sâmbătă, 6 septembrie 2014

Ghidurile Europene pentru CBCT - partea a VI - a


6.4.2 Reject analysis 


A simple and valuable tool in clinical image QC is reject analysis. Over a specified time period, a record is kept of radiological examinations that are rejected and that require repeats to be performed, with the date and the reason for the rejection (e.g. area of interest not imaged, image blurred etc.) and the cause if known (e.g. incorrect positioning, patient movement etc.). This allows the calculation of the proportion of examinations which are rejected over a specified period and the identification of the most frequent causes of rejection. Reject analysis can be carried out prospectively (as images are performed) and/or retrospectively. When performed retrospectively, this procedure is a form of Clinical Audit, which requires assessment against a clearly defined set of Quality Standards. Table 6.1 provides a means of comparing CBCT examinations against a standard.

Table 6.1: Clinical Quality Standards for CBCT images


A. Adequate patient preparation, positioning and instruction
·         No removable metallic foreign bodies which might produce scan artefacts (e.g. earrings, spectacles, dentures)
·         No motion artefacts
·         No evidence of incorrect positioning of imaging guides/stents (e.g. air gap due to incorrect seating of the stent)
·         Where fixed, metallic, restorations are in the teeth, no artefacts overlying the area of primary interest1.

B. Correct anatomical coverage
·         Evidence that the smallest Field of View available on the equipment has been used, consistent with the clinical application.
·         The primary area of interest2 at or near the centre of the Field of View.
·         All of the area of interest included in the scan volume.

C. Adequate exposure factors used
·         Absence of significant image noise, low density and contrast

1It is recognised that it may not always be possible to exclude restoration-related artefacts, but there should be evidence that every effort has been made to limit their impact (e.g. by careful orientation of the occlusal plane during positioning).
2e.g. single tooth or single implant site. It is recognised that where multiple implant sites or larger structures are being imaged, not all can be central in the scan volume.
The European Guidelines on Radiation Protection in Dental Radiology (2004) recommended that, as part of a Clinical Audit of film rejects, conventional radiographs be assessed into one of three categories: “Excellent” (no faults), “Acceptable” (some faults but not affecting image interpretation) and “Unacceptable” (faults leading to the radiograph being unacceptable for interpretation). Furthermore, a minimum target was set that no more than 10% of radiographs should be of unacceptable quality. As stated above, the higher radiation doses often seen with CBCT compared with conventional dental radiography imply that a more rigorous quality standard may be appropriate. No published studies on reject rates for dental CBCT examinations were identified by literature review. The only available recommendation identified in this area was that published in the UK (Health Protection Agency, 2010), which recommended a performance standard (minimum target) of not greater than 5% of CBCT examinations classified as “Unacceptable”. The SEDENTEXCT Guideline Development Panel concluded that this was a pragmatic recommendation in the absence of published evidence of reject rates with CBCT. The achievement of this target of 5% should not be seen as an excuse to relax efforts to improve quality or cease image quality assessments. Clinical Audit should be a cycle of quality improvement, relying on repeated assessments against quality standards and implementation of change. Table 6.2 considers corrective actions that might be taken as part of a Clinical Audit cycle.



Establishments carrying out CBCT examinations should perform reject analysis, either prospectively or as part of retrospective clinical audit, at intervals no greater than once every six months

GP
 

As a minimum target, no greater than 5% of CBCT examinations should be classified as “unacceptable”. The aim should be to reduce the proportion of unacceptable examinations by 50% in each successive audit cycle

GP


The European Guidelines on Radiation Protection in Dental Radiology (2004) recommended that, as part of a Clinical Audit of film rejects, conventional radiographs be assessed into one of three categories: “Excellent” (no faults), “Acceptable” (some faults but not affecting image interpretation) and “Unacceptable” (faults leading to the radiograph being unacceptable for interpretation). Furthermore, a minimum target was set that no more than 10% of radiographs should be of unacceptable quality. As stated above, the higher radiation doses often seen with CBCT compared with conventional dental radiography imply that a more rigorous quality standard may be appropriate. No published studies on reject rates for dental CBCT examinations were identified by literature review. The only available recommendation identified in this area was that published in the UK (Health Protection Agency, 2010), which recommended a performance standard (minimum target) of not greater than 5% of CBCT examinations classified as “Unacceptable”. The SEDENTEXCT Guideline Development Panel concluded that this was a pragmatic recommendation in the absence of published evidence of reject rates with CBCT. The achievement of this target of 5% should not be seen as an excuse to relax efforts to improve quality or cease image quality assessments. Clinical Audit should be a cycle of quality improvement, relying on repeated assessments against quality standards and implementation of change. Table 6.2 considers corrective actions that might be taken as part of a Clinical Audit cycle.

