ALL WALES GASTRO-OESOPHAGEAL MINIMUM DATA SET DRAFT. V7.0d. Indicates AUGIS data item.

Transcription

1 DRAFT ALL WALES GASTRO-OESOPHAGEAL MINIMUM DATA SET V7.0d Changes/additions in line with V2.0 Core Dataset highlighted in bold italics Indicates AUGIS data item. Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 1 of 49

2 1. REGISTRATION Page 3 2. REFERRAL Page 7 3. KEY INVESTIGATIONS Page DIAGNOSIS Page CANCER MANAGEMENT PLAN (Record the original management plan for each disease episode) Page SURGICAL TREATMENT AND PATHOLOGY Page CHEMOTHERAPY AND OTHER DRUGS (including hormonal and biological agents) Page RADIOTHERAPY Page PALLIATIVE CARE/OTHER TREATMENT MODALITIES Page COMPLETION OF PRIMARY TREATMENT Page CLINICAL TRIALS Page FOLLOW UP Page 36 Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 2 of 49

3 1. REGISTRATION / PATIENT IDENTIFIERS *1.1 NHS number The patient s NHS Number Used for unique identification to match records from different service providers. To allow tracking through the clinical pathway. NHS Data Manual The unique identification for NHS health care purposes 10 numeric *1.2 Case record number The local number by which the patient is known at the hospital Used for unique identification to link events within a single service provider. To allow tracking through the clinical pathway. 8 alpha numeric *1.3 Surname Surname of the patient Note: it must be possible to provide Cancer Registries with the patient s surname as at the date of diagnosis. Used for unique identification. To assist tracking through the clinical pathway. NHS Data Manual Patient last name 35 alpha/char *1.4 Forename(s) Forename(s) of the patient Used for unique identification to link records where the new NHS number is not available. To assist tracking through the clinical pathway. NHS Data Manual Patient forename(s) 35 alpha/char *1.5 Address at date of diagnosis The patient s usual address at the date of diagnosis To assist identification of each patient and to derive and/or verify postcode. NHS Data Manual ONS rules for completion of this field will need to be followed. Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 3 of 49

4 1. REGISTRATION / PATIENT IDENTIFIERS *1.6 *1.7 *1.8 Postcode at date of diagnosis Postcode of usual address at time of diagnosis Note: If a patient has no fixed abode this should be recorded with the appropriate code (ZZ99 3VZ). For overseas visitors the postcode field must show the relevant country pseudo postcode commencing ZZ99 plus space followed by a numeric, then an alpha character, then a Z. For example, ZZ99 6CZ is the pseudo-postcode for India. Pseudo- Country postcodes can be found in the NHS Postcode Directory. A list of all pseudo postcodes and country names is also given in the Organisation Codes Service Handbook, Appendix F. This is available on the NHS net. To assist identification of each patient and used to enable analysis by locality of patients. Date of birth The registered date of birth of the patient To enable age at diagnosis to be established for epidemiological and survival analyses. To enable analysis by birth cohort and to assist linkage to ONS/WCISU for women who have changed their name on marriage (or back on separation or divorce) NHS Data Manual 8 alpha/numeric ONS rules for completion of this field will need to be followed. NHS Data Manual Date format dd/mm/ccyy Sex Sex of the patient at birth To enable analysis by sex 0 not known 1 male 2 female 9 not specified Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 4 of 49

5 1. REGISTRATION / PATIENT IDENTIFIERS [continued] 1.81 Height Height of patient in cm at initial assessment at the hospital To enable analysis by height 3 numeric 1.82 Weight Weight of patient in kg at initial assessment at the hospital To enable analysis by weight 3 numeric *1.9 GP practice code Practice with whom the patient is registered To enable analysis by GP practice code NHS Data Manual, Section D 6 alpha / numeric *1.10 Ethnic Category The ethnic category of the patient, as specified by the patient. To enable analysis by ethnicity. White Any White background A Mixed White and Black Caribbean D White and Black African E White and Asian F Any other mixed background G Asian or Asian British Indian H Pakistani J Bangladeshi K Any other Asian background L Black or Black British Caribbean M African N Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 5 of 49

6 1. REGISTRATION / PATIENT IDENTIFIERS [continued] Ethnic Category (continued) Any other Black background P Other ethnic Groups Chinese R Any other ethnic group S Not Stated Not stated Z Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 6 of 49

7 2. REFERRAL *2.1 Source of referral (origin) From where the referral originates To allow tracking through the clinical pathway, to identify patterns of referral and audit of minimum standards. [Note referral may or may not be to a member of the MDT]. 4 character code 01XX Following an emergency admission (includes all acute admissions via A & E, Medical Admissions Unit, etc.) 02XX Following a domiciliary visit 03XX Referral from General Medical Practitioner (for out-patient or other non-emergency referrals) 05OP Referral from out-patients by a consultant, other than in an A&E department 05IP - Referral of an in-patient by a consultant 05SS Referrals from screening services 06XX Self-referral (i.e. the patient was not seen previously by a GP) 08 XX Other source of referral (will include referrals from Private Healthcare) 10XX Following an A&E attendance (i.e. an out-patient clinic attendance after an A&E visit) 92XX General Dental Practitioner 93 XX Community Dental Service 99XX Not known Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 7 of 49

