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1.
JAMA Netw Open ; 7(10): e2440673, 2024 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-39446327

RESUMEN

Importance: The impact of patient-specific, disease-related, and social factors on outcomes in limited-stage small cell lung cancer (LS-SCLC) is not well defined. A post hoc secondary analysis of such factors from the Cancer and Leukemia Group B (CALGB) 30610-Radiation Therapy Oncology Group (RTOG) 0538 trial may impact future trial design. Objective: To assess the comprehensive demographic, disease-related, treatment-related, and social factors for potential associations with survival outcomes and understand whether specific subpopulations may benefit from radiotherapy (RT) dose escalation in LS-SCLC. Design, Setting, and Participants: This post hoc secondary analysis of a randomized clinical trial included 638 adults with LS-SCLC treated at 186 unique treatment sites with at least 1 accrual for all patients from March 15, 2008, to December 1, 2019; 313 patients were randomized to receive RT twice daily to a dosage of 45 Gy for 3 weeks and 325 to receive RT once daily to a dosage of 70 Gy for 7 weeks. Data were locked February 28, 2022, and analyzed from November 28, 2022, to June 4, 2024. Interventions: Twice-daily RT or once-daily RT. Main Outcomes and Measures: Multivariable Cox proportional hazards models evaluated the association of treatment groups and other risk factors with progression-free survival (PFS) and overall survival (OS). Patient-specific factors included age, sex, and Eastern Cooperative Oncology Group performance status. Disease-related factors included tumor, nodal, and overall cancer stages. Treatment-related factors included type of chemotherapy, timing of concurrent RT, RT technique, and prophylactic cranial irradiation. Social factors included marital status and treatment center accrual volume. Results: Among 507 patients (260 [51.3%] female and 247 [48.7%] male; mean [SD] age, 62.6 [7.9] years) included in the multivariate survival analysis, with a median follow-up of 4.7 (IQR, 3.7-7.1) years, female sex was associated with improved OS (hazard ratio [HR], 0.73 [95% CI, 0.58-0.91]; P = .006), while being 70 years or older was associated with decreased OS (HR, 1.50 [95% CI, 1.14-1.98]; P = .004). Neither age nor sex was associated with PFS. When compared with those with N1 disease, OS and PFS were worse in patients with N2 (HRs, 1.64 [95% CI, 1.19-2.26]; P = .002 and 1.36 [95% CI, 1.02-1.81]; P = .04, respectively) and N3 (HRs, 2.03 [95% CI, 1.40-2.93]; P < .001 and 1.63 [95% CI, 1.17-2.26]; P = .004) disease. Compared with stage II cancer, OS was worse for stage IIIA (HR, 1.65 [95% CI, 1.17-2.31]; P = .004) and stage IIIB (HR, 1.94 [95% CI, 1.34-2.83]; P < .001). Compared with high-volume accrual centers, treatment at low- or middle-volume accrual centers was associated with worse PFS (HRs, 1.94 [95% CI, 1.33-2.82; P < .001] and 1.44 [95% CI, 1.15-1.82; P = .002], respectively) and worse OS (HRs, 1.55 [95% CI, 1.03-2.32; P = .03] and 1.33 [95% CI, 1.04-1.70; P = .02], respectively). Conclusions and Relevance: This secondary analysis of the CALGB 30610-RTOG 0538 randomized clinical trial of patients with LS-SCLC found associations between female sex or being younger than 70 years and improved overall survival and between advanced nodal stage or treatment at low- or middle-volume accrual centers and worse outcomes. These findings suggest that stratification by nodal stage, clinical stage, and age should be considered in future randomized trials. Trial Registration: ClinicalTrials.gov Identifier: NCT00632853.


Asunto(s)
Neoplasias Pulmonares , Carcinoma Pulmonar de Células Pequeñas , Humanos , Masculino , Carcinoma Pulmonar de Células Pequeñas/radioterapia , Carcinoma Pulmonar de Células Pequeñas/mortalidad , Carcinoma Pulmonar de Células Pequeñas/tratamiento farmacológico , Femenino , Persona de Mediana Edad , Anciano , Neoplasias Pulmonares/radioterapia , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/terapia , Pronóstico , Estadificación de Neoplasias , Adulto
2.
Pediatr Blood Cancer ; 71(11): e31185, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-39118225

RESUMEN

Historically, total body irradiation (TBI) has been delivered using static, parallel opposed photon beams (2D-TBI). Recently, centers have increasingly used intensity-modulated radiation therapy (IMRT) techniques for TBI. Relative to 2D-TBI, IMRT can reduce doses to critical organs (i.e., lungs and kidneys) while delivering myeloablative doses to the rest of the body, so it may decrease the risk of toxicity while maintaining oncologic outcomes. Despite these potential benefits, delivering TBI using IMRT introduces new challenges in treatment planning and delivery. We describe the extensive experience with IMRT-based TBI at Stanford University and City of Hope Cancer Center. These groups, and others, have reported favorable clinical outcomes and have developed methods to optimize treatment planning and delivery. A critical next step is to evaluate the broader adoption of this approach. Therefore, IMRT-based TBI will be incorporated into a prospective, multi-institutional Children's Oncology Group study with careful procedures and safeguards in place.