Establishments carrying out CBCT examinations should perform reject analysis, either prospectively or as part of retrospective clinical audit, at intervals no greater than once every six months

GP

As a minimum target, no greater than 5% of CBCT examinations should be classified as “unacceptable”. The aim should be to reduce the proportion of unacceptable examinations by 50% in each successive audit cycle

GP


6.4.3 Audit against established clinical image quality criteria 


Visual grading of anatomical features on medical images is a standard method of assessing image quality. Criteria have been established for several types of medical imaging, including adult and paediatric radiography and CT (Report EUR 16260, 1996; Report EUR 16261, 1996; Report EUR 16262, 1999). The aim of such criteria is to characterize a level of acceptability of medical images which can address any clinical indication.
The image quality criteria established for CT (Report EUR 16262, 1999) have little relevance to dental CBCT and there are no comparable established criteria for image quality assessment for the wide range of uses of dental CBCT. Loftag-Hansen et al (2010) described sets of statements used by observers in their study to assess the adequacy of clinical image quality for two uses in upper and lower jaws: implant planning and periapical diagnosis. In their study, these statements proved to be a useful tool in optimisation of radiation doses and can be seen as a good example of how image quality criteria for CBCT might be used. There is, however, a need for further research to develop a comprehensive set of image quality criteria for CBCT that reflect the range of equipment types and their varying clinical capabilities. Ideally, this should be done at a European level rather than various national criteria, as this would assist equipment manufacturers in their work. Until such time as this has been accomplished, clinical image quality assessment must rely either upon the simpler methods described in 6.4.1 and 6.4.2, or by the local development of image quality criteria.  

Image quality criteria should be developed for dental CBCT, ideally at the European level

GP
 

Fault category
Observed fault
Cause
Corrective action
Patient preparation




Streak artefacts over area of interest.
Failure to take out removable metallic objects before scanning (e.g. dentures, earrings and other piercings).
·         Careful pre-scanning procedures to observe and ask patients about removable objects.
Imaging stent not in the correct  
anatomical position.
May be recognised by an air gap under the stent on scans.
Inadequate care in placing the stent or an ill-fitting stent.
·         Greater care in positioning the stent and checking position prior to imaging.
Blurring of image.
·         Patient movement.

·         Failure to instruct patient, or to judge suitability of patient for scanning.

·         Procedures to instruct the patient to stay still.
·         Consider past experience with patient’s cooperation and ensure careful observation of patient during positioning.
·         Use all available immobilisation aids (head restraints, chin rest, etc).
Patient positioning











All, or part of, the area of interest excluded from the scan volume.
·         Failure to position the scan volume over the area of interest during preparation.

·         Patient movement between initial positioning and exposure.

·         Field of View too small for the diagnostic task.

·         Use all available positioning aids (e.g. light beams). Omission of scout views should only be considered under highly selected situations and where alternative positioning aids are fully employed.
·         Protocol to instruct the patient to stay still.
·         Use all available immobilisation aids (head restraints, chin rest, etc.).
Streak artefacts over area of 
interest.
The source of streak artefacts is in the same plane as the area of interest.
·         Consider tipping the head to reduce the impact of artefacts from non-removable objects (dental restorations).
Exposure
Increased “graininess” and reduced sharpness of the image.
Exposure factors too low (kV, mA, reduced number of basis images).
·         Establish exposure protocols to match patient size and the clinical purpose of examination.
Post acquisition manipulation error





Poor contrast and brightness.
Using the image data as acquired, with failure to optimise the contrast and brightness.
·         Operator training Appropriate use of density and contrast controls.
“Pseudoforamina” in volume-
rendered images.
Incorrect thresholding.
·         Operator training Appropriate use of windowing controls.
Incomplete diagnostic
information or exclusion of area  
of interest on reconstructed 
images.
Inappropriate positioning or thickness of reformatted image slices.
·         Operator training in multiplanar reformatting

