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SACT Dataset - Implementation User Guide v0.11.docx

1. cc ccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeees 23 9 Organisational code of provider ccccceeceeeeeeeseeececeeeeeeeeeeeeeeeneeeeeeeees 24 10 Primary diaQnOSis ce eee eeeeeeeeee cette eeeeeeeeeeeeeeeeeeeeeeeeecaaaeeeeeeeeeeeeeeeenaaees 25 TALE MOM S AEII N es A Nee ee Nee chee Aer es ee eed Meee hee ae 26 12 TNM Stage Grouping Final Pretreatment eecceeeeeeeeeeeeeeeeeeeeeeeees 27 13 SACT Programme TUNG css eceteise ede tc ae tid ad ce eee hcaddiee 28 14 Regimen NAUMD Gl cert cee c renee se tek a So eel Se Sok ae 29 15 IMTS AE OT US AUS AT eves ces rasta neocon eases ates eat tees tape ae eet 30 NG THSQUIME Ice cre erete pcm E male he OR E Oe er a ah T 31 17 Height at start of regimenic nia2iwatctvas eal alata alae 32 18 Weight at start of regimen ccc cece eceeeeee cece ee eeeeeteeaeeeeeeeeeeeeeeneseaaaees 33 19 Performance status at start Of regimen ceeeeeeeeeeeeeeeeeeeeeeeeeeesenaeees 34 20 Co morbidity adjustment sacics see cee chieceereaeeaiieraiimeds 36 Zl Date decision TONGA iniaiaiai Eee iiaa aneii 37 22 Start date of VOOIMON cacnsiaicns teat cnscad Sacra ns senna aa Sac selens 38 29 5 SMMC AN tial mensenn tcatecksatieik teaaianh Oeatieik a aE 39 Crown Copyright 2013 Page 4 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 24 ACINSITIO FAG AUIOIN Sess i seca ese cned Satie cdeeetal Sa Sete dense ie
2. Step 2 Add the results of each multiplication together Step 3 Divide the total by 11 and establish the remainder Step 4 Subtract the remainder from 11 to give the check digit If the result is 11 then a check digit of 0 is used If the result is 10 then the NH NUMBER is invalid and not used Step 5 Check the remainder matches the check digit If it does not the NH NUMBER is invalid Crown Copyright 2013 Page 15 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 43 NHS number status indicator code Section Demographics and consultant SACT description NHS NUMBER STATUS INDICATOR CODE NHS data dictionary element NHS NUMBER STATUS INDICATOR CODE Format an2 Relevant code and or pick list 01 Number present and verified 02 Number present but not traced 03 Trace required 04 Trace attempted No match or multiple match found 05 Trace needs to be resolved NHS Number or patient detail conflict 06 Trace in progress 07 Number not present and trace not required 08 Trace postponed baby under six weeks old Schema specification Mandatory Purpose The NHS NUMBER STATUS INDICATOR CODE indicates the verification status of the NHS number provided Source Hospital PAS Comments No further comment Crown Copyright 2013 Page 16 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and na
3. e Is this an issue of immediate clinical concern This will decide the urgency of appropriate action which will be managed by the Chemotherapy Information Group 1 6 Mapping local data to the SACT Information standard There is no requirement to modify local clinical practices or data recording however local system managers will be required to map local nomenclature and data formats to that defined in the SACT information standard before transmission Provider organisations are encouraged to review the content of the standard and consider whether making primary data recording consistent with the standard would benefit their services in terms of safety and efficiency Examples of this are standardisation of chemotherapy cycle numbering particularly relevant where patient management is transferred during treatment and the consistent completion of fields summarising the end of treatment 1 7 Maintenance and updating Any changes required to improve the functionality and changes required from time to time to ensure that the data standard remains consistent with need will be co ordinated through the Chemotherapy Information Group This group reports to the National Cancer Intelligence Network s Steering Group Provider organisations are Crown Copyright 2013 Page 8 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 encouraged to submit comments or requests concerning the dataset its collection and anal
4. As NHS data dictionary NHS data dictionary element ETHNIC CATEGORY ETHNIC CATEGORY is the same as attribute ETHNIC CATEGORY CODE The 16 1 ethnic data categories defined in the 2001 census is the national mandatory standard for the collection and analysis of ethnicity Format an2 Relevant code and or pick list Office for National Statistic ONS 2001 categories 16 1 Schema specification Required Purpose To allow analysis by ethnic category to reveal potential differences in uptake of treatment or types of treatment Source Hospital PAS Comments This field is not always well recorded and may be recorded differently by different sources The incidence of some cancers may vary by ethnic group This may be due to a combination of genetic cultural and dietary factors Crown Copyright 2013 Page 19 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 5 Patient postcode Section Demographics and consultant SACT description As NHS data dictionary NHS data dictionary element POSTCODE OF USUAL ADDRESS The code allocated by the Post Office to identify a group of postal delivery points A code used primarily for the delivery of correspondence to ADDRESSES POSTCODES may also be used to define a GEOGRAPHIC AREA Format max an8 Relevant code and or pick list Not applicable Schema specification Mandatory Purpose This is supportive identifier It al
5. Secure Socket Layer SSL encrypted protocol which is used on a daily basis for online shopping online banking etc No extra action is required at the data suppliers end to establish this apart from being on an N3 network connection 4 5 File Validation and Data Quality Reports Files submitted are processed one at a time The web portal should be able to provide validation results for any uploaded file within one hour of submission This will be via a report generated for the data supplier on the web portal using logged validation data from the database File validation reports will be available for each file uploaded by the treatment supplier Users will only be able to view reports related to their own data Each report should display the following information for each file uploaded and processed Column name Description of column The name of the file that has been validated uploaded Uploaded By The portal username who uploaded the file Load The percentage of records loaded i e valid records divided by DQ The data quality percentage i e number of records with no errors or Sel eee a ee Informational Informational error counts by rule errors File Status The current status of file validated rejected or loaded Note that if the file fails validation of mandatory fields above a certain threshold it will be rejected and therefore not reach the data quality checks Therefore the warning and informational counts will be em
6. Source E prescribing system local recording MDT Comments In the terminology of the SACT data standard the programme is the pre planned sequence of treatment which may include one or more regimens Please refer to the definitions section For example if the patient s clinical situation changes e g from curative to palliative treatment this would require the commencement of a new programme Programmes will be numbered sequentially and the option to start from any number must be available to allow for prior management not recorded on the current system If programme number is not available locally it will be derived via an algorithm in the SACT data repository This corresponds to the term line of chemotherapy expressed in many prescribing systems Crown Copyright 2013 Page 28 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 14 Regimen number Section Programme and regimen SACT description Regimens are numbered according to their chronological order of commencement in the patient s treatment programme NHS data dictionary element ANTI CANCER REGIMEN NUMBER The number of the Anti Cancer Drug Regimen for example Systemic Anti Cancer Therapy Regimen Anti Cancer Drug Regimens are numbered according to their chronological order of commencement in the treatment programme Format max n2 Relevant code and or pick list not applicable Schema specificat
7. skin 06 _ Intraarterial Injection of a medicinal product into an artery 58100008 cavity ll lili ll Intravesical bladder Intralesional medicinal product directly to a lesion 11 Topical Administration of a medicinal product to the skin and or 6064005 E oe Cutaneous obtain a local effect Intradermal Injection of a medicinal product into the dermis 372464004 Purpose To allow analysis by route of administration and identify critical areas e g intrathecal chemotherapy Crown Copyright 2013 Page 50 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Schema specification Required Source E prescribing system or local record Comments The list above is the list currently agreed by the Chemotherapy Information Group The above definitions are from the NHS Dictionary of Medicines and Devices Virtual Therapeutic Moiety VTM SNOMED CT concept identifier Crown Copyright 2013 Page 51 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 34 Administration date Section Drug details SACT Description The date on which the anti cancer drug was administered to a patient an infusion commenced or an oral drug initially dispensed to the patient NHS data dictionary element SYSTEMIC ANTI CANCER THERAPY ADMINISTRATION DATE The date on which the Systemic Anti Cancer Therapy drug was administered to a PATIENT an infu
