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ePaper created 2015-02-10, 15:02:41 | version 1.33.01
Dr Lee M. Whitesides USA Since its commercial intro- duction into dentistry in 2001, cone beam computed tomo- graphy(CBCT)hasbeenrapidly evolving into a new standard of care in maxillofacial imaging. In just over a decade, CBCT has exploded onto the dental land- scape and permitted dental professionals a degree of three- dimensional (3-D) anatomic truth in maxillofacial imaging previously unavailable and unattainable. Like many other new tech- nologies, which have progressed from the extraordinary to the ordinary and thus gained ac- ceptance by professionals and patients, CBCT has advanced from exceptional use to almost commonplace use in dentistry as cost decreases, access to the technologyincreases,andpoten- tial adverse patient interaction (i.e. radiation exposure) is atten- uated. Today, CBCT is seen by many in dentistry as the standard operating procedure for many dental implant, orthognathic, or- thodontic, or endodontic cases. The advancement of CBCT in dentistry has caught the atten- tion of manufacturers of radio- logical equipment. In 2001, only one company sold a CBCT sys- tem. In 2014 there are at least 20 companies selling CBCT ma- chines and technology. Henry Schein, a leading distributor of dentalequipmenthasseenCBCT sales expand from 5 per cent of their digital imaging sales to al- most 50 per cent of digital imag- ing sales in the last five years. CBCT has also been recog- nised by general dentists and spe- cialists as a means by which they can separate, identify, and distin- guish their practices as being on the vanguard of technology in pa- tientcare.Today’spatientsexpect their dentist and physicians to becontemporarywithtechnology and services. CBCT provides the doctor with a technology, which not only has significant advan- tages in treating patients but also has a noteworthy “wow” factor as the3-Dimagesareseenonalarge screen in “real time” for the doc- tor and patient to view. CBCT, like plain film radi- ographic studies, may be con - sidered a revenue generator for a practice. The more a CBCT machineisutilised,themorerev- enue it will generate. Addition- ally, the owner may allow others in the profession to utilise the machineforafee,therebyreduc- ing his overall cost of operation. Standard of care is a legal not a medical or dental concept. Standards of care are constantly evolving as methods and tech- niques in patient care improve. An appropriate definition for standard of care may include such language as: the dentist is under duty to use that degree of skill and care which is ex- pected of a reasonably competent and prudent dentist under the same or similar circumstances. Standards of care may be local, regional or national. Standard of care influences The influence of an emerging technology,likeCBCT,intoanew standard of care involves many criteria. These criteria include but are not limited to: court ver- dicts,experttestimony,literature support, professional guidelines, cost and availability of the tech- nology, reimbursement by third party payers, and multi-specialty use and recognition. Taken individually, these cri- teria do not constitute a mandate for any technology as a standard ofcare.Norarethesetheonlycri- teria one may use in determining standard of care. Taken together, these criteria provide strong evi- dence that CBCT technology has sufficiently evolved to be consid- ered the standard of care in max- illofacial imaging in selected cases to assist the dentist in treatment for patients in need of dental implants, orthognathic surgery,manipulationofdifficult impacted teeth, orthodontics, endodontics, and many other facets of dentistry. The legal perspective The legal system in the United States is complex and fragmented. No database exists to search verdicts in dental mal- practice cases in which CBCT has played an important or piv- otal role. For a new technology to become admissible as a standard of care in court, it must pass the Frey test. This standard comes from Frey v. United States which is a 1923 in a case discussing the admissibility of a polygraph test as evidence. The Frey standard maintains that scientific evi- dencepresentedtothecourtmust be interpreted by the court as “generally accepted” and expert testimony must be based on sci- entific methods that are suffi- cientlyestablishedandaccepted. In Frey, the court opined: “Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recog- nised, and while the courts will goalongwayinadmittingexper- imental testimony deduced from awell-recognisedscientificprin- ciple or discovery, the thing from which the deduction is made must be sufficiently established to have gained general accept- ance in the particular field in which it belongs.” In many jurisdictions and in Federal court, the Frey standard is superseded by the Daubet standard. The Daubet standard is