Fre'Etta M D Brooks, Mohammad Hussein, Jessica Lye, Christopher L Nelson, Nakamura Mitsuhiro, Mallory C Glenn, Patricia Diez, Rushil Patel, Maddison Shaw, Ileana Silvestre Patallo, Miriam Barry, Catharine H Clark, Joerg Lehmann, Stephen F Kry
{"title":"制定评估全球临床试验认证和PSQA系统的参考计划。","authors":"Fre'Etta M D Brooks, Mohammad Hussein, Jessica Lye, Christopher L Nelson, Nakamura Mitsuhiro, Mallory C Glenn, Patricia Diez, Rushil Patel, Maddison Shaw, Ileana Silvestre Patallo, Miriam Barry, Catharine H Clark, Joerg Lehmann, Stephen F Kry","doi":"10.1002/acm2.70113","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To develop a practical framework for creating a diverse set of validated reference plans (varying in complexity) and implement a workflow to introduce beam modeling, calibration, and delivery errors into the reference cohort to test and compare various dosimetry audit methodologies.</p><p><strong>Methods: </strong>Sixteen IMRT and VMAT reference plans were created, using RayStation software, for four phantom geometries based on established credentialing cases from participating Global Harmonization Group (GHG) members. These reference plans were first validated in a multi-ion-chamber phantom. Nine dosimetric errors (perturbations) were introduced into the plans by modifying beam model and/or delivery parameters (MLC-offset, MLC-transmission, leaf-tip-width, PDD, beam calibration, and MLC-position) based on documented community distributions of errors; this produced 144 plans. The dose impact on the clinical target volume (CTV) and organs at risk (OARs) was determined, and a range of classifications was developed to determine if the perturbed plan should pass or should fail an audit.</p><p><strong>Results: </strong>Introducing errors into the reference plans impacted each plan differently. Dose perturbations ranged from <1% to >10% in the mean dose to the CTV and <10% to >30% in the near maximum dose to OAR (D0.03). The 144 plans included clear \"acceptable\" and \"unacceptable\" scenarios, with significant changes in dose (relative to baseline reference values), as well as near pass/fail threshold results. Plan complexity was found to have a strong impact on dose deviation, and the mean MLC Gap metric was found to best capture this relationship.</p><p><strong>Conclusion: </strong>This study presented a framework to develop a set of reference plans and perturbations that can be used to assess and compare various audit and PSQA methodologies. The GHG has developed this framework as part of our ongoing work to test the comparability of their audit systems; this framework supports our work of aligning international dosimetry audits across the globe.</p>","PeriodicalId":14989,"journal":{"name":"Journal of Applied Clinical Medical Physics","volume":" ","pages":"e70113"},"PeriodicalIF":2.0000,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Developing reference plans for evaluating global clinical trials credentialing and PSQA systems.\",\"authors\":\"Fre'Etta M D Brooks, Mohammad Hussein, Jessica Lye, Christopher L Nelson, Nakamura Mitsuhiro, Mallory C Glenn, Patricia Diez, Rushil Patel, Maddison Shaw, Ileana Silvestre Patallo, Miriam Barry, Catharine H Clark, Joerg Lehmann, Stephen F Kry\",\"doi\":\"10.1002/acm2.70113\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To develop a practical framework for creating a diverse set of validated reference plans (varying in complexity) and implement a workflow to introduce beam modeling, calibration, and delivery errors into the reference cohort to test and compare various dosimetry audit methodologies.</p><p><strong>Methods: </strong>Sixteen IMRT and VMAT reference plans were created, using RayStation software, for four phantom geometries based on established credentialing cases from participating Global Harmonization Group (GHG) members. These reference plans were first validated in a multi-ion-chamber phantom. Nine dosimetric errors (perturbations) were introduced into the plans by modifying beam model and/or delivery parameters (MLC-offset, MLC-transmission, leaf-tip-width, PDD, beam calibration, and MLC-position) based on documented community distributions of errors; this produced 144 plans. The dose impact on the clinical target volume (CTV) and organs at risk (OARs) was determined, and a range of classifications was developed to determine if the perturbed plan should pass or should fail an audit.</p><p><strong>Results: </strong>Introducing errors into the reference plans impacted each plan differently. Dose perturbations ranged from <1% to >10% in the mean dose to the CTV and <10% to >30% in the near maximum dose to OAR (D0.03). The 144 plans included clear \\\"acceptable\\\" and \\\"unacceptable\\\" scenarios, with significant changes in dose (relative to baseline reference values), as well as near pass/fail threshold results. Plan complexity was found to have a strong impact on dose deviation, and the mean MLC Gap metric was found to best capture this relationship.</p><p><strong>Conclusion: </strong>This study presented a framework to develop a set of reference plans and perturbations that can be used to assess and compare various audit and PSQA methodologies. The GHG has developed this framework as part of our ongoing work to test the comparability of their audit systems; this framework supports our work of aligning international dosimetry audits across the globe.</p>\",\"PeriodicalId\":14989,\"journal\":{\"name\":\"Journal of Applied Clinical Medical Physics\",\"volume\":\" \",\"pages\":\"e70113\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-05-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Applied Clinical Medical Physics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/acm2.70113\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Applied Clinical Medical Physics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/acm2.70113","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
Developing reference plans for evaluating global clinical trials credentialing and PSQA systems.
