No abstract

Objectives: Real-world data sources can be used to test the feasibility of a proposed study design and inform modifications that can avoid costly delays. The primary study objective is to evaluate the use of real-world data to describe the care pathway of colorectal cancer (CRC) patients from colonoscopy to first treatment (eg., chemotherapy, surgery). The secondary objective is to assess for a correlation between time to first treatment and severity of disease. Methods: This research will analyze a combination of disparate but linkable data sources to describe the care pathway from the time of colonoscopy to first treatment for adult CRC patients diagnosed within the US. The study will utilize an encrypted anonymized patient key that links the patient activities across all data sources to ensure individual patientlevel data is anonymous and protected consistent with US Health Insurance Portability and Accountability Act. US outpatient medical and prescription data linked to electronic medical records will be utilized. Patients age 18 or older who were diagnosed with CRC in the period [01 June 2015] to [01 June 2018] as defined by ICD-9-CM/ICD-10-CM codes for colorectal cancer diagnosis and with colonoscopy prior to or at diagnosis and a treatment post diagnosis will be included. Patients with metastatic cancer may be excluded. Patients will be tracked longitudinally to detect colonoscopy procedures prior to diagnosis and looking post diagnosis until start of first treatment. "First treatment" is defined as first recorded claim/prescription for any of first-line chemotherapy or surgical intervention. Baseline and demographic characteristics of patients will be descriptively summarized. The care pathway will be described in terms of types of specialists who perform colonoscopy; type of procedures done concurrently with colonoscopy; days from colonoscopy to first treatment; correlation of time lapsed with disease severity; types of treatment at time colonoscopy and within subsequent weeks.