LR2 / Patient Safety undergoing high technology radiotherapy

Bulgaria




Type of Patient Safety Practice
Clinical Practice (CP)
Related practices from PaSQ database
"Best fit" category of the reported practice
Medical devices / Equipment
Patient safety theme the SCP/clinical risk management practice is aimed at
Medical devices/equipment
Objective of the CRM practice
Volume modulated arc therapy (VMAT), one of the most modern therapeutic strategies to better preserve critical organs, is implemented for tumors of the rectum, prostate, cervix uteri, urinary bladder, testisis, brain, lympomas etc . Patient Safety is absolute first priority—from the first moment to ensure every patient is treated the best way, radiation oncologists have many checks and balances as part of treatment to ensure safety.
This technology is characterized by two features: (1) simultaneously drastically reduced waiting times for patients and (2) maintaining high performance of treatment.
Its key advantage is the best combination of four factors - providing quality radiation, combined with reduced time of exposure, leading to improved treatment outcomes and quality of life of our community patients. This technology is widely known as the "Technology 2+2"- that is two minutes displaying, two minutes treatment. Its aim is the precise realization of a specific dose at a specific volume with maximum protection of healthy tissue [1].
In radiotherapy it is important to verify the calculated dose distribution with dose measurements. First of all we have to perform the recommended commissioning Tests for multileaf collimaton (MLC) performance. A multileaf collimator (MLC) is a device made up of individual "leaves" of a high atomic numbered material, usually tungsten, that can move independently in and out of the path of a particle beam in order to block it.
MLCs are used on linear accelerators to provide conformal shaping of radiotherapy treatment beams. Specifically, conformal radiotherapy and Intensity Modulated Radiation Therapy (IMRT) can be delivered using MLC’s.
A quality control (QC) program has to be elaborated to verify the inverse planning, leaf motion calculator and dinamic MLC. Our results show that Electronic portal imaging deviceEPID is a fast and practical device for commissioning and QA(quality assurance) of all steps included in the chain of dynamic Intense modulated radiotherapy IMRT patient treatment as well as for pre-treatment verification of the individual dosimetry plan [2].
Short description of the CRM practice, including any references for further information
The main objective of RT (Radiotherapy) is to achieve loco-regional tumor control with minimal impact on surrounding healthy organs and tissues of patients.
Modern high-tech equipment solves the following main issues:
• Ability to an atomic - topographic exact three-dimensional planning of the patient;
• Computer programs for individual three - dimensional dosimetry planning consistent with corrections for inhomogeneities, oblique incidence of the ron beam, etc.;
• A computer program for identification of patient and control performance of planned radiotherapy;
• Monitoring the situation of the patient and verification of exposure volume / shape controlled radiotherapy
• Intensity modulated rotation radiotherapy achieves the realization of high therapeutic dose while protecting critical organs and healthy tissue.
The implementation of these techniques in clinical practice leads to improved results of radiotherapy in reducing early and late radiation responses of patients while protecting critical organs. [3].

The main activities of the laboratory of clinical dosimetry and of ionizing radiation consist of the following: Planning and verification of the radiotherapy course continuum of diagnosis, tumor localization, treatment strategy, evaluation of early and late effects, monitoring clinical outcomes. The purpose of clinical dosimetry is to plan and implement the prescribed dose in clinical volume with no target accuracy of ± 5%, according to the requirements of modern radiology. [8].Simultaneously, it should be possible to achieve maximum protection of healthy tissue and critical organs. Accurate reproduction of patient set up of the PTV (Planet Target Volume) is essential to achieve this task. Modern linear accelerators are equipped with removable shoulder equiped with x-ray tube and detector – kV and cone beam CT to verify the position of PTV. A number of control parameters such as patient identification, number of fractions generated daily and total dose, verification of the treatment plan through measurements in phantom and in “vivo”. [8].
Compared with conventional radiation techniques, the main advantage of Volume modulated arc therapyVMAT is the possibility to be realized higher total tumor dose to clinical no target volume / CTO / at acceptable dose levels in normal and critical tissues and organs for short time. [8].
Implementing in clinic practice image guided radiotherapy (IGRT) is obligatory for target volume verification. [5].
The VMAT technique in the clinic is „Rapid Arc“. This technique simultaneously changes the speed of gantly rotation, the shape and intensity of the radiation field. This enables the realization of high doses in clinical target volume at maximum spareing the critical organs and healthy tissue. [6]

