team Meeting (MDT) based on best knowledge. This may be at any MDT meeting up until first treatment. Added Final TNM staging is a clinical/radiological/pathological classification of the size and extent of the patient s cancer. This represents the poorest (most advanced) stage of disease evident, as agreed by the MDT and informed by all available clinical, radiological and histopathological information. For patients undergoing surgery, the final TNM stage can be recorded from that agreed at the post-operative surgical MDT vi

12 TNM Metastases Classification (Clinical) {Head and Neck Cancer} - Changed from (Clinical) to (Final); remove as determined by pre-treatment investigations (not pathological) from definition; removed Clinical TNM is derived from all the clinical, radiological and biochemical results prior to treatment. The TNM system is base on the assessment of three components (T tumour, N node and M metastases) and the addition of numbers after the letter components to indicate the extent of the malignant disease. This is a pre/non-operative classification as defined by the Multidisciplinary Team Meeting (MDT) based on best knowledge. This may be at any MDT meeting up until first treatment. Added Final TNM staging is a clinical/radiological/pathological classification of the size and extent of the patient s cancer. This represents the poorest (most advanced) stage of disease evident, as agreed by the MDT and informed by all available clinical, radiological and histopathological information. For patients undergoing surgery, the final TNM stage can be recorded from that agreed at the post-operative surgical MDT Inserted codes and values table for Nasopharynx Pharynx Nasopharynx Code Value Explanatory Notes MX Regional metastasis cannot be assessed M0 No distant metastasis M1 Distant metastasis 96 Not applicable 99 Not recorded Type of First Cancer Treatment the following text added to notes for users but if MDT states that the tonsillectomy is the definitive treatment record type of first cancer treatment as surgery. Date of First Cancer Treatment the following text added to notes for users Tonsillectomy is for diagnostic purposes only and should not be recorded as first treatment, but if MDT states that the tonsillectomy is the definitive treatment record as Date of First Cancer Treatment. Date of Definitive Treatment {Head and Neck Cancer} the following text added to notes for users If MDT states that a tonsillectomy is the definitive treatment this is the date that should be recorded Intent of Surgery title changed to Intent of Definitive Surgery Definitive Operative Procedure 1-9 {Head and Neck Cancer} added the codes listed below: F38.8 Extirpation of lesion of other part of mouth other specified F10.4 Extraction of multiple teeth NEC S21.3 Hair bearing flap of skin to nasolabial area D02.1 Excision of lesion of external ear E36.9 Diagnostic endoscopic examination of larynx, unspecified. E02.8 Plastic operations on nose - Other specified E49.1 Diagnostic fibreoptic endoscopic examination of lower respiratory tract and biopsy of lesion of lower respiratory tract F23.8 Extirpation of lesion of tongue F26.8 Other operations on tongue - Other specified T85.9 Blocked dissection of lymph nodes - unspecified vii