8. Satie denice Riba d dd oteie ctor 40 25 Number of cycles planned iiss cteicinis a ttecietdioiniaiieceedieteleataeutienaeihs 41 20 Cycle limber ms aiiaih cee pie a a E a a E eaaa iE 42 21 Start date Of CY CIO iai eana aaie eh ee ee Ea NA EE EAR Ea EEEE EAEE 43 28 Weight at start of ey Clots sane a ee na a ee ite ee 44 29 Performance status at start Of cycle eee ceeeeeeeeeeeeeeeeeeeeeeeeeeeeenteeeeeeeees 45 30 OPCS procurement Code ria Sects teetoa un a 47 31 Drug name this is repeated for each anti cancer drug in the regimen 48 32 Actual dose per administration ccccccceceeeesesseccceeeeeeeeeeeesenneeeeeeeees 49 33 SACT Administration route suc bc sient anced da diiaet de cine bias aiden debt ted dd oboe bles 50 34 Administration date eke shai adhe chendichel atte Dada thane heel a dacectenderedl eect noenins 52 35 Organisational code of provider for each administration 0 53 36 OPCS delivery code acs set eee Ne Ne ces fe SAS Ne el kee ca 54 S a Date OF final treatment cites cnc ces tacesioes tis eins coeccwesCodiaued dace cuesdoceemuncecscues cated 55 38 Regimen modification dose reduction ccccccccccceccccceeeeeeeeeeeeeeeeeees 56 39 Regimen modification time delay ccceeeeeceeecceeeeeeeeeeeeeenneeeeeeeeees 57 40 Regimen modification stopped early cccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeennnees 58 41 Regimen outcome summary ccce
9. Therapy Dataset Implementation User Guide v0 11 Data item number and name 36 OPCS delivery code Section Drug details SACT description Delivery code for each administration NHS data dictionary element PRIMARY PROCEDURE OPCS OPCS 4 code of an OPERATIVE PROCEDURE Format an4 Relevant code and or pick list OPCS 4 6 Schema specification Required Purpose To allow analysis by cost group Source Hospital PAS Used to support Payment by Results PbR Comments Normally entered onto the hospital system by clinical coders Crown Copyright 2013 Page 54 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 37 Date of final treatment Section Outcome SACT Description The date of the start of the final cycle of SACT treatment within a regimen NHS data dictionary element START DATE FINAL SYSTEMIC ANTI CANCER THERAPY The Start Date of the final cycle of Systemic Anti Cancer Therapy within a Systemic Anti Cancer Therapy Regimen This is defined as the End Date of the Systemic Anti Cancer Therapy treatment Format an10 ccyy mm dd Relevant code and or pick list Not applicable Schema specification Required Purpose To register the completion or stopping of a regimen Source E prescribing system or local records Comments This has been made consistent with the definition in the National Confidential Enquiry into Patient Outcome and
10. available in e prescribing systems there is frequently a failure to complete the field Crown Copyright 2013 Page 59 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 42 Date of death Section Outcome SACT description As NHS data dictionary description NHS data dictionary element PERSON DEATH DATE The date on which a PERSON died or is officially deemed to have died Format an10 ccyy mm dd Relevant code and or pick list Not applicable Schema specification Required Purpose To estimate 30 day mortality or analyse survival after chemotherapy Source Office for National Statistic ONS Comments This field will only be filled directly for the submission if a patient dies in hospital or the hospital is informed by the GP For analysis purposes the CIU will draw on ONS data and match death data to the SACT by the Chemotherapy Intelligence Unit Crown Copyright 2013 Page 60 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 4 Technical Guidance for data extraction and submission 4 1 Use of XML for Chemotherapy Data Transmission The NHS will move towards XML as a standard for data transmission in the future and the SACT data set and systems using it need to be able to make this transition The Chemotherapy Intelligence Unit CIU is able to handle both CSV files and XML data in parallel from the outset but initially
11. examination imaging endoscopy biopsy surgical exploration and other relevant examinations Format max an5 Relevant code and or pick list Site specific UICC Union for International Cancer Control coding is used Schema specification Required Purpose To allow analysis by stage of disease Early stage disease will have better outcomes than more advanced disease Source MDT Comments The stage to be recorded is the final pre treatment stage as specified in the COSD dataset Crown Copyright 2013 Page 27 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 13 SACT Programme number Section Programme and regimen SACT Description Programmes of chemotherapy are numbered according to their chronological order of commencement in the patients disease management NHS data dictionary element SYSTEMIC ANTI CANCER THERAPY PROGRAMME NUMBER The number of the Systemic Anti Cancer Therapy Programme The SYSTEMIC ANTI CANCER THERAPY PROGRAMME NUMBER is allocated locally Systemic Anti Cancer Therapy Programmes are numbered according to their chronological order of commencement in the PATIENT s disease management This corresponds to the term line of chemotherapy expressed in many prescribing systems Format max n2 Relevant code and or pick list not applicable Schema specification Required Purpose To facilitate sequential analysis of patient care
12. in all quiet play and activities 06 40 Mostly in bed participates in quiet activities 07 30 In bed needs assistance even for quiet play 08 20 Often sleeping play entirely limited to very passive activities 09 10 No play does not get out of bed 10 5 Unresponsive 11 0 Dead Schema specification Required Purpose To assess the patien s suitability for further treatment Crown Copyright 2013 Page 45 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Source E prescribing system Comments WHO categories 1 4 are a match to the Eastern Cooperative Oncology Group ECOG categories and should be used for adults above 16 years For birth to16 years the Lansky scale should be used This field is only relevant in some patients where the performance status changes during the chemotherapy treatment Crown Copyright 2013 Page 46 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 30 OPCS procurement code Section Cycle SACT description As NHS data dictionary NHS data dictionary element PRIMARY PROCEDURE OPCS OPCS 4 code of an OPERATIVE PROCEDURE Format an4 Relevant code and or pick list OPCS 4 6 Schema specification Required Purpose To allow analysis by cost group Source Hospital PAS Used to support Payment by Results PbR Comments Normally entered onto the hospital system by clinic
13. it is anticipated that the vast majority of returns will be in CSV format XML data can be imported easily into the existing database structure though cost and timescales for suppliers being able to output XML are likely to vary considerably The system will therefore be able to handle both CSV and XML files in parallel for some time Timescales XML schema tested between pilot Site Addenbrookes and CIU database July 2013 XML schema published August 2013 Suppliers to confirm SACT XML is available March 2014 4 2 Data extraction in CSV format Data files are required to be submitted monthly within 7 working weeks of the end of the calendar month e g submissions of April 2013 chemotherapy data 01 04 2013 30 04 2013 to be uploaded to CIU by 15 June 2013 The timetable for monthly data submissions is around the 15 of each calendar month The CIU provides an annual timetable for data submissions to all providers which contains exact dates this is available on the website www chemodataset nhs uk Data will be extracted from electronic prescribing and other electronic systems by system software suppliers working with local IT staff in constructing extraction routines The database import process requires files to be in a consistent format as outlined below Extracted data files should be a single Comma Separated Values CSV only with a csv file extension A CSV file template will be available from the Chemotherapy Intelligence Un
14. of cycles in the standard regimen or be modified by the prescriber NHS data dictionary element NUMBER OF SYSTEMIC ANTI CANCER THERAPY CYCLES PLANNED The number of Systemic Anti Cancer Therapy Cycles specified in the CHEMOTHERAPY PRESCRIPTION This may be the number of Systemic Anti Cancer Therapy Cycles in the standard Systemic Anti Cancer Therapy Regimen or be modified by the prescriber Format max n2 Relevant code and or pick list Not applicable Schema specification Required Purpose To allow comparison with number of cycles actually given Source E prescribing system or local records Comments Many regimens are prescribed with a stated number of cycles this may be specified in a protocol but may be varied by the prescriber Some prescriptions will not have a fixed number prescribed at the outset this is particularly the case with some palliative treatments Crown Copyright 2013 Page 41 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 26 Cycle number Section Cycle SACT description Cycles numbered sequentially within each regimen NHS data dictionary element ANTI CANCER DRUG CYCLE IDENTIFIER A unique identifier for an Anti Cancer Drug Cycle within an Anti Cancer Drug Regimen Anti Cancer Drug Cycle is a CLINICAL INTERVENTION where the CLINICAL INTERVENTION TYPE is National Code 02 Anti Cancer Drug Cycle Format max n2 Relevant
15. submit data through the secure portal Where incorrect data remains the data should be corrected in time for the following month s submission 16 to 20 day of the month o Objectives To ensure that the data submitted satisfies completeness and sequential requirements Where necessary rationalise and remove duplicate records To submit the qualified data for clinical quality assurance o Data quality process Where the data which has been quality assured is 100 correct it may be submitted through for clinical QA and a data quality report sent to the site 1 Recommended initial threshold subject to review based on data quality issues encountered between April 2011 and April 2012 The threshold will increase over time Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Where anomalies exist the data is to be reviewed and updated This will include the correction of obvious errors rationalisation of data and de duplication A data quality report will be returned to the site highlighting any changes Where the data is at least 80 correct the correct data may be submitted for clinical QA The remaining data is retained for correction by the site Where less than 80 of the data is correct the data is retained for correction by the site A data quality report is generated and sent to the site The incorrect data is returned to the site for correction in time for the