 
6.5: References


Advies van de Hoge Gezondheidsraad nr. 8705. Dentale Cone Beam Computed Tomography. Brussel: Hoge Gezondheidsraad, 2011. www.hgr-css.be

Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure Official Journal of the European Communities No L 180/11 1997


European Commission 2004. Radiation Protection 136. European Guidelines on Radiation Protection in Dental Radiology. Luxembourg: Office for Official Publications of the European Communities,. Available from: http://ec.europa.eu/energy/nuclear/radioprotection/publication/doc/136_en.pdf
IPEM 2005 Recommended standards for the routine performance testing of diagnostic X-ray imaging systems IPEM report 91

Haute Autorité de Santé. Tomographie Volumique a Faisceau Conique de la Face (Cone Beam Computerized Tomography). Rapport d‟évaluation Technologique. Service évaluation des actes professionnels. Saint-Denis La Plaine: Haute Autorité de Santé, 2009. http://www.has-sante.fr

Health Protection Agency Recommendations for the design of X-ray facilities and quality assurance of dental Cone Beam CT (Computed tomography) systems HPA-RPD-065 JR Holroyd and A Walker. Chilton: Health Protection Agency, 2010a.

Health Protection Agency. Guidance on the Safe Use of Dental Cone Beam CT (Computed Tomography) Equipment. HPA-CRCE-010. Chilton: Health Protection Agency, 2010b.

Lofthag-Hansen S, Thilander-Klang A, Gröndahl K. Evaluation of subjective image quality in relation to diagnostic task for cone beam computed tomography with different fields of view. Eur J Radiol. 2010 Oct 19. [Epub ahead of print]

Qualitätssicherungs-Richtlinie – QS-RL. Richtlinie zur Durchführung der Qualitätssicherung bei Röntgeneinrichtungen zur Untersuchung oder Behandlung von Menschen nach den §§ 16 und 17 der Röntgenverordnung. Gemeinsames Ministerialblatt 37-38, 2004, S. 731-777.

Report EUR 16260. Carmichael JHE, Maccia C, Moores BM, Oestmann JW, Schibilla H, Teunen D, van Tiggelen R, Wall B. (Eds.). Quality Criteria for Diagnostic Radiographic Images. Luxembourg: Office for Official Publications of the European Communities, 1996.
Report EUR 16261. Kohn MM, Moores BM, Schibilla H, Schneider K, St. Stender H, Stieve FE, Teunen D, Wall B. (Eds). European Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics. Luxembourg: Office for Official Publications of the European Communities,1996.

Report EUR 16262. Menzel H-G, Schibilla H, Teunen D, (Eds.). European Guidelines on Quality Criteria for Computed Tomography. Luxembourg: Office for Official Publications of the European Communities, 1999.

Statens strålevern. Stråleverninfo 8:2010. Krav for bruk av Cone Beam CT ved odontologiske virksomheter. Østerås: Statens strålevern, 2010.

Sundhedsstyrelsen. Statens Institut for Strålebeskyttelse. Krav til 3D dental. Herlev: Statens Institut for Strålebeskyttelse, 2009.

European Commission 1999. Radiation Protection 109. Guidance on Diagnostic Reference Levels (DRLs) for Medical Exposures. Luxembourg: Office for Official Publications of the European Communities,. 



7: STAFF PROTECTION



The general comments on protection of staff made in the European Guidelines No 136 (European Commission 2004) are equally applicable to dental CBCT. However, as dose levels and beam energies are generally higher compared to conventional dental radiology, extra practical protection measures are required for dental CBCT. It is essential that an appropriate qualified expert is consulted both prior to installation and on an on-going basis.



It is essential that a Qualified Expert is consulted over the installation and use of CBCT to ensure that staff dose is as low as reasonably achievable and that all relevant national requirements are met

ED D
 
7.1 Classification of areas


The European Guidelines No 136 (European Commission 2004) recommended that the use of distance to reduce dose was normally the only measure required for conventional dental radiography. Data on dose rates around CBCT units are not available in the literature, but doses measured in the field and information available from manufacturers indicate that the maximum dose at 1 metre due to scattered radiation varies between 2 to 47 Sv per scan, compared with intraoral and panoramic radiography scatter doses of less than 1 Sv per exposure.