13 V19.8 Other operations on mandible - Other specified Z94.1 Bilateral Z94.4 Unilateral Morphology of Tumour added the following code: 8746/3 - Mucosal lentiginous melanoma Intensity-Modulated Radiation Therapy (IMRT) the following text added to notes for users this includes VMAT (eg. Rapid ARC) Type of Systemic Anti-Cancer Therapy (SACT) 1-2 {Head and Neck Cancer} Add code 08 Chemotherapy to codes and values table. New Data Item Added: HPV Status of Tumour p.22 P16 Status of Tumour p.23 Database Specification: Site of Origin of Primary Tumour {Cancer} Field Size changed from 9 to 7 HPV Status of Tumour data item added: Field Name: HPVSTATUS, Field Type: Integer, Field Length: 2. P16 Status of Tumour data item added: Field Name: P16STATUS, Field Type: Integer, Field Length: 2. TNM Tumour Classification (Clinical) {Head and Neck Cancer} title changed to TNM Tumour Classification (Final) {Head and Neck Cancer}; Field Name changed from CT to ct TNM Nodal Classification (Clinical) {Head and Neck Cancer} title changed to TNM Nodal Classification (Final) {Head and Neck Cancer}; Field Name changed from CN to cn TNM Metastases Classification (Clinical) {Head and Neck Cancer} title changed to TNM Metastases Classification (Final) {Head and Neck Cancer}; Field Name changed from CM to cm Intent of Surgery title changed to Intent of Definitive Surgery Definitive Operative Procedure 1-9 {Head and Neck Cancer} Field Type changed from Integer to Characters REVISIONS TO DATASET OUT-WITH REVIEW (November 2014) Definitive Operative Procedure 1-9 {Head and Neck Cancer} add S Distant Myocultaneous to Head or Neck NEC and S36.1 Full Thickness Autograph to Head or Neck Morphology of Tumour add 9290/3 Ameloblastic odontosarcoma (Ameloblastic fibrodentinosarcoma, Ameloblastic fibro-odontosarcoma), 9310/3 Ameloblastoma, malignant (Adamantinoma, malignant), 9330/3 Ameloblastic fibrosarcoma (Ameloblastic sarcoma, Odontogenic fibrosarcoma), 9342/3 Odonteogenic carcinosarcoma REVISIONS TO DATASET OUT-WITH REVIEW (November 2014) Change in version number due to validation changes REVISIONS TO DATASET OUT-WITH REVIEW (September 2014) Dataset: viii

14 Definitive Operative Procedure 1-9 {Head and Neck Cancer} i. Additional field names added OPCODE6-OPCODE9 ii. Amendment to Notes for Users iii. Diagnostic Procedure codes deleted iv. Amendment of codes for Creation of pharyngostome from code E28.1 to E23.8 Y16.1; Reconstruction mouth- with primary closure code will change from code F39.1 to F39.8 and Laser excision lesion hypopharynx and Laser excision oropharynx are combined with code E24.2 Y08.2 Database Specification: Definitive Operative Procedure 1-9 {Head and Neck Cancer} Additional field names added OPCODE6-OPCODE9 Revisions (07/2014): Site of Origin of Primary Tumour (SITE) supplemental notes to users added to indicate which ICD- 10 subcategories do not map to a specific TNM stage. Enhancement to code descriptions and addition of Bone tables to TNM Tumour (ct), Nodal (cn) and Metastases (cm) Classifications (Clinical), New Data Item Added: Page 43: Date of Definitive Treatment {Head and Neck Cancer} Database Specification: Date of Definitive Treatment {Head and Neck Cancer} data item added: Field Name: DEFTREATDATE, Field Type: Date, Field Length: 10. 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 patients with a confirmed new primary invasive cancer of the head and neck (ICD-10 C00.3, C00.4, C00.5, C01-C13, C14.0, C14.8, C30-C32, or C76) and (C41.0 or C41.1 where morphology of tumour is 9270/3) All patients who have had a previous primary malignancy of any site or a concurrent primary malignancy of another site A separate record should be entered for each tumour of distinct origin. However, if there are multiple tumours within the head and neck, which have the same histology, record this as one tumour. Exclude: Patients where the origin of the primary is uncertain Patients with tumour type sarcoma, lymphoma, melanoma (except mucosal), skin (including pinna) ix

15 Patients with neuroendocrine tumours Patients with recurrent disease (as opposed to a new primary) Patients with metastases in the head and neck originating from another primary site Patients with carcinoma in situ, non-invasive tumours, or dysplasia Patients, at date of diagnosis, under 16 years of age i.e. up to 15 years 364 days Patients where the only record of their cancer is from a death certificate (DCO) Patients with normal residence outwith Scotland Patients whose definitive cancer treatment was privately funded or undertaken outwith NHS Scotland. NB: Only treatments as part of the initial treatment plan should be recorded. Patients treated within 6 months of a patient initially refusing further investigation or whose initial treatment is Watch and Wait can also be recorded. x