16. 1 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 17 Height at start of regimen Section Programme and regimen SACT description Height in metres at start of SACT regimen NHS data dictionary element PERSON HEIGHT IN METRES A PERSON S height in metres Format n1 max n2 Relevant code and or pick list Not applicable Schema specification Required Purpose To confirm appropriate dose of chemotherapy and dose by metre Source E prescribing system Comments This field is applicable where a drug dose is being calculated on the basis of a patient s height and weight Crown Copyright 2013 Page 32 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 18 Weight at start of regimen Section Programme and regimen SACT description Weight in kilogrammes at start of SACT regimen NHS data dictionary element PERSON WEIGHT A PERSON S weight in kilogrammes Format max n3 max n3 Relevant code and or pick list Not applicable Schema specification Required Purpose To confirm appropriate dose of chemotherapy and dose by metre Source E prescribing system Comments This field is applicable where a drug dose is being calculated on the basis of a patient s height and weight Crown Copyright 2013 Page 33 of 70 Systemic Anti Cancer Therapy Dataset Implementation
17. Death NCEPOD report 2008 www ncepod org uk It is the most practical date to record Crown Copyright 2013 Page 55 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 38 Regimen modification dose reduction Section Outcome SACT Description Identifies if a regimen was modified by reducing the dose of any anti cancer drug administered at any point in the regimen after commencement of the regimen NHS data dictionary element SYSTEMIC ANTI CANCER THERAPY REGIMEN MODIFICATION INDICATOR DOSE REDUCTION An indication of whether a Systemic Anti Cancer Therapy Regimen was modified by reducing the dose administered Format ani Relevant code and or pick list Y N Schema specification Required Purpose To allow a measurement of regimen toxicity Source E prescribing system or local record Comments This field may also be generated automatically and is one of three fields recording changes in the regimen Crown Copyright 2013 Page 56 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 39 Regimen modification time delay Section Outcome SACT Description Identifies if a regimen was modified by extending the time between administration dates at any point in the regimen after commencement of the regimen NHS data dictionary element SYSTEMIC ANTI CANCER THERAPY REGIMEN MODIFICATION INDICA
18. EMOTHERAPY INTELLIGENCE UNIT CIU HELP DESK AND SUPPORT 1 Recommended initial threshold subject to review based on data quality issues encountered between April 2011 and April 2012 The threshold will increase over time Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Chemotherapy data monthly activity Continuous help desk support will be provided by the Chemotherapy Intelligence Unit CIU As suppliers become more familiar with their monthly SACT data quality submission issues their success rate in having their monthly submission accepted first time Submission 100 correct will increase 1 to 15 day of the month o Objectives To test the data against the agreed business rules and ensure that mandatory fields are completed To ensure that data in all fields satisfies the required format and size Where requirements are satisfied to submit the data through the secure portal for data quality assurance o Testing data against business rules Where the data tested is 100 correct it may be submitted through the secure portal Where at least 80 of the data satisfies the business rules the correct data may be submitted through the portal The remaining data is retained for correction Where less than 80 of the data satisfies the business rules all of the data is retained for correction Sites should aim to correct bad data by the 15 day of the month to be able to
19. NOSIS for the cell type of the malignant disease recorded as part of a Cancer Care Spell Format min an5 max an7 Relevant code and or pick list ICD O3 Schema specification Mandatory Purpose Identification of morphological subgroups of disease not defined by ICD 10 e g varieties of lung cancer and haematological malignancies Source Several possible sources prescribing system MDT linked pathology system Comments This field is more appropriate for haematological malignancy which is not primarily based on anatomical site It also gives added information for some solid tumours e g lung and testis Where a patient has more than one current cancer diagnosis the diagnosis recorded is the one for which treatment is being given Note 11 Morphology and or 10 Primary diagnosis can be submitted Crown Copyright 2013 Page 26 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 12 TNM Stage Grouping Final Pretreatment Section Clinical status SACT description Stage of disease NHS data dictionary element TNM STAGE GROUPING FINAL PRETREATMENT Record the overall clinical TNM stage grouping of the tumour derived from each T N and M component prior to treatment This classification is based on all the evidence available to the clinician s with responsibility for assessing the patient and for the patient s treatment plan Such evidence arises from physical
20. Systemic Anti Cancer Therapy Dataset Implementation User Guide Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Amendment History Version Date Amendment History 0 1 13 05 10 Draft Stage submission 0 2 14 12 10 Amendments following feedback 0 3 21 03 11 Updating of Data Dictionary definitions 0 4 13 04 11 Addition of technical guidance section 0 5 20 04 11 Further amendments and additions 0 6 03 05 11 Full Stage Submission 0 7 23 06 11 Amendments following Appraisal Meeting 0 8 24 06 11 Amendments following XML discussions 0 9 27 06 11 Amendments following communications re Data Dictionary 0 10 19 09 13 Changes to dataset to include additional data item and reference data 0 11 20 09 13 Updated following comments received following the ISB appraisal This version of the guidance incorporates Data Dictionary changes as below Health and Social Care Information Centre NHS Data Model and Dictionary Service Reference Change Request 1158 Version No 1 0 Subject Systemic Anti Cancer Therapy Data Set Effective Date 1 April 2014 Reason for Change Change to Data Standards Publication Date 5 November 2013 Forecast Changes Anticipated Change When NHS NUMBER STATUS INDICATOR CODE added to the 01 04 2014 dataset in order to comply with general information stan
21. TION CODES describing specialties Can be derived from consultant code Format an3 Relevant code and or pick list HES item MAINSPEF Schema specification Required Purpose Identifies the specialty under which the patient is being managed Source Organisation will derive from consultant code Comments This field can be derived from the consultant code but should be included as it provides an effective categorisation of clinical activity Crown Copyright 2013 Page 23 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 9 Organisational code of provider Section Demographics and consultant SACT description As NHS data dictionary NHS data dictionary element ORANGISATION CODE CODE OF PROVIDER See the Organisation Default Codes in the Default Codes Summary Table at http www datadictionary nhs uk web site content supporting information organisati on data service default codes asp shownav 1 Format an3 or an5 Relevant code and or pick list NHS list of provider code and name Additional lists will be required for non NHS providers including home care delivery Schema specification Mandatory Purpose To allow analysis of care by provider and benchmarking between providers Source Hospital PAS other provider codes Comments This is a critical field in the data set as the provider of chemotherapy must be identified This field shows the prov
22. TOR TIME DELAY An indication of whether a Systemic Anti Cancer Therapy Regimen was modified by extending the time between Systemic Anti Cancer Therapy Administration Dates Note Time delays of 5 days or fewer are discounted to allow for bank holidays or other incidental interruptions not related to drug tolerance Format an1 Relevant code and or pick list Y N Schema specification Required Purpose To allow a measurement of regimen toxicity Source E prescribing system or local record Comments This field may also be generated automatically and is one of three fields recording changes in the regimen Time delays in any cycle of 5 days or fewer should be discounted to allow for bank holidays or other incidental interruptions not related to drug tolerance Crown Copyright 2013 Page 57 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 40 Regimen modification stopped early Section Outcome SACT Description Identifies if a regimen was modified by reducing the administration days below the number planned NHS data dictionary element SYSTEMIC ANTI CANCER THERAPY REGIMEN MODIFICATION INDICATOR DAYS REDUCED An indication of whether a Systemic Anti Cancer Therapy Regimen was modified by reducing the administration days below the number planned Note This is only applicable where a fixed number of cycles were specified at the start of treatment For