In addition, tube voltage can be as high as 120kVp, leading to scattered radiation being significantly more penetrating. This is much higher than conventional dental radiography and the increased penetration through protective shielding must also be borne in mind.
Consequently, it is recommended that CBCT equipment be installed in a purpose-built enclosure providing adequate protection to adjacent areas and the operator and that the whole of this enclosure be designated a controlled area. 

CBCT equipment should be installed in a protected enclosure and the whole of the enclosure designated a Controlled Area

D
 


7.2 Design of the CBCT room


7.2.1 Protection for adjacent areas 


It is essential that shielding be provided to control dose in areas adjacent to the CBCT room. This is recognised in national guidance (HPA 2010a; HPA 2010b; Advies van de Hoge Gezondheidsraad, 2011; Statens strålevern 2010). Advice on the design of CBCT facilities has been published by the UK Health Protection Agency (HPA 2010a, HPA 2010b) and provides guidance for the qualified expert on aspects that must be considered when designing a dental CBCT facility.

The amount of scattered radiation per scan depends on a number of factors, and neither kV nor maximum FOV are good predictors of this. Furthermore, the dose distribution may not be uniform in all directions around the CBCT equipment. The HPA (HPA 2010a) report that the maximum scatter dose at a distance of 1m can range from 2 to 40 Gy per scan. Measurements carried out by SEDENTEXCT partners confirmed this range, although the majority of units gave readings between 6 to 12 Gy per scan. Detailed information, e.g. in the form of secondary radiation plots, should be sought from the supplier or manufacturer to allow the calculation of appropriate levels of shielding.

In calculating shielding, the workload of the unit also needs to be taken into consideration. For dental practice, the HPA (HPA 2010a) suggest that a workload of 20 scans per week be assumed, while for a hospital department the figure would be 50 scans per week. A review of workload within the SEDENTEXCT partners again confirms these assumptions as reasonable for current practice, although it must be born in mind that the clinical use of dental CBCT is still developing and workload assumptions should be kept under review.

Working to a dose constraint of 0.3 mSv per year to staff in adjacent areas, shielding up to 1.5mm lead equivalence will be required in the walls provided that the unit is positioned so that the distance to staff in the adjacent area is 1m or greater. However, due to the significant differences in maximum operating potential and levels of scattered radiation, many installations may be satisfactorily shielded with lower requirements. It is likely that doors, which will normally be further away from the unit, could contain less protection. In addition, floor and ceiling protection needs to be considered and it is likely that ground floor windows will need blocking up. A dose constraint of 0.3 mSv per year is in accord with Danish and UK requirements (Sundhedsstyrelsen 2009; HPA 2010b). Alternative national guidance exists but is in broad agreement with this. In Norway, a dose constraint of 0.25mSv per year is established, with shielding equivalent to 1mm lead considered satisfactory where equipment operates below 100kV. Where equipment operates at higher kiloVoltage, the Norwegian guidance recommends that it may be necessary to increase the protection to 3mm lead equivalent, depending on workload, room size and design and the frequency of use of neighbouring rooms. The input of the qualified expert in determining protection needs is advised (Statens strålevern, 2010).

The data in the table (7.1) below may be used for the purposes of initial cost estimates; however, each installation should be assessed on a case by case basis with the input of a qualified expert and in the context of national guidelines and regulations.



Detailed information on the dose due to scattered radiation should be obtained to inform decisions about shielding requirements
D
 



Table 7.1: Summary of shielding requirements at 1 m for dose constraint of 0.3 mSv per annum



7.2.2 Room layout 


The operator position should be outside the room or, if inside, be provided with additional shielding in the form of a protective cubicle to stand behind. The position of the operator must always be such that they can clearly see the patient and the room entrance(s) and be able to interrupt the scan using the emergency stop, if required. This might be via a protected viewing window, a strategically positioned mirror or with the use of a CCTV camera. The emergency stop should be located adjacent to the operator, positioned so that the operator does not need to enter the room unprotected in order to activate it (HPA 2010 a, HPA 2010b).

