ociu is delivered by solutions for public health confidential & proprietary, copyright 2012,...

OCIU is delivered by Solutions for Public Health Confidential & Proprietary, Copyright 2012, Solutions for Public Health

Systemic Anti-Cancer Therapy

Chemotherapy Intelligence Unit (CIU)

Oxford

OCIU is delivered by Solutions for Public Health (SPH). © Copyright SPH, 2012

2

Background• The national collection of all cancer chemotherapy information in

the NHS in England commenced on 1st April 2012. This is in line with the requirements of the Department of Health’s policy document Improving Outcomes: A Strategy for Cancer January 2011.

• The Systemic Anti-Cancer Therapy (SACT) Information Standard:– applies to all organisations providing cancer chemotherapy

services in or funded by the NHS in England

– relates to all cancer patients, both adult AND paediatric, in acute inpatient, daycase outpatient settings and delivery in the community;

– Covers chemotherapy treatment for all solid and haematological malignancies, including those in clinical trials;


3

SACT Data Set

• The dataset consists of 6 sections:

– Section 1: Demographics & Consultant

– Section 2: Clinical Status

– Section 3: Programme & Regimen

– Section 4: Cycle

– Section 5: Drug Details

– Section 6: Outcome


4

Your CIU ContactsName Position Email Telephone Number

Kellie Peters Programme Lead / Trainer

[email protected] 01865 33472507879 813724

Regina Lally Operation Lead / Trainer

[email protected] 01865 33473407796261764

Paul Buckle Project Manager [email protected] 01865 334906

Marcia Bennett Project Manager [email protected] 01865 334740

Heather Davies Data Manager (Helpdesk)

[email protected] 01865 334783

Wayne Brown Data Manager (Helpdesk)


Jacqueline Howes Data Manager (Helpdesk)



5

Section 1: Demographic & ConsultantData Item Commentary NHS Number Primary identifier,

essential for data linkage1010101013 {BLANK}

Date of Birth Secondary identifier, and allows for analysis of provision by age

2000-01-07 {BLANK}

Gender – Current To allow analysis by Gender

1 3

Ethnicity To allow analysis by ONS categories

C Q

Patient Postcode To allow analysis of geographical patterns of care

HA1 1AA {BLANK}

Data items highlighted in bold are mandatory

This is the format required, as detailed in the SACT Data Set User Guidance v.9 published in September 2011.

If your extract does not include data on a mandatory field, the record will be produce an error message at the point of validation.


6

Section 1: Demographic & Consultant (2)Data Item Commentary

Registered GP Practice Code

This allows reporting of commissioning

X00008 X123456789

Consultant GMC Code

This allows identification of consultant team and patterns of management

D1234567 X1234567

Consultant Speciality Code

This allows analysis by speciality

146 X01

Organisational Code of Provider

This is the code of the provider initiating the programme of chemotherapy

SPH00 {BLANK}

In many cases the Demographic & Consultant data items can be imported into the system used to report SACT from the hospital PAS interface

If you report the Trust 3-digit code, all your reports will be produced at a Trust-level.


7

Section 2: Clinical StatusData Item Commentary

Primary Diagnosis ICD10: to allow analysis by tumour site

C348 {BLANK}

Morphology ICD03: is essential for some tumour sites e.g. Haematology & Lung where ICD10 is inadequate

82633 {BLANK}

Stage of Disease To allow analysis by stage, which is essential for outcome analysis

421 000

For SACT, this is the PRIMARY DIAGNOSIS at the start of the Systemic Anti-Cancer Therapy.

This is the PATIENT DIAGNOSIS for the cell type of the malignant disease recorded as part of a Cancer Care Spell.


8

Section 3: Programme & Regimen

Data Item Commentary

Programme ID To allow for sequential analysis of patient care, may start at any number to accommodate previous treatment and is unique to each patient.