23. User Guide v0 11 Data item number and name 19 Performance status at start of regimen Section Programme and regimen SACT description A person s status relating to activity disability at start of SACT regimen NHS data dictionary element PERFORMANCE STATUS FOR ADULTS PERFORMANCE STATUS CODE FOR YOUNG PERSON A World Health Organisation classification indicating a PERSON s status relating to activity disability The Lansky Play Performance Scale indicating a young PERSON s status relating to activity disability This scale is used for young PERSONS aged 16 years and under Format an1 or an2 Relevant code and or pick list WHO codes for adults 0 4 Lansky for children codes 00 11 00 100 Fully active normal 01 90 Minor restrictions in physically strenuous activity 02 80 Active but tires more quickly 03 70 Both greater restriction of and less time spent in play activities 04 60 Up and around but minimal active play keeps busy with quieter activities 05 50 Gets dressed but lies around much of the day no active play able to participate in all quiet play and activities 06 40 Mostly in bed participates in quiet activities 07 30 In bed needs assistance even for quiet play 08 20 Often sleeping play entirely limited to very passive activities 09 10 No play does not get out of bed 10 5 Unresponsive 11 0 Dead Schema specification Required Purpose Crown Co
24. al coders Crown Copyright 2013 Page 47 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 31 Drug name this is repeated for each anti cancer drug in the regimen Section Drug details SACT description BNF or trial name NHS data dictionary element SYSTEMIC ANTI CANCER DRUG NAME The name of the Systemic Anti Cancer Therapy drug given to a PATIENT during an Anti Cancer Drug Regimen The name is taken from British National Formulary chapter 8 Format max an35 Relevant code and or pick list British National Formulary BNF Virtual Therapeutic Moiety VTM list Schema specification Required Purpose To identify drug usage Source E prescribing system or local record Comments This is the approved name in the British National Formulary BNF This is equivalent to the NHS Dictionary of Medicines and Devices Virtual Therapeutic Moiety VTM SNOMED CT concept identifier Drug names may be held as code within e prescribing systems Crown Copyright 2013 Page 48 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 32 Actual dose per administration Section Drug details SACT description Dose in mg or other applicable unit for each administration in a SACT cycle NHS data dictionary element CHEMOTHERAPY ACTUAL DOSE The actual Chemotherapy dose given in milligrams or other applicable un
25. ample 3 admin day admin day 2 cycle 1 o o cycle 3 chemotherapy programme line of treatment regimen 2 o cycle 2 regimen 1 Crown Copyright 2013 Page 13 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 3 Data Set Field Descriptions Data item number and name 1 NHS number Section Demographics and consultant SACT description As NHS data dictionary NHS data dictionary element NHS NUMBER The NHS NUMBER the primary identifier of a PERSON is a unique identifier for a PATIENT within the NHS in England and Wales This will not vary by any ORGANISATION of which a PERSON is a PATIENT Format n10 Relevant code and or pick list Not applicable Schema specification Mandatory Purpose Main identifier and essential for data linkage Source Hospital PAS Comments This is a fundamental field in the data set as the prime identifier The NHS NUMBER is 10 numeric digits in length The tenth digit is a check digit used to confirm its validity The check digit is validated using the Modulus 11 algorithm and the use of this algorithm is mandatory There are 5 steps in the validation of the check digit Step 1 Multiply each of the first nine digits by a weighting factor as follows Digit Position starting from the left Factor 1 10 Crown Copyright 2013 Page 14 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11
26. code and or pick list Not applicable Schema specification Mandatory Purpose Indicates a patient s progress through the regimen and to support analysis between years Source E prescribing system Comments Cycles will be numbered sequentially within a regimen and the option to start from any number must be available to allow for prior management not recorded on the current system Crown Copyright 2013 Page 42 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 27 Start date of cycle Section Cycle SACT description Date of first drug administration in each cycle NHS data dictionary element START DATE SYSTEMIC ANTI CANCER DRUG CYCLE The date of the first drug administration in each Systemic Anti Cancer Therapy Cycle Format an10 ccyy mm dd Relevant code and or pick list Not applicable Schema specification Required Purpose To identify treatment patterns and to support analysis between years Source E prescribing and local records Comments No additional comment Crown Copyright 2013 Page 43 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 28 Weight at start of cycle Section Cycle SACT description A PERSON S weight in kilogrammes at start of cycle NHS data dictionary element PERSON WEIGHT A PERSON S weight in kilogrammes Format max n3 max n3 Relevant co
27. cord from the database along with any backup files An updated Patient Information Leaflet is currently under development which will explain that individuals have the right to access and have their own data held by the National Cancer Registration Service deleted and the process by which to do this The NCRS are currently in the process of drafting the new leaflet and are looking to consult with patient groups on its content in October 2013 A final version of the leaflet will be tested with focus groups and made available to stakeholders for comment prior to a final version being published in early 2014 1 5 Clinical Governance Analysis of the clinical content of the data collected will provide previously impossible insights into the patterns of cancer chemotherapy being delivered by individual providers and to individual patient groups and communities The format and content of reporting will be matched to the reasonable requirements of the various recipients of the data and reports and the confidence intervals applying to each analysis made clear When an apparently unacceptable variation in clinical practice is revealed by analysis a formal staged process of investigation must be undertaken This process will determine the following Is this an issue of variation within acceptable range but with limited patient choice e Is this an acceptable practice but worrying trend e Is this an issue which requires action within an agreed timescale
28. dard rules TNM CATEGORY FINAL PRETREATMENT changed name to 01 04 2014 TNM STAGE GROUPING FINAL PRETREATMENT to align with the Cancer Outcomes and Services Dataset Addition guidance of this also corresponds to the term line of 01 04 2014 chemotherapy expressed in many prescribing systems added to Implementation User Guide Crown Copyright 2013 Page 2 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Additional nation code of D Disease modification and 01 04 2014 corresponding note added to DRUG TREATMENT INTENT Reviewers This document must be reviewed by the following CIU Board CIU Board CIU Board 27 08 2013 CIU Board CIU Board CIU Board 20 09 2013 0 11 Approvals This document must be approved by the following Name Signature _ Title Responsibility Date version sBBoard d S Distribution e ISB distribution list e ISB website Document Status This is a controlled document Whilst this document may be printed the electronic version maintained on the ISB website www isb nhs uk is the controlled copy Any printed copies of the document are not controlled Crown Copyright 2013 Page 3 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Contents Des A IMIROOUCHON oi crcrtcccvad Voss tecemncckndenaceleesendeladenocele ce cdela de noceleds eadala da nace ds eadlnda nacid
29. de and or pick list Not applicable Schema specification Optional Purpose Where relevant to confirm appropriate dose of chemotherapy Source E prescribing system Comments This is only relevant where weight change during a regimen triggers a change in drug dosage Crown Copyright 2013 Page 44 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 29 Performance status at start of cycle Section Cycle SACT description A person s status relating to activity disability at start of cycle NHS data dictionary element PERFORMANCE STATUS FOR ADULTS PERFORMANCE STATUS CODE FOR YOUNG PERSON A World Health Organisation classification indicating a PERSON s status relating to activity disability The Lansky Play Performance Scale indicating a young PERSON s status relating to activity disability This scale is used for young PERSONS aged 16 years and under Format an1 or an2 Relevant code and or pick list WHO codes for adults 0 4 Lansky for children codes 00 11 00 100 Fully active normal 01 90 Minor restrictions in physically strenuous activity 02 80 Active but tires more quickly 03 70 Both greater restriction of and less time spent in play activities 04 60 Up and around but minimal active play keeps busy with quieter activities 05 50 Gets dressed but lies around much of the day no active play able to participate
30. duced capable of targeting individual cancers Historically the recording of chemotherapy has only been held within individual patients notes Despite the considerable costs of cancer chemotherapy estimated to be in the order of one billion pounds a year there has been no comprehensive picture available of the number of patients being treated or details of their care With the advent of electronic recording of treatment and in particular electronic prescribing systems national collection and analysis of cancer chemotherapy being provided within the NHS is now viable The SACT Information Standard addresses the requirement to standardise the recording of chemotherapy treatment and outcomes through electronic systems 1 2 Benefits From April 2012 a staged monthly data collection commenced initially from trusts with e prescribing systems though all organisations delivering any chemotherapy for cancer were expected to provide some information from September 2012 Sufficient Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 data have now been quality assured and analysed to enable initial reports to be issued to contributing providers data collection and reporting processes are now firmly established This is however a continuing process and requires careful governance and maintenance This is an important new initiative with a wide range of benefits in terms of understanding patterns of clinical management in cance