For units requiring authorisation of the exposure from the computer software prior to exposure, it is essential that the computer should be located close to the X-ray unit rather than over a network to reduce the likelihood of the exposure being authorised without the operator at the CBCT control.

CBCT units usually require that the mains power supply be left on, to obviate the need for a lengthy warm up procedure before each exposure. If another unit is located in the same room, the layout should be arranged to reduce the likelihood of the wrong unit being initiated; for example, by providing exposure switches in separate locations or by placing the exposure switches in lockable boxes. Safeguards should also be incorporated into the exposure initiation systems to ensure that the equipment cannot be operated by people not authorised to do so. This can be achieved by the use of password or key control (HPA 2010a).
A system of warning lights is recommended for dental CBCT units, in line with local regulatory requirements for X-ray rooms; ideally providing a two stage indication: stage 1 to indicate readiness to expose (i.e. when the power is switched on to the unit) and stage 2 when X-rays are about to be or are being generated (HPA 2101b).  




7.3 Personal Monitoring


Routine personal dosimetry for dental radiographic staff is generally considered desirable but not universally necessary across all European countries. (European Commission 2004). Given the higher dose levels when using dental CBCT units, the need for personal monitoring should be carefully considered, seeking the advice of a qualified expert if available.


Recent Belgian guidance recommends the routine use of personal dosimetry with dental CBCT (Advies van de Hoge Gezondheidsraad, 2011), while in Norway personal dosimetry is not required if the operator is always adequately protected by shielding (Statens strålevern, 2010). In the UK, the recommendation is for monitoring for an initial trial period and repeat one-off monitoring if the facilities, workload or techniques change, assuming that adequate protection is available for the operator. However, if the room design is such as to allow operation of the unit without being adequately shielded, continuous monitoring is advised. (HPA 2010a, HPA 2010b). The provision of monitoring for reassurance of pregnant staff should also be considered, although the dose to the foetus is likely to be significantly lower than the dose constraint of 1mSv during the term of pregnancy stated in the European Basic Safety Standards Directive (European Commission 1996). 


The provision of Personal Monitoring should be considered
D
 



7.4 References


Advies van de Hoge Gezondheidsraad nr. 8705. Dentale Cone Beam Computed Tomography. Brussel: Hoge Gezondheidsraad, 2011. www.hgr-css.be


European Commission 2004. Radiation Protection 136. European Guidelines on Radiation Protection in Dental Radiology. Luxembourg: Office for Official Publications of the European Communities,. Available from: http://ec.europa.eu/energy/nuclear/radioprotection/publication/doc/136_en.pdf

European Commission 1996 Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation Official Journal of the European Communities L 159/1

HPA 2010a Recommendations for the design of X-ray facilities and quality assurance of dental Cone Beam CT (Computed tomography) systems HPA-RPD-065 JR Holroyd and A Walker Health Protection Agency
HPA 2010b Guidance on the Safe Use of Dental Cone Beam CT (computed tomography) Equipment HPA-CRCE-010

Statens strålevern. Stråleverninfo 8:2010. Krav for bruk av Cone Beam CT ved odontologiske virksomheter. Østerås: Statens strålevern, 2010.

Sundhedsstyrelsen. Statens Institut for Strålebeskyttelse. Krav til 3D dental. Herlev: Statens Institut for Strålebeskyttelse, 2009. 



8: ECONIMIC EVALUATION 



Economic evaluation attempts to weigh costs and effects of alternative interventions with the goal that available resources are used to achieve maximum benefits for patients in terms of health and quality of life. In emerging technologies, this is particularly important to avoid inappropriate and excessive use. As part of the systematic review process described in this document, no literature was identified that fell under the heading “cost effectiveness” or “economic evaluation”. A few studies mentioned the costs of CBCT, usually quoting the hospital fee for a CBCT examination. Such figures do not usually reflect real costs and reflect idiosyncrasies of particular hospitals and healthcare systems.



