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1.  Comparison of Radiation Exposure in Lumbar Pedicle Screw Placement With Fluoroscopy Vs Computer-Assisted Image Guidance With Intraoperative Three-Dimensional Imaging 
Background/Objective:
Little is known about the long-term effects of chronic exposure to ionizing radiation. Studies have shown that spine surgeons may be exposed to significantly more radiation than that observed in surgery on the appendicular skeleton. Computer-assisted image guidance systems have been shown in preliminary studies to enable accurate instrumentation of the spine. Computer-assisted image guidance systems may have significant application to the surgical management of spinal trauma and deformity. The objective of this study was to compare C-arm fluoroscopy and computer-assisted image guidance in terms of radiation exposure to the operative surgeon when placing pedicle screw-rod constructs in cadaver specimens.
Methods:
Twelve single-level (2 contiguous vertebral bodies) lumbar pedicle screw-rod constructs (48 screws) in 4 fresh cadavers were placed using standard C-arm fluoroscopy and computer-assisted image guidance (Stealth Station with Iso-C3D). Pedicle screw-rod constructs were placed at L1–L2, L3–L4, and L5–S1 in 4 fresh cadaver specimens. Imaging was alternated between C-arm fluoroscopy and computer-assisted image guidance with StealthStation Iso-C3D. Radiation exposure was measured using ring and badge dosimeters to monitor the thyroid, torso, and index finger. Postprocedure CT scans were obtained to judge accuracy of screw placement.
Results:
Mean radiation exposure to the torso was 4.33 ± 2.66 mRem for procedures performed with standard fluoroscopy and 0.33 ± 0.82 mRem for procedures performed with computer-assisted image guidance. This difference was statistically significant (P = 0.012). Radiation exposure to the index finger and thyroid was negligible for all procedures. The accuracy of screw placement was similar for both techniques.
Conclusions:
Computer-assisted image guidance systems allow for the safe and accurate placement of pedicle screw-rod constructs with a significant reduction in exposure to ionizing radiation to the torso of the operating surgeon.
PMCID: PMC2607125  PMID: 19086710
C-arm fluoroscopy; Radiation exposure; Minimally invasive surgery; computer-assisted, Image-guided; Pedicle screw; Intraoperative imaging; Surgical navigation systems
2.  Kyphoplasty: Traditional imaging compared with computer-guided intervention—time to rethink technique? 
Study design: Equivalence trial (IRB not required for cadaveric studies).
Objective: To compare computer-guided and fluoroscopic kyphoplasty. Factors of interest were radiation exposure, position of cannula within pedicles and procedure time.
Methods: Kyphoplasty was performed on two cadavers. Computer-navigated, cross-sectional images from a cone-beam CT were used for one and fluoroscopic imaging for the other. In each, T6–9 and T11–L2 vertebrae were selected. For both imaging methods, anteroposterior and lateral x-rays were taken. Radiation exposure for both procedures was measured by four dosimeters. Procedure time, radiation to surgeon and cadaver, and position of cannula placement within pedicles were recorded. The surgeon wore one under the lead gown, another on the lead gown at shoulder level, and a third as a ring on the dominant hand. A dosimeter was also placed on the cadaver.
Results: The radiation from the cone-beam, computer-guided imaging system was 0.0 mrem to the surgeon and 0.52 rads to the cadaver. Using fluoroscopic imaging, surgeon's and cadaver's exposure was 5 mrem and 0.047 rads, respectively. Procedure times were similar and neither device resulted in cannula malposition.
Conclusions: Cone-beam CT appears as accurate as the fluoroscopy; radiation exposure to the surgeon is eliminated, and radiation levels to the patient are acceptable.
doi:10.1055/s-0028-1100893
PMCID: PMC3609000  PMID: 23544024
3.  Radiation Protection in Canada 
Canadian Medical Association Journal  1964;90(19):1114-1120.
The current status of radiation protection in Canada is discussed in the last of a three-part series. Particular emphasis has been placed on the role of the Radiation Protection Division of the Department of National Health and Welfare. A radioactive fallout study program has been established involving the systematic collection of air and precipitation samples from 24 locations, soil samples from 23 locations, fresh-milk samples from 16 locations, wheat samples from nine areas and human-bone specimens from various hospitals throughout Canada. A whole-body-counting facility and a special study of fallout in Northern areas have also been initiated. For any age group, the highest average strontium-90 concentration in human bone so far reported has been less than four picocuries per gram of calcium compared with the maximum permissible level of 67 derived from the International Committee on Radiation Protection (ICRP) recommendations. By the end of 1963 a general downward trend of levels of radioactivity detected in other parts of the program has been observed. Programs to assess the contribution to the radiation exposure of members of the population from medical x-rays, nuclear reactor operations and natural background-radiation sources have also been described. The annual genetically significant dose from diagnostic x-ray examinations in Canadian public hospitals has been estimated to be 25.8 mrem. Results from the reactor-environment monitoring programs have not suggested the presence of radioactivity beyond that contributed from fallout.
PMCID: PMC1922703  PMID: 14143681
4.  Radioactivity in municipal sewage and sludge. 
Public Health Reports  1997;112(4):308-318.
OBJECTIVE: To determine the environmental consequences of discharges of radioactivity from a large medical research facility into municipal sewage, specifically 131I activity in sewage sludge, and the radiation exposures to workers and the public when sludges are incinerated. METHODS: The authors measured radioactivity levels in the sludge at the Ann Arbor, Michigan, Waste Water Treatment Plant following radioiodine treatments of two patients at the University of Michigan hospital complex and performed a series of calculations to estimate potential radiation doses due to releases of 131I from incineration of sewage sludge. RESULTS: Approximately 1.1% of the radioactive 131I administered therapeutically to patients was measured in the primary sludge. Radiation doses from incineration of sludge were calculated to be 0.048 millirem (mrem) for a worker during a period in which the incinerator filtration system failed, a condition that could be considered to represent maximum exposure conditions, for two nine-hour days. Calculated results for a more typically exposed worker (with the filtration system in operation and a 22-week period of incineration) yielded a committed effective dose equivalent of 0.066 mrem. If a worker were exposed to both conditions during the period of incineration, the dose was calculated to be 0.11 mrem. For a member of the public, the committed effective dose equivalent was calculated as 0.003 mrem for a 22-week incineration period. Exposures to both workers and the public were a very small fraction of a typical annual dose (about 100 mrem excluding radon, or 300 mrem with radon) due to natural background radiation. Transport time to the treatment plant for radioiodine was found to be much longer than that of a normal sewage, possibly due to absorption of iodine by organic material in the sewer lines. The residence time of radioiodine in the sewer also appears to be longer than expected. CONCLUSION: 131I in land-applied sludge presents few health concerns because sufficient decay occurs before it can reach the public however, incineration, which is done in winter months, directly releases the 131I from sewage sludge to the atmosphere, and even though exposures to both workers and the public were found to be considerably lower than 1% of natural background, incineration of sludge in a pathway for public exposure. Although 131I was readily measurable in sewage sludge, only about 1% of the radioione administered to patients was found in the sludge. The fate of the remaining radioactivity has not been established; some may be in secondary and tertiary residuals, but it is quite likely that most passed through the plant and was discharged in dilute concentrations in plant emissions. The behavior of radioiodine and other radioactive materials released into municipal seweage systems, such as those from large medical facilities, is not yet well understood.
PMCID: PMC1381970  PMID: 9258296
5.  Human Biodistribution and Radiation Dosimetry of the Tachykinin NK1 Antagonist Radioligand [18F]SPA-RQ: Comparison of Thin-Slice, Bisected, and 2-Dimensional Planar Image Analysis 
18F-Labeled substance P antagonist–receptor quantifier ([18F]SPA-RQ) [2-fluoromethoxy-5-(5-trifluoromethyl-tetrazol-1-yl)-benzyl]-[(2S,3S)-2-phenyl-piperidin-3-yl)amine] is a selective radioligand for in vivo quantification of tachykinin NK1 receptors with PET. The aims of this study were to estimate the radiation safety profile and relative risks of [18F]SPA-RQ with 3 different methods of image analysis.
