National Oesophago-Gastric Cancer
Audit
Prospective Audit Dataset:
Example data collection forms
Registered charity. No 212808
11 October 2007
Version No: Final
Issue Date: September 2007
Purpose of this document
The purpose of this document is to provide example data
collection forms for the prospective audit.
VERSION HISTORY
Version
Date created
Version description
Author
2.0
16/7/07
Revision following comments from CRG
Cromwell / Palser
2.1
23/07/07
Adjustment to oncology dataset: data to be held
on two records rather than one. Same
information collected
Cromwell / Palser
2.2
03/09/07
Comments from User Acceptance Testing
Cromwell / Palser
2.3
11/10/07
Update from Pilot – radiological endoscopic
procedures
Cromwell
For further information, contact
Dr David Cromwell for National Oesophago-Gastric Cancer Audit project team,
Clinical Effectiveness Unit, The Royal College of Surgeons of England,
35-43 Lincoln's Inn Fields, London WC2A 3PE
david.cromwell@lshtm.ac.uk
11 October 2007
1. Introduction
This document outlines the proposed dataset for the prospective audit phase of the National
Oesophago-Gastric Cancer Audit. It also describes the envisaged process of data collection as
this is intrinsically linked to contents of the dataset. The dataset is laid out on data forms so
that the link between the data items and collection process is clear. A technical description of
the dataset is also available.
The proposed dataset contains items necessary to examine the audit questions specified in the
Audit tender document issued by the Healthcare Commission, namely,
1. What are timescales of the process of care?
2. What are characteristics of patients and their cancers, relevant to treatment selection and
outcome?
3. What proportions of patients are offered radical or palliative treatment and what are the
determinants of treatment?
4. Is there an association between social deprivation and timely access to diagnosis and
therapeutic care?
5. What are the short-term outcomes of treatment?
6. What are the survival rates and levels of health status among patients at 1 year after
diagnosis and what factors explain the variation among patients?
The items in the prospective dataset relate primarily to questions 1 to 5. The date of death for
the analysis of survival will be obtained from the Office for National Statistics. Health status
will be measured using EORTC quality of life instruments in a complementary component of
the audit.
2. Design and size of the dataset
Patients with oesophago-gastric cancer present with at various stages of disease progression.
The extent of disease progression dictates the range of treatment options available and, for the
group as a whole, a wide variety of therapies may be performed. As the audit questions do not
focus on either particular patient groups (curative or palliative) or types of treatment, it has
been necessary to capture data across the whole patient pathway.
The dataset for the prospective audit consists for four components:
 Part 1 (patient details, tumour and planned treatment) concerns newly diagnosed
patients and contains data items related to their diagnosis, stage and treatment intent
 Part 2 (surgery) concerns patients who undergo either curative or palliative surgery and
contains data items on the surgical treatment and pathology results (resections only)
 Part 3 (oncology) concerns patients who undergo oncological treatment and contains
data items on neoadjuvant, adjuvant, definitive and palliative treatments.
 Part 4 (endoscopic therapy) concerns patients who undergo endoscopic therapeutic
procedures
Patients will only have one treatment record for surgery and endoscopic therapeutic procedures.
Patients will generally only have one oncology record. However, two oncology records will be
created if the patient undergoes both neoadjuvant and adjuvant therapy (oncology before and
after surgery). Not all items will be relevant to each patient.
11 October 2007
The data items in the Audit dataset have been presented as they might look on data collection
forms. A more formal description of the dataset is contained in the “Prospective Audit
Dataset” document.
Four forms have been produced, reflecting the different stages at which data will become
available along a patient’s care pathway:
 Form 1 collects data on newly diagnosed patients about their diagnosis, stage and
treatment intent
 Form 2 collects data on the surgical treatment and (for patients undergoing a resection)
pathology results
 Form 3 relates to oncological treatment, capturing data on neoadjuvant, adjuvant,
definitive and palliative treatments
 Form 4 collects data on endoscopic therapeutic procedures.
Data items on diagnosis, staging, and planned treatment should be collected on ALL patients.
Further data collection depends upon the treatment given to patients.
Data on the diagnosis, staging and planned treatment of ALL patients
 To be collected at, or very shortly after, the MDT meeting at which the
management plan is decided.