Innovator of the SCP, country of origin
First implemented in 2008, University of British Columbia, Canada, Department of Radiotherapy, Karl Otto [11]. Patients are encouraged to ask their treatment teams about the quality assurance programs where they are receiving radiation [11],

Volumetric modulated radiation intensity is actually rotating machinery, introduced as a concept back in 1995. This is a broad term generally adopted in the professional community of radiologists, not a brand name belonging to a company. Now, physicians and team of Department of Radiotherapy have the latest version of the most advanced methods of modern rotary volumetric modulated radiotherapy, known as Rapid Arc technique. This technology was licensed in 2010, in Bulgaria. For two years the Clinic of Prof. Gocheva is a piloting center in Bulgaria, offering a linear accelerator of the class, the most modern in the country and throughout Eastern Europe withVMAT and IGRT techniques Since the beginning of 2012 the Clinic of Radiotherapy decided to be the first center, which introduced the most advanced technology in radiation treatment in Bulgaria, so called “volumetric modulated in intensity rotational radiotherapy”. It is known that this technology is applied in a number of leading European and global centers of only 2-3 years. [1]
In Bulgaria there is such a device, and it is not a panacea, it would be tantamount to a revolution in cancer and priority rules of Patient safety in RT – Clinic of Radiotherapy, University Hospital “Queen Giovanna –ISUL” [1]

Involved health care staff
• Doctors,
• Nurses,
• Medical physicists,
• Engineers,
• Medical equipment,
• Other medical personnel,
• Scientists,
• Researchers
Tested in which countries/health care systems, health care context(s) and/or clinical specialty/specialties, including references
This safe clinical practice was tested in the following settings:

1. TheCenter of Radiotherapy in Hospital ”Queen Giovanna” – ISUL, BG [1], [4], [8].
Prof. Dr. Lilia Gocheva , PhD, National consultant in Radiotherapy- Head of Department of Radiotherapy,
Prof.Tatyana Hadjieva, Katya Ivanova, Head of Laboratory of clinical dosimetry and metrology of ionizing radiation[4], [8].

The Center of Radiotherapy in Hospital Queen Giovanna – ISUL has worked with all hospitals in Bulgaria (government and private), all Medicals Centers, the Association of Patients with cancer, and Other Patient Organisations in Bulgaria and the Balkan region [4].

