Alfredo Addeo Lung NSSG 15th November 2016 30 days SACT UK Alfredo Addeo Lung NSSG 15th November 2016

Background Cancer chemotherapy has been provided in the NHS for decades Accurate, timely and complete data collection is now seen as a priority and this can be assisted by e-prescribing systems The introduction of the Systemic Anti-Cancer Therapy (SACT) Information Standard (ISB 1533) Collection and submission of SACT data is specifically incorporated in the England NHS Standard Contract Cancer chemotherapy has been provided in the NHS for decades But until recently we have had no way of looking at the national picture in detail. Accurate, timely and complete data collection is now seen as a priority assisted by e-prescribing systems 1 as mentioned in the NCAG (National Chemotherapy Advisory Group) report - Chemotherapy Services in England 2009 This has led to the introduction of the Systemic Anti-Cancer Therapy (SACT) Information Standard, With the aim of which is to collect all cancer chemotherapy information in the NHS in England, Collection with began on 1st April 2012 as part of a 2 year implementation phase, formal implementation 1st April 2014. The submission of SACT data has been included in the NHS standard contract for 2013-14 and is due to be updated for 2014-15 National Chemotherapy Advisory Group report– Chemotherapy Services in England: Ensuring quality and safety - August 2009 http://www.england.nhs.uk/resources/spec-comm-resources/npc-crg/group-b/b15/ and http://www.england.nhs.uk/wp-content/uploads/2013/06/b15-cancr-chemoth.pdf - subject to revision for 2014-15

SACT dataset applies to: All organisations providing cancer chemotherapy services in or funded by the NHS in England and includes: all cancer patients, adult AND paediatric acute inpatient, daycase outpatient settings and delivery in the community; Includes oral chemotherapy Covers chemotherapy treatment for: all solid tumours haematological malignancies and includes those in clinical trials Who does it apply to? All cancer patients, adult and paediatric, acute inpatient, daycase outpatients, delivery in the community which includes homecare and oral chemotherapy. It covers treatments for all solid tumours, haematological malignancies and clinical trials.

SACT dataset Consists of 6 sections across 42 data items: Demographics & Consultant Clinical Status Programme & Regimen Cycle Drug Details Outcome Demographics and Consultant: Patient: NHS No, Date of Birth, Gender, postcode, GP, consultant and specialty codes Organisational code of provider Clinical Status: Primary Diagnosis, Morphology and stage Programme and Regimen Programme No/Line of treatment, Regimen information including dates, Treatment intent, treatment plan, comorbidity, chemo/radiation Cycle Cycle number, performance status and associated dates Drug Details Drug name, dose, administration route and dates as well as organisational code of provider delivering the drug Outcome Date of final treatment, whether the dose has been adjusted, treatment delayed or stopped early, and date of death.

Public Health England CKO Principal developers of the SACT Who? NCIN (PHE) Directors Public Health England CKO Chief Knowledge Officer Dr Ken Lloyd and Sue Forsey Principal developers of the SACT NCIN Clinical Information Specialists CCIG Chemotherapy Clinical Information Group Pharmacist Support Disease Registration National Director for Disease Registration SACT Programme Board SACT Programme Manager SACT Snr. PH Analyst SACT Trainer/Liaison SACT Project Manager SACT Systems Developer CIU Core Team WHO are the Chemotherapy Intelligence Unit (CIU)? The SACT dataset exists as a direct consequence of the cancer audit work undertaken by Dr Ken Lloyd and Sue Forsey spanning in excess of a decade – Clinical information specialists for NCIN. The programme has been commissioned by the NCIN and is governed by the Chemotherapy Clinical Information Group – The SACT programme board is supported by oncology pharmacists. The CIU is composed of a dynamic team of Programme and Project Managers, Clinical information Specialists, Developers and Data Managers, which have achieved the delivery of the SACT dataset Through intensive engagement with the clinical chemotherapy community. The CIU has delivered this England wide project, on time, within budget and entirely within the public sector arena. CIU sits within the disease registration directorate of the chief knowledge officer, in Public Health England. SACT Senior Public Health Data Clerk SACT Senior Public Health Data Clerk

Allows additional scrutiny of clinical decisions Ineffective drug? or insufficient dose of effective drug? The analysis resulting from the SACT dataset will allow additional scrutiny of clinical decisions by looking at outcomes we can establish the effectiveness of the treatment…..