16 DOWNLOAD FORMAT To assist with downloading data to ISD for the National Quality Assurance Programme and other agreed activities, all sites should be able export data according to the following specification. DATABASE SPECIFICATION Data Item Field Name Field Type Size Page Section 1: Demographic Items 1 Person Family Name (at Diagnosis) PATSNAME Characters 35 2 Person Given Name PATSFNAME Characters 35 3 Patient Postcode (at Diagnosis) PATPCODE Characters 8 4 Date Date of Birth DOB (DD/MM/CCYY) 10 5 Person Sex at Birth SEX Integer 2 6 CHI Number CHINUM Characters 10 7 Section 2: Pre-treatment Imaging & Staging Investigations 8 Location of Diagnosis {Cancer} HOSP Characters 5 9 Date Date of Diagnosis {Cancer} DIAGDATE (DD/MM/CCYY) Site of Origin of Primary Tumour {Cancer} SITE Characters 7 11 Date of Histological/Cytological Diagnosis Date HDIAG {Cancer} (DD/MM/CCYY) Imaging Completed (Pre-treatment) CTINVEST Integer 2 15 Date of Imaging Completed (Pretreatment) (DD/MM/CCYY) Date CTDATE Date Date Discussed by Care Team (MDT) MDTDATE (DD/MM/CCYY) Smoking SMOKE Integer 2 18 Smoking Cessation SMOKCESS Integer 2 19 Date Date Referred for Smoking Cessation SMOKCENDATE (DD/MM/CCYY) Date Date of Oral Assessment (Pre-treatment) DENSCREEN (DD/MM/CCYY) Nutritional Screening NUTSCREEN Integer 2 22 Date Date of Nutritional Screening NUTSCREENDATE (DD/MM/CCYY) Specialist Speech and Language Therapist Access SLTASSESS Integer 2 24 Date of Specialist Speech and Language Date SLTDATE Therapist Access (DD/MM/CCYY) TNM Tumour Classification (Final) {Head and Neck Cancer} ct Characters 3 26 TNM Nodal Classification (Final) {Head and Neck Cancer} cn Characters 3 29 TNM Metastases Classification (Final) {Head and Neck Cancer} cm Characters 2 33 WHO/ ECOG Performance Status PSTATUS Integer 1 35 Type of First Cancer Treatment FIRSTTREATTYPE Integer 2 36 Date Date of First Cancer Treatment FIRSTTREATDATE (DD/MM/CCYY) Date of Definitive Treatment {Head and DEFTREATDATE Date xi

17 Neck Cancer} (DD/MM/CCYY) Section 3: Surgery 39 Location Code {Cancer Surgery} HOSPSURG Characters 5 40 Consultant in Charge of Surgery SURGCON Characters Date Date of Definitive Surgery SURGDATE (DD/MM/CCYY) Intent of Definitive Surgery OPINTENT Characters 2 43 Definitive Operative Procedure 1-9 {Head Characters OPCODE1 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters OPCODE2 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE3 10 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE4 10 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE5 10 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE6 10 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE7 10 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE8 10 and Neck Cancer} Definitive Operative Procedure 1-9 {Head Characters 44 OPCODE9 10 and Neck Cancer} Section 4: Pathological Details 49 Morphology of Tumour MORPHOL Characters 6 50 HPV Status of Tumour HPVSTATUS Integer 2 52 P16 Status of Tumour P16STATUS Integer 2 53 Surgical Margins SURGMARG Characters 4 52 Extracapsular Spread EXCAPSPREAD Integer 2 55 Section 5: Oncology 56 Location Code 1-2 {Oncology Treatment} HOSPNONSURG1 Characters 5 57 Location Code 1-2 {Oncology Treatment} HOSPNONSURG2 Characters 5 57 Date Treatment Started (Radiotherapy) Date RSTARTDATE1 {Head and Neck Cancer} (1-2) (DD/MM/CCYY) Date Treatment Started (Radiotherapy) Date RSTARTDATE2 {Head and Neck Cancer} (1-2) (DD/MM/CCYY) Date Treatment Completed (Radiotherapy) Date RCOMPDATE1 {Head and Neck Cancer} (1-2) (DD/MM/CCYY) Date Treatment Completed (Radiotherapy) Date RCOMPDATE2 {Head and Neck Cancer} (1-2) (DD/MM/CCYY) Radiotherapy Course Type {Head and Neck Cancer} (1-2) RCOURSETYPE1 Integer 2 60 Radiotherapy Course Type {Head and Neck Cancer} (1-2) RCOURSETYPE2 Integer 2 60 Intensity-Modulated Radiation Therapy (IMRT) IMRT Integer 2 61 Date Treatment Started Systemic Anti- Date CHEMDATE1 Cancer Therapy (SACT) {Cancer} 1-2 (DD/MM/CCYY) Date Treatment Started Systemic Anti- Date CHEMDATE2 Cancer Therapy (SACT) {Cancer} 1-2 (DD/MM/CCYY) xii