31. e the day the infusion was commenced For continuous oral chemotherapy the administration date will be the first day of the nominal cycle i e one administration date per 28 days Date of final treatment This is date of commencement of the final cycle not the date of final administration Crown Copyright 2013 Page 11 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 The dataset table is included as appendix 1 2 1 SACT Data Model Data fields related Data fields related to each to outcome for administration in each regimen each cycle Data fields Data fields related to start related to start of programme 1 of cycle 2 Data fields Data fields related to start identifying of regimen 2 tumour 1 Data fields Data fields related to start identifying of programme 2 patient tumour 2 repeats Data fields oe nee ide ure ll bathers as above The Data Structures are described below Crown Copyright 2013 Page 12 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Dataset structure example 1 administration day administration day bolus injection infusion commenced oral component commenced chemotherapy programme line of treatment regimen Dataset structure example 2 admin day admin day regimen 1 chemotherapy programme line of treatment regimen 2 Dataset structure ex
32. e v0 11 Data item number and name 22 Start date of regimen Section Programme and regimen SACT description This is the first administration date of the first cycle of a regimen NHS data dictionary element START DATE ANTI CANCER DRUG REGIMEN Format an10 ccyy mm dd Relevant code and or pick list not applicable Schema specification Mandatory Purpose To allow analysis by time period Source E prescribing system Comments In practice this will be the same date as the start date of the first cycle in a regimen It is the date of the first administration of chemotherapy This information may therefore be taken from the e prescribing system or may be recorded on a specific system used for chemotherapy treatments Crown Copyright 2013 Page 38 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 23 Clinical trial Section Programme and regimen SACT description As NHS data dictionary NHS data dictionary element CLINICAL TRIAL INDICATOR For the SYSTEMIC ANTI CANCER THERAPY PROGRAMME NUMBER this identifies if a PATIENT s Chemotherapy treatment is within a CLINICAL TRIAL Format an2 Relevant code and or pick list 01 PATIENT is taking part in a CLINICAL TRIAL 02 PATIENT is not taking part in a CLINICAL TRIAL 99 Not known Schema specification Required Purpose To identify chemotherapy given within clinical trials Source E prescribing sy
33. eeeeeeeeeceeeeeeeeeeeteeeaaeeeeeeeeeeeeeeeeneaaeees 59 42 Date OVaOCa Nase sas Anis in TNS cos et a iret te ota 60 4 Technical Guidance for data extraction and submission cccceeeeeeeeeeeeteees 61 4 1 Use of XML for Chemotherapy Data Transmission ccceeeeeeeeeeeeeeteees 61 4 2 Data extraction in CSV format cccccccccesseceeeceeseeeeeceeseceeeeeeeeseesaeeeeeetenes 61 4 3 File submission via the Chemotherapy Intelligence Unit CIU web portal 63 5 S pporting IMPOMMANOM suc ccecseedecece cose cues eutevetietscuns a aa a i 68 Appendix 1 Systemic Anti Cancer Therapy Dataset eeeeeeeeeeeeeeeeeeeeeeeeeenenees 69 Appendix 2 Implementation timetable ceceeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeneeaaees 70 Crown Copyright 2013 Page 5 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 1 Introduction The Systemic Anti Cancer Therapy SACT Information Standard and phased implementation of national data collection applies to all organisations providing cancer chemotherapy services in or funded by the NHS in England The standard relates to all cancer patients both adult and paediatric in acute inpatient daycase outpatient settings and delivery in the community It covers chemotherapy treatment for all solid tumour and haematological malignancies including those in clinical trials The impact of the standard will vary depend
34. f the patient s clinical situation changes then subsequent treatment constitutes a new programme This is not applicable to dose reduction or time delay in administration e Where a curative programme is completed successfully but the patient subsequently develops recurrent disease further treatment will constitute a new programme e Where a palliative treatment programme achieves the desired response but the patient subsequently relapses requiring further treatment this will constitute a new programme For example a patient may receive four months of a taxane and is thought to have stable disease and the treatment is stopped Two months later progressive disease is identified and the patient is started on Capecitabine this constitutes a new programme e Where a palliative treatment programme fails to achieve the desired response and is discontinued with the formulation of a new treatment plan further treatment will constitute a new programme For example where a patient remains continuously on chemotherapy for a prolonged period having a sequence of palliative regimens each in an attempt to contro disease this would constitute a series of programmes as it was not a planned sequence In the management of the majority of adult solid tumours the chemotherapy programme and regimen will be the same Particularly in the management of haematological and paediatric tumours two or more recognised regimens may be given concurrently or sequen
35. fers from the ACE 27 co morbidity data item in the Cancer Outcomes and Services Dataset The field in the SACT data set records whether the chemotherapy treatment chosen has been modified because of the patient s overall clinical condition This includes treatment with an alternative regimen or varying the dose or treatment interval from the start of treatment Crown Copyright 2013 Page 36 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 21 Date decision to treat Section Programme and regimen SACT description As NHS data dictionary NHS data dictionary element DECISION TO TREAT DATE ANTI CANCER DRUG REGIMEN The date on which it was decided that the PATIENT required a specific Planned Cancer Treatment This is the date that the consultation between the PATIENT and the clinician took place and a Planned Cancer Treatment was agreed Format an10 ccyy mm dd Relevant code and or pick list not applicable Schema specification Required Purpose To allow analysis of wait before start of treatment Source Cancer Waiting Times Comments The Cancer Waiting Times dataset requires the decision date of every treatment to be recorded This information may therefore be taken from a generic software system used to record all Cancer Waiting Times information Crown Copyright 2013 Page 37 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guid
36. fined as an anticipated clinical improvement of at least a year s duration Many current treatment programmes are intended to control cancer often for many years without the expectation of eradicating the disease These situations were not covered adequately by the previous options of intent Crown Copyright 2013 Page 30 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 16 Regimen Section Programme and regimen SACT description As NHS data dictionary NHS data dictionary element DRUG REGIMEN ACRONYM The acronym derived from the drugs used in the Anti Cancer Drug Regimen used to identify the drugs used in the regimen Format max an35 NOTE Non alphanumeric characters dash and round brackets are allowed as these may exist in regimen names This field is not case sensitive Relevant code and or pick list OPCS Classification of Interventions and Procedures version 4 6 Regimen Name Dataset short version NOTE The local acronym may be submitted only where the regimen is currently not included in the OPCS classification Schema specification Mandatory Purpose To allow analysis by individual regimen or drug Source E prescribing system or local records Comments It is expected that there will be an annual update to the OPCS classification main list with 2 or 3 supplementary lists as required during the year Crown Copyright 2013 Page 3
37. following month s submission 21 to 30 day of the month o Objectives The quality assurance of all submissions for the regimen and prescription against diagnosis A review of all data by Clinical Oncologist and Oncology Pharmacist Generation and provision of clinical QA reports to all sites Submission of data for analysis and report generation o Clinical quality assurance process Where no anomalies exist the data is forwarded for analysis and the generation of the CIU reports Feedback reports on clinical quality generated and sent to sites Where anomalies exist the data is reviewed by the Clinical Oncologist and Oncology Pharmacist through an iterative approach involving the treatment site where necessary f at least 80 of the data is correct the correct data may be submitted for analysis and report generation Incorrect data is retained for correction and referred back to the treatment site for correction in time for the following month s submission 1 Recommended initial threshold subject to review based on data quality issues encountered between April 2011 and April 2012 The threshold will increase over time Crown Copyright 2013 Page 67 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 5 Supporting Information Further information from https Awww chemodataset nhs uk Help desk email ciu sph nhs uk ciu phe gov uk Crown Copyri
