The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management.

The increasing complexity of modern radiation therapy planning and delivery challenges traditional prescriptive quality management (QM) methods, such as many of those included in guidelines published by organizations such as the AAPM, ASTRO, ACR, ESTRO, and IAEA. These prescriptive guidelines have traditionally focused on monitoring all aspects of the functional performance of radiotherapy (RT) equipment by comparing parameters against tolerances set at strict but achievable values. Many errors that occur in radiation oncology are not due to failures in devices and software; rather they are failures in workflow and process. A systematic understanding of the likelihood and clinical impact of possible failures throughout a course of radiotherapy is needed to direct limit QM resources efficiently to produce maximum safety and quality of patient care. Task Group 100 of the AAPM has taken a broad view of these issues and has developed a framework for designing QM activities, based on estimates of the probability of identified failures and their clinical outcome through the RT planning and delivery process. The Task Group has chosen a specific radiotherapy process required for "intensity modulated radiation therapy (IMRT)" as a case study. The goal of this work is to apply modern risk-based analysis techniques to this complex RT process in order to demonstrate to the RT community that such techniques may help identify more effective and efficient ways to enhance the safety and quality of our treatment processes. The task group generated by consensus an example quality management program strategy for the IMRT process performed at the institution of one of the authors. This report describes the methodology and nomenclature developed, presents the process maps, FMEAs, fault trees, and QM programs developed, and makes suggestions on how this information could be used in the clinic. The development and implementation of risk-assessment techniques will make radiation therapy safer and more efficient.

Development of a residency program in radiation oncology physics: an inverse planning approach.

Over the last two decades, there has been a concerted effort in North America to organize medical physicists' clinical training programs along more structured and formal lines. This effort has been prompted by the Commission on Accreditation of Medical Physics Education Programs (CAMPEP) which has now accredited about 90 residency programs. Initially the accreditation focused on standardized and higher quality clinical physics training; the development of rounded professionals who can function at a high level in a multidisciplinary environment was recognized as a priority of a radiation oncology physics residency only lately. In this report, we identify and discuss the implementation of, and the essential components of, a radiation oncology physics residency designed to produce knowledgeable and effective clinical physicists for today's safety-conscious and collaborative work environment. Our approach is that of inverse planning, by now familiar to all radiation oncology physicists, in which objectives and constraints are identified prior to the design of the program. Our inverse planning objectives not only include those associated with traditional residencies (i.e., clinical physics knowledge and critical clinical skills), but also encompass those other attributes essential for success in a modern radiation therapy clinic. These attributes include formal training in management skills and leadership, teaching and communication skills, and knowledge of error management techniques and patient safety. The constraints in our optimization exercise are associated with the limited duration of a residency and the training resources available. Without compromising the knowledge and skills needed for clinical tasks, we have successfully applied the model to the University of Calgary's two-year residency program. The program requires 3840 hours of overall commitment from the trainee, of which 7%-10% is spent in obtaining formal training in nontechnical "soft skills".

Is tissue harmonic ultrasound imaging (THI) of the prostatic urethra and rectum superior to brightness (B) mode imaging? An observer study.

Quality ultrasound images are an essential part of prostate brachytherapy procedure. The authors have previously reported that tissue harmonic ultrasound images (THI) are superior to brightness (B) mode for the prostate. The objective of the current study was to compare both imaging modes for visualization of the prostatic urethra and rectum. B and THI mode transrectal ultrasound images were acquired for ten patients. The prostatic urethra and rectal wall were contoured by a radiation oncologist (RO) and five observers on randomly presented images. The contours on one patient were repeated four additional times by four observers. All the images were qualitatively scored using a five-level Likert scale. The values of the Pearson product-moment correlation coefficients showed that the observers were in close agreement with the RO. Two sample paired student t-test showed that the rectum volumes with THI were significantly smaller than B-mode, but no significant difference for urethra. Two-factor analysis of variances showed significant observer variability in defining the rectum and urethra in both imaging modes. Observer consistency of the rectum volumes, estimated by standard deviations as percentages of means was significantly improved for THI. The Likert scale based qualitative assessment supported quantitative observations. The significant improvement in image quality of the prostate (reported previously) and rectum with THI may offer better-quality treatment plans for prostate brachytherapy and potential improvement in local control.

Recommended ethics curriculum for medical physics graduate and residency programs: report of Task Group 159.

The AAPM Professional Council approved the formation of a task group in 2007, whose purpose is to develop recommendations for an ethics curriculum for medical physics graduate and residency programs. Existing program's ethics curricula range in scope and content considerably. It is desirable to have a more uniform baseline curriculum for all programs. Recommended subjects areas, suggested ethics references, and a sample curriculum are included. This report recommends a reasonable ethics course time to be 15-30 h while allowing each program the flexibility to design their course.

A method for evaluating quality assurance needs in radiation therapy.