03 00

Regimen Number To allow for sequential analysis of patient care, may start at any number to accommodate previous treatment and is unique to each patient.

02 00

Intent of Treatment To allow analysis by treatment intent

C X

The national codes•A Adjuvant•N Neo-adjuvant•C Curative•P Palliative


9

Section 3: Programme & Regimen (2)


Regimen To be consistent with the National Regimen List

GEMCARBO Days 1+8 {BLANK}

The National Regimen List (OPCS 4.6) is available for download from the TRUD website.

Hospitals are expected to map local/network regimen names to OPCS 4.6 for the purposes of Payment by Results, which came into affect on 1st April 2012.

The regimen name reported to SACT should be the ‘Dataset Short Version’, which is 35 characters.

Where a regimen cannot be mapped, as it is waiting to be added to the list please send your local/network regimen name.


10

Potential upload content


11

Current OPCS regimens

• Should be sent as 35 character OPCS Regimen Name (Dataset short version)

• These are mapped to SACT analysis groupings


12


13

Pending OPCS regimens

• Pending list will be added to next release of OPCS list but should be available to us in draft form in the Autumn

• In the meantime CIU will hold a temporary list of known new regimens (i.e. ones seen in downloads) mapped to SACT groupings


14

Count OPCS/SACT for analysis1148 DOCETAXEL + LENALIDOMIDE985 LOMUSTINE + VINCRISTINE783 ECX + BEVACIZUMAB611 FEC + DOCETAXEL606 CISPLATIN + DOXORUBICIN + ETOPOSIDE596 FEC 75 + DOCETAXEL528 ABVD R283 FAB LMB242 CISPLATIN + LIPOSOMAL DOX157 GEMCITABINE + RT153 INTERFERON143 EC + CAPECITABINE135 FLUDARABINE + MELPHALAN + ALEMTUZUMAB120 CAPECITABINE + RT106 CYCLO + FLUDARABINE + RITUXIMAB99 ERIBULIN92 TCCAP78 CISPLATIN + EPIRUBICIN77 CVAD/MA72 BEVACIZUMAB + INTEREFERON72 TIVOZANIB69 FULVESTRANT69 METHOTREXATE HD + CYTARABINE HD64 BEVACIZUMAB + IRINOTECAN61 AFATINIB60 BENDAMUSTINE + THALIDOMIDE60 CHOP + ALEMTUZUMAB58 OXALIPLATIN + MDG + PAZOPANIB

Examples of Regimennames that are awaiting to be added to the next iteration of the OPCS list, that have been submitted from contributing providers in April 2012


15

Trial regimens

• This may not exactly match the ‘clinical trial’ field [SACT data item 23]

• It contains trial names which give no indication of the content and are not listed in OPCS regimens


16

Regimen TotalPACS01-Breast= 74ADMYRE- Arm A [CT] 32DEVELOP: Cohort 0 32LD-56= 30FIRST arm A Rd to PD 24MUK One: BTD 60 24SaPPrOC Cycles: 2-4 24CR0802-11 17GAMEC 2: GAMEC-S 16OO TCH= 16Vancouver-AML= 16ADAM: Arm B 15CP1069 Celecoxib/Pla 152478-INT-001 KW Coh4 14CP4055-109 14ARTemis:ArmB D/B/FEC 12CP1003 CEDIRA/SARACT 12CP499 (v3) BILCAP- 12CP956 BIBW 2992 arm 12OO HLH-2004 W1-8= 11REG_2 11A4991014;PF-01367338d1to14+CarboplatinArmACycle1onwards (Early Phase Trial) 10ADMYRE- Arm B [CT] 10COSAK Ced+Sar/Place 10DEVELOP: Cohort 1 10GALLIUM BO21223 Bendamustine-R (NCRN Trial) 10ICON 6 Carboplatin (CrCl) + Paclitaxel + Cediranib / Placebo (NCRN Trial) 10ONYX: CRd Arm 10PANORAMA 1 TP1 10SCOT XELOX Arm B (12wk) (NCRN Trial) 10TeloVac - Arm 1 10

Examples of Trial Regimen names that have been submitted from contributing providers in April 2012.