usedbyatrialjudgetomakeapre- liminary assessment of whether an expert’s scientific testimony is based on reasoning or methodol- ogy that is scientifically valid and can properly be applied to the factsatissue.Underthisstandard, thefactorsthatmaybeconsidered in determining whether the methodology is valid are: • theory or technique in question can be and has been tested, • it has been subjected to peer review and publication, • there is a known or potential error rate, • the existence of maintenance standards controlling its oper- ation, • widespread acceptance within a relevant scientific commu- nity. The theory or technique be- hind medical grade computed tomography and CBCT has been tested and proven sound over many years of application in the medical and dental arena. The Hounsfield unit is the widely recognised standard quantita- tive scale for describing radio- density and provides doctors with a known standard and error rate in computed tomography. The widespread acceptance of CBCT by the medical and dental community is demonstrated by the ever increasing presence in dental and medical practices of the technology. Additionally, The Intersocietal Accreditation Commission, an accreditation organisation for medical and dental imaging, has developed guidelines and accreditation cri- teria for 3-D CBCT imaging. Thus CBCT appears to have sat- isfied both the Frey and Daubet criteria for acceptance as a stan- dard of care technology. Not to discount the value of CBCT imaging or its ability to successfully satisfy the Frey or Daubet criteria, the absence of CBCT is not de facto evidence of lack of a standard of care imag- ing. Many patients present to their dentist with uncomplicated cases where traditional two-di- mensional radiographic studies are appropriate and provide the dentist with standard of care im- aging of the patient. For the more complicated cases, 3-D imaging may be employed to provide the dentist with superior anatomic evidence in treatment planning and diagnosis. Three-dimen- sional imaging with CBCT can also be used in uncomplicated cases, but it may not necessarily be considered as the standard of care for every case in 2014. Expert Testimony An expert is a person with sufficient minimal qualifications to render an opinion on the sub- ject at hand. Not all experts are createdequal,andinfactinthree states (Iowa, South Dakota, and New Hampshire) an expert need onlybequalifiedinarelatedfield to offer an opinion. Experts are used by the courts to educate thejudgeandjuryastowhatcon- stitutes normal minimal accept- able care of a patient in a given environment. Expert testimony is by defi- nition the opinion of one prac- titioner. It is an opinion based on fact, evidence, experience, and knowledge which the expert believes to be relevant, valid, and upheld in the scientific com- munity. When reviewing a case for suspected malpractice the ex- pert examines many things, including, but not limited to: chart notes, radiographic stud- ies,depositions,andprofessional correspondences. In the last five years, the author has noticed a remarkableincreaseinthenum- ber of cases in which plaintiffs and defence attorneys, as well as experts, rely on pre and/or post- procedure CBCT imaging studies to assist in proving malpractice ordefendinggoodpractice. Post- treatment radiographic imaging to prove malpractice or support good practice is not new to med- icine. In fact in the years pre- ceding WWI, some of the highest malpractice claims were award- edincaseswherepost-treatment radiographs played a pivotal role. Logic would dictate that if plaintiffs and defence counsels and experts are making CBCT part of their strategy, then CBCT must be not only prevalent and pertinent but of significant value in the formation of an opinion by an expert (and the jury) when reviewing a case. CBCT can be seen as an additional and impor- tant piece of information to help explain why the doctor did what he did or why an unfortunate outcome occurred. Additionally, CBCT provides powerful and easily understandable images for layperson jury. Recognising the value that CBCT adds to a case does not necessarily indicate that CBCT is the standard of care in each and every case. The decision to obtain a CBCT study before the procedure is determined by the dentist based on his experience and knowledge of the case. Literature Support For any technology to be considered as a standard of care, aplethoraofliteratureinsupport for the technology should exist. The literature must discuss the risk and benefits of the tech- nology, its application to patient care, and guidelines and proto- cols for acceptable use. (DTI/PhotoRobertKneschke) Cone Beam Computed Tomography: Is dentistry ready for a new standard of care? Trends & Applications DENTALTRIBUNE Asia Pacific Edition No. 1+2/201514 ‡ page 16DT DTAP0115_14-18_Whitesides 09.02.15 11:00 Seite 1 DTAP0115_14-18_Whitesides 09.02.1511:00 Seite 1