The increasing complexity of modern radiation therapy planning and delivery techniques challenges traditional prescriptive quality control and quality assurance programs that ensure safety and reliability of treatment planning and delivery systems under all clinical scenarios. Until now quality management (QM) guidelines published by concerned organizations (e.g., American Association of Physicists in Medicine [AAPM], European Society for Therapeutic Radiology and Oncology [ESTRO], International Atomic Energy Agency [IAEA]) have focused on monitoring functional performance of radiotherapy equipment by measurable parameters, with tolerances set at strict but achievable values. In the modern environment, however, the number and sophistication of possible tests and measurements have increased dramatically. There is a need to prioritize QM activities in a way that will strike a balance between being reasonably achievable and optimally beneficial to patients. A systematic understanding of possible errors over the course of a radiation therapy treatment and the potential clinical impact of each is needed to direct limited resources in such a way to produce maximal benefit to the quality of patient care. Task Group 100 of the AAPM has taken a broad view of these issues and is developing a framework for designing QM activities, and hence allocating resources, based on estimates of clinical outcome, risk assessment, and failure modes. The report will provide guidelines on risk assessment approaches with emphasis on failure mode and effect analysis (FMEA) and an achievable QM program based on risk analysis. Examples of FMEA to intensity-modulated radiation therapy and high-dose-rate brachytherapy are presented. Recommendations on how to apply this new approach to individual clinics and further research and development will also be discussed.

Quality assurance needs for modern image-based radiotherapy: recommendations from 2007 interorganizational symposium on "quality assurance of radiation therapy: challenges of advanced technology".

This report summarizes the consensus findings and recommendations emerging from 2007 Symposium, "Quality Assurance of Radiation Therapy: Challenges of Advanced Technology." The Symposium was held in Dallas February 20-22, 2007. The 3-day program, which was sponsored jointly by the American Society for Therapeutic Radiology and Oncology (ASTRO), American Association of Physicists in Medicine (AAPM), and National Cancer Institute (NCI), included >40 invited speakers from the radiation oncology and industrial engineering/human factor communities and attracted nearly 350 attendees, mostly medical physicists. A summary of the major findings follows. The current process of developing consensus recommendations for prescriptive quality assurance (QA) tests remains valid for many of the devices and software systems used in modern radiotherapy (RT), although for some technologies, QA guidance is incomplete or out of date. The current approach to QA does not seem feasible for image-based planning, image-guided therapies, or computer-controlled therapy. In these areas, additional scientific investigation and innovative approaches are needed to manage risk and mitigate errors, including a better balance between mitigating the risk of catastrophic error and maintaining treatment quality, complimenting the current device-centered QA perspective by a more process-centered approach, and broadening community participation in QA guidance formulation and implementation. Industrial engineers and human factor experts can make significant contributions toward advancing a broader, more process-oriented, risk-based formulation of RT QA. Healthcare administrators need to appropriately increase personnel and ancillary equipment resources, as well as capital resources, when new advanced technology RT modalities are implemented. The pace of formalizing clinical physics training must rapidly increase to provide an adequately trained physics workforce for advanced technology RT. The specific recommendations of the Symposium included the following. First, the AAPM, in cooperation with other advisory bodies, should undertake a systematic program to update conventional QA guidance using available risk-assessment methods. Second, the AAPM advanced technology RT Task Groups should better balance clinical process vs. device operation aspects--encouraging greater levels of multidisciplinary participation such as industrial engineering consultants and use-risk assessment and process-flow techniques. Third, ASTRO should form a multidisciplinary subcommittee, consisting of physician, physicist, vendor, and industrial engineering representatives, to better address modern RT quality management and QA needs. Finally, government and private entities committed to improved healthcare quality and safety should support research directed toward addressing QA problems in image-guided therapies.

Taxonometric applications in radiotherapy incident analysis.

Recent publications in both the scientific and the popular press have highlighted the risks to which patients expose themselves when entering a healthcare system. Patient safety issues are forcing us to, not only acknowledge that incidents do occur, but also actively develop the means for assessing and managing the risks of such incidents. To do this, we ideally need to know the probability of an incident's occurrence, the consequences or severity for the patient should it occur, and the basic causes of the incident. A structured approach to the description of failure modes is helpful in terms of communication, avoidance of ambiguity, and, ultimately, decision making for resource allocation. In this report, several classification schemes or taxonomies for use in risk assessment and management are discussed. In particular, a recently developed approach that reflects the activity domains through which the patient passes and that can be used as a basis for quantifying incident severity is described. The estimation of incident severity, which is based on the concept of the equivalent uniform dose, is presented in some detail. We conclude with a brief discussion on the use of a defined basic-causes table and how adding such a table to the reports of incidents can facilitate the allocation of resources.

Using a survey of incident reporting and learning practices to improve organisational learning at a cancer care centre.