18 Date Treatment Completed Systemic Anti- Date CHEMENDATE1 Cancer Therapy (SACT) {Cancer} 1-2 (DD/MM/CCYY) Date Treatment Completed Systemic Anti- Date CHEMENDATE2 Cancer Therapy (SACT) {Cancer} 1-2 (DD/MM/CCYY) Type of Systemic Anti-Cancer Therapy (SACT) 1-2 {Head and Neck Cancer} CHEMTYPE1 Integer 2 64 Type of Systemic Anti-Cancer Therapy (SACT) 1-2 {Head and Neck Cancer} CHEMTYPE2 Integer 2 64 Section 6: Clinical Trial Entry 65 Patient Entered into Clinical Trial {Cancer} TRIAL Integer 2 66 Section 7: Death Details 67 Date Date of Death DOD (DD/MM/CCYY) xiii

19 Section 1: Demographic Items 1

20 Person Family Name (at Diagnosis) Common Name(s): Surname, Family name Main Source of Data Item Standard: Government Data Standards Catalogue Definition: That part of a person's name which is used to describe family, clan, tribal group, or marital association at the time of diagnosis. Field Name: PATSNAME Field Type: Characters Field Length: 35 Notes for Users: Main Source of Standard: Government Data Standards Catalogue The surname of a person represents that part of the name of a person indicating the family group of which the person is part. 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 the data item Name Element Position in the structured name indicating the order of the name elements. From SMR Definitions and Codes 2

21 Person Given Name Common Name(s): Forename, Given Name, Personal Name Main Source of Data Item Standard: Government Data Standards Catalogue Definition: The forename or given name of a person. Field Name: PATSFNAME Field Type: Characters Field Length: 35 Notes for Users: Main Source of Standard: Government Data Standards Catalogue The first forename of a person represents that part of the name of a person which after the surname is the principal identifier of a person. Where the person's preferred forename is not the first forename, the related data item 'Preferred Forename' should be used to indicate this. 3

22 Patient Postcode (at Diagnosis) Main Source of Data Item Standard: Government Data Standards Catalogue Definition: Postcode of patient's usual place of residence on the date of diagnosis Field Name: PATPCODE Field Type: Characters Field Length: Maximum 8 Notes for Users: Postcode is included in BS7666 Address (GDSC) but there is also a separate Post Code standard which will be populated from BS7666 Address Post Code. This item can be derived from the date of diagnosis and patient address at that time Related Data Item(s): Date of Diagnosis {Cancer} 4

23 Date of Birth Main source of Data Item Standard: Government Data Standards Catalogue Definition: The date on which a person was born or is officially deemed to have been born, as recorded on the Birth Certificate. Field Name: DOB Field Type: Date (DD/MM/CCYY) Field Length: 10 Notes for Users: 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 DD/MM/CCYY e.g. 01/02/2011. Related Data Item(s): CHI Number 5