38. formance_status_at_start_of_regimen 19 Comorbidity adjustment 20 Date_decision_to_treat 21 Start_date_of_regimen 22 Clinical_trial 23 Chemo_ radiation 24 Number_of_cycles_ planned 25 Cycle_number 26 Start_date_of_cycle 27 Weight_at_start_of_cycle 28 Performance_status_at_start_of_cycle 29 OPCS _procurement_code 30 Drug_name 31 Actual_dose_per_administration 32 Crown Copyright 2013 Page 62 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Administration _route 33 Administration _date 34 Organisation _code_of provider _administration 35 OPCS delivery code 36 Date_of_final_ treatment 37 Regimen_modification_dose_reduction 38 Regimen_modification_time_delay 39 Regimen_modification_stopped_early 40 Regimen_outcome_summary 41 Date_of_death 42 NHS_number_status_indicator_code 43 4 3 File submission via the Chemotherapy Intelligence Unit CIU web portal When a CSV file is ready for submission to the national database staff at the treatment supplier will connect to the CIU chemotherapy web portal via a whole host of browsers including Internet Explorer Firefox Safari Chrome and others as well as being able to access it on a Mac PC iPhone iPad tablets and even mobile phones The URL for the web portal is https www chemodataset nhs uk The portal requires each registered user to agree to the site s terms and conditions User logins are held wi
39. ght 2013 Page 68 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Appendix 1 Systemic Anti Cancer Therapy Dataset The Mandatory Required or Optional M R O column indicates the recommendation for the inclusion of data M Mandatory this data element is mandatory the message will be rejected if this data element is absent R Required data is required as part of NHS business rules and must be included where available or applicable O Optional the flow of this data is optional It should be included at the discretion of the submitting organisation and their commissioners as required for local purposes In the case of fields 10 and 11 the requirement will be satisfied by one of the two fields being completed The SACT dataset V 2 0 is available on the ISB Website Crown Copyright 2013 Page 69 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Appendix 2 Implementation timetable Current April 2013 October From April April October situation March 2014 2013 2014 2014 Trusts with Continue Continue fully full full implemented downloads downloads e prescribing systems All software Upgrades to Trusts with Continue suppliers Continue all software partially full and NHS _ full systems with implemented downloads Trusts downloads provider trusts e prescribing issued with implemented systems ISN for Trusts Electro
40. ider responsible for initiating the programme of chemotherapy Crown Copyright 2013 Page 24 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 10 Primary diagnosis Section Clinical status SACT description Primary diagnosis at time of decision to treat NHS data dictionary element PRIMARY DIAGNOSIS ICD AT START SYSTEMIC ANTI CANCER THERAPY For the Systemic Anti Cancer Therapy Data Set this is the PRIMARY DIAGNOSIS at the start of the Systemic Anti Cancer Therapy Format an6 Relevant code and or pick list ICD 10 Schema specification Mandatory Purpose To allow analysis by tumour site or group of tumour sites Source Several possible sources PAS prescribing system MDT linked pathology system Comments This field is essential for solid tumours as it defines the anatomical site of the primary tumour Where a patient has more than one current cancer diagnosis the diagnosis recorded is the one for which treatment is being given Note 10 Primary diagnosis and or 11 Morphology can be submitted Crown Copyright 2013 Page 25 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 11 Morphology Section Clinical status SACT description Morphology at time of decision to treat NHS data dictionary element MORPHOLOGY ICD O AT START SYSTEMIC ANTI CANCER THERAPY This is the PATIENT DIAG
41. ing on the configuration of hospitals and services and the existing and planned implementation of electronic prescribing and other clinical electronic systems The contents of this User Guidance document should be made available to all staff groups involved in responding to the standard i e medical and nursing pharmacy information IT and management staff It is not intended that introduction of the standard should have any direct impact on the delivery of patient care However the above groups which are involved in the local implementation of the information standard need to take account of implications of the standard in their work area and develop a strategy to fully meet its requirements by the end of the implementation period If you are a new Provider of chemotherapy as well as reading this Implementation User Guide please contact the Chemotherapy Intelligence Unit Helpdesk at ciu sph nhs uk ciu phe gov uk Other useful recourses to support the collection of the SACT dataset such as Frequently Asked Questions can be found on our website http www chemodataset nhs uk home 1 1 Background The national collection of all cancer chemotherapy information in the NHS in England commenced in 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 Chemotherapy is now a major part of cancer treatment with new types of drugs being intro
42. ion Required Purpose To facilitate sequential analysis of patient care Source E prescribing system local recording MDT Comments Regimens will be numbered sequentially and the option to start from any number must be available to allow for prior management not recorded on the current system If two regimens within a programme start concurrently the one due to finish first should be given the lower number Crown Copyright 2013 Page 29 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 15 Intent of treatment Section Programme and regimen SACT description Intent of SACT regimen NHS data dictionary element DRUG TREATMENT INTENT A classification of the overall aim of the anti cancer drug programme Format ani Relevant code and or pick list National codes as below Schema specification Required Purpose To allow analysis by treatment intent Source E prescribing system MDT Comments National Codes References Cancer Outcomes and Services Dataset A Adjuvant N Neo adjuvant C Curative P Palliative D Disease Modification an anticipated clinical improvement of at least a year s duration The list of options for intent was originally limited to the four options already included in the data dictionary Developments in clinical practice in many speciality areas require the addition of an extra option Disease modification D This is de
43. it CIU for data suppliers and software system developers Note that CSV files must be of the windows type rather than Unix with carriage returns at the end of each line as well as linefeeds None of the data required is case sensitive CSV files should be saved with a text delimiter set to the double quote character in order to allow the use of commas in data values Crown Copyright 2013 Page 61 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 The first row of the CSV file should consist of the Column Headers with the column names in exactly the format shown i e including underscore characters CSV files should not be compressed or packaged in any way CSV files should contain only and all of the following column headers in the following order regardless of the data items that can be supplied The mapping to data set items is shown by the Column Number Column Header Column Number data set Item number NHS_number 1 Date_of_birth 2 Gender_current 8 Ethnicity 4 Patient_postcode 5 Registered_GP_Practice_ Code 6 Consultant_GMC_code 7 Consultant_specialty_code 8 Organisation_code_of_provider 9 Primary diagnosis 10 Morphology 11 Stage_of_disease 12 Programme_number 13 Regimen_number 14 Intent_of_ treatment 15 Regimen 16 Height_at_start_of_regimen 17 Weight_at_start_of_regimen 18 Per
44. it for each administration in a Systemic Anti Cancer Therapy Cycle Format max n7 Relevant code and or pick list Not applicable Schema specification Required Purpose To allow cumulative analysis of drug use by patient and global analysis Source E prescribing system Comments This will normally be in milligrams but a small number of drugs may be prescribed using other units For oral regimens this is the total dose for a single day Crown Copyright 2013 Page 49 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 33 SACT Administration route Section Drug details SACT description The prescribed method of delivery for each administration in a SACT cycle NHS data dictionary element SYSTEMIC ANTI CANCER THERAPY DRUG ROUTE OF ADMINISTRATION The prescribed method of delivery for each administration in a Systemic Anti Cancer Therapy Cycle Format an2 Relevant code and or pick list National codes should be used for this data but the SNOMED CT preferred term has been matched to this along with the corresponding SNOMED CT code to facilitate future change to SNOMED CT coding Codes administration CT Code 03 Intrathecal Injection of a medicinal product through the dura to the 72607000 subarachnoid cavity 04 intramuscular Injection of a medicinal product into muscular tissue 78421000 ee eee of a medicinal product directly underneath the 34206005
