Data Resource Profile: The Systemic Anti-Cancer Therapy (SACT) dataset

The Systemic Anti-Cancer Therapy (SACT) database is a population-based resource of SACT activity reported routinely by National Health Service (NHS) trusts in England. Data are collected on the SACT treatments of adult and paediatric patients, delivered in secondary and tertiary settings with the intention of improving survival, delaying further cancer progression or development and improving disease-free or progression-free survival. As a guide, the types of treatment NHS trusts are required to submit are listed in Box 1. Treatments such as bisphosphonates and steroids should only be submitted to SACT when they are given with disease-modifying intent (e.g. to control cancer by killing cancer cells and preventing, reducing or delaying cancer growth, development and metastasis), although there is no check on such submissions and some trusts may submit all supportive medications without qualification. It is not within the scope of the SACT database to collect treatments when prescribed as supportive therapies (e.g. to improve symptom control, quality of life or to help manage the side effects of SACT). If a treatment is submitted which would only ever be used with supportive intent, we advise that the treatment is excluded from any analysis. If a treatment is submitted which can be used with supportive or disease-modifying intent, we would assume it is being used in line with the treatment intent (Table 1, field: Drug treatment intent) of the associated regimen. However, we advise analysts that there may be a data quality issue, and recommend that exclusion rules are developed on a case-by-case basis by consideration of the specific treatment and disease indication. These are not required submissions, but are allowed for ease of the submitting trust. Data field descriptions and data quality for all fields collected for use in SACT database OPCS, OPCS Classification of Interventions and Procedures; GMC, General Medical Council; TNM tumour, node, metastases staging classification. These fields have been proposed to be removed by NHS Digital in the next revision of the SACT dataset (Systemic Anti-Cancer Therapy Dataset v3.0). A code uniquely identifying a general medical practitioner. The SACT database is collected and curated by the National Cancer Registration and Analysis Service (NCRAS) at Public Health England (PHE), which started receiving data as part of a phased implementation from April 2012. From April 2014 it became mandatory for all NHS trusts providing SACT to submit data; however, this was not achieved by all trusts until July 2014.1 SACT data ascertainment has been compared with other national databases.2,3 Data quality is thought to be sufficient for most purposes from 2013, with the caveat that not all trusts were submitting data until July 2014. Between 1 April 2017 and 31 March 2018, the database recorded a total of 1 220 370 cycles for 209 922 patients. Management of the database is clinically led, and it has been designed to understand patterns in SACT prescribing, and treatment outcomes. The dataset collects information at patient and tumour level and is designed to be linked to other data sources to provide a complete picture of the cancer patient pathway. The SACT dataset design aims to: provide data to support and improve clinical decision making; assess inequalities in access to SACT; and support commissioning [e.g. through providing evaluations for the Cancer Drugs Fund (CDF) and assessing adherence to National Institute for Health and Care Excellence (NICE) guidance]. Summarized SACT data are routinely reported back to the NHS trusts, using an online platform available to users with an N3 connection.4 The reports available on this platform were developed based on feedback regarding what information trusts would find the most useful in supporting clinical decision making and operational delivery of services. Reports are presented at trust, regional and national levels. In addition the data can be filtered and grouped by specialty (e.g. oncology, haematology, paediatrics), patient age and tumour types. Number of patients receiving treatment for each tumour group. Number and proportion of regimens reported for each treatment intent and tumour group. Distribution of performance status at start of regimen by treatment intent and tumour group. Average number of adults treated by day of the week. Number of regimens, number expected to have been completed and number with outcome recorded, stratified by intent of treatment. Outcome summary for completed regimens by intent of treatment. Names of drugs administered by tumour group. NCRAS has been commissioned by NHS England (NHSE) to provide data and analysis for the evaluation of new CDF drugs in England.5 NICE recommends drugs to enter the CDF when there is clinical uncertainty as to whether the drug should go into routine commissioning. In many circumstances uncertainty will be addressed through a randomized controlled trial (RCT), but SACT and broader cancer data provide a secondary source of information on factors including characteristics of the patient cohort receiving the drug, their overall survival and treatment duration. This information acts to confirm the generalizability of findings from RCTs, by determining if efficacy in clinical trials translates into effectiveness in routine care. In some cases, SACT is used as the primary source for evaluation where the NICE committee believe routine data are sufficient to answer areas of clinical uncertainty in the absence or with