24 Person Sex at Birth Common Name(s): Sex at Birth Main Source of Data Item Standard of Standard: Derived from the nearest equivalent Government Data Standards Catalogue standard Person Gender at Registration Definition: This is a factual statement, as far as is known, about the phenotypic (biological) sex of the person at birth Field Name: SEX Field Type: Integer Field Length: 2 Notes for Users: A person s sex has clinical implications, both in terms of the individual s health and the health care provided to them. In the majority of cases, the phenotypic (biological) sex and genotypic sex are the same and the phenotypic sex is usually easily determined. In a small number of cases, accurate determination of genotype may be required Codes and Values: Code Value Explanatory Notes 01 Male 02 Female 09 Not specified/indeterminate Where it has not been possible to determine if the person is male or female at birth, e.g. intersex / hermaphrodite. 99 Not recorded Related Data Item(s): CHI Number 6

25 CHI Number Main Source of Data Item Standard of Standard: Scottish Executive Health Department. 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. Field Name: CHINUM Field Type: Characters Field Length: 10 Notes for Users: The Community Health Index (CHI) is a computer based population index whose main function at present is to support primary care services. CHI contains details of all Scottish residents registered with a General Practitioner and was originally envisaged and implemented as a population-based index to help assess the success of immunisation and screening programmes. It is therefore closely integrated with systems for child health, cervical cytology and breast screening call and recall It is intended that this number, the Scottish equivalent of the new NHS number in England and Wales, should become the Unique Patient Identifier throughout the NHS in Scotland. From Designed to Care - Scottish Office The CHI number is a unique numeric identifier, allocated to each patient on first registration with the system. The CHI number is a 10-character code consisting of the 6-digit date of birth (DDMMYY), two digits, a 9th digit which is always even for females and odd for males and an arithmetical check digit. (ISD, Information Services, NHS National Services Scotland) The CHI number should always be used to identify a patient. However, Health record identifiers, such as hospital numbers in Patient Administration Systems (PAS), may be used locally, in conjunction with the CHI number or in the absence of the CHI number, to track patients and their records. Although there may be no number when a patient presents for treatment, there must be an allocation at some point in the episode of care as CHI is mandatory on all clinical communications. Non-Scottish patients and other temporary residents can have a CHI number allocated if required but it is envisaged that future development may allow the identifying number used in other UK countries to be used in Scotland. Related Data Item(s): Date of Birth Person Sex at Birth 7

26 Section 2: Pre-treatment Imaging & Staging Investigations 8

27 Location of Diagnosis {Cancer} Main Source of Data Item Standard: The National Audit Cancer Datasets developed by the regional Cancer Networks supported by Information Services. Definition: The patient's hospital of investigation in which the diagnosis of cancer was first made. Field Name: HOSP Field Type: Characters Field Length: 5 Notes for Users: Required for analysis purposes and clarifying responsibility for data collection. Details of location codes for hospitals can be found in the "Definitions and Codes for the NHS in Scotland" manual produced by ISD Scotland. 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) e.g. A111H=Crosshouse Hospital G107H=Glasgow Royal Infirmary X9999=Not recorded If a patient was diagnosed at one hospital but transferred to another for confirmation of the diagnosis only e.g. biopsy, then returns to the original hospital, the first hospital should be recorded as the Location of diagnosis and would retain responsibility for collection of the patient record Related Data Items: Date of Diagnosis {Cancer} 9

28 Date of Diagnosis {Cancer} Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: The date on which the cancer was first diagnosed whether by histology, cytology, immunology, cytogenetics or clinical (including radiological) methods. Field Name: DIAGDATE Field Type: Date (DD/MM/CCYY) Field length: 10 Notes for Users: Required for national survival analysis and national comparative analysis. Required for QPI(s) The date recorded is the date of the first investigative procedure that gives a provisional diagnosis of head and neck cancer, whether by cytology, histology or other methods and is subsequently confirmed. In circumstances where there is no cytological or histological diagnosis the date of clinical decision of cancer diagnosis should be recorded. If the exact date is not documented, record as 09/09/0909. The date recorded is the date the procedure was performed, not the date the report was issued. Related Data Items: Location of Diagnosis {Cancer} Date of Histological/Cytological Diagnosis {Cancer} 10