Methods
Whole-body PET images were acquired in 7 healthy subjects after injection of 192 ± 7 MBq (5.2 ± 0.2 mCi) [18F]SPA-RQ. Emission images were serially acquired at multiple time-points from 0 to 120 min and approximately 180–240 min after injection. Urine samples were collected after each imaging session and for 24 h after the last scan to measure excreted radioactivity. Horizontal tomographic images were compressed to varying degrees in the anteroposterior direction to create 3 datasets: thin-slice, bisected, and 2-dimensional (2D) planar images. Regions of interest were drawn around visually identifiable source organs to generate time–activity curves for each dataset. Residence times were determined from these curves, and doses to individual organs and the body as a whole were calculated using OLINDA/EXM 1.0.
Results
The lungs, upper large intestine wall, small intestine, urinary bladder wall, kidneys, and thyroid had the highest radiation-absorbed doses. Biexponential fitting of mean bladder and urine activity showed that about 41% of injected activity was excreted via urine. Assuming a 2.4-h urine voiding interval, the calculated effective doses from thin-slice, bisected, and 2D planar images were 29.5, 29.3, and 32.3 µSv/MBq (109, 108, and 120 mrem/mCi), respectively.
Conclusion
Insofar as effective dose is an accurate measure of radiation risk, all 3 methods of analysis provided quite similar estimates of risk to human subjects. The radiation dose was moderate and would potentially allow subjects to receive multiple PET scans in a single year. Individual organ exposures varied among the 3 methods, especially for structures asymmetrically located in an anterior or posterior position. Bisected and 2D planar images almost always provided higher organ dose estimates than thin-slice images. Thus, either the bisected or 2D planar method of analysis appears acceptable for quantifying human radiation burden, at least for radioligands with a relatively broad distribution in the body and not concentrated in a small number of radiation sensitive organs.
PMCID: PMC4135382  PMID: 17204705
[18F]SPA-RQ; PET dosimetry; biodistribution
6.  Ionizing Radiation and Its Risks 
Western Journal of Medicine  1982;137(6):540-547.
Penetrating ionizing radiation fairly uniformly puts all exposed molecules and cells at approximately equal risk for deleterious consequences. Thus, the original deposition of radiation energy (that is, the dose) is unaltered by metabolic characteristics of cells and tissue, unlike the situation for chemical agents. Intensely ionizing radiations, such as neutrons and alpha particles, are up to ten times more damaging than sparsely ionizing sources such as x-rays or gamma rays for equivalent doses. Furthermore, repair in cells and tissues can ameliorate the consequences of radiation doses delivered at lower rates by up to a factor of ten compared with comparable doses acutely delivered, especially for somatic (carcinogenic) and genetic effects from x- and gamma-irradiation exposure. Studies on irradiated laboratory animals or on people following occupational, medical or accidental exposures point to an average lifetime fatal cancer risk of about 1 × 10-4 per rem of dose (100 per 106 person-rem). Leukemia and lung, breast and thyroid cancer seem more likely than other types of cancer to be produced by radiation. Radiation exposures from natural sources (cosmic rays and terrestrial radioactivity) of about 0.1 rem per year yield a lifetime cancer risk about 0.1 percent of the normally occurring 20 percent risk of cancer death. An increase of about 1 percent per rem in fatal cancer risk, or 200 rem to double the “background” risk rate, is compared with an estimate of about 100 rem to double the genetic risk. Newer data suggest that the risks for low-level radiation are lower than risks estimated from data from high exposures and that the present 5 rem per year limit for workers is adequate.
PMCID: PMC1274230  PMID: 6761969
7.  ORGAN-SPECIFIC EXTERNAL DOSE COEFFICIENTS AND PROTECTIVE APRON TRANSMISSION FACTORS FOR HISTORICAL DOSE RECONSTRUCTION FOR MEDICAL PERSONNEL 
Health physics  2011;101(1):13-27.
While radiation absorbed dose (Gy) to the skin or other organs is sometimes estimated for patients from diagnostic radiologic examinations or therapeutic procedures, rarely is occupationally-received radiation absorbed dose to individual organs/tissues estimated for medical personnel, e.g., radiologic technologists or radiologists. Generally, for medical personnel, equivalent or effective radiation doses are estimated for compliance purposes. In the very few cases when organ doses to medical personnel are reconstructed, the data is usually for the purpose of epidemiologic studies, e.g., a study of historical doses and risks to a cohort of about 110,000 radiologic technologists presently underway at the U.S. National Cancer Institute. While ICRP and ICRU have published organ-specific external dose conversion coefficients (DCCs), i.e., absorbed dose to organs and tissues per unit air kerma and dose equivalent per unit air kerma, those factors have been primarily published for mono-energetic photons at selected energies. This presents two related problems for historical dose reconstruction, both of which are addressed here. It is necessary to derive conversion factors values for (i) continuous distributions of energy typical of diagnostic medical x rays (bremsstrahlung radiation), and (ii) for energies of particular radioisotopes used in medical procedures, neither of which are presented in published tables. For derivation of DCCs for bremsstrahlung radiation, combinations of x-ray tube potentials and filtrations were derived for different time periods based on a review of relevant literature. Three peak tube potentials (70 kV, 80 kV, and 90 kV) with four different amounts of beam filtration were determined to be applicable for historic dose reconstruction. The probability of these machine settings were assigned to each of the four time periods (earlier than 1949, 1949-1954, 1955-1968, and after 1968). Continuous functions were fit to each set of discrete values of the ICRP/ICRU mono-energetic DCCs and the functions integrated over the air-kerma weighted photon fluence of the 12 defined x-ray spectra. The air kerma-weighted DCCs in this work were developed specifically for an irradiation geometry of anterior to posterior (AP) and for the following tissues: thyroid, breast, ovary, lens of eye, lung, colon, testes, heart, skin (anterior side only), red bone marrow (RBM), heart, and brain. In addition, a series of functional relationships to predict DT per Ka values for RBM dependent on body mass index [BMI (kg m−2) ≡ weight per height2] and average photon energy were derived from a published analysis. Factors to account for attenuation of radiation by protective lead aprons were also developed. Because lead protective aprons often worn by radiology personnel not only reduce the intensity of x-ray exposure but also appreciably harden the transmitted fluence of bremsstrahlung x rays, DCCs were separately calculated for organs possibly protected by lead aprons by considering three cases: no apron, 0.25 mm Pb apron, and 0.5 mm Pb apron. For estimation of organ doses from conducting procedures with radioisotopes, continuous functions of the reported mono-energetic values were developed and DCCs were derived by estimation of the function at relevant energies. By considering the temporal changes in primary exposure-related parameters, e.g., energy distribution, the derived DCCs and transmission factors presented here allow for more realistic historical dose reconstructions for medical personnel when monitoring badge readings are the primary data on which estimation of an individual's organ doses are based.
doi:10.1097/HP.0b013e318204a60a
PMCID: PMC3964780  PMID: 21617389
8.  Kinetic Brain Analysis and Whole-Body Imaging in Monkey of [11C]MNPA: A Dopamine Agonist Radioligand 
Synapse (New York, N.Y.)  2008;62(9):700-709.