45. items The NHS Health Research Authority has confirmed that reporting of patient identifiable data to the CIU is covered by the National Cancer Registration Service existing support under the Health Service Control of Patient Information Regulations 2002 Reported data will be managed by the CIU which is part of the National Cancer Registration Service where there is expertise in managing large volumes of confidential data In compliance with the fair processing requirement within the Data Protection Act provider organisations are expected to inform patients of this purpose for reporting their information and of the potential use of the information for service development analysis and statistical research Where patients have requested that their data is not shared the provider organisation must ensure that their records are not included in the data downloads submitted to the CIU It is suggested that a no consent or similar flag is provided in local systems so that the record can then be omitted from the monthly upload If a patient discovers that their information has been uploaded to the central repository and they wish for this to be deleted the organisation must complete a Crown Copyright 2013 Page 7 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Subject Deletion Request form available on the Chemotherapy Upload Portal and send this to the CIU to action The CIU will then delete the re
46. lows analysis by commissioner and geographical area including generation of treatment rates by population It allows demonstration of patient flows and provider catchments Source Hospital PAS Comments This is an important field since it is the only field that allows analysis by defined populations The postcode may change during a patients management either because the patient moves house or with changes in postcode allocation Crown Copyright 2013 Page 20 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 6 Registered GP practice code Section Demographics and consultant SACT description As NHS data dictionary NHS data dictionary element The GENERAL MEDICAL PRACTICE CODE PATIENT REGISTRATION is an ORGANISATION CODE This is the CODE of the GP practice that the patient is registered with Format an6 Relevant code and or pick list NHS list of code and name Schema specification Required Purpose To inform commissioning and allow analysis of patterns of care by commissioner Source Hospital PAS Comments GP practice code has been included as this is an established code which can be grouped for commissioning purposes Crown Copyright 2013 Page 21 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 7 Consultant GMC code Section Demographics and consultant SACT description C
47. mat an1 Relevant code and or pick list Y N Schema specification Required Purpose To allow a measurement of regimen toxicity Source E prescribing system or local record Comments This field is one of three fields recording changes in the regimen It is only applicable where a fixed number of cycles were specified at the start of treatment Crown Copyright 2013 Page 58 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 41 Regimen outcome summary Section Outcome SACT description To record the immediate outcome of the treatment NHS data dictionary element PLANNED TREATMENT CHANGE REASON An indicator of whether the treatment within an Anti Cancer Drug Programme was completed as planned and if not the reason why Format ani Relevant code and or pick list National Codes 0 Treatment completed as prescribed Treatment not completed 1 PATIENT died 2 Progressive disease during chemotherapy 3 Acute chemotherapy toxicity 4 Technical or organisational problems 5 PATIENT choice stopped or interrupted treatment Schema specification Required Purpose To allow outcome analysis Source E prescribing system or local records Comments This is a fundamental field required by the National Chemotherapy Advisory Group NCAG Report August 2009 Chemotherapy Services in England Ensuring Quality and Safety www ncat nhs uk Although this field is
48. me 2 Date of birth Section Demographics and consultant SACT description As NHS data dictionary NHS data dictionary element PERSON BIRTH DATE The date on which a PERSON was born or is officially deemed to have been born Format an10 ccyy mm dd Relevant code and or pick list Not applicable Schema specification Mandatory Purpose This is additional identifier It also allows analysis of provision by age Source Hospital PAS Comments This is a secondary identifier It is generally well collected Crown Copyright 2013 Page 17 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 3 Gender current Section Demographics and consultant SACT description As NHS data dictionary NHS data dictionary element PERSON GENDER CODE CURRENT A PERSON s gender currently Format ani Relevant code and or pick list 0 not known 1 male 2 female 9 not specified Schema specification Required Purpose To allow analysis by gender Source Hospital PAS system Comments Sex at birth would be a more fundamental data item but impractical to collect in some situations therefore current gender has been included Crown Copyright 2013 Page 18 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 4 Ethnicity Section Demographics and consultant SACT description
49. nic Continue modified Start full submitting clinical partial SACT v2 0 downloads amended system but no downloads SACT data set e prescribing Basic hospital Continue Start full systems only partial downloads downloads Crown Copyright 2013 Page 70 of 70
50. o 6 ATES ACKOPOUING eenia tenes tied teers tarsi eats eatin satan 6 t2 Benets cirentsrtr ese aa a lanes cedlanddan blanidcdedldnddcs banal dedldndda blaxidcdlautsdebles 6 1 3 Chemotherapy Intelligence Unit eee eecccececeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeeeenaaeees 7 1 4 Information Governance sccceuawamaeinean na ennanneeenne asco 7 1 5 Clinical GOVEMANCE 4 23 28 esheets anda tak ee tiet hands ahadidet ehhh tt da ictcn alee hedae ait 8 1 6 Mapping local data to the SACT Information standard ccccceeeeeeeeeeeeeeeees 8 1 7 Maintenance and updating c sse2ces zetiveseanerateeet cast faateleteaee cet Asteaat ae eset 8 2 Definitions for the National Systemic Anti Cancer Therapy Data Set 10 2 VAG T Data WOE ssi eisai E E EE E EEEE 12 3 Data Set Field Descriptions sacs asses i a ee i ai a A oe 13 Wis NAS NUMDEN Aaaeeeaa airan Ieeiea AE 14 43 NHS number status indicator COdGC ccccceeeeeeeeeeeenneeeeeeeeeeeeeeeeenaeees 16 2 BiA M ol lal PAR EAS 17 3 Gender current ise ceases st sec cet inetd asda ted deen caddis ited anon cia iais baie cebneabiu 18 4 PHWMMICKY coh sctecet tet tt E ettcb ical ln tats chal statis is 19 5 Patient postcode 2 0 0 cccsaciinescoceeeeesspenseuacdosnteespensbiasdesesnesienterbeatessiexeentes 20 6 Registered GP practice code o cceeeeeeeeececceeeeeeeeeeeeeeeeeeeeeeeeeeeneeenaaeees 21 7 Consultan GMG COJ Erisim iie ae aa aiaa aeaiee a ieda Ee iaa 22 8 Consultant specialty code
51. ode of consultant who initiated SACT programme NHS data dictionary element CONSULTANT CODE INITIATED SYSTEMIC ANTI CANCER THERAPY For the Systemic Anti Cancer Therapy Data Set this is the CONSULTANT CODE of the CONSULTANT who initiated the Systemic Anti Cancer Therapy Format an8 Relevant code and or pick list General Medical Council unique number for each registered medical practitioner Schema specification Required Purpose It allows identification of consultant team responsible for initiating the programme and patterns of management provided Source Hospital PAS or entered directly into prescribing system and code derived Comments In some specialty areas several consultants may work as a team but an individual consultant must be identified as the consultant responsible for initiating the programme of chemotherapy Crown Copyright 2013 Page 22 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 8 Consultant specialty code Section Demographics and consultant SACT description Specialty code of consultant who initiated SACT programme NHS data dictionary element CARE PROFESSIONAL MAIN SPECIALTY CODE For the Systemic Anti Cancer Therapy Data Set this is the MAIN SPECIALTY CODE of the CONSULTANT who initiated the Systemic Anti Cancer Therapy A unique code identifying each MAIN SPECIALTY designated by Royal Colleges This is the same as the OCCUPA
52. pty Crown Copyright 2013 Page 64 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Chemotherapy Data monthly activity Correct bad data by 15 of the month Remaining incorrect data to be corrected correct No Yes v Retain bad A correct No Yes y Retain bad data for _ data for by following month s submission correction Data quality report to sites a A correction Clinical quality report to sites Ne ON st th 15 15 16 20 21 30 30 days after QA f id Clinical QA reports publication Checking and submission of data Data quality snapshot P P F Data piel Check data against CLINICAL QA business rules TO to an Clinical Oncologist y Oncology DATA QUALITY Pharmacist gt Submission Yes Completeness Regimen review 100 correct A De duplication and input Rationalisation No Prescription Sequence review and input No Yes p Load good Clinical quality data reports amp Is data 80 feedback to gt Website reporting compliant S sites v Retain bad data for correction Review update Review update refer refer No l Is data 80 Is data 80 CH
53. pyright 2013 Page 34 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 To allow for casemix adjusted analysis Patients with poor performance status are less likely to tolerate or complete rigorous treatment Source MDT Comments WHO categories 1 4 are a match to the Eastern Cooperative Oncology Group ECOG categories and should be used for adults above 16 years For birth to16 years the Lansky scale should be used Crown Copyright 2013 Page 35 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 20 Co morbidity adjustment Section Programme and regimen SACT description Whether or not patient s overall physical state other diseases and conditions was a significant factor in deciding on regimen or in varying the dose or treatment interval from the start of treatment NHS data dictionary element CO MORBIDITY ADJUSTMENT INDICATOR An indication of whether a PATIENT s overall physical state i e other diseases and conditions was a significant factor in deciding on the type dose or scheduling of Anti Cancer Drug Regimen for example a Systemic Anti Cancer Therapy Regimen Format ani Relevant code and or pick list Y N Schema specification Required Purpose To allow for casemix adjusted analysis Patients with co morbidity are less likely to tolerate or complete rigorous treatment Source MDT Comments This dif