Asunto(s)
Radioterapia de Intensidad Modulada , Irradiación Corporal Total , Humanos , Irradiación Corporal Total/métodos , Radioterapia de Intensidad Modulada/métodos , Niño , Neoplasias/radioterapia , Planificación de la Radioterapia Asistida por Computador/métodos , Dosificación Radioterapéutica
4.
Int J Radiat Oncol Biol Phys ; 120(1): 111-119, 2024 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-38492812

RESUMEN

PURPOSE: Alliance A021501 is the first randomized trial to evaluate stereotactic body radiation therapy (SBRT) for borderline resectable pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant chemotherapy. In this post hoc study, we reviewed the quality of radiation therapy (RT) delivered. METHODS AND MATERIALS: SBRT (6.6 Gy × 5) was intended but hypofractionated RT (5 Gy × 5) was permitted if SBRT specifications could not be met. Institutional credentialing through the National Cancer Institute-funded Imaging and Radiation Oncology Core (IROC) was required. Rigorous RT quality assurance (RT QA) was mandated, including pretreatment review by a radiation oncologist. Revisions were required for unacceptable deviations. Additionally, we performed a post hoc RT QA analysis in which contours and plans were reviewed by 3 radiation oncologists and assigned a score (1, 2, or 3) based on adequacy. A score of 1 indicated no deviation, 2 indicated minor deviation, and 3 indicated a major deviation that could be clinically significant. Clinical outcomes were compared by treatment modality and by case score. RESULTS: Forty patients were registered to receive RT (1 planned but not treated) at 27 centers (18 academic and 9 community). Twenty-three centers were appropriately credentialed for moving lung/liver targets and 4 for static head and neck only. Thirty-two of 39 patients (82.1%) were treated with SBRT and 7 (17.9%) with hypofractionated RT. Five cases (13%) required revision before treatment. On post hoc review, 23 patients (59.0%) were noted to have suboptimal contours or plan coverage, 12 (30.8%) were scored a 2, and 11 (28.2%) were scored a 3. There were no apparent differences in failure patterns or surgical outcomes based on treatment technique or post hoc case score. Details related to on-treatment imaging were not recorded. CONCLUSIONS: Despite rigorous QA, we encountered variability in simulation, contouring, plan coverage, and dose on trial. Although clinical outcomes did not appear to have been affected, findings from this analysis serve to inform subsequent PDAC SBRT trial designs and QA requirements.


Asunto(s)
Fluorouracilo , Neoplasias Pancreáticas , Garantía de la Calidad de Atención de Salud , Hipofraccionamiento de la Dosis de Radiación , Radiocirugia , Humanos , Neoplasias Pancreáticas/radioterapia , Neoplasias Pancreáticas/patología , Fluorouracilo/uso terapéutico , Fluorouracilo/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Leucovorina/uso terapéutico , Leucovorina/administración & dosificación , Oxaliplatino/uso terapéutico , Oxaliplatino/administración & dosificación , Adenocarcinoma/radioterapia , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Terapia Neoadyuvante , Carcinoma Ductal Pancreático/radioterapia , Carcinoma Ductal Pancreático/patología , Carcinoma Ductal Pancreático/cirugía , Masculino , Planificación de la Radioterapia Asistida por Computador , Femenino , Irinotecán
5.
J Appl Clin Med Phys ; 24(11): e14160, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37793084

RESUMEN

The purpose of this guideline is to provide a list of critical performance tests to assist the Qualified Medical Physicist (QMP) in establishing and maintaining a safe and effective quality assurance (QA) program. The performance tests on a linear accelerator (linac) should be selected to fit the clinical patterns of use of the accelerator and care should be given to perform tests which are relevant to detecting errors related to the specific use of the accelerator. Current recommendations for linac QA were reviewed to determine any changes required to those tests highlighted by the original report as well as considering new components of the treatment process that have become common since its publication. Recommendations are made on the acquisition of reference data, routine establishment of machine isocenter, basing performance tests on clinical use of the linac, working with vendors to establish QA tests and performing tests after maintenance and upgrades. The recommended tests proposed in this guideline were chosen based on consensus of the guideline's committee after assessing necessary changes from the previous report. The tests are grouped together by class of test (e.g., dosimetry, mechanical, etc.) and clinical parameter tested. Implementation notes are included for each test so that the QMP can understand the overall goal of each test. This guideline will assist the QMP in developing a comprehensive QA program for linacs in the external beam radiation therapy setting. The committee sought to prioritize tests by their implication on quality and patient safety. The QMP is ultimately responsible for implementing appropriate tests. In the spirit of the report from American Association of Physicists in Medicine Task Group 100, individual institutions are encouraged to analyze the risks involved in their own clinical practice and determine which performance tests are relevant in their own radiotherapy clinics.