As part of the SEDENTEXCT project, the Malmö University partner has led the research on health economic evaluation and has commenced a broader systematic review to analyse evidence on economic evaluation in oral health care, particularly as relates to diagnostic methods. Studies identified by literature search were interpreted by two reviewers using a check-list for assessing economic evaluations (Drummond et al. 2005). Of four publications presenting diagnostic interventions in oral health care, only one publication remained after the reviewers‟ interpretation. This publication (Norlund et al. 2009) presented a model analysis of the cost of true-positive occlusal dentine caries detection in permanent molars assessed by different diagnostic strategies using bitewing radiography. Thus, no publication that presented an economic evaluation of CBCT was identified with the aid of the systematic review.
At the time of writing, cost analysis carried out within the project is unpublished. There are data on cost-analysis collected from examinations of maxillary canines with eruption disturbances that shows that CBCT is more costly than conventional examinations with intraoral and panoramic radiography. A comparison of costs of CBCT-examinations within different health care systems of patients with different clinical conditions showed that estimates for costs varied for examination of one and the same condition between the health care systems. Thus, valuation of costs in monetary terms of CBCT should not be generalized from one health care system to another but a model for cost analysis similar to that designed within the project provides an important tool for economic evaluations in comparing costs and consequences of diagnostic methods and can guide planning of service delivery in both public and private sectors. Considering the results obtained, the use of CBCT needs to involve a comprehensive assessment of economic factors in conjunction with radiation dosage, diagnostic accuracy efficacy and the benefits for the patients in terms of health and life quality in different health care contexts. 



Economic evaluation of CBCT should be a part of assessment of its clinical utility

GP





8.1 References 


Drummond MF, Sculpher MJ, Torrance GW, O´Brian BJ, Stoddart GL. Methods for the economic evaluation of health care programmes. Oxford: Oxford Medical Publications, 3rd ed, 2005.



Norlund A, Axelsson S, Dahlén G, Espelid I, Mejàre I, Tranaeus S, Twetman S. Economic aspects of the detection of occlusal dentine caries. Acta Odontol Scand 2009;67:38-43.


Christell H, Birch S, Horner K, Rohlin M, Lindh C, The SEDENTEXCT consortium. A model for cost-analysis of diagnostic methods in oral health care. An application comparing a new imaging technology with a conventional one for maxillary canines with eruption disturbances. Submitted to Community Dentistry and Oral Epidemiology 2010.


9: TRAINING



9.1 Roles and responsibilities 


As defined in the European Directive (Council Directive 97/43/Euratom, 1997), the roles involved in delivering a diagnostic radiological service to patients are:

The Holder: any natural or legal person who has the legal responsibility under national law for a given radiological installation.

The Prescriber: a medical doctor, dentist or other health professional, who is entitled to refer individuals for medical exposure to a practitioner, in accordance with national requirements. The prescriber is involved in the justification process at the appropriate level.
The Practitioner: a medical doctor, dentist or other health professional, who is entitled to take clinical responsibility for an individual medical exposure in accordance with national requirements.
The medical physics expert (MPE): an expert in radiation physics or radiation technology applied to exposure, within the scope of the Directive, whose training and competence to act is recognized by the competent authorities; and who, as appropriate, acts or gives advice on patient dosimetry, on the development and use of complex techniques and equipment, on optimization, on quality assurance,
including QC, and on other matters relating to radiation protection, concerning exposure within the scope of the Directive.
In hospital practice, these roles are usually straightforward to link to particular individuals; the Holder is the Hospital or Health Service Authority, the Prescriber is the health professional carrying out the patient‟s clinical care, the Practitioner is usually a radiologist and a MPE is appointed to provide specialist support. In primary dental care, however, the first three of these roles are frequently held by one individual. “Self referral”, where the dentist is both Prescriber and Practitioner, is normal. An MPE may, or may not, be normally appointed to a dental practice depending on national regulations.

In addition to these roles, the practical aspects for the procedure, or part of it, may be delegated by the holder of the radiological installation or the practitioner, as appropriate, to one or more individuals entitled to act in this respect in a recognized field of specialization. In hospital practice, this may include a radiographer/ imaging technician, but in primary dental care it may involve the dentist or a dental assistant/ nurse. In the current document, any role involved in practical aspects for the procedure will be referred to by the term “Operator”.
The Directive requires that Member States shall ensure that practitioners and the other individuals mentioned above have adequate theoretical and practical training for the purpose of radiological practices, as well as relevant competence in radiation protection. Where a relatively new technology such as CBCT is concerned, the Panel recognized that existing training of users may be less than ideal and that appropriate arrangements for training must be made. As stated in Section 3 of this document, this is considered a “Basic Principle” of the use of CBCT in dentistry. 



