Medical Record Abstraction: Ciox, Brown University, and the National Lung Screening Trial
BACKGROUND: Ciox coordinated medical record abstraction for one of the largest clinical trials in the U.S.
CHALLENGES: Large scale abstraction effort
Brown University needed to complete a large scale effort to compile and analyze medical record data for thousands of study participants at healthcare providers across the United States. Each selected participant’s medical data was abstracted and analyzed, many across multiple time intervals. “Outcomes intervals” commonly spanned time periods of six months to a year, and review of these records was triggered by an initial clinical trial screening, annual follow-up screenings or more regular visits for medical care. Each outcomes interval report focused on a single patient, and a patient’s medical record may have been reviewed for six or more reported intervals over the course of the eight-year study. Brown asked Ciox Health to build a highly specialized team to support this large scale abstraction effort.
SOLUTION: Build a team of experts; design and implement abstraction and quality control processes
Build a team of experts; design and implement abstraction and quality control processes.
Despite the industry’s well-documented shortage of skilled professionals, Ciox Health successfully assembled a team of medical record abstraction professionals that included:
- Medical Coding experts
- Record Procurement experts
- Certified Cancer Registrars
- Research and Project Managers
Ciox Health’s team worked with Brown University and the study sponsor, the American College of Radiology Imaging Network (ACRIN), to:
- Define where in the medical record clinical data elements can be found
- Participate in the development of data collection guidelines, data entry, and training materials
- Develop and document quality assurance activities
- Assist with procurement of study records under strict HIPAA regulations and provide training and assistance for study sites as needed
- Create policies and procedures to cover all abstraction-related functions, including data abstraction, data entry, data quality assurance, and data security and confidentiality
- Complete medical record abstraction functions onsite and remotely
- Code the study participants’ medical visits, hospitalizations, diagnoses, and procedures using ICD-9-CM, ICD-10, CPT, and ICD-O
- Prepare detailed site reports on productivity, problem logs and corrective actions, amendments to policies and procedures, and weekly project status reporting
Throughout the life of the study, Ciox Health completed more than 40,000 abstracts (representing 18,000 intervals) and completed this medical data abstraction project on time and within federally funded budgets.
“The procurement and abstraction of charts for this large study of screening for lung cancer is complex and challenging. Medical records from diverse sources, both inpatient and outpatient, are collected on thousands of study participants in more than twenty hospitals across the country. These records document health care utilization and clinical outcomes over a period of time spanning several years. Ciox Health took on the challenge and brought it to fruition with remarkable resourcefulness, flexibility and professionalism.”
Constantine Gatsonis, PhD, Principal Investigator and Professor, Community Health, Brown University
At a Glance
The National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: low-dose helical computed tomography (CT) and standard chest X-ray. Both chest X-rays and low-dose helical CT scans have been used to find lung cancer early, but the effects of these screening techniques on lung cancer mortality rates had not been determined. NLST enrolled 53,454 current or former heavy smokers from 33 sites and coordinating
centers across the United States. In November 2010, the initial findings from the NLST were released. These findings reveal that participants who received low-dose helical CT scans had a 20% lower risk of dying from lung cancer than participants who received standard chest X-rays.
As a result of these findings, Medicare and other payors changed their coverage policies to cover the cost of lung cancer screening for beneficiaries who meet certain criteria.