Asunto(s)
Radiometría , Planificación de la Radioterapia Asistida por Computador , Humanos , Aceleradores de Partículas , Cintigrafía , Física
6.
Semin Radiat Oncol ; 33(4): 395-406, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37684069

RESUMEN

Clinical trials have been the center of progress in modern medicine. In oncology, we are fortunate to have a structure in place through the National Clinical Trials Network (NCTN). The NCTN provides the infrastructure and a forum for scientific discussion to develop clinical concepts for trial design. The NCTN also provides a network group structure to administer trials for successful trial management and outcome analyses. There are many important aspects to trial design and conduct. Modern trials need to ensure appropriate trial conduct and secure data management processes. Of equal importance is the quality assurance of a clinical trial. If progress is to be made in oncology clinical medicine, investigators and patient care providers of service need to feel secure that trial data is complete, accurate, and well-controlled in order to be confident in trial analysis and move trial outcome results into daily practice. As our technology has matured, so has our need to apply technology in a uniform manner for appropriate interpretation of trial outcomes. In this article, we review the importance of quality assurance in clinical trials involving radiation therapy. We will include important aspects of institution and investigator credentialing for participation as well as ongoing processes to ensure that each trial is being managed in a compliant manner. We will provide examples of the importance of complete datasets to ensure study interpretation. We will describe how successful strategies for quality assurance in the past will support new initiatives moving forward.


Asunto(s)
Ensayos Clínicos como Asunto , Oncología por Radiación , Humanos , Manejo de Datos , Oncología Médica , Registros
7.
Front Oncol ; 13: 1015596, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36776318

RESUMEN

Clinical trials have become the primary mechanism to validate process improvements in oncology clinical practice. Over the past two decades there have been considerable process improvements in the practice of radiation oncology within the structure of a modern department using advanced technology for patient care. Treatment planning is accomplished with volume definition including fusion of multiple series of diagnostic images into volumetric planning studies to optimize the definition of tumor and define the relationship of tumor to normal tissue. Daily treatment is validated by multiple tools of image guidance. Computer planning has been optimized and supported by the increasing use of artificial intelligence in treatment planning. Informatics technology has improved, and departments have become geographically transparent integrated through informatics bridges creating an economy of scale for the planning and execution of advanced technology radiation therapy. This serves to provide consistency in department habits and improve quality of patient care. Improvements in normal tissue sparing have further improved tolerance of treatment and allowed radiation oncologists to increase both daily and total dose to target. Radiation oncologists need to define a priori dose volume constraints to normal tissue as well as define how image guidance will be applied to each radiation treatment. These process improvements have enhanced the utility of radiation therapy in patient care and have made radiation therapy an attractive option for care in multiple primary disease settings. In this chapter we review how these changes have been applied to clinical practice and incorporated into clinical trials. We will discuss how the changes in clinical practice have improved the quality of clinical trials in radiation therapy. We will also identify what gaps remain and need to be addressed to offer further improvements in radiation oncology clinical trials and patient care.

8.
Front Oncol ; 12: 931294, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36033446

RESUMEN

The future of radiation oncology is exceptionally strong as we are increasingly involved in nearly all oncology disease sites due to extraordinary advances in radiation oncology treatment management platforms and improvements in treatment execution. Due to our technology and consistent accuracy, compressed radiation oncology treatment strategies are becoming more commonplace secondary to our ability to successfully treat tumor targets with increased normal tissue avoidance. In many disease sites including the central nervous system, pulmonary parenchyma, liver, and other areas, our service is redefining the standards of care. Targeting of disease has improved due to advances in tumor imaging and application of integrated imaging datasets into sophisticated planning systems which can optimize volume driven plans created by talented personnel. Treatment times have significantly decreased due to volume driven arc therapy and positioning is secured by real time imaging and optical tracking. Normal tissue exclusion has permitted compressed treatment schedules making treatment more convenient for the patient. These changes require additional study to further optimize care. Because data exchange worldwide have evolved through digital platforms and prisms, images and radiation datasets worldwide can be shared/reviewed on a same day basis using established de-identification and anonymization methods. Data storage post-trial completion can co-exist with digital pathomic and radiomic information in a single database coupled with patient specific outcome information and serve to move our translational science forward with nimble query elements and artificial intelligence to ask better questions of the data we collect and collate. This will be important moving forward to validate our process improvements at an enterprise level and support our science. We have to be thorough and complete in our data acquisition processes, however if we remain disciplined in our data management plan, our field can grow further and become more successful generating new standards of care from validated datasets.

