Implementation of a comprehensive clinical quality assurance system in radiation oncology.

Objective: The objective of this project was to develop and evaluate a comprehensive clinical quality assurance system for radiation oncology, and assess the system using definitive radiation therapy for prostate cancer as a first use case.

Methods: The Zurich Clinical Quality Assurance System in Radiation Oncology (ZH-CLASSIC) was initiated to allow for continuous quality assurance in radiation oncology with respect to indication for radiation therapy, practice of radiation therapy and patient outcome. Data from the sources of the hospital information system, the Radiation Oncology Record and Verify System and a dedicated follow-up database were automatically retrieved, and combined using a unique patient-ID. Data aggregation, continuous analysis and reporting was performed using ten distinct patient care pathways as the basis which covers all aspects of radiation therapy treatments and indications as well as the different follow-up schemes (in-clinic, telemedicine, and external follow-up). The follow-up system was validated through analysis of patients with prostate cancer (≥ 18 years, cT1-3 cN0 cM0) who underwent curative, primary stereotactic radiation therapy. Survival, treatment effectiveness, tumor control, acute and late toxicity, and performance status were analyzed.

Results: Since May 2021, a total of 4,515 individual patients were being managed in ZH-CLASSIC. Personal resources amounted to 0.75 full time equivalent (FTE) project manager for one year prior to implementation, 0.13 FTE physician and 1.00 FTE follow-up manager as ongoing expenses. Compliance with respect to reporting data into ZH-CLASSIC by the physicians increased from a mean of 54% in 2021 to 92% in 2024. For all patients, follow-up was performed as in-clinic visits (51%), via telephone (7%) or as an external query (43%), with missing information (5%) originating from external requests in 96%. Instead of an intended first in-clinic follow-up visit, telemedicine appointments were conducted in 10% and external follow-ups were performed in 22%. Oncological outcomes and toxicities were evaluated for all prostate cancer patients (n = 209) treated with daily online-adaptive SBRT on the MRIdian using 5 × 7.25 Gy every other day or 5 × 7.5 Gy weekly. After a median follow-up of 15 months (range, 6-41 months), 208/209 patients were alive. Over this time period, reported CTCAE toxicities included genitourinary grade 2: 12%, grade 3: 1%, and gastrointestinal grade 2: 3%, grade 3: 0%.

Conclusions: The ZH-CLASSIC system allowed for automated and structured documentation and analysis of the quality with regards to the indication, treatment and outcome of radio-oncological cancer patients. Dedicated staff are needed in the start-up period but personal resources are expected to continuously decrease. Analyses of patients treated with SBRT for localized prostate cancer resulted in plausible results in agreement with reported values in the literature.

Clinical Trial Number: Not applicable.