With a view to future extension of the use of the agonist radioligand [11C]MNPA ([O-methyl-11C]2-methoxy-N-propylnorapomorphine) from animals to humans, we performed two positron emission tomography (PET) studies in monkeys. First, we assessed the ability to quantify the brain uptake of [11C]MNPA with compartmental modeling. Second, we estimated the radiation exposure of [11C]MNPA to human subjects based on whole-body imaging in monkeys. Brain PET scans were acquired for 90 min and included concurrent measurements of the plasma concentration of unchanged radioligand. Time-activity data from striatum and cerebellum were quantified with two methods, a reference tissue model and distribution volume. Whole-body PET scans were acquired for 120 min using four bed positions from head to mid thigh. Regions of interest were drawn on compressed planar whole-body images to identify organs with the highest radiation exposures. After injection of [11C]MNPA, the highest concentration of radioactivity in brain was in striatum, with lowest levels in cerebellum. Distribution volume was well identified with a two-tissue compartmental model and was quite stable from 60 to 90 min. Whole-body PET scans showed the organ with the highest radiation burden (μSv/MBq) was the urinary bladder wall (26.0), followed by lungs (22.5), gallbladder wall (21.9), and heart wall (16.1). With a 2.4-h voiding interval, the effective dose was 6.4 μSv/MBq (23.5 mrem/mCi). In conclusion, brain uptake of [11C]MNPA reflected the density of D2/3 receptors, quantified relative to serial arterial measurements, and caused moderate to low radiation exposure.
doi:10.1002/syn.20544
PMCID: PMC2786063  PMID: 18566975
PET; [11C]MNPA; dosimetry; DA D2/3 receptor agonist radioligand; whole-body biodistribution; kinetic analysis
9.  Surgeons' Exposure to Radiation in Single- and Multi-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion; A Prospective Study 
PLoS ONE  2014;9(4):e95233.
Although minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) has widely been developed in patients with lumbar diseases, surgeons risk exposure to fluoroscopic radiation. However, to date, there is no studies quantifying the effective dose during MIS-TLIF procedure, and the radiation dose distribution is still unclear. In this study, the surgeons' radiation doses at 5 places on the bodies were measured and the effective doses were assessed during 31 consecutive 1- to 3-level MIS-TLIF surgeries. The operating surgeon, assisting surgeon, and radiological technologist wore thermoluminescent dosimeter on the unshielded thyroid, chest, genitals, right middle finger, and on the chest beneath a lead apron. The doses at the lens and the effective doses were also calculated. Mean fluoroscopy times were 38.7, 53.1, and 58.5 seconds for 1, 2, or 3 fusion levels, respectively. The operating surgeon's mean exposures at the lens, thyroid, chest, genitals, finger, and the chest beneath the shield, respectively, were 0.07, 0.07, 0.09, 0.14, 0.32, and 0.05 mSv in 1-level MIS-TLIF; 0.07, 0.08, 0.09, 0.18, 0.34, and 0.05 mSv in 2-level; 0.08, 0.09, 0.14, 0.15, 0.36, and 0.06 mSv in 3-level; and 0.07, 0.08, 0.10, 0.15, 0.33, and 0.05 mSv in all cases. Mean dose at the operating surgeon's right finger was significantly higher than other measurements parts (P<0.001). The operating surgeon's effective doses (0.06, 0.06, and 0.07 mSv for 1, 2, and 3 fusion levels) were low, and didn't differ significantly from those of the assisting surgeon or radiological technologist. Revision MIS-TLIF was not associated with higher surgeons' radiation doses compared to primary MIS-TLIF. There were significantly higher surgeons' radiation doses in over-weight than in normal-weight patients. The surgeons' radiation exposure during MIS-TLIF was within the safe level by the International Commission on Radiological Protection's guidelines. The accumulated radiation exposure, especially to surgeon's hands, should be carefully monitored.
doi:10.1371/journal.pone.0095233
PMCID: PMC3988176  PMID: 24736321
10.  Mortality of employees of the United Kingdom Atomic Energy Authority, 1946-1979. 
An analysis was conducted of 3373 deaths among 39 546 people employed by the United Kingdom Atomic Energy Authority between 1946 and 1979, the population having been followed up for an average of 16 years. Overall the death rates were below those prevailing in England and Wales but consistent with those expected in a normal workforce. At ages 15-74 years the standardised mortality ratios (SMRs) were 74 for deaths from all causes and 79 for deaths from all cancers. Mortality from only four causes was above the national average--namely, testicular cancer (SMR 153; 10 deaths), leukaemia (SMR 123; 35 deaths), thyroid cancer (SMR 122; three deaths), non-Hodgkin's lymphoma (SMR 107; 20 deaths)--but in none was the increase significant at the 5% level. Half of the authority's employees were recorded as having been monitored for exposure to radiation, their collective recorded exposure being 660 Sv (65 954 rem). Among these prostatic cancer was the only condition with a clearly increased mortality in relation to exposure. Of the 19 men who had a radiation record and died from prostatic cancer at ages 15-74 years, nine had been monitored for several different sources of exposure to radiation. The standardised mortality ratios were 889 (six deaths) in employees monitored for contamination by tritium, 254 (nine deaths) in those monitored for contamination by other radionuclides, and 385 (nine deaths) in those with dosimeter readings totalling more than 50 mSv (5 rem); but the same nine subjects tended to account for each of these significantly raised ratios. Because multiple exposures were common and other relevant information was not available the reason for the increased mortality from prostatic cancer in this population could not be determined and requires further investigation. Excess mortality rates of 2.2 and 12.5 deaths per million person years per 10 mSv (1 rem) were estimated for leukaemia and all cancers, respectively. The confidence limits around these estimates were wide, included zero, and made it unlikely that the International Commission on Radiological Protection's cancer risk coefficients were underestimated by more than 15-fold. Thus despite this being the largest British workforce whose mortality has been reported in relation to low level ionising radiation exposure, even larger populations will need to be followed up over longer periods before narrower ranges of risk estimates can be derived.
PMCID: PMC1416316  PMID: 3926232
11.  Radiation Exposure to Physicians During Interventional Pain Procedures 
The Korean Journal of Pain  2010;23(1):24-27.
Background
Fluoroscopy has been an integral part of modern interventional pain management. Yet fluoroscopy can be associated with risks for the patients and clinicians unless it is managed with appropriate understanding, skill and vigilance. Therefore, this study was designed to determine the amount of radiation received by a primary operator and an assistant during interventional pain procedures that involve the use of fluoroscopy
Methods
In order to examine the amount of radiation, the physicians were monitored by having them wear three thermoluminescent badges during each single procedure, with one under a lead apron, one under the apron collar and one on the leg during each single procedure. The data obtained from each thermoluminescent badge was reviewed from September 2008 to November 2008 and the annual radiation exposure was subsequently calculated.
Results
A total of 505 interventional procedures were performed with C-arm fluoroscopy during three months. The results of this study revealed that the annual radiation exposure was relatively low for both the operator and assistant.
Conclusions
With proper precautions, the use of fluoroscopy during interventional pain procedures is a safe practice.
doi:10.3344/kjp.2010.23.1.24
PMCID: PMC2884203  PMID: 20552069
fluoroscopy; interventional pain management; radiation exposure
12.  Long-term follow-up of the residents of the Three Mile Island accident area: 1979-1998. 
Environmental Health Perspectives  2003;111(3):341-348.