17

Local regimens that don’t map

• These will be sent as the regimen local name, preferably as the drug approved name/s in alphabetical order;

• These local regimens will need to be mapped manually to SACT analysis groupings;

• Frequently occurring regimens will be added to the temporary list;


18

Other required SACT drugs/regimens

• These mostly have a direct anti-cancer effect but will not be on the OPCS Regimen list;

• These will ultimately be on an additional national list;

• Many of these have already been identified and mapped to SACT analysis groupings;


19

Supportive drugs/other

• These are drugs including anti-sickness drugs, steroids and antibiotics which are not currently required for analysis but some may be added in the future;


20

Trust regimens

OPCS name list +”other”

PbR procurement and delivery codes for commissioning

OPCS short name for dataset

Trials not in OPCS list

Other regimens that do not map to OPCS

SACT regimen group for analysis

SACT Trial group for analysis

Matches SACT group in temporary list*

No match to any of the above

Amalgamate for analysis

Manual grouping for analysis

“Trial” in analysis

(mapped)

(mapped)

(mapped)

CIU Processing of uploaded regimens

NOT CHEMOOther records ( anti-sickness etc.)

* temporary list will contain regimens destined for OPCS and those that will be commissioned via the hormones/supportive list

(not currently mapped by trust)


21

Section 3: Programme & Regimen (3)Data Item Commentary

Height at Start of Regimen

To allow comparison of dose by metre2

1.66 0.00

Weight at Start of Regimen

To allow comparison of dose by metre2

81.5 0.00

Performance Status at Start of Regimen

WHO or Lansky – to allow case mix adjusted analysis

2 101

Co-morbidity adjustment

Yes/No - to allow case mix adjusted analysis

Y X

Date decision to Treat

To allow analysis of wait before treatment start

2011-05-01 1 May 2011

Start Date of Regimen

To allow analysis by time period

2011-05-10 {BLANK}

0 in both the WHO and Lansky is a valid value – please check that your system is not defaulting to ‘0’


22

Section 3: Programme & Regimen (4)


Clinical Trial Yes/No – to identify chemotherapy given within clinical trials

N X

Chemo-Radiation Yes/No – to identify use of chemo-radiation, only used in recognised treatment regimen

Y X

Number of Planned Cycles

To allow comparison with number of cycles actually given. Not necessary relevant for palliative treatment

4 0


23

Section 4: Cycle


Cycle Number Sequential within each regimen and indicates the patients progress through the regimen.

6 XX

Start Date of Cycle The date of the first administration in each cycle.

2012-01-01 01 Jan 2012

Weight at Start of Cycle

Where relevant to allow for dose reduction.

81.5 0.00

Performance Status at Start of Cycle

To assess patient’s suitability for further treatment.

2 101

OPCS Procurement Code

X719 XXXX

Weight at Start of Cycle is the only optional data item within SACT. All other data items are expected to be reported to the Chemotherapy Intelligence Unit in Oxford.


24

Section 4: Cycle (2)


OPCS Procurement Code

X711 XXXX


25

Section 5: Drug DetailsData Item Commentary

Drug Name This is the approved name in the BNF, it identifies individual drug usage

Gemcitabine X

OPCS Delivery Code

X722 X000


26

Section 5: Drug Details (2)


Actual Dose Per Administration

For oral regimens this is the daily dose. Allows calculation of cumulative dose per patient and global drug usage.

120 XXX

Administration Route

To allow analysis by route of administration

04 22

Administration Date The date of actual administration.

2012-01-01 1 Jan 2012

Organisational Code of Provider

This may change throughout the regimen. To Allow analysis by provider.