2. The world radiotherapy center hospital Charite in Berlin VMAT is used for treatment of over 80% of patient [7].

3. Experience of Hospital Trilmi Zurich Switzerland [9]. [10].

4. The University of British Columbia, Canada, Department of Radiotherapy[11]
Summary of evidence for effectiveness, including references
VMAT (Volume modulated arc therapy) radiotherapy technology is a major advance that improves dose conformity while significantly shortening treatment times. It delivers treatments two to eight times faster than other fastest dynamic treatments today and increases precision - a winning combination that enables physicians to improve the standard of care and treat more patients.
Summary of evidence for transferability (transferability across health care systems or health care contexts or clinical specialties), including references
This technique is transferable if such high technology accelerators are installed in the country. This can be a reality in Bulgaria next year most probably.
Summary of available information on feasibility, including references
In 2012 representatives of radiologists proposed the introduction of a clinical pathway modulated in intensity radiotherapy and surgery of radiotherapy worth 4500 EUR. The team believes that instead of the state to pay 10-20 thousand euros for the treatment of Bulgarian patients abroad, it is better to form such a clinical pathway at national level. Unfortunately, at present the clinical pathway modulated in intensity radiotherapy is worth 1500 EUR. However, radiologists decided to prove to society and state institutions that there is a center in Bulgaria, which accepts the challenge and be the first in introducing the most advanced radiotherapy technology. If this effort is replicated, it will effectively stop the flow of patients to foreign centers of radiotherapy. It is necessary to maintain such a high – tech center and if possible, to build more in order to keep patients in Bulgaria. [1].
One main barrier to the feasibility of adopting this safe clinical practice is represented by staff education and training.
To overcome this challenge, participation in specialized training courses (e.g. ESTRO, ASTRO, IAEA) is key. Furthermore,visiting forums and congresses dealing with problems of radiation therapy and patient safety in its application as well as overall education of patient safety would further help.
Existing implementation tools, including references
The following represent a set of implementation tools to enhance better education about this safe clinical practice.
Achecklist, a statement of informed consent, a starter kit, material that may be compiled for distribution within healthcare settings.
- Standard of Radiotherapy. [12].
- Ordinance for Radiation protection [12].
- Ordinance 30 Modalities for conducting irradiation in patients [12].
- Guidlines IAEA and ASTRO,ESTRO[13].
Potential for/description of patient involvement in the CRM practice, including references
The Patients have an opportunity to make an informed decision about the care and treatment they choose [1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13].
Bibliography (for each reference: author(s), year, title, journal/internet link, page(s))
[[1] Prof. Lilia Gocheva, With the introduction of rotational radiotherapy Bulgaria ranks with the best in Europe, February, 20,2013. www.zdrave.net. /Document/AP/Advertising.pdf, Prof. Lilia Gocheva is Head of the Department of Radiotherapy and Board of Directors of the University Hospital " Queen Giovanna – ISUL, Department Radiotherapy" . National consultant on radiotherapy.
[2] St. Bozhikov, Ant. Tonev, Hr. Sokerov, K. Ivanova; Results of a Multileaf Collimation System commissionning used in the the dynamic mode for implementing intensity modulated radiotherapy; ?uropean Medical Physics and Engineering Conference is incorporating Xith National Conference on Biomedical Physics and Engineering Vith European Conference of Medical Physics, October 18 –20, 2012, Sofia, Bulgaria;
[3].St. Bozhikov, Hr. Sokerov, Ant. Tonev, K. Ivanova; Linear Accelerator Quality Assurance using EPIQA Software, ?uropean Medical Physics and Engineering conference is incorporating Xith NationalConference on Biomedical Physics and Engineering With European Conference of Medical Physics, October 18 –20, 2012, Sofia, Bulgaria.
[4] ://www.giovanna-hospital.com;

[5] www.youtube.com/watch ?V=tqSLXTd5r6c, published on April.14.2012 Respiratory Gating System Radiotherapy;

[6].www.youtube.com/watch?v=nq OdK146jaA, uploaded on Nov. 6,2009, Rapic Arc Treatment Timing;

[7] www.charite.de/en/charite;
Robert Siegel et all, BMC Cancer,2009,9,50, Laboratory of Clinical dosimetry and radiation protection.

[8] Guideline for modern radiotherapy, radiotherapy@isul.eu;
[9] Hospital Trimi Zurich Switzerland,M.K.Jorgensen et all,Med.Phys.38(2011) p.1425;
[10]Hospital Trimi Zurich Switzerland, L.S.Fog et al., Phys.Med.Bios, 56(2010),p 1853
[11]University of British Columbia,Astro,American Society for Radiation oncology,RT answer,www.roinstitute.org.;
[12] www.mh.government.bg ( standard and ordinance);
[13]www.us.iaea.org.Standards and Guides; Safety Standards;
Reviewer
Milena Vladimirova, NCPHA, BG
Katya Ivanova, Hospital”Queen Giovanna”- ISUL, BG
Organisation
The National Center of Public Health and Analyses (NCPHA), Bulgaria
Any additional information on the CRM (e.g. implementation barriers and drivers)
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