8 2. REFERRAL (continued) *2.2 Trust site code The unique code identifying the Trust and site. The trust at which the MDT is based that first enters patient data To enable analysis by Trust code. First 3 characters equal the Trust provider last two the site 5 alpha/numeric *2.3 Referred to The person to whom the referral is made. If the referral is to a team, then this refers to the first consultant seen. To monitor the proportion of cancer patients referred to a cancer site specialist or a cancer site specific team. NHS Data Manual GMC number of consultant *2.4 Date of referral The date on which the referral was made. Date on the letter/fax/electronic form from referring GP or other hospital department Date of telephone call from referring GP or other hospital department. Date of cross-referral, where patient is already in hospital. The date of admission to hospital in the case of patients coming in as emergencies The date of the first out-patient appointment, if the referral was a self referral. Date on the recall letter for patients recalled following a routine screening appointment. To establish the date on which the referring clinician first initiates referral to the specialist involved in the diagnostic process. To identify length of delay in the handling of referrals Audit for minimum standards. Date format dd/mm/ccyy Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 8 of 49

9 2. REFERRAL (continued) *2.5 *2.6 Date of receipt of referral The date that the referral request is received by the provider. [Applies to all referral routes, not just from primary care] Date when letter/fax/electronic form is received. In the case of a written referral, this should be the date on which the letter/fax arrived in the hospital. The most likely source of this date will be a date stamp of the receiving department on the referral letter. Date of verbal request. Date of admission to hospital in the case of patients admitted as an emergency The date of the first out-patient appointment, if the referral was a self referral Priority of Referral The urgency status as specified by the consultant at the time of initial referral. This is only relevant for a referral from primary care. [Following the pilot of GP referral guidelines, decision of urgency will eventually move to the GP] To establish the start date for the specialist-based diagnosis and management process. To identify length of delay in the handling of referrals. Audit for minimum standards. To monitor the 10 working day target (but only for patients with a working diagnosis of cancer) where patients classified as urgent should be seen within 10 working days of receipt of the referral at the hospital. It will also be possible to derive the proportion of cancer patients arising from urgent and non-urgent categories. Date format dd/mm/ccyy 2 numeric 01 = Non-urgent referral classified by consultant 02 = Urgent referral classified by consultant Audit of minimum standards. Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 9 of 49

10 2. REFERRAL (continued) *2.7 Date of 1 st offered appointment The first appointment date offered to the patient To measure the period between receipt by the trust of the referral and first offered appointment for assessment Date format dd/mm/ccyy Audit for minimum standards. *2.8 Date first seen The date of the first outpatient attendance or date of first booked diagnostic procedure or acute admissions date, if first presentation by this means. Record the date of the patient s first contact with the person or group in referred to : Date of first outpatient attendance Date of outpatient visit when a diagnosis of cancer was first considered (out-patient visit for some other condition) Date the patient is first seen by the specialist team in hospital for within-hospital referrals Date of first booked diagnostic procedure if this precedes the first outpatient appointment Date seen as an emergency, if the patient was first seen as an emergency Date the patient was first seen following recall by screening unit. To measure any delay between 1 st offered appointment and first assessment by the MDT Audit for minimum standards. Date format dd/mm/ccyy Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 10 of 49

11 2. REFERRAL (continued) *2.9 Reason for delay in attendance The reason why a patient who was referred with an urgent priority was not first seen within 10 working days of receipt of the GP referral at the hospital. Note: there can be more than one reason for delay recorded Date of referral to Specialist Centre (if different from 1 st hospital referred to) Date of initial visit to specialist centre (if different from 1 st hospital referred to) or date of discussion at the specialist MDT Date of referral to a clinical member of the specialist MDT for the illness that was finally diagnosed as upper gi cancer from the referring source. Date of referral from GP (as above) if referred directly to specialist unit on grounds of clinical suspicion where diagnosis has not been previously made. Date of the first contact with a member of the upper gi cancer specialist team (or his/her appointed deputy) for the illness that was finally diagnosed as upper gi cancer. Date of 1 st hospital appointment (as above) if 1 st appointment is with specialist centre OR Date of specialist outpatient visit when a diagnosis of upper gi cancer was first considered (eg the development of a new symptom or sign in a patient under routine follow-up for another condition) OR Date when the upper gi cancer specialist first saw an IP referred internally from another specialty, OR Discussion at the specialist MDT. To provide ability to remove from any analysis, patients who did not meet the ten working day target, those patients who chose not to attend within 10 working days and to record other reasons for the delay. To establish the start date for the specialist based diagnostic and management process. To measure delay between referral and first assessment by the upper gi specialist team. To help identify organisational and resource issues leading to unacceptable delays. 0 - No delay 1- Patient choice 2 - Clinical Reason 3 - Logistic Reason 4 - DNA - reason unspecified 5 - Other 6 - Not applicable Multiple responses possible Date format dd/mm/ccyy Date format dd/mm/ccyy Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 11 of 49

12 3. KEY INVESTIGATIONS *3.1 Consultant responsible at the time of the initial diagnostic investigation(s) GMC number of consultant at the time of the initial diagnostic investigations. To allow tracking through the clinical pathway. To meet requirements of Clinical Governance. GMC number of consultant 7 numeric *3.2 Staging investigations indicator Were any staging investigations performed? Y Yes N - No 3.21 Type of staging investigation The type of investigation performed to Clinical staging Yes / No determine stage: Radiological staging Yes / No Surgical staging Yes / No *3.3 Investigation(s) performed The investigation (s) that have contributed materially to the staging / diagnosis. To estimate the level of accuracy of the recorded stage when accounting for casemix factors and outcome analysis Endoscopy Biopsy / cytology Other biopsy/cytology Imaging: Contrast studies Ultrasound CT MRI EUS Laparoscopy Laparoscopic ultrasound Peritoneal cytology PET Isotope imaging Chest X-ray Other 3.31 Result of investigations performed. The result of the investigations performed as part of the staging process once upper GI cancer has been diagnosed and prior to a treatment decision being made. Audit of use and value of methods for assessment of tumour spread prior to radical surgery. [codes to be determined] Normal Abnormal, suggestive of cancer Abnormal, not suggestive of cancer Not known Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 12 of 49

