Ongoing Evaluation with a Strong Emphasis on Quality Assurance, Patient Quality of Life and Survivorship

Evaluation

Evaluation refers to a periodic process of gathering data and analysing these in such a way that the resulting information is used to determine whether planned activities are being carried out effectively. An evaluation can also illustrate the extent to which the stated objectives and anticipated results are being achieved.

Evaluation in radiation oncology applies to all components of the service and can include:

• Assessment of treatments in terms of dose distribution
• Prospective and retrospective data collection, particularly for treatment outcome assessment
• Consideration of cost-effectiveness of treatments
• Review of workforce performance
• Assessment of service and facility performance
• Quality Assurance activities

Importance of quality assurance to safety and quality care

Radiation oncology is considered safe, largely because of the decades-long recognition of its risks and the evolution of quality assurance (QA) regimes to mitigate these risks. Medical physicists, radiation engineers, and other technical and quantitative-minded individuals, integral to radiotherapy practice, bring an objective and systematic approach to QA³⁶. The term QA is defined by the International Standard Organization (ISO) as ‘all those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality’³⁷. QA activities are of vital importance in the delivery of safe, quality patient care in radiation oncology. A national approach to QA should be planned and facilitated to make radiotherapy more consistent and ensure safety for patients.

The process of delivering radiotherapy treatments is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of radiation oncology needs quality control and quality assurance to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly³⁸. The World Health Organization (WHO) states that proper QA measures are imperative to reduce the likelihood of accidents and errors and increase the probability that the errors will be recognized and rectified if they do occur³⁹. The incorporation of quality processes into radiation oncology practice allows institutions and individuals to systematically review their processes and adapt them going forward.

Providing safe, quality care is broader than just QA of the techniques and technologies used as part of radiotherapy. QA is part of the broader topic. As part the strategic plan the Radiation Oncology Practice Standards should be promoted and used to help shape the future so that they are an integral part of service planning and implementation. In this regard, the Standards should be used as a foundation and a framework for service planning which would support safe and quality care. Enabling access to a quality service has to be the primary goal of planning any health service. There has been wide stakeholder input into the development of the Radiation Oncology Practice Standards which supports it being used as the foundation for service planning.

The WHO further recommends a number of general preventative measures aimed at reducing radiotherapy errors⁴⁰:

• A thorough quality assurance program to reduce the risks of systematic equipment and procedural-related errors;
• A peer review audit program to improve decision making throughout the treatment process;
• Extensive use of procedural checklists;
• Independent verification through all stages of the process;
• Specific competency certification for all personnel;
• Routine use of in-vivo dosimetry.

The goal of a radiation oncology QA program is to deliver the best and safest radiotherapy treatment to each patient to achieve cure or palliation³⁸. Radiation Oncology Practice Standards, a Tripartite Initiative, outline the components of a quality radiotherapy service at facility level and include a key section on safety and quality management. A number of guidelines on QA have also been developed in Australia, with the Radiation Oncology Practice Standards able to provide the overall framework for these activities.

In a recent study 75% of facilities reported that they were participating in a formal QA system. However, there were considerable variations in the policies followed and QA procedures performed⁴¹. In the absence of national accreditation in line with the Radiation Oncology Practice Standards, the variation in quality programs between facilities presents an ever-increasing risk. This risk increases in line with the following challenges in radiation oncology³⁶:

• Increased time demands and workflow;
• Higher doses of radiation are delivered more precisely and accurately, meaning that with the increase in beam-on time there are higher risks associated with each error;
• Reliance on accurate imaging technology where various imaging factors which previous had low impact on accuracy now have a higher impact on accuracy, for example stereo-tactic radiosurgery;
• Reduced utility of some ‘end of the line’ QA tools as processes evolves to a point where the traditional ‘end of the line’ QA tools are insufficient and so either replaced or discarded;
• Shorter treatment schedules leading to reduced time to assess and manage any error;
• Tighter margins mean that the consequences of geographical misses or dosimetric inaccuracies become larger.

A national and consistent approach to radiation oncology quality assurance is needed in Australia, strengthened through an accreditation program based in the Radiation Oncology Practice Standards. This should include a national reporting framework to identify issues associated with quality, similar to the anonymous reporting mechanism used in the aviation industry, which should be beneficial to identify quality issues early and address these issues to reduce the number of patients affected. This incident reporting strategy is discussed in detail under Continuous Quality Improvement (Incident monitoring). 

Dosimetry

Dosimetry is used to check that the dose of radiation delivered to the patient is accurate and appropriate. It ensures the risks of accidental over- or under-doses are minimised, leading to the best possible results from treatment. The Baume Inquiry recommended that there be a national dosimetry program. This recommendation was amplified by two significant dosimetry incidents in Australia and the pilot of the Australian Clinical Dosimetry Service (ACDS) was established in 2011. This program is well supported by the radiation oncology community in Australia with almost all centres agreeing to participate in the pilot study⁴².

Establishing an independent national dosimetry service places Australia at the forefront of risk mitigation and patient care, even among the most technically advanced countries in the world⁴³. Only the UK, the US and some of the Scandinavian countries have developed programs which provide a level of clinical support similar to that which will be provided by the ACDS. The service will also help to maintain the quality of radiotherapy in Australia, and provide a national approach to radiation measurements, making radiotherapy more consistent across the country and safer for patients⁴³.

The ACDS provide an integrated national approach and extension of this dosimetry service beyond its three year pilot is an important step to enhancing the quality and safety of the Australian radiation oncology sector.

Quality of life and survivorship

The selection of technique and technology for the treatment of patients with radiotherapy strongly influences quality of life (QOL) and survivorship for patients. The increasingly positive survival statistics for individuals diagnosed with cancer indicating increasing lengths of survival mean that QOL many years after diagnosis is becoming increasingly important. QOL and survivorship are strongly dependent on other treatments provided in the multidisciplinary environment and are essentially whole of cancer issues – they cannot be relegated to the silos of radiation oncology, medical oncology, surgery or haematology. These issues need to be examined over time in the context of the multidisciplinary team. The radiation oncology team must have awareness of and sufficient resources to contribute to this process.

Survivorship is a term that represents how a person’s life fares following a diagnosis. It is a concept which can be used in cancer to describe the physical, social, psychological, and spiritual/existential impact of cancer on patient’s life and help understand these factors. Cancer survivorship can be viewed as a continual evolving process starting from the moment of cancer diagnosis which occurs over the course of the remainder of life and can be defined as the experience of “living with, through, or beyond cancer”⁴⁴.

With the implementation of newer radiotherapy techniques and improved delivery technologies, the inference or claimed improvement in QOL or survivorship needs to be assessed. As part of this process, data on the late side effects of radiotherapy need to be systematically collected and evaluated. All of this information can be used to inform health professionals in radiation oncology so that they are aware of changes in QOL and survivorship to better understand and support patients during radiotherapy⁴⁵.

The information gathered from assessing QOL and other survivorship measures is also important as part of the total quality management for cancer care by providing information that can be used to inform appropriate selection of treatment technique in the future.

The contribution of radiation oncology to quality of life and survivorship outcomes needs to be an essential component of the National Cancer Action Plan and is part of the total quality management of radiation oncology for the benefit of the Australian cancer patient.