29 Site of Origin of Primary Tumour {Cancer} Main Source of Data Item Standard: The World Health Organisation (WHO) and the Cancer Registration New Data definitions for Socrates (August 1999 Version 8.0). Definition: The anatomical site of origin of the primary tumour according to the International Classification of Diseases (ICD-10). Field Name: SITE Field Type: Characters ICD-10 Field length: 7 Notes for Users: Required for QPI(s): 1-11 For ICD-10, tumours should be assigned to the subcategory that includes the point of origin of the tumour. A tumour that overlaps the boundaries of two or more subcategories and whose point of origin cannot be determined should be classified as subcategory 8. It should be noted that this subcategory should only be used where it is impossible to identify the specific site of origin of the tumour. ICD-10 codes with subcategory 9 (unspecified) should be avoided whenever possible as many codes listed ending with 9 will not map to a specific TNM stage. There are also some other ICD-10 codes listed which do not map to a specific TNM stage. All ICD-10 codes which do not map to a specific TNM stage have their values listed with an * below. If in doubt clarify the ICD-10 subcategory code with the relevant clinician. If C41 is recorded then Morphology of Tumour should be recorded as M9270/3. Codes and Values: ICD-10 Value Code Oral Cavity C00.3 Lip, inner aspect, mucosa of upper C00.4 Lip, inner aspect, mucosa of lower C00.5 Lip, inner aspect, unspecified C02.0 Tongue, dorsal surface, anterior 2/3 C02.1 Tongue, lateral border, tip of tongue C02.2 Tongue, ventral, inferior surface C02.3 Anterior parts of tongue, part unspecified C02.8 Overlapping lesion of tongue C02.9 Tongue, unspecified C03.0 Upper gum (including alveolar ridge and gingival) C03.1 Lower gum (including alveolar ridge and gingival) C03.9 Gum, unspecified C04.0 Anterior floor of mouth C04.1 Lateral floor of mouth C04.8 Overlapping lesion of floor of mouth C04.9 Floor of mouth, unspecified C05.0 Hard palate C05.8 Overlapping lesion of palate C05.9 Palate, unspecified C06.0 Cheek mucosa C06.1 Mouth, vestibule (buccal sulcus and labial) C06.2 Retromolar trigone C06.8 Overlapping lesion of other and unspecified parts of mouth 11

30 C06.9 Mouth, unspecified Salivary Glands C07.X Parotid gland C08.0 Submandibular gland C08.1 Sublingual gland C08.8 Overlapping lesion of major salivary glands C08.9 Major salivary glands, unspecified Oropharynx C01.X Base of tongue C02.4 Lingual tonsil C05.1 Soft palate C05.2 Uvula C09.0 Tonsillar fossa C09.1 Tonsillar pillar (anterior) (posterior) 1C C09.8 Overlapping lesion of tonsil C09.9 Tonsil, unspecified (faucial, palatine) C10.0 Vallecula C10.1 Anterior surface of epiglottis C10.2 Lateral wall of oropharynx C10.3 Posterior wall of oropharynx C10.4 Branchial cleft* C10.8 Overlapping lesion of oropharynx* C10.9 Oropharynx, unspecified* Nasopharynx C11.0 Superior wall of nasopsharynx (roof) C11.1 Posterior wall of nasopsharynx (adenoid, pharyngeal tonsil) C11.2 Lateral wall of nasopsharynx (fossa of rosenmuller, opening of auditory tube, pharyngeal recess) C11.3 Anterior wall of nasopharynx (floor, nasopharyngeal surface of soft palate, posterior margin of choana septum) C11.8 Overlapping lesion of nasopharynx C11.9 Nasopharynx, unspecified Hypopharynx C12.X Pyriform sinus C13.0 Postcricoid region C13.1 Ayrepiglottic fold, hypopharyngeal aspect C13.2 Posterior wall of hypopharynx C13.8 Overlapping lesion of hypopharynx C13.9 Hypopharynx, unspecified; Hypopharyngeal wall NOS; Laryngopharynx Other and ill-defined sites in lip, oral cavity and pharynx C14.0 Pharynx unspecified* C14.8 Overlapping lesion of lip, oral cavity and pharynx* Nasal cavity and middle ear C30.0 Nasal cavity; Cartilage; concha; internal; septum; vestibule C30.1 Middle ear; Eustachian tube; inner ear; mastoid air cells* 12