Purpose: To develop a practical framework for creating a diverse set of validated reference plans (varying in complexity) and implement a workflow to introduce beam modeling, calibration, and delivery errors into the reference cohort to test and compare various dosimetry audit methodologies.
Methods: Sixteen IMRT and VMAT reference plans were created, using RayStation software, for four phantom geometries based on established credentialing cases from participating Global Harmonization Group (GHG) members. These reference plans were first validated in a multi-ion-chamber phantom. Nine dosimetric errors (perturbations) were introduced into the plans by modifying beam model and/or delivery parameters (MLC-offset, MLC-transmission, leaf-tip-width, PDD, beam calibration, and MLC-position) based on documented community distributions of errors; this produced 144 plans. The dose impact on the clinical target volume (CTV) and organs at risk (OARs) was determined, and a range of classifications was developed to determine if the perturbed plan should pass or should fail an audit.
Results: Introducing errors into the reference plans impacted each plan differently. Dose perturbations ranged from <1% to >10% in the mean dose to the CTV and <10% to >30% in the near maximum dose to OAR (D0.03). The 144 plans included clear "acceptable" and "unacceptable" scenarios, with significant changes in dose (relative to baseline reference values), as well as near pass/fail threshold results. Plan complexity was found to have a strong impact on dose deviation, and the mean MLC Gap metric was found to best capture this relationship.
Conclusion: This study presented a framework to develop a set of reference plans and perturbations that can be used to assess and compare various audit and PSQA methodologies. The GHG has developed this framework as part of our ongoing work to test the comparability of their audit systems; this framework supports our work of aligning international dosimetry audits across the globe.
期刊介绍:
Journal of Applied Clinical Medical Physics is an international Open Access publication dedicated to clinical medical physics. JACMP welcomes original contributions dealing with all aspects of medical physics from scientists working in the clinical medical physics around the world. JACMP accepts only online submission.
JACMP will publish:
-Original Contributions: Peer-reviewed, investigations that represent new and significant contributions to the field. Recommended word count: up to 7500.
-Review Articles: Reviews of major areas or sub-areas in the field of clinical medical physics. These articles may be of any length and are peer reviewed.
-Technical Notes: These should be no longer than 3000 words, including key references.
-Letters to the Editor: Comments on papers published in JACMP or on any other matters of interest to clinical medical physics. These should not be more than 1250 (including the literature) and their publication is only based on the decision of the editor, who occasionally asks experts on the merit of the contents.
-Book Reviews: The editorial office solicits Book Reviews.
-Announcements of Forthcoming Meetings: The Editor may provide notice of forthcoming meetings, course offerings, and other events relevant to clinical medical physics.
-Parallel Opposed Editorial: We welcome topics relevant to clinical practice and medical physics profession. The contents can be controversial debate or opposed aspects of an issue. One author argues for the position and the other against. Each side of the debate contains an opening statement up to 800 words, followed by a rebuttal up to 500 words. Readers interested in participating in this series should contact the moderator with a proposed title and a short description of the topic