9.
Med Phys ; 49(4): e82-e112, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35179229

RESUMEN

The clinical use of surface imaging has increased dramatically, with demonstrated utility for initial patient positioning, real-time motion monitoring, and beam gating in a variety of anatomical sites. The Therapy Physics Subcommittee and the Imaging for Treatment Verification Working Group of the American Association of Physicists in Medicine commissioned Task Group 302 to review the current clinical uses of surface imaging and emerging clinical applications. The specific charge of this task group was to provide technical guidelines for clinical indications of use for general positioning, breast deep-inspiration breath hold treatment, and frameless stereotactic radiosurgery. Additionally, the task group was charged with providing commissioning and on-going quality assurance (QA) requirements for surface-guided radiation therapy (SGRT) as part of a comprehensive QA program including risk assessment. Workflow considerations for other anatomic sites and for computed tomography simulation, including motion management, are also discussed. Finally, developing clinical applications, such as stereotactic body radiotherapy (SBRT) or proton radiotherapy, are presented. The recommendations made in this report, which are summarized at the end of the report, are applicable to all video-based SGRT systems available at the time of writing.


Asunto(s)
Braquiterapia , Radiocirugia , Radioterapia Guiada por Imagen , Humanos , Dosificación Radioterapéutica , Planificación de la Radioterapia Asistida por Computador/métodos , Radioterapia Guiada por Imagen/métodos , Informe de Investigación , Estados Unidos
10.
Technol Cancer Res Treat ; 19: 1533033820920650, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32329413

RESUMEN

BACKGROUND: Lower-dose cone-beam computed tomography protocols for image-guided radiotherapy may permit target localization while minimizing radiation exposure. We prospectively evaluated a lower-dose cone-beam protocol for central nervous system image-guided radiotherapy across a multinational pediatrics consortium. METHODS: Seven institutions prospectively employed a lower-dose cone-beam computed tomography central nervous system protocol (weighted average dose 0.7 mGy) for patients ≤21 years. Treatment table shifts between setup with surface lasers versus cone-beam computed tomography were used to approximate setup accuracy, and vector magnitudes for these shifts were calculated. Setup group mean, interpatient, interinstitution, and random error were estimated, and clinical factors were compared by mixed linear modeling. RESULTS: Among 96 patients, with 2179 pretreatment cone-beam computed tomography acquisitions, median age was 9 years (1-20). Setup parameters were 3.13, 3.02, 1.64, and 1.48 mm for vector magnitude group mean, interpatient, interinstitution, and random error, respectively. On multivariable analysis, there were no significant differences in mean vector magnitude by age, gender, performance status, target location, extent of resection, chemotherapy, or steroid or anesthesia use. Providers rated >99% of images as adequate or better for target localization. CONCLUSIONS: A lower-dose cone-beam computed tomography protocol demonstrated table shift vector magnitude that approximate clinical target volume/planning target volume expansions used in central nervous system radiotherapy. There were no significant clinical predictors of setup accuracy identified, supporting use of this lower-dose cone-beam computed tomography protocol across a diverse pediatric population with brain tumors.


Asunto(s)
Neoplasias Encefálicas/diagnóstico por imagen , Neoplasias Encefálicas/radioterapia , Planificación de la Radioterapia Asistida por Computador/métodos , Errores de Configuración en Radioterapia/prevención & control , Adolescente , Adulto , Neoplasias Encefálicas/patología , Niño , Preescolar , Tomografía Computarizada de Haz Cónico/métodos , Femenino , Humanos , Lactante , Cooperación Internacional , Masculino , Pediatría/métodos , Estudios Prospectivos , Dosificación Radioterapéutica , Radioterapia Guiada por Imagen/métodos , Adulto Joven
11.
Med Phys ; 47(6): e236-e272, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31967655