13 3. KEY INVESTIGATIONS [continued] *3.4 Date of investigation (s) Date the test(s) took place Audit for minimum standards Date format dd/mm/ccyy Reasons for not performing curative resection To record the precise reason why curative resection was not offered to the patient. Functional capacity Recordings of data giving measures of preoperative organ function Audit of minimum standards. 1 More localised procedure deemed adequate for cure 2 convincing staging evidence of distant metastases 3 convincing staging evidence of inoperable local spread 4 Patient considered unfit for curative resection 5 Patient preference 6 Complete response to neoadjuvant therapy and patient preference 7 Poor response to neo-adjuvant therapy not for surgery 8 Other, specify Risk adjusted analysis of mortality related data Multiple choice ( X.XX)FEV1 (Litres) (X.XX)FVC(Litres) (%)LV Ejection Fraction (g/dl) Albumin (X.X)paO2 (kpa) on air Stress Test Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 13 of 49

14 3. KEY INVESTIGATIONS [continued] 3.7 Preoperative (physiological) POSSUM score For each of the physiological components in the table below, the first category scores 1 point, the second 2, the third 4 and the fourth 8 (e.g. for GCS <9 scores 8 points: physiological score = sum of all 12 category scores (therefore minimum score is 12. Risk adjusted analysis of mortality related data Integer Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 14 of 49

15 4. DIAGNOSIS *4.1 Date of diagnosis This field records the date of diagnosis of the tumour. It is required with the date of birth to derive the age at diagnosis and is used in the analysis of incidence trends and in the calculation of survival rates. The definition provided conforms with the international requirements specified by the European Network of Cancer Registries (ENCR). To calculate annual incidence rates and to determine the start date for survival analysis. Audit for minimum standards Date format dd/mm/ccyy Order of declining priority: 1. Date of first histological or cytological confirmation of this malignancy (with the exception of histology or cytology at autopsy). This date should be, in the following order: a. date when the specimen was taken b. or date of receipt by the pathologist c. or date of the pathology report 2. Date of admission to hospital because of this malignancy. 3. When evaluated at an outpatient clinic only: date of first consultation at the outpatient clinic because of this malignancy. 4. Date of diagnosis, other than 1, 2 or Date of death, if no information is available other than the fact that the patient has died because of malignancy. 6. Date of death, if the malignancy is discovered at autopsy. Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 15 of 49

16 4. DIAGNOSIS [continued] *4.2 Basis of diagnosis This field records the eligibility of the tumour for registration based on the best source of information known to the Trust and allows derivation of the degree of certainty of diagnosis. It is therefore an indicator of data quality, with microscopic histological verification being viewed as the gold standard diagnosis. The definition provided conforms with the international requirements specified by the European Network of Cancer Registries (ENCR). To establish the certainty of diagnosis and in particular the histological confirmation rate for epidemiological analyses. For cancer registration (WCISU) and internal audit. Non-microscopic 0 - Death Certificate (The only information available is from a death certificate) 1 Clinical (Diagnosis made before death but without the benefit of any of the following (2-7)) 2 - Clinical Investigation (Includes all diagnostic techniques (e.g. X-rays, endoscopy, imaging, ultrasound, exploratory surgery and autopsy) without a tissue diagnosis) 3 - Specific tumour markers (Includes biochemical and/or immunological markers which are specific for a tumour site) Microscopic 5 Cytology (Examination of calls whether from a primary or secondary site, including fluids aspirated using endoscopes or needles. Also including microscopic examination of peripheral blood films and trephine bone marrow aspirates). 6 - Histology of a metastases (Histological examination of tissues from a metastasis, including autopsy specimens) 7 - Histology of a primary tumour (Histological examination of tissue from the primary tumour, however obtained, including all cutting and bone marrow biopsies. Also includes autopsy specimens of a primary tumour) 9 Unknown (No information on how the diagnosis has been made (e.g. PAS or HISS record only)) Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 16 of 49

17 4. DIAGNOSIS [continued] *4.3 Date GP informed of diagnosis The date that the diagnosis is communicated to the GP. Date when letter/fax/ is written. Date of telephone call. Date of face-to-face communication with GP *4.4 Method of communication of diagnosis to GP *4.5 Date patient informed of diagnosis The method by which the GP is informed of the diagnosis Date of confirmation of malignancy to the patient. Audit for minimum standards Date format dd/mm/ccyy Audit for minimum standards 01 Letter via post 02 Fax Face-to-face 05 Telephone 06 Letter via patient 07 Not specified Audit for minimum standards Date format dd/mm/ccyy 4.51 Clinical Nurse Specialist Was an upper GI cancer clinical nurse specialist available or present when the patient was informed of their diagnosis? Audit for minimum standards Y Yes N No If No please state reason Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 17 of 49