The Three Mile Island (TMI) nuclear power plant accident (1979) prompted the Pennsylvania Department of Health to initiate a cohort mortality study in the TMI accident area. This study is significant because of the long follow-up (1979-1998), large cohort size (32,135), and evidence from earlier reports indicating increased cancer risks. Standardized mortality ratios (SMRs) were calculated to assess the mortality experience of the cohort compared with a local population. Relative risk (RR) regression modeling was performed to assess cause-specific mortality associated with radiation-related exposure variables after adjustment for individual smoking and lifestyle factors. Overall cancer mortality in this cohort was similar to the local population [SMRs = 103.7 (male); 99.8 (female)]. RR modeling showed neither maximum gamma nor likely gamma exposure was a significant predictor of all malignant neoplasms; bronchus, trachea, and lung; or heart disease mortality after adjusting for known confounders. The RR estimates for maximum gamma exposure (less than or equal to 8, 8-19, 20-34, greater than or equal to 35 mrem) in relation to all lymphatic and hematopoietic tissue (LHT) are significantly elevated (RRs = 1.00, 1.16, 2.54, 2.45, respectively) for males and are suggestive of a potential dose-response relationship, although the test for trend was not significant. An upward trend of RRs and SMRs for levels of maximum gamma exposure in relation to breast cancer in females (RRs = 1.00, 1.08, 1.13, 1.31; SMRs = 104.2, 113.2, 117.9) was also noted. Although the surveillance within the TMI cohort provides no consistent evidence that radioactivity released during the nuclear accident has had a significant impact on the overall mortality experience of these residents, several elevations persist, and certain potential dose-response relationships cannot be definitively excluded.
PMCID: PMC1241392  PMID: 12611664
13.  Retrospective analysis of radiation exposure during endoscopic retrograde cholangiopancreatography: Critical determinants 
Although the risk of radiation-induced spontaneous malignancy and genetic anomalies from occupational radiological procedures is relatively low – and perhaps slightly lower still for the general population – patients and endoscopists in particular, should be aware of the cumulative risk associated with all exposure. Radiation dose has a direct linear relationship with fluoroscopy duration; therefore, limiting fluoroscopy time is one of the most modifiable methods of reducing exposure during fluoroscopic procedures. This retrospective study analyzed more than 1000 endoscopic retrograde cholangiopancreatography procedures and aimed to determine the specific patient, physician and procedural factors that affect fluoroscopy duration.
BACKGROUND:
Fluoroscopy during endoscopic retrograde cholangiopancreatography (ERCP) has a logarithmic relationship with radiation exposure, and carries a known risk of radiation exposure to patients and staff. Factors associated with prolonged fluoroscopy duration have not been well delineated.
OBJECTIVES:
To determine the specific patient, physician and procedural factors that affect fluoroscopy duration.
METHODS:
A retrospective analysis of 1071 ERCPs performed at two tertiary care referral hospitals over an 18-month period was conducted. Patient, physician and procedural variables were recorded at the time of the procedure.
RESULTS:
The mean duration of 969 fluoroscopy procedures was 4.66 min (95% CI 4.38 to 4.93). Multivariable analysis showed that the specific patient factors associated with prolonged fluoroscopy duration included age and diagnosis (both P<0.0001). The endoscopist was found to play an important role in the duration of fluoroscopy (ie, all endoscopists studied had a mean fluoroscopy duration significantly different from the reference endoscopist). In addition, the following procedural variables were found to be significant: number of procedures, basket use, biopsies, papillotomy (all P<0.0001) and use of a tritome (P=0.004). Mean fluoroscopy duration (in minutes) with 95% CIs for different diagnoses were as follows: common bile duct stones (n=443) 5.12 (3.05 to 4.07); benign biliary strictures (n=135) 3.94 (3.26 to 4.63); malignant biliary strictures (n=124) 5.82 (4.80 to 6.85); chronic pancreatitis (n=49) 4.53 (3.44 to 5.63); bile leak (n=26) 3.67 (2.23 to 5.09); and ampullary mass (n=11) 3.88 (1.28 to 6.48). When no pathology was found (n=195), the mean fluoroscopy time was 3.56 min (95% CI 3.05 to 4.07). Comparison using t tests determined that the only two diagnoses for which fluoroscopy duration was significantly different from the reference diagnosis of ‘no pathology found’ were common bile duct stones (P<0.0001) and malignant strictures (P<0.0001).
CONCLUSIONS:
Factors that significantly affected fluoroscopy duration included age, diagnosis, endoscopist, and the number and nature of procedures performed. Elderly patients with biliary stones or a malignant stricture were likely to require the longest duration of fluoroscopy. These identified variables may help endoscopists predict which procedures are associated with prolonged fluoroscopy duration so that appropriate precautions can be undertaken.
PMCID: PMC3206549  PMID: 22059160
ERCP; Fluoroscopy time; Radiation
14.  Minimally invasive percutaneous transpedicular screw fixation: increased accuracy and reduced radiation exposure by means of a novel electromagnetic navigation system 
Acta Neurochirurgica  2010;153(3):589-596.
Background
Minimally invasive percutaneous pedicle screw instrumentation methods may increase the need for intraoperative fluoroscopy, resulting in excessive radiation exposure for the patient, surgeon, and support staff. Electromagnetic field (EMF)-based navigation may aid more accurate placement of percutaneous pedicle screws while reducing fluoroscopic exposure. We compared the accuracy, time of insertion, and radiation exposure of EMF with traditional fluoroscopic percutaneous pedicle screw placement.
Methods
Minimally invasive pedicle screw placement in T8 to S1 pedicles of eight fresh-frozen human cadaveric torsos was guided with EMF or standard fluoroscopy. Set-up, insertion, and fluoroscopic times and radiation exposure and accuracy (measured with post-procedural computed tomography) were analyzed in each group.
Results
Sixty-two pedicle screws were placed under fluoroscopic guidance and 60 under EMF guidance. Ideal trajectories were achieved more frequently with EMF over all segments (62.7% vs. 40%; p = 0.01). Greatest EMF accuracy was achieved in the lumbar spine, with significant improvements in both ideal trajectory and reduction of pedicle breaches over fluoroscopically guided placement (64.9% vs. 40%, p = 0.03, and 16.2% vs. 42.5%, p = 0.01, respectively). Fluoroscopy time was reduced 77% with the use of EMF (22 s vs. 5 s per level; p < 0.0001) over all spinal segments. Radiation exposure at the hand and body was reduced 60% (p = 0.058) and 32% (p = 0.073), respectively. Time for insertion did not vary between the two techniques.
Conclusions
Minimally invasive pedicle screw placement with the aid of EMF image guidance reduces fluoroscopy time and increases placement accuracy when compared with traditional fluoroscopic guidance while adding no additional time to the procedure.
doi:10.1007/s00701-010-0882-4
PMCID: PMC3040822  PMID: 21153669
Minimally invasive; Electromagnetic field navigation; Pedicle screw; Fluoroscopy; Accuracy
15.  Evaluation of the Occupational Doses of Interventional Radiologists 
The aim of the present study was to determine whether there is a linear relation between the doses measured above and those measured under the lead apron of the radiologists performing interventional procedures. To monitor radiation exposure the International Commission of Radiological Protection (ICRP) recommends the use of a single dosimeter under the protective apron. To determine the exposure more accurately an additional dosimeter is recommended above the protective apron. The exposure of eight radiologists was monitored with two personal dosimeters during 3 consecutive years. To measure the doses uniformly the two dosimeters were worn in a special holder attached to the lead apron. The two personal dosimeters were replaced every 4 weeks on the same day. The doses above and under the protective aprons of seven radiologists did not differ significantly. A significant lower dose above and under the protective apron was measured for one of the radiologists. During a 4-week period the average dose measured above the lead apron was 3.44 mSv (median, 3.05 mSv), while that under the 0.25-mm lead apron was 0.12 mSv (median, 0.1 mSv). The coefficients of the regression line result in the equation Y = 0.036X − 0.004, with Y as the dose under the lead apron and X as the dose above the lead apron. The statistical analysis of the data established a linear relation between the doses above and those under the lead apron (R2 = 0.59). Before the special holder was introduced it was not possible to derive a relation between the doses above and those under the lead apron, as the doses were measured at varying places above and under the lead apron. There is no evidence that the effective dose can be estimated more accurately when an additional dosimeter is used. The present study revealed a threshold before doses under the lead apron were measured. Due to the threshold it can be concluded that the doses under the lead apron will not be underestimated easily when doses above the lead apron are used to calculate them. This is not the case when the doses above the lead apron are calculated for the doses under the lead apron.