Data on neoadjuvant therapy, surgery and postoperative pathology
 To be collected as soon after surgery as possible. Ideally, this will be at, or
shortly after, the MDT meeting at which the outcomes of treatment are
presented.
Data on chemotherapy / radiotherapy treatment (except neoadjuvant therapy)
 To be collected at the end of the course of treatment.
Data on endoscopic palliative therapy
 Details of the first therapeutic procedure are to be collected at the time of the
procedure.
 Details of complications and any subsequent endoscopic therapeutic
procedures are to be collected 3 months after the initial endoscopic palliative
treatment
11 October 2007
National Oesophago-Gastric Cancer Audit
New Patient Registration datasheet – Page 1
Patient Details
Surname
_______________
Forename
_________________
NHS number
_______________
Postcode
_________________
Sex
Male
Female
Not specified
Date of birth
__________________
Initial Referral and Diagnosis Data
Source of referral:
GP
Hospital consultant
Priority of referral (GP referral only):
Emergency admission
Urgent
Not known
Non-urgent / other referral source
Date of first referral to local oesophago-gastric team for investigation: _________________
Date of diagnosis: _____________________
Local cancer unit where cancer was diagnosed: __________________________ ________
Diagnosis – Site
Oesophagus:
Upper 1/3
Middle 1/3
Lower 1/3
NB: cervical oesophageal tumours
are NOT included in this audit
Gastro-Oesophageal Junction (adenocarcinomas only) Siewert classification:
1
Stomach:
2
Fundus
3
Body
Antrum
Pylorus
Diagnosis – Histology
Adenocarcinoma
Squamous cell carcinoma
Adenosquamous carcinoma
Small-cell carcinoma
Undifferentiated carcinoma
Other epithelial carcinoma
Unspecified malignant neoplasm (histology not done)
NB: Non-epithelial tumours (GIST, sarcomas or melanomas) are NOT included in this audit
Staging Investigations (please tick all that apply)
CT scan
PET / PET – CT scan
Endoscopic ultrasound (EUS)
EUS Fine needle aspiration
Staging laparoscopy
Other investigation
Pre - Treatment Stage
T:
0
1
2
3
N:
0
1
2
3
x
M:
0
1
M1a
M1b
x
11 October 2007
4
x
National Oesophago-Gastric Cancer Audit
New Patient Registration Datasheet – Page 2
ECOG (WHO) Performance Status
0
Carries out all normal activity without restriction
3
Limited self care, confined to bed or chair
1
Restricted but walks/does light work
2
Walks, full self care but no work.
4
Fully disabled, confined to bed/chair
Up and about >50% of the time
5
Not recorded
for >50% waking hours
Comorbidities (please tick all that are appropriate)
Cardiovascular disease
Chronic respiratory disease (including COPD / asthma)
Chronic renal impairment
Liver failure or cirrhosis
Diabetes
Cerebro/periph vascular
Barrett’s oesophagus
Mental illness
Other significant condition
Treatment Plan
Date final care plan agreed:_____________
Treatment intent:
Curative:
Palliative anti-cancer treatment
(ie. surgery, oncological treatment, endoscopic palliation)
Palliative supportive care
(ie. non-specific symptomatic treatments, inpatient or outpatient)
Details of treatment
Curative modality
Palliative modality
Surgery only
Palliative surgery
Chemotherapy and surgery (any combination)
Palliative oncology (unspecified)
Chemo-radiotherapy and surgery (any combination)
Photodynamic therapy
(Definitive) Radiotherapy only
Endoscopic palliation therapy (unspecified)
Definitive chemo-radiotherapy
Endoscopic mucosal resection
Reason for palliative treatment (please tick all that are appropriate):