RESUMEN

BACKGROUND: While the review of radiotherapy treatment plans and charts by a medical physicist is a key component of safe, high-quality care, very few specific recommendations currently exist for this task. AIMS: The goal of TG-275 is to provide practical, evidence-based recommendations on physics plan and chart review for radiation therapy. While this report is aimed mainly at medical physicists, others may benefit including dosimetrists, radiation therapists, physicians and other professionals interested in quality management. METHODS: The scope of the report includes photon/electron external beam radiotherapy (EBRT), proton radiotherapy, as well as high-dose rate (HDR) brachytherapy for gynecological applications (currently the highest volume brachytherapy service in most practices). The following review time points are considered: initial review prior to treatment, weekly review, and end-of-treatment review. The Task Group takes a risk-informed approach to developing recommendations. A failure mode and effects analysis was performed to determine the highest-risk aspects of each process. In the case of photon/electron EBRT, a survey of all American Association of Physicists in Medicine (AAPM) members was also conducted to determine current practices. A draft of this report was provided to the full AAPM membership for comment through a 3-week open-comment period, and the report was revised in response to these comments. RESULTS: The highest-risk failure modes included 112 failure modes in photon/electron EBRT initial review, 55 in weekly and end-of-treatment review, 24 for initial review specific to proton therapy, and 48 in HDR brachytherapy. A 103-question survey on current practices was released to all AAPM members who self-reported as working in the radiation oncology field. The response rate was 33%. The survey data and risk data were used to inform recommendations. DISCUSSION: Tables of recommended checks are presented and recommendations for best practice are discussed. Suggestions to software vendors are also provided. CONCLUSIONS: TG-275 provides specific recommendations for physics plan and chart review which should enhance the safety and quality of care for patients receiving radiation treatments.


Asunto(s)
Braquiterapia , Oncología por Radiación , Humanos , Fotones , Física , Planificación de la Radioterapia Asistida por Computador , Estados Unidos
12.
Pract Radiat Oncol ; 10(3): 151-157, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-31812829

RESUMEN

PURPOSE: To determine whether a combination of data-driven, personalized feedback and implementation of a graduated, sequential intervention model improved key measures of physician workflow and quality in radiation treatment planning. METHODS AND MATERIALS: All radiation oncologists across 3 facilities at a single academic institution were prospectively evaluated on 5 predefined metrics of timeliness and accuracy in the treatment-planning process using a web-based institutional data repository and an institutional incident learning system. The study period encompassed 10 quarters from 2014 to 2016, with 2013 serving as a retrospective baseline. Physicians received quarterly individualized reports of their compliance metrics (a practice labeled the Physician Dashboard), and administrative interventions were initiated if >20% noncompliance with any metric was exceeded within a quarter. Consecutive quarters of noncompliance resulted in escalating interventions, including progress meetings with department leadership, and culminated in financial penalties. Rates of noncompliance were compared before and after implementation of this model. RESULTS: Three thousand six hundred sixty pre-Dashboard and 9497 post-Dashboard simulations were analyzed. After Dashboard implementation, significant reductions were observed in the rates of simulation orders requiring signature by a covering physician (14.1% vs 7.4%, P < .001), and the submission of plan contours ≥1 day (43.1% vs 23.1%, P < .001) or ≥2 days (30.8% vs 18.3%, P = .002) after the due date. There was some decrease in rates of inaccurate or incomplete plan submissions (6.2% vs 3.9%, P = .08). Seven of the 12 physicians received at least 1 intervention, with only 2 receiving all levels of intervention. CONCLUSIONS: Regular assessment and targeted feedback using the Physician Dashboard significantly improved radiation oncologist compliance with clinically meaningful treatment planning responsibilities at a high-volume academic center.


Asunto(s)
Médicos/organización & administración , Flujo de Trabajo , Humanos , Estudios Prospectivos , Estudios Retrospectivos
13.
J Appl Clin Med Phys ; 18(4): 23-39, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28548315

RESUMEN

PURPOSE: The purpose of this guideline is to provide a list of critical performance tests in order to assist the Qualified Medical Physicist (QMP) in establishing and maintaining a safe and effective quality assurance (QA) program. The performance tests on a linear accelerator (linac) should be selected to fit the clinical patterns of use of the accelerator and care should be given to perform tests which are relevant to detecting errors related to the specific use of the accelerator. METHODS: A risk assessment was performed on tests from current task group reports on linac QA to highlight those tests that are most effective at maintaining safety and quality for the patient. Recommendations are made on the acquisition of reference or baseline data, the establishment of machine isocenter on a routine basis, basing performance tests on clinical use of the linac, working with vendors to establish QA tests and performing tests after maintenance. RESULTS: The recommended tests proposed in this guideline were chosen based on the results from the risk analysis and the consensus of the guideline's committee. The tests are grouped together by class of test (e.g., dosimetry, mechanical, etc.) and clinical parameter tested. Implementation notes are included for each test so that the QMP can understand the overall goal of each test. CONCLUSION: This guideline will assist the QMP in developing a comprehensive QA program for linacs in the external beam radiation therapy setting. The committee sought to prioritize tests by their implication on quality and patient safety. The QMP is ultimately responsible for implementing appropriate tests. In the spirit of the report from American Association of Physicists in Medicine Task Group 100, individual institutions are encouraged to analyze the risks involved in their own clinical practice and determine which performance tests are relevant in their own radiotherapy clinics.