doi:10.1007/s00270-008-9307-7
PMCID: PMC2367387  PMID: 18266030
Dosimetry; Fluoroscopy; Radiation protection; Effective dose; Lead apron
16.  Radiation protection: the NCRP guidelines and some considerations for the future. 
The National Council on Radiation Protection and Measurements (NCRP) in the USA and the International Commission on Radiological Protection (ICRP), worldwide, were formed about 1928 and have since made recommendations on appropriate levels of protection from ionizing radiation for workers and for the public. These recommendations and much of the guidance provided by these organizations have usually been adopted by regulatory bodies around the world. In the case of the NCRP, the levels have fallen from 0.1 roentgen per day in 1934 to the current 5 rem per year (a factor of about 5). The present levels recommended by both the ICRP and the NCRP correspond to reasonable levels of risk where the risks of harm from ionizing radiation are compared with the hazards of other, commonly regarded, as safe, industries. Some considerations for the future in radiation protection include trends in exposure levels (generally downward for the average exposure to workers) and improvements in risk estimation; questions of lifetime limits, de minimis levels, and partial body exposures; plus problems of high LET radiations, acceptability of risk, synergisms, and risk systems for protection.
PMCID: PMC2596042  PMID: 7342492
17.  A survey of radiation dose to patients and operators during radiofrequency ablation using computed tomography 
Computed tomography (CT) fluoroscopy is able to give real time images to a physician undertaking minimally invasive procedures such as biopsies, percutaneous drainage, and radio frequency ablation (RFA). Both operators executing the procedure and patients too, are thus at risk of radiation exposure during a CT fluoroscopy.
This study focuses on the radiation exposure present during a series of radio frequency ablation (RFA) procedures, and used Gafchromic film (Type XR-QA; International Specialty Products, USA) and thermoluminescent dosimeters (TLD-100H; Bicron, USA) to measure the radiation received by patients undergoing treatment, and also operators subject to scatter radiation.
The voltage was held constant at 120 kVp and the current 70mA, with 5mm thickness. The duration of irradiation was between 150-638 seconds.
Ultimately, from a sample of 30 liver that have undergone RFA, the study revealed that the operator received the highest dose at the hands, which was followed by the eyes and thyroid, while secondary staff dosage was moderately uniform across all parts of the body that were measured.
doi:10.2349/biij.6.1.e2
PMCID: PMC3097790  PMID: 21611060
radiofrequency ablation; Gafchromic film; thermoluminescent dosimeter; computed tomography fluoroscopy
18.  Fluoroscopic Radiation Exposure during Percutaneous Kyphoplasty 
Objective
The author measured levels of fluoroscopic radiation exposure to the surgeon's body based on the different beam directions during kyphoplasty.
Methods
This is an observational study. A series of 84 patients (96 vertebral bodies) were treated with kyphoplasty over one year. The patients were divided into four groups based on the horizontal and vertical directions of the X-Ray beams. We measured radiation exposure with the seven dosimetry badges which were worn by the surgeon in each group (total of 28 badges). Twenty-four procedures were measured in each group. Cumulative dose and dose rates were compared between groups.
Results
Fluoroscopic radiation is received by the operator in real-time for approximately 50% (half) of the operation time. Thyroid protectors and lead aprons can block radiation almost completely. The largest dose was received in the chest irrespective of beam directions. The lowest level of radiation were received when X-ray tube was away from the surgeon and beneath the bed (dose rate of head, neck, chest, abdomen and knee : 0.2986, 0.2828, 0.9711, 0.8977, 0.8168 mSv, respectively). The radiation differences between each group were approximately 2.7-10 folds.
Conclusion
When fluoroscopic guided-KP is performed, the X-Ray tube should be positioned on the opposite side of the operator and below the table, otherwise the received radiation to the surgeon's body would be 2.7-10 times higher than such condition.
doi:10.3340/jkns.2011.49.1.37
PMCID: PMC3070893  PMID: 21494361
Kyphoplasty; Radiation exposure; Fluoroscopic guidance; Dosimetry; Radiation safety; Fluoroscopy
19.  Analysis of dose measurement other than the radiation protection during the radiographic examination 
SpringerPlus  2014;3:250.
Objectives
The study measured the dose on body regions that were not shielded to protect from radiation exposure during the general procedure, with the goal of providing basic radiation dose data for radiological technologists who perform the radiographic examination.
Materials and methods
Shooting parts with the phantom were similar to human tissues using general shooting equipment in the general examination room. The scattered rays were measured with the ion chamber. The hand received the highest average radiation dose and the kidney the lowest. The same pattern was evident for the average equivalent dose. The available daily shooting was highest in the anterior/posterior skull, followed by the posterior/anterior chest, abdomen, anterior/posterior spine and extremities.
Results
The daily available numbers for the eye were lower than other body regions (6-times, 4-times, 26-times, 3-times and 121-times) and the numbers on the foot were higher than for other regions (73-times, 48-times, 263-times, 39-times and 702-times).
Conclusions
Radiation should be thoroughly blocked by the apron to protect the radiological technologist from the radiation exposure, the proper distance from the irradiation source should be maintained exposure is inevitable and the exposure dose and working environment shall be regularly assessed to ensure minimal exposure dose of the radiological technologist in accordance with the International Commission on Radiological Protection recommendation.
doi:10.1186/2193-1801-3-250
PMCID: PMC4039667  PMID: 24892002
Exposure dose; General shooting; Scattered rays
20.  Major Radiodiagnostic Imaging in Pregnancy and the Risk of Childhood Malignancy: A Population-Based Cohort Study in Ontario 
PLoS Medicine  2010;7(9):e1000337.
In a record-linkage study, Joel Ray and colleagues examine the association between diagnostic imaging during pregnancy and later childhood cancers.
Background
The association between fetal exposure to major radiodiagnostic testing in pregnancy—computed tomography (CT) and radionuclide imaging—and the risk of childhood cancer is not established.
Methods and Findings
We completed a population-based study of 1.8 million maternal-child pairs in the province of Ontario, from 1991 to 2008. We used Ontario's universal health care–linked administrative databases to identify all term obstetrical deliveries and newborn records, inpatient and outpatient major radiodiagnostic services, as well as all children with a malignancy after birth. There were 5,590 mothers exposed to major radiodiagnostic testing in pregnancy (3.0 per 1,000) and 1,829,927 mothers not exposed. The rate of radiodiagnostic testing increased from 1.1 to 6.3 per 1,000 pregnancies over the study period; about 73% of tests were CT scans. After a median duration of follow-up of 8.9 years, four childhood cancers arose in the exposed group (1.13 per 10,000 person-years) and 2,539 cancers in the unexposed group (1.56 per 10,000 person-years), a crude hazard ratio of 0.69 (95% confidence interval 0.26–1.82). After adjusting for maternal age, income quintile, urban status, and maternal cancer, as well as infant sex, chromosomal or congenital anomalies, and major radiodiagnostic test exposure after birth, the risk was essentially unchanged (hazard ratio 0.68, 95% confidence interval 0.25–1.80).
Conclusions
Although major radiodiagnostic testing is now performed in about 1 in 160 pregnancies in Ontario, the absolute annual risk of childhood malignancy following exposure in utero remains about 1 in 10,000. Since the upper confidence limit of the relative risk of malignancy may be as high as 1.8 times that of an unexposed pregnancy, we cannot exclude the possibility that fetal exposure to CT or radionuclide imaging is carcinogenic.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In industrialized countries, childhood cancer (any form of cancer in a child aged 14 years or under) remains a major cause of death. With the exception of a few known risk factors, such as acquired genetic predisposition to cancer, which accounts for about 10% of all childhood cancers, the etiology of most childhood cancer remains unknown. There is thought to be an association between exposure to ionizing radiation in pregnancy and the subsequent risk of development of cancer in the exposed mother's child, but the evidence base to support this association is conflicting. For example, studies examining maternal exposure to plain radiographs in pregnancy and subsequent childhood cancer are inconsistent. Furthermore, although their use has dramatically increased over the past two decades, little is known about the cancer risk related to certain types of radiodiagnostic tests, such as CT and radionuclide imaging, both of which expose the fetus to considerably higher doses of radiation than plain radiographs administered at the same anatomical level.