OBJECTIVES: To motivate improvements in an organisational system by measuring staff perceptions of the organisation's ability to learn from incidents and by analysing their personal experience of incidents. METHODS: Respondents were questioned on the components of the incident learning system from both a personal and an organisational perspective. The respondents (n = 125) were radiotherapists, nurses, dosimetrists, doctors, and other staff at a major academic cancer centre. Responses were analysed in terms of per cent positive responses and response rate, differences between "frontline" and "support" staff, and the respondent's experience with incidents. RESULTS: Respondents were more familiar with and more positive about incident identification and reporting--the first two stages of incident learning. Their overall perception of incident learning was most influenced by the investigation and learning components of the system. Respondents in frontline positions were more positive than those in support positions about responding to, identifying and reporting incidents. Respondents reported having experienced a mean of three incidents per year, of which two were reported and two out of three of the reported incidents were investigated, and a median of two incidents being experienced and reported, but none investigated. Most incidents experienced were not captured by the organisation's existing incident reporting system. CONCLUSION: The survey tool was effective in measuring the ability of the organisation to learn from incidents. Implications of the survey results for improving organisational learning are discussed.

The Equivalent Uniform Dose as a severity metric for radiation treatment incidents.

In allocating resources within a risk management program, ideally we would like to know both the probabilities and consequences of potential incidents. We simulate, on a treatment planning computer, several commonly reported incidents in radiation treatment and explore their consequences for the EUDs of targets and organs at risk.

Risk analysis in radiation treatment: application of a new taxonomic structure.

BACKGROUND AND PURPOSE: Radiation treatment (RT) for cancer is susceptible to clinical incidents resulting from human errors and equipment failures. A systematic approach to collecting and processing incidents is required to manage patient risks. We describe the application of a new taxonomic structure for RT that supports risk analysis and organizational learning. MATERIALS AND METHODS: A systematic analysis of the RT process identified five process domains. Within each domain we defined incident type groups. We then constructed a database reflecting this taxonomic structure and populated it with incidents from publicly available sources. Querying this database provides insights into the nature and relative frequency of incidents in RT. RESULTS: There are relatively few reports of incidents in the Prescription domain compared with the Preparation and Treatment domains. There are also fewer reports of systematic and infrastructure incidents in comparison to sporadic and process incidents. Infrastructure incidents are mainly systematic in nature, while process incidents are more likely to be sporadic. CONCLUSIONS: The lack of a standard, systems-oriented framework for incident reporting makes it difficult to learn from existing incident report sources. A clear understanding of the potential consequences and relationships between different incident types will guide incident reporting, resource allocation, and risk management efforts.

A cost-outcome analysis of long-term adjuvant goserelin in addition to radiotherapy for locally advanced prostate cancer.

To quantify the incremental costs and outcomes of using long-term adjuvant goserelin in addition to radiotherapy for locally advanced prostate cancer. The cost of radiotherapy for prostate cancer has been calculated using an activity-costing model. The total cost of administering adjuvant hormonal therapy for 3 years is based on local pharmacy charges plus typical physician billing fees and additional laboratory costs. Outcome data were obtained from the published EORTC 22,863 randomized trial comparing treatment of locally advanced prostate cancer with radiotherapy alone or in combination with 3 years of adjuvant goserelin. Using this information, the cost-effectiveness of adjuvant goserelin was calculated and expressed in terms of dollars per life-years (LY) gained. The total institutional costs of radiotherapy are $9000 Cdn. and the additional costs of providing adjuvant goserelin for 3 years are approximately $19,800 CDN. The improvement in outcome with the use of adjuvant goserelin was estimated to be 1.2 LY per patient treated, giving a cost-effectiveness ratio of $16,500 Cdn ($11,000 US) per LY from an institutional perspective. Our sensitivity analysis confirms the robustness of our findings since even in our "worst case" scenario the cost-effectiveness ratio was estimated to be $21,600 Can ($14,400 US) per LY gained. This figure is still below $50,000 US per LY gained which is the quoted current standard for cost-effectiveness. This analysis demonstrates that the use of long-term adjuvant goserelin for locally advanced prostate cancer provides substantial benefit at an acceptable cost.

Geographic delivery models for radiotherapy services.

The study described here was undertaken to quantify the societal cost of radiotherapy in idealized urban and rural populations and, hence, to generate a measure of impediment to access. The costs of centralized, distributed comprehensive and satellite radiotherapy delivery formats were examined by decomposing them into institutional, productivity and geographical components. Our results indicate that centralized radiotherapy imposes the greatest financial burden on the patient population in both urban and rural scenarios. The financial burden faced by patients who must travel for radiotherapy can be interpreted as one component of the overall impediment to access. With advances in remote-monitoring systems, it is possible to maintain technical quality while enhancing patient access. However, the maintenance of professional competence will remain a challenge with a distributed service-delivery format.