support of an RCT. As of October 2018, there were 18 drugs in the Cancer Drugs Fund where SACT and broader NCRAS data will contribute to their evaluation for routine commissioning.6 As the SACT database does not collect source of funding for systemic therapies, NHSE initially provides additional data to identify the CDF patients. The SACT data are stored as six data tables: Patient, Tumour, Regimen, Cycle, Drug detail and Outcome (see Table 1). The SACT data tables have a one-to-many relationship as shown in Figure 1; i.e. a record in the patient table may link to one or many records in the tumour table. The exception is the Outcome table for which a one-to-one relationship with the Regimen table exists; i.e. each completed record in the Regimen table will have a maximum of one record in the Outcome table. Each SACT data table contains a primary key that uniquely identifies records within that table. In addition, each table (except the patient table) contains ‘foreign keys’ (rows in tables that uniquely define rows in other tables) which are used to link records between tables. For example, the Drug detail table will contain foreign keys to identify which patient, tumour, regimen and cycle the record corresponds to. The internal linkage of the database means that new data on prescribed SACT will automatically be linked to a patient. Structure of the tables within the SACT database. The SACT database can be linked to other data held by NCRAS, for example the cancer registration data, Hospital Episodes Statistics (HES),7 the Radiotherapy Dataset,8 and the Routes to Diagnosis dataset9 (see Box 2 for full list). Detailed information on these datasets has been published previously.10,11 Linkage of these datasets allows the whole patient pathway to be assessed. Updated regularly and available at [https://www.gov.uk/government/publications/accessing-public-health-england-data#history]. These are derived data items. Table 2 presents the number of patients treated with a SACT treatment by primary diagnosis, who appear in the SACT dataset compared with the HES-admitted patient care and outpatient care datasets. Overall the ascertainment in SACT is higher compared with HES, especially in adults. In childhood, teenage and young adult (CTYA) patients, HES has higher ascertainment for some sites, particularly in brain/central nervous system (CNS), urology and sarcoma sites. In comparison with adult cancers, CTYA tumours have different approaches to classifying diseases and less extensive roll-out of electronic prescribing systems and associated regimen mapping procedures, as well as complex multicentre models for delivering care. These all contribute to poorer ascertainment of SACT in these cancers. HES inpatient and outpatient data were used in these analyses but, due to the incomplete recording of outpatient procedures, they are likely to underestimate any treatments delivered in an outpatient setting. Only site-specific cancers were included due to a high number of secondary malignant neoplasms captured in HES (C77 – C79) that fell into an ‘other’ category. This may be because hospital coding teams are attempting to code the metastases as the site of treatment, as opposed to SACT where all treatments are linked to the primary diagnosis at the start of a patient’s treatment. Number of patients captured in the Systemic Anti-Cancer Therapies (SACT) dataset vs systemic therapiesa in HES between 1 March 2017 and 28 February 2018 CTYA, childhood, teenage and young adult; CNS, central nervous system; GI, gastrointestinal. Systemic therapy in HES defined using OPCS4 codes: X71, X72, X73, X748, X749, X352, X373, X384. bTotal excluding Myeloma- due to small numbers. cnon-zero number under 6. SACT data are recorded on hospital electronic prescribing systems. Patient details and the treatment prescribed are entered during the course of care by clinicians, nurses, pharmacists and other health care providers. There are several electronic prescribing software providers, but all produce a SACT extract in a standard format. Trusts make a data extract monthly according to their submission schedule. The few trusts without electronic prescribing use Patient Administration Systems or a manual system to produce their extracts. SACT data extracts are manually uploaded to a secure portal maintained by PHE (there is no direct interface between the portal and electronic prescribing system). Each trust has at least one registered uploader who is responsible for uploading the extract. If there are any validation errors on the extract, for example missing data in key fields, the uploader must correct these and re-upload the data. Support with errors and the upload process is provided by the SACT helpdesk. A summary report of total administrations, new cycles and regimens is provided on the portal to enable trust users to check the data before submitting the extract. Table 1 provides complete information on the 43 data fields and their description, as well as any data quality issues associated with these. Table 3 provides information on the completeness of each data field by cancer type for the period 1 April 2017 to 31 March 2018. Data completeness has improved over the past years and, as such, cohorts including historical data will not have such complete data. Data field completeness by cancer type for the period 1 April 2017 to 31 March 2018, the ICD-10 codes for the groups are consistent with Table 2 CNS, central nervous system; GI, gastrointestinal; TYA, teenage or young person. Any valid ICD 10 not listed in specific group. Code uniquely identifying a general