Optimal choice of clinical management SACT Dataset young : old stage : performance status : co-morbidity age Clinical status Optimal choice of clinical management for desired outcome benefit toxicity stopped early dose modified - treatment delayed Regimen & delivery curative treatment disease control symptom control By establishing the age and clinical status of the patient Comparing it to the choice of treatment and the corresponding intent, balance in terms of toxicity we should generate a clear view of what works BUT – there must be detailed, accurate and comparable regimen recording to allow effective comparison… recording regimen and detail correctly is critical

National SACT data also: To describe the level and variation of 30 day mortality following SACT on a national level- identified as quality measurement tool To highlight the potential to use SACT data to monitor and improve cancer patient care and outcomes and enhance the data quality and reporting by trusts to that end National SACT data

National SACT data Published in the Lancet Oncology Sept 2016 Data collected for patients treated between January – December 2014 28,400 women with breast cancer 15,000 patients with lung cancer NHS began submitting data in April 2012, and it became mandatory in April 2014 This paper + companion report- 1st major output from this data source National SACT data

SACT DATA 2014

National SACT data Palliative intent: Curative intent: Breast – death within 30 days: 7.5% Lung – 10% Curative intent: Breast – 0.3% Lung – 2.9% National SACT data

England’s 30-day chemotherapy mortality: a measure of quality of care? despite this initiative to collate national data for cancer chemotherapy, there were significant gaps and deficiencies in the national dataset. it remains a tragedy that we still cannot get complete national (anonymised) datasets to inform clinicians and patients and to drive real improvements in patient care. This study sets a standard for what health-care systems should achieve: to routinely record, collate, and report at a national level the negative consequences of medical interventions to improve the quality of health care.

Brest Cancer curative Figure 2 Funnel plot of variation in risk-adjusted 30-day mortality in patients with breast cancer given systemic anticancer therapy with curative intent, by hospital trust Each circle represents a separate hospital trust; blue and red circles represent outliers beyond the 95% and 99·8% confidence interval boundaries that are represented as grey lines. Red line shows national risk-adjusted 30-day mortality rate.

NSCLC curative Figure 4 Funnel plot showing variation in risk-adjusted 30-day mortality in patients with non-small cell lung cancer given systemic anticancer therapy with curative intent, by hospital trust Each circle represents a separate hospital trust; blue and red circles represent outliers beyond the 95% and 99·8% confidence interval boundaries that are represented as grey lines. Red line shows national risk-adjusted 30-day mortality rate.

NSCLC palliative Figure 5 Funnel plot showing variation in risk-adjusted 30-day mortality in patients with non-small cell lung cancer given systemic anticancer therapy with palliative intent, by hospital trust Each circle represents a separate hospital trust; blue and red circles represent outliers beyond the 95% and 99·8% confidence interval boundaries that are represented as grey lines. Red line shows national risk-adjusted 30-day mortality rate.

Summary of 30-day mortality rates in patients with breast or lung cancer by treatment intent Data are n (%) of total patients by cancer type and treatment intent; and n (%) of deaths occurring within 30 days of systemic anticancer therapy for each of those groups.

30-day mortality rates in patients with lung cancer by morphology and treatment intent Data are n (%) of total patients by lung cancer type and treatment intent; and n (%) of deaths occurring within 30 days of systemic anticancer therapy for each of those groups. NSCLC=non-small cell lung cancer. SCLC=small cell lung cancer.

1st important insights into 30-day mortality in a large, representative population of patients with breast or lung cancer receiving systemic anticancer therapy in England. Some trusts having significantly higher rates for early mortality, the reasons require further investigation Conclusion

Media Reaction 1) New Study Finds Chemo Kills 50% of Patients In First 30 Days 2) Landmark Study Shows Half of Cancer Patients are Killed by Chemo — NOT Cancer

LIMITATIONS Submission data mandatory only form april 2014. Possible wrong coding. SACT number for 2014 much lower than real?

National SACT

Data being sent to PHE not a reflection of true 30 day mortality Disparity in number of patients treated compared to national SACT data Possible improvement with increased clinical engagement. Conclusions