31 Accessory sinuses C31.0 Maxillary sinus C31.1 Ethmoidal sinus C31.2 Frontal sinus* C31.3 Sphenoidal sinus* C31.8 Overlapping lesion of accessory sinuses* C31.9 Accessory sinus, unspecified* Larynx C32.0 Glottis; intrinsic larynx; C32.0A True vocal cords C32.0B Anterior commissure C32.0C Posterior commissure C32.1 Supraglottis; extrinsic larynx; posterior (laryngeal) surface of epiglottis; ventricular bands C32.1A Suprahyoid epiglottis; (tip, laryngeal surface) C32.1B Aryepiglottic fold laryngeal aspect C32.1D Infrahyoid epiglottis C32.1E False vocal cords C32.2 Subglottis C32.3 Laryngeal cartilage* C32.3A Arytenoid cartilage* C32.3A2 Laryngeal cartilage, Arytenoid cartilage* C32.3B Cricoid cartilage* C32.3C Thyroid cartilage* C32.8 Overlapping lesion of larynx* C32.9 Larynx, unspecified* Bones C41.0 Maxilla C41.1 Mandible Ill-defined sites C76.0 Ill-defined site, head face and neck; cheek NOS; nose NOS* C99.X Not recorded* Related Data Items: 13

32 Date of Histological/Cytological Diagnosis {Cancer} Main Source of Data Item Standard: The National Audit Cancer Datasets developed by the regional Cancer Networks supported by Information Services. Definition: The date on which the head and neck cancer was first diagnosed whether by histology or cytology.. Field Name: HDIAG Format: Date (DD/MM/CCYY) Field length: 10 Notes for Users: Required for QPI(s): 1 There may be more than one biopsy/histology report. If there is a discrepancy between reports of cytology and histology, the histology report should be recorded as the definitive report if prior to treatment. If no cytological or histological diagnosis was made, record as 10/10/1010 (Not applicable) If the exact date is not documented, record as 09/09/0909 (Not recorded). The date recorded is the date the procedure was performed, not the date the report was issued. Related Data Items: Date of Diagnosis {Cancer} 14

33 Imaging Completed (Pre-treatment) Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by the Information Services. Definition: A record to show that patients with head and neck cancer have complete computed tomography (CT) and/or Magnetic resonance imaging (MRI) of the primary site and draining lymph nodes with CT of the chest.. Field Name: CTINVEST Field Type: Integer Field Length: 2 Notes for Users: Required for QPI(s): 2. A CT and/or MRI of the primary site, draining lymph node and a CT of the chest should be carried out prior to treatment. The primary site, draining lymph node and chest may be assessed separately however, if all three are assessed then select 01 Codes and Values: Code Value Explanatory Notes 01 Yes Primary site, draining lymph nodes and chest assessed 02 No Primary site, draining lymph nodes and chest assessed not assessed 95 Patient declined investigations 96 Not applicable 99 Not recorded Related Data Item(s): Date of Imaging Completed (Pre-treatment) 15

34 Date of Imaging Completed (Pre-treatment) Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes the date the CT or MRI of the primary site and draining lymph nodes and CT chest were completed for staging and assessment. Field Name: CTDATE Field Type: Date (DD/MM/CCYY). Field Length: 10 Notes for Users: Required for QPI(s): 2. A CT and/or MRI scan should be completed and reported by the multi-disciplinary team (MDT) for patients with head and neck cancer who are being considered for treatment with curative intent. If the patient has more than one CT and/or MRI scan the date of the final procedure is recorded. If the exact date of the CT/MRI Scan is not documented, record as 09/09/0909. If CT/MRI scan was not performed, e.g. patient refused, record as 10/10/1010 (not applicable). Related Data Item(s): Imaging Completed (Pre-treatment) 16