medical practitioner. The topography of the tumour is coded using the International Classification of Disease 10th Revision,12 and the histology is coded using the International Classification of Disease Oncology 3rd revision.13 These codes refer to the primary diagnosis of the tumour and the description of the tumour at the start of SACT treatment. Including patient’s postcode as a field means that information can be mapped to other health care geographies, to support service planning within Clinical Commissioning Groups or Cancer Alliances. In addition, the patient’s postcode allows the deprivation score to be determined using quintiles of income domain at the Lower Super Output Area, enabling the investigation of inequalities in prescribing of SACT. A review of the dataset is currently being undertaken. Version 3.0 will be an extension to the standard, introducing new data fields, correcting existing data fields and removing some data fields to reduce the burden of data collection wherever possible. This is to update the NHS Digital Information Standard ISB 1533, to standardize the recording of systemic anti-cancer therapy treatments and outcomes through electronic systems. A phased implementation of the revised data standard will start from September 2019 with full implementation by December 2019. The SACT dataset has been used to investigate 30-day mortality following SACT for lung and breast cancer patients.14 This research provided real-world evidence on the 30-day mortality of patients receiving SACT, as well as demonstrating variation between trusts. Additionally, NCRAS have produced a methodology and process for routine feeds to trusts to highlight patients who have died within 30 days of receiving SACT, to potentially support morbidity and mortality meetings. Reviews of individual deaths have been highlighted as a way to increase the quality of care.15 NCRAS plan to develop additional outcome metrics to feedback to trusts to support the delivery of care. Henson et al.16 used the SACT dataset when investigating sociodemographic variation in the use of chemotherapy and radiotherapy in patients with stage IV lung, oesophageal, stomach or pancreatic cancer. This work has been further developed into an online tool17 and workbooks presenting the data.18,19 Jones et al.20 used the SACT dataset when investigating 30-day mortality after chemotherapy for people with small-cell lung cancer. Annual reports are published for the National Cancer Audits21–23; these report on SACT activity with the overall aim to review the quality of cancer care and identify areas for improvement. A list of all published reports can be found on the SACT dataset website.24 Ongoing research projects are investigating whether age is a barrier to receiving SACT,25 and examining the relationship between SACT prescription in a palliative setting and end-of-life care.26 Health Data Insight CiC (HDI), in partnership with AstraZeneca and IQVIA, have developed a dataset (the Simulacrum) containing artificial patient-like cancer data, which imitates some of the data held by NCRAS, including the SACT dataset. More information is available on the HDI website.27 The SACT and NCRAS websites contains details on the methodologies used in our various outputs.2,28 The key strength of the SACT database is the detailed clinical information collected with whole population coverage for England. The completeness and population-based design of the data source and the of findings from using these and through with in the field of cancer data, we have been to find a data source which is to the SACT database in of or NHS collect data on SACT prescribed to patients, which can be linked to their cancer data, and However, the population of is compared with in and the population coverage of the dataset is there are patients in the dataset. Additionally, these data are not being available to data sources are by only specific or or are not for the collection of population-based such as SACT can be used to whether findings from into groups to are small and of the broader population of cancer There may be in care between patients in an compared with patients in routine NHS This is particularly when the efficacy of a new cancer treatment is and the real-world outcomes for patients may from level data on from these which is given that there is that underestimate treatment can be used to complete research into cancers where may not be Data should be entered into the SACT portal each and SACT is as well as the outcomes associated with treatment. of data collection of all the drugs prescribed to patients the course of their treatment. The to link to a of routine care collected by the NHS (see Box the in which analyses can be on different patient tumour types and care this a number of research to be such as inequalities in access to The use of primary and foreign keys within the data tables allows all records of SACT for a tumour and patient to be linked over This linkage allows of patients to in addition to in prescribing over of the data issues are a of this being a real-world collected routinely at the of care. NCRAS with trusts to support in uploading the data, as well as supporting their to electronic prescribing systems. the number of data which are on the data before submission have In the records that the SACT portal validation process appear as errors and must be before the can be Data quality is addressed when SACT data is linked to the cancer dataset. If any issues are the SACT have data who support trusts to improve the quality of the data they The has a a and a to