Patient declined treatment
Unfit: poor performance status
Unfit: significant co-morbidity
Unfit: advanced stage cancer
Not known
11 October 2007
National Oesophago-Gastric Cancer Audit
Postoperative Datasheet – Page 1
Patient Details (for patient identification only)
Surname
_______________
Forename
_______________
NHS number
_______________
Date of birth
_______________
Admission and Surgical Details (Main procedure only)
Hospital name: ___________________
Patient’s lead surgeon (GMC no.):_________________
Date of admission: ________________
Date of operation: _________________
Pre-operative intent of surgery: Palliative
Curative
Not known
Priority of surgery (NCEPOD):
Urgent (2)
Expedited (3)
Immediate (1)
Fitness for Surgery:
ASA grade:
1
Lung function:
FEV1% predicted _________%
2
3
Elective (4)
4
5
FVC% predicted _________%
Procedure (please tick all that apply)
Oesophageal
Gastric
- Oesophagectomy:
- Gastrectomy:
Left thoraco-abdominal approach
Total
Extended total
2 – Phase (Ivor-Lewis)
Proximal
Distal
3 – Phase (McKeown)
Completion
Merendino
Transhiatal
Wedge/localised gastric resection
Bypass procedure / Jejunostomy only
Thoracotomy (Open & Shut)
Laparotomy (Open and Shut)
Surgical Access (thoracic) – the approach used for the thoracic phase of the operation (if applicable)
Open operation
Thoracoscopic converted to open
Thoracoscopic completed
Not applicable
Surgical Access (abdominal) -the approach used for the thoracic phase of the operation
Open operation
Laparoscopic converted to open
Feeding adjunct:
Feeding jejunostomy
Laparoscopic completed
Parenteral feeding
Other
None
Other Organ removed (please tick all that apply):
Liver
Pancreas
Spleen
Other
Colon
Nodal Dissection
Oesophagectomy:
None
1 – field
2 – field
3 – field
Gastrectomy:
D0 (peri-gut resection)
D1
D2
D3
11 October 2007
National Oesophago-Gastric Cancer Audit
Postoperative Datasheet – Page 2
Postoperative complications and course (please tick all that apply)
Anastomotic leak
Respiratory:
Pneumonia
Chyle leak
ARDS
Haemorrhage
Pulmonary embolism
Cardiac complication:
Pleural effusion
Acute renal failure
Wound infection
Unplanned return to theatre?
Y
N
Death in hospital?
Y
N
Date of discharge or death: ___________________
Postoperative Pathology and Staging
Site
Oesophagus:
Upper 1/3
Middle 1/3
Lower 1/3
NB: cervical oesophageal tumours
are NOT included in this audit
Gastro-Oesophageal Junction (adenocarcinomas only) Siewert classification:
1
Stomach:
2
Fundus
3
Body
Antrum
Pylorus
Histology:
Adenocarcinoma
Squamous cell carcinoma
Adenosquamous carcinoma
Small-cell carcinoma
Undifferentiated carcinoma
Other epithelial carcinoma
NB: Non-epithelial tumours (GIST, sarcomas or melanomas) are NOT included in this audit
Proximal resection margin involved?
Y
N
Unknown
Distal resection margin involved?
Y
N
Unknown
Circumferential resection margin involved? (<1mm)
Y
N
Unknown
N/A
4
x
Number of lymph nodes examined: ___________
Number of lymph nodes positive:
___________
Postoperative staging:
T:
0
1
2
3
N:
0
1
2
3
x
M:
0
1
M1a
M1b
x
History of neo-adjuvant therapy
11 October 2007
Y
N
National Oesophago-Gastric Cancer Audit
Chemotherapy / Radiotherapy Datasheet
Please fill in this datasheet for every course of oncological treatment received by a patient with
oesophago-gastric cancer. Most patients will only require one datasheet to be completed. For
patients who have both neoadjuvant and adjuvant therapy, complete two separate datasheets.