18 4. DIAGNOSIS [continued] *4.6 Primary Site (SITE SPECIFIC ADVICE FROM CANCER SITE STEERING GROUP) It is recognised that it is difficult to differentiate between Lower 1/3 oesophagus and Type 1 gastro-oesophageal junction, and note should be taken of the histological morphology. *4.7 Laterality DEFAULT TO N NOT APPLICABLE The site of the primary cancer for which the patient is receiving care. Unknown primary must be recorded if site not known. The laterality of the primary tumour (where applicable) (Record the laterality, which is used to differentiate tumours in paired organs. For sites where laterality is required, but the laterality is not known, then record U for Unknown. For sites where laterality is not required, record N for Not applicable.) To establish the numbers of various cancers to enable calculation of annual incidence rates. To allow for an assessment of subsequent treatment and outcome rates To differentiate tumours in paired organs. WCISU ICD10 and/or other If other - must map to ICD10 4 character XXX.X Oesophagus Upper 1/3 Mid 1/3 Lower 1/3 Gastro-oesophageal junction Type 1 Type 2 Type 3 Stomach Fundus Body Antrum Codes to be determined 1 character N - Not applicable (Not applicable to Upper GI cancers) Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 18 of 49

19 4. DIAGNOSIS [continued] *4.8 Performance status The patient s performance status, to be recorded at the MDT meeting prior to the beginning of treatment. Note that a different index would be required for children. Performance status using the WHO / ECOG scoring system Nutritional support Did the patient see a member of the nutritional support team? To allow for performance status to be taken into account in the analysis of treatment and outcome To monitor whether patients had access to a member of the nutritional support team. 2 numeric 00- Able to carry out normal activity without restriction Restricted in physically strenuous activity but ambulatory and able to carry out light work Ambulatory and capable of all self-care but unable to carry out any work up and about >50% of waking hours Capable of only limited self care, confined to bed or chair >50% of waking hours Completely disabled, cannot carry out any self care, totally confined to bed or chair. 05 Not recorded Y Yes N No For audit of standards If Yes please state date seen Date format dd/mm/ccyy Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 19 of 49

20 4. DIAGNOSIS [continued] 4.82 Nutritional support provided Was any nutritional support given? To monitor whether patients had access to a member of the nutritional support team. For audit of standards Oral Enteral Parenteral Not known 4.83 Pre-treatment stage The best assessment of stage of disease based on the information available to the gastrooesophageal MDT at the time of making the management plan [TNM]. Cancer registries require the first pretreatment stage i.e. the stage at diagnosis. *4.9 Final staging Most detailed (final) staging available after all diagnostic tests and surgical treatment, where this is the first treatment and contributes to the pathological information. To allow for pre-treatment stage to be taken into account in the analysis of treatment and outcome. Please state date support commenced UICC TNM Classification of Malignant Tumours 5 th Edition To allow for disease stage to be taken into account in the analysis of survival UICC TNM Classification of Malignant Tumours 5 th Edition If the malignancy is discovered only at autopsy, or via a death certificate, then no pre-treatment TNM stage will be recorded. Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 20 of 49

21 4. DIAGNOSIS [continued] *4.10 Histology [SITE SPECIFIC ADVICE FROM CANCER SITE STEERING GROUP] The cell type of the malignant disease Key prognostic indicator. To determine the incidence of different cell types of malignancy for epidemiological purposes. Audit for Minimum Standards Mappable to SNOMed which in turn maps to ICD coding. 0 Normal/Benign 1 ACA 2 HGD 3. GIST (gastrointestinal stromal tumour 4 Leiomyoma 5 Leiomyosarcoma 6 Lymphoma 7 Neuroendocrine 8 SCC 9 Melanoma 10 Undifferentiated 11 Indeterminate/insufficient tissue 12 Other, specify Coding to be confirmed Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 21 of 49

22 4. DIAGNOSIS [continued] 4.10a Pre-treatment histological diagnosis Histological diagnosis of tumour (preoperative e.g. after endoscopy) To identify the pre-operative diagnosis and to identify how the histology of the tumour interacts with outcomes in the treatment of gastro-oesophageal cancer. This enables teams to capture the morphologies for those cancers which are inoperable as well as those which are operable. 0 Normal/Benign 1 ACA 2 HGD 3. GIST (gastrointestinal stromal tumour 4 Leiomyoma 5 Leiomyosarcoma 6 Lymphoma 7 Neuroendocrine 8 SCC 9 Melanoma 10 Undifferentiated 11 Indeterminate/insufficient tissue 12 Other, specify Coding to be confirmed Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 22 of 49

23 5. CANCER MANAGEMENT PLAN *5.1 Was this cancer management plan discussed at an MDT meeting? To record the fact that the care of this patient was formally reviewed by a specialist team. A multidisciplinary team (MDT) is a group of specialists, working together under appropriate leadership to achieve an accurate speedy diagnosis, and decide implement and monitor effective treatment and care as determined by locally and nationally agreed evidence-based guidelines and protocols. Audit of minimum standards Y Yes N - No *5.2 The date of the MDT meeting at which the cancer management plan was first discussed *5.3 Cancer Management Plan intent The date that cancer care plan was first discussed by the specialist team. (Site specific descriptions will apply) The intention of the treatment being planned. Curative High Grade Dysplasia, T1S, T1N0 Potentially Curative treatment aimed at cure, but uncertain Palliative anti-cancer treatment given with the intention of symptom control or disease control Audit for minimum standards. Date format dd/mm/ccyy To monitor treatment outcome against local clinical policies and guidelines. To enable analysis of treatment planned versus treatment given. C Curative PC Potentially Curative P Palliative N - No specific anti-cancer treatment E - Endoscopy only U Unknown Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 23 of 49