All those involved with CBCT must have received adequate theoretical and practical training for the purpose of radiological practices and relevant competence in radiation protection

ED BP
 


A key part of continuing education and training is identification of those most capable of delivering it. Specialists in Dental and Maxillofacial Radiology, with their unique combination of a dental and a radiological training, are likely to be the most appropriate individuals to deliver much of the training, in conjunction with medical physicist support. 


Continuing education and training after qualification are required, particularly when new CBCT equipment or facilities are adopted

BP
 



Dentists and dental specialists responsible for CBCT facilities who have not previously received “adequate theoretical and practical training” should undergo a period of additional theoretical and practical training that has been validated by an academic institution (University or equivalent). Where national specialist qualifications in Dental and Maxillofacial Radiology exist, the design and delivery of CBCT training programmes should involve a Dental and Maxillofacial Radiologist

BP
 



9.2 Curricula for training in CBCT 


While the content of training programmes aimed at delivering “adequate theoretical and practical training” are most appropriately determined nationally within Member States, the Guideline Development Panel involved in devising the “Basic Principles” of the use of CBCT in dentistry (Horner et al, 2009) endorsed a draft core curriculum to provide a basic structure and content for training (Table 9.1). The Guideline Development Panel recognised the large national variation in Europe in the clinical services provided by dentists in primary care.



Table 9.1: Appendix to the EADMFR Basic Principles on the use of Cone Beam CT, outlining “adequate theoretical and practical training” for dentists using CBCT. Adapted from Horner et al, 2009. 



Role
Training content
The Prescriber: a dentist referring a patient for CBCT and receiving images for clinical use
Theoretical instruction
·         Radiation physics in relation to CBCT equipment
·         Radiation doses and risks with CBCT
·         Radiation protection in relation to CBCT equipment, including justification (referral/ selection criteria) and relevant aspects of optimisation of exposures
·         CBCT equipment and apparatus

Radiological interpretation
·         Principles and practice of interpretation of dento-alveolar CBCT images of the teeth, their supporting structures, the mandible and the maxilla up to the floor of the nose (e.g. 8cm x 8cm or smaller fields of view)
·         Normal radiological anatomy on CBCT images
·         Radiological interpretation of disease affecting the teeth and jaws on CBCT images
·         Artefacts on CBCT images

The Practitioner: a dentist responsible for performing CBCT examinations
Theoretical instruction
·         Radiation physics in relation to CBCT equipment
·         Radiation doses and risks with CBCT
·         Radiation protection in relation to CBCT equipment, including justification (referral/ selection criteria), optimisation of exposures and staff protection
·         CBCT equipment and apparatus
·         CBCT image acquisition and processing

Practical instruction
·         Principles of CBCT imaging
·         CBCT equipment
·         CBCT imaging techniques
·         Quality assurance for CBCT
·         Care of patients undergoing CBCT

Radiological interpretation
·         Principles and practice of interpretation of dento-alveolar CBCT images of the teeth, their supporting structures, the mandible and the maxilla up to the floor of the nose (e.g. 8cm x 8cm or smaller fields of view)
·         Normal radiological anatomy on CBCT images
·         Radiological interpretation of disease affecting the teeth and jaws on CBCT images
·         Artefacts on CBCT images

 



In parallel, or subsequently, guidelines on dental CBCT have been developed nationally in Belgium (Advies van de Hoge Gezondheidsraad, 2011), Denmark (Sundhedsstyrelsen, 2009), France (Haute Autorité de Santé, 2009), Germany (Leitlinie der DGZMK, 2009; Schulze & Schulze, 2006), Norway (Statens strålevern, 2010) and the United Kingdom (Health Protection Agency, 2010). These incorporate recommendations for training in varying detail. Authorities in other European countries are in the process of developing their own national guidelines.



