Dag Pavic

A comparative study of mobile electronic data entry systems for clinical trials data collection

PURPOSE To determine the speed, accuracy, ease of use, and user satisfaction of various electronic data entry platforms for use in the collection of mammography clinical trials data. METHOD AND MATERIALS Four electronic data entry platforms were tested: standalone personal digital assistant (PDA), Tablet PC, digitizer Tablet/PDA Hybrid (DTP Hybrid), and digital pen (d-pen). Standard paper data entry was used as control. Each of five radiologist readers was assigned to enter interpretations for 20 screening mammograms using three out of the five data entry methods. Assistants recorded both start and stop data entry times of the radiologists and the number of help requests made. Data were checked for handwriting recognition accuracy for the d-pen platform using handwriting verification software. A user satisfaction survey was administered at the end of each platform reading session. RESULTS Tablet PC and d-pen were statistically equivalent to conventional pen and paper in initial data entry speed. Average verification time for d-pen was significantly less than secondary electronic data entry of paper forms (p-value <0.001). The number of errors in handwriting recognition for d-pen was less than secondary electronic data entry of the paper forms data. Users were most satisfied with Tablet PC, d-pen, and conventional pen and paper for data entry. CONCLUSIONS Tablet PC and d-pen are equally fast and easy-to-use data entry methods that are well tolerated by radiologist users. Handwriting recognition review and correction for the d-pen is significantly faster and more accurate than secondary manual keyboard and mouse data entry.

Cancer Cases from ACRIN Digital Mammographic Imaging Screening Trial: Radiologist Analysis with Use of a Logistic Regression Model

PURPOSE To determine which factors contributed to the Digital Mammographic Imaging Screening Trial (DMIST) cancer detection results. MATERIALS AND METHODS This project was HIPAA compliant and institutional review board approved. Seven radiologist readers reviewed the film hard-copy (screen-film) and digital mammograms in DMIST cancer cases and assessed the factors that contributed to lesion visibility on both types of images. Two multinomial logistic regression models were used to analyze the combined and condensed visibility ratings assigned by the readers to the paired digital and screen-film images. RESULTS Readers most frequently attributed differences in DMIST cancer visibility to variations in image contrast--not differences in positioning or compression--between digital and screen-film mammography. The odds of a cancer being more visible on a digital mammogram--rather than being equally visible on digital and screen-film mammograms--were significantly greater for women with dense breasts than for women with nondense breasts, even with the data adjusted for patient age, lesion type, and mammography system (odds ratio, 2.28; P < .0001). The odds of a cancer being more visible at digital mammography--rather than being equally visible at digital and screen-film mammography--were significantly greater for lesions imaged with the General Electric digital mammography system than for lesions imaged with the Fischer (P = .0070) and Fuji (P = .0070) devices. CONCLUSION The significantly better diagnostic accuracy of digital mammography, as compared with screen-film mammography, in women with dense breasts demonstrated in the DMIST was most likely attributable to differences in image contrast, which were most likely due to the inherent system performance improvements that are available with digital mammography. The authors conclude that the DMIST results were attributable primarily to differences in the display and acquisition characteristics of the mammography devices rather than to reader variability.

CT analysis of missile head injury

Between August 1991 and December 1992, CT was performed on 154 patients who had suffered missile head injury during the war in the Republic of Croatia. In 54% CT was performed 1–24 h after injury, and in 27% follow-up CT was also obtained. The wounds were penetrating, tangential or perforating (45%, 34% and 21%, respectively). Haemorrhage was the most frequent lesion in the brain (84%). Follow-up CT evolution of haemorrhage, oedema, cerebritis, abscess, secondary vascular lesions, necrosis, encephalomalacia and hydrocephalus. The most dynamic changes occurred 7–14 days after injury. In 14% of cases, deep cerebral lesions were found in the corpus callosum, septum pellucidum periventricular region and pons, although bone and shell fragments were in a different part of the brain parenchyma. Such lesions were found in penetrating injuries only. CT proved very useful for assessing the extent and type of lesions. Although different mechanisms of brain damage in missile head injury are known, here they are, to the best of our knowledge, shown for the first time by CT.

The role of magnetic resonance imaging in diagnosis and management of breast cancer

A review of the literature on the current applications of breast magnetic resonance imaging (MRI) indications, their rationale and their place in diagnosis and management of breast cancer was given. Contrast-enhanced breast MRI is developing as a valuable adjunct to mammography and sonography. Its high sensitivity for invasive breast cancer establishes its superiority in evaluation of multifocality/multicentricity, tumor response to neoadjuvant chemotherapy, detection of recurrence, and staging. Emerging applications include spectroscopy, usage of new contrast agents, and MRI-guided interventions, including noninvasive treatment of breast cancer. Its potential benefit in screening high-risk women has yet to be established with prospective studies, particularly with regard to false positive results.