35 Date Discussed by Care Team (MDT) Common name: Date discussed by multidisciplinary team (MDT) {Cancer} Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes the date the care team meeting was held to discuss the management of the patient's care. Field Name: MDTDATE Field Type: Date (DD/MM/CCYY) Field Length: 10 Notes for Users: Required for QPI(s): 3 A cancer multidisciplinary care team may include surgeons, oncologists, radiologists, pathologists, nurses, speech language therapists, physiotherapists and others relevant to the treatment of a specific cancer. The team meets on a regular basis to discuss optimal patient management. Documentation of the discussion should be included in the case-note or other formal documentation. The first MDT meeting date will be recorded. If the patient has not been discussed by the MDT record as 10/10/1010 (Not applicable). If the date of the MDT meeting is unknown record as 09/09/0909 (Not recorded) Related data Item(s): 17

36 Smoking Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes if the patient is an active smoker at the time of referral (GP or other) for head and neck cancer. Field Name: SMOKE Field Type: Integer Field Length: 2 Notes for Users: Required for QPI(s): 4 A smoker is a person who is actively smoking at the time of referral to the head and neck services leading to a diagnosis of head and neck cancer. Codes and Values: Code Value 01 Yes 02 No 99 Not recorded Related data Item(s): Smoking Cessation Date Referred for Smoking Cessation 18

37 Smoking Cessation Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes whether the patient is referred for smoking cessation before first treatment. Field Name: SMOKCESS Field Type: Integer Field Length: 2 Notes for Users: Required for QPI(s): 4 Codes and Values: Code Value Explanatory Notes 01 Yes 02 No 95 Patient declined 96 Not applicable E.g. patient is a non smoker or died before being referred. 99 Not recorded Related data Item(s): Smoking Date Referred for Smoking Cessation 19

38 Date Referred for Smoking Cessation Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes the date the patient is referred for smoking cessation before first treatment. Field Name: SMOKCENDATE Field Type: Date (DD/MM/CCYY) Field Length: 10 Notes for Users: Required for QPI(s): 4 This is the date the patient s first referral for smoking cessation, which should be before they receive their first treatment. If the exact date of the referral is not documented, record as 09/09/0909. If the patient was not referred for smoking cessation, e.g. patient declined or where not applicable, record as 10/10/1010 (not applicable). Related data Item(s): Smoking Smoking Cessation 20

39 Date of Oral Assessment (Pre-treatment) Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes the date when the patient has had pre-treatment dental assessment. Field Name: DENSCREEN Field Type: Date (DD/MM/CCYY) Field Length: 10 Notes for Users: Required for QPI(s): 5 Within the care spell this is the date of the first oral assessment by a dentist, which contributes to the preparation for treatment. Record the date of the patient s first assessment after referral and not the assessment that led to referral. If the exact date of the oral assessment is not documented, record as 09/09/0909. If oral screening was not performed, e.g. patient refused, record as 10/10/1010 (not applicable). Related data Item(s): 21

40 Nutritional Screening Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes whether the patient underwent nutritional screening prior to first treatment. Field Name: NUTSCREEN Field Type: Integer Field Length: 2 Notes for Users: Required for QPI(s): 6 Patient s must receive nutritional screening with the validated Malnutrition Universal Screening Tool (MUST) prior to first treatment. Code Value Explanatory Notes 01 Yes 02 No 95 Patient declined 96 Not applicable E.g. patient died before being screened. 99 Not recorded Related data Item(s): Date of Nutritional Screening 22

41 Date of Nutritional Screening Main Source of Data Item Standard: The National Cancer Audit Datasets developed by the regional Cancer Networks supported by Information Services. Definition: This denotes the date the patient underwent nutritional screening prior to first treatment. Field Name: NUTSCREENDATE Field Type: Date (DD/MM/CCYY) Field Length: 10 Notes for Users: Required for QPI(s): 6 This is the date the patient underwent nutritional screening, which should be before they receive their first treatment. If the exact date of the screening is not documented, record as 09/09/0909. If the patient did not receive nutritional screening, e.g. patient declined or where not applicable, record as 10/10/1010 (not applicable). Related data Item(s): 23