Asunto(s)
Aceleradores de Partículas/normas , Control de Calidad , Sociedades Científicas/normas , Física Sanitaria/normas , Mantenimiento/normas , Radiometría
14.
Int J Radiat Oncol Biol Phys ; 94(5): 993-9, 2016 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-27026305

RESUMEN

PURPOSE: To describe radiation therapy cases during which voluntary incident reporting occurred; and identify patient- or treatment-specific factors that place patients at higher risk for incidents. METHODS AND MATERIALS: We used our institution's incident learning system to build a database of patients with incident reports filed between January 2011 and December 2013. Patient- and treatment-specific data were reviewed for all patients with reported incidents, which were classified by step in the process and root cause. A control group of patients without events was generated for comparison. Summary statistics, likelihood ratios, and mixed-effect logistic regression models were used for group comparisons. RESULTS: The incident and control groups comprised 794 and 499 patients, respectively. Common root causes included documentation errors (26.5%), communication (22.5%), technical treatment planning (37.5%), and technical treatment delivery (13.5%). Incidents were more frequently reported in minors (age <18 years) than in adult patients (37.7% vs 0.4%, P<.001). Patients with head and neck (16% vs 8%, P<.001) and breast (20% vs 15%, P=.03) primaries more frequently had incidents, whereas brain (18% vs 24%, P=.008) primaries were less frequent. Larger tumors (17% vs 10% had T4 lesions, P=.02), and cases on protocol (9% vs 5%, P=.005) or with intensity modulated radiation therapy/image guided intensity modulated radiation therapy (52% vs 43%, P=.001) were more likely to have incidents. CONCLUSIONS: We found several treatment- and patient-specific variables associated with incidents. These factors should be considered by treatment teams at the time of peer review to identify patients at higher risk. Larger datasets are required to recommend changes in care process standards, to minimize safety risks.


Asunto(s)
Errores Médicos , Neoplasias/radioterapia , Seguridad del Paciente , Radioterapia Guiada por Imagen/efectos adversos , Radioterapia de Intensidad Modulada/efectos adversos , Gestión de Riesgos , Adolescente , Adulto , Factores de Edad , Estudios de Casos y Controles , Comunicación , Bases de Datos Factuales/estadística & datos numéricos , Documentación/estadística & datos numéricos , Humanos , Funciones de Verosimilitud , Modelos Logísticos , Errores Médicos/prevención & control , Errores Médicos/estadística & datos numéricos , Neoplasias/patología , Garantía de la Calidad de Atención de Salud , Planificación de la Radioterapia Asistida por Computador/efectos adversos , Planificación de la Radioterapia Asistida por Computador/estadística & datos numéricos , Radioterapia Guiada por Imagen/estadística & datos numéricos , Radioterapia de Intensidad Modulada/estadística & datos numéricos , Medición de Riesgo , Factores de Riesgo , Gestión de Riesgos/clasificación , Gestión de Riesgos/métodos , Gestión de Riesgos/estadística & datos numéricos , Factores Sexuales , Carga Tumoral
15.
J Oncol Pract ; 10(5): e350-7, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-25095825

RESUMEN

PURPOSE: Incident learning systems are important tools to improve patient safety in radiation oncology, but physician participation in these systems is poor. To understand reporting practices and attitudes, a survey was sent to staff members of four large academic radiation oncology centers, all of which have in-house reporting systems. METHODS: Institutional review board approval was obtained to send a survey to employees including physicians, dosimetrists, nurses, physicists, and radiation therapists. The survey evaluated barriers to reporting, perceptions of errors, and reporting practices. The responses of physicians were compared with those of other professional groups. RESULTS: There were 274 respondents to the survey, with a response rate of 81.3%. Physicians and other staff agreed that errors and near-misses were happening in their clinics (93.8% v 88.7%, respectively) and that they have a responsibility to report (97% overall). Physicians were significantly less likely to report minor near-misses (P = .001) and minor errors (P = .024) than other groups. Physicians were significantly more concerned about getting colleagues in trouble (P = .015), liability (P = .009), effect on departmental reputation (P = .006), and embarrassment (P < .001) than their colleagues. Regression analysis identified embarrassment among physicians as a critical barrier. If not embarrassed, participants were 2.5 and 4.5 times more likely to report minor errors and major near-miss events, respectively. CONCLUSIONS: All members of the radiation oncology team observe errors and near-misses. Physicians, however, are significantly less likely to report events than other colleagues. There are important, specific barriers to physician reporting that need to be addressed to encourage reporting and create a fair culture around reporting.