increase and regarding the dataset. the source data are entered in through electronic prescribing systems by during when the patient is and information may not be and there may not be available to other clinical records for this has to be by NCRAS in the data before using it for analysis. As shown in the comparison with HES data, ascertainment is poorer for CTYA cancers. of SACT can be linked to the use of electronic prescribing systems. For CTYA trusts and the to use electronic prescribing was for adult services. to an in ascertainment of SACT CTYA due to the use of electronic prescribing systems. For several operational ascertainment is poorer for example would be that some trusts not use electronic prescribing systems for Drugs which are delivered an (e.g. in or in primary are The most example is the use therapies in breast and cancer. number and number are missing or It is to cycle number by using the cycle to the SACT however, this field was not mandatory until whether a patient has of by can be with support from based their of the clinical pathway. Data quality for fields such as stage and are (see Table 1). However, this can be by to cancer data. data, are to the regimens as they Each trust will have a or data uploader who is responsible for mapping the regimens to a list of this only to be (the regimen uploaded will be automatically it is a electronic prescribing, there was a high number of patients receiving cycle It is to from these data which patients only a cycle of SACT, and treatment, or whether this is a data quality and the patient cycles of SACT which were not A list of data quality issues has been provided in Table 1. As some fields can be with information from the NCRAS these of the NHS PHE to collect information on cancer patients for health and service without the to These are by the of the Health to access potentially SACT or other NCRAS data can be to the for Data at PHE There are to the and and It is that their proposed with the before submission of a full details regarding are available The NCRAS data details data which are available for access and which data are potentially and not available to If linkage to other NCRAS datasets is linkage will be by an NCRAS before of data. There are no on who can to the however, are required to that they are with data including the of the General Data and the must that their for using the data is consistent with the aims of health and service in line with the to collect the data under of the NHS on whether the work is to be research or service will have to from a research committee associated with their to access these data will be on a to the of work required to access to data. will be as as and aim to produce is of and aims to provide to help details regarding are available The SACT is available at to help support trusts with data and to feedback from trusts on the routine In addition, data and are available The SACT dataset is a resource in of the and of information on systemic anti-cancer drugs prescribed to cancer patients. The key are the population-based high level of clinical information standard cancer registration data and the to link to other NCRAS datasets providing the to have a complete picture of the patient pathway. resource has been to increase data however, issues to ascertainment and completeness of fields a of research can be addressed using this which will improve our of SACT prescribing and, variation in as well as the associated treatment outcomes. The Systemic Anti-Cancer Therapy (SACT) dataset is an collection of all SACT prescribed to cancer patients by secondary and tertiary care in the National Health Service Data are collected on patient the and NHS trust where the patient is being tumour the clinical status of the patient and the SACT the patient is SACT data can be linked to several datasets held by the National Cancer Registration and Analysis Service (NCRAS) and Hospital Statistics to provide a complete picture of the patient pathway. SACT data are being used for the of the drugs through the Cancer Drugs Fund and for a of research including investigating 30-day mortality and inequalities in access to treatment. NCRAS routinely support trusts with their data submissions, on improving data quality and The NHS England Commissioning for and has NHS trusts in their to improve data quality for a number of key items. the clinical to SACT prescribing is key in and the of these data. Cancer Drugs Fund teenage and young adult cancer. as a cancer when years prescribing electronic to A field in one table that uniquely identifies a in table Hospital Episodes Statistics dataset. This dataset patient and clinical information on and The International Classification for Disease This is the standard for classifying diseases and is published by the Health The International Classification for Disease Oncology This is the standard for classifying diseases in Public Health England A field which contains a National Cancer Registration and Analysis This service is part of Public Health England responsible for all cancer in England National Health Service controlled trial Systemic Anti-Cancer and therapies NHS trusts and trusts provide health care. The of in England are by NHS trusts. NHS trusts are and have Public Health England is a There is no funding to in to this is in part by Cancer Data for this are based on information collected by the as part of the care and support of cancer patients. The data are maintained and quality by the National Cancer Registration and Analysis which is part of Public Health England. are to and for their regarding this of