SPH00 XX999Two common issues with date fields:•3000+ records with a date out of sequence i.e. Administration Date is before Regimen Start Date•Default date 01/01/1900 being reported


27

Section 6: OutcomeData Item Commentary

Date of Final Cycle Date of Start of Final Treatment

2012-01-01 1 Jan 2012

Regimen Modification – Dose Reduction

Yes/No – Where a dose of any SACT drug is reduced at any cycle

N X

Regimen Modification – Time Delay

Yes/No – Where administration of drugs is delayed > 5 days at any cycle

N X

Regimen Modification – Stopped Early

Yes/No – Where the regimen is abandoned before the planned number of cycles

N X

Regimen Outcome Summary

To record the immediate outcome of the treatment

Patient Choice X

Date of Death To estimate 30-day mortality

2012-02-01 1 Feb 2012

As the Chemotherapy Intelligence Unit is hosted within a Cancer Registry they will receive Date of Death details as part of the Office of National Statistics ‘Cancer Deaths’ and ‘Non Cancer Deaths’ which they will use to append to the patient record.


28

Where are you on the implementation of SACT?

Current situation

Sept 2011 – April 2012

April 2012 – Sept 2012


April 2013 – Sept 2013


From April 2014 onwards

Trusts with fully implemented e-prescribing systems

Preparation including test downloads (voluntary basis)

Start full downloads

Continue full downloads




Trusts with partially implemented e-prescribing systems

Preparation including test downloads (voluntary basis)

Start partial downloads





Electronic clinical system but no e-prescribing

Preparation including test downloads

Start partial downloads, dataset sections 1-4 & 6

Continue partial downloads



Basic hospital systems only

Preparation including test downloads

Start partial downloads, dataset sections 1-3 & 6





29

State of Readiness Questions• How many of the 42 SACT data items will you be reporting?

– If you are using a e-Prescribing system, the expectation is that all 42 data items will be submitted;– It is worth noting that there is only one optional field in the dataset, all other fields are either Mandatory or Required;

• Will your SACT extract include:– All solid tumours

• If no, which tumour groups will you be reporting• When will you report all solid tumours?

– Haematology • If no, when will this be achievable?

– Paediatrics• If no, when will this be achievable?


30

Your SACT CSV Data File

Please note that this is demo data


31

Your SACT CSV Data File (2)

Extract criteria for upload, where a patient has:

• A date decision to treat in the month (Data item 21) • A start date of regimen in the month (Data item 22)• A start date of cycle in the month (data item 27)• A administration date (data item 35)• A Date of final treatment (Data item 37)• A date of death (data item 42)


32

https://www.chemodataset.nhs.uk/home.aspx


33

Notes:•You have to be a registered user to access the SACT Portal;

•When registering you will be asked what permission you require:

•Upload Data•Provider Approver; or•Network

•You can only access the Portal via the NHS N3!


34

State of Readiness Questions (3)

• Roles & Responsibilities

– Who, in your hospital will be responsible for uploading the SACT data on a monthly basis?

– Who, in your hospital will be responsible for approving the chemotherapy activity?

– Who is the Cancer Network will require access to SACT compliance information?


35

Only users with ‘Upload Data’ permission will see information in this box. If this is your first month of submission, there will be ‘no files are waiting for submission’


36

The CIU Helpdesk will update this section each month with relevant information.

The CIU team has developed a video that will talk you through how to upload your SACT file to the Upload Portal.

Note: You will need Abode Flash Player to run the video

You have the ability to filter on the file status.


37

You can also access the video on how to upload your monthly SACT file here.


38


39


40


41


42

Once your monthly file is validated it will display a report on the

quality of the data contained in your extract


43


44


45


46

The minimum threshold is 80% of mandatory fields must be partially valid. Aim for 100%

1. Submit button will not be available until you meet 80% minimum threshold;2. Remember to submit between 1st and 15th of each month!