Why Was This Study Done?
Many women could be exposed to major radiodiagnostic tests, such as those used in emergency situations, before they are aware that they are pregnant, as almost 50% of pregnancies are unplanned. This situation means that it is important to determine the subsequent cancer risk to any child exposed to maternal radiodiagnostic tests before birth.
What Did the Researchers Do and Find?
The researchers conducted a retrospective population-based cohort study of women who delivered a live infant in Ontario, Canada between April 1, 1992 and March 31, 2008. The basis of the research was an anonymized database for the whole province of Ontario, where universal health care, including prenatal care and radiodiagnostic testing, is available to all residents. Database characteristics allowed the researchers to link maternal radiation exposure (a major radiodiagnostic test performed on the mother up to one day before her delivery date) in a specific (index) pregnancy to a subsequent malignancy in the child. After birth, maternal-infant pairs were only followed up if the infant was delivered at term, weighed 2,500 g or more, and survived for at least 30 days.
The researchers were able to follow up 1,835,517 maternal-child pairs. The overall rate of exposure to major radiodiagnostic testing in pregnancy was 3.0 per 1,000 and occurred at an estimated mean gestational age of 15.7 weeks. A total of four childhood cancers occurred in the exposed group and 2,539 cancers in the unexposed group corresponding to a crude hazard ratio of 0.69, which did not significantly change after adjustments were made for potential confounding factors, such as maternal age, sex, and the presence of any chromosomal or congenital anomalies in the infant. The overall prevalence of childhood cancer following exposure to CT or radionuclide imaging in pregnancy is under 0.07%, giving an incidence rate of 1.13 per 10,000 person-years.
What Do These Findings Mean?
These findings can help inform clinicians and mothers about the risk of childhood malignancy following major radiodiagnostic testing in pregnancy. The absolute risk appears to be low, while the relative risk is not materially higher than that of unexposed controls. However, as the upper confidence limit of the relative risk of malignancy may be a maximum of 1.8 times that of an unexposed pregnancy, the possibility that fetal exposure to CT or radionuclide imaging is carcinogenic cannot be excluded. Because this finding means that a very slight risk may exist, beta hCG testing should continue to be done in all potentially pregnant women before undergoing major radiodiagnostic testing, and lead apron shielding used in all women of reproductive age, whether or not known to be pregnant. In addition, nonradiation-emitting imaging, such as MRI and ultrasonography, should be considered first, when clinically appropriate. However, some pregnant women will still be faced with the decision to undergo CT or nuclear imaging because the test is clinically warranted. The findings of this study suggest that when clinically indicated, major radiodiagnostic testing in pregnancy should be performed, along with brief counseling to help lessen the anxiety experienced by an expectant mother before and after the birth of her child.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000337.
For information for patients and caregivers on radiodiagnostic testing, see The Royal College of Radiologists
The National Cancer Institute provides information about childhood cancer
CureSearch for Children's Cancer provides additional information about research into childhood cancer
doi:10.1371/journal.pmed.1000337
PMCID: PMC2935460  PMID: 20838660
21.  The Survey about the Degree of Damage of Radiation-Protective Shields in Operation Room 
The Korean Journal of Pain  2013;26(2):142-147.
Background
Medical doctors who perform C-arm fluoroscopy-guided procedures are exposed to X-ray radiation. Therefore, radiation-protective shields are recommended to protect these doctors from radiation. For the past several years, these protective shields have sometimes been used without regular inspection. The aim of this study was to investigate the degree of damage to radiation-protective shields in the operating room.
Methods
This study investigated 98 radiation-protective shields in the operation rooms of Konkuk University Medical Center and Jeju National University Hospital. We examined whether these shields were damaged or not with the unaided eye and by fluoroscopy.
Results
There were seventy-one aprons and twenty-seven thyroid protectors in the two university hospitals. Fourteen aprons (19.7%) were damaged, whereas no thyroid protectors (0%) were. Of the twenty-six aprons, which have been used since 2005, eleven (42.3%) were damaged. Of the ten aprons, which have been used since 2008, none (0%) was damaged. Of the twenty-three aprons that have been used since 2009, two (8.7%) of them were damaged. Of the eight aprons used since 2010, one (12.3%) was damaged. Of the four aprons used since 2011, none (0%) of them were damaged. The most common site of damage to the radiation-protective shields was at the waist of the aprons (51%).
Conclusions
As a result, aprons that have been used for a long period of time can have a higher risk of damage. Radiation-protective shields should be inspected regularly and exchanged for new products for the safety of medical workers.
doi:10.3344/kjp.2013.26.2.142
PMCID: PMC3629340  PMID: 23614075
fluoroscopy; radiation exposure; radiation-protective shields
22.  Quantitative EEG amplitude across REM sleep periods in depression: preliminary report 
Objective
To determine if there are significant differences in the temporal organization of rapid eye movement (REM) sleep microarchitecture between healthy controls and outpatients with major depressive disorder (MDD).
Methods
Forty age-matched subjects, 20 men and 20 women, half with MDD, were selected from an archive of sleep electroencephalography (EEG) data collected under identical conditions. Each participant spent 2 consecutive nights in the Sleep Study Unit of the University of Texas Southwestern Medical Center at Dallas, the first of which served as adaptation. The average amplitude in each of 5 conventional EEG frequency bands was computed for each REM period across the second night. Data were then coded for group and sex.
Results
Aside from REM latency, none of the key sleep macroarchitectural variables differentiated MDD patients from controls. REM latency was longest in men with MDD. Sleep microarchitecture, however, did show a number of between-group differences. In general, slower frequencies declined across REM periods, with a significant REM period effect for delta, theta and alpha amplitude. Group х sex interactions were also obtained for theta and alpha. Beta activity showed a unique temporal profile in each group, supported by a significant REM period !#!khcy; group х sex interaction. In addition, the temporal change in theta amplitude across REM periods was most striking in women with MDD.
Conclusions
This study suggests that, like during non-REM sleep, EEG amplitude shows a systematic temporal change over successive REM sleep periods and also shows elements that are both disease- and sex-dependent.
PMCID: PMC149794  PMID: 11836975
alpha rhythm; beta rhythm; delta rhythm; depressive disorder; electroencephalography; sex factors; sleep stages; sleep, REM; theta rhythm
23.  Practical Protective Tools for Occupational Exposure: 
Interventional Neuroradiology  2001;6(Suppl 1):33-42.
Summary
Two practical protective tools for occupational exposure for neurointerventional radiologists are presented. The first purpose of this study was to investigate the effectiveness of double focus spectacles for the aged with a highly refracted glass lens (special spectacles for the aged) for radiation protection of the crystalline lens of the eye in comparison with other spectacles on the market, based on the measurement of film density which was obtained by exposure of X-ray through those spectacles. As a result of the film densitometry mentioned above, the effectiveness of special spectacles for the aged in radiation protection was nearly equal to the effectiveness of a goggle type shield which is made with a 0.07 mm lead-equivalent plastic lens.
The second purpose of this study was to investigate the effectiveness of the protective barrier; which we remodeled for cerebral angiography or neuroendovascular therapy, for radiation exposure, based on the measurement in a simulated study with a head phantom, and on the measurement of radiation exposure in operaters during procedures of clinical cases. In the experimental study radiation exposure in supposed position of the crystalline lens was reduced to about one third and radiation exposure in supposed position of the gonadal glands was reduced to about one seventh, compared to radiation exposure without employing the barrier.
