Evaluation of the Representativeness of CPRD Data for Suitability to Conduct Clinical Epidemiological Studies in Patients with Lung Cancer in England : A Feasibility Study

Study type
Feasibility Study
Date of Approval
Study reference ID
FS_002525
Lay Summary

With the growing burden of cancer along with other concurrent conditions (multimorbidity) and the evolving complexities in treatment for different tumour types in the UK, AstraZeneca is leading dedicated programmes research to understand various risks in patients with cancer – with the commitment to support the carers, patients and policymakers effectively.
In this context, there is an urgent need to assess the feasibility of using UK primary care data to address different aspects of evidence generation in the area of cancer (oncology). As part of this programme, we need to explore how similar the lung cancer patients included in CPRD data are to those in the English Cancer Registry ( ECR). The primary reason for this comparison is to assess the suitability of using the primary care data (CPRD) to holistically understand different aspects of risks and treatment in patients with different cancers. The aim of this feasibility study therefore, is to evaluate whether CPRD primary care data can be used to study lung cancer by assessing if the lung patients in CPRD primary care data is similar to (representative of) the lung cancer patients in the ECR. This comparison will be made possible by comparing CPRD analysis findings with those from a recently conducted study of lung cancer patients in England from 2014, using ECR in collaboration with National Cancer Registration and Analysis Service (NCRAS) within NHS Digital. The CPRD dataset will be held and analysed at Astrazeneca, separated from the already analysed ECR dataset held at NHS Digital.

Technical Summary

The aim of the feasibility study is to evaluate whether the primary care data (CPRD Aurum) can be used to conduct clinical-epidemiological studies in people with lung cancer by assessing if the lung patient cohort in CPRD primary care data is representative of the lung cancer cohort in the English Cancer Registry. This will be accomplished by examining the distributions of age, sex, socio-economic status and comorbidities (including all cardio-metabolic comorbidities and mental health diagnoses) at point of diagnosis of lung cancer (any lung cancer) in the primary care, and comparing with the distributions of these variables in the ECR lung cancer cohorts. These distributions have already been assessed for a lung cancer cohort drawn from unlinked ECR data requested directly from the National Cancer Registration and Analysis Service (NCRAS) in a separate study. The CPRD dataset will be held and analysed at Astrazeneca, separated from the already analysed ECR dataset held at NHS Digital.

The proportions (95% CI) or mean / median (95% CI) of the respective study parameters will be evaluated. Density plots of age at diagnosis of lung cancer will be evaluated, for the whole cohort and separately by gender.
In addition, an assessment of the completeness of smoking and body mass index (BMI) data in CPRD will be conducted, for the overall CPRD lung cancer cohort and stratified by gender, and age group, as appropriate. Apart from mean (SD) BMI, the BMI categories (normal weight, over weight, grade 1 obesity and grade 2+ obesity) will be evaluated.

The IMD will be used as a measure of socio-economic status, hence a linked dataset of IMD is needed. IMD is strongly associated with inequalities in cancer screening, care and survival and commonly used to understand risk dynamics in cancer patients.

Health Outcomes to be Measured

Distributions of age, sex, socio-economic status (index of deprivation, IMD), smoking status, BMI, and comorbidities at diagnosis of lung cancer. Comorbidities will include all cardio-metabolic comorbidities, other cancers, and mental health diagnoses including depression.
The presence of comorbidities will be assessed by relevant disease identification SNOMED-CT and other appropriate codes. Atherosclerotic cardiovascular disease (ASCVD) will be defined by the presence of available diagnostic codes for ischemic heart disease (myocardial infarction, unstable angina, or coronary revascularization, excluding stable angina), cerebrovascular disease (ischemic/hemorrhagic stroke, transient ischemic attack, or carotid revascularization), or peripheral arterial/vascular disease. Patients with cardiovascular disease (CVD) will include those with ASCVD and heart failure (HF). The chronic kidney disease (CKD) will include disease identification codes (CKD stages 2–5, end-stage renal disease, dialysis, transplant, nephropathy, proteinuria, albuminuria, nephrotic syndrome, nephritis).
Microvascular disease will be defined by a diagnostic code for neuropathy, retinopathy, or CKD (as defined previously). Hypertension and dyslipidemia will be defined by the presence of a clinical diagnosis or use of antihypertensive and lipid-lowering drugs before lung cancer diagnosis. Individuals who received antihypertensive medications will be identified using prescription records for β-blockers, diuretics, calcium channel blockers, ACE inhibitors, angiotensin II receptor blockers, other agents acting on the renin-angiotensin system, or other antihypertensive drugs. Similarly, lipid-lowering medications will be identified using prescription records for statins, proprotein convertase subtilisin/kexin type 9 inhibitors, fibrates, bile acid sequestrates, nicotinic acid, and other lipid-lowering agents.
Other cancer is defined as any malignant neoplasm, excluding melanoma. The definition of mental health disorder will include depression, anxiety, dementia, schizophrenia, psychosis, bipolar disorder and other mode disorders.

Collaborators

Sanjoy Paul - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Sanjoy Paul - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Aminkeng Leke - Collaborator - AstraZeneca Ltd - UK Headquarters
Puja Myles - Collaborator - CPRD

Linkages

Patient Level Index of Multiple Deprivation