24 5. CANCER MANAGEMENT PLAN [continued] *5.4 Reason for no specific anticancer treatment The reason for no specific anti-cancer treatment at the date of the MDT meeting. Note that this will be a multiple response item i.e. any number of reasons may be recorded. To monitor the reasons why cancer patients received no specific anti-cancer treatment. *5.5 Management modality What treatment(s) are planned for the patient To determine the number of patients undergoing each primary treatment. To determine patterns of primary treatment. To enable analysis of discrete groups of patients particularly where several modalities are used. *5.6 Treatment type sequence The sequence of the treatment(s) above To determine patterns of primary treatment 1, 2, 3 etc. 2 numeric 01 Patient declined treatment 02 - Unfit: poor performance status 03 Unfit: significant co-morbidity 04 Unfit: advanced stage cancer 05 - Unknown Primary Site 06 - Died before treatment 07 - No anti-cancer treatment available 08 Other 09 Watchful waiting 99 Reason not known [multiple responses possible] 2 numeric 01 - surgery 02 - radiotherapy 03 - chemotherapy 04 - hormone therapy 05 - specialist palliative care 06 - brachytherapy 07 biological 08 active monitoring 09 other 10 endoscopic/pdt 99 - unknown Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 24 of 49

25 5. CANCER MANAGEMENT PLAN [continued] *5.7 Date of start of first definitive procedure *5.8 Responsible Consultant for each modality Date of the start of the first definitive procedure which may be surgery, radiotherapy or chemotherapy and other drugs but not examination under anaesthetic which is considered as staging. The consultant in overall charge of each treatment modality. SURGERY Surgeon RADIOTHERAPY Oncologist CHEMOTHERAPY Oncologist GASTROENTEROLOGIST PALLIATIVE CARE PHYSICIAN Audit for minimum standards Date format dd/mm/ccyy To allow tracking through the clinical pathway. To meet requirements of Clinical Governance. 7 numeric GMC number of each consultant *5.9 Trust and unit identifiers for each modality The unique code identifying the Trust and site. Required to bring together all activities for a patient, which may be carried out by different service providers. To enable reports and analysis by hospital and/or cancer network. To allow tracking through clinical pathway First 3 characters equal the Trust provider, last two the site 5 alpha/numeric Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 25 of 49

26 5. CANCER MANAGEMENT PLAN [continued] *5.10 Any significant co-morbidity / clinical feature The nature of any relevant co-morbidity, to be recorded at the MDT meeting prior to the beginning of treatment. Note that a different index would be required for children. [Excludes the stage of the primary tumour] To allow co-morbidity to be taken into account in the analysis of treatment and outcome. Y Yes N - No If Yes, please specify nature: COPD Other respiratory diseases Cardiovascular disease Dementia / cerebrovascular disease Other malignancy Renal Hepatic Muscular/skeletal Other 5.10a Any significant co-morbidity / clinical feature - ASA Grade of case The American Society of Anaesthesiologists grading [codes to be determined] Analysis of mortality related data 1 character 1 Grade I (a normally healthy individual) 2 Grade II (a patient with mild systemic disease) 3 Grade III (a patient with severe systemic disease that is not incapacitating) 4 Grade IV (a patient with incapacitating systemic disease that is a constant threat to life) 5 Grade V (a moribund patient who is not expected to survive 24 hours with or without an operation) 9 Unknown Add E as suffix for emergency operation Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 26 of 49

27 5. CANCER MANAGEMENT PLAN [continued] *5.11 Specialist nurse seen Has the patient seen a cancer specialist nurse Audit of minimum standards 1 character Y Yes N No U Unknown If Yes, please state date seen Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 27 of 49

28 6. SURGICAL TREATMENT *6.1 Surgical intent The purpose of the surgical procedure(s) being carried out To enable analysis by treatment intent D Diagnostic PC Potentially curative P Palliative *6.2 Surgical procedure(s) carried out The surgical intervention carried out To determine type of surgery performed to enable analysis of surgically related data. Oesophageal resection Ivor Lewis (2 stage) 3 Stage Transhiatal Left thoracic/abdominal Gastric resection Total gastrectomy Sub total gastrectomy Local excision of tumour No resection performed: Open/close Laparotomy Open/close Thoracotomy Bypass oesophageal Bypass gastreic Other 6.21 Intraoperative nutritional support Was any intraoperative nutritional support given To use this casemix factor in the analysis of treatment outcomes Mappable to OPCS-4 Feeding jejunostomy Parenteral feeding Other Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 28 of 49

29 6. SURGICAL TREATMENT [continued] * Date on which surgical procedure(s) was started The date that the surgical procedure was started. Urgency of Surgery Whether surgical procedure was performed electively or as an emergency To determine the time interval between referral & diagnosis by the specialist team & start of surgical treatment, & to measure survival time from start of treatment. To enable the date of first definitive treatment to be recorded Audit for minimum standards. To identify mortality/morbidity with relation to urgency of surgery and associated factors. Date format dd/mm/ccyy Elective Emergency (in hours) Emergency (out of hours) Surgeon Code GMC number main operation surgeon To identify particular surgeons GMC number of main operating surgeon Extended Resection Whether any other organs were removed at time of surgery because of tumour invasion (T4) or for other reasons. Multiple choice. Determination of survival/morbidity in relation to multi-organ resection. Mappable to ICD10 None Crura Diaphragm Liver Lung Pericardium Spleen (iatrogenic) Spleen (oncological) Pancreas Colon Adrenal Gallbladder HH sac Ovary Pleura Stomach Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 29 of 49