The radiation exposure was monitored at the left breast of three radiologists, in 215 cases of cerebral angiography. Employing the barrier in cerebral angiography, average equivalent dose at the left breast measured 1.49µ Sv during 10 min of fluoroscopy. In three kinds of neuroendovascular therapy in 40 cases, radiation exposure in an operator was monitored in the same fashion and the dose was recorded less than the result reported in previous papers in which any protective barrier have not been employed in the procedure1,2.
As a result, the two above mentioned protective tools are considered practical in clinical usage and very effective to reduce radiation exposure in an operator of interventional neuroradiolgy which may sometimes require many hours to complete the therapy under extended fluoroscopic time.
PMCID: PMC3685933  PMID: 20667219
occupational exposure, radiation protection, crystalline lens of eye, barrier against X-ray exposure, cerebral angiography, interventional neuroradiology
24.  REM Sleep Episodes During the Maintenance of Wakefulness Test in Patients with Sleep Apnea Syndrome and Patients with Narcolepsy 
Sleep  1983;6(1):23-28.
Summary
Twelve patients with sleep apnea, 12 narcoleptic patients, and 10 controls were given 20-min opportunities to remain awake while sitting comfortably. Test sessions were administered at 10:00, 12:00, 14:00, 16:00, and 18:00. Apneic and narcoleptic subjects were less capable of maintaining wakefulness than controls. Patients with sleep apnea had an average of 1.4 daytime rapid eye movement (REM) episodes with the peak incidence at 14:00. Narcoleptics also had sleep onset REM periods (mean of 2.7), whereas none of the controls had REM episodes during the daytime testing. Narcoleptic and control groups differed in the probability of REM occurring at each session. There were time-of-day differences in the probability of REM occurring between patient groups. The amount of stage REM the night preceding testing was unrelated to the occurrence of REM episodes during the day in either patient group. In addition, there were notable differences in the frequency of sleep onset REM periods when patients were sitting as opposed to being supine during nap studies. Sleep latency and frequency of REM episodes on the maintenance of wakefulness test were independent of the subject’s age. The maintenance of wakefulness test proved unsatisfactory as a diagnostic procedure, but appeared useful as an adjunct procedure in the evaluation of treatment efficacy of hypersomnia.
PMCID: PMC2435606  PMID: 6844794
Maintenance of wakefulness test; REM sleep; Daytime REM sleep; Sleep apnea syndrome; Narcolepsy
25.  Neuroimaging for the Evaluation of Chronic Headaches 
Executive Summary
Objective
The objectives of this evidence based review are:
i) To determine the effectiveness of computed tomography (CT) and magnetic resonance imaging (MRI) scans in the evaluation of persons with a chronic headache and a normal neurological examination.
ii) To determine the comparative effectiveness of CT and MRI scans for detecting significant intracranial abnormalities in persons with chronic headache and a normal neurological exam.
iii) To determine the budget impact of CT and MRI scans for persons with a chronic headache and a normal neurological exam.
Clinical Need: Condition and Target Population
Headaches disorders are generally classified as either primary or secondary with further sub-classifications into specific headache types. Primary headaches are those not caused by a disease or medical condition and include i) tension-type headache, ii) migraine, iii) cluster headache and, iv) other primary headaches, such as hemicrania continua and new daily persistent headache. Secondary headaches include those headaches caused by an underlying medical condition. While primary headaches disorders are far more frequent than secondary headache disorders, there is an urge to carry out neuroimaging studies (CT and/or MRI scans) out of fear of missing uncommon secondary causes and often to relieve patient anxiety.
Tension type headaches are the most common primary headache disorder and migraines are the most common severe primary headache disorder. Cluster headaches are a type of trigeminal autonomic cephalalgia and are less common than migraines and tension type headaches. Chronic headaches are defined as headaches present for at least 3 months and lasting greater than or equal to 15 days per month. The International Classification of Headache Disorders states that for most secondary headaches the characteristics of the headache are poorly described in the literature and for those headache disorders where it is well described there are few diagnostically important features.
The global prevalence of headache in general in the adult population is estimated at 46%, for tension-type headache it is 42% and 11% for migraine headache. The estimated prevalence of cluster headaches is 0.1% or 1 in 1000 persons. The prevalence of chronic daily headache is estimated at 3%.
Neuroimaging
Computed Tomography
Computed tomography (CT) is a medical imaging technique used to aid diagnosis and to guide interventional and therapeutic procedures. It allows rapid acquisition of high-resolution three-dimensional images, providing radiologists and other physicians with cross-sectional views of a person’s anatomy. CT scanning poses risk of radiation exposure. The radiation exposure from a conventional CT scanner may emit effective doses of 2-4mSv for a typical head CT.
Magnetic Resonance Imaging
Magnetic resonance imaging (MRI) is a medical imaging technique used to aid diagnosis but unlike CT it does not use ionizing radiation. Instead, it uses a strong magnetic field to image a person’s anatomy. Compared to CT, MRI can provide increased contrast between the soft tissues of the body. Because of the persistent magnetic field, extra care is required in the magnetic resonance environment to ensure that injury or harm does not come to any personnel while in the environment.
Research Questions
What is the effectiveness of CT and MRI scanning in the evaluation of persons with a chronic headache and a normal neurological examination?
What is the comparative effectiveness of CT and MRI scanning for detecting significant intracranial abnormality in persons with chronic headache and a normal neurological exam?
What is the budget impact of CT and MRI scans for persons with a chronic headache and a normal neurological exam.
Research Methods
Literature Search
Search Strategy
A literature search was performed on February 18, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January, 2005 to February, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established.
Inclusion Criteria
Systematic reviews, randomized controlled trials, observational studies
Outpatient adult population with chronic headache and normal neurological exam
Studies reporting likelihood ratio of clinical variables for a significant intracranial abnormality
English language studies
2005-present
Exclusion Criteria
Studies which report outcomes for persons with seizures, focal symptoms, recent/new onset headache, change in presentation, thunderclap headache, and headache due to trauma
Persons with abnormal neurological examination
Case reports
Outcomes of Interest
Primary Outcome
Probability for intracranial abnormality
Secondary Outcome
Patient relief from anxiety
System service use
System costs
Detection rates for significant abnormalities in MRI and CT scans
Summary of Findings
Effectiveness
One systematic review, 1 small RCT, and 1 observational study met the inclusion and exclusion criteria. The systematic review completed by Detsky, et al. reported the likelihood ratios of specific clinical variables to predict significant intracranial abnormalities. The RCT completed by Howard et al., evaluated whether neuroimaging persons with chronic headache increased or reduced patient anxiety. The prospective observational study by Sempere et al., provided evidence for the pre-test probability of intracranial abnormalities in persons with chronic headache as well as minimal data on the comparative effectiveness of CT and MRI to detect intracranial abnormalities.
Outcome 1: Pre-test Probability.
The pre-test probability is usually related to the prevalence of the disease and can be adjusted depending on the characteristics of the population. The study by Sempere et al. determined the pre-test probability (prevalence) of significant intracranial abnormalities in persons with chronic headaches defined as headache experienced for at least a 4 week duration with a normal neurological exam. There is a pre-test probability of 0.9% (95% CI 0.5, 1.4) in persons with chronic headache and normal neurological exam. The highest pre-test probability of 5 found in persons with cluster headaches. The second highest, that of 3.7, was reported in persons with indeterminate type headache. There was a 0.75% rate of incidental findings.
Likelihood ratios for detecting a significant abnormality
Clinical findings from the history and physical may be used as screening test to predict abnormalities on neuroimaging. The extent to which the clinical variable may be a good predictive variable can be captured by reporting its likelihood ratio. The likelihood ratio provides an estimate of how much a test result will change the odds of having a disease or condition. The positive likelihood ratio (LR+) tells you how much the odds of having the disease increases when a test is positive. The negative likelihood ratio (LR-) tells you how much the odds of having the disease decreases when the test is negative.
