Purpose: Risk management (RM) is a key component of patient safety in radiation oncology (RO). We investigated current approaches on RM in German RO within the framework of the Patient Safety in German Radiation Oncology (PaSaGeRO) project. Aim was not only to evaluate a status quo of RM purposes but furthermore to discover challenges for sustainable RM that should be addressed in future research and recommendations. Methods: An online survey was conducted from June to August 2021, consisting of 18 items on prospective and reactive RM, protagonists of RM, and self-assessment concerning RM. The survey was designed using LimeSurvey and invitations were sent by e‑mail. Answers were requested once per institution. Results: In all, 48 completed questionnaires from university hospitals, general and non-academic hospitals, and private practices were received and considered for evaluation. Prospective and reactive RM was commonly conducted within interprofessional teams; 88% of all institutions performed prospective risk analyses. Most institutions (71%) reported incidents or near-events using multiple reporting systems. Results were presented to the team in 71% for prospective analyses and 85% for analyses of incidents. Risk conferences take place in 46% of institutions. 42% nominated a manager/committee for RM. Knowledge concerning RM was mostly rated “satisfying” (44%). However, 65% of all institutions require more information about RM by professional societies. Conclusion: Our results revealed heterogeneous patterns of RM in RO departments, although most departments adhered to common recommendations. Identified mismatches between recommendations and implementation of RM provide baseline data for future research and support definition of teaching content.
Successful studies on radiation therapy for gastric lymphoma led to a decrease in planning target volume (PTV) and radiation dose with low toxicities, maintaining excellent survival rates. It remains unclear as to which effects are to be expected concerning dose burden on organs at risk (OAR) by decrease in PTV vs. dose and whether a direct impact on toxicity might be expected. We evaluated 72 radiation plans, generated prospectively for a cohort of 18 patients who were treated for indolent gastric lymphoma in our department. As a prospective work, four radiation plans with different radiation doses and target volumes (40 Gy-involved field, 40 Gy-involved site, 30 Gy-involved field, 30 Gy-involved site) were generated for each patient. Mean dose burden on adjacent organs was compared between the planning groups. Cohort toxicity data served to estimate parameters for the Lyman–Kutcher–Burman (LKB) model for normal tissue complication probability (NTCP). These were used to anticipate adverse events for OAR. Literature parameters were used to estimate high-grade toxicities of OAR. Decrease of dose and/or PTV led to median dose reductions between 0.13 and 5.2 Gy, with a significant dose reduction on neighboring organs. Estimated model parameters for liver, spleen, and bowel toxicity were feasible to predict cohort toxicities. NTCP for the endpoints elevated liver enzymes, low platelet count, and diarrhea ranged between 15.9 and 22.8%, 27.6 and 32.4%, and 21.8 and 26.4% for the respective four plan variations. Field and dose reduction highly impact dose burden and NTCP for OAR during stomach radiation. Our estimated LKB model parameters offer a good approximation for low-grade toxicities in abdominal organs with modern radiation techniques.
Patient Safety Indicators (PSIs) allow the evaluation of safety levels in healthcare settings. Despite their use in various medical fields, a specific and comprehensive PSI catalogue for radiation oncology (RO) is lacking. The Patient Safety in German Radiation Oncology (PaSaGeRO) study aims for the development of a specific PSI catalogue in radiation oncology. The primary objective of this systematic literature review as part of the PaSaGeRO study is to identify, formulate, and categorize PSIs specific to RO to bridge existing gaps in comprehensive patient safety evaluation. An electronic search in PubMed included studies from 1989 onwards, in English or German, focusing on safety and quality indicators in RO, patient safety measures, or risk analyses. Exclusions were non-transferable, country-specific measures, techniques exclusive to specific departments, and legally mandated procedures. Additional sources were identified through reference tracking and professional society websites. Two experts independently extracted PSIs from the included references. Out of 157 included publications and nine secondary sources, we identified and formulated 145 PSIs. These were categorized into patient-specific processes (82, 56%), quality and risk management (42, 28%), human resources (15, 10%), and institutional culture (13, 9%). The hereby developed PSIs provides a base for professionals to systematically evaluate and improve safety practices, addressing previously unmet needs in this field. By offering clear guidance on safety assessment, the catalogue has the potential to drive significant improvements in patient care and safety outcomes in RO. Funded by Deutsche Krebshilfe. Registered in the German Clinical Trials Register (DRKS00034690).
Introduction: Primary mediastinal B-cell lymphoma (PMBCL) is a rare form of aggressive B-cell lymphoma with a predominant onset in young patients. The minimization of potential (late) side effects is of cardinal interest for these patients. An anticipation of the individual risk profile is desirable to counsel the patient on the putative impact of radiotherapy (RT). Methods: RT plans for a cohort of 25 patients with PMBCL were prospectively designed. One plan with two parallel- opposing fields (APPA) and another with volume-modulated arc therapy (VMAT) technique with 40 Gy in 2 Gy fractions each. Normal The normal tissue complication probability (NTCP) was calculated using the Lyman-–Kutcher-–Burman model for heart, lung and oesophageal toxicity. Results: APPA planning resulted in lower median doses (Dmedian) for the heart and lungs, whereas all other dose metrics for heart, lungs and esophagus were lower in VMAT planning. A significant difference in the mean NTCPs when comparing the APPA to VMAT plans was seen for increased cardiac mortality, pneumonitis and esophagitis. PTV size correlated with increased cardiac mortality and esophagitis in both plan variations and with pneumonitis for VMAT plans. Dmean, Dmedian, and V20Gy correlated with the risk for pneumonitis, and Dmean, Dmedian, and V1% with the risk for esophagitis in both variants. Conclusions: We showed decreased risk of different NTCPs for VMAT and APPA planning for thoracic toxicities. The use of an IMRT technique like VMAT showed advantages for several DVH metrics in organs at risk and should therefore be recommended for radiation treatment of PMBCL.