30 6. SURGICAL TREATMENT [continued] Extended Resection (continued) Nodal Dissection Type of nodal dissection carried out (extended or limited. For full definition of gastrectomy dissecton types see manual of the Japanese Society for Gastric Cancer Research (2 nd Edition). Determination of survival/morbidity in relation to level of nodal dissection Reconstruction Type of reconstruction performed at surgery. Determination of survival/morbidity in relation to type of reconstruction performed. Oesophagus Duodenum Other(specify) Multiple choice For gastrectomy: record either D1 = removal of all nodes in the gastric and gastro-epiloic arcades adjacent to the segment of stomach removed. D2= D1 plus all the nodes along the left gastric, common hepatic and splenic arteries far as their first major division. D3= D2 plus all nodes in the porta hepatis, around the pancreas and at the oesophageal hiatus. For Oesophagectomy record either: 1-field (upper abdominal) 2-field (Post mediastinum) 3-field (Cervical) Gastroduodenostomy Billroth I Gastrojejunostomy BillrothII Billroth II & Roux en y End side oesophago-jejunostomy Interposed jejunum Neogastric pouch Oesophagogastrectomy Colon interposition None Other Mappable to OPCS4 Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 30 of 49

31 6. SURGICAL TREATMENT [continued] 6.9 Anastomosis Whether anastomosis was stapled or sutured. Determination of outcome and morbidity related to type of anastomosis. Stapled Sutured 6.10 Duration of Operation Length of operation (incision to last suture) Risk adjustment evaluation of effect on duration of surgery on morbidity and mortality Integer (minutes) 6.11 Blood loss (mls) Amount of blood loss at surgery (mls) Determination of survival/morbidity in relation to blood loss at surgery. Integer (mls) Days in ITU and HDU; days in critical care Number of days spent in ITU/HDU following should include both postoperative (routine/elective) and other (emergency/unplanned) days during hospital stay which includes operation. Operative POSSUM Score Score for operative factors predictive of morbidity and mortality. Outcome measure Integer Number of days in ITU Number of days in HDU To allow risk adjusted prediciton of outcome Total number of days in critical care (auto-calculation of above two items) Integer Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 31 of 49

32 6. SURGICAL TREATMENT [continued] Total POSSUM Score Total of operative and physiological possum scores. Date of Discharge Date the patient was discharged following surgery. Post Operative Stay (Days) Number of days patient in hospital following surgery. 30 day mortality Death from any cause within 30 days of the primary operation To allow risk adjusted prediciton of outcome. To determine length of post operative stay. Automatically calculated field. DDMMYYYY Outcome measure Autocalculated Determination of 30 day mortality Yes No Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 32 of 49

33 6. SURGICAL TREATMENT PATHOLOGY Histology The cell type of the malignant disease To determine the incidence of different cell types of malignancy for epidemiological purposes. Final (post-operative) staging T stage Final (post-operative) staging N Stage Final (post-operative) staging M Stage Node numbers number identified Worst staging (including pathology) available after all diagnostic tests and agreed by the MDT. [TNM or other] The absence or presence and extent of regional lymph node metastases. To allow for the final TNM stage (or other) to be taken into account in the analysis of treatment and outcome. Staging and prognosis: RCP Staging outcome analysis. The absence or presence of distant metastases. Staging and prognosis: RCP Staging outcome analysis. Total number of lymph node samples, regardless of site or size. RCP minimum data set for upper GI cancer. Determination of the number of lymph nodes sampled for histological inspection used for determination of spread/staging. Gastric target yield of over 15 regional lymph nodes allows a full lymph node status to be assigned. 0 Normal/Benign 1 ACA 2 HGD 3. GIST (gastrointestinal stromal tumour 4 Leiomyoma 5 Leiomyosarcoma 6 Lymphoma 7 Neuroendocrine 8 SCC 9 Melanoma 10 Undifferentiated 11 Indeterminate/insufficient tissue 12 Other, specify Mappable to ICD10 UICC coding to be used (5 th edition) UICC coding to be used (5 th edition) UICC coding to be used (5 th edition) 2 numeric Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 33 of 49

34 6. SURGICAL TREATMENT PATHOLOGY Node number positive/cancer Total number of positive lymph nodes reported at histological inspection. Must be equal to, or less than the number of lymph nodes sampled. Margin Involvement Whether histological evidence shows tumour cells within 1mm of the relevant resection margin. (1mm rule only relates to the circumferential margin of oesophageal tumours) Size of tumour (mm) Length of tumour (mm) and width of tumour (mm) O/G Junction Position of epicentre of tumours involving the junction of stomach and oesophagus: Type I tumours arise in the oesophagus within 5cm of the OG junction. Type II tumours arise at the OG junction and Type III tumours arise in the gastric cardia within 2 cm of the OG junction. RCP Minimum Data set for Upper GI cancer. Determination of the number of lymph nodes found positive on histological inspection. RCP Minimum data set for upper GI cancer. To confirm whether surgery is potentially curative (microscopic examination of all surgical margins reveal no evidence of carcinoma). Strongest predictor of survival. Blocks remote from tumour can exhibit wide infiltration beyond the macroscopic margins. Royal College of Pathologist Minimum Dataset for upper GI cancer. Gross measurements do not have special biological significance but the dimensions are useful for correlation with endoscopic and imaging findings. The size and position of oesophageal tumours will allow their location with respect to the GOJ to be determined. To document Siewert class of junctional tumours 2 numeric Proximal Yes No Distal Yes No Circumferential Yes (oesophageal No tumours only) Floating point L x W State whether specimen is Formulin fixed Fresh Type I Type II Type III Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 34 of 49