Asunto(s)
Actitud del Personal de Salud , Oncología por Radiación/normas , Recolección de Datos , Humanos , Errores Médicos/prevención & control , Análisis Multivariante , Seguridad del Paciente , Médicos , Oncología por Radiación/organización & administración , Gestión de Riesgos , Encuestas y Cuestionarios
16.
Med Phys ; 41(6): 061709, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24877804

RESUMEN

PURPOSE: Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort. METHODS: FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and used to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project. RESULTS: Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes had RPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator. CONCLUSIONS: Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.


Asunto(s)
Mejoramiento de la Calidad , Radioterapia , Gestión de Riesgos/métodos , Estudios de Factibilidad , Femenino , Humanos , Evaluación de Procesos y Resultados en Atención de Salud , Marcapaso Artificial/efectos adversos , Seguridad del Paciente , Embarazo , Complicaciones Neoplásicas del Embarazo/radioterapia , Radioterapia/normas , Medición de Riesgo , Gestión de la Calidad Total , Flujo de Trabajo
17.
Med Dosim ; 38(3): 243-50, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23540490

RESUMEN

Stereotactic body radiation therapy (SBRT) achieves excellent local control for locally advanced pancreatic cancer (LAPC), but may increase late duodenal toxicity. Volumetric-modulated arc therapy (VMAT) delivers intensity-modulated radiation therapy (IMRT) with a rotating gantry rather than multiple fixed beams. This study dosimetrically evaluates the feasibility of implementing duodenal constraints for SBRT using VMAT vs IMRT. Non-duodenal sparing (NS) and duodenal-sparing (DS) VMAT and IMRT plans delivering 25Gy in 1 fraction were generated for 15 patients with LAPC. DS plans were constrained to duodenal Dmax of<30Gy at any point. VMAT used 1 360° coplanar arc with 4° spacing between control points, whereas IMRT used 9 coplanar beams with fixed gantry positions at 40° angles. Dosimetric parameters for target volumes and organs at risk were compared for DS planning vs NS planning and VMAT vs IMRT using paired-sample Wilcoxon signed rank tests. Both DS VMAT and DS IMRT achieved significantly reduced duodenal Dmean, Dmax, D1cc, D4%, and V20Gy compared with NS plans (all p≤0.002). DS constraints compromised target coverage for IMRT as demonstrated by reduced V95% (p = 0.01) and Dmean (p = 0.02), but not for VMAT. DS constraints resulted in increased dose to right kidney, spinal cord, stomach, and liver for VMAT. Direct comparison of DS VMAT and DS IMRT revealed that VMAT was superior in sparing the left kidney (p<0.001) and the spinal cord (p<0.001), whereas IMRT was superior in sparing the stomach (p = 0.05) and the liver (p = 0.003). DS VMAT required 21% fewer monitor units (p<0.001) and delivered treatment 2.4 minutes faster (p<0.001) than DS IMRT. Implementing DS constraints during SBRT planning for LAPC can significantly reduce duodenal point or volumetric dose parameters for both VMAT and IMRT. The primary consequence of implementing DS constraints for VMAT is increased dose to other organs at risk, whereas for IMRT it is compromised target coverage. These findings suggest clinical situations where each technique may be most useful if DS constraints are to be employed.


Asunto(s)
Duodeno/efectos de la radiación , Neoplasias Pancreáticas/cirugía , Radiocirugia/métodos , Planificación de la Radioterapia Asistida por Computador , Radioterapia de Intensidad Modulada/métodos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dosificación Radioterapéutica
18.
Med Phys ; 39(11): 6968-71, 2012 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23127090

RESUMEN

PURPOSE: A series of examples are presented in which potential errors in the delivery of radiation therapy were prevented through use of incident learning. These examples underscore the value of reporting near miss incidents. METHODS: Using a departmental incident learning system, eight incidents were noted over a two-year period in which fields were treated "out-of-sequence," that is, fields from a boost phase were treated, while the patient was still in the initial phase of treatment. As a result, an error-prevention policy was instituted in which radiation treatment fields are "hidden" within the oncology information system (OIS) when they are not in current use. In this way, fields are only available to be treated in the intended sequence and, importantly, old fields cannot be activated at the linear accelerator control console. RESULTS: No out-of-sequence treatments have been reported in more than two years since the policy change. Furthermore, at least three near-miss incidents were detected and corrected as a result of the policy change. In the first two, the policy operated as intended to directly prevent an error in field scheduling. In the third near-miss, the policy operated "off target" to prevent a type of error scenario that it was not directly intended to prevent. In this incident, an incorrect digitally reconstructed radiograph (DRR) was scheduled in the OIS for a patient receiving lung cancer treatment. The incorrect DRR had an isocenter which was misplaced by approximately two centimeters. The error was a result of a field from an old plan being scheduled instead of the intended new plan. As a result of the policy described above, the DRR field could not be activated for treatment however and the error was discovered and corrected. Other quality control barriers in place would have been unlikely to have detected this error. CONCLUSIONS: In these examples, a policy was adopted based on incident learning, which prevented several errors, at least one of which was potentially severe. These examples underscore the need for a rigorous, systematic incident learning process within each clinic. The experiences reported in this technical note demonstrate the value of near-miss incident reporting to improve patient safety.


