ASTRO: IMRT safety needs improvement

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Intensity-modulated radiation therapy (IMRT), developed to improve the safety and effectiveness of radiation therapy, requires better quality control and improved patient safety, an objective that requires providers, vendors, manufacturers and medical societies to collaborate on more comprehensive quality assurance guidelines, according to a white paper published in the July issue of Practical Radiation Oncology.

Improving accuracy by delivering more targeted doses and thereby sparing nearby healthy tissue, IMRT has marked an important advance in the 100-year history of radiation therapy, wrote Jean M. Moran, PhD, lead author of the study, associate professor and the associate division director for clinical physics at the University of Michigan Medical Center in Ann Arbor. “IMRT is, however, incredibly time and resource intensive,” Moran added.

As part of the Target Safety Initiative, the American Society for Radiation Oncology (ASTRO) released the white paper to outline essential safety measures and areas where additional attention is needed.

The paper classified safety hazards and programs into two sections: environmental and technical. Environmental factors included various quality assurance procedures, while technical components referred to treatment- and equipment-specific uses. Moran and colleagues identified 54 process steps and 15 hand-offs between personnel, highlighting their “critical need for clearly defined roles.”

Among environmental elements, the authors emphasized the importance of trust and communication between caregivers and strong safety support from hospital administration. Meticulous tracking and documentation, continuous training and ongoing quality improvements likewise represent essential protocol, according to Moran and co-authors.

Standard operating procedures should be integral measures to IMRT and “should not permit staff to skip [quality assurance] steps.” Moreover, despite common pressures to rapidly implement an IMRT regimen, standard operating procedures should empower individuals to cut short planning or treatment when a problem surfaces.

“Timely treatment is important, but undue pressure and real-time changes to the treatment plan can lead to errors. The report suggests use of a ‘forced time out’ to assure adequate time to perform reviews and quality assurance at key points in the process. Team members need to acknowledge that initiation of treatment may need to be delayed to allow time for necessary quality assurance checks and subsequent investigations of problems,” Moran and colleagues wrote.

Acknowledging a series of radiotherapy accidents reported this year by The New York Times, some of which included IMRT, the authors paid equal attention to enhancing technical safety to prevent “catastrophic failures.” The white paper quickly broke path with earlier IMRT quality assurance documents that suggested quality control in IMRT might be phased out after prolonged IMRT practice.

Nonetheless, the authors looked to individual clinics to establish their own pre-treatment and equipment guidelines in the absence of national standards, stating that “further guidance is needed from national organizations.” One useful way providers can identify flaws in the IMRT process is to test plans with known errors, to determine whether a normal treatment course would identify or pass over these problems.

Beyond clinical initiatives, Moran and colleagues called for tighter collaboration between manufacturers, users and regulators, namely the FDA. These standards should venture into the equipment, quality assurance, operational and clinical phases of IMRT.

Noting that the organization’s recommendations mark important steps for improving patient safety, ASTRO made clear that its suggestions were incomplete and called on continuing efforts and partnerships between all stakeholders, particularly medical specialty associations, to promote national IMRT safety criteria.