In France, the relevant “Basic Principles”, Nos.16-20 (Section 3) have been reiterated (Haute Autorité de Santé, 2009). In Norway, the emphasis is placed upon “relevant and documented competence” in radiological interpretation, in physics and in operating equipment. It is a requirement in Norway that a radiologist is employed by a dental practice carrying out CBCT examinations, but that limited volume CBCT (definition as given in Table 9.1 and in Basic Principle No.19 in Section 2) can be interpreted by a dentist with relevant and documented competence if the radiologist allows it (Statens strålevern, 2010). The need for training so that competence is achieved is therefore implicit.


More detailed training curricula have been devised in Denmark, Germany and the UK. In the Danish guidance, the dentist responsible must have the supplementary training needed to interpret the CBCT images, while all personnel who work the units must have instructions on how to operate them. The requirements for training include a practical course with training of the responsible dentist and personnel on how to operate the units and also further education of the responsible dentist in the theoretical background for CBCT imaging. The German course concept includes supervised practical training in interpretation, theoretical training, personal study and an examination. The UK guidance document includes a detailed curriculum for theoretical training which differentiates between the training needs of those in Prescriber, Practitioner and Operator roles, and which recommends supplementary training in operating CBCT equipment ideally given by a trained applications specialist from the equipment manufacturer. The recommended duration of training in these national guideline documents varies considerably.

In the light of these differing national developments in training curricula, and recognising the widely varying traditions in different countries, the Panel concluded that it was inappropriate to recommend a more detailed curriculum than that described in Table 9.1. National authorities should build upon this “core” curriculum in a manner which satisfies their specific needs.

There is no comparable curriculum or guidance for medical physics experts on the specific training needs for CBCT. It is clear that a MPE will have substantial existing knowledge, but that CBCT has some unique characteristics that necessitate additional training. While this training might be obtained by self-study, consideration should be given to developing CBCT learning opportunities for MPEs so that they can familiarise themselves with the specific requirements.

The role that has not been addressed above is the training of equipment manufacturers and suppliers, particularly of applications specialists who may contribute themselves to training of dentists and dental staff. Their recommendations to the CBCT user on exposure and optimization are of critical importance in determining future day-to day practices of the CBCT Operators. The Panel believes that the training needs of this stakeholder group should not be ignored. The content of training should be based upon the theoretical content of the curriculum outlined in Table 9.1, with the addition of elements of dental terminology and radiological interpretation which will allow an understanding of clinical needs and more effective communication with clinical staff. The Panel suggest that core training could be delivered in the equivalent of 4 hours. 



CBCT applications specialists and agents of manufacturers and suppliers of CBCT equipment who provide information and training to clinical staff should obtain relevant training in radiation protection and optimization

GP
 



9.3 References



Advies van de Hoge Gezondheidsraad nr. 8705. Dentale Cone Beam Computed Tomography. Brussel: Hoge Gezondheidsraad, 2011. www.hgr-css.be


Council Directive 97/43/Euratom of 30 June 1997 (on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure).

Haute Autorité de Santé. Tomographie Volumique a Faisceau Conique de la Face (Cone Beam Computerized Tomography). Rapport d‟évaluation Technologique. Service évaluation des actes professionnels. Saint-Denis La Plaine: Haute Autorité de Santé, 2009. http://www.has-sante.fr

Health Protection Agency. Guidance on the Safe Use of Dental Cone Beam CT (Computed Tomography) Equipment. HPA-CRCE-010. Chilton: Health Protection Agency, 2010.

Horner K, Islam M, Flygare L, Tsiklakis T, Whaites E. Basic Principles for Use of Dental Cone Beam CT: Consensus Guidelines of the European Academy of Dental and Maxillofacial Radiology. Dentomaxillofac Radiol 2009; 38: 187-195.

Leitlinie der DGZMK. Dentale Volumentomographie (DVT) - S1 Empfehlung. Deutsche Zahnärztliche Zeitschrift 64, 2009: 490 - 496.

Schulze D, Schulze R. Kurskonzept zur Vermittlung der Fachkunde der dentalen digitalen Volumentomographie für Neuanwender. 2006 [Personal Communcation].

Statens strålevern. Stråleverninfo 8:2010. Krav for bruk av Cone Beam CT ved odontologiske virksomheter. Østerås: Statens strålevern, 2010.

Sundhedsstyrelsen. Statens Institut for Strålebeskyttelse. Krav til 3D dental. Herlev: Statens Institut for Strålebeskyttelse, 2009. 

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