A hybrid workflow can reduce the number of trial nonconformities in medical imaging-related clinical trials while saving radiologists considerable time, according to a new study published in the European Journal of Radiology.
The workflow, which involves an imaging technologist and electronic reporting software, saved nearly 90% of readers’ time and may reduce the costs of imaging-related clinical trials, wrote Hubert Beaumont, Median Technologies in Valbonne, France, and colleagues.
“For radiologists, who generally perform routine activities, involvement in clinical trials increases their workload and raises human resources issues at hospitals which are already running chronic medical deficits,” Beaumont et al. noted. “HW (hybrid workflow) could provide an opportunity for effective cost reduction combined with enhanced quality of clinical trials involving imaging.”
Imaging has become “instrumental” in determining the efficacy and safety of drug products, and as a result, the researchers noted, clinical trials involving imaging have steadily increased, draining what little resources many imaging departments have.
And in oncological evaluations, managing clinical trials involves generating two reports per patient, a time-consuming process that includes difficult data management aspects important to maintain for integrating the inclusion of trials with the daily activity of an imaging department.
Therefore, the researchers compared a standard workflow against a new cooperative hybrid workflow for clinical trial follow-ups which involved a supervised imaging technologist assisted by software using electronic-form reporting (eCRF). Specifically, the team analyzed reading times and non-conformity rates.
Beaumont and colleagues prospectively analyzed the imaging data of 40 patients included in RECIST 1.1 clinical trials. Seven radiologists and one technologists reviewed 96 time points; nonconformities using the standard workflow were taken from hospital archives. An independent group compared reading times and nonconformities of radiologists using the standard and hybrid workflows.
Overall, the hybrid workflow saved 87% of radiologists’ time, with standard workflow requiring, on average, 11 minutes and 30 second per time-point for radiologists, compared to the 95 seconds needed for the technologist.
When using standard workflow, the team found 19 types of nonconformity. Blank reports (13%), unsigned reports (11%) and undocumented change of tumor burden (10%) were most common. These nonconformities affected 55% of reports using traditional workflow and 5% using the novel approach.
In terms of cost savings, the researchers argued that additional costs cannot be lowered where imaging is involved, but “can be dramatically reduced” by “streamlining the complete radiology workflow or by inter-connecting electronic systems with the two-fold aim of reducing manual operations and saving time.”
This hybrid approach, according to the group, is one such way to achieve this goal. However, radiology departments must ensure the novel workflow can seamlessly integrate into the day-to-day operations of an institution or nonconformities will likely increase.
“…It is anticipated that the role of radiologists will evolve towards tasks to which they can bring the highest added value,” Beaumont et al. wrote. “Given that prospect, HW probably stands halfway along the evolution of radiology workflow, a next step being the enablement of more and more automation and artificial intelligence.”
The authors of the study declared relationships with Median Technologies.