Future directions in breast imaging.

Breast cancer imaging has improved dramatically over the last decade, with higher and more uniform quality standards for mammography, the increasinguse of sonography and magnetic resonance imaging (MRI), and the widespread availability of imaging-guided percutaneous biopsy for clinically occult disease. This review paper describes the limitations that exist in the current state of the art for breast cancer imaging for detection and diagnosis. Four broad areas of future investigation are described in detail. First, we discuss the use of newer versions of mammography, such as digital mammography, with tomosynthesis and digital subtraction mammography. Secondly, new screening for occult disease might be improved through individualized strategies that stratify by patient risk, for example, through more rigorous screening with new and different tools for women at high risk. Third, the use of tools that might be useful for less invasive therapy of breast cancer with imaging to monitor the efficacy of the therapy is discussed. Finally, we describe the use of imaging tomonitor and adjust neoadjuvant chemotherapy regimens in the course of therapy for advanced breast cancers when the risk of death is high.

Effects of Changes in BI-RADS Density Assessment Guidelines (Fourth Versus Fifth Edition) on Breast Density Assessment: Intra- and Interreader Agreements and Density Distribution.

OBJECTIVE The objective of our study was to determine intra- and interreader agreements for density assessment using the fifth edition of the BI-RADS guidelines and to compare with those for density assessment using the fourth edition of the BI-RADS guidelines. MATERIALS AND METHODS Five radiologists assessed breast density four times in 104 mammographic examinations: twice using the fourth edition of the BI-RADS guidelines and twice using the fifth edition. The intra- and interreader agreements for density assessment based on each guideline were determined and compared. The density distribution pattern under each of the four BI-RADS density categories using each guideline was also noted and compared. RESULTS The intrareader agreement for density assessment using the fifth-edition criteria was lower than that using the fourth-edition criteria (p = 0.0179). The overall intrareader agreement (weighted kappa) using the old criteria was 0.84 (95% CI, 0.80-0.87), and the individual intrareader agreement values in five readers ranged from 0.78 (95% CI, 0.69-0.88) to 0.92 (95% CI, 0.87-0.97). The overall intrareader agreement using the new BI-RADS criteria was 0.77 (95% CI, 0.73-0.81), and the individual intrareader agreement values in five readers ranged from 0.74 (95% CI, 0.64-0.84) to 0.99 (95% CI, 0.98-1.00). The interreader agreement values obtained using the fifth-edition criteria were also lower than those obtained using the fourth-edition criteria (p = 0.006). The overall interreader agreement using the old BI-RADS criteria was 0.65 (95% CI, 0.61-0.69), whereas the overall interreader agreement using the new BI-RADS criteria was 0.57 (95% CI, 0.53-0.61). Overall a higher number of dense assessments were given when the fifth-edition guidelines were used (p < 0.0001). CONCLUSION Compared with the intra- and interreader agreements obtained using the fourth edition of the BI-RADS guidelines, the intra- and interreader agreements were lower using the fifth-edition guidelines. An increased number of dense assessments were given when the fifth-edition guidelines were used.

Comparison of Image Acquisition and Radiologist Interpretation Times in a Diagnostic Mammography Center

RATIONALE AND OBJECTIVES The purpose of this study was to determine the acquisition and interpretation times of screen-film mammography and soft-copy digital mammography in a diagnostic mammography center. MATERIALS AND METHODS The study was conducted in three phases for patients presenting for clinical diagnostic workup to a mammography clinic. In the first phase, technologist acquisition and processing times and radiologist interpretation time were measured for patients imaged with a screen-film mammographic system. During the second phase of the study, times were measured for patients imaged with a direct radiographic digital mammographic system, with interpretation performed on a soft-copy display system. During the third phase, 3 months after installation of the soft-copy display system, times were measured again for patients imaged on the same direct radiographic digital mammographic system, with interpretation with the same soft-copy system. The same four experienced breast imaging radiologists and seven technologists participated in all phases of the study. All data were entered into a database, and statistical analysis was conducted using weighted linear models and logarithmic transformation. RESULTS Times were obtained for 295 patients. There were 100 patients each for phases 1 and 2 and 95 patients for phase 3. Diagnostic mammographic acquisition times with processing were 13.02 min/case for screen film (phase 1), 8.16 min/case for digital (phase 2), and 10.66 min/case for digital (phase 3) (P < .001 and P < .0001, respectively). In addition, the radiologist interpretation time for digital mammography in both phases was not significantly different from that for film mammography (P = .2853 and P = .2893, respectively). There was no significant difference between phases 2 and 3 (P = 1.0000). The mean interpretation times were 3.75 min/case for screen film, 2.14 min/case for digital (phase 2), and 2.26 min/case for digital (phase 3). CONCLUSIONS Digital mammography significantly shortened the acquisition time for diagnostic mammography. There was no significant difference in interpretation time compared to screen-film mammography in a diagnostic mammography setting.