Detsky et al., determined the likelihood ratio for specific clinical variable from 11 studies. There were 4 clinical variables with both statistically significant positive and negative likelihood ratios. These included: abnormal neurological exam (LR+ 5.3, LR- 0.72), undefined headache (LR+ 3.8, LR- 0.66), headache aggravated by exertion or valsalva (LR+ 2.3, LR- 0.70), and headache with vomiting (LR+ 1.8, and LR- 0.47). There were two clinical variables with a statistically significant positive likelihood ratio and non significant negative likelihood ratio. These included: cluster-type headache (LR+ 11, LR- 0.95), and headache with aura (LR+ 12.9, LR- 0.52). Finally, there were 8 clinical variables with both statistically non significant positive and negative likelihood ratios. These included: headache with focal symptoms, new onset headache, quick onset headache, worsening headache, male gender, headache with nausea, increased headache severity, and migraine type headache.
Outcome 2: Relief from Anxiety
Howard et al. completed an RCT of 150 persons to determine if neuroimaging for headaches was anxiolytic or anxiogenic. Persons were randomized to receiving either an MRI scan or no scan for investigation of their headache. The study population was stratified into those persons with a Hospital Anxiety and Depression scale (HADS) > 11 (the high anxiety and depression group) and those < 11 (the low anxiety and depression) so that there were 4 groups:
Group 1: High anxiety and depression, no scan group
Group 2: High anxiety and depression, scan group
Group 3: Low anxiety and depression, no scan group
Group 4: Low anxiety and depression, scan group
Anxiety
There was no evidence for any overall reduction in anxiety at 1 year as measured by a visual analogue scale of ‘level of worry’ when analysed by whether the person received a scan or not. Similarly, there was no interaction between anxiety and depression status and whether a scan was offered or not on patient anxiety. Anxiety did not decrease at 1 year to any statistically significant degree in the high anxiety and depression group (HADS positive) compared with the low anxiety and depression group (HADS negative).
There are serious methodological limitations in this study design which may have contributed to these negative results. First, when considering the comparison of ‘scan’ vs. ‘no scan’ groups, 12 people (16%) in the ‘no scan group’ actually received a scan within the follow up year. If indeed scanning does reduce anxiety then this contamination of the ‘no scan’ group may have reduced the effect between the groups results resulting in a non significant difference in anxiety scores between the ‘scanned’ and the ‘no scan’ group. Second, there was an inadequate sample size at 1 year follow up in each of the 4 groups which may have contributed to a Type II statistical error (missing a difference when one may exist) when comparing scan vs. no scan by anxiety and depression status. Therefore, based on the results and study limitations it is inconclusive as to whether scanning reduces anxiety.
Outcome 3: System Services
Howard et al., considered services used and system costs a secondary outcome. These were determined by examining primary care case notes at 1 year for consultation rates, symptoms, further investigations, and contact with secondary and tertiary care.
System Services
The authors report that the use of neurologist and psychiatrist services was significantly higher for those persons not offered as scan, regardless of their anxiety and depression status (P<0.001 for neurologist, and P=0.033 for psychiatrist)
Outcome 4: System Costs
System Costs
There was evidence of statistically significantly lower system costs if persons with high levels of anxiety and depression (Hospital Anxiety and Depression Scale score >11) were provided with a scan (P=0.03 including inpatient costs, and 0.047 excluding inpatient costs).
Comparative Effectiveness of CT and MRI Scans
One study reported the detection rate for significant intracranial abnormalities using CT and MRI. In a cohort of 1876 persons with a non acute headache defined as any type of headache that had begun at least 4 weeks before enrolment Sempere et al. reported that the detection rate was 19/1432 (1.3%) using CT and 4/444 (0.9%) using MRI. Of 119 normal CT scans 2 (1.7%) had significant intracranial abnormality on MRI. The 2 cases were a small meningioma, and an acoustic neurinoma.
Summary
The evidence presented can be summarized as follows:
Pre-test Probability
Based on the results by Sempere et al., there is a low pre-test probability for intracranial abnormalities in persons with chronic headaches and a normal neurological exam (defined as headaches experiences for a minimum of 4 weeks). The Grade quality of evidence supporting this outcome is very low.
Likelihood Ratios
Based on the systematic review by Detsky et al., there is a statistically significant positive and negative likelihood ratio for the following clinical variables: abnormal neurological exam, undefined headache, headache aggravated by exertion or valsalva, headache with vomiting. Grade quality of evidence supporting this outcome is very low.
Based on the systematic review by Detsky et al. there is a statistically significant positive likelihood ratio but non statistically significant negative likelihood ratio for the following clinical variables: cluster headache and headache with aura. The Grade quality of evidence supporting this outcome is very low.
Based on the systematic review by Detsky et al., there is a non significant positive and negative likelihood ratio for the following clinical variables: headache with focal symptoms, new onset headache, quick onset headache, worsening headache, male gender, headache with nausea, increased headache severity, migraine type headache. The Grade quality of evidence supporting this outcome is very low.
Relief from Anxiety
Based on the RCT by Howard et al., it is inconclusive whether neuroimaging scans in persons with a chronic headache are anxiolytic. The Grade quality of evidence supporting this outcome is low.
System Services
Based on the RCT by Howard et al. scanning persons with chronic headache regardless of their anxiety and/or depression level reduces service use. The Grade quality of evidence is low.
System Costs
Based on the RCT by Howard et al., scanning persons with a score greater than 11 on the High Anxiety and Depression Scale reduces system costs. The Grade quality of evidence is moderate.
Comparative Effectiveness of CT and MRI Scans
There is sparse evidence to determine the relative effectiveness of CT compared with MRI scanning for the detection of intracranial abnormalities. The Grade quality of evidence supporting this is very low.
Economic Analysis
Ontario Perspective
Volumes for neuroimaging of the head i.e. CT and MRI scans, from the Ontario Health Insurance Plan (OHIP) data set were used to investigate trends in the province for Fiscal Years (FY) 2004-2009.
Assumptions were made in order to investigate neuroimaging of the head for the indication of headache. From the literature, 27% of all CT and 13% of all MRI scans for the head were assumed to include an indication of headache. From that same retrospective chart review and personal communication with the author 16% of CT scans and 4% of MRI scans for the head were for the sole indication of headache. From the Ministry of Health and Long-Term Care (MOHLTC) wait times data, 73% of all CT and 93% of all MRI scans in the province, irrespective of indication were outpatient procedures.
The expenditure for each FY reflects the volume for that year and since volumes have increased in the past 6 FYs, the expenditure has also increased with a pay-out reaching 3.0M and 2.8M for CT and MRI services of the head respectively for the indication of headache and a pay-out reaching 1.8M and 0.9M for CT and MRI services of the head respectively for the indication of headache only in FY 08/09.
Cost per Abnormal Finding
The yield of abnormal finding for a CT and MRI scan of the head for the indication of headache only is 2% and 5% respectively. Based on these yield a high-level estimate of the cost per abnormal finding with neuroimaging of the head for headache only can be calculated for each FY. In FY 08/09 there were 37,434 CT and 16,197 MRI scans of the head for headache only. These volumes would generate a yield of abnormal finding of 749 and 910 with a CT scan and MRI scan respectively. The expenditure for FY 08/09 was 1.8M and 0.9M for CT and MRI services respectively. Therefore the cost per abnormal finding would be $2,409 for CT and $957 for MRI. These cost per abnormal finding estimates were limited because they did not factor in comparators or the consequences associated with an abnormal reading or FNs. The estimates only consider the cost of the neuroimaging procedure and the yield of abnormal finding with the respective procedure.
PMCID: PMC3377587  PMID: 23074404

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