54. r chemotherapy This is already recognised as being very valuable for those providing and commissioning chemotherapy services ensuring that services are both of high quality and delivered efficiently Equally importantly 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 This will therefore support patient choice and empowerment in a way that has not previously been possible The SACT dataset is also integrated with the other clinical NHS datasets ultimately enabling the outcome of the complete patient pathway to be understood For details of the implementation timetable refer to Appendix 2 1 3 Chemotherapy Intelligence Unit The national collection of chemotherapy data is held and analysed by a Chemotherapy Intelligence Unit based at the National Cancer Registration Service NCRS Oxford and responsible to the National Cancer Intelligence Network NCIN within Public Health England Section 251 of the NHS Act 2006 bounds the data which the NCRS receives In order to provide an accurate and complete analysis of clinical practice the data collected includes information on the patient and their condition with details of every attendance for chemotherapy It also records a summary of the outcome of treatment 1 4 Information Governance The dataset contains sensitive and patient identifiable information
55. sion commenced or an oral drug was initially dispensed to the PATIENT Format an10 ccyy mm dd Relevant code and or pick list Not applicable Schema specification Required Purpose Defines the date of actual administration Source E prescribing system Comments No additional comment Crown Copyright 2013 Page 52 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 35 Organisational code of provider for each administration Section Drug details SACT description Code of provider for each administration in a SACT cycle NHS data dictionary element ORANGISATION CODE CODE OF PROVIDER See the Organisation Default Codes in the Default Codes Summary Table at http www datadictionary nhs uk web site content supporting information organisati on data service default codes asp shownav 1 Format an3 or an5 Relevant code and or pick list NHS list of provider code and name Additional lists will be required for non NHS providers including home care delivery Schema specification Required Purpose To allow analysis of care by provider and benchmarking between providers Source Hospital PAS other provider codes Comments This is a critical field in the data set as the provider of chemotherapy must be identified Patients may move between providers during their chemotherapy treatment Crown Copyright 2013 Page 53 of 70 Systemic Anti Cancer
56. stem or local records Comments This field is simply to indicate whether a regimen is within a clinical trial which would not be clear otherwise if it was the standard arm of the trial Crown Copyright 2013 Page 39 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 24 Chemo radiation Section Programme and regimen SACT description This field identifies regimens which are given as part of a combined treatment with radiation NHS data dictionary element CHEMO RADIATION INDICATOR An indication of whether a regimen such as a Systemic Anti Cancer Therapy Regimen is given as part of a combined treatment with radiation Format an1 Relevant code and or pick list Y N Schema specification Required Purpose To identify use of chemo radiation only used where this is a recognised treatment regimen Source E prescribing system or local records Comments This field is used to record if a regimen is part of a recognised combined treatment the radiotherapy and chemotherapy may be concurrent or sequential The regimen name may indicate that it is a combined treatment Crown Copyright 2013 Page 40 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Data item number and name 25 Number of cycles planned Section Programme and regimen SACT description The number of cycles specified in the prescription This may be the number
57. thin the repository database along with encrypted passwords for authentication Once users have logged in to the portal they will be presented with links to a choice of pages e Upload data page e Validation and data quality reports pages e User support pages and contact details 4 4 Data submission and file naming The following file naming convention is to be used for submissions UnitID yyyymmdd yyyymmdd CSV Where UnitID is an agreed unique identifier for the supplying chemotherapy provider and matches the user login s unit code and yyyymmdd is the start date of the data date of earliest treatment followed by the end date date of final treatment The name of the file will be created by the user on the web site during the submission process regardless of what the file is called locally on the treatment provider s computers Date picker controls will allow the user to select the date range of the file s data based on drug administration dates The unit s unique identifier will be taken from the user s login credentials held in the database The web portal will then display the Crown Copyright 2013 Page 63 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 proposed filename for user approval preventing user errors in file naming Upload instructions will be available on this page for users Files are transferred using the secure web based Hypertext Transfer Protocol Secure HTTPS
58. tially and constitute a single chemotherapy programme Crown Copyright 2013 Page 10 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 Programme number Programmes will be numbered sequentially and the option to start from any number must be available to allow for prior management not recorded on the current system This corresponds to the term line of chemotherapy expressed in many prescribing systems and constitutes a single chemotherapy programme Regimen Conventionally this term is used to identify a standard or trial group of drugs given in a specific way and may include other instruction concerning the timing and parameters of treatment The regimen title will be as agreed by the Oncology Regimen Steering Group and this will inform the OPCS Guidance for Clinical Coders In the management of the majority of adult solid tumours the chemotherapy programme and regimen will be the same Particularly in the management of haematological and paediatric tumours two or more recognised regimens may be given concurrently or sequentially and constitute a single chemotherapy programme Regimen number Where a patient has two or more regimens of chemotherapy within a programme for a given cancer they should be numbered sequentially irrespective of intent If two or more regimens commence on the same day the regimen planned to be completed first should be given the lower number The option to start from any n
59. umber must be available to allow for prior management not recorded on the current system If a patient develops a second cancer the numbering will start again Cycle Apart from continuous chemotherapy a regimen normally contains identifiable repeating elements and each repeat should be identified and numbered Some regimens have alternating repeating elements and some have consecutive sets of repeating elements In all these cases the term cycle would be equally valid and help to identify the stage of progress of the patient through chemotherapy For continuous normally oral chemotherapy it will be necessary to agree an arbitrary equivalent In order to align with the advice of the Oncology Regimen Steering Group which informs the OPCS Guidance for Clinical Coders a cycle will be 28 days from first administration Cycle number These will be numbered sequentially within a regimen and the option to start from any number must be available to allow for prior management not recorded on the current system Administration date Consistent terminology is required to identify each contact between the patient and the chemotherapy team when chemotherapy is administered This will cover initial and subsequent contacts and needs to be recorded for inpatient treatment chemotherapy clinic attendances attendances ina primary care setting and domiciliary administration by a specialist service In the case of infusions the administration date will b
60. ysis to CIU phe gov uk for consideration Agreed changes or enhancements to the implementation of the data standard will be circulated to all contributors on a regular basis via the Chemotherapy Intelligence Unit Crown Copyright 2013 Page 9 of 70 Systemic Anti Cancer Therapy Dataset Implementation User Guide v0 11 2 Definitions for the National Systemic Anti Cancer Therapy Data Set With the advent of a National Systemic Anti Cancer Therapy Data Set it is important that field naming is consistent within hospital systems and the definitions of the fields are unambiguous and applied by all providers Where possible field naming and definitions should either be aligned with those agreed for the Radiotherapy Dataset ISB 0111 Cancer Outcomes and Services Dataset ISB 1521 or avoided Definitions The term course has not been used in the data set The term is used variably and discussions have highlighted this as a potential risk The term regimen plus the number of cycles has been substituted in the data set The term programme has been added to mean the whole of a sequence of chemotherapy planned The relationships between programmes regimens cycles and administration dates are shown in the accompanying graphic and examples of dataset structures pages 12 13 Programme The key factor in the definition of a programme is that it is a pre planned sequence of treatment that may include one or more regimens I

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