Interview on Ontada research presented at ISPOR 2024.
Use of real-world data in research demands that data pulled from electronic health records are accurate. New research from Ontada shows how doing a pilot ahead of the main chart abstraction process can identify and correct potential error sources, thus ensuring high-quality data.
Sarah Spark, MHA, MBA | Image: Ontada
A poster presented May 7, 2024, at ISPOR—The Professional Society for Health Economics and Outcomes Research detailed the chart abstraction pilot. Sarah Spark, MHA, MBA, director, clinical data quality for Ontada, presented the findings and spoke with Evidence-Based Oncology about the results.
In a typical data-gathering process, Spark explained, chart abstractors pull individual data points for a given study, which can vary from how treatment was sequenced to whether patients were hospitalized. Then, a reviewer goes back through the data to ensure the chart abstraction is accurate.
The pilot process featured a 60-minute education session on the clinical variables to be pulled for the specific study, she said. Abstractors then pulled data from 2 charts each over a 2-week period and investigators calculated an accuracy rate: the number of correctly abstracted variables divided by the total number of variables observed. Abstractors received reeducation if they had an accuracy rate on an individual variable below 80% or if their overall accuracy rate was below 90%.
Abstractors then completed data abstraction on the remaining charts and this process was reviewed for accuracy. Investigators found that the mean accuracy rate for 15 studies during the pilot phase was 94.5%, while the mean fully study accuracy rate was 97.1%. This was “a statistically significant increase over the mean pilot accuracy rate (P = .046),” investigators wrote.
Previously, Spark said, “we didn’t necessarily always do the pilot.” “But what we learned from doing the pilot and getting the metrics is that we can then reeducate specific chart abstractors on specific variables.”
Variables that required reeducation included clinical characteristics and treatment history, they wrote. The need for the pilot process becomes clear, Spark said, as more research involves unstructured data, which calls for abstractors to look deep into the charts for the right data.
Results from this new analysis demonstrate the value of the pilot. “It increases the quality,” Spark said. “Instead of just giving someone 500 charts and saying. ‘Good luck,’ you’re saying, ‘You need to do these 2 charts, [and] I’m going to do source data verification or [quality control] on them. And now they have the opportunity to say, ‘Yes, now I’ve learned. Now I know how to extract it.’”
Reference
Reinwald S, DiIullo S, Fonseca L, et al. Implementing a pilot chart abstraction period improves the overall accuracy rate in chart abstraction. Value Health. 2024;27(6):S1,RWD111.
STEER Data Open Door to SMA Gene Therapy for Wider Age Range of Children
March 19th 2025Delivery of onasemnogene abeparvovec into the intrathecal space was safe and effective for children with spinal muscular atrophy (SMA) aged 2 to 17 years, who had previously been shut out of receiving gene therapy.
Read More
Politics vs Science: The Future of US Public Health
February 4th 2025On this episode of Managed Care Cast, we speak with Perry N. Halkitis, PhD, MS, MPH, dean of the Rutgers School of Public Health, on the public health implications of the US withdrawal from the World Health Organization and the role of public health leaders in advocating for science and health.
Listen
Neurologists Share Tips for Securing Patient Access to Gene Therapies
March 19th 2025Tenacious efforts at every level, from the individual clinician to the hospital to the state to Congress, will be needed to make sure patients can access life-saving gene therapies for neuromuscular diseases.
Read More
EMBARK Data Show Continued Improvements With DMD Gene Therapy
March 19th 2025Data from the EMBARK trial of delandistrogene moxeparvovec in patients with Duchenne muscular dystrophy (DMD) show that benefits in functional outcomes, gene expression, and muscle imaging persist 2 years after receiving the gene therapy.
Read More
How Access to SMA Treatment Varies Globally and by Insurance Type
March 18th 2025Posters presented at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference show that therapeutic advances in treating spinal muscular atrophy (SMA) are not uniformly making it into the hands of patients who could benefit.
Read More