47

In order to get Patient Count you must submit:

•Admin Date•Drug Name

In order to get Cycle Starts you must submit

•Cycle Start Date

1. SACT data awaiting provider approval is available from 16th to end of month.

2. You must be registered with provider approval to view


48

This is the ‘provider approvers’ opportunity to provide commentary on the current month’s activity. These notes will be viewed by the analysis team at the CIU.


49

State of Readiness Questions (4)• Do you wish to test your SACT data file?

–Please review the Frequently Asked Questions, as these have been generated during the testing phase.

• Have you started work on mapping your local Regimen names to the OPCS 4.6 list that was published in February 2012?

–The list can be downloaded from the TRUD website;

•Training materials are available on the CIU upload portal and the CIU website.

• Register with http://www.chemodataset.nhs.uk/home.aspx


50

The CIU has developed a Supplier Test Version of the upload portal•This allows Software Suppliers to test their SACT extracts to ensure they are compliant with the ISB Standard;


51

When to Submit SACT Data?


52

Monitoring SACT Conformance• Monitoring which Trusts have submitted and approved SACT

data;

• 80% minimum quality threshold for mandatory items in force;

• Planned implementation of monthly SACT Data Completeness report.– Sent to all Cancer Networks– Sent to all Trusts


53

Monitoring SACT ConformanceData completeness reports will be produced by:•Trust•Cancer Network**will be sent out by NCAT & NCIN•

You will only appear on this report once you have approved your monthly submission;


54

SACT Analysis - What to Expect...• As soon as sufficient data have been quality assured and analysed, initial

reports will be issued to contributing providers. Once established, this will be a continuing process and will require careful governance and maintenance;

• Benefits– Valuable for those providing and commissioning chemotherapy services;– It will support patients and their clinical teams in choosing appropriate care, based on accurate

knowledge of current practice and the corresponding benefits and toxicities of treatment;


55

“Sense check” completed by next submission

April 1st

Monthly submissions >>>>>>

Analysis sequence - monthly

Technical data quality feedback

(by return)

Diagnostic group

Regimen starts

Cycle starts

Breast 30 200

Lower GI 25 180

Gynae 25 60

Lung 16 80

Lymphoma 28 230

Urology 12 56

etc


56

Global analysis – all submitting trusts

Top 10 regimens by diagnostic group – regimen and cycle starts

% of total patients by diagnostic group


April 1st


Analysis sequence – 3 monthly


57





April 1st





Individual trust analysis – all submitting trusts

+


58

Patients treated by diagnostic group

Once contributing providers have submitted and approved 3 consecutive months of SACT activity they will receive both a global view and a trust view of ‘Patients treated by diagnostic group’


59

105

5

20

32

28

18

16

33

37

59

132

121

20

33

26

31

46

50

34

71

77

143

0 20 40 60 80 100 120 140 160

Other

GEFITINIB

TRIAL

CISPLATIN + ETOPOSIDE

CISPLATIN + VINORELBINE

ERLOTINIB

CISPLATIN + PEMETREXED

CARBOPLATIN + VINORELBINE

CARBOPLATIN + PEMETREXED

GEMCARBO

CARBOPLATIN + ETOPOSIDE

Top 10 Regimens for LungFirst Subsequent

The ‘top 10 regimens by diagnostic group’ will be available to contributing providers who have submitted and approved 3 consecutive months of SACT activity. They will have the opportunity to compare their Trust view with that of the global perspective.


60

“Sense check”completed by next submission

April 1st




61

Comparative trust analysiscycle starts by diagnostic grouping

( - by PbR peer group or network )


62

Analysis sequence – annually


Individual trust analysis – all submitting trusts

Comparative trust analysis – all submitting trusts

+Age profile of treated patients

+Geographical mapping of activity

April 1st


63

QUESTIONS...?

ociu is delivered by solutions for public health confidential & proprietary, copyright 2012,...

Documents