Asunto(s)
Bases de Datos Factuales , Departamentos de Hospitales , Errores de Configuración en Radioterapia/prevención & control , Humanos , Informe de Investigación
19.
Med Phys ; 37(8): 4146-54, 2010 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-20879575

RESUMEN

PURPOSE: Volumetric modulated arc therapy (VMAT) is a rotational delivery technique in which MLC shapes, dose rate, and gantry rotation speed are optimized to produce conformal dose distributions. The aim of this work is to develop a beam projection method for deriving the optimal table and collimator angles for multilesion treatment planning. METHODS: The method consists of four steps. The first step is to define the vector of beam-eye-view (BEV)-Y-axis in the treatment planning CT coordinates. The second step is to project each target onto the BEV-Y-axis vector. In the third step, the best table and collimator angle are found with a brute-force optimization technique that minimizes MLC leaf sharing between lesions. The fourth step is to generate an optimized VMAT plan with appropriate table/collimator angles and evaluate the plan quality. RESULTS: The authors tested the method on three example cases with targets of various locations in the brain and sizes ranging from 1.18 to 17.86 cm(3). Applying the optimized geometric parameter to generate VMAT plan, a reduction of the 12 Gy volume was more than 6.1% for all cases; the plan homogeneity (D2%-D95%) was improved from 5.88 +/- 1.21 to 5.21 +/- 0.93 Gy vs a VMAT plan with the manufacturer recommended table and collimator angles. CONCLUSIONS: The authors conclude that the use of the projection method minimizes the sharing of MLC leaves between lesions and improves the plan quality for multilesion VMAT delivery.


Asunto(s)
Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundario , Aceleradores de Partículas , Radiometría/métodos , Planificación de la Radioterapia Asistida por Computador/métodos , Radioterapia Asistida por Computador/métodos , Radioterapia Conformacional/métodos , Tomografía Computarizada por Rayos X/métodos , Neoplasias Encefálicas/diagnóstico por imagen , Humanos , Dosificación Radioterapéutica
20.
J Appl Clin Med Phys ; 10(1): 103-119, 2009 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-19223830

RESUMEN

A new calculation algorithm has been developed for independently verifying doses calculated by the TomoTherapy Hi.Art treatment planning system (TPS). The algorithm is designed to confirm the dose to a point in a high dose, low dose-gradient region. Patient data used by the algorithm include the radiological depth to the point for each projection angle and the treatment sinogram file controlling the leaf opening time for each projection. The algorithm uses common dosimetric functions [tissue phantom ratio (TPR) and output factor (Scp)] for the central axis combined with lateral and longitudinal beam profile data to quantify the off-axis dose dependence. Machine data for the dosimetric functions were measured on the Hi.Art machine and simulated using the TPS. Point dose calculations were made for several test phantoms and for 97 patient treatment plans using the simulated machine data. Comparisons with TPS-predicted point doses for the phantom treatment plans demonstrated agreement within 2% for both on-axis and off-axis planning target volumes (PTVs). Comparisons with TPS-predicted point doses for the patient treatment plans also showed good agreement. For calculations at sites other than lung and superficial PTVs, agreement between the calculations was within 2% for 94% of the patient calculations (64 of 68). Calculations within lung and superficial PTVs overestimated the dose by an average of 3.1% (sigma=2.4%) and 3.2% (sigma=2.2%), respectively. Systematic errors within lung are probably due to the weakness of the algorithm in correcting for missing tissue and/or tissue density heterogeneities. Errors encountered within superficial PTVs probably result from the algorithm overestimating the scatter dose within the patient. Our results demonstrate that for the majority of cases, the algorithm could be used without further refinement to independently verify patient treatment plans.


Asunto(s)
Algoritmos , Planificación de la Radioterapia Asistida por Computador/métodos , Simulación por Computador , Humanos , Fantasmas de Imagen , Dosificación Radioterapéutica , Reproducibilidad de los Resultados
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