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.

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.

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.