The course of the traumatising force in acceleration head injury: CT evidence

Since brain damage in closed head injury of acceleration-deceleration type depends on the site of impact and on the course of the traumatising force, a reconstruction of these was attempted using CT. The study included 45 standard CT studies of adults with closed acceleration-deceleration head injuries. We selected 32 patients exclusively on the basis of CT findings of soft tissue contusion, skull fractures and cerebral contusions (coup and/or contrecoup, as well as other parenchymal lesions), while in the remaining 13 patients clinical findings were also used. On CT, the axial section of the skull was divided into 12 sections imitating the clock-face, to permit computerised graphic presentation of the direction of the traumatising force. Analysis of cerebral contusions on different CT studies in each case allowed location of “dominant coup” and “dominant contrecoup” lesions to be determined. The site of impact and the course of the traumatising force were reconstructed and graphically presented on the basis of these findings, supplemented with data on soft tissue contusions (present in 71 % of cases), skull fractures (in 36 %) and sometimes on other brain lesions. Comparison of the computerised graphic presentation of the site of impact and direction of the traumatic force and the location of lesions revealed a high correlation between them. In 80 % of cases, the site of impact could be visualised only by CT. The acceleration force acted along the longer axis of the head (centroaxial or semioblique) in 87 % and along the shorter axis in 13 % of cases. Multiple lesions were found in 87 % of cases. The lesions were most frequent in the frontal (51 %) and temporal (26 %) lobes. CT was very useful for reconstruction of the site of impact and of the course of the traumatising force in acceleration head injury. Data obtained by this procedure may have far-reaching prognostic and forensic implications.

Breast MRI, digital mammography and breast tomosynthesis: comparison of three methods for early detection of breast cancer

Breast cancer is the most common malignancy in women and early detection is important for its successful treatment. The aim of this study was to investigate the sensitivity and specificity of three methods for early detection of breast cancer: breast magnetic resonance imaging (MRI), digital mammography, and breast tomosynthesis in comparison to histopathology, as well as to investigate the intraindividual variability between these modalities. We included 57 breast lesions, each detected by three diagnostic modalities: digital mammography, breast MRI, and breast tomosynthesis, and subsequently confirmed by histopathology. Breast Imaging-Reporting and Data System (BI-RADS) was used for characterizing the lesions. One experienced radiologist interpreted all three diagnostic modalities. Twenty-nine of the breast lesions were malignant while 28 were benign. The sensitivity for digital mammography, breast MRI, and breast tomosynthesis, was 72.4%, 93.1%, and 100%, respectively; while the specificity was 46.4%, 60.7%, and 75%, respectively. Receiver operating characteristics (ROC) curve analysis showed an overall diagnostic advantage of breast tomosynthesis over both breast MRI and digital mammography. The difference in performance between breast tomosynthesis and digital mammography was significant (p <0.001), while the difference between breast tomosynthesis and breast MRI was not significant (p=0.20).

Tele-3-dimensional computer-assisted functional endoscopic sinus surgery: new dimension in the surgery of the nose and paranasal sinuses.

One of the main objectives of our 3-dimensional (3D) computer-assisted functional endoscopic sinus surgery was to design a computer-assisted 3D approach to the presurgical planning, intraoperative guidance, and postoperative analysis of the anatomic regions of the nose and paranasal sinuses. Such an extremely powerful approach should allow better insight into the operating field, thereby significantly increasing the safety of the procedure. The last step to implementing the technology in the operating room was to connect the computer workstations and video equipment to remote locations by using a high-speed, wide-bandwidth computer network. During patient preparation, the surgeon in the operating room consulted remote experienced and skillful surgeons by viewing CT images and 3D models on computer workstations. The surgeon and consultants used software for CT image previews and 3D model manipulations on top of collaboration tools to define the pathosis, produce an optimal path to the pathosis, and decide how to perform the real surgical procedure. With tele-flythrough or tele-virtual endoscopy rendered through the use of 3D models, both surgeons can preview all the characteristics of the region (ie, anatomy, pathosis) and so predict and determine the next steps of the operation. This ensures greater safety thanks to the operation guidance and reduces the possibility of intraoperative error. The duration of the teleconsultation is thus shortened, which may prove the greatest benefit of tele-3D computer-assisted surgery. If this method were used, clinical institutions would spend less money for telesurgical consultation.