35 6. SURGICAL TREATMENT PATHOLOGY 6.27 Differentiation Grade of differentiation identified on definitive histology report. To evaluate histological differentiation, which may have prognostic significance or guide radicality of resection. GX grade of differentiation cannot be assessed. G1 Well differentiated G2 Moderately differentiated G3 Poorly differentiated G4 Undifferentiated 6.28 Post-operative minor complications 6.29 Post-operative major complications Minor complications: a complication that did not require re-operation, ITU/HDU care or interventional radiology. Major complications: a complication that requires re-operation, interventional cardiology or ITU/HDU care. Audit and outcome Wound infection Urinary tract infection Prolonged ileus Pleural effusion Cardiac arrhythmia Audit and outcome Anastomotic leak ARDS Pneumonia/chest infection Prolonged ventilation Pulmonary embolism Tracheostomy Myocardial infarction Cardiac failure Septicaemia Renal failure Chylothorax Abscess Bowel obstruction Duodenal stump leak Gi fistula Wound dehiscence Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 35 of 49

36 7. CHEMOTHERAPY *7.1 Date treatment started Record the date on which the first dose of the drug is administered on the patient. *7.2 Treatment intent The intended outcome of treatment Radical (curative): with curative intent: any treatment where long-term survival is the aim of a significant proportion of patient s care Palliative: any treatment where the clear intention is to improve symptoms and possibly prolong life but where long-term survival is unlikely. Unknown: it is highly unlikely that any administration would be undertaken where the intention is unknown. The use of this code should be monitored To measure the time intervals from diagnosis and referral to starting treatment and to measure survival time from start of treatment. To enable the date of first definitive treatment to be recorded. To establish the frequency of different treatment intents. To monitor treatment related outcomes. To assess patterns of chemotherapy or other drug therapy practice for comparison with best practice guidelines. Date format dd/mm/ccyy 1 character Radical (curative) Palliative Unknown Codes to be determined 7.2a Treatment sequence The sequence of the planned treatment. Abjuvant: an adjunct to a potentially ablative local treatment. Neo adjuvant: an adjuvant treatment given prior to a potentially ablative local treatment. To establish the frequency of different treatment intents. To monitor treatment related outcomes. To assess patterns of chemotherapy or other drug therapy practice for comparison with best practice guidelines 1 Adjuvant 2 Neoadjuvant 3 Concurrent with RT Codes to be determined Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 36 of 49

37 7. CHEMOTHERAPY (continued) *7.3 Drug therapy type The type of drug therapy administered To establish patterns of drug therapy treatment 1 character C Chemotherapy H Hormone/endocrine therapy I Immunotherapy O Other *7.4 Number of cycles planned The number of cycles of chemotherapy intended at the time of the initial management decision To establish the appropriateness of initial decisions and the proportion of patients receiving the intended treatment 2 numeric *7.5 Number of cycles given The total number of cycles of chemotherapy administered. *7.6 Reason for change to the number of cycles planned To record whether the treatment was delivered as planned. To establish the appropriateness of initial decisions and the proportion of patients receiving the intended treatment To establish the appropriateness of initial decisions and the proportion of patients receiving the intended treatment 2 numeric N No change C - Change If change was made to the number of cycles planned, please give the reason 1 Toxicity 2 Patient refusal 3 Progressive disease 4 Death 5 Other 7.7 Re-staging after chemotherapy The TNM staging if chemotherapy is neoadjuvant, adjuvant or definitive To establish if tumour stage has changed TNM staging as per UICC coding 5 th Edition Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 37 of 49

38 8. RADIOTHERAPY *8.1 Date treatment started The date on which the patient receives the first radiotherapy treatment. *8.2 Treatment intent Intended outcome of treatment Radical (curative): with curative intent: any treatment where long-term survival is the aim of a significant proportion of patient s care Palliative: any treatment where the clear intention is to improve symptoms and possibly prolong life but where long-term survival is unlikely. Unknown: it is highly unlikely that any administration would be undertaken where the intention is unknown. The use of this code should be monitored To enable the measurement of the interval from referral to starting of treatment To assess patterns of radiotherapy practice for comparisons with the best practice guidelines Date format dd/mm/ccyy 1 character Radical (curative) Palliative Unknown Codes to be determined 8.2a Treatment sequence The sequence of the planned treatment. Abjuvant: an adjunct to a potentially ablative local treatment. Neo adjuvant: an adjuvant treatment given prior to a potentially ablative local treatment. To establish the frequency of different treatment intents. To monitor treatment related outcomes. To assess patterns of chemotherapy or other drug therapy practice for comparison with best practice guidelines 8.2b Concurrent chemotherapy Was concurrent chemotherapy given? Y - Yes N - No 1 - Adjuvant 2 Neoadjuvant Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 38 of 49

