cMDX is a data acquisition model for graphical and textual information. Sensible data were encrypted with 256-bit cryptographic algorithms to enable data analysis compliant with data privacy regulations. The visualization model based on the Four-Layer Model combined a graphical overview of tumour growth in a schematic style with the related textual information. In this manner, the electronic documentation of histopathological information usually given by reports in paper form is realised.
XML enables to extract clinical data and graphical schemes, and to transmit them into different formats like binary graphics (PNG, JPEG) vector graphics (SVG), Portable Document Files (PDF), text files (CVS), and Client Report Definition (rdlc) . Therefore, cMDX can be converted into a data format supported by the HIS. The file architecture is compatible with open package conventions and therefore standard documents like HL7 CDA can be integrated into cMDX .
The software prototype of the cMDX Editor can generate and modify pathology reports according to the clinical requirements of pathologists and urologists. The integration of reports of radical prostatectomy specimens into the HIS improves clinical utilities and acceptance by the clinicians.
The application provided an estimate of the tumour volume, which may be an important prognostic indicator for predicting prostate cancer recurrence following surgery . In the literature several methods to determine tumour volume of PCa can be found. These include visual estimation, computer planimetry with computer-assisted image analysis. Computer planimetry of the full set of slides of a serially sectioned prostate is believed to be the best technique for an accurate measurement of tumour volumes; however, this technique is expensive and time consuming and is therefore not applied in routine clinical practice . The estimation of tumour volume by eyeball judgment is simple and less time consuming, and cheap but shows less precision of measurement , it is performed directly under the microscope or after the transformation of tumour areas into the reconstruction map of the prostate in a schematic style . Our results show that the estimation by eyeball judgment alone resulted in lower tumour volumes as compared with cMDX estimation. The computerised estimation of tumour volume with the cMDX Editor seems to be more accurate than the estimation by eyeball judgment. We anticipate an increase in accuracy of eyeball judgement with a grid method getting close to the accuracy of the computational volume estimation. Nevertheless further investigations are needed here. However, these estimation methods are not accurate in comparison to the computer planimetry because they exclude the real dimensions of the prostate and the PCa foci.
The anatomical representation of the prostate in schematic style facilitates collecting and analysing the spread pattern of PCa in the prostate. For instance, such information can be helpful to assess the biopsy strategy in order to increase the detection rate of PCa [19–21]. Our approach enables to analyse cMDX reports and export the results into programs like SPSS© or Excel©. Our results confirm the consensus that the major tumour mass of PCa is located in the peripheral zone (PZ) . According to Chen et al., 74% of PCa foci were localized in the PZ and toward the base, diverged laterally . We found a significant correlation between tumour volume and pathological stage of the specimens, thus confirming the findings of Nelson et al. . The current analysis tool can detect multifocal PCa with a sensitivity of 90.3%. The multifocality rate of PCa was 52.5%, which is consistent with prior series that reported multifocality rates of 50 to 87% . The accuracy to differentiate multifocal from unifocal PCa depends on the applied algorithm. The transformation of the tumour area into a rectangular shape increases the size of the tumour area and increases the probability of one focus to overlap with another adjacent focus in the vicinity, this way reducing the detection rate of multifocal PCa.
A limitation of our documentation model is the documentation time necessary, cMDX failed to shorten the documentation time. cMDX is still developing and we will focus on this drawback in future versions.
An electronic documentation standard for pathologic findings of prostate specimens has not yet been introduced. We conducted a Pubmed search using the key words "electronic documentation prostate", "electronic report prostate" and "electronic documentation prostatectomy." Only one software program similar to the cMDX Editor could be found: PixelProstate (freeware), developed by Nickels , mainly focuses on the measurement of tumour volume. PixelProstate has an internal database to store clinical data and provides a simplified 3 D illustration of the prostate and PCa foci. To document the patterns of the tumour spread, the PCa foci are drawn using multiple circles. The documentation of histological patterns of each PCa focus is not supported. In contrast, the cMDX Editor enables to convert a pathologic report into a portable file format and to draw PCa foci with the freehand drawing tool. In addition, capsular invasion, extracapsular extension, positive surgical margins, and histological patterns of a PCa focus can be documented, but a 3 D illustration model similar to that of PixelProstate is not available. cMDX is a free open source document architecture. The applications based on cMDX (cMDX Editor and Analysis tool) are still prototypes (Beta-Version). We plan to develop two versions of these applications (commercial and non-commercial) and make them available as soon as possible.
cMDX offers an extensible document architecture by adding a new drawing tool and by providing additional class libraries. If needed, additional pathological parameters or characteristics can be added. For instance, recording the Gleason score of a PCa focus is feasible by adding the class library "eMocS.Definition.Befund" from the corresponding XML part of cMDX. Furthermore, this feature could extend the spectrum of the clinical applications of cMDX to various medical applications, e.g. for protocols for cardiac catheterisation or extension estimates of burn injuries in emergency surgery.