Patient Details (for identification purposes only)
Surname
_______________
Forename
_______________
NHS number
_______________
Date of birth
_______________
Hospital of treatment
Hospital where oncology treatment took place ___________________
Treatment Details
Treatment intent:
Neoadjuvant
Adjuvant
Curative
Palliative
Radiotherapy
Chemo-radiotherapy
Intended treatment modality:
Chemotherapy
Chemotherapy details (if applicable)
Radiotherapy details (if applicable)
Date first cycle started: ___________
Date first fraction started: __________
No. cycles prescribed: ___________
Total dose prescribed
Actual no. cycles given: ___________
No. fractions prescribed: ___________
Chemotherapy treatment protocol:
Total actual dose given
OEO2
MAGIC / STO 2
MacDonald
Other
___________
___________
Actual no. fractions given: ___________
Outcome of treatment:
Outcome of treatment:
Treatment completed as prescribed
Treatment completed as prescribed
Reason if incomplete
Reason if incomplete
Patient died
Patient died
Progressive disease during treatment
Progressive disease during treatment
Acute chemotherapy toxicity
Acute radiotherapy toxicity
Technical or organisational problems
Technical or organisational problems
Patient choice (stopped / interrupted treatment)
Patient choice (stopped / interrupted treatment)
Not known
Not known
11 October 2007
National Oesophago-Gastric Cancer Audit
Endoscopic / Radiological Palliative Therapy Datasheet
– Procedure Details
Please fill in this
datasheet for
every patient
with oesophagogastric cancer on the occasion of their FIRST PALLIATIVE endoscopic / radiological therapeutic
intervention.
Patient Details (for identification purposes only)
Surname
_______________
Forename
_______________
NHS number
_______________
Date of birth _______________
Treatment details
Hospital name: ______________________________________
GMC code of responsible consultant: ____________________
Date of endoscopic / radiological procedure: _______________
Dysphagia Rating Scale
0
1
2
No dysphagia
Able to eat solids
Able to eat semi-solids only
3
4
9
Able to consume liquids only
Complete dysphagia
Not known
Type of procedure (please tick all that apply)
Insertion of stent
Laser therapy
Argon beam coagulation
Photodynamic therapy
Gastrostomy
Brachytherapy
Dilatation
(Tick dilatation if it was the only procedure or if required to facilitate treatment)
Other
Is this procedure part of a planned course of multiple interventions?
Anaesthesia:
Sedation
Yes
Local anaesthetic spray
Sedation and local anaesthetic spray combined
No
Not known
General anaesthesia
Not known
Grade of endoscopist:
Consultant
Assoc. specialist / Staff grade
Registrar
Senior House Officer
Nurse specialist
Other clinician
Details of stent procedure, if inserted:
Type of stent:
Plastic
Metal: covered
Metal: uncovered
Metal: Anti-reflux
Not known
Fluoroscopic & Endoscopic
Not known
Method of stent placement:
Fluoroscopic control
Endoscopic control
Stent crosses gastro-oesophageal junction?
Yes
No
Not known
Did the stent deploy successfully?
Yes
No
Not known
11 October 2007
National Oesophago-Gastric Cancer Audit
Endoscopic / Radiological Palliative Therapy Datasheet –
Outcomes at 3 months
Use this
datasheet to
collect the
details of
complications and any subsequent palliative endoscopic/ radiological therapeutic procedures that
occur 3 months after the initial palliative intervention.
Patient Details (for identification purposes only)
Surname
_______________
Forename
_______________
NHS number
_______________
Date of birth _______________
Hospital name: __________________________________
Date of INITIAL PALLIATIVE endoscopic/radiological therapeutic procedure: __________________
Additional planned endoscopic/radiological palliation that occurred with 3 months of the initial procedure
Number of additional planned treatments
__________
Type of additional planned treatments (please tick all that apply)
Insertion of stent
Laser therapy
Argon beam coagulation
Photodynamic therapy
Gastrostomy
Brachytherapy
Dilatation
(Tick dilatation if it was the only procedure or if required to facilitate treatment)
Other
Complications of palliative endoscopic/radiological interventions and failure to control local disease
(Please tick all that apply)
Aspiration
Perforation
Haemorrhage
Stent migration
Bolus obstruction
Tumour overgrowth
Other
Death in hospital (ie patient did not leave hospital between first procedure and death
)
Additional
unplanned
endoscopic/radiological palliation procedures
Tumour
overgrowth
(due to complications of endoscopic/radiological palliation and/or tumour progression )
Number of additional unplanned interventions ____________
Type of additional unplanned intervention(s) (please tick all that apply)
Stent insertion/replacement
Laser therapy
Argon beam coagulation
Photodynamic therapy
Gastrostomy
Brachytherapy
Dilatation
Other
11 October 2007
(Tick dilatation if it was the only procedure or if required to facilitate treatment)