39 8. RADIOTHERAPY (continued) *8.3 Anatomical Treatment Site The part(s) of the body to which the prescription was administered To establish the patterns of radiotherapy treatment for comparison with best practice guidelines Primary Nodes Distant Multiple choice possible *8.4 Radiotherapy prescribed dose Total dose Total dose prescribed To establish the patterns of radiotherapy treatment for comparison with best practice guidelines [Codes to be determined] NHS Data Dictionary *8.5 Number of fractions planned The total number of fractions planned To establish the patterns of radiotherapy treatment for comparison with best practice guidelines. NHS Data Dictionary *8.6 Duration (days) of treatment course The total number of days over which the treatment was given. To establish the patterns of radiotherapy treatment for comparison with best practice guidelines. NHS Data Dictionary *8.7 Actual dose The total number of fractions given To establish the patterns of radiotherapy treatment for comparison with best practice guidelines. NHS Data Dictionary *8.8 Number of fractions given The total number of fractions given To establish the patterns of radiotherapy treatment for comparison with best practice guidelines. NHS Data Dictionary Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 39 of 49

40 8. RADIOTHERAPY [continued] *8.9 Change in fraction numbers/incomplete prescriptions Comparison of planned and actual treatment Completeness of prescribed treatment and the reason why the planned treatment was not given Re-staging after radiotherapy The TNM staging after radiotherapy completed To monitor the reasons for changes in planned treatment. To establish if tumour stage has changed Y Yes N No ND Not done 2 character 00 - Treatment completed as prescribed 01 - Patient died 02 - Progressive disease during RT 03 - Acute RT toxicity 04 - Technical or organisational problems 05 - Patient choice (stopped or interrupted treatment) 06 - Not known (yptnm staging) Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 40 of 49

41 9. PALLIATIVE CARE *9.1 Date first seen by a member of the specialist palliative care team The date on which the patient was first seen by a member of the specialist palliative care team Audit for minimum standards Date format dd/mm/ccyy Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 41 of 49

42 T. OTHER TREATMENT MODALITIES T.1 Date treatment started The date on which the patient receives the treatment. To enable the measurement of the interval from referral to starting of treatment Date format dd/mm/ccyy T.2 Endoscopic Treatment To determine whether endoscopic treatment was carried out. To assess standards of palliative endoscopic therapy 0 No 1 - Yes T.3 Type of treatment The type of procedure carried out To determine performance analysis of treatment performed Expanding metal stent (covered / uncovered) Other stents Brachytherapy Ethanol injection Diathermy Laser PEG PDT Dilatation Other T.4 If Other, Endoscopic treatment, specify To determine what type of endoscopic treatment was carried out. To assess standards of palliative endoscopic therapy Multiples need to be able to be recorded Codes to be determined Free text Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 42 of 49

43 T. OTHER TREATMENT MODALITIES T.5 Endoscopic Treatment by To identify the clinician who carried out the endoscopic treatment was carried out. To assess standards of palliative endoscopic therapy 1 Radiologist 2 Physician 3 - Surgeon T.6 Endoscopic Treatment morbidity To record whether any morbidity of endoscopic treatment was encountered. To use this casemix factor in the analysis of treatment outcomes 0 None 1 Perforation 2 Bleeding 3 Other, specify T.7 If Other Endoscopic Treatment Morbidity, specify To record any other type of morbidity. To use this casemix factor in the analysis of treatment outcomes Text Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 43 of 49

44 10. COMPLETION OF PRIMARY TREATMENT *10.1 Completion of primary treatment record *10.2 Date primary treatment is completed [Field to be completed at the end of primary treatment] Complications/toxicity Any morbidity, relevant to previous treatments that the patient has received, recorded at any subsequent patient contact (during the period primary treatment).. To enable a clear cut-off for patients to include in reporting timeframe. To determine patterns of adverse events associated with a treatment. Date format dd/mm/ccyy For surgery: anastomotic stricture For Chemotherapy 3 - moderate toxicity 4 - severe toxicity 5 - death due to toxicity For Radiotherapy 3 - moderate toxicity 4 - severe toxicity 5 - death due to toxicity Codes to be determined Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 44 of 49

45 11. CLINICAL TRIALS *11.1 Name of approved clinical trial (SITE SPECIFIC ADVICE FROM CANCER SITE STEERING GROUP) Name of the approved clinical trial To document all approved clinical trials Audit of minimum standards. (Codes for individual trials to be determined) *11.2 Entry indicator To record the number of patients offered entry and the number of patients actually entered into an approved clinical trial To measure the number of patients offered and entered into trials. Audit of minimum standards. 1 character 1 Trial entry offered and accepted 2 Trial entry offered and declined 3 Trial entry not offered 4 Other (e.g. no trial available, ineligible) [codes to be determined] Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 45 of 49

46 12. FOLLOW-UP 12.0 Date of follow up The date of the follow-up appointment. To document patient activity Date format Dd/mm/ccyy Disease status: primary tumour The status of the primary tumour at this contact Disease status: nodal The status of the nodal metastases at this contact Disease status: metastatic The status of the distant metastases at this contact. *12.1 Disease status Was there a significant measurable or symptomatic response following initial treatment? To determine outcome in terms of disease progression/remission rates. To determine outcome in terms of disease progression/remission rates. To determine outcome in terms of disease progression/remission rates. 1 - Residual primary tumour 2 No evidence of primary tumour 3 - Recurrent primary tumour 4 - Not assessed 5 - Uncertain 1 - Residual regional nodal metastases 2 No evidence of regional nodal metastases 3 - New regional nodal metastases 4 - Not assessed 5 Uncertain 1 - Residual distant metastases 2 No evidence of metastases 3 - New distant metastases 4 - Not assessed 5 Uncertain immediately post treatment 9 - Not known To measure disease-free survival Alive with no evidence of disease Alive with disease Dead with no evidence of disease Dead with disease [Codes to be determined] Authors: All Wales Upper GI Steering Group Draft Version 7.0d Page 46 of 49